Pharmacovigilance and Drug Safety Software Market Analysis

Pharmacovigilance & Drug Safety Software Market Analysis

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By functionality, the pharmacovigilance and drug safety software market is classified into adverse event reporting software, drug safety audits software, issue tracking software, fully integrated software, and other functionalities. The fully integrated software segment held 32.9% industry share in 2022. attributed to the increasing demand for automated, user-friendly, and technologically advanced platforms that enhance operational efficiency and ensure adherence to stringent safety regulations. Also, fully integrated software ensures data integrity and consistency, enabling efficient data retrieval, analysis, and reporting. Such aforementioned factors have increased the adoption of fully integrated software.
 

Based on mode of delivery, the pharmacovigilance and drug safety software market is segmented into on-premise and on-demand/cloud-based (SaaS). The on-demand/cloud-based (SaaS) segment held a significant share of the market of 56.7% in 2022. High adoption of on-demand/cloud-based (SaaS) software can be attributed to several advantages such as enhanced accessibility, seamless scalability, and reduced infrastructure costs. The on-demand model also facilitates real-time collaboration among stakeholders, enabling faster decision-making and comprehensive data analysis. Also, the SaaS model's flexibility and ease of implementation have allowed companies to access advanced pharmacovigilance tools that were once exclusive to larger enterprises.
 

By end-use, the pharmacovigilance and drug safety software market is divided into pharmaceutical & biotechnology companies, contract research organizations (CROS), business process outsourcing (BPO) firms, and other end-users. The pharmaceutical and biotechnology companies segment accounted for USD 59.5 million in 2022. These companies widely adopt pharmacovigilance and drug safety software solutions to streamline clinical trial programs and to focus on post-market surveillance. By implementing such software, pharmaceutical and biotechnology companies can streamline their pharmacovigilance processes, improve data collection & analysis, and ensure compliance with regulatory requirements.
 

Moreover, the software helps these companies in reporting adverse events to regulatory authorities, facilitating transparent communication and accountability. Such vast benefits of using this software have increased their adoption by pharmaceutical & biotechnology companies.
 

North America pharmacovigilance and drug safety software market is accounting for 37.4% of the total market’s revenue in 2022. The increasing demand for efficient and reliable drug safety solutions, coupled with stringent regulatory requirements, has propelled the business gains in the region. Also, the rising prevalence of chronic diseases, the growing number of clinical trials, and the escalating volume of drug approvals have further fueled the demand for pharmacovigilance and drug safety software. High number of CRO’s offering pharmacovigilance outsourcing services in the region is expected to increase the demand for such software.