1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Drug Discovery and Development Market in Asia - Introduction 3 Drug Discovery and

Transcription

1 1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Drug Discovery and Development Market in Asia - Introduction 3 Drug Discovery and Development Market in Asia - Overview 3.1 Introduction New Molecule Entity Applications Filed and Approved Total Industry Spend on R&D and Cost to Develop New Drug 3.2 Industry Trends Spending on R&D R&D Expenditure, Percent Invested on the Development of Biologics 4 Drug Discovery and Development Market in Asia - Market Segmentation 4.1 Industry-Sponsored Phase II/III Trials 4.2 Clinical Trials by Therapy Area 4.3 Drug Discovery and Development Market Size China India Russia Japan South Korea Singapore Taiwan 5 Drug Discovery and Development Market in Asia - Strategic Locations 5.1 Population 5.2 Patients Recruited 5.3 Contract Research Organizations (CRO) 5.4 Total Number of Sites for Clinical Trials 5.5 Gross Domestic Product (Purchasing Power Parity) 5.6 Total Healthcare Expenditure as a Percentage of GDP 5.7 Cost Comparison Tax Credits 5.8 Comparison between Countries 6 Drug Discovery and Development Market in Asia - Strategic Shift in R&D 6.1 Introduction 6.2 Switch from Linear Blockbuster Model to Innovation Model Innovation Model 6.3 Strategies for Designing Drug Discovery and Development Model for Global Market 6.4 R&D Rise in Asia R&D by Geographic Area, PhRMA Member Companies, New Strategic Outsourcing Models to Meet Changing Clinical Development Needs Tactical Outsourcing referred Provider Relationship Functional Service Provider Model Business Process Outsourcing Full-Development Outsourcing 6.6 Technology - Central Lab Service Model

2 7 Drug Discovery and Development Market in Asia - Regulatory Landscape 7.1 Introduction 7.2 Taiwan 7.3 South Korea IND Application Process NDA Approval Process 7.4 Japan IND Application Process NDA Approval Process 7.5 Russia 7.6 Timelines for Obtaining Approval for Conducting Clinical Trials in Russia 7.7 India Clinical Trials Registry India Clinical Trial Regulation in India Timeframe for Approval 7.8 China The Ministry of Health State Food and Drug Administration Clinical Trials Registry China Clinical Trial Regulation in China Structure and Procedure for Monitoring Adverse Drug Reactions in China 7.9 Singapore 8 Drug Discovery and Development Market in Asia - Leading Five CROs 8.1 Quintiles 8.2 Pharmaceutical Product Development 8.3 Covance 8.4 PAREXEL International Corporation 8.5 Charles River Laboratories International 9 Drug Discovery and Development Market in Asia - Deals Analysis 9.1 By Year 9.2 By Phase 9.3 By Type 10 Drug Discovery and Development Market in Asia - Appendix 10.1 Market Definitions 10.2 Abbreviations 10.3 Bibliography 10.4 Research Methodology Coverage Secondary Research Primary Research Expert Panel Validation 10.5 Contact Us 10.6 Disclaimer 1.1 List of Tables Table 1: Drug Discovery and Development Market, the US, Total Number of NME Applications Filed and Approved,

3 Table 2: Drug Discovery and Development Market, the US, R&D Expenditure Versus Average Cost to Develop One NME ($bn), Table 3: Drug Discovery and Development Market, Global, R&D Expenditure Versus Turnover for the Top Seven Pharmaceutical Companies, 2011 Table 4: Drug Discovery and Development Market, Global,Top Seven Companies R&D Expenditure on Biologics (%), 2011 Table 5: Drug Discovery and Development Market in Asia, Total Number of Studies (Phase I-IV), by Geography, Through June Table 6: Drug Discovery and Development Market in Asia, Total Number of Industry- Sponsored Clinical Research Studies (Phase I-IV) by Country, Through June Table 7: Drug Discovery and Development Market in Asia, Market Segmentation, Phase II and Phase III Industry-Sponsored Trials by Country, Table 8: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, Growth Rate (%), Table 9: Drug Discovery and Development Market in Asia, Clinical Trials by Therapy Area by Country, Through June Table 10: Drug Discovery and Development Market in Asia, Revenue ($bn), Table 11: Drug Discovery and Development Market in Asia, Revenue Forecasts ($bn), Table 12: Drug Discovery and Development Market in Asia, China, Revenue ($m), Table 13: Drug Discovery and Development Market in Asia, China, Revenue Forecasts Table 14: Drug Discovery and Development Market in Asia, India, Revenue ($m), Table 15: Drug Discovery and Development Market in Asia, India, Revenue Forecasts Table 16: Drug Discovery and Development Market in Asia, Russia, Revenue ($m), Table 17: Drug Discovery and Development Market in Asia, Russia, Revenue Forecasts Table 18: Drug Discovery and Development Market in Asia, Japan, Revenue ($m), Table 19: Drug Discovery and Development Market in Asia, Japan, Revenue Forecasts Table 20: Drug Discovery and Development Market in Asia, South Korea, Revenue ($m), Table 21: Drug Discovery and Development Market in Asia, South Korea, Revenue Forecasts Table 22: Drug Discovery and Development Market in Asia, Singapore, Revenue ($m), Table 23: Drug Discovery and Development Market in Asia, Singapore, Revenue Forecasts Table 24: Drug Discovery and Development Market in Asia, Taiwan, Revenue ($m),

4 Table 25: Drug Discovery and Development Market in Asia, Taiwan, Revenue Forecasts Table 26: Drug Discovery and Development Market in Asia, Population (Millions) by Country, Table 27: Drug Discovery and Development Market in Asia, Patient Recruitment and Growth Rates by Country (%) Table 28: Drug Discovery and Development Market in Asia, Number of CROs by Country, Table 29: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Country, Table 30: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Major Cities, Table 31: Drug Discovery and Development Market in Asia, GDP ($bn) by Country, January 2011 Table 32: Drug Discovery and Development Market in Asia, Total Healthcare Expenditure % GDP by Country, Table 33: Drug Discovery and Development Market in Asia, Cost Efficiency for Conducting Clinical Trials by Country, Table 34: Drug Discovery and Development Market in Asia, Scale for Overall Country Attractiveness by Country, Table 35: Drug Discovery and Development Market, Global, R&D Expenditure ($m) by PhRMA Member Companies by Stage, 2010 Table 36: Drug Discovery and Development Market in Asia, Core R&D Facilities of Top Ten Pharmaceutical Companies, 2010 Table 37: Drug Discovery and Development Market, Global, R&D Expenditures ($m) by PhRMA Member Companies, 2010 Table 38: Drug Discovery and Development Market in Asia, Russia, Timeline for Clinical Trial Approval (Days), Table 39: Drug Discovery and Development Market in Asia, India, Timeframe for Approval of New Drugs, 2009 Table 40: Drug Discovery and Development Market in Asia, China, Number of Days Required for Obtaining Approval for Clinical Trials, 2010 Table 41: Drug Discovery and Development Market in Asia, China, Number of Days Required for Obtaining Approval for Clinical Trials for Imported Drugs, 2010 Table 42: Drug Discovery and Development Market in Asia, Deals by Year and Geography, Table 43: Drug Discovery and Development Market in Asia, Deals by Phase, Table 44: Drug Discovery and Development Market in Asia, Deals by Type, List of Figures Figure 1: Drug Discovery and Development Market, The US, Total Number of NME Applications Filed and Approved, Figure 2: Drug Discovery and Development Market, the US, R&D Expenditure Versus Average Cost to Develop One NME ($bn), Figure 3: Drug Discovery and Development Market, Global, R&D Expenditure Versus Turnover for the Top Seven Pharmaceutical Companies, 2011

5 Figure 4: Drug Discovery and Development Market in Asia, Total Number of Clinical Research Studies (Phase I-IV), (%) by Geography, Through June Figure 5: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, Figure 6: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, Growth Rate (%), Figure 7: Drug Discovery and Development Market in Asia, Clinical Trials by Therapy Area by Country, Through June Figure 8: Drug Discovery and Development Market in Asia, Revenue Forecasts ($bn), Figure 9: Drug Discovery and Development Market in Asia, China, Revenue Forecasts Figure 10: Drug Discovery and Development Market in Asia, India, Revenue Forecasts Figure 11: Drug Discovery and Development Market in Asia, Russia, Revenue Forecasts Figure 12: Drug Discovery and Development Market in Asia, Japan, Revenue Forecasts Figure 13: Drug Discovery and Development Market in Asia, South Korea, Revenue Forecasts Figure 14: Drug Discovery and Development Market in Asia, Singapore, Revenue Forecasts Figure 15: Drug Discovery and Development Market in Asia, Taiwan, Revenue Forecasts Figure 16: Drug Discovery and Development Market in Asia, Population (Millions) by Country, Figure 17: Drug Discovery and Development Market in Asia, Number of CROs by Country, Figure 18: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Country, Figure 19: Drug Discovery and Development Market in Asia, GDP ($bn) by Country, January 2011 Figure 20: Drug Discovery and Development Market in Asia, Total Healthcare Expenditure % GDP by Country, Figure 21: Drug Discovery and Development Market in Asia, Scale for Overall Country Attractiveness by Country, Figure 22: Drug Discovery and Development Market, Factors Causing Changes in the Business Model of Pharmaceutical Companies in Mature Markets, Figure 23: Drug Discovery and Development Market, Global, Switch from Linear Blockbuster Model to Innovation Model, Figure 24: Drug Discovery and Development Market, Global, Switch from Linear Blockbuster Model to Innovation Model, Figure 25: Drug Discovery and Development Market, Global, Innovation Model Involving Multiple Alliances and Partnerships, Figure 26: Drug Discovery and Development Market, Global, R&D Expenditure (%) by PhRMA Member Companies by Stage, 2010

6 Figure 27: Drug Discovery and Development Market, Stepwise Approach for Designing Drug Discovery and Development Strategies, Figure 28: Drug Discovery and Development Market, Global, Therapeutic and Market Analysis Steps in Designing Drug Discovery and Development Strategies, Figure 29: Drug Discovery and Development Market in Asia, Asia Oncology Strategic Alliance, Case Study, 2007 Figure 30: Drug Discovery and Development Market, Global, R&D Expenditures (%) by PhRMA Member Companies, 2010 Figure 31: Drug Discovery and Development Market in Asia. New Strategic Clinical Outsourcing Models, 2010 Figure 32: Drug Discovery and Development Market in Asia, R&D by Function, PhRMA Member Companies, 2010 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 Figure 34: Drug Discovery and Development Market in Asia, Oracle-Based Exchange Platform, 2011 Figure 35: Drug Discovery and Development Market in Asia, Regulatory Approval Process and Timeline for Clinical Research, Figure 36: Drug Discovery and Development Market in Asia,, Taiwan, NDA Review Process, 2011 Figure 37: Drug Discovery and Development Market in Asia, Taiwan, Timeline for Consultation with CDE for Medicinal Products, 2011 Figure 38: Drug Discovery and Development Market in Asia, South Korea, IND and NDA Review and Approval Process, Figure 39: Drug Discovery and Development Market in Asia, South Korea, Drug Approval Process, Figure 40: Drug Discovery and Development Market in Asia, Japan, Flowchart of New Drug Development and Approval Process, 2011 Figure 41: Drug Discovery and Development Market in Asia, Japan, Timeline for Approval, 2011 Figure 42: Drug Discovery and Development Market in Asia, India, Procedure for Registering Clinical Trials with the CTRI, 2009 Figure 43: Drug Discovery and Development Market in Asia, India, Clinical Trial Regulation Approval Process, 2009 Figure 44: Drug Discovery and Development Market in Asia, China, Procedure for Registering Clinical Trials with ChiCTR, 2010 Figure 45: Drug Discovery and Development Market in Asia, China, Clinical Trial Regulation Approval Process, 2010 Figure 46: Drug Discovery and Development Market in Asia, China, Clinical Trial Regulation Approval Process for Imported Drugs, 2010 Figure 47: Drug Discovery and Development Market in Asia, China, Structure for Reporting and Monitoring ADRs, 2010 Figure 48: Drug Discovery and Development Market in Asia, Singapore, Registration Process for a Medicinal Product, 2009

7 Figure 49: Drug Discovery and Development Market in Asia, Singapore, Target Processing Timelines, Figure 50: Drug Discovery and Development Market in Asia, Company Profiles, Quintiles, Figure 51: Drug Discovery and Development Market in Asia, SWOT Analysis, Quintiles, Figure 52: Drug Discovery and Development Market in Asia, Company Profiles, Pharmaceutical Product Development (PPD), Figure 53: Drug Discovery and Development Market in Asia, SWOT Analysis, Pharmaceutical Product Development (PPD), Figure 54: Drug Discovery and Development Market in Asia, Company Profiles, Covance, Figure 55: Drug Discovery and Development Market in Asia, SWOT Analysis, Covance, Figure 56: Drug Discovery and Development Market in Asia, Company Profiles, Parexel, Figure 57: Drug Discovery and Development Market in Asia, SWOT Analysis, Parexel, Figure 58: Drug Discovery and Development Market in Asia, Company Profiles, Charles River Laboratories International, Figure 59: Drug Discovery and Development Market in Asia, SWOT Analysis, Charles River Laboratories International, Figure 60: Drug Discovery and Development Market in Asia, Deals by Year and Geography, Figure 61: Drug Discovery and Development Market in Asia, Deals by Phase, Figure 62: Drug Discovery and Development Market in Asia, Deals by Type, 2004-