PoC診断の技術と世界市場

Report Highlights

The global market for point-of-care diagnostics was valued at $36.9 billion in 2023. It is expected to grow from $40.6 billion in 2024 to $65.9 billion by the end of 2029, at a compound annual growth rate (CAGR) of 10.2% from 2024 through 2029.

ポイントオブケア（PoC）診断の世界市場は、2023 年に 369 億ドルと評価されています。市場は 2024 年の 406 億ドルから、2029 年末までに 659 億ドルまで、年平均成長率 (CAGR) 10.2% で成長すると予想されています。

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 HIV[1]related 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.

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 Synopsis

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.

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

1. 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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