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Increasing Adoption Of Personalized Medicine Drives Growth In The Pharmacovigilance And Drug Safety Software Market: Pivotal Factor Influencing Pharmacovigilance And Drug Safety Software Market Growth in 2025

09-16-2025 08:34 AM CET | Health & Medicine

Press release from: The Business Research Company

Pharmacovigilance And Drug Safety Software Market

Pharmacovigilance And Drug Safety Software Market

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Pharmacovigilance And Drug Safety Software Market Size Growth Forecast: What to Expect by 2025?
In the past few years, the market size for pharmacovigilance and drug safety software has seen rapid growth. The projections indicate that it will rise from $2.26 billion in 2024 to $2.53 billion in 2025, boasting a compound annual growth rate (CAGR) of 12.3%. This growth during the historical period is a result of the escalating demand for pharmacovigilance and drug safety software.

How Will the Pharmacovigilance And Drug Safety Software Market Size Evolve and Grow by 2029?
It is anticipated that the pharmacovigilance and drug safety software market will experience significant expansion in the coming years, reaching an estimated value of "$4.09 billion in 2029 with a compound annual growth rate (CAGR) of 12.7%. The surge expected in the forecast period can be owed to the increasing instances of adverse drug reactions and the international expansion of pharmacovigilance, the increase in complexity in drug safety regulations, the rise in development of new drug treatments and therapies, as well as a growing number of adverse drug reactions. Key trends expected in the forecast period include the infusion of AI and automation, the adoption of cloud-based solutions, innovations in technology, advances in technological methods, and heightened digitalization in the healthcare industry.

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What Drivers Are Propelling the Growth of Pharmacovigilance And Drug Safety Software Market Forward?
The surge in the need for personalized medicine is projected to advance the pharmacovigilance and drug safety software market's trajectory. Customized medicine, also acknowledged as precision medicine, is an approach in healthcare that caters to every individual patient's unique attributes while making decisions and implementing treatments. The escalation in the demand for tailored medicine can be credited to multiple factors, like enhanced healing results, a spotlight on precautionary measures and early diagnosis, and cost efficiency. The pharmacovigilance and drug safety software serve a critical role in the successful implementation of personalized medicine. By utilizing pharmacogenetics, real-time data observation, post-release surveillance, and individualized medication data, these resources augment the protection and effectiveness of tailored treatments. They further provide sturdy risk management plans and address ethical issues. For example, as per the Personalized Medicine Coalition, a US-based non-profit, the FDA granted approval for 16 innovative tailored therapies for patients suffering from rare diseases in 2023, which is a significant increase from only 6 approvals in 2022. Hence, the rising demand for personalized medicine is fuelling the growth of the pharmacovigilance and drug safety software market.

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Which Fast-Growing Trends Are Poised to Disrupt the Pharmacovigilance And Drug Safety Software Market?
Leading organizations in the pharmacovigilance and drug safety software industry have embarked on developing novel technologies like cloud-based data lake platforms to boost patient safety, oversee adverse occurrences more capably, and augment regulatory adherence in clinical research and medical device post-market observation. Cloud-based data lake platforms are expandable, centralized storage systems that enable organizations to handle and analyze copious amounts of structured and unstructured information, as well as provide instant data access and facilitate progressive analytics and AI/ML workloads. As a case in point, Thermo Fisher Scientific Inc., a biotechnology firm in the US, unveiled CorEvidence, a pioneering proprietary cloud-based data lake platform, in December 2023; this platform is specifically developed to improve pharmacovigilance procedures in clinical research registries. The primary objective of this platform is to streamline case handling and safety data management, specifically for post-authorization safety studies.

What Are the Key Segments in the Pharmacovigilance And Drug Safety Software Market?
The pharmacovigilance and drug safety software market 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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Who Are the Key Players Shaping the Pharmacovigilance And Drug Safety Software Market's Competitive Landscape?
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 Geographic Markets Are Powering Growth in 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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