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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)” - 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.

newborn screening market

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.

geographical analysis

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

Research Methodology: Aspects

Market research is a crucial tool for organizations aiming to navigate the dynamic landscape of customer preferences, business trends, and competitive landscapes. At Cognizance Market Research, acknowledging the importance of robust research methodologies is vital to delivering actionable insights to our clientele. The significance of such methodologies lies in their capability to offer clarity in complexity, guiding strategic management with realistic evidence rather than speculation. Our clientele seek insights that excel superficial observations, reaching deep into the details of consumer behaviours, market dynamics, and evolving opportunities. These insights serve as the basis upon which businesses craft tailored approaches, optimize product offerings, and gain a competitive edge in an ever-growing marketplace.

The frequency of information updates is a cornerstone of our commitment to providing timely, relevant, and accurate insights. Cognizance Market Research adheres to a rigorous schedule of data collection, analysis, and distribution to ensure that our reports reflect the most current market realities. This proactive approach enables our clients to stay ahead of the curve, capitalize on emerging trends, and mitigate risks associated with outdated information.

Our research process is characterized by meticulous attention to detail and methodological rigor. It begins with a comprehensive understanding of client objectives, industry dynamics, and research scope. Leveraging a combination of primary and secondary research methodologies, we gather data from diverse sources including surveys, interviews, industry reports, and proprietary databases. Rigorous data analysis techniques are then employed to derive meaningful insights, identify patterns, and uncover actionable recommendations. Throughout the process, we remain vigilant in upholding the highest standards of data integrity, ensuring that our findings are robust, reliable, and actionable.

Key phases involved in in our research process are mentioned below:


Understanding Clients’ Objectives:

Extensive Discussions and Consultations:

  • We initiate in-depth discussions and consultations with our clients to gain a comprehensive understanding of their objectives. This involves actively listening to their needs, concerns, and aspirations regarding the research project.
  • Through these interactions, we aim to uncover the underlying motivations driving their research requirements and the specific outcomes they hope to achieve.

Industry and Market Segment Analysis:

  • We invest time and effort in comprehensively understanding our clients’ industry and market segment. This involves conducting thorough research into market trends, competitive dynamics, regulatory frameworks, and emerging opportunities or threats.
  • By acquiring a deep understanding of the broader industry landscape, we can provide context-rich insights that resonate with our clients’ strategic objectives.

Target Audience Understanding:

  • We analyze our clients’ target audience demographics, behaviors, preferences, and needs to align our research efforts with their consumer-centric objectives. This entails segmenting the audience based on various criteria such as age, gender, income level, geographic location, and psychographic factors.
  • By understanding the nuances of the target audience, we can tailor our research methodologies to gather relevant data that illuminates consumer perceptions, attitudes, and purchase intent.


Identifying Challenges and Opportunities:

  • We proactively identify the challenges and opportunities facing our clients within their respective industries. This involves conducting SWOT (Strengths, Weaknesses, Opportunities, Threats) analyses and competitive benchmarking exercises.
  • By identifying potential obstacles and growth drivers, we can provide strategic recommendations that help our clients navigate complexities and capitalize on emerging opportunities effectively.

Grasping Specific Goals:

  • We delve into the intricacies of our clients’ objectives to gain clarity on the specific goals they aim to accomplish through the research. This entails understanding their desired outcomes, such as market expansion, product development, or competitive analysis.
  • By gaining a nuanced understanding of our clients’ goals, we can tailor our research approach to address their unique challenges and opportunities effectively.

Data Collection:


Primary Research Process:

  • Surveys: We design and administer surveys tailored to capture specific information relevant to our clients’ objectives. This may involve employing various survey methodologies, such as online, telephone, or face-to-face interviews, to reach target audiences effectively.
  • Interviews: We conduct structured or semi-structured interviews with key stakeholders, industry experts, or target consumers to gather in-depth insights and perspectives on relevant topics. These interviews allow us to probe deeper into specific issues and uncover valuable qualitative data.
  • Focus Groups: We organize focus group discussions with carefully selected participants to facilitate interactive discussions and gather collective opinions, attitudes, and preferences. This qualitative research method provides rich contextual insights into consumer behaviors and perceptions.
  • Observations: We conduct observational research by directly observing consumer behaviors, interactions, and experiences in real-world settings. This method enables us to gather objective data on consumer actions and reactions without relying on self-reported information.

Secondary Research Process:

  • Literature Review: We conduct comprehensive literature reviews to identify existing studies, academic articles, and industry reports relevant to the research topic. This helps us gain insights into previous research findings, theoretical frameworks, and best practices.
  • Industry Reports: We analyze industry reports published by reputable trade associations (whitepapers, research studies, etc.), and government agencies (U.S. Census Bureau, Bureau of Labor Statistics, and Securities and Exchange Commission etc.) to obtain macro-level insights into market trends, competitive landscapes, and industry dynamics.
  • Government Publications: We review government publications, such as economic reports, regulatory documents, and statistical databases, to gather relevant data on demographics, market size, consumer spending patterns, and regulatory frameworks.
  • Online Databases: We leverage online databases, such as industry portals, and academic repositories (PubMed Central (PMC), ScienceDirect, SSRN (Social Science Research Network), Directory of Open Access Journals (DOAJ), NCBI, etc.), to access a wide range of secondary data sources, including market statistics, financial data, and industry analyses.





Data Analysis:

The data analysis phase serves as a critical juncture where raw data is transformed into actionable insights that inform strategic decision-making. Through the utilization of analytical methods such as statistical analysis and qualitative techniques like thematic coding, we uncover patterns, correlations, and trends within the data. By ensuring the integrity and validity of our findings, we strive to provide clients with accurate and reliable insights that accurately reflect the realities of the market landscape.



Transformation of Raw Data:

  • Upon collecting the necessary data, we transition into the data analysis phase, where raw data is processed and transformed into actionable insights. This involves organizing, cleaning, and structuring the data to prepare it for analysis.

Utilization of Analytical Methods:

  • Depending on the research objectives, we employ a diverse range of analytical methods to extract meaningful insights from the data. These methods include statistical analysis, trend analysis, regression analysis, and qualitative coding.

Statistical Analysis:

  • Statistical tools are instrumental in uncovering patterns, correlations, and trends within the data. By applying statistical techniques such as descriptive statistics, hypothesis testing, and multivariate analysis, we can discern relationships and derive valuable insights.

Qualitative Analysis Techniques:

  • In addition to quantitative analysis, we leverage qualitative analysis techniques to gain deeper insights from qualitative data sources such as interviews or open-ended survey responses. One such technique is thematic coding, which involves systematically categorizing and interpreting themes or patterns within qualitative data.

Integrity and Validity Maintenance:

  • Throughout the analysis process, we maintain a steadfast commitment to upholding the integrity and validity of our findings. This entails rigorous adherence to established methodologies, transparency in data handling, and thorough validation of analytical outcomes.

Data Validation:

The final phase of our research methodology is data validation, which is essential for ensuring the reliability and credibility of our findings. Validation involves scrutinizing the collected data to identify any inconsistencies, errors, or biases that may have crept in during the research process. We employ various validation techniques, including cross-referencing data from multiple sources, conducting validity checks on survey instruments, and seeking feedback from independent experts or peer reviewers. Additionally, we leverage internal quality assurance protocols to verify the accuracy and integrity of our analysis. By subjecting our findings to rigorous validation procedures, we instill confidence in our clients that the insights they receive are robust, reliable, and trustworthy.


Importance of Data Validation:

  • Data validation is the final phase of the research methodology, crucial for ensuring the reliability and credibility of the findings. It involves a systematic process of reviewing and verifying the collected data to detect any inconsistencies, errors, or biases.

Scrutiny of Collected Data:

  • The validation process begins with a thorough scrutiny of the collected data to identify any discrepancies or anomalies. This entails comparing data points, checking for outliers, and verifying the accuracy of data entries against the original sources.

Validation Techniques:

  • Various validation techniques are employed to ensure the accuracy and integrity of the data. These include cross-referencing data from multiple sources to corroborate findings, conducting validity checks on survey instruments to assess the reliability of responses, and seeking feedback from independent experts or peer reviewers to validate the interpretation of results.

Internal Quality Assurance Protocols:

  • In addition to external validation measures, internal quality assurance protocols are implemented to further validate the accuracy of the analysis. This may involve conducting internal audits, peer reviews, or data validation checks to ensure that the research process adheres to established standards and guidelines.

Report Scope:



Market Size

US$ 1,834.7 Million (2030)

Compound Annual Growth Rate (CAGR)


Base Year


Forecast Period


Forecast Units

Value (US$ Million)

Report Coverage

Revenue Forecast, Competitive Landscape, Growth Factors, and Trends

Geographies Covered

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Countries Covered

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

Key Companies Profiled

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.

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.

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