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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Authors:
Monali Tayade, Jignesh Rawal
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 Key Takeaways
Market Size & Growth
Key Market Drivers
Challenges
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:
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Market Size, By TypeMarket 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:
Research methodology, data sources & validation process
This report draws on a structured research process built around direct industry conversations, proprietary modelling, and rigorous cross-validation and not just desk research.
Our 6-step research process
1. Research design & analyst oversight
At GMI, our research methodology is built on a foundation of human expertise, rigorous validation, and complete transparency. Every insight, trend analysis, and forecast in our reports is developed by experienced analysts who understand the nuances of your market.
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2. Primary research
Primary research forms the backbone of our methodology, contributing nearly 80% to overall insights. It involves direct engagement with industry participants to ensure accuracy and depth in analysis. Our structured interview program covers regional and global markets, with inputs from C-suite executives, directors, and subject matter experts. These interactions provide strategic, operational, and technical perspectives, enabling well-rounded insights and reliable market forecasts.
3. Data mining & market analysis
Data mining is a key part of our research process, contributing nearly 20% to the overall methodology. It involves analysing market structure, identifying industry trends, and assessing macroeconomic factors through revenue share analysis of major players. Relevant data is collected from both paid and unpaid sources to build a reliable database. This information is then integrated to support primary research and market sizing, with validation from key stakeholders such as distributors, manufacturers, and associations.
4. Market sizing
Our market sizing is built on a bottom-up approach, starting with company revenue data gathered directly through primary interviews, alongside production volume figures from manufacturers and installation or deployment statistics. These inputs are then pieced together across regional markets to arrive at a global estimate that stays grounded in actual industry activity.
5. Forecast model & key assumptions
Every forecast includes explicit documentation of:
✓ Key growth drivers and their assumed impact
✓ Restraining factors and mitigation scenarios
✓ Regulatory assumptions and policy change risk
✓ Technology adoption curve parameter
✓ Macroeconomic assumptions (GDP growth, inflation, currency)
✓ Competitive dynamics and market entry/exit expectations
6. Validation & quality assurance
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Our triple-layer validation process ensures maximum data reliability:
✓ Statistical Validation
✓ Expert Validation
✓ Market Reality Check
Trust & credibility
Verified data sources
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GMI archive
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Parameters studied & evaluated
Every data point in this report is validated through primary interviews, true bottom-up modelling, and rigorous cross-checks. Read about our research process →