South & Central 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 South & Central America pharmacovigilance and drug safety software market was valued at US$ 11.09 million in 2023 and is expected to reach US$ 14.93 million by 2031; it is estimated to register a CAGR of 3.8% from 2023 to 2031.

Integration of Software with AI, ML, and NLP Fuels South & Central America Pharmacovigilance and Drug Safety Software Market

Artificial intelligence (AI), machine learning (ML), Natural Language Processing (NLP), and other technologies are transforming resource-intensive pharmacovigilance workloads, ensuring a more informed, more efficient approach. Pharmacovigilance and drug safety software platforms are mostly equipped with advanced analytics and AI capabilities that enhance the detection of safety signals. These tools can analyze vast amounts of data, identifying correlations and patterns that traditional methods might overlook. AI-driven predictive analytics can also forecast potential safety issues, allowing companies to take proactive measures. ML models are leveraged to predict potential adverse events associated with drug consumption. For instance, pharmacovigilance campaigns use ML to sift through vast datasets, detecting patterns that might indicate a risk of adverse drug reactions. ML algorithms are particularly adept at handling unstructured data, such as social media and patient records, to forecast safety concerns.

Several major players in the market are offering automated AI-based monitoring tools to promote drug development for pharmaceutical companies. For instance, in May 2021, Clarivate launched the AI-based pharmacovigilance literature monitoring software platform—DialogML. This software uses artificial intelligence and automation for pharmacovigilance literature monitoring. This automation platform helps in end-to-end medical literature monitoring solutions such as reducing aggregate reports and Safety Signal reviewing. In January 2024, PubHive Ltd., a provider of AI-powered literature and safety information workflows, launched a groundbreaking centralized summary of product characteristics (SmPC) management platform with AI-powered pharmacovigilance workflows for life science, pharmaceutical companies, clinical research organizations (CROs), and their pharmacovigilance and drug safety's divisions. This software streamlines processes, simplifies compliance requirements, and empowers pharmacovigilance teams to work faster and more effectively. AI systems are being progressively used to advance real-time drug safety monitoring. This proactive surveillance includes clinical trial data, scanning medical literature, and patient registries for adverse events (AEs); it can also enhance the accuracy and speed of ADR detections. Further, utilizing NLP, AI systems can extract relevant information, such as drug names and symptoms, from vast textual datasets, enabling accurate and rapid adverse event reporting. This accelerates the identification of unknown or new drug safety issues, thereby significantly enhancing the advancements in pharmacovigilance efforts. Various companies offer AI-based pharmacovigilance and drug safety software, including ArisGlobal. Thus, the integration of pharmacovigilance and drug safety software with AI, ML, and NLP is expected to create lucrative opportunities for the market growth during the forecast period.

South & Central America Pharmacovigilance and Drug Safety Software Market Overview

The pharmacovigilance and drug safety software market in South America is segmented into Brazil, Argentina, and the Rest of South America. Although drug and targeted drug development is accelerating in South America owing to innovative technologies, pharmaceutical companies still face registration challenges for well-characterized molecules due to redundant or additional local regulatory requirements. The South American Office of the Food and Drug Administration (FDA) is primarily responsible for protecting public health by providing the safety, security, and effectiveness of human medicine and veterinary drugs; biological products; medical devices; food supply; cosmetics; and products that emit radiation. Due to differences in regulations in healthcare systems in the region, regulatory authorities, and legal frameworks, pharmacovigilance approaches vary significantly across countries in South America. For example, in Brazil, the ANVISA (Brazilian Health Regulatory Agency) is responsible for overseeing pharmacovigilance activities, setting guidelines, and ensuring compliance. Since pharmacovigilance plays a critical role in the drug industry, companies require access to good-quality software in pharmacovigilance and ensure that their systems are continually updated in line with regulations as well as best practices within the industry. With more developments in technology, the pharmacovigilance software is expected to become even more resourceful as well as offer more complex functionalities and capabilities for enhanced effectiveness in further managing drug safety data. Such advancements in pharmacovigilance and drug safety software are expected to fuel the market growth in the coming years.

South & Central America Pharmacovigilance and Drug Safety Software Market Strategic Insights

South & Central America Pharmacovigilance and Drug Safety Software Market Segmentation Analysis

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

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

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

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

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

By functionality, the South & Central 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 South & Central America pharmacovigilance and drug safety software market share in 2023.

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

Based on country, the South & Central America pharmacovigilance and drug safety software market is categorized into Brazil, Argentina, and the Rest of South & Central America. Brazil dominated the South & Central America pharmacovigilance and drug safety software market share in 2023.

South & Central America Pharmacovigilance and Drug Safety Software Market Report Highlights

South & Central 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 South & Central America pharmacovigilance and drug safety software market.

South & Central America Pharmacovigilance and Drug Safety Software Market Country and Regional Insights