U.S. Newborn Screening Market Size & Outlook, 2025-2033

The newborn screening market in the United States is expected to reach a projected revenue of US$ 263.8 million by 2033. A compound annual growth rate of 8.3% is expected of the United States newborn screening market from 2025 to 2033.
Revenue, 2024 (US$M)
$130.4
Forecast, 2033 (US$M)
$263.8
CAGR, 2025 - 2033
8.3%
Report Coverage
U.S.

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U.S. newborn screening market, 2021-2033 (US$M)

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U.S. newborn screening market highlights

  • The U.S. newborn screening market generated a revenue of USD 130.4 million in 2024 and is expected to reach USD 263.8 million by 2033.
  • The U.S. market is expected to grow at a CAGR of 8.3% from 2025 to 2033.
  • In terms of segment, tandem mass spectrometry was the largest revenue generating technology in 2024.
  • Electrophoresis is the most lucrative technology segment registering the fastest growth during the forecast period.


Newborn screening market data book summary

Market revenue in 2024USD 130.4 million
Market revenue in 2033USD 263.8 million
Growth rate8.3% (CAGR from 2025 to 2033)
Largest segmentTandem mass spectrometry
Fastest growing segmentElectrophoresis
Historical data2021 - 2023
Base year2024
Forecast period2025 - 2033
Quantitative unitsRevenue in USD million
Market segmentationTandem Mass Spectrometry, Pulse Oximetry, Enzyme-based Assay, DNA Assays, Electrophoresis
Key market players worldwideBio-Rad Laboratories Inc, Agilent Technologies, Agilent Technologies Inc, Covidien, Masimo Corp, Waters Corp, Natus Medical, GE HealthCare Technologies Inc Common Stock, PerkinElmer, Danaher Corp


Other key industry trends

  • In terms of revenue, U.S. accounted for 14.5% of the global newborn screening market in 2024.
  • Country-wise, U.S. is expected to lead the global market in terms of revenue in 2033.
  • In North America, U.S. newborn screening market is projected to lead the regional market in terms of revenue in 2033.
  • Canada is the fastest growing regional market in North America and is projected to reach USD 38.8 million by 2033.

Tandem mass spectrometry was the largest segment with a revenue share of 26.61% in 2024. Horizon Databook has segmented the U.S. newborn screening market based on tandem mass spectrometry, pulse oximetry, enzyme-based assay, dna assays, electrophoresis covering the revenue growth of each sub-segment from 2021 to 2033.


Research in newborn screening technology is continuously carried on by the U.S. Developmental work on tandem mass spectrometry along with digital micro fluidics and nextgeneration sequencing for diagnosis of genetic dysfunctioning is the primary area of interest. Currently, the most frequently tested disorders are phenylketonuria and congenital hypothyroidism.

The National Birth Defects Prevention Network includes experts across the industry that work on volunteer basis to help maintain a national data and surveillance system for all the birth defect programs.

Their major focus lies on prevention of secondary disorders listed in the Recommended Uniform Screening Panel (RUSP). To raise awareness, health departments of the state have published free data and created websites that are expected to help parents to cope better with these conditions.

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Newborn Screening Market Companies

Name Profile # Employees HQ Website
Covidien View profile 10001+ Dublin, Dublin, Ireland, Europe http://www.covidien.com
Natus Medical View profile 1001-5000 San Carlos, California, United States, North America http://www.natus.com
Agilent Technologies View profile 10001+ Santa Clara, California, United States, North America http://www.agilent.com
PerkinElmer View profile 10001+ Waltham, Massachusetts, United States, North America http://www.perkinelmer.com
Masimo Corp View profile 3796 52 Discovery, Irvine, CA, United States, 92618 https://www.masimo.com
Waters Corp View profile 7900 34 Maple Street, Milford, MA, United States, 01757 https://www.waters.com
Bio-Rad Laboratories Inc View profile 8030 1000 Alfred Nobel Drive, Hercules, CA, United States, 94547 https://www.bio-rad.com
Agilent Technologies Inc View profile 17700 5301 Stevens Creek Boulevard, Santa Clara, CA, United States, 95051 https://www.agilent.com
Danaher Corp View profile 63000 2200 Pennsylvania Avenue, N.W., Suite 800W, Washington, DC, United States, 20037-1701 https://www.danaher.com
GE HealthCare Technologies Inc Common Stock View profile 51000 500 West Monroe Street, Chicago, IL, United States, 60661 https://www.gehealthcare.com

U.S. newborn screening market size, by technology, 2021-2033 (US$M)

U.S. Newborn Screening Market Outlook Share, 2024 & 2033 (US$M)

U.S. newborn screening market size, by technology, 2021-2033 (US$M)

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