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Drug Development Opportunities in China: Regulation, Key Players and Initiatives for Domestic and International Markets
Tuesday November 13 8:05 PM
Drug Development Opportunities in China: Regulation, key players and initiatives for domestic and international markets
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Description
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.
This report 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 content
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
Conclusion
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
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