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Top Trends Transforming the Pharmacovigilance And Drug Safety Software Market Landscape in 2025: Cloud-Based Data Lake Platforms Revolutionizing Pharmacovigilance And Drug Safety Software Market

08-18-2025 10:23 AM CET | Health & Medicine

Press release from: The Business Research Company

Pharmacovigilance And Drug Safety Software Market Size

Pharmacovigilance And Drug Safety Software Market Size

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What Will the Pharmacovigilance And Drug Safety Software Industry Market Size Be by 2025?
In recent times, there has been a swift expansion in the pharmacovigilance and drug safety software market. The market, which was worth $2.26 billion in 2024, is projected to reach a value of $2.55 billion in 2025, indicating a compound annual growth rate (CAGR) of 13.2%. The notable growth observed in the past can be linked to the surge in demand for pharmacovigilance and drug safety software.

What's the Long-Term Growth Forecast for the Pharmacovigilance And Drug Safety Software Market Size Through 2029?
Expectations indicate a swift expansion in the pharmacovigilance and drug safety software market in the upcoming years. The market size is predicted to surge to $4.15 billion by 2029, projecting a compound annual growth rate (CAGR) of 12.9%. Factors such as escalating incidences of adverse drug reactions and the global outreach of pharmacovigilance, heightened intricacy in drug safety regulations, and an upswing in the introduction of new drugs and therapies are key contributors to the anticipated growth within the forecast period. The market trends in the same period are likely to be dominated by AI integration and automation, the use of cloud-based solutions, technological evolution, advances in technologies, and the rising tide of healthcare digitization.

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What Are the Key Growth Drivers Fueling the Pharmacovigilance And Drug Safety Software Market Expansion?
The increasing need for customized healthcare is projected to drive the expansion of the pharmacovigilance and drug safety software industry. Precision medicine, another term for personalized medicine, refers to a medical procedure that customizes health decisions and interventions based on the unique attributes of each patient. The escalating demand for such personalized healthcare is attributable to multiple factors such as more successful treatment outcomes, emphasis on preemptive measures and early diagnosis, and economic efficiency. The pharmacovigilance and drug safety software play a crucial role in the success of personalized medicine. By integrating pharmacogenetics, real-time data interpretation, post-marketing monitoring, and custom medication details, these tools enhance the safety and effectiveness of customized treatments, while endorsing solid risk management tactics and dealing with ethical issues. For example, the FDA approved 16 new personalized treatments for rare disease patients in 2023, up from 6 in 2022, as reported by the Personalized Medicine Coalition, a non-profit organization based in the US in February 2024. Hence, the rising demand for personalized medicine is fuelling the growth of the pharmacovigilance and drug safety software industry.

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What Are the Key Trends Driving Pharmacovigilance And Drug Safety Software Market Growth?
Leading firms in the pharmacovigilance and drug safety software market are spearheading the development of innovative solutions, such as cloud-based data lake platforms, to bolster patient safety, improve adverse event tracking, and elevate regulatory adherence during clinical trials and post-market monitoring of medical appliances. The cloud-based data lake platform is a scalable and centralised storage system that empowers organizations to handle and examine a large volume of structured and unstructured data. It offers instantaneous data access and facilitates advanced data analysis and AI/ML operations. For instance, Thermo Fisher Scientific Inc., a biotech enterprise based in the US, unveiled CorEvidence, a novel proprietary cloud-based data lake platform in December 2023. The platform is purposed to enhance pharmacovigilance activities within clinical study registries by optimizing case processing and safety data management, with a special focus on post-authorization safety studies.

How Is the Pharmacovigilance And Drug Safety Software Market Segmented?
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 Companies Are Leading the Charge in Pharmacovigilance And Drug Safety Software Market Innovation?
Major companies operating in the pharmacovigilance and drug safety software market are 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

Which Regions Are Leading the Global Pharmacovigilance And Drug Safety Software Market in Revenue?
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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