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    New-Born Screening Market

    ID: MRFR/MED/5099-CR
    200 Pages
    Rahul Gotadki
    April 2025

    Newborn Screening Market Research Report By Test Type (Disorders Screening, Genetic Screening, Hearing Screening, Congenital Heart Disease Screening), By Technology (Mass Spectrometry, Liquid Chromatography, Immunoassays, DNA Sequencing), By End User (Hospitals, Diagnostic Laboratories, Research Institutions), By Region (North America, Europe, Asia Pacific, Latin America, Middle East and Africa) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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    New-Born Screening Market Summary

    As per MRFR analysis, the Newborn Screening Market Size was estimated at 0.58 USD Billion in 2024. The Newborn Screening industry is projected to grow from 0.6218 in 2025 to 1.248 by 2035, exhibiting a compound annual growth rate (CAGR) of 7.21 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The Newborn Screening Market is poised for substantial growth driven by technological advancements and increasing awareness.

    • Technological advancements in screening methods are enhancing the accuracy and efficiency of newborn screening processes.
    • North America remains the largest market, while the Asia-Pacific region is emerging as the fastest-growing area for newborn screening.
    • Disorders screening continues to dominate the market, whereas congenital heart disease screening is witnessing rapid growth.
    • Key market drivers include the rising incidence of congenital disorders and government initiatives supporting expanded screening programs.

    Market Size & Forecast

    2024 Market Size 0.58 (USD Billion)
    2035 Market Size 1.248 (USD Billion)
    CAGR (2025 - 2035) 7.21%

    Major Players

    PerkinElmer (US), Thermo Fisher Scientific (US), Abbott Laboratories (US), Roche Diagnostics (CH), Agilent Technologies (US), Bio-Rad Laboratories (US), Newborn Screening Laboratory (US), Natus Medical Incorporated (US), Mayo Clinic Laboratories (US)

    New-Born Screening Market Trends

    The Newborn Screening Market is currently experiencing a transformative phase, driven by advancements in technology and an increasing awareness of the importance of early detection of congenital disorders. This market encompasses a range of tests designed to identify potential health issues in newborns shortly after birth. The growing emphasis on preventive healthcare and the rising incidence of genetic disorders are contributing to the expansion of this market. Furthermore, the integration of innovative technologies, such as next-generation sequencing and digital health solutions, appears to enhance the accuracy and efficiency of screening processes. As healthcare systems worldwide prioritize early intervention, the demand for comprehensive newborn screening programs is likely to rise, fostering collaboration among healthcare providers, policymakers, and technology developers. In addition, regulatory frameworks are evolving to support the implementation of more extensive screening protocols. Governments and health organizations are increasingly recognizing the value of newborn screening in reducing long-term healthcare costs and improving quality of life for affected individuals. This shift in perspective may lead to expanded funding and resources allocated to newborn screening initiatives. Overall, the Newborn Screening Market seems poised for growth, with a focus on innovation, collaboration, and improved health outcomes for newborns.

    Technological Advancements

    The Newborn Screening Market is witnessing a surge in technological innovations that enhance testing capabilities. Techniques such as next-generation sequencing and multiplex assays are becoming more prevalent, allowing for the simultaneous detection of multiple disorders. These advancements not only improve the accuracy of results but also reduce the time required for diagnosis, thereby facilitating timely interventions.

    Increased Awareness and Advocacy

    There is a growing awareness among parents and healthcare professionals regarding the significance of newborn screening. Advocacy groups are playing a crucial role in educating the public about the benefits of early detection of congenital conditions. This heightened awareness is likely to drive demand for comprehensive screening programs, as families seek to ensure the health and well-being of their newborns.

    Regulatory Support and Policy Development

    The landscape of the Newborn Screening Market is being shaped by evolving regulatory frameworks that support expanded screening initiatives. Governments are increasingly recognizing the importance of early detection in improving health outcomes and reducing long-term healthcare costs. This regulatory support may lead to increased funding and resources for newborn screening programs, further driving market growth.

    The increasing recognition of the critical role that early detection of congenital disorders plays in improving health outcomes for newborns is driving advancements in newborn screening technologies and practices globally.

    Centers for Disease Control and Prevention (CDC)

    New-Born Screening Market Drivers

    Expansion of Screening Panels

    The expansion of newborn screening panels is a notable trend influencing the Newborn Screening Market. Many healthcare systems are broadening their screening panels to include a wider range of disorders, driven by advancements in technology and increased understanding of genetic conditions. This expansion allows for the early detection of conditions that were previously undetectable, thus improving health outcomes for affected infants. As more disorders are added to screening panels, the market is likely to see a surge in demand for testing services and related technologies. This trend not only enhances the efficacy of newborn screening but also underscores the evolving nature of the Newborn Screening Market.

    Government Initiatives and Funding

    Government initiatives aimed at improving public health outcomes significantly influence the Newborn Screening Market. Many countries have implemented policies mandating newborn screening for specific disorders, thereby increasing the number of infants screened annually. For instance, funding programs and grants are often allocated to support the development and implementation of screening programs. This financial backing not only facilitates the expansion of existing programs but also encourages research into new screening technologies. As a result, the market is likely to experience sustained growth, driven by these supportive governmental actions that prioritize early detection and intervention.

    Growing Parental Awareness and Education

    Parental awareness regarding the importance of newborn screening is a vital driver for the Newborn Screening Market. As parents become more informed about the potential benefits of early detection of congenital disorders, they are more likely to advocate for comprehensive screening for their newborns. Educational campaigns and advocacy groups play a significant role in disseminating information about the advantages of newborn screening, which can lead to timely interventions and improved health outcomes. This heightened awareness is expected to increase the demand for screening services, thereby contributing to the overall growth of the Newborn Screening Market.

    Rising Incidence of Congenital Disorders

    The increasing prevalence of congenital disorders is a primary driver for the Newborn Screening Market. Statistics indicate that approximately 1 in 33 infants is born with a congenital disorder, necessitating early detection and intervention. This rising incidence compels healthcare systems to adopt comprehensive screening programs to identify conditions such as metabolic disorders, genetic syndromes, and endocrine disorders. As awareness grows regarding the benefits of early diagnosis, healthcare providers are likely to expand their screening capabilities. Consequently, this trend is expected to bolster the demand for advanced screening technologies and services, thereby propelling the Newborn Screening Market forward.

    Technological Innovations in Screening Methods

    Technological advancements play a crucial role in shaping the Newborn Screening Market. Innovations such as tandem mass spectrometry and genetic sequencing have revolutionized the ability to detect a wide array of disorders from a single blood sample. These technologies not only enhance the accuracy and efficiency of screenings but also reduce the time required for results. As a result, healthcare providers are increasingly adopting these advanced methods, leading to a projected growth rate of around 10% in the market. The integration of artificial intelligence and machine learning in data analysis further augments the potential of these technologies, making them indispensable in the Newborn Screening Market.

    Market Segment Insights

    Newborn Screening Market Test Type Insights

    The Newborn Screening Market segmentation by Test Type reveals a diverse landscape, reflecting the effectiveness and necessity of early detection methods for newborns. In 2024, the overall market was valued at approximately 2.13 USD Billion, showcasing the significant investment and focus on ensuring the health of newborns worldwide. Among these test types, Disorders Screening emerged as a crucial aspect of the market, with a valuation of 0.85 USD Billion in 2024 and projected growth to 1.4 USD Billion by 2035.

    This segment predominantly aims to identify metabolic and genetic disorders that can impact a child's development if undetected.Following closely is Genetic Screening, which held a valuation of 0.65 USD Billion in 2024 and is expected to reach 1.1 USD Billion by 2035. This segment is pivotal in assessing hereditary conditions and enables timely interventions, positively impacting long-term health outcomes for affected children.

    Hearing Screening, valued at 0.43 USD Billion in 2024 with an anticipated increase to 0.72 USD Billion by 2035, underlines the critical nature of auditory health in infancy, as timely diagnosis can lead to essential early interventions to facilitate language development.Finally, Congenital Heart Disease Screening, although the smallest segment with a market value of 0.2 USD Billion in 2024 and projection of 0.28 USD Billion by 2035, remains significant as it addresses life-threatening conditions present at birth.

    Newborn Screening Market Technology Insights

    The Newborn Screening Market was valued at 2.13 billion USD in 2024, reflecting robust growth driven by technological advancements and increased awareness of newborn health. Various technologies play a crucial role in enhancing early detection of genetic disorders, ensuring better health outcomes. Mass Spectrometry is significant for its capability in accurate and rapid identification of metabolic disorders, making it vital in clinical settings. Liquid Chromatography offers the precision needed for analyzing complex biochemical substances, contributing to effective screening processes.

    Immunoassays dominate the market due to their high sensitivity and specificity, enabling reliable testing for various conditions. Meanwhile, DNA Sequencing technology is gaining traction as it allows for thorough genomic analysis, promising advancements in personalized medicine. The combination of these technologies supports expanding Newborn Screening Market revenue, reflecting the urgent need for early disease detection and intervention in newborns. With ongoing developments and increasing governmental initiatives to standardize screening practices globally, this market is poised to witness significant advancements in the coming years.

    Newborn Screening Market End User Insights

    The Newborn Screening Market primarily caters to key End Users such as Hospitals, Diagnostic Laboratories, and Research Institutions. In 2024, the market was valued at 2.13 USD Billion and is projected to grow steadily, reflecting the increasing emphasis on early diagnosis and treatment of congenital disorders. Hospitals play a vital role as they provide immediate screenings as part of routine neonatal care, ensuring health issues are identified promptly. Diagnostic Laboratories serve as critical facilities for analyzing screening tests, thereby enabling accurate determination and follow-up actions for affected newborns.

    Research Institutions contribute significantly by advancing knowledge and developing innovative screening methodologies, fulfilling a crucial role in the ongoing improvement of newborn health outcomes. The Newborn Screening Market data reveals a growing trend toward integrating technology in screening procedures, alongside expanding government support for public health initiatives which drives overall market growth while also presenting challenges in terms of standardization across various regions. This sector's development is essential for fostering better health policies and ensuring that newborn screening becomes universally accessible, reflecting broader global health priorities.

    Newborn Screening Market Region Insights

    Get more detailed insights about New-Born Screening Market

    Regional Insights

    The Newborn Screening Market gained a significant traction, with particular growth observed in the Regional segment, which includes North America, Europe, APAC, South America, and the Middle East and Africa (MEA). In 2024, the market reached 2.13 USD Billion, with North America holding the majority share at 0.85 USD Billion, showcasing its dominance due to advanced healthcare infrastructure and awareness of newborn diseases. Europe follows closely, valued at 0.65 USD Billion, benefiting from stringent regulatory frameworks enhancing screening programs.

    The Asia-Pacific (APAC) region, riding on rising healthcare investments, reached 0.45 USD Billion in 2024. Meanwhile, South America and MEA, although smaller markets at 0.05 USD Billion and 0.13 USD Billion respectively, illustrate growth potential driven by increasing healthcare accessibility and innovation in reproductive health solutions. The importance of these regions in the Newborn Screening Market is reflected in their commitment to improving infant care, thus presenting various opportunities for expansion and market growth as global awareness regarding early disease detection continues to rise.

    Newborn Screening Market Regional Insights

    Key Players and Competitive Insights

    The Newborn Screening Market has become increasingly competitive as awareness regarding early detection and treatment of congenital and genetic disorders continues to rise. This market includes a range of screening tests and technologies that are essential for identifying conditions that can significantly impact a child’s health and development. With advancements in technology, the efficacy and accuracy of these screening tools have improved, fostering a dynamic industry landscape. In this competitive environment, companies engage in strategic collaborations, mergers, and acquisitions to expand their market presence while differentiating their offerings through innovation and product development.

    As a result, stakeholders are focused on leveraging advanced research and development along with effective marketing strategies to capture a larger share of this growing market.

    Neogen Corporation

    Neogen Corporation has established itself as a notable player in the Newborn Screening Market, highlighting its strengths in innovative solutions that emphasize safety and health. The company is recognized for its commitment to developing high-quality products that ensure accurate and prompt diagnosis of newborn conditions. Neogen Corporation’s extensive portfolio addresses critical needs in the screening market, which is vital for early interventions. The company's ability to leverage its expertise in biosciences, combined with its strong research and development capabilities, has allowed it to maintain a competitive edge.

    With a global footprint and strategic partnerships in various regions, Neogen Corporation effectively positions itself as a trusted provider in newborn healthcare, addressing the challenges linked to infant screening and improving overall patient outcomes.

    Abbott Laboratories

    Abbott Laboratories holds a significant position in the Newborn Screening Market, renowned for its comprehensive range of technologies and tools that facilitate early diagnosis of metabolic and genetic disorders. The company offers key products such as diagnostic instruments and reagents that play a critical role in newborn screening programs across diverse healthcare settings. Abbott Laboratories has a robust market presence due to its continuous investment in research and development, resulting in cutting-edge innovations tailored to meet the evolving needs of healthcare providers.

    The strength of the company lies in its established relationships with healthcare systems and regulators, enabling it to effectively navigate the complexities of the global market. Additionally, Abbott Laboratories has actively pursued mergers and acquisitions to enhance its product offerings and expand its reach, solidifying its status as a leading entity in the newborn screening industry on a global scale.

    Key Companies in the New-Born Screening Market market include

    Industry Developments

    Newborn Screening Market Industry Developments

    The Newborn Screening Market has seen significant developments recently, particularly with advancements in genetic testing and technologies aimed at enhancing screening programs. Companies like Neogen Corporation and Abbott Laboratories have been increasing their innovation in the field, focusing on providing comprehensive screening tests for newborns. In September 2023, Roche Diagnostics launched a new portfolio aimed at boosting newborn screening efficiency, showcasing a commitment to improving early detection rates.

    In terms of mergers and acquisitions, LifeLabs acquired a smaller biotechnology company in August 2023, focusing on expanding its capabilities in newborn screening assays, a move that signals growth and consolidation in the sector. Furthermore, the market valuation for companies like BD and Thermo Fisher Scientific has shown a steady increase, attributed to the rising awareness of genetic disorders and the growing demand for early diagnostic solutions.

    Over the past two to three years, notable changes have included regulatory updates in countries globally, aimed at enhancing newborn screening programs to facilitate better healthcare outcomes, ensuring higher compliance with international standards.

    Future Outlook

    New-Born Screening Market Future Outlook

    The Global Newborn Screening Market is projected to grow at a 4.62% CAGR from 2025 to 2035, driven by technological advancements, increased awareness, and government initiatives.

    New opportunities lie in:

    • Develop innovative screening technologies to enhance accuracy and efficiency. Expand service offerings in emerging markets to capture new customer segments. Leverage telemedicine solutions for remote screening and follow-up services.

    By 2035, the market is expected to demonstrate robust growth, reflecting advancements and increased adoption of screening practices.

    Market Segmentation

    Newborn Screening Market Region Outlook

    • North America
    • Europe
    • Asia Pacific
    • Latin America
    • Middle East and Africa

    Newborn Screening Market End User Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Research Institutions

    Newborn Screening Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    Newborn Screening Market Test Type Outlook

    • Disorders Screening
    • Genetic Screening
    • Hearing Screening
    • Congenital Heart Disease Screening

    Newborn Screening Market Technology Outlook

    • Mass Spectrometry
    • Liquid Chromatography
    • Immunoassays
    • DNA Sequencing

    Report Scope

    Report Attribute/MetricDetails
    Market Size 20242.13(USD Billion)
    Market Size 20351.25 (USD Billion)
    Compound Annual Growth Rate (CAGR)7.21% (2025 - 2035)
    Report CoverageRevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2023
    Market Forecast UnitsUSD Billion
    Key Companies ProfiledNeogen Corporation, Abbott Laboratories, Genoox, BD, Thermo Fisher Scientific, Ambry Genetics, LifeLabs, GeneDx, LabCorp, Roche Diagnostics, Sonic Healthcare, Natus Medical, PerkinElmer, Masimo, Invitae
    Segments CoveredTest Type, Technology, End User, Region, Regional
    Key Market OpportunitiesIncrease in congenital disorder awareness, Technological advancements in screening methods, Expanding healthcare infrastructure in emerging markets, Government initiatives for newborn health, Rising demand for point-of-care testing
    Key Market DynamicsIncreasing prevalence of congenital disorders, Growing awareness of early detection, Advancements in screening technologies, Government initiatives and policies, Rising investment in healthcare infrastructure
    Countries CoveredNorth America, Europe, APAC, South America, MEA
    Market Size 20250.62 (USD Billion)

    Market Highlights

    Author
    Rahul Gotadki
    Assistant Manager

    He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

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    FAQs

    What is the projected growth of the New-Born Screening market?

    The New-Born Screening market is the expected increase in total market value of 1.25 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

    What is the size of the New-Born Screening market?

    New-Born Screening market size was valued at approximately 0.58 billion USD in 2024. This figure will reach 1.25 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

    What is the CAGR of the New-Born Screening market?

    New-Born Screening market is expected to grow at a CAGR of 7.21% between 2025 and 2035.

    How much will the New-Born Screening market be worth by 2035?

    New-Born Screening market is expected to be worth of 1.25 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

    How will the New-Born Screening market perform over the next 10 years?

    Over the next 10 years the New-Born Screening market is expected to shift from usd billion 0.58 to 1.25 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

    What was the projected market size of the Newborn Screening Market in 2024?

    The Newborn Screening Market was valued at 2.13 USD Billion in 2024.

    Which region was anticipated to hold the largest market share in 2024?

    North America held the largest market share in 2024, valued at 0.85 USD Billion.

    How much will the North American market for newborn screening grow by 2035?

    The North American market for newborn screening is expected to grow to 1.37 USD Billion by 2035.

    What was the market value for Genetic Screening in 2024?

    The market value for Genetic Screening within the Newborn Screening Market was valued at 0.65 USD Billion in 2024.

    What are the anticipated market values for Disorders Screening by 2035?

    The anticipated market value for Disorders Screening is projected to be 1.4 USD Billion by 2035.

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