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Pharmacovigilance Market - By Type (Software, Service {By Process, By Activity [Spontaneous Reporting, Intensified Adverse Drug Reaction Reporting, Cohort Event Monitoring]}), By Clinical Trial Phase, Service Provider, By End-use, & Forecast, 2023 – 2032

  • Report ID: GMI853
  • Published Date: May 2023
  • Report Format: PDF

Pharmacovigilance Market Size

Pharmacovigilance Market size was over USD 8.5 billion in 2022. Driven by the rising need for new drugs across the globe, the market is expected to grow at over 8.5% CAGR from 2023 to 2032.

Pharmacovigilance Market

Rising prevalence of chronic disorders such as cardiovascular diseases, diabetes, cancer, and others has increased the usage of drugs for disease management. As per the CDC, over 795,000 cases of stroke are diagnosed every year in the U.S. alone. This has increased the number of adverse drug reactions (ADRs) and generated awareness about its potential health risks. Many governments across the world are investing huge amounts in pharmacovigilance to detect, understand, and prevent ADRs, which will fuel market progress. 

However, an acute shortage of skilled healthcare professionals presents challenges to the implementation of pharmacovigilance practices. Pharmacovigilance systems often witness issues related to product quality and falsified and counterfeit medical products, which makes drug safety surveillance expensive and complex. The high cost of these systems and the shortage of qualified healthcare professionals may limit demand for pharmacovigilance services in low and middle-income economies.  

COVID-19 Impact

The COVID-19 pandemic had a positive impact on pharmacovigilance market as it increased the requirement for vaccine development and drug testing. Many regulatory authorities, healthcare organizations, and pharmaceutical giants such as Pfizer inked a deal with pharmacovigilance providers to assess the efficacy and safety of COVID-19 vaccines. Moreover, adverse drug events reported in many countries due to COVID-19 vaccines further increased government spending on pharmacovigilance and similar drug safety measures.

Pharmacovigilance Market Trends

Outsourcing of pharmacovigilance services is one of the major trends driving industry growth. This is due to several benefits associated with outsourcing including access to expertise, regulatory compliance, cost efficiency, focus on core competencies, and scalability. Many pharmaceutical firms are opting for contract outsourcing of pharmacovigilance services as a cost-effective way to comply with drug safety obligations whilst placing a strong emphasis on core business operations.

Pharmacovigilance Market Analysis

Global Pharmacovigilance Market Size, By Type, 2021 - 2032 (USD Billion)

In terms of type, the pharmacovigilance market is divided into software and service. Software segment will be more than USD 13 billion by 2032. The software used in pharmacovigilance helps manage critical medication safety data and reporting requirements about adverse drug reactions to regulatory authorities. Growing efforts by industry players towards introducing advanced capabilities of software will support segment expansion.

For instance, In February 2022, Cognizant, an information technology giant, partnered with Medable Inc., a health tech company, to jointly offer clinical research solutions using Medable’s SaaS platform for decentralized clinical trials. This partnership will offer operational support to sponsors pertaining to their regulatory submissions and assist in pharmacovigilance functions. 

Global Pharmacovigilance Market Size, By Clinical Trial Phases, 2022

Based on clinical trial phase, the pharmacovigilance market is classified into pre-clinical, phase 1, phase 2, phase 3, and phase 4. Phase 4 segment was over 75% in 2022. Phase 4 clinical trials entail testing the efficacy of medications in real-life situations for any long-term risks and rare side effects. Most drugs often show negative results in this phase as they are administered in large populations before marketing. Surging cases of adverse drug reactions have increased government spending on phase 4 clinical trials, creating lucrative prospects for market landscape.

North America Pharmacovigilance Market, 2020 - 2032 (USD Billion)

Regionally, North America pharmacovigilance market share was more than 37% in 2022. Growing investment by industry players and governments in drug development is contributing to regional industry development. In September 2022, the U.S. Department of Health and Human Services announced that it will invest USD 40 million for the expansion of biomanufacturing for active pharmaceutical ingredients, and other starting materials required to produce essential medications. Moreover, the strong presence of industry giants such as IBM, United BioSource LLC, and others is also contributing to industry growth across North America.

Pharmacovigilance Market Share

  • Cognizant
  • IBM Corporation
  • ICON plc
  • Pharmaceutical Development Group, Inc.
  • Labcorp Drug Development
  • ArisGlobal
  • United BioSource LLC

Pharmacovigilance industry news:

  • In November 2021, Deloitte inked a deal with Sanofi, a French pharmaceutical company, for developing ConvergeHEALTH SafetyTM, which is a next-generation AI-enabled SaaS adverse events case intake platform for the transformation of the pharmacovigilance space. This strategy assisted the company in expansion and growth. 
  • In December 2021, Wipro Limited announced the launch of regulatory literature monitoring for pharmaceutical companies by inking a managed services agreement with Springer Nature. This strategy helped the company broaden its service offerings. 

The pharmacovigilance market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032, for the following segments:

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Market Size, By Type

  • Software
  • Service
    • By Process
      • Core services
      • Consulting services
    • By Activity
      • Spontaneous Reporting
      • Intensified Adverse Drug Reaction (ADR) Reporting
      • Cohort Event Monitoring
      • EHR Mining
      • Others

Market Size, By Clinical Trial Phase

  • Pre-clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Phase 4

Market Size, By Service Provider

  • In-house
  • Contract outsourcing

Market Size, By End-use

  • Pharmaceutical & biotechnological companies
  • Medical device companies
  • Hospitals
  • Others

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • Rest of APAC
  • Latin America
    • Brazil
    • Mexico
    • Argentina
    • Rest of Latin America
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • Israel
    • Rest of Middle East & Africa
Authors: Mariam Faizullabhoy, Gauri Wani

Frequently Asked Questions (FAQ) :

Global market size for pharmacovigilance was more than USD 8.5 billion in 2022 and is poised to grow at over 8.5% CAGR from 2023 to 2032, on account of the growing need for new drugs worldwide.

Phase 4 segment was more than 75% in 2022, driven by increasing cases of adverse drug reactions globally.

North America pharmacovigilance market share witnessed over 37% in 2022, on account of surging investment by government authorities and industry players in drug development.

Some of the leading pharmacovigilance industry players are Accenture, Labcorp Drug Development, Cognizant, ArisGlobal, United BioSource LLC, IBM Corporation, and ICON plc, among others.

Pharmacovigilance Market Scope

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Premium Report Details

  • Base Year: 2022
  • Companies covered: 10
  • Tables & Figures: 421
  • Countries covered: 27
  • Pages: 246
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