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North America Pharmacovigilance and Drug Safety Software Market Report (2021-2031) by Scope, Segmentation, Dynamics, and Competitive Analysis

Publisher The Insight Partners
Published Jul 10, 2025
Length 210 Pages
SKU # TIP20415839

Description

The North American pharmacovigilance and drug safety software market was valued at approximately $100.03 million in 2023 and is projected to grow to about $182.72 million by 2031, reflecting a compound annual growth rate (CAGR) of 7.8% during the forecast period from 2023 to 2031.

Increasing Incidence of Adverse Drug Reactions

The rise in adverse drug reactions (ADRs) is a significant factor driving the growth of the pharmacovigilance and drug safety software market in North America. The prevalence of chronic diseases is on the rise, leading to an increase in the number of medications prescribed, which in turn raises the potential for ADRs. Given that all medications can cause adverse reactions, conducting a thorough risk-benefit analysis is crucial whenever a drug is prescribed. ADRs pose a considerable challenge in contemporary healthcare, especially with the increasing complexity of treatment regimens, an aging population, and the prevalence of multiple chronic conditions.

Pharmacovigilance software plays a vital role in enabling healthcare providers and pharmaceutical companies to systematically collect, analyze, and report data related to ADRs. This software is essential for addressing the challenges posed by ADRs, as evidenced by the data from the US Food and Drug Administration's Adverse Event Reporting System (FAERS), which reported over 1.25 million severe adverse cases and more than 175,000 deaths in 2022 alone.

The interaction of certain medications, such as theophylline with macrolide antibiotics and increased vitamin K consumption, has been linked to ADRs. As the number of reported ADRs continues to rise, there is increasing pressure on pharmaceutical companies, healthcare providers, and regulatory bodies to enhance drug safety monitoring and reporting processes. Pharmacovigilance and drug safety software streamline the detection, assessment, and prevention of adverse effects, facilitating quicker response times and more accurate risk assessments. Consequently, the growing incidence of ADRs is a key driver of market growth in pharmacovigilance and drug safety software.

Overview of the North American Market

The North American pharmacovigilance and drug safety software market is segmented into the United States, Canada, and Mexico. North America is recognized as an early adopter of regulations concerning pharmaceutical and drug safety. Additionally, the region is witnessing a surge in digitization within the pharmaceutical sector. According to Canada Health Infoway, pharmaceutical companies in Canada are increasingly adopting digital health services, which is expected to drive demand for pharmacovigilance and drug safety software in the coming years. The growing digitization in the pharmaceutical industry is anticipated to enhance the need for effective monitoring of pharmaceutical drugs, thereby increasing the demand for pharmacovigilance solutions.

As the volume of reported adverse events rises, pharmacovigilance and drug safety professionals face greater challenges in accurately and efficiently evaluating this data. The implementation of advanced technologies is crucial to alleviate the workload of these professionals while ensuring precise and systematic analysis of adverse event data.

Market Segmentation Analysis

The North American pharmacovigilance and drug safety software market can be categorized based on various factors, including offering, deployment, enterprise size, form, functionality, end user, and country.

1. Offering: The market is divided into software and services, with the software segment holding a larger share in 2023.
2. Deployment: The market is further segmented into cloud-based and on-premises solutions, with cloud solutions dominating the market share in 2023.
3. Enterprise Size: The market is categorized into large enterprises and small to medium-sized enterprises (SMEs), with large enterprises holding a significant share in 2023.
4. Form: The software is available in standard and customized forms, with the standard form being more prevalent in the market.
5. Functionality: The market includes various functionalities such as signal and risk management, issue tracking, case management, clinical safety management, quality and compliance, and healthcare analytics, with signal and risk management being the largest segment in 2023.
6. End User: The primary end users include pharmaceutical and biotechnology companies, contract research organizations, and business process outsourcing firms, with pharmaceutical and biotechnology companies leading the market share.
7. Country: The market is segmented into the US, Canada, and Mexico, with the US dominating the market in 2023.

Key Players in the Market

Several prominent companies are active in the North American pharmacovigilance and drug safety software market, including Veeva Systems Inc., IQVIA Holdings Inc., AB Cube S.A.S., ArisGlobal LLC, Oracle Corp, Max Application, ICON Plc, Cognizant Technology Solutions Corp, Accenture Plc, Syneos Health Inc., Genpact Ltd., Laboratory Corp of America Holdings, Parexel International Corp, Qinecsa Solutions, and Clinevo Technologies. These companies are at the forefront of developing innovative solutions to enhance drug safety and pharmacovigilance practices in the region.

Reasons to Buy

Save and reduce time carrying out entry-level research by identifying the growth, size, leading players and segments in the North America pharmacovigilance and drug safety software market.
Highlights key business priorities in order to assist companies to realign their business strategies
The key findings and recommendations highlight crucial progressive industry trends in the North America pharmacovigilance and drug safety software market, thereby allowing players across the value chain to develop effective long-term strategies
Develop/modify business expansion plans by using substantial growth offering developed and emerging markets
Scrutinize in-depth North America market trends and outlook coupled with the factors driving the pharmacovigilance and drug safety software market, as well as those hindering it
Enhance the decision-making process by understanding the strategies that underpin commercial interest with respect to client products, segmentation, pricing and distribution

Table of Contents

210 Pages
1. Introduction
1.1 Report Guidance
1.2 Market Segmentation
2. Executive Summary
2.1 Key Insights
2.2 Market Attractiveness
3. Research Methodology
3.1 Secondary Research
3.2 Primary Research
3.2.1 Hypothesis formulation:
3.2.2 Macroeconomic factor analysis:
3.2.3 Developing base number:
3.2.4 Data Triangulation:
3.2.5 Country-level data:
3.3 Assumptions and Limitations
4. North America Pharmacovigilance and Drug Safety Software Market Landscape
4.1 Overview
4.1.1 Software/Service Providers:
4.1.2 System Integrators:
4.1.3 Regulatory Bodies:
4.1.4 End-Users:
4.2 List of Vendors in the Value Chain
5. North America Pharmacovigilance and Drug Safety Software Market – Key Market Dynamics
5.1
5.1 Market Drivers
5.1.1 Rise in Incidences of Adverse Drug Reactions
5.1.2 Globalization of Pharmacovigilance
5.1.3 Surge in Drug Development Spending
5.2 Market Restraints
5.2.1 High Installation and Maintenance Costs
5.3 Market Opportunities
5.3.1 Integration of Software with AI, ML, and NLP
5.4 Future Trends
5.4.1 Cloud-Based Pharmacovigilance and Drug Safety Software:
5.5 Impact of Drivers and Restraints:
6. North America Pharmacovigilance and Drug Safety Software Market – Analysis
6.1 North America Pharmacovigilance and Drug Safety Software Market Revenue (US$ Thousand), 2021–2031
6.2 North America Pharmacovigilance and Drug Safety Software Market Forecast Analysis
7. North America Pharmacovigilance and Drug Safety Software Market Analysis – by Offering
7.1 Software
7.1.1 Overview
7.1.2 Software: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
7.2 Services
7.2.1 Overview
7.2.2 Services: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
8. North America Pharmacovigilance and Drug Safety Software Market Analysis – by Deployment
8.1 Cloud
8.1.1 Overview
8.1.2 Cloud: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
8.2 On Premises
8.2.1 Overview
8.2.2 On Premises: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
9. North America Pharmacovigilance and Drug Safety Software Market Analysis – by Enterprise Size
9.1 Large Enterprises
9.1.1 Overview
9.1.2 Large Enterprises: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
9.2 SMEs
9.2.1 Overview
9.2.2 SMEs: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
10. North America Pharmacovigilance and Drug Safety Software Market Analysis – by Form
10.1 Standard
10.1.1 Overview
10.1.2 Standard: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
10.2 Customized
10.2.1 Overview
10.2.2 Customized: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11. North America Pharmacovigilance and Drug Safety Software Market Analysis – by Functionality
11.1 Signal and Risk Management
11.1.1 Overview
11.1.2 Signal and Risk Management: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11.2 Issue Tracking and Adverse Event Tracking
11.2.1 Overview
11.2.2 Issue Tracking and Adverse Event Tracking: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11.3 Case Management
11.3.1 Overview
11.3.2 Case Management: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11.4 Clinical Safety Management and Clinical Trial Safety
11.4.1 Overview
11.4.2 Clinical Safety Management and Clinical Trial Safety: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11.5 Quality and Compliance
11.5.1 Overview
11.5.2 Quality and Compliance: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11.6 Medical Writing
11.6.1 Overview
11.6.2 Medical Writing: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11.7 Audit Support and Training Compliance
11.7.1 Overview
11.7.2 Audit Support and Training Compliance: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11.8 Healthcare Analytics
11.8.1 Overview
11.8.2 Healthcare Analytics: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
11.9 Others
11.9.1 Overview
11.9.2 Others: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
12. North America Pharmacovigilance and Drug Safety Software Market Analysis – by End User
12.1 Pharmaceutical and Biotechnology Companies
12.1.1 Overview
12.1.2 Pharmaceutical and Biotechnology Companies: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
12.2 Contract Research Organizations
12.2.1 Overview
12.2.2 Contract Research Organizations: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
12.3 Business Process Outsourcing (BPO) Firms
12.3.1 Overview
12.3.2 Business Process Outsourcing (BPO) Firms: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
12.4 Others
12.4.1 Overview
12.4.2 Others: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
13. North America Pharmacovigilance and Drug Safety Software Market – Country Analysis
13.1 North America
13.1.1 North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast Analysis – by Country
13.1.1.1 North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast Analysis – by Country
13.1.1.2 United States: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
13.1.1.2.1 United States: North America Pharmacovigilance and Drug Safety Software Market Share – by Offering
13.1.1.2.1 United States: North America Pharmacovigilance and Drug Safety Software Market Share – by Deployment
13.1.1.2.2 United States: North America Pharmacovigilance and Drug Safety Software Market Share – by Enterprise Size
13.1.1.2.3 United States: North America Pharmacovigilance and Drug Safety Software Market Share – by Form
13.1.1.2.4 United States: North America Pharmacovigilance and Drug Safety Software Market Share – by Functionality
13.1.1.2.5 United States: North America Pharmacovigilance and Drug Safety Software Market Share – by End User
13.1.1.3 Canada: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
13.1.1.3.1 Canada: North America Pharmacovigilance and Drug Safety Software Market Share – by Offering
13.1.1.3.2 Canada: North America Pharmacovigilance and Drug Safety Software Market Share – by Deployment
13.1.1.3.3 Canada: North America Pharmacovigilance and Drug Safety Software Market Share – by Enterprise Size
13.1.1.3.4 Canada: North America Pharmacovigilance and Drug Safety Software Market Share – by Form
13.1.1.3.5 Canada: North America Pharmacovigilance and Drug Safety Software Market Share – by Functionality
13.1.1.3.6 Canada: North America Pharmacovigilance and Drug Safety Software Market Share – by End User
13.1.1.4 Mexico: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
13.1.1.4.1 Mexico: North America Pharmacovigilance and Drug Safety Software Market Share – by Offering
13.1.1.4.2 Mexico: North America Pharmacovigilance and Drug Safety Software Market Share – by Deployment
13.1.1.4.3 Mexico: North America Pharmacovigilance and Drug Safety Software Market Share – by Enterprise Size
13.1.1.4.4 Mexico: North America Pharmacovigilance and Drug Safety Software Market Share – by Form
13.1.1.4.5 Mexico: North America Pharmacovigilance and Drug Safety Software Market Share – by Functionality
13.1.1.4.6 Mexico: North America Pharmacovigilance and Drug Safety Software Market Share – by End User
14. Competitive Landscape
14.1 Heat Map Analysis by Key Players
14.2 Company Positioning and Concentration
15. Industry Landscape
15.1 Overview
15.2 Market Initiative
15.3 Partnerships and Collaborations
16. Company Profiles
16.1 ArisGlobal LLC
16.1.1 Key Facts
16.1.2 Business Description
16.1.3 Products and Services
16.1.4 Financial Overview
16.1.5 SWOT Analysis
16.1.6 Key Developments
16.2 Max Application
16.2.1 Key Facts
16.2.2 Business Description
16.2.3 Products and Services
16.2.4 Financial Overview
16.2.5 SWOT Analysis
16.2.6 Key Developments
16.3 Oracle Corp
16.3.1 Key Facts
16.3.1 Business Description
16.3.2 Products and Services
16.3.3 Financial Overview
16.3.4 SWOT Analysis
16.3.5 Key Developments
16.4 Veeva Systems Inc
16.4.1 Key Facts
16.4.2 Business Description
16.4.3 Products and Services
16.4.4 Financial Overview
16.4.5 SWOT Analysis
16.4.6 Key Developments
16.5 IQVIA Holdings Inc
16.5.1 Key Facts
16.5.2 Business Description
16.5.3 Products and Services
16.5.4 Financial Overview
16.5.5 SWOT Analysis
16.5.6 Key Developments
16.6 ICON Plc
16.6.1 Key Facts
16.6.2 Business Description
16.6.3 Products and Services
16.6.4 Financial Overview
16.6.5 SWOT Analysis
16.6.6 Key Developments
16.7 Cognizant Technology Solutions Corp
16.7.1 Key Facts
16.7.2 Business Description
16.7.3 Products and Services
16.7.4 Financial Overview
16.7.5 SWOT Analysis
16.7.6 Key Developments
16.8 Accenture Plc
16.8.1 Key Facts
16.8.2 Business Description
16.8.3 Products and Services
16.8.4 Financial Overview
16.8.5 SWOT Analysis
16.8.6 Key Developments
16.9 Syneos Health Inc
16.9.1 Key Facts
16.9.2 Business Description
16.9.3 Products and Services
16.9.4 Financial Overview
16.9.5 SWOT Analysis
16.9.6 Key Developments
16.10 Genpact Ltd.
16.10.1 Key Facts
16.10.2 Business Description
16.10.3 Products and Services
16.10.4 Financial Overview
16.10.5 SWOT Analysis
16.10.6 Key Developments
16.11 AB Cube S.A.S.
16.11.1 Key Facts
16.11.2 Business Description
16.11.3 Products and Services
16.11.4 Financial Overview
16.11.5 SWOT Analysis
16.11.6 Key Developments
16.12 Laboratory Corp of America Holdings
16.12.1 Key Facts
16.12.2 Business Description
16.12.3 Products and Services
16.12.4 Financial Overview
16.12.5 SWOT Analysis
16.12.6 Key Developments
16.13 Parexel International Corp
16.13.1 Key Facts
16.13.2 Business Description
16.13.3 Products and Services
16.13.4 Financial Overview
16.13.5 SWOT Analysis
16.13.6 Key Developments
16.14 Qinecsa Solutions
16.14.1 Key Facts
16.14.2 Business Description
16.14.3 Products and Services
16.14.4 Financial Overview
16.14.5 SWOT Analysis
16.14.6 Key Developments
16.15 Clinevo Technologies
16.15.1 Key Facts
16.15.2 Business Description
16.15.3 Products and Services
16.15.4 Financial Overview
16.15.5 SWOT Analysis
16.15.6 Key Developments
17. Appendix
17.1 About Us
17.2 List of Abbreviations
LIST OF TABLES
Table 1. North America Pharmacovigilance and Drug Safety Software Market Segmentation
Table 2. List of Vendors
Table 3. North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand)
Table 4. North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand) – by Offering
Table 5. North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand) – by Deployment
Table 6. North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand) – by Enterprise Size
Table 7. North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand) – by Form
Table 8. North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand) – by Functionality
Table 9. North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand) – by End User
Table 10. North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021–2031 (US$ Thousand) – by Country
Table 11. United States: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Offering
Table 12. United States: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Deployment
Table 13. United States: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Enterprise Size
Table 14. United States: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Form
Table 15. United States: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Functionality
Table 16. United States: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by End User
Table 17. Canada: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Offering
Table 18. Canada: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Deployment
Table 19. Canada: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Enterprise Size
Table 20. Canada: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Form
Table 21. Canada: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Functionality
Table 22. Canada: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by End User
Table 23. Mexico: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Offering
Table 24. Mexico: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Deployment
Table 25. Mexico: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Enterprise Size
Table 26. Mexico: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Form
Table 27. Mexico: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by Functionality
Table 28. Mexico: North America Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast, 2021 – 2031 (US$ Thousand) – by End User
Table 29. List of Abbreviations

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