Pharmacovigilance and Drug Safety Software Market Size (2024 - 2029)

Pharmacovigilance and Drug Safety Software Market Analysis

The Pharmacovigilance and Drug Safety Software Market size is estimated at USD 210.14 million in 2024, and is expected to reach USD 277.66 million by 2029, growing at a CAGR of 5.73% during the forecast period (2024-2029).

The evolving threat of COVID-19 infection adversely affected communities, industries, businesses, and lives worldwide. Thus, medical monitoring and safety reporting were essential as several potential therapies were used to treat the coronavirus infection. The chances of the suspected adverse drug reaction for some of the medicines used for COVID-19 infections submitted to the individual case safety reports database named VigiBase, were managed by Uppsala Monitoring Centre (UMC). Thus, the rising incidence of adverse drug reactions related to COVID-19 infections accelerated the demand for adverse event reporting systems amid the pandemic. Furthermore, in March 2021, in response to COVID-19, Federal Drug Administration launched the FAERS Public Dashboard for COVID-19 emergency use authorization (EUA) products. The COVID-19 EUA FAERS Public Dashboard provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under EUA in COVID-19. Such government initiatives opened up growth horizons to the market studied. Hence, the COVID-19 pandemic affected the studied market favorably in its early phase, and currently though the pandemic subsided, the market is anticipated to have stable growth during the forecast period of the study.

The pharmacovigilance and drug safety software market is expected to register high growth due to the increasing incidence of adverse drug reactions (ADRs), which is the major driving factor for the growth of the pharmacovigilance and drug safety software market.

For instance, as per the article published by frontiers in 2022, adverse drug reactions (ADRs) represent a public health problem worldwide that deserves attention due to the impact it has on mortality, morbidity, and healthcare costs. Thus, more hospital admissions are due to adverse drug reactions is likely to boost the need for adverse event reporting software in the coming years.

Factors like the increasing adoption of pharmacovigilance and drug safety software by the outsourcing companies involved in contract research and contract manufacturing due to the rising number of drugs, an upward trend in polypharmacy, and government policies about drug safety regulations are driving the market growth.

However, a lack of awareness and knowledge about pharmacovigilance and ADRs among healthcare professionals and the adverse effects of drugs are restraining the growth of the pharmacovigilance and drug safety software market.

Pharmacovigilance and Drug Safety Software Industry Segmentation

As per the scope of the report, pharmacovigilance (PV) software comprises a drug safety management software solution that enables the creation, classification, review, submission, and maintenance of pharmacovigilance data and adverse event reports. This PV software is used by pharma and biotech companies, contract research organizations (CROs), business process outsourcing firms (BPOs), and other pharmacovigilance service providers. The Pharmacovigilance and Drug Safety Software Market is Segmented by Functionality (Adverse Event Reporting Software, Drug Safety Audits Software, Issue Tracking Software, and Fully Integrated Software), Mode of Delivery (On-premise Delivery and On-demand/Cloud-based (SaaS) Delivery), End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations, Business Process Outsourcing Firms, and Other Pharmacovigilance Service Providers), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the above segments.