Pharmacovigilance Market

Global Pharmacovigilance Market Size (2024 to 2032)

The global pharmacovigilance market size is estimated to be worth USD 20.05 billion by 2032 from USD 6.93 billion in 2024 growing at a CAGR of 14.2% from 2024 to 2032.

MARKET DRIVERS

The growing number of drug adverse reactions primarily drives the growth of the global pharmacovigilance market.

The primary goal of pharmacovigilance is to detect, assess, understand, and prevent the adverse effects of drugs. The growing incidence of adverse drug reactions fuels the need for pharmacovigilance services. Adverse drug reactions are the harmful effects resulting from drug consumption. People aged are likely to get diagnosed with various diseases, go under various medications, and report adverse reactions to drugs. In recent years, awareness regarding adverse drug reactions (ADR) has increased dramatically among healthcare professionals and patients. Hence, the need to monitor the safety of drugs and their adverse drug reactions is increasing, driving the demand for pharmacovigilance services. Likewise, the market is expected to be driven by the growing incidence of ADRs.

The growing pharmaceutical industry, increasing R&D activities, and rising number of innovative drugs are fuelling the pharmacovigilance market's growth. The companies operating in the pharmaceutical industry are putting rigorous R&D efforts into developing new drugs. When new drugs enter the market, it becomes essential for the manufacturers to evaluate the safety and efficacy of the drugs, which is expected to increase the scope of pharmacovigilance services. In addition, the growing adoption of technological advancements in pharmacovigilance services is expected to boost the market growth. Technological developments such as EHR, AI, ML, big data, cloud computing, and mHealth have helped the improved monitoring, safety, and efficacy of drugs to trigger the ADRs and risks associated with the proposed drugs by the manufacturers in the early stages.

Furthermore, factors such as stringent regulatory requirements, rising emphasis on patient safety by drug manufacturers, and increasing outsourcing of pharmacovigilance services promote the growth rate of the global market.

MARKET RESTRAINTS

Lack of awareness regarding pharmacovigilance in some countries is hampering the market growth. In addition, the Lack of regulations and standards for pharmacovigilance in some countries is negatively impacting the market growth. Furthermore, factors include limited resources and budget constraints to conduct pharmacovigilance to some of the companies, technical limitations, data accuracy issues, data privacy and security issues, and high costs associated with the implementation of pharmacovigilance systems are further inhibiting the growth rate of the pharmacovigilance market.

REPORT COVERAGE

SEGMENTAL ANALYSIS

Global Pharmacovigilance Market By Clinical Trial Phase

Based on the clinical trial phase, the phase IV segment is expected to lead the global market during the forecast period. The clinical trials and unidentified adverse effects are detected in phase IV by collecting large amounts of relevant data. The drugs are tested intensively on a large group of patients after the commercialization of drugs. The growing importance for post-marketing surveillance and pharmacovigilance activities to monitor drug safety and detect adverse events in real-world settings primarily drive the growth of the Phase IV segment. Regulatory requirements for ongoing safety monitoring and risk management of approved drugs, the rising importance of pharmacovigilance in signal detection, risk assessment, and benefit-risk evaluation and rapid adoption of advanced technologies, such as data mining and artificial intelligence to enhance pharmacovigilance processes boost the growth of the Phase IV segment. The growing number of collaborations between pharmaceutical companies, healthcare providers and regulatory agencies to streamline post-marketing safety reporting and surveillance and growing patient engagement and involvement in pharmacovigilance activities drive the growth of the Phase IV segment.

The phase III segment is likely to grow at a healthy CAGR during the forecast period. These trials also provide data regarding drug safety, drug interactions, and effectiveness and help institute drugs' efficacy. Regulatory requirements for demonstrating the safety and efficacy of a drug on a larger patient population, increasing need for extensive clinical evidence to support marketing authorization applications and drug approvals and rising emphasis on comparative effectiveness studies to assess the drug's performance against existing treatments drive the growth of the phase III segment. The growing focus on real-world data and post-marketing surveillance to evaluate long-term safety and effectiveness and the expansion of global clinical trial networks to access diverse patient populations for Phase III trials contribute to the segmental growth.

Global Pharmacovigilance Market By Service Provider

Based on service provider, the contract outsourcing segment is expected to capture the major share of the global market and it is also the fastest-growing segment in the worldwide market during the forecast period. Contract outsourcing simplifies complex clinical trials and helps in reducing the approval time of trials. Fixed costs can be reduced along with high flexibility and risk mitigation by implementing outsourcing; these benefits fuel the growth of the pharmacovigilance market.

Global Pharmacovigilance Market By Method

Based on the method, the spontaneous reporting segment had the major share of the global pharmacovigilance market in 2024, and the domination of the segment is likely to continue during the forecast period. The segment's growth is primarily driven by factors such as the increasing number of applications for detecting errors and adverse effects related to clinical events. In addition, it is an inexpensive and efficient method. The growing awareness of pharmacovigilance and the importance of reporting ADRs, improvements in reporting systems and regulatory initiatives and guidelines that promote and incentivize spontaneous reporting propel the growth of the spontaneous reporting segment. Technological advancements, such as mobile applications and online reporting portals, facilitating spontaneous reporting and rising focus on patient-centered pharmacovigilance, empowering patients to report ADRs directly further contribute to the growth of the spontaneous reporting segment.

The cohort event monitoring segment is growing rapidly due to integrating data mining systems and statistical tools with cohort event monitoring. The recognition of the value of continuous safety monitoring in real-world patient populations, regulatory requirements for post-marketing safety surveillance and risk management plans and advancements in EHR systems and data capture methods, facilitating cohort event monitoring drive the growth of the cohort event monitoring segment in the worldwide market.

Global Pharmacovigilance Market By End User

Based on the end-user, the hospital segment is anticipated to hold a major share of the global pharmacovigilance market during the forecast period owing to the growing medication errors and rising incidence of ADRs, increasing the need for risk analysis associated with ADRs. Collaboration with regulatory authorities and pharmacovigilance agencies to strengthen drug safety monitoring, growing emphasis on patient safety and the importance of reporting ADRs for improving healthcare outcomes drive the growth of the hospital segment. Training and awareness programs for healthcare professionals to enhance ADR reporting capabilities and rapid adoption of electronic health record (EHR) systems and digital platforms to streamline ADR reporting and surveillance further drive the growth of the hospital segment.

The pharmaceutical companies segment is expected to hold a substantial share of the global market during the forecast period. The growing number of drug development activities and the introduction of new drugs into the market drive the segmental growth. The growing need to comply with pharmacovigilance regulations and fulfill reporting obligations to regulatory authorities, rising focus on patient safety and adverse event monitoring to maintain drug efficacy and safety profiles and the integration of pharmacovigilance into the overall drug development and safety management processes further fuel the growth rate of the pharmaceutical segment in the global market.

REGIONAL ANALYSIS

Geographically, the pharmacovigilance market in North America played the leading role in the global market in 2023 and is anticipated to continue leading the market throughout the forecast period owing to the stringent regulations and guidelines for drug safety monitoring and reporting imposed by regulatory authorities such as the FDA in the United States and Health Canada. The growing prevalence of chronic diseases and the use of medications that necessitate the effective pharmacovigilance practices, increasing investments in healthcare technology and electronic health records (EHR) systems, facilitating efficient reporting and surveillance and the presence of major pharmaceutical companies, contract research organizations (CROs), and academic institutions involved in drug development and pharmacovigilance activities drive the North American market growth. The growing emphasis on real-world evidence generation and post-marketing surveillance to ensure the safety and efficacy of drugs in a diverse patient population and an increasing number of collaborations between regulatory bodies, healthcare organizations, and industry stakeholders to strengthen pharmacovigilance practices and enhance patient safety further fuel the growth rate of the North American market.

The European pharmacovigilance market is anticipated to grow substantially and hold a considerable share worldwide during the forecast period. European Medicines Agency (EMA) regulations and guidelines mandating pharmacovigilance practices and risk management plans for marketed drugs is fuelling the need for pharmacovigilance and driving the European market growth. The rising emphasis on risk-benefit assessments and comparative effectiveness studies in post-marketing surveillance and collaboration among European Union (EU) member states for harmonized pharmacovigilance activities and information sharing further propel the growth rate of the European market. The rapid adoption of innovative technologies and digital platforms for efficient reporting, data analysis, and signal detection, growing focus on proactive safety monitoring, including intensified ADR reporting and targeted spontaneous reporting and involvement of European research institutions and healthcare organizations in pharmacovigilance research and data analysis contribute to the European market growth.

The APAC Pharmacovigilance market is expected to grow exponentially. It is likely to record a CAGR of 14.86% during the forecast period owing to factors such as increasing awareness among patients, the presence of leading outsourcing organizations, increasing investments due to favorable government initiatives, high productivity, and cost management. The rapidly growing pharmaceutical industry and increasing drug development activities in countries like China and India drive the APAC market growth. The growing healthcare expenditure and infrastructure development supporting pharmacovigilance practices, the expansion of clinical trial activities in the Asia-Pacific region that necessitate the robust pharmacovigilance systems and the regulatory initiatives to enhance drug safety monitoring and reporting driven by agencies like China's National Medical Products Administration (NMPA) and India's Central Drugs Standard Control Organization (CDSCO) further boost the growth rate of the APAC market.

The Latin American pharmacovigilance market is expected to grow at a steady CAGR in the coming years.

The pharmacovigilance market in MEA is predicted to hold a moderate share of the worldwide market during the forecast period.

KEY MARKET PARTICIPANTS

Noteworthy companies in the global pharmacovigilance market profiled in this report are Boehringer Ingelheim, Accenture, Bristol-Myers Squibb, Covance, ICON, PAREXEL, Quintiles, United BioSource, Synowlwedge, and Cognizant Technology Solutions Corporation.

DETAILED SEGMENTATION OF THE GLOBAL PHARMACOVIGILANCE MARKET INCLUDED IN THIS REPORT

This research report on the global pharmacovigilance market has been categorized into clinical trials and service providers.

By Clinical Trial Phase

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

By Service Provider

• In-house
• Contract outsourcing

By Method

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

By End User

• Pharmaceutical companies
• Hospitals
• Others

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa