Pharmacovigilance and Related Developments 2011-2021

Date: August 23, 2011
Pages: 117
US$ 2,325.00
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Publisher: Visiongain
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: P609C15525DEN

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Pharmacovigilance and Related Developments 2011-2021
What does the future hold for pharmacovigilance? Visiongain's new report shows you prospects to 2021, discussing opportunities and developments. Find data you need.

Assess events, opportunities and activities shaping pharmacovigilance to 2021: regulations, technologies and services. Through our research and analysis we aim to save you time and help in your decisions.

How will changes affect pharmacovigilance? What are drug producers and service providers doing? What regulations and technologies influence that field? Our study explains, showing you developments and opportunities.

Pharmacovigilance will become more important during this decade. You can discover spending forecasts for pharmacovigilance. Find data and discussions for the overall world market, the US, the EU and Japan.

Discover pharmacovigilance activities of Pfizer, J&J, GSK, Sanofi, Novartis, AstraZeneca, Roche, Abbott, Eli Lilly and Bristol-Myers Squibb. You can find trends and prospects.

Assess leading companies offering pharmacovigilance services - Oracle, Aris Global, NDA, PharSafer Associates and PrimeVigilance. See what activities are shaping the field.

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Analysis with potential future trends, revenue predictions, opinions and discussions

In our report you find revenue forecasts, growth rates, market shares, qualitative analyses, opinions from our survey and discussions of regulations and companies. You receive 56 tables and charts and three research interviews (see the accompanying lists).

Pharmacovigilance and Related Developments 2011-2021 shows you opportunities, challenges and forecasts

Our report gives you the following advantages in particular:
  • Receive wide-ranging data and discussions for pharmacovigilance, seeing the relevance of regulations and practices
  • Assess the activities of top pharma companies and leading service providers
  • Discover a forecast for world pharmacovigilance spending to 2021, seeing trends
  • Find pharmacovigilance spending forecasts to 2021 for the US, the EU and Japan
  • Receive a forecast to 2021 for R&D spending in the world pharma industry
  • Investigate driving and restraining forces in pharmacovigilance, seeing opportunities
  • Assess the implications of pharmacovigilance for stakeholders - drug manufacturers, pharma regulators, prescribers, payers and patients
  • View opinion from our survey of the industry, with three full interview transcripts.
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1.1 Overview
1.2 Aims, Scope and Format of the Report
1.3 Research and Analysis Methods


2.1 Introduction
2.2 Historical Context
  2.2.1 Thalidomide
  2.2.2 Eraldin
  2.2.3 Vioxx
2.3 Adverse Drug Reactions
  2.3.1 Never Events
2.4 Safety Testing Before the Launch of Drugs: Clinical Trials
  2.4.1 Drug Safety Monitoring in Clinical Trials
  2.4.2 Phase I Clinical Trials
  2.4.3 Phase II Clinical Trials
  2.4.4 Phase III Clinical Trials
2.5 The Limitations of Phase I-III Trials
2.6 Pharmacovigilance in the Pharmaceutical Industry
2.7 The Pharmacovigilance Practices of the Leading Pharmaceutical Companies
  2.7.1 Introduction
  2.7.2 Pfizer
  2.7.3 Johnson & Johnson
  2.7.4 GlaxoSmithKline
  2.7.5 Sanofi
  2.7.6 Novartis
  2.7.7 AstraZeneca
  2.7.8 Roche
  2.7.9 Abbott Laboratories
  2.7.10 Eli Lilly
  2.7.11 Bristol-Myers Squibb


3.1 Introduction
3.2 The WHO Programme for International Drug Monitoring
  3.2.1 Members and Associate Members of the WHO Programme
  3.2.2 Data Collection at the Uppsala Monitoring Centre
  3.2.3 VigiBase
  3.2.4 Searching VigiBase
3.3 The International Conference on Harmonisation (ICH)
  3.3.1 Creating Harmony in Regulatory Affairs
  3.3.2 The Trickle-Down Effect
3.4 Leading Companies Offering Pharmacovigilance Services
  3.4.1 Introduction
  3.4.2 Oracle Oracle Argus Safety Suite
  3.4.3 Aris Global ARISg
  3.4.4 NDA
  3.4.5 PharSafer Associates
  3.4.6 PrimeVigilance


4.1 Overview of the Global Pharmacovigilance Market, 2011-2021
4.2 Transparency as the Key Ingredient for Effective Pharmacovigilance
  4.2.1 Transparency and the Approval Process
4.3 Prescription Event Monitoring
4.4 Pharmacogenomics Can Help Identify Safety Concerns
  4.4.1 Pharmaceutical Companies are Wary about Radical Changes to the Blockbuster Model of Drug Discovery
4.5 A Move Towards Live Licensing?


5.1 The Global Pharmacovigilance Market, 2010
5.2 The Global Pharmacovigilance Market, 2010-2015
5.3 The Global Pharmacovigilance Market, 2016-2021
5.4 Global Pharma R&D Expenditure as a Driver of Pharmacovigilance Costs
  5.4.1 Global Pharma R&D Spending, 2010
  5.4.2 Global Pharma R&D Spending, 2010-2015
  5.4.3 Global Pharma R&D Spending, 2016-2021
5.5 The Move Towards Personalised Medicine Will Drive Growth in the Pharmacovigilance Market
  5.5.1 The Healthcare Industry is a Key Driver of the Global Genomic Sequencing Market
5.6 Leading National Markets for Pharmacovigilance, 2010-2021
  5.6.1 Regional Markets for Pharmacovigilance, 2010
  5.6.2 The US Pharmacovigilance Market, 2010-2021
  5.6.3 The EU Pharmacovigilance Market, 2010-2021
  5.6.4 The Japanese Pharmacovigilance Market, 2010-2021
5.7 SWOT Analysis for the Global Pharmacovigilance Market
  5.7.1 Introduction
  5.7.2 Drivers for Global Pharmacovigilance Greater Regulatory Control of Pharmacovigilance The Increasing Cost of Drug Development Historical Drug Safety Scandals
  5.7.3 Restraints in the Global Pharmacovigilance Market Drug Counterfeiting is Still a Significant Problem A Retreat from the Targeted Approach to Drug Development Lack of Harmonisation in Pharmacovigilance Standards and Practices
5.8 Embracing a Collaborative Model for Information Sharing Will Improve Pharmacovigilance


6.1 Introduction
6.2 Post-Vioxx Criticisms of the FDA
6.3 Spontaneous Reporting in the US
6.4 MedWatch and Mobiles
6.5 The FDA Amendments Act 2007
  6.5.1 Using Healthcare Records for a More-Intensive Approach
  6.5.2 Evaluating Potential Risks at the Application Stage
  6.5.3 Communicating Safety Concerns to the Public
6.6 Case Study: Raptiva (Efalizumab)
6.7 FDA REMS Requirements Could Prove Beneficial in Facilitating Greater Uptake of Anti-counterfeiting Track-and-Trace Serialisation


7.1 Introduction
7.2 Pharmacovigilance within the EU
  7.2.1 The European Medicines Agency (EMA)
  7.2.2 The CHMP Pharmacovigilance Working Party
  7.2.3 EudraVigilance
  7.2.4 The UK's Yellow Card Scheme as an Example of a National Patient Reporting System
7.3 New EU Legislation on Pharmacovigilance
  7.3.1 How Does the New Legislation Ensure Patient Safety?
  7.3.2 EU Legislation Calls for a New Committee on Pharmacovigilance
7.4 New EU Directive on Falsified Medicines Will Add Value to Changes in EU Pharmacovigilance Law
7.5 The Progress Made by the EMA
  7.5.1 Timely Access to Innovative Medicines


8.1 Introduction
8.2 Japan is the World's Second Largest Pharmaceutical Market
8.3 Japanese Drug Approval and Regulation
  8.3.1 The MHLW Monitors New Drugs
  8.3.2 Periodic Safety Update Reports (PSURs)
  8.3.3 Drugs Re-examined After 4-10 Years
  8.3.4 Ad-hoc Drug Re-evaluation
8.4 ADR Reporting in Japan
  8.4.1 An Increased Number of Drug Approvals Has Increased ADR Reports
8.5 The Challenge of Drug Lag in Japan
  8.5.1 Case Study: Iressa (Gefitinib)
  8.5.2 Case Study: Usevir (Sorivudine)
  8.5.3 The PMDA Aims to Overcome Drug Lag
8.6 Mid-Term Plans: Japan's Road Maps
  8.6.1 The Second Mid-Term Plan, 2009-2013


9.1 Dr Brian Edwards MD MRCP, Principal Consultant, Pharmacovigilance & Drug Safety, NDA Regulatory Science, UK
  9.1.1 Current State of Pharmacovigilance
  9.1.2 Moving Towards a More Proactive System of Pharmacovigilance
  9.1.3 Pharmacovigilance Services Offered by NDA Regulatory Science
  9.1.4 The Impact of Targeted Therapies on Pharmacovigilance
9.2 Dr Marie Lindquist, Director, Uppsala Monitoring Centre (UMC), Uppsala, Sweden
  9.2.1 Moving From a Reactive to a Proactive System of Pharmacovigilance
  9.2.2 Greater Public Participation in Pharmacovigilance?
  9.2.3 Transparency and Pharmacovigilance
  9.2.4 Public Perception of Pharmacovigilance
  9.2.5 Live Licensing and the Future of Pharmacovigilance
9.3 Dr Graeme Ladds, Director, PharSafer Associates, UK
  9.3.1 Current Pharmacovigilance Practice
  9.3.2 Transparency in Pharmacovigilance
  9.3.3 The Costs of Pharmacovigilance
  9.3.4 Responsibility in Pharmacovigilance
  9.3.5 The Move to Live Licensing
  9.3.6 The Future of National Pharmacovigilance


10.1 Pharmacovigilance Market Will Achieve Growth from 2011-2021
10.2 Collaboration and Transparency is Expected to Increase within Pharmacovigilance
10.3 Need for Innovative Use of Internet and Social Media Tools to Improve Pharmacovigilance Standards
10.4 Epidemiological Studies Will Be Applied More Widely
10.5 Pharmacogenomics Will Become Important In Drug Approval
10.6 A Shift Towards Live Licensing
  10.6.1 The Effects of Live Licensing on the Pharmaceutical Supply Chain
10.7 The Changing Landscape of Pharma Products Poses Significant Challenges for Pharmacovigilance
10.8 The Trend Towards a "Virtual Pharma" Company Will Affect the Quality of APIs and Safety Profiles of Drugs


Table 3.1 Members of the Programme for International Drug Monitoring, 2011
Table 3.2 Origin of ICSRs Held in VigiBase, 2010
Table 3.3 Members of the ICH, 2010
Table 3.4 National Bodies Represented at ICH-GCG, 2011
Table 4.1 Revenues ($bn) for the Global Pharmacovigilance Market, 2011-2021
Table 4.2 Strengths and Weaknesses of PEM, 2011
Table 4.3 Strengths and Weaknesses of a Live Licensing System, 2011
Table 5.1 Revenues ($bn) for the Global Pharmacovigilance Market, 2010-2015
Table 5.2 Revenues ($bn) for the Global Pharmacovigilance Market, 2016-2021
Table 5.3 Global Pharma R&D Spending ($bn), 2010
Table 5.4 Global Pharma R&D Spending ($bn), 2010-2015
Table 5.5 Global Pharma R&D Spending ($bn), 2016-2021
Table 5.6 Forecast Revenues ($bn) for the Sale of Genomic Sequencing Technologies Used within the Global Healthcare Sector, 2010-2015
Table 5.7 Forecast Revenues ($bn) for the Sale of Genomic Sequencing Technologies Used within the Global Healthcare Sector, 2016-2021
Table 5.8 Regional Spending ($bn) on Pharmacovigilance, 2010-2015
Table 5.9 Regional Spending ($bn) on Pharmacovigilance, 2016-2021
Table 5.10 US Pharmacovigilance Spending ($bn), 2010-2015
Table 5.11 US Pharmacovigilance Spending ($bn), 2016-2021
Table 5.12 EU Pharmacovigilance Spending ($bn), 2010-2015
Table 5.13 EU Pharmacovigilance Spending ($bn), 2016-2021
Table 5.14 Japanese Pharmacovigilance Spending ($bn), 2010-2015
Table 5.15 Japanese Pharmacovigilance Spending ($bn), 2016-2021
Table 5.16 SWOT Analysis for the Global Pharmacovigilance Market, 2011
Table 6.1 Number of Reports in the AERS as a Function of the Type of Reporter, 2000-2010
Table 7.1 Sources of Spontaneous Reports Received by MHRA via its Yellow Card Scheme, 2004-2009
Table 7.2 Objectives and Outcomes of the EMA Road Map
Table 8.1 Re-examination Period Lengths for Different Drug Types
Table 8.2 Changes in the Number of Reported Adverse Drug Reactions for the Japanese Fiscal Years, 2005-2009
Table 8.3 Standard and Priority Review Times in the US, EU and Japan, 2011


Figure 2.1 Events in the Lifecycle of Vioxx
Figure 3.1 Adverse Drug Reaction Reporting Mechanism of the WHO, 2011
Figure 3.2 Origins of ICSRs Held in VigiBase, 2010
Figure 4.1 Revenues ($bn) for the Global Pharmacovigilance Market, 2011-2021
Figure 5.1 Revenues ($bn) for the Global Pharmacovigilance Market, 2010-2015
Figure 5.2 Revenues ($bn) for the Global Pharmacovigilance Market, 2016-2021
Figure 5.3 Global Pharma R&D Spending ($bn), 2010
Figure 5.4 Regional Market Shares (%) for Pharma R&D Spending, 2010
Figure 5.5 Global Pharma R&D Spending ($bn), 2010-2015
Figure 5.6 Global Pharma R&D Spending ($bn), 2016-2021
Figure 5.7 Forecast Revenues ($bn) for the Sale of Genomic Sequencing Technologies Used in Healthcare, 2010-2015
Figure 5.8 Forecast Revenues ($bn) for the Sale of Genomic Sequencing Technologies Used in Healthcare, 2016-2021
Figure 5.9 US Pharmacovigilance Spending ($bn), 2010-2015
Figure 5.10 US Pharmacovigilance Spending ($bn), 2016-2021
Figure 5.11 EU Pharmacovigilance Spending ($bn), 2010-2015
Figure 5.12 EU Pharmacovigilance Spending ($bn), 2016-2021
Figure 5.13 Japanese Pharmacovigilance Spending ($bn), 2010-2015
Figure 5.14 Japanese Pharmacovigilance Spending ($bn), 2016-2021
Figure 6.1 Origin of the 490,000 Adverse Events Added to the AERS Database, 2009
Figure 6.2 Number of Reports in the AERS as a Function of the Type of Reporter, 2000-2005
Figure 6.3 Number of Reports in the AERS as a Function of the Type of Reporter, 2006-2010
Figure 7.1 Summary of the Drug Approval Pathways Available in the EU, 2011
Figure 7.2 Spontaneous ADR Reports Received by MHRA, 2008-2009
Figure 7.3 Spontaneous Reports Received by MHRA from Patients (including Parents and Carers), 2004-2009
Figure 7.4 Spontaneous ADR Reports Received by MHRA from GPs and Pharmacists, 2004-2009
Figure 8.1 The Japanese Regulatory Process, 2011
Figure 8.2 Changes in the Number of Reported Adverse Drug Reactions for the Japanese Fiscal Year, 2005-2009


Abbott Laboratories
Acorda Therapeutics
Agencia Nacional de Vigilancia Sanitaria [Brazil]
Alexion Europe SAS
Aris Global
Asia-Pacific Economic Cooperation (APEC)
Association of British Pharmaceutical Industries (ABPI)
Association of British Pharmaceutical Industries' Pharmacovigilance Expert Network
Association of the Southeast Asian Nations (ASEAN)
Brazilian Health Surveillance Agency [Brazil]
Bristol-Myers Squibb
Bureau of Pharmaceutical Affairs (Department of Health) [Chinese Taipei]
Center for Biologics Evaluation and Research (CBER) [USA]
Center for Devices and Radiological Health (CDRH) [USA]
Centers for Disease Control and Prevention
Center for Drug Evaluation and Research (CDER) [USA]
Center for Food Safety and Applied Nutrition (CFSAN) [USA]
Center for Veterinary Medicine (CVM) [USA]
Cerner Galt
Commission on Human Medicines
Committee for Medicinal Products for Human Use (CHMP)
Committee on the Safety of Medicine
Contergan Foundation
Council for International Organization of Medical Sciences
Department of Drug Registration (State Food and Drug Administration) [China]
Department of Health and Ageing [Australia]
Department of International Cooperation (State Food of Drug Administration) [China]
Division of Medical Products Registration [Russia]
Division of Pharmaceutical Chemistry (Department of Health) [Chinese Taipei]
Drug Evaluation Department (Korea Food and Drug Administration [KFDA]) [South Korea]
Drug Logic
Drug Safety Research Unit
Eli Lilly
Elliot Brown Consulting
Eudravigilance Database
European Commission
European Council
European Economic Area
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Free Trade Association
European Pharmacovigilance Guidelines
European Medicines Agency (EMA)
European Medicines Evaluation Agency
European Parliament
Federal Association of Thalidomide Victims
Federal Service on Surveillance in Healthcare and Social Development [Russia]
Food and Drug Administration (US FDA)
Food and Drug Administration Sentinel Initiative
GlaxoSmithKline (GSK)
Gulf Cooperation Council (GCC)
Health Products Regulation Group (Health Sciences Authority) [Singapore]
Health Sciences Authority [Singapore]
Homeland Security Advisory System
Human Genome Project
ICH Global Cooperation Group
Imperial Chemical Industries (ICI)
Imperial College London
Innovative Medicines Initiative
Intensive Medicine s Monitoring Programme
International Conference on Harmonisation (ICH)
Ion Torrent
Japan Pharmaceutical Manufacturers Association (JPMA)
Johnson & Johnson
Korea Food and Drug Administration [South Korea]
Medicines and Healthcare Products Regulatory Agency (MHRA)
Medicines Monitoring Programme
MedImmune Patient Safety
Merck & Co.
Ministry of Health and Welfare [India]
Ministry of Health, Labour and Welfare (MHLW) [Japan]
National Center for Toxicological Research (NCTR) [USA]
National Institute for Clinical Excellence (NICE) [UK]
National Patient Safety Agency (NPSA)
NDA Regulatory Science
Office of Prescription Medicines [Australia]
Office of Regulatory Affairs (ORA) [USA]
Office of the Commissioner (OC) [USA]
Pan American Network for Drug Regulatory Harmonisation (PANDRH)
Pharmaceutical and Medical Devices Agency (PMDA) [Japan]
Pharmaceutical Research and Manufacturers of America (PhRMA)
Pharmaceuticals and Biologics Branch (Health Sciences Authority) [Singapore]
PharSafer Associates
Phase Forward
PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium)
Quintiles Transnational
Serious Adverse Event Consortium
Southern African Development Community (SADC)
State Food and Drug Administration [China]
Tata Consultancy Services
The White House Office of National Drug Control Policy
The Observer
UK Government
Uppsala Monitoring Centre (UMC)
US Federal Government
WHO Collaborating Centre for International Drug Monitoring
World Health Organization (WHO)
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