【レポートの概要（一部）】
1. Executive Summary
1.1 Introduction to This New Study
1.2 Chapter Contents – What You Find in That Work
1.3 Research and Analysis Methods
2. Introduction to Pharmacovigilance
2.1 Adverse Drug Reactions
2.1.1 ADRs are Not Side Effects
2.1.2 Terminology in the US and EU
2.2 Never Events
2.3 Safety Signals, What They Mean and How to Identify Them
2.4 Pharmacovigilance, a Historical Perspective
2.4.1 Thalidomide
2.4.2 Eraldin
2.4.3 Vioxx
2.4.4 Avandia
2.5 Drug Safety Monitoring in Clinical Trials
2.5.1 Phase I Clinical Trials
2.5.2 Phase II Clinical Trials
2.5.3 Phase III Clinical Trials
2.5.3.1 Limitations of Phase I-III Trials
2.6 Phase IV – Post-Marketing Studies
2.7 Pharmacovigilance in the Pharmaceutical Industry
2.8 The Pharmacovigilance Practices of the Leading Pharmaceutical Companies
2.8.1 Pfizer
2.8.2 Johnson & Johnson
2.8.3 GlaxoSmithKline
2.8.4 Sanofi
2.8.5 Novartis
2.8.6 AstraZeneca
2.8.7 Roche
2.8.8 Abbott Laboratories
2.8.9 Eli Lilly
2.8.10 Bristol-Myers Squibb
3. Pharmacovigilance: World Market, 2014-2024
3.1 The WHO Programme for International Drug Monitoring
3.1.1 Data Collection at the Uppsala Monitoring Centre
3.1.2 VigiBase – The Global Drug Safety Repository
3.2 Pharmacovigilance in Research and Development: Forecast 2013-2024
3.3 Global Pharmacovigilance Market Forecast 2013-2024
3.4 Pharmacovigilance Market: Drivers and Restraints 2014-2024
3.4.1 Volume of ADRs Set to Rise
3.4.2 Reduced Pre-Market Safety Data – Focus Shifts to Post-Approval Monitoring
3.4.3 New EU Regulations Will Demand a Revamp of Entire Pharmacovigilance Protocols
3.4.4 Active Drug Safety Monitoring Set to Increase
3.4.5 Lack of Harmonisation Leads to Cross Border Difficulties
3.4.6 Transparency is Crucial in the Future of Pharmacovigilance
3.4.7 Direct Consumer Reports Lack Quality to Detect Causal Safety Signals
3.4.8 Merged Companies Spend Less on Pharmacovigilance
4. Leading National and Regional Markets, 2014-2024
4.1 Regional Breakdown of the World Pharmacovigilance Market, 2013
4.2 World Pharmacovigilance Market: Regional Forecast 2014-2024
4.2.1 How Will Regional Market Shares Change to Between 2013 and 2024?
4.3 The US Pharmacovigilance Market, 2014-2024
4.3.1 Criticism of the FDA
4.3.2 Periodic and Spontaneous Safety Reports
4.3.3 ADR Metrics for the US Market, 2003-2012
4.3.4 US Market Forecast, 2014-2024
4.4 The European Pharmacovigilance Market, 2014-2024
4.4.1 New EU Regulations Making the Biggest Impact for Twenty Years
4.4.2 Quality at the Heart of Safety Monitoring
4.4.3 Pharmacovigilance System Master File – Added Complexity in the Short Term
4.4.4 ADR Reporting and Safety Signal Detection
4.4.5 EU Market Forecast, 2014-2024
4.4.6 ADR Metrics for the European Union, 2012
4.5 The German Pharmacovigilance Market, 2014-2024
4.5.1 German Market Forecast, 2014-2024
4.6 The French Pharmacovigilance Market, 2014-2024
4.6.1 French Market Forecast, 2014-2024
4.7 The UK Pharmacovigilance Market, 2014-2024
4.7.1 UK Market Forecast, 2014-2024
4.8 The Italian Pharmacovigilance Market 2014-2024
4.8.1 Italian Market Forecast, 2014-2024
4.9 The Spanish Pharmacovigilance Market 2014-2024
4.9.1 Spanish Market Forecast, 2014-2024
4.10 Japanese Pharmacovigilance Market 2014-2024
4.10.1 Early Stage Drug Monitoring
4.10.2 Expedited and Periodic Safety Reports
4.10.3 Japanese Market Forecast, 2014-2024
4.11 Pharmacovigilance in the BRIC Nations, 2014-2024
4.12 The Chinese Pharmacovigilance Market, 2014-2024
4.12.1 ADR Metrics for the Chinese Market 2003-2012
4.12.2 Chinese Market Forecast, 2014-2024
4.13 The Brazilian Pharmacovigilance Market, 2014-2024
4.13.1 Brazilian Market Forecast, 2014-2024
4.14 The Russian Pharmacovigilance Market, 2014-2024
4.14.1 Russian Market Forecast, 2014-2024
4.15 The Indian Pharmacovigilance Market, 2014-2024
4.15.1 ADR Metrics for Indian Market 2010-2013
4.15.2 Indian Market Forecast 2014-2024
4.16 The South Korean Pharmacovigilance Market, 2014-2024
4.16.1 ADR Metrics for South Korea, 2003-2012
4.16.2 South Korean Market Forecast, 2014-2024
5. Leading Pharmacovigilance Companies, 2014
5.1 Business Process Outsourcing Firms
5.1.1 Accenture – The Leading Business Process Outsourcing Firm
5.1.2 Cognizant Technology Solutions
5.1.3 Tata Consultancy Services
5.1.4 Capgemini
5.1.5 Tech Mahindra
5.1.6 Infosys
5.1.7 Wipro Limited
5.1.8 HCL Technologies
5.1.9 iGATE Corporation
5.2 Contract Research Organisations (CROs)
5.2.1 Quintiles Transnational
5.2.2 Covance
5.2.3 Parexel
5.2.4 ICON
5.2.5 inVentiv Health
5.2.6 PRA International
5.2.7 PharSafer
5.3 Software Providers
5.3.1 Oracle
5.3.2 ArisGlobal
5.4 Other Outsourcing Companies
5.4.1 Drug Safety Alliance
5.4.2 Foresight Group International
5.4.3 TAKE Solutions
5.5 Other Pharmacovigilance Service Providers
6. Qualitative Analysis of the Pharmacovigilance Market, 2014-2024
6.1 SWOT Analysis of the Pharmacovigilance Market
6.2 STEP Analysis of Factors Affect the Pharmacovigilance Market
6.3 Social Forces
6.4 Technological Forces
6.5 Economic Forces
6.6 Political Forces
6.7 Increased Focus on Pharmacovigilance in the Emerging Markets
6.8 Increasingly Complex Nature of Pharmaceutical Vigilance
6.9 Harmonization of International Regulations Can Lead to Cost Reductions
6.10 The Effect of the Internet and Social Media on ADR Reporting
6.11 Collaboration between the FDA and EMA
6.12 The Challenge of Obtaining High-Quality ADR Information
6.13 Linking Pharmacovigilance to Genomics and Biomarkers
6.14 Generics, Globalisation and Drug Safety
7. Research Interviews
7.1 Interview with Nina Lahanis, Vice President of Marketing and Business Development, Drug Safety Alliance, USA
7.1.1 What Activities Are Outsourced and Why?
7.1.2 Mergers, Big Data, and New Regulations – The Challenges of Pharmacovigilance in the 21st Century
7.1.3 Risk-Benefit Profiles and the Importance of Global Harmonisation
7.1.4 Social Media and Electronic Health Records – Leading Trends in Pharmacovigilance
7.1.5 The True Cost of Off-shoring
7.2 Interview with Dr Angela van der Salm, Director of Pharmacovigilance, DADA Consultancy, Netherlands
7.2.1 What Activities Are Outsourced and Why?
7.2.2 The Challenges Posed by M&A Activity and New EU Regulations
7.2.3 Heightened Awareness of Risk Management
7.2.4 Transparency and Other Trends in Pharmacovigilance
7.2.5 Actively Monitoring Drug Safety
7.3 Interview with Mark Bartlett, Co-Founder and Managing Director, Geneix, UK
7.3.1 Technological Impact on Pharmacovigilance
7.3.2 Digital Healthcare Platforms and Pharmacovigilance
7.3.3 Electronic Healthcare Records
7.3.4 Role of Pharmacogenomics in Pharmacovigilance
8. Conclusions
8.1 International Collaboration Will Increase
8.2 Pharmacogenomics Will Become Important in Drug Approval and Safety Analysis
8.3 Drug Safety Monitoring Will Become Active
8.4 Social Media Will Become a Pharmacovigilance Tool
【レポート販売概要】
■ タイトル：医薬品安全性監視（Pharmacovigilance）及び関連開発市場（2014-2024）■ 英文：Pharmacovigilance and Related Developments: Industry and Market Analysis 2014-2024
■ 発行日：2014年4月
■ 調査会社：visiongain
■ 商品コード：Visiongain-405314
■ 調査対象地域：グローバル
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