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Newborn Screening Market

Newborn Screening Market

Newborn Screening Market Share & Trends Analysis, By Product (Newborn Screening Instruments, Consumables), By Test Type (Dry Blood Spot Newborn Screening Tests, Newborn Hearing Screening Tests), By Technology (Tandem Mass Spectrometry, Others), End User & By Region Forecast, 2021-2031

Newborn Screening Market
FACT6323MR
  • 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

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.

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

Attribute

Details

Forecast Period

2021-2031

Historical Data Available for

2016-2020

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
  • ASEAN
  • 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

Pricing

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

- 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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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.

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