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

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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 Kings College London March 15, 2013 Pranav N. Desai dpranav@hotmail.com Professor, Centre for


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State strategies of governance in global biomedical innovation: the impact of China and India

King’s College London March 15, 2013

Changing Biotechnology Innovation System in India

Pranav N. Desai

dpranav@hotmail.com Professor, Centre for Studies in Science Policy Jawaharlal Nehru University, New Delhi – 110067

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 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

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Structure of the Indian Biotech Industry

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0% 5% 10% 15% 20% 25% 2007-08 2008-09 2009-10 2010-11 2011-12

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Growth of Indian Biotech Industry

Source: Biospectrum-ABLE Survey, 2012

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0% 10% 20% 30% 40% 50% 60% 70% BioPharma BioServices BioAgri BioIndustrial BioInformatics 23% 16% 11% 10%

13% CAGR

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Sectoral Revenue Share and CAGR (2012)

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

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Industrial Structure

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68 76 73 74 74 70 68 63 63 63 12 14 20 20 21 26 27 33 34 33 7 4 4 3 2 3 2 1 1 1 13 5 3 1 1 1 1 2 2 2 1 1 1 1 1 1 1 1 1 2 20 40 60 80 100 120 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12

BioAgri BioIndustrial BioInformatic s BioServices BioPharma

Segment-wise Share of Biotech Export (% share)

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AgriBi

  • tech

PharmaBiotec h Bioservices BioIndustrial BioInformatics BioFert ilizers, BioPes ticides, Seeds, Bioino culants, Plant growth regulat

  • rs

Drugs, Vaccines, Medical equipments and devices, Drug molecules Clinical trials, CROs, clinical research on: cancer, metabolic diseases, diabetes, cardiovascular diseases, central nervous system. Custom manufacturing, data management, site management, bio equivalence, bio availability studies, toxicology studies, kpo for pharma industry, quality assurance and regulatory and medical affairs services to pharma biotech and medical device industries. Enzymes Data on: Genome sequencing, structural genomics, proteomics, micro- arrays, data on medical biotech eg. design of inhibitors for cholera toxin and proteomics with special reference to hepatitis, algorithm design for sequence classification,

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Segmentwise Classification of Biotech Commodity Exports

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 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

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Institutional Challenges

 Inward and outward FDI + Exports  City Cluster Program  Public Private Partnership  Special R&D Incentive for Biotechnology Sector

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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

Biotechnology Industry Partnership Programme (BIPP)

 The Biotechnology Industry Partnership Programme (BIPP) launched recently, has so far benefited 51 companies undertaking research in futuristic high risk technologies

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 enterprises.

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 Knowledge Infrastructure (University, research institutes, private and public R&D)

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Actors

 Production Infrastructure (Firms)  Policy Actors Is meshwork more desirable than a network in the governance structure?

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100 200 300 400 500 600 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Year-wise Publication Trend by India in the Period 2001-2012 in the Reserach Area "Biotechnology and Apllied Microbiology"

Source: ISI Web of Knowledge

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9872 10145 11678 11937 12249 15693 17987 23802 24381 71159 CANADA SPAIN INDIA SOUTH KOREA FRANCE ENGLAND GERMANY JAPAN PEOPLES R CHINA USA

Top 10 Countries Publishing in 'Biotechnology & Applied Microbiology' Research Area in the Period 2001-2012

Source: ibid.

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100 200 300 400 500 600 AUSTRALIA CANADA BRAZIL PEOPLES R CHINA ENGLAND FRANCE JAPAN GERMANY SOUTH KOREA USA

Top 10 Collaborating Countries with India Publishing in 'Biotechnology & Applied Microbiology' Research Area in the Period 2001-2012

Source: ibid.

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

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2 4 6 8 10 12 14 16 18 20 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

  • No. of Publications

Year

Year-wise Publication Graph :India and China Collaboration in 'Biotechnology and Applied Microbiology' Research Area

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GENETICS HEREDITY 17% BIOCHEMISTRY MOLECULAR BIOLOGY 14% AGRICULTURE 12% PLANT SCIENCES 12% MICROBIOLOGY 10% ENERGY FUELS 9% ENGINEERING 5% FOOD SCIENCE TECHNOLOGY 5% MATHEMATICAL COMPUTATIONAL BIOLOGY 5% TOXICOLOGY 5% RESEARCH EXPERIMENTAL MEDICINE 3% VIROLOGY 3%

India and China Collaboration: Research Areas within 'Biotechnology & Applied Microbiology'

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2001-2003 2004-2006 2007-2009 2010-2012 466 712 1115 1387

Indian Patent Filed in Biotechnology (2001-2012)

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Patent Cliff

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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. 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.

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Type Embryonic Cord Adult Other Technology Stem Cell Transplantati

  • n

Cord Blood Banking Xenotranspla ntation Cell Based Genomics Therapeutic Area Neurology Orthopedic Cardiology Hematology Diabetes Oncology Other Dermatology

Segments of Stem Cell Market

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22 500 1000 1500 2000 2500 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Global Trend in Stem Cell Patenting in 2001-2012 (USPTO + EPO)

Source: Thomson Innovation (accessed and analysed on 07.03.2013)

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Hungary New Zealand Finland Spain China Belgium South Korea Denmark India Taiwan Netherlands Italy Australia Sweden Switzerland France UK Germany Japan USA 10 15 26 33 33 70 73 77 78 87 98 99 116 119 219 268 287 578 695 4819

USPTO Granted Patents in Stem Cell in the Period 2001-2012: Top 20 Countries

Source: Thomson Innovation (accessed and analysed on 06.03.2013) Note: India is in 12th Position

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New Zealand Hungary Taiwan India Finland China Spain South Korea Australia Denmark Belgium Netherlands Sweden Italy Switzerland France UK Japan Germany USA 7 12 13 23 25 31 39 40 63 67 79 95 129 152 255 261 308 489 849 2548

Source: Thomson Innovation (accessed and analysed on 06.03.2013) Note: India is in 17th Position

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Brazil South Africa Russia India New Zealand Hungary Austria Switzerland Belgium Finland China Spain South Korea Netherlands Australia Israel Denmark Swede Italy Canada France Germany UK Japan USA 5 7 10 12 15 16 18 18 19 20 21 31 37 39 52 59 67 90 102 164 195 410 422 461 3253

EPO Granted Patents in Stem Cell (2001-2012) Top 25 Countries

Source: Thomson Innovation (accessed and analysed on 05.03.2013) Note: India is in 22nd Position

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Maulana Azad Medical College, New Dehli 3% Sami Labs Ltd, Bangalore 3% Tsar Health Pvt Ltd, Gurgaon 3% Venues Remedies Limited, Panchkula, Haryana 3% Torrent Pharmaceuticals Ltd., Ahmedabad 5% Ranbaxy Laboratories Limited, Gurgaon 7% Biocon Ltd, Bangalore 8% Reliance Life Science Pvt Ltd, Mumbai 13% Wockhardt Limited, Mumbai 13% CSIR, New Delhi 42%

Top 10 Stem Cell Patent Assignees in USPTO from India in 2001-2012

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Assignee/Applicant Type of Stem Cell Number Reliance Life Sciences Pvt. Ltd. Embryonic Stem Cell Adult Stem Cell iPSC 19 8 1 Stempeutics Research Private Limited,Bangalore Embryonic Stem Cell Adult Stem Cell 9 17

  • Smt. G R Doshi and Smt. K M Mehta

Institute of Kidney Diseases and Research Adult Stem Cell 2 Patki Research Foundation & Hospital Adult Stem Cell 1 Advanced Neuro-Science Allies Private Ltd. Adult Stem Cell 1 Geeta Shroff, New Delhi Embryonic Stem Cell 29 Arundhati Mandal Embryonic Stem Cell 1

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Published Patents in Stem Cell

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CTRI Number Cell Type Used Condition Treated Rando mi- zation Total Patient Enrolled Primary Outcome Trial Phase Sponsor Location CTRI/2008/ 091/000046 Autologou s BMMNCs Acute Ischemic Stroke + Phase 2 DBT, Govt.

  • f

India AIIMS, New Delhi Army Hospital (R&R), New Delhi Armed Forces Medical College Hospital, Pune SGPGI, Uttar Pradesh PGI, Chandigarh CTRI/2008/ 091/000232 Bone marrow stem cells Acute Myocardial Infartion + 250 Improvemen t in LV function Phase 3 DBT CMC, Tamil Nadu MHCTC, Maharashtra PGI, Chandigarh Army Hospital, New Delhi SGPGI, Uttar Pradesh CTRI/2009/ 091/000176 Ex Vivo Cultured Adult Allogenic MSCs Myocardial Infarction + 20 Phase 1/ Phase 2 Stempeuti cs Research

  • Pvt. Ltd.

Bhagwan Mahaveer Jain Hospital, Karnataka Care Hospital, Andhra Pradesh Care Institute of Medical Sciences, Gujarat MS Ramaiah Hospital and Narayana Hrudayala Centre, Karnataka CTRI/2009/ 091/00437 Ex Vivo Cultured Adult Allogenic MSCs Dilated Cardiomyo- Pathy + 20 Safety and Tolerability Phase 1 Stempeuti cs Research

  • Pvt. Ltd.

KMC Hospital, Manipal

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Clinical Trials of Stem Cell Therapy for Cardiac Repair Registered With Clinical Trials Registry-India (CTRI), Indian Council of Medial Research

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CTRI Number Cell Type Used Condition Treated Randomi

  • zation

Total Patient Enrolle d Primary Outcome Trial Phase Sponsor Location CTRI/2009/ 091/000590 Stem Cells Heart Diseases

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Increase in myocardial perfusion N/A Frontier Lifeline

  • Pvt. Ltd.

Frontier Lifeline Pvt Ltd.. Tamil Nadu CTRI/2011/ 05/001742 Cardiopoiti c Stem Cells Chronic Heart Failue + 240 Change in Left Ventricular ejection Fraction Phase 2/ Phase 3 Cardio Bioscienc es, Belgium The Heart Care Clinic, Gujarat CTRI/2010/ 091/000626 Autologous MNCs Coronary Heart Disease

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Improvemen t in LVEF perfusion N/A Global Medical Education & Research Centre Global Hospital, Andhra Pradesh CTRI/2010/ 091/000643 Autologous Myocardia l Infarction

  • 50

Improvemen t in LVEF perfusion N/A Global Medical Education & Research Centre Global Hospital, Andhra Pradesh CTRI/2010/ 091/000644 Autologous Myocardia l Infarction

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Improvemen t in Myocardial function Phase 1 Global Medical Education & Research Centre Global Hospital, Andhra Pradesh

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Cipla Ltd, Mumbai

  • Dr. Reddy's Laboratories Ltd, Hyderabad

Lupin Limited, Mumbai Reliance Life Sciences Pvt. Ltd, Mumbai Torrent Pharmaceuticals Ltd, Ahmedabad USV Limited, Mumbai Wockhardt Limited, Mumbai Panacea Biotec Ltd, New Dehli Piramal Life Sciences Ltd, Mumbai Sami Labs Limited, Bangalore CSIR, New Delhi 1 1 1 1 1 1 1 1 2 2 2 2 6

Indian Stem Cell Patent Assigness (EPO) in 2001-2012

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2 4 6 8 10 12 14 16 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Yearwise Graph of Indian Stem Cell Patent Grants (USPTO)

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23 17 15 23 2001-2003 2004-2006 2007-2009 2010-2012

Indian Stem Cell Granted Patents (USPTO) in 2001-2012

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1 2 3 4 5 6 7 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Yearwise Graph of Indian Stem Cell Patent Grants (EPO)

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1 3 7 12 2001-2003 2004-2006 2007-2009 2010-2012

Indian Stem Cell Granted Patents (EPO) in 2001- 2012

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Th Thank you ank you