Pharmacovigilance and Drug Safety Software Market Size
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*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 Market Insights and Trends
Adverse Event Reporting Software Segment is Expected to Have Major Share in the Market Over the Forecast Period
By functionality, the adverse event reporting software (AERS) segment is estimated to have a market size of USD 96.43 million in 2024, which is expected to reach USD 130.60 million by 2029 with a CAGR of 6.25% over the forecast period.
The AERS segment is experiencing significant growth and is expected to have a major pharmacovigilance and drug safety software market share, driven by various factors that underscore the critical need for efficient, accurate, and compliant reporting of adverse drug reactions (ADRs).
Increased drug approvals and the introduction of novel drug types (biologics, gene therapies, etc.) require more extensive post-marketing surveillance and reporting systems. For instance, as per the November 2024 update from the Center for Drug Evaluation and Research (CDER), the United States approved approximately 42 novel drugs in 2024 and 55 in 2023. This trend in drug approvals underscores a rising demand for adverse event reporting software, given the likelihood of these new drugs presenting more adverse effects in a broader population.
Additionally, automation in adverse event reporting reduces human errors, improves data consistency, and accelerates the submission process to regulatory agencies. For instance, in August 2024, Authenticx unveiled its next-generation solution, featuring a suite of AI models tailored to identify healthcare-specific reportable events. The Authenticx Safety Event suite enhances efficiency and mitigates risks in several ways. Notably, it automates the detection of adverse events, product quality complaints, and HIPAA violations. This automation not only eliminates the need for manual notes but also enhances accuracy by reducing subjective documentation. which is expected to boost the segment growth over the forecast period.
By functionality, the trend of new drug approvals and automation in adverse event reporting are the major factors driving the growth of the AERS segment over the forecast period.
The Pharmaceutical and Biotechnology Companies Segment is Expected to Have a Largest Share of the Market Over the Forecast Period
By end user, the pharmaceutical and biotechnology companies segment is estimated to have the largest pharmacovigilance and drug safety software market share with a market size of USD 68.26 million in 2024, which is expected to reach USD 93.18 million by 2029 with a CAGR of 6.42% over the forecast period.
During the forecast period, the pharmaceutical and biotechnology companies segment will continue to dominate the growth in the global pharmacovigilance and drug safety software market. As the demand for regulatory compliance, advanced safety monitoring, and global drug development increases, market leaders as well as other companies in this sector are investing heavily in software solutions that can streamline adverse event reporting, ensure patient safety, and help them stay ahead of the regulatory curve.
The pharmacovigilance and drug safety software market segmentation includes functionality, mode of delivery, and end user. 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. With technological advancements, companies increasingly turn to software solutions powered by artificial intelligence and machine learning, enabling them to manage safety data more effectively and proactively.
North America is Expected to Have the Largest Growth in the Market Over the Forecast Period
By geography, the North America region is likely to hold the largest growth with an estimated market size of USD 84.59 million in 2024, expected to reach USD 116.88 million by 2029 with a CAGR of 6.68% over the forecast period. The North America pharmacovigilance and drug safety software market growth is driven by a combination of stringent regulatory requirements, a focus on patient safety, technological innovation, and the presence of major pharmaceutical and biotechnology companies.
These factors position North America as a major region in the global pharmacovigilance and drug safety software market, with significant contributions from both large enterprises and growing biotech sectors.
North America is adopting advanced technologies, including artificial intelligence (AI), machine learning (ML), and big data analytics, which significantly enhance the capabilities of pharmacovigilance and drug safety software. These innovations enable better signal detection, more accurate adverse event reporting, and faster identification of safety issues in real-time. For instance, in July 2024, Oracle unveiled enhanced features in its AI-driven Oracle Argus and Safety One Intake solutions, aimed at assisting life science organizations in navigating evolving regulatory demands and managing the increasing workload of adverse event cases. These upgrades, tailored to boost productivity, bolster data privacy, and refine reporting, empower users to swiftly adapt to dynamic, country-specific regulations. Furthermore, they expedite the reliability and transparency of safety case management, spanning from clinical trials to post-marketing surveillance, which is likely to result in significant growth in the segment over the forecast period.
Moreover, North America, particularly the United States, has stringent regulatory requirements for drug safety and pharmacovigilance. Agencies like the United States Food and Drug Administration (FDA) and Health Canada enforce rigorous safety monitoring and adverse event reporting standards. Pharmaceutical companies must adhere to these regulations, which makes the adoption of pharmacovigilance and drug safety software crucial to ensure compliance with adverse event reporting and risk management. For instance, as per the May 2024 update Health Canada has aligned its recommendations for reporting Adverse Reactions (ARs) by Marketing Authorization Holders (MAHs) with the guidance documents from the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). These include: "Clinical Safety Data Management: Definitions and Standards for Expedited Reporting," "Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports," and "Post-approval Safety Data Management: Definitions and Standards for Expedited Reporting". Therefore, these factors position North America as a leader in the global pharmacovigilance software market, with significant contributions from both large enterprises and growing biotech sectors.
By geography, the global pharmacovigilance and drug safety software market research 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). Europe is the second-largest region for pharmacovigilance and drug safety software, with significant growth in countries like Germany, the United Kingdom, France, and Switzerland. In addition, the Asia Pacific (APAC) region is witnessing rapid growth in the pharmacovigilance and drug safety software market, fueled by the increasing pharmaceutical industry research in countries like China, India, Japan, and South Korea.
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
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Ennov Solutions Inc.
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Extedo GmbH
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United BioSource Corporation
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Ab Cube
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ArisGlobal
*Disclaimer: Major Players sorted in no particular order
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. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Incidence of Adverse Drug Reactions (ADRs)
4.2.2 Increasing Adoption of Pharmacovigilance Software by Outsourcing Companies
4.3 Market Restraints
4.3.1 Lack of Awareness about Pharmacovigilance
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value in USD billion)
5.1 By Functionality
5.1.1 Adverse Event Reporting Software
5.1.2 Drug Safety Audits Software
5.1.3 Issue Tracking Software
5.1.4 Fully Integrated Software
5.2 By Mode of Delivery
5.2.1 On-premise Delivery
5.2.2 On-demand/ Cloud-based (SaaS) Delivery
5.3 By End User
5.3.1 Pharmaceutical and Biotechnology Companies
5.3.2 Contract Research Organizations
5.3.3 Business Process Outsourcing Firms
5.3.4 Other Pharmacovigilance 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 Australia
5.4.3.5 South Korea
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 Company Profiles
6.1.1 Ab Cube
6.1.2 ArisGlobal
6.1.3 Ennov Solutions Inc.
6.1.4 Extedo GmbH
6.1.5 Anju Software, Inc.
6.1.6 Oracle Corporation
6.1.7 Sarjen Systems Pvt Ltd
6.1.8 Sparta Systems Inc.
6.1.9 United BioSource Corporation
6.1.10 Veeva Systems
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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 | ||||||||
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Pharmacovigilance and Drug Safety Software Market Research FAQs
What are the key features of pharmacovigilance and drug safety software?
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.
How does pharmacovigilance software help improve 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.
What are the market trends in the pharmacovigilance and drug safety software industry?
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.
What are the challenges in implementing pharmacovigilance software in pharmaceutical companies?
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.
How do emerging markets impact the pharmacovigilance software industry?
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.