Published: 2023 March 14

Newborn Screening Market Size, Share, Industry Outlook, Opportunities and Forecast 2023 - 2030

SKU : MD1815
180 pages
Report Summary
Table of Contents
List of Tables and Figures

Newborn Screening Market is Segmented By Product (Assay Kits, Instruments), By Test Type (Blood Test, Cardiac Test, Urine Test, Hearing Test), By Application (Critical congenital heart disease (CCHD), Blood Spot Test, Hearing Disability, Sickle Cell Disease, Maple Syrup Urine Disease, Thyroid Disorder), By End-User (Hospitals, Diagnostic Centers, Maternity & Specialty Clinics) – Share, Size, Outlook, And Opportunity Analysis 2023-2030


Newborn Screening Market Overview

Report on Global Newborn Screening by DataM Intelligence estimates the market to grow at a CAGR of 10.7% during the forecast period 2023-2030. Due to the rising prevalence of congenital disorders in North America, the market is booming. Competitive rivalry intensifies with ZenTech S.A, Agilent Technologies, Trivitron Healthcare and others operating in the market.

Newborn screening tests newborns for certain disorders such as phenylketonuria (PKU), cystic fibrosis, sickle cell disease, critical congenital heart disease, hearing loss, and others. This testing is typically performed before the baby leaves the hospital. Early detection and treatment can help prevent newborns' intellectual and physical disabilities and life-threatening illnesses.


Newborn Screening Market Scope and Summary



Market CAGR


Segments Covered

By Product, By Test Type, By Application, By End User, and By Region

Report Insights Covered

Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights.

Fastest Growing Region

Asia Pacific

Largest Market Share 

North America


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Newborn Screening Market Trends and Dynamics

The newborn screening market's growth is driven by several factors, such as a rising neonatal population base and an increase in cases of congenital diseases in newborns. In addition, increasing healthcare awareness, benefits offered by newborn screening programs, technological advancements in screening, and increasing government funding and support are also driving the growth of the newborn screening market globally.

Technological advancements in newborn screening are expected to drive market growth.

According to the American Association for Clinical Chemistry, the advancement of tandem mass spectrometry (MS/MS) has aided the rapid spread of neonatal screening. Before the introduction of MS/MS, an aliquot of the specimen was required to test for each disease. MS/MS is a multi-analyte technique that detects many disorders from a single blood specimen more rapidly, precisely, and affordably than earlier methods. Physicians may now diagnose more metabolic problems before symptoms appear, saving neonates from death or irreversible health concerns. The application of MS/MS technology has been critical in expanding neonatal screening. Further technological advancements, such as sequencing, should allow laboratories to screen for more disorders.

In addition, the World Health Organization implemented a program to safeguard the health of children globally, in which numerous policies and initiatives have been taken by the U.S. Department of Health and Human Services Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), Japan's Society of Obstetrics and Gynecology (JSOG), the U.K. (PEACH), and advocacy groups. Thus, from the above statements, the market is expected to drive in the forecast period.


However, the lack of improved healthcare infrastructure, trained professionals, and socioeconomic barriers are some of the major factors restraining the growth of the global newborn screening market.

Industry Analysis

The global market provides in-depth analysis of the market based on various industry factors such as porter five forces, unmet needs, pricing analysis, supply chain analysis, regulatory analysis etc.

COVID-19 Impact Analysis on Newborn Screening Market

Newborn screening (NBS) is a vital public health program that screens babies for various illnesses, most of which are genetic. Screening aims to connect the most vulnerable neonates to timely intervention and potentially life-saving therapy. The global COVID-19 epidemic caused interruptions in the US public health system, raising concerns about the viability of newborn screening facilities and follow-up activities. Because COVID-19 had varied effects in different states at different times, NBS programs touched later by the pandemic could learn from the immediate experiences of the earlier impacted programs. Laboratory personnel availability was occasionally reduced due to infection, quarantine, or relocation within the healthcare center. Home sample collection, second-tier tests, and follow-up all suffered as a result. Moreover, the APHL Newborn Screening Technical Assistance and Evaluation Program (NewSTEPs), along with federal partners, state stakeholders, and national organizations, coordinated efforts to ensure that communication, information sharing, just-in-time resources, and funding remained available to state NBS programs during the public health emergency, to support their ongoing operations and evolve needs during a time when staffing, resources, and physical space were compromised.

Furthermore, in the summer of 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES ACT) allotted funding from HRSA to the Association of Maternal and Child Health Programs (AMCHP), resulting in a collaboration between AMCHP and APHL to support state NBS programs with telehealth-focused activities and resource development. Thus, from the above statements, the market got affected. However, the situation is expected to improve gradually in the forecast period.

Newborn Screening Market Segmentation

Blood Spot Test segment is expected to hold the largest market share in the market.

By Product:

  • Assay Kits
  • Instruments

By Test Type:

  • Blood Test
  • Cardiac Test
  • Urine Test
  • Hearing Test
  • Others

By Application:

  • Critical congenital heart disease
  • Blood Spot Test
  • Hearing Disability
  • Sickle Cell Disease
  • Maple Syrup Urine Disease
  • Thyroid Disorder
  • Others

By End-User:

  • Hospitals
  • Diagnostic Centers
  • Maternity & Specialty Clinics
  • Others

The blood spot test dominated the global market for newborn screening, accounting for 2021. Blood collection from a newborn’s heel within 24–48 hours of birth on the screening card for diagnosis of over 50 conditions is termed heel stick or dried blood spot test (DBS). These screening cards are labeled using unique codes and contain no additional identity information. Autism, lymphomas, leukemia and many other metabolic conditions can be diagnosed through this test. The card used for testing is provided free in North America as a plan to promote higher procedure volume. Therefore, it has increased the demand for blood spot tests. Thus, from the above statements, the market segment accounted for the largest market share in the forecast period. ​ ​

Global Newborn Screening Market Geographical Share

The global market has been classified int geographically, such as

  • North America
  • South America
  • Europe
  • Asia Pacific
  • Middle East and Africa

North American region is expected to hold the largest market share in the global newborn screening market.

North America dominates the global market for newborn screening. The rising prevalence of congenital disorders. For instance, according to the Centers for Disease Control and Prevention, a newborn with a congenital impairment is born every 4 1/2 minutes in the United States. Every year, one in every 33 newborns born in the United States has a congenital disability. This equates to approximately 120,000 babies.

Furthermore, congenital impairments account for 1 in every 5 deaths in the first year of life. Congenital impairments are serious conditions that can have long-term consequences. Total hospital costs for children and adults with birth abnormalities in the United States surpassed $2.6 billion per year, not considering outpatient care or various provider charges. Conditions for screening were provided through extensive research by the American College of Medical Genetics (ACMG) under the U.S. Department of Health and Human Services (HHS) supervision. Recently, ACMG has deviated from the traditional screening criteria and added new conditions to the list. The newborn screening program is diligently followed in all the states of North America. In addition, to create awareness, health departments of the states in the U.S. have published free data and created websites that are expected to help parents to cope better with these conditions.

Newborn Screening Market - Company Profile Analysis:

Covidien Plc: Overview:

Covidien was an Irish-headquartered global health care products company and manufacturer of medical devices and supplies. Covidien became an independent publicly traded company after being spun off from Tyco International in 2007. Covidien's portfolio consists of medical devices, including surgical, respiratory, patient monitoring, gastrointestinal, lung health, and renal care products. The Medical Devices segment includes developing, manufacturing and selling endomechanical instruments, energy devices, soft tissue repair products, vascular products, oximetry and monitoring products, airway and ventilation products, and other medical products. In June 2014, Covidien plc was acquired by Medtronic for $42.9 billion in Cash and Stock. With its expanded portfolio of innovative products and services, this acquisition will allow Medtronic to reach more patients.

­Product Portfolio:

Nellcor Pulse Oximetry: The Nellcor pulse oximetry system provides fast, accurate and consistent pulse oximetry performance across a wide range of patients.


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What is the Projected CAGR value of the Newborn Screening Market ?
Newborn Screening Market is expected to grow at a CAGR of 10.7% during the forecast period 2023 - 2030.
Who are the key players in Newborn Screening Market ?
Major players are AB Sciex, Bio Rad Laboratories, Agilent Technologies, Masimo Corporation, Natus Medical, Trivitron Healthcare, PerkinElmer Inc, GE Life Sciences, ZenTech S.A and Covidien Plc.