Pharmacovigilance And Drug Safety Software Market To Reach $388.74 Million By 2033

Pharmacovigilance And Drug Safety Software Market Growth & Trends

The global pharmacovigilance and drug safety software market size is expected to reach USD 388.74 million by 2033, registering a CAGR of 7.1% from 2025 to 2033, according to a new report by Grand View Research, Inc. The key factors driving the market growth include the increasing need to track and manage adverse drug reactions (ADR), comply with regulatory norms, increase adoption by end-users, interoperability, and product upgrades by key companies. In February 2022, Oracle’sArgus (for safety management) and Clinical One (for clinical trial management) were implemented by Clinixir-a Thailand-based CRO.

Various end-users such as pharmaceutical, and biotechnology companies, are adopting pharmacovigilance and drug safety software for cost reduction and minimizing operational expenses by gradually shifting from being fully integrated pharmaceutical companies to sharing costs by collaborating with service providers. Outsourcing helps increase internal resource flexibility, improves timelines, and results in better outcomes in the short as well as long term. Outsourcing also helps achieve better pharmacovigilance (PV) through regulatory compliance, higher quality, better productivity, and improved strategic outcomes. This is expected to fuel market growth.

Pharmacovigilance and drug safety software vendors, in an attempt to ensure sustainability, are providing customized and end-to-end solutions to meet consumer needs. These vendors are also incorporating integrated technologies such as electronic data capture, AI, and interoperability, among others to enhance their offerings. Moreover, the combined pressures of volume, cost, and heightened demand for analytics are propelling industry stakeholders to adopt advanced technology to support their pharmacovigilance activities. Also, the fact that service providers are now operating via a flexible and variable pricing structure and achieving operational excellence through constant product updates is expected to boost usage rates over the forecast period.

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Pharmacovigilance And Drug Safety Software Market Report Highlights

• On the basis of deployment, the on-demand segment dominated the market in 2024, with a market share of 56.59%. Healthcare IT providers are increasingly favoring on-demand solutions due to their numerous advantages, including cost-effectiveness, scalability, real-time data access, and enhanced collaboration among stakeholders

• On the basis of functionality, the adverse event reporting segment dominated the market for PV drug safety software and accounted for the largest revenue share of 38.5% in 2024

• The healthcare companies segment dominated the market and accounted for the largest revenue share of 43.76% in 2024

• The CROs segment is expected to exhibit profitable growth during the forecast period. PV service providers, in an attempt to ensure sustainability, are providing customized end-to-end solutions to meet consumer needs.

• North America pharmacovigilance drug safety software market dominated and accounted for the largest revenue share of 32.11% in 2024. Owing to government-aided initiatives favoring the adoption of PV and drug safety software systems, for instance

Pharmacovigilance And Drug Safety Software Market Segmentation

Grand View Research has segmented the global pharmacovigilance and drug safety software market report based on deployment, functionality, end use, and regions:

Pharmacovigilance And Drug Safety Software Deployment Outlook (Revenue, USD Million, 2021 - 2033)

• On Premise

• On Demand

Pharmacovigilance And Drug Safety Software Functionality Outlook (Revenue, USD Million, 2021 - 2033)

• Case data collection and management

• Adverse event reporting and analysis

• Signal detection and other safety risk assessment

Pharmacovigilance And Drug Safety Software End Use Outlook (Revenue, USD Million, 2021 - 2033)

• Healthcare Companies (Pharmaceuticals & Biotechnology Companies)

• CROs/BPOs or PV service providers when outsourced.

• Others

Pharmacovigilance And Drug Safety Software Regional Outlook (Revenue, USD Million, 2021 - 2033)

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • China

  • Japan

  • India

  • South Korea

  • Australia

  • Thailand

• Latin America

  • Brazil

  • Argentina

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players in the Pharmacovigilance And Drug Safety Software Market

• 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