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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 Market Research Future Analysis, the Newborn Screening Market was valued at 0.58 USD Billion in 2024 and is projected to grow to 1.25 USD Billion by 2035, with a CAGR of 7.21% from 2025 to 2035. The market is driven by rising awareness of congenital disorders, technological advancements in screening methods, and government initiatives supporting screening programs. The increasing incidence of congenital disorders further fuels demand for effective screening solutions.

    Key Market Trends & Highlights

    The Newborn Screening Market is experiencing significant growth due to various trends.

    • The market is expected to reach 2.13 USD Billion in 2024, driven by enhanced healthcare policies.
    • Disorders Screening segment valued at 0.85 USD Billion in 2024, projected to grow to 1.4 USD Billion by 2035.
    • Genetic Screening segment anticipated to rise from 0.65 USD Billion in 2024 to 1.1 USD Billion by 2035.
    • North America held the largest market share at 0.85 USD Billion in 2024, supported by advanced healthcare infrastructure.

    Market Size & Forecast

    2024 Market Size USD 0.58 Billion
    2035 Market Size USD 1.25 Billion
    CAGR (2025-2035) 7.21%

    Major Players

    Key players include Neogen Corporation, Abbott Laboratories, Genoox, BD, Thermo Fisher Scientific, Ambry Genetics, LifeLabs, GeneDx, LabCorp, Roche Diagnostics, Sonic Healthcare, Natus Medical, PerkinElmer, Masimo, and Invitae.

    New-Born Screening Market Trends

    The Newborn Screening Market size is accelerating due to the increase in the healthcare policies oriented towards the reconsideration of congenital disorders. There is an enforcement and encouragement of newborn screening programs on a global basis which focuses on identifying the treatable conditions which fuels the market. New technologies such as rapid testing and better diagnostic aids have made the screening and its processes more efficient and accessible globally. Moreover, there is great potential left to be tapped in the regions that lack awareness and the necessary facilities for newborn screening.

    Programs to build strong public health campaigns and collaborate with healthcare systems on screening programs in these areas would improve newborn health on a larger scale. There is increasing popularity in the adoption of genetic screening and point-of-care testing. More healthcare units are now embracing these changes to better the outcomes for newborns. The inclusion of telemedicine into newborn screening is also on the rise due to the opportunity for remote consultations and follow-ups, which is especially important for less-developed areas.

    This advancement in technology is changing the direction of the market because all newborns will have timely evaluations regardless of their location or financial status.Essentially, the Newborn Screening Market is evolving towards more advanced, holistic frameworks for implementing early detection interventions for congenital disorders worldwide.

     

    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

    Market Growth Projections

    The Global Newborn Screening Market Industry is poised for substantial growth, with projections indicating a rise from 2.13 USD Billion in 2024 to 3.5 USD Billion by 2035. This growth trajectory suggests a compound annual growth rate of 4.62% from 2025 to 2035. Such figures reflect the increasing recognition of the importance of early detection of congenital disorders and the ongoing advancements in screening technologies. The market's expansion is likely to be fueled by a combination of government initiatives, technological innovations, and heightened awareness among healthcare providers and parents.

    Government Initiatives and Policies

    Government initiatives aimed at enhancing newborn health significantly influence the Global Newborn Screening Market Industry. Many countries have established mandatory screening programs to ensure early detection of metabolic and genetic disorders. For instance, the U.S. Department of Health and Human Services has set guidelines for newborn screening, which have been adopted by various states. Such policies not only promote public health but also encourage the development of advanced screening technologies. As governments continue to prioritize newborn health, the market is expected to expand, with projections indicating a growth to 3.5 USD Billion by 2035.

    Rising Prevalence of Congenital Disorders

    The increasing incidence of congenital disorders globally drives the Global Newborn Screening Market Industry. Statistics indicate that approximately 1 in 33 infants is born with a congenital anomaly, necessitating early detection and intervention. This trend emphasizes the importance of newborn screening programs, which can identify conditions such as phenylketonuria and cystic fibrosis. As healthcare systems recognize the need for early diagnosis, investments in screening technologies are likely to rise, contributing to the market's growth. The Global Newborn Screening Market is projected to reach 2.13 USD Billion in 2024, reflecting the urgency of addressing these health challenges.

    Technological Advancements in Screening Methods

    Technological innovations in screening methods are pivotal to the evolution of the Global Newborn Screening Market Industry. Advances in genetic testing, such as next-generation sequencing, enable the identification of a broader range of disorders with higher accuracy. These technologies facilitate faster turnaround times and reduce the need for invasive procedures. As healthcare providers increasingly adopt these advanced methodologies, the market is likely to experience significant growth. The anticipated compound annual growth rate of 4.62% from 2025 to 2035 underscores the potential for continued innovation and expansion within the industry.

    Integration of Screening Programs into Routine Healthcare

    The integration of newborn screening programs into routine healthcare practices is a significant driver of the Global Newborn Screening Market Industry. Many healthcare systems are now incorporating screening as a standard procedure shortly after birth, ensuring that all infants receive necessary evaluations. This systematic approach not only enhances early diagnosis but also fosters a culture of preventive healthcare. As more countries adopt similar practices, the market is expected to grow, reflecting a collective commitment to improving newborn health outcomes globally.

    Increased Awareness Among Parents and Healthcare Providers

    Growing awareness regarding the benefits of newborn screening among parents and healthcare providers plays a crucial role in shaping the Global Newborn Screening Market Industry. Educational campaigns and outreach programs have successfully highlighted the importance of early detection in preventing severe health issues. This heightened awareness leads to increased participation in screening programs, thereby driving market growth. As more parents understand the implications of congenital disorders, the demand for comprehensive screening services is likely to rise, further solidifying the market's trajectory in the coming years.

    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 Newborn Screening Market Research Report - Forecast till 2035

    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 7.21% 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 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.

    What will be the market value of the Newborn Screening Market by 2035?

    By 2035, the Newborn Screening Market is projected to reach a value of 3.5 USD Billion.

    What is the expected compound annual growth rate (CAGR) for the Newborn Screening Market from 2025 to 2035?

    The expected CAGR for the Newborn Screening Market from 2025 to 2035 is 4.62%.

    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.

    Who are the key players in the Newborn Screening Market?

    Major players in the Newborn Screening Market include Neogen Corporation, Abbott Laboratories, and Thermo Fisher Scientific.

    What will be the market size for Hearing Screening by 2035?

    The market size for Hearing Screening is expected to reach 0.72 USD Billion by 2035.

    What was the market value for the APAC region in 2024?

    The APAC region was valued at 0.45 USD Billion in 2024.

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