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 Software, Drug Safety Audits Software, Issue Tracking Software, and Fully Integrated Software), Mode of Delivery (On-premise Delivery and On-demand/Cloud-based (SaaS) Delivery), End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations, Business Process Outsourcing Firms, and Other Pharmacovigilance Service Providers), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The market forecast value is provided (in USD million) for the above segments.

Pharmacovigilance and Drug Safety Software Market Size

Pharmacovigilance and Drug Safety Software Market Market Summary
Study Period 2019 - 2030
Base Year For Estimation 2024
Market Size (2025) USD 222.18 Million
Market Size (2030) USD 293.56 Million
CAGR (2025 - 2030) 5.73 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Pharmacovigilance and Drug Safety Software Market  Major Players

*Disclaimer: Major Players sorted in no particular order

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Pharmacovigilance and Drug Safety Software Market Analysis

The Pharmacovigilance and Drug Safety Software Market size is estimated at USD 222.18 million in 2025, and is expected to reach USD 293.56 million by 2030, at a CAGR of 5.73% during the forecast period (2025-2030).

The pharmacovigilance and drug safety software market focuses on ensuring the safety of pharmaceutical products by monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs). This market is driven by several factors, such as the increasing incidence of adverse drug reactions (ADRs) and the increasing adoption of pharmacovigilance and drug safety software by outsourcing companies. For instance, according to the study report published by Cureus Journal in May 2024, individuals aged 21-30 and 31-40 reported more ADRs. This increased occurrence in these age groups can be linked to their more frequent hospital visits, influenced by various factors. Hence, the increased ADRs among the patients increase the need for pharmacovigilance and drug safety software for proper recording, thereby boosting the market growth over the study period.


Furthermore, cloud computing is a major trend in pharmacovigilance software, offering scalable, cost-effective, and easily accessible solutions. Cloud based platforms are increasingly used for real-time reporting, improving collaboration, and enhancing data storage capacity. For instance, according to data published by Clinevo Technologies in May 2024, pharmacovigilance software has transformed into advanced, cloud-based solutions, boasting various features and capabilities. Key functionalities encompass real-time data collection, automated signal detection, risk management workflows, and seamless integration with other healthcare systems, among others.


Moreover, as healthcare infrastructure improves in emerging economies, there is a significant opportunity for the adoption of pharmacovigilance software to ensure drug safety across various regions. However, industry analysis reveals that the initial investment and ongoing maintenance costs of pharmacovigilance software can be high, especially for smaller pharmaceutical companies or those in developing countries. In addition, the absence of a standardized framework for ADR reporting and data management can lead to inconsistencies and inefficiencies in the pharmacovigilance process, limiting the effectiveness of software solutions, which is likely to restrain the market growth.

Pharmacovigilance and Drug Safety Software Industry Overview

The competitive landscape of the pharmacovigilance and drug safety software market is shaped by the presence of a mix of well-established global players, regional leaders, and emerging companies that are focused on providing innovative solutions to address drug safety monitoring, adverse event reporting, risk management, and regulatory compliance.


Some of the key players currently dominating the market are Ab Cube, ArisGlobal, Ennov Solutions Inc., Extedo GmbH, Anju Software, Inc., Oracle Corporation, Sarjen Systems Pvt Ltd, Sparta Systems Inc., United BioSource Corporation, Veeva Systems. In addition, the growing collaboration between pharmacovigilance software companies is helping them expand their pharmacovigilance and drug safety software market size lead, while driving the overall market growth.


For instance, in March 2024, Qinecsa Solutions (Qinecsa) acquired Insife ApS (Insife), a prominent Danish software and consultancy firm known for its innovative pharmacovigilance platforms. This move aligns with Qinecsa's vision and bolsters its ambition to lead in digital pharmacovigilance solutions. In addition, as the market continues to evolve, companies will need to focus on efficiency, compliance, and integration to maintain a competitive edge.

Pharmacovigilance and Drug Safety Software Market Leaders

  1. Ennov Solutions Inc.

  2. Extedo GmbH

  3. United BioSource Corporation

  4. Ab Cube

  5. ArisGlobal

*Disclaimer: Major Players sorted in no particular order

Pharmacovigilance and Drug Safety Software Market Competitive Landscape
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Pharmacovigilance and Drug Safety Software Market News

  • October 2024: EVERSANA, a global provider of commercialization services for the life sciences sector, unveiled significant enhancements to its pharmacovigilance and drug safety services, addressing the industry's evolving demands. As a primary step, EVERSANA entered into a partnership with Oracle Argus Cloud, integrating advanced features such as AI-driven automation, optimized workflows, and conditional touchless processing. These enhancements aim to adeptly handle the surging caseloads and evolving regulations prevalent in the life sciences domain.
  • August 2024: the 'First Policy Makers' Forum' was inaugurated by the Union Minister of Health and Family Welfare & Chemicals and Fertilizers. Aiming to bolster India's standing in the global pharmaceutical arena, the Indian Pharmacopoeia Commission (IPC), alongside the Ministry of Health & Family Welfare and the Ministry of External Affairs, welcomed an international delegation comprising policymakers and drug regulators from 15 nations. The forum also saw the debut of cutting-edge digital platforms dedicated to pharmacopoeia and drug safety oversight.
  • August 2024: in line with the 'Digital India' vision, the Hon'ble Minister of Health & Family Welfare, alongside the Minister of Chemicals and Fertilizers, unveiled an indigenously developed online ADRMS software for the Pharmacovigilance Programme of India (PvPI).
  • February 2024: ArisGlobal, a pioneering life sciences technology firm and the developer of LifeSphere, forged a strategic alliance with Nextrove, a specialist in implementation, systems integration, and data migration within the life sciences domain. This collaboration empowers Drug Safety teams worldwide with cutting-edge solutions, enhancing their efficiency and cost optimization.

Pharmacovigilance and Drug Safety Software Market Report - Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Incidence of Adverse Drug Reactions (ADRs)

      2. 4.2.2 Increasing Adoption of Pharmacovigilance Software by Outsourcing Companies

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Awareness about Pharmacovigilance

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value in USD billion)

    1. 5.1 By Functionality

      1. 5.1.1 Adverse Event Reporting Software

      2. 5.1.2 Drug Safety Audits Software

      3. 5.1.3 Issue Tracking Software

      4. 5.1.4 Fully Integrated Software

    2. 5.2 By Mode of Delivery

      1. 5.2.1 On-premise Delivery

      2. 5.2.2 On-demand/ Cloud-based (SaaS) Delivery

    3. 5.3 By End User

      1. 5.3.1 Pharmaceutical and Biotechnology Companies

      2. 5.3.2 Contract Research Organizations

      3. 5.3.3 Business Process Outsourcing Firms

      4. 5.3.4 Other Pharmacovigilance Service Providers

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Ab Cube

      2. 6.1.2 ArisGlobal

      3. 6.1.3 Ennov Solutions Inc.

      4. 6.1.4 Extedo GmbH

      5. 6.1.5 Anju Software, Inc.

      6. 6.1.6 Oracle Corporation

      7. 6.1.7 Sarjen Systems Pvt Ltd

      8. 6.1.8 Sparta Systems Inc.

      9. 6.1.9 United BioSource Corporation

      10. 6.1.10 Veeva Systems

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Pharmacovigilance and Drug Safety Software Industry Segmentation

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 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
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
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Pharmacovigilance and Drug Safety Software Market Research FAQs

Key features of pharmacovigilance and drug safety software include adverse event reporting, signal detection, risk management, regulatory compliance, data analytics, case management, and integration with other healthcare systems for efficient drug safety monitoring.

Pharmacovigilance software improves drug safety monitoring by automating adverse event reporting, enabling real-time data analysis, enhancing signal detection, ensuring regulatory compliance, and providing comprehensive risk management solutions.

Key market trends in the pharmacovigilance and drug safety software industry include the increasing adoption of AI and machine learning for signal detection, the shift toward cloud-based platforms, growing regulatory requirements, and the integration of real-time data analytics for more efficient drug safety monitoring.

The challenges in implementing pharmacovigilance software in pharmaceutical companies include data integration complexities, ensuring regulatory compliance across multiple regions, high implementation costs, and the need for specialized training and resources to effectively use the software.

Emerging markets drive significant growth in the pharmacovigilance software industry by increasing demand for regulatory compliance, drug safety monitoring, and technological adoption in regions with expanding pharmaceutical and healthcare sectors.

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