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市场调查报告书

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1629886

全球即时检测设备市场 - 2025-2033

Global Point-of-Care Testing Devices 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

2024年，全球即时检测设备市场规模达到497.3亿美元，预估至2033年将达到1,015.1亿美元，2025-2033年预测期间复合年增长率为8.6%。

护理点测试 (POCT) 是在患者护理点或附近进行的医疗诊断测试，可提供快速结果，有助于治疗决策。这种策略与标准实验室测试不同，标准实验室测试通常涉及将样本运送到中心实验室并等待数小时或数天才能得到结果。 POCT 的根本目的是透过提供即时资讯来改善患者管理，从而实现更快的诊断和治疗。 POCT 涵盖广泛的测试方法和技术，例如手持式电子设备、测试套件和便携式分析仪。常见的例子有血糖监测、快速链球菌检测和妊娠检测。这些设备可用于各种场所，包括医院、诊所、药局甚至家庭，使医疗保健更加便利和有效率。 POCT 技术取得了巨大的发展，仪器尺寸不断缩小，仪器性能得到增强，准确性和易用性不断提高。

技术进步是预测期内推动市场的驱动因素。例如，Masimo 宣布 MightySat Medical 已获得 FDA 批准，使其成为第一个也是唯一一个获得 FDA 批准的医用指尖脉搏血氧仪，无需处方即可向消费者提供非处方药 (OTC)。此次批准为客户提供了 Masimo SET 脉搏血氧仪支援的脉搏血氧仪医疗设备，世界各地的医院和诊所每年都使用同样的技术来监测超过 2 亿患者。

市场动态：

驱动程式和限制

技术进步

技术进步预计将成为全球即时检测设备市场成长的重要因素。技术进步预计将对全球即时检测（POCT）设备市场的扩张产生重大影响。随着医疗保健的发展，对快速、准确且易于存取的诊断解决方案的需求日益增长。生物感测器、微流体和晶片实验室系统等众多技术的创新改变了诊断方法，使其更有效率和可靠。例如，2024 年9 月，雅培实验室(Abbott Laboratories) 宣布其非处方连续血糖监测仪Lingo 在美国上市。正常值时就会出现血糖峰值。

此外，DEXIS 于 2024 年 8 月推出了 DEXIS Connect Pro，这是一个针对 DEXIS CBCT 和口内感测器设备的新型主动服务平台，专注于增加设备的正常运行时间。这个独特的平台使用物联网 (IoT) 技术来持续检查这些设备的运作状况，确保它们以最佳效能运作。 DEXIS Connect Pro 旨在透过自动识别潜在困难并根据需要安排支援或设备更换来显着提高设备正常运行时间，这对于依赖一致操作来提供患者护理的牙科诊所至关重要。

此外，Bio-Rad Laboratories 于 2024 年 4 月推出了首款超灵敏多重数位 PCR 检测，即 ddPLEX ESR1 突变检测试剂盒。该测定增加了该公司在癌症行业的液滴数位 PCR (ddPC) 产品组合，其中极其灵敏的多重突变检测测定可增强转化研究、药物选择和疾病监测。这些最近的推出和 FDA 的批准以及最新的技术进步使得诊断结果高效、快速，从而推动了市场。

初始投资成本高

初始投资成本高等因素预计将阻碍全球即时检测设备市场。儘管 POCT 具有多种优势，例如快速得出结果以及能够在传统实验室环境之外进行测试，但与购买这些设备相关的财务成本可能会阻碍医疗机构使用它们。 POCT 设备的初始投资可能很大，尤其是对于有望提高诊断能力的先进技术。在医疗保健资金紧张的资源有限环境中，这种财务负担尤其严重，使得机构难以优先投资新型诊断方法。

Point-of-Care Testing (POCT) is medical diagnostic testing that is performed at or near the patient's point of care, providing for quick outcomes that may assist in treatment decisions. This strategy differs from standard laboratory testing, which frequently involves transporting samples to central labs and waiting hours or days for findings. The fundamental purpose of POCT is to improve patient management by giving immediate information, which can lead to faster diagnosis and treatment. POCT covers a wide range of testing methods and technologies, such as handheld electronics, test kits, and portable analyzers. Common examples are blood glucose monitoring, quick strep testing, and pregnancy tests. These devices can be used in a variety of venues, including hospitals, clinics, pharmacies, and even the home, making healthcare more accessible and efficient. POCT technology has grown tremendously, with downsizing and enhanced instrumentation increasing accuracy and ease of use.

The technological advancements is the driving factor that drives the market over the forecast period. For instance, Masimo announced that MightySat Medical has received FDA clearance, making it the first and only FDA-cleared medical fingertip pulse oximeter offered over-the-counter (OTC) to consumers without a prescription. This approval provides customers a pulse oximeter medical gadget powered by Masimo SET pulse oximetry, the same technology used by hospitals and clinics around the world to monitor over 200 million patients every year.

Market Dynamics: Drivers & Restraints

Technological advancements

The technological advancements is expected to be a significant factor in the growth of the global point-of-care testing devices market. Technological advances are expected to play a significant influence in the expansion of the global point-of-care testing (POCT) devices market. As healthcare evolves, there is an increasing need for quick, accurate, and accessible diagnostic solutions. Innovations in numerous technologies, including as biosensors, microfluidics, and lab-on-a-chip systems, have altered diagnostics, making them more efficient and reliable. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Moreover in August 2024, DEXIS Launched DEXIS Connect Pro, a New Proactive Service Platform for DEXIS CBCT and Intraoral Sensor Devices, Focused on Increasing Device Uptime. This unique platform uses Internet of Things (IoT) technology to continuously check the health of these devices, ensuring they run at peak performance. DEXIS Connect Pro seeks to significantly improve device uptime by automatically recognizing potential difficulties and arranging for support or equipment replacements as needed, which is crucial for dental offices that rely on consistent operation to provide patient care.

Moreover in April 2024, Bio-Rad Laboratories has launched its first ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit. The assay adds to the company's Droplet Digital PCR (ddPC) portfolio in the cancer industry, where extremely sensitive and multiplexed mutation detection assays enhance translational research, medication selection, and disease monitoring. These recent launches and FDA approvals along with latest technological advancements in them makes the diagnostic results efficient and quick which drives the market.

High initial investment costs

Factors such as high initial investment costs are expected to hamper the global point-of-care testing devices market. Although POCT provides various benefits, such as rapid results and the ability to test outside of traditional laboratory settings, the financial costs associated with procuring these devices may dissuade healthcare organizations from using them. The initial investment for POCT equipment might be significant, especially for advanced technologies that promise improved diagnostic capabilities. This financial burden is particularly acute in resource-constrained environments where healthcare funds are tight, making it difficult for facilities to prioritize investment in novel diagnostic methods.

Segment Analysis

The global point-of-care testing devices market is segmented based on product , application, testing type, distribution channel and region.

Glucose monitoring products segment is expected to dominate the global point-of-care testing devices market share

The glucose monitoring products segment is predicted to dominate the global point-of-care testing (POCT) devices market due to a number of compelling factors, including increased diabetes prevalence, technological improvements, and an increase in demand for rapid diagnostic solutions. Diabetes remains a huge public health challenge around the world, thus effective management strategies are more important than ever. The increasing prevalence is one of the major reasons for the dominance of this segment. For instance, according to the National Institute of Health, approximately 462 million individuals were affected by type 2 diabetes corresponding to 6.28% of the world's population.

In the recent times, there are launches and FDA approvals of glucose monitoring devices. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Moreover, in June 2024, Prevounce Health, a leading provider of remote care management software, devices, and services, announced the launch of its first remote blood glucose monitoring device, Pylo GL1-LTE. The blood glucose meter has been scientifically tested and linked to numerous cellular networks to guarantee more dependable data transmission across the United States. The GL1-LTE is compatible with the Prevounce remote care management platform and may be integrated with other health software using the Pylo cloud API. Prevounce's Pylo cellular-connected gadgets include blood pressure monitors and weight scales.

Geographical Analysis

North America is expected to hold a significant position in the global point-of-care testing devices market share

North America is expected to hold a significant portion of the global point-of-care testing devices market. North America is projected to account for a significant portion of the global point-of-care testing (POCT) device market, owing to a mix of factors such as a strong healthcare infrastructure, rising chronic illness incidence, and technological improvements. The increased prevalence of chronic diseases, such as diabetes, cardiovascular problems, and infectious diseases, is a major driver of market expansion in North America. For instance, according to the Centers for Disease Control and Prevention, in 2024 more than 38 million Americans have diabetes (about 1 in 10), and about 90% to 95% of them have type 2 diabetes. Type 2 diabetes most often develops in people 45 or older, but more and more children, teens, and young adults are also developing it.

There are recent launches in this region due to the presence of major players. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Asia Pacific is growing at the fastest pace in the global point-of-care testing devices market

The Asia Pacific region is experiencing rapid growth in the global point-of-care testing (POCT) device market. Several significant factors contribute to this expansion, including rising healthcare costs, increased awareness of early disease diagnosis, and the demand for quick and precise diagnostic results. The need for POCT has increased as these devices have proven invaluable for the early diagnosis and monitoring of a variety of health disorders, thereby improving disease management results throughout the region.

There are recent launches of devices in this region making it the fastest growing region. For instance, in November 2023, UK-based LumiraDx Healthcare has launched its highly sensitive C-Reactive Protein (CRP) point of care (POC) antigen test across India. The point of care CRP test can be used in multiple clinical settings to help reduce unnecessary antibiotic prescribing that leads to antimicrobial resistance (AMR). From a tiny sample of finger-prick blood, the CRP test gives results within four minutes on the portable LumiraDx platform which weighs just over a kilogram.

Competitive Landscape

The major global players in the global point-of-care testing devices market include Abbott, F. Hoffmann-La Roche, BD, Siemens Healthcare Private Limited, Bio-Rad Laboratories, Inc., Danaher Corporation, SEKISUI Diagnostics, Trinity Biotech, Beckman Coulter, Inc., Nova Biomedical among others.

Emerging Players

PocDoc, Biocode, Sense4Med among others

Key Developments

In January 2023, Cipla has announced the launch of Cippoint, a point-of-care testing device. This state-of-the-art device offers a wide range of testing parameters including cardiac markers, diabetes, infectious diseases, fertility, thyroid function, inflammation, metabolic markers, and coagulation markers. The device is CE IVD approved, indicating the device is approved by the European In-Vitro Diagnostic Device Directive, thus ensuring reliable testing solutions.
In November 2024, Caris Life Sciences announced the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies.

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 testing devices 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 2024

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & 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
3.2. Snippet by Application
3.3. Snippet by Testing Type
3.4. Snippet by Distribution Channel
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
- 4.1.2. Technological Advancements
- 4.1.3. Restraints
- 4.1.4. High Initial Investment Costs
- 4.1.5. Opportunity
- 4.1.6. 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
5.5. Reimbursement Analysis
5.6. Patent Analysis
5.7. SWOT Analysis
5.8. DMI Opinion

6. By Product

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 6.1.2. Market Attractiveness Index, By Product
6.2. Glucose Monitoring Products*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Infectious Disease Testing Products
6.4. Pregnancy and Fertility Testing Products
6.5. Tumor/Cancer Marker Testing Products
6.6. Hematology Testing Products
6.7. Others

7. By Application

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 7.1.2. Market Attractiveness Index, By Application
7.2. Blood Transfusion*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Cardiac Monitoring
7.4. Blood Glucose
7.5. Haematology
7.6. Non-Invasive SPO2 and CO2 Monitoring
7.7. Others

8. By Testing Type

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
- 8.1.2. Market Attractiveness Index, By Testing Type
8.2. Immunoassays*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Cell-Based Assays
8.4. Nucleic Acid Amplification Testing
8.5. Clinical Chemistry Assays
8.6. Hematology
8.7. Others

9. By Distribution Channel

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 9.1.2. Market Attractiveness Index, By Distribution Channel
9.2. Hospital Pharmacies*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Retail Pharmacies
9.4. Online Pharmacies

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 (%), Product
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 10.2.8. The U.S.
- 10.2.9. Canada
- 10.2.10. 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 (%), Product
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 10.3.8. Germany
- 10.3.9. UK
- 10.3.10. France
- 10.3.11. Italy
- 10.3.12. Spain
- 10.3.13. 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 (%), Product
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 10.4.8. Brazil
- 10.4.9. Argentina
- 10.4.10. 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 (%), Product
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 10.5.8. China
- 10.5.9. India
- 10.5.10. Japan
- 10.5.11. South Korea
- 10.5.12. 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 (%), Product
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

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*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. F. Hoffmann-La Roche
12.3. BD
12.4. Siemens Healthcare Private Limited
12.5. Bio-Rad Laboratories, Inc.
12.6. Danaher Corporation
12.7. SEKISUI Diagnostics
12.8. Trinity Biotech
12.9. Beckman Coulter, Inc.
12.10. Nova Biomedical

LIST NOT EXHAUSTIVE