Pharmacovigilance Market Size, Share, By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, and Phase IV), By Service Provider (In-house, Contract, and Outsourcing), By Type of Reporting (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, and EHR Mining), By End User (Hospitals, Pharmaceutical Companies, and Others), and By Region – Market Trends, Analysis and Forecast till 2034

Pharmacovigilance Market Size was valued at USD 7.5 Billion in 2024 and is expected to reach USD 13.8 Billion by 2034, growing at a CAGR of 7.0%

The Pharmacovigilance Market is a vital component of the pharmaceutical industry that focuses on monitoring and ensuring the safety of drugs and medical products post-market approval. It plays a crucial role in safeguarding public health by identifying, assessing, and preventing adverse drug reactions (ADR) and other potential medication risks. This market has been experiencing steady growth in recent years due to several driving factors. One of the key driving factors for the Pharmacovigilance Market's growth is the pharmaceutical industry's increasing complexity. With the development of new drugs and therapies, there is a higher likelihood of unforeseen side effects and interactions. This necessitates a robust pharmacovigilance system to identify and address these issues promptly. Additionally, regulatory authorities worldwide emphasize pharmacovigilance, mandating stricter reporting and safety monitoring standards. This has created a growing demand for pharmacovigilance services and solutions.

Another driving factor is the rising demand for personalized medicine. The need for comprehensive pharmacovigilance becomes even more critical as the healthcare industry moves towards more individualized treatment plans. Tailoring treatments to specific patient profiles requires a deep understanding of drug safety and efficacy, making pharmacovigilance an indispensable part of this evolving landscape. Moreover, advancements in data analytics and artificial intelligence are enhancing the capabilities of pharmacovigilance, allowing for more efficient detection and management of adverse events, further driving the market's growth.

Key Drivers of Target Market:

Patient Safety:

• The safety of patients is probably the main driver of pharmacovigilance among people who use pharmaceutical products. This shall be accomplished by monitoring adverse drug reactions and other safety concerns, with an optimum aim at minimizing harm and maximizing benefit.

Regulatory Requirements:

• Governments and regulatory agencies in developed countries stipulate various pharmacovigilance activities, especially the need for pharmaceutical companies to adhere to set safety standards, such as reporting adverse events and post-marketing surveillance.

Advancements in Medicine:

• With the continuous likeness of evolution in medical research and technology, new drugs and therapies are introduced continuously. Pharmacovigilance allows for monitoring the safety of such innovations following their introduction into the market.

Restrains:

Underreporting:

• One of the major challenges to pharmacovigilance, however, is underreporting. Health professionals, patients, and the pharmaceutical industries may not report due to lack of awareness, time constraints, or caucus considerations.

Resource Limitations:

• Personnel, infrastructure, and funding charges are associated with pharmacovigilance activities. Most countries, especially low-resource settings, may not be able to afford effective pharmacovigilance systems.

Opportunities:

Increasing Global Drug Approval Rates:

• With pharmaceutical firms filing for the approval of new drugs in different markets, opportunities for pharmacovigilance services keep emerging. Each market also has its regulatory requirements regarding post-launch surveillance, thus creating opportunities for global coverage and compliance expertise by the providers of pharmacovigilance.

Growing Pharmaceutical Industry:

• This could be due to the growth in biotechnology, the development of personalized medicine, and new therapies; with all these developments in the pharmaceutical industry, drug volume increases, and the need for monitoring and reporting for pharmacovigilance.

Rising Incidence of Adverse Drug Reactions (ADRs):

• To improve the value proposition of ESG reporting software, industry-specific modules that cater to the particular ESG issues and regulatory constraints of various industries can be developed. For example, the manufacturing industry could need to monitor waste management and emissions closely, whereas the finance industry might be more concerned with governance and moral investment practices.

Pharmacovigilance Market is segmented based on Clinical Trial Phase, Service Provider Type of Reporting, End-User, and Region.

Clinical Trial Phase Insights:          

• Preclinical: This drug should be administered to animal models or in vitro for preclinical studies to determine its safety and efficacy before administration to humans. During this phase, pharmacovigilance studies may monitor adverse effects from animal studies, data on toxicity, and laws on the welfare of animals.
• Phase I: This drug should, therefore, be administered to animal models or in vitro for the preclinical studies to determine its safety and efficacy before administration to humans. Pharmacovigilance studies may monitor adverse effects from animal studies in this phase, as well as data on toxicity and the laws on the welfare of animals. The pharmacovigilance activities in this trial phase consequently focus on close monitoring of participants for adverse reactions and establishing a preliminary safety profile. Safety data generated in this phase is very important in forming subsequent clinical development.
• Phase II:  Phase II studies expose the investigational drug to a larger group of patients with the studied indication. The objective of each study is to evaluate safety further and to establish preliminary evidence of efficacy. Pharmacovigilance activities are conducted throughout these studies to monitor participants for adverse events and to determine if any safety concerns emerge with increased exposure to a larger patient population.
• Phase III:  Large-scale testing in a heterogeneous patient population in Phase III trials should be performed to establish the drug's efficacy, monitor side effects, and compare it with standard treatments. Pharmacovigilance activities are increased during phase III trials to identify less common or more serious adverse events that may not have been witnessed in smaller studies. Strong safety data from phase III trials will be critical for regulatory approval.
• Phase IV: Phase IV trials occur after the regulatory approval of drugs within clinical settings in the real world and are under constant monitoring for their safety and efficacy. Among the most prominent pharmacovigilance activities in clinical trials conducted in Phase IV involve extensive drug safety tracking in a much larger and more diversified patient population. The primary objectives of this phase of the study are to determine any hitherto unrecognized adverse effects of the drugs, in particular their interactions with other medicines, as well as their long-term safety concerns.

Service provider Insights:

• In-house:  In-house pharmacovigilance means that pharmaceutical companies or health organizations handle the activities by themselves through their resources and personnel. The in-house pharmacovigilance team deals with collecting, processing, and analyzing adverse event reports. It ensures that all activities comply with the authorities' requirements and may directly conduct activities on safety assessments, signal detection, and risk management.
• Contract: Contract pharmacovigilance involves outsourcing specific pharmacovigilance activities to specialized paid services or contract research organizations. Service providers, popularly known as contract research organizations, deal mainly with case processing, medical review, aggregate reporting, literature surveillance, and safety database management. They are organized under contracts specifying scope, timelines, deliverables, and quality.
• Outsourcing: Outsourced pharmacovigilance involves outsourcing the whole operation or a big fraction of it to external service providers. Therefore, pharmaceutical firms might create proper strategic outsourcing links with dedicated pharmacovigilance service providers that generally include services in comprehensive pharmacovigilance, strategic consulting, regulatory support, and global operational capabilities.

Type of Reporting Insights:

• Spontaneous Reporting: Healthcare professionals, patients, and consumers may report ADRs suspected to have resulted from the use of drugs at their own instance to regulatory authorities or pharmaceutical companies. These reports are submitted by the reporter and, often, in the form of a standardized form or an online portal. They are not solicited and, therefore, rely on persons recognizing and reporting ADRs based on their clinical experience or personal observations.
• Intensified ADR Reporting: Intensified ADR reporting is a technique of actively soliciting and collecting reports of adverse events from health professionals, hospitals, or other sources over a given time period or for some drugs. The approach actively provokes increased reported events by engaging its stakeholders through well-planned targeted communication, educational campaigns, and outreach activities.
• Targeted Spontaneous Reporting: Targeted spontaneous reporting combines the features of spontaneous and intensified reporting. The interest is focused on some drugs or population groups that would prompt people to report the targeted adverse events.
• Cohort Event Monitoring: Targeted spontaneous reporting shares elements with spontaneous and intensified reporting. It retains a particular focus on some drugs or populations of interest, stimulating the reporting of adverse events. Typically, participants would be followed up for a certain period to detect adverse events and assess the drug's safety profile under investigation in real clinical practice. Data may be collected through periodic follow-up visits, questionnaires, or EHR reviews.
• EHR Mining: EHR mining is a systematic, thorough review of electronic health records, medical charts, and databases to detect and assess possible adverse drug reactions and other problems with safety. Such an approach involves using big data analytics coupled with NLP technologies to extract structured and unstructured data for analysis. In this way, there is a chance for continued monitoring of the trends in drug safety across large patient populations and heterogeneous healthcare settings.

End-User Insights:

• Hospitals: Hospitals and healthcare institutions treat patients with drugs and send reports on the outcome. Hospital doctors are ethically bound to detect and report the adverse drug reactions they encounter while treating patients. They represent a vital part of most spontaneous reporting systems and sometimes participate in cohort event monitoring or target spontaneous reporting concerning some drugs or patient populations.
• Pharmaceutical Companies: Pharmaceutical companies develop, produce, market, and distribute pharmaceutical products. These firms engage in pharmacovigilance to comply with regulatory requirements, ensure safety throughout the product's lifecycle, and manage the risks associated with the drugs they market. Activities include adverse event reporting, signal detection, risk management, and regulatory submissions.
• Regulatory Authorities: The regulatory authorities—the US FDA, EMA in Europe, and others worldwide—are primarily concerned with the safety, effectiveness, and quality of a pharmaceutical product. In turn, the regulatory authorities set guidelines on the requirements for pharmaceutical companies to perform pharmacovigilance activities. Regulatory authorities review and assess the submitted safety data by companies, issue safety communications, conduct inspections, and execute regulatory actions to safeguard public health.

Regional Insights

• North America: North America, particularly the United States and Canada, holds a significant share of the global pharmacovigilance market. The region has stringent regulatory requirements by the FDA and Health Canada that generate demand for pharmacovigilance services. Growing drug approvals, increasing adoption of biopharmaceuticals, and rising public health concerns ignite the market. Some major pharmaceutical companies and the presence of critical CROs further drive demand by engaging in outsourcing activities for pharmacovigilance services.
• Asia Pacific: It will emerge as the fastest-growing regional pharmacovigilance market, driven by the rise in healthcare spending, an expanding pharmaceutical industry, and increasing awareness related to drug safety. The rapidly growing economies, the latest outsourcing trends of pharmaceutical companies, and government initiatives to enhance the healthcare infrastructure are some major drivers behind the market expansion. Significant hubs for pharmacovigilance outsourcing include India and China.
• Europe: Europe and the UK represent a mature pharmacovigilance market with strong regulatory control exerted by the EMA and national competent authorities. The region has well-developed systems on pharmacovigilance, together with a strong focus on patient safety. The pharmacovigilance market is driven by the following factors: rising pharmaceutical R&D activities, growing expenditures on health care, and demand for biologics and biosimilars. The EU pharmacovigilance legislation forms the market dynamics through its legislations like the EU Pharmacovigilance System and Eudra Vigilance.  
• Latin America: Latin America has promising growth, driven by rising investments in healthcare, cases of increasing chronic diseases, and the improving regulatory framework. The growth drivers include the high growth of pharmaceutical industries with growing awareness for healthcare and reforms in regulations related to the quality and safety of drugs. It is also supporting this market growth. Pharmacovigilance outsourcing by major pharmaceutical industry players is also on the rise in this region.
• Middle East & Africa: They embody a nascent, fast-growing pharmacovigilance market brought about by the improving infrastructure of healthcare, increasing expenditure on healthcare, and developments in regulations. They are growing awareness about healthcare, expansion of pharmaceutical industries, and government initiatives related to the safety of drugs—favor market growth. And regional collaborations, alongside outsourcing pharmacovigilance activities by multinational corporations, are also picking up pace.

Pharmacovigilance Market Report Scope:

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2024 to 2034. For the purpose of this study segmented the target market report based on Clinical Trial Phase, Service Provider, Type of Reporting, End-User, and Region.

Segmentation:

Clinical Trial Phase:

• Preclinical
• Phase I
• Phase II
• Phase III
• Phase IV

By service Provider:

• In-house
• Contract
• Outsourcing

By Type of Reporting:

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

By End-User:

• Hospitals
• Pharmaceutical companies
• Others

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating the Pharmacovigilance Market include Accenture, Cognizant, Laboratory Corporation of America Holdings, IBM Corporation, ArisGloba, Foresight Group International AG, ICON PLC., Capgemini, United BioSource Corporation, and Wipro Ltd.

• In February 2024, Ergomed plc's Prime Vigilance acquired Panacea. This acquisition strengthens Prime Vigilance's ability to offer a wider range of services in the drug safety, regulatory affairs, quality assurance, biotech, and medical device industries.
• In February 2023, Parexel International Corporation launched a new initiative named "Expert Series—New Medicines, Novel Insights." This program features fresh perspectives from Parexel's team of experts across various disciplines.
• In December 2021, Wipro Limited announced the launch of regulatory literature monitoring, achieved through a new managed services agreement with Springer Nature. This partnership allows Wipro to offer a wider range of solutions to the pharmaceutical industry.

• Accenture
• Cognizant
• Laboratory Corporation of America Holdings
• IBM Corporation, ArisGloba
• Foresight Group International AG
• ICON PLC
• Capgemini
• United BioSource Corporation
• Wipro Ltd.