U.S. Pharmacovigilance Market Size & Outlook, 2023-2030

The pharmacovigilance market in the United States is expected to reach a projected revenue of US$ 2,756.1 million by 2030. A compound annual growth rate of 4.9% is expected of the United States pharmacovigilance market from 2024 to 2030.
Revenue, 2023 (US$M)
$1,987.4
Forecast, 2030 (US$M)
$2,775.8
CAGR, 2024 - 2030
4.9%
Report Coverage
U.S.

U.S. pharmacovigilance market highlights

  • The U.S. pharmacovigilance market generated a revenue of USD 1,987.4 million in 2023 and is expected to reach USD 2,775.8 million by 2030.
  • The U.S. market is expected to grow at a CAGR of 4.9% from 2024 to 2030.
  • In terms of segment, phase 4 was the largest revenue generating product life cycle in 2023.
  • 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 2023USD 1,987.4 million
Market revenue in 2030USD 2,775.8 million
Growth rate4.9% (CAGR from 2023 to 2030)
Largest segmentPhase 4
Fastest growing segmentPhase 1
Historical data2018 - 2022
Base year2023
Forecast period2024 - 2030
Quantitative unitsRevenue in USD million
Market segmentationPre Clinical, Phase 1, Phase 2, Phase 3, Phase 4
Key market players worldwideAccenture 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 27.2% of the global pharmacovigilance market in 2023.
  • 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 75.83% in 2023. Horizon Databook has segmented the U.S. pharmacovigilance market based on pre clinical, phase 1, phase 2, phase 3, phase 4 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 Companies

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U.S. pharmacovigilance market size, by product life cycle, 2018-2030 (US$M)

U.S. Pharmacovigilance Market Outlook Share, 2023 & 2030 (US$M)

U.S. pharmacovigilance market size, by product life cycle, 2018-2030 (US$M)

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