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体外诊断 POC诊断

市场调查报告书

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1629918

全球护理诊断市场 - 2025-2033

Global Point of Care Diagnostics Market - 2025-2033

出版日期: 2024年12月30日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2个工作天内

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简介目录

2023年，全球护理诊断市场规模达423亿美元，预计2033年将达到1,073亿美元，2025-2033年预测期间复合年增长率为9.6%。

护理点检测 (POCT) 是一种用于患者护理的临床实验室方法，可为治疗实施提供快速结果。电子设备小型化和仪器改进等技术进步彻底改变了 POCT，使设备变得更小、更准确。它可以由各种医疗保健专业人员或患者自行执行。本篇综述探讨了 POCT 的方法、益处、利用率和可能干扰 POCT 的因素，强调跨专业团队在评估和治疗患者方面的重要性。透过将 POCT 整合到患者护理中，可以改善结果和患者满意度。

市场动态：

驱动程式和限制

科技进步的崛起

技术进步正在改变全球即时诊断 (POC) 市场，提高测试的准确性、速度和简易性。微型设备、生物感测器、微流体和先进的分子诊断技术等创新可改善诊断结果。 POC 设备中人工智慧和机器学习的整合可实现快速资料分析和预测洞察。无线连接和智慧型手机整合支援远距医疗和远端患者监护，使资源有限的环境受益，并在全球范围内提供及时、高效的诊断。

例如，2023年5月，Sensible Diagnostics计划在2024年之前推出10分钟POC PCR仪器，重点在于传染病。 Abbott 推出了 ID NOW，这是世界上最快的分子 POC 测试，可在 13 分钟内提供 COVID-19 结果。这些发展预计将推动医疗保健产业的发展，因为政府遏制医疗保健支出和限制传染病发病率的倡议将成为推动力。

此外，2023年1月，Cipla Ltd.推出了经CE IVD认证的Cippoint即时检测设备，该设备使用免疫萤光在3至15分钟内测试各种健康参数，包括心臟病、代谢和感染。这种自动、使用者友善的设备有助于在小型医疗机构、农村地区和行动诊所进行更快的诊断。

品质控制和结果报告

POC 测试面临品质控制和结果报告方面的挑战，这可以透过无线实验室资讯系统连接来解决。测试错误是另一个挑战，家庭测试应该足够稳健，才能获得与中心实验室一样好的结果。在 POC 测试中也会观察到分析干扰，如果结果与临床或其他测试结果不符，连续稀释可以确认可疑的干扰。现在大多数检测试剂都含有异嗜性抗体阻断剂等阻断剂，以减少干扰。

Point-of-Care Testing (POCT) is a clinical laboratory method used in patient care, providing rapid results for treatment implementation. Technological advancements, like miniaturization of electronics and improved instrumentation, have revolutionized POCT, enabling smaller, more accurate devices. It can be performed by various healthcare professionals or patients themselves. This review explores the methodology, benefits, utilization, and factors that can interfere with POCT, emphasizing the importance of an interprofessional team in evaluating and treating patients. By integrating POCT into patient care, it can lead to improved outcomes and patient satisfaction.

Market Dynamics: Drivers & Restraints

Rise in the Technological Advancements

Technological advancements are transforming the global point-of-care (POC) diagnostics market, enhancing accuracy, speed, and ease of testing. Innovations like miniaturized devices, biosensors, microfluidics, and advanced molecular diagnostic techniques improve diagnostic outcomes. The integration of AI and machine learning in POC devices enables rapid data analysis and predictive insights. Wireless connectivity and smartphone integration support telemedicine and remote patient monitoring, benefiting resource-limited settings and providing timely, efficient diagnostics worldwide.

For instance, in May 2023, Sensible Diagnostics plans to launch a 10 minute POC PCR instrument by 2024, focusing on infectious diseases. Abbott has launched ID NOW, the world's fastest molecular POC test, offering COVID-19 results in 13 minutes. These developments are expected to drive the healthcare industry, as government initiatives to curb healthcare expenditure and limit infectious disease incidence will serve as a driver.

Moreover, in January 2023, Cipla Ltd. has introduced the Cippoint point-of-care testing device, CE IVD-approved, which uses immunofluorescence to test various health parameters, including cardiology, metabolic, and infections, within 3 to 15 minutes. This automatic, user-friendly device facilitates faster diagnosis in smaller healthcare facilities, rural areas, and mobile clinics.

Quality Control and Result Reporting

POC testing faces challenges in quality control and result reporting, which can be addressed through wireless laboratory information system connectivity. Test errors are another challenge, and home tests should be robust to achieve results as good as central labs. Analytical interference is also observed in POC tests, and if results don't match clinical or other test results, serial dilution can confirm suspected interference. Most assay reagents now contain blockers like heterophilic antibody blockers to reduce interference.

Segment Analysis

The global point of care diagnostics market is segmented based on product type, technology, application, end user and region.

Product Type:

Glucose Monitoring Kits segment is expected to dominate the Point of Care Diagnostics market share

The glucose monitoring kits segment holds a major portion of the point of care diagnostics market share and is expected to continue to hold a significant portion of the point of care diagnostics market share during the forecast period.

Glucose monitoring kits are essential in the global point-of-care (POC) diagnostics market, providing real-time monitoring of blood glucose levels. They enable timely adjustments to medication, diet, and lifestyle, improving clinical outcomes and reducing complications. Technological advancements have transformed the functionality of these kits, transitioning from traditional finger-prick devices to sophisticated continuous glucose monitoring systems. The integration of these kits with digital platforms, such as smartphone applications and cloud-based systems, has further transformed diabetes management. Artificial intelligence-powered predictive algorithms offer actionable insights, such as hypoglycemia warnings, enhancing patient safety and proactive care.

For instance, in July 2024, EKF Diagnostics Holdings plc has launched the Biosen C-Line, an advanced version of its rapid benchtop glucose and lactate analyzer. The new analyzer features a colour touch screen, advanced connectivity, and seamless integration with hospital and laboratory IT systems via EKF Link, ensuring quick and secure access to patient results for clinicians.

Application:

Infectious Diseases segment is the fastest-growing segment in Point of Care Diagnostics market share

The infectious diseases segment is the fastest-growing segment in the point of care diagnostics market share and is expected to hold the market share over the forecast period.

Infectious diseases are a significant segment of the global point-of-care (POC) diagnostics market, driven by the need for rapid, accurate, and accessible solutions to combat infection spread. POC diagnostics enable healthcare providers to detect pathogens like bacteria, viruses, and parasites at the patient's location, providing immediate results and timely treatment. These tests are crucial for managing diseases like HIV, tuberculosis, malaria, influenza, and emerging threats like COVID-19. Technological advancements in molecular testing, immunoassays, and biosensor technologies have improved test sensitivity and specificity. POC devices enable disease surveillance and outbreak response in remote or resource-limited settings.

Geographical Analysis

North America is expected to hold a significant position in the point of care diagnostics market share

North America holds a substantial position in the point of care diagnostics market and is expected to hold most of the market share due to its robust healthcare infrastructure, high healthcare funding and advanced technology adoption. The rising prevalence of chronic diseases like diabetes and cardiovascular disorders has led to a demand for POC diagnostic solutions. Government initiatives and reimbursement policies further encourage early disease detection and management. Key market players invest in research and development to introduce innovative, portable, and connected diagnostic devices. The growing trend of home-based healthcare and telemedicine integration also contributes to market growth.

For instance, in December 2024, Point-of-care molecular diagnostics developer AmplifiDx announced that the National Institutes of Health has increased the agency's funding for the company's development of a diagnostic testing system by $954,000, to a total of more than $4.5 Billion.

Europe is growing at the fastest pace in the point of care diagnostics market

Europe holds the fastest pace in the point of care diagnostics market and is expected to hold most of the market share due to the rising healthcare awareness, geriatric population, and demand for decentralized services. The region's focus on early diagnosis and preventive care has led to widespread adoption of POC testing for conditions like diabetes, infectious diseases, and cardiovascular disorders. Strong government support, stringent regulatory frameworks, and emphasis on sustainability have further bolstered the market. The presence of well-established healthcare systems and a preference for home-based and patient-centric care further drive the market's growth.

For instance, in June 2023, Sysmex Europe has introduced a new testing system called the System for rapid detection of antimicrobial susceptibility. The system uses urine samples from patients suspected of urinary tract infections to assess the effectiveness of antimicrobials. The system uses proprietary microfluidic technology to deliver results in as little as 30 minutes, significantly reducing the time required for conventional AST. The System promotes proper use of antimicrobial drugs in primary care settings and contributes to the fight against antimicrobial resistance, a global challenge.

Competitive Landscape

The major global players in the point of care diagnostics market include Abbott Laboratories, Becton, Dickinson and Company (BD), QIAGEN, Roche Diagnostics, Siemens Healthineers, Danaher Corporation, Quidel Corporation, BioMerieux SA, OraSure Technologies, Inc, Trinity Biotech and among others.

Key Developments

In November 2024, PixCell Medical has certified its HemoScreen CBC analyzer under the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. The FDA-cleared, point-of-care 5-part differential Complete Blood Count (CBC) analyzer is the first of its kind to meet the stringent IVDR requirements, solidifying PixCell Medical's position as a pioneer in advancing patient care through rapid, accurate, and portable diagnostic solutions.
In April 2024, Roche Diagnostics India has launched its point-of-care (PoC) NT-proBNP test for screening diabetes patients at risk of cardiovascular diseases like heart failure. This innovative test, available exclusively on the Cobas H 232 system, aims to provide faster, more efficient diagnosis and management of heart failure in type 2 diabetes patients, revolutionizing patient care.

Emerging Players

The emerging players in the point of care diagnostics market include Cepheid, Chembio Diagnostics, GenMark Diagnostics, Mesa Biotech, LumiraDx and among others.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global point of care diagnostics market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Component & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Technology
3.3. Snippet by Application
3.4. Snippet by End User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Rise in the Technological Advancements
- 4.1.2. Restraints
  - 4.1.2.1. Quality Control and Result Reporting
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis

6. By Product Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 6.1.2. Market Attractiveness Index, By Product Type
6.2. Glucose Monitoring Kits*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Infectious Disease Testing Kits
6.4. Cardiometabolic Monitoring Kits
6.5. Pregnancy and Fertility Testing Kits
6.6. Hematology Testing Kits
6.7. Urinalysis Kits
6.8. Tumor/Cancer Markers
6.9. Drugs-of-Abuse Testing Kits
6.10. Others

7. By Technology

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 7.1.2. Market Attractiveness Index, By Technology
7.2. Lateral Flow Assays*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Immunoassays
7.4. Molecular Diagnostics
7.5. Microfluidics
7.6. Others

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. Infectious Diseases*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Cardiology
8.4. Oncology
8.5. Endocrinology
8.6. Hematology
8.7. Neurology
8.8. Drug Testing
8.9. Others

9. By End User

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 9.1.2. Market Attractiveness Index, By End User
9.2. Hospitals & Clinics*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Diagnostic Laboratories
9.4. Home Care Settings
9.5. Ambulatory Surgery Centers (ASCs)

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. U.K.
  - 10.3.7.3. France
  - 10.3.7.4. Spain
  - 10.3.7.5. Italy
  - 10.3.7.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. Abbott Laboratories*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Becton, Dickinson and Company (BD)
12.3. QIAGEN
12.4. Roche Diagnostics
12.5. Siemens Healthineers
12.6. Danaher Corporation
12.7. Quidel Corporation
12.8. BioMerieux SA
12.9. OraSure Technologies, Inc
12.10. Trinity Biotech

LIST NOT EXHAUSTIVE