Compiled by Dr Michelle Mulder - OECD.org · 2018-08-02 · Compiled by Dr Michelle Mulder Idea to Industry cc ... international trends, the majority of core biotechnology companies

National Biotech Survey 2003 2

Compiled by Dr Michelle Mulder

Idea to Industry cc

With contributions from Dr Torsten Henschel

Biotechnology Industry Consultant


EXECUTIVE SUMMAR Y

The present survey of biotechnology activities in South Africa (SA) was aimed at establishing the current state of the

industry. This report provides an outline of the biotechnology industry in South Africa, and covers activities in

academia, industry, government, and support organizations, based on both primary and secondary research.

Data for the survey was collected from secondary sources, an email questionnaire, and in-person and telephonic

interviews. Data was accumulated for 84% of the research stakeholders and >90% of the companies. It is

important that the results from the survey are interpreted within the following constraints:

- biotechnology refers to a set of processes or technologies and is not an industry or output, therefore one

cannot use a statistical industry-based framework for analysis

- biotechnology spans a wide range of different sectors and activities and the boundaries are difficult to

define

- the industry in South Africa is fragmented and clouded in secrecy, which makes the identification of

stakeholders and their respective activities challenging

- due to the cross-cutting nature of biotechnology and the fact that it does not fall into any specific industry

classifications, trade data is difficult to come by

The biotechnology industry in South Africa is small by international standards but has a substantial pipeline of

potential new products and processes in the research and development stage. South Africa has great potential for

the further development of the industry with the following contributing factors in its favour:

- a sophisticated and lengthy tradition of first generation biotechnology

- world-class researchers and research institutions

- a pipeline of projects that could lead to new products or processes

- an unrivalled biodiversity and biological resource base

- indigenous medical knowledge going back centuries

- access to a large human genetic diversity pool

- access to a high number of clinical samples for major infectious diseases

- a relatively low cost base for research, product development and manufacturing

- a sound legal and regulatory framework, and a world-class banking system and ICT infrastructure

Despite these factors, IP generation and technology transfer in the biotechnology field to date have been slow and

inefficient. The major factors inhibiting the biotechnology industry to date include:

- a general lack of cohesion in research programmes

- a shortage of market-focused research and a relatively low tendency among academics to commercialize

research

- a scarcity of suitably qualified R&D personnel, particularly at the MSc and PhD levels

- a lack of clear IP policies that incentivize commercialization

- an overall lack of confidence in African governments, which affects foreign investment

- an increasing dependence on imported products, machinery, equipment, materials and technologies


- a relatively small local market

- a severe shortage of entrepreneurial and technology transfer skills and mechanisms

- insufficient public and private funding for research and product commercialization

Biotechnology activities in South Africa span the full pipeline from fundamental research to product development

and commercialization, and include services that make use of biotechnologies as well as support services for

biotechnology stakeholders. For the purposes of the survey, stakeholders were divided into the following

categories:

Research stakeholders

Research projects

• biotech projects/stakeholders - projects that are specifically intended to develop a new product or process

for application in industry

• potential biotech projects/stakeholders - projects that are not directly aimed at developing a new product

or service but have potential applications in industry

• biotech services - projects in which a service is provided in biotechnology, e.g. specific clinical trials,

technology platforms etc.

Biotechnology Companies

• Core biotechnology companies - companies whose business is entirely or substantially biotechnology

related and that have a significant commitment to technological innovation

• Non-core biotechnology companies - companies that do not have biotechnology as their core focus but

utilize biotechnology in some aspects of their general business activities or participate in biotechnology

research and development

Biotechnology can be used in a large number of different industries and processes. A comprehensive review of all

potential companies in South Africa that may utilize biotechnology to some degree was beyond the scope of this

survey. Instead, the survey has concentrated on core biotechnology companies and companies that are

participating in or co-funding biotechnology research and development. It is therefore unlikely that the database

includes all non-core biotechnology companies in SA.

The survey identified 106 companies participating in biotechnology activities, including 47 core and 59 non-core

biotechnology companies/organizations. Emphasis was placed on the modern biotechnology companies; therefore

the list does not include the larger brewing, food & beverage, and wine companies, unless they are involved in

developing innovative products using modern technologies. The majority of core biotechnology companies are

situated in Gauteng (41%) and the Western Cape (37%). Kwazulu Natal also boasts a number of core

biotechnology companies (15%), while the rest of the provinces do not feature significantly in this sample. The

human health sector has the highest representation in terms of numbers of core biotechnology companies (39%),

followed by the support services sector (13%). The rest of the companies are fairly evenly spread across the plant,

animal health, food & beverage, industrial, and environmental sectors, with a small proportion of companies (3%)

contributing to the “other” category.


At least 59 non-core biotechnology companies were identified. The majority of non-core biotechnology companies

in the sample are situated in Gauteng (38%) and the Western Cape (37%), and are active in the plant sector (26%).

The second largest sectors represented in this sample are the human health and industrial sectors (15% each).

A relatively small number of core biotechnology companies were established before 1986, followed by a period of

inactivity in the late 1980’s and early 1990’s, and a relatively steady start-up rate of, on average, 2 new companies

per annum between 1992 and the present. An analysis of 40 core biotechnology companies reveals a relatively

even distribution of new start-ups, spin-offs from research groups, and spin-offs from another enterprise. Research

groups represent an important source of new innovations for commercialization in the future. In line with

international trends, the majority of core biotechnology companies in SA are relatively small, i.e. have a staff

complement of less than 50.

The majority of core and non-core biotechnology companies in SA are involved in either the extraction or

production of products using relatively “low-tech,” though modern methods. In many of these cases, the novelty is

in the application of the products to new problems. This result reveals the hidden danger of excessive focus on

terms such as 3rd generation biotechnology in the SA context, since our historic advantage is built on 1st generation

biotechnologies, some of which are highly sophisticated and globally competitive.

A total of 622 research groups were identified as being involved in biotechnology-related activities, with 296

classified as “biotech,” 205 as “potential biotech,” and 178 as “biotech services”. 57 of the stakeholders in the latter

group overlap with “biotech” and “potential biotech” stakeholders. The majority of relevant research stakeholders

are operating from the Western Cape, followed by Gauteng, Kwazulu Natal and the Free State. Researchers

developing biotechnology products are working predominantly in the human health sector, followed by the plant,

industrial, and food & beverage sectors, in that order. Group leaders within departments were targeted in the

survey, rather than only department heads, therefore the majority of the research groups are small, i.e. consist of 1-

10 people.

A total of 911 projects relevant to biotechnology were identified, including projects undertaken by both research

and industry stakeholders. The majority of research projects are being conducted in the Western Cape, followed by

Gauteng, Kwazulu Natal and Free State; while the dominant sector in terms of projects aimed at developing a

product, is plant biotechnology, followed by human health and industrial. Research projects that have the potential

to lead to a product fall predominantly within the human health sector, followed by the plant sector.

The overall dominant focus areas for each of the sectors are as follows:

- human health - therapeutics, diagnostics, phytopharmaceuticals, natural health products and disease

physiology

- animal health - vaccines and diagnostics

- plant - GM crops, plant propagation, traditional breeding, and biological control

- food & beverage - food ingredients, food analysis, probiotics, nutraceuticals and food processing

- industrial - enzymes, bioproduction and bioprocessing

- environmental - waste treatment, bioremediation and water purification


- other - platform technologies, plant-based cosmetic products and aquaculture and mariculture

- support services - product testing, core technology services, consulting, contract manufacture, and pilot

production

Approximately 43% of the core and non-core biotechnology companies identified together employ a total of around

1020 staff in biotechnology-related activities, while approximately 26% of the research groups identified together

employ a total of around 950 staff members/students that partake in biotechnology-related activities. Research

groups and companies continue to be dominated by white researchers, though there is a less marked difference

between the demographic groups in the companies. This indicates that the demographic transformation of

research groups has not yet reached acceptable levels. Biotechnology companies show a relatively even

distribution of employees by qualification. This is probably a function of the averaging out of R&D personnel and

technical/production staff in a sample that includes R&D-intensive as well as production-orientated companies. As

is to be expected, research groups are dominated by employees with at least a degree qualification, and frequently

a post-graduate degree. Approximately 50% of companies and 81% of research stakeholders that participated in

the survey indicated that they had experienced shortages in human resources. The majority of research

stakeholders listed skilled scientists at various levels, particularly MSc’s and PhD’s, as being in short supply.

The biotechnology industry sector of biotechnology in South African is made up almost exclusively of private

companies, most of which fall into the SMME category. There are relatively few exports to date, and this and other

trade data is not readily available due to the crosscutting nature of the technology and a lack of appropriate

classification. The bio-economy was therefore quantified in terms of numbers of companies, their annual turnovers,

and revenues from products and services. The survey identified at least 106 companies participating in

biotechnology activities with a total turnover for 2002 in excess of R300 million. More than 70% of the core

biotechnology companies in this sample export their products or services.

At least 154 biotechnology products and/or services were identified, earning revenues of at least R368 million in

2002. The majority of these products fall under the human health (23%) and support services sectors (20%),

followed by the plant sector (18%). These products/services include predominantly therapeutics, diagnostics,

natural health products and phytopharmaceuticals in the human health sector; core technology services, contract

research and contract manufacture in the support services sector; and GM crops, plant growth stimulants, and

biological control products in the plant sector. 36% of the products and services listed involve first generation

biotechnology, with only 10% involving genetic modification techniques.

At least 200 biotechnology-related patents were filed by SA inventors with the South African Registrar of Copyright

Designs, Patents, Trade Marks between 1979 and 2002. SA registers around 100 patents per annum with the

USPTO, however; only 65 biotechnology-related patents have been awarded to South African inventors between

1976 and the present. It is interesting to note that around 32% of these patents are assigned to non-South African

entities. Approximately 86 Patent Co-operation Treaty (PCT) applications with South Africa listed as the inventor

country were filed between 1986 and the present. These patent numbers are unlikely to represent the full

complement of intellectual property, and particularly intellectual capital, emerging from SA.


Access to novel, cutting edge technologies and modern, state-of-the-art equipment is required for South African

groups to compete globally. The majority of groups have access to generic, cross-cutting technologies such as cell

or tissue culture facilities, general molecular biology technologies for DNA work and microbiology, and analytical

techniques. The less widely accessible techniques are generally those that are more specialized and are likely to be

required by a smaller number of groups. Future technology priorities emerging from the survey were DNA

sequencing/synthesis/amplification techniques, cell/tissue culture, recombinant DNA technologies, bioinformatics,

biochips, and molecular high throughput screening.

South Africa has a wealth of biological resources at its disposal that include a vast diversity of plant, animal and

microbial life, an excess of clinical cases and pathology samples of globally important diseases such as HIV/AIDS,

tuberculosis etc., and a human population that represents around 90% of the world’s genetic diversity. A number of

research groups and companies have developed biological resource collections in the course of their work. A total

of 42 such collections/centers were identified in the survey.

The biotechnology industry in SA is supported by a number of government departments, organizations and

companies and is affected by health, biosafety and biodiversity legislation. The Department of Science and

Technology (DST) is the lead department with respect to biotechnology (and R&D in general) in South Africa. DST is

involved in the drafting and implementation of the National Biotechnology and National Research and Development

Strategies, coordination of the GODISA programme, and overseeing the activities of the National Research

Foundation (NRF), the major body responsible for funding research and human resource development at higher

education institutes, and NACI, which is involved in managing and developing South Africa’s Innovation System.

The South African National Biotechnology Strategy directly defines the Government’s intentions with respect to

biotechnology, and the National Research and Development (R&D) Strategy modifies this slightly and contextualizes

biotechnology within the broader intent of developing South Africa’s competitiveness in the global knowledge

economy. The R&D strategy will be used to co-ordinate existing institutions and initiatives such as the

biotechnology strategy and the incubation and economic development programmes, in order to improve the

efficiency of South Africa’s R&D and innovation system. It depends on doubling government investment in science

and technology over the next 3 years.

The Department of Trade and Industry (DTI) is focused on innovation and commercialization of biotechnology,

although under the direction of DST. In particular the DTI is responsible for modification of the Patents Act and the

establishment of a venture capital fund through its agency, the IDC. Support is provided in the form of funding

through incentive schemes, information on potential markets, and marketing of local products abroad. The

Department of Health will coordinate the National Bioethics Committee and advise the BAC. It is also responsible

for the registration and regulation of medical products and the labeling of foodstuffs, e.g. the GMO content. The

National Department of Agriculture implements the GMO Act and the Plant Breeders Act and is involved with the

issues relating to indigenous knowledge systems. The Department of Environmental Affairs and Tourism is currently

drafting the Biodiversity and the Protected Areas Bills, which aim to ensure the sustainable use of the country’s

unique biodiversity. The Department of Labour (DoL) has committed to funding human resource development

through the Skills Development Act and the Human Resources Development Strategy. A National Scarce Skills


Financial Assistance Scheme is currently being established by the NRF in partnership with the DoL and DST to

address scarce skills, including those relevant to biotechnology. The Department of Education promotes curriculum

development in line with the needs identified in the R&D strategy and determines the level of financial support of

research at universities and technikons.

Legislation relevant to biotechnology includes the Patents Act of 1978 and two amendment bills passed in 1997,

the Counterfeit goods bill and the Intellectual Property Laws Amendment bill; the Genetically Modified Organism

Act, Act 15 of 1997; regulations for the labeling of food derived from genetic modification; the Cartagena Protocol

on Biosafety; Act 36 of 1947 governing agricultural products; the Plant Breeders Act; the Biodiversity and

Protected Areas Bills; and the Medicines Control Act no. 101 of 1965. In addition to the above legislation, South

Africa has signed bilateral agreements with at least 12 countries that include co-operation on biotechnology

The total spend on support services in biotechnology for last year from those that provided this data was just over

R2 million. This does not represent a significant market opportunity for the support services sector, and at present

there are only a small number of dedicated biotechnology service providers. With the growth in the industry in

response to government and other interventions, the demand for support services is set to grow. The survey

identified at least 196 organizations and companies that currently offer direct or indirect support to biotechnology in

SA, though only a small number of these are specific to biotechnology. These include entities that provide business

or legal support, suppliers of raw materials and scientific tools, incubators, venture capital firms etc.

The most relevant support structures for the development of biotechnology in SA are the Biotechnology Regional

Innovation Centres (BRICs), the National Bioinformatics Network, the GODISA-funded incubators, and the

technology transfer offices associated with the universities. There are 4 BRICs in total, Cape Biotech, BioPAD,

ECoBio, and PlantBio. An Inter-BRIC Forum allows collaboration between the BRICs and a forum for dealing with

common issues. The National Bioinformatics Network (NBN) has been awarded funds by DST and the DoL for a

period of three years to address the development of capacity and expertise in bioinformatics in SA. The GODISA

Programme includes two incubators that focus on the biotechnology sector, eGoli Bio Life Sciences Incubator and

Acorn Technologies. A small number of higher education institutions have a division designed to assist with the

management and commercialization of research and IP emerging from the institution. Examples include UCT

Innovation at the University of Cape Town; Unistel Technologies and the Office for Intellectual Property at the

University of Stellenbosch; Research Enterprises at the University of Pretoria, and Wits Enterprise at the University

of the Witwatersrand. The MRC and the ARC each have their own technology transfer offices responsible for the

commercialization of IP generated by their respective units. In the private sector, there are a handful of companies

offering dedicated biotechnology services, located predominantly in the Western Cape. In addition, there are a

number of companies providing laboratory supplies, scientific equipment and raw materials to biotechnology

stakeholders, though these service providers are not confined to the biotechnology industry.


Industry and government are the main funders of R&D in SA. The total estimated gross expenditure on science,

engineering and technology R&D in 2000 was R5.725 billion, which amounted to 0.64% of GDP. Approximately

38% of core and non-core companies and 7% of research stakeholders were responsible for an estimated total

spending on biotechnology of more than R280 million for 2002. In addition to this, R11.6 from the Innovation Fund

was allocated to biotechnology projects in 2002, and R42 million was invested by South Africa’s only

biotechnology-specific venture capital fund, Bioventures, in 2002 and the beginning of 2003. These estimates

reflect at least a 50% increase in annual spending on biotechnology since 1998, i.e. over the last 4 years. Spending

on biotechnology is set to increase further with a commitment in excess of R450 million from government for the

BRICs over 4 years.

The results of the survey represent minimum figures for the described indicators. The challenges in defining and

obtaining information on the industry have limited the extent of the data, and the results are reported within the

constraints, with few assumptions being made. The survey has the potential, however, to serve as a quantitative

baseline for measuring the growth of the industry over the coming years, particularly in response to new

government interventions in the industry.

It was clear from the survey that South Africa has enormous potential with respect to biotechnology. The challenge

is take advantage of the opportunities for the development of niche markets in which South African stakeholders

can compete on a global scale. This can be facilitated by the creation of an enabling environment that allows

stakeholders to maximize the benefit derived from the potential of biotechnology, whilst minimising the possible

risks to the environment and human health. This enabling environment has to be developed in the context of South

Africa’s particular circumstances and challenges, and must address the key financial, human resources and

i n f r a s t r u c t u r a l d e f i c i t s c u r r e n t l y l i m i t i n g t h e i n d u s t r y . �


CONTENTS

Acknowledgements 14

Foreword 15

Abbreviations and Acronyms 16

SECTION A: INTRODUCTION 19

1. Definition of Biotechnology 19

2. The Importance of Biotechnology 20

3. The Global Biotechnology Industry 21

3.1 Size of the Global Biotechnology Industry 21

3.2 Biotechnology in Africa 21

3.3 Global Biotechnology Trends 21

SECTION B: THE NATIONAL BIOTECHNOLOGY SURVEY, 2003 23

1. Introduction 23

2. Methodology 23

2.1 Background to Methodology 23

2.2 Survey Sample 24

2.3 Survey Methodology 24

2.4 Definitions and Classifications Used for the Survey 25

SECTION C: GENERAL OVERVIEW OF BIOTECHNOLOGY

IN SOUTH AFRICA 29

1. Background Information on Biotechnology in South Africa 29

2. Results of the National Biotechnology Survey 31

2.1 Stakeholder Participation in the Survey 31

2.2 Overview of Biotechnology Activities in South Africa 32

2.2.1 Number of Groups Active in Biotechnology 32

2.2.1.1 Analysis of Companies Active in Biotechnology 32

2.2.1.2 Research Groups Active in Biotechnology 38

2.2.2 Biotechnology Research Projects 40

2.2.3 Human Resources in Biotechnology 43

2.2.4 Size of the Bio-economy in South Africa 46

2.2.5 Intellectual Property 51

2.2.6 Technology Platforms 54

2.2.7 Biological Resources 58


SECTION D:

The Biotechnology Industry Environment in South Africa 62

1. Government Involvement in Biotechnology 62

1.1 Department of Science and Technology (DST) 62

1.1.1 South African National Biotechnology Strategy, 2001 62

1.1.2 National Research and Development (R&D) Strategy 63

1.1.3 Biotechnology Road Mapping Exercise 65

1.1.4 GODISA Incubator Programme 66

1.1.5 National Advisory Council on Innovation (NACI) 66

1.1.6 National Research Foundation (NRF) 66

1.2 Department of Trade and Industry (DTI) 67

1.3 Department of Health (DoH) 67

1.4 National Department of Agriculture (NDA) 67

1.5 Department of Environmental Affairs and Tourism (DEAT) 68

1.6 Department of Labour (DoL) 68

1.7 Department of Education (DoE) 68

1.8 Legislation Relevant to Biotechnology 69

2. Support Services for Biotechnology 70

2.1 Market Opportunity for Support Services 70

2.2 Existing Support Services for Biotechnology 71

2.2.1 Biotechnology Regional Innovation Centres 71

2.2.1.1 BioPAD 72

2.2.1.2 Cape Bio 72

2.2.1.3 ECoBio 73

2.2.1.4 PlantBio 74

2.2.2 National Bioinformatics Network (NBN) 74

2.2.3 GODISA-Funded Incubators 75

2.2.3.1 eGoli Bio Life Sciences Incubator 75

2.2.3.2 Acorn Technologies 75

2.2.4 Other Support Services 76

2.2.4.1 Technology Transfer Offices at Universities 76

2.2.4.2 South African Research and Innovation Managers Association (SARIMA) 77

2.2.4.3 Africa Bio 77

2.2.4.4 A Harvest Biotech Foundation International 77

2.2.4.5 Biotechnology-Specific Service Providers 77

2.2.4.6 Technology Parks 78

3. Funding for Biotechnology 78

3.1 Funding for R&D in SA 79

3.2 Sources of Public Funding for Biotechnology 80

3.2.1 Biotechnology-specific public funding 81


3.2.2 Non-biotechnology-specific public funding 81

3.2.2.1 Incentives for R&D and Innovation 81

3.2.2.2 Incentives for Enterprise Development 82

3.2.2.3 Competitiveness and Export Incentives 82

3.2.2.4 Industrial development zones (IDZ) 82

3.2.2.5 European Union Sixth Framework Programme (EU6FP) 82

3.3 Private Funding for Biotechnology 83

3.3.1 Seed Capital 83

3.3.2 Venture Capital and Private Equity 83

3.4 Foreign Sources of Funding for Biotechnology 84

SECTION E:

BIOTECHNOLOGY ACTIVITIES IN SOUTH AFRICA BY SECTOR 86

1. Human Health 86

1.1 The Application of Biotechnology to the Human Health Sector 86

1.2 Human Health Biotechnology in South Africa 86

2. Animal Health 89

2.1 The Application of Biotechnology to the Animal Health Sector 89

2.2 Animal Health Biotechnology in South Africa 90

3. Plant Biotechnology 93

3.1 The Application of Biotechnology to the Plant/Agricultural Sector 93

3.2 Plant Biotechnology in South Africa 94

4. Food & Beverage 97

4.1 The Application of Biotechnology to the Food & Beverage Sector 97

4.2 Food & Beverage Biotechnology in South Africa 97

5. Industrial Biotechnology 101

5.1 The Application of Biotechnology to the Industrial Sector 101

5.2 Industrial Biotechnology in South Africa 101

6. Environmental Biotechnology 104

6.1 The Application of Biotechnology to the Environmental Sector 104

6.2 Environmental biotechnology in South Africa 105

7. Other Biotechnology Focus Areas 108

7.1 Other Applications of Biotechnology 108

7.2 Other Applications of Biotechnology in South Africa 108

8. Support Services for Biotechnology 111

SECTION F:

BIOTECHNOLOGY ACTIVITIES IN SOUTH AFRICA BY REGION 115

1. Gauteng 115

2. Western Cape 117


3. Kwazulu Natal 119

4. Eastern Cape 120

5. Free State 121

SECTION G: CONCLUSIONS 123

REFERENCES 124

APPENDIX A: CLASSIFICATIONS USED IN THE SURVEY 126

APPENDIX B: INTERNATIONAL PATENT CLASSIFICATIONS RELEVANT

TO BIOTECHNOLOGY 131


ACKNOWLEDGEMENTS

I would like to acknowledge the input and support provided by eGoli Bio Life Sciences Incubator and the work

conducted by Faghri February (PhD student), Morne Du Plessis (M.Sc student in Human Genetics), Tumelo

Seameco (M.Sc student in Apoptosis), and Kaunda Kuanda (Undergraduate student) from the University of the

Western Cape, who had the unenviable task of following up stakeholders telephonically.

This survey was sponsored by the Department of Science and Technology and eGoli Bio Life Sciences Incubator.

Please Note:

All care and diligence has been taken in the compiling, processing and analysis of data for this report; however,

Idea to Industry cc gives no warranty that the information or data supplied contains no errors. Idea to Industry cc

shall not be liable for any loss or damages suffered by the Department of Science and Technology or eGoli Bio Life

Sciences Incubator consequent upon the direct or indirect use of the information supplied in this report.


FOREWORD

Very little information has been published to date on the biotechnology industry in South Africa (SA). In 1993 the

Foundation for Research Development (FRD) carried out a survey of active biotechnology projects in order to

determine the level of biotechnology activity in the country. The survey was repeated in 1995 by Innovation

Biotechnology and was used to publish the ‘Directory of Biotechnology in South Africa.’ This was updated a year

later. The directory was aimed at supporting networking between biotechnology interest groups both within South

Africa and with its neighbours. In 1998, the Council for Scientific and Industrial Research (CSIR) commissioned

ProBio to undertake a review of biotechnology in South Africa in order to inform the organization’s ‘Biology Beyond

2000’ report (30). This data was subsequently used to update the FRD directory, which was posted on the National

Research Foundation’s (NRF) website http://www.nrf.ac.za/ ).

This present survey aims to build on and update the previous survey results in order to establish the current state of

the biotechnology industry in SA. The results of this survey will also serve as a quantitative baseline for measuring

the growth of the industry over the coming years, in particular, the impact of the new measures being undertaken

by the Department of Science and Technology (DST) to stimulate the bio-economy in South Africa (19; 22). In

addition, the information will be used:

• by international parties looking to form partnerships with local groups,

• for marketing of existing biotechnology products and services offered by private sector companies,

• by policy developers and planners to establish working groups and create an enabling environment,

• by government to react to and communicate with biotechnology stakeholders,

• by researchers to network effectively within and between sectors,

• by biotechnology stakeholders as a benchmark against which the impact of the SA Biotechnology Strategy can

be assessed in the next 4-10 years, and

• by investors to assess opportunities, gaps and risks.

This report provides an outline of the biotechnology industry in South Africa, and covers activities in academia,

industry, government, and support organizations, based on both primary and secondary research. The definition,

importance and characteristics of a biotechnology industry are discussed. The methodology used for the survey is

outlined, followed by an in-depth discussion of the results with conclusions and recommendations. A general

overview of the results is provided, as well as a more detailed analysis of biotechnology activities in SA by sector

and region. We do not expect to have 100% coverage of the industry; however, our investigations have been as

broad as possible to ensure wide coverage of the major activities in biotechnology in SA and to give an informed

overview of the current state of the industry. Every attempt has been made to be as objective and as accurate as

possible. Stakeholders who have not participated in the survey or have not been reached are encouraged to

contact eGoli Bio or Idea to Industry with any information that has been omitted.


ABBREVIA TIONS AND AC RONYMS

ACGT African Centre for Gene Technologies

ARC Agricultural Research Council

BAC Biotechnology Advisory Committee

BBP Bumble Bee Programme

BLCF Business Linkage Challenge Fund

BRC Biological Resource Centre

BRIC Biotechnology Regional Innovation Centre

CF Competitiveness Fund

CIP Critical Infrastructure Programme

COS Community of Sciences

CSIR Council for Scientific and Industrial Research

DACST Department of Arts, Culture, Science and Technology

DEAT Department of Environmental Affairs and Tourism

DNA Deoxyribonucleic Acid

DoH Department of Health

DoL Department of Labour

DST Department of Science and Technology

DTI Department of Trade and Industry

EIFAS Export Investment Financial Assistance Scheme

EMEA European Medicines Evaluation Agency

EPO European Patent Office

EU European Union

EU6FP European Union Sixth Framework Programme

EC Executive Council

FABI Forestry and Agricultural Biotechnology Institute

FDA Food and Drug Administration

FEST Foundation for Education, Science and Technology

FRD Foundation for Research Development

FTI Foundation for Technological Innovation

GLP Good Laboratory Practice

GMP Good Manufacturing Practice

GMOs Genetically Modified Organisms

HEI Higher Education Institute

HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome

HS Harmonization System

HSRC Human Sciences Research Council

IDC Industrial Development Corporation

IDEA Initiative for Developing Enterprising Activities


IDZ Industrial Development Zones

IF Innovation Fund

IFC International Finance Corporation

IP Intellectual Property

IPC International Patent Classification

IPF Intellectual Property Fund

LMO Living Modified Organism

MRC Medical Research Council

NACI National Advisory Council on Innovation

NBN National Bioinformatics Network

NDA National Department of Agriculture

NGO Non-governmental Organization

NRF National Research Foundation

NSI National System of Innovation

IPO Initial Public Offering

OECD Organization for Economic Cooperation and Development

OVI Onderstepoort Veterinary Institute

PCR Polymerase Chain Reaction

PCT Patent Co-operation Treaty

PII Partnership in Industrial Innovation

PROMEC Programme on Mycotoxins and Experimental Carcinogenesis

PUB Public Understanding of Biotechnology

R&D Research and Development

RTP Regional Technology Platform

RU Rhodes University

SA South Africa

SAAVI South African AIDS Vaccine Initiative

SABS South African Bureau of Standards

SADC South African Development Community

SANBI South African National Bioinformatics Institute

SARIMA South African Research and Innovation Managers Association

SET Science, Engineering and Technology

SIP Strategic Investment Programme

SMEDP Small and Medium Enterprise Development Programme

SMMEs Small, Medium and Micro-Enterprises

SPF Sector Partnership Fund

SPII Support Programme for Industrial Innovation

SSP Skills Support Programme

TB Tuberculosis

THRIP Technology and Human Resources for Industry Programme

TISA Trade and Investment South Africa


TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights

UCT University of Cape Town

UNISA University of South Africa

UP University of Pretoria

US University of Stellenbosch

USA United States of America

USPTO United States Patents and Trademarks Office

UWC University of the Western Cape

VC Venture capital

VETPLAN Vaccines and Enhanced Therapeutics Platform for Animals

Wits University of the Witwatersrand


SECTION A: INTRODUCTION1. Definition of Biotechnology

Biotechnology is a cross-cutting technology, which supports innovation in health, agriculture, food processing,

industry and environmental management. It can be simply defined as the application of technology to utilize or

modify living organisms for a particular benefit, such as the production of new knowledge, products, processes or

services.

The South African National Biotechnology Strategy (19) defines biotechnology as “a set of technologies including,

but not confined to, tissue culture and recombinant DNA techniques, bioinformatics and genomics, proteomics and

structural biology, and all other techniques employed for the genetic modification of living organisms, used to

exploit and modify living organisms so as to produce new intellectual property, tools, goods, products and

services.” Biotechnology can encompass technologies at various biological levels including:

- DNA: genomics, pharmaco-genetics, gene probes, DNA sequencing/synthesis/amplification, genetic

engineering

- Proteins and molecules: protein/peptide sequencing/synthesis, proteomics, lipid/protein/carbohydrate

engineering, hormones and growth factors, cell receptors/signaling/pheromones

- Cell and tissue culture and engineering: cell/tissue culture, tissue engineering, hybridization, cellular fusion,

vaccines/immune stimulants, embryo manipulation

- Process biotechnologies: Bioreactors, fermentation, bioprocessing, bioleaching, bio-pulping, bio-bleaching,

biodesulphurization, bioremediation, and biofiltration

- Sub-cellular organisms: gene therapy, viral vectors (18)

Biotechnology is typically classified as either first, second or third generation. First generation biotechnology

involves the use of wild type or natural biological organisms to produce a product, for example, the use of yeast to

make beer or wine. Second generation biotechnology refers to the production of specific products using a pure cell

or tissue culture of organisms that have been specifically selected, through random cross-breeding or similar

techniques, for their superior production or expression abilities without introducing foreign DNA. Third generation

biotechnology involves manipulation of the genetic make-up of organisms, by introducing selected foreign (across

the species barrier) DNA, through recombinant DNA technology, to make them produce small molecules,

compounds or proteins they would not normally produce. More recently, first and second generation biotechnology

have been referred to as ‘old biotechnology’ and third generation biotechnology has been referred to as ‘new

biotechnology’ or ‘modern biotechnology.’

Biotechnology activities also include the support services that do not directly make use of biotechnology activities

but provide essential support to those groups that do, e.g. legal services, business and financial support,

equipment and reagent supplies etc. This group also includes organizations that form an essential part of the

product/process development value chain in biotechnology, for example, clinical trial organizations, organizations

conducting field trials for genetically modified organisms (GMOs), groups offering molecular modeling, combinatorial

chemistry and molecular synthesis for drug discovery, organizations that assist with process and plant design and

engineering etc.


2. The Importance of Biotechnology

Biotechnology is not a new field. The biological processes of microorganisms have been used for more than 5000

years to produce food and beverages such as bread, cheese, wine, etc., and to preserve dairy products. However,

it was only during the 1960s and '70s that our understanding of biology reached a point where we could begin to

use the cellular and molecular processes of organisms, in addition to using whole organisms, and to expand the

use of biology to new products and processes.

A number of key scientific milestones in the second half of the twentieth century played a direct role in the rapid

development of molecular biology techniques and modern biotechnology. In 1953, Watson and Crick announced

their discovery of the double helix DNA structure, followed in 1964 by the demonstration that the sequence of

nucleotides in DNA corresponds exactly to the sequence of amino acids in proteins, by scientists at Stanford. The

first genetic engineering event was the insertion of a gene from another species into a bacterial DNA in 1973, by

Stanley Cohen and Herbert Boyer. This was followed in 1982 by the first Food and Drug Administration (FDA)

approval of a genetically engineered drug, a form of human insulin produced by bacteria. The development of the

polymerase chain reaction (PCR) by Kary Mullis of Cetus in 1983, and the discovery of restriction enzymes have

had a particularly significant effect on recombinant DNA technologies. The international Human Genome Project

was launched in 1990, and the first complete draft of the Human Genome was released 10 years later, in 2000.

Other significant milestones in this period include the cloning of Dolly the sheep in 1997, and early successes in the

growing and differentiation of human embryonic stem cells in the late 1990’s (23). New technologies and scientific

breakthroughs continue to emerge at an elevated rate, as do their potential applications in biotechnology.

As we move from a resource-based, industrial, manufacturing economy to a high technology, knowledge-based

economy, biotechnology will play an increasingly important role in shaping economies. Biotechnology has wide

applications in major economic sectors such as health, food production and processing, industrial processing and

mining, agriculture and mariculture, environmental management etc., and a successful biotechnology industry has

the potential to impact positively on the social and economic development of a country such as South Africa (SA). It

can be used, in part, to address many of the major challenges facing the developing world, including food security

through the development of genetically engineered crops that are more robust and have added nutritional benefits;

affordable health care through the development of vaccines, rapid diagnostics and treatments for diseases such as

HIV/AIDS, malaria and tuberculosis; and environmental sustainability through novel bioremediation or waste

utilization processes that minimize environmental impact. The major advantage of using biotechnology is that cells

and biological molecules are extraordinarily specific in their interactions, thus enabling the precise and predictable

solution of specific problems, with fewer side effects and unintended consequences.

Biotechnology provides a tool that can be used to address a number of government imperatives. It is recognized as

a high profit-generating activity, capable of contributing rapidly to economic growth as well as sustainable

development for poverty alleviation. The development of the biotechnology industry is likely to lead to new small,

medium and micro-enterprises (SMMEs) providing employment at different levels of expertise. A biotechnology

industry also has the potential to address some of the historical and socio-economic imbalances in SA through

skilled job creation, international partnering for skills transfer and export opportunities, improved research and

commercialization capacity, and increased foreign direct investment. Furthermore, a substantial and successful


biotechnology industry will attract young students to science and technology education, as well as attracting the

skilled scientists, engineers and entrepreneurs who have left South Africa to explore career development

opportunities abroad, back into the country, thereby building globally relevant and competitive capacity.

3. The Global Biotechnology Industry

3.1 Size of the Global Biotechnology Industry

The global biotechnology industry is substantial in size and has experienced high growth in the past. According to

the latest Ernst &Young global biotechnology report (7), biotechnology companies generated more than US$41

billion in revenues in 2002, with US companies making up US$30 billion of this. There were just over 4300 biotech

companies worldwide employing more than 193 000 people and spending US$22 billion on R&D. In total,

companies recorded a loss of US$12 billion in the same year (7). According to BioWorld Financial Watch, a total of

US$14 billion was invested in the biotechnology industry in 2001, broken down as follows: US$3.8 billion private

companies, US$3.7 public offerings, and US$6.9 other financings (2). The biotechnology industry has been affected

by the global slump in the markets; however, is has been pointed out that the sector “is at the beginning of a

technology curve whose upside potential appears limitless” (7).

3.2 Biotechnology in Africa

There is very little data available on the biotechnology industry in Africa; however, it is clear that, in general, the

biotechnology industry on this continent lags far behind that of the developed world. Biotechnology research and

development is conducted in most countries in sub-Saharan Africa, though the extent and focus varies from

country to country. A number of countries have confined their biotechnology activities to traditional techniques such

as fermentation, e.g. Somalia, Eritrea, Burundi, Sudan, while others, such as Tanzania, Zambia, Nigeria, Ghana,

Ethiopia and Namibia, are using second-generation biotechnology such as tissue culture and in vitro techniques.

South Africa, Egypt, Kenya and Zimbabwe are among the few countries in Africa engaging in third generation

biotechnology using genetic engineering techniques. Biotechnology activities in most African countries are

dominated by international, regional and national research institutions and universities, with very limited private

sector involvement (3).

3.3 Global Biotechnology Trends

The global biotechnology industry has grown and evolved dramatically over the last two decades. It is vital that

South Africa pays careful attention to global trends in the industry in order to identify niches, to become globally

competitive, and to learn from the mistakes of those who have gone before. Ernst and Young has identified a

number of major global biotechnology trends in their Global Biotechnology 2002 report (6), some of which are listed

below. These trends represent the ‘playing rules’ of global biotechnology competitiveness, and need to be carefully

considered and interpreted by biotechnology stakeholders in SA.

The global economic slump is causing consolidation in the biotech industry in place of rapid growth, aggressive

venture funding and initial public offerings (IPOs)

Biotechnology companies are increasingly surviving through a short to medium-term focus on production and

sales, in place of rapid innovation development and licensing or sale as an exit strategy. This allows them to

retain global marketing rights to their core products, which builds more sustainable companies in the long-


term. The most successful biotechnology companies in terms of attracting investments appear to combine a

platform technology with a market-ready product pipeline

There is a strong demand for innovative products that reduce the medical and social costs of disease, fuelled

by the recognition that sustainable development of developed countries includes taking care of public health

and socio-economic challenges in developing countries. There is pressure to ensure equitable access to new

biotechnological products and services, particularly in the case of basic or pandemic health care, but also to

ensure access to breakthrough therapies for rare diseases, particularly in developing regions

The trend towards personalized medicine has resulted in the development of many biopharma companies

providing niche services that compete successfully with and, to some extent, threaten large pharmaceutical

companies

There is a growing intent to harmonize regulation on a global scale. The Japanese Ministry of Health is moving

to harmonizing with the FDA, which will make the second largest market for biopharmaceuticals globally more

accessible. The product registration process in Europe has improved dramatically with the establishment of the

European Medicines Evaluation Agency (EMEA), opening up a large market rivaling that of the USA.

The enactment of the Orphan Medicinal Products Directive has both incentivised companies to seek rapid

marketing approval for their products in Europe and created opportunities in relatively unpopular, but

significant, markets for products addressing rare diseases

Although still volatile, the Latin American market with a population approaching 500 Million is beginning to

command attention

Biotechnology companies are increasingly looking to foreign countries for manufacturing, offering a

combination of proximity to attractive markets, attractive economic incentives and skilled work forces

Scientific and technical competitiveness is intricately linked to global collaborative arrangements. This

specifically includes clinical research

Competitive drug discovery is increasingly reliant on the speed to market, which necessitates awareness of

global technologies available to achieve this goal

The management of biotechnology companies is having to be astute in managing limited resources and

collaborating pre-competitively to decrease costs

Ethical and guiding principles relating to both biotechnology and business are becoming entrenched and are a

prerequisite to sustainability. Ethical and public cross-roads have been reached with respect to stem cell and

therapeutic cloning research and commercialization, with no certain direction

Globalization increases the need for, awareness of, and sensitivity to local regulatory and market characteristics

and diverse cultures and specific medical needs

Securing and protecting global intellectual property (IP) rights is becoming increasingly important in order to

address developing country needs, with TRIPS being a significant step in this direction

Europe and Japan continue to resist GMO applications in food crops and plants

The knowledge workforce is mobile and demands workplace quality beyond remuneration (6)


Section B: The National Biotechnology Survey , 20031. Introduction

In April 2003, the Department of Science and Technology (DST) and eGoli Bio Life Sciences Incubator (eGoli Bio)

commissioned a National Biotechnology Survey for the purposes of:

• identifying private entities currently offering or developing biotechnology products or services in South Africa

• identifying the key biotechnology research organizations (including tertiary education institutes) and activities in

South Africa

• identifying and quantifying the market opportunity for the support services component of the national

biotechnology sector

• quantifying the approximate extent of the South African bio-economy in terms of total turnover, earnings,

employment and number of companies

• quantifying the approximate extent of biotechnology research including total number of projects, turnover and

anticipated outcomes

• identifying sources of funding including local and international public and private sectors, such as donors,

private equity and venture capital.

The results of the survey, reported here, have the potential to serve as a quantitative baseline for measuring the

growth of the industry over the coming years, in particular, the impact of the new measures being undertaken by

the Department of Science and Technology to stimulate the bio-economy in South Africa (19; 22).

2. Methodology

2.1 Background to Methodology

In deciding on the methodology for the survey and drawing up the required questionnaires, careful attention was

paid to the compatibility of the results with global biotechnology statistics and the indicators required by the end

users. In order to measure the success of the biotechnology industry in SA, it is vital that we are able to compare

key indicators with those of the biotechnology sectors in other countries. Thus, the definition of biotechnology used

and the survey methodology were guided by previous international biotechnology surveys.

The Organization for Economic Cooperation and Development (OECD) has published two manuals that guide the

collection and analysis of data for research and development (R&D) surveys in OECD countries, the Frascati and

Oslo Manuals ( www.oecd.org ). The Frascati Manual guides the measurement of R&D inputs and has been used by

the Human Sciences Research Council (HSRC) in their ongoing R&D survey ( www.hsrc.ac.za ), while the Oslo

Manual guides the measurement of R&D outputs. The latter guide is being used in an innovation survey in Gauteng.

Neither of these manuals provides suitable guidance for a biotechnology survey. The OECD has published a

Compendium of Existing National Biotechnology Statistics (28), which aims to highlight the types of biotechnology

data that are currently available and to encourage the future collection of internationally comparable statistics on

biotechnology. They have presented the range of indicators that can be produced from existing statistics, as well as

some of the statistical and methodological problems that exist in the current data. These include: how to define

biotechnology, which sector (public or private) should be the target of measurement, differences of coverage


among national surveys and the classification of biotechnology international trade and patent data. To date there

has been no uniform definition of biotechnology used in country surveys of the sector. The OECD has published a

Discussion Paper in which it suggests uniform biotechnology definitions (18). The paper stresses that biotechnology

refers to a set of processes or technologies and is not an industry or output, therefore one cannot use a statistical

industry-based framework for analysis.

2.2 Survey Sample

The OECD splits biotechnology into “old” biotechnology, which refers to fermentation-type biotechnology, and

“new” or “modern” biotechnology, which refers to the use of DNA manipulation technologies. Most of the country

surveys reported in the OECD compendium limit their survey population to those groups active in 3rd generation or

modern biotechnology (18). In this present survey, both old and new biotechnology activities were examined on the

research side, however, as with biotechnology surveys from other countries, the business activities of the larger

traditional biotechnology companies such as the large breweries and yeast manufacturers, dairy processing

companies, baking companies, wine producers etc., were not explored. Many of these companies are

multinationals earning revenues in excess of R1 billion and their inclusion in the quoted figures would skew the

results considerably. In addition, these companies are not the targets of new government interventions in the

biotechnology industry in SA.

In Phase 1 of the survey, a list of existing biotechnology companies, projects, government groups, funding sources,

key research organizations, researchers, and support services in South Africa was compiled from Idea to Industry’s

own databases and secondary research sources, including: the previous South African biotechnology survey and

directories, web searches, Biotechnology Regional Innovation Centre (BRIC), National Research Foundation (NRF)

and Technology and Human Resources for Industry Programme (THRIP) project lists, the websites of South African

tertiary institutes and research councils, Chambers of Commerce, related industry organizations and export

councils (e.g. for pharmaceuticals, cosmetics, food, etc.), patent applications etc. The total numbers of potential

biotechnology stakeholders identified were as follows: 1032 research groups, 106 companies, 1494 research

projects, and 196 support service groups, including venture capital and private equity firms, government, and non-

governmental and private organizations/departments.

2.3 Survey Methodology

The OECD defines organizations “using biotechnology” as those that use a set of techniques leading to the

transformation of a substance or production of a product, and where living organisms, or parts thereof, are

involved. The living material may be the object that is transformed or produced or may be used in the manipulation

or production process (18). This definition was used to identify stakeholders that should be targeted with the

questionnaire or with interviews. A stakeholder was defined for these purposes, as any individual or organization

that has an interest in or participates in biotechnology activities. The definition purposely did not specify a

commercial intent in order to gain primary information on research groups and projects that may not be directed

towards a product at present but have the potential to feed into the biotechnology industry in the future.

Unfortunately a number of stakeholders declined to participate on the basis that they did not consider themselves

to be “biotechnology” stakeholders, even though it is clear from the projects they are involved in that there is some

commercial potential in their research. Although this may have been due to poor commitment in some cases, it is

more likely a function of the challenge in defining the boundaries of biotechnology activities.


Secondary data was gathered on as many of the stakeholders as possible. An email questionnaire and interviews

were used to confirm and update this information. The questionnaires used were guided by the Compendium of

Existing National Biotechnology Statistics published by OECD (28), as well as the biotechnology surveys from

Finland, Canada, and New Zealand (10; 20; 21), but were limited to the information specifically requested in the

terms of reference for the survey as well as information required for DST’s Road Mapping Exercise. The

questionnaires for the different stakeholder types differed slightly in the information requested. Questionnaires were

emailed to 942 research groups and 87 companies believed to participate in biotechnology activities. A deadline for

return of completed questionnaires was included to encourage stakeholders to attend to the questionnaire

timeously, and was extended due to end-of-term time pressures on academics. Post-graduate Biotechnology

students from the University of the Western Cape (UWC) were employed to follow up with research stakeholders

telephonically and in-person, where necessary. Attempts were made to contact all stakeholders on the list, with

particular emphasis on those that were clearly involved in developing and commercializing a product or process,

and to encourage a response to the questionnaire.

The majority of companies were initially targeted for interviews; however, a number of them indicated their

preference to participate in the electronic survey. In-person interviews were conducted with 26 core biotechnology

companies, 12 non-core biotechnology companies, 22 support service organizations/funders, and 7 research

groups. Telephonic interviews were carried out with 3 biotechnology companies, 16 research groups, and 4

support service organizations/funders. In general, only the major biotechnology-specific companies providing

support services were interviewed. Information on government groups active in biotechnology was obtained from

the relevant websites, publications and strategy documents.

Due to the sensitivity of the information submitted by stakeholders for the survey, the confidentiality of the

information will be maintained by eGoli BIO, DST and Idea to Industry. Only the aggregated data from the survey

has been used in this report. No information on, or identifiable with, individual companies or organizations has been

used, except where this information is publicly available, i.e. on websites, brochures, public reports etc., or where

approval has been given by the organization in question.

2.4 Definitions and Classifications Used for the Survey

Defining biotechnology and drawing the boundaries for the purposes of the survey were extremely challenging,

particularly with respect to research groups and projects. Almost all research in molecular biology and medical

disciplines such as pharmacology, human genetics, immunology, haematology, chemical pathology etc., as well

some aspects of research in engineering, botany, zoology, agricultural and soil sciences, food science, entomology

etc. has the potential to contribute to or utilize biotechnology to some degree. Since it is not practical or informative

to report on all such research being conducted in SA, we have attempted to classify research projects, and their

respective programme leaders, into the following 4 categories:

• biotech projects/stakeholders - projects that are specifically intended to develop a new product or

process for application in industry

• potential biotech projects/stakeholders - projects that are not directly aimed at developing a new product

or service but have potential applications in industry


• biotech services - projects in which a service is provided in biotechnology, e.g. specific clinical trials,

technology platforms etc.

• fundamental research - projects that are not likely to result in any products but provide a vital basis for

the understanding of basic molecular biology, plant, human or animal processes, disease mechanisms,

engineering and reaction principles etc.

The same labels are used to categorize the programme leaders associated with these research projects, i.e.

research stakeholders. These research stakeholders include project or programme leaders from the higher

education institutes and research councils in SA. The most relevant category for this study is the “biotech projects”.

Many of these projects have been the subject of BRIC applications, have been awarded Innovation Fund grants, or

are conducted in partnership with industry, as are a number of the “potential biotech projects.” In the discussion on

biotechnology in SA in general, individual figures are given for the biotech projects, potential biotech projects and

biotech services, while in the more detailed analyses by sector and region, the results for the 3 groups are

combined.

Core biotechnology companies in the database are those whose business is entirely or substantially biotechnology

related. The majority of these companies have a significant commitment to technological innovation. Non-core

biotechnology companies include those companies that do not have biotechnology as their core focus but utilize

biotechnology in some aspects of their general business activities or participate in biotechnology research and

development. Biotechnology can be used in a large number of different industries for waste remediation,

development of organic products, food processing, food safety monitoring, environmental monitoring, development

and production of pharmaceuticals, fine chemicals and natural health products, development of aquaculture and

mariculture methods and supplies etc. A comprehensive review of all companies from the chemical,

pharmaceutical, minerals, food & beverage, agricultural products, natural products, cosmetics, aquaculture and

mariculture industries that may utilize biotechnology to some degree is beyond the scope of this survey. Instead,

the survey has concentrated on non-core biotechnology companies that are participating in or co-funding

biotechnology research and development. It is therefore unlikely that the database includes all non-core

biotechnology companies in SA.

Groups active in biotechnology can be classified according to the technologies they use or the sectors in which the

outputs of the technologies are applied. There are a number of different ways in which the different technologies

and sectors of biotechnology have been categorized in previous country surveys. The OECD has combined the

technology classifications used in the French, Canadian and New Zealand surveys into one list (18). A slight

variation of this list has been used in the questionnaire for this survey in order to map the capacity and shortfalls in

technology platforms in SA (see Section C 2.2.6). The breakdown of biotechnology activities into output sectors in

previous country surveys also varies widely. For the purposes of this survey, the biotechnology groups are classified

according to the output sectors used by DST in the National Biotechnology Strategy (19), with a few additions, i.e.

human health, animal health, industrial, environmental, plant, food and beverage, support services, and other.

These are further subdivided into a number of focus areas (See Appendix A for a complete list).


Another level of classification used to categorize entries in the database is the type of biotechnology being used.

The definitions of 1st, 2nd, and 3rd generation biotechnology and support services for biotechnology are given in

section A.1. The difficulty in using these definitions is that a project needn’t be developing or working on genetically

modified organisms to be using modern technologies. Thus, for example, a group using modern molecular

technologies for the diagnosis of specific diseases or identification of the genetic basis of disease should, according

to the definitions, be classified as 1st generation, since no actual genetic modification is occurring. Yet these

projects may involve innovative and ground-breaking technologies. It therefore seems inappropriate to classify them

together with projects that simply use yeast to produce beer. In addition, there are an increasing number of projects

that involve the extraction of high value materials from plants, animals or microorganisms for use in health or

industrial applications, which are not suitably categorized under existing groupings. For these reasons, we have

developed the following categories and sub-categories for biotechnology type for use in the survey:

• Natural Products – Development and manufacture of products derived from natural living organisms or parts

thereof, either directly or through extraction technologies, e.g. plant extracts, enzymes, seaweed products,

algal products etc.

• 1st Generation - Uses non-genetically modified and unselected living organisms or parts thereof

Traditional Manufacturing – use of biotechnology in manufacturing or manufacturing of biotechnology

products, e.g. yeast production; beer brewing; baking; wine production; dairy; manufacture of enzymes

and biochemicals etc.

Modern Technology – application of modern technologies to non-genetically modified and unselected

living organisms or parts thereof, e.g. diagnostics using serology or DNA analysis; drug discovery on

plant medicinals; process design for food processing; extraction or processing methods for natural

products; design and testing of synthetic substances for use on natural organisms; drug delivery etc.

New Application – use of non-genetically modified and unselected living organisms or parts thereof in

new applications, e.g. naturally occurring microorganisms for biological control, waste remediation,

bioprocessing, bioleaching, vaccines, probiotics etc.; biocatalysts for industrial processes; biofuels etc.

• 2nd Generation - Uses living organisms that have been selected or bred for specific traits

Novel Organism - development of improved organisms without genetic engineering, e.g. through marker-

assisted breeding, conventional breeding techniques, selective pressure etc.

Modern Technology – application of modern technologies to selected living organisms, e.g. as for 1st

generation but living organisms used are generated through selective means

New Application – use of selected living organisms in new applications, e.g. as for 1st generation but

living organisms used are generated through selective means

• 3rd Generation - Uses living organisms or parts thereof that have been genetically modified

Novel Organism - development of genetically modified organisms using genetic engineering techniques

Modern Technology – application of modern technologies to genetically modified living organisms or

parts thereof, e.g. as for 1st generation but with GM organisms, e.g. viral vectors for drug delivery;

recombinant vaccines etc.

New Application – use of genetically modified living organisms or parts thereof in new applications, e.g.

as for 1st generation but with GM organisms


• Technology Platform - Development or use of a novel or modern technology that can be applied to living

organisms, e.g. imaging; bioinformatics; process control for fermentation or bioprocessing; physical

technologies for diagnostics etc.; and core technologies such as sequencing; proteomics; microarrays etc.

• Support Services - Services that provide support to biotechnology projects or companies, e.g. drug analysis;

clinical trials; biosafety; contract or pilot scale manufacturing; raw material supplies; core technology services

• etc.; or form part of biotechnology value chains, e.g. rational drug design; organic synthesis; combinatorial

chemistry etc.

By classifying biotechnology groups and projects according to these groups, we are able to get a better idea of the

level of sophistication of biotechnology activities in SA. Please note that, in some cases, insufficient information on a

project was given to accurately assign biotechnology types.


SECTION C: GENERAL OVERVIEW OF BIOTECHNOLOGY

IN SOUTH AFRICA1. Background Information on Biotechnology in South Africa

According to the last survey done on biotechnology in SA (30), the total spend on biotechnology R&D until 1997

was R100 million, and until 1998 was approximately R200 million. This survey identified >600 biotechnology

research projects and approximately 55 companies involved in biotechnology, spread across the biosafety,

chemical, environmental, food, medical/pharmaceutical, plant, and veterinary sectors (30).

South Africa has been using modern molecular biology, genetic engineering, and chemical engineering techniques

in research for decades, and yet very few local biotechnology products are currently on the market. By international

standards, the biotechnology industry in South Africa is at present underdeveloped and lags far behind that of the

European countries, the USA and other developed countries. It has, however, been acknowledged that our country

has great potential for the successful development of such an industry. The positive aspects of the biotechnology

industry in SA include:

- a sophisticated and lengthy tradition of first generation biotechnology

- world-class researchers and research institutions

- a pipeline of projects that could lead to new products or processes

- an unrivalled biodiversity and biological resource base

- indigenous medical knowledge going back centuries

- access to a large human genetic diversity pool

- access to a high number of clinical samples for major infectious diseases

- a relatively low cost base for research, product development and manufacturing

- a sound legal and regulatory framework, and a world-class banking system and ICT infrastructure

South Africa has an advanced first generation biotechnology industry and its yeast, wine, and beer producers are

amongst the finest in the world. In the private sector as well as in the tertiary education institutions, South Africa

produces world-class researchers and products, and much intellectual property has been generated in its

institutions. South Africa boasts a rich plant, and associated microbial, diversity that can be tapped into for

biotechnology applications. Associated with this is a deep indigenous medical knowledge. Even today,

approximately 80 – 85% of the population in SA relies on traditional medicines and on the 350 000 or so traditional

healers in the country. The country also has access to African populations carrying 90% of the genetic diversity in

the world. The high incidence of major infectious diseases such as HIV/AIDS, tuberculosis, malaria etc. in Africa has

resulted in access to a large number of clinical and pathology samples with which to study these diseases and

potential eradication strategies. SA has a well-developed agricultural industry, and the exceptional plant biodiversity

provides significant opportunities for crop or product improvement and bioprospecting. SA’s first class researchers

and infrastructure coupled, with third-world pathology and prices, make it an attractive investment option.


It is clear that there is potential for the development of a successful biotechnology industry in South Africa. In fact,

SA is one of the top five developing countries earmarked internationally for biotechnology investment by SRI

International (representing the World Bank, 2001), and the country is becoming an increasingly popular choice for

investment and partnering for foreign companies and governments (e.g. those from Germany, Cuba, Japan and the

USA). In addition, the international community is expanding its interest in and ability to promote the development of

Africa as a whole.

There are, however, a number of factors that need to be addressed before a sustainable and globally competitive

biotechnology industry in SA can become a reality. The biotechnology industry and the market for its products in

South Africa are small and generally fragmented. Despite the fact that approximately R100-200 million has been

spent on biotechnology research and development annually, IP generation and technology transfer in the

biotechnology field to date has been slow and inefficient, and very few local products have been developed from

scientific research (30).

The major factors inhibiting the biotechnology industry to date include:

- a general lack of cohesion in research programmes

- a shortage of market-focused research and a relatively low tendency among academics to commercialize

research

- a scarcity of suitably qualified R&D personnel, particularly at the MSc and PhD levels

- a lack of clear IP policies that incentivise commercialization

- an overall lack of confidence in African governments, which affects foreign investment

- an increasing dependence on imported products, machinery, equipment, materials and technologies

- a relatively small local market

- a severe shortage of entrepreneurial and technology transfer skills and mechanisms

- insufficient public and private funding for research and product commercialization

The development of biotechnology innovation and industry in SA is still very immature, with a general emphasis on

institutional R&D. On the whole, research in SA is not carried out with commercialization in mind, and therefore

lacks market focus, i.e. there is a technology push mindset rather than a market pull one. In SA, scientists are

incentivised based on their publication output, rather than on the commercial value of their work. IP management is

also a significant problem. In many cases, IP rights reside within universities, which have neither the means nor the

incentives to develop, present, transfer or commercialize them. There is at present no equivalent of the Bayh Doyle

Act in SA to deal with issues relating to rights to IP generated from government-funded research. In addition, the

protection of IP has been extremely inefficient, often due to the high costs involved, resulting in the loss of a large

amount of it to foreign interests. This is clear from the results of the patent searches, which show that a high

proportion of patents with South Africa listed as an inventor country are assigned to organizations outside of the

country (see section 2.2.5). It must be noted, however, that there is a substantial amount of ongoing research,

which is generating an IP pipeline that may not yet have yielded protectable IP.


According to a 2002 NACI/DACST report (14), SA’s professional R&D workforce totals 30 000, equating to a paltry

7 researchers/100 000 members of the population, as opposed to 48 in Australia and 28 in Korea. Similarly the

number of PhDs per capita is just over 10% of that in Australia and around 16% of that in Korea. A particularly

worrying factor is the ageing of the research population. The number of A-rated scientists is declining annually, with

a substantial number of them retiring, e.g. at UCT (25). In 1998, 45% of all research publications were by authors

over the age of 50. In addition, the publications are still dominated by white (94%) and male (83%) authors, which

suggests that progress in the demographic transformation of science and technology in SA has been slow. Thus

there is a clear need to attract more young students, particularly from previously disadvantaged communities, to

science and technology, and to support their development into world-class researchers and innovators.

There remains a lack of confidence in African governments in general, which serves as a hindrance to economic

development and direct foreign investment. This situation has been exacerbated by the present government’s

stand on HIV/AIDS and the situation in Zimbabwe. The limited size of the local market means that investors will only

take on projects that have an export focus, to ensure a satisfactory return on investment.

One of the largest barriers to the development of a biotechnology industry in South Africa has been a shortage of

the appropriate skills required for converting promising ideas and research into lucrative industries, i.e. a shortage

of bio-entrepreneurs, and a lack of people with the passion to drive the commercialization of biotechnology

projects. Such projects are frequently driven by researchers with no experience in, or passion for, entrepreneurial

business management, and who are not prepared to hand over management responsibility to professional

management teams. Funding for research and product commercialization remains an equally significant problem. In

general, public funding of biotechnology R&D and early commercialization (incubation) is inadequate. This is

compounded by a lack of incentives for privately-funded R&D, e.g. tax incentives. Another key issue is the

requirement for updating and co-ordination of the legal and policy framework in SA in order for it to be effective in

enabling the development of biotechnology start-up ventures.

2. Results of the National Biotechnology Survey

2.1 Stakeholder Participation in the Survey

It is important to note that this study was intended as an survey of biotechnology activities in South Africa rather

than a market survey. Attempts were therefore made to identify all relevant stakeholders and their activities, rather

than defining and targeting a statistically significant sample to determine overall trends. Stakeholders and their

activities were identified through secondary data sources. The email questionnaire and interviews were intended to

provide confirmation of the credibility of the data and to obtain financial information for quantification of the bio-

economy. It is internationally accepted that a response rate of 2% to an email questionnaire is good, while a

response of 10% or higher is considered excellent. For this reason, the majority of core biotechnology companies

were targeted for interviews, to ensure a higher response, particularly with respect to financial data. It was beyond

the scope and budget of the survey to conduct interviews with all relevant research stakeholders.


Current secondary data was available for 84% of the research stakeholders listed in the database. Please note that,

as is the nature of secondary information, some of it may be out of date, and some may be absent. Every effort has

been made to ensure that the data is accurate and relevant. As can be expected from a questionnaire that requires

some effort on the part of stakeholders with little reward, the response to the email questionnaire from the research

community was disappointing, at only 22%, though excellent by accepted standards. It was clear from the

completed questionnaires received that the secondary sources had identified >90% of relevant projects, thus

confirming the credibility of the data. On the whole, the response from biotechnology companies was encouraging.

Approximately 50% of the companies identified either agreed to be interviewed or to complete the questionnaire.

The core biotechnology companies, in particular, were targeted. In this sample, 72% of stakeholders were either

interviewed or completed the electronic questionnaire. A further 8% indicated their intention to participate in the

survey but have not as yet contributed. Secondary data was available for the rest of the companies. The

participation of those stakeholders that responded, and their contribution to the survey are gratefully

acknowledged.

2.2 Overview of Biotechnology Activities in South Africa

The results reported are based on both primary and secondary research on the industry and are extracted directly

from a database of compiled information on research stakeholders, companies, research projects, and

biotechnology products and services. Primary data was collected from a total of 90 interviews (telephonic and in-

person) and 63 completed questionnaires (covering 85 different stakeholders). In general, information on human

resources, turnover, expenditure, and revenues from products and services was only available for those

stakeholders that participated directly in the survey. Where these parameters are discussed, the total number of

entries on which figures are based is given. Please note when interpreting the results that, in many cases,

stakeholders or projects fall within more than one biotechnology type, region, sector or focus area. Where pie

charts are given, entries that fall under more than one category are equally fractionated to each, while bar graphs

indicate absolute numbers and therefore the total contributions from the variables do not add up to 100%. Due to

the limited contribution of stakeholders in Mpumalanga and the Limpopo Province, these are grouped under

Gauteng for the analyses.

2.2.1 Number of Groups Active in Biotechnology

2.2.1.1 Analysis of Companies Active in Biotechnology

The survey identified 106 companies participating in biotechnology activities, including 47 core and 59 non-core

biotechnology companies/organizations. Emphasis was placed on the modern biotechnology companies; therefore

the list does not include the larger brewing, food & beverage, and wine companies, unless they are involved in

developing innovative products using modern technologies. A breakdown of core biotechnology companies by

region and sector is represented graphically in Figure 1.


Figure 1. Distribution of core biotechnology companies in SA by a.) Region and b.) Sector (n=47)

a.) Regional distribution of core biotechnology companies

37%

0%

15%3%

4%

41%

Western Cape

Free State

Kwazulu Natal

North West Province

Eastern Cape

Gauteng

b.) Sectoral distribution of core biotechnology companies

39%

10%10%

8%

9%

8%

3%

13%Human Health

Animal Health

Plant

Food & Beverage

Industrial

Environmental

Other

Support Services

It is clear from the figures that the majority of core biotechnology companies are situated in Gauteng (41%) and the

Western Cape (37%). Kwazulu Natal also boasts a number of core biotechnology companies (15%), while the rest

of the provinces do not feature significantly in this sample. The human health sector has the highest representation

in terms of numbers of core biotechnology companies (39%), followed by the support services sector (13%). The

rest of the companies are fairly evenly spread across the plant, animal health, food & beverage, industrial, and

environmental sectors, with a small proportion of companies (3%) contributing to the “other” category. All of the

latter companies also fall under one or more of the other 7 categories.

A more difficult group of companies to quantify includes those that do not have biotechnology as their core focus,

but utilize biotechnology in some aspects of their general business activities, for example, companies that utilize

biotechnology processes to treat or remediate waste generated by conventional processes, companies that are

turning their R&D to a biotechnology focus etc. The 59 non-core biotechnology companies in the database are

broken down by sector and region in Figure 2. Please note that the number of companies in SA that may utilize

biotechnology to some degree is likely to be higher than this (see section B.2.4).


Figure 2. Distribution of non-core biotechnology companies in SA by a.) Region and b.) Sector (n=59)

a.) Regional distribution of non-core biotechnology companies

37%

3%18%

1%

3%

38%

Western Cape

Free State

Kwazulu Natal

North West Province

Eastern Cape

Gauteng

b.) Sectoral distribution of non-core biotechnology companies

15%

7%

26%

11%

15%

8%

13%5%

Human Health

Animal Health

Plant

Food & Beverage

Industrial

Environmental

Other

Support Services

The majority of non-core biotechnology companies in the sample are situated in Gauteng (38%) and the Western

Cape (37%), and are active in the plant sector (26%). This may be distorted to some degree by the inclusion of a

number of multinational seed and agro-science companies, most of which have their local head offices in

Johannesburg or Pretoria. These companies are generally subsidiaries of larger multinational agricultural companies

that do not conduct research in biotechnology but carry out field trials in SA and sell the resultant products. The

second largest sectors represented in this sample are the human health and industrial sectors (15% each).

Companies partaking in the survey were asked for their date of establishment or, in the case of non-core

biotechnology companies, the year in which they initiated biotechnology activities, in order to determine trends in

the development of new biotechnology companies.


Figure 3. Distribution of core biotechnology companies by age

a.) Number of core biotechnology companies established per year (n=37)

0

1

2

3

4

5

6N

umbe

r of

Com

pani

es

Pre

-198

4

1986

1988

1990

1992

1994

1996

1998

2000

2002

b.) Cumulative number of core biotechnology companies per year (n=37)

05

10152025303540

1984

1986

1988

1990

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1994

1996

1998

2000

2002

Num

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of C

ompa

nies

The age distribution of core biotechnology companies (Figure 3) indicates that a small number of companies were

established before 1986, followed by a period of inactivity in the late 1980’s and early 1990’s, and a relatively

steady start-up rate of, on average, 2 new companies per annum between 1992 and the present. An analysis of 40

core biotechnology companies reveals a relatively even distribution of new start-ups, spin-offs from research

groups, and spin-offs from another enterprise (Figure 4). The latter group includes 2 companies that form part of

large traditional biotechnology companies but are developing novel products or processes. The smallest group in

this sample represents those companies established as spin-offs from research groups. This is not unexpected,

given that the primary role of researchers at higher education institutions is in education and publishing, which often

leaves little time for commercial activities, and may undermine IP value. However, these stakeholders represent an

important source of new innovations for commercialization in the future.


Figure 4. Origin of core biotechnology companies (n=40)

33%

30%

37%

New Start-Up

Spin-off fromResearch Group

Spin-off from AnotherEnterprise

Figure 5 represents the size distribution of core and non-core biotechnology companies based on numbers of

employees. The figures for non-core biotechnology companies represent only those employees that participate in

biotechnology activities. Figures are only given for approximately 43% of the companies, however, the results are in

line with international trends, which indicate that the majority of biotechnology companies are relatively small, i.e.

have a staff complement of less than 50. Companies in this sample together employ a total of approximately 1020

staff in biotechnology-related activities.

Figure 5. Distribution of core and non-core biotechnology companies by number of employees

0

2

4

6

8

10

12

Num

ber

of

Com

pani

es

1-10 11-20 21-50 51-100 >100

Number of Employees

Core BiotechnologyCompanies

Non-Core BiotechnologyCompanies

Core biotechnology companies, n=30

Non-core biotechnology companies, n=16


The biotechnology companies were classified according to the biotechnology types defined in section B.2.4. The

distribution of companies according to biotechnology type (Figure 6) indicates that the majority of companies are

not working with genetically modified organisms, though most are using modern technologies or developing new

applications. Please note that some companies fall under more than one category.

Figure 6. Distribution of core and non-core biotechnology companies by type of biotechnology

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ompa

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Core Biotechnology Companies Non-Core Biotechnology Companies

1st 2nd 3rd

Core biotechnology companies, n=47

Non-core biotechnology companies, n=59

The majority of core and non-core biotechnology companies in SA are involved in either the extraction or

production of products using relatively “low-tech,” though modern methods. In many of these cases, the novelty is

in the application of the products to new problems. Only around 10% of the companies are partaking in highly

innovative research and development that has the potential to result in groundbreaking technologies and/or

products.

As mentioned previously, the list of core biotechnology companies in this study does not include the larger

traditional manufacturing companies that use biotechnology in their core processes. South Africa has a strong

tradition of first generation biotechnology and boasts world-renowned and globally competitive companies. These

companies fall predominantly within the food & beverage sector, and are generally multi-million Rand operations.

They include yeast, cheese and yoghurt manufacturers, baking companies, beer brewers and wine makers, all of

which either produce microorganisms and/or enzymes, or use them for processing. In line with national

biotechnology surveys from other countries, this survey does not include these companies in the analyses, nor

were the companies targeted for participation in the survey, unless they were known to conduct innovative

biotechnology R&D.


2.2.1.2 Research Groups Active in Biotechnology

A total of 1032 research groups were identified as being potentially relevant to the survey. Primary and/or

secondary data was available for 869 of these stakeholders (84%), and was used in the analyses below. As

mentioned in section B.2.4, drawing the boundaries for researchers and research projects that should be included

in this survey was extremely challenging. For the purpose of this survey, research projects and their respective

programme leaders were divided into 4 categories, i.e. “biotech”, “potentially biotech”, “fundamental research”, and

“biotech services”. Please note that a small number of projects and researchers that have been listed as “biotech”

involve different parts of the biotechnology value chain that may not necessarily be using microorganisms directly,

e.g. rational drug design using chemical techniques, synthetic routes to natural drugs etc. The proportions of

researchers in each category are represented in Figure 7.

Figure 7. Distribution of research groups in the database by degree of relevance to biotechnology

33%

24%

32%

11%

Biotech

Potentially Biotech

Fundamental Research

Biotech Services

Please note that where stakeholders were classified as “biotech services” as well as one of the other categories,

the other categories were given priority. Therefore the 11% in the figure represents stakeholders that have been

classified as “biotech services” only, and the true number of stakeholders offering services is higher than this (178 in

total).

In this sample, 296 researchers have been classified as being involved in biotechnology, with a further 205

classified as potential biotech stakeholders, and 178 stakeholders offering biotechnology services, 28 of which are

also classified as “fundamental research,” 22 as “potential biotech,” and 35 as “biotech” stakeholders. The total

number of stakeholders from research institutions identified as being involved in biotechnology-related activities is,

therefore, 622. Those stakeholders involved solely in fundamental research are not included in any further analyses.

The majority of relevant research stakeholders are operating from the Western Cape, followed by Gauteng,

Kwazulu Natal and the Free State. Researchers developing biotechnology products are working predominantly in

the human health sector, followed by the plant, industrial, and food & beverage sectors, in that order (Figure 8).


Figure 8. Distribution of research groups by a.) region, and b.) sector

a.) Regional distribution of research groups

0

20

40

60

80

100

120

140N

umbe

r of

Gro

ups

Wes

tern

Cap

e

Gau

teng

Kw

azul

uN

atal

Fre

e S

tate

Eas

tern

Cap

e

Nor

th W

est

Pro

vinc

e

Biotech

Potentially Biotech

Biotech Services

b.) Sectoral distribution of research groups

0

20

40

60

80

100

120

Num

ber

of G

roup

s

Hum

an H

ealth

Ani

mal

Hea

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Pla

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Bev

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Indu

stria

l

Env

ironm

enta

l

Oth

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Sup

port

Ser

vice

s

Biotech

Potentially Biotech

Biotech Services


Figure 9. Distribution of research groups by number of employees

0

5

10

15

20

25

30

Num

ber

of G

roup

s

1-10 11-20 21-50 51-100 >100

Number of Employees

Biotech

Potentially Biotech

Biotech Services

Biotech Research Groups, n=61

Potentially Biotech Research Groups, n=18 Biotech Services Research Groups, n=19

Human resources figures were only available from research stakeholders that participated in the survey. Figure 9

reveals that the majority of research groups in this sample are small, i.e. have between 1 and 10 people. This is

probably due to the fact that group leaders within departments were targeted rather than only department heads.

This sample represents a total of around 950 employees/students partaking in biotechnology-related activities.

2.2.2 Biotechnology Research Projects

The majority of the research projects in the database were identified through current secondary sources, some of

which were confirmed with primary data. It is assumed that information posted on websites, in publicly available

university or departmental annual reports, local and international research publications, funded project lists etc.,

though it may be outdated, is accurate. The nature of research is such that projects can take many years to

complete, and in some cases are continuously pursued. Changes in research programmes to accommodate new

students and staff generally take place within the same theme. Since the projects in the database are classified into

fairly broad themes, and the annual turnover of project themes is reasonably low, it is assumed that projects listed

for the last 2-3 years remain relevant today. This has been cross-checked wherever possible. Secondary research

will not identify projects that have not yet been publicized. These may include projects that have only been initiated

recently or are too sensitive to publish at present. Information on some of these projects has been provided through

completed questionnaires; however, we understandably have not been provided with access to all of them. It is

impossible to estimate the number of projects in universities and with individuals that have not been identified and

catalogued; however, we have used as many available channels as possible to identify biotechnology research

activities and are reasonably certain that our database covers at least 80% of relevant projects and stakeholders.

The distribution of projects by degree of relevance to biotechnology is represented in Figure 10. The total number

of research projects in the database is 1494. Approximately 30% of these (447) are classified as biotech, 25% (376)

as potentially biotech, 39% (583) as fundamental research, and 6% (88) as biotech services. Taking into account

the overlap between the projects classified as biotech services and the other categories, the total number of

projects relevant to biotechnology is 911. This includes projects undertaken by both research and industry

stakeholders.


Figure 10. Distribution of research projects by degree of relevance to biotechnology

30%

25%

39%

6%

Biotech Projects

Potential Biotech Projects

Fundamental Research

Biotech Services

The projects classified as fundamental research were generally obtained from websites where the posting of

research being conducted by specific groups is inconsistent. Some university or departmental websites, for

example, provide a fairly comprehensive list of the research activities of its staff, while others give few or no details,

resulting in skewing of the data. In addition, these projects are not aimed at commercializing or offering a product

or service. These projects and the corresponding researchers are therefore not included in any further analyses.

The regional and sectoral distributions of the biotech, potentially biotech and biotech services research projects are

represented graphically in Figure 11.

Figure 11. Distribution of research projects by a.) region, and b.) sector

a.) Regional distribution of research projects

0

20

40

60

80

100

120

140

160

180

200

Num

ber

of G

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s

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Fre

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tate

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Cap

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Nor

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vinc

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Biotech

Potentially Biotech

Biotech Services


b.) Sectoral distribution of research projects

0

20

40

60

80

100

120

140

160N

umbe

r of

Gro

ups

Hum

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Indu

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Env

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Oth

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Sup

port

Ser

vice

s

Biotech

Potentially Biotech

Biotech Services

Biotech Projects, n=447

Potentially Biotech Projects, n=376

Biotech Services Projects, n=94 (6 projects also fall under one of the other categories)

The regional distribution of research projects mirrors that of the research stakeholders, i.e. majority in the Western

Cape, followed by Gauteng, Kwazulu Natal and Free State; while the dominant sector in terms of projects aimed at

developing a product, is plant biotechnology, followed by human health and industrial. Research projects that have

the potential to lead to a product are predominantly in the human health sector, followed by the plant sector. The

latter trend mirrors that of the research stakeholders. Please note that the entry of projects into the database is

somewhat subjective. It is often difficult to determine whether a project has its own theme or whether it fits into a

broader one. Therefore the absolute numbers of projects, and hence the sectoral and regional distribution of

projects may not be the most accurate reflection of the distribution of biotechnology activities. If one looks at the

distributions in terms of research stakeholders and research projects together, the clear trend is that the human

health sector dominates, followed closely by the plant sector.

Comparison of the regional and sectoral distributions of “biotech” projects with those of applications received by

the funders/incubators Bioventures, Catalyst Innovation Incubator, Acorn Technologies, and eGoli BIO over the last

year (as of July 2003), reveals similar trends. Please note that the classification systems used in the studies differ

slightly. Overall, the dominant activities are in the human health and plant sectors. The regional distribution of

projects in the present survey shows a similar trend to that seen by Bioventures. The regional distribution of

applications received by Catalyst, Acorn and eGoli BIO is biased by the location of these organizations.

Table 1: Distribution of research projects/applications by sector and region


Sectoral Distribution (%)

Sector Bioventures Catalyst Acorn Technologies eGoli BIO† Present Study

Human Health 153 50 48 27 21

Animal Health <1 1 9 12

Plant 219 540 45 29

Food & Beverage 8 68 8

Industrial 312 10 718 15

Environmental <1 9

Other 48 20 4

Support Services 2

Regional Distribution (%)

Sector Bioventures Catalyst* Acorn Technologies* eGoli BIO† Present Study

Western Cape 50 ~60 >90 37

Gauteng 34 ~30 <1 91 33

Kwazulu Natal 4 <1 <1 11

Eastern Cape 2 5

Free State 2 <1 9 6

Mpumalanga 2 2

Northern Cape 1 -

Off-shore 5 5-10 -

1Includes Bioventures’s categories Pharmaceuticals and Fine Chemicals (28%) and Healthcare (25%)2Agriculture including aquaculture, floriculture etc.3Includes environmental biotechnology4Genomics5Includes a few aquaculture/mariculture projects6Agrifood and health7This figure is for industrial, mining and environmental projects

*Please note that these are rough estimates only and that they are biased by their location in the Western Cape

† Figures are based only on projects showing a strong interest in being incubated by eGoli BIO. The bias in regional distribution of applications is

due to the location of eGoli BIO in Gauteng

2.2.3 Human Resources in Biotechnology

This report is not intended to give a full overview of R&D personnel in South Africa. For broad figures on human

resources in science and technology, the reader is referred to the NACI/DACST publication, South African Science

and Technology, Key Facts and Figures 2002 (14). The difficulty is in identifying what portion of the total R&D

capacity is attributable to biotechnology. Unfortunately it is not meaningful to allocate human resources according

to research groups and industry in this study, since not all of the data is available, and there will be some bias

towards industry where the response was better. It is also not possible to breakdown human resources according

to sector since very few details were given on human resources allocated to specific projects. In addition,

researchers within certain research groups may be involved in more than one project covering different sectors.

Stakeholders were asked to indicate the approximate percentages of employees/researchers in their

company/research group falling within certain demographic and qualification categories. These distributions, shown

in Figures 13 and 14, respectively, are based on completed questionnaires and interviews. They represent only a

small fraction of the total sample but give some indication of the trends. Staff numbers include research, admin and

technical staff. Figure 13 plots the number of groups with >50% representation of each of the demographic groups.


Figure 13: Demographic distribution of human resources in biotechnology

0

5

10

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20

25

30

35

40

45

Num

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of S

take

hold

ers

>50%Black

>50%Coloured

>50%Asian

>50%White

Research Stakeholders

Core BiotechnologyCompanies


Research Groups, n=62

Core Biotechnology Companies, n=26

Non-Core Biotechnology Companies, n=15

It is clear that the demographic transformation of research groups has not yet reached acceptable levels (figures

are for biotech, potentially biotech and biotech services groups combined). The groups are still dominated by white

researchers. It was pointed out by a number of stakeholders that this trend is not through lack of effort. Many found

it difficult to find suitably qualified researchers from other demographic groups. The demographic representation in

biotechnology companies reflects some improvement, with a less marked difference between the demographic

groups.

Figure 14: Human resource allocation by qualifications

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Sta

keho

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s

>50

%N

one

>50

%M

atric

>50

%D

iplo

ma

>50

%D

egre

e

>50

%M

Sc

>50

%P

hD

Qualifications

Research Stakeholders

Core Biotechnology Companies






Biotechnology companies show a relatively even distribution of employees by qualification. This is probably a

function of the averaging out of R&D personnel and technical/production staff in a sample that includes R&D-

intensive as well as production-orientated companies. As is to be expected, research groups are dominated by

employees with at least a degree qualification, and frequently a post-graduate degree.

Approximately 50% of companies and 81% of research stakeholders that participated in the survey indicated that

they had experienced shortages in human resources. The majority of research stakeholders listed skilled scientists

at various levels, particularly MSc’s and PhD’s, as being in short supply. Particular areas where human resource

gaps were identified include:

- engineers with appropriate biology background/training and good mathematical ability

- polymer chemists

- experienced scientists trained in human genetics environments

- biometricians

- technical personnel with experience in tissue culture and other analytical techniques

- business plan writers with an academic background in biotechnology

- laboratory technicians

- bioinformaticists

- biostatisticians

- plant physiologists

- well trained protein purification experts, especially those with experience in plant proteins

- science managers

- people with degrees or experience in botany and genetics

- sugar technologists

- legal professionals.

Biotechnology companies listed the following gaps in human resources:

- scientists and researchers

- engineers

- accountants

- good production staff

- people with the relevant operating experience

- managers, quality control staff and production engineers with pharmaceutical experience

- good laboratory microbiologists

- bioinformaticists

- protein chemists

- baking technologists

- botanists

- entrepreneurs

- marketers.

- trained laboratory and production personnel who understand GLP/GMP


Many of these shortages are within specialized areas, however the general trend is that more science and

technology graduates and post-graduates are required to feed into the biotechnology research and industry

environments. The shortages may be due, in part, to the fact that quality graduate, post-graduate and postdoctoral

scientists leave South Africa to explore opportunities abroad. A successful biotechnology industry in SA that can

offer improved local job opportunities in biotechnology, competitive remuneration and a challenging environment

should serve to attract those graduates, as well as other international experts, back to the country. It should also

encourage a larger number of learners to enroll in science and technology courses at universities and technikons.

2.2.4 Size of the Bio-economy in South Africa

As mentioned previously, a biotechnology industry is very difficult to define. Biotechnology refers to a set of

processes or technologies and is not really an industry or output. This, and the fact that the boundaries are hard to

define, make it very difficult to quantify. The industry sector of biotechnology in South African is made up almost

exclusively of private companies, most of which fall into the SMME category. There are relatively few exports to

date, and this data is not readily available due to the crosscutting nature of the technology and a lack of

appropriate classification by bodies such as Customs and Excise and the Department of Trade and Industry.

Biotechnology products can be classified under a number of different Harmonization System (HS) codes, all of

which are too broad to give meaningful figures.

As mentioned, there is no appropriately classified trade data available for biotechnology products and services in

South Africa. Attempts were therefore made to quantify the size of the biotechnology industry in terms of numbers

of companies, their annual turnovers, and revenues from products and services, through the questionnaires and

interviews. Stakeholders were asked to define the broad categories of biotechnology products and services offered

by them and the revenues earned from these products for the 2002/03 financial year. They were also asked to

classify their turnover for the same period as being R0, <R50 000, R51-500 000, R0.5-1 million, R1-5 million, R5-

10 million, or >R10 million. The vast majority of companies participating in the survey are private companies and, in

many cases, they were unwilling to divulge financial figures. The distribution of core biotechnology companies by

turnover for those companies that did respond to the question (60%) is given in Figure 15.

Figure 15: Distribution of core biotechnology companies by turnover

05

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Per

cent

age

of

Com

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es

0

<R

5000

0

R51

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0 00

0

R0.

5-1

mill

ion

R1-

5m

illio

n

R5-

10m

illio

n

>R

10m

illio

n

Turnover


The majority of core biotechnology companies in this sample (71%) had a turnover of more than R1 million for last

year, with 25% of the total earning more than R10 million. Taking an average for each of the ranges represented

and a conservative of estimate of R10 million for the >R10 million category, the total turnover of this sample is

estimated to be at least R133 million. The turnover ranges given in the questionnaire do not allow for quantification

of companies with a turnover that is far in excess of R10 million; however, the revenues from products and services

(discussed below) give some indication of the extent of earnings of such companies. At least one of the companies

in the sample earned more than R150 million from biotechnology products last year. In addition, the sample

represents only 60% of the total number of core biotechnology companies identified in the survey, and does not

include the non-core biotechnology companies, a number of which are earning >>R10 million from biotechnology

products and services. The total turnover for 2002 that can be attributed to biotechnology in the business sector is,

therefore, likely to be in excess of R300 million.

At least 154 biotechnology products and/or services were identified from completed questionnaires and interviews

(research groups and companies). They are classified by sector and type of biotechnology (Figure 16). The majority

of these products fall under the human health (23%) and support services sectors (20%), followed by the plant

sector (18%). These products/services include predominantly therapeutics, diagnostics, natural health products

and phytopharmaceuticals in the human health sector; core technology services, contract research and contract

manufacture in the support services sector; and GM crops, plant growth stimulants, and biological control products

in the plant sector. 36% of the products and services listed involve first generation biotechnology, with only 10%

involving genetic modification techniques.

Figure 16: Biotechnology products by a.) sector and b.) type of biotechnology

a.) Sectoral Distribution of Biotechnology Products

23%

11%

18%

8%

9%

5%

6%

20%

Human Health

Animal Health

Plant

Food & Beverage

Industrial

Environmental

Other

Support Services


b.) Distribution of Biotechnology Products by Type of Biotechnology

05

10

15

20

25

3035

40N

umbe

r of

P

rodu

cts/

Ser

vice

s

1st 2nd 3rd

Revenues for 2002 were given for 56 of these products and services (around 36%), and total R245.6 million. It is

important to note that this figure is largely skewed by one company that earned R200 million in revenues last year.

Therefore the remaining 55 products/services earned collective revenues of only R45.6 million. Eighteen other

companies gave very broad estimates of revenues from biotech products and services, which together represent at

least another R122.4 million. Thus, the revenues from biotech products and services listed for 2002 total at least

R368 million. In some cases, products have not as yet earned any revenues and in other cases, services are

exchanged for research grants or as a service to parent companies for no fee, which makes quantifying the value of

these products/services difficult. The figure of R368 million represents only 48% of the products and services listed

in the database, which, in turn, probably represents only a fraction of the total number of biotechnology products

and services on offer in SA. As an example, 105 research organizations or departments were identified as offering

services that utilize biotechnologies, such as molecular diagnostics for human, animal, and plant diseases, contract

research, etc. These groups are not included in the above sample. An estimation of the true size of the bio-

economy in SA is not possible without the full cooperation of all stakeholders.

The revenues earned in 2002 from biotechnology products and services are broken down in Figure 17 according to

sector and biotechnology type.


Figure 17: Biotechnology revenues by a.) sector and b.) type of biotechnology

a.) Sectoral Distribution of Biotechnology Revenues i.) All figures included

0

50

100

150

200

250

Rev

enue

s (m

illio

ns)

Hum

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ealth

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Indu

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Oth

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Ser

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s

ii.) Sectoral Distribution of Biotechnology Revenues Without outlying figure

0

10

20

30

40

50

60

Rev

enue

s (m

illio

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Hum

an H

ealth

Ani

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d &

Bev

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Env

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Oth

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\b.) Distribution of Biotechnology Revenues by Type of Biotechnology i.) All figures included

0

20

40

60

80

100

120R

even

ues

(mill

ions

)

1st 2nd 3rd

ii.) Distribution of Biotechnology Revenues by Type of Biotechnology Without outlying figure

0

5

10

15

20

25

30

35

Rev

enue

s (m

illio

ns)

1st 2nd 3rd

Please note that the sample used for the analysis in Figure 17, i.e. products for which companies were prepared to

give financial data, is probably not a representative sample. In addition, many of the products are classified into

more than one sector and biotechnology type. Therefore the figure should not be seen as a true reflection of the

distribution of income in the industry. The distributions are shown with and without the R200 million outlier. The

majority of revenues can be attributed to the industrial sector, followed by human health and food & beverage

sectors. Second and third generation biotechnology account for the largest proportion of revenues. Again it must

be noted that this is skewed by the one product set.


Stakeholders were asked to assign the % of their turnover attributable to exports to one of the following categories:

<10, 10-20, 20-40, 40-60, 60-80, or 80-100 (Figure 18). Sales to neighbouring countries were also counted as

exports.

Figure 18: Export of biotechnology products and services as a percentage of turnover

0

1

2

3

4

5

6

7

Num

ber

of C

ompa

nies

0 <10 10-20 20-40 40-60 60-80 80-100

% Exports





The figure indicates that, for around 50% of the companies, exports account for <10% of turnover. However, it is

interesting to note that >70% of the core biotechnology companies in this sample export their products or services.

Therefore the existing biotechnology companies are actively pursuing markets outside of SA.

2.2.5 Intellectual Property

A solid patent portfolio can be critical to a biotechnology company’s ability to attract investment and compete in the

market. The numbers of patents emerging from biotechnology activities are an important indicator of the

technology/innovation strengths of a country. Stakeholders were, therefore, asked to list the number of patent

applications filed in SA and abroad. Due to an insufficient response to the survey, figures obtained could not be

used to accurately quantify the total number of patents filed by SA biotechnology inventors. Broader figures were

therefore sought from the respective patent offices.

The South African Patents Office (Registrar of Copyright Designs, Patents, Trade Marks), situated in Pretoria,

houses hard copies of all patents registered in SA. Patents are arranged according to broad classes only. It is

therefore not practical to search the office manually for biotechnology-related patents. Spoor & Fischer scans a

copy of the majority of patents registered with the office and therefore has a fairly comprehensive database of SA

patents. A list of all patents registered in SA in certain international patent classification groups (Appendix B) was

obtained from their database. The 25 000 patents were scanned manually and those registered by foreign and

unknown groups discarded. For the remaining 422 patents, titles were used, where possible, to determine which

patents were related to biotechnology. This search revealed at least 200 biotechnology-related patents filed by SA

inventors between 1979 and 2002. Please note that this is only a rough estimate. Classification was only possible

where titles were descriptive, and it wasn’t always possible to determine the country of origin of the inventors.


The necessity for SA organizations to aim for a wider market than SA alone has meant that the majority of them

apply for international patent protection, where financial constraints allow. According to statistics published by the

United States Patents and Trademarks Office (USPTO) (26; 27), SA registers around 100 patents per annum with

the USPTO. The number of patents increased from 101 in 1992 and 1993 to 137 in 2001. Between 1997 and

2001, the ownership of patents registered was as follows: 193 individually owned, 10 Sasol Technology, 9 Denel, 9

Water Research Commission, 8 Implico, 7 Eskom, 5 Atomic Energy Corporation, and 5 Farmac Nederland. The 4

technology classes accounting for the largest contribution over this period were drug, bio-affecting and body

treating compositions (29), liquid purification or separations (26), communications: electrical (24), and hydraulic and

earth engineering (15). The numbers given are for the total number of SA patents registered with the USPTO and is

not confined to biotechnology patents. A search of the USPTO using the US classification code 435, which

includes “molecular biology and microbiology” patents, and the relevant international patent classification groups

revealed a total of 65 biotechnology-related patents awarded to South African inventors between 1976 and the

present. It is interesting to note that around 32% of these patents are assigned to non-South African entities. Figure

19 indicates a clear increase in the number of patents awarded to South African inventors from 1999 to the

present.

Figure 19: Number of US patents awarded to South African inventors per year

0

2

4

6

8

10

12

Num

ber

of P

aten

ts

Pre

-198

5

1986

1988

1990

1992

1994

1996

1998

2000

2002

Patent Co-operation Treaty (PCT) patent applications were searched using the relevant ICP codes and South Africa

as the inventor country. The search revealed 86 applications between 1986 and the present. The distribution of

applications by year is represented in Figure 20. The overall trend is an increase in the number of filings per year.


Figure 20: Number of PCT applications filed by South African inventors per year

02468

101214161820

Num

ber

of P

aten

ts

1995

1996

1997

1998

1999

2000

2001

2002

2003

The European Patent Office (EPO) patent applications can only be searched if the inventor, patent number, filing

date etc. are known, or by international patent classification (ICP) code. Biotechnology fits under a number of

different IPC codes (see Appendix C). It was not practical to extract all patents under these codes and search

through them manually to identify those with SA as the inventor country.

Comparing the patent output of SA with other countries, the NACI/DACST report (14) estimates that SA produces

around 2.5 patents per million population as opposed to 75 in Australia and 779 in South Korea, and US$1.7 per

1000 population in royalties or from licenses as opposed to US$18.2 in Australia and US$9.8 in South Korea.

Therefore, SA lags far behind in terms of patent outputs when compared with other countries. A potential reason

for this, substantiated by a selection of stakeholders in the survey, is the substantial expense involved in registering

foreign patents. A number of groups in SA indicated that they could not afford to patent their IP internationally or

were forced to let their patents lapse due to financial constraints. There is also a substantial amount of ongoing

research, which is generating an IP pipeline that has not yet yielded protectable IP, but may do so in the future. In

addition, the patent applications do not account for Intellectual Capital, i.e. knowledge that resides within an

individual or group of individuals and is not in the public domain. Therefore, the patent numbers reported above are

unlikely to represent the full complement of IP emerging from SA.

The publication output of SA biotechnologists was not explored. It was clear from the questionnaires received and

the interviews conducted that those groups developing proprietary IP do not publish but rather go the patent route.

According to the NACI/DACST report of 2002 (14), South Africa produces around 0.5% of the world’s research in

terms of scientific publications in Institute for Scientific Information articles. The report indicates a slight decline in

scientific output in terms of publications from 1996. They speculate that this may be due to an increase in contract

research, which would not be published publicly. Readers are referred to this report for a detailed analysis of

science and technology publications by South African groups.


2.2.6 Technology Platforms

The availability of and requirement for various technology platforms for biotechnological innovation are addressed in

detail in the final report from the DST Biotechnology Roadmapping Project, due to be released shortly (5). The

current report, therefore, provides only a brief description of technology capabilities and requirements based on

primary and secondary data. In the context of the National Biotechnology Strategy, Regional Technology Platforms

(RTPs) are broadly defined as vital multi-use technologies that underpin broad areas of biotechnology research and

development. These supporting technologies include molecular biological techniques, bioinformatics, large-scale

culturing of organisms, process design and optimization, analytical techniques, product development etc. Without

access to novel, cutting edge technologies and modern, state-of-the-art equipment, South African groups cannot

expect to compete with their foreign counterparts.

A recent report identified the top 10 technologies for improving health in developing countries as being:

- Modified molecular technologies for affordable, simple diagnosis of infections diseases

- Recombinant technologies to develop vaccines against infectious diseases

- Technologies for more efficient drug and vaccine delivery systems

- Technologies for environmental improvement (sanitation, clean water, bioremediation)

- Sequencing pathogen genomes to understand their biology and to identify new antimicrobials

- Female-controlled protection against sexually transmitted diseases, both with and without contraceptive

effect

- Bioinformatics to identify drug targets and to examine pathogen-host interactions

- Genetically modified crops with increased nutrients to counter specific deficiencies

- Recombinant technology to make therapeutic products (for example, insulin, interferons) more affordable

- Combinatorial chemistry for drug discovery (5)

The trend in molecular biology research is a move away from the “one-gene/one-protein” approach to investigating

global cellular features. Disciplines such as genomics, transcriptomics, proteomics, metabolomics etc. are

increasingly subscribed to for both fundamental research and for the development of new products and processes.

The sequencing of the human genome, in particular, has opened the door to vast new opportunities for

diagnostics, vaccine and drug development, and has contributed significantly to the genomics era. New

technologies for application in these disciplines are continually emerging and must be made accessible to the

South African research and biotechnology community to ensure global competitiveness.

In order to map the technology platforms available to biotechnologists in SA, stakeholders were asked to define

which technologies their groups currently had access to, which technologies were required in their research but

were unavailable to them, and which technologies they were likely to use in the future. The response to this

question was variable and difficult to interpret. It was extremely difficult for stakeholders to attach accurate figures

to human and financial resources assigned to particular technology platforms and, understandably, many

stakeholders participating in the survey did not provide quantitative responses to this question. As an example,

DNA sequencing facilities may be available within a particular research group and used erratically by all members of

the group at some time or other within any given time period. Various components of equipment may be upgraded

at different times and reagents used for other applications. In this scenario, which is common to most technology


platforms, except those run specifically for service provision, it is impossible to accurately quantify the human

resources and funding allocated to the technology platform.

For the purposes of analyzing national strengths in technologies, the numbers of groups or departments having

access to specific technology platforms, as determined from completed questionnaires, secondary data, and from

a survey on biotechnology resources conducted earlier this year (13), are plotted in Figure 21.

The relatively low response to the questionnaire, coupled with the fact that many of the technology platforms exist

in laboratories that saw themselves as not being relevant to the survey, means that it is unlikely to be a complete

picture. It is clear from the figure that the majority of groups have access to cell or tissue culture facilities, general

molecular biology technologies for DNA work and microbiology, and analytical techniques. The less widely

accessible techniques are generally those that are more specialized and are likely to be required by a smaller

number of groups.

A plot of the number of groups that will be requiring specific technology platforms within the next 5 years (Figure 22)

indicates a requirement for DNA sequencing/synthesis/amplification techniques. In many cases the request was for

funding to upgrade existing facilities rather than to establish a new facility, though the result also reflects a growing

interest in whole genome sequencing. The high throughput generation of DNA sequence and molecular marker

data is central to many areas of biotechnology, and there is clearly a growing demand for it in SA. The majority of

institutions now own at least one automated DNA sequencer for relatively high throughput generation of sequence

data, and many offer contract services in DNA sequencing. Other priorities emerging from this study are cell/tissue

culture, recombinant DNA technologies, bioinformatics, biochips, and molecular high throughput screening.

Bioinformatics plays an important role in the development of biotechnology, particularly with respect to data

production, processing, analysis, storage, visualization and dissemination. The development of bioinformatics

capacity is being addressed by the National Biotechnology Strategy and is discussed in more detail below.

Access to state of the art equipment is, in some cases, available to research groups and companies in SA;

however, there remains a shortage in equipment and expertise in many areas. In addition, there is a general lack of

integration of equipment, and hence sub-optimal usage and economy. The major problems with developing

capability in technology platforms are the high costs of purchasing, running and maintaining equipment, and the

lack of qualified staff with expertise in the relevant technologies. A significant investment into equipment,

infrastructure and human resources is required to develop capacity in key technology platforms. This is being

addressed in the National Biotechnology Strategy (19), The R&D Strategy (22), and the Biotechnology Road

Mapping Exercise. A portion of the BRIC funding will be allocated to the expansion of existing regional technology

platforms (RTPs) and the development of others. The R&D strategy provides for increased spending on science and

technology equipment as well as the development of new technology platforms for biotechnology. The

Biotechnology Road Mapping Exercise, discussed in more detail below, is mapping current capabilities and the

technologies required for the future development of biotechnology in SA. It will provide a clear road map of

technology requirements in SA over the next 10 years, based on existing capabilities and market demands.


Figure 21: Capacity in Various Technology Platforms

0 10 20 30 40 50 60

Cellular fusion

Molecular High Throughput Screening

Lipid/protein engineering

Combinatorial Chemistry

Tissue engineering

Drug Delivery

Cell Receptors/ Signaling/ Pheromones

Processing of Blood Products and Substitutes

Proteomics

Biomaterials

Product Development

Classical/Traditional Breeding

Structural Biology

Antibodies

Molecular modelling

Pilot Scale Manufacture/Processing

Bioinformatics

Bioprocesses

Genomics

Enzymology

Bioreactors

Recombinant DNA technologies

General Molecular Biology Techniques

Microbiology/ Virology/ Microbial Ecology

Cell/tissue culture


-

Figure 22: Requirements for Various Technology Platforms

0 2 4 6 8 10 12 14 16

Biomaterials

Processing of Blood Products and Substitutes

Viral vectors

Tissue engineering

Combinatorial Chemistry

Protein Work

Structural Biology

Natural Products Chemistry

Embryo manipulation

Hybridization

Molecular modelling

Classical/Traditional Breeding

Cell Receptors/ Signaling/ Pheromones

Drug Delivery

Molecular Synthesis

Hormones and growth factors

Lipid/protein engineering

Extraction/ Purification/ Separation

Transgenesis

Pharmaco-genomics

Antibodies

Bio-nanotechnology

Vaccines/Immunology

Microbiology/ Virology/ Microbial Ecology

Enzymology

Proteomics

Bioreactors

DNA work

Diagnostics

Gene probes/DNA markers

Genomics

Fermentation

Peptide/Protein Sequencing/Synthesis

Biochips

Molecular High Throughput Screening

Recombinant DNA technologies

Bioprocesses

Cell/tissue culture

Bioinformatics

DNA Sequencing/ Synthesis/ Amplification


2.2.7 Biological Resources

A number of biological resource centres have been established by research groups and companies in the course of

their work. These are listed in Table 2. They have been identified through secondary sources and may not represent

a complete list. South Africa has a wealth of resources at its disposal that include a vast diversity of plant, animal

and microbial life, an excess of clinical cases and pathology samples of globally important diseases such as

HIV/AIDS, tuberculosis etc., and a human population that represents around 90% of the world’s genetic diversity.

These resources are potentially invaluable sources of novel molecules and information on disease mechanisms,

drug efficacy etc., and need to be preserved and protected to ensure that maximum benefit is realized locally. The

establishment of a biorepository in South Africa has been proposed by a consortium in the Western Cape. The

biorepository would allow the supervised exploitation of our vast clinical and pathological resources for the

development of breakthrough diagnostics, prognostics and therapeutics. It has been proposed that the

biorepository serve as a central store for clinical samples available to all stakeholders involved in human health

research and development. It is important that more such initiatives are established and that measures are taken to

avoid the flow of our resources and potential IP out of the country.

Table 2. Resource Collections in South Africa

Organization Collection Description

University of Stellenbosch,

Neuropathology Unit

Brain bank Fully archived surgical and medical neurology, paediatric neurology

and forensic neuropathology samples collected since 1977, in many

instances with relevant CT/MR images. The collection is being

continually updated and is a national resource, available for research

by all academic institutions.

ARC-Infruitec-Nietvoorbij, Viticulture

Division: Wine, Table and Raisin

Grapes

Grapevine Genebank The grapevine gene bank provides genetic resources for viticulture,

material for cultivar evaluation, and raw material for taxonomic,

physiological and plant pathological studies. A database for

ampelographic, phenological and viticultural data of different cultivars

has also created and can be used by students and researchers.

University of Cape Town, Division of

Chemical Pathology

UCT Wildlife Cell Bank A major fibroblast cell culture collection of free-ranging Southern

African wildlife developed over the last 18 years. The collection

includes more than 50 species of mammal, and large numbers of

individual samples for some species represented in the bank. This

represents probably the second largest such bank in the world, and

is unique in the variety of species represented.

University of Cape Town, Tissue

Typing Unit, Department of

Immunology

South African Dialysis and

Transplantation Registry

The unit collects and collates information and publishes an annual

report for the South African Dialysis and Transplantation Registry that

covers activities of all the units in South Africa where dialysis and/or

transplantation is performed.

University of Cape Town, Tissue

Typing Unit, Department of

Immunology

South African Bone Marrow

Registry

The South African Bone Marrow Registry collects and lists

prospective bone marrow donors locally and serves as a hub for

procuring unrelated donors for both local and international

transplantation.

Medical Research Council,

Department of Pharmacology,

University of the Western Cape

TRAMED-III - traditional medicines

database

The traditional medicines database, TRAMED-III, has information on

botanical taxonomy; plant vernacular names; and reported medicinal

treatments, chemical information, pharmacological and toxicological

content.


Programme on Mycotoxins and

Experimental Carcinogenesis

(PROMEC)

Cancer Registry PROMEC operates a population-based cancer registry in the

Transkei region of the Eastern Cape Province. The registry provides

basic data on spatial and temporal changes in cancer patterns in the

region, particularly with respect to oesophageal cancer.





(PROMEC)

Transkei region of the Eastern Cape Province. The registry provides

basic data on spatial and temporal changes in cancer patterns in the

region, particularly with respect to oesophageal cancer.




(PROMEC)

MRC Fungal Culture Collection More than 7 000 cultures, mainly Fusarium species, other toxigenic

species and medically important fungi, are preserved and maintained

by either lyophilisation (freeze-drying), at -80°C in glycerol, distilled

water or agar slants. The collection is unique from both a food-borne

and pathogenic fungal point of view and is one of the largest

collections of Fusarium cultures as well as toxigenic fungi in the world

Medical Research Council, Clinical &

Biomedical Tuberculosis Research

Unit

WHO TB specimen bank This is a collaborative project with the WHO and two other countries

aimed at developing a well-characterized specimen bank from TB

patients from various feeder clinics in the urban and peri-urban areas

of Durban.


Department of Food Science

Culture collection of food bacteria A culture collection of bacteria relevant to the food industry

Rhodes University, Department of

Botany, Selmar Schonland

Herbarium

Herbarium Approximately 200 000 plant specimens

National Botanical Institute,

Compton Herbarium

Herbarium Data bank and information centre on the winter-rainfall flora of South

Africa

National Botanical Institute, National

Herbarium Pretoria

Herbarium Largest herbarium in Africa and includes the Saasveld Herbarium and

the Forestry Herbarium.

National Botanical Institute, Audrey

Moriarty Southern Cape Herbarium

Herbarium Herbarium run by the George Botanical Gardens.

Medical Research Council, South

African Cochrane Centre

African Trials Register (ATR) The African Trials Register is a database of controlled trials performed

in Africa. There are currently 2250 records in the register, 1417 of

which are RCTs and 794 CCTs. The remaining 39 records are cohort

and other non-randomised trials. A total of 1160 records were

identified from journals published on the African continent, with the

remainder from journals published elsewhere.

Natal Herbarium Herbarium The Natal Herbarium is a centre for the study of the indigenous plants

of the eastern region of South Africa. This region includes three of the

IUCN internationally recognised centres of plant diversity

University of the Free State,

Department of Microbial,

Biochemical & Food Biotechnology

MIRCEN Yeast Culture Collection

and database

An extensive and unique yeast culture collection which consists of

more than 2 000 yeast cultures representing 90 different genera and

more than 420 species. The collection is continuously expanded by

the depositing of yeasts with unique characteristics isolated from

various southern African habitats. It also serves as a depository for

cultures from S.A. Breweries, SASOL Ltd and AECI Ltd.


Department of Haematology and

Cell Biology

STR allele frequencies database A database for STR allele frequencies for the population of the Free

State.

University of Pretoria, Forestry and

Agricultural Biotechnology (FABI)

TPCP Culture Collection The culture collection of the TPCP currently consists of more than 10

000 cultures of mainly plant pathogenic fungi related to forestry

diseases. This includes one of the largest collections of

Ophiostomatiod fungi in the world, as well as populations of

Sphaeropsis, Botryosphaeria, Cryphonectria, Lasiodiplodia and

Fusarium.

University of Pretoria, Faculty of

Veterinary Science

Onderstepoort Animal Blood bank Animal Blood bank

Technikon Pretoria, Centre for

Tissue Engineering

Tissue bank Cell and tissue banking and transplantation



Tissue Engineering


Department of Microbial,

Biochemical & Food Biotechnology

Mucoralic Fungus Culture

Collection

Mucoralic Fungus Culture Collection


Department of Plant Pathology

Fungal Culture Collection Fungal Culture Collection

ARC-Plant Protection Research

Institute

National Collection of Fungi National Collection of Fungi

SA Bureau of Standards SABS collection of Bacteria and

Fungi

SABS collection of Bacteria and Fungi

University of the Witwatersrand,

Pneumolocal Diseases Research

Unit

Culture Collection of medically

important Bacteria and Fungi

Culture Collection of medically important Bacteria and Fungi

Medical Research Council, National

Tuberculosis Research Programme

South African Mycobacterial Culture

Collection

South African Mycobacterial Culture Collection

ARC-Infruitec-Nietvoorbij Infruitec Culture Collection Infruitec Culture Collection


Institute (Roodeplaat)

South African Rhizobium Culture

Collection

South African Rhizobium Culture Collection

University of the Witwatersrand,

Department of Haematology

DNA databank The DNA databank, comprising of patient specimens is continually

being added to over time. There is an on going collaboration with the

SAPS forensic sciences laboratory in setting up a National DNA

database and DNA bank, for the purposes of forensic identification,

validation of STR technology and the identification of possible

diagnostically important loci.

Potchefstroom University for CHE,

School of Pharmacy

Data bank on pharmaceutical raw

material specifications

These specifications will include data on inter alia crystal size and

form, optical and chiral purity and any other property necessary to

ensure product safety, quality and efficacy

Potchefstroom University for CHE,

Department of Botany

Uni-algal culture collection Algal species found in water systems

Health Knowledge Network Health Knowledge Network

( http://www.sahealthinfo.org/ )

The health knowledge network is a health information resource that

offers information on HIV AIDS, alcohol and drug abuse, chronic

disease prevention, novel drugs, nutrition, tuberculosis, malaria and

other health issues in Southern Africa

National Botanical Institute, Ria

Olivier Herbarium (

Herbarium This collection covers material collected from rivers, estuaries and the

sea. The herbarium consists primarily of specimens collected along

the Eastern Cape coastal plain and contains a collection of

macroalgae.

Medical Research Council, Cancer

Epidemiology Research Group

South African National Cancer

Registry

South African National Cancer Registry

ARC-Small Grain Institute Small Grain Germplasm Collection The collection represents the only one of its kind, and is available to

all interested parties in South Africa

ARC-Grain Crops Institute Groundnut, Soybean and Sunflower

Germplasm Collections

The sunflower germplasm collection consists of 1075 entries which

are renewed in a ten year cycle. The soybean germplasm bank at

Potchefstroom consists of 2162 true breeding lines and populations.

The working collection consists of 250 of these entries and the base

collection includes the other 1912 entries. A database with all the

relevant information is kept and updated annually. The collection is

freely available to interested persons.

ARC-Vegetable and Ornamental

Plant Institute

Fynbos genebank A unique collection of living plants, identified for their economic

horticultural traits and representing biodiversity in the species



ARC-Onderstepoort Veterinary

Institute

Type and secondary worm

collection

Type and secondary worm collection including more than 100

species, described first in South Africa, that affect animals

ARC-Animal Improvement Institute National Allele Database and

National DNA Reference Catalogue

A national reference DNA catalogue to store and index DNA samples

collected by animal owners

Council for Scientific and Industrial

Research, Bio/Chemtek

Mycelial fungi, yeast and bacterial

culture collection

Includes >4,500 isolates from >400 species of mycelial fungi, yeast

and bacteria

Council for Scientific and Industrial

Research, Bio/Chemtek

Indigenous Plant Extracts Library Collection >11,000 plant extracts


SECTION D: THE BIOTECHNOLOGY INDUSTR Y

ENVIRONMENT IN SOUTH AFRICA

This section discusses aspects of the environment in which biotechnology groups operate in SA, including the

various organizations that lend support to biotechnology stakeholders, legislation relevant to biotechnology, the role

of government in biotechnology, strategies and initiatives that affect the industry, and funding for biotechnology.

1. Government Involvement in Biotechnology

There are a number of different departments in national government playing a role in the biotechnology industry in

SA. These departments and their involvement in the industry are detailed below.

1.1 Department of Science and Technology (DST)

The Department of Science and Technology (DST) is the lead department with respect to biotechnology (and R&D

in general) in South Africa. It also co-ordinates the biotechnology-related activities of all other departments and

interacts directly with Treasury with respect to public funding of biotechnology interventions. DST’s involvement in

biotechnology includes, among others, the drafting and implementation of the National Biotechnology and National

Research and Development Strategies, coordination of the GODISA programme, and overseeing the activities of

the NRF and NACI.

1.1.1 South African National Biotechnology Strategy, 2001

( http://www.dst.gov.za/programmes/biodiversity/biotechstrategy.pdf )

The South African National Biotechnology Strategy, published in June 2001 (19), outlines the intentions of

government to focus and co-ordinate interventions aimed at stimulating the development of biotechnology

(particularly 3rd generation) in South Africa. The strategy was developed by a core academic and policy team under

the direction of DACST, and also involving the Department of Trade and Industry (DTI), the Department of Health

(DoH), the Department of Environmental Affairs and Tourism (DEAT), and the National Department of Agriculture

(NDA). It was passed by cabinet following a public feedback process.

In developing the strategy for South Africa the expert panel considered experience and benchmarks from other

countries, successful in biotechnology. The main conclusions drawn from this exercise included the need for a well-

resourced body to champion biotechnology nationally, a deliberate effort to build scientific and technological

capacity and the need to do the latter in response to explicit national and international needs for products and

processes. The key interventions currently being implemented as a result of the strategy include the following:

- The creation of a number of Biotechnology Regional Innovation Centres (BRIC’s) to manage the

dissemination of funds for biotechnology projects and to stimulate the creation, successful protection and

exploitation of new intellectual property

- The creation of a National Bioinformatics Network (NBN) to develop capacity and support services in

bioinformatics


- The development of Biological Resource Centres (BRC’s) to ensure the adequate protection and optimal

use of SA’s biodiversity

- The establishment of a Biotechnology Advisory Committee (BAC), which will be the responsibility of

National Advisory Council on Innovation (NACI), to implement the strategy, co-ordinate R&D, and address

national ethical issues

- The establishment of a Bioethics Committee

- The development of public understanding of biotechnology

Other issues requiring attention, discussed in the strategy, include the incentivising of investment in the BRIC’s by

the biotechnology industry through the DTI; the prioritization of specific national imperatives such as the

development of a HIV vaccine; the review and amendment of the existing legislative framework, e.g. revision of the

Patents Act; the seeking of international co-operation for technology procurement, particularly through the BRIC’s

and existing bilateral agreements; the establishment of a venture capital fund and incentives to support private

sector R&D; and the development of the appropriate human resources.

The BRICs and NBN are discussed in more detail in Section 2. The Public Understanding of Biotechnology (PUB)

programme will promote clear, balanced, and broad understanding and public awareness of biotechnology and its

potential applications. The Foundation for Education, Science and Technology (FEST), which now falls under the

NRF, is the appointed implementing agency of the PUB programme. FEST has been granted R15 million from DST

over a three-year period to promote dialogue and debate on biotechnology issues, including genetic modification,

and to provide a single biotechnology vision for South Africa. The target audience includes all facets of society, with

an emphasis on consumers, educators and learners. PUB will focus on new, innovative approaches to reach and

involve diverse audiences, and will disseminate accurate and factually correct information on biotechnology.

1.1.2 National Research and Development (R&D) Strategy

( http://www.dst.gov.za/legislation_policies/strategic_reps/sa_nat_rd_strat.pdf )

South Africa published its R&D strategy in August 2002. The biotechnology strategy directly defines the

Government’s intentions with respect to biotechnology, and the R&D strategy modifies this slightly and

contextualizes biotechnology within the broader intent of developing South Africa’s competitiveness in the global

knowledge economy. The R&D strategy was also published a year later and suggests further development in the

South African Government’s strategy. As an example, the R&D strategy places relatively more emphasis on

integrating the National System of Innovation. It recognizes that meaningful innovation occurs at the interface

between research institutions and industry, and that only industry can create products and services, employment

and wealth.

The concept of a National System of Innovation (NSI) was first introduced in the White Paper on Science and

Technology published by DACST in 1996 (4). The NSI is defined as "a set of functioning institutions, organisations

and policies which interact constructively in the pursuit of a common set of social and economic goals". Enhanced

innovation in SA has the potential to achieve the following national development imperatives:

• accelerated economic development

• sustainable development for poverty alleviation

• rural development


• small business development

• human resource development

• black economic empowerment

• infrastructure development

The NSI depends largely on the science and technology institutions and on the development of highly skilled

manpower. The government is encouraging innovation through the establishment of programmes to support the

development, commercialization and application of new biotechnologies and to facilitate technology transfer and

technology diffusion. Also being addressed are the improved use of value chains and the existing science and

technology infrastructure, and further integration of these into local economic and provincial growth and

development strategies. The R&D strategy will be used to co-ordinate existing institutions and initiatives such as the

biotechnology strategy and the incubation and economic development programmes, in order to improve the

efficiency of South Africa’s R&D and innovation system, which has been fragmented to date.

The R&D strategy rests on 3 pillars, namely:

Innovation

Science, engineering and technology (SET) human resources and transformation

Creating an effective government science and technology system

The innovation pillar involves the creation and funding of a range of technology missions. One of the key missions is

biotechnology. A dedicated institution, the Foundation for Technological Innovation (FTI) will operate as a

knowledge-based financing agency concentrating on innovation within each of the technology missions. It will fund

innovation across public and private sectors, and across the value chain from concept to market and will be

directed by DST. Its key focus is high-cost development and market acceptance stages through commercialization,

incubation and diffusion.

The strategy recognizes an important systemic weakness in South Africa, described as the ‘innovation chasm’, the

gap between research and successful and sustainable commercialization. This gap needs to be bridged by

appropriate long-term measures and dedicated institutions providing innovation support. Specifically, disparate

innovation, incubation and diffusion initiatives need to be coordinated and focused on strategically important

technology missions. The strategy suggests that national excellence can be achieved by focusing our basic science

on areas where we are most likely to succeed because of important natural or knowledge advantages. One of

these key areas is the confluence of indigenous knowledge and indigenous biotechnological resources, such as

plants or microorganisms.

An important new intervention proposed by the strategy is the establishment and funding of an Intellectual Property

Fund (IPF), which will assist in identifying and protecting competitive IP, so that it can be exploited to the benefit of

the country. Another vital area is human resource development. The NRF is adopting a highly targeted approach

towards increasing excellence in mathematics and the sciences among black matriculants and young women. It is

recognized that the establishment of new Centres of Excellence will be required in order to draw young people

towards careers in scientific research and to ensure that such careers are sustainable.


With respect to appropriate and effective government support, the strategy specifically recognizes the importance

of integrated and seamless funding of the functions of basic research, innovation and venture capital. Venture

capital stimulation and fiscal incentives to stimulate the private sector are the responsibility of the Department of

Trade and Industry and its agency, the Industrial Development Corporation (IDC). All government departments

contributing to the innovation system will be coordinated by the DST. The R&D strategy depends on doubling

government investment in science and technology over the next 3 years and is consequently characterized by the

introduction of key measurable performance indicators as benchmarks.

1.1.3 Biotechnology Road Mapping Exercise

The Biotechnology Roadmapping Project, initiated in 2002, is linked to the implementation of�the National

Biotechnology Strategy, and follows on from DST’s Foresight study. The latter identified the key technology areas

that will play a pivotal role in driving and growing existing and new economic areas as being Information and

Communication Technology, Advanced/New Materials and Biotechnology. The Biotechnology Roadmapping

Project was initially aimed at mapping future human resource, research and development, and infrastructure needs

and identifying strategic actions to ensure the future competitiveness of the industry. The focus has since shifted to

mapping issues directly related to competitiveness. Thus, the final plan will assist in developing strategies for future

markets and technological products or services to support the country’s competitiveness, and will influence the

application of government instruments within the next 1-3 years, with longer-term consequences. The project has

been coordinated by the Medical Research Council (MRC) and is in the final stages of development.

Several working groups were established in 2002 to develop roadmaps for the various focus areas, e.g. human

health, plant biotech, animal health and animal production, industrial processes, mining and environmental

biotechnology, new biotechnology platform/clusters (e.g. marine & aquaculture biotechnology, speciality

biotechnology, bioneutralising technology to neutralize bioweapons, bioenergy), and human resources and skills

development, infrastructure needs and funding requirements. The technology roadmaps developed by these

groups have been assembled into a final report summarizing the future technology requirements for SA (5).

Five key platforms have been identified as being high priority, i.e. genomics, transgenesis, cell and tissue culture,

process and product technologies and convergence technologies. A number of sub-technologies and subsidiary

technologies were defined for each and analyzed in terms of existing capacity, and major gaps and barriers to its

further development. Sub-technologies common to all 5 platforms were found to be functional genomics, high

throughput screening, bioinformatics, gene expression analysis, biosafety and high throughput genome

sequencing. This list closely mirrors the key technology platforms identified in the current survey as being required

by stakeholders within the next 5 years, i.e. DNA sequencing/synthesis/amplification techniques, cell/tissue culture,

recombinant DNA technologies, bioinformatics, biochips, and molecular high throughput screening. The report, due

to be released shortly, maps a plan for the development of the key technologies over the next 5-10 years and

provides an in depth analysis of the driving forces behind the opportunities for improvement.


1.1.4 GODISA Incubator Programme

The GODISA programme is managed by the DST, and supported by the DTI, the Department of Labour and the

European Union. It focuses on stimulating the SMME sector by establishing sector-specific incubation facilities,

support centres and technology demonstration centres. Facilities established to date include the following:

Technology Incubation Centres:

- eGoli BIO Life Sciences Incubator

- Acorn Technologies

- Brainworks Technology Incubator

- Gauteng Software Incubator (SoftStart)

- South African Chemical (SAC)/CHEMIN Incubator

- Timbhale Technology Incubator

Technology Demonstration Centres:

- Zenzele Technology Demonstration Centre

Innovation Support Centres:

- Kwazulu Natal Innovation Support Centre (Voxel Support Centre)

The eGoli BIO and Acorn Incubators, situated in Modderfontein and Cape Town, respectively, are focused on

biotechnology, and are discussed in more detail in Section 2.

1.1.5 National Advisory Council on Innovation (NACI) ( www.naci.org.za )

The National Advisory Council on Innovation (NACI) was created by legislation [NACI Act of 1997] to advise the

Minister of Science and Technology on the role and contribution of science, mathematics, innovation and

technology, including indigenous technologies, in promoting and achieving national objectives. NACI falls under the

auspices of DST and is particularly involved in managing and developing South Africa’s Innovation System. It played

a key role in the development of the R&D strategy and is likely to play a pivotal role in its implementation. The NACI

website is a particularly useful source of links to information on science and technology in SA and different national

and international funding streams

1.1.6 National Research Foundation (NRF) ( www.nrf.ac.za )

The National Research Foundation is an autonomous statutory body established “to support and promote research

through funding, human resource development and the provision of the necessary research facilities in order to

facilitate the creation of knowledge, innovation and development in all fields of science and technology, including

indigenous knowledge and thereby to contribute to the improvement of the quality of life of all people of the

republic.” The ultimate aims of the NRF are to improve the quality and quantity of research outputs and patents,

and the numbers of R&D staff and researchers, hopefully resulting in increased participation in the global

knowledge economy and increased competitiveness. The NRF is the major body responsible for funding research

and human resource development at higher education institutes (HEI’s) in SA, and is a key player in the National

System of Innovation. It is responsible for the full innovation value chain and manages the National Facilities as well

as the Innovation Fund (17). The foundation therefore plays a vital role in the development of biotechnology in SA.


1.2 Department of Trade and Industry (DTI)

The DTI is mandated to support industry development with technology, and specifically biotechnology, as one of its

focal areas. Support is provided in the form of funding through incentive schemes, information on potential markets,

and marketing of local products abroad. Whilst DST is more concerned with R&D the DTI is focused on innovation

and commercialization of biotechnology, although under the direction of DST. In particular the DTI is responsible for

modification of the Patents Act and the establishment of a venture capital fund through its agency, the IDC. It will

promote South African biotechnology internationally and seek further investment for the industry, for example, by

interacting with industry and the Treasury to identify appropriate incentive and fiscal measures to stimulate the local

biotechnology industry. The DTI specifically represents the interests of the private biotechnology industry sector.

The IDC also invests in specific, usually relatively large (in excess of R50 Million), projects related to particular

industries. Although biotechnology is not a current industry sector, the IDC does invest in both agro-industries and

the chemical sector, each of which applies biotechnology. The IDC also supplies consultants to assist with

business planning and research. The DTI and the IDC have made significant contributions to the development of at

least 3 of the existing core biotechnology companies in SA through investment and assistance with foreign trade. In

addition, the IDC contributed to the establishment of SA’s first dedicated biotechnology venture capital fund,

Bioventures.

Trade and Investment South Africa (TISA), a division of the DTI, liaises with provincial agencies to co-ordinate

export and investment opportunities. In particular, TISA focuses on promoting sectors of the South African

economy that show the greatest growth potential and marketability. These sectors include: agro-processing,

textiles and clothing, leather and footwear, automotive and transport industries, cultural industries, tourism,

information and communications technology, chemicals and biotechnology, and metals and mineral beneficiation

and capital equipment.

1.3 Department of Health ( DoH)

The DoH is particularly concerned with identifying new prevention and treatment strategies for pandemics and

diseases such as HIV/AIDS, TB and malaria. It will support the development of and will use, for example a HIV

vaccine developed by means of biotechnology through the South African AIDS Vaccine Initiative (SAAVI). The

department is also concerned with ethics, and will coordinate the National Bioethics Committee and advise the

BAC. Legislation falling within the responsibility of the DoH that is relevant to biotechnology includes the registration

and regulation of medical products and the labeling of foodstuffs, e.g. the GMO content.

1.4 National Department of Agriculture (NDA)

The NDA implements the GMO Act and the Plant Breeders Act and is involved with the issues relating to

indigenous knowledge systems. It is specifically involved with biosafety issues and will advise the BAC on this. The

department has released a Strategic Plan for South African Agriculture in which it defines its future role in the

sector. A major function of the department is the conservation of natural resources through sustainable agricultural

practices.


1.5 Department of Environmental Affairs and Tourism (DEAT)

The Department of Environmental Affairs and Tourism’s primary involvement in biotechnology is in developing

indigenous knowledge protection legislation under the leadership of DST, and regulations for the exploitation of our

biodiversity. The department has published a White Paper on Conservation and Sustainable Use of SA’s biological

diversity ( www.polity.org.za/govdocs/white_papers/diversity.html ) and is currently drafting the Biodiversity Bill and

the Protected Areas Bill, which could have significant implications for all levels of government, industry and

business. The broad aim of the 2 bills is to ensure the sustainable use of the country’s unique biodiversity and to

ensure that it remains for the “common good.” Biodiversity inherently belongs to all and consideration needs to be

given to the application and distribution of rights for the marketing, development and use of biodiversity. The

Biodiversity Bill will set the guidelines for the sustainable use of biodiversity and, as such, will be crucial legislation in

defining and determining biodiversity’s role in biotechnology. Also relevant to biotechnology is the DEAT’s role in

regulating the transfer of technology and materials into and out of South Africa.

1.6 Department of Labour ( DoL)

The DoL has committed to funding human resource development through the Skills Development Act and the

Human Resources Development Strategy. A National Scarce Skills Financial Assistance Scheme is currently being

established by the NRF in partnership with the DoL and DST to address scarce skills, including those relevant to

biotechnology. These departments will be responsible for ensuring scarce skills training especially in SET in HEI’s.

The allocation of resources from the National Skills Funds for bursaries and scholarships will be recommended by

the DoL. Funding for the training of black and woman students in scarce skills will be prioritized, with an emphasis

on quality. It is recognized that a long-term commitment is required to ensure that students are guaranteed funding

for the completion of their studies. As a part of the scarce skills schemes, DoL will provide funding amounting to

R10 million for human resource development in bioinformatics, in partnership with the National Bioinformatics

Network. These funds will be managed by the NRF. Other programmes for training in scarce skills relevant to

biotechnology are planned.

1.7 Department of Education ( DoE)

The DoE promotes curriculum development in line with the needs identified in the R&D strategy – essentially for

mathematics, science and life skills. It is the department responsible for coordinating tertiary level education, for

example specialized biotechnology education, and it determines the level of financial support of research at

universities and technikons. The department’s National Plan for Higher Education was developed for the

transformation of and the provision of increased and broadened access to higher education. An important objective

is the development of human resources to provide the necessary skills for the knowledge economy and to ensure

that staff profiles begin to reflect the race and gender balance of SA. Other issues include language policies in

higher education, especially in relation to indigenous languages, and a greater emphasis on research.

Included in the National Plan is the intention to reduce the number of universities in SA to 11 and technikons to 6

through a series of mergers, and to add 4 “comprehensive institutions” and 2 National Institutes for Higher

Education in provinces where no higher education facilities currently exist. The Department of Education will be

responsible for the mergers, and the Government will provide the financial resources necessary to facilitate the


mergers and to ensure the stability and sustainability of institutions. It is anticipated that the first group of mergers

will take place in January 2004 and the second group in 2005. In addition to the mergers, National Institutions for

Higher Education will be established in Mpumalanga and the Northern Cape, to allow for the coordinated provision

of higher education in regions of the country where there is no university or technikon. Resources have been set

aside for the establishment of a National Higher Education Information and Applications Service. The two most

significant outcomes of the National Plan on Higher Education with respect to research are research concentration

and funding linked to outputs, and increased graduate enrolments and outputs at the masters and doctoral level.

The implementation of the National Plan for Higher Education will have a significant impact on the biotechnology

industry, both in terms of human resource development to feed into the industry and the increased integration of

diverse research activities to create collaborative, multi-disciplinary research efforts that have sufficient critical mass

to make an impact.

1.8 Legislation Relevant to Biotechnology

Patents in SA are governed by the Patents Act of 1978. Two amendment bills were passed in 1997, the Counterfeit

goods bill and the Intellectual Property Laws Amendment bill, to bring South Africa's laws into conformity with

international trade obligations under the trade related intellectual property agreement of the World Trade

Organization. The National biotechnology Strategy highlights the requirements for a review of the patent legislation,

which will be the responsibility of the DTI.

The Genetically Modified Organism Act, Act 15 of 1997 (GMO Act), implemented in November 1999, covers

biosafety issues for most genetically modified products, including the requirement for a full risk assessment before

the introduction and commercialisation of GM crops in South Africa. It provides for the establishment of an

Executive Council (EC), which makes decisions on all applications for work with GMOs, a Scientific Advisory

Committee, which reviews the human and environmental safety of GMOs and advises the EC, a Registrar to

administer the GMO Act on behalf of the Minster of Agriculture and issue permits, and an Inspectorate to monitor

and inspect local work with GMOs. The EC is made up of representatives from 6 government departments, while

the Scientific Advisory Committee consists of a panel of scientists. The Act also makes provision for public

notification of GMO work.

Also related to GMOs are the regulations for the labeling of food derived from genetic modification, released by the

Department of Health, and the Cartagena Protocol on Biosafety, which is the responsibility of the Department of

Environment and Tourism. Agricultural products, including biological control products, are regulated by the

Department of Agriculture through Act 36 of 1947, while the development of new crop cultivars is governed by the

Plant Breeders Act. The Biodiversity and Protected Areas Bills will guide the use of biodiversity for biotechnology.

The Medicines Control Act no. 101 of 1965 governs the registration and use of any substances of medical

importance, excluding medical devices. A review of this act is pending. In addition to the above legislation, South

Africa has signed bilateral agreements with at least 12 countries that include co-operation on biotechnology.


2. Support Services for Biotechnology

2.1 Market Opportunity for Support Services

A clear constraint in the biotechnology industry in SA is the lack of business support for commercialization of IP,

particularly for those stakeholders from the research community. As part of the survey, stakeholders were asked to

indicate which support services they currently make use of, which support services they require but are unavailable

to them, and which support services they are likely to require within the next 5 years. The results are represented in

Figure 23. The aim of the question was to assess the market opportunity for support services in biotechnology.

Therefore, where stakeholders indicated that the services were provided in-house or were not for biotechnology,

these entries were not included in the analyses. The figure therefore represents only those support services that are

likely to be outsourced (60/73 stakeholders that answered the question).

Figure 23: a.) The Current Use of and Future Requirement for Support Services in Biotechnology

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Figure 23.a does not show any clear trends in support service usage or requirement, except for the fact that

financial management and legal services are used by the highest number of participating stakeholders. In most

cases, the financial management services are attributed to surveyors, rather than to the provision of strategic input

into financial management. A smaller number of stakeholders than expected indicated that they would be requiring

support services in the future.

The highest revenues were spent on marketing, followed by legal services and financial management. If one ignores

those revenues attributable to surveying services, the total spend on support services in biotechnology for last year

from those that provided this data was just over R2 million. This does not represent a significant market opportunity

for the support services sector, and at present there are only a small number of dedicated biotechnology service

providers. The primary difficulty in this regard is the inherent shortage in funds for commercializing products, which

means that even less money is available to pay for consulting services in this area. This is where the government-

funded incubators and BRICs will play a crucial role, in that they are designed to provide services at subsidized

rates and can therefore reach a higher number of stakeholders. With the growth in the industry in response to

government and other interventions, the demand for support services is set to grow. This relates not only to

business support services but also to other types of support services, such as laboratory and raw materials

suppliers, core technology services, product testing services etc.

2.2 Existing Support Services for Biotechnology

The survey identified at least 196 organizations and companies that currently offer direct or indirect support to

biotechnology in SA. These include entities that provide business or legal support, suppliers of raw materials and

scientific tools, incubators, venture capital firms etc. It is not practical to list all potential companies that may

indirectly interact with or assist biotechnology stakeholders. The database, therefore lists only those that have

shown a direct interest in biotechnology to date, with the exception of the venture capital/private equity firms, which

are all listed regardless of whether they have expressed an intention to invest in biotechnology or not.

The most relevant support structures for the development of biotechnology in SA are the Biotechnology Regional

Innovation Centres, the National Bioinformatics Network, the GODISA-funded incubators, and the technology

transfer offices associated with the universities.

2.2.1 Biotechnology Regional Innovation Centres

As mentioned previously, the National Biotechnology Strategy (19) makes provision for the establishment of BRICs,

which will serve as a vehicle for the channeling of funds into biotechnology by DST. The first BRICs were

established early this year. There are 4 BRICs in total, Cape Biotech, BioPAD, ECoBio, and PlantBio. An Inter-BRIC

Forum allows collaboration between the BRICs and a forum for dealing with common issues. The Cape Biotech,

BioPAD, and ECoBio BRICs have been awarded R12.5m for 2002, R32 million for 2003, R39 million for 2004 and

R52 million for 2005, while the PlantBio BRIC will receive a minimum of R7 million in years one and two and R42

million in year 3. The strategies of the individual BRICs are discussed below.


2.2.1.1 BioPAD ( www.biopad.org.za )

The Biotechnology Partnerships and Development (BioPAD) BRIC was established by DST as one of five national

innovation and support centres following the publication of the National Biotechnology Strategy. A CEO was

appointed for BioPAD early this year, and, more recently, an Operations Manager. A trust will be established to

administer the funds from DST. A key goal of BioPAD is to set up companies and stimulate economic growth. The

BRIC has committed to funding a broad portfolio of projects in the areas of animal health, industrial, mining and

environmental biotechnology. Four strategic thrusts have been initiated, viz,

1. BioPAD Seed Capital Alliance Platform for Enterprise (BioSCAPE): Via BioSCAPE additional funds will be

leveraged from other investment sources to supplement DST support and to create a seed capital fund.

2. Vaccines and Enhanced Therapeutics Platform for Animals (VETPLAN): World renowned Institutes active in the

area of animal health and production, such as the University of Pretoria, Onderstepoort Veterinary Institute

(OVI), and Onderstepoort Biological Products, will be supported via platforms to cover areas such as DNA

vaccines, unique drug delivery systems, and genetic approaches to breeding disease resistant animals.

3. Bioresource Centres Platform (BioCEP): Seed collections, Fungi collections Gene libraries and breeding

programmes at various institutes will be supported in order to maintain and exploit our natural heritage.

4. Microbial Technology Platform (MiTEP): The exploitation of microorganisms and enzymes in the areas of

environmental bioremediation, waste beneficiation, bioconversion industries and process research underpins

the core activity of this initiative.

BioPAD will take equity in key ventures and royalties from others. It will also work closely with eGoli Bio and

industrial partners for the incubation of projects. BioPAD has recognized its role in facilitating increased networking

by engaging its stakeholders and other industry sectors in order to build a collaborative network that supports the

development of new biotechnology businesses. BioPAD will seek to harness the national skills, expertise and

technology platforms whilst acquiring cutting edge technologies internationally where appropriate. The BioPAD

BRIC will fund consortium-based, biotechnology projects at different stages of the development value chain

through a number of models, including venturing and licensing.

2.2.1.2 Cape Biotech ( http://www.capebiotech.co.za/ )The Cape Biotechnology Initiative (CBI) was established in December 2001 to facilitate networking and information

sharing among biotechnology stakeholders in the Western Cape. The CBI, now known as Cape Biotech, was

incorporated as a section 21 company in 2002 and led the Western Cape’s bid for a BRIC. Cape Biotech was

awarded funding by DST to develop projects in the human health and industrial bioprocessing focus areas. The

Cape Biotech team includes a CEO, appointed in January 2003, a business analyst, a knowledge/public relations

manager, a chief financial officer and an executive assistant. A project manager will be appointed at a later stage.

Cape Biotech promotes and develops the Biotechnology sector in the Western Cape, and represents the interests

of all stakeholders in the region, including industry, academia, government and service providers to the sector. Its

two major functions are industry stimulation and capacity creation, and investment of government funds in

promising biotechnology projects. A trust is being established under the banner of Cape Biotech to manage this

process.


16 projects, approximately 75% of which are in human health and the rest in industrial biotechnology, have been

short-listed for potential inclusion in Cape Biotech’s project portfolio. A strategic framework has been developed to

guide investment decisions. The strategy provides for the identification of relevant technology projects based on

market attractiveness and current capacity and strengths in the region, with the aim of developing technology

platforms that will increase the competitiveness of regional projects. An assessment tool that considers 75 different

aspects of the biotechnology projects across 3 high level dimensions was developed to score projects aimed at

developing specific products or services. Projects selected using this system will undergo a due diligence and

contracting process before funding is committed.

2.2.1.3 ECoBio ( http://www.ecobio.co.za )

The East Coast Biotechnology Consortium (ECoBio) includes a number of biotechnology stakeholders primarily

from the East Coast region, including the area stretching from Nelspruit, through Durban, Pietermaritzburg, to

Grahamstown, and Port Elizabeth. ECoBio has been awarded funding by DST to set up a BRIC that will fund

projects in human health and bioprocessing. A business plan was submitted to DST in mid-February and approved

in late March. The CEO post has been advertised, and is likely to be appointed in September 2003. ECoBio has

appointed a board of trustees and is finalizing the registration of a trust (Deed of trust was lodged with the Master

of the High Court in June). The University of Natal is the lead organization in ECoBio, and will enter into a financial

management contract with the trust to administer the BRIC funds. ECoBio is setting itself up to provide business

and commercialization support services, including legal, accounting, financial, personnel, business planning, and IP

management services to funded projects, occasionally using external service providers. Five projects from a total of

33 applications have been reviewed and short-listed for funding in the first phase i.e. first half of the current financial

year. An independent IP due diligence is currently underway, after which full business plans will be commissioned.

The first biotechnology projects will be funded later this year. A decision has been taken on 3 Regional Technology

Platforms that will be funded in the short term, with seed funding being controlled by ECoBio. These include: the

setting up of an integrated functional genomics and proteomics platform; establishment of a contract/clinical

research organization and a data management system for clinical trials; and establishment of a semi-commercial

bioprocessing facility for the development of large-scale biotechnology processes. A fourth technology platform

centred on the biological control industry will be funded at a later date.

2.2.1.4 PlantBio ( http://www.ecobio.co.za )

The original BRIC Expressions of Interest submitted to DST by the Western Cape, Gauteng and Kwazulu-Natal

consortia in July 2002 lacked critical mass in the area of Plant Biotechnology. Expertise in plant biotechnology is

spread out across SA, and is also a contentious public issue. DST therefore called for a fresh proposal specifically

i n P l a n t B i o t e c h n o l o g y .

After intensive planning, and with the support of the three BRICs and DST, it was agreed that PlantBio would be

established as an independent National Plant Biotechnology Innovation Centre. The PlantBio BRIC will receive a

minimum of R7 million p.a. for the first 2 years and R42 million in Year 3 to invest in plant biotechnology projects.

The implementation of PlantBio is a few steps behind that of the other BRICs, and is being carried out by an Acting

CEO/Interim Director, Prof Mark Laing, at the University of Natal, Pietermaritzburg, where the BRIC will be housed

initially. A trust and a Board of Trustees are currently being set up. The trust will be independent of the University


but will use their financial systems in order to conform to the Public Funding Management Act (PFMA). The position

of CEO will be advertised at a later stage. PlantBio will be run as a Portfolio Manager rather than a grant agency. A

proactive strategy will be used to identify new projects and guide research directions in plant biotechnology. The

primary focus of PlantBio will be on 4th generation genomics, 3rd generation gene manipulation and 2nd

generation plant propagation methods.� DST has requested that funding initially focus on food security crops, e.g.

cassava, sorghum, maize, etc.� Forestry and industrial crop projects will be considered by PlantBio in subsequent

years.

2.2.2 National Bioinformatics Network (NBN) ( http://www.nbn.ac.za )

At present, SA lacks trained personnel, adequate computing, networking, teaching, training and laboratory facilities

for bioinformatics. The development of bioinformatics in the country will require a substantial investment in

infrastructure, particularly in computing and communications. The National Bioinformatics Network (NBN) has been

awarded funds by DST and the DoL for a period of three years to address the development of capacity and

expertise in bioinformatics in SA. The NBN business plan (16), developed by an interim Executive Chairman and

Committee, outlines a 4-phase action plan, i.e. the initial launching phase from January – April 2003, with a

projected budget of R15 million; a consolidation phase until April 2004, with a projected budget of R25 million; an

expansion and consolidation phase of approximately two years with a projected budget of R25 million; and a future

phase covering the next five years. The committee has recently appointed a CEO. A Board of Trustees, consisting

of an Executive Chairman and a representative from each node and DST, will determine the policies and guidelines

of the NBN, and will be responsible for the budget and finances. An Executive Committee will oversee the general

running of the NBN and a Scientific Advisory Board (SAB), consisting of internationally recognized individuals, will

provide advice on research, teaching and training programmes.

The mission of the NBN will be:

- To provide the information, tools, research, capacity development and solutions to serve the development

and exploitation of biotechnology and the advancement of fundamental life sciences in South Africa, and

- To ensure that the rapidly accumulating body of information from molecular and high throughput biology is

centralised in the country and available to the South African community in ways which accelerate and

promote scientific progress and global competitiveness.

An administrative node will be set up at SANBI to oversee the administration and communication and all planning

aspects of the institution. A second center at UP will coordinate the activities of the nodes in that region. The funds

will be administered by a trust and will initially be allocated to 6 nodes, University of Pretoria (UP) and the CSIR,

under the auspices of the African Centre for Gene Technologies (ACGT); University of the Witwatersrand (Wits);

University of Western Cape (UWC); University of Cape Town (UCT); Rhodes University (RU); and University of

Stellenbosch (US). Applications for additional nodes from other institutions are invited. Each node will be managed

by a node director, responsible to the home institution and to the NBN. Nodes will offer local research, training and

teaching programmes, and will participate in the joint activities of the NBN group. Individuals working at non-

participating institutions will also be able to apply for funding for specific projects. NBN funds will only be used to

support Open Source projects. In situations where a BRIC requires a bioinformatics project to be contracted with

the NBN, and the NBN accepts funds, the development of software will be performed according to the structure

required by the funder. The NBN and the BRICs will interact closely, with the NBN providing bioinformatics support


to the BRICs, including the use of data banks and other facilities. The NBN will seek to stimulate the development

of bioinformatics as an internationally competitive scientific and applied discipline in South Africa, to build human

resources, to assist with the application of bioinformatics in business and academia, and to conduct research in

locally relevant problems (16).

2.2.3 GODISA-Funded Incubators

The SA government has recognized the importance of incubation and other support structures for the development

of SMME’s, particularly those involved in the technology industries. The GODISA ("Nurturing - helping to grow")

Programme is a South African Government initiative designed to address SMME development and hence economic

growth and employment creation. The programme provides for the nationwide creation of Pilot Centres and

Technology Incubators, each with its own sector focus, which will contribute to the enhancement of technological

innovation, improvement of productivity, and acceleration of international competitiveness. The GODISA

programme is managed by the DST, and supported by the DTI, the DoL and the European Union. eGoli Bio Life

Sciences Incubator and Acorn Technologies are 2 GODISA-funded incubators that focus on the biotechnology

sector. They are both funded with approximately R3 million p.a. to cover salaries and general running expenses as

well as marketing, the organization of networking events, and other direct costs involved in providing business

support to incubatees.

2.2.3.1 eGoli BIO Life Sciences Incubator ( www.egolibio.co.za )

The eGoli BIO Life Sciences Incubator was established as a result of a joint initiative between the CSIR,

Bio/Chemtek, the Innovation Hub and AfricaBio, and was officially launched in February 2003. The ultimate goal of

the incubator is to support at least 20 biotechnology companies as tenants, and to assist with the

commercialization of life sciences research, products, services and technology platforms, by providing business

infrastructure, guidance, strategy and financial and legal advice. In addition, it will actively source funding streams

for individual tenants and/or projects and assist in the procurement and management of such funds. The incubator

will seek to create an environment of learning and sharing in which information, experience and ideas are freely

exchanged.

The incubator has access to the CSIR Bio/Chemtek’s wet labs and pilot production plants as well as the bioethics

expertise of the University of the Witwatersrand’s Faculty of Health Sciences. Up to 70 people in 15 start-up

companies can be accommodated at any one time at eGoli Bio’s newly refurbished premises in Modderfontein,

Johannesburg. eGoli BIO is at present incubating 2 companies, one of which is an anchor tenant and one an

incubatee, and is consulting to several clients/projects that do not reside as tenants within the incubator. In

addition, there are several other projects that may need incubation in the near future, including 4 BioPAD projects.

eGoli BIO recently launched V-Match, an innovative entrepreneur & venture matching program in which

entrepreneurs are being matched with latent smaller research projects from various institutions and corporates to

create new businesses that will be incubated by eGoli BIO.

2.2.3.2 Acorn Technologies ( www.acorn.org.za )

Acorn Technologies, is a non-profit (Section 21), government-funded life sciences incubator based in Cape Town. It

focuses on the medical technology, biotechnology and pharmaceutical sector. The primary objective is to create


successful businesses, whether start-ups or existing entities. Clients are sourced on a national basis, from industry

and Tertiary Educational Institutions according to selection criteria. Acorn was formed in March 2002 by a

consortium which includes: the University of Stellenbosch Office for Intellectual Property, University of Cape Town

(Faculty of Health Sciences), the Bioengineering Corporation (Pty) Ltd. and Catalyst Innovation Incubator (Pty) Ltd.

Acorn offers on-site and 'virtual' incubation & mentoring, with services that include IP, legal management and

protection, business planning, market research, strategic and financial evaluation, and logistical services.

Importantly, the Incubator assists clients in raising the requisite finance, and to date has leveraged almost R50

million on behalf of its client portfolio. Acorn also provides residential & laboratory facilities, which offer a supportive

environment for entrepreneurs.

�

Acorn will incubate late stage R&D projects (<18 months to market) that are based on an innovative technological

idea with export potential. The project should have an entrepreneurial team and the IP of the project should reside

in South Africa. Projects that make it through an initial screen are taken on as incubatees. Incubation begins with

full due diligence on the projects by Acorn, followed by the development of a business plan. Acorn does not invest

directly in projects nor take equity in them; however, a primary role is the sourcing of the entrepreneurial finance for

incubatees on leaving the incubator. Acorn is at present incubating 13 projects, 2 of which are housed on Acorn’s

premises.

2.2.4 Other Support Services

2.2.4.1 Technology Transfer Offices at Universities

The majority of the HEIs in SA have Research Offices that are responsible for the institution’s research management

system. These offices monitor the quality of research and postgraduate teaching and co-ordinate and administer

research funding. They also facilitate communication between researchers and potential funders. A small number of

institutions have an additional body specifically designed to assist with the management and commercialization of

research and IP emerging from the institution. Examples include UCT Innovation at the University of Cape Town;

Unistel Technologies and the Office for Intellectual Property at the University of Stellenbosch; Research Enterprises

at the University of Pretoria, and Wits Enterprise at the University of the Witwatersrand. These offices are

responsible for managing and commercializing all research emerging from their relevant institutions, and their

resources are, therefore, thinly stretched. This, together with the fact that such offices exist in only 4 out of more

than 35 HEIs, illustrates the severe shortage of skills and support for entrepreneurship and biotechnology

commercialization in SA.

The MRC and the ARC each have their own technology transfer offices responsible for the commercialization of IP

generated by their respective units. Again, the capacity of these offices is insufficient to effectively beneficiate all

emerging IP. Although not aimed directly at biotechnology, a number of business schools associated with HEIs are

starting to focus on entrepreneurship and to provide support for new ventures, e.g. the Centre for Entrepreneurship

and Innovation at UCT’s Graduate School of Business. In many cases, business planning, market research etc. are

provided pro rata or at reduced rates to promising ventures as a part of the business curriculum.


2.2.4.2 South African Research and Innovation Managers Association (SARIMA) ( http://www.sarima.co.za )

The South African Research and Innovation Managers Association (SARIMA) was established in Feb 2001 to

strengthen the research and innovation system in SA. It grew out of the Research Directors Forum (RDF), and is

funded by a number of international institutions. SARIMA spans the divide between academia and business, and

will provide training and development programmes for professional staff as well as attending to the implementation

of the national strategic initiatives in science and technology innovation. Other objectives include the promotion of

best practice in the management and administration of research and innovation, the advocacy of appropriate

national and institutional policy in support of research and innovation, and participation in the development and

testing of policy. SARIMA is developing and piloting standardized institutional research and innovation information

management systems. The Association is open to everyone in both public and private organizations working in

research and related technology transfer and innovation support activities

2.2.4.3 Africa-Bio ( www.africabio.com )

Africa-Bio is a non-political, non-profit biotechnology stakeholders association that serves as a forum for informed

debate on biotechnology issues. Its primary role is to disseminate accurate information on biotechnology and

facilitate networking among biotechnology stakeholders. Networking functions include breakfast sessions with

invited speakers on a range of different topics. Public awareness is raised through workshops on biotechnology

and biotechnology policy, trade and markets, information days, brochures, and introductory courses on

biotechnology. Africa-Bio provides accurate information on biosafety regulations and develops brochures for

information transfer for groups within the SADEC region. The organization has a global network and is affiliated to

all of the foreign national biotech associations.

2.2.4.4 A Harvest Biotech Foundation International ( www.ahbfi.org )

A Harvest Biotech Foundation International is a US company, with offices in Washington DC, Nairobi and

Johannesburg, that was set up to oversee technical and communication programmes for poverty alleviation, using

biotechnology tools. Programmes to date have focused on tissue culture techniques for bananas and clonal trees

to provide clean materials to farmers. In SA, A Harvest will concentrate on capacity building and communication

outreach, particularly in the black communities, to ensure that the biotechnology industry in SA adequately reflects

the demographics of the country. Activities will include working closely with government to review legislation

relevant to biotechnology, e.g. the GMO Act, and drawing grassroot communities into the biotechnology industry. A

Harvest has a comprehensive database of individuals involved in biotechnology in Africa, and is able to

disseminated information to stakeholders, as required.

2.2.4.5 Biotechnology-Specific Service Providers

In the private sector, there are a handful of companies offering dedicated biotechnology services, located

predominantly in the Western Cape. Services on offer include business support services, project management, and

legal services for biotechnology stakeholders. In addition, there are a number of companies providing laboratory

supplies, scientific equipment and raw materials to biotechnology stakeholders, though these service providers are

not confined to the biotechnology industry. The biotechnology industry in SA is at present too small to support

more than a few dedicated biotechnology service providers. Although the biotechnology industry is fairly specialized

and requires a different approach to other industries, a number of generic services available in SA can be used by


stakeholders in the industry. The number of dedicated biotechnology service providers is likely to grow in the future,

in response to growth in the industry itself.

2.2.4.6 Technology Parks

A popular concept in the global biotechnology industry is the development of science or technology parks that

facilitate the proximal location of companies active in the high technology sector. These parks are often associated

with universities and generally include an incubator. As yet, there are no dedicated biotechnology parks in SA. This

is probably a function of the fact that there isn’t sufficient critical mass at present to sustain such a park. There are,

however, a number of “technology” parks either in existence or in the planning stage that do/will cater to high

technology companies, e.g. the Technopark at Stellenbosch and the Innovation Hub in Gauteng. Although the

benefits of clustering stakeholders within the same industry into common geographical locations are clear, it is

important that initiatives to this effect remain realistic about the demand for such an effort. There are a number of

worldwide and local examples of ambitious attempts to establish technology parks that cannot be filled, and hence

are not sustainable. Thus it is important that clustering initiatives in SA are integrated and are guided by market

demand.

3. Funding for BiotechnologyAs with the other issues discussed thus far, the cross-cutting nature of biotechnology as well as the lack of clear

boundaries in biotechnology activities make defining the funding opportunities for biotechnology challenging. It is

not the intention, nor is it within the budget or timeframe, of the survey to capture every potential avenue for the

funding of scientific research in SA, nor is it useful to list all venture capital and private equity firms in the country,

even if they may indirectly have contributed or intend to contribute to biotechnology. We have therefore focused in

this survey on only identifying the more prominent and specific avenues for accessing funds for biotechnology in

SA. The majority of organizations that have contributed funding to biotechnology projects are listed in the database

where available, however, many are applicable only to specific problems, e.g. diabetes, cancer etc., while others

provide support for general scientific research and do not specifically target biotechnology projects.

Funding sources for biotechnology can be divided into public (government-backed) and private sources. Public

funding is channeled through various departments or agencies. Some funds are generic and others specific to

stimulating biotechnology. The survey has focused on the latter category. Public funds can be structured as grants,

loans, rebates, tax incentives or co-investments, as well as venture capital (VC). Private funding can be divided into

seed/incubation funding, angel investments, venture capital and private equity, and private donations, trusts or

foundations. The main public and private funding mechanisms relating to biotechnology in South Africa are

described below.

In addition to local funding sources South African biotechnologists have access to many different international

funding sources. A comprehensive analysis of foreign funding available to biotechnology stakeholders in SA is a full

study in itself, and falls outside the scope of this report. The database does, however, list some foreign agencies

that have funded South African biotechnology projects to date, where available. The majority of these funding

sources fall under the category of donor funding agencies, which provide funding to SA research groups on a

competitive basis. They do not specifically target biotechnology research but may have originally funded research


that has led to a potential biotechnology product. Exhaustive lists of foreign donor agencies supporting general

scientific research can be obtained from university research/contracts offices and are not covered in this survey.

Another particularly useful source of foreign funding agencies is the Community of Sciences (COS) database for

which a subscription is required.

3.1 Funding for R&D in SA

General figures on R&D spending in SA are available from a number of government studies that have been

commissioned over the years (14). The most recent completed R&D survey was conducted in 1997. Another R&D

survey is currently being conducted by the Human Sciences Research Council (HSRC), and will provide updated

figures. Recent estimates of the allocation of government funding to R&D are given in the NACI/DACST report (14).

According to the report, in 2000, R&D performing science councils received a total of R970 million research funding

from the parliamentary grant and R740 million from contract income. According to a CENIS survey in 2001

(CENIS:2002b), R&D income in the higher education sector in 2000 totaled R1.1 billion, with the sources broken

down as follows: 14% internal funds, 18% agency funding, 10% THRIP, and 58% contracts (14). Government

funding for R&D is generally channeled through the NRF. In 2002, the NRF’s core grant was R334 million, excluding

funding for the Innovation Fund and THRIP. The budget allocation for 2003/04 is R377 million, including funding for

FEST, which represents roughly a 10% increase from 2002. The core grant for the Research and Innovation

Support Agency (RISA) of the NRF was R178 million in 2002/03 and is R188 million for 2003/04. The increase in

the NRF allocation was limited resulting in little or no growth in grants, bursaries, the number of grants etc. The NRF

has indicated the need to increase the NRF core grant to R1 billion over the next 3 years, in line with the amount

proposed to fund the human resource development component of the R&D strategy (17; 22).

The 2000 R&D spending of the business sector was estimated by NACI to be R2.5 billion, based on the previous

R&D surveys with 5% annual increases. Based on a limited survey of 17 corporations by DACST in 2002, R&D

expenditure by business decreased from 1.46% of total company budget in 1997 to 0.97% in 2001, and the

percentage of research work outsourced increased from 7% to 26% over this period. The report concludes that

industry and government are the main funders of R&D in SA. The total estimated gross expenditure on R&D in 2000

was R5.725 billion, which amounted to 0.64% of GDP (14). These figures represent total R&D spending in SET and

are not confined to biotechnology.

The 1998 report on biotechnology in SA (30) recorded a spending of around R200 million on biotechnology R&D in

that year. The present survey aimed at quantifying recent spending on biotechnology through specifically targeted

questions. Stakeholders were asked to indicate in which range of figures their annual expenditure on

biotechnology, including running costs and salaries, for the last financial year should be classified. The results for

those stakeholders that responded to this question are represented in the figure below. It is clear that the majority

of research groups spent between R51 000 and R500 000 on biotechnology research in 2002, while the majority of

core biotechnology companies showed spending in the R1-5 million range.


Figure 24: Distribution of research groups and companies by spending on biotechnology activities for 2002

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Num

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of G

roup

s

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R51

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R0.

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Expenditure

Research Groups




Core Biotechnology companies, n=24

Non-core Biotechnology companies, n=16

Only 38% of core and non-core companies could provide details of total spending on biotechnology for 2002.

Taking an average value for each of the ranges represented in the figure, and a conservative estimate of R10 million

for the >R10 million category, the estimated total spending on biotechnology for this sample was R203.9 million.

Approximately 7% of research stakeholders provided financial information amounting to an estimated R77.8 million

spent on biotechnology activities in 2002. The Innovation Fund provided a further R11.6 million for biotechnology

R&D during 2002, bringing total spending on biotechnology research and development for 2002 to in excess of

R293 million. Although these are conservative estimates they reflect a 50% increase in annual spending on

biotechnology since 1998, i.e. over the last 4 years.

Approximate funding amounts were given for 130 of the 911 projects listed as “biotech,” “potentially biotech” and

“biotech services” projects (14%). These total around R256 million. It should be noted, however, that these figures

reflect spending throughout the duration of the relevant projects, and are not confined to spending in 2002. A

breakdown of funding and expenditure by sector, based on the available data, is unlikely to accurately reflect the

relative spending in each, since a large proportion of the stakeholders are active in more than one sector and there

is no indication of the proportion of funds allocated to each sector for these stakeholders.

3.2 Sources of Public Funding for Biotechnology

Public funding and incentives are designed to deliver on the South African government’s strategic plans. The main

imperatives include, but are not limited to, sustaining globally competitive innovation and R&D capacity, capital

investment for critical industrial mass, job creation, particularly for previously disadvantaged individuals, technical

competitiveness and technology transfer, empowerment, export development, social improvement and

infrastructure development.


3.2.1 Biotechnology-specific public funding

The biotechnology strategy has provided for specific funding interventions, channeled through DST, directed at the

development of biotechnology in South Africa. The BAC will be funded with approximately R2 million to cover

salaries of the chairperson and secretariat and to fund policy studies. The 3 primary BRICs have been awarded

R12.5m for 2002, R32 million for 2003, R39 million for 2004 and R52 million for 2005, while the PlantBio BRIC will

receive a minimum of R7 million in years one and two and R42 million in year 3. This represents a total

biotechnology-specific funding commitment in excess of R450 Million over 4 years.

The two biotechnology-focused GODISA incubators, eGoli BIO Life Sciences Incubator and Acorn Technologies,

are each funded with approximately R3 Million p.a. The funding has been committed for a period of 3 years. As a

part of the R&D strategy, DST is in the process of establishing a patent fund, initially resourced with approximately

R10 Million. A series of Biological Resource Centres will also be funded.

3.2.2 Non-biotechnology-specific public funding

Non-biotechnology-specific public funding for research and development in science and technology has, in some

cases, been used to fund biotechnology projects. The majority of public funding for R&D is administered through

the NRF as a parliamentary grant or through science councils. In addition to these funding avenues, the following

incentive schemes are funded and administered by the DTI. These schemes are not directed specifically at

biotechnology, but many of them are utilized by biotechnologists, both in the public and private sectors.

3.2.2.1 Incentives for R&D and Innovation

The Technology and Human Resources for Industry Programme (THRIP) provides funding to innovative research

programmes that involve an industry partner. The programme aims to increase the quality and number of

appropriately skilled people for the management of technology for industry, to promote increased interaction

between public researchers and industry, and to increase investment in research. In 2002/03 a total of R131.285

million was granted through the THRIP programme. This will increase to R199.584 in the next year (17). The major

project categories used to classify THRIP-funded projects are fairly broad and more than one of them could include

biotechnology projects, therefore the proportion of THRIP funding allocated to biotechnology cannot be determined

from the THRIP annual reports.

The Support Programme for Industrial Innovation (SPII) is available to private sector enterprises, and aims to

promote R&D of innovative products or processes. The Partnership in Industrial Innovation (PII) is available to

manufacturing and IT industries and provides funding to stimulate R&D for high potential products and processes.

The Innovation Fund (IF) was established by DST to promote technological innovation, increased networking and

cross-sectoral collaboration, and competitiveness, quality of life, environmental sustainability and the harnessing of

IT. In the IF’s business plan for 2003/04, there are plans to introduce the following new initiatives (funding streams)

to enhance innovation:

• Technology Missions to fund enabling technology platforms in existing, attractive economic sectors

• Technology focus areas to promote innovation in new technology frontiers

• Initiative for Developing Enterprising Activities (IDEA) to promote entrepreneurship through the

commercialization of innovations from young entrepreneurs


• Technology promotion to promote R&D collaboration and entrepreneurship within the business and

research community, especially inter-racial networking

• Patent and technology Transfer Office to offer a comprehensive service with respect to patent applications

and technology transfer for publicly funded research

• Seed and start-up financing to finance the development of a product or prototype, proof of concept and

initial marketing (17)

The fund’s 2002/03 budget was R136 million, and will increase to R158 million in 2003/04. The latest available

details of projects funded by the IF are for Round 3, i.e. 2000/01-2003. In this round, funding for Biotechnology

projects totaled R37.5 million, with R11.6 of this allocated to year 3, i.e. 2002.

3.2.2.2 Incentives for Enterprise Development

Fiscal incentives for SMME development include:

• Small and Medium Enterprise Development Programme (SMEDP) - investment by SMME’s in assets

• Foreign Investment Grant - investment in foreign-sourced capital equipment in South Africa

• Skills Support Programme (SSP) - training costs for new or expanding SMEDP projects

• Strategic Investment Programme (SIP) - tax deduction for investment into capital equipment by private

companies

• Critical Infrastructure Programme (CIP) - infrastructure development to fill gaps

3.2.2.3 Competitiveness and Export Incentives

The Competitiveness Fund (CF) covers 50% of marketing, product, company and service development costs of

South African manufacturers and service providers with the aim of encouraging them become globally competitive.

A component of the CF is the Bumble Bee Programme (BBP), which provides free consulting services to micro-

manufacturers with less than 20 employees. The Sector Partnership Fund (SPF) is available to partnerships of 5 or

more companies aimed at increasing sector competitiveness and productivity. The Business Linkage Challenge

Fund (BLCF) covers costs associated with the development and implementation of business linkages and

improvement of competitiveness. Fiscal incentives for export development include the Export Investment Financial

Assistance Scheme (EIFAS), which provides partial rebates on specific costs related to export marketing, e.g.

travel, accommodation, transport, stands, marketing material, patents etc., and Import Duty Drawbacks, which aim

to stimulate local value addition through manufacture and export.

3.2.2.4 Industrial development zones (IDZ)

Although there are no current IDZ’s related to biotechnology, this incentive is nevertheless worth considering in

terms of biotechnology clustering initiatives focused on industry. IDZ’s are industrial estates that enjoy duty-free

production for exports and provide transport routes, facilities and services tailored for export-oriented industries.

They would characteristically be situated adjacent to a port or an airport to facilitate immediate access to overseas

markets.

3.2.2.5 European Union Sixth Framework Programme (EU6FP)

A major source of public funding is through the EU6FP. The programme promotes the development of collaborative

partnerships between EU members and other scientists and innovators around the world, particularly in developing


countries. The intended output is scientific and technological products and services, which can address health

related challenges in the EU. The proposals must include at least one EU collaborator to qualify, and the

programme is geared towards investing in larger, multi-collaborator and frequently multi-centre research and

development projects. The most recent Sixth Framework Programme call for proposals covers the thematic

research priority: "Life sciences, genomics and biotechnology for health," with a total indicative budget of Euro 411

million. DST is promoting and facilitating access to this extensive programme in South Africa, and offers a form of

bridging finance for the development of proposals. DST’s FP6 Seed Funding Instrument provides financial support

to enable South African researchers to visit Europe to meet with potential FP6 partners.

3.3 Private Funding for Biotechnology

Private funding for biotechnology can be divided into institutional and private funding and funding of specific

innovation budgets within companies. Private funding can be further divided into incubation funding, angel

investments, venture capital and private equity, and private donations, trusts or foundations. A systemic funding

gap has been hypothesized as being a key constraint in the development of the South African biotechnology

market. This gap is best described as the early seed to seed investment stage, and tends to coincide to a large

degree with the innovation chasm, described in the national R&D strategy. Within the biotechnology context the

combination of direct incentives and investments and incubation and support environments aims to decrease the

investment risk in biotechnology start-up ventures, making them more attractive to private investors and gradually

closing the funding and innovation chasm.

3.3.1 Seed Capital

This includes early stage funding for new ventures that require funding to enter into the commercialization process

or are already in the initial phases of commercialization. This funding instrument is not directed towards R&D, and is

high risk capital. There are private funding sources, which are stimulating the development of new biotechnology

SMME’s by means of seed funding. Coupled with the judicial use of fiscal measures, these start-ups have been

funded by angel investors. The angel investors are not easily apparent by virtue of the type of person involved.

There also does not appear to be an obvious angel investor network, as can be seen in some larger economies.

Nevertheless, analysis of the sources of funding used by the existing South African biotechnology SMME’s

indicates the strong presence of angel investors.

The next funding stage, which forms the natural exit opportunity for angel investors or self-funded entrepreneurs,

should be VC’s or private equity investors. In the case of biotechnology, however, the stage of development of the

start-up venture usually coincides with proof of concept or a prototype. Existing VC investments in biotechnology in

South Africa fall into 2 categories: there are a few investments in truly sustainable and competitive South African

companies, with the remainder funding the final development, marketing and licensing or sale of South African

innovations to internationally competitive, non-South African companies.

3.3.2 Venture Capital and Private Equity

Private equity is late stage funding typically reserved for existing businesses with established track records of

profitability that wish to expand operations. This instrument is also utilized in the funding of management buy-outs

and similar deals. The private equity investment community in SA has made no direct investments in biotechnology


to date, although some of the funds have indicated an interest in funding or co-funding biotechnology investments.

Venture capital represents later stage funding that is usually invested by specialized VC firms who manage funds on

behalf of investors. Investments are usually made into medium to low risk ventures for a significant equity stake in

the business.

South Africa has one VC fund dedicated to biotechnology investments, i.e. Bioventures. This R80 Million closed

fund was established in 2001 and has made 6 investments to date totaling R42 million (as of July 2003), with an

additional R3 million committed. The Cape Town-based company, Catalyst Innovations, has invested a total of

around R32 million in biotechnology and medical device SMME’s to date. Although the company holds investments

in biotechnology-related companies, it is not currently positioned as an investment fund. Chrysalis Biotechnology

Holdings is a black economic empowerment company with and initial investment focus on established businesses

and biotechnology service providers. A number of other VC funds have expressed an intention to invest to some

degree in biotechnology, though this is not their core focus.

The IDC is state-owned and was established in 1940. It operates as a private company and looks at development

in SADC. The IDC makes a profit and is self-financing. Its aim is the development of sustainable industries in SA.

The IDC provides equity and loan financing, and focuses on manufacturing (core business), agribusiness (food, and

beverages), mining, tourism, and techno industries. They have around R30 billion in total assets and an R800

million operating budget. Many large companies today were initiated by the IDC, e.g. Sasol, Alusaf etc. The IDC has

made contributions to the development of at least 3 of the existing core biotechnology companies in SA through

investment and assistance with foreign trade, and has contributed to the establishment of SA’s first dedicated

biotechnology venture capital fund, Bioventures.

3.4 Foreign Sources of Funding for Biotechnology

There is no evidence of South African private trusts or foundations investing in biotechnology. There are, however,

international foundations, which specifically target South Africa and invest in biotechnology projects, particularly

related to the biomedical field. Some of these include:

Bill and Melinda Gates Foundation

Ellison Medical Foundation

Kirsch Foundation

Rockefeller Brother Fund – South Africa

Open Society Foundation for South Africa

The Mellon Foundation

The Carnegie Corporation of New York

The Charles Stewart Mott Foundation

The WK Kellogg Foundation

Additional sources of funding for biotechnology-related projects originate from foreign public funders and NGO’s

such as the World Bank, through its subsidiary, the International Finance Corporation (IFC), USAID, UNDP and

OECD, to name a few. The IFC has expressed an interest in funding biotechnology in South Africa. Most of these

funders target poverty alleviation directly through SMME development, but some recognize and promote

technology transfer and innovation support programmes through SMME’s.


Venture capital is an international activity, which means that South African ventures can approach VCs from any

country for funding. The UK has a well-established venture capital sector that is one of the most active in Europe,

particularly in biotechnology and healthcare. Major firms involved in the biomedical sector include 3i, Abingworth,

Advent, Apax, Merlin Bioscience and Schroder Ventures. The USA also has a very wide selection of potential

investors in biotechnology. An exhaustive list is beyond the scope of this study.

The funding sources for biotechnology described above and listed in the database do not represent the full

complement of potential funding sources. Two useful portals for exploring other possible funding opportunities,

including donor funding, are the Business Referral and Information Network ( www.brain.org.za ) and the COS

database ( www.cos.com - subscription required).


SECTION E: BIOTECHNOLOGY ACTIVITIES IN SOUTH

AFRICA BY SECTOR

1. Human Health

1.1 The Application of Biotechnology to the Human Health Sector

The applications of biotechnology in human health are extensive, and include strategies that employ the human

body’s own resources such as proteins, enzymes, antibodies, as well as other naturally produced substances for

disease prevention, treatment and diagnosis. Modern molecular technologies are being used to identify new

markers for diseases and for disease-and drug-resistance that can be applied to the development of new

preventive measures, therapeutics, and novel and rapid diagnostics. In addition, living organisms are increasingly

being explored as potential sources of new biologically active molecules as well as new systems for the large-scale

production of bio-molecules.

The market attractiveness and benefits to mankind make the human health sector the largest contributor to

biotechnology activities globally. The annual global market for health products and services, which includes

pharmaceuticals, medical devices and health care related services, is estimated at more than US$2 trillion.

Biotechnology has the potential to address current healthcare challenges such as HIV/AIDS, tuberculosis, and

malaria as well as developing novel therapeutics for rare diseases, for diseases that do not as yet have cures, for

diseases where high levels of resistance to existing drugs are experienced, for diseases where progression and

response to treatment are dependent on the genetic variability of patients, and for new diseases that are emerging,

particularly in aging populations. The extraordinary specificity of cells and biological molecules and their interactions

enables the development of precise and predictable solutions to specific health problems, with fewer side effects

and unintended consequences. In addition, biotechnology enables cheaper, safer and more ethical production of a

growing number of traditional as well as novel drugs and medical services.

1.2 Human Health Biotechnology in South Africa

The medical challenges facing Africa are among the most extreme in the world, and directly stifle economic and

social development. Focused and sustainable interventions are required to address these challenges. The results of

the survey indicate that the majority of research groups, core biotechnology companies and biotechnology

products and services currently offered are operating or applied in this sector. Healthcare products such as

biopharmaceuticals and vaccines, produced by genetically modified organisms, have been available in South Africa

for some time e.g. Human insulin, human growth hormone, and vaccines, however, the emergence of novel

biotechnology health products from SA has been slow. This is clearly not due to a lack of focus on health issues in

research, though it could be due to the long development periods generally associated with drug discovery, as well

as the challenges in registering new health products in SA and internationally. The research groups and companies

active in the human health sector of biotechnology and the research projects relevant to human health are broken

down by region and focus area in Figures 25 and 26, respectively. Please note that figures for research groups and

projects are for the 3 different categories, i.e. biotech, potentially biotech and biotech services, combined, while

figures for companies include those for core and non-core biotechnology companies combined.


Figure 25. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in human

health by region

a.) Research Groups

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The trends are identical for all 3 categories, i.e. the largest number of groups and projects in human health are in

the Western Cape, followed by Gauteng, Kwazulu Natal, and the Eastern Cape. The concentration of human health

research in the Western Cape is probably due the presence of the headquarters of the MRC as well as 5 tertiary

education institutes, 2 of which have sizeable and world-renowned health faculties.

Figure 26. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in human

health by focus area

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Figure 26 represents only the top 14-15 focus areas for each biotechnology group. It is clear from the figure that

the major focus areas in human health in SA overall are therapeutics, diagnostics, phytopharmaceuticals, natural

health products and disease physiology, though the distributions of these focus areas differ for each group. The

study of disease physiology and general disease mechanisms provides a foundation for development in other focus

areas. The identification of drug targets, disease markers, and host and pathogen genes associated with disease

provide a basis for the development of novel therapeutics, serological, molecular and physical diagnostic

techniques, and preventative measures for the relevant diseases. The major diseases under investigation in this

sample include HIV/AIDS, tuberculosis, malaria, and a number of inherited metabolic disorders.

2. Animal Health

2.1 The Application of Biotechnology to the Animal Health Sector

Biotechnology has similar applications in animal health to those described above for human health, i.e. the

development of rapid diagnostics, and new vaccines and therapies, but also includes animal production and

improvement and animal nutrition (including probiotics and animal feeds). Biotechnology can be used in animal

breeding, the preservation of animal genetic and reproductive material for conservation purposes, and reproductive

technologies such as embryo transfer. In terms of nutrition, new biological products are being developed for use in

animal feeds to enhance productivity and to provide additional fortification against common animal diseases.

The animal health and production sector generally has a lower profit margin in industry, especially products for

livestock, since farmers cannot afford expensive diagnostics and vaccines. However, the application of

technologies from the human health sector to veterinary problems reduces the development time and costs, and a

number of large pharmaceutical companies have a minor veterinary division that is highly profitable. More than $4

billion was spent on animal health products in the United States in 1999, around 66% of which was spent on

livestock and farm animal care (1). The animal feed market is currently worth approximately US$36 billion in annual

revenues (9). Animal health is inextricably linked to the food supply chain, the demand for which is increasing rapidly

with the growing global population. In addition, animal health issues can impact on human health in terms of the

spread of zoonotic diseases, such as mad cow disease (BSE).


2.2 Animal Health Biotechnology in South Africa

SA is an important producer of animal products such as meat, hides, skins, wool and milk. In 2000 the national

herd was estimated at 28,6 million sheep, and 13,5 million commercial cattle. In fact, animal production accounts

for around 35% of South Africa’s total agricultural turnover (15). The health of livestock is therefore a vital factor in

agricultural productivity and plays an important role in South Africa’s ability to export animal products.

Approximately 10% of core biotechnology companies and 11% of research groups fit into the animal health sector,

and the sector ranks 4th out of the 8 sectors among biotechnology research projects. Relatively few stakeholders

are active in animal health, and most of them are associated with the Onderstepoort Veterinary Institute or the

University of Pretoria. BioPAD is the only BRIC to be awarded funding for the animal health sector. Activities in

animal health in SA have, however, not been insignificant. The Onderstepoort Veterinary Institute has played a

prominent role in veterinary health in SA since its establishment in the early 1900’s, and has traditionally enjoyed a

reputation as the top veterinary institute in Africa. Innovations feed into Onderstepoort Biological Products, which

supplies vaccines to countries across the continent. A recent milestone for the animal health sector in SA was the

announcement of the first cloning of a cow, achieved by the Embryo Plus Centre in Brits.

The research groups and companies active in the animal health sector of biotechnology and the research projects

relevant to animal health are broken down by region and focus area in Figures 27 and 28, respectively.

Figure 27. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in animal

health by region

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As expected, the largest number of groups and projects in the animal health sector are from Gauteng. The region

with the next highest capacity in terms of biotechnology companies active in animal health is the Western Cape,

followed by Kwazulu Natal. The majority of companies in this sample are classified into more than one sector, with

animal health being only a subsidiary interest. The Free State also makes a notable contribution to animal health

research groups and projects.


Figure 28. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in animal

health by focus area

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Vaccines and diagnostics are the major focus areas in animal health for all 3 categories. This is followed by disease

physiology for research groups, therapeutics for biotechnology companies, and, animal breeding for research

projects. Animal nutrition is becoming an increasingly popular research subject, particularly the areas of probiotics

and feed supplements. The majority of the research and development in diagnostics, vaccines and therapeutics in

this sector in SA is being conducted on diseases affecting livestock and poultry, though a small fraction of groups

are researching diseases of domestic animals.

3. Plant Biotechnology

3.1 The Application of Biotechnology to the Plant/Agricultural Sector

Africa has an extremely high rate of population growth, resulting in an increasing demand for food. Biotechnology

has the potential to address food shortages through the development of crops with increased resistance to

diseases and drought, increased tolerance to herbicides, increased nutritional benefits, and improved processing

qualities. Additional applications of biotechnology in the plant sector include the development of biological agents,

soil agents and plant growth stimulants for the improvement of crop performance, clonal propagation methods for

the large-scale propagation and conservation of plant species, the use of molecular techniques for plant species

and plant pathogen identification, and bioprospecting for novel molecules that can be applied to the human health,

animal health and industrial sectors. Biotechnology has the potential to impact on forestry, particularly the

improvement of tree production and wood quality. Plants are also now being engineered to produce biochemicals

on a large-scale for application in the human health, animal health and industrial sectors. If managed correctly,

plants represent a renewable source of raw materials and products; therefore, conservation plays a vital role in

plant biotechnology.

The predominant focus area of global plant biotechnology is genetically engineered (GM) crops. The value of the

global market for genetically engineered crops was between US$2 billion and US$3 billion in 2000 (8). GM crops

already on the market include papaya, soybeans, maize and cotton. GM foods remain a contentious issue in some

circles, particularly in the European Union and Japan.


3.2 Plant Biotechnology in South Africa

Agriculture contributes approximately 5% to SA’s GDP and is the biggest employer of labour in the rural areas.

Approximately 13% of South Africa's surface area can be cultivated, though only 22% of this is classified as high

potential arable land. At present, just over 1,2 million hectares are under irrigation. The agricultural sector

accounted for 7% of the total SA exports for 2000, with a foreign exchange value of R14.5 billion. SA exports

maize, sugar, wine, citrus fruit, grapes, preserved fruits and nuts, as well as cut flowers and bulbs. South Africa is

also well known for the high quality of its deciduous fruit, up to 32% of which is exported. In addition, SA exports

48% of its citrus fruit. The varied climatic zones in SA enable the production of almost any kind of crop, which

means that the country is self-sufficient in most of the major crops, with the exception of wheat, oilseeds, rice, tea

and coffee. Maize accounts for the largest use of arable land in SA, followed by wheat and, to a lesser extent, oats,

sugar cane and sunflowers. Sugar cane and maize form the basis of the major commodities such as molasses and

maize meal. Agriculture is also an important market for the manufacturing sector, particularly products such as fuel,

fertilizers, farm feeds, packing materials, dips and sprays, and other farming commodities (15).

It is clear that agriculture plays a significant role in the South African economy. The sector does, however, face

ongoing challenges that include desertification, soil erosion, soaring input costs, increased crime on farms,

population growth, and, most importantly, the scarcity of water resources. Ongoing research and technology

development is required to face these and other challenges. Biotechnology can play an important role in rural

development, poverty alleviation, food security, and the conservation of plant diversity. The development of new

agricultural and soil science methods has allowed the overproduction of agricultural produce and has resulted in SA

being a net exporter of agricultural products, in spite of these challenges (15). The Agricultural Research Council,

established in 1993 by the Department of Agriculture to promote agriculture and related sectors through research,

development and transfer of technology, has played an important role in new developments in the industry to date.

Existing products in the plant biotechnology sector in SA include biological control products, plant growth

stimulants and GM crops/seed. Conditional general release approval has been given to insect resistant cotton and

maize, and herbicide resistant soya and cotton. The selection of GM crops is expected to increase in the future to

include wheat, barley, sunflower seed, fruit, sugar, potatoes and wood (30). The EU is a significant export

destination for SA’s agricultural products, particularly fruit. The strong resistance to GM foods in the EU will impact

negatively on exports, particularly if a full moratorium on GM foods is implemented. It is therefore essential that

farmers exporting products remain sensitive to the issue.

The findings of the present survey for research groups and companies active in plant biotechnology and the

research projects relevant to plant biotechnology are broken down by region and focus area in Figures 29 and 30,

respectively.


Figure 29. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in plant

biotechnology by region

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biotechnology activities being highest in Gauteng, followed by the Western Cape and Kwazulu Natal. The research

groups show a greater bias towards the Western Cape, probably due to the inclusion in the database of a fairly

large number of project leaders from ARC-Infruitec-Nietvoorbij as well as the plant genetics and plant physiology

groups from the HEI’s in the region.

Figure 30. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in plant

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Biotechnology companies in SA are working predominantly in the fields of GM crops, plant propagation and

traditional breeding, followed closely by plant growth stimulants and biological control. The research groups are

classified predominantly into the GM crops, biological control, plant genetics, and traditional breeding focus areas.

Similar focus areas dominate in the research project sample, with the plant genetics focus area being superceded

by plant propagation. Traditional breeding of crops remains an important focus area particularly within divisions of

the ARC. An increasing number of groups and projects involve the identification and development of novel bio-

control methods. This is supported by a relatively strong business sector into which new products can be fed. The

presence of a number of large seed and agricultural companies in SA also provides ample opportunities for the

commercialization of novel GM crop varieties.

4. Food & Beverage

4.1 The Application of Biotechnology to the Food & Beverage Sector

The use of biotechnology to alter the properties of agricultural products is discussed under plant biotechnology.

Other applications of biotechnology in the food & beverage industry include improvement of yeast strains for wine

and beer production, the production of novel food supplements and ingredients, the development of improved

methods in food processing, the analysis and preservation of food, and the development of probiotics and

nutraceuticals. These applications again reveal the importance of biotechnology in addressing global issues such as

starvation and adequate nutrition.

4.2 Food & Beverage Biotechnology in South Africa

The South African food and beverage industry employs 13,5% of the total labour force and has an annual turnover

in excess of US$7.2 billion. Malt drinks and wine constitute 31% of total beverage production, and soft drinks

constitute 21%. Wine is one of the most important export products, and is exported primarily to Japan, UK,

Belgium, and other Asian, European and African markets (24). SA is also an important producer of beer, dominated

by the SA Breweries/Millers Group. Neither the wine nor the beer industries are dealt with in this survey, except

where biotechnological methods are used to improve wine quality or beer brewing.


The distribution of research groups and companies active in the food & beverage sector and the research projects

relevant to the sector are broken down by region and focus area in Figures 31 and 32, respectively.

Figure 31. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in the food &

beverage sector by region

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The trends are similar for all 3 categories, except that capacity in industry is less in the Free State. The highest

concentration of activity in food & beverage biotechnology is in the Western Cape, followed by Gauteng, the Free

State and, to a lesser extent, Kwazulu Natal.

Figure 32. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in the food &

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It is clear from the figures that food ingredients make up the largest focus area in food & beverage biotechnology.

Other prominent focus areas for research groups and projects are food analysis and probiotics, and for

biotechnology companies are nutraceuticals and food processing. The focus area encompassing food ingredients

includes additives such as enzymes of biological origin, flavours, fragrances, and other biological metabolites such

as vitamins etc. The sample includes only those larger food and beverage companies that are involved in

biotechnology R&D. These companies are classified according to their biotechnology R&D focus rather than their

core business areas.


5. Industrial Biotechnology

5.1 The Application of Biotechnology to the Industrial Sector

Despite the emergence of the global knowledge economy, manufacturing and process industries remain essential

both to the generation of consumer and industrial products and to global economies. There is, however, a growing

need for improvement of the processes involved and the reduction of their environmental impact. Biotechnology is

applied to industrial processes to improve efficiency and, in some cases, to allow the development of new

processes and products. Biotechnology is used in mining (bioleaching), the production of high value products from

natural sources and by-products, and the synthesis of fine chemicals, biochemicals, food additives,

pharmaceuticals, nutraceuticals, biomass, enzymes, diagnostics, food, feeds etc. An important aspect of industrial

biotechnology is the development of novel biocatalysts for use in industrial processes. Biotechnology can also be

used to alter industrial processes to reduce resource consumption and negative environmental impact. An

additional focus area is the development of biodegradable materials.

5.2 Industrial Biotechnology in South Africa

The chemicals industry in SA employs approximately 175 000 people and contributes around 5% to GDP. The

country is strong in petrochemicals, plastics, rubber, and agricultural and mining chemicals, and has a number of

companies involved in speciality and performance chemicals. South Africa is one of the richest countries in terms of

minerals, with the world's biggest reserves of gold, manganese, platinum metals, chromium, vanadium, alumino

silicates, iron ore, coal, diamonds, uranium, titanium and nickel. Mining and the mineral processing industries

account for around 10% of GDP in SA. The mining sector, excluding gold, constitutes 17.5% of total exports and

accounts for 3.3% of total employment. Gold accounts for 16% of exports and contributes around 3% of GDP. It

also provides 5% of total employment. Coal is also an important resource in SA, and is the predominant energy

source, providing about 75% of primary energy needs. Approximately 40% of coal produced in the country is

exported (24).

It is clear that the chemical and mineral industries play a significant role in the South African economy. In fact, South

Africa depends more on mineral resources than any other major trading nation. Thus biotechnology methods that

result in more economical and environmentally-friendly processes are likely to make a significant impact on the

industry as well as the SA economy as a whole. A number of SA research groups and companies are active in the

industrial biotechnology. These groups and the relevant research projects are mapped by region and focus area in

Figures 33 and 34, respectively.


Figure 33. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in the

industrial biotechnology sector by region

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Biotechnology companies active in the industrial sector are located predominantly in Gauteng, followed by Kwazulu

Natal and the Western Cape. Research groups and research projects, however, are concentrated in the Western

Cape, with less activity evident in the Free State and Gauteng regions.


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Enzymes, bioproduction and bioprocessing are the dominant focus areas for SA biotechnology groups and

projects, followed closely by process development. The terms bioproduction and bioprocessing are fairly broad and

describe most processes that use microorganisms for the conversion of substrates. The production of enzymes

through extraction and recombinant means represents an important focus area that feeds into other sectors.

Enzymes are used in food processing, the production of pharmaceuticals, research laboratories and other industrial

processes. Although the focus area of biocatalysts does not feature significantly in any of the samples analyzed

here, it represents an important enabling technology for a very large number of industrial processes. A growing

trend is the engineering of enzymes derived from nature, using modern methods, to alter their efficiency, substrate

specificity, and physical properties. The applications of biotechnology in industry are vast, and it is likely that there

are a larger number of non-core biotechnology companies utilizing biotechnology to some extent in their processes

than is reflected in this study. The use of microorganisms in mining for the recovery of metals has been pioneered

by groups in SA. Although the use of the technology in SA is limited, it is being applied by mining companies in

various foreign locations.

6. Environmental Biotechnology

6.1 The Application of Biotechnology to the Environmental Sector

Increasing levels of pollution in the environment have prompted moves to reduce the amount of toxic waste

produced by industrial processes and to develop new methods of waste treatment. In addition, new methods are

being sought to clean up toxic spills and to rehabilitate contaminated sites. Biotechnology provides the tools to

address many of these issues. Applications of biotechnology in the environmental sector include the use of

microorganisms to treat industrial wastes and water resources, to convert waste products into higher value

products, to clean up hazardous waste more efficiently, and to effectively rehabilitate contaminated sites.

Environmental management forms an essential component of all industrial companies, and the adoption of more

environmentally-friendly technologies both in processing and in the treatment of waste products has resulted in an

increasing demand for environmental biotechnology methods, and a growth in their market value. As an illustration,

the bioremediation market in the USA alone is predicted to be worth US$300 million by 2005 (9).


6.2 Environmental biotechnology in South Africa

A number of companies are applying biotechnology to waste and water treatment in SA. The larger industries in the

country, such as the energy, mining, and industrial manufacturing companies are increasingly under pressure to

reduce the impact of their activities on the environment. Many of the non-core biotechnology companies in the

database are utilizing biotechnology for waste treatment and/or beneficiation, while a number of companies are

selling products for waste treatment. The distribution of research groups and companies active in the environmental

sector and the research projects relevant to the sector are broken down by region and focus area in Figures 35 and

36, respectively.


environmental sector by region

a.) Research Groups

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Biotechnology companies and projects that involve the environmental applications of biotechnology are

concentrated in Gauteng, followed by the Western Cape and Kwazulu Natal. In contrast, research groups in the

environmental sector are located predominantly in the Western Cape.


environmental sector by focus area

a.) Research Groups

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The majority of research groups, companies and research projects are active in the field of waste treatment,

bioremediation and water purification. The biotechnologies applied to environmental problems tend to be relatively

“low-tech” and use predominantly 1st-generation methods. Companies active in the environmental sector in SA

include those developing and selling microorganism-based products for cleaning and biodegradation of spills.

Other dominant technologies emerging from the sector are those that utilize microorganisms or components

thereof for large-scale water treatment.


7. Other Biotechnology Focus Areas

7.1 Other Applications of Biotechnology

Other focus areas in biotechnology not covered under the above headings include aquaculture and mariculture,

platform technologies, biological control for non-agricultural purposes, general research and bioprospecting that

are not specific to one sector, and plant-based cosmetic products. Aquaculture and mariculture are rapidly growing

industries, particularly in developing countries, and refer to the culturing of aquatic and marine organisms under

controlled conditions. Over the last 50 years aquaculture has developed into a world-wide industry with a total

production of 36 million tons and a net value of US$52 billion in 1998 ( www.aquaafrica.co.za ). Biotechnology is

applied in aquaculture and mariculture to the genetic engineering of fish and other aquatic species to enhance

growth, stress resistance, disease resistance and sterility, the creation of fish that act as biosensors, the

development of organic biological products to prevent disease and improve yields, and the use of genetically

modified fish such as tilapia for the production of pharmaceuticals.

Platform technologies refer to technologies that are used in research and/or industry applications. Examples of

platform technologies include microarray facilities, plant propagation methods etc. A number of groups are involved

in the development and application of such technology platforms, while others offer commercial services in the

relevant technologies. Also included in the “other” category are plant-based cosmetic products. These include

topical lotions and other cosmetics that are derived from plants such as aloes.

7.2 Other Applications of Biotechnology in South Africa

Relatively few research groups, companies and research projects fall under the “other” category, and the majority

of these are also classified under one of the other 7 sectors. The distribution of these groups by region and focus

area is represented in Figures 37 and 38, respectively.

Figure 37. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in other

sectors by region

a.) Research Groups

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The majority of research groups, companies and research projects are operating in the Western Cape, followed by

Gauteng. There are clearly also a number of research projects being conducted in the Eastern Cape within these

sectors. These fall predominantly under the mariculture/aquaculture focus area and can be attributed to groups

from Rhodes University and the HEI’s in Port Elizabeth.


Figure 38. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in other

sectors by focus area

a.) Research Groups

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The dominant focus areas in the “other” category are platform technologies for research groups, plant-based

cosmetic products for companies, and aquaculture and mariculture for research projects. According to the

Aquaculture Association of Southern Africa (AASA) website ( http://www.sun.ac.za/aasa/ ), South African

aquaculture production has shown a significant increase over the past decade. Total production and value has

increased from 3 000 tons (R51 million) in 1997 to 4 030 tons (R146 million) in 2000 (11). The abalone industry

alone includes 14 producing farms and an investment totaling R130 million to date, with a planned investment of

R27 million for 2003/2004 (Nick Loubser, Abalone Farmers Association of South Africa - Personal Communication).

Although biotechnology can be applied to the mariculture and aquaculture industries, not all of the companies

within these industries are utilizing biotechnology tools. The sample, therefore, only includes those

mariculture/aquaculture companies that have indicated some involvement in biotechnology activities. The same is

true of natural products companies.

8. Support Services for Biotechnology

A small proportion of groups in the research and company database are offering services in biotechnology. These

generally include routine diagnostics, product testing, and core technology services such as DNA sequencing, plant

propagation etc. The distributions of research groups, companies and research projects applicable to this sector by

region and focus area are represented in Figures 39 and 40, respectively.


Figure 39. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in support

services by region

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The distribution of companies and research projects by region shows the same trends, with the highest

concentration being in the Western Cape, followed by Gauteng and Kwazulu Natal. The distribution of research

groups is similar; however, the North West Province shows a greater representation than Kwazulu Natal.

Figure 40. Distribution of a.) research groups, b.) biotechnology companies, and c.) research projects in support

services by focus area

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The majority of research groups in the support services sector are involved in product testing and core technology

services, while research projects focus on consulting and product testing, and companies focus on contract

manufacture, pilot production, and laboratory supplies.


SECTION F: BIOTECHNOLOGY ACTIVITIES IN SOUTH

AFRICA BY REGION

Most regions in SA boast some degree of biotechnology activity. The major centres are Gauteng (Johannesburg

and Pretoria), the Western Cape (Cape Town and the Garden Route), Kwazulu Natal (Durban and Pietermaritzburg),

and the Eastern Cape (Grahamstown and Port Elizabeth). There is also some biotechnology activity in the Free

State, centred on the University of the Free State. The regional strengths in biotechnology are outlined below.

Please note that the report is intended to provide a generic overview of biotechnology activities in SA, therefore

detailed regional analyses of activities are not included.

1. Gauteng

Gauteng and its surrounds, including the North West Province, Mpumalanga, and Limpopo Province are home to

23 of the 47 core biotechnology companies and 28 of the 59 non-core biotechnology companies identified in the

survey. The area also houses 270 of the research stakeholders and 407 of the research projects identified as

belonging to the “biotech,” “potentially biotech,” and “biotech services” categories. The distribution of these groups

by sector is shown in Figure 41. The human health and plant sectors clearly dominate, followed by the animal

health sector.

Figure 41: Distribution of research groups, biotechnology companies and research projects in Gauteng by sector

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The broader Gauteng region is home to a number of major research institutions and organizations with the potential

to supply innovative biotechnology ideas and projects for commercialization (Table 3). It must be noted, however,

that not all of these institutions are currently involved in biotechnology activities.


Table 3: Major Research Institutions and Organizations in Gauteng and Surrounding Regions

Universities Institutes* Technikons Research Organizations

University of the Witwatersrand National Institute of Virology Technikon Pretoria Mintek

University of Pretoria Wits Health Consortium Technikon Witwatersrand CSIR

Rand Afrikaans University FABI North West Technikon ARC Head quarters

Potchefstroom University for CHE ACGT Northern Gauteng

Technikon

ARC-Onderstepoort Veterinary

Institute

University of South Africa (UNISA) Technikon SA ARC-Animal Improvement Institute

Medical University of South Africa

(Medunsa)

Vaal Triangle Technikon ARC-Animal Nutrition and Animal

Products Institute

Vista University ARC-Institute for Tropical and

Subtropical Crops

University of the North ARC-Range and Forage Institute

University of Venda ARC-Vegetable and Ornamental

Plant Institute

ARC-Grain Crops Institute


Institute

ARC-Institute for Industrial Crops

South African Bureau of

Standards

* Institutes that fall within Universities or Technikons

The Gauteng region is home to the headquarters of the Council for Scientific and Industrial Research (CSIR), the

Agricultural Research Council (ARC), and Mintek, as well as the GODISA-funded incubator, eGoli BIO Life Sciences

Incubator, and the BioPAD BRIC.

The CSIR, which is structured around eight distinct business areas, is the largest R&D and implementation

technology agency in Africa. CSIR Bio/Chemtek is a business unit positioned to provide technology solutions in the

food, chemical and biological technology domains. It houses one of the largest biotechnology research facilities in

SA, and is divided into the following programmes:

- Biotechnology Programme

- Technology for Development Programme

- Speciality and Fine Chemicals Programme

- Bioprospecting

- Food Science and Technology Programme

- Analytical Science and Technology Programme

The Biotechnology Programme is further divided into 6 focus areas, with an additional unit, the African Centre for

Genome Technologies (ACGT), that provides technology services to the whole division. CSIR Bio/Chemtek is the

only organization in SA to offer the full development pipeline from fundamental research to product and process

development and commercialization, i.e. creation, development, packaging and exploitation of IP. In addition, the

division has access to Technovent, a business incubation company set up by the CSIR to incubate business

opportunities, and Technifin, which deals with the licensing of technology and IP. The Bio/Chemtek division has the


largest IP portfolio of all the divisions, and is involved in more than 50 different projects. Research and development

projects are conducted in-house or in partnership with other research organizations and companies. In addition, the

CSIR offers services in process and product development, toll manufacture for market and product development,

and a number of other analytical and technology services. The Bio/Chemtek division recently concluded an

agreement with Bioventures to form a new company, Mbuyu Biotech (Pty) Limited, that will initially commercialize 3

technological processes developed by the CSIR, with a view to extending the portfolio to encompass further

technologies in the future.

The mission of the Agricultural Research Council is to promote the agricultural and related sectors through

research, technology development and transfer. This is achieved through a number of different divisions focused on

both the plant and animal segments of agriculture. The ARC interfaces with national, provincial and local

government as well as various universities, technikons, agricultural unions and farmers' associations in SA. Through

its divisions, the ARC has built substantial capacity in research and technologies related to animal health and

production, plant health, cultivar and variety development, plant growth, organic production systems etc. The ARC

is headquartered in Gauteng but has a presence throughout SA through its different divisions and experimental

stations. The ARC has played an important role in biotechnology to date and represents an important source of

new innovations in the future. It also provides support services in all stages of the product development and

commercialization pipeline.

2. Western Cape

The Western Cape, which includes the Garden Route, is home to 20 of the 47 core biotechnology companies and

22 of the 59 non-core biotechnology companies identified in the survey. The area also houses 308 of the research

stakeholders and 346 of the research projects identified as belonging to the “biotech,” “potentially biotech,” and

“biotech services” categories. The distribution of these groups by sector is shown in Figure 42. The human health

sector is by far the dominant sector in terms of number of groups and projects for all 3 categories plotted. This is

followed by the plant and industrial sectors. The food & beverage, “other,” and support services sectors also

feature significantly in the biotechnology company sample.


Figure 42: Distribution of research groups, biotechnology companies and research projects in the Western Cape by

sector

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The Western Cape hosts a strong fundamental and applied research community from 5 tertiary research institutions

and 6 parastatals that contribute to the local biotechnology industry (Table 4).

Table 4: Major Research Institutions and Organizations in the Western Cape

Universities Institutes* Technikons Research Organizations

University of Cape Town Institute for Infectious

Diseases and Molecular

Medicine

Cape Technikon Medical Research Council

University of the Western Cape SANBI Peninsula Technikon ARC Infruitec-Nietvoorbij

University of Stellenbosch Institute for Wine

Biotechnology

PE Technikon (George

Campus)

CSIR

Institute for Plant

Biotechnology

National Botanical Institute

South African Bureau of

Standards

iThemba Laboratories


The Western Cape is home to the headquarters of the Medical Research Council and the National Botanical

Institute, as well as the GODISA-funded incubator, Acorn Technologies, the Cape Biotech BRIC, and the

administrative node of the National Bioinformatics Network. The ARC-Infruitec-Nietvoorbij division provides

research and technology solutions to the local wine and fruit industries. The CSIR has a small division in Cape Town

concerned primarily with food technology. The National Botanical Institute is playing an increasingly important role

in biotechnology with the increased interest of stakeholders in harnessing value from biodiversity. iThemba

Laboratories provides expertise in radionuclides and radiation technologies, and is turning its focus toward radio-

therapies. The Western Cape is also home to a world-renowned wine industry.


The South Cape or George-Garden Route corridor has significant capability in medical biotechnology, and the

development and production of plant-based products. Stakeholders in the region have established an industry-

driven forum, “Eden Biotechnology,” to promote and fund biotechnology-related industry development in the

region.

The Medical Research Council, headquartered in the Western Cape, plays a significant role in medical research in

SA. The MRC’s research is structured into six National Programmes, each with its own focus areas, to form a total

of 48 research units, groups, centres and lead programmes throughout SA. The majority of these units are

conducting research into medical problems in SA, and have the potential to feed into future biotechnology

endeavours. Five units, in particular, are directly involved in the development of products or services, i.e. Medical

Imaging Research Unit, South African AIDS Vaccine Initiative, SA Traditional Medicines Unit, Bone Research Unit,

and Human Genetics Research Unit.

3. Kwazulu Natal

Seven of the 47 core biotechnology companies and 12 of the 59 non-core biotechnology companies identified in

the survey are located or have branches in Kwazulu Natal. The area is also home to 110 of the research

stakeholders and 132 of the research projects identified as belonging to the “biotech,” “potentially biotech,” and

“biotech services” categories. The distribution of these groups by sector is shown in Figure 43. The human health

and plant sectors dominate in the research groups and projects, while the plant and industrial sectors dominate in

the biotechnology companies.

Figure 43: Distribution of research groups, biotechnology companies and research projects in Kwazulu Natal sector

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Kwazulu Natal houses 3 Universities and the newly integrated Durban Institute of Technology (Table 5). The region

boasts a GODISA-funded Innovation Support Centre, i.e. The Voxel Support Centre, and the ECoBio and PlantBio

BRICs. The timber research centres of 4 major paper/timber companies are situated in Pietermaritzburg, and

Durban is an important centre for sugar cane research.

Table 5: Major Research Institutions and Organizations in Kwazulu Natal

Universities Institutes within Universities or

Technikons

Technikons Research Organizations

University of Natal African Centre for Crop

Improvement

Durban Institute of Technology South African Sugar Association

Experiment Station

University of Durban-Westville Sugar Milling Research Institute Medical Research Council

University of Zululand Institute for Commercial Forestry

Research

CSIR


4. Eastern Cape

The Eastern Cape makes a relatively small contribution to the total national biotechnology activities, with only 3 of

the 47 core biotechnology companies and 4 of the 59 non-core biotechnology companies identified in the survey

being located or having branches in the region. The area is also home to 39 of the research stakeholders and 58 of

the research projects identified as belonging to the “biotech,” “potentially biotech,” and “biotech services”

categories. The distribution of these groups by sector is shown in Figure 44. The dominant sector for research

groups and projects is human health, followed by the “other,” industrial, and environmental sectors. The sample

size for the companies is too small to provide accurate trends.

Figure 44: Distribution of research groups, biotechnology companies and research projects in the Eastern Cape by

sector

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The Port Elizabeth area is best known for its manufacturing industries, particularly cars and chemicals. The city also

houses 2 major tertiary education institutions, and the GODISA-funded SAC/CHEMIN Incubator. Rhodes University

in Grahamstown has made a significant contribution to biotechnology activities in SA to date and boasts a number

of experts in the field.

Table 6: Major Research Institutions and Organizations in the Eastern Cape


Technikons


University of Port Elizabeth PE Technikon (Main Campus) CSIR

Rhodes University Eastern Cape Technikon

University of Fort Hare Border Technikon

University of the Transkei


5. Free State

The Free State makes a small contribution to national biotechnology activities, with only 3 non-core biotechnology

companies located or having branches in the region. The area is also home to 57 of the research stakeholders and

70 of the research projects identified as belonging to the “biotech,” “potentially biotech,” and “biotech services”

categories. The distribution of these groups by sector is shown in Figure 45. The 3 non-core biotechnology

companies participate in biotechnology activities that fall under the industrial and environmental sectors. The

research groups and projects are relatively evenly spread over 7 of the 8 sectors, with an emphasis on industrial

biotechnology in the research projects and plant biotechnology in the research groups.

Figure 45: Distribution of research groups, biotechnology companies and research projects in Free State by sector

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The majority of biotechnology activity in the Free State is centred on Bloemfontein, in particular, the University of the

Free State and, to a lesser extent, Free State Technikon.

Table 7: Major Research Institutions and Organizations in the Free State


Technikons


University of the Free State SAPPI Biotechnology Research

Centre

Free State Technikon



SECTION G: CONCLUSIONS

In presenting the state of the biotechnology industry in South Africa, it is important that we highlight the problems

and challenges that SA is facing with respect to the development of a successful industry, in order to inform future

developments and strategies. The report has, at the same time, attempted to emphasize the strengths of the

industry and the potential that exists, in order to encourage stakeholders to continue with their efforts and to attract

new expertise and investment to the industry. The development of biotechnology in SA will require a sustained

positive attitude, critical evaluation and adjustments and the passion to succeed. Thus, it is hoped that the results

presented here will provide some insight as to what needs to be done for the industry as well as igniting a sense of

excitement about the vast possibilities and opportunities available.

The results of the survey represent minimum figures for the described indicators. The challenges in defining and

obtaining information on the industry have limited the extent of the data, and the results are reported within the

constraints, with few assumptions being made. The survey has the potential, however, to serve as a quantitative

baseline for measuring the growth of the industry over the coming years, particularly in response to new

government interventions in the industry.

It is clear from the survey that South Africa has enormous potential with respect to biotechnology. The

biotechnology industry in South Africa is small by international standards but has a substantial pipeline of potential

new products and processes in the research and development stage. Biotechnology activities span the full pipeline

from fundamental research to product development and commercialization, and include services that make use of

biotechnologies as well as support services for biotechnology stakeholders. Activities are supported by

sophisticated laboratories, and a small, but globally leading pool of biotechnologists and bioinformaticists. Although

support for innovation commercialization has been insufficient to date, it is becoming increasingly available through

technology transfer offices associated with tertiary institutions, private consulting companies, GODISA-funded

incubators focused on biotechnology and, more recently, the BRICs.

In the foreword to the Ernst and Young Beyond Borders 2002 report, the South African Director of Genetic

Resources is singled out as an important role player in global biotechnology. Yet South Africa does not feature as a

biotechnology market in the same report nor does it feature in the 2003 report (6; 7). This is the time and

opportunity for South Africa to find its rightful place on the global biotechnology map. The challenge is take

advantage of the opportunities for the sustainable development of niche markets in which South African

stakeholders can compete on a global scale, while at the same time identifying new niche areas for capacity

development. This can be facilitated by the creation of an enabling environment that allows stakeholders to

maximize the benefit derived from the potential of biotechnology, whilst minimising the possible risks to the

environment and human health. This enabling environment has to be developed in the context of South Africa’s

particular circumstances and challenges, and must address the key financial, human resources and infrastructural

deficits currently limiting the industry.


REFERENCES

1.) Biotechnology Industry Organization. Guide to Biotechnology – Agricultural Production, 2002

( http://www.bio.org )

2.) Biotechnology Industry Organization. What Is Biotechnology? ( http://www.bio.org )

3.) Chitsike, LT. Existing Treaties, Trade Agreements And Protocols Relevant To Biotechnology And Biosafety And

Their Implications To Member Countries.

4.) DACST. White Paper on Science and Technology, 1996

5.) Du Preez, C, Morris, J, Walwyn, D, and Webster, J. Draft Emerging Biotechnology Roadmap, July 2003

6.) Ernst and Young. Beyond Borders, The Global Biotechnology Report, June 2002

7.) Ernst and Young. Beyond Borders, The Global Biotechnology Report 2003

8.) Ernst and Young. Eight Annual Life Science Report, 2001

9.) Ernst & Young. The Economic Contributions of the Biotechnology Industry in the US Economy. 2000

10.) Finnfacts. One-in-ten European biotechnology companies Finnish, 31 December 2002

( http://www.finnfacts.fi/english/main/actualities/bio_viikki.htm )

11.) Hoffman, LC, Swart, JJ, and Brink, D. The 1998 production and status of aquaculture in South Africa

( http://www.wrc.org.za )

12.) Li, Jianming and Halal, William E. Reinventing the Biotech Manager. Nature Biotechnology Supplement, Vol 20,

July 2002

13.) Llobell, Antonio. Survey on Biotech Platforms in SA, 20 March 2003

14.) National Advisory Council on Innovation and Department of Arts, Culture, Science and Technology. South

African Science and Technology, Key Facts and Figures 2002, July 2002

15.) National Department of Agriculture. General Information on Agriculture in South Africa

( http://www.nda.agric.za )


16.) NBN Draft Business Plan, 2003 ( http://www.nbn.ac.za )

17.) NRF Business Plan 2003/04 – 2005/06, 27 March 2003

( http://www.nrf.ac.za/profile/business_plan_april03.pdf )

18.) Organization for Economic Cooperation and Development. Biotechnology Definitions: Second ad hoc Meeting

on Biotechnology Statistics, April 2001 ( http://www.oecd.org )

19.) South African National Biotechnology Strategy, 2001

( http://www.dst.gov.za/programmes/biodiversity/biotechstrategy.pdf )

20.) Statistics Canada. Biotechnology Use and Development Survey, 1999

21.) Statistics New Zealand. Modern Biotechnology in New Zealand, April 2001

22.) The Government of the Republic of South Africa. South Africa’s National Research and Development Strategy,

August 2002 ( http://www.dst.gov.za/legislation_policies/strategic_reps/sa_nat_rd_strat.pdf )

23.) TIME. Developments in Molecular Biology, From Mendel to Modern Life Sciences, TIME, March 22, 1999

( http://www.thecore.nus.edu.sg/lifesciences/history.html )

24.) Trade & Investment, Turkey. Business & Investment in SA: Business Opportunities in Dynamic Sectors

( http://www.southafrica.org.tr/eng/trade16.htm )

25.) University of Cape Town. Annual Report, December 2001

26.) USPTO Statistics ( http://www.uspto.gov/web/offices/ac/ido/oeip/taf/clsstc/zax_stc.htm )

27.) USPTO Statistics ( http://www.uspto.gov/web/offices/ac/ido/oeip/taf/asgstc/zax_stc.htm )

28.) van Beuzekom, Brigitte. Organization for Economic Cooperation and Development, Biotechnology Statistics in

OECD Member Countries: Compendium of Existing National Statistics, September 2001 ( www.oecd.org )

29.) van Brunt, Jennifer. Corporate VCs, Signals Magazine, 2002

30.) Webster and Koch. Biotechnology Survey: A Situational Analysis of South Africa and Sub-Saharan Africa. CSIR

internal report, 1998 (see http://www.africabio.org.za , full report available from AfricaBio)


APPENDIX A: CLASSIFICA TIONS USED IN THE

SURVEY

Sectors and Focus Areas

Please note that some stakeholders, projects or products will fall under more than one category

Human Health- Phytopharmaceuticals –pharmaceuticals derived from plants

- Disease Genetics –research and product development on the genetic basis of diseases and resistance to

diseases

- Diagnostics – diagnosis of human diseases using DNA, immunology or physical techniques

- Vaccines – development and/or manufacture of human vaccines (live, attenuated, recombinant or subunit)

- Disease Physiology – research on the physiological basis and mechanisms of diseases

- Drug Resistance – research on the basis of resistance to drugs

- Protein Production – production of proteins and antibodies for therapeutics or diagnostics

- Disease Prevention – research on or development of products for the prevention of diseases (other than vaccines)

- Drug Testing – analytical or in vitro testing of pharmaceuticals

- Therapeutics – pharmaceuticals for the treatment of diseases or precursors of pharmaceuticals

- Immunotherapeutics – pharmaceuticals directed at the immune system

- Gene Therapy – therapeutics based on gene transfer

- Disease Resistance – studies on factors conferring resistance to disease

- Traditional Medicines – medicines based on indigenous medical knowledge

- Clinical Trials – clinical testing of new products

- Tissue Engineering – stem cell research, organ research etc.

- Drug Design and Development – rational drug design, combinatorial chemistry and drug synthesis strategies

- Medical Devices – development of medical devices based on advanced technologies, e.g. cardio stents or

imaging

- Epidemiology – studies on the prevalence and spread of diseases

- Bioprospecting – seeking new pharmaceutically active substances from biodiversity

- Human Physiology – studies on general human physiology

- Population Genetics – genetic studies on specific populations

- Exercise Physiology – physiology of exercise in humans

- Drug Delivery – physical and biological delivery systems for drugs

- Bioinformatics – use of computing in drug discovery

- Reproduction – studies on reproduction and reproductive diseases in humans

- Natural Health Products – non-pharmaceutical products from living organisms for human health, e.g. herbal

extracts

- Microbicides – substances for the removal of bacteria and fungi

- Transplantation – studies on organ transplantation


- Chemical Exposure – the effects of exposure to various chemicals

- Telemedicine – the use of telemedicine for long-distance diagnosis

- Nutrition – aspects of nutrition in humans

Animal Health- Vaccines – development and/or manufacture of animal vaccines (live, attenuated, recombinant or subunit)

- Diagnostics – diagnosis of animal diseases or species identification using DNA, immunology or physical

techniques

- Animal Genetics – studies on animal genetics

- Animal Physiology - studies on general animal physiology

- Therapeutics – pharmaceuticals for the treatment of diseases in animals

- Protein Production – production of proteins and antibodies for therapeutics or diagnostics

- Animal Nutrition – studies on nutrition in animals and animal feed products

- Natural Health Products – non-pharmaceutical products from living organisms for animal health, e.g. herbal

extracts

- Disease Resistance – studies on factors conferring resistance to disease

- Phytopharmaceuticals –pharmaceuticals derived from plants

- Probiotics – microbes for use in animal feeds

- Traditional Medicines – medicines based on indigenous medical knowledge

- Disease Physiology – research on the physiological basis of diseases

- Epidemiology – studies on the prevalence and spread of diseases

- Product Testing – testing of products for use on animals

- Drug Testing – analytical or in vitro testing of pharmaceuticals

- Disease Genetics –research and product development on the genetic basis of diseases and resistance to

diseases

- Disease Control – methods to control animal diseases

- Reproduction – studies on reproduction and reproductive diseases in animals

- Clinical Trials – clinical testing of new products

- Animal Breeding – traditional and GM breeding of animals

- Drug Delivery – delivery systems for animal drugs

Plant- Plant Growth Stimulants – products that promote the growth of plants, including fertilizers

- Traditional Breeding – traditional breeding of plant cultivars

- Marker-Assisted Breeding – identification of markers to select for desired traits in plants

- GM Crops – development of genetically modified crops

- Plant Genetics – genetics of plant characteristics and adaptation to stress

- Forestry Improvement – development of products, processes or technologies for forestry improvement

- Bioprospecting – seeking new products from plant diversity

-


Plant Propagation – development of products and methods for plant propagation

- Diagnostics - species identification and diagnosis of plant diseases using DNA, immunology or physical

techniques

- Natural Products – products derived from plants, algae and seaweed

- Plant Physiology – studies on general plant physiology

- Plant Pests – studies on plant pests including insects, nematodes, and microbial pathogens

- Plant Diseases – studies on diseases affecting plants, e.g. viruses

- Biological Control – development and manufacture of natural products for the control of plant pests

- Soil Improvement – development of products and technologies for soil improvement

- Crop Protection – products for the protection of crops from external stresses

- Seaweed Products – products derived from seaweed or kelp

- Production in Plants – use of plants to express and produce proteins or metabolites

- Plant Adaptation – mechanisms of adaptation to stress in plants

- Plant Manipulation System – systems for the genetic transformation of plants

- Horticulture – general methods in horticulture for crop enhancement

Food & Beverage- Food Supplements – additives to foods for enhanced nutritional qualities

- Nutraceuticals – natural products with nutritional and health benefits

- Food Ingredients – additives to foods, including enzymes, colourants, fragrances, starter cultures etc.

- Food Fermentation – traditional fermentation for food production

- Food Processing – food processing during manufacture

- Food Improvement – improvement of foods through products or processes, e.g. enhanced nutritional benefit

- Food Analysis – analysis of food using biochemical, microbiological or physical techniques

- Food Pathogens and Toxins – studies on the pathogens and toxins found in food

- Food Preservation - products or processes for the sterilization of food, e.g. anti-microbials

- Probiotics – use of microorganisms in food for health benefits

- Wine Production – traditional wine fermentation

- Wine Improvement - products or processes for the improvement of wine

- Yeast Physiology – studies on the physiology of yeast used in food and beverages

- Yeast Improvement - products or processes for the improvement of yeast used in food and beverages

- Beer Brewing – traditional beer brewing

- Food Allergens – study of the compounds causing allergies in food

- Yeast Typing – identification of yeast strains

- Biological Control – development and manufacture of natural products for the control of pests on food

- Food Science – basic research into food science

Industrial- Protein Production – production of enzymes and proteins for industrial applications

- Bioleaching – use of living organisms for the leaching of metals or minerals


- Natural Products – large-scale extraction of products from living organisms

- Biocatalysts – enzymes of biological origin for use in industrial processes

- Bioproduction – use of living organisms or parts thereof for the production of chemicals and other products

- Enzymes – enzymes produced through industrial processes

- Bioprocessing - use of living organisms for industrial processing, including pulping, oxidation etc.

- Process Development – development of processes involving living organisms, including optimization etc.

- Bioprospecting - seeking new enzymes and products from living organisms for use in industrial processes

- Beneficiation – the conversion of industrial by-products to useful products using living organisms

- Production of Biochemicals – production of biological chemicals, e.g. amino acids, antibiotics, vitamins etc.

- Specialized Chemicals – production of specialized and fine chemicals

- Biotransformation – conversion of compounds using organisms

- Acid Mine Drainage – use of bacteria for acid mine drainage

- Pilot Production – pilot scale production of chemicals and biological products for product development

- Biosensors – sensors used in industrial processes

- Biomonitoring – monitoring microbial populations in industrial processes

- Biofuels – use of natural products as fuels

Environmental- Waste Treatment – treatment and conversion of waste products and effluents using living organisms

- Bioremediation – conversion of waste to useful products

- Rehabilitation – use of living organisms to rehabilitate contaminated sites

- Water Purification – products and processes for the purification of water

- Biofuels – use of biomass as fuels

- Diagnostics - detection of environmental pathogens

- Biodegradation – use of microorganisms to degrade toxic compounds or effluents

- Biomonitoring – bioindicators and monitoring of microbes in the environment

- Biosensors – sensors used to monitor the environment

Other- Mariculture/Aquaculture – culturing of marine and aquatic organisms

- Platform Technology – a novel technology that enables biotechnology research and/or product development

- Characteristics of Biological Molecules – studies on biological molecules, e.g. carbohydrates

- General Research – basic research with applications in no specific focus area, e.g. biodiversity

- Biological Control – biocontrol of mosquitos etc.

- Culture Collection – biological resources

- Bioprospecting – seeking new products and processes from biological diversity

- Plant-based Cosmetic Products – cosmetic products and ingredients derived from plants

- Cosmetic Preparations – products used in cosmetics

Support Services- Biosafety – assistance with biosafety issues for GMOs


- Laboratory Supplies – laboratory reagents and biochemicals

- Scientific Equipment – suppliers of scientific equipment

- Contract Manufacture – contract production of chemicals and biological products

- Pilot Production – pilot scale production of chemicals and biological products for product development

- Contract Research – contract research on any area

- Information Technology/Bioinformatics – IT support for research or product development, e.g. bioinformatics

- Raw Materials – supply of raw materials for processes

- Core Technology Services – core technology services, e.g. DNA sequencing, oligo synthesis, plant tissue culture

etc.

- Public Awareness – increasing public awareness of biotechnology

- Analytical Services – chemical or physical analysis of substances

- Quality Control – analysis of food etc. for quality control

- Training – training in various disciplines related to biotechnology

- Consulting – general assistance in technical or business aspects

- Product Testing – testing of products for safety and efficacy

- Packaging – facilities for packaging of products

- Medical Equipment Supplier – supplier of medical devices and equipment


APPENDIX B: INTERNA T IONAL P A TENT

CLASSIFICA TIONS RELE V ANT TO BIOTECHNOLOG Y

A01H: New Plants or Processes for Obtaining them; Plant Reproduction by Tissue Culture Techniques

A01N: Preservation of Bodies of Humans or Animals or Plants or Parts thereof; Biocides, e.g. As Disinfectants,

As Pesticides, As Herbicides

A23J: Protein Compositions for Foodstuffs; Working-up Proteins for Foodstuffs; Phosphatide Compositions for

Foodstuffs

A61B: Diagnosis; Surgery; Identification

A61J: Containers Specially Adapted for Medical or Pharmaceutical Purposes; Devices or Methods Specially

Adapted for Bringing Pharmaceutical Products into Particular Physical or Administering Forms; Devices

for Administering Food or Medicines Orally; Baby Comforters; Devices for Receiving Spittle

A61K: Preparations for Medical, Dental, or Toilet Purposes

C02F: Treatment of Water, Waste Water, Sewage, or Sludge

C05F: Organic Fertilisers not Covered by Subclasses C05B, C05C, e.g. Fertilisers from Waste or Refuse

C12C: Brewing of Beer

C12G: Wine; Other Alcoholic Beverages; Preparation Thereof

C12H: Pasteurisation, Sterilisation, Preservation, Purification, Clarification, Ageing of Alcoholic Beverages or

Removal of Alcohol Therefrom

C12M: Apparatus for Enzymology or Microbiology

C12N: Micro-organisms Enzymes; Compositions Thereof

C12P: Fermentation or Enzyme-Using Processes to Synthesise a Desired Chemical Compound or Composition

or to Separate Optical Isomers from a Racemic Mixture


C12Q: Measuring or Testing Processes Involving Enzymes or Micro-organisms (immunoassay G01N�3 3/53);

Compositions or Test Papers Thereof; Processes of Preparing Such Compositions; Condition-

Responsive Control in Microbiological or Enzymological Processes�

C12S: Processes Using Enzymes or Micro-organisms to Liberate, Separate or Purify a Pre-Existing Compound

or Composition

G01N: Investigating or Analysing Materials by Determining Their Chemical or Physical Properties

Documents

Compiled by Dr Michelle Mulder - OECD.org · 2018-08-02 · Compiled by Dr Michelle Mulder Idea to Industry cc ... international trends, the majority of core biotechnology companies