![]() |
市场调查报告书
商品编码
1930027
即时诊断市场规模、占有率、成长及全球产业分析:依类型、应用和地区划分的洞察与预测(2025-2034)Point of Care Diagnostics Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2025-2034 |
||||||
2025年,全球即时诊断市场规模达到328.7亿美元,预计2026年将成长至344.7亿美元,2034年将达到603.6亿美元。该市场正经历强劲成长,主要得益于对快速检测解决方案的需求不断成长、医疗服务分散化以及慢性病和传染病负担日益加重。2025年,北美将以35.6%的市场占有率占据主导地位,这得益于先进诊断技术的广泛应用和有利的偿付政策。
即时诊断是指在患者就诊点或附近进行的医学诊断测试,能够更快地做出临床决策。 这些检测广泛应用于医院、诊所、急诊中心和家庭环境中,用于检测血糖水准、传染病、心臟标记、妊娠状态和血液系统疾病。能够在几分钟内提供结果,显着提高了治疗效率和患者预后。
市场驱动因素
即时诊断市场的主要驱动因素之一是多重检测平台的日益普及,这些平台能够从单一样本中检测多种病原体。这些平台缩短了检测週转时间,提高了诊断准确性,使其成为急诊和传染病筛检的理想选择。糖尿病、心血管疾病和肾臟疾病等慢性疾病的日益普遍也推动了检测量的成长,尤其是基于血液的诊断。
医疗保健系统也越来越重视早期诊断和分散式检测模式,这支持了在社区健康机构和农村地区采用便携式、易于使用的诊断设备。
市场限制因子
儘管技术不断进步,但结果的一致性和可靠性仍然是重要的限制因素。设备校准、操作人员技能等级和品质控制标准的差异都可能导致结果不一致。监管的复杂性和广泛的验证流程需求增加了开发时间和製造成本,这对目的是拓展全球市场的中小型诊断设备製造商的影响尤其显着。
市场机会
物联网(IoT)与连网诊断设备的整合带来了巨大的成长机会。互联的即时检测(POC)设备能够将患者资料即时传输到电子健康记录和云端系统,促进远端监测和远距医疗服务。这项功能在慢性病管理和治疗后追踪中尤其重要,有助于提高患者的长期参与度和医疗效率。
远距病患监测平台的日益普及预计将进一步推动城乡医疗网路对数位化整合诊断设备的需求。
市场趋势
一个关键的新兴趋势是基于 CRISPR 技术的即时诊断工具的日益普及。这些技术具有高灵敏度、快速检测和极简的样本製备等优点,使其适用于传染病筛检和基因检测。生物技术公司与学术机构之间日益密切的合作加速 CRISPR 诊断技术在便携式检测领域的创新和商业化。
另一个关键趋势是人工智慧(AI)在即时诊断设备中的应用日益广泛,这使得预测分析、结果自动解读以及临床环境中工作流程的改进成为可能。
依产品分类
此市场细分包括血糖监测、传染病检测、心血管代谢检测、怀孕和不孕症检测、血液检测以及其他。 预计到2026年,血糖监测将以 54.93%的市场占有率引领市场,这主要得益于全球糖尿病盛行率的上升以及持续血糖监测设备的广泛应用。生育力和妊娠检测的普及率也随着人们对生殖健康意识的提高以及自测盒的广泛使用而不断成长。
依样本类型划分
依样本类型划分,包括血液、鼻咽拭子、尿液和其他样本。血液检测预计将在2026年占据 77.05%的市场占有率,这主要得益于其在检测传染病、代谢紊乱和器官功能指标方面的广泛应用。尿液检测也因肾臟疾病和泌尿道感染发生率的上升而增加。
依最终使用者划分
最终用户包括医院床边检测、医生诊所实验室、急诊/零售诊所和家庭/自测。 到2026年,医院床边检测将占据40.50%的市场占有率,这主要得益于住院部和急诊对快速诊断工具的日益普及。由于患者更倾向于快速、便利的医疗服务,急诊中心和零售诊所也迅速扩张。
预计到2025年,北美市场规模将达到116.9亿美元,这得益于其完善的医疗基础设施和快速的产品审批流程。光是美国市场预计到2026年就将达到107亿美元。欧洲市场持续稳定成长,预计2026年,德国市场规模将达24.6亿美元,英国将达到22.3亿美元。 由于医疗保健投资的增加,亚太地区显着扩张,预计到2026年,中国市场规模将达到14.3亿美元,日本将达到14.2亿美元,印度将达到18.7亿美元。拉丁美洲的成长得益于医疗保健服务的改善,而中东和非洲地区则在新型诊断产品推出的推动下呈现温和成长。
这份即时诊断市场报告详细评估了2025年、2026年和2034年的市场规模和价值,并全面分析了产业结构、竞争格局和技术发展。报告分析了主要产品类别,包括血糖监测、传染病检测、心血管代谢检测、怀孕和不孕症检测、血液检测以及其他用于床边检测的诊断应用。报告还评估了基于样本的细分,包括血液、尿液、鼻咽拭子和其他用于即时诊断的生物样本。
本报告包含详细的终端使用者分析,涵盖医院床边检测、医师诊室实验室、急诊中心和零售诊所,以及家庭和自测环境。报告评估了医疗服务模式和患者行为对机构和消费者检测环境需求模式的影响。区域分析涵盖北美、欧洲、亚太、拉丁美洲以及中东和非洲,重点介绍了截至2026年美国、德国、英国、中国、日本和印度的具体市场规模,并探讨了截至2025年的区域市场主导地位。
此外,报告还评估了关键市场驱动因素,包括慢性病负担日益加重、多重检测平台的日益普及、分散式医疗服务的扩展,以及互联诊断技术、人工智慧整合和基于CRISPR的诊断工具等技术创新。报告中还详细分析了监管复杂性、结果差异性和品质保证挑战等限制因素。本研究也检视了全球即时诊断市场主要製造商的策略性举措,例如产品审批、设施扩建、合作关係和技术投资。
技术创新是市场发展的核心,多重检测平台、人工智慧驱动的分析系统、互联诊断生态系统和基于 CRISPR 的检测工具重塑检测效率和准确性。虽然血液诊断和血糖监测仍然是关键领域,但由于患者对便利快速服务的需求,急诊诊所和零售医疗中心正成为重要的成长管道。
区域市场呈现不同的成长动态。北美凭藉监管审批和强大的医疗基础设施保持领先地位,而亚太地区则受益于不断成长的医疗投资和日益加重的疾病负担,呈现强劲成长动力。竞争环境依然激烈,现有企业透过研发和监管审批来强化其产品组合,而新进业者则推出便携式、数位化和人工智慧整合的检测平台,以满足尚未满足的诊断需求,并扩大不同医疗机构的检测可及性。
The global point of care diagnostics market size was valued at USD 32.87 billion in 2025 and is projected to grow to USD 34.47 billion in 2026, reaching USD 60.36 billion by 2034. The market is witnessing strong expansion due to rising demand for rapid testing solutions, decentralization of healthcare services, and increasing burden of chronic and infectious diseases. In 2025, North America dominated the market with a share of 35.6%, supported by high adoption of advanced diagnostic technologies and favorable reimbursement policies.
Point of care diagnostics refers to medical diagnostic testing performed near or at the site of patient care, enabling faster clinical decisions. These tests are widely used across hospitals, clinics, urgent care centers, and home settings for detecting glucose levels, infections, cardiac markers, pregnancy status, and hematological conditions. The ability to provide results within minutes significantly improves treatment efficiency and patient outcomes.
Market Drivers
One of the key drivers of the point of care diagnostics market is the rising adoption of multiplex testing platforms that can detect multiple pathogens from a single sample. These platforms reduce turnaround time and improve diagnostic accuracy, making them highly suitable for emergency care and infectious disease screening. Increasing prevalence of chronic diseases such as diabetes, cardiovascular disorders, and kidney diseases is also fueling test volume growth, especially for blood-based diagnostics.
Healthcare systems are also increasingly focusing on early diagnosis and decentralized testing models, which supports the deployment of portable and easy-to-use diagnostic devices in community healthcare settings and rural regions.
Market Restraints
Despite technological progress, result consistency and reliability issues remain a significant restraint. Variations in device calibration, operator skill levels, and quality control standards can lead to inconsistent outcomes. Regulatory complexity and the need for extensive validation processes increase development timelines and manufacturing costs, particularly affecting small and mid-sized diagnostic companies seeking global expansion.
Market Opportunities
The integration of Internet of Things (IoT) and connected diagnostics offers strong growth opportunities. Connected POC devices enable real-time transmission of patient data to electronic health records and cloud-based systems, supporting remote monitoring and telehealth services. This capability is especially valuable for managing chronic diseases and post-treatment follow-ups, enhancing long-term patient engagement and healthcare efficiency.
Growing adoption of remote patient monitoring platforms is expected to further strengthen demand for digitally integrated diagnostic devices across both urban and rural healthcare networks.
Market Trends
A major emerging trend is the rising adoption of CRISPR-based point of care diagnostic tools. These technologies offer high sensitivity, faster detection, and minimal sample preparation, making them suitable for infectious disease screening and genetic testing. Increasing collaboration between biotechnology companies and academic institutions is accelerating innovation and commercialization of CRISPR diagnostics in portable testing formats.
Another important trend is the growing use of artificial intelligence in POC devices, enabling predictive analytics, automated result interpretation, and improved workflow integration in clinical settings.
By Product
The market is segmented into blood glucose monitoring, infectious disease testing, cardiometabolic testing, pregnancy and fertility testing, hematology testing, and others. Blood glucose monitoring dominated the market in 2026 with a share of 54.93%, driven by the rising global prevalence of diabetes and increasing use of continuous glucose monitoring devices. Pregnancy and fertility testing is witnessing increasing adoption due to growing awareness of reproductive health and expanding access to self-testing kits.
By Sample
Based on sample type, the market includes blood, nasal and oropharyngeal swabs, urine, and others. Blood-based diagnostics accounted for 77.05% of the market in 2026, supported by its wide applicability in detecting infections, metabolic disorders, and organ function indicators. Urine testing is also growing due to rising cases of kidney disorders and urinary tract infections.
By End User
End users include hospital bedside, physician office labs, urgent care and retail clinics, and home and self-testing. Hospital bedside testing held 40.50% share in 2026, driven by increased adoption of rapid diagnostic tools in inpatient and emergency departments. Urgent care and retail clinics are expanding rapidly due to patient preference for faster and more accessible healthcare services.
North America generated USD 11.69 billion in 2025, supported by strong healthcare infrastructure and rapid product approvals. The U.S. market alone is projected to reach USD 10.7 billion by 2026. Europe continues to show steady growth, with Germany valued at USD 2.46 billion and the U.K. at USD 2.23 billion by 2026. Asia Pacific is expanding significantly due to rising healthcare investment, with China at USD 1.43 billion, Japan at USD 1.42 billion, and India at USD 1.87 billion by 2026. Latin America is growing due to improving healthcare access, while Middle East & Africa shows moderate growth supported by new diagnostic product launches.
Competitive Landscape
The point of care diagnostics market is semi-consolidated with major players including F. Hoffmann-La Roche Ltd., Abbott, Danaher Corporation, Thermo Fisher Scientific, BD, bioMerieux, and QuidelOrtho. These companies focus heavily on R&D investments, product innovation, and regulatory approvals to strengthen their market positions. New entrants are introducing AI-enabled and portable diagnostic platforms to address unmet clinical needs and expand access to rapid testing solutions.
Report Coverage
The point of care diagnostics market report provides an in-depth assessment of market size and value for the years 2025, 2026, and 2034, along with a comprehensive evaluation of industry structure, competitive positioning, and technological evolution. The report analyzes major product categories including blood glucose monitoring, infectious disease testing, cardiometabolic testing, pregnancy and fertility testing, hematology testing, and other diagnostic applications used in near-patient testing environments. It further evaluates sample-based segmentation such as blood, urine, nasal and oropharyngeal swabs, and other biological samples used in point of care diagnostics.
The report includes detailed end-user analysis covering hospital bedside testing, physician office laboratories, urgent care and retail clinics, and home and self-testing environments. It assesses how healthcare delivery models and patient behavior are influencing demand patterns across institutional and consumer-based testing settings. Regional analysis covers North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, with specific market values highlighted for the U.S., Germany, the U.K., China, Japan, and India for the year 2026, and regional market dominance discussed for 2025.
In addition, the report evaluates major market drivers such as rising chronic disease burden, increasing adoption of multiplex testing platforms, expansion of decentralized healthcare services, and technological advancements including connected diagnostics, artificial intelligence integration, and CRISPR-based diagnostic tools. Market restraints including regulatory complexity, result variability, and quality assurance challenges are assessed in detail. The study also reviews strategic initiatives such as product approvals, facility expansions, partnerships, and technological investments by leading manufacturers operating in the global point of care diagnostics market.
Conclusion
The global point of care diagnostics market demonstrates strong expansion potential from USD 32.87 billion in 2025 to USD 34.47 billion in 2026, reaching USD 60.36 billion by 2034, supported by rapid growth in near-patient testing adoption across both clinical and home-based settings. Increasing demand for faster diagnosis, early disease detection, and decentralized healthcare delivery continues to strengthen the role of point of care diagnostics in routine medical practice.
Technological innovation remains central to market development, with multiplex platforms, AI-enabled interpretation systems, connected diagnostic ecosystems, and CRISPR-based detection tools reshaping testing efficiency and accuracy. Blood-based diagnostics and blood glucose monitoring continue to represent dominant segments, while urgent care clinics and retail healthcare centers are becoming key growth channels due to patient demand for accessible and rapid services.
Regional markets show differentiated growth dynamics, with North America maintaining leadership due to regulatory approvals and healthcare infrastructure, while Asia Pacific exhibits strong expansion driven by rising healthcare investments and increasing disease burden. Competitive activity remains intense, with established players strengthening portfolios through R&D and regulatory approvals, while new entrants introduce portable, digital, and AI-integrated testing platforms to address unmet diagnostic needs and expand testing accessibility across diverse healthcare settings.
Segmentation By Product
By Sample
By End-User
By Region