Drug Development Opportunities in China: Regulation, key players and initiatives for domestic and international markets

Table of Contents

Executive Summary

• Introduction
• Pharmaceutical companies
• Biotechnology companies
• Contract research organizations (CROs)
• Future drug development in China

Chapter 1 Introduction

• Summary
• The current challenges of drug development
• The Chinese population and economy
• Growth trends
• Culture and business environment
• The Chinese healthcare system
• The Chinese drug market
• Traditional Chinese medicine
• Western-style pharmaceuticals
• Patent Issues in China
• Drug pricing
• Corruption and Bribery
• Counterfeiting
• The State Food and Drug Administration
• Drug development in China
• Initiatives for the domestic market
  • Prescription medicines
• Case study: AstraZeneca
  • Over-the-counter remedies
• Initiatives for foreign markets
• Clinical trial recruiting advantages
• Conclusion

Chapter 2 Pharmaceutical companies

• Summary
• Introduction
• Local players
  • Traditional Chinese medicine
• Foreign players
• Sales and R&D activities of leading foreign pharma companies, 2007
• Drivers of expansion in China
• Economic benefits
• Flexible research environment
  • Animal Testing
  • Stem cell research
• Growth constraints
• GMP compliance
• Recent developments
• Case study: Novo Nordisk
• Conclusion

Chapter 3 Biotechnology companies

• Summary
• Introduction
• Local players
• Foreign players
• Sales and R&D activities in of leading foreign biotech companies in China, 2007
• Drivers of expansion in China
• Increasing access to capital
  • Public offerings
  • Venture capital
  • Direct investment
• Returning scientists
• Knowledge transfer from CRO work
• Support from Chinese-controlled drug developers abroad
  • Government support
• Growth constraints
• Constraints on foreign biotech activity in China
• Constraints on domestic Chinese biotech activity
• Recent developments
• Bird flu vaccine
• Monoclonal antibodies

Chapter 4 Contract Research Organizations (CROs)

• Summary
• Introduction
• The CRO industry
• The role of CROs in pre-clinical trials
• The role of CROs in clinical trials
• CROs in China
• Local Players
  • Case study: WuXi PharmaTech
• Foreign CROs
  • Case study: Bridge Pharmaceuticals
• Intermediaries and agents
• Drivers of expansion in China
• Cost advantages
• Returning scientists
• Government support
• Networking opportunities
• Growth constraints
• Pre-clinical testing
• Clinical testing
• Conclusion

Chapter 5 Future of drug development in

• China
• Summary
• Introduction
• R&D trends for the domestic market
• Domestic pharma R&D trends
  • Pharma R&D expectations for 2008 and 2009
  • Pharma R&D expectations for 2010 to 2013
• Domestic biotechnology R&D trends
  • Domestic biotechnology R&D expectations for 2008 and 2009
  • Domestic biotechnology R&D expectations for 2010 to 2013
• Domestic CRO R&D trends
  • Domestic CRO R&D expectations for 2008 and 2009
  • Domestic CRO R&D expectations for 2010 to 2013
• R&D trends for foreign markets
• Pharma R&D trends for foreign markets
  • Expectations for 2008 and 2009
  • Expectations for 2010 to 2013
• Biotechnology R&D trends for foreign markets
  • Expectations for 2008 and 2009
  • Expectations for 2010 and 2013
• CRO R&D trends for foreign markets
  • Expectations for 2008 and 2009
  • Expectations for 2010 and 2013
• Conclusion

Chapter 6 Appendix

• Primary research methodology
• Index

List of Figures

• Figure 1.1: Chinese population growth, 1950 - 2050 (est.)
• Figure 2.2: Growth of China' s pharmaceutical drug market, 2001 - 2006
• Figure 3.3: Growth of biotechnology products in China, 2001 - 2006
• Figure 4.4: Timing advantages of using a CRO, 2007
• Figure 4.5: Growth of CROs in China, 2001 - 2006
• Figure 5.6: Pharmaceutical sales in China, 2007 - 2013
• Figure 5.7: Proportion of R&D spending by type of product, 2008 and 2013
• Figure 5.8: Biotech product sales in China, 2007 - 2013
• Figure 5.9: CRO sales in China, 2007 - 2013

List of Tables

• Table 1.1: Ease of doing business in China compared with 174 other countries
• Table 1.2: OTC Drugs in China, 2007
• Table 1.3: Advantages of working in China for pharma companies, biotech companies and CROs
• Table 2.4: Characteristics of China' s foreign vs. domestic pharmaceutical companies, 2007
• Table 3.5: Characteristics of China' s foreign vs. domestic biotechnology companies, 2007
• Table 3.6: Recent public offerings of Chinese biotechnology companies
• Table 4.7: Summary of drug testing objectives by phase
• Table 4.8: Leading Chinese CROs, 2007
• Table 4.9: Leading foreign CROs operating in China, 2007
• Table 5.10: Effect of growth drivers on drug development sectors in China, 2007 - 2013