Pharmacovigilance and Drug Safety Software Market 2024

The pharmacovigilance and drug safety software market size has grown rapidly in recent years. It will grow from $2.0 billion in 2023 to $2.26 billion in 2024 at a compound annual growth rate (CAGR) of 12.9%. The growth observed during the historical period can be attributed to several factors, including a rising demand for pharmacovigilance and drug safety software, an increasing need for advanced pharmacovigilance solutions, escalating healthcare expenditures, a growing prevalence of chronic diseases, and heightened demand for specialized pharmacovigilance software.

The pharmacovigilance and drug safety software market size is expected to see rapid growth in the next few years. It will grow to $3.68 billion in 2028 at a compound annual growth rate (CAGR) of 13%. The anticipated growth during the forecast period can be attributed to several factors, including a rise in the incidence of adverse drug reactions (ADRs), the globalization of pharmacovigilance practices, increasing complexity in drug safety regulations, a surge in the development of new drugs and therapies, and a growing number of reported ADRs. Key trends expected to shape this period include the integration of automation and AI, the adoption of cloud-based solutions, ongoing technological innovations, advancements in various technologies, and a continued digitalization of healthcare.

The increasing demand for personalized medicine is projected to drive growth in the pharmacovigilance and drug safety software market in the coming years. Also known as precision medicine, personalized medicine is a healthcare approach that customizes medical decisions and treatments based on the unique characteristics of each patient. This growing demand is influenced by several factors, including enhanced treatment outcomes, a focus on prevention and early detection, and improved cost-effectiveness. Pharmacovigilance and drug safety software play a crucial role in the success of personalized medicine. By integrating pharmacogenetics, real-time data analysis, post-marketing surveillance, and personalized medication information, these tools enhance the safety and efficacy of individualized treatments while supporting robust risk management strategies and addressing ethical considerations. For example, in February 2024, the Personalized Medicine Coalition, a US-based non-profit organization, reported that the FDA approved 16 novel personalized therapies for patients with rare diseases in 2023, a significant increase from six in 2022. Consequently, the rising demand for personalized medicine is driving growth in the pharmacovigilance and drug safety software market.

Leading companies in the pharmacovigilance and drug safety software market are developing innovative technologies, such as cloud-based data lake platforms, to improve patient safety, monitor adverse events more effectively, and enhance regulatory compliance in clinical trials and post-market surveillance of medical devices. A cloud-based data lake platform serves as a scalable, centralized storage system that allows organizations to store, manage, and analyze vast amounts of structured and unstructured data. It provides real-time data access and supports advanced analytics as well as AI/ML workloads. For instance, in December 2023, Thermo Fisher Scientific Inc., a US-based biotechnology firm, launched CorEvidence, a proprietary cloud-based data lake platform designed to enhance pharmacovigilance processes within clinical research registries. This platform aims to optimize case processing and safety data management, particularly for post-authorization safety studies.

In April 2024, Qinecsa, a UK-based company, acquired Insife ApS for an undisclosed amount. This strategic acquisition is intended to strengthen Qinecsa's offerings in end-to-end pharmacovigilance technology solutions, aligning with its ambition to become a leading provider in the digital pharmacovigilance sector. Insife ApS is a Denmark-based company specializing in pharmacovigilance software.

Major companies operating in the pharmacovigilance and drug safety software market are Accenture plc, International Business Machines Corporation, Deloitte Touche Tohmatsu Limited, Oracle Corporation, Capgemini SE, Cognizant Technology Solutions, IQVIA, Wipro Limited, Genepact, Parexel Academy, PharmaLex, Indegene Limited, RXLogix, Sarjen Systems Pvt Ltd, Anju Software Inc., Ennov Group, EXTEDO GmbH, ArisGlobal, AB Cube, Clinevo Technologies.

North America was the largest region in the pharmacovigilance and drug safety software market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the pharmacovigilance and drug safety software market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the pharmacovigilance and drug safety software market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Pharmacovigilance and drug safety software comprises a suite of digital tools aimed at monitoring, analyzing, and reporting adverse drug reactions (ADRs) and other safety-related information linked to pharmaceuticals and medical products. This software is essential for ensuring patient safety and maintaining regulatory compliance throughout a drug's lifecycle, from development to post-marketing surveillance.

The primary types of pharmacovigilance and drug safety software include adverse event reporting software, drug safety audit software, issue tracking software, and fully integrated software solutions. Adverse event reporting software specifically focuses on tracking, documenting, and managing adverse events associated with pharmaceutical products or medical devices. These solutions are available in both on-premise and cloud-based delivery modes and are utilized by a variety of end users, including pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and others.

The pharmacovigilance and drug safety software market research report is one of a series of new reports that provides pharmacovigilance and drug safety software market statistics, including pharmacovigilance and drug safety software industry global market size, regional shares, competitors with a pharmacovigilance and drug safety software market share, detailed pharmacovigilance and drug safety software market segments, market trends and opportunities, and any further data you may need to thrive in the pharmacovigilance and drug safety software industry. This pharmacovigilance and drug safety software market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The pharmacovigilance and drug safety software market includes revenues earned by entities by signal detection and management tools, risk assessment, and management software. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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