Global Pharmacovigilance Market Forecast 2018-2028
US, Japan, Germany, the UK, France, Italy, Spain, Brazil, Russia, India, China, South Korea, National Pharmacovigilance Systems, Leading Companies, Trends
The global pharmacovigilance market is expected to grow at a CAGR of 4.8% in the first half of the forecast period. The pharmacovigilance market is estimated to reach $ 11.5bn in 2023.
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In this brand new 150-page report you will receive 47 tables and 61 figures– all unavailable elsewhere.
The 150-page report provides clear detailed insight into the global pharmacovigilance market. Discover the key drivers and challenges affecting the market.
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Report Scope
• Global Pharmaceutical R&D Spending forecasts from 2017-2028
• Global Pharmacovigilance market forecasts from 2017-2028
• This report provides individual revenue forecasts to 2027 for these regional and national markets: – US – Japan – EU: Germany, France, the UK, Italy, Spain, Others – BRIC: Brazil, Russia, India, China – South Korea – Others
• This report provides a SWOT and STEP Analysis of the pharmacovigilance market. This report also discusses the Drivers and Restraints of the pharmacovigilance market.
• Our study discusses the selected leading companies that are the major players in the pharmacovigilance market: – Accenture PLC – Cognizant Technology Solutions Corporation – Tata Consultancy Services (TCS) – Capgemini SE – Tech Mahindra Limited – Infosys Limited (Infosys) – Wipro Limited (Wipro) – Oracle Corporation (Oracle) – Bristol-Myers Squibb Company – HCL Technologies Ltd. – Olympus Corporation
• Moreover, this report discusses the following: – Reporting systems for adverse drug reactions (ADRs) – their present and future, including data on reported and recorded events by year and region – Safety monitoring using reporting from social media – Improvements in data collection and communication leading to more-flexible drug approval processes – changing routes of marketing authorization – Policies of national and international bodies, and regulators’ roles in present and future pharmacovigilance plans – Collaboration between the FDA and EMA, and application of pharmacogenomics and biomarkers – Use of electronic health record (EHR) systems – a live model for drug safety, applying information systems.
Visiongain’s study is intended for anyone requiring commercial analyses for the global pharmacovigilance market. You find data, trends and predictions.
Buy our report today Global Pharmacovigilance Market Forecast 2018-2028: US, Japan, Germany, the UK, France, Italy, Spain, Brazil, Russia, India, China, South Korea, National Pharmacovigilance Systems, Leading Companies, Trends.
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1. Report Overview 1.1 Introduction to This New Study 1.2 Why You Should Read This Report 1.3 Key Questions Answered by This Analytical Report 1.4 Who is This Report For? 1.5 Methodology 1.6 Frequently Asked Questions (FAQ) 1.7 Associated Visiongain Reports 1.8 About Visiongain
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 2018-2028 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 2018-2028 3.3 Pharmacovigilance Market: Drivers and Restraints 2018-2028 3.3.1 Volume of ADRs Set to Rise 3.3.2 Reduced Pre-Market Safety Data – Focus Shifts to Post-Approval Monitoring 3.3.3 New EU Regulations Will Demand a Revamp of Entire Pharmacovigilance Protocols 3.3.4 Active Drug Safety Monitoring Set to Increase 3.3.5 Lack of Harmonisation Leads to Cross Border Difficulties 3.3.6 Transparency is Crucial in the Future of Pharmacovigilance 3.3.7 Direct Consumer Reports Lack Quality to Detect Causal Safety Signals 3.3.8 Merged Companies Spend Less on Pharmacovigilance
4. Leading National and Regional Markets, 2018-2028 4.1 Regional Breakdown of the World Pharmacovigilance Market, 2017 4.2 World Pharmacovigilance Market: Regional Forecast 2018-2028 4.2.1 How Will Regional Market Shares Change to Between 2018 and 2028? 4.3 The US Pharmacovigilance Market, 2018-2028 4.3.1 Criticism of the FDA 4.3.2 Periodic and Spontaneous Safety Reports 4.3.3 ADR Metrics for the US Market 4.3.4 US Market Forecast, 2018-2028 4.4 The European Pharmacovigilance Market, 2018-2028 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, 2018-2028 4.4.6 ADR Metrics for the European Union, 2012 4.5 The German Pharmacovigilance Market, 2018-2028 4.5.1 German Market Forecast, 2018-2028 4.6 The French Pharmacovigilance Market, 2018-2028 4.6.1 French Market Forecast, 2018-2028 4.7 The UK Pharmacovigilance Market 2018-2028 4.7.1 UK Market Forecast, 2018-2028 4.8 The Italian Pharmacovigilance Market, 2018-2028 4.8.1 Italian Market Forecast, 2018-2028 4.9 The Spanish Pharmacovigilance Market 2018-2028 4.9.1 Spanish Market Forecast, 2018-2028 4.10 Japanese Pharmacovigilance Market 2018-2028 4.10.1 Early Stage Drug Monitoring 4.10.2 Expedited and Periodic Safety Reports 4.10.3 Japanese Market Forecast, 2018-2028 4.11 Pharmacovigilance in the BRIC Nations, 2018-2028 4.12 The Chinese Pharmacovigilance Market, 2018-2028 4.12.1 ADR Metrics for the Chinese Market 2003-2012 4.12.2 Chinese Market Forecast, 2018-2028 4.13 The Brazilian Pharmacovigilance Market, 2018-2028 4.13.1 Brazilian Market Forecast, 2018-2028 4.14 The Russian Pharmacovigilance Market, 2018-2028 4.14.1 Russian Market Forecast, 2018-2028 4.15 The Indian Pharmacovigilance Market, 2018-2028 4.15.1 ADR Metrics for Indian Market 4.15.2 Indian Market Forecast 2018-2028 4.16 The South Korean Pharmacovigilance Market, 2018-2028 4.16.1 ADR Metrics for South Korea 4.16.2 South Korean Market Forecast, 2018-2028
6. Qualitative Analysis of the Pharmacovigilance Market 2018-2028 6.1 SWOT Analysis of the Pharmacovigilance Market 6.2 STEP Analysis of 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. Conclusions 7.1 International Collaboration Will Increase 7.2 Pharmacogenomics Will Become Important in Drug Approval and Safety Analysis 7.3 Drug Safety Monitoring Will Become Active 7.4 Social Media Will Become a Pharmacovigilance Tool
Appendices Associated Visiongain Reports Visiongain Report Sales Order Form Appendix A About Visiongain Appendix B Visiongain report evaluation form
List of Tables Table 2.1 Pharmacovigilance Terminology in the EU and US, 2017 Table 2.2 Sample Size Required to Detect ADRs Based on Incidence, 2017 Table 2.3 Number of Phase IV Clinical Trials by Registration Date, 2004-2016 Table 3.1 Full Members of the WHO Program for Drug Safety Monitoring, 2017 Table 3.2 Global Pharmaceutical R&D Spending Forecast: Global Spending on R&D ($bn), Annual Growth (%), CAGR (%), 2017-2028 Table 4.1 Spending on Pharmacovigilance in National and Regional Markets: Market Size ($bn), 2017 Table 4.2 Forecast Spending on Pharmacovigilance in National and Regional Markets: Spending ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.3 Forecast Spending on Pharmacovigilance in National and Regional Markets: Market Shares (%), 2018-2028 Table 4.4 Forecast Spending on Pharmacovigilance in the US: Spending ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.5 Forecast Spending on Pharmacovigilance in the European Union: National Market Sizes ($bn), Annual Growth (%), EU Market Shares (%), CAGRs (%), 2018-2028 Table 4.6 Individual Case Safety Reports Made to the Eudravigilance Database by Nation, 2017 Table 4.7 Forecast Spending on Pharmacovigilance in Germany: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.8 Forecast Spending on Pharmacovigilance in France: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.9 Forecast Spending on Pharmacovigilance in the UK: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.10 Forecast Spending on Pharmacovigilance in Italy: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.11 Forecast Spending on Pharmacovigilance in Spain: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.12 Drug Re-examination Schedule in Japan, 2017 Table 4.13 Forecast Spending on Pharmacovigilance in Japan: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.14 Forecast Spending on Pharmacovigilance in the BRIC Nations: Market Size ($bn), Annual Growth (%), Market Share (%), CAGR (%), 2018-2028 Table 4.15 Forecast Spending on Pharmacovigilance in China: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.16 Forecast Spending on Pharmacovigilance in Brazil: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.17 Forecast Spending on Pharmacovigilance in Russia: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.18 Forecast Spending on Pharmacovigilance in India: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 4.19 Forecast Spending on Pharmacovigilance in South Korea: Market Size ($bn), Annual Growth (%), CAGR (%), 2018-2028 Table 5.1 Accenture PLC: Company Overview Table 5.2 Accenture PLC: Product Portfolio Table 5.3 Cognizant Technology Solutions Corporation: Company Overview Table 5.4 Cognizant Technology Solutions Corporation: Product Portfolio Table 5.5 Tata Consultancy Services: Company Overview Table 5.6 Capgemini SE: Company Overview Table 5.7 Capgemini SE: Product Portfolio Table 5.8 Tech Mahindra Limited: Company Overview Table 5.9 Tech Mahindra Limited: Recent Developments Table 5.10 Infosys Limited: Company Overview Table 5.11 Infosys Limited: Product Portfolio Table 5.12 Wipro Limited: Company Overview Table 5.13 Wipro Limited: Product Portfolio Table 5.14 Oracle Corporation: Company Overview Table 5.15 Oracle Corporation: Product Portfolio Table 5.16 Oracle Corporation: Recent Developments Table 5.17 Bristol-Myers Squibb: Company Overview Table 5.18 Bristol-Myers Squibb: Product Portfolio Table 5.19 HCL Technologies Ltd.: Company Overview Table 5.20 HCL Technologies Ltd.: Product Portfolio Table 5.21 Olympus corporation: Company Overview Table 5.22 Olympus corporation: Product Portfolio Table 6.1 Social, Technological, Economic, and Political Factors (STEP) Affecting Pharmacovigilance, 2018
List of Figures Figure 2.1 Lifecycle of Adverse Events for Vioxx, 1999-2004 Figure 2.2 Lifecycle of Adverse Events for Avandia, 1999-2010 Figure 2.3 Number of Phase IV Clinical Trials by Registration Date, 2004-2016 Figure 3.1 Country of Origin of ICSRs on UMC VigiBase: National Percentage of Cumulative ISCR Total (%), 2017 Figure 3.2 Per Capita ISCRs Submitted to VigiBase: Number ICSRs Submitted Per Million Inhabitants Per Year, Yearly Average, 2017 Figure 3.3 Global Pharmaceutical R&D Spending Forecast: Spending ($bn), AGR (%), 2018-2028 Figure 3.4 Pharmacovigilance Market: Drivers and Restraints, 2018-2028 Figure 4.1 Spending on Pharmacovigilance in National and Regional Markets: Market Share (%), 2017 Figure 4.2 Forecast Spending on Pharmacovigilance in National and Regional Markets: Spending ($bn), 2018-2028 Figure 4.3 Forecast Spending on Pharmacovigilance in National and Regional Markets: Market Share (%), 2023 Figure 4.4 Forecast Spending on Pharmacovigilance in National and Regional Markets: Market Share (%), 2028 Figure 4.5 Forecast Spending on Pharmacovigilance in the US: Market Size ($bn), 2018-2028 Figure 4.6 Forecast Spending on Pharmacovigilance in European Union (EU5): National Market Sizes ($bn), 2018-2028 Figure 4.7 Individual Case Safety Reports Made to the Eudravigilance Database by Nation, 2017 Figure 4.8 Forecast Spending on Pharmacovigilance in Germany: Market Size ($bn), 2018-2028 Figure 4.9 Forecast Spending on Pharmacovigilance in France: Market Size ($bn), 2018-2028 Figure 4.10 Forecast Spending on Pharmacovigilance in the UK: Market Size ($bn), 2018-2028 Figure 4.11 Forecast Spending on Pharmacovigilance in Italy: Market Size ($bn), 2018-2028 Figure 4.12 Forecast Spending on Pharmacovigilance in Spain: Market Size ($bn), 2018-2028 Figure 4.13 Forecast Spending on Pharmacovigilance in Japan: Market Size ($bn), 2018-2028 Figure 4.14 Forecast Spending on Pharmacovigilance in BRIC Nations: National Marker Sizes ($bn), 2018-2028 Figure 4.15 Forecast Spending on Pharmacovigilance in China: Market Size ($bn), 2018-2028 Figure 4.16 Forecast Spending on Pharmacovigilance in Brazil: Market Size ($bn), 2018-2028 Figure 4.17 Forecast Spending on Pharmacovigilance in Russia: Market Size ($bn), 2018-2028 Figure 4.18 Forecast Spending on Pharmacovigilance in India: Market Size ($bn), 2018-2028 Figure 4.19 Forecast Spending on Pharmacovigilance in South Korea: Market Size ($bn), 2018-2028 Figure 5.1 Accenture PLC, Revenue, ($million), 2012-2016 Figure 5.2 Accenture PLC, Product Segments Share (%), 2016 Figure 5.3 Accenture PLC, Geography Share (%), 2016 Figure 5.4 Cognizant Technology Solutions Corporation, Revenue, ($million), 2012-2016 Figure 5.5 Cognizant Technology Solutions Corporation, Product Segments Share (%), 2016 Figure 5.6 Cognizant Technology Solutions Corporation, Geographical Presence Share (%), 2016 Figure 5.7 Tata Consultancy Services, Revenue, ($million), 2013-2017 Figure 5.8 Tata Consultancy Services, Product Segments Share (%), 2017 Figure 5.9 Tata Consultancy Services, Geographical Presence Share (%), 2017 Figure 5.10 Capgemini SE, Revenue, ($million), 2012-2016 Figure 5.11 Capgemini SE, Product Segments Share (%), 2016 Figure 5.12 Capgemini SE, Geographical Presence Share (%), 2016 Figure 5.13 Tech Mahindra Limited, Revenue, ($million), 2013-2017 Figure 5.14 Tech Mahindra Limited, Product Segments Share (%), 2017 Figure 5.15 Tech Mahindra Limited, Geographical Presence Share (%), 2017 Figure 5.16 Infosys Limited, Revenue, ($million), 2013-2017 Figure 5.17 Infosys Limited, Product Segments Share (%), 2017 Figure 5.18 Infosys Limited, Geographical Presence Share (%), 2017 Figure 5.19 Wipro Limited, Revenue, ($million), 2013-2017 Figure 5.20 Wipro Limited, Product Segments Share (%), 2016 Figure 5.21 Wipro Limited, Geographical Presence Share (%), 2016 Figure 5.22 Oracle Corporation, Revenue, ($million), 2013-2017 Figure 5.23 Oracle Corporation, Product Segments Share (%), 2017 Figure 5.24 Oracle Corporation, Geographical Presence Share (%), 2017 Figure 5.25 Bristol-Myers Squibb, Revenue, ($million), 2012-2016 Figure 5.26 Bristol-Myers Squibb, Product Segments Share (%), 2016 Figure 5.27 Bristol-Myers Squibb, Geographical Presence Share (%), 2016 Figure 5.28 HCL Technologies Ltd., Revenue, ($million), 2013-2017 Figure 5.29 HCL Technologies Ltd., Product Segments Share (%), 2017 Figure 5.30 HCL Technologies Ltd., Geographical Presence Share (%), 2017 Figure 5.31 Olympus corporation, Revenue, ($million), 2013-2017 Figure 5.32 Olympus corporation, Product Segments Share (%), 2017 Figure 5.33 Olympus corporation, Geographical Presence Share (%), 2017 Figure 6.1 Strengths and Weaknesses Within Pharmacovigilance, 2017 Figure 6.2 Opportunities and Threats Within Pharmacovigilance, 2017
Abbott Laboratories Accenture Accovion Actavis Aprova Aptiv Solutions Aris Global AstraZeneca Bayer Bristol-Myers Squibb Capgemini Cognizant Technology Solutions Covance Crossoak Pharma Crown Consultants CSO Pharma Consulting DADA Consultancy Dose Spot Drug Safety Alliance Dun & Bradstreet Eli Lilly Epidemico Facebook First Databank Foresight Group International Forest Laboratories GB Pharma Geneix GlaxoSmithKline (GSK) Handle My Health Harten Group HCL Technologies ICON iGATE Corporation Illumina iMED Global Imperial Chemical Industries INC Research Infosys inVentiv Health IPM Safety Services Johnson & Johnson Kinapse Lindeq Mahindra Satyam MedImmune Merck & Co. Merck Serono NDA Group Nhumi Technologies Novartis November Research Group Novo Nordisk Optum Oracle Orbis Clinical ParagonRX Parexel PatientsLikeMe Patni Computer Systems Paul Ehrlich Institute Pfizer PharSafer PPD PRA International Primevigilance Quanticate Quantum Solutions India Quintiles Transnational Ranbaxy Roche Sanofi Sciformix Servier SGS Life Sciences Sun Pharmaceuticals Symogen Synowledge TAKE Solutions Tata Consultancy Services Tech Mahindra Twitter UDG Healthcare uMotif Unified Health System United Biosource Company Uppsala Monitoring Centre (UMC)) Warner Chilcott Watson Wipro Limited Wockhardt Xendo
List of Organizations Mentioned in the Report Agence française de sécurité sanitaire des produits de santé Agencia Española de Medicamentos y Productos Sanitarios Agenzia Italiana del Farmaco (AIFA) Brazilian Health Surveillance Agency (ANVISA) Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Central Drugs Standard Control Organization China Food and Drug Agency China Food and Drug Agency (CFDA) Chinese Ministry of Health Commission on Human Medicines Committee for Medicinal Products for Human Use Committee on the Safety of Medicine Contergan Foundation Danish Medicines Agency Dutch Medicines Evaluation Board European Federation of Pharmaceutical Industries and Associations (EFPIA) European Medicines Agency (EMA) European Medicines Evaluation Agency (EMEA) European Union (EU) Federal Association of Thalidomide Victims Federal Centre for Monitoring Drug Safety Federal Institute for Drugs and Medical Devices Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor, Russia) Food and Drug Administration (US FDA) Indian Pharmacopoeia Commission International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Japanese Pharmaceuticals and Medical Devices Agency Korea Food and Drug Administration Medicines and Healthcare Products Regulatory Agency (MHRA, UK) Ministero della Salute Ministry of Food and Drug Safety (MFDS, Korea) Ministry of Health, Labour and Welfare (MHLW, Japan) National Agency for Safety of Medicine and Health Products National Patient Safety Agency Norwegian Medicines Agency Pharmaceutical and Medical Devices Agency (PMDA, Japan) Pharmacovigilance Risk Assessment Committee Serious Adverse Event Consortium (SAEC) Shenyang Pharmaceutical University State Food and Drug Agency World Bank World Health Organization (WHO)
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