The global newborn screening market size was estimated to be USD 1.60 billion in 2023 and is expected to reach at USD 3.81 billion by 2034 with a CAGR of 8.21% during the forecast period 2024-2034. Increasing newborn screening programs, expanding newborn population, growing prevalence of congenital diseases, rising government funding for newborn screening, surge in newborn screening programs operated by governments across the continent, increasing technological advancements used in newborn screening, and rising approvals of advanced diagnostic testing by regulatory bodies are some of the key factors boosting the market growth.
Rising approvals of advanced diagnostic testing by regulatory bodies is predicted to boost the market growth during the forecast period. Newborn screening detects conditions that could affect a child's long-term health or even their chances of survival. This screening method consists of a number of assessments that are crucial for prompt discovery, early diagnosis, and health care in order to avoid overall impairment and prevent a child's mortality. For instance, in November 2022, PerkinElmer Inc. has disclosed that the U.S. Food and Drug Administration (FDA) has granted approval for the marketing of the EONIS™ SCID-SMA assay kit. This kit is intended for in vitro diagnostic (IVD) use by certified laboratories. It facilitates the concurrent identification of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns. Remarkably, this marks the first FDA-approved assay for SMA screening in newborns within the United States. The assay is a component of PerkinElmer's comprehensive EONIS Platform.
By technology, tandem mass spectrometry was the highest revenue-grossing segment in the global newborn screening market in 2023 owing to the cost-effectiveness & high applicability, rising technological advancements in mass spectrometer devices, growing research & development expenditure by government & private bodies, and increasing launch of innovative devices. For instance, in March 2022, Waters Corporation has unveiled the Xevo™ TQ Absolute system, which is positioned as the most compact and highly sensitive benchtop tandem mass spectrometer in its category. Additionally, enzymes-based assays is predicted to grow at fastest CAGR during the forecast period owing to the advantages of enzymatic assays, such as cost-effectiveness, high applicability, short turnaround time, and rapid technological advancements.
By test, dried blood spot was the highest revenue-grossing segment in the global newborn screening market in 2023 owing to increasing demand for DBS newborn screening tests, rising development of novel NBS tests, surge in diseases among newborns, and growing focus on development of innovative technologies. For instance, in March 2022, Oxford University has commenced a population-centered study for screening newborns in the Thames Valley region. This screening process will be integrated into the standard United Kingdom newborn blood spot screening procedure, utilizing available space on a Guthrie card (dried blood spot sample) collected from newborns. Additionally, critical congenital heart defect (CCHD) is predicted to grow at fastest CAGR during the forecast period owing to the growing prevalence of critical congenital heart disease (CCHD), increasing demand for pulse oximeter-based technology for screening.
By end-user, hospitals was the highest revenue-grossing segment in the global newborn screening market in 2023 owing to the preference for using hospitals for labor delivery, improved infrastructure, the use of cutting-edge procedures there, and the availability of qualified experts. Additionally, diagnostic centres is predicted to grow at fastest CAGR during the forecast period owing to the increasing demand for advanced diagnostic testing, growing prevalence of congenital disease among newborns, and rising launch of advanced tools by market players. For instance, in June 2022, The Rady Children’s Institute for Genomic Medicine has initiated a program aimed at testing and expanding the applicability of a diagnostic and precision medicine advisory tool named BeginNGS (pronounced 'beginnings'). This tool is designed to conduct swift whole genome sequencing for newborns, screening them for around 400 genetic disorders with established treatment options.
North America region is anticipated for the highest revenue share during the forecast period owing to the rising prevalence of birth defects, increasing technological developments in newborn screening technology, growing demand for newborn screening, and surge in launch of new systems. For instance, in January 2023, Masimo has introduced Stork, an innovative home baby monitoring system that represents a groundbreaking development. This system provides parents with valuable information about their baby's health, fostering a deeper understanding and stronger connection between parents and their infants. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the growing awareness programs & quality assurance of newborn diagnostic procedures, surge in improving healthcare infrastructure, high birth rate, increasing prevalence of congenital diseases, and rising initiatives by market players. For instance, in August 2022, Trivitron Healthcare has established a Center of Excellence (CoE) at the AMTZ Campus in Vishakhapatnam, India, featuring advanced research and development as well as manufacturing capabilities. This center is dedicated to metabolomics, genomics, newborn screening, and molecular diagnostics.
Rising approvals of advanced diagnostic testing by regulatory bodies is predicted to boost the market growth during the forecast period. Newborn screening detects conditions that could affect a child's long-term health or even their chances of survival. This screening method consists of a number of assessments that are crucial for prompt discovery, early diagnosis, and health care in order to avoid overall impairment and prevent a child's mortality. For instance, in November 2022, PerkinElmer Inc. has disclosed that the U.S. Food and Drug Administration (FDA) has granted approval for the marketing of the EONIS™ SCID-SMA assay kit. This kit is intended for in vitro diagnostic (IVD) use by certified laboratories. It facilitates the concurrent identification of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns. Remarkably, this marks the first FDA-approved assay for SMA screening in newborns within the United States. The assay is a component of PerkinElmer's comprehensive EONIS Platform.
By technology, tandem mass spectrometry was the highest revenue-grossing segment in the global newborn screening market in 2023 owing to the cost-effectiveness & high applicability, rising technological advancements in mass spectrometer devices, growing research & development expenditure by government & private bodies, and increasing launch of innovative devices. For instance, in March 2022, Waters Corporation has unveiled the Xevo™ TQ Absolute system, which is positioned as the most compact and highly sensitive benchtop tandem mass spectrometer in its category. Additionally, enzymes-based assays is predicted to grow at fastest CAGR during the forecast period owing to the advantages of enzymatic assays, such as cost-effectiveness, high applicability, short turnaround time, and rapid technological advancements.
By test, dried blood spot was the highest revenue-grossing segment in the global newborn screening market in 2023 owing to increasing demand for DBS newborn screening tests, rising development of novel NBS tests, surge in diseases among newborns, and growing focus on development of innovative technologies. For instance, in March 2022, Oxford University has commenced a population-centered study for screening newborns in the Thames Valley region. This screening process will be integrated into the standard United Kingdom newborn blood spot screening procedure, utilizing available space on a Guthrie card (dried blood spot sample) collected from newborns. Additionally, critical congenital heart defect (CCHD) is predicted to grow at fastest CAGR during the forecast period owing to the growing prevalence of critical congenital heart disease (CCHD), increasing demand for pulse oximeter-based technology for screening.
By end-user, hospitals was the highest revenue-grossing segment in the global newborn screening market in 2023 owing to the preference for using hospitals for labor delivery, improved infrastructure, the use of cutting-edge procedures there, and the availability of qualified experts. Additionally, diagnostic centres is predicted to grow at fastest CAGR during the forecast period owing to the increasing demand for advanced diagnostic testing, growing prevalence of congenital disease among newborns, and rising launch of advanced tools by market players. For instance, in June 2022, The Rady Children’s Institute for Genomic Medicine has initiated a program aimed at testing and expanding the applicability of a diagnostic and precision medicine advisory tool named BeginNGS (pronounced 'beginnings'). This tool is designed to conduct swift whole genome sequencing for newborns, screening them for around 400 genetic disorders with established treatment options.
North America region is anticipated for the highest revenue share during the forecast period owing to the rising prevalence of birth defects, increasing technological developments in newborn screening technology, growing demand for newborn screening, and surge in launch of new systems. For instance, in January 2023, Masimo has introduced Stork, an innovative home baby monitoring system that represents a groundbreaking development. This system provides parents with valuable information about their baby's health, fostering a deeper understanding and stronger connection between parents and their infants. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the growing awareness programs & quality assurance of newborn diagnostic procedures, surge in improving healthcare infrastructure, high birth rate, increasing prevalence of congenital diseases, and rising initiatives by market players. For instance, in August 2022, Trivitron Healthcare has established a Center of Excellence (CoE) at the AMTZ Campus in Vishakhapatnam, India, featuring advanced research and development as well as manufacturing capabilities. This center is dedicated to metabolomics, genomics, newborn screening, and molecular diagnostics.
Segmentation: Newborn Screening Market Report 2022 - 2033
Newborn Screening Market Analysis & Forecast by Technology 2023 - 2034 (Revenue USD Bn)
- Pulse Oximetry
- DNA Assays
- Enzymes Based Assays
- Tandem Mass Spectrometry
- Others
Newborn Screening Market Analysis & Forecast by Test 2023 - 2034 (Revenue USD Bn)
- Critical Congenital Heart Defect (CCHD)
- Dried Blood Spot
- Hearing Screening
- Others
Newborn Screening Market Analysis & Forecast by End-user 2023 - 2034 (Revenue USD Bn)
- Hospitals
- Diagnostic Centres
- Others
Newborn Screening Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
North America
- U.S.
- Canada
Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Newborn Screening Market: Technology Estimates & Trend Analysis
8. Newborn Screening Market: Test Estimates & Trend Analysis
9. Newborn Screening Market: End-user Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Newborn Screening Market
12. Europe Global Newborn Screening Market
13. Asia Pacific Global Newborn Screening Market
14. Latin America Global Newborn Screening Market
15. MEA Global Newborn Screening Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Perkinelmer Inc.
- Medtronic Inc.
- GE Healthcare
- ZenTech SA
- Masimo Corporation
- Demant A/S
- Bio-Rad Laboratories Inc.
- Thermo Fisher Scientific
- Agilent Technologies Inc.
- Hill-Rom Holdings Inc.
- Trivitron Healthcare
- Waters Corporation
- Natus Medical Incorporated
- Ab Sciex Llc
- Covidien Plc
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 145 |
| Published | October 2023 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 1.6 Billion |
| Forecasted Market Value ( USD | $ 3.81 Billion |
| Compound Annual Growth Rate | 8.2% |
| Regions Covered | Global |
| No. of Companies Mentioned | 15 |
