Growth Opportunities and Trends in the Pharmacovigilance And Drug Safety Software Market: Key Insights for 2025-2034
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How has the pharmacovigilance and drug safety software market grown in recent years?
The pharmacovigilance and drug safety software market has experienced significant growth, increasing from $2.26 billion in 2024 to $2.55 billion in 2025 at a CAGR of 13.2%. This growth has been driven by the rising demand for pharmacovigilance and drug safety solutions.
How is the pharmacovigilance and drug safety software market size expected to evolve during the forecast period?
The pharmacovigilance and drug safety software market is anticipated to grow rapidly, reaching $4.15 billion by 2029 at a CAGR of 12.9%. Growth factors include increasing incidences of adverse drug reactions (ADRs), globalization of pharmacovigilance, more complex drug safety regulations, growth in drug development, and a rise in new therapies. Major trends include automation and AI integration, cloud-based solutions, continued technological innovations, increased healthcare digitalization, and advancements in pharmacovigilance systems.
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Which key drivers are propelling the pharmacovigilance and drug safety software market’s growth?
The expanding demand for personalized medicine is expected to accelerate the growth of the pharmacovigilance and drug safety software market. Personalized medicine, driven by improved treatment outcomes and early detection, requires tools like pharmacovigilance software to improve safety and efficacy in treatments. This software integrates pharmacogenetics, real-time data, and personalized medication details to enhance drug safety. For example, in 2023, 16 new personalized therapies were approved for rare diseases, compared to six in 2022. The increasing demand for personalized medicine is, therefore, contributing to the growth of the pharmacovigilance and drug safety software market.
What are the market segments in the 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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Which leading companies are shaping the growth of 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 key trends are currently impacting the pharmacovigilance and drug safety software market’s development?
Leading firms in the pharmacovigilance and drug safety software market are developing cutting-edge technologies like cloud-based data lake platforms to improve patient safety, more efficiently monitor adverse events, and enhance regulatory compliance within clinical trials and medical device post-market surveillance. A cloud-based data lake platform is a centralized storage system with scalability, which provides organizations the ability to store, manage, and analyze large quantities of data, be it structured or unstructured. It supports advanced analytics and AI/ML workloads, providing real-time access to data. For example, Thermo Fisher Scientific Inc., a biotechnology company based in the United States, introduced CorEvidence, a revolutionary proprietary cloud-based data lake platform, in December 2023. This platform, specifically designed for clinical research registries, aims to improve the management of safety data and processing of cases, especially for post-authorization safety studies.
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Which geographic areas are influencing the growth of 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.
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