Newborn Screening Market - Growth, Trends, and Forecast (2019-2024)

The market is segmented by Product Type, Test Type, End User (Hospitals, Diagnostic Centers, and Other End Users), and Geography

Market Snapshot

Newborn Screening Market
Study Period:


Base Year:


Fastest Growing Market:

Asia Pacific

Largest Market:

North America

Key Players:

80% of our clients seek made-to-order reports. How do you want us to tailor yours?

Market Overview

The newborn screening market is expected to register a CAGR of 9.0%, over the forecast period. Factors that are responsible for the growth of this 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 expanded 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 rise 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. The examples include the use of tandem mass spectrometry (MS/MS) for amino acidopathies and organic acidurias, multi-marker HPLC testing for hemoglobinopathies, multi-analyte immunoassays for HIV, Hepatitis B, and C antibodies, as well as second-tier DNA-based assays that detect mutation panels, and next-generation sequencing technologies for cystic fibrosis and other disorders. The aforementioned factors are likely to drive the market, globally.

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 healthy development of an infant. The newborn screening market is driven by increase in the incidence of neonatal diseases, which leads to high demand for newborn screening tests. 

By Product Type
Pulse Oximeter
Mass Spectrometer
Hearing Screening Devices
Ultrasound Machine
Assay Kits
By Test Type
Dried Blood Spot
Hearing Screening
Critical Congenital Heart Defect (CCHD)
Urine Test
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 & Africa
South Africa
Rest of Middle East & Africa
South America
Rest of South America

Report scope can be customized per your requirements. Click here.

Key Market Trends

Dried Blood Spot is Expected to Hold the Major Revenue Share in the Test Type Segment

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. 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 is easily transported. Thus, rising diseases in the newborns are boosting the market growth.

However, factors, such as the lack of uniformity of newborn screening policies and procedures across the world, and false positive and false negative results, may hinder the growth of the market.

Newborn Screening Market

To understand key trends, Download Sample Report

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 the disorders in the newborn and rising demand for advanced systems. The presence of a developed healthcare infrastructure is expected to further propel the market in the United States.

Newborn Screening Market

To understand geography trends, Download Sample Report

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., and among others.

Major Players

  1. Agilent Technologies Inc.
  2. Natus Medical Incorporated
  3. Trivitron Healthcare
  4. Medtronic Inc.
  5. Bio-Rad Laboratories Inc.

* Complete list of players covered available in the table of contents below

Newborn Screening Market

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 Growing Newborn Screening Programs

      2. 4.2.2 Rising Incidences of Congenital Diseases

      3. 4.2.3 Rising Funding from Government Sectors for Newborn Screening

      4. 4.2.4 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 Product Type

      1. 5.1.1 Device

        1. Pulse Oximeter

        2. Mass Spectrometer

        3. Hearing Screening Devices

        4. Laparoscope

        5. Retinoscope

        6. Ultrasound Machine

      2. 5.1.2 Assay Kits

    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 Urine Test

      5. 5.2.5 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 & Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East & 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 Agilent Technologies Inc.

      3. 6.1.3 Bio-Rad Laboratories Inc.

      4. 6.1.4 GE Healthcare

      5. 6.1.5 Masimo Corporation

      6. 6.1.6 Medtronic Inc.

      7. 6.1.7 Natus Medical Incorporated

      8. 6.1.8 PerkinElmer Inc.

      9. 6.1.9 Trivitron Healthcare

      10. 6.1.10 ZenTech SA

    2. *List Not Exhaustive

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

80% of our clients seek made-to-order reports. How do you want us to tailor yours?

Please Enter a Valid Message!

Complete your payment details below

Shipping & Billing Information

Payment Information