United States Pharmacovigilance Market Overview 2025 | Regulatory Framework & Key Developments

United States: The U.S. pharmacovigilance market was valued at USD 2,117.2 million in 2024. It is projected to reach USD 2,785.9 million by 2030, representing a CAGR of about 4.5% between 2025-2030

Japan: The Japan market was valued at USD 502.6 million in 2024, with forecasts estimating USD 975.1 million by 2033 - a CAGR of approximately 7.8% for 2025-2033.

DataM Intelligence has published a new research report on "Pharmacovigilance Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

United States: Recent Industry Developments
✅ October 2025: The FDA expanded its Sentinel Initiative to improve real-time drug safety monitoring using AI and big data analytics.
✅ September 2025: Pfizer and Johnson & Johnson implemented advanced pharmacovigilance platforms to detect adverse drug reactions earlier.
✅ August 2025: Collaborations between CROs and tech firms enhanced automated case processing and compliance with global safety standards.

Japan: Recent Industry Developments
✅ October 2025: Takeda Pharmaceuticals launched an AI-driven pharmacovigilance system to streamline post-marketing surveillance.
✅ September 2025: The Pharmaceuticals and Medical Devices Agency (PMDA) strengthened guidelines for digital safety reporting and adverse event management.
✅ August 2025: Japanese pharma companies adopted machine learning tools to improve pharmacovigilance efficiency and global data integration.

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Latest M&A

The pharmacovigilance (PV) sector experienced significant M&A activity in 2025 as pharma companies and specialized PV service providers consolidate capabilities for enhanced drug safety, regulatory compliance, and AI-driven signal detection.​

Deals include acquisitions of AI-focused PV analytics firms and expansions of safety data management platforms, aiming to reduce manual workloads and accelerate adverse event reporting and risk assessment.

Top Industry Players:

ArisGlobal, BioClinica, Capgemini, Cognizant, FMD K&L Inc., Foresight Group International AG, IBM Corporation, Wipro Limited, and IQVIA

Growth Forecast Projected:

The Global Pharmacovigilance Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Key Industry Developments

✅ The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has launched a formal review of medicines containing Levamisole for a risk of leukoencephalopathy, including fatal cases, signalling increased regulatory scrutiny of serious neurological adverse events.

✅ The integration of real-world data (RWD) and real-world evidence (RWE) into PV is accelerating: PV teams increasingly utilise electronic health records (EHRs), wearable devices, patient registries and other non-trial sources to detect rare/long-term drug safety issues outside controlled settings.
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✅ Use of advanced analytics/AI in PV operations is growing rapidly: for example, the PVLens system automates label-extraction from product labels with high accuracy (F1 ~0.88) and another model improves detection of duplicate adverse-event reports - both boosting signal-detection efficiency

Research Process:

Both primary and secondary data sources have been used in the global Pharmacovigilance Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

By Service Provider: (Contract Outsourcing, In-house)

By Type of Reporting: (Intensified ADR Reporting, Spontaneous Reporting, Cohort Event Monitoring, Targeted Spontaneous Reporting, EHR Mining)

By Clinical Trial Phase: (Preclinical, Phase I, Phase II, Phase III, Phase IV)

By End-User: (Hospitals, Pharmaceutical Companies)

Regional Analysis for Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Pharmacovigilance producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Pharmacovigilance revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FDA Developments

The FDA released draft AI guidance related to supporting regulatory decision-making in pharmacovigilance, emphasizing risk-based credibility assessments for algorithms analyzing safety signals.​

New safety communication requirements and postmarketing study expectations reinforce continuous monitoring of opioid medications, biologics, and gene therapies.

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Reimbursement Landscape

Pharmacovigilance-related costs are increasingly integrated into broader drug development and postmarketing safety budgets, with value-based contracts and risk-sharing agreements emerging in innovative therapy markets.​

Payers are recognizing the role of comprehensive safety monitoring and real-world evidence in supporting drug reimbursement, especially for high-cost biologics and gene therapies.

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