The global pharmacovigilance market size is evaluated at USD 10.36 billion in 2025 and is forecasted to be worth around USD 22.25 billion by 2034, growing at a CAGR of 8.88% from 2025 to 2034.
The global pharmacovigilance market is experiencing significant growth, driven by the increasing incidence of Adverse Drug Reactions (ADRs) and the rising consumption of pharmaceuticals worldwide.
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Pharmacovigilance Market Key Points
🔸 North America led the market by holding 31.14% of market share in 2024.
🔸 Asia Pacific is growing at a CAGR of 10.9% from 2025 to 2034.
🔸 The pharmaceutical companies segment has held a largest market share of 42.8% in 2024.
🔸 The contract outsourcing segment contributed the biggest market share of 60% in 2024.
🔸 The phase IV segment accounted for a major market share of 76% in 2024.
🔸 The signal detection segment captured the biggest market share of 39.6% in 2024.
🔸 The oncology segment held a maximum market share of 26.8% in 2024.
🔸 The spontaneous reporting generated the highest market share of 30.4% in 2024.
Market Overview and Industry Potential
Pharmacovigilance involves the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems. With the growing complexity of drug therapies and the introduction of novel pharmaceuticals, the importance of robust pharmacovigilance systems has escalated. The integration of advanced technologies and the emphasis on proactive risk management strategies are further propelling the market's expansion.
Pharmacovigilance comprises activities that include the screening of adverse effects and medicine-related problems and their evaluation comprehension and prevention methodologies. Rising drug therapy complexity along with new pharmaceutical developments has led to an increase in the critical importance of strong pharmacovigilance systems. The market growing, as the growing adoption of sophisticated technologies together with risk management practices which focus on prevention.
WHO announced in 2024 that the Programme for International Drug Monitoring (PIDM) expanded its network to 159 full members combined with 22 associate members further as a demonstration of worldwide dedication to improve various methodologies, including pharmacovigilance methodologies. During 2024 The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency convened multiple meetings which reflected continuous European Union activities to assess and monitor medicinal products safety.
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Major Trends in the Pharmacovigilance Market
Increased Adoption of Automation
Companies in the pharmaceutical domain have started adopting automated systems and artificial intelligence technologies that improve drug safety inspections by identifying adverse effects efficiently and effectively. The automation of tasks by advanced systems makes pharmaceutical case evaluation faster while boosting administrative processing and decreasing human labor requirements.
According to The Journal of mHealth 2024 report, over 75% of surveyed pharmaceutical organizations stated that they currently utilize some form of advanced automation in their processes, reflecting a 13% increase from 2022 and a significant jump from just 5% in 2020. However, only 8% of these organizations have implemented advanced automation across "all" or "most" of their processes, highlighting the potential for further integration and optimization within the industry.
Growing Trend Towards Outsourcing
Pharmacovigilance activity outsourcing has grown extensively as companies choose specialized providers to do their pharmacovigilance work and improve core business performance while cutting operational expenses. Pharmaceutical organizations benefit from outsourcing, as they use specialized knowledge along with sophisticated reporting technologies and better regulatory compliance systems.
Emphasis on Proactive Risk Management
The regulatory authorities have launched initiatives for proactive risk management within pharmacovigilance operations. Companies must use Risk Management Plans (RMPs) and maintain drug safety profiling through each product stage from planning to post-market surveillance. Pharmacovigilance systems now use predictive safety analytics to monitor real-time data actively in order to stop adverse events from happening. The preventive methods for risk management match with worldwide regulatory agency initiatives from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration.
The advancements in artificial intelligence (AI) are changing pharmacovigilance operations by improving drug safety supervision along with rapid adverse event recognition while better-managing data. AI algorithms evaluate very large medical databases from electronic health records alongside social media and patient reports to accelerate adverse drug reaction identification. Regulatory agencies alongside pharmaceutical companies make use of AI systems that enhance safety assessment precision and diminish human mistakes. AI facilitates heightened safety management since it operates predictive monitoring alongside active safety analytics to deliver instant decision support.
Pharmacovigilance Market Report Coverage
|
Report Attribute |
Key Statistics |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
CAGR 2025-2034 |
8.88% |
|
Market Size in 2025 |
USD 10.36 Billion |
|
Market Size by 2034 |
USD 22.25 Billion |
|
Leading Region |
North America |
|
Segments Covered |
Clinical Trial Phase, Service Provider, End User, and Regions |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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Key Regions Analysis:
U.S. Pharmacovigilance Market Size to Hit USD 5.17 Bn by 2034
The U.S. pharmacovigilance market size surpassed USD 2.09 billion in 2024 and is expected to hit around USD 5.17 billion by 2034, growing at a CAGR of 8.90% from 2025 to 2034.
Adoption of Big Analytics: North America to Sustain as a Leader
North America remains the dominant region in the pharmacovigilance market, largely due to stringent regulatory requirements enforced by the U.S. FDA and Health Canada. Market growth emerges from the presence of main pharmaceutical firms and biotechnology corporations and from high clinical trial activities in this region. North American pharmaceutical companies embrace AI-based pharmacovigilance solutions to detect adverse events automatically while simultaneously generating reports for enhanced patient safety analyses.
The market expands, as governments make efforts to enhance drug safety monitoring functions and devote substantial funds to research and development activities. The implementation of big data analytics in pharmacovigilance systems enhances the operational efficiency of safety assessments together with compliance monitoring throughout the region.
🔹The U.S. Food and Drug Administration (FDA) handled 2 million adverse events which were reported to the FDA Adverse Event Reporting System (FAERS) in 2023 to sustain drug safety standards. The Canada Vigilance Program under Health Canada continues to play a vital role by monitoring adverse health reactions to products sold through the Canadian market.
Rising Government Initiatives: Asian Countries to Witness a Boom
The Asia-Pacific region is emerging as a key player in the pharmacovigilance market, driven by the increasing number of clinical trials, expanding pharmaceutical manufacturing, and growing regulatory compliance efforts. The investment of China and India into pharmacovigilance infrastructure matches worldwide safety standards for regulatory compliance purposes.
Market expansion in this area accelerates, as regulatory agencies are enhancing their connections and assessing drug safety reporting structures while manufacturers implement cloud-based pharmacovigilance solutions. The efforts of governments to enhance pharmacovigilance systems in developing economies establish fresh business potential for both technology providers and service companies.
Pharmacovigilance Market Segmentation Analysis:
Clinical Trial Phase Analysis
The phase IV segment has dominated the market with the highest share in 2024. Post-marketing surveillance needs have grown stronger leading to the expansion of this market segment primarily, as the regulatory approval monitoring requirements. Since pharmaceutical regulators enforce strict requirements about risk management and adverse event reporting businesses need phase IV pharmacovigilance solutions.
The phase III segment is expected to grow at a rapid pace during the forecast period, due to the increase in number and drug development requires complex safety assessments during late stages. A strong need exists for phase III pharmacovigilance solutions because pharmaceutical organizations focus on discovering uncommon side effects while conducting thorough safety evaluations before market authorization approval.
Service Provider Analysis
The contract outsourcing segment has accounted for the largest share in 2024. The cost benefits together with improved operational efficiency achieved through outsourcing pharmacovigilance activities explain this trend. This segment continues to dominate the market because of the increasing number of pharmaceutical companies choosing outsourcing services in India and China and other emerging markets.
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The in-house segment is expected to rise moderately over the forecast period. The cost benefits together with improved operational efficiency achieved through outsourcing pharmacovigilance activities explain this trend. This segment continues to dominate the market with increasing pharmaceutical companies choosing outsourcing services in India and China and other emerging markets.
End User Analysis
The pharmaceutical companies held the highest share in 2024. Drug discovery combined with clinical trials along with post-marketing surveillance requires businesses to develop rigorous pharmacovigilance systems for their deep involvement. Pharmaceutical manufacturers advance their safety solutions, as expanded regulatory oversight and active risk management requirements.
The hospitals segment is expected to grow at a rapid pace during the forecast period. Hospital pharmacovigilance adopts fast growth, as healthcare facilities place greater value on both adverse drug reaction reporting and medical safety surveillance systems. Key hospitals and healthcare institutions have incorporated pharmacovigilance programs into their operations for mandatory ADR reporting requirements thus driving this segment upward.
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Pharmacovigilance Market Key Players
• Accenture Plc
• Bioclinica
• Covance Inc.
• IBM Corporation
• ICON Plc
• IQVIA
• Novartis
• Parexel International Corporation
• Pharmaceutical Product Development LLC
• Quanticate
What is Going Around the Globe?
🔹 In July 2024, Oracle introduced new capabilities in its AI-powered Oracle Argus and Safety One Intake solutions to help life science organizations navigate evolving regulatory requirements and manage the growing volume of adverse event cases. Seema Verma, Executive Vice President and General Manager of Oracle Health and Life Sciences, stated, “Pharmacovigilance teams are seeking innovative solutions to keep up with the unprecedented spike in drug safety cases. With the AI-powered enhancements to our life sciences safety solutions, these teams can automate routine processes, accelerate case submissions, fulfill global regulatory reporting requirements, and maintain compliance.”
🔹 In December 2023, Thermo Fisher Scientific Inc. launched CorEvidence, a cloud-based data lake platform designed to optimize pharmacovigilance case processing and safety data management. The platform enhances CorEvitas clinical research registries offered through Thermo Fisher’s PPD clinical research division, streamlining safety data workflows and improving case processing efficiency.
🔹 In August 2024, aligning with Prime Minister Narendra Modi’s ‘Digital India’ initiative, the Pharmacovigilance Programme of India (PvPI) launched an indigenously developed online ADRMS software. Shri J.P. Nadda, the Minister of Health & Family Welfare and Minister of Chemicals and Fertilizers, inaugurated the software during the 1st Policy Makers Forum at Dr. Ambedkar International Centre, New Delhi. The event saw participation from senior officials from the Ministry of Health and Family Welfare, Ministry of External Affairs, Department of Pharmaceuticals, Central Drugs Standard Control Organization, and Indian Pharmacopoeia Commission.
The research report categorizes the preclinical imaging market into the following segments and subsegments:
By Clinical Trial Phase
• Phase I
• Phase II
• Phase III
• Phase IV
By Service Provider
• In-house
• Contract Outsourcing
By End User
• Hospitals
• Pharmaceutical Companies
• Others
By Therapeutic Area
• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others
By Type
• Spontaneous Reporting
•Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining
By Process Flow
• Case Data Management
o Case Logging
o Case Data Analysis
o Medical Reviewing & Reporting
• Signal Detection
o Adverse Event Logging
o Adverse Event Analysis
o Adverse Event Review & Reporting
• Risk Management System
o Risk Evaluation System
o Risk Mitigation System
By Geography
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)
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