Artificial Intelligence (AI)-Driven Drug Safety and Pharmacovigilance Platforms Market Global Report 2026

The artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms market size has grown exponentially in recent years. It will grow from $2.14 billion in 2025 to $2.59 billion in 2026 at a compound annual growth rate (CAGR) of 20.6%. The growth in the historic period can be attributed to rise in global adverse drug reaction reporting requirements, increasing digitization of clinical trial data, expansion of pharmacovigilance regulatory frameworks, growth in pharmaceutical research activity, adoption of electronic health records in healthcare systems.

The artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms market size is expected to see exponential growth in the next few years. It will grow to $5.39 billion in 2030 at a compound annual growth rate (CAGR) of 20.2%. The growth in the forecast period can be attributed to integration of ai into drug safety surveillance systems, expansion of real-world evidence based pharmacovigilance, increasing regulatory demand for automated compliance reporting, growth in predictive safety analytics platforms, rising adoption of cloud-based drug safety monitoring systems. Major trends in the forecast period include AI-powered adverse event detection systems, natural language processing based safety signal extraction, predictive pharmacovigilance analytics platforms, real-time drug safety monitoring using real-world data, automated regulatory safety reporting systems.

The increasing volume of adverse event (AE) reports is expected to propel the growth of the artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms 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)-driven drug safety and pharmacovigilance platforms process adverse event (AE) reports by aggregating data from clinical systems, electronic health records, and real-world sources to detect and classify safety signals, automate case processing, and improve the speed and accuracy of regulatory decision-making. 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)-driven drug safety and pharmacovigilance platforms market.

Key companies operating in the artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms 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 solutions company, launched the upgraded PVOne.AI platform, an AI-enabled pharmacovigilance system that integrates agentic AI capabilities to automate and orchestrate end-to-end drug safety workflows. The platform operates across case intake, adverse event monitoring, literature surveillance, signal detection, aggregate reporting, and risk management, leveraging contextual reasoning and domain-trained models to support regulatory-grade decision-making. It also includes 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%, improving reviewer productivity by up to 75%, and enabling up to 50% touchless workflows by minimizing repetitive tasks and enhancing prioritization of safety signals in large-scale pharmaceutical datasets.

In October 2024, EVERSANA Inc., a US-based pharmaceutical manufacturing company specializing in providing comprehensive AI-driven platforms and solutions for drug safety and pharmacovigilance (PV), partnered with Oracle Corporation to enhance pharmacovigilance and drug safety capabilities. Through this partnership, EVERSANA Inc. entered into a strategic collaboration agreement with Oracle Corporation to implement Oracle Argus Cloud Service, enabling AI-powered automation, workflow optimization, and touchless processing to improve safety case management, regulatory compliance, and global patient support services across the life sciences industry. Oracle Corporation is a US-based technology company specializing in cloud infrastructure, enterprise software, and healthcare and life sciences solutions.

Major companies operating in the artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms market are Microsoft Corporation; International Business Machines Corporation; Accenture plc; Oracle Corporation; Cognizant Technology Solutions Corporation; IQVIA Holdings Inc.; Wipro Limited; ICON Public Limited Company; Fortrea; Clarivate Plc; Genpact Limited; Veeva Systems Inc.; ArisGlobal; Certara Inc.; Tempus AI Inc.; Komodo Health Inc.; Elsevier B.V.; Navitas Life Sciences; PrimeVigilance; Ennov Group SAS; Cloudbyz Inc.; Phesi; Medrio Inc.; Genomics England Limited.

North America was the largest region in the artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms 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)-driven drug safety and pharmacovigilance platforms 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)-driven drug safety and pharmacovigilance platforms market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms market includes revenues earned by entities by providing services such as software licensing and subscription, cloud-based pharmacovigilance solutions, adverse event detection and reporting systems, data integration and interoperability solutions, predictive safety analytics, regulatory compliance support, system customization and integration, maintenance and technical support, consulting, and training services. 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)-driven drug safety and pharmacovigilance platforms market research report is one of a series of new reports that provides artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms market statistics, including artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms industry global market size, regional shares, competitors with a artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms market share, detailed artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms industry. This artificial intelligence (AI)-driven drug safety and pharmacovigilance platforms 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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