Europe Pharmacovigilance and Drug Safety Software Market Report (2021-2031) by Scope, Segmentation, Dynamics, and Competitive Analysis
No. of Pages: 224 | Report Code: TIPRE00022771 | Category: Technology, Media and Telecommunications
No. of Pages: 224 | Report Code: TIPRE00022771 | Category: Technology, Media and Telecommunications
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; it is estimated to register a CAGR of 6.2% from 2023 to 2031.
Pharmacovigilance is the process of monitoring and evaluating adverse drug reactions, and it is a major component of effective drug regulation systems, clinical practice, and public health programs. The globalization of pharmacovigilance fosters collaboration among stakeholders, including regulatory authorities, healthcare providers, and pharmaceutical companies. For instance, the European Medicines Agency (EMA) has placed a growing importance on collaborating with international pharmaceutical regulators to focus on areas such as the safety of medicines, inspections, and exchange of information on issues of mutual concern. Such a collaborative environment enhances data sharing and improves the overall understanding of drug safety profiles. As companies seek to leverage these global networks, the need for integrated pharmacovigilance solutions that can operate across the globe is becoming increasingly essential.
Governments of various countries across the globe are conducting pharmacovigilance programs by collaborating with regulatory bodies in their respective countries. Regulators understand the importance of pharmacovigilance in ensuring drug safety. Increasing awareness and adoption of the best pharmacovigilance practices in different countries across the globe have created a massive demand for pharmacovigilance and drug safety software. For instance, in June 2022, the National Pharmacovigilance Network (RNF) was launched by Italy's Medical Agency, which is the system to detect suspected adverse drug reactions (ADRs). The new RNF system features advanced functions for the management and analysis of reports of suspected adverse reactions to ensure an accurate assessment of the safety of medicines. Also, in all European countries, a suspected adverse reaction report is generated with the help of the EudraVigilance System from the European pharmacovigilance database for suspected adverse drug reactions.
The globalization of pharmacovigilance encourages cross-border collaboration. Many European countries have shown an increased willingness to collaborate with the aim of expanding access to medicines. BeNeLuxA, the Nordic collaborations, and the Valletta Declaration are a few initiatives that help enhance timely and efficient patient access to innovative therapies. The BeNeLuxA initiative, for instance, aims to leverage cooperation and the sharing of expertise on drug pricing and reimbursement between the Governments of Belgium, the Netherlands, Luxembourg, Austria, and Ireland by giving middle income countries greater negotiating power in discussing drug pricing, sharing policy expertise, information on products and markets, and reducing unnecessary duplication. These initiatives can support robust joint health technology assessments and horizon scanning processes, providing more transparency while marketing pharmaceuticals. The implementation of comprehensive pharmacovigilance systems that can efficiently manage and report adverse drug reactions (ADRs) on a global scale contributes to the globalization of pharmacovigilance. Thus, the rapid globalization of pharmacovigilance drives the global pharmacovigilance and drug safety software market.
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.
The pharmaceutical sector in Europe has experienced a surge in new drug approvals, leading to greater demand for pharmacovigilance and drug safety software to monitor safety data. For instance, in the second quarter of 2023, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) approved drugs, including more than 21 new oncology agents. With more drugs entering the market, pharmaceutical companies require robust software solutions to manage the safety and efficacy of these products. Various companies, including Oracle Corp, are investing heavily in pharmacovigilance software to enhance their safety monitoring capabilities for newly approved products. These companies are utilizing platforms such as Oracle Argus Safety and Veeva Vault Safety to manage and report adverse events effectively. Governments of various countries in Europe are taking several compliance measures for software data protection. For instance, with the implementation of the EU General Data Protection Regulation (GDPR), pharmacovigilance and drug safety software must meet regulatory expectations as well as provide operational efficiencies without compromising data protection. GDPR adheres to the sector-specific requirements, privacy, and information security frameworks of the relevant organizations. Such regulations are essential for maintaining trust with patients as well as regulatory bodies. Therefore, the adoption of pharmacovigilance and drug safety software is increasing across Europe. The incorporation of artificial intelligence (AI), machine learning (ML), and other advanced technologies are transforming pharmacovigilance processes. These technologies enable automated data processing, real-time signal detection, and advanced analytics, which makes it easier for companies to manage safety data and comply with regulatory requirements. For instance, ArisGlobal offers the LifeSphere platform integrated with AI to automate case processing and enhance signal detection capabilities. Therefore, with such technological innovations, the demand for pharmacovigilance and drug safety software is increasing in Europe.
The Europe pharmacovigilance and drug safety software market is categorized into offering, deployment, enterprise size, form, functionality, end user, and country.
Based on offering, the Europe pharmacovigilance and drug safety software market is bifurcated into software and services. The software segment held a larger Europe pharmacovigilance and drug safety software market share in 2023.
In terms of deployment, the Europe pharmacovigilance and drug safety software market is segmented into cloud and on premises. The cloud segment held a larger Europe pharmacovigilance and drug safety software market share in 2023.
By enterprise size, the Europe pharmacovigilance and drug safety software market is divided into large enterprises and SMEs. The large enterprises segment held a larger Europe pharmacovigilance and drug safety software market share in 2023.
Based on form, the Europe pharmacovigilance and drug safety software market is categorized into standard and customized. The standard segment held a larger Europe pharmacovigilance and drug safety software market share in 2023.
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 the largest Europe pharmacovigilance and drug safety software market share in 2023.
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 the largest Europe pharmacovigilance and drug safety software market share in 2023.
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. Germany dominated the Europe pharmacovigilance and drug safety software market share in 2023.
| Report Attribute | Details |
|---|---|
| Market size in 2023 | US$ 52.38 Million |
| Market Size by 2031 | US$ 84.67 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 |
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 are some of the leading companies operating in the pharmacovigilance and drug safety software market.
The Europe Pharmacovigilance and Drug Safety Software Market is valued at US$ 52.38 Million in 2023, it is projected to reach US$ 84.67 Million by 2031.
As per our report Europe Pharmacovigilance and Drug Safety Software Market, the market size is valued at US$ 52.38 Million in 2023, projecting it to reach US$ 84.67 Million by 2031. This translates to a CAGR of approximately 6.2% during the forecast period.
The Europe Pharmacovigilance and Drug Safety Software Market report typically cover these key segments-
The historic period, base year, and forecast period can vary slightly depending on the specific market research report. However, for the Europe Pharmacovigilance and Drug Safety Software Market report:
The Europe Pharmacovigilance and Drug Safety Software Market is populated by several key players, each contributing to its growth and innovation. Some of the major players include:
The Europe Pharmacovigilance and Drug Safety Software Market report is valuable for diverse stakeholders, including:
Essentially, anyone involved in or considering involvement in the Europe Pharmacovigilance and Drug Safety Software Market value chain can benefit from the information contained in a comprehensive market report.
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