Newborn Screening Market

Global Newborn Screening Market “By Product Type (Consumables { Assay Kits & Reagents and Other Consumables} and Instruments {Disorder Screening Instruments-Fully Automated Instruments and Other Instruments; Hearing Screening Instruments- Accessories & Devices and Pulse Oximeters}); By Test (Dry Blood Spot Tests, Hearing Screening Tests and Critical Congenital Heart Disease (CCHD) Test); By Technology (Immune Assays & Enzymatic Assays, Tandem Mass Spectrometry, Molecular Assays, Hearing Screening Technologies, Pulse Oximetry and Other Technologies); By Application (Congenital Heart Disease; Inherited Disorders-Metabolic Disorders, Endocrine Disorders, Haemoglobin Disorders and Other Inherited Disorders; Infectious Diseases; Hearing Disorders and Other Applications); By End-User (Hospitals; Diagnostic Laboratories; Maternity & Specialty Clinics and Other End-Users)” - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2023-2030

A prominent research firm, Cognizance Market Research added a cutting-edge industry report on “Global Newborn Screening Market”. The report studies the current as well as past growth trends and opportunities for the market to gain valuable insights during the forecast period from 2023 to 2030.

Global Newborn Screening Market Analysis

According to cognizance market research, the global newborn screening market was valued at US$ 980.7 Million in 2022 and is anticipated to reach US$ 1,834.7 Million by the end of 2030 with a CAGR of 8.2% from 2023 to 2030.

What is Newborn screening?

A public health initiative known as newborn screening involves checking newborns for illnesses that are curable but not clinically obvious in the newborn period. Early detection of children at risk for these illnesses is the key to confirming the diagnosis and implementing interventions that will change the disease’s clinical course and avoid or lessen its clinical symptoms. Governing bodies at the state or federal levels frequently organise screening programmes to test all newborns within their jurisdiction for a specified panel of curable illnesses.

Each jurisdiction determines the number of diseases to be examined, and this number can vary substantially. Testing for newborns who appear healthy but have a major medical issue is known as newborn screening. It is necessary to screen newborns for several dangerous or deadly illnesses that are not immediately visible at birth. These testing procedures include hearing exams, pulse oximetry, blood tests, and others. These screening tests give medical practitioners the ability to spot and address specific issues that help a baby develop normally and grow up healthy.

Newborn Screening Market Outlook

In the Newborn screening report, the market outlook segment mainly includes important dynamics of the market which include drivers, restraints, opportunities and challenges tackled by the industry. Opportunities and challenges are extrinsic factors whereas, drivers and restraints are intrinsic factors of the market.

The primary drivers of this market’s growth are the expanding neonatal population and the rising incidence of congenital disorders in neonates. Various screening-required situations are also anticipated to hasten the market’s expansion.

Additionally, it is anticipated that rising demand and increased awareness will propel market expansion. Additionally, newborn screening’s advantages in detecting conditions like phenylketonuria, congenital hypothyroidism, galactosemia, sickle cell disease, and tyrosinemia, among others, help to moderate the market’s expansion during the anticipated time. The market is expected to develop as a result of the newborn screening test’s multiple advantages.

Additionally, it is predicted that advantageous government policies, laws, and technical breakthroughs would create profitable business opportunities. The introduction of oximeters and mass spectrometers with increased performance will also present the market with a wide range of potential opportunities. The market for newborn screening is anticipated to be constrained during the forecast period by a lack of uniformity in newborn screening policies and processes around the globe and a high rate of false positive and false negative test results.

On the other hand, a scarcity of qualified personnel and technologically advanced testing equipment is anticipated to impede market expansion. Additionally, the demand for newer newborn screening goods is expected to be reduced by the availability of refurbished products, which is expected to pose a challenge to the newborn screening market.

Segment Analysis:

The newborn screening market has been segmented into product type, test, technology, application, end-user and geography.

Based on product type, the newborn screening market has been segmented into consumables and instruments. The consumables segment is further sub-segmented into assay kits & reagents and other consumables such as columns & screening cards. The instruments segment has been categorised into disorder screening instruments, hearing screening instruments and pulse oximeters. The market’s highest share is anticipated to go to the consumables sector. The availability of advanced kits, repeated purchasing of consumables for newborn screening, and high newborn screening awareness in developed nations are the primary reasons influencing this segment’s significant market share.

Based on tests, the market for newborn screening has been bifurcated into dry blood spot tests, hearing screening tests and critical congenital heart disease (CCHD) tests. In terms of test types, the dry blood spot test dominates and is mostly utilised for clinical and pre-clinical pharmacokinetic research because of its smaller sample size requirements and ease of sample collection and handling.

Based on technology, the newborn screening market has been segmented into immune assays & enzymatic assays, tandem mass spectrometry, molecular assays, hearing screening technologies, pulse oximetry and other technologies such as electrophoresis, haematology, microbiology and urinalysis. The market’s highest share is anticipated to belong to the immunological and enzymatic assays segment. The advantages of immunological tests & enzymatic assays, such as cost-effectiveness, high applicability, quick turnaround time, and rapid technical improvements, are responsible for this segment’s significant market share.

Based on application, the market for newborn screening is classified into congenital heart disease; inherited disorders such as metabolic disorders, endocrine disorders, haemoglobin disorders; infectious diseases; hearing disorders and other applications. The market segment for inherited disorders is predicted to hold the biggest proportion. The high prevalence of inherited illnesses among infants, gene variants or mutations, inherited gene defects, and abnormalities in genetic makeup all contribute to this segment’s significant market share.

Based on end-user, the newborn screening market has been segmented into hospitals, diagnostic laboratories, maternity & speciality clinics, and others. The market’s highest share is anticipated to go to the hospital sector. A few factors that contribute to the huge market share of this sector include the high preference of hospitals for childbirth delivery, superior infrastructure, the use of cutting-edge procedures in the hospitals, and the availability of qualified personnel.

Geographical Analysis:

Based on geography the global newborn screening market has been segmented into five main regions namely, North America, Asia Pacific, Europe, Latin America, and Middle East & Africa.

Due to the high prevalence of birth defects in the region, government regulations, the presence of a strong healthcare infrastructure, and recent technological advancements in newborn screening technology by players based in the region, the North American region is anticipated to hold a significant share in the newborn screening market. For instance, a research study titled “Association of Birth Defects with Child Mortality Before Age 14 Years” published in April 2022 found a strong association between birth defects and mortality due to circulatory, respiratory, and digestive causes. This finding suggests that the contribution of birth abnormalities to mortality rates may be understated. The study was done in Canada, and according to the same source, birth defects like heart issues, chromosomal abnormalities, and disorders of the central nervous system all increased the chance of dying by more than ten times, eight times, and seventeen times, respectively. The risk of dying was also significantly higher between days 28 and 364 of life, though it was also higher at other times. As a result, the market is anticipated to expand in the region and the demand for newborn screening is anticipated to rise over time.

The report offers the revenue of the newborn screening market for the period 2020-2030, considering 2020 & 2021 as a historical years, 2022 as the base year and 2023 to 2030 as the forecast year. The report also provides the compound annual growth rate (CAGR) for the newborn screening market for the forecast period. The newborn screening market report provides insights and in-depth analysis into developments impacting enterprises and businesses on a regional and global level. The report covers the newborn screening market performance in terms of revenue contribution from several segments and comprises a detailed analysis of key drivers, trends, restraints, and opportunities prompting revenue growth of the newborn screening market.

The report has been prepared after wide-ranging secondary and primary research. Secondary research included internet sources, numerical data from government organizations, trade associations, and websites. Analysts have also employed an amalgamation of bottom-up and top-down approaches to study numerous phenomena in the newborn screening market. Secondary research involved a detailed analysis of significant players’ product portfolios. Literature reviews, press releases, annual reports, white papers, and relevant documents have been also studied to understand the Newborn screening market. Primary research involved a great extent of research efforts, wherein experts carried out interviews telephonic as well as questioner-based with industry experts and opinion-makers.

The report includes an executive summary, along with a growth pattern of different segments included in the scope of the study. The Y-o-Y analysis with elaborate market insights has been provided in the report to comprehend the Y-o-Y trends in the newborn screening market. Additionally, the report focuses on altering competitive dynamics in the global market. These indices serve as valued tools for present market players as well as for companies interested in participating in the newborn screening market. The subsequent section of the newborn screening report highlights the USPs, which include key industry events (Product launch, research partnership, acquisition, etc.), technology advancements, pipeline analysis, prevalence data, and regulatory scenario.

Newborn Screening Market Competitive Landscape

The “Global Newborn screening Market” study report will provide valuable insight with an emphasis on the global market including some of the major players such as –

  • AB Sciex
  • Agilent Technologies Inc.
  • ArcherDX, Inc.
  • Baebies, Inc.
  • Bio-Rad Laboratories Inc.
  • Covidien PLC
  • Demant A/S
  • GE Healthcare
  • Labsystems Diagnostics Oy
  • LifeCell International Pvt.Ltd
  • Masimo Corp.
  • Medtronic Inc.
  • Natus Medical Inc.
  • PerkinElmer Inc.
  • Trivitron Healthcare
  • Waters Corporation
  • ZenTech S.A.

Recent developments in the newborn screening market-

  • The EONIS screening assay, which is used to check neonates for SMA (spinal muscular atrophy), SCID (severe combined immunodeficiency), and XLA (X-linked agammaglobulinemia), was given CE-IVD clearance in September 2020 by PerkinElmer (US).
  • A newborn screening test for cystic fibrosis, fragile X syndrome, and spinal muscular atrophy was added to ArcherDX, Inc.’s product line through the February 2019 announcement of the acquisition of Baby Genes, Inc.
  • RightStart, a newborn DNA test that can identify approximately 50 medical disorders, was introduced by LifeCell International Pvt. Ltd. in October 2018.

The report explores the competitive scenario of the newborn screening market. Major players operating in the newborn screening market have been identified and profiled for unique commercial attributes. Company overview (company description, product portfolio, geographic presence, employee strength, Key management, etc.), financials, SWOT analysis, recent developments, and key strategies are some of the features of companies profiled in the newborn screening market report.


Global Newborn Screening Market, By Product Type

  • Consumables
    • Assay Kits & Reagents
    • Other Consumables (Columns & Screening Cards)
  • Instruments
    • Disorder Screening Instruments
      • Fully Automated Instruments
      • Other Instruments (Semi-Automated Instruments, Shakers, Incubators, Etc)
    • Hearing Screening Instruments
      • Accessories
      • Devices
    • Pulse Oximeters

Global Newborn Screening Market, By Test

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

Global Newborn Screening Market, By Technology

  • Immune Assays & Enzymatic Assays
  • Tandem Mass Spectrometry
  • Molecular Assays
  • Hearing Screening Technologies
  • Pulse Oximetry
  • Other Technologies (Electrophoresis, Haematology, Microbiology And Urinalysis)

Global Newborn Screening Market, By Application

  • Congenital Heart Disease
  • Inherited Disorders
    • Metabolic Disorders
    • Endocrine Disorders
    • Haemoglobin Disorders
    • Other Inherited Disorders
  • Infectious Diseases
  • Hearing Disorders
  • Other applications

Global Newborn Screening Market, by End-user

  • Hospitals
  • Diagnostic laboratories
  • Maternity & specialty clinics
  • Other end-user

Global Newborn Screening Market, by Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Spain
    • Italy
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia & New Zealand
    • South Korea
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of the Middle East & Africa
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Table of Content

Key Questions Answered in Newborn Screening Market Report

The major players operating in the newborn screening market include AB Sciex, Agilent Technologies Inc, Bio-Rad Laboratories Inc, Covidien PLC, GE Healthcare, Masimo Corporation, Medtronic Inc, Natus Medical Incorporated, PerkinElmer Inc, Trivitron Healthcare, Waters Corporation, and ZenTech S.A.

North America is the leading region in the newborn screening market.

The segments covered in the Newborn Screening Market report are based on product type, test, application, end-user and geography.

The forecast period for the newborn screening market is 2023-2030.

Based on technology, the immune assays & enzymatic assays segment is expected to lead the market because of its cost-effectiveness, high applicability, quick turnaround time, and rapid technical improvements.

cognizance market research(cmr)

Newborn Screening Market

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