New-Born Screening Market Analysis

Global New-Born Screening Market Overview

The New-Born Screening Market Size was valued at USD 0.54 Billion in 2023 and is projected to grow from USD 0.58 Billion in 2024 to USD 1.02 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 7.21% during the forecast period (2024 - 2032). The rising spread of diseases across newborn babies and government measures to prevent the same are market drivers expediting the market’s expansion. 

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

In March 2024, The World Health Organization (WHO) initiated a guideline for universal screening of neonatal jaundice, eye abnormalities and hearing impairment in Southeast Asia.

In February 2024: Niloufer Hospital in Hyderabad introduced a newborn screening program to detect rare genetic conditions.

In February 2024: A research study titled Early Check has screened one thousand newborns after birth to provide treatment, give parents educational information, identify rare conditions early and connect families with specialists throughout the state of North Carolina.

In April 2023, Waters Corporation launched the Xevo TQ Absolute IVD Mass Spectrometer intended for clinical diagnosis.

In March 2023, researchers at CDC’s Division of Laboratory Sciences announced modernized diagnostic tests that use novel technology to detect genetic disorders.

In March 2023, GC Labs unveiled its new test for diagnosing Inborn Errors of Metabolism (IEM) among newborns by integrating novel disease detection techniques.

Moreover, Masimo revealed its latest cutting-edge baby monitoring system that enables caregivers to monitor baby data in real time in January 2023.

In June 2022, partnered with the American Society of Hematology (ASH) to bring their technology to six more African places. This technology is already being used in Ghana to help diagnose babies with sickle cell disease. This partnership allows more areas in Africa to join the consortium for neonate screening activities.

The first partnership happened between them and Revvity Inc. in June 2022, which is a part of PerkinElmer Inc., and Novartis AG, which is an international pharmaceutical firm as well. Their aim is to create awareness about newborn screening and starting hydroxyurea (HU) treatment early, among other treatments for Sickle Cell Disease (SCD).

Oxford University reported that it had started its pilot studies aimed at diagnosing spinal muscular atrophy in March 2022.

PerkinElmer received European certification for the EONIS screening test in September 2020. It helps to diagnose three diverse health conditions in infants: X-linked agammaglobulinemia (XLA), spinal muscular dystrophy (SCID) and severe combined immunodeficiency (SMA).

New-Born Screening Market Trends

• Rising cases of diseases among newborns are driving the market growth

Market CAGR for new-born screening is being driven by the rise in the number of infant diseases. The newborn screening market is anticipated to be largely affected by growing neonatal population percentage, a rise in the spread of congenital illnesses in newborns, favorable government policies and laws, and technical improvements.

One of the main market drivers is the increase in the number of newborns. The world population meter estimates that approximately 88 billion births—or around 250 births per minute—were reported in 2015. Of them, more than 2.8 million babies passed away during first month due to inadequate screening and medical care. Organizations like the WHO, Healthy Newborn Network, and others. are working to inform parents about potential problems and associated testing methods in an effort to stop this number from rising. Additionally, North American organizations mandated the complete screening of all infants delivered in private-sector hospitals.

Government policies and programs also help to develop a favorable climate for market expansion. The WHO recommends the newborn screening program to protect children's health worldwide. The Secretary's Advisory Committee on Heritable Disorders in Newborns and Children of the U.S. Department of Health and Human Services, the Japan Society of Obstetrics and Gynaecology (JSOG), the United Kingdom (PEACH), and advocacy organizations like the March of Dimes have all taken various policies and initiatives under this program. Thus, driving the New-Born Screening Market revenue.

New-Born Screening Market Segment Insights

New-Born Screening Technology Insights

The New-Born Screening Market segmentation, based on technology includes Tandem mass spectrometry, Hearing screening technology, DNA assays, Immunoassays and enzymatic assays, and pulse oximetry, and Antigen typing. Tandem mass spectrometry (TMS), a sophisticated tool used across labs to analyze bodily fluids and other pollutants, can analyze such things. Owing to its strong demand, cost-effectiveness, broad applicability, and technological advancements, tandem mass spectrometry has controlled the whole industry. Due to its high utility in diagnosing a range of problems across a single operation, tandem mass spectrometry is also anticipated to expand at the fastest CAGR during the projection period.

New-Born Screening Test Type Insights

The New-Born Screening Market segmentation, based on test type, includes the Hearing screening test, Dry blood spot test, and Critical congenital heart disease test. The market for newborn screening as a whole was dominated by dry blood spot test. A heel stick, also known as a dried blood spot test (DBS), is the collection of blood from a newborn's heel within the first 24 to 48 hours of life over the screening card for the treatment of over 50 diseases. These screening cards are identified by specific codes but don't include any other personal data.

New-Born Screening Products Insights

The New-Born Screening Market segmentation, based on product, includes Reagents, Assay kits, and Instruments. Mass spectrometers, pulse oximeters, fractionators, and other devices are used to screen newborns. Due to the rising need for newborn screening around the world, the instruments market sector is anticipated to increase.

New-Born Screening End-User Insights

The New-Born Screening Market segmentation, based on end-user, includes Hospitals, Maternity and specialty clinic, and Diagnostic centers. Since newborn illnesses are becoming more common, disposable income has increased along with the requirement for patient hospitalization, and the hospitals segment, which formerly held the majority of the market, is predicted to develop at a rapid rate. High-tech hospital equipment and healthcare infrastructure advancements further fuel the market's expansion.

Figure 1: New-Born Screening Market, by End-User, 2023 & 2032 (USD Billion) 

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

New-Born Screening Regional Insights

By region, the study provides market insights into North America, Europe, Asia-Pacific, and the Rest of the World. Due to the rising spread of congenital diseases and mandate testing across all 50 states of the country, North America accounted for the majority of the market for newborn screening. Every state in North America strictly adheres to the newborn screening program.

Further, the major countries studied in the market report are The US, Canada, German, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: NEW-BORN SCREENING MARKET SHARE BY REGION 2023 (USD Billion) 

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

Europe’s New-Born Screening Market accounts for the second-largest position in the market. The region's expansion is being driven by an increase in the frequency of newborn problems such as congenital diseases and neonatal diseases as well as rising healthcare costs. Further, the UK New-Born Screening Market held the largest market share, and the Germany New-Born Screening Market was the quickest-growing market in the European region

The Asia Pacific New-Born Screening Market is anticipated to expand at the quickest CAGR. This is because government agencies have created favorable healthcare plans. The importance of awareness campaigns and newborn diagnostic procedure quality assurance has increased in recent years in the developing nations of Sri Lanka, India, China, Taiwan, and Korea. Moreover, China New-Born Screening Market held the fastest CAGR, and the India New-Born Screening Market was the quickest-growing market in the Asia-Pacific region.

New-Born Screening Key Market Players & Competitive Insights

Leading market players are investing largely in research & development-related activities to extend their product/service lines, which will aid the New-Born Screening Market, to grow faster. Market leaders are also adopting a range of strategies to expand their worldwide position, with important market developments including new product launches & developments, contractual agreements among companies with complementary service lines, mergers & acquisitions, increased investments, & collaboration with other organizations having complementary products and services. To grow in a competitive and rising market climate, the New-Born Screening industry needs to offer cost-efficient products.

Producing locally to cut operational expenses is one of the prime business strategies used by manufacturers in the New-Born Screening industry to benefit clients and increase the market sector. In recent years, the New-Born Screening industry has served with some of the key perks of medicine. Major players in the New-Born Screening Market, including Waters (US), SCIEX (US), Natus Medical Incorporated (US), PerkinElmer Inc. (US), Masimo Corporation (US), Bio-Rad Laboratories Inc. (US), Agilent Technologies Inc. (US), GENERAL ELECTRIC (Boston), Medtronic PLC (Ireland), and Trivitron Healthcare (India), and others are attempting to increase market growth via investing in research and development operations.

The company Agilent Technologies Inc. (Agilent) sells equipment, chemicals, consumables, services, and software for complete laboratory workflow. Its product line includes, among other things, automation systems, microarray solutions, clinical and diagnostic tests, liquid and gas chromatography systems, and components. The business provides services to a variety of industries, including biotechnology, pharmaceuticals, contract research organizations (CROs) and contract manufacturing organizations (CMOs), chemical and energy, environmental and forensics, food, and others. Agilent sells its goods directly to consumers, through distributors, manufacturers' agents, resellers, and online retailers. In January 2023, An arrangement between Agilent Technologies Inc. and Quest Diagnostics was disclosed. The agreement will make the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test available to providers and patients across the United States. The test is now available for ordering by healthcare professionals.

A provider of informatics solutions, accessories, consumables, detection and imaging technologies, and other services, PerkinElmer Inc. Cytogenetic reagents, ELISA kits, tissue biomarker reagents, chromatography equipment, molecular spectroscopy equipment, newborn screening equipment, and thermal analysis equipment are a few of the company's main products. It provides software, assay platforms, reagents, and tools to hospitals, doctors, medical labs, and researchers in the field of medicine. Additionally, PerkinElmer provides laboratory, research, and banking services for tissue and cord blood. Its goods are employed, among other things, in atomic spectroscopy, cell analysis, and imaging, chromatography, analysis, and detection, DNA/RNA isolation, in vivo imaging, molecular spectroscopy, protein analysis and detection, and tissue imaging. The corporation has operations in the Americas, Europe, and Asia. In November 2022, The FDA approved the marketing of the EONISTM SCID-SMA assay kit for in vitro diagnostic (IVD) use by accredited laboratories for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns, according to a press release from PerkinElmer Inc. This assay, which is a component of the company's larger EONIS Platform, is the first FDA-approved test for newborn SMA screening in the United States.

Key Companies in the New-Born Screening Market include

• Waters (US)


• SCIEX (US)


• Natus Medical Incorporated (US)


• PerkinElmer Inc. (US)


• Masimo Corporation (US)


• Bio-Rad Laboratories Inc. (US)


• Agilent Technologies Inc. (US)


• GENERAL ELECTRIC (Boston)


• Medtronic PLC (Ireland)


• Trivitron Healthcare (India)

New-Born Screening Industry Developments

August 2022:At the AMTZ Campus in Vishakhapatnam, India, Trivitron Healthcare opened a Centre of Excellence (CoE) with cutting-edge capabilities for research, development, and manufacturing in the fields of metabolomics, genomics, newborn screening, and molecular diagnostics.

June 2022:BeginNGS (pronounced "beginnings") is a program that Rady Children's Institute for Genomic Medicine launched to advance and assess the scalability of a diagnostic and precision medicine guidance tool for newborn screening for 400 or so genetic diseases with known treatments using rapid whole genome sequencing.

New-Born Screening Market Segmentation

New-Born Screening Technology Outlook (USD Billion, 2018-2032)

• Tandem mass spectrometry


• Immunoassays and enzymatic assays


• Hearing screening technology


• DNA assays and pulse oximetry


• Antigen typing

New-Born Screening, Test type Outlook (USD Billion, 2018-2032)

• Dry blood spot test


• Hearing screening test


• Critical congenital heart diseases (CCHD) test

• Reagents


• Assay kits


• Instruments

New-Born Screening End-user Outlook (USD Billion, 2018-2032)

• Hospitals


• Maternity and specialty clinic


• Diagnostic centers

New-Born Screening Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


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


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America