약물감시 및 의약품 안전성 소프트웨어 시장 보고서 : 기능, 제공 모드, 최종사용자, 지역별(2025-2033년)

The global pharmacovigilance and drug safety software market size reached USD 214.2 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 350.8 Million by 2033, exhibiting a growth rate (CAGR) of 5.63% during 2025-2033. The growing prevalence of chronic diseases among the masses, the implementation of strict regulations on the commercialization of drugs, and continual advancements in software capabilities and user-friendly interfaces are some of the major factors propelling the market.

Pharmacovigilance and drug safety software refers to specialized computer programs designed to streamline and enhance the monitoring, analysis, and reporting of adverse drug reactions (ADRs) and other drug-related safety concerns. These software systems play a crucial role in the field of pharmacovigilance, which is dedicated to ensuring the safe and effective use of medications. These software solutions enable pharmaceutical companies, regulatory authorities, and healthcare professionals to efficiently collect, manage, and analyze large volumes of data pertaining to drug safety. They also facilitate the detection of potential risks and patterns, allowing for timely intervention and risk mitigation strategies.

The pharmacovigilance and drug safety software market is driven by the increasing adoption of these software solutions by clinical research and outsourcing companies. These organizations recognize the importance of robust pharmacovigilance systems to ensure the safety and efficacy of drugs in development and post-marketing surveillance. Moreover, the growing prevalence of chronic diseases is also contributing to the growth of the market. As the number of patients requiring long-term medication increases, so does the need for effective drug safety monitoring and management. Apart from this, governments worldwide are imposing strict regulations on the commercialization of drugs, leading to increased complexity in drug safety regulations, further impelling the demand. Besides, the availability of cutting-edge technology is facilitating the easy adoption of pharmacovigilance and drug safety software. Furthermore, continual advancements in software capabilities and user-friendly interfaces make it easier for organizations to implement and integrate these solutions into their existing workflows, thus impacting the market favorably.

Pharmacovigilance and Drug Safety Software Market Trends/Drivers:

Expansion of the Pharmaceutical Industry

The development of the pharmaceutical industry is having a significant influence on the global pharmacovigilance (PV) and drug safety software market. As the pharmaceutical industry expands, there has been an increase in the development of new drugs and therapies. This leads to a greater need for PV and drug safety software to monitor, analyze, and manage adverse events, leading to an increase in demand for this software. Moreover, the pharmaceutical industry's expansion has led to a rise in data volume and complexity, requiring sophisticated software for managing and analyzing data. This is driving the development and adoption of AI and machine learning within PV and drug safety software to handle, such complex datasets effectively. Also, pharmacovigilance and drug safety software help manage these risks, and the growing need for risk management is driving demand in this market.

Growing Incidence of Adverse Drug Reactions

The increasing incidence of adverse drug reactions (ADRs) is significantly influencing the global pharmacovigilance and drug safety software market. The raising number of reported ADRs has created a greater need for robust pharmacovigilance systems and software solutions to ensure the safety and efficacy of drugs in the market. Adverse drug reactions can have serious consequences on patient health and well-being, leading to hospitalizations, additional medical costs, and even fatalities. Therefore, regulatory authorities worldwide have implemented stringent guidelines and regulations for pharmaceutical companies to monitor and report ADRs effectively. Along with this, the global pharmacovigilance and drug safety software market has experienced significant growth as a direct response to the rising incidence of ADRs since companies offering these software solutions are continuously innovating to provide advanced tools and functionalities that can handle large volumes of adverse event data efficiently.

The Increasing Healthcare Expenditure

As healthcare expenditure continues to rise globally, there is a growing emphasis on optimizing patient safety and improving the overall quality of healthcare delivery. Pharmacovigilance and drug safety software play a crucial role in achieving these objectives by ensuring the effective monitoring, assessment, and management of adverse drug reactions (ADRs) and other drug-related problems. With higher healthcare spending, there has been a growing focus on patient safety. Pharmacovigilance software provides healthcare organizations and regulatory authorities with the tools to monitor and prevent ADRs, thereby reducing the economic burden associated with medication-related harm. Moreover, healthcare expenditure growth necessitates the optimization of resources. Furthermore, pharmacovigilance software enables the efficient management of adverse event data, streamlining the reporting and analysis processes.

Pharmacovigilance and Drug Safety Software Industry Segmentation:

Breakup by Functionality:

• Adverse Event Reporting Software
• Drug Safety Audits Software
• Issue Tracking Software
• Fully Integrated Software

Adverse event reporting software dominates the market

Adverse event reporting software dominates the market as it is a critical aspect of regulatory compliance in the healthcare and pharmaceutical industries. It offers robust data management capabilities, allowing efficient collection, organization, and analysis of adverse event data. It enables the identification of patterns, trends, and potential safety issues associated with specific products or interventions. This data-driven approach helps pharmaceutical companies, healthcare providers, and regulatory agencies make informed decisions regarding product safety and risk mitigation strategies. Additionally, it provides a systematic and standardized approach to capturing and reporting these events, ensuring compliance with regulatory requirements. It provides a centralized platform for healthcare professionals, drug safety experts, and other stakeholders involved in adverse event reporting. Additionally, the software can scale to handle large volumes of adverse event data, ensuring its effectiveness even for organizations with extensive reporting requirements.

Breakup by Delivery Mode:

• On-premises
• Cloud-based

On- premises delivery holds the largest share in the market

On-premises deployment holds the largest share of the market as it provides organizations with a higher level of control and security over their data. It offers greater flexibility for customization and integration with existing systems. Organizations can tailor the software to their specific requirements and integrate it seamlessly with other on-premises applications or infrastructure. This level of customization and integration is beneficial for organizations with complex IT environments or unique business processes. The deployment allows organizations to maintain data sovereignty by ensuring that sensitive data remains within the borders of their own country. Moreover, the widespread adoption of on-premises software help eliminate the potential performance issues related to network latency or dependence on internet connectivity. Also, it allows organizations to maintain compliance and meet regulatory standards more easily.

Breakup by End User:

• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations
• Business Process Outsourcing Firms
• Others

Contract research organizations hold the largest share in the market

CROs hold a significant position and are the leading users of the market's products or services. They specialize in providing comprehensive research services, allowing pharmaceutical and biotech companies to outsource various aspects of their R&D activities. This outsourcing model offers numerous benefits, including access to specialized expertise, reduced operational costs, and increased efficiency in trial execution. They provide in-depth knowledge of industry best practices, regulatory requirements, and emerging trends which makes it an attractive choice for companies seeking reliable partners to navigate complex research processes and achieve successful outcomes. They also have the ability to scale their resources and infrastructure according to project requirements, enabling them to support both small-scale studies and large multinational trials. They can provide expertise in risk management, data integrity, and compliance, helping companies navigate the complex regulatory landscape and mitigate potential pitfalls.

Breakup by Region:

• North America
• United States
• Canada
• Asia-Pacific
• China
• Japan
• India
• South Korea
• Australia
• Indonesia
• Others
• Europe
• Germany
• France
• United Kingdom
• Italy
• Spain
• Russia
• Others
• Latin America
• Brazil
• Mexico
• Others
• Middle East and Africa

North America exhibits a clear dominance, accounting for the largest pharmacovigilance and drug safety software market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada), Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others), Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others), Latin America (Brazil, Mexico, and others), and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America has a robust and well-established pharmaceutical industry, with numerous companies involved in drug discovery, development, and commercialization. The region is at the forefront of technological innovation, including advancements in healthcare and information technology. The region has a robust IT infrastructure, a favorable investment climate for research and development, and a strong focus on adopting digital solutions. North American pharmaceutical companies and research institutions often collaborate with academic institutions, healthcare providers, and technology companies to drive innovation in pharmacovigilance and drug safety. These collaborations foster the development and adoption of state-of-the-art software solutions, further enhancing North America's dominance in the market. Additionally, the region has stringent regulatory requirements for drug safety and pharmacovigilance is another significant factor responsible for impelling the market across the North America region.

Competitive Landscape:

Top companies in the market are investing in research and development activities to create advanced pharmacovigilance and drug safety software solutions. These software platforms are designed to capture, process, analyze, and report adverse events, safety data, and other relevant information related to pharmaceutical products and medical interventions. Various companies offer flexible and scalable software platforms that can be tailored to meet the unique needs of pharmaceutical companies, CROs, and healthcare institutions. Additionally, companies leverage advanced data analytics techniques, such as artificial intelligence (AI) and machine learning (ML), to analyze large volumes of safety data and identify potential safety signals. These analytics capabilities help in the early detection of adverse events, signal management, risk assessment, and trend analysis.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• Ab Cube
• Anju Software Inc.
• ArisGlobal LLC
• Cognizant
• Ennov Solutions Inc.
• Extedo GmbH
• Max Application
• Oracle Corporation
• Sarjen Systems Pvt Ltd
• Sparta Systems Inc. (Honeywell International Inc.)
• Tata Consultancy Services Limited
• United BioSource LLC
• Wipro Limited.

Key Questions Answered in This Report

• 1.What was the size of the global pharmacovigilance and drug safety software market in 2024?
• 2.What is the expected growth rate of the global pharmacovigilance and drug safety software market during 2025-2033?
• 3.What has been the impact of COVID-19 on the global pharmacovigilance and drug safety software market?
• 4.What are the key factors driving the global pharmacovigilance and drug safety software market?
• 5.What is the breakup of the global pharmacovigilance and drug safety software market based on the functionality?
• 6.What is the breakup of the global pharmacovigilance and drug safety software market based on the delivery mode?
• 7.What is the breakup of the global pharmacovigilance and drug safety software market based on the end user?
• 8.What are the key regions in the global pharmacovigilance and drug safety software market?
• 9.Who are the key players/companies in the global pharmacovigilance and drug safety software market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Pharmacovigilance and Drug Safety Software Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Functionality

• 6.1 Adverse Event Reporting Software
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Drug Safety Audits Software
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Issue Tracking Software
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast
• 6.4 Fully Integrated Software
  • 6.4.1 Market Trends
  • 6.4.2 Market Forecast

7 Market Breakup by Delivery Mode

• 7.1 On-premises
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Cloud-based
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast

8 Market Breakup by End User

• 8.1 Pharmaceutical and Biotechnology Companies
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Contract Research Organizations
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Business Process Outsourcing Firms
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast
• 8.4 Others
  • 8.4.1 Market Trends
  • 8.4.2 Market Forecast

9 Market Breakup by Region

• 9.1 North America
  • 9.1.1 United States
    • 9.1.1.1 Market Trends
    • 9.1.1.2 Market Forecast
  • 9.1.2 Canada
    • 9.1.2.1 Market Trends
    • 9.1.2.2 Market Forecast
• 9.2 Asia-Pacific
  • 9.2.1 China
    • 9.2.1.1 Market Trends
    • 9.2.1.2 Market Forecast
  • 9.2.2 Japan
    • 9.2.2.1 Market Trends
    • 9.2.2.2 Market Forecast
  • 9.2.3 India
    • 9.2.3.1 Market Trends
    • 9.2.3.2 Market Forecast
  • 9.2.4 South Korea
    • 9.2.4.1 Market Trends
    • 9.2.4.2 Market Forecast
  • 9.2.5 Australia
    • 9.2.5.1 Market Trends
    • 9.2.5.2 Market Forecast
  • 9.2.6 Indonesia
    • 9.2.6.1 Market Trends
    • 9.2.6.2 Market Forecast
  • 9.2.7 Others
    • 9.2.7.1 Market Trends
    • 9.2.7.2 Market Forecast
• 9.3 Europe
  • 9.3.1 Germany
    • 9.3.1.1 Market Trends
    • 9.3.1.2 Market Forecast
  • 9.3.2 France
    • 9.3.2.1 Market Trends
    • 9.3.2.2 Market Forecast
  • 9.3.3 United Kingdom
    • 9.3.3.1 Market Trends
    • 9.3.3.2 Market Forecast
  • 9.3.4 Italy
    • 9.3.4.1 Market Trends
    • 9.3.4.2 Market Forecast
  • 9.3.5 Spain
    • 9.3.5.1 Market Trends
    • 9.3.5.2 Market Forecast
  • 9.3.6 Russia
    • 9.3.6.1 Market Trends
    • 9.3.6.2 Market Forecast
  • 9.3.7 Others
    • 9.3.7.1 Market Trends
    • 9.3.7.2 Market Forecast
• 9.4 Latin America
  • 9.4.1 Brazil
    • 9.4.1.1 Market Trends
    • 9.4.1.2 Market Forecast
  • 9.4.2 Mexico
    • 9.4.2.1 Market Trends
    • 9.4.2.2 Market Forecast
  • 9.4.3 Others
    • 9.4.3.1 Market Trends
    • 9.4.3.2 Market Forecast
• 9.5 Middle East and Africa
  • 9.5.1 Market Trends
  • 9.5.2 Market Breakup by Country
  • 9.5.3 Market Forecast

10 SWOT Analysis

• 10.1 Overview
• 10.2 Strengths
• 10.3 Weaknesses
• 10.4 Opportunities
• 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

• 12.1 Overview
• 12.2 Bargaining Power of Buyers
• 12.3 Bargaining Power of Suppliers
• 12.4 Degree of Competition
• 12.5 Threat of New Entrants
• 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

• 14.1 Market Structure
• 14.2 Key Players
• 14.3 Profiles of Key Players
  • 14.3.1 Ab Cube
    • 14.3.1.1 Company Overview
    • 14.3.1.2 Product Portfolio
  • 14.3.2 Anju Software Inc.
    • 14.3.2.1 Company Overview
    • 14.3.2.2 Product Portfolio
  • 14.3.3 ArisGlobal LLC
    • 14.3.3.1 Company Overview
    • 14.3.3.2 Product Portfolio
  • 14.3.4 Cognizant
    • 14.3.4.1 Company Overview
    • 14.3.4.2 Product Portfolio
    • 14.3.4.3 Financials
    • 14.3.4.4 SWOT Analysis
  • 14.3.5 Ennov Solutions Inc.
    • 14.3.5.1 Company Overview
    • 14.3.5.2 Product Portfolio
  • 14.3.6 Extedo GmbH
    • 14.3.6.1 Company Overview
    • 14.3.6.2 Product Portfolio
  • 14.3.7 Max Application
    • 14.3.7.1 Company Overview
    • 14.3.7.2 Product Portfolio
  • 14.3.8 Oracle Corporation
    • 14.3.8.1 Company Overview
    • 14.3.8.2 Product Portfolio
    • 14.3.8.3 Financials
    • 14.3.8.4 SWOT Analysis
  • 14.3.9 Sarjen Systems Pvt Ltd
    • 14.3.9.1 Company Overview
    • 14.3.9.2 Product Portfolio
  • 14.3.10 Sparta Systems Inc. (Honeywell International Inc.)
    • 14.3.10.1 Company Overview
    • 14.3.10.2 Product Portfolio
  • 14.3.11 Tata Consultancy Services Limited
    • 14.3.11.1 Company Overview
    • 14.3.11.2 Product Portfolio
    • 14.3.11.3 Financials
    • 14.3.11.4 SWOT Analysis
  • 14.3.12 United BioSource LLC
    • 14.3.12.1 Company Overview
    • 14.3.12.2 Product Portfolio
  • 14.3.13 Wipro Limited
    • 14.3.13.1 Company Overview
    • 14.3.13.2 Product Portfolio
    • 14.3.13.3 Financials
    • 14.3.13.4 SWOT Analysis