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North America Newborn Screening Market Size & Outlook

The newborn screening market in North America is expected to reach a projected revenue of US$ 340.6 million by 2033. A compound annual growth rate of 8.4% is expected of North America newborn screening market from 2026 to 2033.

  • Clinical Diagnostics
    • Genetic Testing
      • Newborn Screening Market Outlook
Revenue, 2025 (US$M)
$180.4
Estimate, 2026 (US$M)
$193.9
Forecast, 2033 (US$M)
$340.6
CAGR, 2026 - 2033
8.4%
North America Newborn Screening Market, 2021-2033 (US$M)

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North America newborn screening market highlights

  • The North America newborn screening market generated a revenue of USD 180.4 million in 2025.
  • The market is expected to grow at a CAGR of 8.4% from 2026 to 2033.
  • In terms of segment, tandem mass spectrometry was the largest revenue generating technology in 2025.
  • Electrophoresis is the most lucrative technology segment registering the fastest growth during the forecast period.
  • Country-wise, Canada is expected to register the highest CAGR from 2026 to 2033.


North America data book summary

Market revenue in 2025USD 180.4 million
Market revenue in 2033USD 340.6 million
Growth rate8.4% (CAGR from 2026 to 2033)
Largest segmentTandem mass spectrometry
Fastest growing segmentElectrophoresis
Historical data covered2021 - 2024
Base year for estimation2025
Forecast period covered2026 - 2033
Quantitative unitsRevenue in USD million
Market segmentationTandem Mass Spectrometry, Electrophoresis, Pulse Oximetry, Enzyme-based Assay, DNA Assays
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, North America region accounted for 18.7% of the global newborn screening market in 2025.
  • Globally, Asia Pacific is projected to lead the regional market in terms of revenue in 2033.
  • Asia Pacific is the fastest growing regional market and is projected to reach USD 630.2 million by 2033.

Newborn screening program is diligently followed in all the states of North America. According to statistics published by CDC’s in 2013, more than four million babies born annually are screened for various possible conditions.

Recently, ACMG has deviated from the traditional screening criteria and added new conditions to the list. Hearing screen was added in 2011. Congenital disorders left undetected may lead to arrested mental and physical development, hampering the life-long health of individuals.

North America is highly active in its aim to retain health and well-being of future citizens, and has advocacy groups and federal government, which provide funding to promote market growth. The National Association for Retarded Citizens (NARC) along with Public Health Services have initiated pilot diagnoses program in collaboration with state laboratories.

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Publish Date: Nov 10, 2025

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Newborn Screening Market Companies

NameProfile# EmployeesHQWebsite
GE HealthCare Technologies Inc Common StockView profile 51,000500 West Monroe Street, Chicago, IL, United States, 60661www.gehealthcare.com
Danaher CorpView profile 63,0002200 Pennsylvania Avenue, N.W., Suite 800W, Washington, DC, United States, 20037-1701www.danaher.com
Agilent Technologies IncView profile 17,7005301 Stevens Creek Boulevard, Santa Clara, CA, United States, 95051www.agilent.com
Bio-Rad Laboratories IncView profile 8,0301000 Alfred Nobel Drive, Hercules, CA, United States, 94547www.bio-rad.com
Waters CorpView profile 7,90034 Maple Street, Milford, MA, United States, 01757www.waters.com
Masimo CorpView profile 3,79652 Discovery, Irvine, CA, United States, 92618www.masimo.com
PerkinElmerView profile 10001+Waltham, Massachusetts, United States, North Americawww.perkinelmer.com
Agilent TechnologiesView profile 10001+Santa Clara, California, United States, North Americawww.agilent.com
Natus MedicalView profile 1001-5000San Carlos, California, United States, North Americawww.natus.com
CovidienView profile 10001+Dublin, Dublin, Ireland, Europewww.covidien.com

North America Newborn Screening 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 Newborn Screening Market Outlook will help companies and investors design strategic landscapes.


Tandem Mass Spectrometry was the largest segment with a revenue share of 26.77% in 2025.

Horizon Databook has segmented the North America newborn screening market based on tandem mass spectrometry, electrophoresis, pulse oximetry, enzyme-based assay, dna assays covering the revenue growth of each sub-segment from 2021 to 2033.




Newborn screening program is diligently followed in all the states of North America. According to statistics published by CDC’s in 2013, more than four million babies born annually are screened for various possible conditions.

Recently, ACMG has deviated from the traditional screening criteria and added new conditions to the list. Hearing screen was added in 2011. Congenital disorders left undetected may lead to arrested mental and physical development, hampering the life-long health of individuals.

North America is highly active in its aim to retain health and well-being of future citizens, and has advocacy groups and federal government, which provide funding to promote market growth. The National Association for Retarded Citizens (NARC) along with Public Health Services have initiated pilot diagnoses program in collaboration with state laboratories.

  • North America Newborn Screening Market Technology Outlook (Revenue, USD Million , 2021-2033)
    • Tandem Mass Spectrometry
    • Pulse Oximetry
    • Enzyme-based Assay
    • DNA Assays
    • Electrophoresis
    • Others
  • North America Newborn Screening Market Test Type Outlook (Revenue, USD Million , 2021-2033)
    • Dry Blood Spot Test
    • CCHD
    • Hearing Screen
  • North America Newborn Screening Market Product Outlook (Revenue, USD Million , 2021-2033)
    • Instruments
    • Reagents

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Horizon Databook provides a detailed overview of continent-level data and insights on the North America Newborn Screening Market Outlook, including forecasts for subscribers. This continent databook contains high-level insights into North America Newborn Screening Market Outlook from 2021 to 2033, including revenue numbers, major trends, and company profiles.

North America Newborn Screening Market, 2021-2033 (US$M)

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North America newborn screening market statistics, by technology, 2021-2033 (US$M)

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North America newborn screening market statistics, by country, 2021-2033 (USD Million)

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