Published by TMR Research Insights
Posted on August 9, 2021
6 min readLast updated: February 18, 2026
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Newborn Screening Market: Introduction
According to the report, the global newborn screening market was valued at ~US$ 940 Mn in 2019 and is projected to expand at a CAGR of ~11% from 2021 to 2031. Newborn screening is a preventive pediatric screening test conducted to diagnose congenital or inborn abnormalities of metabolism in order to identify the disease. Newborn screening helps in the early detection of serious genetic diseases, which may result in disability or death if not treated at the initial stage. Different types of instrument and assay kits are used in the diagnosis of newborn disorders. Hearing screening devices and pulse oximeter are regularly used in the diagnosis of newborn disorders.
The growth of the global newborn screening market can be ascribed to the rise in prevalence of critical congenital heart defects and government support. The U.S. has a national program of newborn screening tests to check for several different disorders that can be treated, if found very early in life.
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North America dominated the global newborn screening market in 2019. This trend is anticipated to continue during the forecast period. Highly structured healthcare industry, early new product adoption, high prevalence rate of critical congenital heart diseases, and presence of major players are expected to drive the newborn screening market in North America. Asia Pacific is anticipated to be a highly lucrative region of the global newborn screening market during the forecast period. The market in the region is projected to expand at a high CAGR during the forecast period.
Rise in Prevalence of Critical Congenital Heart Defects and Government Support to Drive Global Market
Rise in prevalence and incidence of critical congenital heart diseases across the globe are driving the global newborn screening market. According to the National Center for Biotechnology Information, about 1.35 million babies are born with congenital heart disease each year across the globe. According to the Indian Academy of Pediatrics, more than 200,000 children are estimated to be born with CHD in India every year. About one-fifth of these suffer from critical heart disease that requires early intervention.
Supportive governmental programs and increase in funding for neonatal research also create a favorable environment for the expansion of the market. For instance, in June 2018, the American Society of Hematology (ASH) led a campaign to fight the sickle cell disease in Africa and urged governments, particularly in Sub-Saharan Africa, to invest in newborn screening of the disease.
Instruments to Dominate Newborn Screening Market
In terms of product, the global newborn screening market has been bifurcated into instruments and assay kits. The instruments segment has been split into tabletop and point-of-care testing. The instruments segment dominated the global newborn screening market in 2019. This trend is likely to continue during the forecast period. Instruments allow early detection and management of congenital disorders, thereby providing a better life to the affected infant. This is estimated to boost the segment during the forecast period. Major market players are focusing on the launch of new tabletop and point-of-care testing instruments for newborn screening. This is also likely to propel the segment during the forecast period.
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Assay kits was the second-largest segment of the global market in 2019, in terms of market share. Increase in use of assay kit in newborn screening is projected to fuel the growth of the segment.
Dry Blood Spot Test to be Highly Lucrative Test Type
Based on test type, the global newborn screening market has been categorized into dry blood spot test, hearing screen test, critical congenital heart disease (CCHD) test, X-ray or CT scan, electrocardiogram (ECG) test, and others. The dry blood spot test segment accounted for a prominent share of the global newborn screening market in 2019. Dry blood spot test helps analyze specific biochemistry parameters, such as uric acid, cholesterol, triglycerides, glucose, and creatinine. The dry blood spot test can be used when a baby requires re-testing, as it provides a fast alternative to bringing the parents and infant back to the hospital for a new blood draw. This is critical, as many of the conditions screened for by newborn screening need to be diagnosed as quickly as possible. This is boosting the dry blood spot test segment.
Hospitals to be Key End User
In terms of end user, the global newborn screening market has been classified into hospitals, diagnostic centers, maternity & specialty clinics, and others. The hospitals segment led the global newborn screening market in terms of revenue in 2019. This trend is projected to continue during the forecast period. Rapid increase in the number of hospitals and wide range of services available in multispecialty hospitals are likely to augment the segment during the forecast period.
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North America to Dominate Newborn Screening Market
In terms of region, the global newborn screening market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global newborn screening market in 2019, followed by Europe. North America’s large market share can be ascribed to the increase in number of infants with critical congenital heart diseases, new product launches, and presence of major players in the region. The newborn screening market in Asia Pacific is anticipated to expand at a high CAGR from 2021 to 2031. This can be ascribed to the presence of developing countries with commercial hubs, expanding business organizations, rise in birth rate, improvement in healthcare infrastructure, and increase in investments by companies in research and development activity.
Competition Landscape of Newborn Screening Market
The global newborn screening market is fragmented in terms of number of players. Key players operating in the global market include PerkinElmer, Inc., Trivitron Healthcare, Natus Medical Incorporated, Medtronic Plc, Thermo Fisher Scientific, Inc, Bio-Rad Laboratories, Inc., GE Healthcare (General Electric Company), ZenTech S.A., MP BIOMEDICALS, Baebies, Inc. and Masimo.
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The global newborn screening market is projected to reach approximately US$ 3.3 billion by 2031.
The growth can be attributed to the rise in prevalence of critical congenital heart defects and increased government support for neonatal research.
North America dominated the global newborn screening market in 2019 and is expected to maintain this position during the forecast period.
The newborn screening market is bifurcated into instruments and assay kits, with instruments being the leading segment.
Key players in the global newborn screening market include PerkinElmer, Inc., Trivitron Healthcare, and Natus Medical Incorporated.
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