Emerging Market for Clinical Trials in China - Communication Problems and Unresolved Intellectual Property Issues Restrict Growth
2011 Apr 11
97 Pages (PDF)
Emerging Market for Clinical Trials in China - Communication Problems and Unresolved Intellectual Property Issues Restrict Growth 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 Researchs 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.
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 - 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