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Pharmacovigilance Market - Global Forecast 2025-2032

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    Report

  • 184 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 5306611
UP TO OFF until Jan 01st 2026
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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

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of artificial intelligence and machine learning for proactive adverse event signal detection and risk assessment
5.2. Adoption of real-world evidence derived from electronic health records and wearable tech to complement safety data
5.3. Expansion of patient-centric pharmacovigilance apps enabling direct reporting of adverse events via mobile platforms
5.4. Implementation of blockchain technologies to ensure auditability and integrity of individual case safety reports across systems
5.5. Deployment of natural language processing tools to mine social media and clinical notes for early adverse event signals
5.6. Shift towards global regulatory harmonization and data standardization under ICH E2B(R3) guidelines for cross-border safety reporting
5.7. Emergence of cloud-based safety databases with automated workflows for case intake, triage, and regulatory submission
5.8. Growth in decentralized clinical trials requiring remote pharmacovigilance monitoring and virtual patient safety assessments
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Pharmacovigilance Market, by Type
8.1. Cohort Event Monitoring
8.2. EHR Mining
8.3. Intensified ADR Reporting
8.4. Spontaneous Reporting
8.5. Targeted Spontaneous Reporting
9. Pharmacovigilance Market, by Product Life Cycle
9.1. Phase I
9.2. Phase II
9.3. Phase III
9.4. Phase IV
9.5. Pre-clinical
10. Pharmacovigilance Market, by Delivery Mode
10.1. In-house
10.2. Outsourced
11. Pharmacovigilance Market, by Process Flow
11.1. Case Data Management
11.1.1. Case Data Analysis
11.1.2. Case Logging
11.1.3. Medical Reviewing & Reporting
11.2. Risk Management System
11.2.1. Risk Evaluation System
11.2.2. Risk Mitigation System
11.3. Signal Detection
11.3.1. Adverse Event Analysis
11.3.2. Adverse Event Logging
11.3.3. Adverse Event Review & Reporting
12. Pharmacovigilance Market, by Therapeutic Area
12.1. Cardiovascular
12.2. Infectious Diseases
12.3. Neurology
12.4. Oncology
12.5. Respiratory
13. Pharmacovigilance Market, by End-user
13.1. Biotechnology Companies
13.2. Medical Device Manufacturers
13.3. Pharmaceuticals
14. Pharmacovigilance Market, by Region
14.1. Americas
14.1.1. North America
14.1.2. Latin America
14.2. Europe, Middle East & Africa
14.2.1. Europe
14.2.2. Middle East
14.2.3. Africa
14.3. Asia-Pacific
15. Pharmacovigilance Market, by Group
15.1. ASEAN
15.2. GCC
15.3. European Union
15.4. BRICS
15.5. G7
15.6. NATO
16. Pharmacovigilance Market, by Country
16.1. United States
16.2. Canada
16.3. Mexico
16.4. Brazil
16.5. United Kingdom
16.6. Germany
16.7. France
16.8. Russia
16.9. Italy
16.10. Spain
16.11. China
16.12. India
16.13. Japan
16.14. Australia
16.15. South Korea
17. Competitive Landscape
17.1. Market Share Analysis, 2024
17.2. FPNV Positioning Matrix, 2024
17.3. Competitive Analysis
17.3.1. Accenture, PLC
17.3.2. Bristol-Myers Squibb Company
17.3.3. Capgemini SE
17.3.4. ClinChoice
17.3.5. F. Hoffmann-La Roche AG
17.3.6. GlaxoSmithKline PLC
17.3.7. HCL Technologies Limited
17.3.8. ICON PLC
17.3.9. Infosys Limited
17.3.10. International Business Machines Corporation
17.3.11. IQVIA Inc.
17.3.12. ITclinical
17.3.13. Laboratory Corporation of America Holdings
17.3.14. Linical Co., Ltd.
17.3.15. Novartis AG
17.3.16. Oracle Corporation
17.3.17. Parexel International
17.3.18. Pfizer Inc.
17.3.19. Quanticate International limited
17.3.20. Sanofi S.A.
17.3.21. Syneos Health
17.3.22. TAKE Solutions Limited
17.3.23. TATA Consultancy Services Limited
17.3.24. Wipro Limited

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