Changing Biotechnology Innovation System in India State strategies - PowerPoint PPT Presentation

Changing Biotechnology Innovation System in India State strategies of governance in global biomedical innovation: the impact of China and India King’s College London March 15, 2013 Pranav N. Desai dpranav@hotmail.com Professor, Centre for Studies in Science Policy Jawaharlal Nehru University, New Delhi – 110067

2 Structure of the Indian Biotech Industry  India holds 2% share of the global biotech market and has undergone a structural change  Biopharma is the most dominant segment  Bioservices and bioinformatics have emerged as new segments  Agribio grew almost at the rate of 50% CAGR and the growth has tapered off  The biotech industry remained export and urban oriented industry. It is for the first time that in 2012, the revenues from the domestic sources (US $ 1.93 billion) surpassed that of

3 Growth of Indian Biotech Industry 25% 20% 15% 10% 5% 0% 2007-08 2008-09 2009-10 2010-11 2011-12 Source: Biospectrum-ABLE Survey, 2012

4 Sectoral Revenue Share and CAGR (2012) 70% 60% 13% CAGR 50% 40% 30% 20% 16% 23% 10% 11% 10% 0% BioPharma BioServices BioAgri BioIndustrial BioInformatics

5 Industrial Structure 15% 24% Micro Small Medium Large 13% 48% Is the Governance structure task different in India and China ensuring funding and knowledge transfer?

6 Segment-wise Share of Biotech Export (% share) 120 BioAgri 1 1 1 1 100 2 1 1 1 2 3 1 1 1 2 2 1 1 3 1 1 5 1 1 2 2 3 4 13 4 BioIndustrial 21 20 7 14 20 26 27 80 34 33 33 12 BioInformatic s 60 BioServices BioPharma 40 76 74 74 73 70 68 68 63 63 63 20 0 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12

Segmentwise Classification of Biotech Commodity Exports 7 AgriBi PharmaBiotec Bioservices BioIndustrial BioInformatics otech h BioFert Drugs, Clinical trials, CROs, clinical Enzymes Data on: Genome ilizers, Vaccines, research on: cancer, metabolic sequencing, BioPes Medical diseases, diabetes, structural ticides, equipments and cardiovascular diseases, genomics, Seeds, devices, Drug central nervous system. proteomics, micro- Bioino molecules Custom manufacturing, data arrays, data on culants, management, site medical biotech eg. Plant management, bio equivalence, design of inhibitors growth bio availability studies, for cholera toxin regulat toxicology studies, kpo for and proteomics ors pharma industry, quality with special assurance and regulatory and reference to medical affairs services to hepatitis, algorithm pharma biotech and medical design for sequence device industries. classification,

8 Institutional Challenges  Moving from Multi-tiered Regulatory Framework i. Recombinant DNA Advisory Committee (RDAC) ii. Institutional Biosafety Committees (IBSC) iii. Review Committee on Genetic Manipulation (RCGM) iv. Genetic Engineering Approval Committee (GEAC) v. State Biosafety Coordination Committees (SBCC) vi. District Level Committees (DLC) to a single window clearance The Biotechnology Regulatory Authority of India (BRAI)  Venture Capital Drivers  Inward and outward FDI + Exports  City Cluster Program  Public Private Partnership  Special R&D Incentive for Biotechnology Sector

Biotechnology Industry Research Assistance Programme (BIRAP)  A 200 per cent weighted deduction is available to firms that are engaged in biotechnology manufacturing or production.  100 per cent tax free status for Biotech Special Economic Zones (SEZs) for 5 years Small Business Innovation Research Initiative (SBIRI)  The Small Business Innovative Research Initiative (SBIRI) scheme of Department of Biotechnology to fund early stage research has benefited more than 89 small and medium biotech Biotechnology Industry Partnership Programme (BIPP) enterprises.  The Biotechnology Industry Partnership Programme (BIPP) launched recently, has so far benefited 51 companies undertaking research in futuristic high risk technologies 9

10 Actors  Production Infrastructure (Firms)  Knowledge Infrastructure (University, research institutes, private and public R&D)  Policy Actors Is meshwork more desirable than a network in the governance structure?

11 Year-wise Publication Trend by India in the Period 2001-2012 in the Reserach Area "Biotechnology and Apllied Microbiology" 600 500 400 300 200 100 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Source: ISI Web of Knowledge

12 Top 10 Countries Publishing in 'Biotechnology & Applied Microbiology' Research Area in the Period 2001-2012 USA 71159 PEOPLES R CHINA 24381 JAPAN 23802 GERMANY 17987 ENGLAND 15693 FRANCE 12249 SOUTH KOREA 11937 INDIA 11678 SPAIN 10145 CANADA 9872 Source: ibid.

Top 10 Collaborating Countries with India Publishing in 13 'Biotechnology & Applied Microbiology' Research Area in the Period 2001-2012 USA SOUTH KOREA GERMANY JAPAN FRANCE ENGLAND PEOPLES R CHINA BRAZIL CANADA AUSTRALIA 0 100 200 300 400 500 600 Source: ibid.

FOOD SCIENCE TOXICOLOGY CHEMISTRY 14 TECHNOLOGY 2% 4% 4% PLANT SCIENCES 5% BIOCHEMISTRY MOLECULAR GENETICS BIOLOGY HEREDITY 21% 7% ENGINEERING MICROBIOLOG 10% Y 19% ENERGY FUELS 13% AGRICULTURE 15%

15 Year-wise Publication Graph :India and China Collaboration in 'Biotechnology and Applied Microbiology' Research Area 20 18 16 14 No. of Publications 12 10 8 6 4 2 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Year

16 India and China Collaboration: Research Areas within 'Biotechnology & RESEARCH EXPERIMENTAL Applied Microbiology' MEDICINE 3% VIROLOGY 3% TOXICOLOGY 5% MATHEMATICAL COMPUTATIONAL BIOLOGY 5% GENETICS FOOD SCIENCE HEREDITY TECHNOLOGY 17% 5% BIOCHEMISTRY ENGINEERING MOLECULAR 5% BIOLOGY 14% ENERGY FUELS 9% AGRICULTURE 12% MICROBIOLOGY 10% PLANT SCIENCES 12%

17 Indian Patent Filed in Biotechnology (2001-2012) 1387 1115 712 466 2001-2003 2004-2006 2007-2009 2010-2012

18

Patent Cliff 19

Stem cell research also has enormous potential for cell culture. Cell culture methods ensure standardized production and propagation of highly purified stem cells and their differentiated progeny. Conventional therapies manage the disease symptoms, while stem cell therapies treat the cause of the disease, and from a commercial perspective this deficit of curative treatments in conventional therapies makes stem cell research a potential goldmine. 20

Segments of Stem Cell Market Type Embryonic Cord Adult Other Stem Cell Cord Blood Xenotranspla Cell Based Technology Transplantati Banking ntation Genomics on Therapeutic Dermatology Neurology Orthopedic Cardiology Area Oncology Diabetes Hematology Other 21

Global Trend in Stem Cell Patenting in 2001-2012 (USPTO + EPO) 2500 2000 1500 1000 500 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 22 Source: Thomson Innovation (accessed and analysed on 07.03.2013)

USPTO Granted Patents in Stem Cell in the Period 2001-2012: Top 20 Countries 4819 USA 695 Japan 578 Germany 287 UK 268 France 219 Switzerland 119 Sweden 116 Australia 99 Italy 98 Netherlands 87 Taiwan 78 India 77 Denmark 73 South Korea 70 Belgium 33 China 33 Spain 26 Finland 15 New Zealand 10 Hungary Source: Thomson Innovation (accessed and analysed on 06.03.2013) 23 Note: India is in 12 th Position

2548 USA 849 Germany 489 Japan 308 UK 261 France 255 Switzerland 152 Italy 129 Sweden 95 Netherlands 79 Belgium 67 Denmark 63 Australia 40 South Korea 39 Spain 31 China 25 Finland 23 India 13 Taiwan 12 Hungary 7 New Zealand Source: Thomson Innovation (accessed and analysed on 06.03.2013) 24 Note: India is in 17 th Position

EPO Granted Patents in Stem Cell (2001-2012) Top 25 Countries 3253 USA 461 Japan 422 UK 410 Germany 195 France 164 Canada 102 Italy 90 Swede 67 Denmark 59 Israel 52 Australia 39 Netherlands 37 South Korea 31 Spain 21 China 20 Finland 19 Belgium 18 Switzerland 18 Austria 16 Hungary 15 New Zealand 12 India 10 Russia 7 South Africa 5 Brazil Source: Thomson Innovation (accessed and analysed on 05.03.2013) 25 Note: India is in 22 nd Position

Venues Top 10 Stem Cell Patent Assignees in USPTO from India in 2001-2012 Remedies Maulana Azad Limited, Tsar Health Pvt Sami Labs Ltd, Medical College, Panchkula, Ltd, Gurgaon Bangalore New Dehli Haryana 3% 3% 3% 3% Torrent Pharmaceuticals Ltd., Ahmedabad 5% Ranbaxy CSIR, New Delhi Laboratories 42% Limited, Gurgaon Biocon Ltd, Bangalore 7% 8% Reliance Life Science Pvt Ltd, Mumbai 13% Wockhardt Limited, Mumbai 13% 26

27 Published Patents in Stem Cell Assignee/Applicant Type of Stem Cell Number Reliance Life Sciences Pvt. Ltd. Embryonic Stem Cell 19 Adult Stem Cell 8 iPSC 1 Stempeutics Research Private Embryonic Stem Cell 9 Limited,Bangalore Adult Stem Cell 17 Smt. G R Doshi and Smt. K M Mehta Adult Stem Cell 2 Institute of Kidney Diseases and Research Patki Research Foundation & Hospital Adult Stem Cell 1 Advanced Neuro-Science Allies Private Adult Stem Cell 1 Ltd. Geeta Shroff, New Delhi Embryonic Stem Cell 29 Arundhati Mandal Embryonic Stem Cell 1