Increasing number of newborn screenings, owing to rising awareness among parents and governments is expected to drive the newborn screening market growth. According to the Centers for Disease Control and Prevention (CDC) 2017, four million infants in the U.S. are routinely screened, using a few drops of blood from their heel, for certain endocrine, genetic, and metabolic disorders. The infants are also tested for hearing loss and Critical Congenital Heart Defects (CCHDs) prior to discharge from a hospital or birth center.
Furthermore, increasing incidence of hospital acquired diseases create an acute need for newborn screening. For instance, according to the Center for Disease Control and Prevention (CDC), in 2011, around one in every 25 infants was infected with at least one hospital acquired infections.
Government initiatives to support screening of newborns is also a major factor driving the newborn screening market. For instance, CDC is working to harness the latest advances in science and technology so that more disorders can be identified accurately and treated quickly. In 2005, CDC established the Newborn Screening Translation Research Initiative (NSTRI) with the CDC Foundation. NSTRI works with corporate, academic, and foundation partners to assure the quality of research methods during both pilot studies and routine screening.
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However, lack of skilled professional, proper infrastructure and parent awareness in emerging regions are some of the major factors confining the newborn screening market. Moreover, the natural history for several diseases has not been well characterized and the effective follow-up and treatment may not be known. Excessive false-positive results of screening tests may produce additional costs to the healthcare system. However, improvements in newborn screening tests is expected to reduce number of false positives.
Manufacturer in the newborn screening market are focused on developing new test kits and devices in order to diagnose more diseases or disorders at birth. For instance, in February 2018, Sema4, a health information company offering advanced genomic testing, launched Sema4 Natalis, a supplemental newborn screening test designed to detect 193 childhood-onset diseases or disorders.
Furthermore, several governments are supporting manufacturers to develop new screening tests by relaxing regulations for manufacturing and marketing products. For instance, in February 2017, the U.S. FDA approved marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed to detect Fabry, Gaucher, Mucopolysaccharidosis Type I (MPS I), and Pompe. It is the first newborn screening test permitted to be marketed by the FDA for these disorders.
Key players operating in the global newborn screening market include, Agilent Technologies, AB SCIEX, Bio-Rad Laboratories, Covidien PLC, GE Life Sciences, Masimo Corporation, Natus Medical Inc., PerkinElmer Inc., and ZenTech S.A.
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