Pharmacovigilance Market to Reach USD 15.2 Billion by 2034

Pune, India, November 11, 2025 - The global Pharmacovigilance Market is projected to expand from USD 8.9 billion in 2024 to USD 15.2 billion by 2034, registering a CAGR of 5.5 %, according to Exactitude Consultancy. Growing emphasis on drug-safety analytics, post-marketing surveillance, and AI-powered adverse-event detection is reshaping pharmacovigilance across the global life-sciences ecosystem.

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Key Takeaways
• Market Size (2024): USD 8.9 Billion
• Forecast (2034): USD 15.2 Billion
• CAGR (2025 - 2034): 5.5 %
• Leading Companies: IQVIA Inc., Parexel International Corp., Oracle Corp., Cognizant Technology Solutions Corp., Capgemini SE, ArisGlobal LLC, ICON plc, Labcorp Drug Development, and Syneos Health Inc.
• Core Services: Case Processing & Adverse-Event Reporting | Signal Detection | Risk Management | Data Integration & AI Analytics.

Market Story
Pharmacovigilance has evolved from manual case tracking to real-time, AI-driven safety intelligence. Regulatory agencies like the U.S. FDA and EMA are intensifying post-marketing requirements, pushing pharma and CRO players to invest in advanced automation, machine learning, and cloud databases.

The integration of natural-language processing (NLP) and predictive analytics is enabling early signal detection and pattern recognition from clinical, EHR, and social-media data sources. As clinical trial complexity and biologic approvals increase, global pharmacovigilance networks are becoming the cornerstone of regulatory compliance and patient safety.

Market Segmentation
• By Service Type: Pre-clinical Safety Data Management | Clinical Trial Phase Monitoring | Post-Marketing Surveillance | Specialty Adverse Event Management

• By Process Flow: Case Data Management | Signal Detection | Risk Management | Data Mining & Analytics

• By End User: Pharmaceutical & Biotech Companies | Contract Research Organizations (CROs) | Hospitals | Regulatory Agencies

• By Region:
o North America: Largest market driven by FDA E2B(R3) mandates and mature pharma outsourcing.
o Europe: Strong focus on EudraVigilance and GDPR-compliant data platforms.
o Asia Pacific: Fastest growth due to CRO expansion in India and pharmacovigilance outsourcing in Japan & China.
o Latin America & MEA: Improving regulatory frameworks and WHO-backed drug-safety initiatives.

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Recent Developments
• 2025: IQVIA launched an AI-enabled pharmacovigilance suite integrated with EHR systems for real-time adverse-event tracking.
• 2024: Oracle expanded its Argus Safety Cloud to support multi-regional signal analytics and compliance automation.
• 2023: Parexel introduced blockchain-based audit trails to enhance data traceability and regulatory confidence.
• 2022: ArisGlobal partnered with Cognizant to deploy an AI-first platform for pharma risk assessment.

Expert Quote
"Pharmacovigilance is undergoing a digital revolution where AI, automation, and big-data integration are delivering faster and more reliable safety signals than ever before. This technology-driven shift is building trust and compliance across global regulatory landscapes," said Irfan Tamboli, Business Development Executive at Exactitude Consultancy.

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Market Drivers
1. Increasing Drug Approvals and Complex Therapeutic Pipelines.
2. Regulatory Mandates for Real-Time Safety Reporting and Signal Detection.
3. Rising Pharmacovigilance Outsourcing to CROs and Technology Vendors.
4. AI and Automation Integration in Adverse-Event Analysis.

Forecast Outlook
Between 2025 and 2034, the market will see rapid adoption of cloud-native pharmacovigilance systems, digital twin monitoring, and multi-lingual adverse-event analytics. Asia Pacific will emerge as a strategic outsourcing hub while North America continues to lead in AI-driven regulatory compliance.

Conclusion
The Pharmacovigilance Market is on the brink of a new era of digital drug-safety surveillance. As biotech and pharma companies embrace predictive AI tools and integrated data ecosystems, pharmacovigilance is evolving into a strategic pillar for both innovation and regulatory trust.

This report is also available in the following languages : Japanese (医薬品安全性監視市場), Korean (약물 안전 감시 시장), Chinese (药物警戒市场), French (Marché de la pharmacovigilance), German (Pharmakovigilanzmarkt), and Italian (Mercato della farmacovigilanza), etc.

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