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

The newborn screening market is projected to register a CAGR of 9.0% 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 article published in 2020, Shan Liu stated that 15 million newborns are delivered in China every year, and the New Born Screening (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 and thereby drives 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 for 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.

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-effective equipment 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.

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.

North America Dominates the Market and Similar Trend is Expected Over the Forecast Period

The United States is the most COVID affected country across the world. The supply chain of medical devices was highly impacted in this country. However the demand for new born screening tests during the COVID will keep growing as these procedures were not on hold and thus it has positively impacted the overall market growth.

Currently, North America dominates the market for newborn screening and is expected to continue its stronghold for a few more years. This is primarily due to the growing prevalence of congenital disorders and enforced testing in all 50 states of the nation. In the North American region, the United States holds the largest market share. This can be majorly attributed to the increasing incidence rates of disorders in newborns and the rising demand for advanced systems. In the United States, every newborn is screened post-birth, and this screening is performed by the analysis of diagnostic markers in blood spots collected on filter paper on the second day of an infant’s life. Newborn screening programs are run on a state basis within the United States; therefore, it has been observed that there is a lack of uniformity among the testing panels of many states.

According to the data published by the Centers for Disease Control and Prevention, in 2022, about 3,613,647 new births were reported in the country, and the birth rate in the country for 2022 was 11.0 per 1,000 population. In May 2019, Parent Project Muscular Dystrophy (PPMD) launched a pilot program to screen newborns in New York state for Duchenne, one of the most common forms of muscular dystrophy. In the same month of the same year, the US government introduced the Newborn Screening Saves Lives Reauthorization Act in the country to eliminate preventable newborn deaths and severe disabilities through the increased use of comprehensive and standardized newborn screening tests. In addditon the presence of developed healthcare infrastructure is expected to further propel the market in the United States.

Competitive Landscape

The newborn screening market is moderately competitive and consists of several major players. In terms of the market share, few of the major players currently dominate the market. A large portion of the market share is held by Agilent Technologies Inc., Natus Medical Inc., Trivitron Healthcare, Medtronic Inc., Masimo Corp., and Bio-Rad Laboratories Inc., among others.

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