首頁 > 市場調查報告書 > 醫療設備

體外診斷 POC診斷

市場調查報告書

商品編碼

1629918

全球護理診斷市場 - 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個工作天內

價格

※ 本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

簡介目錄

2023年，全球護理診斷市場規模達423億美元，預計2033年將達到1,073億美元，2025-2033年預測期間複合年成長率為9.6%。

照護端檢測 (POCT) 是一種用於患者護理的臨床實驗室方法，可為治療實施提供快速結果。電子設備小型化和儀器改進等技術進步徹底改變了 POCT，使設備變得更小、更準確。它可以由各種醫療保健專業人員或患者自行執行。本篇綜述探討了 POCT 的方法、益處、利用率和可能干擾 POCT 的因素，強調跨專業團隊在評估和治療患者方面的重要性。透過將 POCT 整合到患者護理中，可以改善結果和患者滿意度。

市場動態：

驅動程式和限制

科技進步的崛起

技術進步正在改變全球即時診斷 (POC) 市場，提高測試的準確性、速度和簡易性。微型設備、生物感測器、微流體和先進的分子診斷技術等創新可改善診斷結果。 POC 設備中人工智慧和機器學習的整合可實現快速資料分析和預測洞察。無線連接和智慧型手機整合支援遠距醫療和遠端患者監護，使資源有限的環境受益，並在全球範圍內提供及時、高效的診斷。

例如，2023年5月，Sensible Diagnostics計劃在2024年之前推出10分鐘POC PCR儀器，重點在於傳染病。 Abbott 推出了 ID NOW，這是世界上最快的分子 POC 測試，可在 13 分鐘內提供 COVID-19 結果。這些發展預計將推動醫療保健產業的發展，因為政府遏制醫療保健支出和限制傳染病發病率的舉措將成為推動力。

此外，2023年1月，Cipla Ltd.推出了經CE IVD認證的Cippoint即時檢測設備，該設備使用免疫螢光在3至15分鐘內測試各種健康參數，包括心臟病、代謝和感染。這種自動、使用者友善的設備有助於在小型醫療機構、農村地區和行動診所進行更快的診斷。

品質控制和結果報告

POC 測試面臨品質控制和結果報告方面的挑戰，這可以透過無線實驗室資訊系統連接來解決。測試錯誤是另一個挑戰，家庭測試應該足夠穩健，才能獲得與中心實驗室一樣好的結果。在 POC 測試中也會觀察到分析干擾，如果結果與臨床或其他測試結果不符，連續稀釋可以確認可疑的干擾。現在大多數檢測試劑都含有異嗜性抗體阻斷劑等阻斷劑，以減少干擾。

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