Pharmacovigilance market

Pharmacovigilance Market, By Type of Clinical Trial Phases (Pre-clinical Studies, Clinical Trial Phase I, Clinical Trial Phase II, Clinical Trial Phase III, Post Marketing Surveillance or Phase IV), By Type of Method (Spontaneous Reporting, Intensified ADR Reporting, Targeted Reporting, Cohort Event Monitoring, EHR Monitoring), By Type of Service Providers (In-House, Contract Outsourcing), By Region (North America, Latin America, Europe, Asia Pacific, Middle East & Africa) - Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027

  • Sep 2020
  • CMI1047
  • 175 Pages
  • Excel & Pdf
  • Healthcare IT

Pharmacovigilance is a study of safety and efficacy of a medical product or drug. It is a science associated with the collection, detection, assessment, and prevention of adverse effects related with the medical product or drug.

Statistics:

The global pharmacovigilance market is estimated to account for US$ 13,284.0 Mn in terms of value by the end of 2027.

Global Pharmacovigilance Market: Drivers

Adverse drug or vaccine reactions are expected to propel growth of the global pharmacovigilance market over the forecast period. For instance, in September 2020, AstraZeneca voluntarily paused a randomized clinical trial of its coronavirus vaccine, owing to development of an unexplained illness in a volunteer.

Moreover, increasing number of clinical trials is also expected to aid in growth of the global pharmacovigilance market. For instance, according to the U.S. National Library of Medicine, the number of clinical trials conducted in the U.S. increased from 30,978 in 2018 to 32,523 in 2019. 

Statistics:

North America held dominant position in the global pharmacovigilance market in 2019, accounting for 37.2% share in terms of value, followed by Asia Pacific and Europe, respectively.

Figure 1: Global Pharmacovigilance Market Share (%) Value, By Region, 2019

Global Pharmacovigilance Market: Restraints

Hurdles in automating pharmacovigilance are expected to hinder growth of the global pharmacovigilance market. For instance, in September 2020, Arriello, a provider of regulatory affairs & pharmacovigilance solutions and services for life sciences, reported that while the majority of organizations professed to have implemented some form of pharmacovigilance automation, or plan to do so over the next 12 months, most lack sufficient IT insight and capability to automate adverse event case intake.

Moreover, stringent and varied regulatory approval processes are also expected to limit the market growth. Regulatory bodies are increasingly scrutinizing the safety of newly launched and established drugs in the market. The U.S. FDA, in particular, has implemented new rules and regulations to curb the growing number of adverse drug reactions through amendments such as RiskMap, the Amendments Act of 2007 and the Sentinel Initiative of 2008. The FDA Amendments Act of 2007 was especially created to fund additional safety review resources within the FDA. Furthermore, safety agencies in Europe have introduced rules and regulations in the wake of adverse drug reactions. According to the EU clinical trials directive, the failure to report adverse drug reactions during clinical trials is a criminal offence.

Pharmacovigilance Market Report Coverage

Report Coverage Details
Base Year: 2019 Market Size in 2019: US$ 5,008.2 Mn
Historical Data for: 2016 to 2019 Forecast Period: 2020 to 2027
Forecast Period 2020 to 2027 CAGR: 13.0% 2027 Value Projection: US$ 13,284.0 Mn
Geographies covered:
  • North America: U.S., Canada
  • Latin America: Brazil, Argentina, Mexico, Rest of Latin America
  • Europe: Germany, U.K., France, Spain, Italy, Russia, Rest of Europe
  • Asia Pacific: China, Japan, India, Australia, South Korea, ASEAN, Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, Rest of Middle East
  • Africa: North Africa, Central Africa, South Africa
Segments covered:
  • By Type of Clinical Trial Phases: Pre-clinical Studies, Clinical Trial Phase I, Clinical Trial Phase II, Clinical Trial Phase III, Post Marketing Surveillance or Phase IV.
  • By Type of Method: Spontaneous Reporting, Intensified ADR Reporting, Targeted Reporting, Cohort Event Monitoring, EHR Monitoring.
  • By Type of Service Provider: In-House , Contract Outsourcing.
Companies covered:

Accenture Plc, Bristol-Myers Squibb, Clinquest Group B.V., Cognizant Technology Solutions, Covance, Inc., GlaxoSmithKline, ICON, Plc, iGATE Corporation, Arriello, iMEDGlobal Corporation, Diamond Pharma Services, Infosys, Ergomed plc, inVentiv Health Inc., APCER Life Sciences, ArisGlobal, and Johnson and Johnson.

Growth Drivers:
  • Increasing prevalence of chronic diseases
  • Approval and launch of new products
Restraints & Challenges:
  • High cost

Statistics:

The global pharmacovigilance market was valued at US$ 5,008.2 Mn in 2019 and is forecast to reach a value of US$ 13,284.0 Mn by 2027 at a CAGR of 13.0% between 2020 and 2027.

Figure 2: Global Pharmacovigilance Market Value (US$ Mn), 2016 – 2027

Market Trends/Key Takeaways

Major regulatory bodies are focused on issuing guidelines regarding pharmacovigilance. For instance, in September 2020, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for U.K. authorized products.

Initiatives to promote pharmacovigilance in academics is expected to propel growth of the global pharmacovigilance market. For instance, in August 2020, Parexel International collaborated with Chitkara University, India, under which, the university will offer a 2-year M.Sc Program in Pharmacovigilance & Clinical Research.

Regulations

Global Pharmacovigilance Market: Competitive Landscape

Major players operating in the global pharmacovigilance market include, Accenture Plc, Bristol-Myers Squibb, Clinquest Group B.V., Cognizant Technology Solutions, Covance, Inc., GlaxoSmithKline, ICON, Plc, iGATE Corporation. Arriello, iMEDGlobal Corporation, Diamond Pharma Services, Infosys, Ergomed plc, inVentiv Health Inc., APCER Life Sciences, ArisGlobal, and Johnson and Johnson.

Global Pharmacovigilance Market: Key Developments

Major players in the global pharmacovigilance market are focused on adopting M&A strategies to enhance their market share. For instance, in January 2020, Ergomed plc acquired Ashfield Pharmacovigilance Inc., a specialist pharmacovigilance services provider based in Cary in the Research Triangle, North Carolina (U.S.) from UDG Healthcare US Holdings, Inc.

Major players in the market are focused on adopting M&A strategies to enhance their market share. For instance, in April 2020, Diamond PV Services, the pharmacovigilance division of Diamond Pharma Services, acquired PharmaCentral, a pharmacovigilance services and medical affairs business based in Dublin, Ireland.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Clinical Trail Phases
      • Market Snippet, By Type of Method
      • Market Snippet, By Type of Service Providers
      • Market Snippet, By Region
      • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Key Highlights
    • Product launch
    • PEST Analysis
    • Technological Advancements
    • Regulatory Scenario
    • Mergers and Acquisitions
  4. Global Pharmacovigilance Market, By Clinical Trail Phases, 2019 – 2027, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017 – 2027
      • Segment Trends
    • Pre-clinical Studies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Clinical Trial Phase I
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Clinical Trial Phase II
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Clinical Trial Phase III
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Post Marketing Surveillance or Phase IV
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
  5. Global Pharmacovigilance Market, By Type of Method, 2019 – 2027, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017 – 2027
      • Segment Trends
    • Spontaneous Reporting
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Intensified ADR Reporting
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Targeted Reporting
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Cohort Event Monitoring
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • EHR Monitoring
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
  6. Global Pharmacovigilance Market, By Type of Service Providers, 2019 – 2027, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017 – 2027
      • Segment Trends
    • In-House
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Contract Outsourcing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
  7. Global Pharmacovigilance Market, By Region, 2019 – 2027, (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
    • North America
      • Market Size and Forecast, By Clinical Trail Phases, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Method, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Service Providers, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • U.S.
        • Canada
    • Latin America
      • Market Size and Forecast, By Clinical Trail Phases, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Method, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Service Providers, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Clinical Trail Phases, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Method, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Service Providers, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • Germany
        • U.K.
        • France
        • Spain
        • Italy
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Clinical Trail Phases, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Method, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Service Providers, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • China
        • Japan
        • India
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • Market Size and Forecast, By Clinical Trail Phases, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Method, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Service Providers, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • GCC Countries
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Clinical Trail Phases, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Method, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, Type of Service Providers, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • North Africa
        • Central Africa
        • South Africa
  8. Competitive Landscape
    • Company Profiles
      • Accenture Plc
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Bristol-Myers Squibb
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Clinquest Group B.V.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Cognizant Technology Solutions
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Covance, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • GlaxoSmithKline, ICON, Plc
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • iGATE Corporation
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • iMEDGlobal Corporation
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Diamond Pharma Services
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Infosys
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Ergomed plc
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • inVentiv Health Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • APCER Life Sciences
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • ArisGlobal
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Johnson and Johnson
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 22 market data tables and 14 figures on “Pharmacovigilance Market - Global forecast to 2027”.

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- Frequently Asked Questions -

What is the current market size and Compound Annual Growth Rate (CAGR) of the market during the forecast period (2020-2027)?

The Global Pharmacovigilance market size was valued at US$ 5,008.2 million in 2019 and is estimated to exhibit a CAGR of 13.0% between 2020 and 2027.

Which segment, based on product type, accounted for the highest demand in the market?

Post Marketing Surveillance or Phase IV segment held the major market share in 2019 owing to technological advancement in product design and increasing product approvals is expected to propel growth of the market.

Which are the key factors driving the growth of the Global Pharmacovigilance market?

Major factor driving the growth of Global Pharmacovigilance market during the forecast period increasing prevalence of chronic diseases, increasing research & development , and adoption of expansion strategies from major companies.

What are the key factors hampering the growth of the market?

Major factors hampering the growth of the Global Pharmacovigilance market during the forecast period constitutes of high cost and stringent regulatory scenario.

Which region held the largest market share in the Global Pharmacovigilance market?

North America market is expected to generate the highest revenue during the forecast period.

Who are the key players operating in this market?

Some of the key players operating in the market are Accenture Plc, Bristol-Myers Squibb, Clinquest Group B.V., Cognizant Technology Solutions, Covance, Inc., GlaxoSmithKline, ICON, Plc, iGATE Corporation. Arriello, iMEDGlobal Corporation, Diamond Pharma Services, Infosys, Ergomed plc, inVentiv Health Inc., APCER Life Sciences, ArisGlobal, and Johnson and Johnson.
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