‘Global Pharmacovigilance Spending Will be worth $15.46bn by 2015′ Says Visiongain Analyst

By Visiongain Ltd, PRNE
Tuesday, September 6, 2011

LONDON, September 7, 2011 -


A new report by visiongain, a London-based business information company, predicts that global pharmacovigilance spending will be worth $15.46bn by 2015. The market was worth just under $12bn in 2010, according to Pharmacovigilance and Related Developments 2011-2021, published in August 2011.

Pharmacovigilance has evolved rapidly over the past three decades. The monitoring of drug safety standards is now overseen by a number of regulatory authorities. With the increasing cost of getting a drug to market (now estimated to be $800m to $1bn), pharmaceutical companies cannot afford to have a drug recalled because of severe adverse events. The damage to brand reputation may also be irreparable.

Dr Sharmarke Mohamed, healthcare industry analyst, says: “Pharmacovigilance is now at a stage where regulatory authorities are starting to understand the importance of having greater consumer participation in the reporting of adverse drug reactions (ADRs). This has been mandated in the new EU legislation on pharmacovigilance. There is still significant work to be done, however, in improving pharmacovigilance standards across different countries. Despite the efforts of the ICH, there are still considerable discrepancies in how the recommendations of the ICH are interpreted across different countries. This is a significant market restraint.”    

Visiongain predicts that this market will grow steadily to 2021. The future of the pharmacovigilance market looks promising. This new report adds to visiongain’s wide range of analytical reports in healthcare and other industries.

To see sample pages of this report please click on:


Table of Contents
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 Oracle Argus Safety Suite
3.4.3 Aris Global 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 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. 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

Notes for Editors

If you are interested in a more detailed overview of this report, please send an e-mail to sara.peerun@visiongainglobal.com or call her on +44 (0) 207 336 6100

About visiongain


Visiongain is one of the fastest growing and most innovative independent media companies in Europe. Based in London, UK, visiongain produces a host of business-2-business conferences, newsletters, management reports and e-zines focusing on the Pharmaceutical, Telecoms, Energy, Defence and Materials sectors.

Visiongain publishes reports produced by its in-house analysts, who are qualified experts in their field. Visiongain has firmly established itself as the first port-of-call for the business professional, who needs independent, high quality, original material to rely and depend on. 

For an exec summary please email Sara Peerun
Email: sara.peerun@visiongainglobal.com
Tel: +44 2027 3366100

Web: www.visiongain.com


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