Pharmacovigilance Market 2025–2030 — Comprehensive Industry Growth & Forecast Report

The global pharmacovigilance market size was estimated at USD 7.95 billion in 2024 and is projected to reach USD 11.78 billion by 2030, growing at a CAGR of 6.5% from 2025 to 2030. The market’s growth is primarily driven by the rising incidence of Adverse Drug Reactions (ADRs) due to factors such as drug abuse and the increasing use of combination therapies for treating complex diseases.

Furthermore, the upward trend in the production of novel drugs and the presence of stringent regulatory frameworks governing drug safety significantly bolster market expansion. Regulatory bodies such as the U.S. FDA and the European Medicines Agency (EMA) formulate and enforce guidelines across all phases of clinical trials, ensuring that safety monitoring and reporting are maintained throughout the drug development lifecycle. Additionally, advancements in the development of ADR databases and information systems have facilitated accurate and timely reporting of drug-related adverse events. These systems enable researchers and healthcare professionals to utilize the data for prospective clinical studies, contributing to safer drug development and further fueling market growth.

The global rise in drug consumption due to the increasing prevalence of chronic and lifestyle-related diseases is another critical driver. Chronic conditions such as cancers, diabetes, cardiovascular disorders, and respiratory diseases have led to higher medication usage worldwide. According to a WHO report on pharmaceutical consumption, drugs used to treat chronic diseases account for a larger proportion of total drug use in nonhospital settings. Over the past five years, the global use of medicines has increased by 414 billion defined daily doses (DDD) and is projected to rise by an additional 400 billion DDD by 2028. This surge highlights the growing necessity for robust pharmacovigilance systems to monitor drug safety and efficacy across various populations and therapeutic areas.

The increasing incidence of ADRs and drug toxicity further reinforces the demand for pharmacovigilance services. Data from the National Center for Biotechnology Information (NCBI) indicates that approximately 5% of total hospitalizations in Europe each year are due to ADRs. Moreover, a study published in February 2022 in the Journal of Current Medicine Research and Practice, titled "Characterization of Seriousness and Outcome of Adverse Drug Reactions in Patients Receiving Cancer Chemotherapy Drugs - A Prospective Observational Study", revealed that serious ADRs in the U.S. result in over 100,000 deaths annually, underscoring the critical need for continuous drug safety monitoring and the growth of the pharmacovigilance industry.

Key Market Trends & Insights:

• North America dominated the global pharmacovigilance market in 2024, holding the largest revenue share of over 32.11%. This regional dominance is primarily driven by the high prevalence of Adverse Drug Reactions (ADRs), which is closely linked to the elevated drug consumption in the region. The U.S. pharmacovigilance industry remains the largest contributor within North America, owing to advanced healthcare infrastructure, stringent regulatory requirements, and a growing need for continuous monitoring of drug safety.

• By product, the phase IV (post-marketing) segment led the pharmacovigilance market in the product life cycle category, accounting for over 75.90% of revenue in 2024. Phase IV monitoring is critical as it involves continuous surveillance of drugs after they have been released to the market, ensuring their long-term safety, identifying rare adverse effects, and supporting regulatory compliance.

• By service provider, the contract outsourcing segment held the largest share of the market in 2024. Pharmaceutical and biotechnology companies increasingly rely on outsourcing pharmacovigilance services to specialized Contract Research Organizations (CROs) and other third-party providers. This approach enables companies to leverage external expertise, advanced technology, and cost efficiencies while maintaining compliance with regulatory requirements.

• By installation, the spontaneous reporting segment dominated the pharmacovigilance market in 2024, holding the largest share. Spontaneous reporting involves the collection and evaluation of ADRs reported voluntarily by healthcare professionals, patients, or manufacturers. It is a fundamental method of pharmacovigilance that helps identify unexpected adverse effects and contributes significantly to the ongoing assessment of drug safety across diverse populations.

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Market Size & Forecast:

• 2024 Market Size: USD 7.95 Billion

• 2030 Projected Market Size: USD 11.78 Billion

• CAGR (2025-2030): 6.5%

• North America: Largest market in 2024

• Asia Pacific: Fastest growing market

Key Companies & Market Share Insights:

The pharmacovigilance market is highly fragmented, comprising a mix of both small and large companies that offer diverse services and solutions. This fragmentation results in intense competition, particularly among smaller players, as they strive to maintain their market positions and expand their reach. To stay competitive, companies are increasingly adopting strategies such as new product launches, service expansions, strategic partnerships, and collaborations, which play a crucial role in driving overall market growth.

For example, in November 2022, Linical Americas, a U.S. subsidiary of The Linical Group, entered into a partnership with Science 37 Holdings, Inc. The collaboration aims to enable the deployment of hybrid and fully decentralized clinical trials, allowing for broader and more efficient access to Linical’s pharmacovigilance services. This partnership highlights how strategic alliances can enhance a company’s service offerings, improve operational efficiency, and strengthen its market position in an increasingly competitive pharmacovigilance landscape. Such initiatives are expected to continue shaping the growth trajectory of the global market, fostering innovation and improving access to advanced drug safety monitoring solutions.

Key Players

• Accenture

• IQVIA Inc.

• Cognizant

• Clinquest Group B.V. (Linical Americas)

• IBM

• Laboratory Corporation of America Holdings

• ArisGlobal

• Capgemini

• ITClinical

• ICON plc.

• TAKE Solutions Limited

• Parexel International (MA) Corporation

• Wipro

• United BioSource LLC

• BioClinica Inc. (Clario)

• ClinChoice (formerly FMD K&L)

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Conclusion:

The pharmacovigilance market is set for robust growth over the coming years, driven by a rising incidence of adverse drug reactions (ADRs), higher drug consumption, and increased development of novel therapies. Growing global regulatory scrutiny and the need for comprehensive safety monitoring make pharmacovigilance services essential. Outsourcing remains the dominant delivery model, enabling pharmaceutical and biotechnology firms to handle complex safety surveillance cost effectively. The expansion of post marketing monitoring (Phase IV) and the use of advanced data management and reporting tools further strengthen market demand.