Newborn Screening Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

The Newborn Screening Market is segmented by Technology, Test Type, End User (Hospitals, Diagnostic Centers, and Other End Users), and Geography.

Market Snapshot

Newborn Screening Market
Study Period:

2018 - 2026

Base Year:


Fastest Growing Market:

Asia Pacific

Largest Market:

North America


9 %

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Market Overview

Factors that are responsible for the growth of the newborn screening market include growing newborn screening programs, rising incidences of congenital diseases, raising funding from government sectors for newborn screening, and advancements in technologies used in newborn screening.

  • Newborn screening represents one of the major child health advances of the past century, and there have been many advancements in the technologies used in newborn screening. The rapid pace of developments in the field of newborn screening has been made possible, by technological advances in the ability to detect multiple compounds diagnostic of different inborn errors of metabolism in neonatal dried blood specimens. After the success of newborn screening in phenylketonuria, experts in this area are optimistic that further health benefits may arise in the future. 
  • Also, one of the most exciting and powerful advancements in this field is the commercialization of hybrid instruments. The manufacturers are focusing on the high sensitivity, resolution, throughput, and cost-effectiveness to gain a foothold in the market. Hence, many companies have been influenced by emerging technologies and have adopted many new clinical testing platforms for use.
  • However, factors, such as the lack of uniformity of newborn screening policies and procedures, across the world, may hinder the market growth.

Scope of the Report

Newborn screening is a preventive pediatric screening test conducted to diagnose congenital or inborn abnormalities of metabolism, in order to identify the disease. The early detection and appropriate standards of diagnosis and treatment can prevent death and promote the healthy development of an infant.

By Technology
Tandem Mass Spectrometry
Pulse Oximetry
Enzyme Based Assays
DNA Assays
Other Technologies
By Test Type
Dried Blood Spot
Hearing Screening
Critical Congenital Heart Defect (CCHD)
Other Test Types
By End User
Diagnostic Centers
Other End Users
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle-East and Africa
South Africa
Rest of Middle-East and Africa
South America
Rest of South America

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Key Market Trends

The Dried Blood Spot Segment is Expected to Hold the Major Revenue Share

Dried blood spot tests (DBS) are expected to continue their domination during the forecast period. DBS sampling has been used to screen newborn babies for congenital metabolic diseases for over 50 years. The advantages of DBS sampling include minimal volume requirements (approximately 30 – 100 µL per spot), ease of sample attainment by finger or heel stick with minimal training required, and ease of transport and sample stability. Autism, lymphomas and leukemia, and many other metabolic conditions can be diagnosed through this test. Dried blood spot analysis offers the advantage of collecting a small sample volume, which can be easily transported. Thus, rising diseases in newborns are boosting the market growth.


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North America Dominates the Market and is Expected to do Same during the Forecast Period

Currently, North America dominates the market for newborn screening and is expected to continue its stronghold for a few more years. This is primarily due to the growing prevalence of congenital disorders and enforced testing in all the 50 states of the nation. In the North American region, the United States holds the largest market share. This can be majorly attributed to the increasing incidence rates of disorders in newborns and the rising demand for advanced systems. The presence of developed healthcare infrastructure is expected to further propel the market in the United States.

Newborn Screening Market

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Competitive Landscape

The newborn screening market is moderately competitive and consists of several major players. In terms of the market share, few of the major players currently dominate the market. A large portion of the market share is held by companies, like Agilent Technologies Inc., Natus Medical Inc., Trivitron Healthcare, Medtronic Inc., Masimo Corp., and Bio-Rad Laboratories Inc., among others.

Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Rising Incidences of Congenital Diseases

      2. 4.2.2 Rising Funding from Government Sectors for Newborn Screening

      3. 4.2.3 Advancements in Technologies Used in Newborn Screening

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Uniformity of Newborn Screening Policies and Procedures, Across the World

      2. 4.3.2 False Positive and False Negative Results

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 By Technology

      1. 5.1.1 Tandem Mass Spectrometry

      2. 5.1.2 Pulse Oximetry

      3. 5.1.3 Enzyme Based Assays

      4. 5.1.4 DNA Assays

      5. 5.1.5 Other Technologies

    2. 5.2 By Test Type

      1. 5.2.1 Dried Blood Spot

      2. 5.2.2 Hearing Screening

      3. 5.2.3 Critical Congenital Heart Defect (CCHD)

      4. 5.2.4 Other Test Types

    3. 5.3 By End User

      1. 5.3.1 Hospitals

      2. 5.3.2 Diagnostic Centers

      3. 5.3.3 Other End Users

    4. 5.4 Geography

      1. 5.4.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.4.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.4.4 Middle-East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle-East and Africa

      5. 5.4.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 AB Sciex

      2. 6.1.2 Bio-Rad Laboratories Inc.

      3. 6.1.3 GE Healthcare

      4. 6.1.4 Masimo Corporation

      5. 6.1.5 Medtronic Inc.

      6. 6.1.6 Natus Medical Incorporated

      7. 6.1.7 PerkinElmer Inc.

      8. 6.1.8 Trivitron Healthcare

      9. 6.1.9 ZenTech SA

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Newborn Screening Market market is studied from 2018 - 2026.

The Newborn Screening Market is growing at a CAGR of 9% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2020.

  • Natus Medical Incorporated
  • Trivitron Healthcare
  • Medtronic Inc.
  • Bio-Rad Laboratories Inc.
  • PerkinElmer

Are the major companies operating in Newborn Screening Market.

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