Point of Care Diagnostics: Technologies and Global Markets

Table of Contents

Chapter 1 Introduction

• Study Goals and Objectives
• Reasons for Doing This Study
• What's New in this Report?
• Scope of Report
• Defining POC Testing
• Information Sources
• Methodology
• Geographic Breakdown
• Analyst's Credentials
• Publisher Custom Research
• Related Publisher Research Reports

Chapter 2 Summary and Highlights

• Overview

Chapter 3 Market and Technology Background

• Overview
• Novel Approaches for POC
• Laser PCR: Expanding the Possibilities at the POC
• Significance of CLIA in the United States
• Regulatory Guidelines
• The FDA's Role in POC Testing
• Good Manufacturing Practice
• Conclusion

Chapter 4 Market Dynamics

• Drivers
• High Incidences of Infectious Diseases
• Increasing R&D Budget
• Aging Population
• Opportunities
• COVID-19
• Emerging Economies

Chapter 5 COVID-19 Impact Analysis

• Introduction
• Impact on MedTech
• Elective and Noncritical Procedures
• Shift in Manufacturing
• Regulatory Delays, Clinical Trials and Product Launches
• Supply Chain Disruptions
• Medical Tourism
• FDA's Contribution to COVID-19 Diagnostic Testing
• Prioritizing of OTC and At-Home Testing Solutions
• Synopsis of FDA-Associated Testing Milestones Since May 2020

Chapter 6 Global Point of Care Diagnostics Market, by Test Type

• BGEM
• Electrolytes
• CLIA Quality Control Requirements for Blood Gas Analysis
• Market Size and Forecast
• Cardiac Markers
• Market Size and Forecast
• Cholesterol Testing/Monitoring
• Market Size and Forecast
• Drug and Alcohol Screening
• Market Size and Forecast
• Glucose Testing and Monitoring
• Market Size and Forecast
• Infectious Disease Testing
• Market Size and Forecast
• Pregnancy and Fertility Testing
• Market Size and Forecast
• Hemoglobin and Hemostasis
• Hematology and Hemostasis
• Hemostasis (Coagulation)
• Market Size and Forecast
• Tumor Marker
• Fecal and Gastric Occult Blood
• Bladder Tumor Antigen Test
• Market Size and Forecast
• Urinalysis/Urine Chemistry
• Market Size and Forecast
• Others
• Vaginal pH Tests
• Thyroid Stimulating Hormone Tests
• Male Reproductive Tests
• Menopause
• Dry Eye
• Market Size and Forecast

Chapter 7 Market Breakdown by Product

• Hardware
• Market Size and Forecast
• Software
• Market Size and Forecast

Chapter 8 Market Breakdown by End User

• Home Care Settings
• Market Size and Forecast
• Hospitals and Critical Care Settings
• Critical-Care Units
• Bedside Testing
• Operating Rooms/Procedure Rooms
• Physicians' Offices/Clinics/Treatment Centers/Other Noncritical-Care Sites
• Nursing Homes and Hospice
• Market Size and Forecast

Chapter 9 Market Breakdown by Region

• Global Market for Point of Care Diagnostics by Region
• North America
• United States
• Canada
• Europe
• Germany
• United Kingdom
• France
• Italy
• Spain
• Rest of Europe
• Asia-Pacific
• China
• Japan
• India
• Rest of Asia-Pacific
• Rest of the World (RoW)
• Market Size and Forecast

Chapter 10 Competitive Landscape

• Overview
• Company Share Analysis
• Strategies
• Regional Distributors
• End Users
• Recent Developments

Chapter 11 Company Profiles

• Abaxis
• Abbott
• Becton, Dickinson And Co.
• Bio-Rad Laboratories Inc.
• Cardinal Health
• Chembio Diagnostics
• Danaher Corp.
• Ekf Diagnostics Holdings Plc
• Elitech Group
• Esaote S.P.A.
• General Electric
• Lifescan
• Lumos Diagnostics Holdings Ltd.
• Medtronic Plc
• Mindray Medical International Ltd.
• Nexus Dx
• Nova Biomedical
• Orasure Technologies
• Philips Healthcare
• Quidel
• Roche Holding Ag (F. Hoffmann-La Roche Ltd.)
• Siemens Healthcare
• Thermo Fisher Scientific Inc.
• Zoetis Inc.

List of Tables
Summary Table: Global Market for Point of Care Diagnosis, by Region, Through 2026
Table 1: Synonyms of POCT
Table 2: Clinical Outcomes from Using Point of Care Testing
Table 3: Commercial Systems for Near Patient Testing
Table 4: Selected CLIA-Waived POC Tests
Table 5: CLIA-Waived Tests Applications, by Test System/Manufacturers, 2018–October 2021
Table 6: GMP Regulations Relevant Parameters Affecting In Vitro Diagnostics
Table 7: Global HIV Data, 2000-2020
Table 8: Global Estimated Number of New Cases of Curable STIs, 2019
Table 9: Estimated Global Population and Annual Growth, by Selected Age Group and Selected Years, Through 2030
Table 10: Global Geriatric Population (60 Years+), by Region, 2015-2050
Table 11: Number of Deaths Due to COVID-19 Worldwide, by Country, as of Dec. 4, 2020
Table 12: Leading Causes of Diseases around the World, 2004 and 2030
Table 13: Global Market for Point of Care Diagnostics, by Test Type, Through 2026
Table 14: Global Market for BGEM, by Region, Through 2026
Table 15: Global Deaths from CVD, 2015 and 2030
Table 16: Global Market for Cardiac Markers, by Region, Through 2026
Table 17: Global Market for Cholesterol Testing/Monitoring, by Region, Through 2026
Table 18: Prevalence of Cannabis Use, by Region, 2019
Table 19: Global Market for Drug and Alcohol Screening, by Region, Through 2026
Table 20: Diabetes Patients by Region, 2019, 2030 and 2045
Table 21: Global Market for Glucose Testing and Monitoring, by Region, Through 2026
Table 22: Global Market for Infectious Disease Testing, by Region, Through 2026
Table 23: Global Market for Pregnancy and Fertility Testing, by Region, Through 2026
Table 24: Global Market for Hemoglobin and Hemostasis, by Region, Through 2026
Table 25: Global Deaths from Cancer, 2015 and 2030
Table 26: Global Market for Tumor Markers, by Region, Through 2026
Table 27: Global Market for Urinalysis/Urine Chemistry, by Region, Through 2026
Table 28: Global Market for Others, by Region, Through 2026
Table 29: Global Market for Point of Care Diagnostics, by Product, Through 2026
Table 30: Global Market for Hardware in Point of Care Diagnostics, by Region, Through 2026
Table 31: Global Market for Software in Point of Care Diagnostics, by Region, Through 2026
Table 32: Global Market for Point of Care Diagnostics, by End User, Through 2026
Table 33: Global Market for Point of Care Diagnostics in Home Care Settings, by Region, Through 2026
Table 34: Estimated Number of Hospitals Beds Available, by Country, 2018-2019
Table 35: Estimated Nursing Homes Residents in U.S., by U.S. State, 2020
Table 36: Number of Hospice Providers in America, by Type, in 2018
Table 37: Global Market for Point of Care Diagnostics in Hospital and Critical Care End Use, by Region, Through 2026
Table 38: Global Market for Point of Care Diagnostics, by Region, Through 2026
Table 39: North American Market for Point of Care Diagnostics, by Test Type, Through 2026
Table 40: North American Market for Point of Care Diagnostics, by Product, Through 2026
Table 41: North American Market for Point of Care Diagnostics, by End User, Through 2026
Table 42: North American Market for Point of Care Diagnostics, by Country, Through 2026
Table 43: COVID-19 Confirmed Cases and Deaths in the U.S., by State
Table 44: STI Cases Across Canada, by Gender and Disease Type, 2018
Table 45: European Market for Point of Care Diagnostics, by Test Type, Through 2026
Table 46: European Market for Point of Care Diagnostics, by Product, Through 2026
Table 47: European Market for Point of Care Diagnostics, by End User, Through 2026
Table 48: European Market for Point of Care Diagnostics, by Country, Through 2026
Table 49: Geriatric Population in Germany, 2015-2030
Table 50: Health Spending and Financing in France, 2005-2017
Table 51: New Cancer Cases in Spain, by Type, 2020
Table 52: Asia-Pacific Market for Point of Care Diagnostics, by Test Type, Through 2026
Table 53: Asia-Pacific Market for Point of Care Diagnostics, by Product, Through 2026
Table 54: Asia-Pacific Market for Point of Care Diagnostics, by End User, Through 2026
Table 55: Asia-Pacific Market for Point of Care Diagnostics, by Country, Through 2026
Table 56: Japanese Market Statistics
Table 57: Commonly Used POC Devices in the Indian Healthcare System.
Table 58: Rest of the World Market for Point of Care Diagnostics, by Test Type, Through 2026
Table 59: Rest of the World Market for Point of Care Diagnostics, by Product, Through 2026
Table 60: Rest of the World Market for Point of Care Diagnostics, by End User, Through 2026
Table 61: Middle East and North Africa HIV and AIDS Statistics, 2019
Table 62: Recent Developments in Point of Care Diagnostics Market, 2019-2021
Table 63: Abbaxis: Point of Care Diagnostic/Testing Products
Table 64: Abbott: Financials, 2016-2020
Table 65: Abbott: Product Portfolio, by Business Segment
Table 66: Abbott: Point of Care Diagnostic Products
Table 67: Abbott: Recent Developments, 2021
Table 68: BD: Product Portfolio
Table 69: BioRad Laboratories Product Portfolio
Table 70: Cardinal Health Inc.: Product Portfolio
Table 71: Chembio Diagnostics Inc.: Product Portfolio
Table 72: Chembio Diagnostics: Recent Developments, 2021
Table 73: Danaher Product Portfolio
Table 74: EKF Diagnostics Holdings plc: Product Portfolio
Table 75: ELITech Group: Product Portfolio
Table 76: Esaote S.p.A.: Product Portfolio
Table 77: GE: Financial Performance, 2019 and 2020
Table 78: GE Healthcare: Point of Care Diagnostics Products
Table 79: LifeScan Product Portfolio
Table 80: Lumos Diagnostics Holdings Ltd.: Product Portfolio
Table 81: Medtronic plc: Product Portfolio
Table 82: Mindray Medical International Ltd.: Product Portfolio
Table 83: Nexus DX: Product Portfolio
Table 84: Nova Biomedical Product Portfolio
Table 85: OraSure Technologies: Product Portfolio
Table 86: Philips Healthcare: Product Portfolio
Table 87: Quidel Corp.: Product Portfolio
Table 88: F. Hoffmann-La Roche Ltd.: Financials, 2019
Table 89: F. Hoffmann-La Roche Ltd.: Revenue, by Diagnostic Segment, 2016-2018
Table 90: F. Hoffmann-La Roche Ltd.: Product Portfolio
Table 91: F. Hoffmann-La Roche Ltd.: Recent Developments, 2021
Table 92: Siemens Healthcare GmbH: Product Segments
Table 93: Siemens Healthcare GmbH: Point of Care Diagnostics Products
Table 94: Siemens Healthcare GmbH: Financials, 2019
Table 95: Siemens Healthcare GmbH: Key Developments, 2020
Table 96: Thermo Fisher Scientific: Product Portfolio
Table 97: Thermo Fisher Scientific: Key Developments, 2021
Table 98: Zoetis Inc. Product Portfolio

List of Figures
Summary Figure A: Global Market for Point of Care Diagnosis, by Region, 2019-2026
Summary Figure B: Global Market Shares of Point of Care Diagnosis, by Region, 2020
Figure 1: Distribution of Malaria Cases, by Country, 2018
Figure 2: Incidences of Diagnosed Infectious Disease, by Country, 2019
Figure 3: Flow of Funding for Disease Research, 2014-2018
Figure 4: Worldwide Funding in Tuberculosis Research and Development, by Institutions, 2019
Figure 5: Estimated Global Population, by Selected Age Group and Selected Years, 2000-2030
Figure 6: Global Population Age 60+, 2014-2022
Figure 7: Trends in the Number of Deaths Due to Chronic Disease, 2005-2020
Figure 8: Global Market Shares of Point of Care Diagnostics, by Test Type, 2020
Figure 9: Global Market Shares of Point of Care Diagnostics, by Test Type, 2019-2026
Figure 10: Number of People Aged 65 Years and Above, by Region, 2019 and 2050
Figure 11: Global Market for BGEM, 2019-2026
Figure 12: Global Market for BGEM, by Region, 2019-2026
Figure 13: Global Deaths from CVD, 2015 and 2030
Figure 14: Global Market for Cardiac Markers, 2019-2026
Figure 15: Global Market for Cardiac Markers, by Region, 2019-2026
Figure 16: Global Market for Cholesterol Testing/Monitoring, 2019-2026
Figure 17: Global Market for Cholesterol Testing/Monitoring, by Region, 2019-2026
Figure 18: Global Market for Drug and Alcohol Screening, 2019-2026
Figure 19: Global Market for Drug and Alcohol Screening, by Region, 2019-2026
Figure 20: Global Market for Glucose Testing and Monitoring, 2019-2026
Figure 21: Global Market for Glucose Testing and Monitoring, by Region, 2019-2026
Figure 22: Number of New HIV Infections in 2019, by Region
Figure 23: Global Market for Infectious Disease Testing, 2019-2026
Figure 24: Global Market for Infectious Disease Testing, by Region, 2019-2026
Figure 25: Global Market for Pregnancy and Fertility Testing, 2019-2026
Figure 26: Global Market for Pregnancy and Fertility Testing, by Region, 2019-2026
Figure 27: Global Market for Hemoglobin and Hemostasis, 2019-2026
Figure 28: Global Market for Hemoglobin and Hemostasis, by Region, 2019-2026
Figure 29: Global Deaths from Cancer, 2015 and 2030
Figure 30: Global Market for Tumor Markers, 2019-2026
Figure 31: Global Market for Tumor Markers, by Region, 2019-2026
Figure 32: Global Market for Urinalysis/Urine Chemistry, 2019-2026
Figure 33: Global Market for Urinalysis/Urine Chemistry, by Region, 2019-2026
Figure 34: Global Market for Others, 2019-2026
Figure 35: Global Market for Others, by Region, 2019-2026
Figure 36: Global Market Shares of Point of Care Diagnostics, by Product, 2020
Figure 37: Global Market for Hardware in Point of Care Diagnostics, 2019-2026
Figure 38: Global Market for Hardware in Point of Care Diagnostics, by Region, 2019-2026
Figure 39: Global Market for Software in Point of Care Diagnostics, 2019-2026
Figure 40: Global Market for Software in Point of Care Diagnostics, by Region, 2019-2026
Figure 41: Global Market Shares of Point of Care Diagnostics, by End User, 2020
Figure 42: Global Market for Point of Care Diagnostics in Home Care Settings, 2019-2026
Figure 43: Global Market for Point of Care Diagnostics in Home Care Settings, by Region, 2019-2026
Figure 44: Number of Operating Hospice Facilities in the U.S., 2014-2018
Figure 45: Global Market for Point of Care Diagnostics in Hospital and Critical Care Centers, 2019-2026
Figure 46: Global Market for Point of Care Diagnostics in Hospital and Critical Care Centers, by Region, 2019-2026
Figure 47: Global Market for Point of Care Diagnostics, by Region, 2019-2026
Figure 48: Global Market Shares of Point of Care Diagnostics, by Region, 2020
Figure 49: North American Market Shares of Point of Care Diagnostics, by Country, 2020
Figure 50: Venture Investment in Infectious Disease Companies Across U.S., 2006-2018
Figure 51: The U.S. Market for Point of Care Diagnostics, 2019-2026
Figure 52: Canadian Market for Point of Care Diagnostics, 2019-2026
Figure 53: Geriatric Population in Germany, 2000-2030
Figure 54: German Market for Point of Care Diagnostics, 2019-2026
Figure 55: U.K. Market for Point of Care Diagnostics, 2019-2026
Figure 56: Health Spending and Financing in France, 2005-2017
Figure 57: French Market for Point of Care Diagnostics, 2019-2026
Figure 58: Italian Market for Point of Care Diagnostics, 2019-2026
Figure 59: Deaths Due to Infectious and Parasitic Diseases in Spain in 2018, by Age Group
Figure 60: New Cancer Cases in Spain, by Type, 2020
Figure 61: Spanish Market for Point of Care Diagnostics, 2019-2026
Figure 62: Rest of the European Market for Point of Care Diagnostics, 2019-2026
Figure 63: Allocation of Diagnosed Infectious Diseases in Selected Countries, by Gender, 2019
Figure 64: Chinese Incidence of Infectious Diseases, by Type, 2019
Figure 65: Chinese Incidence of STDs, by Type, 2019
Figure 66: Chinese Market for Point of Care Diagnostics, 2019-2026
Figure 67: Trends in Aging in Japan, 2010-2040
Figure 68: Japanese Market for Point of Care Diagnostics, 2019-2026
Figure 69: Limitations of Using POC Devices in India
Figure 70: Indian Market for Point of Care Diagnostics, 2019-2026
Figure 71: Rest of Asia-Pacific Market for Point of Care Diagnostics, 2019-2026
Figure 72: Rest of the World Market for Point of Care Diagnostics, 2019-2026
Figure 73: Global Manufacturer/Supplier Market Shares of Point of Care Diagnostics, 2020
Figure 74: Strategies Adopted by Key Market Players
Figure 75: Abbott: Revenue Share, by Region/Country, 2019
Figure 76: Abbott: Revenue Share, by Business Segment, 2019
Figure 77: BD: Annual Revenue, 2018-2020
Figure 78: BD: Revenue Share, by Region, 2020
Figure 79: BD: Revenue Share, by Business Segment, 2020
Figure 80: Danaher Corp.: Annual Revenue, 2018-2020
Figure 81: Danaher Corp.: Revenue Share, by Geography, 2020
Figure 82: Danaher Corp.: Revenue Share, by Segment, 2020
Figure 83: GE: Revenue Share, by Business Segment, 2020
Figure 84: GE Healthcare: Revenue Share, by Region, 2020
Figure 85: F. Hoffmann-La Roche Ltd.: Revenue Share, by Segment, 2019
Figure 86: F. Hoffmann-La Roche Ltd.: Revenue Share, by Region/Country, 2019
Figure 87: Siemens Healthcare GmbH: Revenue Share, by Business Segment, 2019
Figure 88: Siemens Healthcare GmbH: Revenue Share, by Region, 2019
Figure 89: Thermo Fisher Scientific: Annual Revenue, 2019-2020
Figure 90: Thermo Fisher Scientific: Revenue Share, by Region, 2020
Figure 91: Thermo Fisher Scientific: Revenue Share, by Segment, 2020

Executive Summary

Globally, the diagnostic testing business is a multi-billion-dollar industry with intense competition and areas of high growth. The United States is the world’s largest single market for diagnostic testing. This study focuses on POC testing, which is one of the most active segments within the diagnostic industry.

POC testing is growing in both home use and POC testing near-patient applications. Both segments are included in this market study.

The global market for point of care diagnostics was valued at $24.8 billion in 2021. The market is expected to grow at a compound annual growth rate (CAGR) of 11.9% to reach $43.5 billion by 2026. The major factor contributing to the growth of the POC diagnostics market is the rising prevalence of infectious diseases. POC tests help to 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.

Funding and grants from governments for the advancement and development of innovative products are contributing towards the adoption of innovative technologies for infectious diseases diagnosis. All such innovation within the market is expected to increase the reach of POC devices to remote areas in developing and underdeveloped countries and make them pocket friendly and can be adopted by the economically challenged populace. The increasing prevalence of diabetes and other chronic diseases is also contributing towards growth in the global market.

The strict regulation for approval and commercialization is the primary factor restraining the growth of the market. POC devices are being regulated as other diagnostics devices and In-Vitro devices that are regulated by U.S. Food and Drug Administration (FDA). POC devices are considered by FDA as high risk and therefore require pre-market approval. Strict healthcare standards and high regulatory barriers have a significant impact on the introduction of innovative technology. The regulations and standards are strict and require substantial expertise to navigate; this resulted in increased times for pre-market approval and commercialization process.

Companies Mentioned

• Abaxis
• Abbott
• Becton, Dickinson And Co.
• Bio-Rad Laboratories Inc.
• Cardinal Health
• Chembio Diagnostics
• Danaher Corp.
• Ekf Diagnostics Holdings Plc
• Elitech Group
• Esaote S.P.A.
• General Electric
• Lifescan
• Lumos Diagnostics Holdings Ltd.
• Medtronic Plc
• Mindray Medical International Ltd.
• Nexus Dx
• Nova Biomedical
• Orasure Technologies
• Philips Healthcare
• Quidel
• Roche Holding Ag (F. Hoffmann-La Roche Ltd.)
• Siemens Healthcare
• Thermo Fisher Scientific Inc.
• Zoetis Inc.