Pharmacovigilance Market

Global Pharmacovigilance Market: Increased regulatory convergence and stringent reporting measures to define pharmacovigilance activities globally

Introduction

The pharmacovigilance is defined as an exercise of monitoring the effects of drugs after they have been approved for use, particularly in order to identify and assess previously unreported adverse reactions. Rise in the prevalence of acute and chronic diseases has consequently led to an increase in the incidences of drug consumption, thus leading to growth in the number of adverse drug events and drug toxicity cases. Furthermore, factors such as safety regulations, risk of high-profile safety issues and large volume of post-market events to be reviewed along with negative media coverage have compelled the pharmaceutical players to take support of various outsourcing services for drug monitoring. Intensifying regulatory expectations, tougher inspection system and instant need for patient reporting are boosting the adoption rate of pharmacovigilance among pharmaceutical companies. Pharmaceutical companies are now entering into long-term partnerships/service agreements with CROs and BPOs to reduce the pharmacovigilance process related expenditure, incurred right from drug discovery to post-marketing approvals.

Market Value and Forecast

In terms of value, the global pharmacovigilance market is estimated to expand at a CAGR of 14.2% over the forecast period (2015-2020). The global pharmacovigilance market value is anticipated to increase from US$ 2,759.1 Mn in 2014 to US$ 6,104.1 Mn by 2020 end.

Market Dynamics

Growth of the pharmacovigilance market is mainly driven by rising prevalence of acute and chronic diseases, continuously increasing drug event monitoring as a result of the increasing drug consumption, surge in adverse drug reactions and drug toxicity and rise in adoption of outsourcing services. However, high risk associated with maintaining data security in pharmacovigilance outsourcing as well as unavailability of an appropriate pharmacovigilance system for herbal products in Asia Pacific might obstruct growth of the global pharmacovigilance market in the coming years.   

Market Segmentation by Phase of Drug Development

On the basis of phase of drug development, the market has been segmented into preclinical studies, phase I clinical trial, phase II clinical trial, phase III clinical trial and phase IV clinical trial or post-marketing surveillance. The post marketing surveillance or phase IV segment is accounted as largest market contributor, accounting for US$ 630.7 Mn in 2014. However, the clinical trial phase III segment is projected to expand at a CAGR of 15.5% during the forecast period from 2015 to 2020 due to strict regulatory compliances, increasing realisation among pharmaceuticals industries regarding the critical significance of safety data and need for complying to stringent public health policies.

Global Pharmacovigilance Market Value

Key Players

Some of the key players identified in the global pharmacovigilance market report are: Accenture plc, Bristol-Myers Squibb, Clinquest Group B.V., Cognizant Technology Solutions, Covance, Inc., F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc (GSK), ICON plc, iGATE Corporation, iMEDGlobal Corporation, inVentiv Health, Inc., Novartis International AG, PAREXEL International Corporation, Pfizer, Inc., Pharmaceutical Product Development, LLC. (PPD), PRA Health Sciences, Inc., Quintiles Transnational Holdings, Inc., Sanofi S.A., Synowledge LLC and Wipro Limited. The above mentioned companies are focused on monitoring proper documentation of adverse drug reactions, monitoring and regulating proper drug usage and identifying the proper drug administration levels – the basic tenets of pharmacovigilance.

Future Market Insights offers a 6-year forecast of the global pharmacovigilance market between 2015 and 2020. In terms of value, the market is expand at a CAGR of 14.2% during the forecast period. This study demonstrates market dynamics and trends in all seven regions that are expected to influence the current environment and future status of the pharmacovigilance market over the forecast period.

Report Description

This Future Market Insights report examines the pharmacovigilance market for the period 2015-2020. The primary objective of the report is to offer insights into developments in the pharmacovigilance market that are significantly transforming global businesses and enterprises.

The global pharmacovigilance market report begins by defining pharmacovigilance and its various segments. This is followed by an overview of the global pharmacovigilance market. The overview section includes FMI analysis of key trends, drivers, restraints, trends and opportunities that are influencing growth of the pharmacovigilance market currently. It also includes information related to the market shares of the major players in the market. Impact analyses of key growth drivers and restraints based on the weighted average model have been included in this report on the global pharmacovigilance market to better equip customers and readers with region specific trends and insights.

The primary driving factor for growth of the pharmacovigilance market is the significant increase witnessed in the intake of medical drugs. Besides, increase in prevalence of acute and chronic diseases has consequently led to an increase in incidences of drug consumption, thereby leading to a rise in the number of adverse drug events and drug toxicity cases. This, in turn, has triggered the growth of the pharmacovigilance market globally. Furthermore, safety regulations, risk of high-profile safety issues and need to review large volume of post-market events along with negative media coverage have compelled the pharmaceutical players to take support of various outsourcing services for drug monitoring. Factors such as intensifying regulatory expectations, tougher inspection system and instant need for patient reporting are boosting the adoption rate of pharmacovigilance among pharmaceutical companies globally. Pharmaceutical companies are now entering into long-term partnerships/service agreements with CROs and BPOs to reduce the pharmacovigilance process related expenditure, incurred right from drug discovery to post-marketing approvals.

The global pharmacovigilance market is segmented based on phase of drug development, type of reporting methods and type of service providers. On the basis of phase of drug development, the market has been segmented into preclinical studies, phase I clinical trial, phase II clinical trial, phase III clinical trial and phase IV clinical trial or post-marketing surveillance. On the basis of type of reporting methods, the market has been segmented into spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring and EHR mining. On the basis of the type of service providers, the market has been segmented into in-house and contract outsourcing. A detailed analysis has been provided for all segments and sub-segments in terms of market size, Y-o-Y growth rate, absolute $ opportunity and BPS analysis.

A deep market analysis along with market attractiveness index for each of the categories have been provided in the report. The next section of the report highlights the pharmacovigilance market by region. It provides a market outlook for 2015–2020 and sets the forecast within the context of the pharmacovigilance market. The study discusses key regional trends contributing to growth of the pharmacovigilance market worldwide, as well as analyses the extent to which the drivers are influencing this market in each region. Key regions assessed in this report include North America, Latin America, Western Europe, Eastern Europe, Asia Pacific Excluding Japan (APEJ), Japan and the Middle East & Africa.

The above sections, by phase of drug development, type of reporting methods and type of service providers and region, evaluate the present scenario and growth prospects of the pharmacovigilance market for the period 2015 –2020. We have considered 2014 as the base year and provided data for the forecast period, i.e. 2015–2020.

To ascertain the market size of pharmacovigilance, we have also considered revenue generated by pharmacovigilance companies. The forecast presented here assesses the total revenue generated across the pharmacovigilance market. In order to offer an accurate forecast, we started by sizing the current market, which forms the basis of how the pharmacovigilance market is expected to develop in the future. Given the characteristics of the market, we triangulated the outcome of three different types of analysis, based on supply side, downstream industry demand and the economic envelope.

In addition, it is imperative to note that in an ever-fluctuating global economy, we not only conduct forecasts in terms of CAGR, but also analyse the market based on key parameters, such as Year-on-Year (Y-o-Y) growth rates, to understand the predictability of the market and to identify the right growth opportunities in the market.

In this report, the pharmacovigilance market is segmented in terms of phase of drug development, type of reporting methods, type of service providers and region. These segments are analysed in terms of Basis Point Share (BPS) to understand individual segment’s relative contributions to market growth. This detailed level of information is important for identification of various key trends in the pharmacovigilance market.

Another key feature of this report is the analysis of key segments in terms of absolute dollar opportunity. This is traditionally overlooked while forecasting the market. However, absolute dollar opportunity is critical for assessing the level of opportunity that a provider can look to achieve, as well as to identify potential resources from a sales and delivery perspective of the pharmacovigilance market.

To understand key growth segments in terms of growth across the globe in the near future, Future Market Insights developed the pharmacovigilance market attractiveness index. The resulting index should help providers identify real market opportunities.

In the final section of the report, the ‘Competitive Landscape’ of the market is included to provide report audiences with a dashboard view, based on categories of providers in the value chain of the pharmacovigilance product portfolio and key differentiators. Key categories of providers covered in the report are pharmacovigilance companies. This section is primarily designed to provide clients with an objective and detailed comparative assessment of key providers specific to a market segment of the pharmacovigilance value chain and the potential players with respect to the same. Report audiences can gain segment-specific vendor insights to identify and evaluate key competitors based on their in-depth assessment of capabilities and successes in the pharmacovigilance marketplace.

Detailed profiles of the pharmacovigilance companies are also included in the scope of the report to evaluate their long-term and short-term strategies, key offerings, SWOT analysis and recent developments. Key players included in the report are Accenture plc, Bristol-Myers Squibb, Clinquest Group B.V., Cognizant Technology Solutions, Covance, Inc., F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc (GSK), ICON plc, iGATE Corporation, iMEDGlobal Corporation, inVentiv Health, Inc., Novartis International AG, PAREXEL International Corporation, Pfizer, Inc., Pharmaceutical Product Development, LLC. (PPD), PRA Health Sciences, Inc., Quintiles Transnational Holdings, Inc., Sanofi S.A., Synowledge LLC and Wipro Limited.

Key Segments Covered

By Phases of Drug Development

  • Preclinical Studies
  • Phase I
  • Phase II
  • Phase III
  • Phase IV or Post Marketing Surveillance

By Type of Method

  • Spontaneous Reporting
  • Intensified ADR Reporting
  • Targeted Spontaneous Reporting
  • Cohort Event Monitoring
  • EHR Mining

By Type of Service Provider

  • In-house Pharmacovigilance
  • Contract Outsourcing

Key Regions/Countries Covered

  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Western Europe
    • U.K.
    • France
    • Germany
    • Spain
    • Italy
    • Nordics
    • BENELUX
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
  • Asia Pacific Excluding Japan (APEJ)
    • Greater China
    • India
    • ASEAN
    • Australia and New Zealand
    • Rest of APEJ
  • Japan
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of MEA

Key Companies

  • Accenture plc
  • Bristol-Myers Squibb
  • Clinquest Group B.V.
  • Cognizant Technology Solutions
  • Covance, Inc.
  • Hoffmann-La Roche Ltd.
  • GlaxoSmithKline plc (GSK)
  • ICON plc
  • iGATE Corporation
  • iMEDGlobal Corporation
  • inVentiv Health, Inc.
  • Novartis International AG
  • PAREXEL International Corporation
  • Pfizer, Inc.
  • Pharmaceutical Product Development, LLC. (PPD)
  • PRA Health Sciences, Inc.
  • Quintiles Transnational Holdings, Inc.
  • Sanofi A.
  • Synowledge LLC
  • Wipro Limited

Table Of Content

1 Introduction 

1.1 Report Description 

1.2 Research Methodology 

1.3 Market Segmentation 

2 Executive Summary 

3 Global Pharmacovigilance Market Dynamics     

3.1 Introduction 

3.2 Market Drivers 

3.2.1 Increasing Consumption of Drugs Would Fuel Demand for Continuous Drug Event Monitoring 

3.2.2 Rise in Cases of Adverse Drug Reactions and Drug Toxicity Would Boost Demand for Pharmacovigilance Activities 

3.2.3 Rise in Adoption of Outsourcing Services Expected to Accentuate the Market Growth 

3.3 Market Restraints 

3.3.1 High Risk Associated with Data Security in Pharmacovigilance Outsourcing 

3.3.2 Lack of Availability of Skilled Labour Might Hinder the Market Growth 

3.3.3 Inadequate Pharmacovigilance System for Herbal Products in Asia Pacific Might Hamper the Market Growth 

3.4 Market Opportunities 

3.4.1 Huge Scope for Rapid Growth of Pharmacovigilance Market in Emerging Economies 

3.4.2 Shift in Preference for Outsourcing among Various Pharmaceutical and Life Sciences Companies 

3.5 Porter’s Five Forces Analysis: Global Pharmacovigilance Market 

3.5.1 Bargaining Power of Suppliers 

3.5.2 Bargaining Power of Buyers 

3.5.3 Threat of Substitutes 

3.5.4 Threat of New Entrants 

3.5.5 Competitive Rivalry 

3.6 Market Attractiveness Analysis: Global Pharmacovigilance Market, by Geography 

3.7 Competitive Landscape 

3.7.1 Market Share Analysis: Global Pharmacovigilance Market, 2014 (Value %) 

4 Global Pharmacovigilance Market, by Phase of Drug Development 

4.1 Overview 

4.1.1 Global Pharmacovigilance Market Revenue, by Phase of Drug Development, 2014-2020 (US$ Mn) 

4.1.2 Comparative Analysis: Global Pharmacovigilance Market Revenue, by Type of Clinical Trial Phases, 2014(Value %) 

4.2 Preclinical Studies 

4.2.1 Global Preclinical Studies Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

4.3 Phase I 

4.3.1 Global Phase I Clinical Trial Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

4.4 Phase II 

4.4.1 Global Phase II Clinical Trial Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

4.5 Phase III 

4.5.1 Global Phase III Clinical Trial Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

4.6 Phase IV or Post Marketing Surveillance 

4.6.1 Global Phase IV Clinical Trial Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

5 Global Pharmacovigilance Market, By Type of Methods 

5.1 Overview 

5.1.1 Global Pharmacovigilance Market Revenue, by Type of Method , 2014-2020 (US$ Mn) 

5.2 Comparative Analysis: Global Pharmacovigilance Market Revenue, by Type of Method, 2014(Value %) 

5.3 Spontaneous Reporting 

5.3.1 Global Spontaneous Reporting Market Revenue, 2014-2020 (US$ Mn) 

5.4 Intensified ADR Reporting 

5.4.1 Global Intensified ADR Reporting Market Revenue, 2014-2020 (US$ Mn) 

5.5 Targeted Spontaneous Reporting 

5.5.1 Global Targeted Spontaneous Reporting Market Revenue, 2014-2020 (US$ Mn) 

5.6 Cohort Event Monitoring 

5.6.1 Global Cohort Event Monitoring Market Revenue, 2014-2020 (US$ Mn) 

5.7 EHR Mining 

5.7.1 Global EHR Mining Market Revenue, 2014-2020 (US$ Mn) 

6 Global Pharmacovigilance Market, by Type Service Provider 

6.1 Overview 

6.1.1 Global Pharmacovigilance Market Revenue, by Type of Service Provider, 2014-2020 (US$ Mn) 

6.1.2 Comparative Analysis: Global Pharmacovigilance Market, by Type of Service Providers, 2014 (Value %) 

6.2 In-house Pharmacovigilance 

6.2.1 Global In-House Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

6.3 Contract Outsourcing 

6.3.1 Global Contract Outsourcing Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

7 Global Pharmacovigilance Market, by Geography 

7.1 Overview 

7.1.1 Global Pharmacovigilance Market Revenue, by Geography, 2014-2020 (US$ Mn) 

7.2 North America 

7.2.1 North America Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

7.3 Europe 

7.3.1 Europe Pharmacovigilance Market Revenue, 2014-2020  (US$ Mn) 

7.4 Asia Pacific 

7.4.1 Asia Pacific Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

7.5 Rest of the World (RoW) 

7.5.1 RoW pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

8 Recommendations

8.1 Market Strategy 

8.1.1 Strategic Partnerships and Collaborations With CROs And Life Sciences BPOs 

8.1.2 Optimization of Drug Safety Through Hub and Spoke Model 

8.1.3 Developing Operational Activities for Better Outcomes 

8.1.4 Regional Expansion 

9 Company Profiles 

9.1 Accenture plc  

9.2 Bristol-Myers Squibb  

9.3 Clinquest Group B.V.  

9.4 Cognizant Technology Solutions  

9.5 Covance, Inc. 

9.6 F. Hoffmann-La Roche Ltd.  

9.7 GlaxoSmithKline plc (GSK)  

9.8 ICON plc 

9.9 iGATE Corporation  

9.10 iMEDGlobal Corporation  

9.11 inVentiv Health, Inc.  

9.12 Novartis International AG  

9.13 PAREXEL International Corporation  

9.14 Pfizer, Inc.

9.15 Pharmaceutical Product Development, LLC. (PPD)

9.16 PRA Health Sciences, Inc.

9.17 Quintiles Transnational Holdings, Inc.

9.18 Sanofi S.A.

9.19 Synowledge LLC

9.20 Wipro Limited

List of Tables

TABLE 1 : Market Snapshot: Pharmacovigilance Market 

TABLE 2 : Global Pharmacovigilance Market Revenue, by Phases of Drug Development, 2014-2020 (US$ Mn) 

TABLE 3 : Global Pharmacovigilance Market Revenue, by Type of Method, 2014-2020 (US$ Mn) 

TABLE 4: Global Pharmacovigilance Market Revenue, by Type of Service Provider, 2014-2020 (US$ Mn) 

TABLE 5 : Global Pharmacovigilance Market Revenue, by Geography, 2014-2020 (US$ Mn)

List of Figures

FIG. 1: Drug Safety from Molecule to Market 

FIG. 2: Pharmacovigilance: Market Segmentation 

FIG. 3: Global Pharmacovigilance Market, by Phase of Drug Development, 2014 (US$ Mn) 

FIG. 4: Global Pharmacovigilance Market, by Type of Service Provider, 2014 (US$ Mn) 

FIG. 5: Global Pharmacovigilance Market, by Type of Method, 2014 (US$ Mn) 

FIG. 6: Comparative Analysis: Global Pharmacovigilance Market, by Geography, 2014 (Value %) 

FIG. 7: Porter’s Five Forces Analysis: Global Pharmacovigilance Market 

FIG. 8: Market Attractiveness Analysis: Global Pharmacovigilance Market, by Geography (2014) 

FIG. 9: Global Pharmacovigilance Market Share Analysis, by Key Player, 2014(%) 

FIG. 10: Safety Services: Product Lifecycle 

FIG. 11: Comparative Analysis: Global Pharmacovigilance Market Revenue, by Phase of Drug Development, 2014(Value %) 

FIG. 12: Global Preclinical Studies Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 13: Global Phase I Clinical Trial Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 14: Global Phase II Clinical Trial Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 15: Global Phase III Clinical Trial Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 16: Global Phase IV Clinical Trial Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 17: Comparison of Methods: Pharmacovigilance reporting 

FIG. 18: Comparative Analysis: Global Pharmacovigilance Market Revenue, by Type of Method, 2014 & 2020 (Value %) 

FIG. 19: Global Spontaneous Reporting Market Revenue, 2014-2020 (US$ Mn) 

FIG. 20: Global Intensified ADR Reporting Market Revenue, 2014-2020 (US$ Mn) 

FIG. 21: Global Targeted Spontaneous Reporting Market Revenue, 2014-2020 (US$ Mn) 

FIG. 22: Global Cohort Event Monitoring Market Revenue, 2014-2020 (US$ Mn) 

FIG. 23: Global EHR Mining Market Revenue, 2014-2020 (US$ Mn) 

FIG. 24: End-to-End Safety Across the Lifecycle 

FIG. 25: Comparative Analysis: Global Pharmacovigilance Market, by Type of Service Provider, 2014 & 2020 (Value %) 

FIG. 26: Global In-House Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 27: Global Contract Outsourcing Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 28: North America Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 29: Europe Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 30: Asia Pacific Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 31: RoW Pharmacovigilance Market Revenue, 2014-2020 (US$ Mn) 

FIG. 32: Accenture, Plc.: Annual Revenue 2014 (US$ Bn)     

FIG. 33: Bristol-Myers Squibb: Annual Revenue, 2014 (US$ Mn) 

FIG. 34: Cognizant Technology Solutions: Annual Revenue, 2014 (US$ Mn) 

FIG. 35: COVANCE, Inc.: Annual Revenue, 2014 (US$ Mn) 

FIG. 36: F. Hoffmann-La Roche Ltd., Annual Revenue: 2014 (US$ Mn) 

FIG. 37: GlaxoSmithKline plc (GSK): Annual Revenue, 2014(US$ Mn) 

FIG. 38: ICON plc: Annual Revenue, 2014 (US$ Mn) 

FIG. 39 iGATE Corporation: Annual Revenue, 2014 (US$ Mn) 

FIG. 40: Novartis International AG: Annual Revenue, 2014 (US$ Mn) 

FIG. 41: PAREXEL International Corporation: Annual Revenue 2014 (US$ Mn) 

FIG. 42: Pfizer, Inc.: Annual Revenue, 2014 (US$ Mn) 

FIG. 43: PRA Health Sciences, Inc., Annual Revenue: 2014 (US$ Mn) 

FIG. 44: Quintiles Transnational Holdings, Inc.: Annual Revenue, 2014 (US$ Mn) 

FIG. 45: Sanofi: Annual Revenue, 2014 (US$ Mn) 

FIG. 46: Wipro Limited: Annual Revenue 2014 (US$ Mn)