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市場調查報告書
商品編碼
1871934
全球按需即時檢測盒式實驗室市場:預測至 2032 年—按測試類型、技術、應用、最終用戶和地區分類的分析On-Demand Point-of-Care Lab-in-a-Box Market Forecasts to 2032 - Global Analysis By Test Type, Technology, Application, End User, and By Geography. |
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根據 Stratistics MRC 的數據,全球按需 POC 盒式實驗室市場預計將在 2025 年達到 478 億美元,並在 2032 年達到 713 億美元,預測期內複合年成長率為 5.8%。
按需即時檢測(POC)一體化實驗室系統是一種攜帶式自主型診斷平台,可在患者所在地直接提供快速臨床檢測和結果。這些設備整合了微型分析儀器、流體技術和數位連接功能,使臨床醫生無需依賴中央檢查室即可進行血液、尿液或拭子檢測。透過在照護端提供全面及時的診斷,該解決方案可加快決策速度,改善偏遠地區的醫療服務,並支援分散式醫療保健。
世界衛生組織表示,小型自動化檢測系統正在偏遠診所部署,可在 30 分鐘內完成瘧疾和愛滋病毒等疾病的診斷測試,從而大大縮短開始治療的時間。
對分散式診斷的需求日益成長
對分散式診斷日益成長的需求源於偏遠和醫療資源匱乏地區對快速便捷檢測的需求。按需提供的「盒式實驗室」平台無需集中式檢查室即可實現照護現場(POC),從而縮短檢測結果的周轉時間,並最佳化臨床決策。慢性病盛行率的上升、人口老化以及個人化醫療的進展進一步推動了這一趨勢。醫療系統正在採用攜帶式診斷解決方案,以減輕醫院的負擔,並提升居家醫療和急診等醫療服務水準。
小型分析儀高成本
儘管小型分析儀效用,但由於採用了先進的微流體整合技術、專用試劑和小型化硬體,用於“盒式實驗室”系統的小型分析儀價格仍然昂貴。這些成本限制了它們在資源匱乏地區和小規模診所的普及。此外,維護、校準和耗材也會增加營運成本。缺乏規模經濟和有限的報銷機制進一步限制了市場滲透。價格敏感的買家往往會等待更具成本效益的替代方案或補貼,在臨床需求強勁的情況下,減緩了整體市場成長。
與遠端醫療平台整合
實驗室一體化診斷和遠端醫療平台的整合帶來了變革性的機會。即時數據共用、遠端監測和虛擬會診能夠改善診斷流程並提升病人參與。這種整合使臨床醫生能夠即時解讀結果並遠端啟動治療,尤其是在偏遠和偏遠地區。這種協同效應有助於慢性病管理、術後照護和感染疾病監測。隨著遠端醫療在全球的快速普及,嵌入虛擬醫療生態系統的診斷技術將推動創新並擴大市場覆蓋範圍。
嚴格的規章制度和精確度標準
由於其對臨床的重大影響,實驗室一體化解決方案面臨嚴格的監管審查。確保分析的準確性、可重複性以及符合ISO和FDA標準極具挑戰性,尤其對於多重檢測和新型平台而言更是如此。法規核准的延遲、複雜的核准流程以及上市後監測要求都會延長產品上市時間並增加成本。任何性能偏差都可能導致產品召回和訴訟,從而損害品牌聲譽。這些障礙阻礙了新進入者,並要求企業在檢驗、文件記錄和品質保證系統方面進行大量投資。
新冠疫情顯著加速了即時檢測(POC)一體化診斷技術的應用,尤其是在快速分子檢測和抗原檢測方面。疫情凸顯了對分散式、擴充性和非接觸式診斷解決方案的需求。各國政府和醫療機構已投入大量資金攜帶式平台,以控制疫情傳播並緩解檢查室壓力。然而,隨著疫情後世界逐漸恢復正常,緊急資金投入減少,優先事項也正在轉變。儘管對呼吸道疾病和感染疾病檢測的需求依然旺盛,但供應商必須將業務重心轉向更廣泛的慢性病和預防保健應用領域。
預計在預測期內,分子診斷領域將佔據最大的市場佔有率。
由於分子診斷具有高靈敏度和特異性,且在感染疾病、腫瘤和基因篩檢領域應用廣泛,預計在預測期內,分子診斷領域將佔據最大的市場佔有率。盒式實驗室平台正擴大整合PCR、等溫擴增和定序技術,用於快速病原體檢測和突變分析。該領域受益於對早期診斷、個人化醫療和疫情管理日益成長的需求。與數位健康工具的整合以及小型化設計使其成為即時檢測(POC)部署的理想選擇,從而鞏固了其市場主導地位。
預計在預測期內,微流體領域將實現最高的複合年成長率。
預計在預測期內,微流體領域將實現最高成長率,這主要得益於其能夠將複雜的實驗室流程微型化並整合到攜帶式晶片中。這些系統能夠進行多重檢測,減少試劑用量,並快速提供檢測結果。晶片設計、材料科學和流體學領域的創新正在推動微流控技術在血液學、免疫檢測和分子診斷等領域的應用不斷拓展。隨著市場對緊湊、自動化和方便用戶使用型平台的需求日益成長,微流體技術將成為下一代「盒式實驗室」解決方案的基礎,吸引投資並促進技術的快速發展。
亞太地區預計將在預測期內佔據最大的市場佔有率,這主要得益於其龐大的人口基數、不斷成長的醫療保健支出以及對分散式診斷日益成長的需求。中國、印度和日本等國家正在投資建造攜帶式診斷基礎設施,以解決醫療保健資源分配不均和農村地區感染疾病負擔過重的問題。政府的積極舉措、不斷擴展的遠端醫療網路以及本地化的製造能力都在推動市場成長。該地區多樣化的醫療保健需求和快速的都市化使其成為「盒式實驗室」應用的理想目標區域。
在預測期內,北美預計將實現最高的複合年成長率,這主要得益於其先進的醫療基礎設施、強大的研發投入以及對創新診斷技術的早期應用。美國在遠距遠端醫療整合、監管核准以及即時檢測(POC)技術的報銷框架方面處於主導地位。對居家檢測、慢性病管理和個人化醫療日益成長的需求正在推動市場擴張。策略合作、創業投資和有利的政策支援將進一步促進成長,使北美成為「盒式實驗室」解決方案的領先創新中心。
According to Stratistics MRC, the Global On-Demand Point-of-Care Lab-in-a-Box Market is accounted for $47.8 billion in 2025 and is expected to reach $71.3 billion by 2032 growing at a CAGR of 5.8% during the forecast period. On-Demand Point-of-Care Lab-in-a-Box systems are portable, self-contained diagnostic platforms that provide rapid clinical testing and results directly at the patient location. Incorporating miniaturized analytical instruments, fluidics, and digital connectivity, these devices allow clinicians to perform blood, urine, or swab tests without centralized lab infrastructure. The solution accelerates decision-making, improves access in remote areas, and supports decentralized healthcare by offering comprehensive, timely diagnostics at the point of care.
According to the WHO, compact, automated lab systems are being deployed in remote clinics to perform diagnostic tests like malaria or HIV in under 30 minutes, drastically reducing time-to-treatment.
Growing need for decentralized diagnostics
The rising demand for decentralized diagnostics is driven by the need for rapid, accessible testing in remote and underserved areas. On-demand lab-in-a-box platforms enable point-of-care testing without centralized labs, improving turnaround times and clinical decision-making. This trend is reinforced by increasing chronic disease prevalence, aging populations, and the push for personalized medicine. Healthcare systems are adopting portable diagnostic solutions to reduce hospital burden and enhance care delivery in outpatient, homecare, and emergency settings.
High cost of compact analyzers
Despite their utility, compact analyzers used in lab-in-a-box systems remain expensive due to advanced microfluidic integration, proprietary reagents, and miniaturized hardware. These costs limit adoption in low-resource settings and small clinics. Additionally, maintenance, calibration, and consumables add to operational expenses. The lack of economies of scale and limited reimbursement frameworks further constrain market penetration. Price-sensitive buyers often delay procurement, awaiting cost-effective alternatives or subsidies, which slows overall market growth despite strong clinical demand.
Integration with telehealth platforms
The convergence of lab-in-a-box diagnostics with telehealth platforms presents a transformative opportunity. Real-time data sharing, remote monitoring, and virtual consultations enhance diagnostic workflows and patient engagement. Integration enables clinicians to interpret results instantly and initiate treatment remotely, especially in rural or quarantined settings. This synergy supports chronic disease management, post-operative care, and infectious disease surveillance. As telemedicine adoption accelerates globally, embedded diagnostics within virtual care ecosystems will drive innovation and expand market reach.
Stringent regulatory and accuracy standards
Lab-in-a-box solutions face stringent regulatory scrutiny due to their clinical impact. Ensuring analytical accuracy, reproducibility, and compliance with ISO and FDA standards is challenging, especially for multiplexed assays and novel platforms. Regulatory delays, complex approval pathways, and post-market surveillance requirements increase time-to-market and cost. Any deviation in performance can lead to recalls or litigation, damaging brand reputation. These hurdles deter new entrants and require substantial investment in validation, documentation, and quality assurance systems.
COVID-19 significantly accelerated the adoption of point-of-care lab-in-a-box diagnostics, especially for rapid molecular and antigen testing. The pandemic highlighted the need for decentralized, scalable, and contactless diagnostic solutions. Governments and healthcare providers invested heavily in portable platforms to manage outbreaks and reduce lab overload. However, post-pandemic normalization has led to reduced emergency funding and shifting priorities. While demand remains strong for respiratory and infectious disease testing, vendors must pivot toward broader chronic and preventive applications.
The molecular diagnostics segment is expected to be the largest during the forecast period
The molecular diagnostics segment is expected to account for the largest market share during the forecast period, due to its high sensitivity, specificity, and versatility across infectious diseases, oncology, and genetic screening. Lab-in-a-box platforms increasingly incorporate PCR, isothermal amplification, and sequencing technologies for rapid pathogen detection and mutation analysis. The segment benefits from rising demand for early diagnosis, personalized medicine, and outbreak management. Its integration with digital health tools and miniaturized formats makes it ideal for point-of-care deployment, driving its market leadership.
The microfluidics segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the microfluidics segment is predicted to witness the highest growth rate, driven by its ability to miniaturize complex lab processes into portable cartridges. These systems enable multiplexed assays, reduced reagent use, and faster turnaround times. Innovations in chip design, material science, and fluid control are expanding applications in hematology, immunoassays, and molecular diagnostics. As demand grows for compact, automated, and user-friendly platforms, microfluidics will underpin next-generation lab-in-a-box solutions, attracting investment and fueling rapid technological advancement.
During the forecast period, the Asia Pacific region is expected to hold the largest market share, due to its vast population, rising healthcare expenditure, and growing demand for decentralized diagnostics. Countries like China, India, and Japan are investing in portable diagnostic infrastructure to address rural healthcare gaps and infectious disease burdens. Favorable government initiatives, expanding telemedicine networks, and local manufacturing capabilities support market growth. The region's diverse healthcare needs and rapid urbanization make it a prime target for lab-in-a-box deployment.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR fueled by advanced healthcare infrastructure, strong R&D investment, and early adoption of innovative diagnostics. The U.S. leads in telehealth integration, regulatory approvals, and reimbursement frameworks for point-of-care technologies. Growing demand for home-based testing, chronic disease management, and personalized care drives market expansion. Strategic partnerships, venture capital funding, and favorable policy support further accelerate growth, positioning North America as a key innovation hub for lab-in-a-box solutions.
Key players in the market
Some of the key players in On-Demand Point-of-Care Lab-in-a-Box Market include Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, Danaher Corporation, Becton Dickinson, Thermo Fisher Scientific, QuidelOrtho, PerkinElmer, Mesa Biotech, Cue Health, LumiraDx, Bio-Rad Laboratories, BioMerieux, Cardinal Health, Hologic, BD Veritor, and OraSure Technologies
In Aug 2025, Siemens Healthineers & Cardinal Health announced a deepened partnership to deploy the "CLINITEST" lab-in-a-box systems across retail pharmacy clinics and urgent care centers in the U.S. The collaboration enhances supply chain logistics for test cartridges and includes a proprietary data analytics dashboard for population health trends.
In July 2025, Cue Health released its "Cue Pro" 2.0 system, featuring a new cartridge form factor for at-home monitoring of chronic inflammation markers (e.g., CRP) and vitamin D levels. The update includes enhanced Bluetooth connectivity with smart devices and a subscription service for personalized health insights and physician notifications.
In June 2025, Thermo Fisher Scientific enhanced its "Accelerate" Arc system with GPU-accelerated data analysis for its antimicrobial susceptibility testing (AST) module. The update supports faster identification of resistant pathogens and optimal antibiotic recommendations directly at the point of care, aiding in the fight against antimicrobial resistance (AMR).
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.