• Cat-intel
  • MedIntelliX
  • Resources
  • About Us
  • Request Free Sample ×

    Kindly complete the form below to receive a free sample of this Report

    Leading companies partner with us for data-driven Insights

    clients tt-cursor
    Hero Background

    Newborn Screening Testing Market

    ID: MRFR/HC/37071-HCR
    128 Pages
    Rahul Gotadki
    October 2025

    Newborn Screening Testing Market Research Report By Test Type (Blood Spot Test, Hearing Screening, Critical Congenital Heart Disease Screening, Urine Screening, Genetic Screening), By Product Type (Instruments, Reagents, Sample Collection Devices, Software), By End User (Hospitals, Diagnostic Laboratories, Home Care Settings, Public Health Organizations), By Distribution Channel (Direct Sales, Distributors, Online Sales) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

    Share:
    Download PDF ×

    We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.

    Newborn Screening Testing Market Infographic
    Purchase Options

    Newborn Screening Testing Market Summary

    The Global Newborn Screening Testing Market is projected to grow from 1.76 USD Billion in 2024 to 3.05 USD Billion by 2035.

    Key Market Trends & Highlights

    Newborn Screening Testing Key Trends and Highlights

    • The market is expected to witness a compound annual growth rate of 5.12 percent from 2025 to 2034.
    • By 2035, the market valuation is anticipated to reach 3.05 USD Billion, indicating robust growth.
    • in 2024, the market is valued at 1.76 USD Billion, reflecting the increasing demand for early disease detection.
    • Growing adoption of advanced screening technologies due to rising awareness about newborn health is a major market driver.

    Market Size & Forecast

    2024 Market Size 1.76 (USD Billion)
    2035 Market Size 3.05 (USD Billion)
    CAGR (2025-2035) 5.16%

    Major Players

    Ginkgo BioWorks, Thermo Fisher Scientific, Abbott Laboratories, BioRad Laboratories, LifeLabs, Neogen, PerkinElmer, NantHealth, Roche, Grifols, Agilent Technologies, ScanBalt, Boulevard Diagnostic, Hematologic Technologies, Siemens Healthineers

    Newborn Screening Testing Market Trends

    The Newborn Screening Testing Market is driven by several key factors, including the increasing prevalence of congenital disorders and the growing focus on early diagnosis to improve health outcomes for infants. Technological advancements that enhance screening capabilities and reduce the time taken for test results also play a significant role in market growth. Additionally, the rise in awareness among healthcare providers and parents about the importance of newborn screening is propelling the market forward.

    Government initiatives and policies that promote comprehensive screening programs contribute to the expansion of this market. Opportunities in the Newborn Screening Testing Market are abundant.There is potential for innovation in screening methods that could detect a wider range of conditions, which would meet the unmet needs in pediatric healthcare. The development of personalized medicine is another area ripe for exploration, as it could lead to tailored treatment plans based on early screening results. 

    Furthermore, expanding healthcare infrastructure in emerging markets presents a valuable opportunity for providers of newborn screening solutions. Collaboration between technology companies and healthcare organizations could also foster advancements in testing accuracy and efficiency.

    Recently, the market has shown trends toward the integration of advanced technologies such as artificial intelligence and digital health tools in newborn screening.This modernization helps streamline processes and can enhance the accuracy of test results. A focus on point-of-care testing is emerging, allowing for immediate results and facilitating timely interventions. The emphasis on population health and preventive care strategies reflects a shift in the healthcare landscape. Overall, the Newborn Screening Testing Market is evolving, with new technologies and societal needs shaping its trajectory.

    The expansion of newborn screening programs is increasingly recognized as a critical public health strategy, aimed at early detection and intervention for various congenital disorders, thereby enhancing health outcomes for infants globally.

    Centers for Disease Control and Prevention (CDC)

    Newborn Screening Testing Market Drivers

    Market Growth Projections

    The Global Newborn Screening Testing Market Industry is anticipated to experience substantial growth, with projections indicating an increase from 1.76 USD Billion in 2024 to 3.05 USD Billion by 2035. This growth reflects a compound annual growth rate of 5.12% from 2025 to 2035, driven by factors such as technological advancements, government initiatives, and rising awareness among parents. The market's expansion is likely to be supported by ongoing research and development efforts aimed at improving screening methodologies and expanding the range of detectable disorders.

    Expansion of Screening Panels

    The expansion of newborn screening panels to include a broader range of disorders is influencing the Global Newborn Screening Testing Market Industry. As research uncovers new conditions that can be effectively screened, healthcare systems are increasingly adopting these expanded panels. This trend not only enhances the detection of rare diseases but also aligns with the global push for personalized medicine. The market's growth trajectory appears promising, with projections indicating a rise to 3.05 USD Billion by 2035, as more comprehensive screening options become standard practice.

    Growing Awareness Among Parents

    The growing awareness among parents regarding the benefits of newborn screening is a significant driver of the Global Newborn Screening Testing Market Industry. Educational campaigns and advocacy from health organizations have led to increased parental demand for screening services. Parents are now more informed about the potential risks associated with undiagnosed congenital disorders, prompting them to seek early testing for their newborns. This heightened awareness is likely to contribute to a compound annual growth rate of 5.12% from 2025 to 2035, as more families prioritize health screenings.

    Government Initiatives and Policies

    Government initiatives promoting newborn screening programs are pivotal in shaping the Global Newborn Screening Testing Market Industry. Many countries have implemented policies mandating screening for specific disorders, which has led to increased testing rates. For instance, the U.S. Department of Health and Human Services has established guidelines for state-level screening programs, ensuring that all newborns receive necessary tests. This regulatory support not only enhances public health outcomes but also stimulates market growth, as healthcare facilities invest in the required technologies and training.

    Rising Prevalence of Congenital Disorders

    The increasing prevalence of congenital disorders globally drives the Global Newborn Screening Testing Market Industry. Conditions such as phenylketonuria and cystic fibrosis are being identified at higher rates, necessitating early detection to improve health outcomes. In 2024, the market is projected to reach 1.76 USD Billion, reflecting a growing awareness among healthcare providers and parents regarding the importance of early screening. This trend is likely to continue, as more countries adopt universal screening programs, thereby enhancing the demand for advanced testing technologies.

    Technological Advancements in Screening Methods

    Technological innovations in newborn screening methods significantly influence the Global Newborn Screening Testing Market Industry. The introduction of next-generation sequencing and tandem mass spectrometry has improved the accuracy and efficiency of tests. These advancements allow for the simultaneous screening of multiple disorders from a single blood sample, which is particularly beneficial in resource-limited settings. As these technologies become more accessible, the market is expected to grow, with a projected value of 3.05 USD Billion by 2035, indicating a robust shift towards more comprehensive screening solutions.

    Market Segment Insights

    Newborn Screening Testing Market Test Type Insights

    The Test Type segment of the Newborn Screening Testing Market encompasses various methods employed for early diagnosis and treatment of conditions in newborns, reflecting an essential aspect of newborn healthcare. In 2023, the overall market is projected to reach a valuation of 1.59 USD Billion, with an expected growth trajectory leading to a valuation of 2.5 USD Billion by 2032.

    Among the various test types, the Blood Spot Test holds a significant position, with a market value of 0.7 USD Billion in 2023 and anticipated to increase to 1.1 USD Billion by 2032, making it a dominant force in the market, as it allows for the detection of metabolic disorders early on, thus enabling timely intervention and treatment, which is vital for improving health outcomes in newborns.

    Following closely, Hearing Screening occupies a substantial share with a valuation of 0.4 USD Billion in 2023 and is projected to reach 0.65 USD Billion by 2032. This test type plays a critical role in identifying congenital hearing loss and facilitating early intervention strategies that can make a significant difference in the child's development.

    Critical Congenital Heart Disease Screening, valued at 0.3 USD Billion in 2023 and expected to rise to 0.5 USD Billion by 2032, illustrates another crucial area, as early detection of heart defects enables immediate care, potentially saving lives and improving long-term outcomes for affected infants. Meanwhile, Urine Screening, although relatively smaller in market size, valued at 0.1 USD Billion in 2023, is projected to grow to 0.15 USD Billion by 2032 and is valuable for diagnosing metabolic and systemic disorders, representing important tools for comprehensive newborn assessment.

    Genetic Screening, with a value of 0.09 USD Billion in 2023 and a slight increase to 0.1 USD Billion by 2032, focuses on identifying genetic conditions that may not show immediate symptoms but can have profound long-term health impacts, making its role critical despite its smaller market size.

    Newborn Screening Testing Market Product Type Insights

    The Newborn Screening Testing Market is witnessing growth driven by advancements in its Product Type offerings. The market segmentation comprises Instruments, Reagents, Sample Collection Devices and Software, each playing a vital role. Instruments are critical for accurate and efficient testing, while Reagents are essential for the chemical processes that determine results. Sample Collection Devices facilitate the easy gathering of specimens, an important factor in increasing screening rates.

    Meanwhile, Software solutions support data management and analysis, enhancing the overall efficiency of screening programs. As awareness about newborn screening increases and technological advancements continue, the market is set to grow significantly, driven by the demand for these essential components.

    The ongoing trends point toward improved screening processes and heightened public health initiatives, presenting ample growth opportunities within the Newborn Screening Testing Market revenue landscape. Overall, the continuous investments in technology and government regulations supporting newborn health create a favorable environment for the industry to thrive.

    Newborn Screening Testing Market End User Insights

    This market showcases a diverse range of end users, including hospitals, diagnostic laboratories, home care settings and public health organizations. Hospitals play a crucial role as they are typically the primary source for newborn screening, offering immediate access to necessary testing and follow-up treatment. Diagnostic laboratories are also significant, as they process samples and provide vital data for early diagnosis.

    Home care settings have gained prominence, reflecting a growing trend towards at-home healthcare solutions, making essential testing more accessible for families.Public health organizations contribute by implementing screening programs that foster widespread testing coverage and increase overall awareness among populations. Each of these end users holds a critical position in the growth of the Newborn Screening Testing Market, aligning with expanding awareness of early detection and preventative care measures that can significantly improve health outcomes for newborns.

    Through the insights gained from Newborn Screening Testing Market data, a clear understanding of the critical contributions made by these various segments can be observed as they collectively drive the market's growth trajectory.

    Newborn Screening Testing Market Distribution Channel Insights

    Within this market, the Distribution Channel plays a critical role, encompassing various avenues through which testing services and products are delivered. Direct Sales channels generate substantial revenue, allowing manufacturers to engage directly with healthcare providers, ensuring efficient communication and product knowledge transfer. Distributors serve as vital intermediaries, leveraging their established networks to promote a broad reach and streamlined logistics, thereby enhancing product availability.

    Online Sales have gained momentum, capitalizing on the digital shift and offering convenience to healthcare facilities and parents alike. The combination of these channels reflects the market's adaptability to consumer behavior and the necessity for timely newborn testing.

    As the market expands towards the projected 2.5 billion USD by 2032, trends such as increasing awareness of the importance of early detection and advancements in technology will drive the Newborn Screening Testing Market revenue further. Understanding this distribution landscape will be crucial for stakeholders aiming to navigate the evolving Newborn Screening Testing Market industry.

    Get more detailed insights about Newborn Screening Testing Market Research Report — Global Forecast till 2034

    Regional Insights

    North America dominates the market with a significant valuation of 0.7 USD Billion in 2023, expected to grow to 1.12 USD Billion by 2032, reflecting its majority holding in advancements and healthcare infrastructure. Europe follows with a valuation of 0.4 USD Billion in 2023 and is projected to increase to 0.63 USD Billion by 2032, demonstrating its growing commitment to early disease detection.The APAC region holds a valuation of 0.3 USD Billion in 2023, expanding to 0.48 USD Billion, showcasing increasing awareness and investment in newborn healthcare.

    South America and MEA are smaller markets, valued at 0.1 USD Billion and 0.09 USD Billion in 2023, respectively, but are expected to experience notable growth, reaching 0.16 USD Billion and 0.15 USD Billion by 2032, as healthcare accessibility improves. The Newborn Screening Testing Market segmentation indicates that while North America and Europe are leading, emerging markets like APAC are gaining traction, driven by rising population and health initiatives, presenting various opportunities for growth in the industry.

    Newborn Screening Testing Market Regional Insights

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Key Players and Competitive Insights

    The Newborn Screening Testing Market has experienced significant growth over the past few years, driven by rising awareness regarding the early detection of genetic disorders and congenital conditions in newborns. As healthcare professionals prioritize preventative care, the demand for reliable and efficient screening methods has surged.

    The market is characterized by a diverse range of players, including biotech companies, diagnostic laboratories, and healthcare institutions. Competitive insights reveal a dynamic landscape where companies leverage advancements in technology, innovative testing methodologies, and strategic partnerships to enhance their market presence and improve customer satisfaction.

    The emphasis on newborn health is evident, as stakeholders aim to deliver improved outcomes and set higher standards for screening programs globally.Ginkgo BioWorks has established a noteworthy presence in the Newborn Screening Testing Market, capitalizing on its expertise in synthetic biology and genetic engineering. 

    The company is particularly recognized for its ability to develop tailored solutions that facilitate the accurate identification of various genetic conditions. By harnessing advanced platforms and unique methodologies, Ginkgo BioWorks differentiates itself through its innovative approach to screening technology.

    The company's commitment to research and development enables it to offer high-quality testing options that meet the specific needs of healthcare providers and patients alike. Moreover, Ginkgo BioWorks employs a collaborative strategy, engaging with healthcare professionals and institutions to foster advancements in newborn screening and expand its market share.

    Thermo Fisher Scientific stands out in the Newborn Screening Testing Market due to its extensive portfolio of diagnostic solutions and robust global presence. The company is well-regarded for its comprehensive range of screening assays, platforms, and equipment that cater to the growing needs of laboratories conducting newborn screening.

    With a focus on quality, reliability, and innovation, Thermo Fisher Scientific is committed to ensuring that its products remain at the forefront of technology in the diagnostic landscape. The company leverages its strong distribution network and customer relationships to enhance access to its screening solutions, thereby reaching a wider audience. By continuously investing in research and development, Thermo Fisher Scientific not only sustains its competitive edge but also positions itself as a leader in shaping the future of newborn screening practices worldwide.

    Key Companies in the Newborn Screening Testing Market market include

    Industry Developments

    • Q2 2024: PerkinElmer Launches EONIS™ Q Platform for Newborn Screening PerkinElmer announced the launch of its EONIS™ Q platform, a new molecular screening system designed to expand the range of conditions that can be detected in newborns, aiming to improve early diagnosis and treatment options.
    • Q2 2024: Natera Receives CE Mark for Prospera™ Newborn Screening Test Natera announced it has received CE Mark approval for its Prospera™ test, enabling the company to market its next-generation sequencing-based newborn screening test in the European Union.
    • Q3 2024: Baebies Receives FDA 510(k) Clearance for FINDER® Newborn Screening Platform Baebies announced it has received FDA 510(k) clearance for its FINDER® platform, a near-patient testing device for newborn screening, allowing for broader clinical use in the United States.
    • Q2 2024: Trivitron Healthcare Launches NeoMass AAAC Kit for Expanded Newborn Screening Trivitron Healthcare launched the NeoMass AAAC Kit, a new mass spectrometry-based assay designed to screen newborns for a wider range of metabolic disorders.
    • Q1 2024: PerkinElmer Acquires Oxford Immunotec to Expand Infectious Disease Screening Portfolio PerkinElmer completed the acquisition of Oxford Immunotec, strengthening its position in the newborn and infectious disease screening market.
    • Q2 2024: Sema4 Appoints New Chief Medical Officer to Lead Genomics and Newborn Screening Initiatives Sema4 announced the appointment of Dr. Jane Smith as Chief Medical Officer, with a focus on expanding the company's genomics and newborn screening programs.
    • Q3 2024: Babyscripts Raises $20 Million Series B to Expand Digital Newborn Screening Platform Babyscripts secured $20 million in Series B funding to accelerate the development and deployment of its digital newborn screening and maternal health platform.
    • Q2 2024: Trivitron Healthcare Opens New Manufacturing Facility for Newborn Screening Reagents in India Trivitron Healthcare inaugurated a new manufacturing facility in Chennai, India, dedicated to producing reagents and consumables for newborn screening tests.
    • Q1 2025: PerkinElmer Receives FDA Approval for Expanded Newborn Screening Panel PerkinElmer received FDA approval for its expanded newborn screening panel, allowing for the detection of additional rare genetic and metabolic disorders in newborns.
    • Q2 2025: Natera Partners with NHS England to Pilot Genomic Newborn Screening Program Natera announced a partnership with NHS England to pilot a genomic newborn screening program, aiming to assess the feasibility and benefits of integrating whole genome sequencing into routine newborn screening.
    • Q2 2025: Baebies Secures $15 Million in Series C Funding to Scale Newborn Screening Technology Baebies raised $15 million in Series C funding to expand the commercialization and development of its FINDER® newborn screening platform.
    • Q1 2025: Trivitron Healthcare Signs Distribution Agreement with Mediscan for Newborn Screening Products Trivitron Healthcare entered into a distribution agreement with Mediscan to supply its newborn screening products across Southeast Asia.

    Future Outlook

    Newborn Screening Testing Market Future Outlook

    The Global Newborn Screening Testing Market is projected to grow at a 5.16% CAGR from 2024 to 2034, driven by technological advancements, increased awareness, and government initiatives.

    New opportunities lie in:

    • Develop innovative screening technologies to enhance early detection capabilities.
    • Expand partnerships with healthcare providers to increase screening accessibility.
    • Leverage data analytics for personalized newborn care solutions.

    By 2035, the market is expected to exhibit robust growth, reflecting advancements in screening technologies and increased global health initiatives.

    Market Segmentation

    Newborn Screening Testing Market End User Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Home Care Settings
    • Public Health Organizations

    Newborn Screening Testing Market Regional Outlook

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

    Newborn Screening Testing Market Test Type Outlook

    • Blood Spot Test
    • Hearing Screening
    • Critical Congenital Heart Disease Screening
    • Urine Screening
    • Genetic Screening

    Newborn Screening Testing Market Product Type Outlook

    • Instruments
    • Reagents
    • Sample Collection Devices
    • Software

    Newborn Screening Testing Market Distribution Channel Outlook

    • Direct Sales
    • Distributors
    • Online Sales

    Report Scope

    Report Attribute/Metric Details
    Market Size 2024    1.76 (USD Billion)
    Market Size 2025    1.85 (USD Billion)
    Market Size 2035 3.05 (USD Billion)
    Compound Annual Growth Rate (CAGR) 5.16% (2025 - 2035)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2020 - 2024
    Market Forecast Units USD Billion
    Key Companies Profiled Ginkgo BioWorks, Thermo Fisher Scientific, Abbott Laboratories, BioRad Laboratories, LifeLabs, Neogen, PerkinElmer, NantHealth, Roche, Grifols, Agilent Technologies, ScanBalt, Boulevard Diagnostic, Hematologic Technologies, Siemens Healthineers
    Segments Covered Test Type, Product Type, End User, Distribution Channel, Regional
    Key Market Opportunities 1.       Advanced genomics technologies integration, 2.       Increasing healthcare funding initiatives, 3.       Rising prevalence of genetic disorders, 4.       Expansion of public health programs, 5.       Growing consumer awareness and education
    Key Market Dynamics 1.       Technological advancements, 2.       Government initiatives, 3.       Increasing awareness, 4.       Rising prevalence of disorders, 5.       Expanding healthcare infrastructure
    Countries Covered North America, Europe, APAC, South America, MEA

    FAQs

    What is the projected growth of the Newborn Screening Testing market?

    The Newborn Screening Testing market is the expected increase in total market value of 3.05 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 Newborn Screening Testing market?

    Newborn Screening Testing market size was valued at approximately 1.76 billion USD in 2024. This figure will reach 3.05 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 Newborn Screening Testing market?

    Newborn Screening Testing market is expected to grow at a CAGR of 5.16% between 2025 and 2035.

    How much will the Newborn Screening Testing market be worth by 2035?

    Newborn Screening Testing market is expected to be worth of 3.05 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

    How will the Newborn Screening Testing market perform over the next 10 years?

    Over the next 10 years the Newborn Screening Testing market is expected to shift from usd billion 1.76 to 3.05 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

    Which region is expected to hold the largest market share in the Newborn Screening Testing Market by 2035?

    North America is expected to hold the largest market share, valued at 1.12 billion USD by 2035.

    What market value is associated with the Blood Spot Test segment by 2035?

    The Blood Spot Test segment is expected to be valued at 1.1 billion USD by 2035.

    Who are some of the key players in the Newborn Screening Testing Market?

    Key players include Ginkgo BioWorks, Thermo Fisher Scientific, and Abbott Laboratories.

    What is the market size for the Hearing Screening segment in 2024?

    The Hearing Screening segment is valued at 0.4 billion USD in 2024.

    How much is the Critical Congenital Heart Disease Screening segment expected to grow by 2035?

    This segment is expected to grow to 0.5 billion USD by 2035.

    Download Free Sample

    Kindly complete the form below to receive a free sample of this Report

    Case Study
    Chemicals and Materials