신생아 스크리닝 시장 규모, 점유율, 동향 분석 리포트 : 제품별, 기술별, 검사 유형별, 지역별, 부문 예측(2025-2033년)

Newborn Screening Market Summary

The global newborn screening market size was estimated at USD 900.63 million in 2024 and is projected to reach USD 1,797.38 million by 2033, growing at a CAGR of 8.1% from 2025 to 2033. The rising neonatal population, increasing cases of congenital diseases in newborns, growing consumer awareness, and favorable initiatives & support from various governments, which are organizing several programs & legislations, are factors estimated to propel the market over the forecast period.

According to the United Nations Department of Economic and Social Affairs (UN DESA) World Population Prospects 2024, the global number of births remains high, with an estimated 132.4 million babies born worldwide in 2024. Moreover, according to the World Health Organization (WHO), congenital disorders - structural or functional anomalies that occur during intra-uterine life - affect an estimated 6% of all births worldwide. In a more detailed assessment, a global, regional, and national epidemiology study of congenital disabilities found that in 2021, about 31.64 million children (aged 0-14 years) were living with congenital disabilities, representing a 6.68% increase since 1990. In addition, technological advancements in screening methodologies are also expected to boost the market. For instance, in November 2023, Revvity, Inc. (US) launched its EONIS Q system, a CE-IVD declared platform enabling laboratories in countries that accept the CE marking to adopt molecular testing for spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns.

Furthermore, extensively increasing prevalence of congenital diseases in newborns is expected to have a positive impact on the newborn screening market growth. According to data published by WHO in February 2023, an estimated 240,000 newborns within 28 days of birth die each year globally due to congenital diseases. Congenital disorders are further responsible for an estimated 170, 000 child deaths in the age group of 1 month to 5 years. In addition, according to information from Indian Pediatrics, congenital hypothyroidism occurs in 2.1 out of every 1,000 infants in India, and the prevalence of inborn metabolic abnormalities ranges from 2 to 7.8%. Such a substantial occurrence of congenital diseases amongst newborns is likely to increase the adoption of tests, which is expected to accelerate the market growth by 2030.

In addition, the introduction of government programs and legislation is also expected to offer a favorable environment for newborn screening market growth. Programs around the globe bring newborn screening into the Genome Era. For instance, in 2023, an anticipated 100,000 infants participated in an NGS newborn screening pilot program. Illumina has participated in at least nine large-scale national and international genomic NBS investigations, screening up to 40,000 babies. This includes GUARDIAN in the U.S., Generation Study in the United Kingdom, BabyScreen+ in Australia, and BabyDetect in Belgium.

The demand for newborn procedures is expected to be influenced by the introduction of new technologies and the availability of treatment options enabling the diagnosis of about 29 possible disorders, such as galactosemia (GS), phenylketonuria (PKU), hearing disorders, and congenital hypothyroidism (CH) in neonates. In March 2023, a group of scientists at the Division of Laboratory Sciences, CDC, announced the introduction of improved tests that offer advanced technology for the diagnosis of genetic diseases.

Global Newborn Screening Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the newborn screening market based on product, technology, test type, and region:

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Instruments
• Reagents
• Technology Outlook (Revenue, USD Million, 2021 - 2033)
• Tandem mass spectrometry
• Pulse oximetry
• Enzyme based assay
• DNA assay
• Electrophoresis
• Others
• Test Type Outlook (Revenue, USD Million, 2021 - 2033)
• Dry blood spot test
• CCHD
• Hearing screen
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
  • South Korea
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Newborn Screening Market: Methodology and Scope

• 1.1. Market Segmentation and Scope
  • 1.1.1. Segment Definitions
    • 1.1.1.1. Product Method
    • 1.1.1.2. Technology Segment
    • 1.1.1.3. Test Type Segment
• 1.2. Regional Scope
• 1.3. Estimates and Forecast Timeline
• 1.4. Objectives
  • 1.4.1. Objective - 1
  • 1.4.2. Objective - 2
  • 1.4.3. Objective - 3
• 1.5. Research Methodology
• 1.6. Information Procurement
  • 1.6.1. Purchased Database
  • 1.6.2. GVR's Internal Database
  • 1.6.3. Secondary Sources
  • 1.6.4. Primary Research
• 1.7. Information or Data Analysis
  • 1.7.1. Data Analysis Models
• 1.8. Market Formulation & Validation
• 1.9. Model Details
  • 1.9.1. Commodity Flow Analysis
• 1.10. List of Secondary Sources
• 1.11. List of Abbreviations

Chapter 2. Newborn Screening Market: Executive Summary

• 2.1. Market Snapshot
• 2.2. Product Snapshot
• 2.3. Technology Snapshot
• 2.4. Test Type Snapshot
• 2.5. Competitive Landscape Snapshot

Chapter 3. Newborn Screening Market Variables, Trends, & Scope

• 3.1. Market Segmentation and Scope
• 3.2. Market Lineage Outlook
  • 3.2.1. Parent Market Outlook
  • 3.2.2. Related/Ancillary Market Outlook
• 3.3. Market Dynamics
• 3.4. Market Drivers Analysis
  • 3.4.1. Rising neonatal population
  • 3.4.2. Increasing cases of congenital diseases in newborns
  • 3.4.3. Growing consumer awareness, and favorable initiatives
  • 3.4.4. Support from various governments organizing several programs & legislations
• 3.5. Market Restraint Analysis
  • 3.5.1. High costs and limited accessibility
  • 3.5.2. Infrastructure and skilled workforce deficiencies
  • 3.5.3. Variations in screening practices
• 3.6. Porter's Five Forces Analysis
• 3.7. PESTLE Analysis
• 3.8. Pipeline Analysis

Chapter 4. Newborn Screening Market: Product Estimates & Trend Analysis

• 4.1. Newborn Screening Market: Product Movement Analysis
• 4.2. Instruments
  • 4.2.1. Instruments market, 2021 - 2033 (USD Million)
• 4.3. Reagents
  • 4.3.1. Reagents market, 2021 - 2033 (USD Million)

Chapter 5. Newborn Screening Market: Technology Estimates & Trend Analysis

• 5.1. Newborn Screening Market: Technology Movement Analysis
• 5.2. Tandem mass spectrometry
  • 5.2.1. Tandem mass spectrometry market, 2021 - 2033 (USD Million)
• 5.3. Pulse oximetry
  • 5.3.1. Pulse oximetry market, 2021 - 2033 (USD Million)
• 5.4. Enzyme based assay
  • 5.4.1. Enzyme based assays market, 2021 - 2033 (USD Million)
• 5.5. DNA assays
  • 5.5.1. DNA assays market, 2021 - 2033 (USD Million)
• 5.6. Electrophoresis
  • 5.6.1. Electrophoresis market, 2021 - 2033 (USD Million)

Chapter 6. Newborn Screening Market: Test Type Estimates & Trend Analysis

• 6.1. Newborn Screening Market: Test Type Movement Analysis
• 6.2. Dry blood spot test
  • 6.2.1. Dry blood spot test market, 2021 - 2033 (USD Million)
• 6.3. CCHD
  • 6.3.1. CCHD test market, 2021 - 2033 (USD Million)
• 6.4. Hearing screen
  • 6.4.1. Hearing screen test market, 2021 - 2033 (USD Million)

Chapter 7. Newborn Screening Market: Regional Business Analysis

• 7.1. Regional Market Snapshot
• 7.2. North America
  • 7.2.1. North America Newborn Screening Market Estimates and Forecast, 2021 - 2033 (USD Million)
  • 7.2.2. U.S.
    • 7.2.2.1. U.S. Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.2.2.2. Key Country Dynamics
    • 7.2.2.3. Regulatory Framework
    • 7.2.2.4. Reimbursement Scenario
    • 7.2.2.5. Competitive Scenario
  • 7.2.3. Canada
    • 7.2.3.1. Canada Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.2.3.2. Key Country Dynamics
    • 7.2.3.3. Regulatory Framework
    • 7.2.3.4. Reimbursement Scenario
    • 7.2.3.5. Competitive Scenario
  • 7.2.4. Mexico
    • 7.2.4.1. Mexico Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.2.4.2. Key Country Dynamics
    • 7.2.4.3. Regulatory Framework
    • 7.2.4.4. Reimbursement Scenario
    • 7.2.4.5. Competitive Scenario
• 7.3. Europe
  • 7.3.1. Europe Newborn Screening Market, 2021 - 2033 (USD Million)
  • 7.3.2. UK
    • 7.3.2.1. UK Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.3.2.2. Key Country Dynamics
    • 7.3.2.3. Regulatory Framework
    • 7.3.2.4. Reimbursement Scenario
    • 7.3.2.5. Competitive Scenario
  • 7.3.3. Germany
    • 7.3.3.1. Germany Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.3.3.2. Key Country Dynamics
    • 7.3.3.3. Regulatory Framework
    • 7.3.3.4. Reimbursement Scenario
    • 7.3.3.5. Competitive Scenario
  • 7.3.4. Spain
    • 7.3.4.1. Spain Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.3.4.2. Key Country Dynamics
    • 7.3.4.3. Regulatory Framework
    • 7.3.4.4. Reimbursement Scenario
    • 7.3.4.5. Competitive Scenario
  • 7.3.5. France
    • 7.3.5.1. France Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.3.5.2. Key Country Dynamics
    • 7.3.5.3. Regulatory Framework
    • 7.3.5.4. Reimbursement Scenario
    • 7.3.5.5. Competitive Scenario
  • 7.3.6. Italy
    • 7.3.6.1. Italy Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.3.6.2. Key Country Dynamics
    • 7.3.6.3. Regulatory Framework
    • 7.3.6.4. Reimbursement Scenario
    • 7.3.6.5. Competitive Scenario
  • 7.3.7. Denmark
    • 7.3.7.1. Denmark Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.3.7.2. Key Country Dynamics
    • 7.3.7.3. Regulatory Framework
    • 7.3.7.4. Reimbursement Scenario
    • 7.3.7.5. Competitive Scenario
  • 7.3.8. Sweden
    • 7.3.8.1. Sweden Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.3.8.2. Key Country Dynamics
    • 7.3.8.3. Regulatory Framework
    • 7.3.8.4. Reimbursement Scenario
    • 7.3.8.5. Competitive Scenario
  • 7.3.9. Norway
    • 7.3.9.1. Norway Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.3.9.2. Key Country Dynamics
    • 7.3.9.3. Regulatory Framework
    • 7.3.9.4. Reimbursement Scenario
    • 7.3.9.5. Competitive Scenario
• 7.4. Asia Pacific
  • 7.4.1. Asia-Pacific Newborn Screening Market, 2021 - 2033 (USD Million)
  • 7.4.2. Japan
    • 7.4.2.1. Japan Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.4.2.2. Key Country Dynamics
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Reimbursement Scenario
    • 7.4.2.5. Competitive Scenario
  • 7.4.3. China
    • 7.4.3.1. China Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.4.3.2. Key Country Dynamics
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Reimbursement Scenario
    • 7.4.3.5. Competitive Scenario
  • 7.4.4. India
    • 7.4.4.1. India Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.4.4.2. Key Country Dynamics
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Reimbursement Scenario
    • 7.4.4.5. Competitive Scenario
  • 7.4.5. South Korea
    • 7.4.5.1. South Korea Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.4.5.2. Key Country Dynamics
    • 7.4.5.3. Regulatory Framework
    • 7.4.5.4. Reimbursement Scenario
    • 7.4.5.5. Competitive Scenario
  • 7.4.6. Thailand
    • 7.4.6.1. Thailand Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.4.6.2. Key Country Dynamics
    • 7.4.6.3. Regulatory Framework
    • 7.4.6.4. Reimbursement Scenario
    • 7.4.6.5. Competitive Scenario
  • 7.4.7. Australia
    • 7.4.7.1. Australia Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.4.7.2. Key Country Dynamics
    • 7.4.7.3. Regulatory Framework
    • 7.4.7.4. Reimbursement Scenario
    • 7.4.7.5. Competitive Scenario
• 7.5. Latin America
  • 7.5.1. Latin America Newborn Screening Market, 2021 - 2033 (USD Million)
  • 7.5.2. Brazil
    • 7.5.2.1. Brazil Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.5.2.2. Key Country Dynamics
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Reimbursement Scenario
    • 7.5.2.5. Competitive Scenario
  • 7.5.3. Argentina
    • 7.5.3.1. Argentina Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.5.3.2. Key Country Dynamics
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Reimbursement Scenario
    • 7.5.3.5. Competitive Scenario
• 7.6. MEA
  • 7.6.1. MEA Newborn Screening Market, 2021 - 2033 (USD Million)
  • 7.6.2. South Africa
    • 7.6.2.1. South Africa Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.6.2.2. Key Country Dynamics
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Reimbursement Scenario
    • 7.6.2.5. Competitive Scenario
  • 7.6.3. Saudi Arabia
    • 7.6.3.1. Saudi Arabia Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.6.3.2. Key Country Dynamics
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Reimbursement Scenario
    • 7.6.3.5. Competitive Scenario
  • 7.6.4. UAE
    • 7.6.4.1. UAE Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.6.4.2. Key Country Dynamics
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Reimbursement Scenario
    • 7.6.4.5. Competitive Scenario
  • 7.6.5. Kuwait
    • 7.6.5.1. Kuwait Newborn Screening Market, 2021 - 2033 (USD Million)
    • 7.6.5.2. Key Country Dynamics
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Reimbursement Scenario
    • 7.6.5.5. Competitive Scenario

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Strategy Mapping
  • 8.2.1. New Product Launch
  • 8.2.2. Partnerships
  • 8.2.3. Acquisition
  • 8.2.4. Collaboration
  • 8.2.5. Funding
• 8.3. Key Company Market Share Analysis, 2024
• 8.4. Company Heat Map Analysis
• 8.5. Company Profiles
  • 8.5.1. Bio-Rad Laboratories
    • 8.5.1.1. Overview
    • 8.5.1.2. Financial Performance
    • 8.5.1.3. Product Benchmarking
    • 8.5.1.4. Strategic Initiatives
  • 8.5.2. Agilent Technologies
    • 8.5.2.1. Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. Masimo
    • 8.5.3.1. Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. Waters Corporation
    • 8.5.4.1. Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. Natus Medical
    • 8.5.5.1. Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. Trivitron Healthcare
    • 8.5.6.1. Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. GE Lifesciences
    • 8.5.7.1. Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. PerkinElmer Inc
    • 8.5.8.1. Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives
  • 8.5.9. AB SCIEX
    • 8.5.9.1. Overview
    • 8.5.9.2. Financial Performance
    • 8.5.9.3. Product Benchmarking
    • 8.5.9.4. Strategic Initiatives
  • 8.5.10. Demand A/S
    • 8.5.10.1. Overview
    • 8.5.10.2. Financial Performance
    • 8.5.10.3. Product Benchmarking
    • 8.5.10.4. Strategic Initiatives
  • 8.5.11. Parseq LAB
    • 8.5.11.1. Overview
    • 8.5.11.2. Financial Performance
    • 8.5.11.3. Product Benchmarking
    • 8.5.11.4. Strategic Initiatives
  • 8.5.12. Otodynamics
    • 8.5.12.1. Overview
    • 8.5.12.2. Financial Performance
    • 8.5.12.3. Product Benchmarking
    • 8.5.12.4. Strategic Initiatives
  • 8.5.13. Zentech
    • 8.5.13.1. Overview
    • 8.5.13.2. Financial Performance
    • 8.5.13.3. Product Benchmarking
    • 8.5.13.4. Strategic Initiatives
  • 8.5.14. Centogene
    • 8.5.14.1. Overview
    • 8.5.14.2. Financial Performance
    • 8.5.14.3. Product Benchmarking
    • 8.5.14.4. Strategic Initiatives