Newborn Screening Market Major Players SWOT Analysis with Top Players Agilent Technologies, AB SCIEX, Bio-Rad Laboratories, Covidien PLC, GE Life Sciences, Masimo Corporation, Natus Medical

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).

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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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.

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.

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.

Newborn Screening Market Restraints

However, lack of consensus for screening is a major restraining factor for newborn screening market growth. There is little agreement among countries on which specific disorders should be included in NBS programs. Although some countries screen for only one Inherited Metabolic Disorders (IMD), others screen for over 30 conditions. For instance, according to the Nature Medicine Journal 2012 study, screening strategies in Europe vary between countries. Moreover, in some countries such as Belgium, Italy, and Spain, policy-making is decentralized to regions or provinces that have separate NBS programs.

Similar conditions are observed in the U.S. where one state may result in screening a different set of disorders compared to a neighboring state. This absence of agreement on screening tests is due to the lack of high-quality observational evidence for most disorders. Furthermore, multiple challenges need to be confronted including false negative and false positive results of screening tests, inadequate information about the natural history of disease, limited access in some geographic areas to advanced technologies, and treatment of conditions with various phenotypes.

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