Pharmacovigilance And Drug Safety Software Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Pharmacovigilance and Drug Safety Software Market is Segmented by Functionality (Adverse Event Reporting, Drug Safety Audit Software, and More), Mode of Delivery (On-Premise, Cloud/SaaS, and More), End User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Sizes and Forecasts are Provided in Terms of Value (USD).

Pharmacovigilance And Drug Safety Software Market Size and Share

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Pharmacovigilance And Drug Safety Software Market Analysis by Mordor Intelligence

The pharmacovigilance software market is valued at USD 222.18 million in 2025 and is forecast to reach USD 293.56 million by 2030, advancing at a steady 5.73% CAGR. Growth pivots on the transition from basic compliance systems to AI-enabled safety intelligence platforms that help sponsors evaluate real-world evidence in near-real time. Intensifying harmonization of global reporting rules, spearheaded by the FDA’s E2B(R3) mandate and the European Health Data Space Regulation, converts regulatory deadlines into non-discretionary IT spending.[1]Food and Drug Administration, “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products,” fda.govCloud adoption crosses 80% penetration among life-science firms, creating a preferred deployment backbone for modern safety databases. Meanwhile, explainable-AI modules that automate case triage lower processing costs by as much as 50%, giving early adopters an economic edge. Geopolitical stability in Asia Pacific, coupled with streamlined ethics approvals, is relocating a rising share of clinical trials eastward and lifting regional demand for advanced surveillance tools.

Key Report Takeaways

  • By functionality, adverse event reporting led the pharmacovigilance software market with 40.7% of the share in 2024, while signal detection and risk management tools are poised to expand at an 18.4% CAGR through 2030.
  • By mode of delivery, cloud and SaaS deployments captured 67.1% revenue share in 2024; the segment is growing at a 22.0% CAGR over the forecast period.
  • By end user, pharmaceutical and biotechnology companies held 54.6% of the pharmacovigilance software market size in 2024, whereas business process outsourcing firms registered the fastest 17.9% CAGR.
  • By geography, North America commanded 35.9% revenue share in 2024; Asia Pacific is forecast to post a 14.3% CAGR to 2030.

Segment Analysis

By Functionality: Predictive Analytics Surges Ahead

Adverse events reporting software retained a commanding 40.7% share of the pharmacovigilance software market in 2024, underscoring its status as a non-negotiable compliance pillar. Yet signal detection and risk-management modules are forecast to grow at an 18.4% CAGR, demonstrating the pivot toward preventive analytics that flag anomalies before regulators intervene. Many sponsors now favor unified platforms that merge intake, triage, analytics, and submission into one workflow. Oracle added AI-powered conditional touchless processing to Argus in 2024, illustrating how embedded intelligence elevates legacy solutions. Continuous rise in biological approvals coupled with diverse real-world data feeds widens the opportunity for platforms that draw correlations across ethnic, genomic, and social determinants of health datasets. 

Integrated suites also reduce validation overhead because a single quality-management system covers multiple modules. As a result, vendors capable of harmonizing point solutions into end-to-end architecture are expanding their installed bases faster than niche competitors. Signal detection units may ultimately outpace event-reporting revenue, yet both modules remain symbiotic because regulatory filings still stem from source case data. The pharmacovigilance software market size attributable to advanced analytics is therefore set to climb more rapidly than the aggregate market, even as reporting retains foundational relevance.

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Note: Segment shares of all individual segments available upon report purchase

By Mode of Delivery: Cloud-Native Platforms Set the Pace

Cloud deployments accounted for 67.1% of the pharmacovigilance software market in 2024 and are advancing at a 22.0% CAGR, accelerating digital transformation across sponsors of all sizes. Many firms embrace software-as-a-service because quarterly updates keep pace with shifting regulations without the downtime typical of on-premises patches. Hybrid models act as an interim bridge: sensitive identifiable data stay on local servers while anonymized datasets feed cloud-based AI models. Pfizer’s AWS architecture and Moderna’s Google Cloud approach validate the scalability and compliance of multi-tenant environments. 

Security certifications such as ISO 27001 and SOC 2 have become table stakes for vendors, addressing lingering apprehension over confidential patient data. Nonetheless, data-sovereignty rules compel providers to offer regionally partitioned environments, adding complexity and incremental cost. As hyperscale cloud providers open additional life-science compliance zones in Europe and Asia, barriers recede, and the pharmacovigilance software market size under cloud deployment continues expanding at a rate far above on-premises installation.

By End User: Outsourcing Momentum Builds

Pharmaceutical and biotechnology firms controlled 54.6% of the pharmacovigilance software market in 2024 because they hold ultimate responsibility for product safety under global regulations. However, business-process outsourcing (BPO) providers are demonstrating a 17.9% CAGR as sponsors externalize case intake, triage, and submission. The strategy allows innovators to concentrate capital on core R&D while leveraging BPO scale for routine safety tasks. ProPharma Group’s acquisition of iSafety Systems in 2024 exemplifies how service providers extend reach to meet global sponsor demand. 

Contract research organizations now incorporate post-marketing surveillance into traditional clinical-trial packages, offering end-to-end lifecycle support. This bundling increases appeal to biotechnology start-ups that lack in-house PV infrastructure. Medical-device manufacturers form a niche but growing cohort asthe convergence of drug and device vigilance rules boosts cross-sector platform demand. The pharmacovigilance software industry thus balances in-house stewardship with expanding managed-service ecosystems

Pharmacovigilance And Drug Safety Software Market
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Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

North America led with 35.9% revenue share in 2024, anchored by stringent FDA oversight and a dense concentration of top 20 pharmaceutical companies. Many regional sponsors pioneered cloud-based safety systems before 2020; Pfizer's COVAES platform processed more than 1.5 million COVID-19 vaccine cases using automated triage and de-duplication. The FDA's 2025 creation of a chief AI officer underscores the regulator's readiness to evaluate algorithmic submissions, reinforcing regional appetite for AI-rich upgrades. Talent shortages remain a hurdle, inflating salaries for data-science specialists and pressuring smaller firms to outsource. 

Asia Pacific records the fastest 14.3% CAGR on the back of clinical-trial migration to South Korea, Taiwan and Singapore, where shorter ethics-committee timelines accelerate recruitment. China's expanding contract research landscape, led by Wuxi AppTec, pulls in global clients that need local PV capacity aligned with National Medical Products Administration rules. Government investment programs, such as Japan's AMED grants for AI drug-safety research, further stimulate domestic software adoption. Despite diverse legal frameworks, many Asia-Pacific regulators now accept ICH E2B(R3) XML, reducing localization barriers. 

Europe maintains significant scale because mature pharmacovigilance obligations and GDPR heightens the need for configurable, audit-ready platforms. The European Health Data Space Regulation formalizes secondary health-data use, prompting sponsors to adopt software capable of granular consent management. Germany's new Digital Act unlocks de-identified claims datasets for research, enabling safety algorithms to mine national repositories once off-limits. However, strict data-sovereignty clauses require EU-based hosting, spurring demand for region-specific cloud zones. Collectively, these dynamics keep Europe a premium market for feature-rich platforms even though growth trails Asia Pacific.

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Competitive Landscape

The pharmacovigilance software market exhibits moderate concentration, with platform vendors favoring breadth of functionality and deep integration over discount pricing. Oracle, ArisGlobal, and Veeva Systems defend incumbency through continuous feature expansion. Oracle’s July 2024 Argus upgrade added conditional touchless processing that pushes automation rates toward 80%. ArisGlobal reported record new-logo growth in 2024 and widened its partnership with Sitero to span clinical and regulatory domains. Veeva, historically strong in quality and content, unveiled a unified safety suite with NLP support in April 2025. 

Emerging challengers target specific pain points, such as literature mining, machine translation, or duplicate detection. Their specialized offerings integrate via open APIs into larger ecosystems, forcing majors to maintain aggressive R&D roadmaps. The FDA’s Emerging Drug Safety Technology Meetings program levels the playing field by giving smaller firms a formal pathway to validate novel AI models.

M&A continues as scale becomes a prerequisite for global regulatory support. Valsoft’s August 2024 purchase of Anju Software afforded the acquirer an immediate PV footprint, illustrating how consolidators seek synergies between life-science verticals. Meanwhile, service providers such as PrimeVigilance rebrand and reposition to capture outsourced processing demand, creating adjacent competition for pure software vendors. These dynamics keep pricing power balanced, with differentiation residing in automation depth, compliance agility and ecosystem partnerships.

Pharmacovigilance And Drug Safety Software Industry Leaders

  1. Ennov Solutions Inc.

  2. Extedo GmbH

  3. United BioSource Corporation

  4. Ab Cube

  5. ArisGlobal

  6. *Disclaimer: Major Players sorted in no particular order
Pharmacovigilance And Drug Safety Software Market
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Recent Industry Developments

  • April 2025: Veeva Systems announced AI enhancements across its pharmacovigilance platform portfolio, adding machine-learning-based adverse-event detection and NLP for regulatory document analysis.
  • January 2025: Veeva Systems partnered with Zifo to accelerate quality-control modernization, integrating analytics with pharmacovigilance workflows.
  • September 2024: ArisGlobal expanded its partnership with Sitero to deliver an integrated technology suite covering clinical and safety domains.
  • September 2024: Veeva Systems introduced field-action and recall management capabilities in Vault QMS, extending into post-market surveillance.

Table of Contents for Pharmacovigilance And Drug Safety Software Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Incidence Of Adverse Drug Reactions (ADRs)
    • 4.2.2 Stringent Global E2B(R3)/IDMP Compliance Deadlines
    • 4.2.3 Cloud-First Migration Of Safety Databases
    • 4.2.4 Explainable-AI Modules Slash Case-Processing Costs
    • 4.2.5 Real-World-Evidence (RWE) Integration For Early Signals
    • 4.2.6 Low-Code Localisation For Emerging-Market Forms
  • 4.3 Market Restraints
    • 4.3.1 Data-Sovereignty & Cross-Border-Transfer Restrictions
    • 4.3.2 Shortage Of PV Data-Science Talent
    • 4.3.3 Algorithmic-Bias Scrutiny Delaying AI Approvals
    • 4.3.4 Escalating API Pricing From Dominant DB Vendors
  • 4.4 Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter's Five Forces Analysis
    • 4.7.1 Threat of New Entrants
    • 4.7.2 Bargaining Power of Buyers
    • 4.7.3 Bargaining Power of Suppliers
    • 4.7.4 Threat of Substitutes
    • 4.7.5 Intensity of Rivalry

5. Market Size & Growth Forecasts (Value)

  • 5.1 By Functionality
    • 5.1.1 Adverse Event Reporting Software
    • 5.1.2 Drug Safety Audit Software
    • 5.1.3 Issue Tracking Software
    • 5.1.4 Fully Integrated Safety Suites
    • 5.1.5 Signal Detection & Risk-Management Tools
  • 5.2 By Mode of Delivery
    • 5.2.1 On-premise
    • 5.2.2 Cloud / SaaS
    • 5.2.3 Hybrid Deployment
  • 5.3 By End User
    • 5.3.1 Pharmaceutical & Biotechnology Companies
    • 5.3.2 Contract Research Organizations (CROs)
    • 5.3.3 Business-Process-Outsourcing (BPO) Firms
    • 5.3.4 Medical-Device Manufacturers
    • 5.3.5 Other PV Service Providers
  • 5.4 Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of Asia Pacific
    • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
    • 6.3.1 Oracle Corporation
    • 6.3.2 ArisGlobal
    • 6.3.3 Veeva Systems
    • 6.3.4 Sparta Systems
    • 6.3.5 IQVIA
    • 6.3.6 Ennov Solutions
    • 6.3.7 Extedo GmbH
    • 6.3.8 AB Cube
    • 6.3.9 Anju Software
    • 6.3.10 Sarjen Systems
    • 6.3.11 United BioSource Corp.
    • 6.3.12 Accenture
    • 6.3.13 Cognizant
    • 6.3.14 Tata Consultancy Services (TCS ADD)
    • 6.3.15 Parexel International
    • 6.3.16 Medidata Solutions
    • 6.3.17 Saama Technologies
    • 6.3.18 Intellimed (Vigilance 360)

7. Market Opportunities & Future Outlook

  • 7.1 White-Space & Unmet-Need Assessment
Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Global Pharmacovigilance And Drug Safety Software Market Report Scope

As per the report's scope, pharmacovigilance (PV) software comprises a drug safety management software solution that enables the creation, classification, review, submission, and maintenance of pharmacovigilance data and adverse event reports. This PV software is used by pharma and biotech companies, contract research organizations (CROs), business process outsourcing firms (BPOs), and other pharmacovigilance service providers.


The pharmacovigilance and drug safety software market segmentation includes functionality, mode of delivery, end user, and geography. By functionality, the market is segmented into adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. By mode of delivery, the market is segmented into on-premise delivery and on-demand/cloud-based (SaaS) delivery. By end user, the market is segmented into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and other pharmacovigilance service providers. By geography, the global market is segmented into North America (United States, Canada, Mexico), Europe (Germany, United Kingdom, France, Italy, Spain, Rest of Europe), Asia-Pacific (China, Japan, India, Australia, South Korea, Rest of Asia-Pacific), Middle East and Africa (GCC, South Africa, Rest of Middle East and Africa), and South America (Brazil, Argentina, Rest of South America). The industry report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the market value (in USD million) for the above segments. By Functionality Adverse Event Reporting Software   Drug Safety Audits Software Issue Tracking Software Fully Integrated Software By Mode of Delivery On-premise Delivery   On-demand/Cloud-based (SaaS) Delivery By End User Pharmaceutical and Biotechnology Companies   Contract Research Organizations Business Process Outsourcing Firms Other Pharmacovigilance Service Providers   By Geography North America United States Canada Mexico Europe Germany United Kingdom France Italy Spain Rest of Europe Asia Pacific China Japan India Australia South Korea Rest of Asia Pacific Middle East and Africa GCC South Africa Rest of Middle East and Africa South America Brazil Argentina Rest of South America

By Functionality Adverse Event Reporting Software
Drug Safety Audit Software
Issue Tracking Software
Fully Integrated Safety Suites
Signal Detection & Risk-Management Tools
By Mode of Delivery On-premise
Cloud / SaaS
Hybrid Deployment
By End User Pharmaceutical & Biotechnology Companies
Contract Research Organizations (CROs)
Business-Process-Outsourcing (BPO) Firms
Medical-Device Manufacturers
Other PV Service Providers
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia Pacific China
Japan
India
South Korea
Australia
Rest of Asia Pacific
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
South America Brazil
Argentina
Rest of South America
By Functionality
Adverse Event Reporting Software
Drug Safety Audit Software
Issue Tracking Software
Fully Integrated Safety Suites
Signal Detection & Risk-Management Tools
By Mode of Delivery
On-premise
Cloud / SaaS
Hybrid Deployment
By End User
Pharmaceutical & Biotechnology Companies
Contract Research Organizations (CROs)
Business-Process-Outsourcing (BPO) Firms
Medical-Device Manufacturers
Other PV Service Providers
Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia Pacific China
Japan
India
South Korea
Australia
Rest of Asia Pacific
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

What is the current size of the pharmacovigilance software market?

The market stands at USD 222.18 million in 2025 and is projected to reach USD 293.56 million by 2030.

How fast is the pharmacovigilance software market expected to grow?

It is forecast to expand at a 5.73% CAGR over 2025-2030.

Which functionality segment holds the largest share?

Adverse event reporting software led with 40.7% revenue share in 2024.

What deployment model is growing the quickest?

Cloud and SaaS deployments are advancing at a 22.0% CAGR and already represent 67.1% of market revenue.

Which region is expanding the fastest?

Asia Pacific is forecast to register a 14.3% CAGR through 2030, benefiting from the eastward shift of clinical trials.

Page last updated on: June 22, 2025