1. Executive Summary
1.1 Overview
1.2 Aims, Scope and Format of the Report
1.3 Research and Analysis Methods
2. Introduction to Pharmacovigilance
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. Global Regulatory Framework for Pharmacovigilance, 2011-2021
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
3.4.2.1 Oracle Argus Safety Suite
3.4.3 Aris Global
3.4.3.1 ARISg
3.4.4 NDA
3.4.5 PharSafer Associates
3.4.6 PrimeVigilance
4. Summary of the Global Pharmacovigilance Market, 2011-2021
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. Global Pharmacovigilance Market, 2011-2021
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
5.7.2.1 Greater Regulatory Control of Pharmacovigilance
5.7.2.2 The Increasing Cost of Drug Development
5.7.2.3 Historical Drug Safety Scandals
5.7.3 Restraints in the Global Pharmacovigilance Market
5.7.3.1 Drug Counterfeiting is Still a Significant Problem
5.7.3.2 A Retreat from the Targeted Approach to Drug Development
5.7.3.3 Lack of Harmonisation in Pharmacovigilance Standards and Practices
5.8 Embracing a Collaborative Model for Information Sharing Will Improve Pharmacovigilance
6. Pharmacovigilance in the US Market
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. Pharmacovigilance in the EU Market
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. Pharmacovigilance in Japan
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. Research Interviews
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. Conclusions
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
List of Tables
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
List of Figures
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