Newborn screening is the practice of testing newborn 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 intellectual and physical disabilities and life-threatening illnesses in newborn.
The newborn screening market growth is driven by several factors such as rising neonatal population base, increase in number of cases of congenital diseases in newborns. For instance, according to UNICEF data, globally, 2.5 million children died in the first month of life in 2017 alone, approximately 7,000 neonatal deaths every day, most of which occurred in the first week. About 1 million dying on the first day and close to 1 million dying within the next six days due to lack of skilled care and screening of the babies. To reduce the death count, several efforts are being taken by organizations such as the WHO, CDC, Healthy Newborn Network, etc., to educate parents for the possible disorders and their diagnostic procedures. North American agencies have also ordered 100% screening of all children born in private sector hospitals.
In addition, increasing healthcare awareness, benefits offered by newborn screening programs, and technological advancements in screening, and increasing government funding and support are also driving the growth of the newborn screening market globally. For instance, the WHO 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), UK (PEACH), and advocacy groups.
However, lack of improved healthcare infrastructure and trained professionals, and socioeconomic barriers are some of the major factors restraining the growth of the global newborn screening market.
On the basis of product, the market has been segmented into assay kits and instruments. The assay kits segment is further sub-segmented into enzymatic assay kits, DNA assay kits, immunoassay kits, and others. Among these, the immunoassay kits segment accounted for the largest market share in 2018 as immunoassay is a primary test used in screening and estimated to grow significantly over the forecast period (2019-2026). The instruments segment has been further divided into Mass Spectrometer, Pulse Oximetry, Hearing Screening Devices, Laparoscope, Retinoscope, Ultrasound Machine, and Others.
By application, the blood spot test dominated the newborn screening market accounting in 2018. The collection of blood from newborn’s heel within 24-48 hours of birth on the screening card for diagnosis of over 50 conditions is termed as heel stick or dried blood spot test (DBS). These screening cards are labeled using unique codes and contain no additional identity information. Autisms, Lymphomas and 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.
Critical Congenital Heart Disease (CCHD) is one of the commonly occurring disorders, which is screened using the pulse oximeter based technology. It is estimated that 18 out of 10,000 infants suffer from CCHD, which may lead to death if undetected. Growth of this segment is anticipated to affect the newborn screening market substantially over the forecast period.
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Geographical Trends:-
Geographically, the market is divided into North America, Europe, South America, Asia-Pacific and the rest of the world.
The North America is dominating the Newborn Screening market with highest market size in 2018 and estimated to hold the largest market share over the forecast period (2019-2026). The U.S. is leading the North America newborn screening market due to rising prevalence of congenital disorders. According to CDC in 2017, more than five million babies born annually are screened for various possible conditions. In 2017, number of infant deaths was about 22,335 and the leading causes of infant deaths were congenital malformations, deformations and chromosomal abnormalities. Conditions for screening were provided through extensive research by the American College of Medical Genetics (ACMG) under the supervision of the U.S. Department of Health and Human Services (HHS). Recently, ACMG has deviated from the traditional screening criteria and added new conditions to the list. Newborn screening program is diligently followed in all the states of North America. In addition, to create awareness, health departments of the states in U.S. have published free data and created websites that are expected to help parents to cope better with these conditions.
The Asia Pacific newborn screening market is growing at the highest CAGR during the forecast period (2019-2026) due to rising awareness programs and quality assurance of newborn diagnostic procedures in the developing economies of Korea, China, Taiwan, India and Sri Lanka. Improving infrastructure and healthcare plans and the availability of new opportunities for expansion are expected to play a major role in driving demand over the forecast period.
The Middle East region is also contributing to the rising growth of the newborn screening market. For instnace, as part of the National Newborn Screening Program, over 295,000 babies born in Qatar have been screened for metabolic and endocrine disorders, including rare diseases, Of these, 958 babies have been diagnosed with a rare disorder or genetic condition. Qatar was the first country in the region to establish a national newborn screening program, which was implemented in December 2003.
Competitive Landscape:-
Some of the major players of the global ECMO system market include Covidien Plc., AB SCIEX, Bio Rad Laboratories, Agilent Technologies, Masimo Corporation, Natus Medical, Trivitron Healthcare, PerkinElmer Inc, GE Life Sciences, and ZenTech S.A.
In October 2018, Trivitron’s Labsystems Diagnostics Oy, a leading brand that develops and manufactures high-quality diagnostic tests for clinical laboratories and physicians, expanded its portfolio on advancing newborn screening (NBS) by launching six new high-quality NBS products at ISNS 2018, Slovakia.
In February 2018, Sema4, a health information company providing advanced genomic testing, launched Sema4 Natalis, a supplemental newborn screening test designed to detect 193 childhood-onset diseases or disorders so parents can gain early insight into their baby's health.
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