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Developing Country Vaccine
Industry and Global Vaccine Needs
ADVAC 2016
Dr. Suresh JadhavExecutive Director
Serum Institute of India Limited
Maharashtra, India, 411028
Outline Immunization landscape
Vaccine Industry: DCVMN Overview
Role of DCVM
- UN Supplies
- Global Vaccination Coverage
- Global Health Threats
- Vaccine Affordability
Summary and discussion
Ecosystem: Immunization Landscape
Last decade, great advances in developing, introducing and improving
access to vaccines.
Annual number of deaths among children under five years of age fell
from an estimated 9.6 million in 2000 to 5.9 million in 2014, despite an
increase in number of children born each year.
Number of deaths in vaccine preventable diseases such as
diphtheria, pertussis, measles, neonatal tetanus and poliomyelitis
dropped from 0.9 million in 2000 to 0.4 million in Year 2010.
Newer vaccines, including pneumococcal conjugate vaccines and
vaccines against rotavirus and HPV, are currently being rolled out
globally.
Through global innovative international collaboration, an affordable
conjugate vaccine against Nesseria meningitidis serogroup A was
developed and is now in use in African Meningitis belt.
Global Action Vaccine Plan 2010-2020, WHO 2013
• The world has achieved
tremendous progress in
reducing child mortality
• Promisingly, progress has
accelerated in recent years,
especially in some of the
most challenging contexts
• However, progress is not
enough to meet the MDG 4
target of a two-third reduction
in the under-five mortality rate
between 1990 and 2015
• Most under-five deaths are
still caused by diseases that
are readily preventable or
treatable with proven, cost-
effective interventions
Most under-five deaths are still caused by diseases that are preventable or treatable
UNICEF Presentation: 2015
Global Vaccine Market
Source: Kaddar, WHO Presentation 2014
Global Vaccine supply
• Comprise 25 leading international companies.
• Majority of revenue stake owned by Big 5 Pharma.
• Represents research-based pharmaceutical and biotech companies.
• Generates 80-85 % of total revenue in global vaccine market.
• Contributes 12-15 % in volumes to global vaccine requirement.
• Formed in Year 2000.
• January 2016: 44 members in 16
countries; Latin America, Middle East,
Africa, and the Asia-Pacific region.
• supplies over 40 different types of
vaccines, totalling around 200 products.
From those nearly 40 are prequalified by
WHO.
• Year 2013, Emerging vaccine
manufacturers catered to 50 % of
volumes and 50 % by value of UNICEF
shares.
• Largely kept prices of traditional
vaccines affordable in-spite of declining
interest of Big Pharma in EPI vaccines.
Jadhav et al 2014, CMI.
Developing countries: Vaccine Industry
Supplies vaccines to 85 % of population: However shares less than
20% of global market in value
Increase in production capacities and potential to undertake or
partner for newer vaccines development
Business models based on access to emerging economies and
markets, UN market and Private sector in Low and Middle income
countries
Growth drivers: Large population, Unmet vaccination needs and low vaccination rates, Increasing governments focus on prevention/childhood rates
Future growth Expectations: Combination vaccines, -Influenza, -Traveller vaccines, Neglected Tropical diseases, pneumococcal and rotavirus, HPV vaccines; Malaria, Dengue Vaccine.
DCVMN Members
1 Arab Company for Pharmaceutical Products (Arabic) Saudi Arabia
2 Beijing Minhai Biotechnology Co. Ltd. P.R. China
3 Beijing Tiantan Biological Products Co. Ltd. P.R. China
4 Bharat Biotech international Limited India
5 Biological E. Limited India
6 Bio Farma Indonesia
7 Bio-Manguinhos-Institute of Technology on Immunobiologicals Brazil
8 BioNet-Asia Co., Ltd. Thailand
9 Bravo Vax Co., Ltd. P.R. China
10 Cadila Pharmaceuticals Limited. India
11 Center for Research and production of Vaccine and Biological Vietnam
12 Changchun BCHT Biotechnology Co. P.R. China
13 China National Biotec Group (CNBG) P.R. China
14 EuBiologics Co. Ltd. Republic of Korea
15 Finlay Institute Cuba
16 Fundacao Ataulpho de Paiva Brazil
DCVMN Members
17 Green Cross Corporation Korea
18 Haffkine Bio-Pharmaceutical Corporation Limited. India
19 Incepta Vaccine Ltd. Bangladesh
20 Indian Immunologicals Limited. India
21 Institute of Vaccines and Medical Biologicals Vietnam
22 Instituto Butantan Brazil
23 Institute of Medical Biology, Chinese Academy of Medical Sciences P.R. China
24 Laboratorios de Biologicos y Reactivos de Mexico. S.A.de
C.V.(BIRMEX)
Mexico
25 LG Life Sciences Ltd. Republic of Korea
26 Liaoning Cheng Da Biotechnology Co.,Ltd. (CDBIO) P.R. China
27 Medigen Vaccinology Corporation Taiwan
28 National Administration of Laboratories and Institutes of Health
ANLIS “Dr. Carlos G. Malbran”
Argentina
29 National Institute of Infectious Disease and Vaccinology Taiwan
30 Panacea Biotec Ltd. India
DCVMN Members
31 Pasteur Institute of Iran IR of Iran
32 Queen Saovabha Memorial Institute Thailand
33 Razi Vaccine & Serum Research Institute IR of Iran
34 Serum Institute of India Pvt Ltd. India
35 Sinergium Biotech S.A. Argentina
36 Sinovac Biotech Ltd. P.R. China
37 S.K. Chemicals (Life Science Biz division) Republic of Korea
38 The Biovac Institute South Africa
39 The Center for Genetic Engineering and Biotechnology Cuba
40 The Company for vaccine and biological production No.1-VABIOTECH Vietnam
41 The Government Pharmaceutical Organization Thailand
42 The Holding Company for Biological Products & Vaccines(VACSERA) Egypt
43 Vins Bioproducts Ltd. India
44 Walvax Biotechnology Co. Ltd. P.R. China
45 Xiamen Innovax Biotech Co.Ltd. P.R. China
Jan 2016: 45 members in 16 countries; Latin America, Middle East, Africa and Asia Pacific Region
Sr.No
.
Name of DCVMN member WHO prequalified vaccines
1 Bio Farma/Indonesia TT, DT, Td, DTwP, Hep B, DTwP-HepB, Measles,mOPV,
bOPV, tOPV
2 Biological-E/India TT, DTwP-HepB, Hib, JE
3 BioManguinhos/Fiocruz/Brazil YF, MenA+C
4 The Center for Genetic Engineering and
Biotechnology/ Cuba
HepB, Hib
5 Chengdu Institute/ China JE
6 Green Cross Corpn/Korea Seasonal and Influenza A (H1N1)-Pandemic Influenza
vaccines
7 The Government Pharmaceutical
Organization/ Thailand
Measles
8 Haffkine Institute/ Mumbai Mopv, bOPV, tOPV
9 The Pasteur Institute Dakar YF
10 Serum Institute of India TT, DT, Td, DTwP, HepB, BCG, Hib, Measles, Rubella,
MR, MMR, Meningococcal conjugate vaccine against
serotype A, HINI Pandemic Inflenza, bOPV, tOPV, DTwP-
HepB, DTwP-Hib, DTwP-HepB-Hib
11 LG Life Sciences/ South Korea Hep-B, DTwP-HepB-Hib
12 Panacea Biotech, India. DTwP-HepB-Hib
DCVMN and Vaccines
UNICEF Supplies
In Year 2014, UNICEF procured 2.71 billion doses of vaccines for 100
countries, from polio and measles to tetanus, BCG and yellow fever vaccines,
at a value of $1.48 billion.
Emergence of DCVMs
UNICEF publication, 2014; SAGE meeting April 2016
Year 2011 to 2015, increased supply of Pentavalent Vaccine resulted in increase in
the coverage in 73 GAVI eligible countries to 81% in 2014
Rapid growth in Emerging Economy
producers (DCVMs).
From Year 2008 to Year 2015: GAVI funded vaccines from DCVMN was above 60 %.
Jadhav et al 2014, CMI;SAGE April 2016.
Measles vaccine
Global coverage of children by their second birthday with one dose of measles
-containing vaccine in 2014: 85%. (From 148 countries in 2013 to 154 countries in
2014. Global Immunization data : July 2015
Hepatitis B Vaccine
Global coverage with three doses of hepatitis B vaccine is estimated at 79 % in year 2013. (WHO data; 2014)
This coverage further increased to 82 % in Year 2014.
Global Immunization data : July 2015
Polio eradication
Global Immunization data : July 2015
Hib Vaccine
Global coverage with three doses of Hib vaccine is estimated at 45 % in 2013; which
increased to 56 % in Year 2014 (WHO estimates, 2013)
Pentavalent vaccine and UNICEF
Supplies
Hib Vaccine was introduced in 192 countries in Year 2014.
Global coverage (3 doses) is at 56 % Global Immunization data : July 2015
DCVMN and Global Threats
DCVMN and Global Pandemic threats
WHO Global Action Plan for Pandemic Influenza (GAP).
-This represent an leading
example wherein pandemic
threats led to capacity building.
-New manufacturers have been
established in developing
countries, which brings hopes to
more adequate production
capacity and equitable access in
case of a future pandemic.
- By 2015, production capacity
of more than 1 billion doses is
expected by DC manufacturers.
DCVM and Global Health Threats Meningitis
Vaccine ProjectSuccessful example of Global Partnerships
MenAfric Vac: Impact
MVP and NIBSC presentation
Maternal and Neonatal Tetanus
Elimination from South East Asia
Year 2016: WHO South-East Asia Region has
achieved a major public health feat – the Region has
eliminated maternal and neonatal tetanus (MNT) with
all districts across the 11 countries having reduced cases
to less than one per 1000 live births.
DCVMN is major supplier to UN agencies for
tetanus toxoids.
Poliomyelitis (Polio)
Launch of Global Polio Eradication Initiative has led to 99% drop in cases since 1988
3 countries remain polio-endemic: Afghanistan, Nigeria, Pakistan (vs 125 in 1988)
Polio Eradication and Endgame Strategic Plan 2013–2018 – aims to eradicate disease by 2018
One of major challenge in end game strategy will be vaccine supplies.
Supply of IPV and DCVM Existing price from developed country vaccine manufacturer (Big
Pharma): 4.50 Euros/dose.
EVM* Price: 2.50 Euros/dose till year 2013.
Year 2013 DCVM price: 1.25 Euro/dose in single dose container.
0.90 Euro/dose in multidose container for immediate use. Future
pricing may reduce to 0.60 Euros/dose in multidose vial.
Year 2014: 10 dose vial cost EUR 0.75 per dose from Big Pharma.
* Pricing from IPV producer in Europe acquired by Indian Vaccine Manufacturer
Global Immunization Coverage
UNICEF- data_2014.
Vaccine Pricing and Affordability
Year 1974: EPI program was launched.
Year 1999: Total cost of full course of EPI vaccine averaged USD
1.37
Year 2000: Adding two priority vaccines-Hepatitis B and Hib to EPI
vaccines increased the cost to USD10.
Year 2011: The expansion of EPI Program have raised the price of
purchasing the full course of vaccine in GAVI country to 38.80 USD.
(Price does not include programmatic or cost associated with vaccine
wastage).
Price of vaccine became a significant issue for immunization
stakeholders in Year 2011, when GAVI faced a US $ 3.7 billion
financial shortfall for its 2011-2015 programme implementation.
In Past 5 Years: WHO is recommending high unit cost products such
as pneumococcal conjugate vaccine and rotavirus vaccine for global
use in infants and HPV vaccines for adolescents.
The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012
Pricing and DCVMN
Crucell GSK DCVMN (SII/BE)
Presentation Single
dose
Two dose
lyophilized
Single
dose
-liquid
Two dose
lyo
Ten dose
liquid
Country of
manufacture
Republic
of Korea
Belgium India India India
2011 price
per dose
$2.80-
3.20
$2.95 $2.25-2.50 $2.25 $1.19-
2.11
DCVMN supplied Pentavalent vaccines, mainstay of GAVI Purchase at prices
almost 40 % less than Crucell, a European company.
GAVI’s support for pentavalent vaccine has averted 474,000 future deaths. source: WHO Department of Immunisation, Vaccines and Biologicals’ estimates and projections, November 2010
2011 Price Per dose of DTP-Hep-B-Hib (Pentavalent)
The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012
DCVMN and Pneumococcal Vaccines
Year 2000: PCV 7: CDC Purchase price was USD 44.25/dose.
Year 2009; PCV 13 CDC Purchase price was at 71.04 USD per dose.
Following deliberation in Year 2007, access to PCV 7 and 13 was supported by AMC with initial target price of USD 2.00 per dose. Finally the price was locked in with tail price of 3.50 USD/dose.
No competition from low cost producers as on date. However, some DCVMN members are expected to enter this segment of vaccines by Year 2016.
The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012
DCVMN and Rotavirus Vaccines
Year 2006: USD 15.00 for full course; PAHO supplies
Year 2011: Big Pharma manufacturers reduced the
price in range of 5.00 to 10.00 USD per course
following sales of 30 million doses.
One of DCVMN member, launched the rotavirus
vaccines in Year 2015, at USD 1.00 per dose.
Another DCVMN member is expected to launch
another Rotavirus vaccine in Year 2016-17The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012
Human papillomavirus (HPV)
Most common viral infection of the reproductive tract (> 100 types)
Can cause cervical cancer, other types of cancer, and genital warts
> 85% of cervical cancer deaths are in low- and middle-income countries
HPV vaccine introduced in 45 countries by end of 2012
HPV Vaccines and GAVI
DCVMN and Access to New Vaccines
Vaccine 2010, 28, 2115-21.
Vaccines DCVMN manufacturer Country Comments
Pneumococcal
Conjugate
BioManguinhos/GSK
Chengdu Institute/PATH
SII, India/PATH
Finlay Institute
Brazil
China
India
Cuba
Under development
Rotavirus Serum Institute of India
-Instituto Butantan
-China National Biotech Group
-Biological Evans
India
Brazil
China
India
Phase-3
Phase-2
Under development
Under development
Meningococcal
vaccines
Includes
polysaccharide and
conjugate vaccines
Biological Evans
China National Biotech Group
Finlay
Serum Institute of India Ltd
Panacea Biotech
BioManguinhos
India
China
Cuba
India
India
Brazil
Under development
Japanese
encephalitis vaccine
Vabiotech
Bharat Biotech
Indian Immunologicals
Panacea Biotech
Vietnam
India
India
India
Under development
Phase 3
Under development
Under development
Seasonal and
Pandemic Influenza
Vaccines
(also includes vaccines
with oil in water
adjuvants
-Vabiotech
-GPO
- IVAC
- Butantan
- Chinese National Biotech Grp
- Birmax
- BioManguinhos
Vietnam
Thailand
Vietnam
Brazil
China
Mexico
Brazil
Under development
Phase III
Under development
Phase I/II (new adjuvant)
Under development
Under development
Under development
DCVMN and Access to New Vaccines
Vaccines DCVMN manufacturer Country Comments
Malaria vaccine Bharat Biotech India Under development
Typhoid Vaccine Finlay Institute Cuba Under development
Dengue Vaccine Biological Evans
Bio-anguinhos/Bionet
India
Brazil
Under development
Yellow fever ANLIS Argentina Phase III
Hepatitis A Bio-manguinhos Brazil Under development
Leishmaniases Bio-manguinhos Brazil Under development
Leptospirosis Bio-manguinhos Brazil Under development
HPV Vaccine Serum Institiute
CCGEB
Innovax
Indian Immunologicals
India
Cuba
China
India
Under development
Chikungaya Indian immunologicals India Under development
Anthrax vaccine Panacea Biotech India Phase III
36
Summary
DCVM have moved from dependency to self sufficiency and has finally emerged as global suppliers for affordable vaccines.
DCVM look forward to supplies and markets in developed world:- Will have to overcome challenges and would need partnerships/collaborations with scientific community and Big Pharma to address issues of access, IP.
-Support from international agencies/foundations in terms of funding and advocacy.
The Facts
1 in 5 children do not have access to
life-saving immunizations
Vaccines
prevent
2 to 3
million deaths
annually
around
the world$20 can fully
vaccinate a
child against
pneumonia,
diarrhea, polio
and measles
Over 22 million infants remain
unimmunized in
the world each
year
Discussion
Do we have sufficient funding provisions for sustaining
decade of vaccine targets and objectives
For how long can we keep vaccine affordable in lieu of
increasing product complexities, regulatory
expectations, Intellectual property , product
development costs, inflation, challenges in advocacy
and lack of political will.
Can partnerships, collaborations, product development
partnerships help us ?
Thank You
We have to choose between a global market driven only by calculations of short-term profit,
Or one which has a human face
— Kofi Annan
We at DCVMN believe in second option
