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Biotechnology for Pharmaceutical and Health

Classification of Biotechnology Conventional Is a technique that makes use of living organism for specific purpose eg: bread/cheese making Modern Is a technique that makes use of cellular molecular processes like rdna, monoclonal antibodies, genomics, proteomics etc. - also referred as gene technology

Scope of Biotechnology

Healthcare Biotechnology Medicines Vaccines Gene Therapy Diagnostics Monoclonal Antibodies Healthcare biotech

Healthcare Biotechnology Biotechnology in health care uses proteins, enzymes, antibodies and other substances naturally produced in the human body as a tool and weapon to fight infection, disease and also to correct genetic disorders. Diagnostics Detects wide variety of disease & genetic conditions Vaccines Uses antigens and not actual virus against infections and diseases Healthcare biotech Medicines Uses proteins to fight body infections and carry out specific functions Gene Therapy Uses genetic material used to correct genetic disorders Monoclonal Antibody Uses anti-bodies of high purity research, diagnostics & therapeutics

Healthcare Biotechnology Application of Healthcare Biotech Veterinary Human Therapeutics Diagnostics Therapeutics Diagnostics Drugs Vaccines Drugs Vaccines

Biotechnology Industry - Worldwide Presently there are about 5,000 biotech companies Total biotechnology industry revenues were about US$ 25 billion in 2000 Long term product sales expected to be approximately US$ 50 billion in 2010

Global Biotech Overview No. of Companies : approx. 3500 USA - 1500 Europe - 1300 Japan - 500

Global Biotech : Therapeutics Market Size (in 2000) : $ 11.7 bn Market size expected in 2005 : $ 20.6 bn CAGR : 16% Current Biogenerics market size : $ 8 bn

Global Biotech : Markets Japan 23% Rest of World 7% USA 42% Europe 28%

Global Biotech : Major Products EPO GCSF HepB vaccine hgh Human Insulin Interferon Alfa They account for 80% of the global sales

Biotechnology Industry - India Biotech market in India was estimated at US $ 800 million in 1999 and has risen approximately to US $ 2.5 billion this year Indian biotech industries employs about 20,000 people Indian share in the global market is about 2% only Consumption of biotech products is expected to reach INR 1,460 Crores by 2005 72% of biotech products consumed domestically is met through local production About 800 companies are operating in various sector of biotechnology About 80 companies are operating in modern biotech sectors

Biotechnology Industry - India India has core competence in manpower and support system in the form of research institutes like CSIR CCMB ICMR CDFD IISc and IICB ICGEB Due to inherent geographical and skilled and low-cost manpower advantages, there is an upsurge in collaborations with multinational companies

Biotechnology Industry - India Healthcare biotech market in India consists of vaccine, diagnostic and veterinary The vaccine market is estimated at US$ 100 million with an annual growth rate of 20% Diagnostic market is estimated at US$ 200 million with a growing demand for veterinary vaccines, diagnostics, therapeutics and protein feeds Veterinary market is also estimated at US$ 200 million and have seen many multinationals setup subsidiaries in India like Eli Lilly-Ranbaxy

Biotechnology Industry - India Consumption & Future estimates Rupees in Crores Biotech Sub-sectors Consumption Consumption 1997 Consumption 2000 Estimate 2005 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% Source : P K Ghosh, DBT

Biotechnology Industry - India Thrust Areas: New Ventures Genetic Engineering Immuno technology Tissue culture Plant based drugs Marine biotechnology DNA finger printing DNA vaccines Bio-sensors Peptide-based drugs Pharmacogenomics Bioinformatics

Biotechnology Industry - India New ventures - What needs to be done? Adequate market and feasibility study Identify development work to make a project commercially viable Optimal size of the project Skilled staff, modern equipment and other infrastructure Time-scale for implementation of the project Tie-ups with well established research institutes

Biotechnology Industry - India Enormous bio-diversity Large gene pool Agrarian Economy Advantages Right ambient temperatures throughout the country Strong industry base for Pharma and IT Potential base for Global Production, Intellectual Capital and Bio-resources Technical manpower Low cost of labour and infrastructure Changing attitudes towards institutional building

Biotechnology Industry - India Problems to be overcome Finances Import of certain equipment Strict adherence to international and domestic regulatory rules and procedures Delays in obtaining sanctions Unethical competition and poaching of talent Creation of infrastructural facilities Training of skilled manpower

Biotechnology Industry - India Growing awareness In India, the biotechnology industry has grown tremendously due to undivided and focussed efforts of mainly private companies Now, many State Govts. are evincing keen interest in promoting biotechnology Support in the form of land, finance, research etc., is now being extended by the State Govts. In line with WTO requirements, long pending regulatory reforms are proposed to be implemented

Indian Scenario - SWOT Analysis Strengths Trained manpower and knowledge base Good network of research laboratories Rich bio diversity Well developed base industries e.g. pharmaceuticals, seeds Weaknesses Missing link between research and commercialisation Lack of venture capital Abysmally low R&D expenditure by industry Lack of innovative R&D culture Image of Indian industry

Indian Scenario - SWOT Analysis Opportunities Large local market Export potential Contract research Increasing number of patients Threats Heavy investment by other developing countries like China Anti-biotech propaganda IPR policies Inadequate regulatory framework

Biotechnology & Pharma The success of Shantha has attracted established large pharma companies to set up separate biotech divisions to focus on biogenerics Alliances with global biotech companies/major institutions

Pharma Value Chain Integrated Players Research Manufacturing Marketing Focussed Players Contract Research Contract Manufacturing Contract Marketing

Medical Biotechnology The Indian Biotech model will initially focus on biogenerics The potential for Indian companies is that in the five years some $ 10 billion worth of bio- drugs will lose patent protection developed markets, besides the domestic one, could throw a big opportunity for biopharmaceuticals once the patent issues are resolved Valuation visibility will emerge

Medical Biotechnology Health biotech product market worth $ 1.5 billion Human biotech accounts for 60% of sales Diagnostic market is in excess of $ 50 million (monoclonal and polyclonal antibodies for disease immunodiagnostics) Hep-B B vaccine market alone is Rs. 1000 million Investment to the tune of Rs. 400 million is expected in the vaccine segment in the next 5 years

Product Pipeline Recombinant products Interferons Human Insulin GCSF, etc. Monoclonal antibodies therapeutic and diagnostic Vaccines against TB malaria typhoid cholera

Opportunities Exports Contract R&D Contract Manufacturing Licensing Marketing BT offers the same template of growth as in the IT sector

Resources Available Bio diversity Vast gene pool Institutions with excellent knowledge base Skilled manpower Low cost of innovation

IPR Is a contentious issue e.g are genes inventions or discoveries? No clear regulatory framework Biologicals are being considered as a different category than synthetic drugs

Success Story of Shantha First Company to indigenously develop and manufacture a biotech product - rdna based Hepatitis-B B vaccine (Shanvac-B) First Company to produce highly efficacious Hepatitis-B vaccine and make it available at affordable prices to common man First Company to place India on the map of Genetic Engineering World First Company to source financial assistance from Technology Development Board, Govt. of India First Biotech Company to be awarded the first ever National Technology Award (year 1999) for Successful development and commercialisation of indigenous technology

Generics Recombinant Products Infectious diseases Cardiac Endocrinology Vaccines

Basic Functional genomics Immunology Designing of novel expression vectors

Basic/Applied Focus on creation and acquisition of intellectual property through significant investment in collaborations and licensing. Eg: TB vaccine, triclosan, hgh

New Drug Discovery Recombinant products Monoclonal antibodies DNA vaccines Gene therapy

Contract Services Research & Development Manufacturing

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