USD 1.25 Billion
Newborn Screening Market Size, Share, Growth Analysis, By Product (Consumables, Instruments), By Technology (Tandem Mass Spectrometry, Pulse Oximetry), By Test Type (Dry Blood Spot Test, CCHD), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35E2050 |
Region:
Global |
Published Date: November, 2024
Pages:
177
|Tables:
89
|Figures:
71
Newborn Screening Market Insights
Global Newborn Screening Market size was valued at USD 1.25 Billion in 2023 and is poised to grow from USD 1.34 Billion in 2024 to USD 2.12 Billion by 2031, growing at a CAGR of 6.8% in the forecast period (2024-2031).
The factors which fuel growth over the forecast period include the increasing birth rate, increasing instances of congenital illness in infants, growing awareness among consumers, positive efforts and support from different governments arranging several programs & legislations. Technological advancements in screening techniques drive the market. The emergence of congenital disorders among newborns is projected to drive the growth rate in the newborn screening market. According to WHO, it is estimated that about 240,000 baby deaths are accounted for by congenital disorders yearly, within the first 28 days of birth, as of the available data for February 2023. In addition, another estimate is that approximately 170,000 child deaths between one month and five years of age are congenitally related. Furthermore, from Indian Pediatrics, in-born metabolic disorders are estimated to be 2–7.8% of Indian children and congenital hypothyroidism affects 2.1 out of every 1,000 babies. Since congenital disorders are found to be very high among infants, the use of tests is more probable to rise, and this is expected to boost the growth of the market by 2031. Promoting a favorable environment for the growth of the newborn screening market comes through initiating government schemes and passing policies. For instance, in June 2022, the government of Manitoba declared it was advancing to expand its newborn screening program to include testing for spinal muscular atrophy along with others.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Hospitals
Fastest Growth
Consumables
Growth Rate
6.8%
Global Newborn Screening Market ($ Bn)
Country Share for Asia-Pacific Region (%)
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Newborn Screening Market Segmental Analysis
Global Newborn Screening Market is segmented by Product, Test, technology, end user and region. Based on Product, the market is segmented into Consumables, Instruments, Hearing screening instruments, Pulse oximeters. Based on Test, the market is segmented into Dry blood spot tests, Hearing screening tests, CCHD screening tests. Based on technology, the market is segmented into Immune assays & enzymatic assays, Tandem mass spectrometry, Molecular assays, Hearing screening technologies, Pulse oximetry, Other Technologies. Based on end user, the market is segmented into Clinical Laboratories, Hospitals. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.
Analysis By Product
The instruments segment held a significant market share with 75.91%. This segment has the potential for the highest compound annual growth rate during the forecasting period. The key factors for this direction are the increasing newborn screening operations, the broad awareness among people of the importance of early disease detection, and greater investment in newborn screening technology. Another factor that drives the growth of this segment is technological advancement. This is highlighted in the fact that GC Labs has just recently started offering a new diagnostic test for Inborn Errors of Metabolism (IEM) in neonates, incorporating improved techniques for the detection of diseases, thus putting emphasis on how this equipment segment is pivotal for improvements in screening capacity.
The reagent segment over the projection period shall be expected to gain a high compound annual growth rate. The foremost drivers for this forecasted growth are the need for thorough newborn screening and the increased emphasis on early illness detection, especially in developing nations. There has been greater demand for screening test reagents with increased healthcare infrastructure and awareness of the benefits of early detection. This creates a profitable space for the reagent industry because it serves to move the more general aim of more effective and efficient detection and management of potential issues with the health of neonates.
Analysis By Test Type
The dry blood spot tests segment accounted for around 45.9% of the market revenue share in the newborn screening market and led the industry in 2023. With its availability to detect more than 50 issues in newborn screening, the market is expected to grow at the fastest compound annual growth rate in the forecast decade. Like the government actions, such as the one that started in March 2022-the Oxford University pilot trial for the diagnosis of spinal muscular atrophy-government policies aimed at stimulating segment development are supposed to be a reason for the high demand for DBS tests as a very popular newborn screening option. Another reason makes DBS tests a very popular choice for newborn screening: they are cheap, barely invasive, and easy to use.
The escalating birth defects of infants' congenital hearing impairments are predicted to drive the hearing screens segment during the forecast period to a high compound annual growth rate. As per a 2023 study carried out by the University of Manchester, among every 1000 babies born in the UK, one suffered from birth impairment, hearing. Increased awareness among parents and healthcare providers about the need for early identification and intervention is anticipated to fuel sector expansion. Industry growth can be attributed to technological advancement in regard to hearing screening through automated auditory brainstem response (AABR) and otoacoustic emission (OAE), which makes it possible to accurately and promptly diagnose hearing impairments in babies.
Global Newborn Screening Market By Product
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Newborn Screening Market Regional Insights
Asia Pacific had the highest share of 32.90% in the newborn screening market. This leadership is due to new growth prospects along with better healthcare services and infrastructure. The demand for newborn screening techniques is a result of a high birth rate, dense population, and rising incidence of congenital disorders in the region. Government programs and spending on healthcare facilities are forecast to push the market further. The Asia Pacific is expected to grow at the fastest rate, followed by countries such as China and India that are setting benchmarks for advanced newborn screening techniques.
The increasing birth defect prevalence and widespread screening in each state across the union are expected to drive the growth in North America at an extra-ordinary compounded annual growth rate (CAGR) in the next years. Every newborn is screened for birth defects through universal screening programs such as the Texas Newborn Screening Program, the California Newborn Screening Program, and the New York State Newborn Screening Program. This enforcement goes along with the advanced health care system and high parental awareness. Hence, this has resulted in a substantial market share in the region. North America is expected to gain more market share in the newborn screening market due to continued R&D in newborn screening technologies.
Global Newborn Screening Market By Geography
- Largest
- Fastest
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Newborn Screening Market Dynamics
Drivers
Growing Prevalence of Congenital Abnormalities
- The increasing prevalence of congenital abnormalities is said to be the primary cause for the rising trend of newborn screening. These kinds of congenital anomalies include genetic disorders, hearing impairment, and metabolic disorders. It is crucially important to diagnose such anomalies early because a proper intervention may sharply improve the quality of life and the desired outcome of the treatment for neonates suffering from these conditions. With the advancement of medical technology and an improved understanding of early advantages of diagnosis, the importance of screening programs is rising. As an increased awareness of congenital illnesses grows and more attention has been paid to it in recent years, the use of thorough screening techniques to better protect the health of newborns in their later years by identifying abnormalities before symptoms develop continues to be done with utmost interest.
Governmental Initiatives and Compulsory Screening Programs
- The governmental oversight of newborn screening programs such as those followed in the US helps increase adoptions. Governments requiring that all newborns be tested for a specific set of diseases encourage not only public education but also business development. Its adoption is desirable for governments in terms of savings made on long-term healthcare expenses and in increased chances of effective treatment through early identification of diseases. Widespread adoption is therefore fundamental to neonatal health preservation and, in turn, how early is vital to improving population health outcomes generally.
Restraints
Expensive Cost of Newborn Screening Tests
- The newborn screening tests are too costly, which makes them inaccessible, and this especially includes the low and middle-income nations. It means that the cost of conducting the most complex genetic test puts it out of reach for many of these families, and therefore they cannot access treatments that may be potentially lifesaving. This monetary limitation will delay the start of detection and treatment, which is bad for the health of the affected neonates. The disparity in the availability of the tests poses the opportunity for more accessible and cheaper screening programs with support networks, focused on equal early diagnostic services throughout the entire globe and infant health equality.
False Positive Results and Parental Stress
- Newborn screening tests can result in extreme worry and anxiety in parents if they return false positive results. Such outcomes can call for further tests and treatment, thus increasing the health care cost and making families emotionally vulnerable. The anxiety and confusion around a false-positive outcome may lead to parental mental stress or make the diagnosis process even tougher. By addressing these issues, test accuracy will have to be enhanced, and families should be given clear, useful information to empower them to understand the outcome and what follows. This will cut down the unproductive expenditure on hospital treatments and anxiety.
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Newborn Screening Market Competitive Landscape
The newborn screening market is highly competitive, dominated by the main manufacturers Abbott, Roche, and PerkinElmer, which have been at the forefront with wide screening panels and new modern methodologies of testing. Expanding due to increased awareness of genetic disorders, support programs from the government are emerging for early identification. New companies are trying digital health integration and rapid testing methods. Two major challenges are reimbursement rules and regulatory compliance. Congenital disorders are becoming increasingly common and drive the demand for more such drugs, indicating continued investment in R&D and strategic alliances with other big pharma companies.
Top Player’s Company Profiles
- Masimo Corp.
- Covidien Plc
- AB Sciex LLC
- Natus Medical Inc.
- Agilent Technologies Inc.
- PerkinElmer Inc.
- GE Healthcare
- Bio-Rad Laboratories Inc.
- Trivitron Healthcare
- Medtronic Inc.
- Rady Children's Institute for Genomic Medicine
- GE Lifesciences
- Waters Corporation
- Danaher Corporation
- Thermo Fisher Scientific Inc.
- VIVOSONIC
- ZIVAK TECHNOLOGIES
- CAMAG
- OTODYNAMICS
- ZENTECH
Recent Developments
- In January 2023, Masimo made public its new, high-tech baby monitoring system. Using this technology, which was recently introduced, caregivers can now view baby data in real time.
- In August 2022, Trivitron Healthcare set up a Centre of Excellence (CoE) for Metabolomics, Genomics, Newborn Screening, and Molecular Diagnostics in the AMTZ campus located in Vishakhapatnam, India. The CoE is well-equipped with the world's best R&D, manufacturing, and R&D capabilities.
- In June 2022, BeginNGS, which is the acronym for "beginnings" in short, is a diagnostic and precision medicine guidance tool that Rady Children's Institute for Genomic Medicine launched a program to advance and assess the scalability. This tool will screen about 400 diseases caused by genetics in newborns, for which there are known treatments, using rapid whole genome sequencing.
Newborn Screening Key Market Trends
- Advanced Genetic Testing Integration: There is probably no area where innovation in newborn screening has possibly brought about as significant a development as advanced genetic testing. This includes WGS and NGS, which enable the more accurate detection of an increasingly larger group of genetic disorders. These technologies can have more advanced screening through the complex and rare genetic disorders that may not be identified by traditional techniques. As technology advances, more comprehensive panels are now available because the cost of conducting genetic tests will continue to fall. This will enable earlier detection and with greater accuracy genetic abnormalities and improve the outcomes, hence expanding newborn screening programs.
- Global Expansion of Newborn Screening Program: Another growth factor is the increase of newborn screening programs globally, especially in previously unreached areas, most especially in low- and middle-income countries. Governments and international organizations now work harder to introduce or enhance screening programs across the globe as they become increasingly aware of how critical it is to identify certain conditions early for improved health care results. This growth will help ensure that all babies have the chance to participate in basic screening tests and reduce international health inequities. Increases are made possible through financing, international cooperation, and innovation in hand-held and affordable diagnostic tools. The spectrum of communities will benefit from a wide cross-section afforded equal chances for health care options and early lifesaving interventions.
Newborn Screening Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, due to technological advances in genetic testing and efforts globally to expand screening programs, the newborn screening market is changing very fast. Even new technologies such as next-generation sequencing, which currently enable a wider range of genetic abnormalities to be detected, set up better and more precise detection capabilities for early detection. While assuring that more babies have timely care, initiatives aimed at setting up and strengthening screening programs in deprived places keep improving global health equity. In these developments, as they envision better protection and quality of life among affected babies, there exists an immediate need for sustained innovation and availability of newborn screening to everybody.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 1.25 Billion |
| Market size value in 2031 | USD 2.12 Billion |
| Growth Rate | 6.8% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Newborn Screening Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Newborn Screening Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Newborn Screening Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Newborn Screening Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Newborn Screening Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Newborn Screening Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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