Emerging Markets for Clinical Trials in India - Favorable Regulatory Environment and Cost Effectiveness Will Accelerate the Number of Clinical Trials by GBIResearch

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									        Emerging Markets for Clinical Trials in India - Favorable
         Regulatory Environment and Cost Effectiveness Will
               Accelerate the Number of Clinical Trials
 Reference Code: GBIHC072MR                                                                                                             Publication Date: January 2011


                                     GBI Research finds that India is an emerging market for conducting clinical trials. The presence of
                                     good infrastructural facilities and support from the regulatory authorities has increased the
                                     registration of clinical trials in India. In comparison to the other BRIC (Brazil, Russia, India and
                                     China) Countries, India has recorded a higher number of clinical trials in 2010. This increase in
                                     registration of clinical trials makes India a destination for many pharmaceutical companies to
                                     conduct clinical trials.
                                     Rising Cost of Drug Development and Decrease in R&D Output has Resulted in Outsourcing
                                     of Clinical Trials to India.

In 2004, there were 36                 Clinical Trials in India, Global BLA and NME Approvals vs R&D Spending, ($bn),
NME/BLA approvals with                 1995-2009
R&D spending of $47.6
billion whereas in 2009                                                 60                                                                                        70.0
there were 25 NME/BLA
approvals with R&D
spending of $65.3 billion.                                                                                                                                        60.0
                                                                        50




                                                                                                                                                                         Research and Development Spending, ($bn)
                                                                                                                                                                  50.0
                                          Number of NDA/BLA Approvals




                                                                        40


                                                                                                                                                                  40.0

                                                                        30

                                                                                                                                                                  30.0


                                                                        20
                                                                                                                                                                  20.0


                                                                        10
                                                                                                                                                                  10.0



                                                                         0                                                                                        0.0
                                                                             1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

                                                                                             BLA Approvals    NME App rovals    R&D Spending ($bn)


                                       Source: GBI Research, FDA, PhRMA.org




                                     GBI Research suggests that pharmaceutical R&D expenditure over the years has been increasing
                                     relative to the number of drug approvals. The decreasing number of New Molecule Entity (NME)
                                     approvals against ever increasing R&D expenditure has made it difficult for pharmaceutical
                                     companies to extract better ROI (Return on Investment) from their drugs as the cost of developing
                                     a single drug has increased exponentially.




Emerging Market for Clinical Trials in India - Favorable                                                                                 GBIHC072MR / Published JAN 2011
Regulatory Environment and Cost Effectiveness Will Accelerate
the Number of Clinical Trials                                                                                                                                           Page 1
                                                                                                      © GBI Research. This is a licensed product and is not to be photocopied
                                     India is an Attractive Market for Contract Research Organizations due to Infrastructural
                                     Benefits and Regulatory Compliance
                                     The US and Europe dominate the contract research organization market and account for a majority
                                     of clinical research activities. However, this trend is changing with the emergence of regions such
                                     as Central and Eastern Europe, Latin America, India and China as preferred locations for
                                     outsourcing. India provides access to a large patient pool, good infrastructural facilities and a
                                     skilled pool of healthcare professionals. India is more cost effective with comparable quality
                                     standards to the developed regions such as the US and Europe. Also India has aligned the clinical
                                     research regulations with international standards and requirements, which allows them to conduct
                                     clinical trials and research on behalf of pharmaceutical companies in developed countries.
                                     Therefore, pharmaceutical and biotechnology companies will have good reasons to increasingly
                                     outsource clinical trials to India in order to benefit from the cost, time and expertise benefits and
                                     also to leverage emerging countries’ compliance with international standards such as the Good
                                     Laboratory Practices (GLP) and Good Clinical Practices (GCP).
                                     The Key Players in the Market Look to Strengthen Competitive Positions Through M&A and
                                     Strategic Collaborations With the Industry
                                     M&A activities, service agreements, and strategic collaboration have increased over the last four
                                     years. The increase in these deals suggests a highly competitive and active market. The majority of
                                     the deals in the contract research organizations market focused on establishing strategic alliances
                                     with other contract research organizations, technology providers and pharmaceutical and biotech
                                     companies. The players have entered into the strategic alliances and collaboration with other
                                     companies in order to enhance their competitive positioning. The increased number of M&As
                                     suggests a further consolidation which will increase the competition in the industry, and they are
                                     aimed at enhancing service portfolios and expanding geographic presence. The intense
                                     competition will force medium-sized players to expand services or geographic presence. The niche
                                     players focusing only on a specific function or therapeutic area will also continue to grow.
                                     Therefore, the larger diversified players or niche contract research organizations will be
                                     competitively placed in the future.




Emerging Market for Clinical Trials in India - Favorable                                                  GBIHC072MR / Published JAN 2011
Regulatory Environment and Cost Effectiveness Will Accelerate
the Number of Clinical Trials                                                                                                          Page 2
                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                     1         Table of Contents
                                     1   Table of Contents ........................................................................................................................ 3
                                         1.1    List of Tables..................................................................................................................... 6
                                         1.2    List of Figures ................................................................................................................... 7
                                     2   Emerging Market for Clinical Trials - India - Introduction ............................................................. 9
                                         2.1    GBI Research Report Guidance ....................................................................................... 9
                                     3   Emerging Market for Clinical Trials - India - Overview ............................................................... 10
                                         3.1    The Clinical Research Process – Overview .................................................................... 10
                                            3.1.1     Drug Discovery Phase ............................................................................................. 10
                                            3.1.2     Pre-Clinical Phase ................................................................................................... 10
                                            3.1.3     Phase I .................................................................................................................... 11
                                            3.1.4     Phase II ................................................................................................................... 11
                                            3.1.5     Phase III .................................................................................................................. 11
                                            3.1.6     Review and Approval from the Regulatory Agencies ............................................... 11
                                            3.1.7     Post-marketing Studies ........................................................................................... 11
                                         3.2    Clinical Trial Design and Types....................................................................................... 11
                                            3.2.1     Types of Design....................................................................................................... 12
                                         3.3    Role of CROs .................................................................................................................. 18
                                         3.4    Sponsors of Clinical Trials............................................................................................... 19
                                         3.5    Intellectual Property Protection in India ........................................................................... 20
                                            3.5.1     Patent Act 2005 – First Step towards Improving IP Protection ................................ 20
                                            3.5.2     Intellectual Property Rights (IPR) Enforcement Rules, 2007 ................................... 20
                                            3.5.3     Trademarks Bill 2007 ............................................................................................... 21
                                            3.5.4     Drugs and Cosmetics Act (Amendment) 2008......................................................... 21
                                            3.5.5     Enforcers of Intellectual Property Rights (EIPR) – Ensuring IPR Laws
                                                      Implementation in India ........................................................................................... 21
                                         3.6    The Need for Outsourcing Clinical Trials ........................................................................ 22
                                            3.6.1     High Risks and Costs Associated With Drug Development ..................................... 22
                                            3.6.2     Escalating Costs of Clinical Trials............................................................................ 23
                                            3.6.3     Global Increase in the Number of Clinical Trials Conducted ................................... 24
                                            3.6.4     Restructuring the R&D ............................................................................................. 25
                                            3.6.5     Increased Screening Rates During R&D ................................................................. 26
                                            3.6.6     Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs ............ 26
                                     4   Emerging Market for Clinical Trials – India - Clinical Trial Trends ............................................. 27
                                         4.1    Registration of Phase l Clinical Trials .............................................................................. 27
                                         4.2    Registration of Phase ll Clinical Trials ............................................................................. 28
                                         4.3    Registration of Phase lll Clinical Trials ............................................................................ 29
                                         4.4    Registration of Phase lV Clinical Trials ........................................................................... 30
                                         4.5    Clinical Trials Registered in 2009 .................................................................................... 31
                                         4.6    Comparative Analysis of Registered Clinical Trials in BRIC Countries ........................... 32
                                         4.7    Comparative Analysis of Industry Sponsored Clinical Trials Started in BRIC Countries . 33
                                         4.8    Comparative Analysis of Population Statistics in BRIC Countries ................................... 34
                                            4.8.1     Comparative Analysis of Epidemiology and Prevalence of Major Disease .............. 35
                                     5   Emerging Market for Clinical Trials – India - Market Environment Characterization .................. 42
                                         5.1    Increase in Growth of Global CRO Market will Foster the Growth of Indian Clinical Trial
                                                Market ............................................................................................................................. 42
                                            5.1.1     Increase in Multinational Sites to Conduct Clinical Trials will Drive the Clinical Trial
                                                      Market in India ......................................................................................................... 43
                                            5.1.2     Access to a Large Patient Pool................................................................................ 44
                                            5.1.3     Patient Availability for Major Diseases ..................................................................... 46
                                            5.1.4     Ethnicity and Genetic Diversity ................................................................................ 52
                                            5.1.5     Subject Recruitment and Speed of Trials ................................................................ 52
                                            5.1.6     Cost of Conducting Clinical Trials in India is Approximately 55% of the Cost of
                                                      Conducting a Clinical Trial in the US ....................................................................... 52
                                            5.1.7     Infrastructural Facilities Improve the Clinical Trial Environment .............................. 53

Emerging Market for Clinical Trials in India - Favorable                                                                              GBIHC072MR / Published JAN 2011
Regulatory Environment and Cost Effectiveness Will Accelerate
the Number of Clinical Trials                                                                                                                                                Page 3
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                          5.1.8    Facilities for Conducting Clinical Trials .................................................................... 54
                                          5.1.9    Biotechnology Laboratories that Conduct Clinical Trials in India ............................. 54
                                          5.1.10 GLP Approved Facilities in India.............................................................................. 55
                                          5.1.11 US FDA Approved New Drug Molecules Being Researched in India ...................... 56
                                          5.1.12 Increase in Skilled Pool of Healthcare Professionals ............................................... 57
                                       5.2    Market Restraints ............................................................................................................ 60
                                          5.2.1    Lack of Training for Clinical Trial Professionals ....................................................... 60
                                          5.2.2    Quality of Clinical Trial Data .................................................................................... 60
                                          5.2.3    ICH GCP Versus Indian GCP .................................................................................. 60
                                          5.2.4    Ethical Issues .......................................................................................................... 61
                                          5.2.5    The Need for Proposed Additional Documents for Importing Drugs ........................ 61
                                       5.3    Clinical Trial Market Size in India .................................................................................... 62
                                     6 Emerging Market for Clinical Trials – India - Regulatory Landscape ......................................... 63
                                       6.1    Introduction ..................................................................................................................... 63
                                          6.1.1    Drugs and Cosmetics Act ........................................................................................ 63
                                          6.1.2    The Institutional Ethics Committee (IEC) ................................................................. 64
                                          6.1.3    The Ministry of Health and Family Welfare .............................................................. 64
                                          6.1.4    Central Drug Standard Control Organization (CDSCO) ........................................... 64
                                          6.1.5    Drug Controller General of India (DCGI) ................................................................. 64
                                          6.1.6    Indian Council of Medical Research (ICMR) ............................................................ 65
                                          6.1.7    Clinical Trials Registry India .................................................................................... 65
                                       6.2    Clinical Trial Regulation in India ...................................................................................... 67
                                          6.2.1    Documents Required for Phase l Clinical Trial Application for Molecules Discovered
                                                   in India ..................................................................................................................... 69
                                          6.2.2    Documents Required for Phase l Clinical Trial (Molecules Discovered Outside India)
                                                    ................................................................................................................................ 71
                                          6.2.3    Documents Required for Phase ll Clinical Trial Application ..................................... 71
                                          6.2.4    Documents Required for Phase lll Clinical Trials ..................................................... 72
                                       6.3    Time Frame for Approval ................................................................................................ 72
                                       6.4    Recent Regulatory Changes in Clinical Trials ................................................................. 73
                                          6.4.1    Amended Schedule Y .............................................................................................. 73
                                          6.4.2    Informed Consent and its Elements......................................................................... 73
                                          6.4.3    Investigator Undertaking .......................................................................................... 74
                                       6.5    Government Incentives ................................................................................................... 74
                                     7 Emerging Market for Clinical Trials – India - CRO Landscape .................................................. 75
                                       7.1    CRO Locations................................................................................................................ 75
                                       7.2    Service Portfolio and Benchmarking of Indian CROs ...................................................... 76
                                       7.3    Acquisitions by Indian CROs........................................................................................... 77
                                       7.4    CRO Profiles ................................................................................................................... 78
                                          7.4.1    Reliance Life Sciences ............................................................................................ 78
                                          7.4.2    Asian Clinical Trials ................................................................................................. 79
                                          7.4.3    Diagnosearch Life Sciences .................................................................................... 80
                                          7.4.4    Clininvent ................................................................................................................. 81
                                          7.4.5    Synchron Research Services Pvt Ltd ...................................................................... 82
                                          7.4.6    Lambda Therapeutic Research Ltd ......................................................................... 83
                                          7.4.7    GVK Biosciences Pvt Ltd ......................................................................................... 84
                                          7.4.8    Sristek ..................................................................................................................... 85
                                          7.4.9    Lotus Laboratories Pvt Ltd ....................................................................................... 86
                                          7.4.10 Veeda Clinical Research Ltd ................................................................................... 87
                                          7.4.11 Vimta Labs Ltd......................................................................................................... 88
                                          7.4.12 Ecron Acunova ........................................................................................................ 89
                                          7.4.13 SIRO Clinpharm Pvt Ltd .......................................................................................... 90
                                          7.4.14 Catalyst Clinical Services ........................................................................................ 91
                                     8 Emerging Market for Clinical Trials – India - Appendix .............................................................. 92
                                       8.1    Market Definitions ........................................................................................................... 92


Emerging Market for Clinical Trials in India - Favorable                                                                              GBIHC072MR / Published JAN 2011
Regulatory Environment and Cost Effectiveness Will Accelerate
the Number of Clinical Trials                                                                                                                                                Page 4
                                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                         8.2    Abbreviations .................................................................................................................. 92
                                         8.3    Research Methodology ................................................................................................... 94
                                            8.3.1    Coverage ................................................................................................................. 94
                                            8.3.2    Secondary Research ............................................................................................... 94
                                            8.3.3    Primary Research .................................................................................................... 94
                                            8.3.4    Expert Panel Validation ........................................................................................... 95
                                         8.4    Contact Us ...................................................................................................................... 95
                                         8.5    Disclaimer ....................................................................................................................... 95
                                         8.6    Sources ........................................................................................................................... 96




Emerging Market for Clinical Trials in India - Favorable                                                                             GBIHC072MR / Published JAN 2011
Regulatory Environment and Cost Effectiveness Will Accelerate
the Number of Clinical Trials                                                                                                                                               Page 5
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                     1.1       List of Tables
                                     Table 1: Clinical Trials in India, Global BLA and NME Approvals vs R&D Spending, ($bn), 1995-
                                                2009 ............................................................................................................................... 22
                                     Table 2: Clinical Trials in India, Drug Patent Expiry, Global, ($m), 2009-2016 ................................ 26
                                     Table 3: Clinical Trials in India, Number of Phase l Clinical Trials Registered, India, 2004-2009 .... 27
                                     Table 4: Clinical Trials in India, Number of Phase ll Clinical Trials Registered, India, 2004-2009 28
                                     Table 5: Clinical Trials in India, Number of Phase lll Clinical Trials Registered, India, 2004-2009 . 29
                                     Table 6: Clinical Trials in India, Number of Phase lV Clinical Trials Registered, India, 2004-2009 . 30
                                     Table 7: Clinical Trials in India, Number of Clinical Trials Registered, BRIC, 2010 ......................... 32
                                     Table 8: Clinical Trials in India, Number of Industry Sponsored Clinical Trials, BRIC, 2010 ........... 33
                                     Table 9: Clinical Trials in India, Distribution of World Population among BRIC Countries, (%), 2008
                                                ....................................................................................................................................... 34
                                     Table 10: Clinical Trials in India, Number of Recruiting Sites for Major Therapeutic Areas in Brazil,
                                                India and China, 2005-2009 ........................................................................................... 36
                                     Table 11: Clinical Trials in India, Number of Sites Recruited by MNCs, Brazil, India and China, (%),
                                                2005-2009 ...................................................................................................................... 38
                                     Table 12: Clinical Trials in India, Industry Sponsored Trials Registered with the US Trial Register,
                                                India, China, Brazil, 2004-2009 ...................................................................................... 39
                                     Table 13: Clinical Trials in India, Local and Multinational Sites Registered With the US Trial
                                                Register, India, China, Brazil, 2004-2009 ....................................................................... 40
                                     Table 14: Clinical Trials in India, Total Number of Sites Involved in Planning, Recruiting, Ongoing
                                                and Completed Clinical Trials in Brazil, India and China, 2004-2009 ............................. 41
                                     Table 15: Clinical Trials in India, CRO Market, Global, 2006-2015 ................................................. 42
                                     Table 16: Clinical Trials in India, Number of Local and Multinational Sites, India, 2005-2009......... 43
                                     Table 17: Clinical Trials in India, Population Growth in India, (Millions), 2000-2020 ....................... 44
                                     Table 18: Clinical Trials in India, Population of Different Countries, Global, (Millions), 2008 .......... 45
                                     Table 19: Clinical Trials in India, DALY Rate Per 100,000 Population, Global, 2008 ...................... 46
                                     Table 20: Clinical Trials in India, Population Forecast for HIV, India, (Millions), 2009-2015............ 47
                                     Table 21: Clinical Trials in India, Population Forecast for Cardiovascular Diseases, India, (Millions),
                                                2009-2015 ...................................................................................................................... 48
                                     Table 22: Clinical Trials in India, Population Forecast for Diabetes, India, (Millions), 2009-2015 .. 49
                                     Table 23: Clinical Trials in India, Population Forecast for Cancer, India, (Millions), 2009-2015 ...... 50
                                     Table 24: Clinical Trials in India, Population Forecast for COPD and Asthma, India, (Millions), 2009-
                                                2015 ............................................................................................................................... 51
                                     Table 25: Clinical Trials in India, Cost Comparison, The US vs. India, ($’000), 2009 ..................... 52
                                     Table 26: Clinical Trials in India, Medical Colleges with Number of Students
								
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