Artificial Intelligence (AI) in Pharmacovigilance Market Global Report 2026

The artificial intelligence (AI) in pharmacovigilance market size has grown rapidly in recent years. It will grow from $0.77 billion in 2025 to $0.92 billion in 2026 at a compound annual growth rate (CAGR) of 19.3%. The growth in the historic period can be attributed to rise in global adverse drug reaction reporting requirements, expansion of pharmacovigilance regulatory frameworks, increasing adoption of electronic health records, growth in clinical trial data complexity, early use of rule based drug safety monitoring systems.

The artificial intelligence (AI) in pharmacovigilance market size is expected to see rapid growth in the next few years. It will grow to $1.88 billion in 2030 at a compound annual growth rate (CAGR) of 19.6%. The growth in the forecast period can be attributed to rapid adoption of ai powered drug safety surveillance systems, increasing volume of real world healthcare data for analysis, expansion of regulatory compliance requirements for drug safety, growing use of predictive analytics in adverse event detection, rising integration of multi source clinical data for pharmacovigilance. Major trends in the forecast period include rise of automated literature screening for adverse drug reaction identification, increasing adoption of real world evidence analytics in drug safety monitoring, growing use of generative AI for regulatory pharmacovigilance reporting, expansion of automated case intake and workflow processing systems, surge in cross-border regulatory harmonization for drug safety data exchange.

The increasing volume of adverse event (AE) reports is expected to propel the growth of the artificial intelligence (AI) in pharmacovigilance market going forward. Adverse event (AE) reports refer to documented cases of unintended and harmful reactions or outcomes experienced after the use of a medical product or drug. The volume of adverse event (AE) reports is increasing due to stricter regulatory requirements that require healthcare providers and pharmaceutical companies to report a broader range of safety issues more frequently and in greater detail. Artificial intelligence (AI) in pharmacovigilance processes adverse event (AE) reports by automatically collecting and analyzing large volumes of safety data from multiple sources in real time, enabling faster detection of drug safety signals while improving the accuracy, consistency, and regulatory compliance of reporting. For instance, in February 2024, according to the Analysis of Adverse Drug Reactions 2023 Report by the Department of Health Abu Dhabi, a UAE-based regulatory body, a total of 1,522 adverse drug reaction reports were submitted to the pharmacovigilance program between January and December 2023, representing a 235% increase compared to the average annual number of reports recorded in previous years. Therefore, the increasing volume of adverse event (AE) reports is driving the growth of the artificial intelligence (AI) in pharmacovigilance market.

Key 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 example, 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.

In January 2023, Certara Inc., a US-based healthcare technology and biosimulation company, acquired Vyasa LLC for an undisclosed amount. Through this acquisition, Certara Inc. aimed to strengthen its end-to-end drug development and biosimulation platform by integrating Vyasa’s deep learning and artificial intelligence capabilities, thereby enhancing its ability to analyze structured and unstructured biomedical data, accelerate predictive modeling, and improve decision-making across drug discovery and development workflows. Vyasa LLC is a US-based company that provides AI software and services relevant to pharmacovigilance and drug development through its AI-powered data analytics platform used in life sciences workflows.

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.

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. The countries covered in the artificial intelligence (AI) in pharmacovigilance market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The artificial intelligence (AI) in pharmacovigilance market includes revenues earned by entities by providing services such as drug safety data mining and analytics, case processing and narrative generation, regulatory compliance and reporting solutions, predictive risk modeling, and integration of pharmacovigilance systems with healthcare databases. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

The artificial intelligence (AI) in pharmacovigilance market research report is one of a series of new reports that provides artificial intelligence (AI) in pharmacovigilance market statistics, including artificial intelligence (AI) in pharmacovigilance industry global market size, regional shares, competitors with a artificial intelligence (AI) in pharmacovigilance market share, detailed artificial intelligence (AI) in pharmacovigilance market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence (AI) in pharmacovigilance industry. This artificial intelligence (AI) in pharmacovigilance market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

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