The global newborn screening market size was estimated at USD 900.63 million in 2024 and is projected to reach USD 1.79 billion by 2033, growing at a CAGR of 8.1% from 2025 to 2033. The rising neonatal population, increasing cases of congenital diseases in newborns, growing consumer awareness, and favorable initiatives & support from various governments, which are organizing several programs & legislations, are factors estimated to propel the market over the forecast period.
According to the United Nations Department of Economic and Social Affairs (UN DESA) World Population Prospects 2024, the global number of births remains high, with an estimated 132.4 million babies born worldwide in 2024. Moreover, according to the World Health Organization (WHO), congenital disorders - structural or functional anomalies that occur during intra-uterine life - affect an estimated 6% of all births worldwide. In a more detailed assessment, a global, regional, and national epidemiology study of congenital disabilities found that in 2021, about 31.64 million children (aged 0-14 years) were living with congenital disabilities, representing a 6.68% increase since 1990. In addition, technological advancements in screening methodologies are also expected to boost the market. For instance, in November 2023, Revvity, Inc. (US) launched its EONIS Q system, a CE-IVD declared platform enabling laboratories in countries that accept the CE marking to adopt molecular testing for spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns.
Furthermore, extensively increasing prevalence of congenital diseases in newborns is expected to have a positive impact on the newborn screening market growth. According to data published by WHO in February 2023, an estimated 240,000 newborns within 28 days of birth die each year globally due to congenital diseases. Congenital disorders are further responsible for an estimated 170, 000 child deaths in the age group of 1 month to 5 years. In addition, according to information from Indian Pediatrics, congenital hypothyroidism occurs in 2.1 out of every 1,000 infants in India, and the prevalence of inborn metabolic abnormalities ranges from 2 to 7.8%. Such a substantial occurrence of congenital diseases amongst newborns is likely to increase the adoption of tests, which is expected to accelerate the market growth by 2030.
In addition, the introduction of government programs and legislation is also expected to offer a favorable environment for newborn screening market growth. Programs around the globe bring newborn screening into the Genome Era. For instance, in 2023, an anticipated 100,000 infants participated in an NGS newborn screening pilot program. Illumina has participated in at least nine large-scale national and international genomic NBS investigations, screening up to 40,000 babies. This includes GUARDIAN in the U.S., Generation Study in the United Kingdom, BabyScreen+ in Australia, and BabyDetect in Belgium.
The demand for newborn procedures is expected to be influenced by the introduction of new technologies and the availability of treatment options enabling the diagnosis of about 29 possible disorders, such as galactosemia (GS), phenylketonuria (PKU), hearing disorders, and congenital hypothyroidism (CH) in neonates. In March 2023, a group of scientists at the Division of Laboratory Sciences, CDC, announced the introduction of improved tests that offer advanced technology for the diagnosis of genetic diseases.
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According to the United Nations Department of Economic and Social Affairs (UN DESA) World Population Prospects 2024, the global number of births remains high, with an estimated 132.4 million babies born worldwide in 2024. Moreover, according to the World Health Organization (WHO), congenital disorders - structural or functional anomalies that occur during intra-uterine life - affect an estimated 6% of all births worldwide. In a more detailed assessment, a global, regional, and national epidemiology study of congenital disabilities found that in 2021, about 31.64 million children (aged 0-14 years) were living with congenital disabilities, representing a 6.68% increase since 1990. In addition, technological advancements in screening methodologies are also expected to boost the market. For instance, in November 2023, Revvity, Inc. (US) launched its EONIS Q system, a CE-IVD declared platform enabling laboratories in countries that accept the CE marking to adopt molecular testing for spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns.
Furthermore, extensively increasing prevalence of congenital diseases in newborns is expected to have a positive impact on the newborn screening market growth. According to data published by WHO in February 2023, an estimated 240,000 newborns within 28 days of birth die each year globally due to congenital diseases. Congenital disorders are further responsible for an estimated 170, 000 child deaths in the age group of 1 month to 5 years. In addition, according to information from Indian Pediatrics, congenital hypothyroidism occurs in 2.1 out of every 1,000 infants in India, and the prevalence of inborn metabolic abnormalities ranges from 2 to 7.8%. Such a substantial occurrence of congenital diseases amongst newborns is likely to increase the adoption of tests, which is expected to accelerate the market growth by 2030.
In addition, the introduction of government programs and legislation is also expected to offer a favorable environment for newborn screening market growth. Programs around the globe bring newborn screening into the Genome Era. For instance, in 2023, an anticipated 100,000 infants participated in an NGS newborn screening pilot program. Illumina has participated in at least nine large-scale national and international genomic NBS investigations, screening up to 40,000 babies. This includes GUARDIAN in the U.S., Generation Study in the United Kingdom, BabyScreen+ in Australia, and BabyDetect in Belgium.
The demand for newborn procedures is expected to be influenced by the introduction of new technologies and the availability of treatment options enabling the diagnosis of about 29 possible disorders, such as galactosemia (GS), phenylketonuria (PKU), hearing disorders, and congenital hypothyroidism (CH) in neonates. In March 2023, a group of scientists at the Division of Laboratory Sciences, CDC, announced the introduction of improved tests that offer advanced technology for the diagnosis of genetic diseases.
Global Newborn Screening Market Report Segmentation
This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this report, the analyst has segmented the newborn screening market based on product, technology, test type, and region:Product Outlook (Revenue, USD Million, 2021-2033)
- Instruments
- Reagents
Technology Outlook (Revenue, USD Million, 2021-2033)
- Tandem mass spectrometry
- Pulse oximetry
- Enzyme based assay
- DNA assay
- Electrophoresis
- Others
Test Type Outlook (Revenue, USD Million, 2021-2033)
- Dry blood spot test
- CCHD
- Hearing screen
Regional Outlook (Revenue, USD Million, 2021-2033)
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa (MEA)
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- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
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This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
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Table of Contents
Chapter 1. Newborn Screening Market: Methodology and Scope
Chapter 2. Newborn Screening Market: Executive Summary
Chapter 3. Newborn Screening Market Variables, Trends, & Scope
Chapter 4. Newborn Screening Market: Product Estimates & Trend Analysis
Chapter 5. Newborn Screening Market: Technology Estimates & Trend Analysis
Chapter 6. Newborn Screening Market: Test Type Estimates & Trend Analysis
Chapter 7. Newborn Screening Market: Regional Business Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The key companies profiled in this Newborn Screening market report include:- Bio-Rad Laboratories
- Agilent Technologies
- Masimo
- Waters Corporation
- Natus Medical
- Trivitron Healthcare
- GE Lifesciences
- PerkinElmer Inc
- AB SCIEX
- Demand A/S
- Parseq LAB
- Otodynamics
- Zentech
- Centogene
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | November 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 900.63 Million |
| Forecasted Market Value ( USD | $ 1790 Million |
| Compound Annual Growth Rate | 8.1% |
| Regions Covered | Global |
| No. of Companies Mentioned | 15 |
