Global Pharmacovigilance Market By Clinical Trial Phase (Pre-Clinical, Phase 1, Phase 2, Phase 3, and Phase 4), By Method (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, EHR Mining), By Service Provider (In-House, Contract Outsourcing), By Process Flow (Case Data Management, Signal Detection, Risk Management System), By Therapeutic Area (Oncology, Neurology, Cardiology, Others), By End-User (Pharmaceutical & Biotechnology Companies, Medical Device Manufacturers, Others), By Region, Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 8.21 Billion
CAGR (2026-2031)	11.02%
Fastest Growing Segment	Contract Outsourcing
Largest Market	North America
Market Size (2031)	USD 15.37 Billion

Market Overview

The Global Pharmacovigilance Market will grow from USD 8.21 Billion in 2025 to USD 15.37 Billion by 2031 at a 11.02% CAGR. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. The growth of this market is primarily supported by the rising global consumption of pharmaceuticals and the increasing prevalence of chronic diseases, which necessitate prolonged medication use and monitoring. Furthermore, stringent regulatory frameworks enforced by health authorities worldwide compel pharmaceutical companies to maintain rigorous safety surveillance systems to ensure patient safety and compliance, acting as a foundational driver for the industry.

A significant challenge that could impede market expansion is the complexity and high cost associated with managing and processing the exponential volume of safety data generated globally. This surge in data volume places a substantial strain on resources and demands robust infrastructure. According to the European Medicines Agency, in 2024, over 1.7 million adverse drug reaction reports were submitted to EudraVigilance, illustrating the immense scale of information that organizations must accurately capture and analyze to maintain regulatory compliance.

Key Market Drivers

The rising prevalence of chronic diseases and the subsequent increase in drug consumption act as a primary catalyst for the Global Pharmacovigilance Market. As the global burden of conditions such as oncology, diabetes, and cardiovascular disorders grows, the volume of medications administered escalates, necessitating rigorous monitoring for adverse events. According to the World Health Organization, February 2024, in the 'Global Status Report on Cancer 2024', there were an estimated 20 million new cancer cases in 2022, highlighting the expanding patient pool that requires long-term pharmacological intervention. This surge in disease incidence compels pharmaceutical entities to scale their pharmacovigilance operations to accurately track the safety profiles of complex therapeutic regimens used in chronic care management, ensuring that benefits continue to outweigh risks for a growing demographic.

The expansion of drug R&D and clinical trial activities further accelerates market development by generating vast quantities of safety data that must be processed prior to authorization. Pharmaceutical companies are investing heavily in innovation to address unmet medical needs, which increases the demand for surveillance during both clinical phases and post-marketing surveillance. According to the European Federation of Pharmaceutical Industries and Associations, June 2024, in the 'The Pharmaceutical Industry in Figures 2024', research and development expenditure in Europe was estimated to reach €50,000 million in 2023. To manage the regulatory oversight accompanying this significant investment, agencies are also bolstering their capabilities; according to the US Food and Drug Administration, in 2024, the agency requested a budget of $7.2 billion for the fiscal year 2025 to strengthen safety programs and public health infrastructure.

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Key Market Challenges

The rapid escalation in the volume of safety data presents a formidable barrier to the expansion of the Global Pharmacovigilance Market. As the quantity of adverse event reports increases exponentially, pharmaceutical companies are forced to divert substantial capital toward maintaining basic compliance rather than investing in market-expanding innovations. The complexity and high expense associated with validating and processing this influx create a significant financial strain, particularly for small and medium-sized enterprises. These smaller entities often lack the budgetary elasticity to absorb the soaring operational costs required for rigorous safety surveillance, which effectively limits their market participation and hampers the overall industry's growth potential.

This resource-intensive environment is further aggravated by the sheer scale of information that must be managed to avoid regulatory penalties. The relentless acceleration of data intake compels organizations to prioritize immediate processing capabilities over long-term strategic development. According to the Uppsala Monitoring Centre, in 2024, the global VigiBase system received an average of approximately 50,000 new individual case safety reports per week. This magnitude of data influx underscores the immense pressure on industry stakeholders, who must continuously expand their infrastructure solely to keep pace with reporting requirements, thereby stifling broader market opportunities and profitability.

Key Market Trends

The Integration of Artificial Intelligence and Machine Learning is fundamentally reshaping the Global Pharmacovigilance Market by transitioning safety operations from reactive compliance to proactive risk management. As the industry faces an exponential rise in adverse event reports, pharmaceutical companies are increasingly deploying predictive algorithms and natural language processing to automate labor-intensive tasks such as case intake, validity checks, and narrative generation. This technological shift allows safety teams to focus on complex benefit-risk assessments rather than manual data entry, thereby enhancing the speed and accuracy of signal detection while mitigating resource constraints. According to the Pistoia Alliance, September 2025, in the 'Lab of the Future 2025 Report', 60% of respondents indicated that AI and machine learning will be the top technology investment over the next two years, highlighting the sector's aggressive commitment to digital transformation.

Strategic Outsourcing to Contract Research Organizations (CROs) has simultaneously emerged as a dominant structural trend, driven by the need to navigate complex regulatory landscapes and manage fluctuating resource demands without incurring fixed overheads. Small and medium-sized enterprises, in particular, are leveraging the specialized infrastructure of CROs to ensure global compliance and scalability, effectively converting fixed operational costs into variable expenses. This reliance on external partners enables bio-pharmaceutical firms to access advanced vigilance platforms and global safety networks that would be prohibitively expensive to build in-house, ensuring continuous monitoring across diverse territories. According to the Association of Clinical Research Organizations, July 2025, in the 'Economic Impact of CROs/CTOs on the Biopharmaceutical Industry' report, member companies generated an estimated $98 billion in revenue in 2024, reflecting the substantial scale of operations now entrusted to third-party providers.

Segmental Insights

The Contract Outsourcing segment is currently positioned as the fastest-growing category within the Global Pharmacovigilance Market due to the increasing demand for cost containment and operational flexibility among pharmaceutical companies. Manufacturers are actively partnering with specialized third-party providers to navigate the rigorous safety reporting standards enforced by major regulatory bodies such as the US Food and Drug Administration and the European Medicines Agency. This strategic shift allows organizations to access scalable resources and specific regulatory expertise, thereby mitigating the high financial burden of maintaining extensive in-house safety infrastructure while ensuring strict global compliance.

Regional Insights

North America maintains a dominant position in the global pharmacovigilance market, driven by stringent regulatory mandates and a high volume of drug development. The region benefits from the extensive presence of major pharmaceutical companies that prioritize safety monitoring to ensure compliance. Specifically, the United States Food and Drug Administration enforces rigorous standards for post-market surveillance, compelling manufacturers to maintain robust adverse event reporting systems. This regulatory pressure, combined with substantial healthcare expenditure, sustains the consistent demand for pharmacovigilance services across the United States and Canada.

Recent Developments

• In December 2024, PubHive Ltd. launched its "Advanced Pharmacovigilance Services" to further streamline drug safety operations for life sciences organizations. This new service offering integrated artificial intelligence and machine learning algorithms to automate critical tasks such as signal management and the generation of narrative case summaries. The launch aimed to enhance operational efficiency, ensure data accuracy, and facilitate compliance with global regulatory demands. By combining these advanced services with its existing workflow platform, the company sought to provide a holistic solution for managing safety information effectively from pre-market research through to post-market surveillance.
• In July 2024, Oracle announced significant AI-supported enhancements to its Argus and Safety One Intake solutions to address the growing complexity of global pharmacovigilance regulations. The new capabilities included a smart duplicate search algorithm to reduce manual case management efforts and automated data redaction features compliant with European privacy standards. Additionally, the updates introduced improvements for medical device reporting to align with requirements in the United States and Japan. These advancements were designed to help life sciences organizations increase productivity and maintain compliance amidst rising adverse event case volumes and evolving safety reporting obligations.
• In April 2024, Qinecsa Solutions acquired Insife ApS, a Danish technology and consultancy firm specialized in pharmacovigilance software. This strategic acquisition was intended to expand Qinecsa's end-to-end pharmacovigilance platform by integrating Insife's HALOPV safety database and its regulatory intelligence capabilities. The collaboration between the two entities aimed to combine their technological strengths and industry expertise to offer enhanced safety solutions to pharmaceutical companies and regulatory agencies globally. The move reinforced Qinecsa's position as a leading provider of digital safety and regulatory compliance services, ensuring comprehensive support throughout the drug life cycle.
• In March 2024, ArisGlobal unveiled "Advanced Intake," a groundbreaking offering powered by its LifeSphere NavaX cognitive computing engine. This launch distinguished the company as the first in the life sciences R&D technology sector to introduce a solution leveraging Generative AI (GenAI) specifically for adverse event intake. The innovative technology was designed to revolutionize pharmacovigilance operations by automating the extraction and processing of safety data from disparate sources. By integrating these advanced capabilities, the solution aimed to significantly improve intake efficiency and data accuracy, thereby addressing critical pain points organizations face in handling the increasing volumes of safety reports.

Key Market Players

• IQVIA Inc.
• ArisGlobal
• Parexel International Corporation
• Labcorp Drug Development
• Accenture
• Cognizant Technology Solutions
• Ergomed Group
• ICON plc
• Syneos Health
• Wipro Limited

By Clinical Trial Phase	By Method	By Service Provider	By Process Flow	By Therapeutic Area	By End-User	By Region
Pre-Clinical Phase 1 Phase 2 Phase 3 Phase 4	Spontaneous Reporting Intensified ADR Reporting Targeted Spontaneous Reporting Cohort Event Monitoring EHR Mining	In-House Contract Outsourcing	Case Data Management Signal Detection Risk Management System	Oncology Neurology Cardiology Others	Pharmaceutical & Biotechnology Companies Medical Device Manufacturers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Pharmacovigilance Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Pharmacovigilance Market, By Clinical Trial Phase:

• Pre-Clinical
• Phase 1
• Phase 2
• Phase 3
• Phase 4

• Pharmacovigilance Market, By Method:

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

• Pharmacovigilance Market, By Service Provider:

• In-House
• Contract Outsourcing

• Pharmacovigilance Market, By Process Flow:

• Case Data Management
• Signal Detection
• Risk Management System

• Pharmacovigilance Market, By Therapeutic Area:

• Oncology
• Neurology
• Cardiology
• Others

• Pharmacovigilance Market, By End-User:

• Pharmaceutical & Biotechnology Companies
• Medical Device Manufacturers
• Others

• Pharmacovigilance Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE