U.S. Companion Diagnostics Market Size & Outlook

The companion diagnostics market in the United States is expected to reach a projected revenue of US$ 4,938.4 million by 2030. A compound annual growth rate of 8.5% is expected of the United States companion diagnostics market from 2025 to 2030.
Revenue, 2024 (US$M)
$3,018.9
Forecast, 2030 (US$M)
$4,938.4
CAGR, 2025 - 2030
8.5%
Report Coverage
U.S.

U.S. companion diagnostics market, 2018-2030 (US$M)

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U.S. companion diagnostics market, 2018-2030 (US$M)

U.S. companion diagnostics market highlights

  • The U.S. companion diagnostics market generated a revenue of USD 3,018.9 million in 2024 and is expected to reach USD 4,938.4 million by 2030.
  • The U.S. market is expected to grow at a CAGR of 9% from 2025 to 2030.
  • In terms of segment, assays, kits, and reagents was the largest revenue generating product and services in 2024.
  • Software and Services is the most lucrative product and services segment registering the fastest growth during the forecast period.


Companion diagnostics market data book summary

Market revenue in 2024USD 3,018.9 million
Market revenue in 2030USD 4,938.4 million
Growth rate9% (CAGR from 2025 to 2030)
Largest segmentAssays, kits, and reagents
Fastest growing segmentSoftware and Services
Historical data2018 - 2023
Base year2024
Forecast period2025 - 2030
Quantitative unitsRevenue in USD million
Market segmentationAssays, Kits, and Reagents, Instruments and Systems, Software and Services


Other key industry trends

  • In terms of revenue, U.S. accounted for 33.3% of the global companion diagnostics 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. companion diagnostics market is projected to lead the regional market in terms of revenue in 2030.
  • Mexico is the fastest growing regional market in North America and is projected to reach USD 305.9 million by 2030.

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Companion Diagnostics Market Companies

Name Profile # Employees HQ Website

U.S. companion diagnostics market outlook

The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to companion diagnostics market will help companies and investors design strategic landscapes.


Assays, kits, and reagents was the largest segment with a revenue share of 62.97% in 2024. Horizon Databook has segmented the U.S. companion diagnostics market based on assays, kits, and reagents, instruments and systems, software and services covering the revenue growth of each sub-segment from 2018 to 2030.


The U.S. is projected to see significant market expansion, driven by the high prevalence of chronic diseases (including cancer) and the rapid adoption of advanced diagnostic solutions. 

Ongoing technological advancements, frequent FDA approvals for novel tests, and growing competition among biotechnology companies further bolster market growth prospects in the country.

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Target buyers of U.S. companion diagnostics market databook

  • Our clientele includes a mix of companion diagnostics market companies, investment firms, advisory firms & academic institutions.
  • 30% of our revenue is generated working with investment firms and helping them identify viable opportunity areas.
  • Approximately 65% of our revenue is generated working with competitive intelligence & market intelligence teams of market participants (manufacturers, service providers, etc.).
  • The rest of the revenue is generated working with academic and research not-for-profit institutes. We do our bit of pro-bono by working with these institutions at subsidized rates.

Horizon Databook provides a detailed overview of country-level data and insights on the U.S. companion diagnostics market , including forecasts for subscribers. This country databook contains high-level insights into U.S. companion diagnostics market from 2018 to 2030, including revenue numbers, major trends, and company profiles.

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US Product And Services - Companion Diagnostics Market size, 2024 - 2030 (US$M)

U.S. Companion Diagnostics Market Outlook Share, 2024 & 2030 (US$M)

US Product And Services - Companion Diagnostics Market size, 2024 - 2030 (US$M)

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