Press release
Pharmacovigilance Market to Reach USD 15.2 Billion by 2034
Pharmacovigilance
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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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About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
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PHONE NUMBER +1 (704) 266-3234
EMAIL ADDRESS: sales@exactitudeconsultancy.com
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