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

Pharmacovigilance  | Coherent Market Insights

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.

request-sample

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

Pharmacovigilance  | Coherent Market Insights

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.

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. Pharmacovigilance comprises drug discovery and development, preclinical research, clinical research, and post marketing surveillance. Increasing prevalence of adverse drug reaction and implementation of safety regulations by government regulatory bodies is expected to fuel growth of the pharmacovigilance market over the forecast period.

Key features of the study:

  • This report provides in-depth analysis of the Global Pharmacovigilance market  and provides market size (US$ million) and compound annual growth rate (CAGR %) for the forecast period (2020–2027), considering 2019 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategy adopted by key players
  • It profiles key players in the Global Pharmacovigilance market  based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study 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
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics
  • The Global Pharmacovigilance market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the Global Pharmacovigilance market

Detailed Segmentation:

  • Global 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
  • Global Pharmacovigilance Market, By Type of Method:
    • Spontaneous Reporting
    • Intensified ADR Reporting
    • Targeted Reporting
    • Cohort Event Monitoring
    • EHR Monitoring
  • Global Pharmacovigilance Market, By Type of Service Providers:
    • In-House
    • Contract Outsourcing
  • Global Pharmacovigilance Market, By Region:
    • North America
      • By Clinical Trail Phases:
        • Pre-clinical Studies
        • Clinical Trial Phase I
        • Clinical Trial Phase II
        • Clinical Trial Phase III
        • Post Marketing Surveillance or Phase IV
      • Type of Method
        • Spontaneous Reporting
        • Intensified ADR Reporting
        • Targeted Reporting
        • Cohort Event Monitoring
        • EHR Monitoring
      • Type of Service Providers
        • In-House
        • Contract Outsourcing
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Clinical Trail Phases:
        • Pre-clinical Studies
        • Clinical Trial Phase I
        • Clinical Trial Phase II
        • Clinical Trial Phase III
        • Post Marketing Surveillance or Phase IV
      • Type of Method
        • Spontaneous Reporting
        • Intensified ADR Reporting
        • Targeted Reporting
        • Cohort Event Monitoring
        • EHR Monitoring
      • Type of Service Providers
        • In-House
        • Contract Outsourcing
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Clinical Trail Phases:
        • Pre-clinical Studies
        • Clinical Trial Phase I
        • Clinical Trial Phase II
        • Clinical Trial Phase III
        • Post Marketing Surveillance or Phase IV
      • Type of Method
        • Spontaneous Reporting
        • Intensified ADR Reporting
        • Targeted Reporting
        • Cohort Event Monitoring
        • EHR Monitoring
      • Type of Service Providers
        • In-House
        • Contract Outsourcing
      • By Country
        • U.K.
        • Germany
        • France
        • Spain
        • Italy
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Clinical Trail Phases:
        • Pre-clinical Studies
        • Clinical Trial Phase I
        • Clinical Trial Phase II
        • Clinical Trial Phase III
        • Post Marketing Surveillance or Phase IV
      • Type of Method
        • Spontaneous Reporting
        • Intensified ADR Reporting
        • Targeted Reporting
        • Cohort Event Monitoring
        • EHR Monitoring
      • Type of Service Providers
        • In-House
        • Contract Outsourcing
      • By Country
        • China
        • Japan
        • India
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Clinical Trail Phases:
        • Pre-clinical Studies
        • Clinical Trial Phase I
        • Clinical Trial Phase II
        • Clinical Trial Phase III
        • Post Marketing Surveillance or Phase IV
      • Type of Method
        • Spontaneous Reporting
        • Intensified ADR Reporting
        • Targeted Reporting
        • Cohort Event Monitoring
        • EHR Monitoring
      • Type of Service Providers
        • In-House
        • Contract Outsourcing
      • By Country
        • GCC Countries
        • Israel
        • Rest of Middle East
    • Africa
      • By Clinical Trail Phases:
        • Pre-clinical Studies
        • Clinical Trial Phase I
        • Clinical Trial Phase II
        • Clinical Trial Phase III
        • Post Marketing Surveillance or Phase IV
      • Type of Method
        • Spontaneous Reporting
        • Intensified ADR Reporting
        • Targeted Reporting
        • Cohort Event Monitoring
        • EHR Monitoring
      • Type of Service Providers
        • In-House
        • Contract Outsourcing
      • By Country
        • North Africa
        • Central Africa
        • South Africa
  • Company Profiles
    • Accenture Plc *
      • Company Overview
      • Product Portfolio
      • Key Highlights
      • Financial Overview
      • Strategies
    • 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
    • Johnson and Johnson
  •  “*” marked represents similar segmentation in other categories in the respective section.

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”.

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users