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Report
Point-of-Care Diagnostics: Technologies and Global Markets
Market Research Report I 2024-10-01 I 159 Pages I BCC Research
Description
Report Scope
The point-of-care diagnostics market is extensive and constantly evolving with new technologies and methodologies. This report explores the current and future market potential, competitive environment, regulatory scenario, and market trends, including projections through 2029 and an analysis of key players.
This report covers the entire industry, including hardware (devices, equipment, consumables), software, and analytics. The market is analyzed by test type, including alcohol and drug abuse, blood gas electrolyte and metabolite (BGEM), cardiac markers, cholesterol, glucose monitoring, hemoglobin/hemostasis, infectious disease, pregnancy and fertility, tumor markers, and urine chemistry, and it includes comprehensive regional analyses.
The report highlights ongoing R&D efforts focused on improving accuracy accessibility and incorporating innovative diagnostic procedures. It provides insights into market drivers, challenges, opportunities, industry status, developments, trends, and strategies like mergers, acquisitions, and collaborations. It is a valuable resource for market players, potential entrants, government agencies, and other stakeholders, especially those interested in geographic expansion.
Report Includes
- 98 data tables and 46 additional tables
- An overview of the global markets and technologies for point-of-care (POC) diagnostics
- Analyses of global market trends, with market revenue data (sales figures) for 2021-2023, estimates for 2024, and projected CAGRs through 2029
- Estimates of the market size and revenue forecasts for the PoC diagnostics market, with market share analysis by test type, product type, end user, and region
- Discussions of the market dynamics, opportunities and challenges, as well as emerging technologies
- Coverage of government regulations and policies, R&D initiatives, exploration activities, and government programs
- Overview of the sustainability trends and ESG developments in the industry, with emphasis on the ESG practices of leading companies, their ESG scores, and consumer attitudes
- Competitive intelligence, including companies' market shares, recent M&A activity and venture funding
- Profiles of the leading companies, including Abbott, BD, Danaher Corp., Thermo Fisher Scientific Inc., and F. Hoffmann-La Roche Ltd.
Executive Summary
Summary:
This study focuses on point-of-care (POC) testing, one of the most active segments in the diagnostic industry. POC testing is growing in both home use and near-patient applications. Both segments are included in this market study. Globally, the diagnostic testing business is a multi-billion-dollar industry with intense competition and high growth areas. The United States is the world's largest single market for diagnostic testing.
The global market for point-of-care diagnostics was valued at $36.9 billion in 2023. The market is expected to grow at a compound annual growth rate (CAGR) of 10.2% to reach $65.9 billion by the end of 2029. The primary factor contributing to the growth of the POC diagnostics market is the rising prevalence of infectious diseases. POC tests help enhance the management of infectious diseases, particularly in developing countries where it is difficult to access timely diagnosis due to a lack of healthcare infrastructure. For instance, According to a World Health Organization report on HIV and AIDS, approximately 39 million people were living with the human immunodeficiency virus (HIV) at the
end of 2022, including 1.5 million children (0-14 years old). In 2022, 630,000 people died from HIVrelated causes globally. According to America's Health Rankings 2023 Annual Report, by 2022, over 29 million adults in the U.S. disclosed having three or more chronic conditions.
Additionally, funding and grants from the government for advancing and developing innovative products also contribute to adopting innovative technologies for infectious disease diagnosis. The adoption of innovative technologies, such as artificial intelligence (AI), machine learning, and advanced biosensors, is further accelerating the growth of the point-of-care diagnostics market. These cutting-edge technologies enhance diagnostic accuracy, speed, and accessibility, allowing more efficient patient care. Additionally, innovations in portable diagnostic devices and telemedicine integration are expanding the reach of POC diagnostics, enabling real-time health monitoring and timely interventions. These market innovations are expected to increase the reach of POC devices to remote areas in developing and underdeveloped countries and make them budget-friendly; they also ensure that an economically challenged populace adopts these units. The increasing prevalence of diabetes and other chronic diseases also contributes to growth in the global market.
Strict approval and commercialization regulations are the primary factors restraining market growth. POC devices are regulated like other diagnostic devices, and in vitro devices are regulated by the U.S. Food and Drug Administration (FDA). The FDA considers POC devices to be high-risk and, therefore, requires that they have pre-market approval. Strict healthcare standards and high regulatory barriers significantly impact the introduction of innovative technologies. The regulations and standards are rigorous and require substantial expertise to navigate; this has resulted in increased time spans for the pre-market approval and commercialization process.
Table of Contents
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
BCC Research Viewpoint
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 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
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
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