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Artificial Intelligence (AI) In Pharmacovigilance Market Forecast Highlighting Growth From $1.78 Billion To $2.22 Billion
The artificial intelligence (AI) in pharmacovigilance market size has experienced substantial expansion in recent years. It is projected to grow from $0.77 billion in 2025 to $0.92 billion in 2026, achieving a compound annual growth rate (CAGR) of 19.3%. The historical period’s growth can be attributed to an increase in global adverse drug reaction reporting requirements, the broadening of pharmacovigilance regulatory frameworks, greater adoption of electronic health records, an escalation in clinical trial data complexity, and the early implementation of rule based drug safety monitoring systems.
The artificial intelligence (AI) in pharmacovigilance market size is anticipated to experience rapid growth over the next few years. It is projected to expand to $1.88 billion by 2030, demonstrating a compound annual growth rate (CAGR) of 19.6%. This growth during the forecast period is attributable to the swift adoption of AI-powered drug safety surveillance systems, the increasing volume of real-world healthcare data available for analysis, the expansion of regulatory compliance requirements concerning drug safety, the growing application of predictive analytics in adverse event detection, and the rising integration of multi-source clinical data for pharmacovigilance. Major trends expected in this period include the rise of automated literature screening for identifying adverse drug reactions, the increasing adoption of real-world evidence analytics in drug safety monitoring, the growing use of generative AI for regulatory pharmacovigilance reporting, the expansion of automated case intake and workflow processing systems, and a surge in cross-border regulatory harmonization for drug safety data exchange.
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Artificial Intelligence (AI) In Pharmacovigilance Market Demand Drivers: What Is Fueling Industry Growth?
The increasing number of adverse event (AE) reports is anticipated to drive the expansion of the artificial intelligence (AI) in pharmacovigilance market in the future. These reports document unforeseen and detrimental responses or effects observed subsequent to the administration of a medical product or drug. The rise in AE report volume stems from more stringent regulatory mandates, obliging healthcare professionals and drug manufacturers to submit information on a broader spectrum of safety concerns with increased frequency and specificity. Artificial intelligence (AI) in pharmacovigilance manages these adverse event (AE) reports by automatically gathering and examining extensive safety data from various real-time sources. This capability allows for quicker identification of drug safety signals and enhances the precision and uniformity of reporting and adherence to regulations. For example, in February 2024, the Analysis Of Adverse Drug Reactions 2023 Report from the Department of Health Abu Dhabi, a UAE-based regulatory authority, indicated that 1,522 adverse drug reaction reports were submitted to the pharmacovigilance program from January to December 2023. This figure marked a 235% rise compared to the average yearly number of reports from prior years. Consequently, the expanding volume of adverse event (AE) reports is fueling the expansion of the artificial intelligence (AI) in pharmacovigilance market.
Artificial Intelligence (AI) In Pharmacovigilance Market Segmentation: How Is The Market Structured Across Key Categories?
The artificial intelligence (AI) in pharmacovigilance market covered in this report is segmented –
1) By Component: Software; Services
2) By Technology: Machine Learning; Natural Language Processing; Predictive Analytics; Robotic Process Automation; Generative Artificial Intelligence Or Large Language Models
3) By Deployment Mode: Cloud-Based; On-Premises
4) By Application: Adverse Event Detection; Signal Detection; Data Integration And Management; Drug Safety Monitoring; Automated Report Generation
5) By End User: Pharmaceutical Companies; Biotechnology Companies; Contract Research Organizations; Regulatory Agencies; Hospitals And Healthcare Providers; Academic And Research Institutes
Subsegments:
1) By Software: Case Processing And Workflow Automation Software; Predictive Analytics And Risk Assessment Tools; Natural Language Processing Based Pharmacovigilance Software; Artificial Intelligence Based Literature Screening Software; Regulatory Compliance Management Software; Real World Evidence Analytics Platforms; Clinical Data Mining Software
2) By Services: Pharmacovigilance Consulting Services; Artificial Intelligence Model Training And Validation Services; Regulatory Reporting Services; Medical Review And Case Assessment Services; Literature Monitoring Services; Pharmacovigilance Outsourcing Services; Safety Data Analytics Services
Next-Generation AI Pharmacovigilance Systems Improve Adverse Event Detection And Compliance
Major companies operating in the artificial intelligence (AI) in pharmacovigilance market are focusing on developing innovative treatments, such as agentic AI-driven pharmacovigilance platforms, to enhance automated adverse event detection, regulatory compliance, and efficiency in drug safety monitoring by reducing manual case-processing workloads and improving signal detection accuracy. Agentic AI pharmacovigilance platforms are advanced software systems that use domain-trained machine learning models, natural language processing, and workflow orchestration to independently perform and coordinate safety tasks such as case intake, literature surveillance, signal detection, and aggregate reporting. For instance, in May 2026, RxLogix Systems Inc., a US-based pharmacovigilance technology provider, launched an upgraded PVOne.AI platform, an innovative AI-enabled pharmacovigilance system that integrates agentic AI capabilities to automate and orchestrate end-to-end drug safety workflows. The platform is designed to operate across case intake, adverse event monitoring, literature surveillance, signal detection, aggregate reporting, and risk management, using contextual reasoning and domain-trained models to support regulatory-grade decision-making. It introduces human-in-the-loop controls to ensure compliance with FDA and global pharmacovigilance standards while significantly reducing manual effort in case processing by up to 80% and improving reviewer productivity by up to 75%. The system also aims to enable up to 50% touchless workflows by minimizing repetitive processing tasks and enhancing prioritization of safety signals in large-scale pharmaceutical datasets.
Artificial Intelligence (AI) In Pharmacovigilance Market Competitive Landscape And Leading Companies
Major companies operating in the artificial intelligence (AI) in pharmacovigilance market are Oracle Corporation; Microsoft Corporation; Google LLC; Accenture plc; NVIDIA Corporation; IQVIA Holdings Inc.; ArisGlobal; Veeva Systems Inc.; Cognizant Technology Solutions Corporation; Tata Consultancy Services Limited; Infosys Limited; Wipro Limited; SAS Institute Inc.; Genpact Limited; Snowflake Inc.; ICON Public Limited Company; Open Text Corporation; Certara Inc.; ExlService Holdings Inc.; Ennov Group; EXTEDO; Biologit; Anju Software; Bronze Oak
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Artificial Intelligence (AI) In Pharmacovigilance Market Geographic Landscape: Which Region Dominates Industry Growth?
North America was the largest region in the artificial intelligence (AI) in pharmacovigilance market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the artificial intelligence (AI) in pharmacovigilance market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
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Wasay has over a decade of experience in market research, data modelling, and analytics, with prior experience at GlobalData and Decision Tree Consulting Services. At The Business Research Company , he leads research operations across syndicated studies, customized consulting engagements, and the Global Market Model platform. His professional experience includes supporting organizations such as Boston Consulting Group, KPMG, and Ernst & Young. Wasay holds a degree in Electronics and Communications Engineering, postgraduate management qualifications from International Management Institute Belgium and Indian School of Business and Entrepreneurship, and completed the Integrated Program in Business Analytics from Indian Institute of Management Indore.