Newborn Screening Market Growth Report | Revenue & Size 2030

Newborn Screening Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Product Type (Reagents and Assay Kits, and Instruments), Technology [Tandem Mass Spectrometry (TMS), Molecular Assays, Immunoassays and Enzymatic Assays, Pulse Oximetry Screening Technology, and Others], Test Type [Dry Blood Spot Test, Hearing Screen Test, Critical Congenital Heart Diseases (CCHD) Test, and Others], End User (Hospitals and Clinics, and Diagnostic Laboratories), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

Publication Month : Sep 2023

  • Report Code : TIPHE100001294
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 226
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[Research Report] The newborn screening market size was valued at US$ 1,206.74 million in 2022 and is projected to reach US$ 2,484.16 million by 2030; it is estimated to register a CAGR of 9.4% from 2022 to 2030.

Market Insights and Analyst View:

Newborn screening aims to identify infants with congenital diseases before symptoms appear so that therapy can begin as soon as feasible to avoid or lessen the condition's long-term effects. Every state in the US has several newborn screening procedures that are implemented. An extended and standardized uniform panel revealed screening for at least 26 diseases across all states. The most complete screening panel looks for 40 different illnesses. However, some people continue to refer to the newborn screening as "the PKU test" as phenylketonuria (PKU) was the condition for which this screening test was designed initially. The surging funding from government sectors for newborn screening, rising burden of congenital diseases, and increasing prevalence of newborn disorders are the key factors driving the newborn screening market growth. However, the lack of uniformity in newborn screening policies and practices hinders the market growth.

Growth Drivers and Restraints:

Congenital diseases can lead to lifelong health challenges if not detected and managed early. These diseases can contribute to long-term disability, significantly affecting families, individuals, healthcare systems, and societies. The WHO estimates that 240,000 newborns worldwide succumb to death each year within 28 days of birth due to these diseases. Approximately 170,000 children die between 1 month and 5 years of age due to congenital diseases. A growing understanding of the genetic basis of many congenital diseases is one of the several factors contributing to the increasing burden of these conditions. Progress in genomics and genetic testing have enabled healthcare providers to identify a broader range of genetic mutations and conditions in newborns. This expanded knowledge has highlighted the importance of early diagnosis through newborn screening to initiate timely interventions and treatments.

Changing demographics such as maternal age, environmental exposures, and altering lifestyle habits increase newborns' risk of congenital conditions. Moreover, the number of births occurring daily is on the rise due to the burgeoning global population, resulting in an expanding pool of infants at risk of congenital diseases. Healthcare systems and policymakers recognize the long-term benefits of early disease detection. They increasingly incorporate newborn screening into routine healthcare protocols and insurance coverage, further stimulating market growth.

Variations regarding the conditions screened for in different countries result in non-uniformity in newborn screening policies and practices worldwide. A few nations screen for a comprehensive range of disorders, while others focus on a limited set. This difference creates barriers for companies developing screening tests and technologies, as they must modify their products to specific markets, limiting economies of scale. Moreover, the lack of standardized protocols can result in inconsistent quality control and data collection practices. This leads to inaccuracies in screening results and difficulties in comparing data between regions, making it challenging for researchers and healthcare providers to assess the effectiveness of screening programs implemented in localities understudy.

Additionally, the absence of universal standards complicates the regulatory landscape for companies operating in the newborn screening market, as they need to focus on complying with a complex web of regulations for seeking approvals in different countries, which can be time-consuming and expensive. The lack of uniformity can also hinder international collaborations and data sharing, limiting the potential of newborn screening research and technology development. Thus, the lack of uniformity in newborn screening policies and procedures limits the progress of the newborn screening market.

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Newborn Screening Market: Strategic Insights

newborn-screening-market
Market Size Value inUS$ 1,206.74 million in 2022
Market Size Value byUS$ 2,484.16 million by 2030
Growth rateCAGR of 9.4% from 2022 to 2030
Forecast Period2022-2030
Base Year2022
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Report Segmentation and Scope:

The “Global Newborn Screening Market” is segmented on the basis of product type, test type, technology, and end user. The market, by product type, is segmented into reagents and assay kits and instruments. Based on technology, the newborn screening market is segmented into tandem mass spectrometry (TMS), molecular assays, immunoassays and enzymatic assays, pulse oximetry screening technology, and other technologies. The newborn screening market, by test type, is segmented into dry blood spot tests, hearing screen tests, critical congenital heart disease tests, and other tests. The global newborn screening market, by end user, is segmented into hospitals, clinics, and diagnostic laboratories.

The newborn screening market, based on geography, is segmented into North America (US, Canada, and Mexico), Europe (Germany, France, Italy, UK, Russia, and Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and Rest of Asia Pacific), Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).

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Segmental Analysis:

The newborn screening market, by product type, is segmented into reagents and assay kits and instruments. In 2022, the reagents and assay kits segment held a larger market share and is expected to register a higher CAGR during 2022–2023. Different reagents and assay kits for newborn screening are categorized into DNA-based assays, immunoassays, and enzymatic assays. Various companies in the market have developed a range of reagents and assay kits specifically for neonatal screening. Labsystems Diagnostics launched a fluorometric microplate-based assay in 2022, for detecting phenylketonuria (PKU) in newborns based on phenylalanine content, as increasing the phenylalanine level in the baby can cause intellectual disability. All the reagent kits offered by the company are manual modular systems or fully automated hands-off systems.

Newborn Screening Market, by Product Type  – 2022 and 2030

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The newborn screening market, by technology, is segmented into tandem mass spectrometry (TMS), molecular assays, immunoassays and enzymatic assays, pulse oximetry screening technology, and other technologies. In 2022, the pulse oximetry screening technology segment held the largest share of the market. Moreover, the immunoassays and enzymatic assays segment is expected to record the fastest CAGR during 2022-2030. Congenital heart disease (CCHD) is one of the most common birth defects, and duct-dependent disorders are common forms of this disease. It may be detected during the prenatal and postnatal period, while it can be life-threatening if goes undiagnosed and untreated in the neonatal period or infancy. Pulse oximetry screening is used to detect critical CCHD in infants. It is a painless, non-invasive, and cost-effective method of screening infants. The pulse oximeter screening is used to determine haemoglobin percentage in the blood saturated with oxygen. .

The newborn screening market, by test type, is segmented into dry blood spot tests, hearing screen tests, critical congenital heart disease tests, and other tests. In 2022, the blood spot test segment held the largest share of the market. The newborn screening market for this segment is estimated to grow at a significant CAGR during 2022–2030.

The newborn screening market, by end user, is segmented into hospitals, clinics, and diagnostic laboratories. In 2022, the hospitals and clinics segment held the largest market share. However, the hospitals and clinics segment is estimated to register a CAGR during 2022–2030. Healthcare providers perform newborn screening tests in a room or a newborn/nursery area at hospitals. The hospitals and clinics segment is projected to hold a larger share of the newborn screening market in the coming years as these facilities receive maximum patient footfall for newborn baby screening. The availability of better facilities and different treatment options, and good nursing care offered under one roof attract patients toward these facilities for different diagnostic and therapeutic procedures.

Regional Analysis:

Based on geography, the global newborn screening market is segmented into five key regions: North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. In 2022, North America held the largest market share. Asia Pacific is estimated to register the highest CAGR in the newborn screening market from 2022 to 2030.

The newborn screening market in North America has experienced significant growth in recent years. The demand for newborn screening services has increased significantly with the surging awareness among parents and healthcare professionals about the importance of early screening for identifying and managing congenital disorders. Additionally, improvements in medical technology have been crucial in enhancing newborn screening capabilities—laboratory automation has boosted screening accuracy, speed, and cost-effectiveness. This has made it possible for medical professionals to give thorough newborn screening panels that cover a larger spectrum of genetic and metabolic disorders. Favorable legislation and regulatory measures also benefit the newborn screening market in North America. Many states and provinces have implemented mandatory newborn screening programs, ensuring all infants are screened shortly after birth. For instance, every state in the US offers newborn screening as a public health program; yearly, ~4 million babies are screened under this program for illnesses that aren't often present at the time of delivery. The Texas Department of Health and Human Services began screening newborns for Spinal Muscular Atrophy (SMA) in June 2021.

Industry Developments and Future Opportunities:

Various initiatives taken by key players operating in the global newborn screening market are listed below:

  1. In May 2023, Masimo launched Stork, a revolutionary home baby monitoring system. This innovative system offers parents insights into their baby’s health data, allowing them to stay more connected with their babies. The Masimo Stork baby monitor system comprises several components and is available in multiple configurations. Masimo Stork Vitals+, the flagship solution, consists of a boot with a sensor, video camera, and mobile app.
  2. In November 2022, PerkinElmer Inc. received US Food and Drug Administration (FDA) authorization for the marketing of the EONIS SCID-SMA assay kit for in vitro diagnostic (IVD) use by certified laboratories for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns. This is the first FDA-authorized assay for SMA screening in newborns in the US and is a part of PerkinElmer’s broader EONIS Platform.
  3. In July 2022, Baebies Inc. expanded its partnership with Medical Horizons S.r.L, a medical device supplier, to help introduce newborn screening solutions to various European countries.
  4. In July 2022, Natus Medical Incorporated revealed that the MED Platform II fund of ArchiMed, a leading investment firm focused exclusively on the healthcare industry, completed the acquisition of Natus. Under the definitive agreement, Natus shareholders received US$ 33.50 in cash for each share of Natus common stock.

Competitive Landscape and Key Companies:

LifeCell International Pvt Ltd, Zentech SA, Trivitron Healthcare Pvt Ltd, PerkinElmer Inc, Waters Corp, Bio-Rad Laboratories Inc., Masimo Corp, Natus Medical Inc., Baebies Inc, MRC Holland BV, and Medtronic Plc are among the prominent players operating in the newborn screening market. These companies focus on new technologies, advancements in existing products, and geographic expansions to meet the growing consumer demand worldwide and increase their product range in specialty portfolios.

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Product Type, Technology, Test Type, End User, and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What was the estimated newborn screening market size in 2022?

The newborn screening market was valued at US$ 1,206.74 million in 2022.

What are the growth estimates for the newborn screening market till 2030?

The newborn screening market is expected to be valued at US$ 2,484.16 million in 2030.

What is newborn screening?

Testing for babies with a major medical issue is known as newborn screening. Screening newborns for various dangerous or deadly illnesses that are not immediately visible at birth is necessary. These testing procedures include hearing exams, pulse oximetry, and blood tests, and these tests allow medical practitioners to spot and address specific issues that help a baby develop normally and grow up healthy.

Which segment is dominating the newborn screening market?

The global newborn screening market, based on product type, is segmented into reagents and assay kits and instruments. The reagents and assay kits segment held a larger market share in 2022 and is anticipated to register a higher CAGR during the forecast period.

What are the driving and restraining factors for the newborn screening market?

The factors driving the growth of the newborn screening market include rising funding from government sectors for newborn screening, rising burden of congenital diseases, and increasing prevalence of newborn disorders. However, lack of global uniformity in newborn screening policies and practices hamper the growth of the newborn screening market.

Who are the major players in the newborn screening market?

The newborn screening market majorly consists of the players, including Medtronic Plc, PerkinElmer Inc, Waters Corp, Bio-Rad Laboratories Inc, LifeCell International Pvt Ltd, Zentech SA, Trivitron Healthcare, Masimo Corp, Natus Medical Inc, Baebies Inc, and MRC Holland BV.

The List of Companies - Newborn Screening Market

  1. LifeCell International Pvt Ltd
  2. Zentech SA
  3. Trivitron Healthcare Pvt Ltd
  4. PerkinElmer Inc
  5. Waters Corp
  6. Bio-Rad Laboratories Inc.
  7. Masimo Corp
  8. Natus Medical Inc.
  9. Baebies Inc
  10. MRC Holland BV
  11. Medtronic Plc

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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