Biotechnology In India

R&D IN BIOTECHNOLOGY

BIOTECHNOLOGY The application of Science & Technology to living organisms as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services

India and Biotechnology Base 

India is one of the emerging economies in the World.

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Biotechnology - One of the most promising industry of the future

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Bio-diversity of India will be an advantage for Biotech companies.

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Vast reservoir of scientific human resource with reasonable cost, wealth of R&D institutions, centers of academic excellence in Biosciences

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Vibrant Pharmaceutical Industry and fast developing clinical capabilities collectively point to promising biotech sector

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Over 300 companies and 241 institutions use some form of biotechnology in agricultural, medical or environmental application.

Biotechnology Industry in India • • •

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Nascent stage Vast growth and opportunity Over 300 registered biotechnology companies, out of which ~100 in are modern biotech sector Twelfth most successful biotechnology sector in the world as measured by number of companies (Ernst & Young) 96 enterprises exclusively as Biotech companies, making India the third largest in Asia [after Australia (228) and China (136)]

Biotechnology market •

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Total Biotech sector: $2200 million in 20072008 Bio-pharma sector (70%) Bio-service sector including clinical research, contract research and contract manufacturing: (7%) Agricultural Biotech sector: (6%) Projections: Total Biotech sector to increase to $ 5000 million by 2010

Break up of Biotech market

Pharmaceutical Biotechnology in India •

Market

2005: $1100 million 2009 : $3000 million (expected) •

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Vaccines (new generation and combinations) Bharat Biotech, Bharat Serum, Biological E, Haffkine Bio-Pharmaceutical, Panacea, Pfizer, Serum Institute of India, Shanta Bio-techniques, Smithkline Beecham and Wockhardt Therapeutics Biocon, Eli Lilly and Wockhardt Diagnostics Bharat Biotech, Qualigens Diagnostics, Span Diagnostics, J. Mitra

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VACCINE MARKET VALUED

AROUND US $ 100 Million.

GROWTH 20% RATE •

DIAGNOSTICS

MARKET DEMAND US $ 50 Million.

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ANIMAL HEALTH

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ENZYMES 70% REQUIREMENT IMPORTED MARKET GROWING WITH INCREASING AWARENESS

BIOTECHNOLOGY MARKET

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PHARMA : Today 40-45% of all drugs originate in bio-technology but in the next decades biotechnology will have a much greater role on the production of drugs and pharmaceuticals. FERMENTATION : Modest fermentation industry mainly breweries, Antibiotics and chemicals. But great potential in the of food processing, Pharma and chemicals

areas

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FOOD India Is The Largest Producer Processing Of Milk And Second Largest Industry Producer Of Fruits, Vegetables And Food grains. But processing is limited to only 2% of fruits and vegetables and 15% milk. Thus, Tremendous scope for the development of processing of milk Fruits &vegetables, meat, fish and Foodgrains

Key Methods of Doing Business in India •

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Set up joint venture companies to locally manufacture the product Collaborative research Contract research Contract manufacturing Technology transfer Marketing arrangement for bio-supplies (appoint distributor/agent) Clinical research

Why outsourcing in India ? •

Proven scientific talent pool

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No language barrier English is an official language

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Cost effective – Makes innovation affordable

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Signatory to WTO, Acceptance of Indian Patent

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Strong judicial systems

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Strong financial systems

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Strong Government support

Indian opportunity in outsoursing of R&D •

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Drug Discovery/Optimization/ informatics/ Novel delivery systems Target identification and validation, Proof of concept development, drug discovery , lead optimization. New Formulation development. Process development /drug manufacturing Chemistry& biology based process development – for Biologics & Small molecules. Biomanufacturing as well as conventional manufacturing for clinical trials . Final dosage form and fill/ finish . Pre-clinical & Clinical Development – Pre-clinical animal studies, Phase 1 to 4 Clinical Trials, BA/BE studies, Clinical lab. Services, Data management, Pharmaco-vigilance Ag Biotech Increasing crop yields/ disease resistance/ new traits.

MAIN ACTITIVITES AND POTENTIAL •

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Rich biodiversity-India has 7.76% of total mammal species 12.6% of bird species, 11.7% of fish and roughly 6.0% of total flowering plants present in the world with excellent agro-climatic conditions. This is a great resource for research and developmental activities in biotechnology. Focus– Genomics, recombinant DNA, Transgenics. Stem cell research and new drugs development

Institutions & Manpower       

Number of hospitals : 16,000 Number of doctors : 5,00,000 Number of research institutions : 200 Number of Scientists : 25,000 Medical graduates produced : 17,500 per yr Science graduates produced : 5,00,000 per yr Number of Agriculture Univs. : 40

Main R&D players • Universities • Public research institutes • Private research institutes • Large industry (mainly Pharma industry)

India - R&D Hotspot •

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In a recent survey conducted by EIU, India was featured as the 3rd most preferred overseas R&D destination – after China & the US Indian R&D salaries are about one fourth that in US Scope to lower capex through indigenization of equipment Overheads can be managed through smart operation

The ‘Hot’ Jobs in Biotech 1.

R&D 28%

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QA/QC 17%

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Clinical Research 11%

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Process Development/Mfg 10%

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Sales and Marketing 9%

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Admin/Operations 7%

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Information systems 5%

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Regulatory Affairs 5%

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Finance 4%

10. Business Development 4% 11. HR .5%

IMPLICATIONS FOR OUTSOURCING – Bio-manufacturing  

Market Growth - Outsourcing A recent survey by NIH found: only 21% of respondents currently outsourced mammalian cell culture for biomanufacturing, but 44% of the respondents estimated that by 2008 they would outsource mammalian cell culture

Contract Research •

Compound Discovery & Development

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Process Development & Synthesis expertise in chemical synthesis can be utilized for development of cost-effective processes for new drugs and intermediates .

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Clinical trials one of potential attraction for foreign big player

Advantage India : Clinical Trials •

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Large and heterogeneous population and prevalence of wide spectrum of disease conditions offer wide patient-resource. Low clinical trials cost in India . India has the 2nd highest number of qualified doctors in the world. Patient enrollment rate for Phase III studies could be up to 6 times faster in India than in the Western countries.

Indian Biotechnology Industry Number of biotech companies : 300 Global ranking in terms biotech companies : 11 Investment growth in last 5 years : 50 % per annum Annual Turnover (Apr 06 – Mar 07) : US $ 1.27 Billion Annual increase : 57 % Percentage of global business (2006-07) : 2.8% (2005-06) : 2.3% (2004-05) : 1.6 % (2003-04) : 1.5 % (2002-03) : 1.2 % Exports : 63 % Major areas : Biopharma, Bioservices, Bioindustries, Bioagriculture, Bioinformatics, Biosupplies

Biotechnology in India Initiative in early 1980’s Agencies - DST, CSIR, ICAR, ICMR, UGC National Biotechnology Development Board – 1982 Department of Biotechnology – 1986 Strategy : • Creation of Infrastructure • Human Resources Development • Promotion of R & D • Technology Transfer • Promotion of Industry • Public Private Partnership • Regulation • International Co-operation

Indian Biotech Industry

Number of health-biotechnology patents (Major developing countries) issued by US in 2006

India South Korea China Brazil Cuba South Africa Egypt

0

5

10

15

20

25

30

35

Manpower in Biotechnology

TOTAL INVESTMENT IN BIOTECH INDUSTRY

Core Areas of competence in India Core Areas of competence in India •Capacity in bioprocess engineering •Skills in gene manipulation of microbes and animal cells •Capacity in downstream processing and isolation methods •Skills in extraction and isolation of plants and animals products •Competence in recombinant DNA technology of plants and animals •Excellence in traditional and molecular marker assisted breeding of plants and animals •Infrastructure in fabricating bio-reactors and processing equipment

Indian Biotechnology: Strengths • Human Resource: Trained manpower and knowledge base. • Academic Resource: Good network of research laboratories. • Industry Base: Well developed base industries (e.g. pharmaceuticals, seeds). • International Experts: Access to intellectual resources of NRI’s in this area. • Clinical Capability: Extensive clinical trials and research access to vast and diverse disease in the huge population. • Bio-diversity: India’s human gene pools and unique plant, animal & microbial diversity offer an exciting opportunity for genomic research. • Stem Cells Research: Several labs have commenced research in stem cells and have valuable stem cell lines.

Indian Biotechnology: Weakness •Missing link between research and commercialization •Lack of venture capital •Relatively low R&D expenditure by industry •Image of Indian industry –doubts about ability of Indian products to meet International standards of quality

Indian Biotechnology: Opportunities •Large domestic market •Large export potential •Low cost research base for international companies in comparison with other countries •Vast and diverse disease based patient populations provide unique opportunities for clinical research and clinical trials •Supportive Government policy on embryonic stem cells research provides a useful opportunity for International companies to pursue such research in India •Human bio-diversity provides unique research opportunity in genomics •Plant & microbial bio-diversity provides vast prospecting opportunities for new drugs •Conducive Government policy on GM crops provides useful opportunities for Agri-biotech companies

Indian Biotechnology: Threats •Danger of anti-biotech propaganda gaining ground •Inadequate protection of Intellectual Property Rights (IPR), significant improvement remains in the areas of implementation and enforcemen

Indian Policy on Biotechnology •DBT (started in 1985) is developing policy for India •Indian Council of Medical Research (ICMR) •Indian Council of Agricultural Research (ICAR) •Council of Scientific and Industrial Research (CSIR) •Department of Science and Technology (DST) –Current focus on genomics, proteomics, transgenics, stem cell research and product development. –Technology Development Fund (TDF) and additional VC funds to promote small and medium biotech enterprises •Regulatory framework is in place to approve GM crops and rDNA products for human health •State government initiatives: AP, KA, MH

IPR Issues & R&D management •IP is a central issue in any industry •Robust intellectual property rights framework is the need of the hour •India is already member of Paris Convention Berne Convention Convention on biological diversity WTO •Should make legislation clear on the criteria for the patentability of biotechnological inventions

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Patents provide owner with “market exclusivity" that creates increased profits profits motivate innovation Patents require disclosure of new innovations that fosters dissemination of knowledge and further innovation Patents discourage the keeping of trade secrets

Trend in biotechnology patent in India

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Year patents 1995 1998 2002 2006

no. of 172 287 395 305

Patents in Biotechnology • • •

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1980 -Diamond v. Chakrabarty 1980 -First Cohen-Boyer recombinant DNA patent 1984 -Cell line derived from human leukemia patient patented 1986 -Genetically engineered corn patented 1988 -Harvard Onco-mouse patent - extends Chakrabarty concept to transgenic animals 1991 -Isolated human bone marrow stem cells patent

What can be Claimed?       

Diagnostic tests Research tools Gene therapy Therapeutic proteins Sensors Bioinformatics Sequences Pharmaceuticals

R&D management      

Build culture Build data base Sharing of knowledge Documentation Promote for paper publication Regular meeting

Biotech Products in Indian market • • • • • • • • • • • •

r DNA Hep ‘B’ vaccine Recombinant streptokinase Erythropoietin α, β, γ – interferon Haemophilus influenzae B vaccine Human insulin Human Growth Hormone Human Interleukin Streptokinase Granulocyte Colony Stimulating Factor Follicle Stimulating Hormone Tissue Plasminogen Activator

My Experience in R&D    

Microcarreier 3-D culture S- adenocylmethionine Selenium enriched yeast

Conclusion • • • • •

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Growing market Strong base , proven quality Cheapest health facility Vaccines, diagnostics and therapeutics Biomedical devices, instruments and sensors Bioartificial organs using tissue engineering and stem cells Clinical trial and contract research

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