Drug Discovery and Development Market in Asia - Partnerships Between MNCs and Asian Academic Institutions and 4 Research Organizations are Driving R&D Innovation

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 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.

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
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
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