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Global Pharmacovigilance And Drug Safety Software Opportunities 2025, Forecast To 2034

19 Mar, 2025

How Has the Pharmacovigilance And Drug Safety Software Market Evolved Historically and What is its Current Size?

The pharmacovigilance and drug safety software market has seen considerable growth due to a variety of factors.
• The market for pharmacovigilance and drug safety software has been expanding swiftly over the recent years. It's set to increase from $2.26 billion in 2024 to $2.55 billion in 2025, with a compound annual growth rate (CAGR) of 13.2%.
The notable growth during the historical period is credited to the rising demand for this type of software.

What Is The Projected Growth Of The Pharmacovigilance And Drug Safety Software Template Market?

The pharmacovigilance and drug safety software market is expected to maintain its strong growth trajectory in upcoming years.
• The market for pharmacovigilance and drug safety software is predicted to experience substantial growth over the next several years, with projections indicating an increase to $4.15 billion by 2029, reflecting a compound annual growth rate (CAGR) of 12.9%.
Factors contributing this growth during the projected period include an increase in the occurrences of negative drug reactions and the international expansion of pharmacovigilance. Other influential factors include growing complexity in drug safety rules, the acceleration in the production of novel drugs and therapies, and the escalating rate of adverse drug reactions (ADRs). Key trends anticipated during the forecast period involve AI integration and automation, the adoption of cloud-based solutions, technological advancements, and a rise in the digitalization of healthcare.

What Are The Key Drivers Fueling Growth In The Pharmacovigilance And Drug Safety Software Market?

The accelerating necessity for individualized healthcare provisions is projected to drive the expansion of the pharmacovigilance and drug safety software market. Personal or precision medicine provides tailored health decisions and treatment options according to the distinct attributes of every patient. Several elements contribute to the increasing need for personalized medicine, including enhanced treatment results, emphasis on early detection and prevention, and cost-efficiency. Pharmacovigilance and drug safety software play a pivotal part in the effectiveness of personal medicine. Utilizing pharmacogenetics, real-time data interpretation, post-sale surveillance, and individualized medication data, these technological aids enhance the safety and efficiency of personalized treatment protocols, back up comprehensive risk management plans, and address moral considerations. As an example, in February 2024, the US-based non-profit, Personalized Medicine Coalition, stated that in 2023 the FDA approved 16 new personalized treatments for patients afflicted with unusual diseases, which is a considerable increase from the 6 approved in 2022. Thus, the increasing need for personalized medicine is fuelling the expansion of the pharmacovigilance and drug safety software market.

What Are The Principal Market Segments In The Global Pharmacovigilance And Drug Safety Software Industry?

The pharmacovigilance and drug safety softwaremarket covered in this report is segmented –
1) By Software Type: Adverse Event Reporting Software, Drug Safety Audits Software, Issue Tracking Software, Fully Integrated Software
2) By Delivery Mode: On-premise, Cloud-based
3) By End User: Pharmaceutical And Biotechnology Companies, Contract Research Organizations, Business Process Outsourcing Firms, Other End Users Subsegments:
1) By Adverse Event Reporting Software: Spontaneous Reporting Systems, EHR Integration Solutions, Mobile Reporting Applications
2) By Drug Safety Audits Software: Audit Management Solutions, Compliance Tracking Tools, Reporting And Analytics Modules
3) By Issue Tracking Software: Incident Reporting Systems, Workflow Management Tools, Collaboration Platforms
4) By Fully Integrated Software: Pharmacovigilance Platforms, Regulatory Compliance Systems, Data Analytics And Visualization Tools

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What Trends Are Reshaping The Future Of The Pharmacovigilance And Drug Safety Software Market?

Prominent companies engaged in the market for pharmacovigilance and drug safety software are innovating in technology. This includes the development of solutions such as cloud-based data lake platforms, designed to augment patient security, increase the efficacy of adverse event tracking, and heighten regulatory compliance during clinical trials and surveillance after devices have entered the market. To clarify, a cloud-based data lake platform is an expandable, centralized storage system that permits organizations to house, oversee, and assess large quantities of both structured and unstructured data. It enables instant access to data and underpins advanced analytics and AI/ML workloads. To highlight an example, Thermo Fisher Scientific Inc., a biotech company based in the United States, introduced CorEvidence in December 2023. This innovative, exclusive cloud-based data lake platform was specifically created to fortify pharmacovigilance procedures within clinical research registries. The platform is intended to streamline case processing and safety data management, particularly in relation to post-authorization safety investigations.

Who Are the Key Players In The Pharmacovigilance And Drug Safety Software Market?

Major companies operating in the pharmacovigilance and drug safety software market are:
• Accenture plc
• International Business Machines Corporation
• Deloitte Touche Tohmatsu Limited
• Oracle Corporation
• Capgemini SE
• Cognizant Technology Solutions
• IQVIA
• Wipro Limited
• Genepact
• Parexel Academy
• PharmaLex
• Indegene Limited
• RXLogix
• Sarjen Systems Pvt Ltd.
• Anju Software Inc.
• Ennov Group
• EXTEDO GmbH
• ArisGlobal
• AB Cube
• Clinevo Technologies

What Are The Regional Insights Into The Pharmacovigilance And Drug Safety Software Market?

North America was the largest region in the pharmacovigilance and drug safety software market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the pharmacovigilance and drug safety software market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.