Pharmacovigilance and Related Developments Industry 2014-2024


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Pharmacovigilance and Related Developments Industry 2014-2024

  1. 1. Pharmacovigilance and Related Developments: Industry and Market Analysis 2014-2024 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain.You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  2. 2. Contents 1.1 Introduction to This New Study 1.2 Chapter Contents – What You Find in That Work 1.3 Research and Analysis Methods 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 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. Introduction to Pharmacovigilance 1. Executive Summary
  3. 3. Contents 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 3.1 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. Pharmacovigilance: World Market, 2014-2024
  4. 4. Contents 3.4.7 Direct Consumer Reports Lack Quality to Detect Causal Safety Signals 3.4.8 Merged Companies Spend Less on Pharmacovigilance 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. Leading National and Regional Markets, 2014-2024
  5. 5. Contents 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
  6. 6. Contents 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 Aris Global 5.4 Other Outsourcing Companies 5. Leading Pharmacovigilance Companies, 2014
  7. 7. Contents 5.4.1 Drug Safety Alliance 5.4.2 Foresight Group International 5.4.3 TAKE Solutions 5.5 Other Pharmacovigilance Service Providers 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 7.1 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. Research Interviews 6. Qualitative Analysis of the Pharmacovigilance Market, 2014-2024
  8. 8. Contents 7.1.2 Mergers, Big Data, and New Regulations – The Challenges of Pharmacovigilance in the 21 st 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 M&A 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 8.1 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 8. Conclusions
  9. 9. Page 93 Pharmacovigilance and Related Developments: Industry and Market Analysis 2014-2024 4.12.2 Chinese Market Forecast, 2014-2024 At currently levels, China is the national market with the greatest volume of safety data processed annually. In some ways this is not surprising, given how populous the country is. On the other hand, the entire pharmacovigilance programme started fifteen years ago in 1989, so there has been huge progressing in getting the programme to this stage so rapidly. Visiongain believes this is only the start of a secular increase in the demands of drug safety monitoring in China. In 2013, pharmacovigilance spending in China was $0.34bn; by 2018 this figure will have risen to $0.66. Pharmacovigilance spending will increase at a CAGR of 14.0% for the first five years of the forecast. Between 2018 and 2024 spending will continue to grow, at a marginal reduced CAGR of 12.5% (Table 4.22 and Figure 4.19). Growth in spending will be driven by an overall increase in volume of ADRs reported and recorded in China over the next ten years. This data will require proportional increase in staffing levels at all points of the pharmaceutical supply chain. Regulators will also have to increase their staffing levels to cope with the increased workload for monitoring drug safety. Visiongain anticipates an increased demand for statisticians and informatic systems to rapidly identify emerging drug safety signals. By 2024, spending on pharmacovigilance operations in China will have reached $1.34bn annually, an increase of 294% over the course of ten years. The Chinese pharmacovigilance market will be the second largest national market in 2024, having eclipsed Germany during 2020. Visiongain believes that strong collaborative ties between the pharmaceutical industry and the CFDA will improve drug safety standard in China. Jansen, a subsidiary of J&J, has held training workshops in China every year since 2009. Initiatives in China to develop high standards for drug safety reports and analysis will help to protect consumers worldwide. The huge population of consumers in China will allow for a rapid exposure to a large cohort of patients. Potentially rare events are more likely to be identified in these situations, helping to flag potential safety issues as quickly as possible. Drug safety issues from China will also be particularly important to drug marketed in other Asian markets. Genetic differences between Europeans and Asian populations can lead to issues with interpreting drug safety signals that arise in different markets. Japanese drug safety monitors would be well advised to form strong collaborative links with China’s national centre for ADR monitoring. As drug safety issues arising in China are likely to have more relevance to the Japanese population than safety issues that arise in European populations. In summary, visiongain believes that China will be the most important emerging pharmacovigilance market over the next ten years. Outsourcing agencies will see a growth in consulting and off- shoring of operations domiciled in China. While pharmaceutical manufacturers will have to allocate an increased proportion of resources to monitoring the safety of drug approved for the Chinese
  10. 10. Page 94 Pharmacovigilance and Related Developments: Industry and Market Analysis 2014-2024 market. Pertinent to this, Parexel has been expanding its Chinese operations over the course of 2013. The company now has a presence in Shenyang, Beijing, Chengdu, Guangzhou, Shanghai, and Hong Kong. In addition they are partnered with Shenyang Pharmaceutical University to train the next generation of pharmacovigilance officers and data analysts. Table 4.22 Forecast Spending on Pharmacovigilance in China: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024 2013 2014 2015 2016 2017 2018 China ($bn) 0.34 0.41 0.46 0.52 0.59 0.66 Annual Growth (%) 20.0 12.5 12.5 12.5 12.5 CAGR (%) 14.0 2019 2020 2021 2022 2023 2024 China ($bn) 0.74 0.84 0.94 1.06 1.19 1.34 Annual Growth (%) 12.5 12.5 12.5 12.5 12.5 12.5 CAGR (%) 12.5 Figure 4.19 Forecast Spending on Pharmacovigilance in China: Market Size ($bn), 2013-2024 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 MarketSize($bn) Year Source: visiongain 2014 Source: visiongain 2014, CAGR for the period 2013-2018 and 2018-2024