United States Pharmacovigilance and Drug Safety Software Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Pharmacovigilance and Drug Safety Software Market is growing with a High CAGR during the forecast period (2024-2031).

Key Development:

United States: Recent Industry Developments

✅ In October 2025, Graph AI raised USD 3 million in seed funding to launch its AI‐driven drug‐safety platform, streamlining adverse‐event processing and regulatory compliance workflows.

✅ In October 2025, Thermo Fisher Scientific announced the acquisition of Clario for up to USD 9.4 billion, gaining its clinical‐software platform that supports drug‐trial data and safety workflows.

✅ In August 2025, ArisGlobal announced that a major Japanese pharmaceutical company deployed its LifeSphere® Safety pharmacovigilance platform across three regions, marking a strategic expansion of AI‐enabled safety operations in the U.S.‐partnered global roll‐out.

✅ In June 2025, North America achieved USD 72.7 million revenue in the pharmacovigilance and drug‐safety software segment in 2024, with projected strong AI and cloud‐based system uptake in 2025 onwards.

✅ In May 2025, industry‐reporting noted accelerated adoption of AI‐ and cloud‐based pharmacovigilance systems by U.S. biotech and pharma firms, driven by rising adverse‐drug‐event data volumes and regulatory scrutiny.

✅ In March 2025, Japanese firms conducted 7 acquisitions across APAC including high‐purity chemicals and specialty businesses, signalling outward investment momentum that may overlap with safety‐software vendors

✅ In February 2025, Mitsubishi Tanabe Pharma Corporation was acquired by Bain Capital Private Equity, LP for USD 3.3 billion, in a major healthcare‐sector deal that may entail downstream expansion of drug‐safety software and PV capabilities in Japan.

Japan: Recent Industry Developments

✅ In August 2025, the ArisGlobal deployment signalled Japan‐based operations upgrading to AI‐first PV platforms, reflecting Japan's pharma shift toward global safety‐software standards.

✅ In July 2025, the Japan Pharmaceutical Manufacturers Association's "PV Innovation Conference Japan" drew industry stakeholders on July 17 in Tokyo to explore new pharmacovigilance software, high‐end analytics and AI tools for Japanese safety operations.

✅ In February 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) held a three‐day "PMDA‐ATC Pharmacovigilance Seminar 2025" from February 26-28 offering regulatory‐safety training and platform‐validation guidance for global drug‐safety software in Japan.

✅ In January 2025, HiroPharmaConsulting® Co., Ltd. launched its "GVP Validation Consulting Service" for evaluating PV‐system installations with AI‐functions, aimed at Japanese pharma companies modernising safety‐software systems.

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Key Players:

=> Ennov Solutions Inc., Oracle Corporation, ArisGlobal LLC, EXTEDO, Clinevo Technologies, IQVIA, AB Cube, ICON Plc, Paraxel International Corporation

Growth Forecast Projected:

The Global Pharmacovigilance and Drug Safety Software Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Pharmacovigilance and Drug Safety Software Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Mode of Delivery: On-Premise, Cloud-based, Others

➥ By Functionality: Issue Tracking Software, Drug Safety Audit Software, Adverse Event Reporting Software, Others

➥ By End User: Contract Research Organizations (CROs), Biotechnological Companies, Healthcare Providers, Others

Regional Analysis for Pharmacovigilance and Drug Safety Software Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Pharmacovigilance and Drug Safety Software producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Pharmacovigilance and Drug Safety Software revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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