Newborn Screening Market Report by Product (Instruments, Reagents), Technology (Tandem Mass Spectrometry, Pulse Oximetry, Enzyme Based Assay, DNA Assay, Electrophoresis, and Others), Test Type (Dry Blood Spot Test, CCHD, Hearing Screen), and Region 2023-2028

The global newborn screening market size reached US$ 956 Million in 2022. Looking forward, the publisher expects the market to reach US$ 1,467 Million by 2028, exhibiting a growth rate (CAGR) of 7.4% during 2022-2028. The growing awareness about early disease detection of various severe diseases, favorable government initiatives, and innovations in medical technology for more accurate outcomes and efficiency of disease detection are some of the major factors propelling the market.

Newborn screening is a vital public health approach that is designed to identify certain health conditions in infants shortly after birth. It is performed through a few drops of blood taken from the heel of the baby. It allows for the early detection of potentially serious conditions, even before symptoms appear. It assists in assessing a wide range of congenital disorders, metabolic irregularities, and genetic diseases. Besides this, it enables healthcare professionals to initiate timely interventions and treatments by preventing or minimizing the impact of these conditions.

At present, the rising demand for enhanced quality of life among children is supporting the growth of the market. Besides this, the increasing prevalence of genetic and metabolic disorders, along with rising birth rates across the globe, is strengthening the growth of the market. Additionally, the growing demand for screening tests that offer improved outcomes and reduced healthcare costs is positively influencing the market. Apart from this, the increasing integration of data management and analysis tools to enhance the efficiency of newborn screening is offering lucrative growth opportunities to industry investors. Furthermore, the rising focus on holistic well-being and preventive healthcare measures among parents is bolstering the growth of the market. In line with this, the increasing popularity of automation and digitalization in the healthcare sector is propelling the growth of the market.

Newborn Screening Market Trends/Drivers:

• Rising awareness about early disease detection

The rising awareness among parents about the critical importance of early disease detection is contributing to the growth of the market. In line with this, early disease detection assists in offering timely intervention, improved treatment outcomes, and enhanced quality of life for the child. It also aids in safeguarding individual health and well-being. Apart from this, it can avoid potential complications, reduce the burden on healthcare systems, and improve the overall quality of life. Furthermore, the increasing demand for advanced screening technologies and healthcare services that offer early disease detection is bolstering the growth of the market.

Favorable government initiatives

Governing agencies of various countries are encouraging the adoption of newborn screening to prevent and manage health conditions around the world, which is offering a positive market outlook. In addition, they are implementing mandatory newborn screening programs, which makes these services more accessible to a larger population. They are also taking initiatives that often cover a comprehensive panel of disorders and ensure that a wide range of potential health issues are addressed efficiently. Furthermore, they are organizing educational campaigns to spread knowledge among healthcare providers to provide guidance to people.

As a result, these initiatives benefit in generating awareness among the masses about the benefits of early detection of diseases across the globe.

Innovations in medical technology

Various manufacturers are rapidly advancing their medical technologies to enhance newborn screening methods. In addition, innovative techniques, such as tandem mass spectrometry (MS) and deoxyribonucleic acid (DNA)-based testing, assist in increasing the accuracy and efficiency of disease detection. These technologies enable the simultaneous screening of a broader range of disorders, enhance diagnostic capabilities, and allow for early identification of even rare conditions. Apart from this, the emergence of these screening technologies encourages healthcare providers to adopt and offer these services. Furthermore, advancements in technologies minimize invasiveness, reduce recovery times, and improve patient comfort while enhancing the speed of medical interventions.

Newborn Screening Industry Segmentation:

The publisher provides an analysis of the key trends in each segment of the global newborn screening market report, along with forecasts at the global, regional and country levels from 2023-2028. Our report has categorized the market based on product, technology and test type.

Breakup by Product:

• Instruments
• Reagents

Instruments represents the largest market segment

The report has provided a detailed breakup and analysis of the market based on the product. This includes instruments and reagents. According to the report, instruments represented the largest segment. Instruments play an important role in the screening process by providing the necessary tools for sample collection, analysis, and result interpretation. These devices comprise a diverse range of technologies, such as mass spectrometry systems, deoxyribonucleic acid (DNA) analyzers, and automated screening platforms. These instruments are designed to ensure accuracy, efficiency, and reproducibility in the screening procedures. They enable healthcare professionals to process a high volume of samples with precision and facilitate the early detection of various disorders. Furthermore, the rising demand for reliable and user-friendly instruments is supporting the growth of the market.

Breakup by Technology:

• Tandem Mass Spectrometry
• Pulse Oximetry
• Enzyme Based Assay
• DNA Assay
• Electrophoresis
• Others

Tandem mass spectrometry accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the technology. This includes tandem mass spectrometry, pulse oximetry, enzyme based assay, DNA assay, electrophoresis, and others. According to the report, tandem mass spectrometry represented the largest segment. Tandem mass spectrometry is an analytical technique that is employed in newborn screening to identify a range of metabolic disorders. It involves two stages of mass spectrometry, where ions are fragmented and analyzed for precise identification of compounds. Apart from this, it offers enhanced accuracy and speed and can detect rare disorders. In line with this, technological advancements in the medical field enhance the sensitivity and specificity of tandem mass spectrometry that offers improved health outcomes for infants worldwide.

Breakup by Test Type:

• Dry Blood Spot Test
• CCHD
• Hearing Screen

Dry blood spot holds the biggest market share

The report has provided a detailed breakup and analysis of the market based on the test type. This includes dry blood spot test, CCHD, and hearing screen. According to the report, dry blood spot test represented the largest segment. A dry blood spot test is a non-invasive and widely utilized screening technique that involves collecting a small amount of blood from the heel of a newborn onto a special filter paper. This dried blood sample is then analyzed for the presence of specific markers associated with various disorders. Apart from this, it enables early detection of conditions, such as congenital hypothyroidism and sickle cell disease. Moreover, the rising preference for dry blood spot tests in many newborn screening programs, as they offer the convenience of sample collection, ease of transportation, and the ability to simultaneously screen for multiple conditions, is bolstering the growth of the market.

Breakup by Region:

• North America
• United States
• Canada
• Asia-Pacific
• China
• Japan
• India
• South Korea
• Australia
• Indonesia
• Others
• Europe
• Germany
• France
• United Kingdom
• Italy
• Spain
• Russia
• Others
• Latin America
• Brazil
• Mexico
• Others
• Middle East and Africa

North America exhibits a clear dominance, accounting for the largest newborn screening market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America held the biggest market share due to the presence of advanced healthcare infrastructure. In addition, the rising awareness about the long-term benefits of newborn screening among individuals is strengthening the growth of the market in the region. Apart from this, favorable government initiatives and regulations are offering a positive market outlook. In line with this, the increasing focus on preventive healthcare is supporting the growth of the market in the North America region.

Competitive Landscape:

Various manufacturers are investing in research and development (R&D) activities to provide innovative screening technologies and methods. This includes refining existing techniques like tandem mass spectrometry and exploring new approaches to broaden the scope of conditions detected. In addition, companies are providing a more comprehensive screening service by adding more conditions to their test panels. Apart from this, key players are focusing on developing automated systems that streamline the screening process, from sample collection to result interpretation, to enhance efficiency, reduce human error, and allow for faster turnaround times. Furthermore, companies are focusing on data management solutions to ensure accurate record-keeping, easy access to results, and data integration with electronic health records.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• Agilent Technologies Inc.
• Baebies Inc.
• Bio-RAD Laboratories Inc.
• Chromsystems Instruments & Chemicals GmbH
• Danaher Corporation
• Masimo Corporation
• Medtronic plc
• Natus Medical Incorporated
• Perkinelmer Inc.
• RECIPE Chemicals + Instruments GmbH
• Thermo Fisher Scientific Inc.
• Trivitron Healthcare
• Waters Corporation

Recent Developments:

In August 2022, Trivitron Healthcare inaugurated its centre-of-excellence with state-of-the-art research and development (R&D) and manufacturing facilities at AMTZ Campus, Vishakhapatnam, India for metabolomics, genomics, newborn screening, and molecular diagnostics.

In November 2020, Natus Medical Inc., a leading provider of medical device solutions, acquired German healthcare equipment company Babybe GmbH and its patented remote mother to baby communication technology. The Babybe technology has been added to Natus’s market leading Newborn Care portfolio of products.

In November 2022, PerkinElmer Inc. announced that the U.S. Food and Drug Administration (FDA) has authorized the marketing of the EONIS™ SCID-SMA assay kit for in vitro diagnostic (IVD) use by certified laboratories for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns.

Key Questions Answered in This Report

1. What was the size of the global newborn screening market in 2022?
2. What is the expected growth rate of the global newborn screening market during 2023-2028?
3. What are the key factors driving the global newborn screening market?
4. What has been the impact of COVID-19 on the global newborn screening market?
5. What is the breakup of the global newborn screening market based on the product?
6. What is the breakup of the global newborn screening market based on the technology?
7. What is the breakup of the global newborn screening market based on the test type?
8. What are the key regions in the global newborn screening market?
9. Who are the key players/companies in the global newborn screening market?