The global newborn screening market size was valued at US$ 561.5 million in 2018, and is expected to witness a CAGR of 12.4% over the forecast period (2018 – 2026).

Newborn screening describes various tests that are performed during first few hours or days of an infant’s life. These tests have the potential for preventing severe health problems, including death. Newborn screening has evolved from a simple urine or blood screening test to a more comprehensive and complex screening system capable of detecting over 50 different conditions. Newborn screening tests measure a number of markers in infant’s blood that can be either decreased or increased if an infant has certain diseases. Currently, conditions such as cystic fibrosis (CF), congenital hypothyroidism, phenylketonuria (PKU), and around 22 other metabolic conditions that affect protein or fat metabolism can be diagnosed through newborn screening tests.

Several governments are taking initiative in increasing awareness about newborn screening tests and are offering free screening services in some regions. For instance, in September 2018, the Florida Department of Health launched the Newborn Screening (NBS) Web Order Application. This statewide initiative has been developed to ensure efficiency and accuracy of newborn screening information submitted to the Bureau of Public Health Laboratories.

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Moreover, novel biomarkers and analytical technologies are driving the evolution of Newborn Screening (NBS) programs. For instance, a rapid and highly sensitive point-of-care testing device has been developed and commercialized for the diagnosis of Sickle Cell Disease (SCD). According to a BMC Medicine Journal study 2015, SCD test demonstrated 99% specificity and 99% sensitivity for the diagnosis of several hemoglobin (Hb) variants: sickle cell trait (Hb AS), sickle cell anemia (Hb SS), Hb AA, Hb AC, and Hb SC, and requires only 5 μL of blood. Similarly, Next-Generation Sequencing (NGS) technologies are expected to impact newborn screening in the near future.

On the basis of region, the global newborn screening market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. By 2026, North America and Europe are expected to generate major revenue share in the global newborn screening market, owing to the presence of a better reimbursement structure, development of well-equipped healthcare infrastructure, and availability of trained medical professionals. According to the U.S. government, for the 2018 fiscal year, the Newborn Screening Quality Assurance Program at the CDC is funded at US$ 8.4 million and the Heritable Disorders program at Health Resources and Services Administration (HRSA) is funded at $13.88 million. The most common newborn screening tests in the U.S. include, hypothyrodism, galactosemia, PKU (phenylketonuria), and sickle cell disease. Increasing government funding in Europe for NBS within a national health service or a statutory health insurance, is expected to drive newborn screening market growth in Europe.

Asia Pacific newborn screening market is expected to foresee highest growth rate during the forecast period, owing to increasing incidences of premature births, high birth rates in countries such as China and India, and increasing healthcare awareness among regional population. According to WHO, 2012 report, most neonatal deaths occur in Asia, which accounted for 40% of the global neonatal deaths. Moreover, in India, less than 1% of infants are screened and over 1.6 million infants are born with birth defects, annually. These factors are expected to propel growth of the global newborn screening market in the region.

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