Drug Safety Software Market By Mode of Delivery (Cloud-Based, On-Premises) By End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations, Pharmacovigilance Service Providers) and Geography

Drug Safety Software Market size was valued at USD 312.3 million in 2023 and is expected to grow at a 6.6% CAGR from 2024 to 2030. Drug Safety Software, also known as Pharmacovigilance Software, is a specialized tool designed to monitor, detect, assess, and prevent adverse effects of pharmaceutical products. It helps healthcare organizations and pharmaceutical companies manage the safety of drugs throughout their lifecycle, from clinical trials to post-market surveillance. The volume of Individual Case Safety Reports (ICSRs) has been growing at an annual rate of 30-35% globally, putting immense pressure on pharmacovigilance teams and driving the demand for efficient drug safety software solutions. The rising occurrence of adverse drug reactions and medication errors emphasizes the significance of pharmacovigilance and drug safety protocols. Pharmacovigilance software facilitates the effective identification, documentation, and examination of adverse events, aiding pharmaceutical firms and healthcare entities in managing risks and improving patient safety.

However, ensuring regulatory compliance stands as the most crucial hurdle in drug safety software implementation. Regulatory bodies such as the FDA and EMA impose strict guidelines on pharmacovigilance activities. Any non-compliance can lead to severe consequences such as fines, product recalls, and reputational damage. North America region held the major market share in 2023 and is expected to dominate the global Drug Safety Software Market in the forecasted years.

Drug Safety Software Market Key Developments:      

In August 2023, Parexel and Partex announced Innovative Alliance Leveraging Artificial Intelligence and Big Data to Accelerate Drug Discovery and Development.

• The collaboration combines clinical research expertise with artificial intelligence capabilities to help drug developers better understand the probability of clinical success for their assets.

In December 2021, Oracle Corporation acquired Cerner Corporation. The underlying reasons for the acquisition were:

• To expand Oracle's presence in the healthcare IT sector, specifically Drug safety& Pharmacovigilance.
• To integrate Cerner's vast healthcare data and clinical information with Oracle's cloud capabilities, potentially enhancing drug safety monitoring and analysis.
• To leverage Cerner's expertise in electronic health records (EHRs) to improve the collection and analysis of real-world data for drug safety.