1. Drug Discovery and Development Market in Asia - Partnerships
Between MNCs and Asian Academic Institutions and Healthcare
Research Organizations are Driving R&D Innovation
Report Details:
Published:November 2012
No. of Pages: 106
Price: Single User License – US$3500
Drug Discovery and Development Market in Asia - Partnerships Between MNCs and Asian
Academic Institutions and Healthcare Research Organizations are Driving R&D Innovation
Summary
GBI Research, a leading business intelligence provider, has released its latest research, “Drug
Discovery and Development Market in Asia - Partnerships Between MNCs and Asian Academic
Institutions and Healthcare Research Organizations are Driving R&D Innovation”. The report
provides key data, information and analysis of the major trends and issues affecting the drug
discovery and development market in seven major countries in Asia, namely China, India, Russia,
Japan, Singapore, Taiwan and South Korea. The report provides a comprehensive insight into
market segmentation, covering drug discovery and development market sizes, the strategic
context for deciding a location in Asia to conduct clinical research, strategies adopted by global
pharmaceutical companies in outsourcing R&D processes to Asian countries, and the regulatory
landscapes there. The report provides a detailed analysis of the regulatory authorities, clinical trial
approval processes and recent regulatory changes in the clinical trial environment. The report
analyzes the competitive landscape of the market, profiling key Contract Research Organizations
(CRO) market players, along with a brief description of the business, major services and major
M&A and partnership deals. The report also provides detailed analysis of major partnership and
M&A deals that have taken place in the Asian drug discovery and development market along with
segmentation by year, deal type, geography and phase of development.
The report is built using data and information sourced from proprietary databases, primary and
secondary research and in-house analysis by GBI Research’s team of industry experts.
GBI Research finds that the total drug discovery and development market size in the top seven
Asian countries was estimated at $5.3 billion in 2011 and is forecast to reach $17.3 billion by the

2. end of 2018. Revenue growth has been surpassed by investments in pharmaceutical R&D that
have not increased the output of new medicines. Research-based pharmaceutical companies
outsource R&D processes to CROs which offer integrated services across the life-sciences R&D
value chain. Globalization in the clinical trial industry has led to an increased number of trials being
conducted in emerging markets.
The CRO industry has been witnessing strategic deals between large global CROs with broad
therapeutic and functional expertise, and subcontracting local CROs. This will enable global CROs
to increase their market access capabilities, thereby further increasing the extent of their
outsourcing activities. The entry of new participants into the biopharmaceutical sector will augment
the drug discovery and development market in Asian countries. For example, Samsung
Electronics entered into the biopharmaceutical market in April 2011 through the formation of
Samsung Biologics, a joint venture company between Samsung Electronics and Quintiles. In
December, 2011 Samsung entered into another agreement with Biogen Idec to set up a joint
venture for the development, manufacture and marketing of biosimilars.
Scope
- Detailed overview of global trends in pharmaceutical R&D, followed by market segmentation of
the Asian drug discovery and development market in seven major countries, which are China,
India, Japan, South Korea, Taiwan, Russia and Singapore.
- Annualized market data from 2007 and forecasts to 2018.
- Strategies adopted by global pharmaceutical companies in outsourcing R&D processes to Asian
countries, along with the strategic context for deciding locations in Asia for conducting clinical
research.
- Competitive landscape analysis, with profiles of the leading companies such as Quintiles
Transnational Corp, Pharmaceutical Product Development Inc., Covance Inc., Parexel
International Corporation and Charles River Laboratories International, Inc.
- Analysis of partnership and M&A deals from 2004 to June 2012 along with segmentation by year
and geography, deal type, and phases of development.
Reasons to buy
- Align your product portfolio to markets with high growth potential.
- Develop market-entry and market expansion strategies by identifying the key areas for high
growth and opportunities.
- Understand the factors shaping the Asian drug discovery and development market.
- Identify the key players best positioned to take the advantage of the opportunities in the Asian
drug discovery and development market.
- Accelerate and strengthen your market position by identifying key companies for mergers,
acquisitions and strategic partnerships.

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innovation.html
Major points covered in Table of Contents of this report include
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 9
2 Drug Discovery and Development Market in Asia - Introduction 11
3 Drug Discovery and Development Market in Asia - Overview 12
3.1 Introduction 12
3.1.1 New Molecule Entity Applications Filed and Approved 12
3.1.2 Total Industry Spend on R&D and Cost to Develop New Drug 14
3.2 Industry Trends 15
3.2.1 Spending on R&D 15
3.2.2 R&D Expenditure, Percent Invested on the Development of Biologics 16
4 Drug Discovery and Development Market in Asia - Market Segmentation 17
4.1 Industry-Sponsored Phase II/III Trials 19
4.2 Clinical Trials by Therapy Area 22
4.3 Drug Discovery and Development Market Size 24
4.3.1 China 26
4.3.2 India 28
4.3.3 Russia 30
4.3.4 Japan 32
4.3.5 South Korea 34
4.3.6 Singapore 36
4.3.7 Taiwan 37
5 Drug Discovery and Development Market in Asia - Strategic Locations 38
5.1 Population 38
5.2 Patients Recruited 40
5.3 Contract Research Organizations (CRO) 41
5.4 Total Number of Sites for Clinical Trials 43
5.5 Gross Domestic Product (Purchasing Power Parity) 46
5.6 Total Healthcare Expenditure as a Percentage of GDP 47
5.7 Cost Comparison 48
5.7.1 Tax Credits 48
5.8 Comparison between Countries 50
6 Drug Discovery and Development Market in Asia - Strategic Shift in R&D 52
6.1 Introduction 52
6.2 Switch from Linear Blockbuster Model to Innovation Model 53
6.2.1 Innovation Model 55

4. 6.3 Strategies for Designing Drug Discovery and Development Model for Global Market 58
6.4 R&D Rise in Asia 60
6.4.1 R&D by Geographic Area, PhRMA Member Companies, 2010 63
6.5 New Strategic Outsourcing Models to Meet Changing Clinical Development Needs 65
6.5.1 Tactical Outsourcing 65
6.5.2 referred Provider Relationship 65
6.5.3 Functional Service Provider Model 66
6.5.4 Business Process Outsourcing 66
6.5.5 Full-Development Outsourcing 66
6.6 Technology - Central Lab Service Model 67
7 Drug Discovery and Development Market in Asia - Regulatory Landscape 70
7.1 Introduction 70
7.2 Taiwan 71
7.3 South Korea 73
7.3.1 IND Application Process 73
7.3.2 NDA Approval Process 74
7.4 Japan 74
7.4.1 IND Application Process 74
7.4.2 NDA Approval Process 76
7.5 Russia 76
7.6 Timelines for Obtaining Approval for Conducting Clinical Trials in Russia 77
7.7 India 77
7.7.1 Clinical Trials Registry India 77
7.7.2 Clinical Trial Regulation in India 79
7.7.3 Timeframe for Approval 81
7.8 China 82
7.8.1 The Ministry of Health 82
7.8.2 State Food and Drug Administration 82
7.8.3 Clinical Trials Registry China 83
7.8.4 Clinical Trial Regulation in China 84
7.8.5 Structure and Procedure for Monitoring Adverse Drug Reactions in China 88
7.9 Singapore 89
8 Drug Discovery and Development Market in Asia - Leading Five CROs 91
8.1 Quintiles 91
8.2 Pharmaceutical Product Development 93
8.3 Covance 95
8.4 PAREXEL International Corporation 96
8.5 Charles River Laboratories International 97
9 Drug Discovery and Development Market in Asia - Deals Analysis 98
9.1 By Year 98
9.2 By Phase 99
9.3 By Type 100

5. 10 Drug Discovery and Development Market in Asia - Appendix 101
10.1 Market Definitions 101
10.2 Abbreviations 101
10.3 Bibliography 102
10.4 Research Methodology 104
10.4.1 Coverage 104
10.4.2 Secondary Research 105
10.4.3 Primary Research 105
10.4.4 Expert Panel Validation 105
10.5 Contact Us 106
10.6 Disclaimer 106
1.1 List of Tables
Table 1: Drug Discovery and Development Market, the US, Total Number of NME Applications
Filed and Approved, 2002-2011 13
Table 2: Drug Discovery and Development Market, the US, R&D Expenditure Versus Average
Cost to Develop One NME ($bn), 2003-2011 14
Table 3: Drug Discovery and Development Market, Global, R&D Expenditure Versus Turnover for
the Top Seven Pharmaceutical Companies, 2011 15
Table 4: Drug Discovery and Development Market, Global,Top Seven Companies R&D
Expenditure on Biologics (%), 2011 16
Table 5: Drug Discovery and Development Market in Asia, Total Number of Studies (Phase I-IV),
2012 by Geography, Through June 2012 17
Table 6: Drug Discovery and Development Market in Asia, Total Number of Industry-Sponsored
Clinical Research Studies (Phase I-IV) by Country, Through June 2012 18
Table 7: Drug Discovery and Development Market in Asia, Market Segmentation, Phase II and
Phase III Industry-Sponsored Trials by Country, 2005-2012 20
Table 8: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-
Sponsored Trials by Country, Growth Rate (%), 2005-2012 21
Table 9: Drug Discovery and Development Market in Asia, Clinical Trials by Therapy Area by
Country, Through June 2012 23
Table 10: Drug Discovery and Development Market in Asia, Revenue ($bn), 2007-2011 24
Table 11: Drug Discovery and Development Market in Asia, Revenue Forecasts ($bn), 2011-2018
24
Table 12: Drug Discovery and Development Market in Asia, China, Revenue ($m), 2007-2011 26
Table 13: Drug Discovery and Development Market in Asia, China, Revenue Forecasts ($m),
2011-2018 26
Table 14: Drug Discovery and Development Market in Asia, India, Revenue ($m), 2007-2011 28
Table 15: Drug Discovery and Development Market in Asia, India, Revenue Forecasts ($m), 2011-
2018 28
Table 16: Drug Discovery and Development Market in Asia, Russia, Revenue ($m), 2007-2011 30
Table 17: Drug Discovery and Development Market in Asia, Russia, Revenue Forecasts ($m),

6. 2011-2018 30
Table 18: Drug Discovery and Development Market in Asia, Japan, Revenue ($m), 2007-2011 32
Table 19: Drug Discovery and Development Market in Asia, Japan, Revenue Forecasts ($m),
2011-2018 32
Table 20: Drug Discovery and Development Market in Asia, South Korea, Revenue ($m), 2007-
2011 34
Table 21: Drug Discovery and Development Market in Asia, South Korea, Revenue Forecasts
($m), 2011-2018 34
Table 22: Drug Discovery and Development Market in Asia, Singapore, Revenue ($m), 2007-2011
36
Table 23: Drug Discovery and Development Market in Asia, Singapore, Revenue Forecasts ($m),
2011-2018 36
Table 24: Drug Discovery and Development Market in Asia, Taiwan, Revenue ($m), 2007-2011 37
Table 25: Drug Discovery and Development Market in Asia, Taiwan, Revenue Forecasts ($m),
2011-2018 37
Table 26: Drug Discovery and Development Market in Asia, Population (Millions) by Country,
2007-2011 39
Table 27: Drug Discovery and Development Market in Asia, Patient Recruitment and Growth
Rates by Country (%) 40
Table 28: Drug Discovery and Development Market in Asia, Number of CROs by Country, 2012 41
Table 29: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial
Investigator Sites by Country, 2006-2008 43
Table 30: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial
Investigator Sites by Major Cities, 2006-2008 44
Table 31: Drug Discovery and Development Market in Asia, GDP ($bn) by Country, January 2011
46
Table 32: Drug Discovery and Development Market in Asia, Total Healthcare Expenditure % GDP
by Country, 2007-2010 47
Table 33: Drug Discovery and Development Market in Asia, Cost Efficiency for Conducting Clinical
Trials by Country, 2012 48
Table 34: Drug Discovery and Development Market in Asia, Scale for Overall Country
Attractiveness by Country, 2012 50
Table 35: Drug Discovery and Development Market, Global, R&D Expenditure ($m) by PhRMA
Member Companies by Stage, 2010 57
Table 36: Drug Discovery and Development Market in Asia, Core R&D Facilities of Top Ten
Pharmaceutical Companies, 2010 60
Table 37: Drug Discovery and Development Market, Global, R&D Expenditures ($m) by PhRMA
Member Companies, 2010 64
Table 38: Drug Discovery and Development Market in Asia, Russia, Timeline for Clinical Trial
Approval (Days), 2005-2009 77
Table 39: Drug Discovery and Development Market in Asia, India, Timeframe for Approval of New
Drugs, 2009 81

7. Table 40: Drug Discovery and Development Market in Asia, China, Number of Days Required for
Obtaining Approval for Clinical Trials, 2010 85
Table 41: Drug Discovery and Development Market in Asia, China, Number of Days Required for
Obtaining Approval for Clinical Trials for Imported Drugs, 2010 87
Table 42: Drug Discovery and Development Market in Asia, Deals by Year and Geography, 2004-
2012 98
Table 43: Drug Discovery and Development Market in Asia, Deals by Phase, 2004-2012 99
Table 44: Drug Discovery and Development Market in Asia, Deals by Type, 2004-2012 100
1.2 List of Figures
Figure 1: Drug Discovery and Development Market, The US, Total Number of NME Applications
Filed and Approved, 2002-2011 12
Figure 2: Drug Discovery and Development Market, the US, R&D Expenditure Versus Average
Cost to Develop One NME ($bn), 2003-2011 14
Figure 3: Drug Discovery and Development Market, Global, R&D Expenditure Versus Turnover for
the Top Seven Pharmaceutical Companies, 2011 15
Figure 4: Drug Discovery and Development Market in Asia, Total Number of Clinical Research
Studies (Phase I-IV), (%) by Geography, Through June 2012 17
Figure 5: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-
Sponsored Trials by Country, 2005-2012 19
Figure 6: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-
Sponsored Trials by Country, Growth Rate (%), 2005-2012 21
Figure 7: Drug Discovery and Development Market in Asia, Clinical Trials by Therapy Area by
Country, Through June 2012 22
Figure 8: Drug Discovery and Development Market in Asia, Revenue Forecasts ($bn), 2007-2018
24
Figure 9: Drug Discovery and Development Market in Asia, China, Revenue Forecasts ($m),
2007-2018 26
Figure 10: Drug Discovery and Development Market in Asia, India, Revenue Forecasts ($m),
2007-2018 28
Figure 11: Drug Discovery and Development Market in Asia, Russia, Revenue Forecasts ($m),
2007-2018 30
Figure 12: Drug Discovery and Development Market in Asia, Japan, Revenue Forecasts ($m),
2007-2018 32
Figure 13: Drug Discovery and Development Market in Asia, South Korea, Revenue Forecasts
($m), 2007-2018 34
Figure 14: Drug Discovery and Development Market in Asia, Singapore, Revenue Forecasts ($m),
2007-2018 36
Figure 15: Drug Discovery and Development Market in Asia, Taiwan, Revenue Forecasts ($m),
2007-2018 37
Figure 16: Drug Discovery and Development Market in Asia, Population (Millions) by Country,
2007-2011 38

8. Figure 17: Drug Discovery and Development Market in Asia, Number of CROs by Country, 2012
41
Figure 18: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial
Investigator Sites by Country, 2006-2008 43
Figure 19: Drug Discovery and Development Market in Asia, GDP ($bn) by Country, January 2011
46
Figure 20: Drug Discovery and Development Market in Asia, Total Healthcare Expenditure % GDP
by Country, 2007-2010 47
Figure 21: Drug Discovery and Development Market in Asia, Scale for Overall Country
Attractiveness by Country, 2012 50
Figure 22: Drug Discovery and Development Market, Factors Causing Changes in the Business
Model of Pharmaceutical Companies in Mature Markets, 2012 52
Figure 23: Drug Discovery and Development Market, Global, Switch from Linear Blockbuster
Model to Innovation Model, 2012 53
Figure 24: Drug Discovery and Development Market, Global, Switch from Linear Blockbuster
Model to Innovation Model, 2012 54
Figure 25: Drug Discovery and Development Market, Global, Innovation Model Involving Multiple
Alliances and Partnerships, 2012 55
Figure 26: Drug Discovery and Development Market, Global, R&D Expenditure (%) by PhRMA
Member Companies by Stage, 2010 57
Figure 27: Drug Discovery and Development Market, Stepwise Approach for Designing Drug
Discovery and Development Strategies, 2012 58
Figure 28: Drug Discovery and Development Market, Global, Therapeutic and Market Analysis
Steps in Designing Drug Discovery and Development Strategies, 2012 59
Figure 29: Drug Discovery and Development Market in Asia, Asia Oncology Strategic Alliance,
Case Study, 2007 62
Figure 30: Drug Discovery and Development Market, Global, R&D Expenditures (%) by PhRMA
Member Companies, 2010 63
Figure 31: Drug Discovery and Development Market in Asia. New Strategic Clinical Outsourcing
Models, 2010 65
Figure 32: Drug Discovery and Development Market in Asia, R&D by Function, PhRMA Member
Companies, 2010 67
Figure 33: Drug Discovery and Development Market in Asia, Data Integration Linking Clinical Trial
Patient Data to Central Laboratory Data via Oracle-Based Exchange Platform, 2011 68
Figure 34: Drug Discovery and Development Market in Asia, Oracle-Based Exchange Platform,
2011 69
Figure 35: Drug Discovery and Development Market in Asia, Regulatory Approval Process and
Timeline for Clinical Research, 2012 70
Figure 36: Drug Discovery and Development Market in Asia, , Taiwan, NDA Review Process, 2011
71
Figure 37: Drug Discovery and Development Market in Asia, Taiwan, Timeline for Consultation
with CDE for Medicinal Products, 2011 72

9. Figure 38: Drug Discovery and Development Market in Asia, South Korea, IND and NDA Review
and Approval Process, 2012 73
Figure 39: Drug Discovery and Development Market in Asia, South Korea, Drug Approval Process,
2012 74
Figure 40: Drug Discovery and Development Market in Asia, Japan, Flowchart of New Drug
Development and Approval Process, 2011 75
Figure 41: Drug Discovery and Development Market in Asia, Japan, Timeline for Approval, 2011
76
Figure 42: Drug Discovery and Development Market in Asia, India, Procedure for Registering
Clinical Trials with the CTRI, 2009 78
Figure 43: Drug Discovery and Development Market in Asia, India, Clinical Trial Regulation
Approval Process, 2009 79
Figure 44: Drug Discovery and Development Market in Asia, China, Procedure for Registering
Clinical Trials with ChiCTR, 2010 83
Figure 45: Drug Discovery and Development Market in Asia , China, Clinical Trial Regulation
Approval Process, 2010 84
Figure 46: Drug Discovery and Development Market in Asia, China, Clinical Trial Regulation
Approval Process for Imported Drugs, 2010 86
Figure 47: Drug Discovery and Development Market in Asia, China, Structure for Reporting and
Monitoring ADRs, 2010 88
Figure 48: Drug Discovery and Development Market in Asia, Singapore, Registration Process for a
Medicinal Product, 2009 89
Figure 49: Drug Discovery and Development Market in Asia, Singapore, Target Processing
Timelines, 2012 90
Figure 50: Drug Discovery and Development Market in Asia, Company Profiles, Quintiles, 2012 91
Figure 51: Drug Discovery and Development Market in Asia, SWOT Analysis, Quintiles, 2012 92
Figure 52: Drug Discovery and Development Market in Asia, Company Profiles, Pharmaceutical
Product Development (PPD), 2012 93
Figure 53: Drug Discovery and Development Market in Asia, SWOT Analysis, Pharmaceutical
Product Development (PPD), 2012 94
Figure 54: Drug Discovery and Development Market in Asia, Company Profiles, Covance, 2012 95
Figure 55: Drug Discovery and Development Market in Asia, SWOT Analysis, Covance, 2012 95
Figure 56: Drug Discovery and Development Market in Asia, Company Profiles, Parexel, 2012 96
Figure 57: Drug Discovery and Development Market in Asia, SWOT Analysis, Parexel, 2012 96
Figure 58: Drug Discovery and Development Market in Asia, Company Profiles, Charles River
Laboratories International, 2012 97
Figure 59: Drug Discovery and Development Market in Asia, SWOT Analysis, Charles River
Laboratories International, 2012 97
Figure 60: Drug Discovery and Development Market in Asia, Deals by Year and Geography, 2004-
2012 98
Figure 61: Drug Discovery and Development Market in Asia, Deals by Phase, 2004-2012 99
Figure 62: Drug Discovery and Development Market in Asia, Deals by Type, 2004-2012 100

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