
Published On: Jul 2025
Published On: Jul 2025
At 7.8% CAGR, North America Pharmacovigilance and Drug Safety Software Market is Projected to be Worth US$ 182.72 Million by 2031, says Business Market Insights
According to Business Market Insights’ research, 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, registering a CAGR of 7.8% from 2023 to 2031. Cloud-based pharmacovigilance and drug safety software and integration of software with AI, ML, and NLP are among the critical factors attributed to drive the North America pharmacovigilance and drug safety software market growth.
Cloud-based platforms enable real-time monitoring of adverse events that allow pharmaceutical companies to detect and respond to safety signals more quickly. With real-time data access, companies can generate safety reports on demand, significantly reducing the time required for decision-making. This immediacy is crucial in preventing adverse events from escalating into serious public health issues. Also, one of the most significant advantages of cloud-based drug safety solutions is their scalability. As a company grows or as the volume of data increases, the cloud platform can scale accordingly without requiring additional infrastructure investments. This flexibility is essential in pharmacovigilance, where the volume of data can fluctuate significantly depending on the stage of the drug's lifecycle. Cloud-based systems are enabling the creation of global pharmacovigilance networks, where data can be shared across borders in real-time. These networks will enable more comprehensive drug safety monitoring, with insights and safety signals being shared worldwide, leading to faster identification and mitigation of risks.
Cloud-based platforms enable real-time monitoring of adverse events, permitting pharmaceutical companies to detect and respond to safety signals more quickly. With real-time data access, companies can generate safety reports on demand, significantly reducing the time required for decision-making. This immediacy is crucial in preventing adverse events from escalating into serious public health issues. Various companies are offering and launching cloud-based pharmacovigilance and drug safety software, such as Clinevo Technologies, Thermo Fisher Scientific Inc., and Sarjen Systems Pvt. Ltd. For instance, in December 2023, Thermo Fisher Scientific Inc. launched a cloud-based CorEvidence data lake platform to optimize pharmacovigilance case processing and drug safety data management. The new platform aimed to enhance CorEvitas clinical research offered by Thermo Fisher Scientific Inc.'s clinical research business. CorEvidence is the first cloud-based application to support improved pharmacovigilance workflow and deliverables management. It was designed to handle multiple adverse events and ensure safety events post-authorization of drug safety studies.
Therefore, cloud-based pharmacovigilance and drug safety software is expected to bring significant trends in the global pharmacovigilance and drug safety software market in the coming years.
On the contrary, the high installation and maintenance costs hampers the growth of North America pharmacovigilance and drug safety software market.
Based on offering, the North America pharmacovigilance and drug safety software market is bifurcated into software and services. The software segment held 59.4% market share in 2023, amassing US$ 59,423.43 thousand. It is projected to garner US$ 1,14,135.98 thousand by 2031 to register 8.5% CAGR during 2023–2031.
In terms of deployment, the North America pharmacovigilance and drug safety software market is segmented into cloud and on premises. The cloud segment held 73.9% share of North America pharmacovigilance and drug safety software market in 2023, amassing US$ 73,944.75 thousand. It is anticipated to garner US$ 1,44,437.30 thousand by 2031 to expand at 8.7% CAGR during 2023–2031.
By enterprise size, the North America pharmacovigilance and drug safety software market is divided into large enterprises and SMEs. The large enterprises segment held 63.9% share of North America pharmacovigilance and drug safety software market in 2023, amassing US$ 63,896.16 thousand. It is projected to garner US$ 1,20,261.50 thousand by 2031 to expand at 8.2% CAGR from 2023 to 2031.
Based on form, the North America pharmacovigilance and drug safety software market is categorized into standard and customized. The standard segment held 70.4% share of North America pharmacovigilance and drug safety software market in 2023, amassing US$ 70,386.69 thousand. It is predicted to garner US$ 1,25,615.79 thousand by 2031 to expand at 7.5% CAGR between 2023 and 2031.
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 26.0% share of North America pharmacovigilance and drug safety software market in 2023, amassing US$ 26,033.85 thousand. It is estimated to garner US$ 55,380.01 thousand by 2031 to expand at 9.9% CAGR during 2023–2031.
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 44.2% share of North America pharmacovigilance and drug safety software market in 2023, amassing US$ 44,249.71 thousand. It is projected to garner US$ 89,789.07 thousand by 2031 to expand at 9.2% CAGR from 2023 to 2031.
Based on country, the North America pharmacovigilance and drug safety software market is categorized into the US, Canada, and Mexico. Our regional analysis states that the US captured 82.9% share of North America pharmacovigilance and drug safety software market in 2023. It was assessed at US$ 82,887.06 thousand in 2023 and is likely to hit US$ 1,58,581.68 thousand by 2031, registering a CAGR of 8.4% during 2023–2031.
Key players operating in the pharmacovigilance and drug safety software market are 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, among others.
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