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The pharmacovigilance market is undergoing transformative change, propelled by tighter regulations, advanced analytics, and increasing demand for proactive drug safety management. As healthcare complexity intensifies, organizations must adopt agile, data-driven solutions to ensure ongoing patient safety and compliance.
Market Snapshot: Pharmacovigilance Market Size, Growth, and Momentum
In 2024, the global pharmacovigilance market was valued at USD 10.24 billion and is projected to reach USD 11.84 billion in 2025, signaling continuous sector growth. With a compound annual growth rate (CAGR) of 16.25%, the market is expected to surpass USD 34.17 billion by 2032, reflecting surging demand for comprehensive drug safety systems and real-time analytics across healthcare ecosystems.
Scope & Segmentation: Pharmacovigilance Landscape and Market Coverage
- Type: Cohort event monitoring, EHR mining, intensified adverse drug reaction reporting, spontaneous reporting, targeted spontaneous reporting.
- Product Life Cycle: Pre-clinical, phase I, phase II, phase III, phase IV.
- Delivery Mode: In-house and outsourced pharmacovigilance service models.
- Process Flow: Case data analysis, case logging, medical reviewing and reporting, risk evaluation systems, risk mitigation systems, adverse event analysis, logging, and reporting.
- Therapeutic Area: Cardiovascular, infectious diseases, neurology, oncology, respiratory segments.
- End-user: Biotechnology firms, medical device manufacturers, and pharmaceutical companies.
- Regions: Americas (United States, Canada, Mexico, Brazil, Argentina, Chile, Colombia, Peru), Europe, Middle East & Africa (United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland, UAE, Saudi Arabia, Qatar, Turkey, Israel, South Africa, Nigeria, Egypt, Kenya), Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan).
- Technology Adoption: Advanced analytics, artificial intelligence, cloud-based solutions, electronic health records integration, and initiatives to enhance cross-jurisdictional data sharing underpin pharmacovigilance excellence.
Key Takeaways: Strategic Insights for Senior Executives
- Real-time safety monitoring and AI-driven analytics are streamlining detection of adverse drug reactions, supporting earlier risk intervention throughout the drug life cycle.
- Increasing cross-border collaboration and harmonization of global regulatory standards is shaping unified pharmacovigilance processes and accelerating best practice adoption.
- Blended service models, balancing in-house and outsourced capabilities, provide operational agility, access to specialized expertise, and resilience against supply chain disruptions.
- As electronic health data expands, integration with centralized analytics platforms enhances signal detection and fosters transparency in reporting adverse events.
- Therapeutic segmentation highlights distinct compliance needs across cardiovascular, oncology, neurology, infectious disease, and respiratory therapies.
- Technology partnerships enable secure data sharing and robust case management, essential to managing complex market and compliance requirements at a global level.
Tariff Impact: Navigating U.S. Trade Policy Shifts
Tariffs instituted on imported pharmacovigilance technologies and services in 2025 are driving a reevaluation of vendor strategies and supply chains. Domestic innovation is being prioritized, with greater investment in local platforms and services to mitigate import-related cost pressures. Key operational adjustments include diversifying procurement, strengthening in-house expertise through targeted training, and forming strategic local alliances to uphold regulatory standards and continuous monitoring.
Methodology & Data Sources
Analysis is based on data aggregated from electronic health records, case reports, and literature reviews. Robust validation protocols—including subject matter expert review and standardized documentation—guarantee data consistency and compliance with privacy regulations such as GDPR and HIPAA.
Why This Report Matters: Actionable Value for Decision-Makers
- Gain a comprehensive overview of advanced pharmacovigilance strategies, technology trends, and regional compliance landscapes to guide strategic planning.
- Benchmark against leading public and private organizations that are innovating in safety data management, risk mitigation, and supply chain resilience.
- Anticipate the impact of trade policy and regulatory harmonization on operational models and cross-border reporting requirements.
Conclusion
As global healthcare systems redefine the role of pharmacovigilance, success requires continuous investment in technology, talent, and integrated frameworks. Organizations that lead with data transparency, collaborative intelligence, and proactive risk management will remain at the forefront of patient safety and regulatory leadership.
Additional Product Information:
- Purchase of this report includes 1 year online access with quarterly updates.
- This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.
Table of Contents
3. Executive Summary
4. Market Overview
7. Cumulative Impact of Artificial Intelligence 2025
Companies Mentioned
The companies profiled in this Pharmacovigilance market report include:- Accenture, PLC
- Bristol-Myers Squibb Company
- Capgemini SE
- ClinChoice
- F. Hoffmann-La Roche AG
- GlaxoSmithKline PLC
- HCL Technologies Limited
- ICON PLC
- Infosys Limited
- International Business Machines Corporation
- IQVIA Inc.
- ITclinical
- Laboratory Corporation of America Holdings
- Linical Co., Ltd.
- Novartis AG
- Oracle Corporation
- Parexel International
- Pfizer Inc.
- Quanticate International limited
- Sanofi S.A.
- Syneos Health
- TAKE Solutions Limited
- TATA Consultancy Services Limited
- Wipro Limited
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 184 |
| Published | November 2025 |
| Forecast Period | 2025 - 2032 |
| Estimated Market Value ( USD | $ 11.84 Billion |
| Forecasted Market Value ( USD | $ 34.17 Billion |
| Compound Annual Growth Rate | 16.2% |
| Regions Covered | Global |
| No. of Companies Mentioned | 25 |

