Primary Catalyst Driving Pharmacovigilance And Drug Safety Software Market Evolution in 2025: Increasing Adoption Of Personalized Medicine Drives Growth In The Pharmacovigilance And Drug Safety Software Market Driver

What industry-specific factors are fueling the growth of the pharmacovigilance and drug safety software market?
A surge in the need for personalized medicine, also known as precision medicine, is anticipated to fuel the expansion of the pharmacovigilance and drug safety software market. Personalized medicine links healthcare decisions and treatments to the unique attributes of every patient and the increased demand for it can be attributed to multiple factors. These include improved treatment outcomes, an emphasis on prevention and early detection, and economic efficacy. Pharmacovigilance and drug safety software are crucial to the triumph of precision medicine. With the integration of pharmacogenetics, real-time data analysis, post-marketing surveillance, and customized medication information, these platforms augment the safety and effectiveness of individual treatments and fortify comprehensive risk management methods while tackling ethical deliberations. For example, as per the Personalized Medicine Coalition, a non-profit organization based in the US, the FDA gave its nod to 16 novel personalized therapies for those afflicted with rare diseases in 2023, an uptick from 6 in 2022. Hence, the escalating demand for tailored medicine contributes to the overall growth of the pharmacovigilance and drug safety software market.

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What Is the projected market size and growth rate for the pharmacovigilance and drug safety software market?
The market size of pharmacovigilance and drug safety software has seen a fast-paced expansion in the past few years. It is projected to escalate from a size of $2.26 billion in 2024 to $2.55 billion in 2025, exhibiting a compound annual growth rate (CAGR) of 13.2%. The past growth trend in this market sector is primarily credited to the mounting demand for pharmacovigilance and drug safety software.

In the coming years, it's anticipated that the pharmacovigilance and drug safety software market will experience rapid expansion, escalating to $4.15 billion in 2029 with a compound annual growth rate (CAGR) of 12.9%. The growth foreseen during this period can be credited to increasing instances of adverse drug reactions and pharmacovigilance becoming global, the rising occurrence of ADRs, more intricate safety regulations for drugs, the surge in the creation of new drugs and therapies, as well as escalating counts of ADRs. The automation and AI integration, adoption of cloud-based solutions, technological innovation, advancements in technology, and the surge in medical digitalization are also major trends for the projected period.

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What new trends are reshaping the pharmacovigilance and drug safety software market and its opportunities?
Leading players in the pharmacovigilance and drug safety software market are creating groundbreaking technologies, including cloud-based data lake platforms, to boost patient safety, manage adverse effects more efficiently, and increase regulatory compliance during clinical tests and post-market monitoring of medical equipment. A cloud-based data lake platform serves as an expandable, centralized storage system, offering organizations the capacity to store, handle, and evaluate vast quantities of structured and non-structured data. It provides access to real-time data and supports sophisticated analytics and AI/ML workloads. For example, Thermo Fisher Scientific Inc., a biotechnology company headquartered in the US, launched the revolutionary proprietary cloud-based data lake platform CorEvidence in December 2023. This platform targets the enhancement of pharmacovigilance operations within clinical research registries, focusing on optimizing case processing and safety data management, especially for post-authorization safety studies.

What major market segments define the scope and growth of the pharmacovigilance and drug safety software market?
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 region dominates 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.

Which key market leaders are driving the pharmacovigilance and drug safety software industry growth?
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

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What Is Covered In The Pharmacovigilance And Drug Safety Software Global Market Report?

•Market Size Forecast: Examine the pharmacovigilance and drug safety software market size across key regions, countries, product categories, and applications.
•Segmentation Insights: Identify and classify subsegments within the pharmacovigilance and drug safety software market for a structured understanding.
•Key Players Overview: Analyze major players in the pharmacovigilance and drug safety software market, including their market value, share, and competitive positioning.
•Growth Trends Exploration: Assess individual growth patterns and future opportunities in the pharmacovigilance and drug safety software market.
•Segment Contributions: Evaluate how different segments drive overall growth in the pharmacovigilance and drug safety software market.
•Growth Factors: Highlight key drivers and opportunities influencing the expansion of the pharmacovigilance and drug safety software market.
•Industry Challenges: Identify potential risks and obstacles affecting the pharmacovigilance and drug safety software market.
•Competitive Landscape: Review strategic developments in the pharmacovigilance and drug safety software market, including expansions, agreements, and new product launches.

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