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Global Pharmacovigilance (PV) Market - Analysis & Forecast 2016 – 2022

The pharmacovigilance market is expected to reach a market size of $8.23 billion by 2022. Stringent compliance with drug safety regulations and increasing incidents of ADRs are acting as key drivers for the growth of this market.

SKU: MD12
Published Year: 2016
 
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Medicinal products have changed the way in which diseases are managed and controlled in the current era of medical technology. Regardless of the benefits, Adverse Drug Reactions (ADRs) continue to increase leading to illness, disability and even death of the patients. Globally, ADRs are one of the leading causes of mortality. Monitoring and evaluation of drug safety becomes vital in order to enhance public health, which requires a pharmacovigilance (PV) system in place. Globalization and free trade explosion have changed the way individuals today access medicinal products. Therefore, effective collaboration is required between pharmaceutical organizations and the key pharmacovigilance players in order to minimize the risks associated with the use of medicines.

The report titled “Global Pharmacovigilance Market” provides an in-depth analysis of the key development strategies and market trend dynamics which includes drivers, challenges and opportunities prevailing in the pharmacovigilance market. Key regulatory bodies have also been considered in the report because of the compliance requirements with drug safety regulations. Moreover, value chain analysis, consortiums and patents have also been included in the report. Porter’s five forces analysis has also been examined for deeper understanding of the nature of competition prevailing in the market

The pharmacovigilance market estimation and Full Time Equivalent (FTE) pricing analysis for case processing has been built on detailed assumptions. The market has been estimated based on clinical trials, service provider type and geography.

The report profiles 43 organizations on the basis of service providers working for different clinical trials across different geographies.

Key questions answered in the report:
•    What are the key drivers, challenges and opportunities for the global pharmacovigilance market?
•    What kind of development strategies do pharmacovigilance players leverage on? 
•    What is the Cost/FTE/hr pricing analysis related to case processing for specific market players?
•    Who are the major, medium and minor outsourcing case processors market players?
•    What are the clinical trial phases and their pharmacovigilance market size?
•    What types of service provider prevail in the PV market with their market share and size?
•    Which region is currently dominating the pharmacovigilance market and the market size by different geography?
•    What is the case processing graph for specific pharmacovigilance market players for the past five years (2011-2015)?

TABLE OF CONTENT
Executive Summary
1 Research Scope and Methodology
1.1 Scope of the Report
1.2 The Global Pharmacovigilance Market Research Methodology
1.2.1 Research Methodology for Case Processing Cost FTE/HR Calculation
1.2.2 Primary Data Sources
1.2.3 Secondary Data Sources
1.3 Assumptions and Limitations for Market Estimation and FTE Pricing
1.3.1 Assumptions
1.3.2 Limitations
2 Market Overview
2.1 Need for Pharmacovigilance
2.2 Benefits of Pharmacovigilance
2.3 Reporting in Pharmacovigilance
2.4 Pharmacovigilance Service Types
2.5 Outsourcing Pricing Delivery Models
2.6 Applications for Pharmacovigilance
3 Market Dynamics
3.1 Market Drivers
3.1.1 Increase in Drug Consumption due to rise in Chronic Illness
3.1.2 Evolving Drug Safety Regulations and Safety Issues
3.1.3 High Data Volumes of Adverse Events
3.1.4 Role of Emerging Markets in Driving Pharmacovigilance
3.1.5 Emergence of Social Media and Digital Health
3.2 Challenges
3.2.1 Globalization
3.2.2 Web Based Sales and Information
3.2.3 Broader Safety Concerns
3.2.4 Public Health versus Pharmaceutical Industry Economic Growth
3.2.5 Data Privacy
3.3 Opportunities in Pharmacovigilance
3.3.1 Proactive Pharmacovigilance
3.3.2 Personalized Medicines
3.3.3 Innovations and Advancements in Technologies
3.3.4 Database Analytics
4 Competitive Landscape
4.1 Key Development Strategies
4.1.1 Mergers and Acquisitions
4.1.2 Product Development and Launches
4.1.3 Partnerships, Collaborations and Agreements
4.1.4 Business Expansions
4.1.5 Awards and Recognitions
4.2 Industry Attractiveness
5 Industry Analysis
5.1 Regulatory Agencies
5.2 Consortiums and Agencies
5.3 Patents
5.4 Value Chain Analysis
6 Global Pharmacovigilance Market Analysis & Forecast by Clinical Trials Insights
6.1 Market Overview
6.2 Preclinical Trial
6.2.1 Market Overview
6.3 Phase I Clinical Trial
6.3.1 Market Overview
6.4 Phase II Clinical Trial
6.4.1 Market Overview
6.5 Phase III Clinical Trial
6.5.1 Market Overview
6.6 Phase IV Clinical Trial
6.6.1 Market Overview
7 Global Pharmacovigilance Market Analysis & Forecast by Service Provider Type
7.1 Market Overview
7.2 In-House Pharmacovigilance
7.2.1 Market Overview
7.3 Outsourcing Pharmacovigilance
7.3.1 Market Overview
8 Global Pharmacovigilance Market Analysis & Forecast by Geography
8.1 Market Overview
8.2 North America
8.2.1 Market Overview
8.2.2 U.S.
8.2.3 Canada
8.3 Europe
8.3.1 Market Overview
8.3.2 United Kingdom (U.K.)
8.3.3 Germany
8.3.4 France
8.3.5 Italy
8.3.6 Spain
8.3.7 Others
8.4 Asia Pacific (APAC)
8.4.1 Market Overview
8.4.2 India
8.4.3 Japan
8.4.4 China
8.4.5 Korea
8.4.6 Others
8.5 Rest of the World (RoW)
8.5.1 Market Overview
9 Company Profiles
9.1 PrimeVigilance
9.1.1 Company Overview
9.1.2 Global Footprint
9.1.3 PV Case Processing Snapshot
9.2 Accenture
9.2.1 Company Overview
9.2.2 Global Footprint
9.2.3 PV Case Processing Snapshot
9.3 4C Pharma Solutions
9.3.1 Company Overview
9.3.2 Global Footprint
9.3.3 PV Case Processing Snapshot
9.4 PharSafer Associates
9.4.1 Company Overview
9.4.2 Global Footprint
9.4.3 PV Case Processing Snapshot
9.5 Clinquest
9.5.1 Company Overview
9.5.2 Global Footprint
9.5.3 PV Case Processing Snapshot
9.6 iMEDGlobal Corporation
9.6.1 Company Overview
9.6.2 Global Footprint
9.6.3 PV Case Processing Snapshot
9.7 InVentiv Health Clinical
9.7.1 Company Overview
9.7.2 Global Footprint
9.7.3 PV Case Processing Snapshot
9.8 United BioSource Corporation (UBC)
9.8.1 Company Overview
9.8.2 Global Footprint
9.8.3 PV Case Processing Snapshot
9.9 Parexel
9.9.1 Company Overview
9.9.2 Global Footprint
9.9.3 PV Case Processing Snapshot
9.10 PPD
9.10.1 Company Overview
9.10.2 Global Footprint
9.10.3 PV Case Processing Snapshot
9.11 Apcer LifeSciences
9.11.1 Company Overview
9.11.2 Global Footprint
9.11.3 PV Case Processing Snapshot
9.12 iSafety Systems
9.12.1 Company Overview
9.12.2 Global Footprint
9.12.3 PV Case Processing Snapshot
9.13 4G Pharmacovigilance
9.13.1 Company Overview
9.13.2 Global Footprint
9.13.3 PV Case Processing Snapshot
9.14 Redline Pharmacovigilance
9.14.1 Company Overview
9.14.2 Global Footprint
9.14.3 PV Case Processing Snapshot
9.15 Oviya Medsafe
9.15.1 Company Overview
9.15.2 Global Footprint
9.15.3 PV Case Processing Snapshot
9.16 ProductLife Group (PLG)
9.16.1 Company Overview
9.16.2 Global Footprint
9.16.3 PV Case Processing Snapshot
9.17 Lindeq
9.17.1 Company Overview
9.17.2 Global Footprint
9.17.3 PV Case Processing Snapshot
9.18 Voisin Consulting LifeSciences (VCLS)
9.18.1 Company Overview
9.18.2 Global Footprint
9.18.3 PV Case Processing Snapshot
9.19 Ecron Acunova
9.19.1 Company Overview
9.19.2 Global Footprint
9.19.3 PV Case Processing Snapshot
9.20 Cmed Group
9.20.1 Company Overview
9.20.2 Global Footprint
9.20.3 PV Case Processing Snapshot
9.21 Regulis Consulting
9.21.1 Company Overview
9.21.2 Global Footprint
9.21.3 PV Case Processing Snapshot
9.22 NDA Group
9.22.1 Company Overview
9.22.2 Global Footprint
9.23 Synowledge
9.23.1 Company Overview
9.23.2 Global Footprint
9.23.3 PV Case Processing Snapshot
9.24 Prosar
9.24.1 Company Overview
9.24.2 Global Footprint
9.24.3 PV Case Processing Snapshot
9.25 Premier Research
9.25.1 Company Overview
9.25.2 Global Footprint
9.25.3 PV Case Processing Snapshot
9.26 Medpace
9.26.1 Company Overview
9.26.2 Global Footprint
9.26.3 PV Case Processing Snapshot
9.27 Vigilex
9.27.1 Company Overview
9.27.2 Global Footprint
9.27.3 PV Case Processing Snapshot
9.28 Sciformix
9.28.1 Company Overview
9.28.2 Global Footprint
9.28.3 PV Case Processing Snapshot
9.29 Symogen
9.29.1 Company Overview
9.29.2 Global Footprint
9.29.3 PV Case Processing Snapshot
9.30 RxLogix
9.30.1 Company Overview
9.30.2 Global Footprint
9.30.3 PV Case Processing Snapshot
9.31 Drug Safety Alliance
9.31.1 Company Overview
9.31.2 Global Footprint
9.31.3 PV Case Processing Snapshot
9.32 Quintiles
9.32.1 Company Overview
9.32.2 Global Footprint
9.32.3 PV Case Processing Snapshot
9.33 Sentrx Safety Solutions
9.33.1 Company Overview
9.33.2 Global Footprint
9.33.3 PV Case Processing Snapshot
9.34 Tata Consultancy Services (TCS)
9.34.1 Company Overview
9.34.2 Global Footprint
9.34.3 PV Case Processing Snapshot
9.35 ICON plc
9.35.1 Company Overview
9.35.2 Global Footprint
9.35.3 PV Case Processing Snapshot
9.36 Covance
9.36.1 Company Overview
9.36.2 Global Footprint
9.36.3 PV Case Processing Snapshot
9.37 PRA Health Sciences
9.37.1 Company Overview
9.37.2 Global Footprint
9.37.3 PV Case Processing Snapshot
9.38 Cognizant
9.38.1 Company Overview
9.38.2 Global Footprint
9.38.3 PV Case Processing Snapshot
9.39 Bristol-Myers-Squibb
9.39.1 Company Overview
9.39.2 Global Footprint
9.40 GlaxoSmithKline
9.40.1 Company Overview
9.40.2 Global Footprint
9.41 Sanofi
9.41.1 Company Overview
9.41.2 Global Footprint
9.42 Pfizer
9.42.1 Company Overview
9.42.2 Global Footprint
9.43 Roche
9.43.1 Company Overview
9.43.2 Global Footprint
List of Tables
Table 1  Case Processing Organizations Classification
Table 1.1  Sample FTE/Hour Cost Calculation Sheet
Table 2.1  Indicators to Measure ADRs
Table 2.2  Detection and Prevention of Adverse Events
Table 4.1  Mergers in Pharmacovigilance Market (2014-16)
Table 4.2  Acquisitions in Pharmacovigilance Market (2014-16)
Table 4.3  Latest Product Launches in Pharmacovigilance Market (2013-16)
Table 4.4  Key Partnerships and Collaborations in Pharmacovigilance Industry (2014-16)
Table 4.5  Key Expansions in Pharmacovigilance Industry (2013-16)
Table 4.6  Awards and Recognitions to Pharmacovigilance Companies (2013-16)
Table 4.7  Buyers and Suppliers in Global Pharmacovigilance Market
Table 4.8  Key Factors considered for threat from New Entrants in Global Pharmacovigilance Market
Table 4.9  Key Factors Affecting Bargaining Power of Buyers in the Global Pharmacovigilance Market
Table 4.10  Key Factors affecting the Bargaining Power of Suppliers in the Global Pharmacovigilance Market
Table 4.11  Key Factors affecting threat of Substitute Products or Services in the Global Pharmacovigilance Market
Table 4.12  Key Factors determining Rivalry among Existing Firms in the Global Pharmacovigilance Market
Table 5.1  Prominent Regulatory Agencies Region wise Working for Pharmacovigilance
Table 5.2  List of Consortiums and Agencies active in the Pharmacovigilance Industry
Table 5.3  List of Patents in Pharmacovigilance Market (2014-16)
Table 6.1  Clinical Trial Safety Monitoring Key Stakeholders
Table 6.2  Key Drugs Safety Issues
Table 6.4  Pharmacovigilance Market by Clinical Trials Insights, 2015-2022
Table 6.5  Pharmacovigilance Market Value for Preclinical Trials Insight by Service Provider Type, 2015-2022
Table 6.6  Pharmacovigilance Market Value for Preclinical Trials Insight by Geography, 2015-2022
Table 6.7  Pharmacovigilance Market Value for Phase I Clinical Trials Insight by Service Provider Type, 2015-2022
Table 6.8  Pharmacovigilance Market Value for Phase I Clinical Trials Insight by Geography, 2015-2022
Table 6.9  Pharmacovigilance Market Value for Phase II Clinical Trials Insight by Service Provider Type, 2015-2022
Table 6.10  Pharmacovigilance Market Value for Phase II Clinical Trials Insight by Geography, 2015-2022
Table 6.11  Pharmacovigilance Market Value for Phase III Clinical Trials Insight by Service Provider Type, 2015-2022
Table 6.12  Pharmacovigilance Market Value for Phase III Clinical Trials Insight by Geography, 2015-2022
Table 6.13  Pharmacovigilance Market Value for Phase IV Clinical Trials Insight by Service Provider Type, 2015-2022
Table 6.14  Pharmacovigilance Market Value for Phase IV Clinical Trials Insight by Geography, 2015-2022
Table 7.1  Pharmacovigilance Market Value by Service Provider Type, 2015-2022
Table 7.2  In-House Pharmacovigilance Market Value by Clinical Trials Insights, 2015-2022
Table 7.3  In-House Pharmacovigilance Market Value by Geography, 2015-2022
Table 7.4  Outsource Pharmacovigilance Market Value by Clinical Trial, 2015-2022
Table 7.5  Outsource Pharmacovigilance Market Value by Geography, 2015-2022
Table 8.1  North America Pharmacovigilance Market Value by Clinical Trials, 2015-2022
Table 8.2  North America Pharmacovigilance Market Value by Service Provider Type, 2015-2022
Table 8.3  Europe Pharmacovigilance Market Value by Clinical Trials, 2015-2022
Table 8.4  Europe Pharmacovigilance Market Value by Service Provider Type, 2015-2022
Table 8.5  APAC Pharmacovigilance Market Value by Clinical Trials, 2015-2022
Table 8.6  APAC Pharmacovigilance Market Value by Service Provider Type, 2015-2022
Table 8.7  ROW Pharmacovigilance Market Value by Clinical Trials, 2015-2022
Table 8.8  ROW Pharmacovigilance Market Value by Service Provider Type, 2015-2022
List of Figures
Figure 1  Serious Adverse Events Reported to FDA
Figure 2  Global Pharmacovigilance Market Size Snapshot
Figure 3  Global Pharmacovigilance Market by Clinical Trials Snapshot
Figure 4  Global Pharmacovigilance Service Provider Type Share (%), 2015 and 2022
Figure 5  Global Pharmacovigilance Market by Geography Snapshot
Figure 1.1  Global Pharmacovigilance Market Scope
Figure 1.2  Top Down and Bottom up Approach for Market Estimation
Figure 1.3  Average Cost/FTE/Region Case Processing Trend Analysis
Figure 2.1  Objectives of Pharmacovigilance
Figure 2.2  Pharmacovigilance Evolution
Figure 2.3  Need for Pharmacovigilance
Figure 2.4  ADEs Types
Figure 2.5  Number of Deaths due to various causes in the U.S. (2013)
Figure 2.6  Types of Medication Errors
Figure 3.1  Market Dynamics Snapshot
Figure 3.2  YoY growth of Adverse Events (2011-14)
Figure 3.3  Parameters for Safety Concerns
Figure 4.1  Pharmacovigilance Market Development Trends Share Analysis
Figure 4.2  Porter’s Five Forces Analysis for Global Pharmacovigilance Market
Figure 5.1  Pharmacovigilance Value Chain
Figure 6.1  Clinical Trial Phases in Drug Development Process
Figure 6.2  Key Preclinical Pharmacovigilance Services
Figure 6.3  Phase I-IV Pharmacovigilance Services
Figure 6.4  Pharmacovigilance Opportunity Matrix for Clinical Trials
Figure 6.5  Preclinical Safety Evaluation: Considerations
Figure 6.6  Preclinical Safety Evaluation Elements
Figure 6.7  Preclinical Safety Evaluation Primary Goals
Figure 6.8  Key Preclinical Pharmacovigilance Services Providers
Figure 6.9  Phase I Clinical Trial Process
Figure 6.10  Phase I Data Collection Parameters
Figure 6.11  Key Phase I Pharmacovigilance Services Providers
Figure 6.12  Phase II Clinical Trial Primary Goals
Figure 6.13  Key Phase II Pharmacovigilance Services Providers
Figure 6.14  Phase III Clinical Trial Primary Goals
Figure 6.15  Key Phase III Pharmacovigilance Services Providers
Figure 6.16  Phase IV Clinical Trial Primary Goals
Figure 6.17  Key Phase IV Pharmacovigilance Services Providers
Figure 7.1  Key Benefits of Outsourcing PV Activities
Figure 7.2  Pharmacovigilance Opportunity Matrix for Service Provider Type
Figure 7.3  Key In-House Pharmacovigilance Services Providers
Figure 7.4  Key Outsourcing Pharmacovigilance Services Providers
Figure 8.1  Global PV Market Geographical Segmentation
Figure 8.2  Pharmacovigilance Opportunity Matrix for Different Regions
Figure 8.3  Pharmacovigilance Market Value Snapshot by Geography, 2015-2022
Figure 8.4  Evolution of FDA Pharmacovigilance Activities and Requirements
Figure 8.5  Key Changes in the PV Legislation of Europe

Drug safety implies that the drug benefits outweigh the risks associated with them. During the past decade, there has been an increase in the serious outcomes related to the side effects of the drugs. Serious outcomes imply hospitalization, life-threats, disability, and death among others. 10-20% of patients suffer from serious Adverse Drug Reactions (ADRs) in hospitals and these ADRs may contribute to 5-10% of the hospital costs. Therefore, the monitoring and evaluation of the drug adverse effects becomes crucial for an effective medical practice.

The pharmacovigilance market is expected to reach a market size of $8.23 billion by 2022. Stringent compliance with drug safety regulations and increasing incidents of ADRs are acting as key drivers for the growth of this market. Pharmaceutical organizations are entering into collaborations with CROs and BPOs to perform pharmacovigilance activities during all the clinical trials phases. 

Pharmacovigilance in clinical trial Phase III is expected to grow at the highest CAGR during the forecast period because this phase covers large patient population for the medicinal product safety analysis before it becomes available officially. 

Pharmaceutical organizations perform their Pharmacovigilance (PV) activities either in-house or outsource them to outside vendors. Organizations may outsource either some of their specific PV activities or all their drug safety requirements. Pharmacovigilance acquired largest market share of for outsourcing in 2015 and is estimated to grow at a double digit CAGR during the forecast period. The growth of pharmacovigilance outsourcing will be driven by the outreach to a larger domain expertise, enhanced work output and reduced cost.

North America and Europe accounted for the largest and second largest market share respectively of the Pharmacovigilance market in 2015. Asia Pacific (APAC) is expected to grow at the highest CAGR during the forecast period because of the availability of cost effective Pharmacovigilance workforce. APAC region has the presence of 60% of the world population which is expected to increase clinical trials and act as a key driving factor for the growth of Pharmacovigilance in this region.

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