中国における新薬開発の機会

Abstract

Drug developments in the US and EU are becoming increasingly expensive and time consuming, with new products typically requiring investment of over 4 years and $1billion from concept to commercialization. As a result, China has emerged as an increasingly attractive option for companies aiming to reduce such prohibitive investments in time and finance. Human clinical studies have historically dominated outsourced R&D activities in China, with the country' s relative lack of capital and expertise being insufficient to facilitate technologically intensive discovery and pre-clinical work. However, an influx of western-trained scientists and increasing access to global capital markets are rapidly extending the development opportunities available to China' s expanding base of pharma and biotech companies. ' Drug Development Opportunities in China' is a new report published by Business Insights that provides a comprehensive review of China' s drug development industry, both in terms of expanding domestic markets and the country' s role as a third-party provider of outsourced global drug developments. This report will examine the methods of expansion adopted by China' s pharma companies, biotech developers and CRO' s to increase the scale of their drug development operations, in addition to identifying their therapeutic interests and development lifecycle focus. It will also provide forecasts for drug development trends in China over the next five years. Identify the factors attracting global drug developers to China, assess future growth opportunities within the domestic pharma and biotech markets and deploy outsourced R&D more effectively with this new report...

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