The Brazil pharmacovigilance market size reached USD 157.25 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 282.92 Million by 2033, exhibiting a CAGR of 6.24% during 2025-2033. The market growth is fueled by rising regulatory oversight, widespread adoption of artificial intelligence (AI) and Big Data, increased outsourcing of pharmacovigilance services, and growing demand for advanced drug safety monitoring systems to ensure patient safety and operational efficiency.
Brazil pharmacovigilance market
drug safety monitoring Brazil
pharmacovigilance outsourcing Brazil
AI in pharmacovigilance Brazil
clinical trials drug monitoring Brazil
regulatory compliance Brazil pharma
post-marketing drug surveillance Brazil
Market reached USD 157.25 Million in 2024.
Expected to hit USD 282.92 Million by 2033, with a 6.24% CAGR.
Strong adoption of AI and Big Data analytics in drug safety monitoring.
Increased outsourcing of pharmacovigilance services to specialized providers.
Stricter regulatory compliance and post-market surveillance requirements in Brazil.
Artificial intelligence (AI) is transforming pharmacovigilance in Brazil by enabling real-time monitoring, predictive analytics, and efficient case management. With increasing drug launches, clinical trials, and post-marketing surveillance, AI and Big Data analytics allow pharmaceutical companies and healthcare providers to process massive volumes of adverse event reports faster and more accurately.
AI algorithms are being used to detect drug safety signals earlier, reducing risks associated with delayed reporting. Natural language processing (NLP) tools extract insights from unstructured data sources such as electronic health records, social media, and patient forums, helping identify hidden adverse reactions. Moreover, predictive analytics can forecast potential drug interactions and side effects before they escalate into larger health concerns.
Reports such as “Global Pharmacovigilance Market Report 2024-2029” and “Drug Safety and Pharmacovigilance Market Report 2023-2028” highlight how AI-driven automation and outsourcing partnerships are key to strengthening efficiency and compliance. In Brazil, where healthcare systems are increasingly digitalized, the integration of AI enhances safety reporting accuracy while reducing operational costs, making pharmacovigilance more proactive than reactive.
Download a sample copy of the Report: https://www.imarcgroup.com/brazil-pharmacovigilance-market/requestsample
Brazil’s National Health Surveillance Agency (ANVISA) has intensified regulatory requirements, pushing pharmaceutical companies to adopt more robust pharmacovigilance systems. Companies must now ensure timely reporting of adverse drug reactions (ADRs), particularly during the post-marketing surveillance phase, where unexpected side effects often emerge.
Key Drivers:
Stricter ANVISA pharmacovigilance guidelines.
Rising clinical trial activities in Brazil.
Growing demand for regulatory-compliant monitoring solutions.
Expansion of risk management and reporting obligations.
Pharmaceutical companies in Brazil are increasingly outsourcing pharmacovigilance activities to contract research organizations (CROs) and specialized service providers to reduce costs and improve efficiency. This outsourcing trend enables companies to focus on core drug development while ensuring compliance and accurate safety monitoring.
Key Drivers:
Growing role of CROs in pharmacovigilance outsourcing.
Increasing demand for specialized expertise in signal detection and case reporting.
Cost-effectiveness of outsourcing compared to in-house pharmacovigilance teams.
Partnerships between Brazilian pharma companies and global PV service providers.
The adoption of AI, cloud computing, and blockchain is reshaping Brazil’s pharmacovigilance landscape. Automated platforms are being used to streamline adverse event reporting, improve accuracy, and enhance traceability across the pharmaceutical supply chain. Digital health tools, including wearable devices and mobile health apps, are also contributing to real-world data collection for drug safety analysis.
Key Drivers:
AI and NLP tools for adverse event detection.
Cloud-based pharmacovigilance platforms ensuring scalability.
Increased use of real-world evidence (RWE) in safety monitoring.
Blockchain adoption for secure and transparent reporting systems.
Ask an analyst for your customized sample: https://www.imarcgroup.com/request?type=report&id=29051&flag=C
Service Provider Insights:
In-House
Contract Outsourcing
Product Life Cycle Insights:
Pre-clinical
Phase I
Phase II
Phase III
Phase IV
Type Insights:
Spontaneous Reporting
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
EHR Mining
Process Flow Insights:
Case Data Management
Case Logging
Case Data Analysis
Medical Reviewing and Reporting
Signal Detection
Adverse Event Logging
Adverse Event Analysis
Adverse Event Review and Reporting
Risk Management System
Risk Evaluation System
Risk Mitigation System
Therapeutic Area Insights:
Oncology
Neurology
Cardiology
Respiratory System
Others
End Use Insights:
Pharmaceutical Companies
Bio Technology Companies
Medical Device Companies
Others
Regional Insights:
Southeast
South
Northeast
North
Central-West
In May 2024, several Brazilian pharmaceutical companies adopted cloud-based pharmacovigilance platforms to enhance real-time safety monitoring.
In July 2024, ANVISA updated its drug safety reporting guidelines, tightening post-market surveillance requirements.
In August 2024, a partnership between Brazilian CROs and global pharmacovigilance firms was announced to expand outsourcing opportunities.
IMARC Group is a global consulting firm. We help ambitious changemakers make a lasting impact. The company provides a comprehensive suite of market entry and expansion services. IMARC offers a wide range of services. We provide market assessments and feasibility studies. We also help with company incorporation and factory setup. Our team navigates regulatory approvals and licensing. Additionally, we assist with branding, marketing, and sales strategies. We analyze the competitive landscape and benchmark performance. Our services include pricing and cost research, along with procurement research.
IMARC Group
134 N 4th St., Brooklyn, NY 11249, USA
Email: sales@imarcgroup.com
Tel No: (D) +91 120 433 0800
United States: +1-631-791-1145