Newborn Screening Market, By Product (Instruments, and Reagents and Assay Kits), By Technology (Tandem mass spectrometry, Pulse oximetry, Enzyme and Immunoassays, DNA assay, Electrophoresis, and Hearing Screen), By Test Type (Dry blood spot test, Critical Congenital Heart Disease (CCHD) test, and Hearing screen test), and By Region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa), Trends, Analysis and Forecast till 2034

Report Code: PMI43819 | Publish Date: April 2024 | No. of Pages: 170

Global Newborn Screening Market By Overview

Newborn Screening  Market was valued at US$ 5.5 Billion in 2024 and is projected to grow at a CAGR of 10.00% to reach US$ 14.2 Billion by 2034.

The Newborn Screening Market focuses on tests that are performed to detect and identify the presence of any harmful or potentially fatal disorders that can affect a child’s long-term health and survival.

The growing prevalence of newborn disorders is one of the major factors boosting the growth of the target market. An immature and not fully developed immune system is the reason why newborns are more susceptible to infections and illnesses that need appropriate screening to be detected, thereby boosting the growth of the Newborn Screening Market.

For instance, in 2020, according to the CDC (Centers for Disease Control and Prevention), it was reported that the infant mortality rate in the United States was 5.4 deaths per 1,000 live births. Furthermore, almost 20,000 infants succumbed to death in the United States in 2020 due to various birth defects.

Global Newborn Screening Market By Dynamics

The rising neonatal population, along with the rising prevalence of newborn disorders, is one of the key factors boosting the target market's growth. Certain congenital disorders like neural tube defects, heart defects, and Down syndrome, either due to environmental factors or genetic mutations, are quite commonly seen in infants suffering from newborn disorders, eventually leading to the growth of the Newborn Screening Market.

For instance, in July 2023, according to the WHO (World Health Organization), it was reported that at least 26 infants in Croatia, France, Italy, Spain, Sweden, and the United Kingdom were infected with a rare strain of enterovirus, known as echovirus 11.

Furthermore, in February 2023, according to The Guardian, it was reported that Mississippi had registered a significant rise in the number of infants undergoing treatment for congenital syphilis, and the number of infants who had been treated for congenital syphilis had increased by more than 900% over five years.

Favorable Government Programs and Advancements to boost the target market growth

Numerous favorable government programs and legislations are propelling the growth of the target market. The launch of various improved technology and instruments of mass spectroscopy and oximeters are also contributing a lot towards the growth of the Newborn Screening Market.  

For instance, in May 2018, The Connecticut Department of Public Health launched their innovative approach, “Connecticut Newborn Screening Network”, in which Connecticut children were selected by The Connecticut Department of Public Health for the screening of fatal diseases.

Restrains of the Newborn Screening Market:

The Lack of Uniformity in Newborn Screening Policies and Procedures across the world is the key factor restraining the growth of the target market. The increased number of false positive and false negative results from the tests are responsible for restraining the growth of the Newborn Screening Market.

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Global Newborn Screening Market By Segmentation

Newborn Screening Market - segmentation

Newborn Screening Market is segmented based on Product, Technology, Test-Type and Region.

Product Insight

On the basis of Product, Newborn Screening Market is segmented into Instruments, and Reagents and Assay Kits.

Technology Insights

On the basis of Technology, Newborn Screening Market is segmented into Tandem Mass Spectrometry, Pulse Oximetry, Enzyme and Immunoassays, DNA Assay, Electrophoresis and Hearing Screen. The Tandem Mass Spectrometry technology segment is expected to dominate the growth of the target market attributing to its cost-effectiveness, high applicability and numerous technology upgrades.

Test Type Insights

On the basis of Test-Type, Newborn Screening Market is segmented into Dry Blood Spot Test, Critical Congenital Heart Disease (CCHD) Test and Hearing Screen Test. The Dry Blood Spot Test type segment is expected to dominate the growth of the target market owing to the increased usage of blood test for serological diagnosis of infectious or autoimmune diseases as well as easy and effective diagnosis compared to other testing methods.

Regional Insights:

On the basis of Region, the Newborn Screening Market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is expected to dominate the target market in the near future, owing to their advancements in technology, availability of newborn screening programs, incorporation of advanced devices, improved healthcare facilities as well as research and development programs. 

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Report Scope:

Attribute

Details

Base year for estimation

2023

Forecast period

2024 – 2034

Market representation

Revenue in USD Billion & CAGR from 2024 to 2034

Market Segmentation

By Product - Instruments, and Reagents and Assay Kits

By Technology - Tandem Mass Spectrometry, Pulse Oximetry, Enzyme and Immunoassays, DNA Assay, Electrophoresis, and Hearing Screen

By Test-Type - Dry Blood Spot Test, Critical Congenital Heart Disease (CCHD) Test and Hearing Screen Test

Regional scope

North America - U.S., Canada

Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe

Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific

Latin America - Brazil, Mexico, Argentina, Rest of Latin America

Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors, and trends

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2022 to 2032. For the purpose of this study, has segmented the Newborn Screening Market report based on Product, Technology, Test-Type and Region:

Newborn Screening Market, By Product:

  • Instruments
  • Reagents and Assay Kits

Newborn Screening Market, By Technology:

  • Tandem Mass Spectrometry
  • Pulse Oximetry
  • Enzyme and Immunoassays
  • DNA Assay
  • Electrophoresis
  • Hearing Screen

Newborn Screening Market, By Test-Type:

  • Dry Blood Spot Test
  • Critical Congenital Heart Disease (CCHD) Test
  • Hearing Screen Test

Newborn Screening Market, By Region:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Russia
    • Italy
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • Israel
    • South Africa
    • Rest of Middle East & Africa

Global Newborn Screening Market By Key Players

The key players operating the Newborn Screening Market includes, Thermo Fisher Scientific Inc., GE Healthcare, Bio Rad Laboratories Inc., PerkinElmer Inc., ZenTech S.A., Trivitron Healthcare Pvt. Ltd., MP Biomedicals LLC, Agilent Technologies, Medtronic plc, and Natus Medical Incorporated.

Global Newborn Screening Market By Key Issues Addressed

Recent Development:

  • In September 2020, PerkinElmer (US) received a CE-IVD approval for the “EONIS screening assay” which is used for screening SMA (spinal muscular astrophy), SCID (severe combined immunodeficiency) and XLA (X-linked agammaglobulinemia) in infants.
  • In December 2019, PerkinElmer (US) received FDA (Food and Drug Administration) approval for their “GSP Neonatal Creatine Kinase MM (CK-MM) kit” for the screening of newborns affected by Duchenne muscular dystrophy (DMD).
  • In October 2019, Demant A/S (Denmark) announced the launch of its “easyScreen BERAphone”, which is a hearing screening device, at the 64th International Congress of Hearing Aid Acousticians in Nuremberg, Germany.

Global Newborn Screening Market By Company Profile

  • Thermo Fisher Scientific Inc.*
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • GE Healthcare
  • Bio Rad Laboratories Inc.
  • PerkinElmer Inc.
  • ZenTech S.A.
  • Trivitron Healthcare Pvt. Ltd.
  • MP Biomedicals LLC
  • Agilent Technologies
  • Medtronic plc
  • Natus Medical Incorporated

“*” marked represents similar segmentation in other categories in the respective section.

Global Newborn Screening Market By Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Product
      • Market Snippet, By Technology
      • Market Snippet, By Test Type
      • Market Snippet, By Region
    • Opportunity Map Analysis
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Market Trends
    • Merger and Acquisitions
    • Impact Analysis
    • PEST Analysis
    • Porter’s Analysis
  4.  Market Segmentation, By Product, 2019 – 2029, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2019 — 2029
      • Y-o-Y Growth Analysis (%), 2019 – 2029
      • Segment Trends
    • Instruments
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Reagents and Assay Kits
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
  5. Market Segmentation, By Technology, 2019 – 2029, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2019 — 2029
      • Y-o-Y Growth Analysis (%), 2019 – 2029
      • Segment Trends
    • Tandem mass spectrometry
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Pulse oximetry
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Enzyme and Immunoassays
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • DNA Assay
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Electrophoresis
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Hearing Screen
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
  6. Market Segmentation, By Test Type, 2019 – 2029, (US$ Mn)
    •  Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2019 — 2029
      • Y-o-Y Growth Analysis (%), 2019 – 2029
      • Segment Trends
    • Dry blood spot test
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Critical Congenital Heart Disease (CCHD) test
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Hearing screen test
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
  7. Global Market, By Region, 2019 – 2029, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2019 — 2029
      • Y-o-Y Growth Analysis (%), 2019 – 2029
      • Regional Trends
    • North America
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Technology, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test Type, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Technology, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test Type, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • Germany
        • UK
        • France
        • Russia
        • Italy
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Technology, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test Type, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • China
        • India
        • Japan
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Technology, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test Type, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • Brazil
        • Mexico
        • Rest of Latin America
    • Middle East & Africa
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Technology, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test Type, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • GCC
        • Israel
        • South Africa
        • Rest of Middle East & Africa
  8. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Thermo Fisher Scientific Inc
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • GE Healthcare
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Bio Rad Laboratories Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • PerkinElmer Inc
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • ZenTech S.A.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Trivitron Healthcare Pvt. Ltd.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • MP Biomedicals LLC
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Agilent Technologies
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Medtronic plc
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Natus Medical Incorporated
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Analyst Views

Section

  • Research Methodology
  • About Us
  • Contact

FAQs

Newborn Screening Market report segments the market basis of product, technology, test type and region.

Increase in the incidence of neonatal diseases drives the growth of the newborn screening market

North America dominates the newborn screening market

The leading players operating in the Newborn Screening Market include Thermo Fisher Scientific Inc., GE Healthcare, Bio Rad Laboratories Inc., PerkinElmer Inc., ZenTech S.A., Trivitron Healthcare Pvt. Ltd., MP Biomedicals LLC, Agilent Technologies, Medtronic plc, and Natus Medical Incorporated