Newborn Screening Market – Insights
Newborn screening includes various tests that are conducted during first few hours or days of child birth. These tests are capable of preventing severe health conditions, including death. Convention newborn screening included urine or blood screening test. Current tests in newborn screening are more comprehensive and complex and can identify over 50 different conditions. These tests measure several markers in an infant’s blood, the amount of which determines whether or not the infant has certain diseases. Newborn screening can be used to diagnose conditions such as cystic fibrosis (CF), congenital hypothyroidism, phenylketonuria (PKU), and around 22 other metabolic conditions that affect protein or fat metabolism.
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).
Increasing government initiatives related to newborn screening and recent developments in the technology is expected to boost the newborn screening market growth
Various governments around the world are focused on increasing the awareness regarding the importance of newborn screening and are offering free screening services. For instance, in September 2018, the Florida Department of Health launched the Newborn Screening (NBS) Web Order Application. This statewide initiative was launched to ensure efficiency and accuracy of newborn screening information submitted to the Bureau of Public Health Laboratories.
Furthermore, development of new biomarkers and analytical technologies is boosting growth of the market. For instance, the Sickle Cell Disease (SCD) test is a rapid and highly sensitive point-of-care testing for the diagnosis of 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 significantly contribute to the market growth over the forecast period.
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Newborn Screening Market Restraints
However, lack of consensus for screening is a major factor hampering the newborn screening market growth. Lack of agreement among countries on which specific disorders should be included in NBS programs. Some countries screen for only one Inherited Metabolic Disorders (IMD), whereas 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.
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Furthermore, other challenges such as 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 any hinder the market growth.
New Born Screening Test Market – Regional Insights
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.
- Global Newborn Screening Market, By Product:
- Assay Kits
- Hearing Screening Devices
- Mass Spectrometer
- Pulse Oximetry
- Global Newborn Screening Market, By Test:
- Blood Test
- Cardiac Test
- Hearing Test
- Urine Test
- Global Newborn Screening Market, By Application:
- Blood Spot Disease
- Critical Congenital Cardiac Disease
- Maple Syrup Urine Disease
- Hearing Disability
- Sickle Cell Disease
- Thyroid Disorder
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