Newborn Screening Market, by Product Type (Assay Kits, Hearing Screening Devices, Mass Spectrometer, and Pulse Oximetry), by Application (Blood Spot Disease, Critical Congenital Cardiac Disease, Maple Syrup Urine Disease, Hearing Disability, Sickle Cell Disease, and Thyroid Disorder), by Test (Blood Test, Cardiac Test, Hearing Test, and Urine Test), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Trends, and Forecast to 2026

  • Published On : Oct 2018 |
  • Pages : 167 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Newborn Screening Market – Insights

Newborn screening describes various tests that are performed during first few hours or days of an infant’s life. These tests have the potential for preventing severe health problems, including death. Newborn screening has evolved from a simple urine or blood screening test to a more comprehensive and complex screening system capable of detecting over 50 different conditions. Newborn screening tests measure a number of markers in infant’s blood that can be either decreased or increased if an infant has certain diseases. Currently, conditions such as cystic fibrosis (CF), congenital hypothyroidism, phenylketonuria (PKU), and around 22 other metabolic conditions that affect protein or fat metabolism can be diagnosed through newborn screening tests.

The global newborn screening market size was valued at US$ 561.5 million in 2018, and is expected to witness a CAGR of 12.4% over the forecast period (2018 – 2026).

Global Newborn Screening Market Share (%) Analysis, By Product 2018

Source: Coherent Market Insights Analysis (2018)

Increasing government support for newborn screening and developments in screening technologies is expected to drive the newborn screening market growth

Several governments are taking initiative in increasing awareness about newborn screening tests and are offering free screening services in some regions. For instance, in September 2018, the Florida Department of Health launched the Newborn Screening (NBS) Web Order Application. This statewide initiative has been developed to ensure efficiency and accuracy of newborn screening information submitted to the Bureau of Public Health Laboratories.

Moreover, novel biomarkers and analytical technologies are driving the evolution of Newborn Screening (NBS) programs. For instance, a rapid and highly sensitive point-of-care testing device has been developed and commercialized for the diagnosis of Sickle Cell Disease (SCD). According to a BMC Medicine Journal study 2015, SCD test demonstrated 99% specificity and 99% sensitivity for the diagnosis of several hemoglobin (Hb) variants: sickle cell trait (Hb AS), sickle cell anemia (Hb SS), Hb AA, Hb AC, and Hb SC, and requires only 5 μL of blood. Similarly, Next-Generation Sequencing (NGS) technologies are expected to impact newborn screening in the near future.

Newborn Screening Market Restraints

However, lack of consensus for screening is a major restraining factor for newborn screening market growth. There is little agreement among countries on which specific disorders should be included in NBS programs. Although some countries screen for only one Inherited Metabolic Disorders (IMD), others screen for over 30 conditions. For instance, according to the Nature Medicine Journal 2012 study, screening strategies in Europe vary between countries. Moreover, in some countries such as Belgium, Italy, and Spain, policy-making is decentralized to regions or provinces that have separate NBS programs.

Similar conditions are observed in the U.S. where one state may result in screening a different set of disorders compared to a neighboring state. This absence of agreement on screening tests is due to the lack of high-quality observational evidence for most disorders.

Furthermore, multiple challenges need to be confronted including false negative and false positive results of screening tests, inadequate information about the natural history of disease, limited access in some geographic areas to advanced technologies, and treatment of conditions with various phenotypes.

New Born Screening Test Market - Regional Insights

On the basis of region, the global newborn screening market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. By 2026, North America and Europe are expected to generate major revenue share in the global newborn screening market, owing to the presence of a better reimbursement structure, development of well-equipped healthcare infrastructure, and availability of trained medical professionals. According to the U.S. government, for the 2018 fiscal year, the Newborn Screening Quality Assurance Program at the CDC is funded at US$ 8.4 million and the Heritable Disorders program at Health Resources and Services Administration (HRSA) is funded at $13.88 million. The most common newborn screening tests in the U.S. include, hypothyrodism, galactosemia, PKU (phenylketonuria), and sickle cell disease. Increasing government funding in Europe for NBS within a national health service or a statutory health insurance, is expected to drive newborn screening market growth in Europe.

Asia Pacific newborn screening market is expected to foresee highest growth rate during the forecast period, owing to increasing incidences of premature births, high birth rates in countries such as China and India, and increasing healthcare awareness among regional population. According to WHO, 2012 report, most neonatal deaths occur in Asia, which accounted for 40% of the global neonatal deaths. Moreover, in India, less than 1% of infants are screened and over 1.6 million infants are born with birth defects, annually. These factors are expected to propel growth of the global newborn screening market in the region.

Global New Born Screening Test Market Value (US$ Mn) & Y-o-Y Growth (%)

          

 Source: Coherent Market Insights Analysis (2018)

Key players operating in the global newborn screening market include, Agilent Technologies, AB SCIEX, Bio-Rad Laboratories, Covidien PLC, GE Life Sciences, Masimo Corporation, Natus Medical Inc., PerkinElmer Inc., and ZenTech S.A.

Newborn screening programs test infants for disorders that are often not apparent at birth. Such disorders may be infectious, inherited, or caused by a medical problem in the mother.  Early detection and treatment of some disorders can help prevent severe intellectual disability, health problems, growth problems, or even sudden infant death.

Furthermore, early disease diagnosis can reduce treatment cost. According to the Association of Public Health Laboratories 2012 report, the Medicaid cost of treating an infant with Severe Combined Immunodeficiency (SCID), which is fatal in the first two years of life without immune reconstitution, can reach US$ 2 million. However, if infants are diagnosed early, before developing life-threatening infections, from exposure to live childhood vaccines or common germs, they can be cured with a bone marrow transplant. The cost of the transplant is approximately US $100,000 when performed within the first 3.5 months of life.

Market Dynamics

Increasing number of newborn screenings, owing to rising awareness among parents and governments is expected to drive the newborn screening market growth. According to the Centers for Disease Control and Prevention (CDC) 2017, four million infants in the U.S. are routinely screened, using a few drops of blood from their heel, for certain endocrine, genetic, and metabolic disorders. The infants are also tested for hearing loss and Critical Congenital Heart Defects (CCHDs) prior to discharge from a hospital or birth center.

Furthermore, increasing incidence of hospital acquired diseases create an acute need for newborn screening. For instance, according to the Center for Disease Control and Prevention (CDC), in 2011, around one in every 25 infants was infected with at least one hospital acquired infections.

Government initiatives to support screening of newborns is also a major factor driving the newborn screening market. For instance, CDC is working to harness the latest advances in science and technology so that more disorders can be identified accurately and treated quickly. In 2005, CDC established the Newborn Screening Translation Research Initiative (NSTRI) with the CDC Foundation. NSTRI works with corporate, academic, and foundation partners to assure the quality of research methods during both pilot studies and routine screening.

However, lack of skilled professional, proper infrastructure and parent awareness in emerging regions are some of the major factors confining the newborn screening market. Moreover, the natural history for several diseases has not been well characterized and the effective follow-up and treatment may not be known. Excessive false-positive results of screening tests may produce additional costs to the healthcare system. However, improvements in newborn screening tests is expected to reduce number of false positives.

Key features of the study:

  • This report offers in-depth analysis of the global newborn screening market, market size (US$ Mn), and Compound Annual Growth Rate (CAGR (%)) for the forecast period: 2018 – 2026, considering 2017, as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by the key players
  • It profiles key players in the global newborn screening market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies
  • Key players covered as a part of this study include, Agilent Technologies, AB SCIEX, Bio-Rad Laboratories, Covidien PLC, GE Life Sciences, Masimo Corporation, Natus Medical Inc., PerkinElmer Inc., and ZenTech S.A.
  • Insights from this report would allow marketers and management authorities of companies to make informed decision with respect to their future product launch, governmental initiatives, technological up-gradation, market expansion, and marketing tactics
  • The global newborn screening market report caters to various stakeholders in this industry, including investors, product manufacturers, distributors and suppliers for new born screening test market, research and consulting firms, new entrants, and financial analysts

Detailed Segmentation:

  • Global Newborn Screening Market, By Product:
    • Assay Kits
    • Hearing Screening Devices
    • Mass Spectrometer
    • Pulse Oximetry
  • Global Newborn Screening Market, By Test:
  • Blood Test
  • Cardiac Test
  • Hearing Test
  • Urine Test
  • Global Newborn Screening Market, By Application:
    • Blood Spot Disease
    • Critical Congenital Cardiac Disease
    • Maple Syrup Urine Disease
    • Hearing Disability
    • Sickle Cell Disease
    • Thyroid Disorder
  • Global Newborn Screening Market, By Region:
    • North America
      • By Country:
        • U.S.
        • Canada
      • By Product Type:
        • Assay Kits
        • Hearing Screening Devices
        • Mass Spectrometer
        • Pulse Oximetry
      • By Test:
        • Blood Test
        • Cardiac Test
        • Hearing Test
        • Urine Test
      • By Application:
        • Blood Spot Disease
        • Critical Congenital Cardiac Disease
        • Maple Syrup Urine Disease
        • Hearing Disability
        • Sickle Cell Disease
        • Thyroid Disorder
    • Europe
      • By Country:
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
      • By Product Type:
        • Assay Kits
        • Hearing Screening Devices
        • Mass Spectrometer
        • Pulse Oximetry
      • By Test:
        • Blood Test
        • Cardiac Test
        • Hearing Test
        • Urine Test
      • By Application:
        • Blood Spot Disease
        • Critical Congenital Cardiac Disease
        • Maple Syrup Urine Disease
        • Hearing Disability
        • Sickle Cell Disease
        • Thyroid Disorder
    • Asia Pacific
      • By Country:
        • Australia
        • India
        • China
        • Japan
        • ASEAN
        • South Korea
        • Rest of Asia Pacific
      • By Product Type:
        • Assay Kits
        • Hearing Screening Devices
        • Mass Spectrometer
        • Pulse Oximetry
      • By Test:
        • Blood Test
        • Cardiac Test
        • Hearing Test
        • Urine Test
      • By Application:
        • Blood Spot Disease
        • Critical Congenital Cardiac Disease
        • Maple Syrup Urine Disease
        • Hearing Disability
        • Sickle Cell Disease
        • Thyroid Disorder
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
      • By Product Type:
        • Assay Kits
        • Hearing Screening Devices
        • Mass Spectrometer
        • Pulse Oximetry
      • By Test:
        • Blood Test
        • Cardiac Test
        • Hearing Test
        • Urine Test
      • By Application:
        • Blood Spot Disease
        • Critical Congenital Cardiac Disease
        • Maple Syrup Urine Disease
        • Hearing Disability
        • Sickle Cell Disease
        • Thyroid Disorder
    • Middle East
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
      • By Product Type:
        • Assay Kits
        • Hearing Screening Devices
        • Mass Spectrometer
        • Pulse Oximetry
      • By Test:
        • Blood Test
        • Cardiac Test
        • Hearing Test
        • Urine Test
      • By Application:
        • Blood Spot Disease
        • Critical Congenital Cardiac Disease
        • Maple Syrup Urine Disease
        • Hearing Disability
        • Sickle Cell Disease
        • Thyroid Disorder
    • Africa
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
      • By Product Type:
        • Assay Kits
        • Hearing Screening Devices
        • Mass Spectrometer
        • Pulse Oximetry
      • By Test:
        • Blood Test
        • Cardiac Test
        • Hearing Test
        • Urine Test
      • By Application:
        • Blood Spot Disease
        • Critical Congenital Cardiac Disease
        • Maple Syrup Urine Disease
        • Hearing Disability
        • Sickle Cell Disease
        • Thyroid Disorder
  • Company Profiles
    • Agilent Technologies*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • AB SCIEX
    • Bio-Rad Laboratories
    • Covidien PLC
    • GE Life Sciences
    • Masimo Corporation
    • Natus Medical Inc.
    • PerkinElmer Inc.
    • ZenTech S.A.

 “*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Overview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Product
      • Market Snippet, By Test
      • Market Snippet, By Application
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Market Trends
    • Key Developments
    • Technological Advancements
    • Regulatory Scenario
    • Reimbursement Scenario
    • PEST Analysis
  4. Global Newborn Screening Market, By Product, 2018 - 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Assay Kits
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Hearing Screening Devices
      • Introduction  
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Mass Spectrometer
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Pulse Oximetry
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
  5. Global Newborn Screening Market, By Application, 2018 - 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Blood Spot Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Critical Congenital Cardiac Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Maple Syrup Urine Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Hearing Disability
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Sickle Cell Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Thyroid Disorder
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
  6. Global Newborn Screening Market, By Test, 2018 - 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Blood Test
      •  Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Cardiac Test
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Hearing Test
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
    • Urine Test
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 - 2026, (US$ Million)
  7. Global Newborn Screening Market, By Region, 2018 - 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, By Region, 2017 - 2026
      • Regional Trends
    • North America
      • Market Size and Forecast, By Product, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Test, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2017 - 2026, (US$ Million)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Product, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Test, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2017 - 2026, (US$ Million)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Product, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Test, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2017 - 2026, (US$ Million)
        • China
        • Japan
        • India
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast, By Product, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Test, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2017 - 2026, (US$ Million)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Africa
      • Market Size and Forecast, By Product, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Test, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2017 - 2026, (US$ Million)
        • Northern Africa
        • Central Africa
        • South Africa
    • Middle East
      • Market Size and Forecast, By Product, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Test, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2017 - 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2017 - 2026, (US$ Million)
        • GCC Countries
        • Israel
        • Rest of Middle East
  8. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Agilent Technologies
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • AB SCIEX
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Bio-Rad Laboratories
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Covidien PLC
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • GE Life Sciences
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Masimo Corporation
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Natus Medical Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • PerkinElmer Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • ZenTech S.A.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
    • Analyst Views
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 32 market data tables and 20 figures on "Newborn Screening Market” - Global forecast to 2026”.

Research Methodology

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  • Desk Research
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In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
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Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

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The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

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Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

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  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

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