Pharmacovigilance Market Revenue to Attain USD 20.64 Bn by 2033

02 Apr 2025

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Table of Content

1. Pharmacovigilance Market Revenue and Trends 2025 to 2033 2. Market Overview 3. Report Highlights 4. Market Trends 5. Regional Insights 6. Pharmacovigilance Market Coverage 7. Market News 8. Pharmacovigilance Market Key Players 9. Market Segmentation

Pharmacovigilance Market Revenue and Trends 2025 to 2033

The global pharmacovigilance market revenue reached USD 10.36 billion in 2025 and is predicted to attain around USD 20.64 billion by 2033 with a CAGR of 8.88%. Expanding rapidly due to the increasing focus on drug safety, stringent regulatory requirements, and the rising incidence of adverse drug reactions (ADRs).

Market Overview

The pharmacovigilance market encompasses a wide range of activities, including case reporting, risk management, and regulatory compliance, aimed at enhancing drug safety. Pharmaceutical companies, contract research organizations (CROs), and regulatory agencies are increasingly investing in advanced data analytics and real-world evidence (RWE) to improve pharmacovigilance outcomes. Advancements in chronic diseases with the parallel growth of global drug development led to an increased urgency for predictive adverse event monitoring.

The WHO Programme for International Drug Monitoring and the FDA’s Sentinel Initiative work together to speed up drug-related risk detection and prevention efforts. The FDA started the Sentinel Initiative in 2008, and it developed into a complete system to track the safety aspects of FDA-regulated products.   Enhanced pharmacovigilance practices receive a commitment from public health stakeholders worldwide through their implemented global efforts.

• The Sentinel Initiative organized its 16th Annual Public Workshop in 2024 to discuss recent medical product surveillance and stakeholder interaction developments.

Report Highlights

• By clinical trial phase, the phase IV segment held the highest pharmacovigilance market share in 2024. This can be attributed to the changing guidelines and advancements in medical technologies. On the other hand, the phase III segment is projected to show exponential growth as the results of this phase are crucial for receiving regulatory approval for marketing.
• By service provider, the contract outsourcing segment accounted for the highest revenue share, driven by the increasing reliance of pharmaceutical companies on external pharmacovigilance service providers. Growing regulatory complexities and rising adverse event reporting requirements are encouraging companies to collaborate with specialized contract research organizations (CROs). The in-house segment is expected to witness moderate growth as large pharmaceutical and biotechnological companies continue investing in proprietary safety monitoring systems. Increasing adoption of AI-driven pharmacovigilance solutions and real-world evidence (RWE) is transforming drug safety surveillance across both outsourced and in-house models.
• By end user, the pharmaceutical companies segment held the largest market share due to the growing emphasis on post-market drug safety and risk management. Rising drug approvals and stringent regulatory mandates are driving companies to enhance their pharmacovigilance capabilities through automation and predictive analytics. The hospital segment is expected to witness rapid growth in pharmacovigilance adoption as healthcare institutions integrate safety monitoring systems into their workflows. Increasing collaboration between hospitals and regulatory agencies is improving adverse drug reaction (ADR) reporting and patient safety measures.

Market Trends

Growing Regulatory Focus on Drug Safety

Global regulatory agencies, including the FDA, EMA, and WHO, are enforcing stricter pharmacovigilance guidelines to mitigate drug safety risks. The FDA’s Adverse Event Reporting System (FAERS) and WHO’s VigiBase database have implemented expanded abilities to detect adverse events. Drug safety detections occur earlier through these advancements while regulatory responses become faster, thus minimizing patient exposure to risks and ensuring effective drug performance.

• As part of recent updates, the European Medicines Agency (EMA) improved its EudraVigilance system by processing 3.3 million adverse reaction reports in 2023 to support immediate drug safety monitoring.
• Worldwide pharmacovigilance networks have benefited from the VigiBase database at the World Health Organization, as the largest collection of individual case safety reports exceeded 30 million by 2024.

Increasing Adoption of AI in Drug Safety Monitoring

AI-powered pharmacovigilance tools are improving real-time case assessment, reducing manual workload, and enhancing accuracy in adverse event reporting. The pharmacovigilance operations become automated through AI technologies. The systems reduce expenses while improving adherence to regulatory standards. The U.S. Food and Drug Administration (FDA) identified an acute rise of artificial intelligence and machine learning (ML) applications within Investigational New Drug (IND) processes across different fields that include pharmacovigilance.

• The FDA published "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products" in 2024 as a document for stakeholder discussion regarding the proper implementation of AI/ML throughout drug creation and safety surveillance. 

Expansion of Pharmacovigilance Outsourcing Services

Companies in the pharmacovigilance market are increasingly outsourcing drug safety activities to CROs and specialized pharmacovigilance service providers. Operating from this strategic move enables companies to decrease their operational expenses without breaching global pharmacovigilance regulatory standards. The World Health Organization (WHO) maintains that proper pharmacovigilance systems must exist because they secure patient safety effectively. The use of external expertise enables pharmaceutical companies to handle core competencies better while speeding up new therapy development and sustaining strict safety tests against complex regulations.

• At its 20th meeting in May 2024, the WHO's Advisory Committee on Safety of Medicinal Products (ACSoMP) analyzed modern pharmacovigilance methods while examining how outsourcing enhances drug security observation programs. Such collaborative partnerships work to improve the efficiency of drug safety operations while promoting increased outsourcing activities.

Rising Importance of Real-World Data (RWD) and Real-World Evidence (RWE)

Regulatory agencies and pharmaceutical companies are leveraging RWD and RWE to enhance drug safety assessments, identify long-term risks, and improve patient outcomes. The worldwide move toward medical product assurance includes RWD along with RWE in regulatory decisions. The World Health Organization (WHO) recognizes RWE's capability to strengthen pharmacovigilance practices, thus supporting its implementation into the drug safety framework.  Public health benefit arises from stakeholders who adopt RWE and RWD approaches to drug safety management.

• The FDA, through its guidance of August 2023, explained "Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products," which illustrates RWE's essential role in regulatory approval processes.

Regional Insights

North America is projected to dominate the pharmacovigilance market, driven by stringent FDA guidelines, rising drug approvals, and increasing adoption of automated pharmacovigilance solutions. Strong pharmacovigilance practices have become essential to monitor drug safety during the post-market phase, as recent increases in drug approvals. The FDA's guidance under Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment requires both safety signal identification and complete pharmacovigilance plan development.

Automation in pharmacovigilance systems now enables immediate adverse event monitoring together with regulatory obligations compliance. These important factors have established North America as the top market leader in pharmacovigilance, which secures both the effectiveness and safety of treatment medications.

• The Center for Drug Evaluation and Research at the FDA approved 55 novel therapeutics during 2023, making it the second-most approved product within the previous 30 years.
• The FDA accomplished drug approval expansions by permitting Avadel Pharmaceuticals to receive authorization in 2024 for Lumryz treatment of children older than seven with narcolepsy symptoms.

Asia Pacific is anticipated to experience the fastest growth in the pharmacovigilance market, attributed to increasing clinical trial activities, government-led pharmacovigilance programs, and the rising presence of CROs in countries like India and China. Chinese clinical research falls under the National Medical Products Administration (NMPA), which uses streamlined regulations to develop pharmaceutical innovation.

Healthcare experts recommend that India reform its clinical trial regulations to enhance market participation in the worldwide sector. The region shows its dedication to drug safety and efficacy enhancement through strong pharmacovigilance practice development. Regulatory agencies in emerging economies are strengthening pharmacovigilance frameworks, encouraging pharmaceutical companies to enhance their drug monitoring systems.

• Southeast Asia recorded a quick rise in reported clinical trials per year based on World Health Organization statistics, where India performed 90% of reported trials during 2023. The pharmaceutical industry is experiencing an expansion as it utilizes treatment-naïve participants at lower trial expenses than the United States and European Union.

Pharmacovigilance Market Coverage

Market News

• In August 2024, to fulfill the vision of Hon’ble Prime Minister Shri Narendra Modi's 'Digital India,' the Hon’ble Minister of Health and Family Welfare, Shri J.P. Nadda, launched an online, indigenously developed Adverse Drug Reaction Management System (ADRMS) software as part of the Pharmacovigilance Programme of India (PvPI).
• 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. This new platform aims to enhance the CorEvitas clinical research registries provided by Thermo Fisher’s PPD clinical research business.
• In September 2024, Truliant Consulting is set to launch a white paper titled "AI and Automation in Pharmacovigilance: Transformative Trends and Future Outlook." This white paper is based on an open survey targeting pharmaceutical companies to understand how they are implementing artificial intelligence (AI) within their pharmacovigilance structures.
• In October 2024, the Pan American Health Organization and the National Institute for Drug and Food Surveillance (Invima) of Colombia held the XIX International Pharmacovigilance Meeting, along with a face-to-face regional meeting of pharmacovigilance focal points in the Americas.

Pharmacovigilance Market Key Players

• ICON Plc
• Pharmaceutical Product Development LLC
• Parexel International Corporation
• IQVIA
• Quanticate
• Bioclinica
• Covance Inc.
• Accenture Plc
• IBM Corporation
• Novartis

Market Segmentation

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
  
  • Case Logging
  • Case Data Analysis
  • Medical Reviewing & Reporting
• Signal Detection
• • Adverse Event Logging
  • Adverse Event Analysis
  • Adverse Event Review & Reporting
• Risk Management System
  
  • Risk Evaluation System
  • Risk Mitigation System

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