Point of Care Diagnostics: Technologies and Global Markets

Report Scope:

The current report offers a detailed picture of the point of care diagnostics market.

This report highlights the current and future market potential for point of care diagnostics and provides a detailed analysis of the competitive environment, regulatory scenario, drivers, restraints, opportunities, and trends in the market. The report also covers market projections through 2026, as well as key market players.

This report discusses the point of care diagnostics industry and its various resources. It covers the overall point of care diagnostics market including hardware (devices, equipment, consumables (reagents and kits)), software and analytics. The report further analyzes the market based on test type, providing an analysis of alcohol and drug abuse, BGEM, cardiac markers, cholesterol, glucose monitoring, hemoglobin/hemostasis, infectious disease, pregnancy and fertility, tumor markers, urine chemistry and others. A complete regional analysis of the market is also studied in the report.

Based on geography, the market has been segmented into North America, Europe, Asia-Pacific, Latin America, the Middle East and Africa. Detailed analyses of major countries include the U.S., Canada, Germany, the U.K., France, Spain, Italy, Japan, China, and India. For market estimates, data have been provided for 2020 as the base year, with forecasts for 2021 through 2026. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars that have not been adjusted for inflation.

Report Includes:

- 59 data tables and 40 additional tables
- An overview of the global markets and technologies for point of care (POC) diagnostics within healthcare industry
- Estimation of market size and analyses of global market trends, with data from 2019, 2020, estimates for 2021 and projections of compound annual growth rates (CAGRs) through 2026
- Evaluation of current market trends, and technological advancements within the industry and market share analysis by test type, product, end user, and region
- Coverage of novel approaches for the POC; discussion on significance of CLIA in the United States and FDAs role in POC testing; and information on laser PCR
- Detailed description about COVID-19 impact on MedTech and medical tourism, discussion on FDAs contribution to COVID-19 diagnostic testing and synopsis of FDA-Associated testing milestones since May 2020
- Detailed analysis of relevant R&D activities, new products launches and product enhancement in the industry, clinical trials, and discussion of regulatory elements that are affecting the future marketplace
- Market share analysis of the key companies of the industry and coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies
- Company profiles of major players of the industry, including Abbott, Siemens Healthcare GmbH, F. Hoffmann-La Roche Ltd, Medtronic plc, Chembio Diagnostics Inc. and Philips Healthcare
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 worlds 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 $REDACTED billion in 2020. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED% to reach $REDACTED billion by 2026. The major factor contributing to the growth of the POC diagnostics market is the rising prevalence ofinfectious diseases. POC tests helps to enhance management of infectious diseases, particularly indeveloping countries where it is difficult to access timely diagnosis due to lack of healthcareinfrastructure. For instance, in 2020, around REDACTED million people globally are living with HIV according to United Nations Program on HIV/AIDS. According to World Health Organization, HIV/AIDS accounted at REDACTED deaths globally that ranked REDACTED in most deadly diseases globally in 2019. Moreover, lowerrespiratory infection ranked REDACTED in worlds most deadly diseases and accounted for around REDACTED million deaths in 2019. Additionally, funding and grants from government for advancement and development ofinnovative products also 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 under developed countries and make them pocket friendly and can be adopted by economically challenged populace. Increasing prevalence of diabetes and otherchronic diseases is also contributing towards growth in 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 significant impact on the introduction of innovative technology. The regulations and standards are strict and requires substantial expertise to navigate; this resulted in increased times for pre-market approval and commercialization process.
Table of Contents
Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Whats New in this Report?
Scope of Report
Defining POC Testing
Information Sources
Methodology
Geographic Breakdown
Analysts Credentials
BCC Custom Research
Related BCC 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 FDAs 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
FDAs 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

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, 2018October 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

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

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