• 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

    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

    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.

    Prenatal screening tests devices Market Infographic
    Purchase Options

    Prenatal screening tests devices Market Summary

    The Global Prenatal Screening Tests Devices Market is projected to grow from 0.89 USD Billion in 2024 to 2.81 USD Billion by 2035, reflecting a robust CAGR of 10.97%.

    Key Market Trends & Highlights

    Prenatal Screening Tests Devices Key Trends and Highlights

    • The market is expected to expand significantly, reaching 2.81 USD Billion by 2035.
    • From 2025 to 2035, the market is anticipated to grow at a compound annual growth rate of 10.97%.
    • In 2024, the market valuation stands at 0.89 USD Billion, indicating a strong foundation for future growth.
    • Growing adoption of advanced prenatal screening technologies due to increasing awareness of maternal health is a major market driver.

    Market Size & Forecast

    2024 Market Size 0.89 (USD Billion)
    2035 Market Size 2.81 (USD Billion)
    CAGR (2025-2035) 10.97%

    Major Players

    Illumina Inc, BGI Genomics Co Ltd, Yourgene Health Plc, Eurofins Scientific SE, Agilent Technologies Inc, Roche Diagnostics International Ltd, PerkinElmer Inc, Beckman Coulter Inc, Abbott Laboratories, Siemens Healthineers AG, Quidel Corp, Thermo Fisher Scientific Inc, Tosoh Corp

    Prenatal screening tests devices Market Trends

    Growing maternal age is driving the market growth

    Market CAGR for prenatal screening tests devices is being driven by the Growing Maternal Age. Prenatal testing gives you details about the health of your unborn child. It finds any issues, including as genetic flaws and congenital disorders that might have an impact on the health of fetuses. While some women require specialized screening procedures, doctors advise certain prenatal screenings. Testing is done on newborns to find anomalies that may lead to inborn genetic disorders or other health issues. During screening, genetic disorders such as homocystinuria, phenylketonuria, and Down syndrome can be identified in neonates.

    Additionally, the tendency to put off having children raises the risk of chromosomal abnormalities and genetic illnesses in babies. Prenatal screening tests to identify such anomalies are becoming more and more necessary as more women want to become pregnant at older ages. Growth in the industry is stimulated by increased healthcare spending, particularly in developed and emerging nations where it leads to better access to screening tests and prenatal care.

    However, due to high costs or inadequate healthcare infrastructure, access to advanced prenatal screening tests may be restricted in some areas or healthcare settings, which could have an impact on broad adoption.

    A greater frequency of chromosomal abnormalities and genetic illnesses in babies is a result of the trend of postponing delivery. Prenatal screening tests are becoming more and more necessary to identify these anomalies as more women choose to become pregnant at older ages. Prenatal screening tests that don't involve risk are more frequently adopted because expectant parents are drawn to non-invasive, risk-free ways of keeping an eye on their unborn child's health. 

    Prenatal screening tests are in high demand because early discovery of fetal anomalies enables better medical management and educates parents and healthcare providers in making decisions. For instance, the World Health Organization (WHO) estimates that congenital anomalies account for 6% of all births and are a major contributor to the  illness burden, particularly in low- and middle-income nations. Additionally, the Prenatal and Newborn Genetic Testing Market Size is positively impacted by the increase in demand for non-invasive prenatal screening. Thus, result in driving the prenatal screening tests devices market revenue.

    The increasing emphasis on early detection of genetic disorders in fetuses is driving advancements in prenatal screening technologies, which may enhance maternal and fetal health outcomes.

    U.S. Department of Health and Human Services

    Prenatal screening tests devices Market Drivers

    Market Growth Projections

    The Global Prenatal Screening Tests Devices Market Industry is projected to experience substantial growth in the coming years. With a market value of 0.89 USD Billion in 2024, it is expected to reach 2.81 USD Billion by 2035, indicating a robust expansion trajectory. The compound annual growth rate (CAGR) of 10.97% from 2025 to 2035 reflects the increasing demand for prenatal screening solutions driven by various factors, including technological advancements, rising awareness, and government initiatives. This growth presents opportunities for stakeholders in the industry to innovate and expand their offerings, catering to the evolving needs of expectant mothers and healthcare providers.

    Increasing Healthcare Expenditure

    The rise in global healthcare expenditure is positively impacting the Global Prenatal Screening Tests Devices Market Industry. As countries allocate more resources to healthcare, there is a corresponding increase in funding for prenatal care services. This trend is particularly pronounced in developed nations, where healthcare budgets are expanding to include advanced prenatal screening technologies. Increased investment in healthcare infrastructure and services enhances the availability and accessibility of prenatal screening tests, thereby driving market growth. The anticipated growth from 0.89 USD Billion in 2024 to 2.81 USD Billion by 2035 underscores the potential for continued expansion in this sector.

    Government Initiatives and Funding

    Government initiatives aimed at improving maternal health are significantly influencing the Global Prenatal Screening Tests Devices Market Industry. Various countries are implementing policies that promote access to prenatal care and screening services. Funding for research and development of new screening technologies is also on the rise, which further supports market growth. For instance, government programs that subsidize the cost of prenatal screenings make these services more accessible to a broader population. This increased accessibility is expected to drive market expansion, contributing to the projected growth from 0.89 USD Billion in 2024 to 2.81 USD Billion by 2035.

    Rising Awareness of Prenatal Health

    The increasing awareness regarding prenatal health among expectant mothers is a key driver for the Global Prenatal Screening Tests Devices Market Industry. Educational initiatives and healthcare campaigns have significantly contributed to this awareness, leading to a higher demand for prenatal screening tests. As more women understand the importance of early detection of genetic disorders and other complications, the market is expected to grow. In 2024, the market is valued at 0.89 USD Billion, reflecting this heightened awareness. This trend is likely to continue, as healthcare providers emphasize the necessity of prenatal screenings for better maternal and fetal health outcomes.

    Growing Incidence of Genetic Disorders

    The rising incidence of genetic disorders among newborns is a critical factor propelling the Global Prenatal Screening Tests Devices Market Industry. As the prevalence of conditions such as Down syndrome and other chromosomal abnormalities increases, the demand for effective prenatal screening solutions grows correspondingly. This trend is particularly evident in regions with advanced healthcare systems, where early detection is prioritized. The market's growth is further supported by the increasing number of women opting for advanced maternal age pregnancies, which correlates with a higher risk of genetic disorders. Consequently, the market is poised for substantial growth as more families seek comprehensive prenatal screening options.

    Technological Advancements in Screening Devices

    Technological innovations in prenatal screening devices are transforming the Global Prenatal Screening Tests Devices Market Industry. The introduction of non-invasive prenatal testing (NIPT) and advanced imaging techniques has enhanced the accuracy and reliability of screenings. These advancements not only improve diagnostic capabilities but also reduce the risks associated with invasive procedures. As a result, healthcare providers are increasingly adopting these technologies, which is reflected in the market's growth trajectory. The anticipated compound annual growth rate (CAGR) of 10.97% from 2025 to 2035 indicates a robust expansion driven by ongoing technological improvements.

    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 Research Report — Global Forecast till 2032

    Regional Insights

    By region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. The North American prenatal screening tests devices market area will dominate this market. Newborns in North America are more likely to have chromosomal abnormalities and genetic illnesses as a result of the tendency of women delaying childbirth. As a result, older pregnant mothers are calling for prenatal screening tests more frequently.

    Further, the major countries studied in the market report are The US, German, France, the UK, Canada, Italy, Spain, India, Australia, South Korea, China, Japan, and Brazil.

    Figure2:  PRENATAL SCREENING TESTS DEVICES MARKET SHARE BY REGION 2022 (USD Billion)

    PRENATAL SCREENING TESTS DEVICES MARKET SHARE BY REGION 2022

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

    Europe prenatal screening tests devices market has the second-largest portion of the market. Prenatal screening test uptake and general availability are supported by this infrastructure. Further, the German prenatal screening tests devices market held the largest proportion of the market, and the UK prenatal screening tests devices market was the European market with the quickest rate of growth.

    The Asia-Pacific Prenatal screening tests devices Market has the quickest predicted compound annual growth rate (CAGR) between 2023 and 2032. Infrastructure improvements for healthcare, particularly in the region's fast developing economies. Moreover, China’s prenatal screening tests devices market had the biggest market share, and the Indian prenatal screening tests devices market was the Asia-Pacific region's fastest-growing market.

    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 10.97% CAGR from 2024 to 2035, driven by technological advancements, increasing awareness, and rising demand for non-invasive testing.

    New opportunities lie in:

    • Develop AI-driven analytics tools for personalized prenatal screening solutions.
    • Expand product offerings to include at-home testing kits for greater accessibility.
    • Forge partnerships with healthcare providers to enhance distribution channels and market reach.

    By 2035, the market is expected to achieve substantial growth, reflecting advancements in prenatal screening technologies.

    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

    Report Attribute/Metric Details
    Market Size2022 USD 0.7 Billion
    Market Size 2023 USD 0.8 Billion
    Market Size2032 USD 2 Billion
    Compound Annual Growth Rate (CAGR) 12.00% (2023-2032)
    Base Year 2022
    Market Forecast Period 2023-2032
    Historical Data 2018- 2022
    Market Forecast Units Value (USD Billion)
    Report Coverage Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
    Segments Covered Test, and Region
    Geographies Covered North America, Europe, AsiaPacific, and the Rest of the World
    Countries Covered The US, German, France, UK, Canada, Italy, Spain, India, Australia, South Korea, China, Japan, and Brazil
    Key Companies Profiled  Illumina Inc, BGI Genomics Co Ltd, Yourgene Health Plc, Eurofins Scientific SE, Agilent Technologies Inc, Roche Diagnostics International Ltd, PerkinElmer Inc, Beckman Coulter Inc.,
    Key Market Opportunities ·         Market penetration may be impacted by disparities in reimbursement laws among various geographic areas.
    Key Market Dynamics ·         It is essential to guarantee the clinical validity and precision of prenatal screening tests.

    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.

    Download Free Sample

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

    Case Study
    Chemicals and Materials