Newborn Screening Market By Product Type (Instruments, Reagents & Consumables, Others), By Test Type (Metabolic Disorders Screening, Endocrine Disorders Screening, Genetic Disorders Screening, Hemoglobinopathies Screening, Hearing Screening, Other Disorders Screening), By Technology (Tandem Mass Spectrometry (TMS), Polymerase Chain Reaction (PCR), Enzyme-linked Immunosorbent Assay (ELISA), DNA Sequencing, Immunoassay), By Screening Method (Blood Spot Screening, Urine Screening, Saliva Screening, Sweat Testing, Others), By End-User (Hospitals & Clinics, Laboratories, Research Institutes, Public Health Organizations). Global Market Size, Segmental analysis, Regional Overview, Company shares analysis, Leading Company Profiles and Market Forecast, 2025 – 2035

Industry Outlook

The Newborn Screening market accounted for USD 1.32 Billion in 2024 and is expected to reach USD 3.44 Billion by 2035, growing at a CAGR of around 9.1% between 2025 and 2035. The Newborn Screening Market is aimed at screening newborn infants for potentially life-threatening but manageable diseases soon after birth. Some of them include metabolic, genetic, hormonal, and hematological screening, all these are made to ensure that the possibility of common health risks is detected from the onset.

These conditions are also further developing through the continual evolution of diagnostic equipment and respective tests, which means more diseases can be identified and treated at the initial stage. if diagnosed at early stages, the child has been prescribed medication or a change of diet to avoid serious health complications for infants. The Newborn Screening Market has been enjoying steady expansion due to rapid improvement in screening methods and heightened awareness of the problem.

Report Scope:

Market Dynamics

Precision medicine offers targeted, efficient newborn screening tailored to individuals.

Precision medicine plays an important role in the Newborn Screening Market as it allows for targeted and effective screening depending on the genetic makeup of newborns. This approach is very effective in a way that the beginning of any health adversity is easily detected, allowing for immediate and personal treatment. To solve this, precision medicine targets each newborn with unique genes that only they possess. This improves the effectiveness of screening programs and may prevent incorrect positive or negative results.

Genomic technologists point out that in light of the advancement of genomic technologies, diagnosis of additional disorders is achievable, enhancing health. In recent years, the number of conditions in newborn screening panels has increased to over 35, and the NIH notes that the improvement of precision medicine has significantly increased the detection rates of newborn screening tests. Increased efficacy and efficiency in baby health research are the reasons behind the rise of newborn screening types.

Technological advancements improve screening accuracy and detection capabilities.

The Newborn Screening Market has mainly benefited from technological advancements that have increased the accuracy and detection rate of newborn screening tests. Techniques best illustrated by next-generation sequencing, mass spectrometry, and real-time PCR have enhanced the early diagnosis of genetic and metabolic disorders. They improve the accuracy of the screenings—make tests more sensitive, increase specificity, and decrease the risk of false negative/positive results.

Nonetheless, the development of automated systems has become more efficient in reducing human error thanks to advancements in computerization. As a result of these advancements, screening has broadened its scope to encompass additional illnesses, making it easier to detect early interferences and, consequently, attain suitable health outcomes for children. Newborn screening programs and the advantages they offer are anticipated to expand and improve the standard of future healthcare as technology advances.

High costs of advanced technologies limit adoption in low-income regions.

The high costs associated with advanced technologies pose a significant challenge to the widespread adoption of newborn screening, particularly in low-income regions. A range of expensive technical platforms, including next-generation sequencing and proteomics by mass spectrometry, may be limited in accessibility to resource-poor settings due to the costs of acquiring the equipment, staff training and calibration, and consumables.

This keeps many healthcare systems away from adopting these technologies and reduces their capability to diagnose hereditary and metabolic diseases early in needy communities. Therefore, although there is evidence that enhanced methods of newborn screening have multiple advantages, financial factors can limit the use of the technology that nevertheless should be used to eliminate healthcare inequality. Regarding this, it implies that through cost-efficient measures, government sponsorships, or perhaps international donations, the accessibility needs to be enhanced to ensure all the infants receive the right screenings at the right time.

Telemedicine expands newborn screening access in rural and underserved areas.

Telemedicine presents a significant opportunity for the Newborn Screening Market, particularly in rural and underserved areas where access to healthcare services can be limited. Healthcare providers can use digital technologies to virtually communicate with specialists, receive results of tests, and advise parents or other healthcare givers on the child’s status for early diagnosis and treatment.

Those regions where there are scanty health facilities resulting in late presentation are addressed in this technology, hence enabling the newborns to receive the best screening methods without having to cover long distances. Telemedicine also eliminates or decreases the need to be transported to screening and follow-up visits for families often located in rural areas. With the increase in the uptake of telemedicine, newborn screening may be enhanced in terms of access, equity, and efficiency, especially in areas that are poorly endowed.

AI-driven technology enhances the efficiency and accuracy of newborn screening.

AI-driven technology promises an exciting opportunity to make newborn screening more efficient and accurate. Using AI, data analysis, and interpretation can be automated for the quick identification of potential health conditions in newborns, reducing the likelihood of human error in results. Machine learning algorithms can analyze patterns in massive datasets, allowing for rare genetic disorders that may go unnoticed with traditional methods.

Furthermore, it speeds up the screening process while enabling early detection, which improves newborn health outcomes. AI also makes newborn screening more accessible and effective in places with limited resources, allowing for more efficient workflows in healthcare settings that reduce resource management and, consequently, operating expenses.

Industry Experts Opinion

, “Technology is a vital and principal force that moves newborn screening forward. Transitioning from traditional biochemical markers to molecular markers will improve the accuracy and performance of screening methods. This shift will allow for the detection of more conditions, but it also raises complex questions about which conditions should be included, how to report findings, and the ethical considerations of screening for mild cases or genetic predispositions.”​

• Dr. David Millington, an emeritus professor at Duke University Medical Center

Segment Analysis

Based on the Test Type, the Newborn Screening Market has been classified into Metabolic Disorders Screening, Endocrine Disorders Screening, Genetic Disorders Screening, Hemoglobinopathies Screening, Hearing Screening, and Others. Metabolic disorders screening is the largest and most revolutionary segment in the Newborn Screening Market. This is mainly because more detection programs for congenital inherited metabolic disorders are being practiced and recognized to closely affect the health of infants. PKU and cystic fibrosis are examples of the various metabolic diseases for which screening is done at birth.

The fact is that most such disorders can be identified at an early stage; thus, the appropriate intervention should be planned as soon as possible to avoid further complications and to achieve a satisfactory long-term prognosis. Hospitals and governments all around the world have been increasing their spending on newborn screening programs, and this increases the demand for metabolic disorder testing. Moreover, enhancements in screening techniques like tandem mass spectrometry also paved the way for better identification of metabolic disorders, making the segment dominant and strong. Because metabolic screening is so important in enhancing the health of newborns, it is a key component of newborn screening programs.

Based on the Technology, the Newborn Screening Market has been classified into Tandem Mass Spectrometry (TMS), Polymerase Chain Reaction (PCR), Enzyme-linked Immunosorbent Assay (ELISA), DNA Sequencing, and Immunoassay. Among the technologies used in the Newborn Screening Market, Tandem Mass Spectrometry (TMS) accounts for the biggest and the most dominating segment. TMS is currently considered the best approach to screening metabolic disorders from the perspective of their sensitivity and accuracy, in addition to allowing the measurement of multiple biomarkers individually. This technology can now diagnose a whole host of inherited metabolic diseases, such as amino acidopathies, organic acidurias, or defects in fatty acid oxidation.

The flexibility of TMS, coupled with its capacity to carry out analytical work at high throughput, has made the method popular in newborn screening programs all over the world. In addition, the continuous progress of TMS technology has led to its higher accuracy in diagnosis, thus providing newborns with more favorable outcomes. TMS is already core to many organized nations and regional screening programs, and this has put it in a strategic position in the market. TMS growing in this respect is therefore well positioned to lead the way in newborn screening technology as early diagnosis and intervention gain more currency.

Regional Analysis

The North American Newborn Screening Market is the largest and consists of two regions: the United States and Canada. Newborn screening is mandatory in all fifty states across the United States and has extensive programs that screen for multiple disorders. Market growth has been attributed to factors such as the region’s operating healthcare infrastructure, expenditure on healthcare, and regulatory policies of the government. Innovative technologies for early danger diagnostics are being developed by American and Canadian companies to increase the effectiveness of neonatal screening.

In essence, the need for screening solutions is driven by the need for early diagnosis and check-ups as well as increased health literacy. Furthermore, industry organizations like the NIH and CDC provide significant support for the cause, and the market continues to grow. Similar laws are in place in Canada with the same goal as the one mentioned above: to expand the reach of its early screening programs and improve access to healthcare.

The major factor driving the European Newborn Screening Market is that there are strong healthcare systems and also established screening programs in several nations of Europe. Newborn screening programs are well developed in Europe, with some countries making screening for a host of metabolic, genetic, and hormonal disorders compulsory. It has been proven by the continuing popular use of screening technologies, government support, and improvement of people’s consciousness on the necessity of early detection of diseases.

The growing propensity of the European Union towards supporting innovation in healthcare facilities and investment in public healthcare-related projects adds to it. Innovative technologies for early danger diagnostics are being developed by American and Canadian companies to increase the effectiveness of neonatal screening. In essence, the need for screening solutions is driven by the need for early diagnosis and check-ups as well as increased health literacy. Industry organizations like the NIH and CDC provide significant support for the cause, and the market continues to grow. Similar laws are in place in Canada with the same goal as the one mentioned above: to expand the reach of its early screening programs and improve access to healthcare.

Competitive Landscape

The Newborn Screening Market faced high competitiveness due to its major market players, such as PerkinElmer, Bio-Rad Laboratories, Natus Medical, Abbott Laboratories, and Thermo Fisher Scientific. They are at the forefront in manufacturing screening technologies, diagnostic equipment, and reliable solutions to introducing and identifying different illnesses in a neonate. PerkinElmer specializes in having high-throughput screening platforms, while Bio-Rad Laboratories specializes in having high-quality reagent kits.

Natus Medical specializes in dealing with neonate care products, while Abbott Laboratories has invested a lot of effort in designing lightweight, powerful screening equipment. Third, Thermo Fisher Scientific has a strong molecular diagnosis capacity. The market also remains highly saturated due to the persistent introduction of new products, expansion of client portfolios, and various strategic collaborations to address the increasing need for more inclusive newborn screen services all over the globe.

Newborn Screening Market, Company Shares Analysis, 2024

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Recent Developments:

• In January 2023, Masimo introduced a cutting-edge baby monitoring system designed to allow caregivers to instantly track vital infant data, improving the care and safety of newborns through real-time monitoring.
• In November 2023, Trivitron Healthcare launched the EkSahiShuruat campaign in India, aimed at raising awareness about the importance of newborn screening. The initiative focuses on educating the public about the crucial role of screening in early disease detection and promoting its widespread adoption across the country.

Report Coverage:

By Product Type

• Instruments
• Reagents & Consumables
• Others

By Test Type

• Metabolic Disorders Screening
• Endocrine Disorders Screening
• Genetic Disorders Screening
• Hemoglobinopathies Screening
• Hearing Screening
• Others

By Technology

• Tandem Mass Spectrometry (TMS)
• Polymerase Chain Reaction (PCR)
• Enzyme-linked immunosorbent Assay (ELISA)
• DNA Sequencing
• Immunoassay

By Screening Method

• Blood Spot Screening
• Urine Screening
• Saliva Screening
• Sweat Testing
• Others

By End-user

• Hospitals & Clinics
• Laboratories
• Research Institutes
• Public Health Organizations

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• PerkinElmer, Inc.
• Bio-Rad Laboratories, Inc.
• Natus Medical Incorporated
• Abbott Laboratories
• Agilent Technologies, Inc.
• Thermo Fisher Scientific Inc.
• Medtronic PLC
• Hamilton Company
• LabCorp
• Tecan Group Ltd.
• F. Hoffmann-La Roche AG
• Quest Diagnostics Incorporated
• MSD Animal Health
• Sonic Healthcare
• Sysmex Corporation

Frequently Asked Questions (FAQs)