According to the report, the global AI in pharmacovigilance market is projected to expand from USD 0.4 billion in 2025 to USD 1.9 billion by 2035, registering a CAGR of 17.1%, the highest during the forecast period. The AI in pharmacovigilance segment is growing as the volume of adverse events continues to rise, regulatory agencies are placing increased importance on speedy adverse event reporting, cloud-based pharmacovigilance platforms are gaining acceptance, and generative AI is increasingly being used to automate case processing, literature review, and signal detection.
Real-world evidence and analytics from electronic health records are also being incorporated in the development of predictive drug safety monitoring and regulatory compliance by drug companies. For instance, in November 2025, HiroPharmaConsulting has won the first Japanese patent for pharmacovigilance validation using AI, introducing a regulatory compliant framework for reliable, auditable, and continuously validated AI pharmacovigilance systems.
Further, the U.S. Food and Drug Administration (FDA) is still making strides in promoting the responsible use of AI in drug development and pharmacovigilance by providing guidance in a risk-based manner to facilitate greater adoption of AI to support drug safety technologies. This is driving the smart, conformant and predictive pharmacovigilance ecosystem and continues to fuel growth in the market.
Key Driver, Restraint, and Growth Opportunity Shaping the Global AI in Pharmacovigilance Market
The limited availability of professionals with expertise in both artificial intelligence and pharmacovigilance is constraining AI adoption. Organizations face challenges in AI model validation, safety data interpretation, governance, and regulatory compliance, increasing implementation complexity, operational costs, and deployment timelines.
The expansion of the AI use in pharmacovigilance is being driven by the rising use of wearable devices, mHealth apps, patient support initiatives and digital therapeutics. Patient-generated health data can be continuously analyzed by AI to detect new safety concerns earlier, to facilitate real-world safety monitoring and to guide personalized benefit-risk assessments throughout product lifecycle.
Expansion of the Global AI in Pharmacovigilance Market
Expansion of Predictive Pharmacovigilance Using Machine Learning Analytics
Regional Analysis of Global AI in Pharmacovigilance Market
Prominent players operating in the global AI in pharmacovigilance market is Cognizant Technology Solutions, Accenture, ArisGlobal, Capgemini SE, ICON plc, IQVIA, Oracle Corporation, Parexel International Corporation, Tata Consultancy Services (TCS), Wipro Limited, Other Key Players.
The global AI in pharmacovigilance market has been segmented as follows:
Global AI in Pharmacovigilance Market Analysis, By Component
Global AI in Pharmacovigilance Market Analysis, By Technology
Global AI in Pharmacovigilance Market Analysis, By Deployment Mode
Global AI in Pharmacovigilance Market Analysis, By Process Stage
Global AI in Pharmacovigilance Market Analysis, By Application
Global AI in Pharmacovigilance Market Analysis, By End-users
Global AI in Pharmacovigilance Market Analysis, By Region
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