Emerging Market for Clinical Trials in China - Communication Problems and Unresolved Intellectual Property Issues Restrict Growth

Published : April 2011
No. of Pages : 97

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Report Summary

GBI Research has released its pharmaceutical report, “Emerging Market for Clinical Trials in China - Communication Problems and Unresolved Intellectual Property Issues Restrict Growth” that provides key data, information and analysis of the major trends and issues affecting the clinical trial market in China. The report provides a comprehensive insight into the reasons for outsourcing clinical trials to China and the key services provided by the CROs of China. The report provides a detailed analysis of the Chinese market in terms of its size, and major service offerings of the CROs in China. The report also discusses the factors that are driving the clinical trial market in China. The report delves into the key documents required by the investigator and the sponsor before, during and after the conduct of clinical trials. It also provides an insight into the government support initiatives in China to encourage clinical trials. The report also provides key alliances and acquisitions between the western CROs and the local CROs of China, and the key trends emerging out of such partnerships. The report also looks into the major challenges that can restrict the growth of the clinical trials market in China. This report is built using data and information sourced from proprietary databases, primary and secondary research, and in house analysis by GBI Research’s team of industry experts.

With increasing cost cutting pressures due to decreasing R&D productivity, patent expiries of blockbusters, drying pipelines and stringent regulations of the western governments, the cost of conducting research in the western world is increasing and in turn is putting immense financial pressures on the big pharma companies. On the other hand, China has developed significant capabilities in drug discovery research to match the western standards, while providing substantial cost advantages of up to 50-60%, and is becoming an attractive option to conduct discovery and preclinical stage research. The availability of a huge talent pool and favorable infrastructure support are also two major advantages in China. Although China controls a very small part of the global discovery research, this share is expected to rise in the future as the western pharmaceuticals realize the need to outsource the maximum possible amount of R&D work to the low cost countries. With discovery research occupying close to one-third of the R&D costs, there is a huge opportunity for significant cost savings.

Scope

The scope of this report includes -

The need for outsourcing clinical trials to China.
Trends in clinical trial registration in China and a comparative analysis of clinical trial registration in BRIC countries.
Analysis of the key drivers that are fueling the growth of the clinical trial market in China.
Qualitative analysis of the key infrastructural facilities required for conducting clinical trials in China.
Analysis of key government regulations in China affecting the clinical trial market.
Study of nine key CROs in the clinical trial services space and their deals/partnerships with western pharma in the clinical trial space.

Reasons to buy

The report will enhance your decision making capability. It will allow you to -

Compare the key capabilities of major clinical trial service providers with your requirements and optimize your R&D costs.
Develop market entry and market expansion strategies by identifying the key drivers and challenges in the Chinese market.
Develop effective strategies to maximize the advantages in China through the understanding of the regulatory environment and government support.
Understand the regulatory structure in China and key documents required to register clinical trials in China.

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 - China – Introduction 9
2.1 GBI Research Report Guidance 10

3 Emerging Market for Clinical Trials - China – Overview 11
3.1 The Clinical Research Process – Overview 11
3.1.1 Drug Discovery 11
3.1.2 Pre-Clinical 12
3.1.3 Phase I 12
3.1.4 Phase II 12
3.1.5 Phase III 12
3.1.6 Review and Approval from the Regulatory Agencies 12
3.1.7 Post-marketing Studies 12
3.2 Clinical Trial Design and Types 13
3.2.1 Types of Design 13
3.3 Role of CROs 19
3.4 Sponsors of Clinical Trials 20
3.5 Intellectual Property Protection in China 21
3.5.1 Article 15 21
3.5.2 Aritcle 20 22
3.5.3 Articles 22 and 23 22
3.5.4 Article 62 22
3.5.5 Articles 48 and 50 22
3.5.6 Article 69(5) 22
3.5.7 Article 5 and 26 22
3.6 The Need for Outsourcing Clinical Trials 23
3.6.1 High Risks and Costs Associated With Drug Development 23
3.6.2 Escalating Costs of Clinical Trials 24
3.6.3 Global Increase in the Number of Clinical Trials Conducted 25
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 27

4 Emerging Market for Clinical Trials – China - Clinical Trial Trends 28
4.1 Registration of Phase l Clinical Trials 28
4.2 Registration of Phase ll Clinical Trials 29
4.3 Registration of Phase lll Clinical Trials 30
4.4 Registration of Phase lV Clinical Trials 31
4.5 Clinical Trials Registered in 2010 32
4.6 Comparative Analysis of Registered Clinical Trials in Brazil, Russia, India and China (BRIC) Countries 33
4.7 Comparative Analysis of Population Statistics in BRIC Countries 34
4.8 Population Forecast of China 35
4.9 Analysis of Epidemiology and Prevalence of Major Diseases in China 36
4.9.1 Number of Recruiting Sites for Major Therapeutics in China 36

5 Emerging Market for Clinical Trials – China - Market Environment Characterization 44
5.1 Increase in Growth of Global CRO Market will Foster the Growth of Chinese Clinical Trial Market 44
5.1.1 Increase in Multinational Sites to Conduct Clinical Trials will Drive the Clinical Trial Market in China 45
5.1.2 Access to a Large Patient Population 47
5.1.3 Comparison of Population of Different Countries 48
5.1.4 Patient Availability for Major Diseases 49
5.1.5 Subject Recruitment and Speed of Trials 56
5.1.6 Cost Comparison China Vs the US 56
5.1.7 Annual Median Salaries of Doctors in China 57
5.1.8 Annual Median Salaries of Doctors in Different Provinces of China 58
5.1.9 Infrastructural Facilities Improve the Clinical Trial Environment 59
5.1.10 Increase in Number of Graduates in Colleges and Universities of China 61
5.2 Market Restraints 64
5.2.1 Slow Regulatory Approvals 64
5.2.2 Insufficient Communication Platform 64
5.2.3 Intellectual Property Issues are not Fully Resolved 64
5.2.4 In depth Training in Good Clinical Practices (GCP) for Health Care Professionals 64
5.3 Clinical Trial Market Size in China 65

6 Emerging Market for Clinical Trials – China - Regulatory Landscape 66
6.1 Introduction 66
6.1.1 Drug Administration Law 66
6.1.2 Implementing Regulation of Drug Administrative Law 67
6.1.3 Good Clinical Practices (GCP) of Pharmaceutical Products (1999) 67
6.1.4 Work Rules for Clinical Research of Drugs (2000) 68
6.1.5 Structure and Procedure for Monitoring Adverse Drug Reactions in China 69
6.2 The Ministry of Health 70
6.3 State Food and Drug Administration (SFDA) 70
6.4 Clinical Trials Registry China (ChiCTR) 71
6.5 Clinical Trial Regulation in China 72
6.5.1 Approval Process for Clinical Trials in China 72
6.5.2 Number of Days Required For Getting the Approval for Clinical Trials (Individual Procedures) 73
6.5.3 Approval Process for Clinical Trials in China for Imported Drugs 74
6.5.4 Number of Days Required For Getting the Approval for Clinical Trials for Imported Drugs (Individual Procedures) 75
6.5.5 Documents Required With the Investigator of Clinical Trials 75
6.5.6 Documents Required With the Sponsor of Clinical Trials 77
6.6 Recent Regulatory Changes in Clinical Trials 79
6.6.1 Longer lead-times on specified exports 79
6.6.2 Need for Chinese-based applicant. 79
6.7 Government Incentives 79
6.8 Activity of International Pharmaceutical Companies in China 80

7 Emerging Market for Clinical Trials – China - CRO Landscape 81
7.1 Classification of CROs in China 81
7.2 Number of CROs in China Based on Types of Services Rendered 82
7.3 Acquisitions of Chinese CROs 83
7.4 Recent Alliances of Chinese CROs 83
7.5 CRO Profiles 84
7.5.1 BO JI Medicine Services Co. Ltd 84
7.5.2 Giant Med-Pharma Services Inc 85
7.5.3 InCROM 86
7.5.4 Pharmaron 87
7.5.5 Venturepharm Service Group (VPS) 88
7.5.6 PPD 89
7.5.7 CCBR-SYNARC 90
7.5.8 Quintiles 91
7.5.9 Kendle 92

8 Emerging Market for Clinical Trials – China - Appendix 93
8.1 Market Definitions 93
8.2 Abbreviations 93
8.3 Research Methodology 94
8.3.1 Coverage 94
8.3.2 Secondary Research 95
8.3.3 Primary Research 95
8.3.4 Expert Panel Validation 95
8.4 Contact Us 96
8.5 Disclaimer 96
8.6 Sources 96

1.1 List of Tables

Table 1: Clinical Trials in China, Global BLA and NME Approvals vs. R&D Spending, ($bn), 1995-2009 23
Table 2: Clinical Trials in China, Drug Patent Expiry, Global, ($m), 2009-2016 27
Table 3: Clinical Trials in China, Number of Phase l Clinical Trials Registered, 2005-2010 28
Table 4: Clinical Trials in China, Number of Phase ll Clinical Trials Registered, 2005-2010 29
Table 5: Clinical Trials in China, Number of Phase lll Clinical Trials Registered, 2005-2010 30
Table 6: Clinical Trials in China, Number of Phase lV Clinical Trials Registered, 2005-2010 31
Table 7: Clinical Trials in China, Number of Clinical Trials Registered, BRIC, 2010 33
Table 8: Clinical Trials in China, Distribution of World Population among BRIC Countries, (%), 2010 34
Table 9: Clinical Trials in China, Population Forecast, (Millions), 1950 – 2050 35
Table 10: Clinical Trials in China, Number of Recruiting Sites for Major Therapeutic Areas, 2005-2009 36
Table 11: Clinical Trials in China, Number of Sites Recruited by MNCs, (%), 2005-2009 37
Table 12: Clinical Trials in China, Number of Clinical Trials by MNCs, 2010 38
Table 13: Clinical Trials in China, Number of Clinical Trials by MNCs, Hong Kong, 2010 39
Table 14: Clinical Trials in China, Number of SFDA Study Sites by Therapeutics, 2008 41
Table 15: Clinical Trials in China, Number of Institutions Accredited by SFDA for Therapeutic Areas, 2008 43
Table 16: Clinical Trials in China, Global, CRO Market, 2006-2015 44
Table 17: Clinical Trials in China, Number of Local and Multinational Sites, 2005-2009 46
Table 18: Clinical Trials in China, Number of Patients, 2010 47
Table 19: Clinical Trials in China, Global, Population of Different Countries, (Million), 2009 - 2011 48
Table 20: Clinical Trials in China, Incidence Number of Common Diseases, 2009 49
Table 21: Clinical Trials in China, Number of Deaths by Diseases, (%), 2009 50
Table 22: Clinical Trials in China, Population Forecast for HIV, (‘000), 2010-2015 51
Table 23: Clinical Trials in China, Population Forecast for CVD, (Millions), 2010-2015 52
Table 24: Clinical Trials in China, Population Forecast for Diabetes, (Millions), 2010-2015 53
Table 25: Clinical Trials in China, Population Forecast for Cancer, (Millions), 2010-2015 54
Table 26: Clinical Trials in China, Population Forecast for COPD (Millions), 2010-2015 55
Table 27: Clinical Trials in China, Cost Comparison China vs. The US, ($), 2010 56
Table 28: Clinical Trials in China, Annual Median Salaries of Doctors, ($), 2011 57
Table 29: Clinical Trials in China, Annual Median Salaries of Doctors in Different Provinces, ($), 2011 58
Table 30: Clinical Trials in China, Number of Health Care Institutions, 2009 59
Table 31: Clinical Trials in China, Growth of HealthCare Professionals, 2000 - 2009 60
Table 32: Clinical Trials in China, Number of Graduates, 2001 - 2009 61
Table 33: Clinical Trials in China, Number of Medical Graduates, 2001-2009 62
Table 34: Clinical Trials in China, Growth Rate of Principal Investigators, Global, (%), 2002-2008 63
Table 35: Clinical Trials in China, Clinical Trial Market, ($m), 2010-2016 65
Table 36: Clinical Trials in China, Number of Articles in Drug Administration Law, 2010 66
Table 37: Clinical Trials in China, Number of Articles in Implementing Regulation of Drug Administration Law, 2010 67
Table 38: Clinical Trials in China, Number of Articles in Good Clinical Practices of Pharmaceutical Products, 2010 67
Table 39: Clinical Trials in China, Work Rules For Clinical Research of Drugs, 2010 68
Table 40: Clinical Trials in China, Number of Days Required for Individual Processes, 2010 73
Table 41: Clinical Trials in China, Number of Days Required for Individual Processes, 2010 75
Table 42: Clinical Trials in China, Documents With Investigator Before Commencement of Clinical Trials, 2010 75
Table 43: Clinical Trials in China, Documents With Investigator During Clinical Conduct of Trials, 2010 76
Table 44: Clinical Trials in China, Documents With Investigator After Completion of Clinical Trials, 2010 76
Table 45: Clinical Trials in China, Documents With Sponsor Before Commencement of Clinical Trials, 2010 77
Table 46: Clinical Trials in China, Documents With Sponsor During Clinical Conduct of Trials, 2010 78
Table 47: Clinical Trials in China, Documents With Sponsor After Completion of Clinical Trials, 2010 78
Table 48: Clinical Trials in China, Classification of CROs, (%), 2010 81
Table 49: Clinical Trials in China, Classification of CROs Based on Services, 2010 82
Table 50: Clinical Trials in China, Acquisitions of Chinese CROs, 2009 – 2010 83
Table 51: Clinical Trials in China, Alliances of Chinese CROs, 2007 – 2010 83

1.2 List of Figures

Figure 1: Clinical Trials in China, Parallel Group Trial Design, 2010 13
Figure 2: Clinical Trials in China, Cross Over Trial Design, 2010 14
Figure 3: Clinical Trials in China, Adaptive Clinical Trial Design, 2010 15
Figure 4: Clinical Trials in China, Wyeth Learn and Confirm Model, 2010 17
Figure 5: Clinical Trials in China, Services Offered by CROs, 2010 19
Figure 6: Clinical Trials in China, Preclinical Research to Market Launch Via Clinical Trials, 2009 20
Figure 7: Clinical Trials in China, Acts Related to Intellectual Property Protection, 2005-2008 21
Figure 8: Clinical Trials in China, Global BLA and NME Approvals vs. R&D Spending, ($bn), 1995-2009 23
Figure 9: Clinical Trials in China, Activities of R&D Restructuring, 2010 25
Figure 10: Clinical Trials in China, Number of Phase l Clinical Trials Registered, 2005-2010 28
Figure 11: Clinical Trials in China, Number of Phase ll Clinical Trials Registered, 2005-2010 29
Figure 12: Clinical Trials in China, Number of Phase lll Clinical Trials Registered, 2005-2010 30
Figure 13: Clinical Trials in China, Number of Phase lV Clinical Trials Registered, 2005-2010 31
Figure 14: Clinical Trials in China, Distribution of Clinical Trials by Phase, (%), 2010 32
Figure 15: Clinical Trials in China, Number of Clinical Trials Registered, BRIC, 2010 33
Figure 16: Clinical Trials in China, Distribution of World Population among BRIC Countries, (%), 2010 34
Figure 17: Clinical Trials in China, Population Forecast, (Millions), 1950 – 2050 35
Figure 18: Clinical Trials in China, Number of Recruiting Sites for Major Therapeutic Areas, 2005-2009 36
Figure 19: Clinical Trials in China, Number of Sites Recruited by MNCs, (%), 2005-2009 37
Figure 20: Clinical Trials in China, Number of Clinical Trials by MNCs, 2010 38
Figure 21: Clinical Trials in China, Number of Clinical Trials by MNCs, Hong Kong, 2010 39
Figure 22: Clinical Trials in China, Number of Major SFDA Study Sites by Therapeutics, 2008 40
Figure 23: Clinical Trials in China, Number of Institutions Accredited by SFDA for Therapeutic Areas, 2008 42
Figure 24: Clinical Trials in China, Global, CRO Market, ($bn), 2006-2015 44
Figure 25: Clinical Trials in China, Number of Local and Multinational Sites, 2005-2009 45
Figure 26: Clinical Trials in China, Patient population, (Millions), 2010 47
Figure 27: Clinical Trials in China, Global, Population of Different Countries, (Million), 2009 - 2011 48
Figure 28: Clinical Trials in China, Number of Deaths by Diseases, (%), 2009 50
Figure 29: Clinical Trials in China, Population Forecast for HIV, (‘000), 2010-2015 51
Figure 30: Clinical Trials in China, Population Forecast for CVD, (Millions), 2010-2015 52
Figure 31: Clinical Trials in China, Population Forecast for Diabetes, (Millions), 2010-2015 53
Figure 32: Clinical Trials in China, Population Forecast for Cancer, (Millions), 2010-2015 54
Figure 33: Clinical Trials in China, Population Forecast for COPD, (Millions), 2009-2015 55
Figure 34: Clinical Trials in China, Annual Median Salaries of Doctors, ($), 2011 57
Figure 35: Clinical Trials in China, Annual Median Salaries of Doctors in Different Provinces, ($), 2011 58
Figure 36: Clinical Trials in China, Number of Graduates, (Millions), 2001 - 2009 61
Figure 37: Clinical Trials in China, Number of Medical Graduates, (‘000), 2001-2009 62
Figure 38: Clinical Trials in China, Growth Rate of Principal Investigators, Global, (%), 2002-2008 63
Figure 39: Clinical Trials in China, Clinical Trial Market, ($m), 2010-2016 65
Figure 40: Clinical Trials in China, Structure for Reporting and Monitoring Adverse Drug Reaction (ADR), 2010 69
Figure 41: Clinical Trials in China, Procedure for Registering Clinical Trials with ChiCTR, 2010 71
Figure 42: Clinical Trials in China, Clinical Trial Regulation Approval Process, 2010 72
Figure 43: Clinical Trials in China, Clinical Trial Regulation Approval Process For Imported Drugs, 2010 74
Figure 44: Clinical Trials in China, Classification of CROs, (%), 2010 81
Figure 45: Clinical Trials in China, Classification of CROs Based on Services, 2010 82
Figure 46: BOJI Medicine Services Co. Ltd, Company Profile, 2010 84
Figure 47: Giant Med-Pharma Services Inc, Company Profile 2010 85
Figure 48: InCROM, Company Profile, 2010 86
Figure 49: Pharmaron, Company Profile, 2010 87
Figure 50: Venturepharm Service Group, Company Profile, 2010 88
Figure 51: PPD, Company Profile, 2010 89
Figure 52: CCBR-SYNARC, Company Profile, 2010 90
Figure 53: Quintiles, Company Profile, 2010 91
Figure 54: Kendle, Company Profile, 2010 92

Emerging Market for Clinical Trials in China - Communication Problems and Unresolved Intellectual Property Issues Restrict Growth

Published By: GBI Research

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