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 Ot

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


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


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
Table 1 Global Newborn Screening Market Outlook, By Region (2021-2030) ($MN)
Table 2 Global Newborn Screening Market Outlook, By Product (2021-2030) ($MN)
Table 3 Global Newborn Screening Market Outlook, By Instruments (2021-2030) ($MN)
Table 4 Global Newborn Screening Market Outlook, By Shakers (2021-2030) ($MN)
Table 5 Global Newborn Screening Market Outlook, By Disorder Screening Instruments (2021-2030) ($MN)
Table 6 Global Newborn Screening Market Outlook, By Incubator (2021-2030) ($MN)
Table 7 Global Newborn Screening Market Outlook, By Consumables (2021-2030) ($MN)
Table 8 Global Newborn Screening Market Outlook, By Columns & Screening Cards (2021-2030) ($MN)
Table 9 Global Newborn Screening Market Outlook, By Assay kits & Reagents (2021-2030) ($MN)
Table 10 Global Newborn Screening Market Outlook, By Hearing Screening Instruments (2021-2030) ($MN)
Table 11 Global Newborn Screening Market Outlook, By Accessories (2021-2030) ($MN)
Table 12 Global Newborn Screening Market Outlook, By Devices (2021-2030) ($MN)
Table 13 Global Newborn Screening Market Outlook, By Pulse Oximeters (2021-2030) ($MN)
Table 14 Global Newborn Screening Market Outlook, By Test (2021-2030) ($MN)
Table 15 Global Newborn Screening Market Outlook, By Hearing Screening Test (2021-2030) ($MN)
Table 16 Global Newborn Screening Market Outlook, By Dried Blood Spot Test (2021-2030) ($MN)
Table 17 Global Newborn Screening Market Outlook, By Critical Congenital Heart Defect (CCHD) Test (2021-2030) ($MN)
Table 18 Global Newborn Screening Market Outlook, By Other Tests (2021-2030) ($MN)
Table 19 Global Newborn Screening Market Outlook, By Technology (2021-2030) ($MN)
Table 20 Global Newborn Screening Market Outlook, By Gel Electrophoresis (2021-2030) ($MN)
Table 21 Global Newborn Screening Market Outlook, By Tandem Mass Spectrometry (2021-2030) ($MN)
Table 22 Global Newborn Screening Market Outlook, By Enzyme Based Assays (2021-2030) ($MN)
Table 23 Global Newborn Screening Market Outlook, By DNA Assays (2021-2030) ($MN)
Table 24 Global Newborn Screening Market Outlook, By Fluorescence (2021-2030) ($MN)
Table 25 Global Newborn Screening Market Outlook, By Other Technologies (2021-2030) ($MN)
Table 26 Global Newborn Screening Market Outlook, By End User (2021-2030) ($MN)
Table 27 Global Newborn Screening Market Outlook, By Hospitals (2021-2030) ($MN)
Table 28 Global Newborn Screening Market Outlook, By Clinical Laboratories (2021-2030) ($MN)
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook
Cookie Settings