Artificial Intelligence (AI) In Pharmacovigilance Market Report 2026

Artificial Intelligence (AI) In Pharmacovigilance Market Overview

• Artificial Intelligence (AI) In Pharmacovigilance market size has reached to $0.77 billion in 2025 • Expected to grow to $1.88 billion in 2030 at a compound annual growth rate (CAGR) of 19.6% • Growth Driver: Rising Volume Of Adverse Event (AE) Reports Driving The Market Growth Due To Increasing Regulatory Reporting Requirements • Market Trend: Next-Generation AI Pharmacovigilance Systems Improve Adverse Event Detection And Compliance • North America was the largest region in 2025 and Asia-Pacific is the fastest growing region.

What Is Covered Under Artificial Intelligence (AI) In Pharmacovigilance Market?

Artificial intelligence (AI) in pharmacovigilance refers to the application of machine learning, natural language processing, and advanced data analytics to detect, assess, monitor, and prevent adverse drug reactions and other drug safety issues. It enhances the efficiency and accuracy of drug safety surveillance by automating the processing of large volumes of structured and unstructured healthcare data, enabling faster signal detection, risk assessment, and regulatory reporting. It supports improved decision-making in drug safety management by reducing manual effort and increasing the reliability of safety insights. The main components of artificial intelligence (AI) in pharmacovigilance include software and services. Software refers to AI-powered platforms that automate the detection, assessment, monitoring, and reporting of adverse drug reactions and safety signals throughout a product’s lifecycle. These solutions utilize technologies including machine learning, natural language processing, predictive analytics, robotic process automation, and generative artificial intelligence or large language models and are deployed through cloud-based and on-premises models. They find application in adverse event detection, signal detection, data integration and management, drug safety monitoring, and automated report generation, serving end users including pharmaceutical companies, biotechnology companies, contract research organizations, regulatory agencies, hospitals and healthcare providers, and academic and research institutes.

What Is The Artificial Intelligence (AI) In Pharmacovigilance Market Growth Forecast?

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.

Global Artificial Intelligence (AI) In Pharmacovigilance Market Segmentation

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

What Is The Driver Of The Artificial Intelligence (AI) In Pharmacovigilance Market?

The rising 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 compel healthcare providers and pharmaceutical companies to report a wider 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 and improving the accuracy and consistency of reporting and regulatory compliance. 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 rising volume of adverse event (AE) reports is driving the growth of the artificial intelligence (AI) in pharmacovigilance industry.

Key Players In The Global Artificial Intelligence (AI) In Pharmacovigilance Market

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

Global Artificial Intelligence (AI) In Pharmacovigilance Market Trends and Insights

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.

What Are Latest Mergers And Acquisitions In The Artificial Intelligence (AI) In Pharmacovigilance Market?

In January 2023, Certara Inc., a US-based healthcare technology and biosimulation company, acquired Vyasa LLC for an undisclosed amount. With 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 improving its ability to analyze structured and unstructured biomedical data, accelerate predictive modeling, and enhance decision-making across drug discovery and development workflows. Vyasa LLC is a US-based company that offers AI software and services relevant to pharmacovigilance and drug development through its AI-powered data analytics platform used in life sciences workflows.

Regional Outlook

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 this market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

What Defines the Artificial Intelligence (AI) In Pharmacovigilance Market?

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.

How is Market Value Defined and Measured?

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.

What Key Data and Analysis Are Included in the Artificial Intelligence (AI) In Pharmacovigilance Market Report 2026?

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