Frontiers of Medical Biotechnologyris.org.in/images/RIS_images/pdf/asianbio2002_sen.pdf · Biotechnology Industry Biotechnology Industry -Biotechnology Industry - IndiaIIndiandia

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Welcome to all Welcome to all DelegatesDelegates


Biotechnology for Pharmaceutical and Health

Biotechnology for Biotechnology for Pharmaceutical and HealthPharmaceutical and Health


Classification of BiotechnologyClassification of BiotechnologyClassification of Biotechnology

ConventionalConventional ModernModern

Is a technique that makes Is a technique that makes use of cellular molecular use of cellular molecular processes like rDNA, processes like rDNA, monoclonal antibodies, monoclonal antibodies, genomics, proteomics etc.genomics, proteomics etc.-- also referred as gene also referred as gene technology

Is a technique that makes Is a technique that makes use of living organism for use of living organism for specific purposespecific purposeeg: bread/cheese makingeg: bread/cheese making

technology


Scope of BiotechnologyScope of BiotechnologyScope of Biotechnology


Healthcare BiotechnologyHealthcare BiotechnologyHealthcare Biotechnology

Healthcare biotechHealthcare biotech

DiagnosticsDiagnosticsDiagnostics

Gene TherapyGene TherapyGene Therapy

MedicinesMedicinesMedicines

VaccinesVaccinesVaccines

MonoclonalAntibodies

MonoclonalMonoclonalAntibodiesAntibodies


Healthcare BiotechnologyHealthcare BiotechnologyHealthcare BiotechnologyBiotechnology in health care uses proteins, enzymes, antibodies Biotechnology in health care uses proteins, enzymes, antibodies and other substances naturally produced in the human body as a and other substances naturally produced in the human body as a tool and weapon to fight infection, disease and also to correct tool and weapon to fight infection, disease and also to correct genetic disorders.genetic disorders.

Detects wide variety of disease & genetic conditionsDetects wide variety of disease & genetic conditions

Uses antigens and not actual virus against infections and Uses antigens and not actual virus against infections and diseasesdiseases

Uses proteins to fight body infections and carry out Uses proteins to fight body infections and carry out specific functionsspecific functions

Uses genetic material used to correct genetic disordersUses genetic material used to correct genetic disorders

Uses antiUses anti--bodies of high purity research, diagnostics & therapeuticsbodies of high purity research, diagnostics & therapeutics

Hea

lthca

re

Hea

lthca

re

biot

ech

biot

ech

DiagnosticsDiagnostics

VaccinesVaccines

MedicinesMedicines

Gene TherapyGene Therapy

MonoclonalMonoclonalAntibodyAntibody


Healthcare BiotechnologyHealthcare BiotechnologyHealthcare Biotechnology

Application of Healthcare BiotechApplication of Healthcare Biotech

VeterinaryVeterinary

TherapeuticsTherapeutics DiagnosticsDiagnostics

DrugsDrugs VaccinesVaccines

HumanHuman

TherapeuticsTherapeutics DiagnosticsDiagnostics

DrugsDrugs VaccinesVaccines


Biotechnology Industry - WorldwideBiotechnology Industry Biotechnology Industry -- WorldwideWorldwide

•• Presently there are about 5,000 biotech Presently there are about 5,000 biotech companiescompanies

•• Total biotechnology industry revenues were Total biotechnology industry revenues were about US$ 25 billion in 2000about US$ 25 billion in 2000

•• Long term product sales expected to be Long term product sales expected to be approximately US$ 50 billion in 2010approximately US$ 50 billion in 2010


Global Biotech OverviewGlobal Biotech OverviewGlobal Biotech Overview

•• No. of Companies : approx. 3500No. of Companies : approx. 3500USAUSA -- 15001500EuropeEurope -- 13001300JapanJapan -- 500500


Global Biotech : TherapeuticsGlobal Biotech : TherapeuticsGlobal Biotech : Therapeutics

Market Size (in 2000)Market Size (in 2000) :: $ 11.7 bn$ 11.7 bnMarket size expected in 2005Market size expected in 2005 :: $ 20.6 bn$ 20.6 bnCAGRCAGR :: 16%16%Current Biogenerics market sizeCurrent Biogenerics market size :: $ 8 bn$ 8 bn


Global Biotech : MarketsGlobal Biotech : MarketsGlobal Biotech : Markets

USA42%

Japan23%

Rest of World7%

Europe28%


Global Biotech : Major ProductsGlobal Biotech : Major ProductsGlobal Biotech : Major Products

•• EPOEPO•• GCSFGCSF•• HepB vaccineHepB vaccine•• hGHhGH•• Human InsulinHuman Insulin•• Interferon AlfaInterferon Alfa

They account for 80% of the global They account for 80% of the global salessales


Biotechnology Industry - IndiaBiotechnology Industry Biotechnology Industry -- IndiaIndia

•• Biotech market in India was estimated at US $ 800 million in Biotech market in India was estimated at US $ 800 million in 1999 and has risen approximately to US $ 2.5 billion this year1999 and has risen approximately to US $ 2.5 billion this year

•• Indian biotech industries employs about 20,000 peopleIndian biotech industries employs about 20,000 people

•• Indian share in the global market is about 2% onlyIndian share in the global market is about 2% only

•• Consumption of biotech products is expected to reach INR Consumption of biotech products is expected to reach INR 1,460 Crores by 20051,460 Crores by 2005

•• 72% of biotech products consumed domestically is met 72% of biotech products consumed domestically is met through local productionthrough local production

•• About 800 companies are operating in various sector of About 800 companies are operating in various sector of biotechnologybiotechnology

•• About 80 companies are operating in modern biotech sectorsAbout 80 companies are operating in modern biotech sectors



•• India has core competence in manpower and support India has core competence in manpower and support system in the form of research institutes likesystem in the form of research institutes like

–– CSIRCSIR–– CCMBCCMB–– ICMRICMR–– CDFDCDFD–– IISc and IISc and –– IICBIICB–– ICGEBICGEB

•• Due to inherent geographical and skilled and lowDue to inherent geographical and skilled and low--cost cost manpower advantages, there is an upsurge in manpower advantages, there is an upsurge in collaborations with multinational companiescollaborations with multinational companies



•• Healthcare biotech market in India consists of vaccine, Healthcare biotech market in India consists of vaccine, diagnostic and veterinary diagnostic and veterinary

–– The vaccine market is estimated at US$ 100 million with The vaccine market is estimated at US$ 100 million with an annual growth rate of 20%an annual growth rate of 20%

–– Diagnostic market is estimated at US$ 200 million with a Diagnostic market is estimated at US$ 200 million with a growing demand for veterinary vaccines, diagnostics, growing demand for veterinary vaccines, diagnostics, therapeutics and protein feedstherapeutics and protein feeds

–– Veterinary market is also estimated at US$ 200 million Veterinary market is also estimated at US$ 200 million and have seen many multinationals setup subsidiaries in and have seen many multinationals setup subsidiaries in India like Eli LillyIndia like Eli Lilly--RanbaxyRanbaxy



1. Human & Animal Health care 264 36.9% 353 37.6% 575 39.5%2. Agriculture 203 28.3% 289 30.7% 477 32.8%3. Industrial Products 245 34.2% 285 30.3% 365 25.0%4. Other biotech Products 4 00.6% 13 01.4% 40 02.7%

Total 715 100% 940 100% 1,456 100%

Rupees in CroresBiotech Sub-sectors Consumption

Estimate 2005Consumption 2000Consumption 1997

Source : P K Ghosh, DBTSource : P K Ghosh, DBT

Consumption & Future estimates



New Ventures

•• Thrust Areas: Thrust Areas: –– Genetic Engineering Genetic Engineering

–– Immuno technologyImmuno technology

–– Tissue cultureTissue culture

–– Plant based drugsPlant based drugs

–– Marine biotechnologyMarine biotechnology

–– DNA finger printingDNA finger printing

–– DNA vaccinesDNA vaccines

–– BioBio--sensorssensors

–– PeptidePeptide--based drugsbased drugs

–– PharmacogenomicsPharmacogenomics

–– BioinformaticsBioinformatics



New ventures - What needs to be done ?

•• Adequate market and feasibility studyAdequate market and feasibility study

•• Identify development work to make a project Identify development work to make a project commercially viablecommercially viable

•• Optimal size of the projectOptimal size of the project

•• Skilled staff, modern equipment and other infrastructureSkilled staff, modern equipment and other infrastructure

•• TimeTime--scale for implementation of the projectscale for implementation of the project

•• TieTie--ups with well established research institutesups with well established research institutes



Advantages

•• Enormous bioEnormous bio--diversitydiversity

•• Large gene poolLarge gene pool

•• Agrarian EconomyAgrarian Economy

•• Right ambient temperatures throughout the countryRight ambient temperatures throughout the country

•• Strong industry base for Pharma and ITStrong industry base for Pharma and IT

•• Potential base for Global Production, Intellectual Capital Potential base for Global Production, Intellectual Capital and Bioand Bio--resourcesresources

•• Technical manpowerTechnical manpower

•• Low cost of labour and infrastructureLow cost of labour and infrastructure

•• Changing attitudes towards institutional buildingChanging attitudes towards institutional building



Problems to be overcome

•• FinancesFinances

•• Import of certain equipmentImport of certain equipment

•• Strict adherence to international and domestic Strict adherence to international and domestic regulatory rules and proceduresregulatory rules and procedures

•• Delays in obtaining sanctionsDelays in obtaining sanctions

•• Unethical competition and poaching of talentUnethical competition and poaching of talent

•• Creation of infrastructural facilitiesCreation of infrastructural facilities

•• Training of skilled manpowerTraining of skilled manpower



Growing awareness

•• In India, the biotechnology industry has grown In India, the biotechnology industry has grown tremendously due to undivided and focussed efforts of tremendously due to undivided and focussed efforts of mainly private companiesmainly private companies

•• Now, many State Govts. are evincing keen interest in Now, many State Govts. are evincing keen interest in promoting biotechnologypromoting biotechnology

•• Support in the form of land, finance, research etc., is now Support in the form of land, finance, research etc., is now being extended by the State Govts.being extended by the State Govts.

•• In line with WTO requirements, long pending regulatory In line with WTO requirements, long pending regulatory reforms are proposed to be implementedreforms are proposed to be implemented


Indian Scenario - SWOT AnalysisIndian Scenario Indian Scenario -- SWOT AnalysisSWOT Analysis

StrengthsStrengths

•• Trained manpower and knowledge baseTrained manpower and knowledge base•• Good network of research laboratoriesGood network of research laboratories•• Rich bio diversityRich bio diversity•• Well developed base industries e.g. pharmaceuticals, seedsWell developed base industries e.g. pharmaceuticals, seeds

•• Missing link between research and commercialisationMissing link between research and commercialisation•• Lack of venture capitalLack of venture capital•• Abysmally low R&D expenditure by industryAbysmally low R&D expenditure by industry•• Lack of innovative R&D cultureLack of innovative R&D culture•• Image of Indian industryImage of Indian industry

WeaknessesWeaknesses


Indian Scenario - SWOT AnalysisIndian Scenario Indian Scenario -- SWOT AnalysisSWOT Analysis

OpportunitiesOpportunities

•• Large local marketLarge local market•• Export potentialExport potential•• Contract researchContract research•• Increasing number of patientsIncreasing number of patients

ThreatsThreats

•• Heavy investment by other developing countries like ChinaHeavy investment by other developing countries like China•• AntiAnti--biotech propagandabiotech propaganda•• IPR policiesIPR policies•• Inadequate regulatory frameworkInadequate regulatory framework


Biotechnology & PharmaBiotechnology & PharmaBiotechnology & Pharma

The success of Shantha has attracted The success of Shantha has attracted established large pharma companies to set up established large pharma companies to set up separate biotech divisions to focus on separate biotech divisions to focus on biogenericsbiogenerics

Alliances with global biotech companies/major Alliances with global biotech companies/major institutionsinstitutions


Pharma Value ChainPharmaPharma Value ChainValue Chain

ResearchResearch ManufacturingManufacturing MarketingMarketing

Integrated PlayersIntegrated Players

Contract ResearchContract Research Contract Contract ManufacturingManufacturing

ContractContractMarketingMarketing

Focussed PlayersFocussed Players


Medical BiotechnologyMedical BiotechnologyMedical Biotechnology

•• The Indian Biotech model will initially focus The Indian Biotech model will initially focus on biogenericson biogenerics

•• The potential for Indian companies is that in The potential for Indian companies is that in the five years some $ 10 billion worth of biothe five years some $ 10 billion worth of bio--drugs will lose patent protectiondrugs will lose patent protection

•• developed markets, besides the domestic developed markets, besides the domestic one, could throw a big opportunity for one, could throw a big opportunity for biopharmaceuticals once the patent issues biopharmaceuticals once the patent issues are resolvedare resolved

•• Valuation visibility will emergeValuation visibility will emerge


Medical BiotechnologyMedical BiotechnologyMedical Biotechnology

•• Health biotech product market worth $ 1.5 billionHealth biotech product market worth $ 1.5 billion•• Human biotech accounts for 60% of salesHuman biotech accounts for 60% of sales•• Diagnostic market is in excess of $ 50 million Diagnostic market is in excess of $ 50 million

(monoclonal and polyclonal antibodies for disease (monoclonal and polyclonal antibodies for disease immunodiagnostics)immunodiagnostics)

•• HepHep--B vaccine market alone is Rs. 1000 millionB vaccine market alone is Rs. 1000 million•• Investment to the tune of Rs. 400 million is Investment to the tune of Rs. 400 million is

expected in the vaccine segment in the next 5 yearsexpected in the vaccine segment in the next 5 years


Product PipelineProduct PipelineProduct Pipeline

•• Recombinant productsRecombinant products–– InterferonsInterferons–– Human InsulinHuman Insulin–– GCSF, etc.GCSF, etc.

•• Monoclonal antibodiesMonoclonal antibodies–– therapeutic and diagnostictherapeutic and diagnostic

•• VaccinesVaccines–– against TBagainst TB–– malariamalaria–– typhoidtyphoid–– choleracholera


OpportunitiesOpportunitiesOpportunities

•• ExportsExports•• Contract R&DContract R&D•• Contract ManufacturingContract Manufacturing•• LicensingLicensing•• MarketingMarketing

BT offers the same template of growth as in BT offers the same template of growth as in the IT sectorthe IT sector


Resources AvailableResources AvailableResources Available

•• Bio diversityBio diversity•• Vast gene poolVast gene pool•• Institutions with excellent knowledge Institutions with excellent knowledge

basebase•• Skilled manpowerSkilled manpower•• Low cost of innovationLow cost of innovation


IPRIPRIPR

•• Is a contentious issue e.g are genes Is a contentious issue e.g are genes inventions or discoveries ?inventions or discoveries ?

•• No clear regulatory frameworkNo clear regulatory framework•• Biologicals are being considered as a Biologicals are being considered as a

different category than synthetic drugsdifferent category than synthetic drugs


Success Story of ShanthaSuccess Story of ShanthaSuccess Story of Shantha

•• First Company to indigenously develop and manufacture a First Company to indigenously develop and manufacture a biotech product biotech product -- rDNA based HepatitisrDNA based Hepatitis--B vaccine B vaccine (Shanvac(Shanvac--B)B)

•• First Company to produce highly efficacious HepatitisFirst Company to produce highly efficacious Hepatitis--B B vaccine and make it available at affordable prices to common vaccine and make it available at affordable prices to common man man

•• First Company to place India on the map of Genetic First Company to place India on the map of Genetic Engineering WorldEngineering World

•• First Company to source financial assistance from Technology First Company to source financial assistance from Technology Development Board, Govt. of IndiaDevelopment Board, Govt. of India

•• First Biotech Company to be awarded the first ever National First Biotech Company to be awarded the first ever National Technology Award (year 1999) for Technology Award (year 1999) for “Successful development “Successful development and commercialisation of indigenous technology”and commercialisation of indigenous technology”


GenericsGenericsGenerics

•• Recombinant ProductsRecombinant Products–– Infectious diseasesInfectious diseases–– CardiacCardiac–– EndocrinologyEndocrinology

•• VaccinesVaccines


BasicBasicBasic

•• Functional genomicsFunctional genomics•• ImmunologyImmunology•• Designing of novel expression vectorsDesigning of novel expression vectors


Basic/AppliedBasic/AppliedBasic/Applied

Focus on creation and acquisition of Focus on creation and acquisition of intellectual property through significant intellectual property through significant investment in collaborations and licensing.investment in collaborations and licensing.

Eg: TB vaccine, triclosan, hGHEg: TB vaccine, triclosan, hGH


New Drug DiscoveryNew Drug DiscoveryNew Drug Discovery

•• Recombinant productsRecombinant products•• Monoclonal antibodiesMonoclonal antibodies•• DNA vaccinesDNA vaccines•• Gene therapyGene therapy


Contract ServicesContract ServicesContract Services

Research & DevelopmentResearch & DevelopmentManufacturingManufacturing


Thank YouThank YouThank You

Documents

Frontiers of Medical Biotechnologyris.org.in/images/RIS_images/pdf/asianbio2002_sen.pdf · Biotechnology Industry Biotechnology Industry -Biotechnology Industry - IndiaIIndiandia