Newborn Screening Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

Market Overview

The newborn screening market is projected to register a CAGR of 9.0% during the forecast period, 2022-2027.

The COVID-19 pandemic affected every aspect of the healthcare system around the world due to the high influx of COVID-19 patients owing to the high infectivity rate of the SARS-COV-2 virus. The newborn screening procedures were also impacted initially due to the diversion of resources towards COVID-19 management which is anticipated to have an impact on the market. For instance, according to a research study titled 'Global impact of COVID-19 on newborn screening programs' published in March 2022, most newborn screening centers responded that the pandemic created little effect (47.7%), 18.6% a moderate effect, and 12.8% a lot, while 16.3% of the centers reported no effect. Also, as per the same source, in 29 of the 38 countries that responded, COVID-19 had some effect on the newborn screening programs and most of the screening centers encountered a wide range of issues, and the majority were more negatively impacted by the pandemic's second wave. Hence, COVID-19 is expected to have a significant impact on the newborn screening market.

Factors responsible for the growth of the newborn screening market include growing newborn screening programs, rising incidences of congenital diseases, raising funding from government sectors for newborn screening, and advancements in technologies used in newborn screening. For instance, according to a research study published in April 2022, titled “Epidemiology of Congenital Heart Disease in Jinan, China From 2005 to 2020: A Time Trend Analysis”, in urban regions, the prevalence of congenital heart disease (CHD) was 4.81 per 1,000 births from 2005 to 2020, compared to 3.17 per 1,000 births in rural areas and the prevalence of CHD grew by 157.45% and 316.03%, respectively, in urban and rural areas between 2005 and 2020, according to a time trend analysis of the data. Similarly, according to the February 2022 data of the World Health Organization, an estimate, birth abnormalities are responsible for the death of about 240,000 newborns in the first 28 days of life each year across the glove and an additional 170,000 children between the ages of 1 month and 5 years die because of birth abnormalities. Hence, newborn screening becomes very important as it can provide a proper health analysis of newborns in determining various birth defects or diseases, which can be used to provide adequate medical attention to the newborn and save the life of the newborn. Thus, the demand for newborn screening is expected to increase which will fuel growth in the studied market over the forecast period.

Further, the newborn screening programs run by governments across the continent are expected to have a significant impact on the growth of the newborn screening market as several governments have made newborn screening compulsory before getting discharged from the hospital. For instance, according to the March of Dimes (MoD) report of 2021, before leaving the hospital, every baby in the United States receives newborn screening and the nation screens around 4 million newborns annually. Moreover, the technological advancement in newborn screening platforms and devices is also expected to have a significant positive impact on the newborn screening market over the forecast period. However, the lack of uniformity in newborn screening policies and procedures across the world, and a high number of false positive and false negative results from the tests are expected to restrain the newborn screening market during the forecast period.

Scope of the Report

As per the scope of this report, newborn screening is a preventive pediatric screening test conducted to diagnose congenital or inborn abnormalities of metabolism to identify the disease. The early detection and appropriate standards of diagnosis and treatment can prevent death and promote the healthy development of an infant. The newborn screening market is segmented by technology (tandem mass spectrometry, pulse oximetry, enzyme-based assays, DNA assays, and other technologies), test type (dried blood spot, hearing screening, critical congenital heart defect (CCHD), and other test types), end user (hospitals, diagnostic centers, and other end users), and geography (North America, Europe, Asia Pacific, Middle East And Africa, and South America). The Market report also covers the estimated market sizes and trends of 17 countries across major regions globally. The report offers values (in USD million) for the above segments.

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Key Market Trends

Dried Blood Spot Segment is Expected to Hold the Major Share in the Market Over the Forecast Period

The COVID-19 pandemic has created a massive demand for DBS newborn screening tests, which has led to the development of novel NBS tests during the pandemic. In July 2020, PerkinElmer Inc. launched a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP/DELFIA platform, enabling the processing of up to 5,000 samples per day. The DBS assay runs on PerkinElmer's GSP analyzer and, combined with the universal TRF (time-resolved fluorescence) of the DELFIA platform, screens more than 30% of all newborn babies worldwide, spanning 32 countries.

Dried blood spot tests (DBS) are expected to continue their domination during the forecast period. DBS sampling has been used to screen newborn babies for congenital metabolic diseases for over 50 years. The advantages of DBS sampling include minimal volume requirements (approximately 30 – 100 µL per spot), ease of sample attainment by finger or heel stick with minimal training required, and ease of transport and sample stability. Autism, lymphomas, leukemia, and many other metabolic conditions can be diagnosed through this test. Dried blood spot analysis offers the advantage of collecting a small sample volume, which can be easily transported. Thus, rising diseases in newborns are boosting market growth.

Additionally, few organizations and Academic institutes in the segment have been developing novel products and technologies to compete with the existing products. For instance, in March 2022, Oxford University initiated a population-based newborn screening study in the Thames valley. The screening will be done through the routine United Kingdom newborn blood spot screening pathway, using spare capacity from a newborn's Guthrie card (dried blood spot sample). Thus the factors mentioned above are expected to drive the growth of the studied segment during the forecast period.

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