United States Pharmacovigilance Software Market 2033 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Global Pharmacovigilance Software Market reached US$218.95 million in 2024 and is expected to reach US$415.42 million by 2033, growing at a CAGR of 7.4% during the forecast period of 2025-2033, according to DataM Intelligence research.

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Key Development:

United States: Recent Pharmacovigilance Software Developments

✅ In December 2025, HiroPharmaConsulting announced a major milestone with its AI-enabled reliability assurance framework gaining industry traction for pharmacovigilance systems used by global pharma companies. The development strengthens validation and compliance for AI-driven safety platforms. It supports higher trust in automated adverse event detection and reporting workflows.

✅ In November 2025, Veeva Systems advanced its Vault Safety platform with expanded AI-assisted workflow automation and analytics capabilities. These enhancements improve case intake efficiency, safety signal management, and regulatory submission readiness. The update reflects growing demand for scalable cloud-based pharmacovigilance software.

✅ In October 2025, multiple U.S. life sciences organizations expanded adoption of AI-powered pharmacovigilance modules integrated into enterprise safety platforms. The focus is on faster adverse event triage, narrative generation, and MedDRA coding. This shift highlights rising confidence in compliant AI-enabled safety operations.

✅ In September 2025, U.S. pharmacovigilance software providers increased investments in interoperability and real-world data integration. The upgrades enable seamless linkage between clinical, post-marketing, and regulatory safety datasets. This supports more proactive risk detection and lifecycle safety management.

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Japan: Recent Pharmacovigilance Software Developments

✅ In December 2025, HiroPharmaConsulting secured a Japanese patent for its AI-based reliability assurance method specifically designed for pharmacovigilance systems. The innovation addresses regulatory validation challenges in AI-enabled drug safety platforms. It marks a significant advancement for compliant AI adoption in Japan's PV ecosystem.

✅ In November 2025, Japanese pharmaceutical companies accelerated deployment of cloud-based pharmacovigilance software aligned with PMDA regulatory expectations. These platforms emphasize automated adverse event processing and audit-ready reporting. The trend reflects Japan's push toward digital safety transformation.

✅ In October 2025, AI-driven MedDRA coding and signal detection tools gained wider use among Japan-based life sciences firms. The software enhancements improve accuracy, reduce manual workload, and shorten safety case turnaround times. This supports more efficient post-marketing surveillance.

✅ In September 2025, Japan-focused pharmacovigilance software initiatives prioritized data quality, traceability, and cross-functional safety analytics. Vendors enhanced system validation and governance features to meet strict compliance standards. These developments strengthen Japan's drug safety infrastructure.

Key Players:

=> Ennov, Oracle, ArisGlobal, EXTEDO, Clinevo Technologies, IQVIA, Quanticate, Cloudbyz, and Flex Databases, among others.

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Key Segments:

By Functionality

Adverse Event Reporting Software holds the largest share at 35%, driven by stringent regulatory requirements, rising drug safety monitoring activities, and increasing adverse event reporting volumes across global markets.
Drug Safety Audits Software accounts for 20%, supported by growing regulatory inspections, compliance audits, and pharmacovigilance quality assurance needs.
Issue Tracking Software represents 18%, fueled by the need for real-time case tracking, signal detection, and workflow optimization across pharmacovigilance operations.
Fully Integrated Software captures 27%, driven by increasing adoption of end-to-end pharmacovigilance platforms integrating reporting, analytics, compliance, and risk management functionalities.

By Delivery Mode

On-demand/Cloud-based (SaaS) Delivery Mode dominates with a 60% share, owing to scalability, cost efficiency, rapid deployment, remote accessibility, and increasing preference for subscription-based solutions.
On-premise Delivery Mode accounts for 40%, primarily adopted by large pharmaceutical enterprises requiring enhanced data control, customization, and compliance with internal IT policies.

By End-User

Pharma and Biotech Companies lead the market with a 45% share, driven by expanding drug pipelines, post-marketing surveillance obligations, and global regulatory compliance requirements.
Contract Research Organizations (CROs) account for 25%, supported by increasing outsourcing of pharmacovigilance activities by pharmaceutical companies.
Business Process Outsourcing (BPO) Firms hold 18%, driven by demand for cost-effective pharmacovigilance services and specialized safety monitoring capabilities.
Other Pharmacovigilance Service Providers represent 12%, including independent safety monitoring firms and technology-enabled service providers.

By Region

North America - 35% Share
North America leads the market due to strong regulatory frameworks, high adoption of advanced pharmacovigilance software, and the presence of major pharmaceutical and biotech companies.

Europe - 28% Share
Europe accounts for 28%, driven by stringent EMA regulations, increasing post-marketing surveillance activities, and growing adoption of integrated safety solutions.

Asia Pacific - 22% Share
Asia Pacific represents 22%, supported by expanding pharmaceutical manufacturing, rising clinical trial activity, and increasing outsourcing of pharmacovigilance services.

Latin America - 8% Share
Latin America holds 8%, driven by improving regulatory infrastructure and growing awareness of drug safety compliance.

Middle East & Africa - 7% Share
Middle East & Africa account for 7%, supported by evolving regulatory standards, improving healthcare infrastructure, and international collaborations for drug safety monitoring.

FAQ

What is the current size of the Pharmacovigilance Software Market?

A: In 2024, the Pharmacovigilance Software Market was valued at US$218.95 million , reflecting its strong industry presence.

Q2: How large is the Pharmacovigilance Software Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Pharmacovigilance Software Market will grow to around US$415.42 million, demonstrating significant expansion.

Q3: What is the growth rate of the Pharmacovigilance Software Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 7.4% during the forecast period from 2025 to 2033.

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