Why are Enzymatic Assay-Based Newborn Screening Consumables Gaining Traction : Check Fact.MR’s Latest Study

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.

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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.

Key Takeaways from Market Study

• By product, newborn screening consumables to expand impressively, growing at approximately 8% CAGR through 2031
• Demand for newborn immunoassays & enzymatic screening tests to expand at nearly 7% CAGR over the next ten years
• By test, dry blood spot tests to experience high demand, expanding at around 9% CAGR through 2031
• The U.S. to open up positive expansion prospects, with the market likely to expand at approximately 5% CAGR from 2021 to 2031
• Rising infant mortality rates to bolster growth prospects for India, expected to generate 30% of overall revenue
• China to account for 50% of demand amid high uptake of congenital hypothyroidism (CH) and phenylketonuria (PKU) diagnosis

“High concentration of infant population across key emerging economies are attracting a plethora of newborn screening service providers across major countries, poised to generate new revenue streams in the future,” comments a Fact.MR analyst.

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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

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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.

More Insights Available

Fact.MR, in its new offering, presents an unbiased analysis of the newborn screening market, presenting historical demand data (2016-2020) and forecast statistics for the period of 2021-2031. The study divulges essential insights on the market on the basis of product (instruments and consumables), test (dry blood spot tests, hearing screening tests, and CCHD screening tests), technology (immunoassays & enzymatic tests, tandem mass spectrometry, molecular assays, hearing screening technologies, pulse oximetry, and others [fluorescence, gel electrophoresis, etc.]), and end user (clinical laboratories and hospitals), across seven major regions of the world (North America, Latin America, Europe, East Asia, South Asia, Oceania, and the Middle East & Africa).

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