Summary

Newborn screening is a public health program designed to identify genetic, metabolic, and congenital disorders in newborns shortly after birth. Through a series of tests, such as blood spot tests, hearing tests, and pulse oximetry, healthcare providers can detect conditions that may not be immediately apparent but could lead to serious health issues if untreated. Early detection allows for timely interventions, improving the chances of preventing disabilities or life-threatening complications. The global newborn screening market value in 2023 stood at US$1.24 billion, and is likely to reach US$2.16 billion by 2029.

The newborn screening market has experienced significant growth over the years primarily due to advancements in screening technologies. Innovations like tandem mass spectrometry, DNA assays, and pulse oximetry have significantly improved the accuracy, speed, and range of conditions that can be detected in newborns. These advancements allow for earlier and more reliable diagnoses, which can lead to timely interventions and better health outcomes, ultimately driving the demand for advanced screening tools and equipment in hospitals and government mandates for mandatory screening programs, and growing awareness about the importance of early diagnosis and treatment, have further propelled market growth. Other significant trends including AI and machine learning based newborn screening, point-of-care testing, advances in genomic and molecular technologies, expansion of screening panels, emerging markets, telehealth expansion etc. are expected to drive market growth further. The global newborn screening market value is projected to grow at a CAGR of 9.86%, during the forecast period of 2024-2029.

Market Segmentation Analysis:

By Product: According to the report, the global newborn screening market is bifurcated into two segments based on product type: Instruments and Reagents and assays. Instruments segment acquired majority of share in the market in 2023 and is expected to grow the fastest during forecasted period due to the growing adoption of advanced diagnostic equipment and technologies, which enable faster, more accurate, and comprehensive testing for multiple disorders in newborns. Additionally, continuous innovation in screening devices has increased their usage in hospitals and diagnostic labs.

The global newborn screening instruments market is further bifurcated into four segments: newborn disorder screening instruments, pulse oximeters, newborn hearing screening instruments, and other instruments. Newborn disorder screening instruments acquired majority of the share in 2023 and is expected to growth the fastest as well. The global newborn screening reagents and assays market is further bifurcated into two segments: Immunoassay and Enzymatic Assays and DNA-Based Assays. Immunoassay and Enzymatic Assays acquired majority of the share in 2023 and is expected to growth the fastest as well.

By Technology: According to the report, the global newborn screening market is bifurcated into six technologies: tandem mass spectrometry, pulse oximetry screening technology, immunoassays and enzymatic assays, DNA assays, electrophoresis and others. Tandem mass spectrometry segment acquired majority of share in the market in 2023 due to its ability to screen for multiple disorders simultaneously with high precision and speed. Its effectiveness in detecting metabolic and genetic conditions early in newborns has made it a preferred technology in hospitals and diagnostic labs globally. While, immunoassays and enzymatic assays are expected to be the fastest-growing segment due to their increasing use in detecting specific metabolic and genetic disorders with high sensitivity and specificity. The growing demand for targeted, disease-specific screening and the expanding range of conditions they can detect contribute to their rapid adoption in newborn screening programs.

By Test Type: According to the report, the global newborn screening market is bifurcated into four types of tests: dry blood spot test, critical congenital heart diseases (CCHD) test, hearing screen test, and others. Dry blood spot test segment acquired majority of share in the market in 2023 is expected to grow at the fastest CAGR during forecasted period, due to its ability to screen for a wide range of disorders from a single, minimally invasive sample. This test is cost-effective, easy to collect, transport, and store, making it ideal for large-scale screening programs, particularly in resource-limited settings. Additionally, its role in early detection of life-threatening conditions enhances its appeal, driving increased adoption across healthcare systems worldwide.

By End-user: The report further bifurcates the market into two end-users: hospitals and clinics and diagnostic labs. Hospitals and clinics segment acquired majority of share in the market in 2023 and is expected to grow fastest due to the centralized role they play in newborn care. Hospitals and clinics are the primary points for childbirth and immediate postnatal care, making them key locations for initial screenings. Additionally, the increasing number of births, coupled with government-mandated screening programs conducted in hospitals, has led to higher adoption of screening technologies and equipment in these settings, driving growth in this segment.

By Region: The report provides insight into the Newborn Screening market based on the geographical operations, namely, North America, Europe, Asia Pacific, and rest of the world. North America Newborn Screening market enjoyed the highest market share in 2023 due to well-established healthcare infrastructure, mandatory newborn screening programs across most states, and significant government support for early diagnosis of congenital disorders. Additionally, the presence of advanced screening technologies, high healthcare spending, and widespread awareness of the importance of early detection among healthcare professionals and parents further fueled the market’s dominance in the region.

While, Asia Pacific region has been experiencing the fastest growth in the global newborn screening market due to increasing birth rates, growing awareness about the importance of early diagnosis, and expanding government initiatives to implement mandatory screening programs in countries like China and India. Additionally, improvements in healthcare infrastructure, rising disposable incomes, and a growing demand for advanced diagnostic technologies in emerging economies have driven the rapid adoption of newborn screening across the region.

Global Newborn Screening Market Dynamics:

Growth Drivers: The rising burden of congenital diseases is a significant driver of growth in the global newborn screening market. As the prevalence of genetic and metabolic disorders increases, there is a heightened demand for early detection and intervention to improve patient outcomes and reduce long-term healthcare costs. Newborn screening programs enable early identification of these conditions, allowing for timely treatment and management that can prevent severe health issues and enhance quality of life. This growing need for early diagnosis is fueling the expansion of screening programs and the adoption of advanced technologies worldwide. Other factors driving the growth of global newborn screening market include rising birth rates and population growth, upsurge in healthcare expenditure, government initiatives and mandatory screening programs, increased awareness and education etc.

Challenges: Lack of standardization poses a significant challenge to the global newborn screening market by creating inconsistencies in screening practices and outcomes across different regions and healthcare systems. Variations in the types of tests used, protocols followed, and quality control measures can lead to disparities in the accuracy and reliability of screening results. This lack of uniformity not only affects the effectiveness of early disease detection but also complicates data comparison and analysis on a global scale, hindering the development of universally effective screening programs and potentially impacting patient outcomes. Other challenge might include regulatory hurdles.

Trends: Point-of-care testing is emerging as a key future trend in the global newborn screening market due to its potential to enhance the speed and convenience of testing. This approach involves conducting diagnostic tests at or near the location of patient care, such as in hospitals or clinics, rather than sending samples to centralized laboratories. By providing immediate results, point-of-care testing can facilitate quicker decision-making and earlier intervention, which is crucial for effective newborn screening. This trend is driven by advancements in technology that enable more compact, user-friendly devices and a growing emphasis on improving healthcare accessibility and efficiency. The market is also projected to grow at a fast pace during the forecast period, due to various other latest trends such as AI and machine learning based newborn screening, advances in genomic and molecular technologies, expansion of screening panels, emerging markets, telehealth expansion etc.

Impact Analysis of COVID-19 and Way Forward:

The COVID-19 pandemic disrupted the global newborn screening market by causing delays in screening services due to lockdowns, limited hospital access, and resource reallocation. However, the growing awareness of the importance of early diagnosis and healthcare resilience during the pandemic has spurred demand for improved screening technologies and home-based screening options, driving market recovery post-pandemic.

Competitive Landscape and Recent Developments:

The global newborn screening market is fragmented catering to domestic and international demand. Players operating in the global newborn screening market focus on providing high-quality products to fulfill customer demand. They also focus on strategies such as investments in research and development activities, new product launches, and expanding production capacities. Key players of global newborn screening market are:

Agilent Technologies Inc
Revvity Inc.
Waters Corporation
Bio-Rad Laboratories Inc.
Masimo Corporation
Medtronic plc
LifeCell International Pvt. Ltd.
Zentech
Trivitron Healthcare
MRC Holland
Natus Medical Incorporated
Baebies Inc.

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Table of Contents

1. Executive Summary

2. Introduction

2.1 Newborn Screening: An Overview
2.1.1 Definition of Newborn Screening
2.1.2 Continuous Benefits and Importance of Newborn Screening

2.2 Newborn Screening Segmentation: An Overview
2.2.1 Newborn Screening Segmentation

3. Global Market Analysis

3.1 Global Newborn Screening Market: An Analysis

3.1.1 Global Newborn Screening Market: An Overview
3.1.2 Global Newborn Screening Market by Value
3.1.3 Global Newborn Screening Market by Product
3.1.4 Global Newborn Screening Market by Technology
3.1.5 Global Newborn Screening Market by Test Type
3.1.6 Global Newborn Screening Market by End User
3.1.7 Global Newborn Screening Market by Region

3.2 Global Newborn Screening Market: Product Analysis

3.2.1 Global Newborn Screening Market by Product: An Overview
3.2.2 Global Newborn Screening Instruments Market by Value
3.2.3 Global Newborn Screening Instruments Market by Product
3.2.4 Global Newborn Screening Instruments Market Product by Value
3.2.5 Global Newborn Screening Reagents and Assays Market by Value
3.2.6 Global Newborn Screening Reagents & Assays Market by Product
3.2.7 Global Newborn Screening Reagents and Assays Market Product by Value

3.3 Global Newborn Screening Market: Technology Analysis

3.3.1 Global Newborn Screening Market by Technology: An Overview
3.3.2 Global Tandem Mass Spectrometry Newborn Screening Market by Value
3.3.3 Global Pulse Oximetry Newborn Screening Market by Value
3.3.4 Global Immunoassays and Enzymatic Assays Newborn Screening Market by Value
3.3.5 Global DNA Assays Newborn Screening Market by Value
3.3.6 Global Electrophoresis Newborn Screening Market by Value
3.3.7 Global Others Newborn Screening Market by Value

3.4 Global Newborn Screening Market: Test Type Analysis

3.4.1 Global Newborn Screening Market by Test Type: An Overview
3.4.2 Global Dry Blood Spot Newborn Screening Market by Value
3.4.3 Global Critical Congenital Heart Diseases (CCHD) Newborn Screening Market by Value
3.4.4 Global Hearing Newborn Screening Market by Value
3.4.5 Global Others Newborn Screening Market by Value

3.5 Global Newborn Screening Market: End User Analysis

3.5.1 Global Newborn Screening Market by End User: An Overview
3.5.2 Global Hospitals and Clinics Newborn Screening Market by Value
3.5.3 Global Diagnostic Labs Newborn Screening Market by Value

4. Regional Market Analysis

4.1 North America Newborn Screening Market: An Analysis

4.1.1 North America Newborn Screening Market: An Overview
4.1.2 North America Newborn Screening Market by Value
4.1.3 North America Newborn Screening Market by Region
4.1.4 The US Newborn Screening Market by Value
4.1.5 The US Newborn Screening Market Product by Value
4.1.6 The US Newborn Screening Instruments Market by Product
4.1.7 The US Newborn Screening Reagents and Assays Market by Product
4.1.8 The US Newborn Screening Market Test Type by Value
4.1.9 Canada Newborn Screening Market by Value
4.1.10 Mexico Newborn Screening Market by Value

4.2 Europe Newborn Screening Market: An Analysis

4.2.1 Europe Newborn Screening Market: An Overview
4.2.2 Europe Newborn Screening Market by Value
4.2.3 Europe Newborn Screening Market by Region
4.2.4 Germany Newborn Screening Market by Value
4.2.5 United Kingdom Newborn Screening Market by Value
4.2.6 France Newborn Screening Market by Value
4.2.7 Italy Newborn Screening Market by Value
4.2.8 Spain Newborn Screening Market by Value
4.2.9 Rest of Europe Newborn Screening Market by Value

4.3 Asia Pacific Newborn Screening Market: An Analysis

4.3.1 Asia Pacific Newborn Screening Market: An Overview
4.3.2 Asia Pacific Newborn Screening Market by Value
4.3.3 Asia Pacific Newborn Screening Market by Region
4.3.4 China Newborn Screening Market by Value
4.3.5 Japan Newborn Screening Market by Value
4.3.6 India Newborn Screening Market by Value
4.3.7 South Korea Newborn Screening Market by Value
4.3.8 Rest of Asia Pacific Newborn Screening Market by Value

4.4 Rest of the World Newborn Screening Market: An Analysis

4.4.1 Rest of the World Newborn Screening Market: An Overview
4.4.2 Rest of the World Newborn Screening Market by Value

5. Impact of COVID-19

5.1 Impact of COVID-19 on Global Newborn Screening Market
5.2 Post COVID-19 Impact on Global Newborn Screening Market

6. Market Dynamics

6.1 Growth Drivers
6.1.1 Rising Birth Rates and Population Growth
6.1.2 Upsurge in Healthcare Expenditure
6.1.3 Rising Burden of Congenital Diseases
6.1.4 Government Initiatives and Mandatory Screening Programs
6.1.5 Increased Awareness and Education

6.2 Challenges
6.2.1 Lack of Standardization
6.2.2 Regulatory Hurdles

6.3 Market Trends
6.3.1 Artificial Intelligence and Machine Learning Based Newborn Screening
6.3.2 Point-of-Care Testing (POCT)
6.3.3 Advances in Genomic and Molecular Technologies
6.3.4 Expansion of Screening Panels
6.3.5 Growth in Emerging Markets
6.3.6 Telehealth Expansion

7. Competitive Landscape

7.1 Global Newborn Screening Market: Recent Developments
7.2 Global Newborn Screening Market Players: Product Comparison

8. Company Profiles

8.1 Agilent Technologies, Inc.
8.1.1 Business Overview
8.1.2 Operating Segments
8.1.3 Business Strategy

8.2 Revvity, Inc.
8.2.1 Business Overview
8.2.2 Operating Segments
8.2.3 Business Strategy

8.3 Waters Corporation
8.3.1 Business Overview
8.3.2 Operating Segments
8.3.3 Business Strategy

8.4 Bio-Rad Laboratories, Inc.
8.4.1 Business Overview
8.4.2 Operating Segments
8.4.3 Business Strategy

8.5 Masimo Corporation
8.5.1 Business Overview
8.5.2 Operating Segments
8.5.3 Business Strategy

8.6 Medtronic plc
8.6.1 Business Overview
8.6.2 Operating Segments
8.6.3 Business Strategy

8.7 LifeCell International Pvt. Ltd.
8.7.1 Business Overview
8.7.2 Business Strategy

8.8 Zentech
8.8.1 Business Overview
8.8.2 Business Strategy

8.9 Trivitron Healthcare
8.9.1 Business Overview
8.9.2 Business Strategy

8.10 MRC Holland
8.10.1 Business Overview
8.10.2 Business Strategy

8.11 Natus Medical Incorporated
8.11.1 Business Overview

8.12 Baebies, Inc.
8.12.1 Business Overview

List of Figures

Figure 1: Continuous Benefits and Importance of Newborn Screening
Figure 2: Newborn Screening Segmentation
Figure 3: Global Newborn Screening Market by Value; 2019-2023 (US$ Billion)
Figure 4: Global Newborn Screening Market by Value; 2024-2029 (US$ Billion)
Figure 5: Global Newborn Screening Market by Product; 2023 (Percentage, %)
Figure 6: Global Newborn Screening Market by Technology; 2023 (Percentage, %)
Figure 7: Global Newborn Screening Market by Test Type; 2023 (Percentage, %)
Figure 8: Global Newborn Screening Market by End User; 2023 (Percentage, %)
Figure 9: Global Newborn Screening Market by Region; 2023 (Percentage, %)
Figure 10: Global Newborn Screening Instruments Market by Value; 2019: 2023 (US$ Million)
Figure 11: Global Newborn Screening Instruments Market by Value; 2024-2029 (US$ Billion)
Figure 12: Global Newborn Screening Instruments Market by Product; 2023 (Percentage, %)
Figure 13: Global Newborn Screening Instruments Market Product by Value; 2019-2023 (US$ Million)
Figure 14: Global Newborn Screening Instruments Market Product by Value; 2024-2029 (US$ Million)
Figure 15: Global Newborn Screening Reagents and Assays Market by Value; 2019-2023 (US$ Million)
Figure 16: Global Newborn Screening Reagents and Assays Market by Value; 2024-2029 (US$ Million)
Figure 17: Global Newborn Screening Reagents & Assays Market by Product; 2023 (Percentage, %)
Figure 18: Global Newborn Screening Reagents and Assays Market Product by Value; 2019-2023 (US$ Million)
Figure 19: Global Newborn Screening Reagents and Assays Market Product by Value; 2024-2029 (US$ Million)
Figure 20: Global Tandem Mass Spectrometry Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 21: Global Tandem Mass Spectrometry Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 22: Global Pulse Oximetry Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 23: Global Pulse Oximetry Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 24: Global Immunoassays and Enzymatic Assays Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 25: Global Immunoassays and Enzymatic Assays Newborn Screening Market by Value; 2024: 2029 (US$ Million)
Figure 26: Global DNA Assays Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 27: Global DNA Assays Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 28: Global Electrophoresis Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 29: Global Electrophoresis Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 30: Global Others Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 31: Global Others Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 32: Global Dry Blood Spot Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 33: Global Dry Blood Spot Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 34: Global Critical Congenital Heart Diseases (CCHD) Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 35: Global Critical Congenital Heart Diseases (CCHD) Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 36: Global Hearing Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 37: Global Hearing Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 38: Global Others Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 39: Global Others Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 40: Global Hospitals and Clinics Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 41: Global Hospitals and Clinics Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 42: Global Diagnostic Labs Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 43: Global Diagnostic Labs Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 44: North America Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 45: North America Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 46: North America Newborn Screening Market by Region; 2023 (Percentage, %)
Figure 47: The US Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 48: The US Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 49: The US Newborn Screening Market Product by Value; 2023-2029 (US$ Million)
Figure 50: The US Newborn Screening Instruments Market by Product; 2023 (Percentage, %)
Figure 51: The US Newborn Screening Reagents and Assays Market by Product; 2023 (Percentage, %)
Figure 52: The US Newborn Screening Market Test Type by Value; 2023-2029 (US$ Million)
Figure 53: Canada Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 54: Canada Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 55: Mexico Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 56: Mexico Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 57: Europe Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 58: Europe Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 59: Europe Newborn Screening Market by Region; 2023 (Percentage, %)
Figure 60: Germany Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 61: Germany Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 62: United Kingdom Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 63: United Kingdom Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 64: France Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 65: France Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 66: Italy Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 67: Italy Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 68: Spain Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 69: Spain Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 70: Rest of Europe Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 71: Rest of Europe Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 72: Asia Pacific Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 73: Asia Pacific Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 74: Asia Pacific Newborn Screening Market by Region; 2023 (Percentage, %)
Figure 75: China Newborn Screening Market by Value, 2019-2023 (US$ Million)
Figure 76: China Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 77: Japan Newborn Screening Market by Value, 2019-2023 (US$ Million)
Figure 78: Japan Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 79: India Newborn Screening Market by Value, 2019-2023 (US$ Million)
Figure 80: India Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 81: South Korea Newborn Screening Market by Value, 2019-2023 (US$ Million)
Figure 82: South Korea Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 83: Rest of Asia Pacific Newborn Screening Market by Value, 2019-2023 (US$ Million)
Figure 84: Rest of Asia Pacific Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 85: Rest of the World Newborn Screening Market by Value; 2019-2023 (US$ Million)
Figure 86: Rest of the World Newborn Screening Market by Value; 2024-2029 (US$ Million)
Figure 87: Global Population; 2020-2024 (Billion)
Figure 88: The US National Health Expenditure Per Capita; 2020-2031 (US$ Thousand)
Figure 89: Global Artificial Intelligence (AI) in Healthcare Market; 2021-2030 (US$ Billion)
Figure 90: Agilent Technologies, Inc. Revenue by Segments; 2022 (Percentage, %)
Figure 91: Revvity, Inc. Revenue by Segments; 2023 (Percentage, %)
Figure 92: Waters Corp. Net Sales by Product; 2023 (Percentage, %)
Figure 93: Waters Corp. Net Sales by Service; 2023 (Percentage, %)
Figure 94: Bio: Rad Laboratories, Inc. Net Sales by Segments; 2023 (Percentage, %)
Figure 95: Masimo Corporation Revenue by Segments; 2023 (Percentage, %)
Figure 96: Medtronic plc Net Sales by Segment: 2023 (Percentage, %)
Table 1: Global Newborn Screening Market Players: Product Comparison; 2024