Medical Devices US

US Newborn Screening Market Analysis, 2024–2034

US Newborn Screening Market Industry Trends and Forecast to 2034: Segmented by (Test, Technology, End User, Region) - Growth, Market Size, Future Prospects & Competitive Analysis, 2024-2034

Overview

Market Dashboard

US · 2024–2034 · estimates

Values shown here are estimates. Researched 2024 historical, 2025 base-year and 2026–2034 forecast values are prepared with the full report.

Estimate 2024 $431.0 Mn Estimated value
Estimate 2025 $459.4 Mn 38.7% of the global market
Projected 2034 $816.6 Mn 77.8% Adds $357.2 Mn over 9 forecast years
CAGR 2025–2034 6.6% Faster than 49% of 173 Medical Devices markets here
Key players 5
  • US is 38.67% of the global market.
  • In North America, the largest is US (this report) at $459.4 Mn.
  • Fastest growing: Canada at 9.1% a year.
  • US ranks 1st of 2 by size in North America.

Market size projection

US

Source: Acuitas Health Analytics. Full methods, sources and usage terms come with report purchase.

Value added each year

$357.2 Mn total, 2026–2034

Year-by-year market size, 2024–2034
Newborn Screening Market market size by year, US
YearMarket sizeChange that yearSince 2025
2024 (estimate) $431.0 Mn — —
2025 (base) $459.4 Mn +$28.4 Mn —
2026 (forecast) $489.8 Mn +$30.3 Mn +6.6%
2027 (forecast) $522.1 Mn +$32.3 Mn +13.6%
2028 (forecast) $556.5 Mn +$34.5 Mn +21.1%
2029 (forecast) $593.3 Mn +$36.7 Mn +29.1%
2030 (forecast) $632.4 Mn +$39.2 Mn +37.7%
2031 (forecast) $674.2 Mn +$41.7 Mn +46.7%
2032 (forecast) $718.7 Mn +$44.5 Mn +56.4%
2033 (forecast) $766.1 Mn +$47.4 Mn +66.7%
2034 (forecast) $816.6 Mn +$50.6 Mn +77.8%

Estimates. Each year is projected from our earlier market estimate and its CAGR. Researched values come with the full report.

Same market worldwide

By geography

  1. Global $1.19 Bn
  2. North America $567.9 Mn
  3. US (this report) $459.4 Mn
  4. Europe $219.2 Mn
  5. APAC $219.1 Mn
  6. Canada $102.6 Mn
  7. China $90.1 Mn
  8. Japan $85.7 Mn
  9. Latin America $58.8 Mn
  10. Middle East $47.7 Mn
  11. Germany $39.8 Mn
  12. UK $31.3 Mn
  13. Brazil $31.6 Mn
  14. Italy $30.5 Mn
  15. France $28.9 Mn
  16. Saudi Arabia $23.7 Mn
  17. Ecuador $22.7 Mn
  18. Spain $20.0 Mn
  19. Africa $20.5 Mn
  20. India $19.9 Mn
  21. Mexico $15.6 Mn
  22. Australia $13.7 Mn
  23. New Zealand $12.6 Mn
  24. Russia $10.8 Mn
  25. South Africa $8.6 Mn
  26. UAE $5.4 Mn
  27. Egypt $3.1 Mn
  28. Philippines $2.5 Mn
  29. Malaysia $2.2 Mn
  30. Hong Kong $1.7 Mn
  31. Singapore $1.6 Mn
  32. Thailand $1.4 Mn
  33. Kenya $0.9 Mn

The US Newborn Screening Market Analysis Executive Summary

Newborn screening tests babies shortly after birth for rare but serious conditions such as metabolic, hormone and genetic disorders.

Key segments of the newborn Screening market include test (Dried Blood Spot Tests, Hearing Screening and Pulse Oximetry) and technology (Tandem Mass Spectrometry, Immunoassays and DNA Assays).

US Newborn Screening Market Dynamics

Market Growth Drivers

Demand for earlier and faster diagnosis, growth of testing outside hospitals, new molecular technologies and the shift to preventive care are driving the newborn Screening market.

Opportunity

Home testing, connected devices that send results to doctors and multiplex tests that check many conditions at once give the newborn Screening market room to grow, especially in emerging markets.

Market Restraints

Pricing pressure, uneven reimbursement for new tests, regulatory approval times and the need for skilled lab staff hold back the newborn Screening market.

Competitive Landscape for Newborn Screening Market in US

The newborn Screening market is moderately concentrated. Leading companies compete on product innovation, clinical evidence, pricing and geographic reach, and use partnerships and acquisitions to expand their portfolios.

Key Players

Healthcare Policies and Regulatory Landscape for Newborn Screening Market in US

Policy changes and Reimbursement scenario

Medical device rules, such as the US FDA 510(k) and PMA pathways and the EU Medical Device Regulation, govern how newborn Screening products are approved and monitored. Reimbursement codes and hospital purchasing policies decide how widely they are used in US.

Beyond the market numbers

Research, trials and patients

What doctors and scientists are doing in Newborn Screening right now, from free public sources.

Latest research 3,809 papers since 2021 (worldwide)

  1. Early-onset epilepsy and inborn errors of metabolism: A large retrospective pediatric cohort. Epilepsy & behavior : E&B, 2026
  2. [Newborn screening in Spain: equity, clinical value and challenges in the context of technological expansion]. Revista espanola de salud publica, 2026
  3. Regional newborn screening for Gaucher disease in Kumamoto and Fukuoka Prefectures, Japan: an updated report and long-term outcomes of screen-identified patients. Molecular genetics and metabolism, 2026
  4. Newborn Screening for Duchenne Muscular Dystrophy: Contemporary Considerations for Implementation of an Early Diagnostic Paradigm. Neurology, 2026
  5. Cystic fibrosis: remarkable success but still not at the finish line. Proceedings (Baylor University. Medical Center), 2026
Search all of them on PubMed (opens in a new tab)

Sources: PubMed (US National Library of Medicine), ClinicalTrials.gov, World Bank. Fetched 12 Nov 2026. Papers and trials are found by search words, so the counts are a guide. Titles only; read each paper at its source.

Public data, with sources

Newborn Screening in context

The US compared

  • Health spending per person: 13,473 US$ per person (2023). World: 1,317 US$ per person (2023).[1]
  • Doctors: 3.68 per 1,000 people (2022). World: 1.86 per 1,000 people (2022).[2]
  • People aged 65 and over: 18.4% of people (2025). World: 10.4% of people (2025).[3]

Questions, answered with public data

How much research is published on Newborn Screening?
PubMed lists 3,809 papers added since January 2021 that match this market, worldwide.[4]

[1] World Bank Open Data, Health spending per person (US$ per person). Retrieved 13 Nov 2026.

[2] World Bank Open Data, Doctors (per 1,000 people). Retrieved 13 Nov 2026.

[3] World Bank Open Data, People aged 65 and over (% of people). Retrieved 13 Nov 2026.

[4] PubMed, Papers added since 1 January 2021 matching this market. Retrieved 12 Nov 2026.

Free data on this topic

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