Artificial Intelligence (AI) in Pharmacovigilance Global Market Report 2026 | Capitalize on 19.6% CAGR to 2030 as Oracle, Microsoft, Google and IQVIA Accelerate Automation

Dublin, Oct. 27, 2026 -- "Artificial Intelligence (AI) in Pharmacovigilance Market Global Report 2026" has been added to ResearchAndMarkets.com's offering.

The global artificial intelligence (AI) in pharmacovigilance market is experiencing rapid growth as pharmaceutical companies, healthcare organizations and regulators adopt advanced technologies to strengthen drug safety monitoring. The market is projected to increase from $0.77 billion in 2025 to $0.92 billion in 2026, representing a compound annual growth rate (CAGR) of 19.3%.

Historical market growth has been supported by rising global adverse drug reaction reporting requirements, the expansion of pharmacovigilance regulations, increasing adoption of electronic health records and the growing complexity of clinical trial data. Early deployment of rule-based drug safety monitoring systems also established a foundation for the wider use of AI-powered pharmacovigilance solutions.

The AI in pharmacovigilance market is forecast to reach $1.88 billion by 2030, expanding at a CAGR of 19.6%. Growth during the forecast period will be driven by the rapid adoption of AI-powered drug safety surveillance, greater availability of real-world healthcare data, expanding regulatory compliance requirements and increased use of predictive analytics to identify adverse event signals. The integration of clinical, regulatory and real-world data from multiple sources is also expected to improve the speed and accuracy of pharmacovigilance operations.

Key artificial intelligence in pharmacovigilance market trends include automated literature screening, real-world evidence analytics, generative AI for regulatory reporting and automated case intake. Pharmaceutical companies are also implementing intelligent workflow processing systems to reduce administrative workloads and accelerate safety assessments. Cross-border regulatory harmonization is expected to support more efficient drug safety data exchange among healthcare organizations, life sciences companies and regulatory authorities.

The increasing volume of adverse event reports is a major driver of market expansion. Stricter regulations require healthcare providers and pharmaceutical companies to document a broader range of safety issues with greater frequency and detail. AI-based pharmacovigilance systems can collect and analyze large volumes of safety data from multiple sources in real time, supporting earlier signal detection while improving reporting accuracy, consistency and regulatory compliance.

According to the Department of Health Abu Dhabi's Analysis of Adverse Drug Reactions 2023 Report, 1,522 adverse drug reaction reports were submitted to the pharmacovigilance program between January and December 2023. This represented a 235% increase compared with the average annual number recorded in previous years. Rising report volumes reinforce the need for scalable AI technologies capable of streamlining case processing and prioritizing significant drug safety signals.

Technology providers are responding by developing agentic AI-driven pharmacovigilance platforms that automate adverse event detection, literature surveillance, signal management, aggregate reporting and risk management. In May 2026, RxLogix Systems Inc. launched an upgraded version of its PVOne.AI platform with agentic AI capabilities designed to coordinate end-to-end drug safety workflows. The platform uses contextual reasoning and domain-trained models to support regulatory-grade decision-making while retaining human oversight for compliance with U.S. Food and Drug Administration and international pharmacovigilance standards.

RxLogix reported that the upgraded platform can reduce manual case-processing effort by up to 80%, improve reviewer productivity by up to 75% and support up to 50% touchless workflows. These capabilities demonstrate how AI-enabled pharmacovigilance software can minimize repetitive tasks, improve case prioritization and help organizations manage large pharmaceutical datasets more efficiently.

Strategic acquisitions are also shaping the competitive environment. In January 2023, Certara Inc. acquired Vyasa LLC for an undisclosed amount. The transaction strengthened Certara's drug development and biosimulation platform by adding deep learning and AI capabilities for analyzing structured and unstructured biomedical data. The integration is intended to accelerate predictive modeling and improve decision-making across drug discovery, development and safety workflows.

North America was the largest region in the artificial intelligence in pharmacovigilance market in 2025, supported by advanced healthcare infrastructure, strong regulatory oversight and broad adoption of digital drug safety technologies. Asia-Pacific is expected to be the fastest-growing region during the forecast period. The market analysis covers Asia-Pacific, Southeast Asia, Western Europe, Eastern Europe, North America, South America, the Middle East and Africa, including Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, the United Kingdom, the United States, Canada, Italy and Spain.

Markets Covered:
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

Time Series: Five years historic and ten years forecast.

Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.

Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.

Key Attributes:

Companies Featured

• 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

For more information about this report visit https://www.researchandmarkets.com/r/jp27n5

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