The pharmacovigilance market size was exhibited at USD 7.55 billion in 2024 and is projected to hit around USD 13.78 billion by 2033, growing at a CAGR of 6.2% during the forecast period 2024 to 2033.
The U.S. pharmacovigilance market size was exhibited at USD 188.60 million in 2024 and is projected to hit around USD 290.10 million by 2033, growing at a CAGR of 4.4% during the forecast period 2024 to 2033.
North America dominated the pharmacovigilance market in 2023 and held the largest market share of over 33.0%. This can be attributed to the presence of key pharmaceutical players in this region, which results in a major contribution to the overall revenue generated by this region. The rise in drug abuse and associated ADRs is a leading cause of morbidity and mortality. The abovementioned elements act as high-growth rendering factors for North America's Pharmacovigilance (PV) market. Furthermore, growing patient awareness and concerns related to the safety of drugs are expected to positively impact the market.
U.S. Pharmacovigilance Market Trends
Pharmacovigilance market in the U.S. held the largest market share in 2023, owing to high drug consumption and strict regulatory environment. The U.S. FDA strictly regulates pharmacovigilance activities for drugs and medical devices for New Drug Applications (NDA). Implementation of acts and regulations such as Risk Evaluation and Mitigation Strategy (REMS) Act to unveil the potential risks associated with a drug following a series of drug safety-related events. Drugs that fail to follow the REMS provision could be considered misbranded. Such factors are expected to fuel the market growth.
Europe Pharmacovigilance Market Trends
The pharmacovigilance market in Europe is driven by stringent regulatory requirements, increasing drug development, and growing awareness of drug safety. In 2020, 16,256 clinical trials were registered, primarily by the European pharmaceutical industry. Moreover, in 2021, 3.5 million adverse ADRs were received by EudraVigilance, a 93% increase from the previous year. The European Medicine Agency (EMA) has implemented a Risk Management Plan (RMP) for the PV system, requiring approval for every drug or biologic before commercialization. The EMA has also launched www.adrreports.eu, a new public website that publishes suspected adverse effects of all medicines and active substances authorized under the European Economic Area. Furthermore, the growing demand for clinical trials and the need for novel drug development due to the geriatric population and an increasing number of pharmaceutical and biotechnology firms are the factors driving the market growth in the region
| Report Coverage | Details |
| Market Size in 2024 | USD 8.02 Billion |
| Market Size by 2033 | USD 13.78 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 6.2% |
| Base Year | 2023 |
| Forecast Period | 2024-2033 |
| Segments Covered | Service Provider, Product Life Cycle, Type, Process Flow, Therapeutic Area, End use, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Regional scope | North America, Europe, Asia Pacific, Latin America, MEA |
| Key Companies Profiled | Accenture; IQVIA; Cognizant; Clinquest Group B.V. (Linical Americas); IBM; Laboratory Corporation of America Holdings; ArisGlobal; Capgemini; ITClinical; ICON plc.; TAKE Solutions Ltd.; PAREXEL International Corporation.; Wipro; United BioSource LLC; BioClinica Inc (Clario).; ClinChoice (formerly FMD K&L) |
The pharmacovigilance market is currently experiencing moderate growth at an accelerating pace. This growth is attributed to factors such as rising drug consumption and development rates, a higher incidence of adverse drug reactions (ADR) and drug toxicity, and an increasing trend in outsourcing pharmacovigilance services. Outsourced services include medical writing, clinical trial data collection, medical reporting, and other pharmacovigilance-related services. Manufacturers are actively seeking ways to reduce costs and minimize operational expenses by transitioning from fully integrated pharmaceutical companies to collaborative partnerships with service providers.
Market players are utilizing key strategies, including new product launches, expansions, acquisitions, partnerships, etc. For instance, In January 2023, IQVIA announced a collaboration with Alibaba Cloud, an intelligence and digital technology arm of Alibaba Group. The goal of this collaboration is to deliver commercial clinical solutions in the Chinese market.
Phase IV (post-marketing) segment dominated the overall pharmacovigilance market in the product life cycle segment with over 75.9% revenue share in 2023. The phase IV trial is crucial in the entire clinical trial process as unsuspected ADRs can be detected in this stage. This can be attributed to intensive drug testing on a large patient demographic of the highest relevance post the drug commercialization. A phase IV study is conducted on a nonmedicated population. Some examples of phase clinical studies are:
Phase III segment in the product life cycle segment is projected to witness growth at a lucrative CAGR during the forecast period. Phase III trials are conducted to specify and establish drug efficacy. These trials provide supplementary information about drug safety, possible drug interactions, and pre-commercialization effectiveness. In addition, players operating in the segment are undertaking strategic initiatives to integrate effective trial management practices in drug development and trials. For instance, in June 2022, Florence Healthcare raised USD 27 million to support the expansion of its technology platform to integrate the growing demand for clinical trials. These factors are anticipated to drive the segment over the forecast period.
The contract outsourcing segment held the largest market share of 60.4% in 2023. The segment dominated the market owing to the rapid entry of multiple Contract Research Organizations (CROs), which provide end-to-end clinical trial solutions, especially in key Asia Pacific economies of India, China, & Japan. The segment is anticipated to grow at the fastest CAGR over the forecast period, as contract outsourcing partners offer a balanced and flexible solution within cost-contained models, ensuring overall quality. Pharmacovigilance outsourcing now encompasses intricate tasks, including benefit-risk management, signal detection, pharmacoeconomics, and comprehensive risk management planning.
The spontaneous reporting segment dominated the market in 2023 with a share of 30.2%, owing to its wide-scale usage in detecting new, serious, and rare ADRs efficiently & affordably. The growing use of surveillance reports developed through this procedure by regulatory authorities and pharmaceutical industries is responsible for the significant market share of spontaneous reporting.
The targeted spontaneous reporting segment is anticipated to witness a lucrative CAGR during the forecast period, owing to the rising government initiatives to incorporate reporting methodologies other than spontaneous reporting by the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Associated benefits such as greater affordability, lower labor costs, feasibility in poor resource settings, and usage in routine monitoring are expected to drive the demand over the forecast period. These factors are contributing to a steady growth of this segment.
The oncology segment dominated the pharmacovigilance market, with a share of 26.9% in 2023. It is also expected to be the fastest-growing segment over the forecast period. Pharmacovigilance in oncology refers to the specialized monitoring and assessment of safety data related to anticancer drugs and therapies. It involves the systematic collection and analysis of adverse events specific to oncology patients, identification of potential drug-related risks, and proactive risk management strategies to ensure cancer treatments' safe and effective use.
An increasing number of research activities undertaken by various biopharmaceutical firms for cancer treatments and the rising government support to improve the living conditions of people living with cancer propelling the research activities is anticipated to accelerate the need for pharmacovigilance in clinical research activities. For instance, the White House in 2023 announced an ambitious project to reduce the death rate of Cancer by at least 50.0% in the next 25 years. In addition, USD 2 billion was granted for R&D purposes in the Cancer Moonshot initiative, which will support clinical, laboratory, public health, and others for cancer treatment. These factors are responsible for the growth and dominance of the segment during the forecast period.
The signal detection segment held the largest revenue share in 2023. Signal detection refers to identifying various safety signals and actively searching for such signals across registries and plausible healthcare data sources. Regulators require biopharmaceutical firms to maintain spontaneous reporting systems, and most commonly, signals are generated from such systems. Furthermore, data for processes can be stored in databases maintained by the pharmaceutical firm, a technology partner, or a contract research organization. The signal source may vary from spontaneous reporting, interventional studies, and clinical & non-clinical studies to literature, social media, free text, etc.; thus, effective signal detection is important.
The case data management segment is anticipated to grow at a lucrative CAGR in the coming years. As adverse event information can be produced from diverse modes such as spontaneous reports, clinical trials, post-marketing programs, and literature. In addition, emerging technologies such as artificial intelligence (AI) and machine learning are widely used for case data management. Some data management software include repClinical, PvNET, Siebel Clinical, ClinSource, Oracle, and more.
The pharmaceuticals segment dominated the market with a revenue share of over 44.0% in 2023. Pharmacovigilance for pharmaceutical companies involves systematically collecting, monitoring, and evaluating safety data related to their marketed drugs or investigational products. It ensures compliance with regulatory requirements, promotes patient safety, and supports the ongoing evaluation and optimization of drug safety profiles. Moreover, pharmacovigilance allows pharmaceutical firms to limit drug development costs, as it provides an early warning system.
The biotechnology companies segment is expected to grow at the fastest CAGR during the forecast period. Biotechnology firms prioritize the development of innovative products, such as novel therapies, biologics, and gene therapies. These products often leverage cutting-edge technologies and may target rare diseases or feature unique mechanisms of action. For instance, in December 2022, the U.S. FDA approved ADSTILADRIN biologic manufactured by Ferring Pharmaceuticals A/S. This biologic is indicated for use in adult patients with high-risk BCG-unresponsive nonmuscle invasive bladder cancer. Such advancements are expected to propel the segment growth over the forecast period.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the pharmacovigilance market
Product Life Cycle
Service Provider
Type
End Use
Therapeutic Area
Process Flow
Regional
Cross-segment Market Size and Analysis for Mentioned Segments
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