Newborn Screening Market

Global Newborn Screening Market:

The global newborn screening market size reached USD 1,089.3 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 1,818.1 Million by 2033, exhibiting a growth rate (CAGR) of 5.9% during 2025-2033. The increasing awareness among individuals towards early detection of severe diseases in newborns, improvements in medical technology for more accurate outcomes, and favorable government initiatives represent some of the key drivers bolstering the market growth.

Global Newborn Screening Market Analysis:

• Major Market Drivers: The growing prevalence of metabolic and genetic disorders and the increasing birth rates are primarily driving the newborn screening market share. Apart from this, the escalating demand for screening tests that provide reduced healthcare costs and improved outcomes is also acting as another significant growth-inducing factor.
• Key Market Trends: The rising integration of data management and analysis tools to improve the efficiency of newborn screening is one of the emerging trends bolstering the newborn screening market outlook. Additionally, the inflating emphasis on preventive healthcare measures and holistic well-being among parents is further propelling the newborn screening market demand.
• Geographical Trends: According to the newborn screening market research report, North America exhibits a clear dominance, owing to the presence of advanced healthcare infrastructures. Besides this, favorable government initiatives and regulations are further positively influencing the regional market.
• Competitive Landscape: Some of the key players in the global newborn screening 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, and Waters Corporation, among many others.
• Challenges and Opportunities: One of the primary challenges hindering the newborn screening market is the lack of standardization in newborn screening tests across numerous countries and regions. Besides this, legal and ethical considerations, including data privacy and consent, can pose challenges in expanding and implementing newborn screening programs. However, the launch of favorable initiatives that ensure that a wide range of potential health issues are addressed efficiently is projected to augment the global market over the forecasted period.

Global Newborn Screening Market Trends:

Increasing Awareness about Early Disease Detection

The growing awareness among parents towards the critical importance of early disease detection, as it helps in enhancing treatment outcomes, improving quality of life for the child, offering timely intervention, etc., represents one of the primary drivers bolstering the newborn screening market. Besides this, the rising occurrence of congenital diseases is also acting as another significant growth-inducing factor. For example, according to the data published by the WHO in February 2023, an estimated 240,000 newborns die within 28 days of birth each year globally due to congenital diseases. Moreover, according to the information from Indian Pediatrics, congenital hypothyroidism occurs in 2.1 out of every 1,000 infants in India, and the prevalence of inborn metabolic abnormalities ranges from 2-7.8%.

Favorable Government Initiatives

The launch of policies by regulatory authorities that often cover a comprehensive panel of disorders and ensure that potential health issues are addressed efficiently is bolstering the global newborn screening market. For example, in June 2022, government bodies in Manitoba, Canada, announced the expansion of their newborn screening program with an aim to extend screening for spinal muscular atrophy, along with other diseases. Moreover, various government authorities have also made newborn screening compulsory before getting discharged from the hospital, thereby positively impacting the overall market growth. For instance, according to the March of Dimes (MoD) report of 2021, before leaving the hospital, every baby in the United States went through the screening process. Furthermore, newborn screening programs in Texas, California, and New York also gained extensive traction across the U.S., which will continue to drive the newborn screening market over the forecasted period.

Improvements in Medical Technology

Key players are advancing their medical technologies to improve newborn screening methods, which is acting as another significant growth-inducing factor. Moreover, emerging screening technologies encourage healthcare providers to offer and adopt these services, thereby fueling the global market. For example, in June 2021, the Texas Health and Human Services introduced newborn screening for Spinal Muscular Atrophy (SMA). In line with this, Trivitron Healthcare developed a Centre of Excellence (CoE) with state-of-the-art R&D and manufacturing facilities at AMTZ Campus in India for genomics, newborn screening, metabolomics, and molecular diagnostics. Furthermore, in January 2023, Masimo announced the launch of its new state-of-the-art baby monitoring system that allows caretakers to monitor the data of babies in real-time.

Global Newborn Screening Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2025-2033. Our report has categorized the market based on product, technology and test type. 

Breakup by Product:

• Instruments
• Reagents
   

Instruments represent 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 accounted for the largest market share. 

Instruments play a crucial role in the screening process for sample collection, analysis, result interpretation, etc. In addition to this, they comprise a wide array of technologies, such as deoxyribonucleic acid (DNA) analyzers, automated screening platforms, mass spectrometry systems, etc. Moreover, the rising investments by key healthcare companies in diagnostics tests that require instruments are expected to bolster the market growth in this segmentation. For instance, in March 2023, GC Labs announced the launch of its new test for the diagnosis of Inborn Errors of Metabolism (IEM) among newborns with the integration of novel disease detection methods.

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 accounted for the largest market share.

Tandem mass spectrometry refers to an analytical technique that is employed in newborn screening to identify several metabolic disorders. In line with this, it provides improved accuracy and speed. Numerous technological advancements in the medical field enhance tandem mass spectrometry, which will continue to drive the market growth in this segmentation. For example, in April 2023, Waters Corporation announced the development of its new Xevo TQ Absolute IVD Mass Spectrometer for clinical applications.

Breakup by Test Type:

• Dry Blood Spot Test
• CCHD
• Hearing Screen
   

Dry blood spot test 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, the dry blood spot test accounted for the largest market share. 

A dry blood spot test refers to a non-invasive screening technique that generally involves collecting a small amount of blood from the heel of a newborn onto a special filter paper. The dried blood sample is then analyzed for the presence of specific markers associated with several disorders. The test is widely preferred among newborn screening programs, as it provides ease of transportation, convenience of sample collection, and the ability to simultaneously screen for various conditions. Besides this, the elevating number of initiatives by government bodies is acting as another significant growth-inducing factor in this segmentation.

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 leads the market, accounting for the largest newborn screening market share

The market research 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.

The increasing prevalence of congenital disabilities in North America is augmenting the need for newborn screening. Moreover, the implementation of stringent regulations by government bodies across the region is also acting as another significant growth-inducing factor. For example, according to the March of Dimes (MoD) report of 2021, before leaving the hospital, every baby in the United States went through the screening process. Apart from this, the elevating focus of key players on preventive healthcare is inflating the popularity of advanced technologies, which is expected to bolster the North America newborn screening market over the foreseeable future.

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 also 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.

The market research report has provided a comprehensive analysis of the competitive landscape. 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
   

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Global Newborn Screening Market News:

• March 2024: The World Health Organization (WHO) launched implementation guidance in Southeast Asia for universal screening of eye abnormalities, hearing impairment, and neonatal jaundice among newborns.
• February 2024: Niloufer Hospital in Hyderabad introduced a newborn screening program to detect rare genetic conditions.
• February 2024: A research study titled Early Check has screened 1,000 newborns after birth to provide treatment, give parents educational information, identify rare conditions early, and connect families with specialists throughout the state of North Carolina.

Newborn Screening Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the newborn screening market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global newborn screening market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the newborn screening industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.