Early Detection for Improved Outcomes: An Analysis of the Global Newborn Screening Market

The newborn screening market is a rapidly growing sector of the healthcare industry that involves the testing of newborn babies for a range of genetic and metabolic disorders. The aim of newborn screening is to identify babies who may have a condition that, if left untreated, could cause serious health problems or even death. Early detection and intervention can improve health outcomes for affected babies and reduce the burden on the healthcare system

With the increasing birth rates, there’s a surge in the cases of infant disorders such as hearing impairment, congenital thyroidisim and other hormonal disorders. Thereby, improving the adoption of newborn screening tests.  Demand for effective diagnostic solutions has compounded with rising mortality rates among newborns, prompting healthcare professionals to increase the investment in the development of advanced newborn screening tests. Manufacturers are increasing their research and development activities to foray into emerging economies such as IndiaChina and Brazil amid the increasing birth rates in the countries.

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Key Takeaways

  • In terms of product, newborn screening consumables demand is poised to expand at nearly 8% CAGR through 2031
  • Based on technology, immunoassay-and enzymatic assay, collectively, are expected to lead the segment, exhibiting a CAGR of over 7% during the forecast period
  • In terms of test, dry blood spot newborn screening is poised to acquire precedence, registering growth at 9% CAGR
  • The U.S. newborn screening market is likely to generate significant opportunities for the market players, expanding at a CAGR of 5% over the forecast period
  • Increasing government initiatives to curb the infant mortality rates across India will bolster the demand of newborn screening, generating around 30% of revenue
  • China is anticipated to lead the East Asia market, accounting for over 50% of market share owing to the increasing cases of congenital hypothyroidism in the region

Key Segments Covered in the Newborn Screening Industry Survey

  • by 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
    • Newborn Screening Consumables
      • Newborn Screening Assay Kits & Reagents
      • Other Newborn Screening Consumables (Columns and Screening Cards)
  • by Test Type :
    • Dry Blood Spot Newborn Screening Tests
    • Newborn Hearing Screening Tests
    • Critical Congenital Heart Disease (CCHD) Screening Tests
  • by 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.)
  • by End User :
    • Newborn Screening at Clinical Laboratories
    • Newborn Screening at Hospitals
  • by Region :
    • North America
    • Latin America
    • Europe
    • Asia Pacific
    • The Middle East & Africa

Competitive Landscape       

Key players are focusing on expansion of their product portfolios through acquisition of existing players and forming alliance with top companies. Manufacturers are also reliant on strategic partnerships and mergers to expand their global reach and maintain their position in the industry.

  • In September 2020, PerkinElmer received approval for its new launch of CE-IVD approval for EONIS screening assay used to screen spinal muscular atrophy, X-linked agammaglobulinemia, and severe combined immunodeficiency among newborns.
  • In February 2021, LifeCell, India’s largest stem cell back announced relief fund and special offers to the parents for the screening of newborns. Baby shield Newborn Screening combines biochemical testing of 100+ metabolic and genetic conditions with confirmatory genetic testing.
  • In December 2019, PerkinElmer received the U.S. Food and Drugs Administration approval for GSP Neonatal Creatine Kinase-MM kit for newborn screening affected by Duchenne muscular dystrophy.

Prominent newborn screening manufacturers listed in Fact.MR’s report are listed below:

  • Bio-Rad Laboratories
  • Danaher Corporation
  • Medtronic Plc.
  • Chromsystems Instruments & Chemicals GmbH
  • Trivitron Healthcare
  • Baebies
  • Masimo Corporation
  • Natus Medical Inc.
  • RECIPE Chemicals + Instruments GmbH

Key Questions Covered in the Report

  • What are the growth prospects for newborn screening products manufacturers during the forecast period?
  • Which are the prominent manufacturers operating in the newborn screening market?
  • Which region will be the most lucrative for newborn screening markets?
  • Which technology of newborn screening will be the most preferred in the upcoming decade?
  • Which test type of newborn screening market will have the highest market share during the forecast period?
  • What are the key challenges faced by newborn screening manufacturers?
  • What is the impact of Covid-19 on newborn screening market?

The market for newborn screening is driven by several factors, including an increasing awareness of the benefits of early detection and treatment, advances in technology that have made screening more accurate and cost-effective, and growing government support for screening programs. In addition, there is a growing demand for point-of-care testing, which allows for faster and more convenient screening

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