Pharmacovigilance & Drug Safety Software Market - Global Forecast 2025-2032

Pharmacovigilance and drug safety software has become essential for healthcare organizations seeking to modernize risk control, boost compliance, and respond swiftly to changes in the global regulatory environment. As senior decision-makers focus on efficiency and proactive management, these solutions serve as a core enabler of smarter oversight and operational agility.

Pharmacovigilance and Drug Safety Software Market Snapshot

The pharmacovigilance and drug safety software market is experiencing accelerated growth, expanding from USD 629.31 million in 2024 to USD 723.35 million in 2025. Supported by a compound annual growth rate (CAGR) of 15.05%, forecasts project the market to attain USD 1.93 billion by 2032. This notable trajectory is fueled by heightened software adoption across healthcare sectors, evolving regulatory mandates, and increasing leverage of real-world data. Enterprise buyers are prioritizing scalable, cloud-first solutions designed with robust analytics and advanced automation, addressing regulatory complexity and streamlining critical workflows in diverse operational contexts. Innovations in interoperability and integration are also influencing platform selection and deployment strategies.

Scope & Segmentation

This analysis provides a comprehensive examination of the pharmacovigilance and drug safety software market, clarifying key segments, technology drivers, and buyer requirements for global health organizations:

• Component: Includes pharmacovigilance analytics, regulatory reporting, safety database management, signal detection, and risk management tools that collectively power drug safety initiatives.
• Organization Size: Solutions are tailored for both large enterprises and small to medium-sized enterprises, ensuring scalability and resource alignment for varied operational models.
• End User: Target end users comprise contract research organizations, pharmaceutical companies, and biotechnology firms requiring reliable and compliant pharmacovigilance infrastructure.
• Deployment Mode: Flexible options span private cloud, public cloud, and on-premise configurations to support internal policies and regional compliance needs.
• Application: Encompasses adverse event case management, aggregate reporting, risk communication, and risk management functions to support holistic safety oversight.
• Regional Coverage: Broad geographic reach includes the Americas (such as United States, Canada, Brazil, Mexico, and other major markets), EMEA (covering the United Kingdom, Germany, France, Italy, as well as key Middle Eastern and African economies), and Asia-Pacific (spanning China, India, Japan, Australia, and leading Southeast Asian countries).
• Key Companies Profiled: Leading providers such as Oracle Corporation, ArisGlobal LLC, Veeva Systems Inc., EXTEDO GmbH, Ennov Solutions SA, Dassault Systèmes SE, Clarivate Plc, RELX PLC, Lorenz Life Sciences Group GmbH, and Genpact Ltd. drive innovation across segments.

Key Takeaways for Senior Decision-Makers

• AI-driven analytics and machine learning are elevating process accuracy and reducing manual intervention, resulting in more predictive pharmacovigilance workflows and increased confidence in risk assessment outcomes.
• Integrated software platforms are streamlining interoperability with enterprise and external data systems, supporting rapid decision-making across geographies and functions.
• Cloud adoption is facilitating flexible deployment options while minimizing capital investments, which is significant for organizations navigating varying regional regulations or capital allocation priorities.
• Market demand is trending towards platforms that offer real-time monitoring, visualization, and configurable dashboards, supporting strategic oversight by enabling enhanced visibility into safety risks.
• Vendors are focusing on modularity and configurable workflow capabilities, ensuring that solutions remain adaptable for both established enterprises and emerging firms while easing multi-jurisdictional compliance.

Tariff Impact and Response Strategies

The introduction of new United States tariffs in 2025 is prompting organizations to reassess sourcing and financial strategies for pharmacovigilance platforms. Companies are responding by prioritizing cloud-based deployments to mitigate hardware-related tariff burdens, expanding regional service capabilities, and renegotiating long-term contracts with fixed-pricing structures. These measures are reducing tariff exposure and supporting uninterrupted global procurement and compliance continuity.

Methodology & Data Sources

This report is based on primary interviews with industry leaders in drug safety, specialized technology vendors, and regulatory authorities, supplemented by a rigorous review of industry standards and regulatory filings. Qualitative insights are carefully triangulated with quantitative data to ensure comprehensive coverage and analytical reliability throughout the report.

Why This Report Matters

• Delivers an actionable, segment-focused analysis enabling executives to shape informed investment and technology adoption strategies in the pharmacovigilance software market.
• Clarifies the evolving regulatory landscape and procurement ecosystem, supporting forward-looking planning and organizational agility in the face of global compliance shifts.
• Presents emerging practices and technology innovations, enabling senior leadership to benchmark operations and reinforce capabilities for sustained risk mitigation.

Conclusion

The pharmacovigilance and drug safety software landscape continues to evolve quickly, driven by digital transformation, shifting regional considerations, and changing safety management practices. This report empowers senior leaders to proactively navigate market developments and shape adaptive, future-ready operational models.

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