Surge in Drug Development Rates Fuels Europe Pharmacovigilance and Drug Safety Software Market Growth
According to our latest study, “Europe Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031), Regional Share, Trend, and Growth Opportunity Analysis – by Offerings, Organization Size, Deployment, Form, Functionality, and End User," the market was valued at US$ 52.37 million in 2023 and is expected to reach US$ 84.66 million by 2031; it is estimated to record a CAGR of 6.2% from 2023 to 2031. The report includes growth prospects owing to the current Europe pharmacovigilance and drug safety software market trends and their foreseeable impact during the forecast period.
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, the European Medicines Agency (EMA) and other regulatory bodies 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 accelerated development and deployment of drugs increased the need for robust pharmacovigilance software systems. Therefore, the rise in drug development rates fuels the Europe pharmacovigilance and drug safety software market growth.
Europe Pharmacovigilance and Drug Safety Software Market Share (%) – by Offering, 2023 and 2031
Europe Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021 - 2031), Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Offering (Software and Services), Deployment (Cloud and On-Premises), Enterprise Size (Large Enterprises and SMEs), Form (Standard and Customized), Functionality (Signal and Risk Management, Issue Tracking and Adverse Event Tracking, Case Management, Clinical Safety Management and Clinical Trial Safety, Quality and Compliance, Medical Writing, Audit Support and Training Compliance, Healthcare Analytics, and Others), End User [Pharmaceutical and Biotechnology Companies, Contract Research Organizations, Business Process Outsourcing (BPO) Firms, and Others], and Country
Europe Pharmacovigilance and Drug Safety Software Market 2031
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Source: The Insight Partners Analysis
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 Europe 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 Europe 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 analysis is carried out by considering the following subsegments: software and services. In terms of revenue, the software segment held a larger share of the market and is expected to record a higher CAGR during the forecast period.
The scope of the Europe pharmacovigilance and drug safety software market report focuses on Spain, the UK, Germany, France, Italy, and the Rest of Europe. Germany held the largest Europe pharmacovigilance and drug safety software market share, in terms of revenue. The Rest of Europe is the second largest economy in Europe and houses several leading industry verticals. Russia, Poland, Austria, Switzerland, Sweden, Norway, Denmark, Belgium, and the Netherlands are among the major countries in the Rest of Europe pharmacovigilance and drug safety software market. The growing healthcare industries in these countries are likely to fuel the growth of the market during the forecast period. Further, Russia has imposed strict pharmacovigilance regulations, especially after the introduction of the Eurasian Economic Union (EAEU) regulations on drug safety in 2016. This has pushed pharmaceutical companies to adopt advanced pharmacovigilance software solutions to ensure compliance with these stringent regulations. In addition, Sweden’s healthcare system is undergoing digital transformation, and various companies are providing pharmacovigilance software, which is enhancing drug safety monitoring. For instance, PharmaLex, a Swedish start-up, is offering pharmacovigilance software platforms that integrate real-time monitoring and reporting of ADRs. Therefore, the demand for pharmacovigilance and drug safety software in these countries is increasing owing to evolving regulations and the overall focus on enhancing drug safety.
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