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體外診斷 POC診斷

市場調查報告書

商品編碼

1804277

POCT (就地檢驗) 的全球市場:產品·檢驗類型·適應症·技術·樣品類型·購買形態·終端用戶·流通管道·各地區 - 市場規模·產業動態·機會分析·預測 (2025～2033年)

Global Point-of-Care Testing Market: By product, Test Type, Indication, Technology, Sample Type, Mode of Purchase, End Users, Distribution Channel, Region-Market Size, Industry Dynamics, Opportunity Analysis and Forecast for 2025-2033

出版日期: 2025年07月16日 | 出版商:

Astute Analytica | 英文 260 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

由於對快速診斷解決方案的需求不斷增長，尤其是在分散式醫療環境中，全球即時檢驗 (POCT) 市場正經歷重大轉型。預計市場規模將從 2024 年的 4,648 萬美元成長至 2033 年的 8,555 萬美元，預測期內的複合年增長率為 7.33%。糖尿病和心血管疾病等慢性疾病的盛行率不斷上升，以及對傳染病快速診斷的需求，正在推動市場擴張。

許多醫療機構正在從傳統的集中式檢測過渡到即時檢驗 (POCT)，這可以加快決策速度並提高可及性。這種轉變也體現在採用率上，使用即時診斷檢測 (POCT) 的醫療機構數量將從 2020 年的 42,000 家增加到 2024 年的 68,000 家。這些進步實現了即時患者數據分析，在糖尿病管理、心臟事件監測和急救等領域發揮關鍵作用。

市場區隔

依產品類型劃分，檢測試劑盒和耗材因其重複性和診斷重要性，佔市場主導地位，市場佔有率達 65.55%。這包括血糖試紙（128 億美元）、側流檢測試劑盒（84 億美元）和凝血監測試劑盒。它們在常規和緊急檢測中的廣泛使用持續推動著收入成長。製造技術的進步也在推動成本降低和擴大可近性。

按檢測類型劃分，免疫學即時診斷 (POCT) 佔市場主導地位，佔全球收入的 41.41% 以上。這些檢測能夠快速、現場診斷愛滋病毒、肝炎、心臟病和其他疾病。其易用性和成本效益（每次檢測約 2.85 美元）使其成為城市和服務不足地區快速診斷的基礎。

按適應症劃分，傳染病是主要應用領域，佔超過 31.30% 的市場。呼吸道感染、愛滋病毒和肝炎的高發病率，以及公共衛生對大規模檢測的需求，鞏固了該領域的主導地位。 2024 年，全球進行了超過 28 億次呼吸道檢測和 14 億次胃腸道病原體檢測。

區域洞察

北美

北美是全球領先者，2024 年收入超過 186.4882 億美元，這得益於廣泛的保險覆蓋和強大的醫療保健基礎設施。美國是最大的市場，擁有23.8萬家診所，每年進行18億次檢測。領先研究機構和政府機構的大規模投資確保了持續的技術進步和市場滲透。

亞太地區

亞太地區是成長最快的地區，複合年增長率高達8.27%。中國、印度、日本和東南亞等國家的醫療現代化正受到政府大量資金的推動。例如，印度的 "印度醫療衛生計畫" （Ayushman Bharat）服務超過5億人，對即時診斷（POCT）的需求龐大。此外，本地製造和公私合作也進一步增強了區域能力。

歐洲

歐洲國家也正在透過歐盟招標、集中醫療保健計畫以及廣泛採用抗菌素抗藥性檢測等方式加大力度。德國、法國和英國等國家正在透過全民健康覆蓋和創新撥款來增加即時診斷（POCT）的可及性。

本報告研究了全球 POCT（即時檢驗）市場，並提供了市場概況、影響市場成長的各種因素分析、市場規模趨勢和預測、各細分市場的詳細分析、競爭格局以及主要公司的概況。

The global Point-of-Care Testing (POCT) Market is undergoing a significant transformation, driven by the rising demand for rapid diagnostic solutions, especially in decentralized healthcare environments. Valued at US$ 46.48 million in 2024, the market is forecast to reach US$ 85.55 million by 2033, growing at a CAGR of 7.33% between 2025 and 2033. The accelerating prevalence of chronic illnesses such as diabetes and cardiovascular disorders, combined with the need for swift diagnosis of infectious diseases, is propelling market expansion.

A growing number of healthcare facilities are transitioning from centralized lab-based testing to POCT for faster decision-making and greater accessibility. The adoption rate reflects this shift, with 68,000 healthcare sites worldwide integrating POCT in 2024, compared to 42,000 in 2020. This evolution enables real-time patient data analysis, particularly critical in managing diabetes, monitoring cardiac events, and administering treatment during emergencies.

Noteworthy Market Developments

The year 2024 saw 67 new POCT devices cleared by the FDA, a testament to the market's innovation momentum. Several of these solutions are equipped with AI capabilities and integrated with Electronic Health Records (EHRs) to streamline clinical workflows. Multiplex assays capable of detecting multiple pathogens from a single sample are also revolutionizing diagnostics by reducing testing complexity and result turnaround time.

Concurrently, the at-home testing segment is expanding rapidly, supported by regulatory endorsements such as the FDA's clearance of an over-the-counter dual test for influenza and COVID-19 in early 2025. Companies are investing in developing portable PCR-based systems and mobile diagnostics suited for emergency and rural environments. The direct-to-consumer market alone is expected to grow from US$ 7.8 billion in 2025 to over US$ 11.8 billion by 2035.

Strategic partnerships, acquisitions, and technology funding have shaped a competitive environment where companies such as Roche, Abbott, and Danaher are not only consolidating their market position but also pioneering advanced diagnostics through AI, cloud connectivity, and miniaturized devices.

Core Growth Drivers

Chronic Disease Burden: Increasing global incidence of diabetes, cardiovascular disorders, and infectious diseases demanding continual monitoring.
Rapid Diagnostics Demand: Emergency and remote settings necessitate quicker turnaround times, fueling POCT adoption.
Technological Integration: AI, cloud computing, and smartphone compatibility are enhancing test accuracy and accessibility.
Regulatory Acceleration: Government incentives and expedited device approvals are encouraging market entry and innovation.
Decentralized Healthcare Models: Shifting care delivery to homes, pharmacies, and community health centers is creating sustained demand.

Emerging Technology Trends

AI in Diagnostics: Integration of machine learning to interpret results and guide clinical decisions is becoming a standard feature in new POCT devices.
Multiplex POCT Assays: Advanced tests that detect multiple biomarkers in one go are growing at a projected rate of 25%.
Smartphone Connectivity: The number of devices linked to smartphones is set to increase by 30%, facilitating remote care models.
Cloud-Based Reporting: The use of cloud platforms for real-time result sharing and storage is expected to grow by 35% over the next few years.
Miniaturized Platforms: Portable diagnostics, such as mobile CT and PCR devices, are making POCT viable even in ambulances and rural settings.

Barriers to Optimization

High Cost of Advanced Devices: AI-integrated and multiplex systems come with significant capital and operational expenses.
Training and Standardization Gaps: Ensuring accuracy in non-laboratory environments remains a challenge due to variability in user expertise.
Regulatory Complexity Across Regions: Diverse regulations for OTC vs. prescription-based testing can complicate global product rollouts.
Data Security: The rise in cloud-based diagnostics raises cybersecurity concerns related to patient data.

Market Segment Analysis

The Testing Kits & Consumables category leads the market with a 65.55% share, driven by their recurring nature and indispensable use in diagnostics. These include high-demand items like glucose test strips (US$ 12.8 billion), lateral flow cartridges (US$ 8.4 billion), and coagulation monitoring kits. Their role in routine and emergency testing ensures a continuous revenue stream, with advanced manufacturing helping reduce costs and widen accessibility.

From a test-type perspective, Immunological PoC Tests dominate the landscape, contributing over 41.41% of global revenue. These tests enable fast, point-of-use diagnosis of conditions like HIV, hepatitis, and cardiac diseases. Their ease of use and cost-effectiveness (as low as US$ 2.85/test) have made them the cornerstone of rapid diagnostics in both urban and underserved settings.

In terms of indication, Infectious Diseases remain the primary application, accounting for over 31.30% of the market. High incidence rates of conditions like respiratory infections, HIV, and hepatitis, combined with public health mandates for mass testing, reinforce this segment's leadership. More than 2.8 billion respiratory tests and 1.4 billion gastrointestinal pathogen tests were conducted globally in 2024.

Additionally, Prescription-Based Testing remains the dominant mode, holding a 53.25% share. These tests, such as HbA1c and metabolic panels, require physician oversight and are tightly integrated into insurance reimbursement and regulatory frameworks, ensuring quality and proper clinical guidance.

Market Segmentation

By Product

Devices & Instruments
Diagnostic Analyzers & Testing Devices
Blood Gas & Electrolyte Analyzers
Cardiac Biomarker Analyzers
Glucose Monitoring Devices
Coagulation Testing Analyzers
Urinalysis Analyzers
Routine Clinical Chemistry Analyzers
Others
Monitoring Devices
Blood Pressure Monitors
Thermometers
Pulse Oximeters
Others
Testing Kits & Consumables
Blood Gas & Electrolyte Test Kits
Cardiac Biomarker Test Kits
Routine Clinical Chemistry Test Kits
Hematology Test Kits Coagulation Testing Kits
Urinalysis Test Strips & Kits
Cholesterol Test Strips
Drugs Abuse Testing Kits
Pregnancy And Fertility Testing Kits
Others

By Test Type

Immunological PoC Tests
Nucleic Acid-Based PoC Tests
Biomarker-Based PoC Tests

By Indication

Infectious Diseases
HIV
COVID-19
Others
Oncology
Cardiovascular Diseases
Metabolic Disorders
Respiratory Diseases
Neurological Disorders
Gastrointestinal Disorders
Others

By Technology

Biosensor Technology
Microfluidic Lab-On-A-Chip Technology
Molecular Diagnostics
Immunoassays
Others

By Sample Type

Blood
Urine
Saliva
Others

By Mode Of Purchase

Prescription-based Testing
Over the Counter (OTC) Testing

By End User

Hospitals & Clinics
Diagnostic Centers
Homecare Settings
Research Laboratories
Others

By Distribution Channel

Direct Distribution
Retail Pharmacies
Online Pharmacies
Others

Geographic Insights

North America

North America stands as the global leader, with 2024 revenue exceeding US$ 18,648.82 million, supported by extensive insurance coverage and robust healthcare infrastructure. The U.S., in particular, is the top-performing country, conducting 1.8 billion annual tests across 238,000 physician offices. Massive investment from leading institutions and government bodies ensures continued technological advancement and market penetration.

Asia Pacific

Asia Pacific is the fastest-growing region with a CAGR of 8.27%. Healthcare modernization across countries such as China, India, Japan, and Southeast Asia is bolstered by massive government funding. For instance, India's Ayushman Bharat scheme serves over 500 million citizens, driving high-volume POCT demand. Local manufacturing and public-private partnerships further amplify regional capabilities.

Europe

European nations are also ramping up efforts through EU tenders, centralized healthcare initiatives, and widespread adoption of antimicrobial resistance testing. Countries like Germany, France, and the UK are enhancing POCT accessibility through universal health schemes and innovation grants.

By Region

North America
The U.S.
Canada
Mexico
Europe
Western Europe
The UK
Germany
France
Italy
Spain
Rest of Western Europe
Eastern Europe
Poland
Russia
Hungary
Rest of Eastern Europe
Asia Pacific
China
India
Japan
South Korea
Australia & New Zealand
ASEAN
Rest of Asia Pacific
Middle East
UAE
Saudi Arabia
Bahrain
Kuwait
Qatar
Rest of Middle East
Africa
Morocco
Egypt
Nigeria
South Africa
Rest of Africa
South America
Argentina
Brazil
Rest of South America

Leading Market Participants

Abbott Laboratories
F. Hoffmann-La Roche Ltd
Danaher Corporation
Becton, Dickinson and Company (BD)
bioMerieux SA
Bio-Rad Laboratories, Inc.
Other Prominent Players

Table of Content

Chapter 1. Research Framework

1.1. Research Objective
1.2. Type Overview
1.3. Market Segmentation

Chapter 2. Research Methodology

2.1. Qualitative Research
- 2.1.1. Primary & Secondary Sources
2.2. Quantitative Research
- 2.2.1. Primary & Secondary Sources
2.3. Breakdown of Primary Research Respondents, By Region
2.4. Assumption for the Study
2.5. Market Size Estimation
2.6. Data Triangulation

Chapter 3. Executive Summary: Global Point-of-Care Testing Market

Chapter 4. Global Point-of-Care Testing Market Overview

4.1. Industry Value Chain Analysis
- 4.1.1. Material Provider
- 4.1.2. Manufacturer
- 4.1.3. Distributor
- 4.1.4. End User
4.2. Industry Outlook
4.3. PESTLE Analysis
4.4. Porter's Five Forces Analysis
- 4.4.1. Bargaining Power of Suppliers
- 4.4.2. Bargaining Power of Buyers
- 4.4.3. Threat of Substitutes
- 4.4.4. Threat of New Entrants
- 4.4.5. Degree of Competition
4.5. Market Dynamics and Trends
- 4.5.1. Growth Drivers
- 4.5.2. Restraints
- 4.5.3. Opportunities
- 4.5.4. Key Trends
4.6. Market Growth and Outlook
- 4.6.1. Market Revenue Estimates and Forecast (US$ Mn), 2020-2033
- 4.6.2. Price Trend Analysis
4.7. Competition Dashboard
- 4.7.1. Market Concentration Rate
- 4.7.2. Company Market Share Analysis (Value %), 2024
- 4.7.3. Competitor Mapping & Benchmarking
4.8. Actionable Insights (Analyst's Recommendations)

Chapter 5. Global Point-of-Care Testing Market Analysis, By Product

5.1. Key Insights
5.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 5.2.1. Devices & Instruments
  - 5.2.1.1. Diagnostic Analyzers & Testing Devices
    - 5.2.1.1.1. Blood Gas & Electrolyte Analyzers
    - 5.2.1.1.2. Cardiac Biomarker Analyzers
    - 5.2.1.1.3. Glucose Monitoring Devices
    - 5.2.1.1.4. Coagulation Testing Analyzers
    - 5.2.1.1.5. Urinalysis Analyzers
    - 5.2.1.1.6. Routine Clinical Chemistry Analyzers
    - 5.2.1.1.7. Others
  - 5.2.1.2. Monitoring Devices
    - 5.2.1.2.1. Blood Pressure Monitors
    - 5.2.1.2.2. Thermometers
    - 5.2.1.2.3. Pulse Oximeters
    - 5.2.1.2.4. Others
- 5.2.2. Testing Kits & Consumables
  - 5.2.2.1. Blood Gas & Electrolyte Test Kits
  - 5.2.2.2. Cardiac Biomarker Test Kits
  - 5.2.2.3. Routine Clinical Chemistry Test Kits
  - 5.2.2.4. Hematology Test Kits Coagulation Testing Kits
  - 5.2.2.5. Urinalysis Test Strips & Kits
  - 5.2.2.6. Cholesterol Test Strips
  - 5.2.2.7. Drugs Abuse Testing Kits
  - 5.2.2.8. Pregnancy And Fertility Testing Kits
  - 5.2.2.9. Others

Chapter 6. Global Point-of-Care Testing Market Analysis, By Test Type

6.1. Key Insights
6.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 6.2.1. Immunological PoC Tests
- 6.2.2. Nucleic Acid-Based PoC Tests
- 6.2.3. Biomarker-Based PoC Tests

Chapter 7. Global Point-of-Care Testing Market Analysis, By Indication

7.1. Key Insights
7.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 7.2.1. Infectious Diseases
  - 7.2.1.1. HIV
  - 7.2.1.2. COVID-19
  - 7.2.1.3. Others
- 7.2.2. Oncology
- 7.2.3. Cardiovascular Diseases
- 7.2.4. Metabolic Disorders
- 7.2.5. Respiratory Diseases
- 7.2.6. Neurological Disorders
- 7.2.7. Gastrointestinal Disorders
- 7.2.8. Others

Chapter 8. Global Point-of-Care Testing Market Analysis, By Technology

8.1. Key Insights
8.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 8.2.1. Biosensor Technology
- 8.2.2. Microfluidic Lab-On-A-Chip Technology
- 8.2.3. Molecular Diagnostics
- 8.2.4. Immunoassays
- 8.2.5. Others

Chapter 9. Global Point-of-Care Testing Market Analysis, By Sample Type

9.1. Key Insights
9.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 9.2.1. Blood
- 9.2.2. Urine
- 9.2.3. Saliva
- 9.2.4. Others

Chapter 10. Global Point-of-Care Testing Market Analysis, By Mode of Purchase

10.1. Key Insights
10.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 10.2.1. Prescription-based Testing
- 10.2.2. Over the Counter (OTC) Testing

Chapter 11. Global Point-of-Care Testing Market Analysis, By End User

11.1. Key Insights
11.2. Market Size and Forecast, 2020-2033 (US$ Mn)

Chapter 12. Global Point-of-Care Testing Market Analysis, By Distribution Channel

12.1. Key Insights
12.2. Market Size and Forecast, 2020-2033 (US$ Mn)

Chapter 13. Global Point-of-Care Testing Market Analysis, By Region

13.1. Key Insights
13.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 13.2.1. North America
  - 13.2.1.1. The U.S.
  - 13.2.1.2. Canada
  - 13.2.1.3. Mexico
- 13.2.2. Europe
  - 13.2.2.1. Western Europe
    - 13.2.2.1.1. The UK
    - 13.2.2.1.2. Germany
    - 13.2.2.1.3. France
    - 13.2.2.1.4. Italy
    - 13.2.2.1.5. Spain
    - 13.2.2.1.6. Rest of Western Europe
  - 13.2.2.2. Eastern Europe
    - 13.2.2.2.1. Poland
    - 13.2.2.2.2. Russia
    - 13.2.2.2.3. Rest of Eastern Europe
- 13.2.3. Asia Pacific
  - 13.2.3.1. China
  - 13.2.3.2. India
  - 13.2.3.3. Japan
  - 13.2.3.4. South Korea
  - 13.2.3.5. Australia & New Zealand
  - 13.2.3.6. ASEAN
  - 13.2.3.7. Rest of Asia Pacific
- 13.2.4. Middle East & Africa
  - 13.2.4.1. UAE
  - 13.2.4.2. Saudi Arabia
  - 13.2.4.3. South Africa
  - 13.2.4.4. Rest of MEA
- 13.2.5. South America
  - 13.2.5.1. Argentina
  - 13.2.5.2. Brazil
  - 13.2.5.3. Rest of South America

Chapter 14. North America Point-of-Care Testing Market Analysis

14.1. Key Insights
14.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 14.2.1. By Product
- 14.2.2. By Test Type
- 14.2.3. By Indication
- 14.2.4. By Technology
- 14.2.5. By Sample Type
- 14.2.6. By Mode of Purchase
- 14.2.7. By End User
- 14.2.8. By Distribution Channel
- 14.2.9. By Country

Chapter 15. Europe Point-of-Care Testing Market Analysis

15.1. Key Insights
15.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 15.2.1. By Product
- 15.2.2. By Test Type
- 15.2.3. By Indication
- 15.2.4. By Technology
- 15.2.5. By Sample Type
- 15.2.6. By Mode of Purchase
- 15.2.7. By End User
- 15.2.8. By Distribution Channel
- 15.2.9. By Country

Chapter 16. Asia Pacific Point-of-Care Testing Market Analysis

16.1. Key Insights
16.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 16.2.1. By Product
- 16.2.2. By Test Type
- 16.2.3. By Indication
- 16.2.4. By Technology
- 16.2.5. By Sample Type
- 16.2.6. By Mode of Purchase
- 16.2.7. By End User
- 16.2.8. By Distribution Channel
- 16.2.9. By Country

Chapter 17. Middle East & Africa Point-of-Care Testing Market Analysis

17.1. Key Insights
17.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 17.2.1. By Product
- 17.2.2. By Test Type
- 17.2.3. By Indication
- 17.2.4. By Technology
- 17.2.5. By Sample Type
- 17.2.6. By Mode of Purchase
- 17.2.7. By End User
- 17.2.8. By Distribution Channel
- 17.2.9. By Country

Chapter 18. South America Point-of-Care Testing Market Analysis

18.1. Key Insights
18.2. Market Size and Forecast, 2020-2033 (US$ Mn)
- 18.2.1. By Product
- 18.2.2. By Test Type
- 18.2.3. By Indication
- 18.2.4. By Technology
- 18.2.5. By Sample Type
- 18.2.6. By Mode of Purchase
- 18.2.7. By End User
- 18.2.8. By Distribution Channel
- 18.2.9. By Country