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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 - Product Image

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

  • Published: November 2012
  • Region: Asia
  • 106 Pages
  • GBI Research

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 READ MORE >

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
3.1.1 New Molecule Entity Applications Filed and Approved
3.1.2 Total Industry Spend on R&D and Cost to Develop New Drug
3.2 Industry Trends
3.2.1 Spending on R&D
3.2.2 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
4.3.1 China
4.3.2 India
4.3.3 Russia
4.3.4 Japan
4.3.5 South Korea
4.3.6 Singapore
4.3.7 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
5.7.1 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
6.2.1 Innovation Model
6.3 Strategies for Designing Drug Discovery and Development Model for Global Market
6.4 R&D Rise in Asia
6.4.1 R&D by Geographic Area, PhRMA Member Companies, 2010
6.5 New Strategic Outsourcing Models to Meet Changing Clinical Development Needs
6.5.1 Tactical Outsourcing
6.5.2 referred Provider Relationship
6.5.3 Functional Service Provider Model
6.5.4 Business Process Outsourcing
6.5.5 Full-Development Outsourcing
6.6 Technology - Central Lab Service Model

7 Drug Discovery and Development Market in Asia - Regulatory Landscape
7.1 Introduction
7.2 Taiwan
7.3 South Korea
7.3.1 IND Application Process
7.3.2 NDA Approval Process
7.4 Japan
7.4.1 IND Application Process
7.4.2 NDA Approval Process
7.5 Russia
7.6 Timelines for Obtaining Approval for Conducting Clinical Trials in Russia
7.7 India
7.7.1 Clinical Trials Registry India
7.7.2 Clinical Trial Regulation in India
7.7.3 Timeframe for Approval
7.8 China
7.8.1 The Ministry of Health
7.8.2 State Food and Drug Administration
7.8.3 Clinical Trials Registry China
7.8.4 Clinical Trial Regulation in China
7.8.5 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
10.4.1 Coverage
10.4.2 Secondary Research
10.4.3 Primary Research
10.4.4 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, 2002-2011
Table 2: Drug Discovery and Development Market, the US, R&D Expenditure Versus Average Cost to Develop One NME ($bn), 2003-2011
Table 3: Drug Discovery and Development Market, Global, R&D Expenditure Versus Turnover for the Top Seven Pharmaceutical Companies, 2011
Table 4: Drug Discovery and Development Market, Global,Top Seven Companies R&D Expenditure on Biologics (%), 2011
Table 5: Drug Discovery and Development Market in Asia, Total Number of Studies (Phase I-IV), 2012 by Geography, Through June 2012
Table 6: Drug Discovery and Development Market in Asia, Total Number of Industry-Sponsored Clinical Research Studies (Phase I-IV) by Country, Through June 2012
Table 7: Drug Discovery and Development Market in Asia, Market Segmentation, Phase II and Phase III Industry-Sponsored Trials by Country, 2005-2012
Table 8: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, Growth Rate (%), 2005-2012
Table 9: Drug Discovery and Development Market in Asia, Clinical Trials by Therapy Area by Country, Through June 2012
Table 10: Drug Discovery and Development Market in Asia, Revenue ($bn), 2007-2011
Table 11: Drug Discovery and Development Market in Asia, Revenue Forecasts ($bn), 2011-2018
Table 12: Drug Discovery and Development Market in Asia, China, Revenue ($m), 2007-2011
Table 13: Drug Discovery and Development Market in Asia, China, Revenue Forecasts ($m), 2011-2018
Table 14: Drug Discovery and Development Market in Asia, India, Revenue ($m), 2007-2011
Table 15: Drug Discovery and Development Market in Asia, India, Revenue Forecasts ($m), 2011-2018
Table 16: Drug Discovery and Development Market in Asia, Russia, Revenue ($m), 2007-2011
Table 17: Drug Discovery and Development Market in Asia, Russia, Revenue Forecasts ($m), 2011-2018
Table 18: Drug Discovery and Development Market in Asia, Japan, Revenue ($m), 2007-2011
Table 19: Drug Discovery and Development Market in Asia, Japan, Revenue Forecasts ($m), 2011-2018
Table 20: Drug Discovery and Development Market in Asia, South Korea, Revenue ($m), 2007-2011
Table 21: Drug Discovery and Development Market in Asia, South Korea, Revenue Forecasts ($m), 2011-2018
Table 22: Drug Discovery and Development Market in Asia, Singapore, Revenue ($m), 2007-2011
Table 23: Drug Discovery and Development Market in Asia, Singapore, Revenue Forecasts ($m), 2011-2018
Table 24: Drug Discovery and Development Market in Asia, Taiwan, Revenue ($m), 2007-2011
Table 25: Drug Discovery and Development Market in Asia, Taiwan, Revenue Forecasts ($m), 2011-2018
Table 26: Drug Discovery and Development Market in Asia, Population (Millions) by Country, 2007-2011
Table 27: Drug Discovery and Development Market in Asia, Patient Recruitment and Growth Rates by Country (%)
Table 28: Drug Discovery and Development Market in Asia, Number of CROs by Country, 2012
Table 29: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Country, 2006-2008
Table 30: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Major Cities, 2006-2008
Table 31: Drug Discovery and Development Market in Asia, GDP ($bn) by Country, January 2011
Table 32: Drug Discovery and Development Market in Asia, Total Healthcare Expenditure % GDP by Country, 2007-2010
Table 33: Drug Discovery and Development Market in Asia, Cost Efficiency for Conducting Clinical Trials by Country, 2012
Table 34: Drug Discovery and Development Market in Asia, Scale for Overall Country Attractiveness by Country, 2012
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), 2005-2009
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, 2004-2012
Table 43: Drug Discovery and Development Market in Asia, Deals by Phase, 2004-2012
Table 44: Drug Discovery and Development Market in Asia, Deals by Type, 2004-2012

1.2 List of Figures

Figure 1: Drug Discovery and Development Market, The US, Total Number of NME Applications Filed and Approved, 2002-2011
Figure 2: Drug Discovery and Development Market, the US, R&D Expenditure Versus Average Cost to Develop One NME ($bn), 2003-2011
Figure 3: Drug Discovery and Development Market, Global, R&D Expenditure Versus Turnover for the Top Seven Pharmaceutical Companies, 2011
Figure 4: Drug Discovery and Development Market in Asia, Total Number of Clinical Research Studies (Phase I-IV), (%) by Geography, Through June 2012
Figure 5: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, 2005-2012
Figure 6: Drug Discovery and Development Market in Asia, Phase II and Phase III Industry-Sponsored Trials by Country, Growth Rate (%), 2005-2012
Figure 7: Drug Discovery and Development Market in Asia, Clinical Trials by Therapy Area by Country, Through June 2012
Figure 8: Drug Discovery and Development Market in Asia, Revenue Forecasts ($bn), 2007-2018
Figure 9: Drug Discovery and Development Market in Asia, China, Revenue Forecasts ($m), 2007-2018
Figure 10: Drug Discovery and Development Market in Asia, India, Revenue Forecasts ($m), 2007-2018
Figure 11: Drug Discovery and Development Market in Asia, Russia, Revenue Forecasts ($m), 2007-2018
Figure 12: Drug Discovery and Development Market in Asia, Japan, Revenue Forecasts ($m), 2007-2018
Figure 13: Drug Discovery and Development Market in Asia, South Korea, Revenue Forecasts ($m), 2007-2018
Figure 14: Drug Discovery and Development Market in Asia, Singapore, Revenue Forecasts ($m), 2007-2018
Figure 15: Drug Discovery and Development Market in Asia, Taiwan, Revenue Forecasts ($m), 2007-2018
Figure 16: Drug Discovery and Development Market in Asia, Population (Millions) by Country, 2007-2011
Figure 17: Drug Discovery and Development Market in Asia, Number of CROs by Country, 2012
Figure 18: Drug Discovery and Development Market in Asia, Total Number of Clinical Trial Investigator Sites by Country, 2006-2008
Figure 19: Drug Discovery and Development Market in Asia, GDP ($bn) by Country, January 2011
Figure 20: Drug Discovery and Development Market in Asia, Total Healthcare Expenditure % GDP by Country, 2007-2010
Figure 21: Drug Discovery and Development Market in Asia, Scale for Overall Country Attractiveness by Country, 2012
Figure 22: Drug Discovery and Development Market, Factors Causing Changes in the Business Model of Pharmaceutical Companies in Mature Markets, 2012
Figure 23: Drug Discovery and Development Market, Global, Switch from Linear Blockbuster Model to Innovation Model, 2012
Figure 24: Drug Discovery and Development Market, Global, Switch from Linear Blockbuster Model to Innovation Model, 2012
Figure 25: Drug Discovery and Development Market, Global, Innovation Model Involving Multiple Alliances and Partnerships, 2012
Figure 26: Drug Discovery and Development Market, Global, R&D Expenditure (%) by PhRMA Member Companies by Stage, 2010
Figure 27: Drug Discovery and Development Market, Stepwise Approach for Designing Drug Discovery and Development Strategies, 2012
Figure 28: Drug Discovery and Development Market, Global, Therapeutic and Market Analysis Steps in Designing Drug Discovery and Development Strategies, 2012
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, 2012
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, 2012
Figure 39: Drug Discovery and Development Market in Asia, South Korea, Drug Approval Process, 2012
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
Figure 49: Drug Discovery and Development Market in Asia, Singapore, Target Processing Timelines, 2012
Figure 50: Drug Discovery and Development Market in Asia, Company Profiles, Quintiles, 2012
Figure 51: Drug Discovery and Development Market in Asia, SWOT Analysis, Quintiles, 2012
Figure 52: Drug Discovery and Development Market in Asia, Company Profiles, Pharmaceutical Product Development (PPD), 2012
Figure 53: Drug Discovery and Development Market in Asia, SWOT Analysis, Pharmaceutical Product Development (PPD), 2012
Figure 54: Drug Discovery and Development Market in Asia, Company Profiles, Covance, 2012
Figure 55: Drug Discovery and Development Market in Asia, SWOT Analysis, Covance, 2012
Figure 56: Drug Discovery and Development Market in Asia, Company Profiles, Parexel, 2012
Figure 57: Drug Discovery and Development Market in Asia, SWOT Analysis, Parexel, 2012
Figure 58: Drug Discovery and Development Market in Asia, Company Profiles, Charles River Laboratories International, 2012
Figure 59: Drug Discovery and Development Market in Asia, SWOT Analysis, Charles River Laboratories International, 2012
Figure 60: Drug Discovery and Development Market in Asia, Deals by Year and Geography, 2004-2012
Figure 61: Drug Discovery and Development Market in Asia, Deals by Phase, 2004-2012
Figure 62: Drug Discovery and Development Market in Asia, Deals by Type, 2004-2012

Drug Research in Asia Goes Native

High recruitment rates and a robust regulatory framework strongly favour the Asian clinical research industry - and now pharma giants are going beyond simple outsourcing to study the region’s own health problems, states a new report by healthcare experts GBI Research.

The new report* explains that Asia offers a favourable environment for pharmaceutical progress, thanks to low costs, a large potential trial population and regulatory support. For example, oncology studies have now started to investigate the Asian phenotype, in order to learn even more about the nature of cancer.

During this year, over 12% of global clinical trials were carried out in the seven major markets of Asia, trailing behind the US share of 48.5%, and Europe’s 26.5%. Many Western biopharmaceutical companies are beginning to take advantage of emerging countries, where Asian regulatory agencies are streamlining the clinical trial process to meet global demand for cheap clinical research, but the vast opportunity in Asia has not yet been fully leveraged by the developed markets.

The cost of conducting clinical trials in Asian countries is 35%–45% lower than the cost of conducting similar trials in the US, as they are able to recruit a large number of patients from urban centres easily and at a low cost. The regulatory systems in Asia also offer a favourable environment, as the adoption of Good Clinical Practice (GCP) guidelines and the establishment of Institutional Review Boards (IRBs) is helping the region to quickly evolve and integrate with international standards.

Oncology is a key therapeutic area where the study of Asian patients can help pharma companies. The regional population has a high prevalence of liver cancer (due to infections of hepatitis B and C), stomach cancer, and head and neck cancer, so companies are focusing on discovering and developing medicines specifically to treat Asian diseases. This has developed from an earlier trend of finding use of an approved drug developed for a non-Asian phenotype. The Asia Oncology Strategic Alliance, launched by AstraZeneca in 2007, highlights the interest pharmaceutical companies have in the discovery and development of medicines specifically to treat Asian diseases. The aim of the alliance was to evaluate novel treatments for stomach and liver cancers in China, Japan, South Korea and Singapore, as the governments of these countries prioritized cancer therapy.

GBI Research estimates that the total market size of China, India, Russia, Japan, Singapore, Taiwan and South Korea’s drug discovery and development markets reached an impressive $5.3 billion in 2011, following growth at a Compound Annual Growth Rate (CAGR) of 21.9% from 2007. The market is expected to reach $17.3 billion in 2018, at a CAGR of 18.4%.

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