North America Pharmacovigilance and Drug Safety Software Market Forecast to 2031 - Regional Analysis - by Offering (Software and Services), Deployment (Cloud and On Premises), Enterprise Size (Large Enterprises and SMEs), Form (Standard and Customized), Functionality (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), and End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations, Business Process Outsourcing (BPO) Firms, and Others)

The North America pharmacovigilance and drug safety software market was valued at US$ 100.03 million in 2023 and is expected to reach US$ 182.72 million by 2031; it is estimated to register a CAGR of 7.8% from 2023 to 2031.

Rise in Incidences of Adverse Drug Reactions Fuel North America Pharmacovigilance and Drug Safety Software Market

The cases of adverse drug reactions (ADRs) are increasing worldwide owing to the increasing prevalence of chronic diseases. 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 across the globe. Pharmacovigilance software enables healthcare providers and pharmaceutical companies to collect, analyze systematically, and report data related to ADRs and overcome the challenges associated with it. The increasing prevalence of ADRs across the globe is propelling the demand for pharmacovigilance and drug safety software market growth. According to the database of ADRs available in the US Food and Drug Administration's Adverse Event Reporting System (FAERS), in 2022, more than 1.25 million severe adverse cases were reported, along with over 175,000 deaths.

Theophylline and respiratory depression exposure grows with the use of macrolide antibiotics and increased consumption of vitamin K, leading to ADRs. 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. Pharmacovigilance and drug safety software helps avoid the risks associated with excessive drug consumption. 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 pharmacovigilance and drug safety software market growth.

North America Pharmacovigilance and Drug Safety Software Market Overview

The North America pharmacovigilance and drug safety software market is segmented into the US, Canada, and Mexico. North American economies are the early adopters of regulations for pharmaceutical and drug safety. In addition, the region is experiencing a rise in digitization in the pharmaceutical sector. According to the Canada Health Infoway, pharmaceutical companies in the country are adopting digital health services; it is also estimated that the demand for pharmacovigilance and drug safety software will increase in the coming years. Thus, growing digitization in the pharmaceutical sector is projected to raise the need for pharmacovigilance and drug safety software among pharmaceutical providers to conduct the monitoring of pharmaceutical drugs efficiently in the region. With the increase in the volume of reported adverse events, the burden on pharmacovigilance and drug safety professionals to evaluate accurately and efficiently as the data also increases. Therefore, the implementation of new technologies is essential to reduce these professionals' workload while ensuring accurate and systematic analysis of the adverse event data.

North America Pharmacovigilance and Drug Safety Software Market Strategic Insights

North America Pharmacovigilance and Drug Safety Software Market Segmentation Analysis

The North America pharmacovigilance and drug safety software market is categorized into offering, deployment, enterprise size, form, functionality, end user, and country.

Based on offering, the North America pharmacovigilance and drug safety software market is bifurcated into software and services. The software segment held a larger North America pharmacovigilance and drug safety software market share in 2023.

In terms of deployment, the North America pharmacovigilance and drug safety software market is bifurcated into cloud and on premises. The cloud segment held a larger North America pharmacovigilance and drug safety software market share in 2023.

By enterprise size, the North America pharmacovigilance and drug safety software market is divided into large enterprises and SMEs. The large enterprises segment held a larger North America pharmacovigilance and drug safety software market share in 2023.

Based on form, the North America pharmacovigilance and drug safety software market is bifurcated into standard and customized. The standard segment held a larger North America pharmacovigilance and drug safety software market share in 2023.

By functionality, the North America 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 North America pharmacovigilance and drug safety software market share in 2023.

In terms of end user, the North America 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 North America pharmacovigilance and drug safety software market share in 2023.

Based on country, the North America pharmacovigilance and drug safety software market is categorized into the US, Canada, and Mexico. The US dominated the North America pharmacovigilance and drug safety software market share in 2023.

North America Pharmacovigilance and Drug Safety Software Market Report Highlights

North America Pharmacovigilance and Drug Safety Software Market 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 North America pharmacovigilance and drug safety software market.

North America Pharmacovigilance and Drug Safety Software Market Country and Regional Insights