Newborn Screening Market Size, Share, Forecast, & Trends Analysis by Technology (Tandem Mass Spectrometry, Pulse Oximeter, Molecular Assay, Immune Assay) Application (CHD, Infectious Diseases, Hearing Disorder) Product, End User – Global Forecast to 2031

The Newborn Screening Market was valued at $1.49  billion in 2023. This market is expected to reach $2.69  billion by 2031, from an estimated $1.6  billion in 2024, at a CAGR of 7.8% during the forecast period 2024-2031.

Newborn Screening Market Size & Forecast

The rising prevalence of congenital heart diseases and genetic disorders, the increasing neonatal population, and the rising awareness regarding newborn screening are the factors driving the growth of the newborn screening market. Additionally, emerging economies and government programs & legislation promoting newborn screening serve as opportunities for the market.

Newborn Screening Market Growth Drivers

Use of Advanced Technologies for Newborn Screening

Ever since its introduction in the early 1960s, newborn screening has been carried out using traditional technologies such as tandem mass spectrometry and biochemical testing, among others. These technologies are effective and reliable, however, the emergence of advanced technologies has improved the accuracy of results. Next-generation sequencing (NGS) and artificial intelligence (AI) are two of the most researched technologies in the newborn screening industry.

These technologies are still in the research phase but are being tested to screen newborns. NGS screening will help in screening more disorders compared to other conventional technologies using techniques such as targeted gene panels, whole exome sequencing (WES), and whole genome sequencing (WGS). NGS technology will also follow the Wilson and Jungner principles to identify genes associated with treatable disorders. It is economically feasible, and many tools and software are available for result interpretation.

Another technology that can be incorporated along with conventional methods is artificial intelligence. A study was conducted at the Neonatal Disease Screening Center of the Maternal and Child Health Hospital in Shaoyang City (China) to screen newborns for inborn errors of metabolism. In total, 96,648 newborns were enrolled during 2016-2020. An AI algorithm was used to analyze the screening results. According to the results, 1,988 newborns were screened, and 23 of them were confirmed to have an inborn error of metabolism. It was also observed that the occurrence of false positives could be decreased by more than 24.9%, improving screening efficiency.

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Increasing Neonatal Population

Newborn screening has been recognized and initiated by governments of various countries worldwide due to the high prevalence of genetic and/or metabolic conditions in newborns. Owing to the increasing importance of newborn screening in identifying infants at risk of diseases and aiding in timely diagnosis and management, various countries have made newborn screening tests compulsory. For instance, the U.S. government has made newborn screening compulsory soon after birth. Since the 1960s, NBS programs have become the most effective health programs in the U.S., which test for 31 out of 35 core conditions recommended by the Uniform Screening Panel (RUSP). It is estimated that around 4 million babies are screened annually for serious disorders present at birth in the U.S.

Collaborations are also being done between public and private organizations for newborn screening. For instance, in 2021, PerkinElmer, Inc. (U.S.) collaborated with the International Society for Neonatal Screening (ISNS) to bring attention to India’s rare diseases policy in 2021 and discuss strategies to improve newborn and maternal health. The Government of India and PerkinElmer (U.S.) had also collaborated for genetic testing and newborn screening training. Additionally, in 2018, the government of Ghana collaborated with the Sickle Cell Foundation of Ghana and the U.S. Centers for Disease Control and Prevention (CDC) to provide technical assistance regarding post and pre-term screening activities, including genetic counseling, to health workers and parents. Thus, the growing importance of newborn screening and key developments in the newborn screening market are collectively driving the market.

Newborn Screening Market Opportunity

Government Programs & Legislation Promoting Newborn Screening

Newborn screening programs in newborns is conducted for early intervention and detection in several metabolic, genetic, and congenital disorders. The programs identify conditions early on, allowing for timely management and treatment, which reduces the risk of severe health complications and improves outcomes.

For instance, The Newborn Screening Saves Lives Act (U.S.): enacted in 2008, aims to promote and support newborn screening programs across the country. It further aids and grants to states for enhancing their newborn screening programs, improve laboratory capacity and quality, and expand screening for additional disorders.

European Union Newborn Screening Program: Specific legislation differs from country to country within the EU, several efforts at the EU level are made for promotion of standardization and harmonization of newborn screening programs across member states. This further includes sharing guidelines, best practices, and funding opportunities for members of the EU for improving their newborn screening programs.

Newborn Screening Market Analysis: Key Findings

By Product: In 2024, The Consumables Segment to Dominate the Newborn Screening Market

Based on product, the newborn screening market is segmented into consumables and instruments. In 2024, the consumables segment is expected to account for the largest share of 44.2% of the market. The main factors contributing to the large market share of this segment are repeat purchases of consumables for screening of newborns, availability of advanced kits, and high awareness about newborn screening in developed countries.

Furthermore, the consumables’ segment is projected to witness the highest growth rate of 8.8% during the forecast period of 2024–2031.

By Technology: In 2024, The Tandem Mass Spectrometry Segment to Dominate the Newborn Screening Market

Based on technology, the newborn screening market is segmented into immune assays & enzymatic assays, tandem mass spectrometry, molecular assays, hearing screening technologies, pulse oximetry, and other technologies. In 2024, the tandem mass spectrometry segment is expected to account for the largest share of the market. The large market share of this segment is attributed to the increasing prevalence of genetic diseases, increasing demand for specialists, and increasing awareness of newborn screening.

By Applications: In 2024, The Inherited Disorders to Dominate the Newborn Screening Market

Based on application, the newborn screening market is segmented into congenital heart disease, inherited disorders, infectious diseases, hearing disorders, and other applications. In 2024, the inherited disorders segment is expected to account for the largest share of the 29.6% of the market. The large market share of this segment is due to the high prevalence of inherited disorders among newborns, variations or mutations in the genes, inherited gene defects, and abnormality in genetic composition.

By End User: In 2024, The Hospitals Segment is Expected to Account for the Largest Share of the Market in 2024

Based on end user, the newborn screening market is segmented into hospitals and reference laboratories. In 2024, the hospitals segment is expected to account for the largest share of the market. The high preference of hospitals for childbirth delivery, better infrastructure, utilization of advanced techniques in the hospitals, and the availability of skilled professionals are some factors contributing to the large market share of this segment.

Geographical Analysis

North America to Dominate the Newborn Screening Market

In 2024, North America is expected to account for the largest share of 48.3% of the newborn screening market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America’s significant market share can be attributed due to the increasing prevalence of genetic diseases, a robust healthcare system in the region, mandatory newborn screening statutes, and the presence of key market players.

Moreover, Asia-Pacific is slated to register the highest CAGR in the newborn screening market 8.6% during the forecast period. The high market growth in Asia-Pacific is attributed to high fertility rates in the region, improving healthcare infrastructure, and increasing disposable income. In 2020, the fertility rates in India and China were 2.2 and 1.8, respectively. Additionally, government initiatives and growing awareness in the region about newborn screening and its advantages, and rising healthcare expenditure are likely to boost the newborn screening market in Asia-Pacific.

Newborn Screening Market: Key Companies

The report includes a competitive landscape based on an extensive assessment of the key strategic developments that led market participants to adopt over the past three years. The key players profiled in the global newborn screening market are Thermo Fisher Scientific, Inc. (U.S.), ARCHIMED Group (France), PerkinElmer, Inc. (U.S.), Medtronic plc (Ireland), Trivitron Healthcare Pvt Ltd. (India), Bio-Rad Laboratories, Inc. (U.S.), Demant A/S (Denmark), Baebies, Inc. (U.S.), ZenTech s.a. (Belgium), and F. Hoffmann-La Roche AG (Switzerland).

Newborn Screening Market Research Summary:

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