Pharmacovigilance and Drug Safety Software Market Trends Analysis and Growth Forecasts, 2025-2033

Key market opportunities include leveraging advancements in pharmacovigilance technologies to enhance real-time drug safety monitoring, outsourcing pharmacovigilance tasks for cost efficiency, and adapting to stringent global safety regulations. Growth is driven by rising adverse drug reactions and complex therapies.

Dublin, Jan. 30, 2026 (GLOBE NEWSWIRE) -- The "Pharmacovigilance and Drug Safety Software Market Size, Share & Trends Analysis Report by Functionality (Case Data Collection and Management, Adverse Event Reporting and Analysis), Deployment (on Premise, on Demand), End Use and Region with Growth Forecasts, 2025-2033" has been added to ResearchAndMarkets.com's offering.

The global pharmacovigilance and drug safety software market is expected to grow significantly, increasing from a valuation of USD 210.96 million in 2024 to USD 388.74 million by 2033, at a CAGR of 7.1% from 2025 to 2033.

Key drivers include the rising availability of data, stringent reporting standards, and frequent software upgrades by major companies. One notable product, INTIENT Pharmacovigilance by Accenture , offers a comprehensive suite for managing pharmacovigilance data, identifying compliance issues, and reporting adverse events. The surge in adverse drug reactions (ADRs) and medication errors emphasizes the necessity for advanced pharmacovigilance solutions.

As drug therapies grow more complex and polypharmacy becomes prevalent, healthcare systems face increased risks of patient safety threats leading to higher hospitalization rates. According to a Springer Nature article, ADRs caused 5.0% of urgent hospitalizations among 5,707 patients hospitalized for acute illnesses between June 2018 and May 2021, highlighting the urgent need for automated pharmacovigilance systems that can monitor and report drug-related risks in real-time.

Regulatory pressures from institutions like the European Medicines Agency and the U.S. FDA are pushing for widespread adoption of pharmacovigilance systems. Consequently, many pharmaceutical companies are outsourcing these activities to reduce operational costs. The trend is moving away from fully integrated pharmaceutical companies towards collaborations with service providers, covering services from medical writing to clinical trial data management. Outsourcing fosters flexible resource use and improved timelines and outcomes.

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Key Attributes:

Global Pharmacovigilance and Drug Safety Software AG Market Report Segmentation

Deployment Outlook (Revenue, USD Million, 2021-2033)

• On Premise
• On Demand

Functionality Outlook (Revenue, USD Million, 2021-2033)

• Case data collection and management
• Adverse event reporting and analysis
• Signal detection and safety risk assessment

End Use Outlook (Revenue, USD Million, 2021-2033)

• Healthcare Companies (Pharmaceuticals & Biotechnology)
• CROs/BPOs or outsourced PV service providers
• Others

Regional Outlook (Revenue, USD Million, 2021-2033)

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)

Companies Featured

• Oracle (Cerner)
• Accenture
• IBM Corporation
• ITClinical
• UBC (United BioSource Corporation)
• Ab Cube
• Ennov
• EXTEDO
• Veeva Systems
• IQVIA
• Sarjen Systems Pvt. Ltd.
• Flex Databases
• Tepsivo Oy
• ArisGlobal
• EVERSANA

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• Pharmacovigilance and Drug Safety Software Market

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