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

Business Insights
09.2007
141 Seiten

 
Typ:
Studie
Verfüg­barkeit:
verfügbar
Regionen/­Länder:
  • China

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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

Drug development opportunities in China

Executive Summary 10

Introduction 10

Pharmaceutical companies 11

Biotechnology companies 12

Contract research organizations (CROs) 13

Future drug development in China 14

Chapter 1 Introduction 18

Summary 18

The current challenges of drug development 19

The Chinese population and economy 20

Growth trends 21

Culture and business environment 22

The Chinese healthcare system 25

The Chinese drug market 27

Traditional Chinese medicine 28

Western-style pharmaceuticals 29

Patent Issues in China 31

Drug pricing 32

Corruption and Bribery 33

Counterfeiting 34

The State Food and Drug Administration 35

Drug development in China 36

Initiatives for the domestic market 37

Prescription medicines 38

Case study: AstraZeneca 39

Over-the-counter remedies 40

Initiatives for foreign markets 43

Clinical trial recruiting advantages 46

Conclusion 47

Chapter 2 Pharmaceutical companies 50

Summary 50

Introduction 51

Local players 52

Traditional Chinese medicine 54

Foreign players 54

Sales and R&D activities of leading foreign pharma companies, 2007 55

Drivers of expansion in China 58

Economic benefits 59

Flexible research environment 60

Animal Testing 60

Stem cell research 61

Growth constraints 62

GMP compliance 63

Recent developments 64

Case study: Novo Nordisk 66

Conclusion 68

Chapter 3 Biotechnology companies 70

Summary 70

Introduction 71

Local players 73

Foreign players 76

Sales and R&D activities in of leading foreign biotech companies in China, 2007 77

Drivers of expansion in China 79

Increasing access to capital 79

Public offerings 79

Venture capital 80

Direct investment 81

Returning scientists 83

Knowledge transfer from CRO work 84

Support from Chinese-controlled drug developers abroad 85

Government support 85

Growth constraints 87

Constraints on foreign biotech activity in China 87

Constraints on domestic Chinese biotech activity 88

Recent developments 89

Bird flu vaccine 89

Monoclonal antibodies 90

Conclusion 92

Chapter 4 Contract Research Organizations

(CROs) 94

Summary 94

Introduction 95

The CRO industry 95

The role of CROs in pre-clinical trials 99

The role of CROs in clinical trials 100

CROs in China 101

Local Players 103

Case study: WuXi PharmaTech 106

Foreign CROs 107

Case study: Bridge Pharmaceuticals 108

Intermediaries and agents 111

Drivers of expansion in China 112

Cost advantages 112

Returning scientists 113

Government support 113

Networking opportunities 114

Growth constraints 114

Pre-clinical testing 114

Clinical testing 115

Conclusion 117

Chapter 5 Future of drug development in

China 120

Summary 120

Introduction 121

R&D trends for the domestic market 121

Domestic pharma R&D trends 122

Pharma R&D expectations for 2008 and 2009 124

Pharma R&D expectations for 2010 to 2013 125

Domestic biotechnology R&D trends 125

Domestic biotechnology R&D expectations for 2008 and 2009 126

Domestic biotechnology R&D expectations for 2010 to 2013 127

Domestic CRO R&D trends 128

Domestic CRO R&D expectations for 2008 and 2009 129

Domestic CRO R&D expectations for 2010 to 2013 129

R&D trends for foreign markets 129

Pharma R&D trends for foreign markets 130

Expectations for 2008 and 2009 131

Expectations for 2010 to 2013 132

Biotechnology R&D trends for foreign markets 133

Expectations for 2008 and 2009 133

Expectations for 2010 and 2013 133

CRO R&D trends for foreign markets 134

Expectations for 2008 and 2009 135

Expectations for 2010 and 2013 136

Conclusion 136

Chapter 6 Appendix 138

Primary research methodology 138

Index 139

List of Figures

Figure 1.1: Chinese population growth, 1950 — 2050 (est.) 22

Figure 2.2: Growth of China’s pharmaceutical drug market, 2001 - 2006 51

Figure 3.3: Growth of biotechnology products in China, 2001 - 2006 74

Figure 4.4: Timing advantages of using a CRO, 2007 101

Figure 4.5: Growth of CROs in China, 2001 - 2006 102

Figure 5.6: Pharmaceutical sales in China, 2007 - 2013 123

Figure 5.7: Proportion of R&D spending by type of product, 2008 and 2013 124

Figure 5.8: Biotech product sales in China, 2007 - 2013 126

Figure 5.9: CRO sales in China, 2007 - 2013 135

List of Tables

Table 1.1: Ease of doing business in China compared with 174 other countries 25

Table 1.2: OTC Drugs in China, 2007 41

Table 1.3: Advantages of working in China for pharma companies, biotech companies and CROs 45

Table 2.4: Characteristics of China’s foreign vs. domestic pharmaceutical companies, 2007 52

Table 3.5: Characteristics of China’s foreign vs. domestic biotechnology companies, 2007 73

Table 3.6: Recent public offerings of Chinese biotechnology companies 80

Table 4.7: Summary of drug testing objectives by phase 98

Table 4.8: Leading Chinese CROs, 2007 105

Table 4.9: Leading foreign CROs operating in China, 2007 109

Table 5.10: Effect of growth drivers on drug development sectors in China, 2007 - 2013 121

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