The global newborn screening market is expected to register a CAGR of 9.0% during the forecast period, 2018 to 2023. North America dominates the market, due to growing awareness regarding newborn screening in the region.
The rapid pace of developments in the field of expanded newborn screening has been made possible through technological advancement in the devices and kits. This enables the detection of multiple compounds in the diagnosis of diverse inborn errors of metabolism in the neonatal dried blood specimens. After the success of newborn screening in phenylketonuria, major competitors in this field have continued to develop and introduce new models with significant performance improvements, which is likely to drive the market. Additionally, growing newborn screening programs worldwide, rising incidences of congenital diseases, and rising funding from government sectors are likely to surge the market growth of newborn screening market globally.
Newborn screening tests are only the screening tests and not confirmatory tests. According to a survey, screening tests can have a higher margin of error and be less valid than diagnostic tests, but they should have a very low false negative rate. It is estimated that, on the expanded newborn screening panel, only about one in fifty of every positive new-born screening test detects actual disease. It is also noted that the average rate of false positives can vary widely, and it depends on the conditions tested. One in ten positive tests for cystic fibrosis is a true positive result, while one in 100 or one in 200 positive tests for congenital adrenal hyperplasia is a true positive result. The unreliability of few newborn screening tests and lack of uniformity of newborn screening policies and procedures, across the globe, is likely to impede the growth of the market.
North America is expected to hold the largest share of the newborn screening market during the forecast period, due to growing awareness regarding newborn screening tests. For instance, in the United States, over 4,000,000 screenings are performed annually.
In the United States, both federal and state governments make policies governing newborn screening, which is augmenting the demand for newborn screening tests in the region.
Major Players: AB Sciex Pte Ltd, Agilent Technologies, Bio-Rad Laboratories, Inc., GE Healthcare, Masimo Corporation, Medtronic, Natus Medical Incorporated, PerkinElmer, Inc., Trivitron Healthcare, and ZenTech S.A, amongst others.