U.S. Pharmacovigilance Market Size & Outlook, 2025-2030
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U.S. pharmacovigilance market highlights
- The U.S. pharmacovigilance market generated a revenue of USD 2,116.1 million in 2024 and is expected to reach USD 2,775.8 million by 2030.
- The U.S. market is expected to grow at a CAGR of 4.4% from 2025 to 2030.
- In terms of segment, phase 4 was the largest revenue generating product life cycle in 2024.
- Phase 1 is the most lucrative product life cycle segment registering the fastest growth during the forecast period.
Pharmacovigilance market data book summary
| Market revenue in 2024 | USD 2,116.1 million |
| Market revenue in 2030 | USD 2,775.8 million |
| Growth rate | 4.4% (CAGR from 2025 to 2030) |
| Largest segment | Phase 4 |
| Fastest growing segment | Phase 1 |
| Historical data | 2018 - 2023 |
| Base year | 2024 |
| Forecast period | 2025 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | Phase 2, Phase 1, Phase 3, Phase 4, Pre Clinical |
| Key market players worldwide | Accenture PLC Class A, IQVIA Holdings Inc, Cognizant Technology Solutions Corp Class A, Linical Americas, International Business Machines Corp, Labcorp Holdings Inc, ArisGlobal, Capgemini SE, ITClinical, Icon PLC, TAKE Solutions, PAREXEL, Wipro Ltd ADR, United Biosource Corporation, FMD K&L, BioClinica |
Other key industry trends
- In terms of revenue, U.S. accounted for 26.6% of the global pharmacovigilance market in 2024.
- Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
- In North America, U.S. pharmacovigilance market is projected to lead the regional market in terms of revenue in 2030.
- Canada is the fastest growing regional market in North America and is projected to reach USD 697.7 million by 2030.
Phase 4 was the largest segment with a revenue share of 80.38% in 2024. Horizon Databook has segmented the U.S. pharmacovigilance market based on phase 2, phase 1, phase 3, phase 4, pre clinical covering the revenue growth of each sub-segment from 2018 to 2030.
The U.S. held the dominant share of the pharmacovigilance market owing to a high incidence of Adverse Drug Reactions (ADRs) in this region due to high drug consumption. In 2007, U.S. FDA implemented Risk Evaluation and Mitigation Strategy (REMS) Act to unveil the potential risks associated with a drug following a series of drug safety-related events.
After the implementation of this act, all manufacturers of drugs were required to submit REMS to the FDA. Drugs that fail to follow the REMS provision could be considered misbranded. Moreover, the U.S. FDA launched Sentinel Initiative in 2008, a national electronic system that tracks the safety of drugs and medical devices.
The increasing geriatric population and rising prevalence of chronic diseases have resulted in the rise in demand for the development of novel drugs, which in turn is expected to boost the demand for clinical trials in the U.S. In addition, the presence of various biotechnology funding initiatives in this region is expected to significantly increase the volume of clinical trials, thereby propelling demand for Pharmacovigilance (PV) services over the forecast period.
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Pharmacovigilance Market Scope
Pharmacovigilance Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|---|---|---|---|
| BioClinica | View profile | 1001-5000 | Newtown, Pennsylvania, United States, North America | http://www.bioclinica.com |
| FMD K&L | View profile | 51-100 | Fort Washington, Pennsylvania, United States, North America | https://clinchoice.com |
| United Biosource Corporation | View profile | 1001-5000 | Bethesda, Maryland, United States, North America | http://ubc.com |
| ITClinical | View profile | 11-50 | Lisboa, Lisboa, Portugal, Europe | https://itclinical.com/ |
| Linical Americas | View profile | 501-1000 | Stuart, Florida, United States, North America | https://www.linicalamericas.com |
| TAKE Solutions | View profile | 1001-5000 | Princeton, New Jersey, United States, North America | http://www.takesolutions.com |
| Capgemini SE | View profile | 340400 | 11 rue de Tilsitt, Paris, France, 75017 | https://www.capgemini.com |
| ArisGlobal | View profile | 1001-5000 | Coral Gables, Florida, United States, North America | https://www.arisglobal.com |
| PAREXEL | View profile | 10001+ | Waltham, Massachusetts, United States, North America | http://www.parexel.com |
| IQVIA Holdings Inc | View profile | 87000 | 2400 Ellis Road, Durham, NC, United States, 27703 | https://www.iqvia.com |
| Icon PLC | View profile | 41150 | South County Business Park, Leopardstown, Dublin, Ireland, D18 X5R3 | https://www.iconplc.com |
| Labcorp Holdings Inc | View profile | 67000 | 358 South Main Street, Burlington, NC, United States, 27215 | https://www.labcorp.com |
| Cognizant Technology Solutions Corp Class A | View profile | 344400 | 300 Frank West Burr Boulevard, Suite 36, 6th Floor, Teaneck, NJ, United States, 07666 | https://www.cognizant.com |
| Accenture PLC Class A | View profile | 742000 | 1 Grand Canal Square, Grand Canal Harbour, Dublin, Ireland, 2 | https://www.accenture.com |
| Wipro Ltd ADR | View profile | 244707 | Sarjapur Road, Doddakannelli, Bangalore, KA, India, 560 035 | https://www.wipro.com |
| International Business Machines Corp | View profile | 282200 | One New Orchard Road, Armonk, NY, United States, 10504 | http://www.ibm.com |
U.S. pharmacovigilance market size, by product life cycle, 2018-2030 (US$M)
U.S. Pharmacovigilance Market Outlook Share, 2024 & 2030 (US$M)
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