The Europe pharmacovigilance and drug safety software market size 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% during 2023–2031. Cloud-based pharmacovigilance and drug safety software is likely to bring new key trends into the market in the coming years.
Pharmacovigilance and drug safety software ensures quick detection and assessment of adverse reactions associated with medications. By enhanced safety monitoring and automating data collection and analysis, the software expedites the identification of potential safety concerns, allowing for quick intervention to mitigate risks. This proactive approach enhances regulatory compliance, patient safety, and overall public health outcomes. Also, with the presence of advanced analytics and real-time monitoring capabilities, pharmacovigilance and drug safety software provide a strong framework for optimizing drug safety surveillance. The integration of AI and predictive analytics with pharmacovigilance and drug safety software enhances the capability to identify potential safety risks before they escalate into serious issues. These advanced technologies help analyze large volumes of structured and unstructured data to detect upcoming safety signals and trends, which triggers proactive risk mitigation strategies. Therefore, owing to various advantages, the demand for pharmacovigilance and drug safety software is increasing in Europe.
Pharmacovigilance is the science of maintaining public health by ensuring the safety and efficacy of pharmaceutical products. Pharmacovigilance and drug safety software is a vital tool that addresses manual data entry errors, the overwhelming volume of safety data, and various other challenges. From clinical trials to post-marketing surveillance, this software is indispensable throughout the drug development lifecycle. Pharmacovigilance and drug safety software helps reduce adverse event processing time as well as improve patient safety through early signal detection. As regulations evolve and European collaboration intensifies, the adoption of pharmacovigilance and drug safety software is advantageous, making it imperative for pharmaceutical companies and regulatory bodies. In 2022, The Pharmaceutical Inspection Co-operation Scheme (PIC/S) updated its guidelines on pharmacovigilance to adhere to international standards, highlighting the importance of robust pharmacovigilance and drug safety software. Further, the software ensures compliance with regulatory standards by facilitating the creation of comprehensive safety reports and submissions to regulatory authorities, which helps companies avoid penalties and maintain their reputation.
In Europe, adverse drug reactions (ADRs) can be a significant cause of death and illness. As all drugs have the potential for adverse drug reactions, a risk-benefit analysis is necessary whenever a drug is prescribed. ADRs remain a challenge in modern healthcare, particularly given the growing complexity of therapeutics, an aging population, and rising multimorbidity in Europe. Pharmacovigilance software enables healthcare providers and pharmaceutical companies to systematically collect, analyze, and report data related to ADRs and overcome the challenges associated with it.
ADRs are a major cause of rising mortality death rates in Europe. According to the report of The European Union Drugs Agency (EUDA), in terms of overdoses, the mortality rate in the European Union in 2021 accounted for ~18.3 deaths per million population aged from 15 to 64. Also, at least 6,166 deaths caused by overdoses involving illicit drugs occurred in the European Union in 2021 (5,796 in 2020). This total reached ~6,677 deaths when Norway and Türkiye were included (6,434 in 2020).
As more ADRs are reported and recognized, pharmaceutical companies, healthcare providers, and regulatory bodies face greater pressure to improve drug safety monitoring and reporting processes. This necessitates the adoption of pharmacovigilance and drug safety software to collect, analyze, and manage the growing volume of safety data. This software helps streamline the process of detecting, assessing, and preventing adverse effects, enabling faster response times and more accurate risk assessments. Thus, the rising incidences of adverse drug reactions fuel 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.
AI systems are progressively being 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 the market growth during the forecast period.
Key segments that contributed to the derivation of the Europe pharmacovigilance and drug safety software market analysis are offerings, organization size, deployment, form, functionality, and end user.
The Europe pharmacovigilance and drug safety software market is segmented into France, Germany, Italy, Spain, the UK, and the Rest of Europe. The rising demand for pharmacovigilance and drug safety software in Europe is attributed to various factors, including regulatory requirements, increasing drug approvals, growing emphasis on patient safety, and advancements in technology. The EU's pharmacovigilance system is one of the most advanced in the world. The European Medicines Agency (EMA) and other regulatory bodies are imposing stringent pharmacovigilance requirements that necessitate the adoption of advanced software solutions. For instance, the introduction of the EU Pharmacovigilance Directive (2010/84/EU) and the subsequent Regulation (EU) No 1235/2010 have imposed stricter rules for the monitoring of adverse drug reactions (ADRs). Companies must report safety data in real time, significantly increasing the demand for efficient software systems capable of handling large volumes of data.
| Report Attribute | Details |
|---|---|
| Market size in 2023 | US$ 52.37 Million |
| Market Size by 2031 | US$ 84.66 Million |
| Global CAGR (2023 - 2031) | 6.2% |
| Historical Data | 2021-2022 |
| Forecast period | 2024-2031 |
| Segments Covered |
By Offering
|
| Regions and Countries Covered | Europe
|
| Market leaders and key company profiles |
The Europe pharmacovigilance and drug safety software market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the key developments in the Europe pharmacovigilance and drug safety software market are listed below:
The "Europe Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031)" provides a detailed analysis of the market covering the areas mentioned below:
The Europe pharmacovigilance and drug safety software market was estimated to be US$ 52.37 million in 2023 and is expected to grow at a CAGR of 6.2% during the forecast period 2023 - 2031.
Cloud-based pharmacovigilance and drug safety software, which is anticipated to play a significant role in the Europe pharmacovigilance and drug safety software market in the coming years.
Rise in incidences of adverse drug reactions, globalization of pharmacovigilance, surge in drug development rates are the major factors that propel the Europe pharmacovigilance and drug safety software market.
The key players holding majority shares in the Europe pharmacovigilance and drug safety software market are 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.
The incremental growth expected to be recorded for the Europe pharmacovigilance and drug safety software market during the forecast period is US$ 32.29 million.
The Europe pharmacovigilance and drug safety software market is expected to reach US$ 84.66 million by 2031.