Table of Content
Chapter 1 Executive Summary
Market Outlook
Scope of Report
Market Summary
Chapter 2 Market Overview
Overview
Novel Approaches for POC
Significance of CLIA in the United States
Regulatory Guidelines
Good Manufacturing Practice
The FDA’s Role in POC Testing
Conclusion
Chapter 3 Market Dynamics
Factors Affecting the Point-of-Care Diagnostic Market
Market Drivers
High Incidences of Infectious Diseases
Growing Prevalence of Chronic Diseases
Increasing Demand for Self-Testing
Aging Population
Market Restraints
Challenges Faced by POC Manufacturers Due to Pricing Pressure
Technical Complexity
Lack of Specialized Training
Market Challenges
Challenges in Deploying Point-of-Care (POC) Diagnostics in Remote Settings
Environmental and Contamination Challenges in Point-of-Care Diagnostics
Market Opportunities
Increasing R&D Budget
Excellent Market Potential for POCT with AI and ML Integration
Emerging Economies
Chapter 4 Market Segmentation Analysis
Segmentation Breakdown
Point-of-Care Diagnostics Market, by Test Type
Drug and Alcohol Screening
Blood Gas Electrolyte and Metabolite (BGEM)
Cardiac Markers
Cholesterol Testing/Monitoring
Glucose Testing and Monitoring
Infectious Disease Testing
Pregnancy and Fertility Testing
Hemoglobin and Hemostasis
Tumor Marker
Urinalysis/Urine Chemistry
Others
Point-of-Care Diagnostics Market, by Product
Hardware
Software
Point-of-Care Diagnostics Market, by End User
Hospitals and Critical Care Settings
Home Care Settings
Geographic Breakdown
Point-of-Care Diagnostics Market, by Region
North America
Europe
Asia-Pacific
Rest of the World (RoW)
Chapter 5 Emerging and Upcoming Technologies in the Market
Emerging and Upcoming Technologies
AI in Point-of-Care Diagnostics
CRISPR-Cas Systems
3D Rapid Prototyping
Quantum Dots
RFID (Radio-Frequency Identification) and NFC (Near Field Communication)
Smartphone-Based Medical Imaging
Nanomaterials in POC Devices for Pathogen Detection
Microfluidics-Based Sensing Technologies
Cloud-Integrated AI
D3 Array-UTI
EVIK DxSpheres: A Solid Assay Solution
UNIQO 160 Automated IIFT System
Recent Developments
Chapter 6 ESG Development
Introduction
Sustainability in Plastics and Bio-Based Alternatives
ESG Risk Ratings
The WHO Global Action Plan
Chapter 7 Competitive Landscape
Mergers, Acquisitions and Collaborations
Strategic Alliances
FDA Approvals
Patent Analysis
Patent Analysis, by Year
Company Share Analysis
Chapter 8 Appendix
Methodology
Sources
Abbreviations
Company Profiles
ABBOTT
BD
DANAHER CORP.
GE HEALTHCARE
F. HOFFMANN-LA ROCHE LTD.
MEDTRONIC
QUEST DIAGNOSTICS INC.
QUIDELORTHO CORP.
SIEMENS HEALTHINEERS AG
THERMO FISHER SCIENTIFIC INC.
List of Figures
Summary Figure : Global Market for Point-of-Care Diagnostics, by Region, 2021–2029
Figure 1 : Global Market Dynamics of Point-of-Care Diagnostics
Figure 2 : Malaria-Endemic Countries, 2022
Figure 3 : Top 10 Common Chronic Conditions in Adults 65+, U.S., 2024
Figure 4 : Annual Investment in STI Research Needs of People in Low- and Middle-Income Countries, 2018–2022
Figure 5 : Global Market Shares of Point-of-Care Diagnostics, by Test Type, 2023
Figure 6 : Share of New Cancer Cases Globally, by Region, 2022
Figure 7 : Share of Cancer Mortality Cases Globally, by Region, 2022
Figure 8 : Global Market Shares of Point-of-Care Diagnostics, by Product, 2023
Figure 9 : Global Market Shares of Point-of-Care Diagnostics, by End User, 2023
Figure 10 : COVID-19 Diagnostic Possibilities, Sampling, and Turnaround Time
Figure 11 : Global Market Shares of Point-of-Care Diagnostics, by Region, 2023
Figure 12 : North American Market Shares in Point-of-Care Diagnostics, by Country, 2023
Figure 13 : Limitations of Using POC Devices in India
Figure 14 : Overview of the POCT Life Cycle Associated with Environmental Burdens and Sustainable Solutions for Each Stage
Figure 15 : Share of Patents Published on Point-of-Care Diagnostics, by Country, 2021-2024
Figure 16 : Global Market Shares of Point-of-Care Diagnostics, by Manufacturer/Supplier, 2023
Figure 17 : Abbott: Revenue Share, by Country/Region, FY 2023
Figure 18 : Abbott: Revenue Share, by Business Unit, FY 2023
Figure 19 : BD: Revenue Share, by Country/Region, FY 2023
Figure 20 : BD: Revenue Share, by Business Unit, FY 2023
Figure 21 : Danaher Corp.: Revenue Share, by Business Unit, FY 2023
Figure 22 : Danaher Corp.: Revenue Share, by Country/Region, FY 2023
Figure 23 : GE Healthcare: Revenue Share, by Business Unit, FY 2023
Figure 24 : GE Healthcare: Revenue Share, by Country/Region, FY 2023
Figure 25 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Business Unit, FY 2023
Figure 26 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Country/Region, FY 2023
Figure 27 : Medtronic: Revenue Share, by Country/Region, FY 2023
Figure 28 : Medtronic: Revenue Share, by Business Unit, FY 2023
Figure 29 : Quest Diagnostics Inc.: Revenue Share, by Business Unit, FY 2023
Figure 30 : QuidelOrtho Corp.: Revenue Share, by Business Unit, FY 2023
Figure 31 : QuidelOrtho Corp.: Revenue Share, by Country/Region, FY 2023
Figure 32 : Siemens Healthineers AG: Revenue Share, by Business Unit, FY 2023
Figure 33 : Siemens Healthineers AG: Revenue Share, by Country/Region, FY 2023
Figure 34 : Thermo Fisher Scientific Inc.: Revenue Share, by Business Unit, FY 2023
Figure 35 : Thermo Fisher Scientific Inc.: Revenue Share, by Region, FY 2023
List of Tables
Summary Table : Global Market for Point-of-Care Diagnostics, by Region, Through 2029
Table 1 : POCT Alternatative Terms
Table 2 : Commonly Used POC Devices
Table 3 : Recent Tests Approved by the FDA as Waived Tests Under CLIA
Table 4 : Estimated Number of People Living with HIV, 2010, 2021 and 2022
Table 5 : Number of Hepatitis B Infections (All Ages) in 2022
Table 6 : Global Incidences of STIs, 2020 and 2022
Table 7 : Projected Number of Adults 50 Years and Older with ?1 Chronic Condition in the United States, 2020–2050
Table 8 : Number and Proportion of Persons Aged 65 Years and Over, by Development Group, 2023 and 2050
Table 9 : Number of Persons Aged 65 Years and Over, by Region, 2019 and 2050
Table 10 : Number of Deaths and the Age-Adjusted Death Rate for the 10 Leading Causes of Death in 2022: United States, 2021 and 2022
Table 11 : Global Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 12 : Global Market for Drug and Alcohol Screening, by Region, Through 2029
Table 13 : Global Market for BGEM, by Region, Through 2029
Table 14 : Global Market for Cardiac Markers, by Region, Through 2029
Table 15 : Global Market for Cholesterol Testing/Monitoring, by Region, Through 2029
Table 16 : Global Market for Glucose Testing and Monitoring, by Region, Through 2029
Table 17 : Annual Estimated Deaths from HIV/AIDS, Diarrhea, Malaria, Respiratory Infections, and All Other Infectious Diseases in Major Countries, 1980 to 2021
Table 18 : Global Market for Infectious Disease Testing, by Region, Through 2029
Table 19 : Global Market for Pregnancy and Fertility Testing, by Region, Through 2029
Table 20 : Global Market for Hemoglobin and Hemostasis, by Region, Through 2029
Table 21 : Examples of Commercially Available POC Devices for Cancer Detection
Table 22 : Global Market for Tumor Markers, by Region, Through 2029
Table 23 : Some Currently Available Point-of-Care Tests for Proteins in Urine
Table 24 : Global Market for Urinalysis/Urine Chemistry, by Region, Through 2029
Table 25 : Global Market for Other Types of Point-of-Care Diagnostics Tests, by Region, Through 2029
Table 26 : Global Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 27 : Global Market for Hardware in Point-of-Care Diagnostics, by Region, Through 2029
Table 28 : Global Market for Software in Point-of-Care Diagnostics, by Region, Through 2029
Table 29 : Global Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 30 : Global Market for Point-of-Care Diagnostics in Hospital and Critical Care End Uses, by Region, Through 2029
Table 31 : Global Market for Point-of-Care Diagnostics in Home Care Settings, by Region, Through 2029
Table 32 : Global Market for Point-of-Care Diagnostics, by Region, Through 2029
Table 33 : North American Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 34 : North American Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 35 : North American Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 36 : North American Market for Point-of-Care Diagnostics, by Country, Through 2029
Table 37 : U.S. Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 38 : U.S. Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 39 : U.S. Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 40 : Canadian Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 41 : Canadian Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 42 : Canadian Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 43 : Mexican Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 44 : Mexican Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 45 : Mexican Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 46 : European Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 47 : European Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 48 : European Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 49 : European Market for Point-of-Care Diagnostics, by Country, Through 2029
Table 50 : Leading Causes of Disease Burden by DALYs (Level 3)
Table 51 : German Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 52 : German Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 53 : German Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 54 : U.K. Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 55 : U.K. Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 56 : U.K. Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 57 : French Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 58 : French Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 59 : French Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 60 : Italian Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 61 : Italian Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 62 : Italian Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 63 : Spanish Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 64 : Spanish Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 65 : Spanish Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 66 : Rest of European Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 67 : Rest of European Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 68 : Rest of European Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 69 : Asia-Pacific Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 70 : Asia-Pacific Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 71 : Asia-Pacific Market for Point-of-Care Diagnostics, by End User Through 2029
Table 72 : Asia-Pacific Market for Point-of-Care Diagnostics, by Country, Through 2029
Table 73 : Chinese Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 74 : Chinese Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 75 : Chinese Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 76 : Japanese Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 77 : Japanese Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 78 : Japanese Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 79 : Indian Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 80 : Indian Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 81 : Indian Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 82 : Australian Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 83 : Australian Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 84 : Australian Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 85 : South Korean Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 86 : South Korean Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 87 : South Korean Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 88 : Rest of Asia-Pacific Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 89 : Rest of Asia-Pacific Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 90 : Rest of Asia-Pacific Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 91 : Rest of the World Market for Point-of-Care Diagnostics, by Test Type, Through 2029
Table 92 : Rest of the World Market for Point-of-Care Diagnostics, by Product, Through 2029
Table 93 : Rest of the World Market for Point-of-Care Diagnostics, by End User, Through 2029
Table 94 : Growing Burden of Waste from Diagnostic Devices
Table 95 : Emerging and Sustainable Materials for the Fabrication of Single-Use POCT
Table 96 : ESG Highlights, by Major Players, 2023
Table 97 : ESG Rankings for Point-of-Care Diagnostics Manufacturing Companies, 2023
Table 98 : Mergers and Acquisitions: Point-of-Care Diagnostics Market, by Manufacturers, 2021–2024
Table 99 : Major Strategic Alliances in the Point-of-Care Diagnostic Industry, 2021–2024
Table 100 : FDA Approved Point-of-Care Diagnostics Devices, 2022–2023
Table 101 : Patents on on Point-of-Care Diagnostics, by Year, 2021–August 2024
Table 102 : Information Sources in this Report
Table 103 : Major Abbreviations Used in This Report
Table 104 : Abbott: Company Snapshot
Table 105 : Abbott: Financial Performance, FY 2022 and 2023
Table 106 : Abbott: Product Portfolio
Table 107 : Abbott: News/Key Developments, 2021–2024
Table 108 : BD: Company Snapshot
Table 109 : BD: Financial Performance, FY 2022 and 2023
Table 110 : BD: Product Portfolio
Table 111 : BD: News/Key Developments, 2022–2023
Table 112 : Danaher Corp.: Company Snapshot
Table 113 : Danaher Corp.: Financial Performance, FY 2022 and 2023
Table 114 : Danaher Corp.: Product Portfolio
Table 115 : Danaher Corp.: News/Key Developments, 2023 and 2024
Table 116 : GE Healthcare: Company Snapshot
Table 117 : GE Healthcare: Financial Performance, FY 2022 and 2023
Table 118 : GE Healthcare: Product Portfolio
Table 119 : GE Healthcare: News/Key Developments, 2023 and 2024
Table 120 : F. Hoffmann-La Roche Ltd.: Company Snapshot
Table 121 : F. Hoffmann-La Roche Ltd.: Financial Performance, FY 2022 and 2023
Table 122 : F. Hoffmann-La Roche Ltd.: Product Portfolio
Table 123 : F. Hoffmann-La Roche Ltd.: News/Key Developments, 2021–2024
Table 124 : Medtronic: Company Snapshot
Table 125 : Medtronic: Financial Performance, FY 2022 and 2023
Table 126 : Medtronic: Product Portfolio
Table 127 : Medtronic: News/Key Developments, 2023
Table 128 : Quest Diagnostics Inc.: Company Snapshot
Table 129 : Quest Diagnostics Inc.: Financial Performance, FY 2022 and 2023
Table 130 : Quest Diagnostics Inc.: Product Portfolio
Table 131 : Quest Diagnostics Inc.: News/Key Developments, 2021–2024
Table 132 : QuidelOrtho Corp.: Company Snapshot
Table 133 : QuidelOrtho Corp.: Financial Performance, FY 2022 and 2023
Table 134 : QuidelOrtho Corp.: Product Portfolio
Table 135 : QuidelOrtho Corp.: News/Key Developments, 2022–2024
Table 136 : Siemens Healthineers AG: Company Snapshot
Table 137 : Siemens Healthineers AG: Financial Performance, FY 2022 and 2023
Table 138 : Siemens Healthineers AG: Product Portfolio
Table 139 : Siemens Healthineers AG: News/Key Developments, 2023 and 2024
Table 140 : Thermo Fisher Scientific Inc.: Company Snapshot
Table 141 : Thermo Fisher Scientific Inc.: Financial Performance, FY 2022 and 2023
Table 142 : Thermo Fisher Scientific Inc.: Product Portfolio
Table 143 : Thermo Fisher Scientific Inc.: News/Key Developments, 2021–2024