Pharmacovigilance Market

Pharmacovigilance Market Size and Share:

The global pharmacovigilance market size was valued at USD 8.5 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 16.3 Billion by 2033, exhibiting a CAGR of 7.5% from 2025-2033. North America currently dominates the market driven by robust investments in infrastructure modernization, residential housing demand, and the adoption of advanced building technologies to meet sustainability goals.

The pharmacovigilance market is driven by the growing prevalence of adverse drug reactions, increasing demand for post-market drug monitoring, and stricter regulatory requirements worldwide. In addition, the rising adoption of artificial intelligence (AI) and big data analytics enhances signal detection and drug safety evaluation, improving efficiency and aiding the market growth. For instance, in 2024 European Medicines Agency (EMA) released tools and guidelines for using artificial intelligence (AI) in pharmacovigilance, hereby showing a willingness to use technology to improve drug safety monitoring. Additionally, the growth of the pharmaceutical and biotechnology industries drives the demand for thorough safety monitoring during drug development, further contributing to the market's expansion. Besides this, the surge in chronic diseases and new drug launches boosts the demand for robust pharmacovigilance systems, providing an impetus to the market. Furthermore, outsourcing pharmacovigilance activities to specialized firms reduces operational costs while maintaining compliance, thus catalyzing the market growth.

The United States pharmacovigilance market is strongly driven by the country's extensive pharmaceutical industry, which conducts numerous clinical trials requiring thorough safety monitoring. In line with this, the rise of biosimilars and personalized medicine increases the complexity of drug safety assessments, boosting the market demand. Concurrently, government initiatives promoting drug safety surveillance, such as the Food and Drug Administration’s (FDA) Sentinel Initiative, are fostering the market growth. In confluence with this, the growing integration of patient-centric approaches emphasizes real-world data collection for safety evaluations, strengthening the market share. Also, collaborations between regulatory bodies and pharmaceutical companies enhance compliance and monitoring systems, supporting the market growth. Apart from this, the rapid adoption of telemedicine and digital health tools fosters remote reporting and monitoring of adverse drug reactions, propelling the market forward.

Pharmacovigilance Market Trends:

The development of continuous technological advancements

The increasing integration of novel technologies, such as machine learning (ML), natural language processing (NLP), AI, big data analytics, etc., is enhancing the pharmacovigilance processes. The global ML market size reached USD 31.0 Billion in 2024. In line with this, these technologies are gaining extensive traction, as they help identify adverse events, perform risk assessments, enable efficient signal detection, etc., which is expected to fuel the market growth over the forecasted period. For instance, Sanofi and Deloitte collaborated on ConvergeHEALTH Safety, a next-generation AI software-as-a-service adverse events case intake platform that transformed pharmacovigilance (PV) processes and addressed some of the industry's most pressing operational safety issues. In line with this, ArisGlobal introduced the go-live of the USFDA Adverse Event Reporting System (FAERS II), an electronic safety reporting platform powered by LifeSphere MultiVigilance, which propelled the market growth. Furthermore, Saama Technologies Inc. established a new Active Safety Analytics for Pharma (ASAP) products. ASAP is one of the first validated pharmacovigilance solutions to leverage the TreeScan methodology and the United States FDAs Sentinel Common Data Model for detecting safety signals.

Stringent regulations implemented by government bodies

Government authorities across the globe are implementing strict rules in clinical trials and generating awareness regarding the proper utilization of medicines, which is stimulating the usage of pharmacovigilance services. For example, according to a study published in Frontiers in Drug Safety and Regulation, the significance of post-marketing medication evaluation is important for characterizing drug safety profiles in real-world settings. Such studies are further raising the profile of pharmacovigilance, thus, propelling the market growth. Furthermore, Aurobindo Pharma USA repositioned Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg due to the flowing; Nitrosamine Drug Substance Related Impurity (NDSRI) and N-Nitroso-Quinapril. Consequently, the inflating need for medical information among regulatory authorities is expected to fuel the market growth over the forecasted period.

The rising adoption of pharmacovigilance services by pharmaceutical companies

Pharmacovigilance services are used widely by leading pharma companies because of the opportunities such as performance enhancement in a shorter time span and rising internal resource versatility. Concurrently, the growing need for pharmacovigilance services is also supporting the market growth. In addition to this, key industry players are also entering into strategic collaborations, which will continue to propel the pharmacovigilance market over the forecasted period. For instance, Medtech Firm IQVIA joined a strategic partnership with NRx Pharmaceuticals to provide medical information and pharmacovigilance services in light of prospective regulatory measures.

The growing number of advanced clinical trial phases

Major prominent players are developing advanced clinical trials to enhance the efficacy of clinical trials, which are stimulating the global pharmacovigilance market. GlobalData’s Pharmaceutical Intelligence Centre reveals that there were 22,338 clinical trial starts in 2023. Additionally, Cognizant collaborated with Medable Inc., an innovative provider of SaaS platforms for Decentralized Clinical Trials. As a result, Viedoc partnered with LINK Medical, establishing a partnership that was founded by Viedoc. The integration was designed to enhance trial productivity for LINK Medical and its clients. The partnership allowed for the exchange of needs, experience, ideas, etc., and the testing of new features.

Pharmacovigilance Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global pharmacovigilance market, along with forecasts at the global, regional, and country levels from 2025-2033. The market has been categorized based on service provider, product life cycle, type, process flow, therapeutic area, and end use.

Analysis by Service Provider:

• In-house
• Contract Outsourcing

Contract outsourcing is the most popular segment and holds the largest market share because it is more affordable and productive in terms of compliance with regulatory requirements and risk monitoring. The pharmacovigilance outsourcing trend has grown common with more pharmaceutical and biotechnology companies opting to outsource the processes as a way of avoiding operational costs and focusing on business strengths such as product research and marketing. The increasing stringency of the safety requirements for drugs across the world also increases the need for contract service organizations that have niche competence in the regulation’s affairs and other safety assessment techniques. These providers use advanced technologies such as AI and big data analytics to enhance the outcomes of adverse event identification and notification. Also, the increase in the number of clinical trials, new drug launches, and growth in the biosimilars segment supports the growth of this segment. Both, contract service providers and pharmaceutical firms are continuously building up their capabilities through more strategic collaborations, making this segment more dominant in the pharmacovigilance market.

Analysis by Product Life Cycle:

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

Phase IV or the post-marketing surveillance phase has the biggest market share in the pharmacovigilance market because the monitoring of drug safety after the drugs are approved is crucial. The dominance of the segment is due to the regulatory requirements for constant safety assessments and risk management procedures. Higher numbers of adverse drug reactions observed after approval add to the need for Phase IV to ascertain long-term safety. The pharmaceutical business and increasing number of drugs launches again broaden this segment as firms have to follow safety surveillance standards. Furthermore, new Phase IV activities that combine real-world evidence (RWE) and big data analytics enable efficient and compliant safety assessments. The fourth is the ability to outsource Phase IV pharmacovigilance services to specialized service providers that offer cost-effective and compliant post-market surveillance.

Analysis by Type:

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

The global pharmacovigilance market is led by the spontaneous reporting method due to its high usage in identifying adverse drug reactions (ADRs) at a relatively low cost and time. The growth of this segment is due to the compliance standards on healthcare professionals and pharma companies, to report ADRs to central repositories such as the FDA Adverse Event Reporting System (FAERS). This approach to data collection is quicker and means that safety issues can be identified very quickly. Greater public awareness and patient promotion to report ADRs directly also expand the size of this segment. The use of sophisticated technologies like ML and natural language processing advanced data analysis from spontaneous reports, signals, and risks. With the steady rise in the consumption of drugs all over the world, the need for monitoring the safety of these drugs through spontaneous reporting systems enhances the growth of this segment.

Analysis 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 constitutes the largest segment of the pharmacovigilance market because it plays a central role in detecting and managing safety concerns that may exist about a drug during its development and after launch. The foundation of this process lies in the collection of real-time data from clinical trials, electronic health records, and patient records, gathered through adverse event logging. Modern technologies particularly ML algorithms increase the efficiency of adverse event analysis thus enhancing the improvement of drug safety. The increasing trend in compliance with regulatory frameworks also enhances adverse event review and reporting to meet the required time and quality standards of reporting to the regulatory authorities. Signal detection is anticipated to record strong growth due to the rising uptake of big data analytics as well as the integration of RWE alongside growth in drug development projects and public awareness of drug safety.

Analysis by Therapeutic Area:

• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others

The pharmacovigilance market is led by oncology as it has the largest market share; oncology has the highest number of clinical trials and approved drugs as a therapeutic area. The increasing occurrence of cancer all over the world, estimated to be 29,564,943 cases in 2040, fosters the development of oncology drugs and the comprehensiveness of safety measures. Personalized medicine and immunotherapies increase the complexity of adverse event reporting by targeted therapies, and for this reason, the use of pharmacovigilance processes. The US FDA pressure on the highly secure oncology treatment adds to the market intensity. Also, expensive, and long oncology trials stress the need to have optimum risk management approaches and post-market vigilance to safeguard the patient from any harm while meeting legal compliance requirements. Due to this directed focus on oncology pharmacovigilance, the development of data analytics and AI signal detection innovation is further fueled and market expansion is sustained.

Analysis by End Use: 

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

The largest segment in the pharmacovigilance market is occupied by pharmaceutical companies because of their significant responsibilities within drug development and safety. They spend a lot of money on pharmacovigilance to meet set regulatory requirements and reduce the potential consequences of ADRs. The increasing numbers of new chemical entities and clinical trials contribute to the escalating demand for sound pharmacovigilance practices. In personal medicine and other biologic products, tracking and risk assessment become difficult; hence, pharmaceutical companies use robust instruments like AI for signal detection. Further, the global engagements between pharmaceutical firms and other regulatory authority organizations improve compliance and data sharing. The continuously rising public concern over drug safety and the shift towards real-world evidence continue to cause pharmaceutical companies to be the most significant drivers of the pharmacovigilance market growth.

Analysis 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 holds the largest share of the pharmacovigilance market, driven by advanced healthcare infrastructure, including the 6,120 hospitals and 916,752 staffed beds in the U.S. along with stringent regulatory frameworks established by FDA. The region benefits from significant investments in drug safety programs and the widespread adoption of technology for adverse event reporting and data analysis. The rising prevalence of chronic diseases and an aging population are driving the increase in drug consumption, which in turn heightens the demand for effective pharmacovigilance practices. Moreover, the region leads in the integration of AI and big data for signal detection and real-time monitoring, improving efficiency and compliance. Robust collaboration between pharmaceutical companies and research institutions also plays a key role in supporting drug safety initiatives, driving ongoing market growth. The growing focus on patient safety and rising awareness about ADRs solidify North America’s leadership in the pharmacovigilance market.

Key Regional Takeaways:

United States Pharmacovigilance Market Analysis

The US pharmacovigilance market is driven by a combination of stringent regulatory frameworks, technological advancements, and increasing healthcare awareness. The Food and Drug Administration (FDA) enforces robust pharmacovigilance requirements, fostering the demand for comprehensive adverse event reporting and monitoring systems. With rising concerns over medication safety and side effects, there is a growing need for post-market surveillance, further propelling market growth. According to the US Department of Health and Human Services, an estimated 129 million people in the US suffer from at least one major chronic disease, such as heart disease, cancer, diabetes, obesity, or hypertension, which drives the demand for continuous drug safety monitoring. Technological advancements like AI, ML, and automation are improving drug safety monitoring by increasing both efficiency and accuracy in the detection of adverse events. The integration of electronic health records (EHRs) and wearable devices also contributes to real-time safety data collection, enabling faster response to potential risks. Additionally, increasing collaborations between pharmaceutical companies and third-party service providers for pharmacovigilance outsourcing optimize operational costs and ensure compliance with global safety standards. The focus on personalized medicine and the growth of biologics further intensifies the need for robust pharmacovigilance practices in the US market.

Europe Pharmacovigilance Market Analysis

The pharmacovigilance market in Europe is highly driven by an effective regulatory framework set down by the EMA and individual country agencies. The uptake of the EU Pharmacovigilance Directive (2010/84/EU) has provided more impetus to the expected safety monitoring and reporting by the pharmaceutical industries. With concern for patient safety, estimations of pharmacovigilance services have acted up as adverse event reporting and risk management plans are a substantial part of drug development and post-marketing surveillance. The threat level of diseases including cancer, diabetes, and respiratory illnesses amongst others, along with the growing elderly population creates the need for constant safety evaluation of drugs. According to reports, on January 1, 2023, the EU population of 448.8 million, and more than one-fifth of the people are 65 years and above, thus requiring better pharmacovigilance to address the aging population. Furthermore, the application of modern technologies, including big data, AI, and electronic health records (EHRs), as a consequence, contributes to the pharmacovigilance improvement and early identification of adverse drug reactions. The European market is also following the overall trend towards outsourcing pharmacovigilance services to specialized contract research organizations contract research organizations (CROs), thus supporting the market growth.

Asia Pacific Pharmacovigilance Market Analysis

The pharmacovigilance market in the Asia-Pacific (APAC) region is expanding rapidly, driven by the region’s growing pharmaceutical industry and increasing drug consumption. The prevalence of chronic diseases and the rising need for effective post-market surveillance are key factors fueling this growth. The demand for pharmacovigilance services is particularly prominent due to the increasing focus on drug safety and the need for risk management. As reported by PubMed Central, the prevalence of knee pain among older Asian populations varies significantly, with rates ranging from 11% to 56% in China, 33% in Japan, 38% in Korea, and 61% in Vietnam, underscoring the importance of monitoring treatments in aging populations. Emerging markets like China and India are witnessing significant investments in healthcare infrastructure, improving the collection and analysis of pharmacovigilance data. Moreover, the rising trend of clinical trials in the region further necessitates robust pharmacovigilance systems. Technological advancements, such as EHRs, are enhancing the monitoring of adverse drug reactions, further boosting market growth in the region.

Latin America Pharmacovigilance Market Analysis

The Latin American pharmacovigilance market is driven by an increasing demand for regulatory compliance and drug safety monitoring, primarily due to the region's expanding pharmaceutical sector and rising healthcare awareness. According to PubMed Central, in Brazil, an estimated 928,000 deaths annually are attributed to chronic diseases, highlighting the need for effective pharmacovigilance systems to manage medication risks in such populations. Key factors contributing to market growth include the implementation of stricter regulatory guidelines by national agencies such as ANVISA in Brazil and COFEPRIS in Mexico. Moreover, the growing adoption of advanced technologies for drug monitoring and the outsourcing of pharmacovigilance services are major factors driving the market.

Middle East and Africa Pharmacovigilance Market Analysis

The pharmacovigilance market in the Middle East and Africa (MEA) is influenced by regulatory improvements, increasing healthcare infrastructure, and rising awareness of drug safety. According to PubMed Central, in the UAE, the prevalence of self-reported chronic diseases is 23.0%, with obesity, diabetes, and asthma/allergies being the most common (12.5%, 4.2%, and 3.2%, respectively). This high prevalence of chronic conditions drives the demand for robust pharmacovigilance systems to ensure patient safety. The region’s pharmaceutical market is expanding, and with rising healthcare infrastructure and the growth of clinical trials, the need for comprehensive drug safety monitoring continues to rise across MEA.

Competitive Landscape:

The pharmacovigilance market is experiencing heightened competition, with leading players concentrating on technological innovations and strategic partnerships to improve their service offerings. There is a growing trend toward leveraging AI and ML for automated adverse event detection and predictive analytics. Companies are expanding their global presence by outsourcing pharmacovigilance services to emerging markets, aiming to reduce operational costs while maintaining high standards. Strategic partnerships with clinical research organizations and healthcare providers are becoming common to streamline data collection and analysis. Additionally, the integration of real-world evidence and patient-reported outcomes into safety assessments is gaining momentum, reflecting the industry's commitment to improving drug safety and regulatory compliance. These activities underline the dynamic evolution of the market landscape.

The report provides a comprehensive analysis of the competitive landscape in the pharmacovigilance market with detailed profiles of all major companies, including:

• 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

Latest News and Developments:

• In August 2024: The Pharmacovigilance Programme of India (PvPI) launched ADRMS software as part of the ‘Digital India’ initiative. Launched by Health Minister Shri J.P. Nadda, it is India’s first safety database for proper reporting of adverse events by patients, doctors, nurses, and pharmaceutical industries.
• In March 2024: The American Society of Pharmacovigilance (ASP), along with several partners, is aimed at enhancing drug safety by reducing ADE, which is the fourth cause of death in the United States of America.
• In February 2024: The Indian Pharmacopoeia Commission (IPC) released the Draft Pharmacovigilance Guidance Document for pharmaceutical products for its latest Version 2.0. Marketing Authorization Holders (MAHs) also provided their inputs on the draft document to the Commission as well.
• In February 2024: The US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) launched the standardization of Risk Evaluation and Mitigation Strategies (REMS) data to facilitate its use.
• In December 2023: Thermo Fisher Scientific launched CorEvidence, a cloud-based platform to streamline pharmacovigilance workflows and safety data management. As a complementary product with CorEvitas clinical registries, it enables post-authorization safety studies with adaptable and compliant solutions.

Pharmacovigilance Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the pharmacovigilance market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global pharmacovigilance market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's Five Forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the pharmacovigilance industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.