Middle East & Africa Pharmacovigilance and Drug Safety Software Market
Middle East & Africa Pharmacovigilance and Drug Safety Software Market is growing at a CAGR of 3.1% to reach US$ 8.32 Million by 2031 from US$ 6.50 Million in 2023 by Offering, Deployment, Enterprise Size, Form, Functionality, End User.

Published On: Jul 2025

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Middle East & Africa Pharmacovigilance and Drug Safety Software Market

At 3.1% CAGR, Middle East & Africa Pharmacovigilance and Drug Safety Software Market is Projected to be Worth US$ 8.32 Million by 2031, says Business Market Insights

According to Business Market Insights’ research, the Middle East & Africa pharmacovigilance and drug safety software market was valued at US$ 6.50 million in 2023 and is expected to reach US$ 8.32 million by 2031, registering a CAGR of 3.1% from 2023 to 2031. Rise in incidences of adverse drug reactions and integration of software with AI, ML, and NLP are among the critical factors attributed to drive the Middle East & Africa pharmacovigilance and drug safety software market growth.

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.

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.

On the contrary, the high installation and maintenance costs hamper the growth of Middle East & Africa pharmacovigilance and drug safety software market.

Based on offering, the Middle East & Africa pharmacovigilance and drug safety software market is bifurcated into software and services. The software segment held 84.7% market share in 2023, amassing US$ 5,502.76 thousand. It is projected to garner US$ 7,165.39 thousand by 2031 to register 3.4% CAGR during 2023–2031.

In terms of deployment, the Middle East & Africa pharmacovigilance and drug safety software market is segmented into cloud and on premises. The cloud segment held 53.5% share of Middle East & Africa pharmacovigilance and drug safety software market in 2023, amassing US$ 3,476.95 thousand. It is anticipated to garner US$ 4,982.68 thousand by 2031 to expand at 4.6% CAGR during 2023–2031.

By enterprise size, the Middle East & Africa pharmacovigilance and drug safety software market is divided into large enterprises and SMEs. The large enterprises segment held 87.5% share of Middle East & Africa pharmacovigilance and drug safety software market in 2023, amassing US$ 5,682.63 thousand. It is projected to garner US$ 7,349.83 thousand by 2031 to expand at 3.3% CAGR from 2023 to 2031.

Based on form, the Middle East & Africa pharmacovigilance and drug safety software market is categorized into standard and customized. The standard segment held 91.7% share of Middle East & Africa pharmacovigilance and drug safety software market in 2023, amassing US$ 5,958.77 thousand. It is predicted to garner US$ 7,600.76 thousand by 2031 to expand at 3.1% CAGR between 2023 and 2031.

By functionality, the Middle East & Africa 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 28.6% share of Middle East & Africa pharmacovigilance and drug safety software market in 2023, amassing US$ 1,855.09 thousand. It is estimated to garner US$ 2,588.29 thousand by 2031 to expand at 4.3% CAGR during 2023–2031.

In terms of end user, the Middle East & Africa 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 71.5% share of Middle East & Africa pharmacovigilance and drug safety software market in 2023, amassing US$ 4,643.62 thousand. It is projected to garner US$ 6,116.10 thousand by 2031 to expand at 3.5% CAGR from 2023 to 2031.

Based on country, the Middle East & Africa pharmacovigilance and drug safety software market is categorized into Saudi Arabia, the UAE, South Africa, and the Rest of Middle East & Africa. Our regional analysis states that Saudi Arabia captured 37.0% share of Middle East & Africa pharmacovigilance and drug safety software market in 2023. It was assessed at US$ 2,401.04 thousand in 2023 and is likely to hit US$ 3,158.68 thousand by 2031, registering a CAGR of 3.5% 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.

  • In 2023, IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, announced a strategic collaboration with Argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions.
  • In 2021, Cognizant announced it has been named one of the leading companies in the pharmacovigilance market, offering an end-to-end spectrum of patient safety services in a new report by analyst firm Everest Group. Pharmacovigilance is the practice area aimed at ensuring drug safety through in-depth data collection and evaluation.

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