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Newborn Screening Market

Newborn Screening Market

Newborn Screening Market, Forecast, Trend, Analysis & Competition Tracking - Global Market Insights 2021 to 2031

Newborn Screening Market
  • Jun-2021
  • List of Tables : 80
  • List of Figures : 227
  • 170 Pages
  • Healthcare

Key Questions Answered in Report

  • What are the growth prospects for newborn screening product manufacturers from 2021-2031?

    Fact.MR forecasts demand for newborn screening products to incline at over 8% CAGR to reach a valuation of more than US$ 1 billion by the end of 2031.

  • Which is likely to be the most common newborn screening product until 2031?

    By product, demand for newborn screening consumables is expected to experience an expansion of nearly 8% CAGR until 2031.

  • Which newborn screening technology is expected to emerge as the dominant one?

    By technology, Fact.MR expects extensive deployment of immunoassays & enzymatic assays, expanding at a CAGR of 9% from 2021-2031.

  • Which is likely to be the most promising newborn screening market over the coming years?

    India and China will likely emerge as the most lucrative newborn screening markets over the coming years, amid a high infant population base. The former shall hold 30% of revenue while the latter is poised to account for 50% of market share in Asia.

Report Also Addresses:

  • Market Estimates and Forecasts (2016-2031)
  • Key Drivers and Restraints Shaping Market Growth
  • Segment-wise, Country-wise, and Region-wise Analysis
  • Competition Mapping and Benchmarking
  • Brand Share and Market Share Analysis
  • Key Product Innovations and Regulatory Climate
  • COVID-19 Impact on Newborn Screening and How to Navigate
  • Recommendation on Key Winning Strategies

Know More Details About the Report

Newborn Screening Demand from 2016 to 2020 Vs Future Market Projections for 2021 to 2031

From 2016 to 2020, demand for newborn screening solutions expanded at under 8% CAGR, primarily driven by increase in birth rates across major developing and developed economies.

Increased birth rates have entailed greater spending in newborn health infrastructure spending, prompting hospitals and other stakeholders to deploy advanced screening procedures, inclining prospects. From 2021 to 2031, the market is poised to surpass a CAGR of 8%, being valued at above US$ 1 billion.

How are Surging Cases of Infant Disorders Stimulating Newborn Screening Demand?

Prevalence of infant diseases has multiplied in recent years, causing a sharp incline in mortality rates. Hearing impairment, metabolic and hormonal disorders are some most common conditions affecting newborns across prominent regions, which are mostly treatable.

According to the Centers for Disease Control & Prevention (CDC), birth defects affect one in every 33 babies, or 3% of all infants, across the United States. Furthermore, the Indian Academy of Pediatrics (IAP) estimates that congenital hearing loss impacts 30 per 100,000 children.

Consequently, demand for effective diagnostic solutions has compounded, prompting key healthcare providers to invest in advanced newborn screening approaches, generating increased demand.

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Why are Newborn Screening Providers Foraying into Emerging Markets?

Major newborn screening providers are looking to capitalize on the ever brimming opportunities present across three major emerging markets: China, India and Brazil, amid the exponentially high birth rates in these countries.

According to estimates, India records 25 million births every year, or nearly one-fifth of the global annual childbirths. The high birth rate and the availability of newborn screening in public hospitals indicates a strong demand for market products and consumables.

Moreover, China has achieved significant progress in newborn screening, with overall uptake rate for congenital hypothyroidism and phenylketonuria screening surpassing 90% in 2017.

newborn screening market

Country-wise Analysis

Why is the U.S. Likely to Generate Significant Opportunities for Newborn Screening Product Manufacturers?

Prospects for newborn screening across the U.S. are expected to take a turn for the better, with an anticipated CAGR of around 5% throughout the forecast period. The Center for Disease Control and Prevention (CDC) estimates that millions of babies are routinely screened every year.

Testing for possible diseases or conditions is largely administered via blood samples drawn from a newborn’s heel for genetic, endocrine or metabolic disorders, as well as for congenital heart defects. Players such as PerkinElmer and Danaher Corporation actively provide various newborn screening solutions.

Why is India Expected to Emerge as a Potential Revenue Hub for Newborn Screening?

Unceasing progress towards reducing infant mortality rates through various governmental and non-governmental initiatives is widening scope for newborn screening across India, contributing around 30% revenue by 2031.

According to UNICEF, every day 67,385 babies are born in India, representing a sixth of the world’s child births, with the yearly total amounting to 25 million. Every minute, one of those babies die due to some or the other disorder. Hence, healthcare providers are pushing forward to develop a robust child care system, which is upscaling demand for advanced children’s diagnostics.

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Category-wise Insights

Why are Newborn Screening Consumables Gaining Traction?

Based on product, demand for newborn screening consumables is poised to witness impressive growth, expanding at a CAGR of nearly 8% until 2031. This elevated share is an outcome of growing hygiene concerns, especially in the wake of the recent pandemic crisis.

Amongst all consumables, demand for assay kits & reagents shall remain elevated, attributed to their ability to produce faster output times which helps in timely detection and diagnosis or prevention of any serious pediatric conditions.

Which is Likely to be the Dominant Newborn Screening Technology?

Based on technology, immunoassay- and enzymatic assay-based newborn screening is poised to acquire precedence, registering a CAGR of around 7% through 2031. This technology is widely deployed to ascertain various conditions amongst newborns.

For instance, ELISA-based is being widely deployed to screen newborns for cystic fibrosis using conventional radioimmunoassay. Similarly, monoclonal antibody immunoassay tests for hemoglobin variants identification is deployed for neonatal screening.

Why is Dry Blood Spot Newborn Screening Tests Grabbing Eyeballs?

In terms of test, dry blood spot newborn screening is anticipated to expand at an impressive 9% CAGR, as this approach enables collection of small sample volumes, making them easier to transport.

Dried blood spots can be used in the event that a baby requires re-testing, providing a fast alternative to bringing the parents and infant back to the hospital for a new blood draw. Dried blood spots are useful in ensuring quality control and assurance to ensure proper functioning of testing equipment.

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Competitive Landscape

Notable developments in the newborn screening landscape are as follows:

  • In September 2020, PerkinElmer received the CE-IVD approval for its EONISTM screening assay for newborns which simultaneously tests for spinal muscular atrophy (SMA), severe combined immunodeficiency (SCID) and X-linked agammaglobulinemia (XLA).
  • In November 2020, Natus Medical Inc. acquired Baybe GmbH and its patented remote mother to baby communication technology. This acquisition adds a new dimension to the company’s leading Newborn Care portfolio of products.

*This list is indicative- full details about prominent players is available upon request.

Report Scope



Forecast Period


Historical Data Available for


Market Analysis

US$ Mn for Value & ‘000 Units for Volume

Key Regions Covered

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania
  • Middle East & Africa

Key Countries Covered

  • U.S.
  • Canada
  • Brazil
  • Mexico
  • Argentina
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • GCC
  • South Africa

Key Segments Covered

  • Product
  • Test
  • Technology
  • End User
  • Region

Key Companies Profiled

  • PerkinElmer
  • Demant A/S
  • Natus Medical Inc.
  • Bio-Rad Laboratories
  • Danaher Corporation
  • Medtronic Plc.
  • Chromsystems Instruments & Chemicals GmbH
  • Trivitron Healthcare
  • Baebies
  • RECIPE Chemicals + Instruments GmbH


Available upon Request

Key Market Segments Covered

  • Product

    • Newborn Screening Instruments
      • Disorder Screening Instruments
        • Fully Automated Newborn Screening Instruments
        • Other Newborn Screening Instruments (Semi-automated Instruments, Shakers, Incubators, etc.)
      • Hearing Screening Instruments
        • Newborn Screening Accessories
        • Newborn Screening Devices
      • Pulse Oximeters
    • Consumables
      • Newborn Screening Assay Kits & Reagents
      • Other Newborn Screening Consumables (Columns and Screening Cards)
  • Test Type

    • Dry Blood Spot Newborn Screening Tests
    • Newborn Hearing Screening Tests
    • Critical Congenital Heart Disease (CCHD) Screening Tests
  • Technology

    • Newborn Immunoassays & Enzymatic Screening Tests
    • Tandem Mass Spectrometry
    • Molecular Assays
    • Newborn Hearing Screening Technologies
    • Pulse Oximetry
    • Other Newborn Screening Technologies (Fluorescence, Gel Electrophoresis, etc.)
  • End User

    • Newborn Screening at Clinical Laboratories
    • Newborn Screening at Hospitals
  • Region

    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Mexico
      • Argentina
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • France
      • Spain
      • Italy
      • Rest of Europe
    • East Asia
      • China
      • Japan
      • South Korea
    • South Asia
      • India
      • ASEAN
      • Rest of South Asia
    • Oceania
      • Australia
      • Rest of Oceania
    • Middle East & Africa
      • GCC
      • South Africa
      • Rest of MEA

Newborn Screening Market - Scope of Report

A recent study by Fact.MR on the newborn screening market offers a 10-year forecast for 2021 to 2031. The study analyzes crucial trends that are currently determining the growth of the market. This report explicates on vital dynamics, such as the drivers, restraints, and opportunities for key market players along with key stakeholders as well as emerging players associated with offering newborn screening products.

The study also provides the dynamics responsible for influencing the future status of the market over the forecast period. A detailed assessment of value chain analysis, business execution, and supply chain analysis across regional markets has been covered in the report.

A list of prominent companies operating in the newborn screening market, along with their product portfolios, enhances the reliability of this comprehensive research study.

Report Summary

The study offers comprehensive analysis on diverse features, including production capacities, demand, product developments, revenue generation, and sales of newborn screening products across the globe.

A comprehensive estimate on the market has been provided through an optimistic as well as a conservative scenario, taking into account the sales of newborn screening products during the forecast period. Price point comparison by region with global average price is also considered in the study.

Key Questions Answered in Report

  • Which are the most lucrative market for newborn screening?
  • Which factors will impact the growth of the market?
  • How will changing trends impact the strategies of market players?
  • How can market players capture the low-hanging opportunities across regions?
  • Which companies are leading the newborn screening industry?
  • What are the winning strategies of stakeholders in the market?

Analysis on Market Size Evaluation

The market has been analyzed for each segment in terms of volume (‘000 Units) and value (US$ Mn).

Market estimates at global and regional levels for newborn screening are available in terms of “US$ Mn” for value and in “000 Units” for volume. A Y-o-Y growth contrast on prominent market segments, along with market attractiveness evaluation, has been incorporated in the report. Furthermore, absolute dollar opportunity analysis of all the segments adds prominence to the report. Absolute dollar opportunity plays a crucial role in assessing the level of opportunity that a manufacturer/distributor can look to achieve, along with identifying potential resources, considering the sales and distribution perspective in the global newborn screening market.

Inspected Assessment on Regional Segments

Key sections have been elaborated in the report, which have helped deliver projections on regional markets. These chapters include regional macros (political, economic, and business environment outlook), which are expected to have a momentous influence on the growth of the newborn screening market during the forecast period.

Country-specific valuation on demand for newborn screening has been offered for each region, along with market scope estimates and forecasts, price index, and impact analysis of the dynamics of prominence in regions and countries. For all regional markets, Y-o-Y growth estimates have also been incorporated in the report.

Detailed breakup in terms of value and volume for emerging countries has also been included in the report.

In-depth Analysis on Competitive Landscape

The report sheds light on leading manufacturers of newborn screening products, along with their detailed profiles. Essential and up-to-date data related to market performers who are principally engaged in offering newborn screening has been brought with the help of a detailed dashboard view. Market share analysis and comparison of prominent players provided in the report permits report readers to take preemptive steps in advancing their businesses.

Research Methodology

In Fact.MR’s study, a unique research methodology is utilized to conduct extensive research on the growth of the newborn screening market, and reach conclusions on the future growth parameters. This research methodology is a combination of primary and secondary research, which helps analysts ensure the accuracy and reliability of the drawn conclusions.

Secondary resources referred to by analysts during the preparation of the market study include statistics from governmental organizations, trade journals, white papers, and internal and external proprietary databases. Analysts have interviewed senior managers, product portfolio managers, CEOs, VPs, marketing/product managers, and market intelligence managers, all of whom have contributed to the development of the research report as a primary resource.

- FAQs -

Fact.MR forecasts demand for newborn screening products to incline at over 8% CAGR to reach a valuation of more than US$ 1 billion by the end of 2031.
By product, demand for newborn screening consumables is expected to experience an expansion of nearly 8% CAGR until 2031.
By technology, Fact.MR expects extensive deployment of immunoassays & enzymatic assays, expanding at a CAGR of 9% from 2021-2031.
India and China will likely emerge as the most lucrative newborn screening markets over the coming years, amid a high infant population base. The former shall hold 30% of revenue while the latter is poised to account for 50% of market share in Asia.

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Is the market research conducted by Fact.MR?

Yes, the report has been compiled by expert analysts of Fact.MR, through a combination of primary and secondary research. To know more about how the research was conducted, you can speak to a research analyst.

What research methodology is followed by Fact.MR?

Fact.MR follows a methodology that encompasses the demand-side assessment of the market, and triangulates the same through a supply-side analysis. This methodology is based on the use of standard market structure, methods, and definitions.

What are the sources of secondary research?

Fact.MR conducts extensive secondary research through proprietary databases, paid databases, and information available in the public domain. We refer to industry associations, company press releases, annual reports, investor presentations, and research papers. More information about desk research is available upon request.

Who are the respondents for primary research?

Fact.MR speaks to stakeholders across the spectrum, including C-level executives, distributors, product manufacturers, and industry experts. For a full list of primary respondents, please reach out to us.

Is a sample of this report available for evaluation?

Yes, you can request a sample, and it will be sent to you through an email.