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Drug Development Opportunities In China: Regulation, Key Players And Initiatives For Domestic And International Markets

Published by: Business Insights

Published: Sep. 1, 2007 - 141 Pages


Table of Contents



Drug development opportunities in China

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

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...

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