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Demand for Newborn Immunoassays & Enzymatic Screening Tests To Expand At Nearly 7% CAGR Over The Next Ten Years: Fact.MR Report 2022

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

/EIN News/ -- ROCKVILLE, Md., March 22, 2022 (GLOBE NEWSWIRE) -- Award-winning consulting firm Fact.MR’s recent report on the newborn screening market forecasts an optimistic outlook, predicting a CAGR surpassing 8% to reach a valuation of over US$ 1 billion by 2031. Increased spending on infant care in the wake of accelerating birth rates is principally driving demand for newborn screening solutions.

The market posted impressive gains in the past, expanding at under 8% CAGR from 2016 to 2020. Stakeholders have been inclining specifically towards the use of newborn screening consumables to predict highly accurate outcomes and growing hygiene concerns associated with reusable screening products.

According to the World Health Organization, the world has seen a dramatic reduction to the tune of 60% in the under-five category, from 93 deaths per 1,000 live births in 1990 to 38 in 2019. However, global burden of child and youth death remains high, with over 7 million children, adolescents, and youth aged 0-14 years succumbing to preventable diseases. Consequently, governments across key regions are spending on improving existing infant care infrastructure, prompting the entry of key newborn screening solutions providers.

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 Newborn Screening Market (2031) US$ 1 billion
 Global Market Growth Rate - 2031 8% CAGR
 Segments End-use industry, Type, and Region
 Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends

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.

Key Market Segments Covered

  • 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


  • 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

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Competitive Landscape
Prominent newborn screening providers are reliant on such key expansion strategies as product portfolio expansion by virtue of new releases, acquisition of existing manufacturers and entering into strategic agreements and collaborations. These measures help existing providers secure a firm footing in the market.

  • For instance, Bio-Rad Laboratories offers the VARIANTnbs automated newborn screening for sickle cell disease and other hemoglobin disorders, featuring fully automated analysis and advanced result reporting for maximum efficiency. It uses dried blood spot specimens to provide results.
  • Recently, in May 2021, Baebies was awarded US$ 2.7 million in a Phase-II B SBIR grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) which supports validation, clinical evaluation and FDA submission of a rapid test panel for near-patient heparin monitoring.

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

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.

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Newborn Screening Market 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.

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