JZMed Research Report The New Trends of Global Clinical Development Outsourcing Market

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1 JZMed Research Report The New Trends of Global Clinical Development Outsourcing Market JZMed, Inc.

2 Table of Contents Scope of the Report About Author Executive Summary Latest trends of global clinical development outsourcing Latest trends of clinical development outsourcing in developed countries Latest trends of clinical development outsourcing in emerging countries Outlook of future growth potentials of global clinical development outsourcing market Chapter One Latest Trends of Global Clinical Development Outsourcing Summary Introduction Analysis of low productivity of clinical development Analysis of low clinical trial success rate Analysis of factors causing clinical trial failure Low success rates forcing drug companies to make reform on their R&D Major pharma revising their R&D focuses Major pharma narrowing down their therapeutic focuses Major pharma stopping R&D programs in some individual therapeutic areas Major pharma companies new R&D focuses Focusing on disease biology Focusing on new technologies Patient genomic data increasingly incorporated into clinical trials Incorporating biomarkers in clinical development becoming a must Co-development of therapeutics with companion diagnostics becoming a trend Major pharma companies new R&D models Major pharma companies new R&D outsourcing strategies Externalization becoming key strategy for R&D Relying on biotech companies for innovation Academia playing increasingly important roles in major pharma s R&D Summary of major pharma companies virtually integrated R&D model Biotech companies current R&D outsourcing demands and strategies Improving funding opportunities to small biotech companies 1

3 boosting their R&D activities Current R&D outsourcing strategies and activities of biotech companies Latest trends of global clinical trial outsourcing Globalization becoming a must for advanced clinical trials Virtual clinical development model in major pharma companies Streamlining clinical trial process Improving performance of global clinical trial outsourcing market Chapter Two Latest Trends of Clinical Development Outsourcing in Developed Countries Summary Introduction Current trends of clinical trials in developed countries Clinical trials turning to digitalization Clinical trials embracing big data Major pharma companies current clinical trial outsourcing demands, strategies and activities Selectively choosing preferred service providers as their close partners One-on-one exclusive strategic partnership emerging as a new model Major pharma having different strategies for clinical trial partnership Examples of major pharma s clinical trial outsourcing model Eli Lilly s preferred partnership outsourcing strategies Merck s clinical trial outsourcing strategy Current clinical trial outsourcing demands of biotech companies Latest trends in clinical trial service market in developed countries Current growth trends of early phase clinical trial outsourcing market Current growth trends of late phase clinical trial outsourcing market Current growth trends of central lab service market Major CROs gaining main service revenue from strategic partnerships with major pharma companies Analysis of strategies for small-sized CROs to prospect Clinical trial CRO consolidation becoming a trend CROs acquired by private equity firms - Investment industry considering CRO a proven model Latest activities of major CROs Shares of top CROs in global clinical trial outsourcing market Chapter Three Latest Trends of Clinical Development Outsourcing in Emerging Countries Summary Introduction

4 3.2 Emerging countries gaining more shares in global clinical trial market Global clinical trials moving toward emerging countries Asia outstanding in global clinical trials among all emerging countries Latest trends of clinical trials in Asia Latest trends of clinical trials in China Multinational drug companies conducting clinical trials in China Current clinical trial outsourcing in China Multinational CROs in China Key domestic Chinese CROs Latest trends of clinical trials in India New regulations on clinical trials in India Clinical trials declining in India Multinational CROs in India Key domestic Indian CROs Latest trends of clinical trials in other Asian countries Latest trends of clinical trials in Japan Latest trends of clinical trials in South Korea Latest trends of clinical trials in Taiwan Latest trends of clinical trials in East Europe Latest trends of clinical trials in Latin America Current regulatory environment in Latin America Global and local CROs in Latin America Chapter Four Outlook of Future Growth Potentials of Global Clinical Development Outsourcing Market Summary Introduction Analysis of future clinical trial outsourcing strategies of major pharma companies Analysis of future development trends of global clinical trial industry Evolving solutions to shorten clinical trial process Efforts toward clinical trial standardization Analysis of future growth patterns of global CRO industry Consolidation will still be a trend in clinical trial service industry Both major CROs and niche service providers will still co-exist Analysis of future growth potentials of global clinical trial outsourcing market Current global clinical trial outsourcing market Future growth forecast of global clinical trial outsourcing market Forecast of total global clinical trial service market Forecasts of clinical trial service market in each phase Forecast of central lab service market Analysis of future growth potentials of clinical trial outsourcing market in developed countries

5 4.6.1 Current clinical trial service market of developed countries Current clinical trial service market in the US Current clinical trial service market in West Europe Analysis of future growth drivers and resistors of clinical trial outsourcing market in developed countries Growth drivers Growth resistors Future growth forecast of clinical trial service market in developed countries Analysis of future growth potentials of clinical trial outsourcing market in emerging countries Asia expected to lead emerging countries in future growth of clinical trial service market Analysis of future growth potentials of clinical trial service market in China Current Chinese clinical trial service market Analysis of future growth drivers and resistors of Chinese clinical trial service market a. Growth drivers b. Growth resistors Future growth forecast of Chinese clinical trial service market Analysis of future growth potentials of Indian clinical trial service market Current Indian clinical trial service market Analysis of future growth drivers and resistors of Indian clinical trial service market Future growth forecast of Indian clinical trial service market Analysis of future growth potentials of clinical trial service markets in other Asian countries Analysis of advantages and disadvantages of conducting clinical trials in other Asian countries a. Key advantages b. Key challenges Current sizes and future growth potentials of clinical trial service markets in other Asian countries Analysis of future growth potentials of clinical trial service market in East Europe Growth drivers Growth resistors Current size and future growth potentials of clinical trial service market in East Europe Analysis of future growth potentials of clinical trial service market in Latin America Growth drivers Growth resistors

6 3. Current size and future growth potentials of clinical trial service market in Latin America Total clinical trial service market in all emerging countries Preferred CROs Major pharma s selection criteria and CRO s development goals Appendix Appendix I. Research Methodology Appendix II. About JZMed, Inc List of Tables Table 1. Factors causing clinical trials so difficult Table 2. Statistic distributions of failure rate in each development stage of drug R&D Table 3. Drug R&D productivity declining while cost climbing Table 4. Main factors causing clinical trials to fail Table 5. Lack of efficacy is key factor causing failure in middle phase trials Table 6. Examples of major pharma companies narrowing down their therapeutic focuses Table 7. Compositions of major pharma companies current R&D system Table 8. Factors determining drug R&D failure actually embedded in the beginning - 36 Table 9. Biomarkers involved in drug development Table 10. New drug R&D models currently pursued by major pharma companies Table 11. Analysis of relationships between major pharma and small biotech companies Table 12. Increasing involvement of academics in global drug R&D industry Table 13. Current partnership models of major pharma companies with academics Table 14. Latest R&D outsourcing strategies of major pharma companies Table 15. Major pharma companies new outsourcing models Table 16. R&D-focused small biotech companies experiencing increasing funding opportunities Table 17. Biotech companies currently experiencing best R&D environment Table 18. Clinical trials can be completely virtual Table 19. Current bottlenecks in global clinical trial Table 20. New techniques and developments in clinical trial Table 21. Distributions of clinical trial sites for products targeting US market Table 22. Total numbers of clinical trials conducted in each major geographic region in past fourteen years Table 23. Annual growth rates of clinical trials in major geographic regions in past seven years Table 24. Clinical trials become more electronic Table 25. Benefits and positive consequences of strategic partnerships between major pharma companies and major CROs

7 Table 26. Long term partnerships recently forged between major pharma companies and major CROs Table 27. Major CROs forming close partnerships with major drug companies Table 28. Growth trends of Covance s service revenue in recent three years Table 29. Shares of combined service revenues from top clients in major CROs total service revenues Table 30. Latest examples of M&As by major CROs Table 31. More CROs strengthening their positions in patient recruiting to get ready for higher demand for clinical trials Table 32. Examples of privative equity (PE) firms acquiring clinical trial service CROs Table 33. Key attractions of CRO model to PEs Table 34. Latest developments in CRO industry Table 35. Top five public CROs latest service revenue and their rankings Table 36. Comparison of clinical trial cost between China and developed countries Table 37. Changes in patient distributions participating in clinical trials conducted in EU over last six years Table 38. Clinical trials conducted in BRIC countries in past seven years Table 39. Attractions of Asia countries for global clinical trials Table 40. Numbers of clinical trial applications submitted by major pharma companies to CFDA in recent years Table 41. Examples of global biotech companies conducting clinical trials in China Table 42. Clinical trial approvals in China in recent years Table 43. Comparison of major pharma companies approaches of establishing clinical trial data management centers in China and India Table 44. More examples of multinational CROs recently entering Chinese clinical trial service market Table 45. Clinical trial approvals in India in recent five years Table 46. Clinical trials conducted by CROs in India in recent years Table 47. Current situation of clinical trials in India Table 48. Outsourcing proportion of clinical trials in India is low Table 49. Growth trend of clinical trial approvals in Russia in recent years Table 50. Analysis of major pharma R&D spending on clinical trials Table 51. R&D functions that can be completely outsourced Table 52. Types of organizations major pharma companies will rely on for R&D in future Table 53. Analysis of major pharma companies future clinical trial outsourcing strategies Table 54. Strategies to accelerate patient recruiting process for clinical trials Table 55. Expected new trends in future clinical trials Table 56. Techniques most desired by drug companies and CROs must possess Table 57. Analysis of future development directions of global CRO industry Table 58. Growth history of global clinical trial service market in past six years

8 Table 59. Current global clinical trial service markets in each trial phase Table 60. Forecasted future growth of global clinical trial service market by Table 61. Forecasted global clinical trial service markets in each trial phase Table 62. Current clinical trial service markets in developed countries Table 63. FDA s requirements for marketing applications for drugs whose clinical trials conducted outside the US Table 64. Forecasted future growth of clinical trial service market in developed countries Table 65. Forecasted clinical trial service markets in developed countries ( ) Table 66. Current and forecasted (by 2020) pharmaceutical markets in each major global region and their shares in total global pharmaceutical market Table 67. Growth history of Chinese clinical trial service market in past six years Table 68. Growth drivers of Chinese clinical trial service market Table 69. Key resistors for future growth of Chinese clinical trial service market Table 70. Forecasted future growth of Chinese clinical trial service market Table 71. Growth history of Indian clinical trial service market in past six years Table 72. Drivers and resistors for future growth of Indian clinical trial service market Table 73. Analysis of future growth potentials of clinical trial service market in India Table 74. Forecasted future growth of Indian clinical trial service market Table 75. Advantages of conducting clinical trials in South Korea Table 76. Growth drivers and resistors for Asian clinical trial service market Table 77. Current and forecasted clinical trial service markets in top five Asian countries Table 78. Current and forecasted shares of China and combined top five Asian countries in entire Asian and total global clinical trial service markets Table 79. Advantages for conducting clinical trials in East Europe Table 80. Current and forecasted clinical trial service markets in East Europe Table 81. Advantages for conducting clinical trials in Latin America Table 82. Current and forecasted clinical trial service markets in Latin America Table 83. Combined emerging countries current and forecasted clinical trial service markets Table 84. Current and forecasted clinical trial service markets in developed countries and emerging countries and their shares in total global market Table 85. How to become a preferred clinical trial service provider Table 86. Criteria of major pharma companies choosing preferred service providers List of Figures Figure 1. Growth trend of global clinical trial service market in past six years Figure 2. Forecasted growth trend of global clinical trial service market ( )

9 Figure 3. Current and predicted distributions of global clinical trial service market in each phase Figure 4. Forecasted future growth trend of clinical trial service market in developed countries ( ) Figure 5. Current and predicted distributions of global pharmaceutical market Figure 6. Past growth trend of Chinese clinical trial service market Figure 7. Forecasted future growth trend of Chinese clinical trial service market ( ) Figure 8. Forecasted future growth trend of Indian clinical trial service market ( ) List of Case Studies Case Study 1. Unvalidated therapeutic targets causing failure of clinical trials Case Study 2. AstraZeneca reviewed and revised its R&D strategy Case Study 3. Major pharma companies partnering with genomics company to acquire patient s genomic data in clinical trials Case Study 4. Example of major pharma companies emphasizing importance of external resources to their R&D effort Case Study 5. Merck s latest restructuring with focus on externalization Case Study 6. Major pharma letting small biotech companies handle early phase clinical trials Case Study 7. Pfizer s new R&D unit Centers for Therapeutic Innovation (CTI) Case Study 8. Example of major pharma s relationship with academics Case Study 9. Pfizer s virtual clinical trial attempt Case Study 10. Example of major pharma companies successfully improving R&D efficiency through virtually integrated R&D model Case Study 11. More R&D-focused biotech companies adopting virtual operation model Case Study 12. Pfizer choosing ICON and Parexel as preferred service providers Case Study 13. Analysis of the way Merck Serono narrowing down its clinical trial service providers to only one Case Study 14. Private equity (PE) firm acquiring clinical trial service CROs Case Study 15. Clinical trials declining in the UK Case Study 16. PRA forming partnership with WuXi PharmaTech to enter Chinese clinical trial service market Case Study 17. WuXi PharmaTech competing with Tigermed in Chinese clinical trial service market Case Study 18. Major pharma companies forming clinical trial training consortium in Asia Case Study 19. Major pharma companies focusing on standardization of clinical trial process