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Pharmacovigilance Market 2026 | Size, Growth, and Forecast by 2034

Market Overview:

According to IMARC Group's latest research publication, "Pharmacovigilance Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2025-2033", The global pharmacovigilance market size reached USD 8.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 16.3 Billion by 2033, exhibiting a growth rate (CAGR) of 7.5% during 2025-2033.

This detailed analysis primarily encompasses industry size, business trends, market share, key growth factors, and regional forecasts. The report offers a comprehensive overview and integrates research findings, market assessments, and data from different sources. It also includes pivotal market dynamics like drivers and challenges, while also highlighting growth opportunities, financial insights, technological improvements, emerging trends, and innovations. Besides this, the report provides regional market evaluation, along with a competitive landscape analysis.

How AI is Reshaping the Future of Pharmacovigilance Market

• AI enhances adverse event detection by automating case processing, reducing manual workload by 40% and improving accuracy by 30% through natural language processing and machine learning algorithms.
• The European Medicines Agency released AI tools and guidelines in 2024 to improve drug safety monitoring, with FDA's Emerging Drug Safety Technology Program exploring AI applications for signal detection.
• Companies like Sanofi and Deloitte use ConvergeHEALTH Safety platform with AI to streamline case intake, while ArisGlobal's FAERS II integration enhances electronic safety submissions for faster regulatory reporting.
• AI-powered predictive analytics enable proactive risk management by anticipating adverse drug reactions, with machine learning industry reaching USD 31 billion in 2024, pharmacovigilance being one of fastest-growing applications.
• Signal detection efficiency improves as AI processes massive datasets from clinical trials and patient registries, automating medical coding and reducing processing time by 60%, enhancing patient safety across global markets.

Download a sample PDF of this report: https://www.imarcgroup.com/pharmacovigilance-market/requestsample

Key Trends in the Pharmacovigilance Market

• Surge in Contract Outsourcing Services: Pharmaceutical companies increasingly outsource pharmacovigilance activities to specialized firms for cost efficiency and regulatory compliance. Contract outsourcing holds 61.2% market share, with companies like IQVIA partnering with pharmaceutical firms to streamline operations and reduce overhead costs while maintaining comprehensive drug safety monitoring.
• Technology-Driven Safety Monitoring: Advanced technologies like machine learning and natural language processing transform traditional pharmacovigilance into data-rich ecosystems. In 2024, Cognizant introduced machine learning-driven solutions to automate pharmacovigilance case processing, improving accuracy and speed of adverse drug reaction detection.
• Real-World Evidence Integration: The increasing use of real-world evidence in pharmacovigilance enhances post-market surveillance capabilities. FDA's Sentinel Initiative and EMA's DARWIN platform with data for 130 million patients demonstrate regulatory support for RWE, enabling faster safety signal detection and validation.
• Post-Marketing Surveillance Dominance: Phase IV post-marketing surveillance leads with 76.5% market share due to regulatory requirements for continuous safety assessments. Rising numbers of adverse drug reactions observed after approval drive the need for long-term safety monitoring and risk management procedures.
• Automation and Digital Transformation: Around 25% of organizations currently operate with 20% automation in case processing, expected to rise to 60% and above in the next year. Cloud-based platforms like Accenture's data lake solution optimize pharmacovigilance case processing and ensure regulatory compliance.

Growth Factors in the Pharmacovigilance Market

• Rising Adverse Drug Reactions: The prevalence of adverse drug reactions due to polypharmacy and substance abuse drives market expansion. With an estimated 129 million people in the US suffering from chronic diseases, the demand for continuous drug safety monitoring intensifies, boosting pharmacovigilance services.
• Stringent Regulatory Requirements: Regulatory agencies like FDA, EMA, CDSCO, and TGA are increasing vigilance, issuing strict mandates around safety reporting. Incidents like Aurobindo Pharma's recall of Quinapril tablets due to nitrosamine contaminants highlight how stricter testing standards drive internal system reinforcement.
• Growing Clinical Trial Complexity: Over 22,000 new clinical trials launched in 2023, with many featuring adaptive protocols and decentralized elements. The increasing complexity of drug development, especially in biologics and personalized medicine, necessitates robust pharmacovigilance systems for comprehensive safety monitoring.
• Outsourcing for Operational Efficiency: Pharmaceutical firms are outsourcing pharmacovigilance to expert service providers for scalable infrastructure and access to regional regulatory intelligence. In 2024, ProPharma Group acquired Clinres Farmacija to enhance pharmacovigilance service capabilities, demonstrating market consolidation trends.
• Expansion in Emerging Markets: Asia Pacific region expands at CAGR of 10.9% between 2025 to 2034, driven by growing clinical trials in emerging economies like China and India. Around 97% of country-level regions in China reported adverse drug reactions, reflecting robust monitoring systems.

Leading Companies Operating in the Global Pharmacovigilance Industry:

• Accenture plc
• ArisGlobal LLC
• BioClinica Inc. (Cinven Partners LLP)
• Capgemini
• Cognizant
• International Business Machines Corporation
• ICON plc.
• IQVIA Inc.
• ITClinical
• Parexel International Corporation
• Wipro Limited

Pharmacovigilance Market Report Segmentation:

Breakup By Service Provider:

• In-house
• Contract Outsourcing

Contract outsourcing accounts for the majority of shares (61.2%) on account of cost efficiency, access to specialized expertise, and enabling pharmaceutical companies to focus on core competencies while maintaining regulatory compliance.

Breakup By Product Life Cycle:

• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV

Phase IV dominates the market with 76.5% share due to regulatory requirements for continuous post-marketing surveillance and long-term drug safety evaluation, ensuring ongoing monitoring of adverse effects in real-world settings.

Breakup By Type:

• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining

Spontaneous reporting holds 31.9% market share due to its widespread usage in detecting new, serious, and rare adverse drug reactions efficiently and affordably, with compliance standards requiring healthcare professionals to report ADRs to central repositories.

Breakup By Process Flow:

• 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

Signal detection accounts for 38.2% market share as it plays a central role in detecting and managing safety concerns through real-time data collection from clinical trials, electronic health records, and patient records.

Breakup By Therapeutic Area:

• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others

Oncology leads with 27.8% market share due to the highest number of clinical trials, approved drugs, and increasing cancer prevalence worldwide, with an estimated 29.6 million cases projected by 2040.

Breakup By End Use:

• Pharmaceuticals Companies
• Biotechnology Companies
• Medical Device Companies
• Others

Pharmaceutical companies dominate with 44.2% share due to their significant responsibilities in drug development and safety, spending extensively on pharmacovigilance to meet regulatory requirements and reduce potential consequences of adverse drug reactions.

Breakup By Region:

• North America (United States, Canada)
• Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)
• Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)
• Latin America (Brazil, Mexico, Others)
• Middle East and Africa

North America enjoys the leading position with 33.7% market share owing to advanced healthcare infrastructure, stringent FDA regulations, significant investments in drug safety programs, and early adoption of AI-driven solutions for adverse event reporting.

Recent News and Developments in Pharmacovigilance Market

• April 2025: ELIQUENT Life Sciences acquired Truliant Consulting, a leading pharmacovigilance, risk management, and regulatory compliance firm, enhancing its end-to-end product lifecycle support with technology-driven, scalable solutions for global compliance.
• March 2025: Tech Mahindra and NVIDIA collaborated to develop an agentic AI-powered pharmacovigilance solution using Tech Mahindra's TENO framework and NVIDIA AI Enterprise software, improving turnaround times by 40%, data accuracy by 30%, and cutting operational costs by 25%.
• March 2025: ArisGlobal launched three new AI-driven products at Breakthrough 2025: LifeSphere Unify, NavaX Insights, and Advanced Compliance Docs, advancing regulatory operations and pharmacovigilance with responsible AI adoption.
• January 2025: Clinigen formed a strategic partnership with Tepsivo, acquiring a minority stake in the global digital pharmacovigilance services provider, combining expertise in PV, regulatory affairs, and medical information with innovative technology to modernize services.
• August 2024: The Pharmacovigilance Programme of India launched ADRMS software as part of the 'Digital India' initiative, India's first safety database for proper reporting of adverse events by patients, doctors, nurses, and pharmaceutical industries.

Note: If you require specific details, data, or insights that are not currently included in the scope of this report, we are happy to accommodate your request. As part of our customization service, we will gather and provide the additional information you need, tailored to your specific requirements. Please let us know your exact needs, and we will ensure the report is updated accordingly to meet your expectations.

About Us:

IMARC Group is a global management consulting firm that helps the world's most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.

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by sujeet rai on 2026-01-20 05:02:23