Pharmacovigilance Market Size & Share 2023 to 2032
Market Size 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.
Report ID: GMI853
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Published Date: May 2023
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Report Format: PDF
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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.
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
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.
Based on clinical trial phase, the pharmacovigilance marketis 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.
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: 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: Monali Tayade, Jignesh Rawal
Pharmacovigilance Market Scope
Pharmacovigilance Market Size
Pharmacovigilance Market Trends
Pharmacovigilance Market Analysis
Pharmacovigilance Market Share
Report Content
Chapter 1 Methodology & Scope
1.1 Industry coverage
1.2 Market scope and definitions
1.3 Base estimates and working
1.4 Forecast parameters
1.5 COVID-19 impact analysis at global level
1.6 Data validation
1.7 Data sources
1.7.1 Primary
1.7.2 Secondary
1.7.2.1 Paid sources
1.7.2.2 Unpaid sources
Chapter 2 Executive Summary
2.1 Pharmacovigilance industry 3600 synopsis, 2018 - 2032
2.1.1 Business trends
2.1.2 Type trends
2.1.3 Clinical trial phase trends
2.1.4 Service provider trends
2.1.5 End-user trends
2.1.6 Regional trends
Chapter 3 Pharmacovigilance Industry Insights
3.1 Industry segmentation
3.2 Industry landscape, 2018 – 2032
3.3 Industry impact forces
3.3.1 Growth drivers
3.3.1.1 Increasing need of new drugs
3.3.1.2 Rising investment on R&D by pharmaceutical companies
3.3.1.3 Rise in incidences of adverse drug reactions (ADR) and drug toxicity
3.3.1.4 Increasing focus on personalized medicine
3.3.1.5 Increasing trend of outsourcing pharmacovigilance services
3.3.2 Industry pitfalls & challenges
3.3.2.1 High risk associated with data security
3.3.2.2 Lack of skilled healthcare professionals
3.4 Growth potential analysis
3.4.1 By type
3.4.2 By clinical trial phase
3.4.3 By service provider
3.4.4 By end-use
3.5 COVID-19 impact analysis
3.6 Regulatory landscape
3.6.1 U.S.
3.6.2 Europe
3.7 Technology landscape
3.7.1 Artificial intelligence (AI) in pharmacovigilance
3.7.2 Natural language processing (NLP) in pharmacovigilance
3.8 Porter’s analysis
3.9 PESTEL analysis
Chapter 4 Competitive Landscape, 2022
4.1 Introduction
4.2 Company matrix analysis, 2022
4.3 Company positioning matrix
4.4 Competitive analysis of major market players
4.5 Strategic outlook matrix
4.6 Company market share analysis, 2022
4.7 Strategy dashboard, 2022
Chapter 5 Pharmacovigilance Market, By Type
5.1 Key type trends
5.2 Software
5.2.1 Market estimates and forecast, 2018 - 2032 (USD Million)
5.3 Service
5.3.1 Market estimates and forecast, 2018 - 2032 (USD Million)
5.3.2 By Process
5.3.2.1 Core services
5.3.2.1.1 Market estimates and forecast, 2018 - 2032 (USD Million)
5.3.2.2 Consulting services
5.3.2.2.1 Market estimates and forecast, 2018 - 2032 (USD Million)
5.3.3 By Activity
5.3.3.1 Spontaneous Reporting
5.3.3.1.1 Market estimates and forecast, 2018 - 2032 (USD Million)
5.3.3.2 Intensified Adverse Drug Reaction (ADR) Reporting
5.3.3.2.1 Market estimates and forecast, 2018 - 2032 (USD Million)
5.3.3.3 Cohort Event Monitoring
5.3.3.3.1 Market estimates and forecast, 2018 - 2032 (USD Million)
5.3.3.4 EHR Mining
5.3.3.4.1 Market estimates and forecast, 2018 - 2032 (USD Million)
5.3.3.5 Others
5.3.3.5.1 Market estimates and forecast, 2018 - 2032 (USD Million)
Chapter 6 Pharmacovigilance Market, By Clinical Trial Phase
6.1 Key clinical trial phase trends
6.2 Pre-clinical
6.2.1 Market estimates and forecast, 2018 - 2032 (USD Million)
6.3 Phase 1
6.3.1 Market estimates and forecast, 2018 - 2032 (USD Million)
6.4 Phase 2
6.4.1 Market estimates and forecast, 2018 - 2032 (USD Million)
6.5 Phase 3
6.5.1 Market estimates and forecast, 2018 - 2032 (USD Million)
6.6 Phase 4
6.6.1 Market estimates and forecast, 2018 - 2032 (USD Million)
Chapter 7 Pharmacovigilance Market, By Service Provider
7.1 Key service provider trends
7.2 In-house
7.2.1 Market estimates and forecast, 2018 - 2032 (USD Million)
7.3 Contract outsourcing
7.3.1 Market estimates and forecast, 2018 - 2032 (USD Million)
Chapter 8 Pharmacovigilance Market, By End-use
8.1 Key end-use trends
8.2 Pharmaceutical & biotechnological companies
8.2.1 Market estimates and forecast, 2018 - 2032 (USD Million)
8.3 Medical device companies
8.3.1 Market estimates and forecast, 2018 - 2032 (USD Million)
8.4 Hospitals
8.4.1 Market estimates and forecast, 2018 - 2032 (USD Million)
8.5 Others
8.5.1 Market estimates and forecast, 2018 - 2032 (USD Million)
Chapter 9 Pharmacovigilance Market, By Region
9.1 Key regional trends
9.2 North America
9.2.1 U.S.
9.2.2 Canada
9.3 Europe
9.3.1 Germany
9.3.2 UK
9.3.3 France
9.3.4 Italy
9.3.5 Spain
9.3.6 Rest of Europe
9.4 Asia Pacific
9.4.1 China
9.4.2 India
9.4.3 Japan
9.4.4 Australia
9.4.5 Rest of Asia Pacific
9.5 Latin America
9.5.1 Brazil
9.5.2 Mexico
9.5.3 Argentina
9.5.4 Rest of Latin America
9.6 Middle East & Africa
9.6.1 South Africa
9.6.2 Saudi Arabia
9.6.3 UAE
9.6.4 Qatar
9.6.5 Israel
9.6.6 Rest of Middle East & Africa
Chapter 10 Company Profiles
10.1 Accenture
10.2 Cognizant
10.3 Labcorp Drug Development
10.4 IBM Corporation
10.5 ArisGlobal
10.6 ICON plc
10.7 United BioSource LLC
10.8 Pharmaceutical Development Group, Inc.
10.9 Wipro Limited
10.10 Allucent
Don't see your key competitors?
The companies listed in this report are a curated selection - not the full competitive universe.
Our market revenue calculations use a bottom-up methodology that accounts for all players across all regions - including manufacturers, distributors, and specialists not individually profiled. The profiles section spotlights strategically significant players; it does not define the scope of our market sizing.
Your competitive landscape may also include
Regional or domestic-only leaders not in the global top tier
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Emerging disruptors, startups, or adjacent-industry entrants
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Premium Report Details
Base Year: 2022
Companies Profiled: 10
Tables & Figures: 421
Countries covered: 27
Pages: 246
Download Free PDF
Premium Report Details
Base Year: 2022
Companies covered: 10
Tables & Figures: 421
Countries covered: 27
Pages: 246
Download Free PDF
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Monali Tayade. 2023, May. 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). Global Market Insights Inc. Retrieved June 1, 2026, from https://www.gminsights.com/toc/details/pharmacovigilance-market
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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.
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
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.
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.
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
Pharmacovigilance industry news:
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: Market Size, By Type
Market Size, By Clinical Trial Phase
Market Size, By Service Provider
Market Size, By End-use
The above information is provided for the following regions and countries: