Europe Pharmacovigilance and Drug Safety Software Market
Europe Pharmacovigilance and Drug Safety Software Market is growing at a CAGR of 6.2% to reach US$ 84.67 Million by 2031 from US$ 52.38 Million in 2023 by Offering, Deployment, Enterprise Size, Form, Functionality, End User.

Published On: Jul 2025

Available Report Formats

pdf-format excel-format pptx-format
Request Free Sample Buy Now
Europe Pharmacovigilance and Drug Safety Software Market

At 6.2% CAGR, Europe Pharmacovigilance and Drug Safety Software Market is Projected to be Worth US$ 84.67 Million by 2031, says Business Market Insights

According to Business Market Insights’ research, the Europe pharmacovigilance and drug safety software market was valued at US$ 52.38 million in 2023 and is expected to reach US$ 84.67 million by 2031, registering a CAGR of 6.2% from 2023 to 2031. Cloud-based pharmacovigilance and drug safety software and integration of software with AI, ML, and NLP are among the critical factors attributed to drive the Europe pharmacovigilance and drug safety software market growth.

Artificial intelligence (AI), machine learning (ML), Natural Language Processing (NLP), and other technologies are transforming resource-intensive pharmacovigilance workloads, ensuring a more informed, more efficient approach. Pharmacovigilance and drug safety software platforms are mostly equipped with advanced analytics and AI capabilities that enhance the detection of safety signals. These tools can analyze vast amounts of data, identifying correlations and patterns that traditional methods might overlook. AI-driven predictive analytics can also forecast potential safety issues, allowing companies to take proactive measures. ML models are leveraged to predict potential adverse events associated with drug consumption. For instance, pharmacovigilance campaigns use ML to sift through vast datasets, detecting patterns that might indicate a risk of adverse drug reactions. ML algorithms are particularly adept at handling unstructured data, such as social media and patient records, to forecast safety concerns.

Several major players in the market are offering automated AI-based monitoring tools to promote drug development for pharmaceutical companies. For instance, in May 2021, Clarivate launched the AI-based pharmacovigilance literature monitoring software platform—DialogML. This software uses artificial intelligence and automation for pharmacovigilance literature monitoring. This automation platform helps in end-to-end medical literature monitoring solutions such as reducing aggregate reports and Safety Signal reviewing. In January 2024, PubHive Ltd., a provider of AI-powered literature and safety information workflows, launched a groundbreaking centralized summary of product characteristics (SmPC) management platform with AI-powered pharmacovigilance workflows for life science, pharmaceutical companies, clinical research organizations (CROs), and their pharmacovigilance and drug safety's divisions. This software streamlines processes, simplifies compliance requirements, and empowers pharmacovigilance teams to work faster and more effectively. AI systems are being progressively used to advance real-time drug safety monitoring. This proactive surveillance includes clinical trial data, scanning medical literature, and patient registries for adverse events (AEs); it can also enhance the accuracy and speed of ADR detections. Further, utilizing NLP, AI systems can extract relevant information, such as drug names and symptoms, from vast textual datasets, enabling accurate and rapid adverse event reporting. This accelerates the identification of unknown or new drug safety issues, thereby significantly enhancing the advancements in pharmacovigilance efforts. Various companies offer AI-based pharmacovigilance and drug safety software, including ArisGlobal. Thus, the integration of pharmacovigilance and drug safety software with AI, ML, and NLP is expected to create lucrative opportunities for market growth during the forecast period.

On the contrary, the high installation and maintenance costs hamper the growth of Europe pharmacovigilance and drug safety software market.

Based on offering, the Europe pharmacovigilance and drug safety software market is bifurcated into software and services. The software segment held 70.8% market share in 2023, amassing US$ 37,075.34 thousand. It is projected to garner US$ 62,336.78 thousand by 2031 to register 6.7% CAGR during 2023–2031.

In terms of deployment, the Europe pharmacovigilance and drug safety software market is segmented into cloud and on premises. The cloud segment held 66.2% share of Europe pharmacovigilance and drug safety software market in 2023, amassing US$ 34,668.42 thousand. It is anticipated to garner US$ 61,763.84 thousand by 2031 to expand at 7.5% CAGR during 2023–2031.

By enterprise size, the Europe pharmacovigilance and drug safety software market is divided into large enterprises and SMEs. The large enterprises segment held 70.5% share of Europe pharmacovigilance and drug safety software market in 2023, amassing US$ 36,928.09 thousand. It is projected to garner US$ 61,558.74 thousand by 2031 to expand at 6.6% CAGR from 2023 to 2031.

Based on form, the Europe pharmacovigilance and drug safety software market is categorized into standard and customized. The standard segment held 72.2% share of Europe pharmacovigilance and drug safety software market in 2023, amassing US$ 37,794.96 thousand. It is predicted to garner US$ 60,085.34 thousand by 2031 to expand at 6.0% CAGR between 2023 and 2031.

By functionality, the Europe pharmacovigilance and drug safety software market is segmented into 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. The signal and risk management segment held 29.2% share of Europe pharmacovigilance and drug safety software market in 2023, amassing US$ 15,283.01 thousand. It is estimated to garner US$ 28,261.93 thousand by 2031 to expand at 8.0% CAGR during 2023–2031.

In terms of end user, the Europe pharmacovigilance and drug safety software market is categorized into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing (BPO) firms, and others. The pharmaceutical and biotechnology companies segment held 52.7% share of Europe pharmacovigilance and drug safety software market in 2023, amassing US$ 27,578.21 thousand. It is projected to garner US$ 48,730.02 thousand by 2031 to expand at 7.4% CAGR from 2023 to 2031.

Based on country, the Europe pharmacovigilance and drug safety software market is categorized into Germany, France, the UK, Italy, Spain, and the Rest of Europe. Our regional analysis states that Germany captured 25.6% share of Europe pharmacovigilance and drug safety software market in 2023. It was assessed at US$ 13,429.45 thousand in 2023 and is likely to hit US$ 24,708.52 thousand by 2031, registering a CAGR of 7.9% during 2023–2031.

Key players operating in the pharmacovigilance and drug safety software market are 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, among others.

  • In 2023, IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, announced a strategic collaboration with Argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions.
  • In 2021, Cognizant announced it has been named one of the leading companies in the pharmacovigilance market, offering an end-to-end spectrum of patient safety services in a new report by analyst firm Everest Group. Pharmacovigilance is the practice area aimed at ensuring drug safety through in-depth data collection and evaluation.

Contact Us
Phone: +16467917070
Email Id: sales@businessmarketinsights.com