A comprehensive new market study forecasts that the global pharmacovigilance market—critical for monitoring drug safety across all clinical phases—will surge from an estimated US$ 8.3 billion in 2024 to US$ 19.4 billion by 2035, growing at a robust 7.9 percent CAGR from 2025 through 2035.
Key Highlights:
Market Size & Growth: Valued at US$ 8.3 billion in 2024; forecast to exceed US$ 19.4 billion by 2035 (CAGR: 7.9%).
By Phase: Comprehensive coverage across Pre‐clinical, Phase I–IV trials, and post‐marketing surveillance.
By Type: Leading segments include Spontaneous Reporting and Post‐Marketing Surveillance, with emerging strength in Cohort Event Monitoring and Epidemiological Studies.
Delivery Mode: Contract outsourcing continues to dominate, driven by pharmaceutical companies’ need for scalable, cost‐efficient safety‐monitoring solutions.
Therapeutic Areas: Oncology leads demand, followed by Neurology, Cardiology, Respiratory, and Autoimmune indications.
End Users: Pharmaceutical & biotechnology firms and CROs account for the majority of service procurements.
Regional Outlook: North America commands the largest share, propelled by stringent FDA regulations, advanced healthcare infrastructure, and widespread AI/automation adoption.
Analysts’ Perspective
“Increasing global drug consumption, burgeoning clinical trial activity—particularly in emerging markets—and the continued shift toward outsourced pharmacovigilance have created unprecedented demand for robust safety surveillance systems,” said Dr. Maya Patel, Senior Research Director at Insight Pharma Reports. “Integrating AI, machine learning, and automation into PV workflows is no longer optional; it’s essential to accelerate adverse-event detection and streamline regulatory reporting.”
Market Drivers:
Clinical Trial Expansion: With India’s trial market expected to top US$ 2 billion by 2030, the volume of safety data requiring real‐time monitoring has soared.
Chronic Disease Prevalence: Rising incidence of diabetes, cancer, and cardiovascular conditions fuels higher medication use and heightens ADR risks.
Outsourcing Efficiency: In 2024, automation utilization in case processing climbed from 20 percent to over 60 percent at leading PV providers, while 40 percent of organizations outsourced more than 60 percent of their safety‐case processing.
Notable Recent Developments:
Ergomed plc (February 2024): PrimeVigilance acquisition of Panacea strengthens global PV, regulatory, and QA service offerings.
ICON plc (September 2023): Partnership with BARDA to conduct clinical trials for next‐generation COVID-19 vaccine candidates.
Competitive Landscape:
Major players profiled include Accenture, IQVIA, Cognizant, ArisGlobal, Parexel, Wipro, and Quanticate, among others, each leveraging strategic partnerships, technology integration, and global footprints to capture market share.