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Post-marketing surveillance for medicines – discover trends, outlooks, and revenues
Where are pharmacovigilance and related needs heading? For those pharmaceutical testing studies you get new analysis, also exploring sales predictions. You unlock that medical industry. And you assess its results, trends, technologies, prospects, and opportunities.
Visiongain’s updated report forecasts those revenues to 2024 at overall world market, regional, and national level. There stay ahead in data, benefiting your influence. And hear about gains for patients, doctors, healthcare providers, and companies.
Read on, then, to explore assessments of drugs in use, also finding those services’ future commercial value.

Analyses exclusive to that study, discussing the most important needs and potentials

Demand rises for those testing, data storage, and monitoring operations. There our study benefits your plans, decisions, and authority by interpreting medical needs, regulations, and companies’ efforts. Save time and effort.
And you see what’s happening in surveillance of pharmaceuticals, assessing likely challenges, events, and gains. In particular discover prospects for phase IV clinical trials, contract research organisations (CROs), and pharmaceutical companies.
And in those analyses you get data found nowhere else. Our forecasting system goes to the core of sales potentials in those drug safety assessments, showing revenue predictions.

Our report gives 36 tables, 35 charts, and interviews with three companies. There you discover historical results, growth rates, market shares, discussions, and forecasts.
And the following sections show how our new investigation helps you stay ahead.
National markets – what outlooks for service demand and provision?
What’s the commercial potential of post-marketing studies for medicines? For those testing activities our work forecasts overall world spending to 2024.

Our report also gives you individual forecasts to 2024 for 12 national markets:

- United States (US)
- Japan
- Germany, France, UK, Italy, and Spain (EU5), also with EU regional prediction
- Brazil, Russia, India, and China (BRIC nations), and South Korea.
Stay ahead, then, for information. There you find regions and countries with highest demands, spending, and potential sales growth. Explore progress, needs and opportunities.
Also what events, challenges, and advances in technology affect that industry and market? Our work shows you, discussing progress, policies, and trends influencing that pharma field.

Market forces, events, and issues – developments influencing pharmacovigilance

Find what’s happening. Our new report explains issues, processes, and events affecting that industry and market from 2014, including these:
- Reporting systems for adverse drug reactions (ADRs) – their present and future, including data on reported and recorded events by year and region
- Drug approval moving towards post-marketing studies, inc. advances in therapies
- Safety monitoring using reporting from social media – explore possibilities in big data
- Improvements in data collection and communication leading to more-flexible drug approval processes – changing routes of marketing authorisation
- Strengths and weaknesses of procedures and practice in 2014, and how pharma regulatory affairs can progress there to 2024.
And it discusses these trends and influences, among others:
- Policies of national and international bodies, and regulators’ roles in present and future pharmacovigilance programmes
- Companies in business process outsourcing (BPO), software providers, regulatory consultants, and contract research organisation (CROs)
- Prediction of overall pharma R&D spending and its effects on that drug monitoring
- Collaboration between the FDA and EMA, and application of pharmacogenomics and biomarke

Table Of Contents

Pharmacovigilance and Related Developments: Industry and Market Analysis 2014-2024
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 and 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 MandA 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


List of Tables
Table 2.1 Pharmacovigilance Terminology in the EU and US, 2014
Table 2.2 Sample Size Required to Detect ADRs Based on Incidence, 2014
Table 2.3 Number of Phase IV Clinical Trials by Registration Date, 2004-2014
Table 3.1 Full Members of the WHO Program for Drug Safety Monitoring, 2014
Table 3.2 Global Pharmaceutical RandD Spending Forecast: Global Spending on RandD ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 3.3 Global Pharmacovigilance Spending Forecast: Global Spending on Pharmacovigilance Operations ($bn), Proportion of RandD Spending (%), Annual Growth (%), CAGR (%), 2013-2024
Table 4.1 Spending on Pharmacovigilance in National and Regional Markets: Market Size ($bn), Market Share (%), 2013
Table 4.2 Forecast Spending on Pharmacovigilance in National and Regional Markets: Spending ($bn), Annual Growth (%), CAGR (%), 2013-2018
Table 4.3 Forecast Spending on Pharmacovigilance in National and Regional Markets: Spending ($bn), Annual Growth (%), CAGR (%), 2018-2024
Table 4.4 Forecast Spending on Pharmacovigilance in National and Regional Markets: Market Shares (%), 2013-2024
Table 4.5 Adverse Drug Reactions Entered into the FAERS Database: Expedited (000s), Medwatch (000s), Periodic (000s), Total Entered (000s), Annual Growth (%), 2003-2012
Table 4.6 Adverse Drug Reactions Entered into the FAERS Database by Country of Origin: Domestic (000s), Foreign (000s), Unknown (000s), Total Entered (000s), Annual Growth (%), 2003-2012
Table 4.7 Forecast Spending on Pharmacovigilance in the US: Spending ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.8 Forecast Spending on Pharmacovigilance in the European Union: National Market Sizes ($bn), Annual Growth (%), EU Market Shares (%), CAGRs (%), 2013-2018
Table 4.9 Forecast Spending on Pharmacovigilance in the European Union: National Market Sizes ($bn), Annual Growth (%), EU Market Shares (%), CAGRs (%), 2018-2024
Table 4.10 Individual Case Safety Reports Made to the Eudravigilance Database by Nation, 2012
Table 4.11 Forecast Spending on Pharmacovigilance in Germany: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.12 Forecast Spending on Pharmacovigilance in France: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.13 Forecast Spending on Pharmacovigilance in the UK: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.14 Forecast Spending on Pharmacovigilance in Italy: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.15 Forecast Spending on Pharmacovigilance in Spain: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.16 Drug Re-examination Schedule in Japan, 2013
Table 4.17 ADRs Reported to Japanese Regulators: Domestic (000s), Foreign (000s), Healthcare Providers (000s), Annual Growth (%), 2008-2012
Table 4.18 Forecast Spending on Pharmacovigilance in Japan: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.19 Forecast Spending on Pharmacovigilance in the BRIC Nations: Market Size ($bn), Annual Growth (%), Market Share (%), CAGR (%), 2013-2018
Table 4.20 Forecast Spending on Pharmacovigilance in the BRIC Nations: Market Size ($bn), Annual Growth (%), Market Share (%), CAGR (%), 2018-2024
Table 4.21 ADRs Reported to Chinese Regulators: ADRs Reported (000s), Annual Growth (%), 2003-2012
Table 4.22 Forecast Spending on Pharmacovigilance in China: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.23 Forecast Spending on Pharmacovigilance in Brazil: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.24 Forecast Spending on Pharmacovigilance in Russia: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.25 ADRs Reported in India Regulators: ADRs Reported (000s), Annual Growth (%), 2010-2013
Table 4.26 Forecast Spending on Pharmacovigilance in India: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 4.27 ADRs Reported to South Korean Regulators: ADRs Reported (000s), Annual Growth (%), 2003-2012
Table 4.28 Forecast Spending on Pharmacovigilance in South Korea: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024
Table 5.1 Other Pharmacovigilance Service Providers, 2014
Table 7.1 Social, Technological, Economic, and Political Factors (STEP) Affecting Pharmacovigilance, 2014


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, 2004-2014
Figure 3.1 Country of Origin of ICSRs on UMC VigiBase: National Percentage of Cumulative ISCR Total (%), Aug 2013
Figure 3.2 Per Capita ISCRs Submitted to VigiBase: Number ISCR Submitted Per Million Inhabitants Per Year, Yearly Average 2008-2013
Figure 3.3 Global Pharmaceutical RandD Spending Forecast ($bn), 2013-2024
Figure 3.4 Global Pharmacovigilance Spending Forecast: Global Spending on Pharmacovigilance Operations ($bn), Proportion of RandD Spending (%), 2013-2024
Figure 3.5 Pharmacovigilance Market: Drivers and Restraints, 2013-2024
Figure 4.1 Spending on Pharmacovigilance in National and Regional Markets: Market Share (%), 2013
Figure 4.2 Forecast Spending on Pharmacovigilance in National and Regional Markets: Spending ($bn), 2013-2024
Figure 4.3 Forecast Spending on Pharmacovigilance in National and Regional Markets: Market Share (%), 2018
Figure 4.4 Forecast Spending on Pharmacovigilance in National and Regional Markets: Market Share (%), 2024
Figure 4.5 Adverse Drug Reactions Entered into the FAERS Database: Expedited (000s), Medwatch (000s), Periodic (000s), 2003-2012
Figure 4.6 Adverse Drug Reactions Entered into the FAERS Database by Country of Origin: Domestic (000s), Foreign (000s), Unknown (000s), 2003-2012
Figure 4.7 Forecast Spending on Pharmacovigilance in the US: Market Size ($bn), 2013-2024
Figure 4.8 Forecast Spending on Pharmacovigilance in European Union (EU5): National Market Sizes ($bn), 2013-2024
Figure 4.9 Individual Case Safety Reports Made to the Eudravigilance Database by Nation, 2012
Figure 4.10 Forecast Spending on Pharmacovigilance in Germany: Market Size ($bn), 2013-2024
Figure 4.11 Forecast Spending on Pharmacovigilance in France: Market Size ($bn), 2013-2024
Figure 4.12 Forecast Spending on Pharmacovigilance in the UK: Market Size ($bn), 2013-2024
Figure 4.13 Forecast Spending on Pharmacovigilance in Italy: Market Size ($bn), 2013-2024
Figure 4.14 Forecast Spending on Pharmacovigilance in Spain: Market Size ($bn), 2013-2024
Figure 4.15 ADRs Reported to Japanese Regulators: Domestic (000s), Foreign (000s), Healthcare Providers (000s), 2008-2012
Figure 4.16 Forecast Spending on Pharmacovigilance in Japan: Market Size ($bn), 2013-2024
Figure 4.17 Forecast Spending on Pharmacovigilance in BRIC Nations: National Marker Sizes ($bn), 2013-2024
Figure 4.18 ADRs Reported to Chinese Regulators: ADRs Reported (000s), 2003-2012
Figure 4.19 Forecast Spending on Pharmacovigilance in China: Market Size ($bn), 2013-2024
Figure 4.20 Forecast Spending on Pharmacovigilance in Brazil: Market Size ($bn), 2013-2024
Figure 4.21 Forecast Spending on Pharmacovigilance in Russia: Market Size ($bn), 2013-2024
Figure 4.22 ADRs Reported in India: ADRs Reported (000s), 2010-2013
Figure 4.23 Forecast Spending on Pharmacovigilance in India: Market Size ($bn), 2013-2024
Figure 4.24 ADRs Reported to South Korean Regulators: ADRs Reported (000s), 2003-2012
Figure 4.25 Forecast Spending on Pharmacovigilance in South Korea: Market Size ($bn), 2013-2024
Figure 7.1 Strengths and Weaknesses in Pharmacovigilance, 2014
Figure 7.2 Opportunities and Threats in Pharmacovigilance, 2014

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