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

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

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

Summary

Asia Asia China India Russia Japan Singapore Taiwan South Korea Asia

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 Contents1 Table of Contents 51.1 List of Tables 71.2 List of Figures 92 Drug Discovery and Development Market in Asia - Introduction 113 Drug Discovery and Development Market in Asia - Overview 123.1 Introduction 123.1.1 New Molecule Entity Applications Filed and Approved 123.1.2 Total Industry Spend on R&D and Cost to Develop New Drug 143.2 Industry Trends 153.2.1 Spending on R&D 153.2.2 R&D Expenditure, Percent Invested on the Development of Biologics 164 Drug Discovery and Development Market in Asia - Market Segmentation 174.1 Industry-Sponsored Phase II/III Trials 194.2 Clinical Trials by Therapy Area 224.3 Drug Discovery and Development Market Size 244.3.1 China 264.3.2 India 284.3.3 Russia 304.3.4 Japan 324.3.5 South Korea 344.3.6 Singapore 364.3.7 Taiwan 375 Drug Discovery and Development Market in Asia - Strategic Locations 385.1 Population 385.2 Patients Recruited 405.3 Contract Research Organizations (CRO) 415.4 Total Number of Sites for Clinical Trials 435.5 Gross Domestic Product (Purchasing Power Parity) 465.6 Total Healthcare Expenditure as a Percentage of GDP 475.7 Cost Comparison 485.7.1 Tax Credits 485.8 Comparison between Countries 506 Drug Discovery and Development Market in Asia - Strategic Shift in R&D 526.1 Introduction 526.2 Switch from Linear Blockbuster Model to Innovation Model 536.2.1 Innovation Model 556.3 Strategies for Designing Drug Discovery and Development Model for Global Market 586.4 R&D Rise in Asia 606.4.1 R&D by Geographic Area, PhRMA Member Companies, 2010 636.5 New Strategic Outsourcing Models to Meet Changing Clinical Development Needs 656.5.1 Tactical Outsourcing 656.5.2 referred Provider Relationship 656.5.3 Functional Service Provider Model 666.5.4 Business Process Outsourcing 666.5.5 Full-Development Outsourcing 666.6 Technology - Central Lab Service Model 677 Drug Discovery and Development Market in Asia - Regulatory Landscape 707.1 Introduction 707.2 Taiwan 717.3 South Korea 737.3.1 IND Application Process 737.3.2 NDA Approval Process 747.4 Japan 747.4.1 IND Application Process 747.4.2 NDA Approval Process 767.5 Russia 767.6 Timelines for Obtaining Approval for Conducting Clinical Trials in Russia 777.7 India 777.7.1 Clinical Trials Registry India 777.7.2 Clinical Trial Regulation in India 797.7.3 Timeframe for Approval 817.8 China 827.8.1 The Ministry of Health 827.8.2 State Food and Drug Administration 827.8.3 Clinical Trials Registry China 837.8.4 Clinical Trial Regulation in China 847.8.5 Structure and Procedure for Monitoring Adverse Drug Reactions in China 887.9 Singapore 898 Drug Discovery and Development Market in Asia - Leading Five CROs 918.1 Quintiles 918.2 Pharmaceutical Product Development 938.3 Covance 958.4 PAREXEL International Corporation 968.5 Charles River Laboratories International 979 Drug Discovery and Development Market in Asia - Deals Analysis 989.1 By Year 989.2 By Phase 999.3 By Type 10010 Drug Discovery and Development Market in Asia - Appendix 10110.1 Market Definitions 10110.2 Abbreviations 10110.3 Bibliography 10210.4 Research Methodology 10410.4.1 Coverage 10410.4.2 Secondary Research 10510.4.3 Primary Research 10510.4.4 Expert Panel Validation 10510.5 Contact Us 10610.6 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 13Table 2: Drug Discovery and Development Market, the US, R&D Expenditure Versus Average Cost to Develop One NME ($bn), 2003-2011 14Table 3: Drug Discovery and Development Market, Global, R&D Expenditure Versus Turnover for the Top Seven Pharmaceutical Companies, 2011 15Table 4: Drug Discovery and Development Market, Global,Top Seven Companies R&D Expenditure on Biologics (%), 2011 16Table 5: Drug Discovery and Development Market in Asia, Total Number of Studies (Phase I-IV), 2012 by Geography, Through June 2012 17Table 6: Drug Discovery and Development Market in Asia, Total Number of Industry-Sponsored Clinical Research Studies (Phase I-IV) by Country, Through June 2012 18Table 7: Drug Discovery and Development Market in Asia, Market Segmentation, Phase II and Phase III Industry-Sponsored Trials by Country, 2005-2012 20Table 8: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, Growth Rate (%), 2005-2012 21Table 9: Drug Discovery and Development Market in Asia, Clinical Trials by Therapy Area by Country, Through June 2012 23Table 10: Drug Discovery and Development Market in Asia, Revenue ($bn), 2007-2011 24Table 11: Drug Discovery and Development Market in Asia, Revenue Forecasts ($bn), 2011-2018 24Table 12: Drug Discovery and Development Market in Asia, China, Revenue ($m), 2007-2011 26Table 13: Drug Discovery and Development Market in Asia, China, Revenue Forecasts ($m), 2011-2018 26Table 14: Drug Discovery and Development Market in Asia, India, Revenue ($m), 2007-2011 28Table 15: Drug Discovery and Development Market in Asia, India, Revenue Forecasts ($m), 2011-2018 28Table 16: Drug Discovery and Development Market in Asia, Russia, Revenue ($m), 2007-2011 30Table 17: Drug Discovery and Development Market in Asia, Russia, Revenue Forecasts ($m), 2011-2018 30Table 18: Drug Discovery and Development Market in Asia, Japan, Revenue ($m), 2007-2011 32Table 19: Drug Discovery and Development Market in Asia, Japan, Revenue Forecasts ($m), 2011-2018 32Table 20: Drug Discovery and Development Market in Asia, South Korea, Revenue ($m), 2007-2011 34Table 21: Drug Discovery and Development Market in Asia, South Korea, Revenue Forecasts ($m), 2011-2018 34Table 22: Drug Discovery and Development Market in Asia, Singapore, Revenue ($m), 2007-2011 36Table 23: Drug Discovery and Development Market in Asia, Singapore, Revenue Forecasts ($m), 2011-2018 36Table 24: Drug Discovery and Development Market in Asia, Taiwan, Revenue ($m), 2007-2011 37Table 25: Drug Discovery and Development Market in Asia, Taiwan, Revenue Forecasts ($m), 2011-2018 37Table 26: Drug Discovery and Development Market in Asia, Population (Millions) by Country, 2007-2011 39Table 27: Drug Discovery and Development Market in Asia, Patient Recruitment and Growth Rates by Country (%) 40Table 28: Drug Discovery and Development Market in Asia, Number of CROs by Country, 2012 41Table 29: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Country, 2006-2008 43Table 30: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Major Cities, 2006-2008 44Table 31: Drug Discovery and Development Market in Asia, GDP ($bn) by Country, January 2011 46Table 32: Drug Discovery and Development Market in Asia, Total Healthcare Expenditure % GDP by Country, 2007-2010 47Table 33: Drug Discovery and Development Market in Asia, Cost Efficiency for Conducting Clinical Trials by Country, 2012 48Table 34: Drug Discovery and Development Market in Asia, Scale for Overall Country Attractiveness by Country, 2012 50Table 35: Drug Discovery and Development Market, Global, R&D Expenditure ($m) by PhRMA Member Companies by Stage, 2010 57Table 36: Drug Discovery and Development Market in Asia, Core R&D Facilities of Top Ten Pharmaceutical Companies, 2010 60Table 37: Drug Discovery and Development Market, Global, R&D Expenditures ($m) by PhRMA Member Companies, 2010 64Table 38: Drug Discovery and Development Market in Asia, Russia, Timeline for Clinical Trial Approval (Days), 2005-2009 77Table 39: Drug Discovery and Development Market in Asia, India, Timeframe for Approval of New Drugs, 2009 81Table 40: Drug Discovery and Development Market in Asia, China, Number of Days Required for Obtaining Approval for Clinical Trials, 2010 85Table 41: Drug Discovery and Development Market in Asia, China, Number of Days Required for Obtaining Approval for Clinical Trials for Imported Drugs, 2010 87Table 42: Drug Discovery and Development Market in Asia, Deals by Year and Geography, 2004-2012 98Table 43: Drug Discovery and Development Market in Asia, Deals by Phase, 2004-2012 99Table 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 12Figure 2: Drug Discovery and Development Market, the US, R&D Expenditure Versus Average Cost to Develop One NME ($bn), 2003-2011 14Figure 3: Drug Discovery and Development Market, Global, R&D Expenditure Versus Turnover for the Top Seven Pharmaceutical Companies, 2011 15Figure 4: Drug Discovery and Development Market in Asia, Total Number of Clinical Research Studies (Phase I-IV), (%) by Geography, Through June 2012 17Figure 5: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, 2005-2012 19Figure 6: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, Growth Rate (%), 2005-2012 21Figure 7: Drug Discovery and Development Market in Asia, Clinical Trials by Therapy Area by Country, Through June 2012 22Figure 8: Drug Discovery and Development Market in Asia, Revenue Forecasts ($bn), 2007-2018 24Figure 9: Drug Discovery and Development Market in Asia, China, Revenue Forecasts ($m), 2007-2018 26Figure 10: Drug Discovery and Development Market in Asia, India, Revenue Forecasts ($m), 2007-2018 28Figure 11: Drug Discovery and Development Market in Asia, Russia, Revenue Forecasts ($m), 2007-2018 30Figure 12: Drug Discovery and Development Market in Asia, Japan, Revenue Forecasts ($m), 2007-2018 32Figure 13: Drug Discovery and Development Market in Asia, South Korea, Revenue Forecasts ($m), 2007-2018 34Figure 14: Drug Discovery and Development Market in Asia, Singapore, Revenue Forecasts ($m), 2007-2018 36Figure 15: Drug Discovery and Development Market in Asia, Taiwan, Revenue Forecasts ($m), 2007-2018 37Figure 16: Drug Discovery and Development Market in Asia, Population (Millions) by Country, 2007-2011 38Figure 17: Drug Discovery and Development Market in Asia, Number of CROs by Country, 2012 41Figure 18: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Country, 2006-2008 43Figure 19: Drug Discovery and Development Market in Asia, GDP ($bn) by Country, January 2011 46Figure 20: Drug Discovery and Development Market in Asia, Total Healthcare Expenditure % GDP by Country, 2007-2010 47Figure 21: Drug Discovery and Development Market in Asia, Scale for Overall Country Attractiveness by Country, 2012 50Figure 22: Drug Discovery and Development Market, Factors Causing Changes in the Business Model of Pharmaceutical Companies in Mature Markets, 2012 52Figure 23: Drug Discovery and Development Market, Global, Switch from Linear Blockbuster Model to Innovation Model, 2012 53Figure 24: Drug Discovery and Development Market, Global, Switch from Linear Blockbuster Model to Innovation Model, 2012 54Figure 25: Drug Discovery and Development Market, Global, Innovation Model Involving Multiple Alliances and Partnerships, 2012 55Figure 26: Drug Discovery and Development Market, Global, R&D Expenditure (%) by PhRMA Member Companies by Stage, 2010 57Figure 27: Drug Discovery and Development Market, Stepwise Approach for Designing Drug Discovery and Development Strategies, 2012 58Figure 28: Drug Discovery and Development Market, Global, Therapeutic and Market Analysis Steps in Designing Drug Discovery and Development Strategies, 2012 59Figure 29: Drug Discovery and Development Market in Asia, Asia Oncology Strategic Alliance, Case Study, 2007 62Figure 30: Drug Discovery and Development Market, Global, R&D Expenditures (%) by PhRMA Member Companies, 2010 63Figure 31: Drug Discovery and Development Market in Asia. New Strategic Clinical Outsourcing Models, 2010 65Figure 32: Drug Discovery and Development Market in Asia, R&D by Function, PhRMA Member Companies, 2010 67Figure 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 68Figure 34: Drug Discovery and Development Market in Asia, Oracle-Based Exchange Platform, 2011 69Figure 35: Drug Discovery and Development Market in Asia, Regulatory Approval Process and Timeline for Clinical Research, 2012 70Figure 36: Drug Discovery and Development Market in Asia, , Taiwan, NDA Review Process, 2011 71Figure 37: Drug Discovery and Development Market in Asia, Taiwan, Timeline for Consultation with CDE for Medicinal Products, 2011 72Figure 38: Drug Discovery and Development Market in Asia, South Korea, IND and NDA Review and Approval Process, 2012 73Figure 39: Drug Discovery and Development Market in Asia, South Korea, Drug Approval Process, 2012 74Figure 40: Drug Discovery and Development Market in Asia, Japan, Flowchart of New Drug Development and Approval Process, 2011 75Figure 41: Drug Discovery and Development Market in Asia, Japan, Timeline for Approval, 2011 76Figure 42: Drug Discovery and Development Market in Asia, India, Procedure for Registering Clinical Trials with the CTRI, 2009 78Figure 43: Drug Discovery and Development Market in Asia, India, Clinical Trial Regulation Approval Process, 2009 79Figure 44: Drug Discovery and Development Market in Asia, China, Procedure for Registering Clinical Trials with ChiCTR, 2010 83Figure 45: Drug Discovery and Development Market in Asia , China, Clinical Trial Regulation Approval Process, 2010 84Figure 46: Drug Discovery and Development Market in Asia, China, Clinical Trial Regulation Approval Process for Imported Drugs, 2010 86Figure 47: Drug Discovery and Development Market in Asia, China, Structure for Reporting and Monitoring ADRs, 2010 88Figure 48: Drug Discovery and Development Market in Asia, Singapore, Registration Process for a Medicinal Product, 2009 89Figure 49: Drug Discovery and Development Market in Asia, Singapore, Target Processing Timelines, 2012 90Figure 50: Drug Discovery and Development Market in Asia, Company Profiles, Quintiles, 2012 91Figure 51: Drug Discovery and Development Market in Asia, SWOT Analysis, Quintiles, 2012 92Figure 52: Drug Discovery and Development Market in Asia, Company Profiles, Pharmaceutical Product Development (PPD), 2012 93Figure 53: Drug Discovery and Development Market in Asia, SWOT Analysis, Pharmaceutical Product Development (PPD), 2012 94Figure 54: Drug Discovery and Development Market in Asia, Company Profiles, Covance, 2012 95Figure 55: Drug Discovery and Development Market in Asia, SWOT Analysis, Covance, 2012 95Figure 56: Drug Discovery and Development Market in Asia, Company Profiles, Parexel, 2012 96Figure 57: Drug Discovery and Development Market in Asia, SWOT Analysis, Parexel, 2012 96Figure 58: Drug Discovery and Development Market in Asia, Company Profiles, Charles River Laboratories International, 2012 97Figure 59: Drug Discovery and Development Market in Asia, SWOT Analysis, Charles River Laboratories International, 2012 97Figure 60: Drug Discovery and Development Market in Asia, Deals by Year and Geography, 2004-2012 98Figure 61: Drug Discovery and Development Market in Asia, Deals by Phase, 2004-2012 99Figure 62: Drug Discovery and Development Market in Asia, Deals by Type, 2004-2012 100