Market Research Reports

Pharmacovigilance Market Clinical Trial Phases (Pre-Clinical Studies, Phase I, Phase II, Phase III, Phase IV or Post-Marketing Surveillance) and Service Providers (In-House and Contract Outsourcing - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019

159pages
Published Date: 2014-02-28
 

Description



A rising tide of regulatory expectations, tougher inspection regime and instant need of patient reporting has provided the much needed impetus for the growth of the pharmacovigilance market. An upsurge in number of acute and chronic diseases has consequently led to a rise in number of drug consumption, which has also elicited a growth in the number of adverse drug events and drug toxicity cases. Moreover, several high-profile safety issues, regulatory warnings, large volume of events to be reviewed along with negative media coverage have compelled the pharmaceutical players to take support of various outsourcing services. Contract manufacturing is a concept favored by the recent army of big and successful manufacturers. Reducing cost helps a company to assign its investments into other areas like branding, marketing and other sales promoting activities that require constant attention. There are two major outsourcing services opted by these pharmaceutical players i.e. traditional CROs and BPOs. These outsourcing services not only provide cost savings but also help in bringing process efficiency; they also help reduce stagnancy in productivity volume and cost pressures and arrest any concerns of regulatory changes. Pharmaceutical companies are now forming long term partnership with the CROs and BPOs to share the costs involved in PV process right from drug discovery to post marketing approvals. In addition, PV requires skilled resources with excellent language skills and strong knowledge pertaining to case reporting. 

This research report provides a detailed analysis of the global pharmacovigilance market and helps in understanding the various driving factors for the growth of the market. The market overview section of this report analyzes the market dynamics and trends such as drivers, restraints and opportunities that influence the current nature and future status of this market. The executive summary provides detailed insights about the report and the market in general. It also provides a market snapshot, which in ways a glimpse into the present scenario of the pharmacovigilance market.  Impact factors such as market attractiveness analysis and Porter’s five forces analysis have also been explained in the market overview section of the report in order to deliver a thorough analysis of the overall competitive scenario of the global pharmacovigilance market. 

The report further discusses the market of pharmacovigilance market on the bases of clinical trials phases i.e. Phase I to III and post marketing surveillance (PMS). We have also mapped the trend for preference of the pharmaceutical players for in-house and outsourcing in our chapter by type of service.

The global pharmacovigilance market has been segmented based on all the above mentioned parameters and market size estimates and forecasts for the period of 2011 to 2019 have been provided for each of the segments, in term of USD million, considering 2012 as the base year for calculations and 2011 representing as the historical year. The CAGR (%) of each market segment for the forecast period 2013 to 2019 has also been provided along with market size estimations.

The report exclusively studies the aforementioned segments with respect to geography. Under geographic section we have covered four regions, namely, North America, Europe, Asia-Pacific and Rest of the World (ROW). 

This is followed by the market recommendations for the healthcare CMO market; these include factors that may play a critical role in enhancing or boosting the market in the near future, as well as the steps that need to be taken to ensure success for manufacturers in the near future. 

The report concludes with the competitive landscape and company profiles of major market players. These market players have been profiled on the basis of various attributes such as company overview, financial overview, business strategies, product portfolio and recent developments. Some of the major players profiled in this report include PRA International Inc., Covance Inc., Synowledge LLC, OptumInsight Inc., iMedGlobal, TCS, iGATE Corporation, Cognizant Technology Solutions, Quintiles and others.

Table of Contents


Table of Content

Chapter 1 Introduction
1.1 Report Description
1.2 Research Methodology
1.3 Market Segmentation

Chapter 2 Executive Summary

Chapter 3 Global Pharmacovigilance Market Dynamics
3.1 Introduction
      3.1.1 Drivers
               3.1.1.1 Rise in number of drug consumption
               3.1.1.2 Rise in drug toxicity cases producing significant morbidity and mortality
               3.1.1.3 Embracing new technologies to mitigate risk
               3.1.1.4 Rise in adoption of pharmacovigilance outsourcing services
               3.1.1.5 Globalization of drug development with shift from manufacturing activities from high cost to low cost regions
      3.1.2 Restraints
               3.1.2.1 Stringent and varied regulatory approval processes
      3.1.3 Challenges
               3.1.3.1 Lack of availability of skilled labor
3.2 Porter’s Five Force Analysis: Global Pharmacovigilance Market
      3.2.1 Bargaining Power of Suppliers
      3.2.2 Bargaining Power of Buyers
      3.2.3 Threat of New Entrants
      3.2.4 Threat of Substitutes
      3.2.5 Competitive Rivalry
3.3 Market Attractiveness Analysis of the Global Pharmacovigilance Market, by Geography
      3.3.1 Market Attractiveness Analysis: Global Pharmacovigilance Market, 2012, by Geography

Chapter 4 Global Pharmacovigilance Market, by Clinical Trial Phases
4.1 Overview
      4.1.1 Preclinical Studies
              4.1.1.1 Global Preclinical Studies Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
      4.1.2 Phase I trial
              4.1.2.1 Global Clinical Trial Phase I Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
      4.1.3 Phase II trial
               4.1.3.1 Global Clinical Trial Phase II Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
      4.1.4 Phase III trial
              4.1.4.1 Global Clinical Trial Phase III Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
      4.1.5 Phase IV trial (Post marketing surveillance)
              4.1.5.1 Global Clinical Trial Phase IV Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)

Chapter 5 Global Pharmacovigilance Market, By Type of Methods
5.1 Overview
      5.1.1 Spontaneous Reporting
               5.1.1.1 Global Spontaneous Drug Safety Reporting Market Revenue, 2011 – 2019 (USD Million)
      5.1.2 Targeted Reporting
               5.1.2.1 Global Targeted Drug Safety Reporting Market Revenue, 2011 – 2019 (USD Million)
      5.1.3 Cohort Event Monitoring
               5.1.3.1 Global Cohort Event Monitoring Market Revenue, 2011 – 2019 (USD Million)
      5.1.4 EHR Monitoring
              5.1.4.1 Global Electronic Health Records (EHR) Monitoring Market Revenue, 2011 – 2019 (USD Million)
      5.1.5 Intensified ADR Reporting
               5.1.5.1 Global Intensified ADR Reporting Market Revenue, 2011 – 2019 (USD Million)

Chapter 6 Global Pharmacovigilance Market, by Type of Service Providers
6.1 Overview
      6.1.1 In-House
               6.1.1.1 Global In-House Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
      6.1.2 Contract Outsourcing
               6.1.2.1 Global Contract Outsourcing Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)

Chapter 7 Global Pharmacovigilance Market, by Geography
7.1 Overview
      7.1.1 Comparative Analysis: Global Pharmacovigilance Market, by Geography, 2012 & 2019 (Value %)
7.2 North America
      7.2.1 North America Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
7.3 Europe
      7.3.1 Europe Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
7.4 Asia Pacific
      7.4.1 Asia-Pacific Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
7.5 Rest of the World
      7.5.1 Rest of the World Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)

Chapter 8 Global Pharmacovigilance Market Share Analysis
8.1 Market Share Analysis by Key Players of Global Pharmacovigilance Market
      8.1.1 Global CRO Market Share Analysis, by Key Players, 2012 (%)

Chapter 9 Recommendations
9.1 Success Strategies
      9.1.1 Developing Strategic Alliances and Partnerships With CROs and Life Science BPOs Companies
      9.1.2 Hub and Spoke model to optimize drug safety
      9.1.3 Enhancing operational activities for better outcomes
      9.1.4 Expand Market into Emerging Countries

Chapter 10 Company Profiles
10.1 Accenture, Plc
      10.1.1 Company Overview
      10.1.2 Financial Overview
      10.1.3 Product Portfolio
      10.1.4 Business Strategies
                10.1.4.1 Mergers and acquisitions
      10.1.5 Recent Developments
10.2 Bristol-Myers Squibb
      10.2.1 Company Profile
      10.2.2 Financial overview
      10.2.3 Product Portfolio
      10.2.4 Business Strategies
                10.2.4.1 Strategic collaboration
                10.2.4.2 Research and Development Initiatives
                10.2.4.3 Recent Developments
10.3 Clinquest Group B.V.
      10.3.1 Company Overview
      10.3.2 Product Portfolio
      10.3.3 Business Strategies
                10.3.3.1 Strategic partnership
      10.3.4 Recent Developments
10.4 Cognizant Technology Solutions
       10.4.1 Company Overview
       10.4.2 Financial Overview
       10.4.3 Product Portfolio
       10.4.4 Business Strategies
                 10.4.4.1 Expansion of geographical footprint
                 10.4.4.2 Expansion of product portfolio
                 10.4.4.3 Highly-skilled manpower
                 10.4.4.4 Strategic acquisitions
      10.4.5 Recent Developments
10.5 Covance, Inc.
       10.5.1 Company Overview
       10.5.2 Financial Overview
       10.5.3 Product Portfolio
       10.5.4 Business Strategies
                 10.5.4.1 New product development and innovation
                 10.5.4.2 Agreements and collaborations
                 10.5.4.3 Strategic acquisitions
                 10.5.4.4 Geographical expansion of business
       10.5.5 Recent Developments
10.6 GlaxoSmithKline (GSK)
        10.6.1 Company Overview
        10.6.2 Financial overview
        10.6.3 Product Portfolio
        10.6.4 Business strategies
                  10.6.4.1 Research and development initiatives
                  10.6.4.2 Direct to Consumer Advertising
                  10.6.4.3 Mergers and acquisitions
       10.6.5 Recent developments
10.7 ICON, Plc
       10.7.1 Company Overview
       10.7.2 Financial Overview
       10.7.3 Product Portfolio
       10.7.4 Business Strategies
                 10.7.4.1 Business expansion in APAC region
                 10.7.4.2 Expansion of services offered
       10.7.5 Recent Developments
10.8 iGATE Corporation
       10.8.1 Company Overview
       10.8.2 Financial Overview
       10.8.3 Product Portfolio
       10.8.4 Business Strategies
                 10.8.4.1 Strategic Acquisition
       10.8.5 Recent Developments
10.9 iMEDGlobal Corporation
       10.9.1 Company Overview
       10.9.2 Product Portfolio
       10.9.3 Business Strategies
                 10.9.3.1 Geographical Expansion
       10.9.4 Recent Developments
10.10 Infosys
       10.10.1 Company Overview
       10.10.2 Financial Overview
       10.10.3 Product Portfolio
       10.10.4 Business Strategies
                   10.10.4.1 Extensive product portfolio
                   10.10.4.2 Geographical expansion of business
       10.10.5 Recent Developments
10.11 inVentiv Health Inc.
       10.11.1 Company Overview
       10.11.2 Product Portfolio
       10.11.3 Business Strategies
                   10.11.3.1 Strategic Partnership
                   10.11.3.2 Strategic Acquisition
       10.11.4 Recent Developments
10.12 Johnson and Johnson
       10.12.1 Company Profile
       10.12.2 Financial Overview
       10.12.3 Product Portfolio
       10.12.4 Business Strategies
                   10.12.4.1 Extensive Research and Development Investments
                   10.12.4.2 Strategic Collaborative Arrangements
                   10.12.4.3 Recent Developments
10.13 Novartis International AG
         10.13.1 Company Overview
         10.13.2 Financial Overview
         10.13.3 Product Portfolio
         10.13.4 Business Strategy
                     10.13.4.1 Mergers and Acquisitions
         10.13.5 Recent Developments
10.14 OptumInsight, Inc.
         10.14.1 Company Overview
         10.14.2 Product Portfolio
         10.14.3 Business Strategies
                     10.14.3.1 Strategic product launch
                     10.14.3.2 Strategic collaboration
         10.14.4 Recent Developments
10.15 Parexel International Corporation
         10.15.1 Company Overview
         10.15.2 Financial Overview
         10.15.3 Product Portfolio
                     10.15.3.1 Strong presence in Asia and emerging markets
                     10.15.3.2 Strategic alliances
                     10.15.3.3 Mergers & Acquisitions
         10.15.4 Recent Developments
10.16 Pfizer, Inc.
          10.16.1 Company Overview
          10.16.2 Financial Overview
          10.16.3 Product Portfolio
          10.16.4 Business Strategies
                      10.16.4.1 Acquisitions
          10.16.5 Recent Developments
10.17 Pharmaceutical Product Development, Inc. (PPD, Inc.)
          10.17.1 Company Overview
          10.17.2 Product Portfolio
          10.17.3 Business Strategies
                      10.17.3.1 Expanding geographic presence
                      10.17.3.2 Incorporation of innovative technologies
                      10.17.3.3 Strategic acquisitions
                      10.17.3.4 New product launch and innovation
          10.17.4 Recent Developments
10.18 PRA International, Inc.
          10.18.1 Company Overview
          10.18.2 Product Portfolio
          10.18.3 Business Strategies
                      10.18.3.1 Mergers and acquisitions
          10.18.4 Recent Developments
10.19 Quantum Solutions India
          10.19.1 Company Overview
          10.19.2 Product Portfolio
          10.19.3 Business Strategies
                      10.19.3.1 Strategic Collaborations
10.20 Quintiles Transnational Corporation
          10.20.1 Company Overview
          10.20.2 Financial Overview
          10.20.3 Product Portfolio
          10.20.4 Business Strategies
                      10.20.4.1 Expansion of services
                      10.20.4.2 Acquisitions and partnerships
                      10.20.4.3 Innovation in services offered
          10.20.5 Recent Developments
10.21 F. Hoffmann-La Roche Ltd.
          10.21.1 Company Overview
          10.21.2 Financial Overview
          10.21.3 Product Portfolio
          10.21.4 Business Strategies
                      10.21.4.1 Licensing Agreement
                      10.21.4.2 Product portfolio expansion
10.22 Sanofi Aventis
          10.22.1 Company Overview
          10.22.2 Financial Overview
          10.22.3 Product Portfolio
          10.22.4 Business Strategy
                      10.22.4.1 Renewal of cooperation protocol
                      10.22.4.2 Recent developments
10.23 Synowledge LLC
          10.23.1 Company Overview
          10.23.2 Product Portfolio
          10.23.3 Business Strategies
                      10.23.3.1 Geographical Expansion
                      10.23.3.2 Strategic Partnership
          10.23.4 Recent Developments
10.24 United BioSource Corporation
          10.24.1 Company Overview
          10.24.2 Product Profiling
          10.24.3 Business Strategies
                      10.24.3.1 Strategic acquisitions
10.25 Wipro Limited
          10.25.1 Company Overview
          10.25.2 Financial Overview
          10.25.3 Product Portfolio
          10.25.4 Business Strategies
                      10.25.4.1 Geographical expansion

List of Figures

FIG. 1 Drug Safety From Molecule to Market
FIG. 2 Global Pharmacovigilance : Market Segmentation
FIG. 3 Global Pharmacovigilance Market, by Type of Service Providers, 2012 (USD Million)
FIG. 4 Global Pharmacovigilance Market, by Type of Clinical Trial Phases, 2012 (USD Million)
FIG. 5 Global Pharmacovigilance Market, by Type of Methods, 2012 (USD Million)
FIG. 6 Global Pharmacovigilance Market: Drivers and Restraints
FIG. 7 Porter’s Five Force Analysis: Global Pharmacovigilance Market
FIG. 8 Market Attractiveness Analysis: Global Pharmacovigilance Market, 2012, by Geography
FIG. 9 Safety Services : Product Lifecycle
FIG. 10 Global Preclinical Studies Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 11 Global Clinical Trial Phase I Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 12 Global Clinical Trial Phase II Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 13 Global Clinical Trial Phase III Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 14 Global Clinical Trial Phase IV Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 15 Comparison of Methods: Pharmacovigilance reporting
FIG. 16 Global Spontaneous Drug Safety Reporting Market Revenue, 2011 – 2019 (USD Million)
FIG. 17 Global Targeted Drug Safety Reporting Market Revenue, 2011 – 2019 (USD Million)
FIG. 18 Global Cohort Event Monitoring Market Revenue, 2011 – 2019 (USD Million)
FIG. 19 Global Electronic Health Records (HER) Monitoring Market Revenue, 2011 – 2019 (USD Million)
FIG. 20 Global Intensified ADR Reporting Market Revenue, 2011 – 2019 (USD Million)
FIG. 21 End-to-End Safety Across the Lifecycle
FIG. 22 Global In-House Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 23 Global Contract Outsourcing Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 24 Comparative Analysis: Global Pharmacovigilance Market, by Geography, 2012 & 2019 (Value %)
FIG. 25 North America Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 26 Europe Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 27 Asia-Pacific Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 28 Rest of the World Pharmacovigilance Market Revenue, 2011 – 2019 (USD Million)
FIG. 29 Global CRO: Market Share, by Key Players, 2012 (%)
FIG. 30 Accenture, Plc.: Annual Revenue (USD Billion) 2010 – 2012
FIG. 31 Bristol-Myers Squibb: annual sales revenue, USD million, 2010 – 2012
FIG. 32 Cognizant Technology Solutions: Annual Sales Revenue, USD Million (2010– 2012)
FIG. 33 COVANCE, Inc.: Annual Sales Revenue, USD Billion (2010– 2012)
FIG. 34 GSK, Annual Sales Revenue, 2010 – 2012 (USD million) (Conversion rate: 1 GBP = 1.6651 USD)
FIG. 35 ICON, PLC: Annual Sales Revenue, USD Million (2010– 2012)
FIG. 36 iGATE Corporation, Annual Revenue: 2010 – 2012 (USD Million)
FIG. 37 Infosys: Annual Sales Revenue, USD Million (2010– 2012)
FIG. 38 Johnson and Johnson: annual sales revenue, USD million, 2010 – 2012
FIG. 39 Novartis International AG., Annual Sales: 2010 – 2012 (USD Million)
FIG. 40 Parexel International Corporation: Annual Sales Revenue, USD Million (2010– 2012)
FIG. 41 Pfizer, Inc.: Annual Revenue, 2010 – 2012 (USD Million)
FIG. 42 Quintiles Transnational Corporation: Annual Sales Revenue, USD Billion (2010– 2012)
FIG. 43 F. Hoffmann-La Roche Ltd., Annual Revenue: 2010 – 2012 (USD Million) (1 CHF = 1.09 USD)
FIG. 44 Sanofi: Annual Sales Revenue, 2010 – 2012 (USD million)
FIG. 45 Wipro Limited: Annual Revenue (USD Million) 2010 – 2012

List of Tables

TABLE 1 Market Snapshot : Pharmacovigilance Market
TABLE 2 List of Drugs Withdrawn Recently:
TABLE 3 Global Pharmacovigilance Market Revenue, By Type of Clinical Trial Phases, 2011 – 2019 (USD Million)
TABLE 4 Global Pharmacovigilance Market Revenue, By Type of Methods, 2011 – 2019 (USD Million)
TABLE 5 Global Pharmacovigilance Market Revenue, By Type of Service Providers, 2011 – 2019 (USD Million)
TABLE 6 Global Pharmacovigilance Market Revenue, By Geography, 2011 – 2019 (USD Million)

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Free Market Analysis


Pharmacovigilance is defined as the science and activities involved in detecting, assessing, evaluating and preventing adverse reactions or any other drug related problems of medicinal products. The rapid and interminable growth of pharmaceutical industry has resulted in an increased availability of medications that can treat, diagnose, prevent and manage various diseases efficiently. Despite surfeit of benefits, these newly developed drugs are associated with a number of adverse reactions that may range from mild to severe side effects frequently resulting in illness, disabilities and even death. To remedy this most of the pharmaceutical companies are monitoring and assessing safety issues of the newly developed medical products through well-organized system called Pharmacovigilance. Today, pharmacovigilance is considered as a continuous process of evaluation in most of the pharmaceutical companies to reduce the risks associated in bringing the new drug in to the market and to improve the safe usage of medicinal products. The proper rules and guidelines for implementation of drug safety monitoring programs has been formulated by various national and international regulatory authorities such as World Health Organization (WHO) and United States Food and Drugs Administration (USFDA). 

The global pharmacovigilance market has been segmented based on the type of clinical trials phases, type of service providers and by type of methods used in drug safety reporting. The total market for global pharmacovigilance services is estimated to be USD 2,147.3 million in 2012 and is forecast to grow at a CAGR of 12.9% from 2013 to 2019. Based on the type of service providers, the market has been segmented in to in-house and contract outsourcing services. Among these, contract outsourcing services market accounts for the largest market share in 2012 and expected to continue the same till 2019 owing to the high cost involvement, growing regulatory concerns and requirement of highly qualified professionals for drug safety reporting. Based on type of clinical trials phases, the total market for pharmacovigilance services is categorized into pre-clinical studies, phase I, II, III and IV (post-marketing surveillance services). Among afore-mentioned services, the market for phase IV services accounts for the largest market share in 2012. The contributing factors for such an assessment includes rise in the number safety concerns for marketed products and rise in public safety issues coupled with growing public awareness about the drug safety issues. In addition, based on type of methods used in drug safety reporting, the market for pharmacovigilance services market has beenclassified in to spontaneous reporting, intensified ADR reporting, targeted reporting, EHR monitoring and cohort event monitoring. Among all the above mentioned types, spontaneous reporting is the most commonly used system by the pharmaceutical companies foradverse event reporting and accounts for largest market of overall market in 2012 i.e. 29.6%.   

Geographically, the North American region constituted the largest market for global pharmacovigilance market in 2012; however, Asia-Pacific is predicted to foresee the highest growth rate of 15.2% from 2013 to 2019. This growth has been attributed tolarge population base, low healthcare cost and high enrolment rate of patients. In addition, favorable government support coupled withgrowing pharmaceutical industry would trigger the growth of this market in Asian-Pacific region.

The leading market players for pharmacovigilance services include Quintiles Transnational Corporation, Parexel International Corporation, PRA International, PPD, Novartis, Pfizer, Cognizant Technology Solutions and iGATE Corporation.

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