即时检测生物感测器市场－全球产业规模、份额、趋势、机会、预测：按产品、平台、最终用户、地区和竞争对手划分，2021-2031年

全球照护现场生物感测器市场预计将从 2025 年的 815.6 亿美元成长到 2031 年的 1,302.2 亿美元，复合年增长率为 8.11%。

这些生物感测器是至关重要的分析工具，能够将生物反应转化为可测量的讯号，因此无需依赖中心检查室即可在患者附近进行即时诊断检测。这种增长主要源于需要定期监测和快速临床干预的慢性疾病盛行率不断上升。例如，国际糖尿病联盟 (IDF) 报告称，到 2024 年，全球将有约 5.89 亿成年人患有糖尿病，这将显着增加对携带式血糖监测设备的需求。此外，医疗服务从医院转向居家照护的转变也进一步加速了这些便利诊断设备的普及。

儘管市场前景广阔，但由于卫生监管机构严格而复杂的核准程序，该市场仍面临许多挑战。製造商在努力满足这些严格标准的过程中，往往面临产品开发週期延长和合规成本增加的问题。这些挑战减缓了新型诊断设备的商业化进程，并阻碍了其在医疗领域的广泛应用。

市场驱动因素

生物感测器与智慧型手机和穿戴式技术的融合正在改变市场格局，实现持续的生理监测和无缝的数据传输。这种融合使患者能够即时监测关键生物标记，从而最大限度地减少频繁就医的需求，并支持主动健康管理。领先的监测平台表现出色，凸显了此趋势的商业性成功。例如，雅培在2024年10月的财报中宣布，其FreeStyle Libre连续血糖监测系统的全球销售额已达16亿美元。这种普及表明，互联互通和直观的介面正在推动从零星检测向长期健康追踪的转变，巩固了这些设备作为现代医疗保健基础设施重要组成部分的地位。

同时，随着感染疾病传播的加剧，全球医疗卫生系统正优先发展快速就地检验，以便迅速发现并控制感染。有效的诊断工具对于控制感染疾病和及时启动治疗至关重要，尤其是在检测设施匮乏的资源匮乏地区。世界卫生组织（世卫组织）发布的《2024年全球结核病报告》显示，预计2023年全球将有1,080万人感染结核病，凸显了便利筛检方法的迫切需求。为了建构大规模检测所需的基础设施，相关产业正在进行大规模的投资和整合。例如，罗氏公司于2023年同意以2.95亿美元收购Lumira DX的照护现场平台，以扩展其分散式诊断能力。

市场挑战

全球照护现场生物感测器市场受到卫生监管机构严格而复杂的核准流程的严重限制。这些严格的标准延长了产品开发週期，迫使製造商应对复杂的合规挑战，从而延缓了创新诊断工具的上市。因此，企业不得不承担巨额财务成本，并将大量资源用于行政审批，而非研发。这种资源重新分配减缓了新设备的商业化进程，限制了需要快速检测解决方案的医疗机构的即时供应，并最终阻碍了整个产业的发展。

此外，这些法规的不确定性影响了策略规划，并阻碍了製造商在新产品上市时优先考虑特定市场。认证相关的高昂成本和不可预测性正在减缓关键技术惠及病患的速度。根据2024年欧洲医疗技术协会（MedTech Europe）的一项调查，与传统法规结构相比，选择欧盟作为新医疗设备主要上市区域的主要製造商比例下降了40%。这项数据表明，监管壁垒正在积极阻碍市场成长，并限制先进照护现场生物感测器在全球的应用。

市场趋势

多重检测技术的兴起，使得同时检测多种分析物成为可能，并透过单次检测即可诊断合併症，从而对产业产生了重大影响。这一趋势在呼吸系统诊断领域尤其明显，能够区分 COVID-19、流感和呼吸道合胞病毒 (RSV) 等疾病的综合征特异性检测组合正在取代单靶点检测，并有助于改善患者管理。由于医疗机构寻求有效识别症状重迭的病原体，因此对这些综合解决方案的需求非常高。丹纳赫公司 (Danaher Corporation) 在 2024 年 10 月发布的数据显示，其采用多重检测技术的 Cefeed 呼吸系统诊断部门的收入达到 4.25 亿美元，这印证了这一转变，表明同时检测正成为感染疾病控制的标准做法。

此外，微流体和实验室晶片技术的应用正在推动市场成长。透过将复杂的检查室工作流程整合到携带式晶片中，可以在临床环境中进行精确的分子生物学实验，例如PCR，其速度和准确性可与中心检查室相媲美。这种小型化也使得在急诊诊所和私人诊所等分散式医疗机构部署高灵敏度诊断工具成为可能。这些平台的商业性成功也反映了这项技术进步。例如，2024年9月，生物梅里埃公司报告称，其基于微流体的SPOTFIRE系统的销售额达到3300万欧元，凸显了晶片实验室创新在扩大诊断服务覆盖范围方面的重要性。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：全球即时检测生物感测器市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 产品分类（血糖监测、爱滋病毒检测、C型肝炎检测、妊娠检测）
  • 平台特异性（微流体、试纸条、免疫检测）
  • 依最终使用者（医院/诊所、药局、其他）划分
  • 按地区
  • 按公司（2025 年）
• 市场地图

第六章：北美即时检测生物感测器市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国别分析
  • 我们
  • 加拿大
  • 墨西哥

第七章：欧洲即时侦测生物感测器市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国别分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太地区即时检测生物感测器市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国别分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：中东和非洲即时检测生物感测器市场展望

• 市场规模及预测
• 市占率及预测
• 中东与非洲：国别分析
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 南非

第十章：南美洲即时检测生物感测器市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国别分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章 市场动态

• 促进因素
• 任务

第十二章 市场趋势与发展

• 併购
• 产品发布
• 近期趋势

第十三章 全球即时侦测生物感测器市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的议价能力
• 顾客权力
• 替代品的威胁

第十五章 竞争格局

• Abbott Laboratories Inc.
• Koninklijke Philips NV
• Accubiotech Co, Ltd.
• ACON Laboratories, Inc
• Becton, Dickinson and Company
• Biolytical Laboratories Inc.
• Danaher Corporation（HemoCue）
• Siemens Healthineers AG
• Meridian Bioscience, Inc
• GE HealthCare Technologies Inc.

第十六章 策略建议

第十七章：关于研究公司及免责声明

The Global Point-of-care Biosensors Market is projected to expand from USD 81.56 Billion in 2025 to USD 130.22 Billion by 2031, reflecting a CAGR of 8.11%. These biosensors serve as critical analytical tools that translate biological responses into measurable signals, facilitating immediate diagnostic testing near the patient instead of relying on centralized labs. This growth is primarily underpinned by the increasing burden of chronic diseases, which require regular monitoring and swift clinical interventions. For instance, the International Diabetes Federation reported that around 589 million adults worldwide were living with diabetes in 2024, generating significant demand for portable glucose monitoring options. Additionally, the shift of healthcare services from hospital settings to home care environments further accelerates the adoption of these accessible diagnostic devices.

Despite these growth prospects, the market faces substantial obstacles due to the stringent and intricate regulatory approval procedures mandated by health authorities. Manufacturers frequently grapple with extended product development timelines and escalated compliance costs while adhering to these rigorous standards. Such challenges often postpone the commercialization of novel diagnostic devices and hinder their widespread availability within the healthcare sector.

Market Driver

The convergence of biosensors with smartphones and wearable technology is transforming the market by enabling continuous physiological tracking and seamless data transfer. This integration empowers patients to monitor vital biomarkers in real-time, minimizing the need for frequent hospital visits and supporting proactive health management. The commercial success of this trend is highlighted by the robust performance of major monitoring platforms; for example, Abbott reported in its October 2024 financial results that worldwide sales for the FreeStyle Libre continuous glucose monitoring system hit USD 1.6 billion. This widespread usage demonstrates how connectivity and intuitive interfaces are driving the transition from sporadic testing to long-term health tracking, cementing these devices as essential components of modern medical infrastructure.

Concurrently, the increasing prevalence of infectious diseases is pushing global healthcare systems to emphasize rapid point-of-care testing for immediate detection and outbreak control. Effective diagnostic tools are crucial for managing infections and starting timely treatments, especially in resource-constrained areas with limited laboratory access. The World Health Organization's 'Global Tuberculosis Report 2024' estimated that 10.8 million people fell ill with tuberculosis globally in 2023, underscoring the urgent need for accessible screening methods. To build the necessary infrastructure for such extensive testing, the industry is seeing significant investment and consolidation, such as Roche's 2023 agreement to acquire LumiraDx's point-of-care platform for USD 295 million to broaden its decentralized diagnostic capabilities.

Market Challenge

The expansion of the Global Point-of-care Biosensors Market is significantly impeded by the rigorous and complicated regulatory approval processes enforced by health authorities. These strict standards result in prolonged product development cycles, compelling manufacturers to navigate complex compliance routes that delay the launch of innovative diagnostic tools. As a result, companies endure heavy financial costs and must allocate vital resources toward administrative requirements instead of research and development. This reallocation slows the commercialization of new devices and restricts their immediate availability to healthcare providers needing rapid testing solutions, thereby stalling the sector's overall progress.

Furthermore, this regulatory uncertainty influences strategic planning and deters manufacturers from prioritizing specific markets for new product introductions. The substantial costs and unpredictability linked to securing certifications decrease the pace at which critical technologies reach patients. According to MedTech Europe in 2024, the choice of the European Union as the primary launch region for new medical devices among large manufacturers fell by 40% compared to earlier regulatory frameworks. This statistic demonstrates how regulatory barriers actively hinder market growth and limit the global reach of advanced point-of-care biosensors.

Market Trends

The rise of multiplexing capabilities, which allow for the simultaneous detection of multiple analytes, is significantly influencing the sector by facilitating the diagnosis of co-existing conditions in a single test. This trend is particularly important in respiratory diagnostics, where syndromic panels that distinguish between COVID-19, influenza, and RSV are replacing single-target assays to improve patient management. There is substantial demand for these comprehensive solutions as healthcare providers look for efficiency in identifying pathogens with overlapping symptoms. Highlighting this shift, Danaher Corporation reported in October 2024 that revenue for Cepheid's respiratory diagnostics, utilizing these multiplexed assays, reached USD 425 million, proving that simultaneous detection is becoming a standard practice in infectious disease management.

Additionally, the adoption of microfluidic and lab-on-a-chip technologies is driving market growth by shrinking complex laboratory workflows into portable cartridges. These systems handle minute fluid volumes to execute intricate molecular processes, such as PCR, at the point of care, delivering speed and accuracy similar to central laboratories. This miniaturization enables the deployment of highly sensitive diagnostic tools in decentralized locations like urgent care clinics and physician offices. The commercial success of these platforms reflects this technological evolution; for instance, bioMerieux reported in September 2024 that sales for its microfluidic-based SPOTFIRE system reached EUR 33 million, underscoring the importance of lab-on-a-chip innovations in widening diagnostic access.

Key Market Players

• Abbott Laboratories Inc.
• Koninklijke Philips N.V.
• Accubiotech Co, Ltd.
• ACON Laboratories, Inc
• Becton, Dickinson and Company
• Biolytical Laboratories Inc.
• Danaher Corporation (HemoCue)
• Siemens Healthineers AG
• Meridian Bioscience, Inc
• GE HealthCare Technologies Inc.

Report Scope

In this report, the Global Point-of-care Biosensors Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Point-of-care Biosensors Market, By Product

• Glucose Monitoring
• HIV
• Hepatitis C
• Pregnancy

Point-of-care Biosensors Market, By Platforms

• Microfluidics
• Dipsticks
• Immunoassays

Point-of-care Biosensors Market, By End User

• Hospitals & Clinics
• Pharmacy
• Others

Point-of-care Biosensors Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Point-of-care Biosensors Market.

Available Customizations:

Global Point-of-care Biosensors Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Point-of-care Biosensors Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Glucose Monitoring, HIV, Hepatitis C, Pregnancy)
  • 5.2.2. By Platforms (Microfluidics, Dipsticks, Immunoassays)
  • 5.2.3. By End User (Hospitals & Clinics, Pharmacy, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2025)
• 5.3. Market Map

6. North America Point-of-care Biosensors Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By Platforms
  • 6.2.3. By End User
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Point-of-care Biosensors Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Product
      • 6.3.1.2.2. By Platforms
      • 6.3.1.2.3. By End User
  • 6.3.2. Canada Point-of-care Biosensors Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Product
      • 6.3.2.2.2. By Platforms
      • 6.3.2.2.3. By End User
  • 6.3.3. Mexico Point-of-care Biosensors Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Product
      • 6.3.3.2.2. By Platforms
      • 6.3.3.2.3. By End User

7. Europe Point-of-care Biosensors Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By Platforms
  • 7.2.3. By End User
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Point-of-care Biosensors Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Product
      • 7.3.1.2.2. By Platforms
      • 7.3.1.2.3. By End User
  • 7.3.2. France Point-of-care Biosensors Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Product
      • 7.3.2.2.2. By Platforms
      • 7.3.2.2.3. By End User
  • 7.3.3. United Kingdom Point-of-care Biosensors Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Product
      • 7.3.3.2.2. By Platforms
      • 7.3.3.2.3. By End User
  • 7.3.4. Italy Point-of-care Biosensors Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Product
      • 7.3.4.2.2. By Platforms
      • 7.3.4.2.3. By End User
  • 7.3.5. Spain Point-of-care Biosensors Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Product
      • 7.3.5.2.2. By Platforms
      • 7.3.5.2.3. By End User

8. Asia Pacific Point-of-care Biosensors Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By Platforms
  • 8.2.3. By End User
  • 8.2.4. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Point-of-care Biosensors Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Product
      • 8.3.1.2.2. By Platforms
      • 8.3.1.2.3. By End User
  • 8.3.2. India Point-of-care Biosensors Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Product
      • 8.3.2.2.2. By Platforms
      • 8.3.2.2.3. By End User
  • 8.3.3. Japan Point-of-care Biosensors Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Product
      • 8.3.3.2.2. By Platforms
      • 8.3.3.2.3. By End User
  • 8.3.4. South Korea Point-of-care Biosensors Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Product
      • 8.3.4.2.2. By Platforms
      • 8.3.4.2.3. By End User
  • 8.3.5. Australia Point-of-care Biosensors Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Product
      • 8.3.5.2.2. By Platforms
      • 8.3.5.2.3. By End User

9. Middle East & Africa Point-of-care Biosensors Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By Platforms
  • 9.2.3. By End User
  • 9.2.4. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Point-of-care Biosensors Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Product
      • 9.3.1.2.2. By Platforms
      • 9.3.1.2.3. By End User
  • 9.3.2. UAE Point-of-care Biosensors Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Product
      • 9.3.2.2.2. By Platforms
      • 9.3.2.2.3. By End User
  • 9.3.3. South Africa Point-of-care Biosensors Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Product
      • 9.3.3.2.2. By Platforms
      • 9.3.3.2.3. By End User

10. South America Point-of-care Biosensors Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By Platforms
  • 10.2.3. By End User
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Point-of-care Biosensors Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Product
      • 10.3.1.2.2. By Platforms
      • 10.3.1.2.3. By End User
  • 10.3.2. Colombia Point-of-care Biosensors Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Product
      • 10.3.2.2.2. By Platforms
      • 10.3.2.2.3. By End User
  • 10.3.3. Argentina Point-of-care Biosensors Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Product
      • 10.3.3.2.2. By Platforms
      • 10.3.3.2.3. By End User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Point-of-care Biosensors Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Abbott Laboratories Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Koninklijke Philips N.V.
• 15.3. Accubiotech Co, Ltd.
• 15.4. ACON Laboratories, Inc
• 15.5. Becton, Dickinson and Company
• 15.6. Biolytical Laboratories Inc.
• 15.7. Danaher Corporation (HemoCue)
• 15.8. Siemens Healthineers AG
• 15.9. Meridian Bioscience, Inc
• 15.10. GE HealthCare Technologies Inc.

16. Strategic Recommendations

17. About Us & Disclaimer