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市場調查報告書
商品編碼
1930027
即時診斷市場規模、佔有率、成長及全球產業分析:依類型、應用和地區劃分的洞察與預測(2025-2034)Point of Care Diagnostics Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2025-2034 |
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2025年,全球即時診斷市場規模達到328.7億美元,預計2026年將成長至344.7億美元,2034年將達到603.6億美元。該市場正經歷強勁成長,主要得益於對快速檢測解決方案的需求不斷成長、醫療服務分散化以及慢性病和傳染病負擔日益加重。2025年,北美將以35.6%的市場佔有率佔據主導地位,這得益於先進診斷技術的廣泛應用和有利的償付政策。
即時診斷是指在患者就診點或附近進行的醫學診斷測試,能夠更快地做出臨床決策。 這些檢測廣泛應用於醫院、診所、急診中心和家庭環境中,用於檢測血糖水準、傳染病、心臟標記、妊娠狀態和血液系統疾病。能夠在幾分鐘內提供結果,顯著提高了治療效率和患者預後。
市場驅動因素
即時診斷市場的主要驅動因素之一是多重檢測平台的日益普及,這些平台能夠從單一樣本中檢測多種病原體。這些平台縮短了檢測週轉時間,提高了診斷準確性,使其成為急診和傳染病篩檢的理想選擇。糖尿病、心血管疾病和腎臟疾病等慢性疾病的日益普遍也推動了檢測量的成長,尤其是基於血液的診斷。
醫療保健系統也越來越重視早期診斷和分散式檢測模式,這支持了在社區健康機構和農村地區採用便攜式、易於使用的診斷設備。
市場限制因子
儘管技術不斷進步,但結果的一致性和可靠性仍然是重要的限制因素。設備校準、操作人員技能等級和品質控制標準的差異都可能導致結果不一致。監管的複雜性和廣泛的驗證流程需求增加了開發時間和製造成本,這對目的是拓展全球市場的中小型診斷設備製造商的影響尤其顯著。
市場機會
物聯網(IoT)與連網診斷設備的整合帶來了巨大的成長機會。互聯的即時檢測(POC)設備能夠將患者資料即時傳輸到電子健康記錄和雲端系統,促進遠端監測和遠距醫療服務。這項功能在慢性病管理和治療後追蹤中尤其重要,有助於提高患者的長期參與度和醫療效率。
遠距病患監測平台的日益普及預計將進一步推動城鄉醫療網路對數位化整合診斷設備的需求。
市場趨勢
一個關鍵的新興趨勢是基於 CRISPR 技術的即時診斷工具的日益普及。這些技術具有高靈敏度、快速檢測和極簡的樣本製備等優點,使其適用於傳染病篩檢和基因檢測。生物技術公司與學術機構之間日益密切的合作加速 CRISPR 診斷技術在便攜式檢測領域的創新和商業化。
另一個關鍵趨勢是人工智慧(AI)在即時診斷設備中的應用日益廣泛,這使得預測分析、結果自動解讀以及臨床環境中工作流程的改進成為可能。
依產品分類
此市場細分包括血糖監測、傳染病檢測、心血管代謝檢測、懷孕和不孕症檢測、血液檢測以及其他。 預計到2026年,血糖監測將以 54.93%的市場佔有率引領市場,這主要得益於全球糖尿病盛行率的上升以及持續血糖監測設備的廣泛應用。生育力和妊娠檢測的普及率也隨著人們對生殖健康意識的提高以及自測盒的廣泛使用而不斷成長。
依樣本類型劃分
依樣本類型劃分,包括血液、鼻咽拭子、尿液和其他樣本。血液檢測預計將在2026年佔據 77.05%的市場佔有率,這主要得益於其在檢測傳染病、代謝紊亂和器官功能指標方面的廣泛應用。尿液檢測也因腎臟疾病和泌尿道感染發生率的上升而增加。
依最終使用者劃分
最終用戶包括醫院床邊檢測、醫生診所實驗室、急診/零售診所和家庭/自測。 到2026年,醫院床邊檢測將佔據40.50%的市場佔有率,這主要得益於住院部和急診對快速診斷工具的日益普及。由於患者更傾向於快速、便利的醫療服務,急診中心和零售診所也迅速擴張。
預計到2025年,北美市場規模將達到116.9億美元,這得益於其完善的醫療基礎設施和快速的產品審批流程。光是美國市場預計到2026年就將達到107億美元。歐洲市場持續穩定成長,預計2026年,德國市場規模將達24.6億美元,英國將達到22.3億美元。 由於醫療保健投資的增加,亞太地區顯著擴張,預計到2026年,中國市場規模將達到14.3億美元,日本將達到14.2億美元,印度將達到18.7億美元。拉丁美洲的成長得益於醫療保健服務的改善,而中東和非洲地區則在新型診斷產品推出的推動下呈現溫和成長。
這份即時診斷市場報告詳細評估了2025年、2026年和2034年的市場規模和價值,並全面分析了產業結構、競爭格局和技術發展。報告分析了主要產品類別,包括血糖監測、傳染病檢測、心血管代謝檢測、懷孕和不孕症檢測、血液檢測以及其他用於床邊檢測的診斷應用。報告還評估了基於樣本的細分,包括血液、尿液、鼻咽拭子和其他用於即時診斷的生物樣本。
本報告包含詳細的終端使用者分析,涵蓋醫院床邊檢測、醫師診室實驗室、急診中心和零售診所,以及家庭和自測環境。報告評估了醫療服務模式和患者行為對機構和消費者檢測環境需求模式的影響。區域分析涵蓋北美、歐洲、亞太、拉丁美洲以及中東和非洲,重點介紹了截至2026年美國、德國、英國、中國、日本和印度的具體市場規模,並探討了截至2025年的區域市場主導地位。
此外,報告還評估了關鍵市場驅動因素,包括慢性病負擔日益加重、多重檢測平台的日益普及、分散式醫療服務的擴展,以及互聯診斷技術、人工智慧整合和基於CRISPR的診斷工具等技術創新。報告中還詳細分析了監管複雜性、結果差異性和品質保證挑戰等限制因素。本研究也檢視了全球即時診斷市場主要製造商的策略性舉措,例如產品審批、設施擴建、合作關係和技術投資。
技術創新是市場發展的核心,多重檢測平台、人工智慧驅動的分析系統、互聯診斷生態系統和基於 CRISPR 的檢測工具重塑檢測效率和準確性。雖然血液診斷和血糖監測仍然是關鍵領域,但由於患者對便利快速服務的需求,急診診所和零售醫療中心正成為重要的成長管道。
區域市場呈現不同的成長動態。北美憑藉監管審批和強大的醫療基礎設施保持領先地位,而亞太地區則受益於不斷成長的醫療投資和日益加重的疾病負擔,呈現強勁成長動力。競爭環境依然激烈,現有企業透過研發和監管審批來強化其產品組合,而新進業者則推出便攜式、數位化和人工智慧整合的檢測平台,以滿足尚未滿足的診斷需求,並擴大不同醫療機構的檢測可及性。
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