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    Prenatal screening tests devices Market

    ID: MRFR/HC/14595-HCR
    128 Pages
    Rahul Gotadki
    October 2025

    Prenatal Screening Tests Devices Market Research Repor: Information By Test (Alpha-Fetoprotein (AFP) Tests, Free Beta Human Chorionic Gonadotropin (hCG) Tests, Inhibin A Tests, Non-invasive prenatal testing (NIPT), Pregnancy Associated Plasma Protein A (PAPP-A) Tests, Total Human Chorionic Gonadotropin (hCG) Tests, and Unconjugated Estriol (uE3) Tests), And By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2035

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    Prenatal screening tests devices Market Summary

    As per MRFR analysis, the Prenatal Screening Tests Devices Market was estimated at 0.896 USD Billion in 2024. The Prenatal Screening Tests Devices industry is projected to grow from 1.004 USD Billion in 2025 to 3.117 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 12.0 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The Prenatal Screening Tests Devices Market is experiencing robust growth driven by technological advancements and a shift towards non-invasive testing.

    • Technological advancements are enhancing the accuracy and efficiency of prenatal screening tests.
    • North America remains the largest market, while Asia-Pacific is emerging as the fastest-growing region in this sector.
    • Non-invasive prenatal testing (NIPT) dominates the market, whereas Alpha-Fetoprotein (AFP) tests are witnessing the fastest growth.
    • Increasing awareness of prenatal health and rising incidence of genetic disorders are key drivers propelling market expansion.

    Market Size & Forecast

    2024 Market Size 0.896 (USD Billion)
    2035 Market Size 3.117 (USD Billion)
    CAGR (2025 - 2035) 12.0%

    Major Players

    Roche (CH), Abbott (US), Thermo Fisher Scientific (US), PerkinElmer (US), Natera (US), Hologic (US), Illumina (US), F. Hoffmann-La Roche (CH), Genomic Health (US)

    Prenatal screening tests devices Market Trends

    The Prenatal Screening Tests Devices Market is currently experiencing a notable evolution, driven by advancements in technology and increasing awareness regarding maternal and fetal health. The integration of non-invasive techniques, such as cell-free DNA testing, appears to be reshaping the landscape of prenatal diagnostics. This shift not only enhances the accuracy of screening but also minimizes risks associated with traditional invasive procedures. Furthermore, the growing emphasis on early detection of genetic disorders is likely to propel demand for innovative screening solutions, as healthcare providers and expectant parents seek reliable options for informed decision-making. In addition, the market seems to be influenced by a rising trend towards personalized medicine, where tailored approaches to prenatal care are gaining traction. This trend indicates a shift towards more individualized screening protocols, which may improve outcomes for both mothers and infants. As healthcare systems worldwide adapt to these changes, the Prenatal Screening Tests Devices Market is poised for continued growth, reflecting a broader commitment to enhancing maternal-fetal health through advanced technology and comprehensive care strategies.

    Technological Advancements

    The ongoing development of cutting-edge technologies in prenatal screening is transforming the market landscape. Innovations such as next-generation sequencing and improved imaging techniques are enhancing the accuracy and efficiency of tests, thereby increasing their adoption among healthcare providers.

    Shift Towards Non-Invasive Testing

    There is a discernible movement towards non-invasive prenatal testing methods, which are perceived as safer alternatives to traditional invasive procedures. This trend is likely to gain momentum as more expectant parents prioritize the health and safety of both mother and child.

    Personalized Medicine Approach

    The growing inclination towards personalized medicine in prenatal care suggests a future where screening tests are tailored to individual risk profiles. This approach may lead to more effective monitoring and management of pregnancies, ultimately improving health outcomes.

    Prenatal screening tests devices Market Drivers

    Regulatory Support and Guidelines

    Regulatory bodies play a crucial role in shaping the Prenatal Screening Tests Devices Market. The establishment of supportive guidelines and regulations by health authorities encourages the development and adoption of innovative screening technologies. For instance, the introduction of streamlined approval processes for new devices has facilitated quicker market entry for advanced prenatal screening solutions. This regulatory support is expected to foster a competitive environment, driving innovation and improving the quality of prenatal care. As a result, the market is anticipated to expand, with an estimated increase in device adoption rates by 15% over the next few years.

    Rising Incidence of Genetic Disorders

    The increasing incidence of genetic disorders is a significant driver for the Prenatal Screening Tests Devices Market. As the prevalence of conditions such as Down syndrome and other chromosomal abnormalities rises, the demand for effective screening solutions becomes more pronounced. This trend is further exacerbated by factors such as advanced maternal age, which is associated with higher risks of genetic anomalies. Consequently, the market is expected to experience a robust growth trajectory, with an estimated compound annual growth rate of 12% as healthcare providers seek to implement comprehensive screening protocols to address these challenges.

    Increasing Awareness of Prenatal Health

    The rising awareness regarding prenatal health is a pivotal driver for the Prenatal Screening Tests Devices Market. As more expectant parents become informed about the importance of early detection of genetic disorders and congenital anomalies, the demand for prenatal screening devices is likely to surge. Educational campaigns and healthcare initiatives have contributed to this awareness, leading to a projected growth rate of approximately 10% annually in the market. This heightened focus on prenatal health not only encourages expectant parents to seek screening but also prompts healthcare providers to adopt advanced technologies, thereby enhancing the overall market landscape.

    Technological Innovations in Screening Devices

    Technological innovations are transforming the Prenatal Screening Tests Devices Market. The integration of artificial intelligence and machine learning into screening devices enhances accuracy and efficiency, allowing for earlier detection of potential issues. These advancements not only improve patient outcomes but also increase the appeal of prenatal screening among healthcare providers. The market is witnessing a shift towards more sophisticated devices, with a projected increase in sales of AI-driven screening tools by 20% in the coming years. This trend indicates a growing reliance on technology to facilitate better prenatal care.

    Growing Investment in Healthcare Infrastructure

    Investment in healthcare infrastructure is a vital driver for the Prenatal Screening Tests Devices Market. Governments and private entities are increasingly allocating resources to enhance maternal and child health services, which includes the procurement of advanced prenatal screening devices. This investment not only improves access to quality prenatal care but also encourages the adoption of innovative technologies. As healthcare systems evolve, the market is likely to benefit from increased funding, leading to a projected growth in device availability and utilization by approximately 18% over the next few years.

    Market Segment Insights

    Prenatal screening tests devices Test Insights

    The  prenatal screening tests devices market segmentation, based on test includes Alpha-Fetoprotein (AFP) Tests, Free Beta Human Chorionic Gonadotropin (hCG) Tests, Inhibin A Tests, Non-invasive prenatal testing (NIPT), Pregnancy Associated Plasma Protein A (PAPP-A) Tests, Total Human Chorionic Gonadotropin (hCG) Tests, and Unconjugated Estriol (uE3) Tests. The non-invasive prenatal testing (NIPT) segment dominated the market. A blood test called NIPT is more precise than the initial pregnancy screening exam.

    It is provided to expectant mothers whose unborn child has been diagnosed with a higher probability of developing Down syndrome, Edwards’s syndrome, or Patau syndrome based on results from prior screening tests.

    Figure1:  Prenatal screening tests devices Market, by Test, 2022&2032(USD Billion)

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

    Get more detailed insights about Prenatal screening tests devices Market

    Regional Insights

    North America : Leading Innovation and Demand

    North America is the largest market for prenatal screening tests, accounting for approximately 45% of the global share. The region's growth is driven by advanced healthcare infrastructure, increasing awareness of prenatal health, and supportive regulatory frameworks. The demand for non-invasive prenatal testing (NIPT) is particularly strong, fueled by rising maternal age and a growing focus on early disease detection. The United States is the primary contributor to this market, with significant investments from key players like Roche, Abbott, and Thermo Fisher Scientific. The competitive landscape is characterized by innovation and strategic partnerships, enhancing product offerings. Canada also plays a vital role, with a growing emphasis on genetic testing and prenatal care, further solidifying North America's position in the global market.

    Europe : Regulatory Support and Growth

    Europe is the second-largest market for prenatal screening tests, holding around 30% of the global market share. The region benefits from stringent regulatory standards and a strong emphasis on maternal health, which drives demand for advanced screening technologies. Countries like Germany and the UK are leading the charge, with increasing investments in healthcare and a focus on innovative testing solutions. The competitive landscape in Europe is marked by the presence of major players such as Illumina and PerkinElmer. The European market is also characterized by collaborations between healthcare providers and technology firms, enhancing the availability of cutting-edge prenatal screening devices. Regulatory bodies are actively promoting the adoption of non-invasive testing methods, ensuring high standards of safety and efficacy.

    Asia-Pacific : Rapid Growth and Adoption

    Asia-Pacific is witnessing rapid growth in the prenatal screening tests market, driven by increasing healthcare expenditure and rising awareness of prenatal health. The region holds approximately 20% of the global market share, with countries like China and India leading the way. The growing trend of late pregnancies and the demand for advanced diagnostic tools are significant growth drivers in this region. China is the largest market in Asia-Pacific, supported by government initiatives promoting maternal health. The competitive landscape features both local and international players, including Natera and Hologic, who are expanding their presence through strategic partnerships. The region's focus on improving healthcare infrastructure is expected to further boost the adoption of prenatal screening technologies, making it a key player in the global market.

    Middle East and Africa : Emerging Market Potential

    The Middle East and Africa region is gradually emerging in the prenatal screening tests market, holding about 5% of the global share. The growth is primarily driven by increasing healthcare investments and a rising awareness of prenatal health issues. Countries like South Africa and the UAE are at the forefront, with initiatives aimed at improving maternal healthcare services and access to advanced screening technologies. The competitive landscape is still developing, with a mix of local and international players entering the market. Key players are focusing on expanding their product offerings and enhancing accessibility to prenatal screening tests. The region's unique demographic trends and increasing healthcare spending are expected to drive further growth in this sector, making it an area of interest for future investments.

    Key Players and Competitive Insights

    Leading market players are putting a lot of money on R&D to expand their product lines, which will drive the market for prenatal screening test devices to continue growing. Additionally, market players are engaging in a range of calculated initiatives to increase their worldwide presence, with important market developments involving the introduction of new products, contracts, M&A transactions, increased investment, and cooperation with other enterprises. To grow and endure in an increasingly cutthroat and dynamic market, prenatal screening tests devices industry must provide reasonably priced goods.

    Manufacturing locally is one of the primary business techniques used by manufacturers to cut operational costs in the  prenatal screening tests devices industry to help customers and expand the market segment. In recent years, the prenatal screening tests devices industry has provided some of the biggest benefits to medicine. Major players in the prenatal screening tests devices market, including Illumina Inc, BGI Genomics Co Ltd, Yourgene Health Plc, Eurofins Scientific SE, Agilent Technologies Inc, Roche Diagnostics International Ltd, PerkinElmer Inc, Beckman Coulter Inc., and others, are engaging in research and development activities in an effort to boost market demand.

    Illumina creates and sells integrated solutions for biological function and genetic variation analysis. Illumina recorded revenue growth of about 6% in 2019. The business put forth an acquisition proposal for Pacific Biosciences that same year for $8.00 per share, or about $1.2 billion. Illumina revealed in 2020 that it will pay $8 billion in cash and stock to purchase Grail. The goal of Illumina's iHope Genetic Health program, which was launched in 2021 in partnership with Genetic Alliance, is to give low- and middle-income populations affected by genetic disease access to whole genome sequencing.

    BGI Genomics is a Chinese genomics company that offers genomic testing and research services to medical organizations, research institutes, businesses, and public agencies. The functional microbiome analyses were made possible by the publication of 1,520 reference genomes from farmed human gut bacteria by BGI Genomics in 2019. Using its in-house DNBSEQ TM technology platform, BGI has been offering a rapid whole genome sequencing (rWGS) service since 2019. This service is designed to expedite the processing of massive sequencing data. A BGI subsidiary, Forensic Genomics International, developed a nationwide genetic profile database that was compatible with WeChat in the same year.

    Key Companies in the Prenatal screening tests devices Market market include

    Industry Developments

    • Q2 2024: Natera Announces CE Mark for Prospera™ Heart and Prospera™ Kidney Transplant Rejection Tests and Launch of Prospera™ Lung in Europe Natera, a leader in cell-free DNA testing, announced it received CE Mark for its Prospera™ Heart and Prospera™ Kidney transplant rejection tests and launched Prospera™ Lung in Europe, expanding its portfolio of advanced cfDNA-based diagnostics, which includes non-invasive prenatal screening solutions.
    • Q2 2024: Illumina Launches NextSeq 2000Dx, Expanding Clinical Sequencing Portfolio Illumina launched the NextSeq 2000Dx, a new clinical-grade sequencing system designed for diagnostic applications, including non-invasive prenatal testing (NIPT), supporting laboratories in delivering high-throughput, accurate prenatal screening.
    • Q2 2024: Myriad Genetics Announces Launch of New Prequel Prenatal Screen with Expanded Capabilities Myriad Genetics launched an updated version of its Prequel Prenatal Screen, offering expanded detection capabilities for chromosomal abnormalities and microdeletions, enhancing its non-invasive prenatal testing portfolio.
    • Q1 2024: BillionToOne Announces $130 Million Series D Financing to Accelerate Commercial Expansion BillionToOne, a molecular diagnostics company specializing in prenatal screening, raised $130 million in Series D funding to expand its commercial operations and further develop its Unity prenatal test platform.
    • Q1 2024: Roche launches new Harmony prenatal test in select European markets Roche announced the launch of its updated Harmony prenatal test in select European countries, providing improved accuracy and broader screening options for expectant mothers.
    • Q2 2024: Invitae Launches Enhanced Non-Invasive Prenatal Screening Test Invitae launched an enhanced version of its non-invasive prenatal screening test, offering improved detection of chromosomal abnormalities and single-gene disorders.
    • Q2 2024: Yourgene Health Announces Partnership with Thermo Fisher Scientific to Expand NIPT Access Yourgene Health entered a partnership with Thermo Fisher Scientific to expand global access to non-invasive prenatal testing (NIPT) solutions, leveraging Thermo Fisher’s distribution network.
    • Q1 2024: Agilent Technologies Acquires Resolution Bioscience, Expanding Genomic Testing Portfolio Agilent Technologies completed the acquisition of Resolution Bioscience, strengthening its position in genomic testing, including non-invasive prenatal screening technologies.
    • Q2 2024: Berry Genomics Receives NMPA Approval for New NIPT Solution in China Berry Genomics received approval from the National Medical Products Administration (NMPA) in China for its new non-invasive prenatal testing (NIPT) solution, enabling broader clinical adoption.
    • Q1 2024: Genetron Holdings Announces Strategic Partnership with BGI Genomics for Prenatal Screening Genetron Holdings entered a strategic partnership with BGI Genomics to jointly develop and commercialize advanced prenatal screening tests in China and international markets.
    • Q2 2024: Eurofins Scientific Opens New Genomics Laboratory in Germany to Support Prenatal Testing Eurofins Scientific opened a new genomics laboratory in Germany, expanding its capacity to deliver non-invasive prenatal screening and other genetic testing services across Europe.
    • Q1 2024: Labcorp Launches New Non-Invasive Prenatal Test with Expanded Genetic Screening Labcorp launched a new non-invasive prenatal test that offers expanded screening for chromosomal and genetic conditions, enhancing its prenatal diagnostics portfolio.

    Future Outlook

    Prenatal screening tests devices Market Future Outlook

    The Prenatal Screening Tests Devices Market is projected to grow at a 12.0% CAGR from 2024 to 2035, driven by technological advancements, increasing awareness, and rising demand for early diagnosis.

    New opportunities lie in:

    • Development of AI-driven predictive analytics tools for risk assessment.
    • Expansion of telehealth services for remote prenatal screening.
    • Partnerships with healthcare providers for integrated screening solutions.

    By 2035, the market is expected to be robust, reflecting substantial growth and innovation.

    Market Segmentation

    Prenatal screening tests devices Test Outlook

    • Alpha-Fetoprotein (AFP) Tests
    • Free Beta Human Chorionic Gonadotropin (hCG) Tests
    • Inhibin A Tests
    • Non-invasive prenatal testing (NIPT)
    • Pregnancy Associated Plasma Protein A (PAPP-A) Tests
    • Total Human Chorionic Gonadotropin (hCG) Tests
    • Unconjugated Estriol (uE3) Tests

    Prenatal screening tests devices Regional Outlook

    • US
    • Canada
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
    • Middle East
    • Africa
    • Latin America

    Report Scope

    MARKET SIZE 20240.896(USD Billion)
    MARKET SIZE 20251.004(USD Billion)
    MARKET SIZE 20353.117(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR)12.0% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Billion
    Key Companies ProfiledMarket analysis in progress
    Segments CoveredMarket segmentation analysis in progress
    Key Market OpportunitiesIntegration of advanced genetic testing technologies enhances accuracy in the Prenatal Screening Tests Devices Market.
    Key Market DynamicsTechnological advancements and regulatory changes drive innovation and competition in the prenatal screening tests devices market.
    Countries CoveredNorth America, Europe, APAC, South America, MEA

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    FAQs

    What is the market size of devices for prenatal screening tests?

    In 2022, the prenatal screening test devices market was estimated to be worth USD 0.7 billion ly.

    How quickly is the market for prenatal screening test devices growing?

    From 2023 to 2032, Around 12.00%(CAGR) is anticipated for the

    Which geographical area had the biggest market share for prenatal screening test devices?

    North America held the most market share worldwide.

    Who are the leading companies in the market for prenatal screening test devices?

    The leading companies in the market are Beckman Coulter Inc., Roche Diagnostics International Ltd., Agilent Technologies Inc., Illumina Inc., BGI Genomics Co Ltd., Yourgene Health Plc, and Eurofins Scientific SE.

    Which test dominated the market for prenatal screening test devices?

    In 2022, the market was led by the non-invasive prenatal testing (NIPT) category.

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