Newborn Screening Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

Market Overview

The newborn screening market is projected to register a CAGR of 7.5% during the forecast period, 2021-2026

The lifesaving newborn screening continues even during the COVID-19 outbreak. All the laws, obligations, and policies for collecting samples and screening procedures remain intact without any changes. In his article published in 2020, Shan Liu stated that 15 million newborns are delivered in China every year, and the NBS will be effectively done. The article stated that along with the NBS screening, the COVID-19 screening is expected to also be done for all newborns during the pandemic situation.

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. As per the Heart Disease and Stroke Statistical Fact Sheet 2020, a minimum of 40,000 infants are expected to be affected by congenital heart defects in the United States every year. About 25% (2.4 per 1,000 live births) of these affected children are expected to require treatment during the first year of their lives. This is expected to increase the use of newborn screening tests in the field of pediatrics, and it is expected to drive the growth of the market.

Newborn screening represents one of the major child health advances of the past century, and there have been many advancements in the technologies used in newborn screening. The rapid pace of developments in the field of newborn screening has been made possible by technological advances in the ability to detect multiple compounds diagnostic of different inborn errors of metabolism in neo-natal dried blood specimens. After the success of newborn screening in phenylketonuria, experts in this area are optimistic that further health benefits may arise in the future.

Additionally, one of the most exciting and powerful advancements in this field is the commercialization of hybrid instruments. The manufacturers are focusing on high sensitivity, resolution, throughput, and cost-effectiveness to gain a foothold in the market. Hence, many companies have been influenced by emerging technologies and have adopted many new clinical testing platforms for use.

Since the last five years, it has also been seen that most screening programs have been using tandem mass spectrometry (MS/MS) as the principal tool for analyzing blood spots. TMS has revolutionized the newborn screening market. It has reduced false-positive results and has made the screening process easier. The test can screen for over forty metabolic conditions. Before MS/MS was used for newborn screening, a separate bacterial assay was needed for every condition. Now, except endocrine disorders (i.e., congenital hypothyroidism and congenital adrenal hyperplasia), hemoglobin disorders (i.e., sickle cell disease, S-beta thalassemia, and sickle-C disease), and a few others (e.g., biotinidase, cystic fibrosis, transferase-deficient galactosemia, and hearing disorders), none other need separate tests. The technical advances have also facilitated the expansion of newborn screening to include the detection of additional disorders. Thus, improvements in technology and the expansion of the uniform newborn screening panel of diseases have led to earlier life-saving treatment and intervention for at least 12,000 additional newborns each year in the United States with selected genetic, hearing, and endocrine disorders.

However, factors, such as the lack of uniformity of newborn screening policies and procedures, across the world, may hinder the market growth.

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 report offers the value (in USD million) for the above segments.

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Key Market Trends

The Dried Blood Spot Segment is Expected to Hold the Major Share of the Market

The COVID-19 pandemic has created a huge 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 the market growth.

Additionally, few of the key market players in the segment have been developing novel products and technologies to compete with the existing products. In 2018, Trivitron’s Labsystems Diagnostics expanded its diagnostic portfolio to advance newborn screening (NBS) by launching six new high-quality dried blood spot newborn screening tests.

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