Newborn Screening Market
PUBLISHED: 2024 ID: SMRC24629
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Newborn Screening Market

Newborn Screening Market Forecasts to 2030 - Global Analysis By Product (Instruments, Consumables, Hearing Screening Instruments and Pulse Oximeters), Test (Hearing Screening Test, Dried Blood Spot Test, Critical Congenital Heart Defect (CCHD) Test and Other Tests), Technology, End User and By Geography

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4.3 (87 reviews)
Published: 2024 ID: SMRC24629

This report covers the impact of COVID-19 on this global market
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According to Stratistics MRC, the Global Newborn Screening Market is accounted for $1.15 billion in 2023 and is expected to reach $2.29 billion by 2030 growing at a CAGR of 10.3% during the forecast period. Newborn screening is a vital public health initiative that involves testing infants for serious, yet treatable, conditions shortly after birth. Typically conducted through a blood sample, it helps identify genetic, metabolic, and congenital disorders early on, allowing for prompt intervention and improved outcomes. The screening process varies by region but often includes tests for conditions like phenylketonuria, congenital hypothyroidism, and sickle cell disease. Early detection enables timely medical intervention, preventing or minimizing potential developmental issues, ensuring a healthier start for newborns.

According to the US CDC, during 2015–2017, the prevalence of newborn disorders was 34 per 10,000 live births in the US. Approximately 12,900 infants are expected to be identified each year with a disorder.

Market Dynamics: 

Driver: 

Rising prevalence of genetic disorders

Advances in genetic testing technologies have enabled early detection of various congenital conditions, prompting higher demand for newborn screening programs. Timely identification allows for prompt intervention and treatment, improving long-term outcomes for affected infants. This rising awareness of the importance of early detection in managing genetic disorders contributes to the expansion of the newborn screening market as healthcare systems prioritize comprehensive screening initiatives.

Restraint:

Ethical and legal concerns

In the newborn screening, ethical concerns revolve around issues such as consent, privacy, and the potential psychological impact on families. Legal constraints include varying regulations across jurisdictions, data protection laws, and the need for clear guidelines on the storage and use of genetic information. Parents may grapple with the dilemma of making informed decisions for their infants. Privacy breaches and misuse of genetic data raise concerns about confidentiality. Therefore, this element hinders the market expansion.

Opportunity:

Development & adoption of point-of-care testing solutions

The development and widespread adoption of point-of-care testing solutions offer timely and convenient diagnostic capabilities, enabling healthcare professionals to quickly assess newborns for various conditions. The shift towards point-of-care testing enhances accessibility, reduces turnaround times, and improves overall screening efficiency. This trend not only meets the growing demand for early and accurate diagnoses but also contributes to better healthcare outcomes for newborns, fostering advancements in the newborn screening.

Threat:

Stigma and discrimination

Stigma and discrimination pose significant threats to newborn screening programs, deterring parents from participating due to fear of labeling or communal judgment. Families with affected infants may face societal bias, isolation, and misconceptions about their child's condition. This can lead to emotional distress and hinder open discussions about the screening process. Discrimination may also result in limited access to support services, exacerbating the burden on affected families.

Covid-19 Impact

The covid-19 pandemic has affected the newborn screening market by disrupting healthcare systems, delaying routine screenings, and diverting resources to pandemic-related priorities. Access to newborn screening services has been limited, potentially leading to delays in early detection of certain disorders. Additionally, the pandemic has underscored the importance of resilient healthcare infrastructure to ensure the continuity of essential services, including newborn screening, in the face of global health crises. Moreover, the post-pandemic era has spurred advancements in the newborn screening market and contributed to the overall improvement of pediatric healthcare outcomes.

The dried blood spot segment is expected to be the largest during the forecast period

The dried blood spot segment is estimated to have a lucrative growth, due to its minimally invasive methods. Small blood drops are collected on filter paper, dried, and then analyzed for various metabolic, genetic, and endocrine disorders. This cost-effective and convenient screening approach allows for early detection of conditions such as phenylketonuria and hypothyroidism. DBS testing facilitates timely intervention, contributing to improved outcomes for affected newborns while providing an efficient and accessible means for population-wide screening programs.

The clinical laboratories segment is expected to have the highest CAGR during the forecast period

The clinical laboratories segment is anticipated to witness the highest CAGR growth during the forecast period. Newborn screening plays a pivotal role in clinical laboratories by detecting inherited disorders early in a child's life. Timely results enable prompt medical interventions, preventing irreversible damage and improving outcomes. As a cornerstone of preventive medicine, it facilitates the early management of treatable conditions, showcasing the indispensable role of clinical laboratories in safeguarding the health of newborns through efficient and accurate screening processes.

Region with largest share:

Asia Pacific is projected to hold the largest market share during the forecast period owing to the high population density, higher birth rate, and soaring prevalence of congenital diseases. Ethical considerations, cultural sensitivities, and variations in regulatory frameworks influence the implementation of screening initiatives in the region. Factors such as improving infrastructure and healthcare plans and the availability of new opportunities for expansion are expected to play a major role in driving industry demand over the forecast period.

Region with highest CAGR:

North America is projected to have the highest CAGR over the forecast period, owing to the growing prevalence of congenital disorders and awareness programmes. United States has the major share the region’s market. In the United States, every newborn is screened post-birth, and this screening is performed by the analysis of diagnostic markers in blood spots collected on filter paper on the second day of an infant's life. Further, the launch of new services and products in the region is expected to have a significant impact on the market.

Key players in the market

Some of the key players profiled in the Newborn Screening Market include Agilent Technologies Inc., Ab Sciex LLC, GE Healthcare, Covidien Plc, Bio-Rad Laboratories Inc., Natus Medical Incorporated, PerkinElmer India Pvt. Limited, Rady Children's Institute for Genomic Medicine, Waters Corporation, Trivitron Healthcare, Masimo Corporation, Zivak Technologies, MP Biomedicals, DRG International, Regis Technologies, Parseq Lab, Zentech, Danaher Corporation, Hill-Rom Holdings Inc. and Thermo Fisher Scientific.

Key Developments:

In April 2023, Thermo Fisher Scientific launched the first of 37 CE-IVD-marked real-time PCR assay kits, mostly for infectious diseases, that it plans to roll out this year, providing users of its QuantStudio Dx series of instruments with a menu of company-branded test kits for the first time.

In August 2022, Trivitron Healthcare launched a Centre of Excellence (CoE) with state-of-the-art research and development and manufacturing facilities at AMTZ Campus, Vishakhapatnam, India, for metabolomics, genomics, newborn screening, and molecular diagnostics.

In June 2022, Rady Children's Institute for Genomic Medicine launched a program to advance and evaluate the scalability of a diagnostic and precision medicine guidance tool called BeginNGS (pronounced 'beginnings') to screen newborns for approximately 400 genetic diseases that have known treatment options using rapid whole genome sequencing. 

Products Covered:
• Instruments
• Consumables
• Hearing Screening Instruments
• Pulse oximeters

Tests Covered:
• Hearing Screening Test
• Dried Blood Spot Test
• Critical Congenital Heart Defect (CCHD) Test
• Other Tests

Technologies Covered:
• Gel Electrophoresis
• Tandem Mass Spectrometry
• Enzyme Based Assays
• DNA Assays
• Fluorescence
• Other Technologies

End Users Covered:
• Hospitals
• Clinical Laboratories

Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan        
o China        
o India        
o Australia  
o New Zealand
o South Korea
o Rest of Asia Pacific    
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa 
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings: 
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
o Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary          
            
2 Preface           
 2.1 Abstract          
 2.2 Stake Holders         
 2.3 Research Scope         
 2.4 Research Methodology        
  2.4.1 Data Mining        
  2.4.2 Data Analysis        
  2.4.3 Data Validation        
  2.4.4 Research Approach        
 2.5 Research Sources         
  2.5.1 Primary Research Sources       
  2.5.2 Secondary Research Sources       
  2.5.3 Assumptions        
            
3 Market Trend Analysis         
 3.1 Introduction         
 3.2 Drivers          
 3.3 Restraints         
 3.4 Opportunities         
 3.5 Threats          
 3.6 Product Analysis         
 3.7 Technology Analysis        
 3.8 End User Analysis         
 3.9 Emerging Markets         
 3.10 Impact of Covid-19         
            
4 Porters Five Force Analysis         
 4.1 Bargaining power of suppliers        
 4.2 Bargaining power of buyers        
 4.3 Threat of substitutes        
 4.4 Threat of new entrants        
 4.5 Competitive rivalry         
            
5 Global Newborn Screening Market, By Product       
 5.1 Introduction         
 5.2 Instruments         
  5.2.1 Shakers         
  5.2.2 Disorder Screening Instruments      
  5.2.3 Incubator         
 5.3 Consumables         
  5.3.1 Columns & Screening Cards       
  5.3.2 Assay kits & Reagents       
 5.4 Hearing Screening Instruments       
  5.4.1 Accessories        
  5.4.2 Devices         
 5.5 Pulse Oximeters         
            
6 Global Newborn Screening Market, By Test       
 6.1 Introduction         
 6.2 Hearing Screening Test        
 6.3 Dried Blood Spot Test        
 6.4 Critical Congenital Heart Defect (CCHD) Test      
 6.5 Other Tests         
            
7 Global Newborn Screening Market, By Technology       
 7.1 Introduction         
 7.2 Gel Electrophoresis         
 7.3 Tandem Mass Spectrometry        
 7.4 Enzyme Based Assays        
 7.5 DNA Assays         
 7.6 Fluorescence         
 7.7 Other Technologies         
            
8 Global Newborn Screening Market, By End User       
 8.1 Introduction         
 8.2 Hospitals          
 8.3 Clinical Laboratories         
            
9 Global Newborn Screening Market, By Geography       
 9.1 Introduction         
 9.2 North America         
  9.2.1 US         
  9.2.2 Canada         
  9.2.3 Mexico         
 9.3 Europe          
  9.3.1 Germany         
  9.3.2 UK         
  9.3.3 Italy         
  9.3.4 France         
  9.3.5 Spain         
  9.3.6 Rest of Europe        
 9.4 Asia Pacific         
  9.4.1 Japan         
  9.4.2 China         
  9.4.3 India         
  9.4.4 Australia         
  9.4.5 New Zealand        
  9.4.6 South Korea        
  9.4.7 Rest of Asia Pacific        
 9.5 South America         
  9.5.1 Argentina        
  9.5.2 Brazil         
  9.5.3 Chile         
  9.5.4 Rest of South America       
 9.6 Middle East & Africa        
  9.6.1 Saudi Arabia        
  9.6.2 UAE         
  9.6.3 Qatar         
  9.6.4 South Africa        
  9.6.5 Rest of Middle East & Africa       
            
10 Key Developments          
 10.1 Agreements, Partnerships, Collaborations and Joint Ventures     
 10.2 Acquisitions & Mergers        
 10.3 New Product Launch        
 10.4 Expansions         
 10.5 Other Key Strategies        
            
11 Company Profiling          
 11.1 Agilent Technologies Inc.        
 11.2 Ab Sciex LLC         
 11.3 GE Healthcare         
 11.4 Covidien Plc         
 11.5 Bio-Rad Laboratories Inc.        
 11.6 Natus Medical Incorporated        
 11.7 PerkinElmer India Pvt. Limited        
 11.8 Rady Children's Institute for Genomic Medicine      
 11.9 Waters Corporation         
 11.10 Trivitron Healthcare         
 11.11 Masimo Corporation        
 11.12 Zivak Technologies         
 11.13 MP Biomedicals         
 11.14 DRG International         
 11.15 Regis Technologies         
 11.16 Parseq Lab         
 11.17 Zentech          
 11.18 Danaher Corporation        
 11.19 Hill-Rom Holdings Inc.        
 11.20 Thermo Fisher Scientific        
            
List of Tables           
1 Global Newborn Screening Market Outlook, By Region (2021-2030) ($MN)    
2 Global Newborn Screening Market Outlook, By Product (2021-2030) ($MN)    
3 Global Newborn Screening Market Outlook, By Instruments (2021-2030) ($MN)    
4 Global Newborn Screening Market Outlook, By Shakers (2021-2030) ($MN)    
5 Global Newborn Screening Market Outlook, By Disorder Screening Instruments (2021-2030) ($MN)  
6 Global Newborn Screening Market Outlook, By Incubator (2021-2030) ($MN)    
7 Global Newborn Screening Market Outlook, By Consumables (2021-2030) ($MN)    
8 Global Newborn Screening Market Outlook, By Columns & Screening Cards (2021-2030) ($MN)  
9 Global Newborn Screening Market Outlook, By Assay kits & Reagents (2021-2030) ($MN)   
10 Global Newborn Screening Market Outlook, By Hearing Screening Instruments (2021-2030) ($MN)  
11 Global Newborn Screening Market Outlook, By Accessories (2021-2030) ($MN)    
12 Global Newborn Screening Market Outlook, By Devices (2021-2030) ($MN)    
13 Global Newborn Screening Market Outlook, By Pulse Oximeters (2021-2030) ($MN)   
14 Global Newborn Screening Market Outlook, By Test (2021-2030) ($MN)     
15 Global Newborn Screening Market Outlook, By Hearing Screening Test (2021-2030) ($MN)   
16 Global Newborn Screening Market Outlook, By Dried Blood Spot Test (2021-2030) ($MN)   
17 Global Newborn Screening Market Outlook, By Critical Congenital Heart Defect (CCHD) Test (2021-2030) ($MN) 
18 Global Newborn Screening Market Outlook, By Other Tests (2021-2030) ($MN)    
19 Global Newborn Screening Market Outlook, By Technology (2021-2030) ($MN)    
20 Global Newborn Screening Market Outlook, By Gel Electrophoresis (2021-2030) ($MN)   
21 Global Newborn Screening Market Outlook, By Tandem Mass Spectrometry (2021-2030) ($MN)  
22 Global Newborn Screening Market Outlook, By Enzyme Based Assays (2021-2030) ($MN)   
23 Global Newborn Screening Market Outlook, By DNA Assays (2021-2030) ($MN)    
24 Global Newborn Screening Market Outlook, By Fluorescence (2021-2030) ($MN)    
25 Global Newborn Screening Market Outlook, By Other Technologies (2021-2030) ($MN)   
26 Global Newborn Screening Market Outlook, By End User (2021-2030) ($MN)    
27 Global Newborn Screening Market Outlook, By Hospitals (2021-2030) ($MN)    
28 Global Newborn Screening Market Outlook, By Clinical Laboratories (2021-2030) ($MN)   
            
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.

List of Figures

RESEARCH METHODOLOGY


Research Methodology

We at Stratistics opt for an extensive research approach which involves data mining, data validation, and data analysis. The various research sources include in-house repository, secondary research, competitor’s sources, social media research, client internal data, and primary research.

Our team of analysts prefers the most reliable and authenticated data sources in order to perform the comprehensive literature search. With access to most of the authenticated data bases our team highly considers the best mix of information through various sources to obtain extensive and accurate analysis.

Each report takes an average time of a month and a team of 4 industry analysts. The time may vary depending on the scope and data availability of the desired market report. The various parameters used in the market assessment are standardized in order to enhance the data accuracy.

Data Mining

The data is collected from several authenticated, reliable, paid and unpaid sources and is filtered depending on the scope & objective of the research. Our reports repository acts as an added advantage in this procedure. Data gathering from the raw material suppliers, distributors and the manufacturers is performed on a regular basis, this helps in the comprehensive understanding of the products value chain. Apart from the above mentioned sources the data is also collected from the industry consultants to ensure the objective of the study is in the right direction.

Market trends such as technological advancements, regulatory affairs, market dynamics (Drivers, Restraints, Opportunities and Challenges) are obtained from scientific journals, market related national & international associations and organizations.

Data Analysis

From the data that is collected depending on the scope & objective of the research the data is subjected for the analysis. The critical steps that we follow for the data analysis include:

  • Product Lifecycle Analysis
  • Competitor analysis
  • Risk analysis
  • Porters Analysis
  • PESTEL Analysis
  • SWOT Analysis

The data engineering is performed by the core industry experts considering both the Marketing Mix Modeling and the Demand Forecasting. The marketing mix modeling makes use of multiple-regression techniques to predict the optimal mix of marketing variables. Regression factor is based on a number of variables and how they relate to an outcome such as sales or profits.


Data Validation

The data validation is performed by the exhaustive primary research from the expert interviews. This includes telephonic interviews, focus groups, face to face interviews, and questionnaires to validate our research from all aspects. The industry experts we approach come from the leading firms, involved in the supply chain ranging from the suppliers, distributors to the manufacturers and consumers so as to ensure an unbiased analysis.

We are in touch with more than 15,000 industry experts with the right mix of consultants, CEO's, presidents, vice presidents, managers, experts from both supply side and demand side, executives and so on.

The data validation involves the primary research from the industry experts belonging to:

  • Leading Companies
  • Suppliers & Distributors
  • Manufacturers
  • Consumers
  • Industry/Strategic Consultants

Apart from the data validation the primary research also helps in performing the fill gap research, i.e. providing solutions for the unmet needs of the research which helps in enhancing the reports quality.


For more details about research methodology, kindly write to us at info@strategymrc.com

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