Dublin, April 30, 2026 (GLOBE NEWSWIRE) — The “Pharmacovigilance and Drug Safety Software Market Report 2026” has been added to ResearchAndMarkets.com’s offering. The report provides vital statistics, including market size, regional shares, competitive landscape, and emerging opportunities, offering a holistic view of the industry’s trajectory.
The pharmacovigilance and drug safety software market is witnessing significant growth, expanding from $2.53 billion in 2025 to an anticipated $2.86 billion in 2026, achieving a CAGR of 12.8%. This surge is driven by increasing adverse drug reaction reporting, globalization of clinical trials, stringent safety regulations, growing pharmaceutical production, and expanding post-marketing surveillance needs.
The market shows promising prospects, projected to reach $4.6 billion by 2030 with a CAGR of 12.6%. Contributing factors include advances in AI-driven signal detection, biologics and specialty drug growth, heightened regulatory scrutiny, increased outsourcing of pharmacovigilance services, and the demand for real-time safety analytics. Emerging trends emphasize cloud-based pharmacovigilance platforms, real-world evidence monitoring, and automation in adverse event reporting.
The shift towards personalized medicine is further anticipated to propel market expansion. This healthcare approach tailors treatment to individual genetic profiles and is gaining traction for its superior treatment outcomes, prevention, diagnosis, and cost efficiency. Pharmacovigilance software enhances personalized medicine by integrating pharmacogenomics and real-time data analytics. Notably, the FDA approved 16 new personalized therapies for rare diseases in 2023, significantly up from six in 2022, underscoring the rising demand and its impact on market growth.
Leading companies in the sector are innovating with advanced technologies such as cloud-based data lake platforms. These solutions bolster adverse event detection and regulatory compliance, enhancing patient safety throughout clinical trials and post-marketing phases. For instance, Thermo Fisher Scientific’s launch of CorEvidence, a proprietary cloud-based platform, exemplifies this trend by streamlining pharmacovigilance activities with a focus on post-authorization safety studies.
Strategic acquisitions are also shaping the market. In April 2024, Qinecsa acquired Insife ApS, enhancing its pharmacovigilance technology capabilities and strengthening its global market position. This acquisition integrates Insife’s cutting-edge safety software into Qinecsa’s digital ecosystem.
Major industry players include IQVIA, Oracle Corporation, ArisGlobal, RXLogix, Anju Software Inc., among others. North America led the market in 2025, while Asia-Pacific is forecasted to grow swiftly.
Reasons to Purchase:
- Obtain a global perspective with coverage across 16 geographies.
- Understand the impact of macro factors such as geopolitical conflicts, trade policy shifts, regulatory environments, and fluctuating economic conditions.
- Develop targeted regional and country strategies informed by local data.
- Identify key segments for growth and strategic investment.
- Utilize forecast data to outperform competitors and enhance customer understanding through end-user analysis.
- Evaluate the total addressable market (TAM) and scoring to gauge market potential, enhancing internal and external presentations with high-quality data.
- The report includes comprehensive updates and an Excel dashboard for in-depth analysis.
Report Scope
Markets Covered:
- By Software Type: Adverse Event Reporting, Drug Safety Audits, Issue Tracking, Fully Integrated Software.
- By Delivery Mode: On-premise, Cloud-based.
- By End User: Pharmaceutical, Biotechnology Companies, Contract Research Organizations, Others.
Subsegments:
- Adverse Event Reporting: Spontaneous Systems, EHR Solutions, Mobile Apps.
- Drug Safety Audits: Audit Management, Compliance, Reporting Modules.
- Issue Tracking: Incident Systems, Workflow Tools, Collaboration Platforms.
- Fully Integrated Software: Pharmacovigilance Platforms, Regulatory Systems, Data Tools.
Companies Mentioned: IQVIA, Oracle Corporation, ArisGlobal, RXLogix, and others.
Countries: Includes Australia, Brazil, China, France, Germany, and more.
Regions: Comprehensive coverage of Asia-Pacific, Southeast Asia, Europe, North America, and others.
Time Series: Five years historic data and ten years forecast.
Data and Customization: Market size ratios, GDP proportions, and expenditure per capita, delivered in multiple formats with expert support.
Key Attributes
| Report Attribute | Details |
| No. of Pages | 250 |
| Forecast Period | 2026-2030 |
| Estimated Market Value (USD) in 2026 | $2.86 Billion |
| Forecasted Market Value (USD) by 2030 | $4.6 Billion |
| Compound Annual Growth Rate | 12.6% |
| Regions Covered | Global |
The companies featured in this Pharmacovigilance and Drug Safety Software market report include:
- IQVIA
- Oracle Corporation
- ArisGlobal
- RXLogix
- Anju Software Inc.
- EXTEDO GmbH
- Sarjen Systems Pvt. Ltd.
- Ennov Group
- AB Cube
- Clinevo Technologies
- Accenture plc
- International Business Machines Corporation
- Capgemini SE
- Cognizant Technology Solutions
- Wipro Limited
- Genpact
- Indegene Limited
- PharmaLex
- Deloitte Touche Tohmatsu Limited
- Parexel
For more information about this report visit https://www.researchandmarkets.com/r/k8c7hd
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- Pharmacovigilance and Drug Safety Software Market
