Global Pharmacovigilance Market Overview

Global Pharmacovigilance Market size was valued at USD 7.95 Billion in 2024 and is poised to grow from USD 8.55 Billion in 2025 to USD 16.39 Billion by 2034, growing at a CAGR of 7.5 % in the forecast period (2025-2034).

The basis of the global pharmacovigilance market is strong national regulatory regimes that ensure drug safety, the Food and Drug Administration (FDA) in the United States being the prime player. Pharmacovigilance here is defined as the science and activities pertaining to the detection, assessment, understanding, and prevention of adverse effects or any drug-related problem during a drug's life cycle after it has been marketed. However, it should be noted that the FDA's Adverse Event Reporting System (FAERS) remains the primary focus for all post-marketing surveillance as it likely represents the largest post-marketing database. Indeed, billions of individual case safety reports are being generated-on a continuous basis-by the system through different sources such as healthcare professionals, consumers, and pharmaceutical manufacturers. For instance, Data obtained from the FDA's FAERS Public Dashboard show that during 2022, over 2 billion U.S. reports concerning adverse events were submitted into the system, confirming the vast and yet exponentially growing scope of safety monitoring. Over the years, the volume of data available has continued to grow with the exertion of the FDA in seeking to enhance drug safety by early identification of risk and safety signals. The Agency leverages advanced analytics methods, along with real-world data and pharmacoepidemiologic studies for the analysis of these massive data sets, thereby triggering regulatory action on the issuing of safety communications or updates to prescribing information. Such a well-established and evolving post-marketing surveillance system, in compliance with federal law, guarantees a continual evaluation of the safety profile of all drugs and biologics placed on the market. Hence, the well-built U.S. pharmacovigilance system makes a significant contribution to the global drug safety intelligence and public health in an increasingly complex arena characterized by burgeoning pharmaceutical pipeline development and increased public health expectations on medicinal products.

Market Dynamics — Market Drivers

Increasing Volume of Drug Development and Regulatory Approvals

• An increasing number of new drug approvals are the main reason for continuous expansions in the global pharmaceutical pipeline, thereby acting as a major driver for the pharmacovigilance market. Agencies like the U.S. FDA and EMA give reports consistently of an increasing number of IND applications and marketing authorizations available annually. For example, novel drug approvals reported by FDA's Centre for Drug Evaluation and Research (CDER) demonstrate that innovative therapies reach the market at a steady pace. Post-marketing surveillance of newly approved drugs must be rigorous to detect, assess, and prevent adverse drug reactions (ADRs) that may not have been fully characterized in clinical trials. With the increasing number of drugs available to patients, the extent and complexity of activities related to pharmacovigilance will have to grow correspondingly because of this regulatory obligation. The increasing complexity of modern therapeutics, including biologics and cell and gene therapies, as well as personalized medicines, usually demands a more intensive and specialized pharmacovigilance approach. However, this growth does not only increase pharmaceutical innovation and the launching of more products but also increases the demand for and development of comprehensive pharmacovigilance services and systems put in place by official regulatory bodies to monitor drug safety across different patients.

Intensification and Harmonization of Regulatory Requirements  

• The worldwide regulatory authorities are strengthening and harmonizing pharmacovigilance regulations and improving investments and activities in the market. For example, the EMA has enacted a wide-ranging pharmacovigilance legislation which includes the EU Pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). This requires the post-authorization safety monitoring to be supplemented with risk management planning and enhanced signal detection. Similarly, the FDA operates in an environment that has been continuously augmented by legislations such as the FDA Amendments Act (FDAAA) of 2007, enhancing the Agency's power concerning post-market safety. Therefore, these legislative and guidance documents require, inter alia, the pharmaceutical companies to set up well-functioning pharmacovigilance systems, initiate ongoing safety reporting, and undertake proper risk management programs.

Market Opportunities

Integration of Artificial Intelligence (AI) and Machine Learning (ML) for Enhanced Signal Detection

• Such opportunities arise within the area of pharmacovigilance. Integrating AI and ML technologies promises to enable an efficient and robust means of safety signal detection and reporting. Both the FDA and the EMA are acting as promoters and regulators of the responsible use of AI in drug development and other aspects of post-market surveillance. The FDA, for example, has developed several discussion papers and taken part in initiatives on AI and ML in drug development, highlighting the capability of these technologies to sift through enormous collections of adverse event reports, detect patterns, and home in on potential safety signals with vastly superior speed and accuracy than through manual means. In a similar vein, the regulatory science strategy of the EMA highlights the use of big data and advanced analytics, including AI, to enhance the efficiency and effectiveness of pharmacovigilance activities. Hence, these advancements can automate data intake, fast-track case processing, allow for more enhanced real-time signal detection from various data sources, and even point to potential safety issues so that resources are optimally allocated on the part of both regulatory authorities and pharmaceutical companies. With clear government backing and ongoing studies into the uses of AI in pharmacovigilance, the stage is set for innovation and market development.

Expansion into Digital Health and Connected Devices for Real-Time Monitoring

• Digital health technologies, such as wearable sensors, mobile health apps, and connected medical devices, are rapidly emerging, thus creating a significant opportunity for enlargement in pharmacovigilance through the collection of real-time objective health data. In the U.S. major funding of research into digital health and its applications for disease management and health monitoring is provided through federal agencies like the NIH, while regulatory structures for digital health devices have been set up by the FDA acknowledging their potential to site real-world data. Such technologies enable constant monitoring of physiologic parameters, activity levels, and patient-reported outcomes, thus furnishing rich streams of granular data capable of amalgamating with classical adverse event reporting. For example, subtle changes in a patient's condition suggestive of an adverse drug reaction could be picked up via a remote monitoring device long before identification on the part of the patient or healthcare provider using traditional methods. A most lucrative possibility opens with the ability to access such passive, objective continuous data for proactive safety surveillance, refined signal detection, and greater insight into drug effects in real-world settings, thus creating an immense demand for systems and expertise to arrive at such data types that integrate and analyse these novel systems within the pharmacovigilance ecosystem.

Market Restraining Factors

High Cost and Operational Complexity of Pharmacovigilance Systems

• Setting up and maintaining a comprehensive pharmacovigilance system is inherently difficult and resource-intensive; hence, they are significant restraints on the market. Regulatory bodies such as the FDA and EMA require that the pharmacovigilance system include highly sophisticated IT infrastructure, highly trained human resources, ongoing monitoring capabilities, and stringent quality management systems. The costs for huge amounts of safety data, compliance with ever-changing global regulations, signal detection, and risk assessment can be very high, especially for small pharmaceutical firms or firms with many products in their portfolios. These direct costs are generally not published by authorities, but according to the very detailed requirements presented in the GVP modules that are published by EMA and in the very detailed expectations presented by the FDA for safety reporting, it is very clear what an operational burden all these sorts of things are. Such activities require a great deal of financial investment in technology, human resources, and training on the job, which could be seen as a barrier toward smooth, efficient, and compliant pharmacovigilance working practices across the industry.

Market Challenges

Competition from Alternative Packaging Materials

• The glass packaging market is constrained by tough competition coming from competing materials such as plastics and metals. While plastics have long been touted as having benefits in lower cost, lighter weight, design flexibility, and durability-all attributes that could be considered for any number of applications-plastics are making strong competition. However, the main advantage is the sustainability movement for all really prohibits plastics because of the established system for producing plastics and recycling it, along with their cost-effectiveness. Metal packaging such as aluminium cans also tends to provide high recyclability and lightweight properties making them a strong competition, especially in the beverage segment. The continued innovation of alternatives adds to the competition.

Segmentation Analysis

The market scope is segmented because of By Product Life Cycle, By Deployment, By Type, By End User.

By Product Life Cycle

Based on Product Life Cycle, the market is segmented into Pre-clinical, Phase I, Phase II, Phase III, Phase IV).

The Phase IV period (post-marketing surveillance), which includes the long-term safety monitoring of drugs studied after approval on larger, more diverse populations, becomes an even heavier market regulation than any other. Regulatory mandates, higher volumes of adverse event reporting, and risk minimization strategies are indeed fostering this dominance. Unlike previous phases, Phase IV essentially runs throughout the commercial life of a drug and, therefore, requires continuous pharmacovigilance efforts. Hence, this is the largest and most important segment.

By Deployment

Based on Deployment, the market is segmented into In-house, Outsource.

The outsourcing part accounts for the largest share of the global pharmacovigilance market, based on cost-reduction strategies, scaling options, and the possibility of gaining access to specialist expertise. In most instances, outsourcing is opted-for to reduce overhead in operations, to comply rapidly with new, often changing regulations, and to make available advanced technology at very low levels of upfront investment. For ensuring that adverse events are monitored and reported efficiently, such a model is better suited for the pharmaceutical firms as it will enable them to duly focus on other core activities. The increasing complexity associated with international pharmacovigilance requirements also contributes greatly to this outsourcing demand.

Regional Snapshots

• North America

North America, led essentially by the U.S. and Canada, is the major and largest continent of the global pharmacovigilance market. The region's ranking has been derived basically from stringent regulations by the FDA (Food and Drug Administration) and Health Canada regarding adverse drug reaction (ADR) monitoring and reporting, which must be done very diligently. Another contributing factor to the demand for pharmacovigilance services is the high volume of clinical trials, wide drug approvals, and, of course, a good pharmaceutical industry standing behind them. North America is also way ahead in AI and big data analytics in drug safety, with RWE and automated signal detection tools being embraced. The other trend that supports the growth of the market is outsourcing to specialized Contract Research Organizations (CROs). As biosimilars and specialty drugs increase, the need for robust pharmacovigilance systems keeps expanding, just anchoring North America's dominance.

• Europe

The European pharmacovigilance market, with the European Medicines Agency (EMA) and Surveillance to impose stern guidelines on the post-marketing surveillance, qualifies as the second-largest market for pharmacovigilance. Germany, the United Kingdom, and France stand out as the leaders, owing to their favourable healthcare systems, extensive investment in R&D, and strong regulatory frameworks. The Pharmacovigilance Legislation of the EU, imposing the GVP guidelines, demands comprehensive risk management plans and thus generates the need for pharmacovigilance services. The amount of outsourcing to CROs in this region is claimed to be high, especially in Eastern European countries, given that cost efficiencies attract pharmaceutical firms worldwide. Furthermore, personalized medicine and biosimilars increase the need for specialized safety monitoring. Europe has, therefore, enhanced its market position by focusing on integrating RWD and patient-centric pharmacovigilance.

• Asia-Pacific (APAC)

The world’s fastest-paced region for pharmacovigilance is identified as APAC in which the driving giants are India, China, Japan, and South Korea. This region benefits significantly from cost-effective outsourcing hubs, especially India, where many global CROs and IT-enabled pharmacovigilance services are based. For instance, advancements in drug safety standards are being made by the PMDA in Japan and the CDSCO in India. An increase in clinical studies, generic drug production, and the expansion of pharmaceutical markets all contribute to growth. The digital transformation finds a large-scale application in AI and blockchain for ADR reporting. However, varying degrees of maturity of regulatory systems across APAC countries create challenges, although some initiatives like the harmonization processes of ASEAN are helping in bridging these gaps, thereby ensuring a steady growth of the market.

• Middle East & Africa (MEA)

GCC countries (Saudi Arab, UAE) and South Africa are the key markets driving growth for the emerging yet fragmented MEA pharmacovigilance market. The Saudi FDA, along with South Africa's MCC (Medicines Control Council), is in the process of reinforcing the frameworks for pharmacovigilance. However, regulations are inconsistent in the region, and this results in some uniformity when it comes to growth. Rising chronic diseases and drug consumption are increasing the demands for ADR monitoring. However, this market is still constrained by poor healthcare infrastructure, underreporting of ADRs, and use of imported medicines. Some countries have started implementing the WHO Guidelines for Pharmacovigilance, while partnerships with global CROs are progressively improving their capabilities. This region shows promise, but it is still a niche market compared to more mature areas.

• Latin America (LATAM)

The Latin American market emerging for pharmacovigilance is led primarily by Brazil and Mexico, which have made significantly more regulatory progress in ANVISA and COFEPRIS, respectively. The entire continent is benefiting from increasing clinical trial practices and growing investments within pharmaceuticals. Challenges include economic instability, bureaucratic delays, and uneven regulatory enforcement. The emergence of increasingly available generic medications and biosimilar products will augment demand for pharmacovigilance, while advancing digital health initiatives also yield greater efficiency in terms of ADR reporting. Some countries are adopting the ICH-GCP guidelines, helping to raise drug safety standards. Although this region has further potential for growth, it pales in comparison with North America and Europe. Growth is contingent on increased regulatory harmonization and further outsourcing.

Leading Key Players

• IQVIA
• Accenture
• Cognizant
• Labcorp (Covance)
• ICON plc
• Parexel
• Bioclinica (Clario)
• Capgemini
• Tata Consultancy Services (TCS)
• Wipro
• IBM (IBM Watson Health) ArisGlobal
• United Biosource LLC (UBC)
• Syneos Health
• Thermo Fisher Scientific (PPD)
• Foresight Group International AG
• TAKE Solutions
• Pharmaceutical Product Development, LLC (PPD)
• Quanticate
• Novo Nordisk A/S

Key Industry Developments

• In July 2025, Accenture (NYSE: ACN) is about to acquire Maryville Consulting Group, a technology consulting firm based in America, with core competencies in product growth strategy, ES, digital operations boasting technology business management (TBM). More than 100 people employed by Maryville Consulting Group will be joining Accenture Example: With this acquisition, Accenture strengthens its capabilities to help clients realign their technology investments and business outcomes while they reinvent themselves.
• In August 2024, upon announcing its acquisition of Belcan for an estimated value of $1.3 billion, in cash and stock, Cognizant has reported the completion of its acquisition. Belcan is a recognized global leading supplier of Engineering Research & Development (ER&D) services in the commercial aerospace, defence, space, marine, and industrial verticals.

Report Coverage

The report will cover the qualitative and quantitative data on the Global Pharmacovigilance Market. The qualitative data includes latest trends, market players analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations

Global Pharmacovigilance Market Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Pharmacovigilance market and is expected to expand at a CAGR of xx% during the forecast period. This growth can be attributed to the growing adoption of Pharmacovigilance. The market in APAC is expected to witness significant growth and is expected to register a CAGR of xx% over upcoming years, because of the presence of key Pharmacovigilance companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Pharmacovigilance Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language.

Pharmacovigilance Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S.
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K.
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 12 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Reasons to Purchase

• To gain insightful analyses of the Pharmacovigilance market and have comprehensive understanding of the global market and its commercial landscape.
• Assess the production processes, major issues, and solutions to mitigate the development risk.
• To understand the most affecting driving and restraining forces in the market and its impact in the global market.
• Learn about the Pharmacovigilance market strategies that are being adopted by leading respective organizations.
• To understand the future outlook and prospects for the Pharmacovigilance market. Besides the standard structure reports, we also provide custom research according to specific requirements.

Research Scope of Pharmacovigilance Market

• Historic year: 2019-2023
• Base year: 2024
• Forecast: 2025 to 2034
• Representation of Market revenue in USD Billion

Pharmacovigilance Market Trends: Market key trends which include Increased Competition and Continuous Innovations Trends: