Global pharmacovigilance and drug safety software Market
Pharmaceuticals

Pharmacovigilance And Drug Safety Software Market Forecast and Analysis: Key Insights into Growth, Trends, and Emerging Opportunities

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How Will the Growth Rate of the Pharmacovigilance And Drug Safety Software Market Shape Industry Trends by 2034?

The market size of pharmacovigilance and drug safety software has seen a swift expansion in the past few years. It is projected to escalate from $2.26 billion in 2024 to $2.55 billion in 2025, with a compound annual growth rate (CAGR) of 13.2%. The growth experienced in the previous period is due to the rising demand for pharmacovigilance and drug safety software.

The market for pharmacovigilance and drug safety software is projected to experience rapid expansion in the upcoming years. The market size is set to soar to $4.15 billion in 2029, with a compound annual growth rate (CAGR) of 12.9%. This projected growth in the forecast period is linked to the escalating cases of adverse drug reactions and the internationalization of pharmacovigilance, growing incidents of adverse drug reactions, heightened complexities in drug safety regulations, a surge in the development of new drug and therapy options, increasing instances of adverse drug reactions (ADRs), and a rising count of adverse drug reactions. The key trends to watch during the forecast period include the integration of automation and AI, the rise of cloud-based solutions, technological innovations, advancements in technology, and the escalating digitalization of healthcare.

How Are Key Drivers in the Industry Acting as Catalysts for the Growth of the Pharmacovigilance And Drug Safety Software Market?

The booming interest in personalized health care is projected to accelerate the expansion of the pharmacovigilance and drug safety software market. Personalized health care, often referred to as precision medicine, crafts healthcare choices and treatments based on each patient’s unique features. This growing interest is attributed to numerous factors, such as enhanced treatment results, emphasis on early detection and prevention, and cost-efficiency. Pharmacovigilance and drug safety software play a vital role in the success of personalized health care. They enhance the safety and effectiveness of individualized treatments by incorporating pharmacogenetics, real-time data analysis, post-marketing surveillance, and personalized medication details, all while fostering strong risk management strategies and tackling ethical issues. In February 2024, the US-based non-profit organization, Personalized Medicine Coalition, disclosed that the FDA had approved 16 novel personalized therapies for rare diseases patients in 2023, a significant increase from the 6 approved in 2022. Thus, the escalating demand for personalized health care is fueling the expansion of the pharmacovigilance and drug safety software market.

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Who Are the Key Market Players Influencing the Growth of the Pharmacovigilance And Drug Safety Software Industry?

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 Market Trends Are Shaping the Future of the Pharmacovigilance And Drug Safety Software Industry?

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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What Are the Main Segments of the Pharmacovigilance And Drug Safety Software Market, and How Are They Evolving?

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

Which Regions Are Emerging as Leaders 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.

What Defines the Scope of the Pharmacovigilance And Drug Safety Software Market?

Pharmacovigilance and drug safety software refers to a suite of digital tools designed to monitor, analyze, and report adverse drug reactions (ADRs) and other safety-related information associated with pharmaceuticals and medical products. This software plays a critical role in ensuring patient safety and regulatory compliance throughout the lifecycle of a drug, from development to post-marketing surveillance.

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