Newborn Screening Market (By Product: Instruments and Assay Kits; By Test Type: Dry Blood Spot Test, Hearing Screen Test, Critical Congenital Heart Disease [CCHD] Test, X-ray or CT Scan, Electrocardiogram [ECG] Test, and Others; By End User) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2021-2030

Published Date : Jul 2021 | No. of Pages : 150+ Pages | Category : Healthcare

The global newborn screening market value reached at US$ 950 million in 2020 and predicted to surpass US$ 3.2 billion by 2030, expanding at a noteworthy CAGR of 11% from 2021 to 2030.

Newborn screening is a preventive pediatric screening test conducted to diagnose congenital or inborn abnormalities of metabolism in order to identify the disease. Newborn screening helps in the early detection of serious genetic diseases, which may result in disability or death if not treated at the initial stage. Different types of instrument and assay kits are used in the diagnosis of newborn disorders. Hearing screening devices and pulse oximeter are regularly used in the diagnosis of newborn disorders.

The growth of the global newborn screening market can be ascribed to the rise in prevalence of critical congenital heart defects and government support. The U.S. has a national program of newborn screening tests to check for several different disorders that can be treated, if found very early in life.

Rise in Prevalence of Critical Congenital Heart Defects and Government Support to Drive Global Market

Rise in prevalence and incidence of critical congenital heart diseases across the globe are driving the global newborn screening market. According to the National Center for Biotechnology Information, about 1.35 million babies are born with congenital heart disease each year across the globe. According to the Indian Academy of Pediatrics, more than 200,000 children are estimated to be born with CHD in India every year. About one-fifth of these suffer from critical heart disease that requires early intervention.

Supportive governmental programs and increase in funding for neonatal research also create a favorable environment for the expansion of the market. For instance, in June 2018, the American Society of Hematology (ASH) led a campaign to fight the sickle cell disease in Africa and urged governments, particularly in Sub-Saharan Africa, to invest in newborn screening of the disease.

Evaluation of Screening Methods Helps in Policy Recommendations for New Treatments

Healthcare providers in the newborn screening market are setting their collaboration wheels in motion to assess the current state of pediatric screening. Rare disease-focused organizations such as the EveryLife Foundation for Rare Diseases, Retrophin, Inc., BioMarin Pharmaceutical Inc., Orchard Therapeutics Inc., and Sarepta Therapeutics have joined forces to evaluate the capacity of newborn screening in the U.S. Timely diagnosis to all newborns who may benefit from new treatments requires careful evaluation from healthcare organizations.

The evaluation by organizations in the newborn screening market will ensure policy recommendations that enable equitable access to newborn screening for all babies in the U.S.

Medical Outcomes Increase with Connectivity Between Screening Programs and Healthcare Providers

Companies in the newborn screening market are focusing on reducing the morbidity and mortality associated with heritable disorders in newborns and children. Altarum - a non-profit research and consulting organization has been selected by the Health Resources and Services Administration (HRSA) to lead the Innovations in Newborn Screening Interoperability Resource Center. Such initiatives explain why the newborn screening market is expected to advance at a robust CAGR of ~11% during the forecast period.

In order to improve medical outcomes of newborns and children, healthcare providers are taking efforts to enhance the connectivity between state public health newborn screening programs and healthcare providers. This is being achieved with the help of information management and technical assistance for newborn screening programs.

Report Highlights

In terms of product, the global newborn screening market has been bifurcated into instruments and assay kits. The instruments segment has been split into tabletop and point-of-care testing. The instruments segment dominated the global newborn screening market in 2020. This trend is likely to continue during the forecast period. Instruments allow early detection and management of congenital disorders, thereby providing a better life to the affected infant. This is estimated to boost the segment during the forecast period. Major market players are focusing on the launch of new tabletop and point-of-care testing instruments for newborn screening. This is also likely to propel the segment during the forecast period.

Assay kits was the second-largest segment of the global market in 2020, in terms of market share. Increase in use of assay kit in newborn screening is projected to fuel the growth of the segment.

Based on test type, the global newborn screening market has been categorized into dry blood spot test, hearing screen test, critical congenital heart disease (CCHD) test, X-ray or CT scan, electrocardiogram (ECG) test, and others. The dry blood spot test segment accounted for a prominent share of the global newborn screening market in 2020. Dry blood spot test helps analyze specific biochemistry parameters, such as uric acid, cholesterol, triglycerides, glucose, and creatinine. The dry blood spot test can be used when a baby requires re-testing, as it provides a fast alternative to bringing the parents and infant back to the hospital for a new blood draw. This is critical, as many of the conditions screened for by newborn screening need to be diagnosed as quickly as possible. This is boosting the dry blood spot test segment.

In terms of end user, the global newborn screening market has been classified into hospitals, diagnostic centers, maternity & specialty clinics, and others. The hospitals segment led the global newborn screening market in terms of revenue in 2020. This trend is projected to continue during the forecast period. Rapid increase in the number of hospitals and wide range of services available in multispecialty hospitals are likely to augment the segment during the forecast period.


In terms of region, the global newborn screening market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global newborn screening market in 2020, followed by Europe. North America’s large market share can be ascribed to the increase in number of infants with critical congenital heart diseases, new product launches, and presence of major players in the region. The newborn screening market in Asia Pacific is anticipated to expand at a high CAGR from 2021 to 2030. This can be ascribed to the presence of developing countries with commercial hubs, expanding business organizations, rise in birth rate, improvement in healthcare infrastructure, and increase in investments by companies in research and development activity.

Key Players

The global newborn screening market is fragmented in terms of number of players. Key players operating in the global market include PerkinElmer, Inc., Trivitron Healthcare, Natus Medical Incorporated, Medtronic Plc, Thermo Fisher Scientific, Inc, Bio-Rad Laboratories, Inc., GE Healthcare (General Electric Company), ZenTech S.A., MP BIOMEDICALS, Baebies, Inc. and Masimo.

Global Newborn Screening Market: Segmentation

  • By Product
    • Instruments
      • Tabletop
      • Point-of-care Testing
    • Assay Kits
  • By Test Type
    • Dry Blood Spot Test
    • Hearing Screen Test
    • Critical Congenital Heart Disease (CCHD) Test
    • X-Ray or CT Scan
    • Electrocardiogram (ECG) Test
    • Others (Phototherapy Eye Examination, etc.)
  • By End User
    • Hospitals
    • Diagnostic Centers
    • Maternity & Specialty Clinics
    • Others
  • By Region
    • North America
      • U.S.
      • Canada
    • Europe
      • Germany
      • U.K.
      • France
      • Italy
      • Spain
      • Rest of Europe
    • Asia Pacific          
      • China
      • India
      • Japan
      • South Korea
      • Rest of Asia Pacific
    • Latin America
      • Brazil
      • Mexico
      • Rest of Latin America
    • Middle East & Africa
      • GCC Countries
      • South Africa
      • Rest of Middle East & Africa


The Newborn screening market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Newborn screening market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Newborn screening market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Newborn screening market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Newborn screening market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Newborn screening capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Newborn screening by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Newborn screening market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Newborn screening market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Newborn screening market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Newborn screening industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

Newborn screening market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Newborn screening market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Newborn screening market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Newborn screening market. These factors have benefited the growth of the global market for Newborn screening. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Newborn screening. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

Major Key Points Covered in Report:

Executive Summary: It includes key trends of the newborn screening market related to products, applications, and other crucial factors. It also provides analysis of the competitive landscape and CAGR and market size of the newborn screening market based on production and revenue.

Production and Consumption by Region: It covers all regional markets to which the research study relates. Prices and key players in addition to production and consumption in each regional market are discussed.

Key Players: Here, the report throws light on financial ratios, pricing structure, production cost, gross profit, sales volume, revenue, and gross margin of leading and prominent companies competing in the Newborn screening market.

Market Segments: This part of the report discusses about product, application and other segments of the newborn screening market based on market share, CAGR, market size, and various other factors.

Research Methodology: This section discusses about the research methodology and approach used to prepare the report. It covers data triangulation, market breakdown, market size estimation, and research design and/or programs.

In this study, the years considered to estimate the market size of Newborn screening are as follows:

  • History Year: 2017-2020
  • Base Year: 2020
  • Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.


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