1. Introduction
1.1. Market Definition & Scope
1.2. Market Ecosystem
1.3. Currency & Limitations
1.4. Key Stakeholders
2. Research Methodology
2.1. Research Approach
2.2. Process of Data Collection and Validation
2.2.1. Secondary Research
2.2.2. Primary Research/Interviews with Key Opinion Leaders of the Industry
2.3. Market Sizing and Forecast
2.3.1. Market Size Estimation Approach
2.3.2. Growth Forecast Approach
2.4. Assumptions for the Study
3. Executive Summary
4. Market Insights
4.1. Overview
4.2. Factors Affecting Market Growth
4.2.1. Impact Analysis of Market Dynamics
4.2.2. Factor Analysis
4.3. Regulatory Analysis
4.3.1. Overview
4.3.2. U.S.
4.3.3. Canada
4.3.4. Europe
4.3.5. Asia-Pacific
4.3.5.1. China
4.3.5.2. Japan
4.3.5.3. India
4.3.6. Latin America
4.3.7. Middle East
4.4. Pricing Analysis
4.5. Industry & Technology Trends
4.5.1. Shift from Traditional Newborn Screening to Advanced Technologies
4.5.2. Laws and Initiatives Supporting Newborn Screening Across Countries
4.6. Porter’s Five Forces Analysis
4.6.1. Bargaining Power of Buyers
4.6.2. Bargaining Power of Suppliers
4.6.3. Threat of Substitutes
4.6.4. Threat of New Entrants
4.6.5. Degree of Competition
5. Newborn Screening Market Assessment—by Product
5.1. Overview
5.2. Instruments
5.3. Consumables
6. Newborn Screening Market Assessment—by Technology
6.1. Overview
6.2. Tandem Mass Spectrometry
6.3. Immune Assays & Enzymatic Assays
6.4. Molecular Assays
6.5. Pulse Oximetry
6.6. Hearing Screening Technologies
6.7. Other Technologies
7. Newborn Screening Market Assessment—by Application
7.1. Overview
7.2. Inherited Disorders
7.2.1. Metabolic Disorders
7.2.2. Hemoglobin Disorders
7.2.3. Endocrine Disorders
7.2.4. Other Inherited Disorders
7.3. Infectious Diseases
7.4. Congenital Heart Disease
7.5. Hearing Disorders
7.6. Other Applications
8. Newborn Screening Market Assessment–by End User
8.1. Overview
8.2. Hospitals
8.3. Reference Laboratories
9. Newborn Screening Market Assessment–by Geography
9.1. Overview
9.2. North America
9.2.1. U.S.
9.2.2. Canada
9.3. Europe
9.3.1. Germany
9.3.2. France
9.3.3. U.K.
9.3.4. Italy
9.3.5. Spain
9.3.6. Rest of Europe (RoE)
9.4. Asia-Pacific
9.4.1. China
9.4.2. Japan
9.4.3. India
9.4.4. Rest of Asia-Pacific (RoAPAC)
9.5. Latin America
9.5.1. Brazil
9.5.2. Mexico
9.5.3. Rest of Latin America
9.6. Middle East & Africa
10. Competition Analysis
10.1. Overview
10.2. Key Growth Strategies
10.3. Competitive Benchmarking
10.4. Competitive Dashboard
10.4.1. Industry Leaders
10.4.2. Market Differentiators
10.4.3. Vanguards
10.4.4. Emerging Companies
11. Company Profiles (Company Overview, Financial Overview, Product Portfolio, and Strategic Developments)
11.1. PerkinElmer, Inc.
11.2. Thermo Fisher Scientific, Inc.
11.3. Bio-Rad Laboratories, Inc.
11.4. Medtronic plc
11.5. F. Hoffmann-La Roche AG
11.6. ARCHIMED Group
11.7. Trivitron Healthcare Pvt Ltd.
11.8. Demant A/S
11.9. Baebies, Inc.
11.10. ZenTech s.a.
11.11. Other Companies
(Note: SWOT Analysis of the Top 5 Companies Will Be Provided)
12. Appendix
12.1. Available Customization
12.2. Related Reports
List of Tables
Table 1 Infant Mortality Rates (Deaths Per 1,000 Live Births), By Country, 2010 VS. 2019 VS. 2021
Table 2 Number of Midwifery Personnel, By Country, 2020
Table 3 Recent Key Developments in the Newborn Screening Market
Table 4 Physicians Per 1000 People, By Country, 2020
Table 5 Central Drugs Standard Control Organisation (CDSCO) Medical Device Classification
Table 6 Newborn Screening Products: Pricing Analysis
Table 7 Global Newborn Screening Market, BY Product, 2022–2031 (USD Million)
Table 8 Major Features of a Newborn Screening Instrument
Table 9 Global Newborn Screening Instruments Market, By Country/Region, 2022–2031 (USD Million)
Table 10 Global Newborn Screening Consumables Market, By Country/Region, 2022–2031 (USD Million)
Table 11 Global Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 12 Global Newborn Screening Market for Tandem Mass Spectrometry, By Country/Region, 2022–2031 (USD Million)
Table 13 Global Newborn Screening Market for Immune Assays & Enzymatic Assays, By Country/Region, 2022–2031 (USD Million)
Table 14 Some of the Companies Offering Molecular Assays
Table 15 Global Newborn Screening Market for Molecular Assays, By Country/Region, 2022–2031 (USD Million)
Table 16 Global Newborn Screening Market for Pulse Oximetry, By Country/Region, 2022–2031 (USD Million)
Table 17 Global Newborn Screening Market for Hearing Screening Technologies, By Country/Region, 2022–2031 (USD Million)
Table 18 Global Newborn Screening Market for Other Technologies, By Country/Region, 2022–2031 (USD Million)
Table 19 Global Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 20 Global Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 21 Global Newborn Screening Market for Inherited Disorders, By Country/Region, 2022–2031 (USD Million)
Table 22 Global Newborn Screening Market for Metabolic Disorders, By Country/Region, 2022–2031 (USD Million)
Table 23 Global Newborn Screening Market for Hemoglobin Disorders, By Country/Region, 2022–2031 (USD Million)
Table 24 Global Newborn Screening Market for Endocrine Disorders, By Country/Region, 2022–2031 (USD Million)
Table 25 Global Newborn Screening Market for Other Inherited Disorders, By Country/Region, 2022–2031 (USD Million)
Table 26 Global Newborn Screening Market for Infectious Diseases, By Country/Region, 2022–2031 (USD Million)
Table 27 Global Newborn Screening Market for Congenital Heart Disease, By Country/Region, 2022–2031 (USD Million)
Table 28 Global Newborn Screening Market for Hearing Disorders, By Country/Region, 2022–2031 (USD Million)
Table 29 Global Newborn Screening Market for Other Applications, By Country/Region, 2022–2031 (USD Million)
Table 30 Global Newborn Screening Market, BY End User, 2022–2031 (USD Million)
Table 31 Global Newborn Screening Market for Hospitals, By Country/Region, 2022–2031 (USD Million)
Table 32 Global Newborn Screening Market for Reference Laboratories, By Country/Region, 2022–2031 (USD Million)
Table 33 Global Newborn Screening Market, By Country/Region, 2022–2031 (USD Million)
Table 34 North America: Newborn Screening Market, By Country, 2022–2031 (USD Million)
Table 35 North America: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 36 North America: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 37 North America: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 38 North America: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 39 North America: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 40 U.S.: Macroeconomic Indicators
Table 41 U.S.: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 42 U.S.: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 43 U.S.: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 44 U.S.: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 45 U.S.: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 46 Canada: Macroeconomic Indicators
Table 47 Canada: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 48 Canada: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 49 Canada: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 50 Canada: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 51 Canada: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 52 Europe: Newborn Screening Market, By Country/Region, 2022–2031 (USD Million)
Table 53 Europe: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 54 Europe: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 55 Europe: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 56 Europe: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 57 Europe: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 58 Germany: Macroeconomic Indicators
Table 59 Germany: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 60 Germany: Newborn Screening, By Technology, 2022–2031 (USD Million)
Table 61 Germany: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 62 Germany: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 63 Germany: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 64 France: Macroeconomic Indicators
Table 65 France: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 66 France: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 67 France: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 68 France: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 69 France: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 70 U.K.: Macroeconomic Indicators
Table 71 U.K.: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 72 U.K.: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 73 U.K.: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 74 U.K.: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 75 U.K.: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 76 Italy: Macroeconomic Indicators
Table 77 Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 78 Italy: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 79 Italy: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 80 Italy: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 81 Italy: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 82 Spain: Macroeconomic Indicators
Table 83 Spain: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 84 Spain: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 85 Spain: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 86 Spain: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 87 Spain: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 88 RoE: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 89 RoE: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 90 RoE: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 91 RoE: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 92 RoE: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 93 Asia-Pacific: Newborn Screening Market, By Country/Region, 2022–2031 (USD Million)
Table 94 Asia-Pacific: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 95 Asia-Pacific: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 96 Asia-Pacific: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 97 Asia-Pacific: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 98 Asia-Pacific: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 99 China: Macroeconomic Indicators
Table 100 China: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 101 China: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 102 China: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 103 China: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 104 China: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 105 Japan: Macroeconomic Indicators
Table 106 Japan: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 107 Japan: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 108 Japan: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 109 Japan: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 110 Japan: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 111 India: Macroeconomic Indicators
Table 112 India: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 113 India: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 114 India: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 115 India: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 116 India: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 117 RoAPAC: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 118 RoAPAC: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 119 RoAPAC: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 120 RoAPAC: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 121 RoAPAC: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 122 Latin America: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 123 Latin America: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 124 Latin America: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 125 Latin America: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 126 Latin America: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 127 Brazil: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 128 Brazil: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 129 Brazil: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 130 Brazil: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 131 Brazil: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 132 Mexico: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 133 Mexico: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 134 Mexico: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 135 Mexico: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 136 Mexico: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 137 Rest of Latin America: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 138 Rest of Latin America: Newborn Screening Market, for Technology, 2022–2031 (USD Million)
Table 139 Rest of Latin America: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 140 Rest of Latin America: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 141 Rest of Latin America: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 142 Middle East & Africa: Newborn Screening Market, By Product, 2022–2031 (USD Million)
Table 143 Middle East & Africa: Newborn Screening Market, By Technology, 2022–2031 (USD Million)
Table 144 Middle East & Africa: Newborn Screening Market, By Application, 2022–2031 (USD Million)
Table 145 Middle East & Africa: Newborn Screening Market for Inherited Disorders, By Application, 2022–2031 (USD Million)
Table 146 Middle East & Africa: Newborn Screening Market, By End User, 2022–2031 (USD Million)
Table 147 Recent Developments, By Company, 2020–2024
List of Figures
Figure 1 Research Process
Figure 2 Secondary Sources Referenced for This Study
Figure 3 Primary Research Techniques
Figure 4 Key Executives Interviewed
Figure 5 Breakdown of Primary Interviews (Supply Side & Demand Side)
Figure 6 Market Sizing and Growth Forecast Approach
Figure 7 Global Newborn Screening Market, By Product, 2024 Vs. 2031 (USD Million)
Figure 8 Global Newborn Screening Market, By Technology, 2024 Vs. 2031 (USD Million)
Figure 9 Global Newborn Screening Market, By Application, 2024 Vs. 2031 (USD Million)
Figure 10 Global Newborn Screening Market, By End User, 2024 Vs. 2031 (USD Million)
Figure 11 Newborn Screening Market, By Geography
Figure 12 Global Newborn Screening Market: Impact Analysis of Market Drivers, Restraints, Opportunities, and Challenges (2024–2031)
Figure 13 Benefits of Newborn Screening
Figure 14 USFDA Regulatory Pathways for Medical Devices
Figure 15 EU Regulatory Pathway - IVDR 2017/746
Figure 16 China: Medical Device Classification and Premarket Requirements for IVD Devices
Figure 17 Porter's Five Forces Analysis
Figure 18 Global Newborn Screening Market, By Product, 2024 Vs. 2031 (USD Million)
Figure 19 Global Newborn Screening Market, By Technology, 2024 Vs. 2031 (USD Million)
Figure 20 Protocol for Newborn Screening
Figure 21 Global Newborn Screening Market, By Application, 2024 Vs. 2031 (USD Million)
Figure 22 Two-Stage Screening Protocol for Hearing Disorders
Figure 23 Global Newborn Screening Market, By End User, 2024 Vs. 2031 (USD Million)
Figure 24 Global Newborn Screening Market, By Geography, 2024 Vs. 2031 (USD Million)
Figure 25 North America: Newborn Screening Market Snapshot
Figure 26 Europe: Newborn Screening Market Snapshot
Figure 27 Asia-Pacific: Newborn Screening Market Snapshot
Figure 28 Latin America: Newborn Screening Market Snapshot
Figure 29 Key Growth Strategies Adopted By Leading Players 2020-2024
Figure 30 Newborn Screening Market: Competitive Benchmarking, By Product Type
Figure 31 Newborn Screening Market: Competitive Benchmarking, By Region
Figure 32 Competitive Dashboard: Newborn Screening Market
Figure 33 PerkinElmer, Inc.: Financial Overview (2023)
Figure 34 Thermo Fisher Scientific, Inc.: Financial Overview (2023)
Figure 35 Bio-Rad Laboratories, Inc.: Financial Overview (2023)
Figure 36 Medtronic Plc: Financial Overview (2023)
Figure 37 F. Hoffmann-La Roche AG: Financial Overview (2023)
Figure 38 Demant A/S: Financial Overview (2023)