Pharmacovigilance and Drug Safety Software Market is expected to reach US$ 359.30 Million by 2031

Surge in Drug Development Spending to Fuel Pharmacovigilance and Drug Safety Software Market Growth During Forecast Period 

According to our latest study, “Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031), Global and Regional Share, Trend, and Growth Opportunity Analysis – by Offerings, Organization Size, Deployment, Form, Functionality, and End User," the market was valued at US$ 214.39 million in 2023 and is expected to reach US$ 359.30 million by 2031; it is estimated to record a CAGR of 6.7% from 2023 to 2031. The report includes growth prospects owing to the current pharmacovigilance and drug safety software market trends and their foreseeable impact during the forecast period.    

Pharmaceutical companies across the globe are investing significant amounts in drug development. For instance, the world's major 20 pharmaceutical companies collectively spent more than US$ 145 billion on research and development related to drug development in 2023, increasing investment from US$ 139 billion as compared to 2022. The average research and development cost for the discovery of new drugs was ~US$ 2.3 billion in 2022 and 2023. Pharmacovigilance and drug safety software helps in the assessment, detection, understanding, and prevention of the adverse effects of any other medicine-related problem.

Pharmacovigilance and Drug Safety Software Market Analysis — by Geography

Source: The Insight Partners Analysis

Europe has become a hub for pharmaceutical innovation, with drug development activity on the rise across several therapeutic areas. This surge in drug discovery and clinical trials has directly impacted the need for advanced pharmacovigilance and drug safety software to manage safety reporting and compliance efficiently. The growing number of drugs entering clinical trials and eventually gaining market authorization in Europe has created an increased burden for pharmaceutical companies to monitor drug safety. With every new drug, regulatory bodies, such as the European Medicines Agency (EMA), demand that companies maintain stringent pharmacovigilance practices—including tracking adverse events, drug interactions, and patient outcomes. For instance, the rapid development and approval of COVID-19 vaccines in Europe by EMA. Companies such as Pfizer-BioNTech and Moderna went through accelerated clinical trials, and the EMA granted conditional marketing authorizations for these vaccines in record time.

The number of clinical trials in developing countries such as India, China, Malaysia, Mexico, and Brazil is rising. Drug development companies across the globe initiated more than 4,900 clinical trials in 2023, according to the IQVIA Institute report.    

ArisEurope, ICON plc, Syneos Health, Accenture, IQVIA, Genpact, Cognizant, Paraxel International Corporation, Laboratory Corporation of America Holdings, Max Application, Clinevo Technologies, Qinecsa Solutions, AB Cube, and Veeva Systems are among the key players profiled in the pharmacovigilance and drug safety software market report. Several other major players were also studied and analyzed during the market study to get a holistic view of the market and its ecosystem.

The report includes the pharmacovigilance and drug safety software market forecast by offerings, organization size, deployment, form, functionality, and end user. Based on offering, the Europe pharmacovigilance and drug safety software market is divided into software and services. In terms of revenue, the software segment held a larger pharmacovigilance and drug safety software market share and is expected to record a higher CAGR during the forecast period.

The scope of the pharmacovigilance and drug safety software market report focuses on North America (US, Canada, and Mexico), Europe (Spain, UK, Germany, France, Italy, and Rest of Europe), Asia Pacific (South Korea, China, India, Japan, Australia, and Rest of Asia Pacific), the Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America). North America dominated the market in 2023, followed by Europe and APAC.  

The Asia Pacific pharmacovigilance and drug safety software market is segmented into Australia, China, Japan, India, South Korea, and the Rest of APAC. In terms of revenue, China held the largest pharmacovigilance and drug safety software market share in APAC. The pharmacovigilance system has proven to be an effective method to prevent or mitigate events associated with drug-related side effects or adverse reactions. In 2019, after two decades of implementing the drug-related adverse reaction reporting system, China officially launched a pharmacovigilance system with the pharmacovigilance quality management rules or standards and a series of supporting technical documents prepared to improve the safety of medicines administered to patients. Such government initiatives toward ensuring public safety from drug-related adverse reactions are expected to raise the demand for pharmacovigilance and drug safety software during the forecast period. According to the annual report for national adverse drug reaction monitoring by the National Medical Products Administration, in 2020, China's National ADR monitoring network received ~1.68 million copies of adverse drug reaction reports. This reporting is achieved through the efforts of various parties such as marketing authorization holders, distributors, and medical institutions. Such a rise in ADR has resulted in surging demand for pharmacovigilance and drug safety software in the country, which is fueling the pharmacovigilance and drug safety software market growth.  

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