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市场调查报告书
商品编码
1865466
照护现场诊断市场预测至2032年:按产品、检体类型、检测方法、技术、应用、最终用户和地区分類的全球分析Point-of-Care Diagnostics Market Forecasts to 2032 - Global Analysis By Product, Sample Type, Mode of Testing, Technology, Application, End User and By Geography |
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根据 Stratistics MRC 的数据,全球照护现场诊断市场预计将在 2025 年达到 506 亿美元,并在 2032 年达到 750 亿美元,预测期内复合年增长率为 5.8%。
照护现场诊断是指在患者照护地点或附近进行的医学检测,无需中心实验室即可快速获得结果。这些检测旨在提供便利、快速和易用的服务,使医护人员能够立即做出临床决策。常见的应用包括血糖监测、感染疾病检测、怀孕检测和心臟标记检测。即时诊断使用携带式设备和易于使用的试剂盒,通常只需极少的培训即可操作。它们在急诊室、诊所、偏远地区和家庭环境中都至关重要。透过缩短检测结果等待时间并改善患者预后,照护现场诊断在现代分散式医疗服务中发挥关键作用。
对快速早期诊断的需求日益增长
对快速早期诊断日益增长的需求是推动照护现场市场发展的主要因素。这些检测能够帮助医护人员即时做出临床决策,尤其是在急诊、农村和居家照护等场景下。随着感染疾病和慢性病病例的增加,医疗专业人员需要快速、准确的检测结果才能及时启动治疗。照护现场解决方案能够缩短结果等待时间,改善患者预后,并支援分散式医疗服务。其便利性和快速性使其成为全球医疗系统中现代医学不可或缺的工具。
监理和合规挑战
监管和合规方面的挑战是照护现场市场面临的重大阻碍因素。设备必须满足严格的安全、准确性和品质标准,而这些标准因地区而异,这可能会延迟产品核可和市场准入。复杂的法规结构要求在测试、文件编制和认证方面投入大量资金。这些障碍尤其给Start-Ups和中小型製造商带来了沉重的负担。此外,不断变化的资料隐私和诊断准确性法规也进一步加剧了合规工作的复杂性。
技术进步
技术进步为市场成长提供了强劲机会。生物感测器、微流体和携带式分析仪的创新正在提升检测速度、准确性和易用性。与数位平台和行动应用程式的整合实现了即时数据共用和远端监控。这些创新为个人化医疗、远端医疗和分散式医疗模式提供了支援。随着对使用者友善诊断工具的需求日益增长,科技主导的解决方案正在改变医疗服务模式。持续的研发投入可望开拓新的应用领域,并提高已开发市场和新兴市场的医疗服务可近性。
成本和报销问题
成本和报销问题对照护现场市场构成重大威胁。设备和耗材的高昂前期成本会阻碍其普及,尤其是在资源匮乏的地区。各地不同的报销政策为医疗机构和製造商带来不确定性。由于缺乏明确的保险覆盖范围,患者需要自费,这可能会限制他们获得必要的诊断服务。这些经济障碍阻碍了市场扩张和创新。解决价格承受能力问题并建立支持性的报销机制对于确保即时诊断技术的广泛应用至关重要。
新冠疫情显着加速了照护现场技术的应用。对快速检测和分散式医疗解决方案的迫切需求凸显了便携式、易用型诊断工具的价值。即时检测在筛检、监测和疫情控制中发挥了关键作用,尤其是在偏远和高风险地区。此次危机也推动了生物感测器和移动诊断技术的创新,进而重塑了公共卫生策略。随着医疗系统适应后疫情时代的新常态,照护现场系统的韧性、提升应对能力并促进以患者为中心的医疗服务。
预计在预测期内,生物感测器细分市场将占据最大的市场份额。
由于生物感测器在实现快速、准确的照护现场方面发挥关键作用,预计在预测期内,生物感测器领域将占据最大的市场份额。生物感测器能够即时检测生物标记物,支援感染疾病检测、血糖监测和心臟诊断等应用。将其整合到携带式设备中,提高了便利性和可及性。随着对快速可靠诊断的需求不断增长,生物感测器始终处于创新前沿。灵敏度、小型化和连接性的持续进步将进一步巩固其在即时诊断领域的领先地位。
预计在预测期内,糖尿病细分市场将实现最高的复合年增长率。
预计在预测期内,糖尿病领域将实现最高成长率,这主要得益于全球糖尿病盛行率的不断上升以及对持续血糖监测的需求。照护现场技术能够提供便利的即时血糖检测,帮助患者有效管理自体病情。生物感测器和穿戴式装置的进步正在提升检测的准确性和易用性。随着医疗保健系统将慢性病管理置于优先地位,对便利、个人化的糖尿病诊断的需求持续增长。该领域的快速成长反映了其在预防和长期照护中的重要作用。
由于医疗保健需求不断增长、中产阶级人口不断壮大以及各国政府为改善医疗保健服务可及性而采取的倡议,预计亚太地区将在预测期内占据最大的市场份额。中国、印度和日本等国家正在投资建造分散式医疗保健基础设施和提供价格合理的诊断解决方案。该地区强大的製造业基础和行动医疗技术的日益普及将进一步推动市场扩张。亚太地区充满活力的医疗保健环境使其成为照护现场技术创新和应用领域的领导者。
在预测期内,北美预计将实现最高的复合年增长率,这主要得益于其先进的医疗基础设施、强劲的研发投入以及对快速诊断的旺盛需求。该地区对个人化医疗、远端医疗和慢性病管理的重视,推动了即时诊断(POC)技术的广泛应用。监管支持和报销系统也促进了创新和市场准入。北美拥有许多主要製造商和早期采用者,预计将继续引领照护现场的技术进步和市场成长。
According to Stratistics MRC, the Global Point-of-Care Diagnostics Market is accounted for $50.6 billion in 2025 and is expected to reach $75.0 billion by 2032 growing at a CAGR of 5.8% during the forecast period. Point-of-care diagnostics refers to medical testing conducted at or near the site of patient care, providing rapid results without the need for centralized laboratory facilities. These tests are designed for convenience, speed, and accessibility, enabling healthcare providers to make immediate clinical decisions. Common applications include glucose monitoring, infectious disease detection, pregnancy testing, and cardiac markers. POC diagnostics utilize portable devices and easy-to-use kits, often requiring minimal training. They are essential in emergency rooms, clinics, remote areas, and home settings. By reducing turnaround time and improving patient outcomes, point-of-care diagnostics play a vital role in modern, decentralized healthcare delivery.
Growing Demand for Rapid and Early Diagnosis
The increasing need for rapid and early diagnosis is a major driver of the point-of-care diagnostics market. These tests enable immediate clinical decisions, especially in emergency settings, rural areas, and home care. With rising cases of infectious and chronic diseases, healthcare providers rely on fast, accurate results to initiate timely treatment. Point-of-care solutions reduce turnaround time, improve patient outcomes, and support decentralized healthcare delivery. Their convenience and speed make them indispensable tools in modern medical practice across global health systems.
Regulatory and Compliance Challenges
Regulatory and compliance challenges pose a significant restraint to the point-of-care diagnostics market. Devices must meet stringent safety, accuracy, and quality standards across different regions, which can delay product approvals and market entry. Navigating complex regulatory frameworks requires substantial investment in testing, documentation, and certification. These hurdles are especially burdensome for startups and small manufacturers. Additionally, evolving regulations around data privacy and diagnostic accuracy further complicate compliance.
Advancements in technology
Technological advancements offer a powerful opportunity for growth in the market. Innovations in biosensors, microfluidics, and portable analyzers are enhancing test speed, accuracy, and usability. Integration with digital platforms and mobile apps enables real-time data sharing and remote monitoring. These breakthroughs support personalized medicine, telehealth, and decentralized care models. As demand for user-friendly diagnostic tools rises, technology-driven solutions are transforming healthcare delivery. Continued R&D investment will unlock new applications and improve accessibility in both developed and emerging markets.
Cost and Reimbursement Issues
Cost and reimbursement issues represent a key threat to the point-of-care diagnostics market. High upfront costs for devices and consumables can deter adoption, especially in low-resource settings. Inconsistent reimbursement policies across regions create uncertainty for providers and manufacturers. Without clear coverage, patients may face out-of-pocket expenses, limiting access to essential diagnostics. These financial barriers hinder market expansion and innovation. Addressing affordability and establishing supportive reimbursement frameworks are critical to ensuring widespread adoption.
The COVID-19 pandemic significantly accelerated the adoption of point-of-care diagnostics. The urgent need for rapid testing and decentralized healthcare solutions highlighted the value of portable, easy-to-use diagnostic tools. POC tests played a crucial role in screening, monitoring, and managing outbreaks, especially in remote and high-risk areas. The crisis also spurred innovation in biosensors and mobile diagnostics, reshaping public health strategies. As healthcare systems adapt to post-pandemic realities, point-of-care diagnostics continue to support resilience, preparedness, and patient-centered care across global markets.
The biosensors segment is expected to be the largest during the forecast period
The biosensors segment is expected to account for the largest market share during the forecast period, due to its central role in enabling rapid, accurate point-of-care testing. Biosensors detect biological markers in real time, supporting applications in infectious disease detection, glucose monitoring, and cardiac diagnostics. Their integration into portable devices enhances usability and accessibility. As demand for fast, reliable diagnostics grows, biosensors remain at the forefront of innovation. Continued advancements in sensitivity, miniaturization, and connectivity will further solidify their dominance in the POC diagnostics landscape.
The diabetes segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the diabetes segment is predicted to witness the highest growth rate, due to global rise in diabetes prevalence and the need for continuous glucose monitoring. Point-of-care diagnostics offer convenient, real-time blood sugar testing, empowering patients to manage their condition effectively. Advances in biosensors and wearable devices are enhancing accuracy and ease of use. As healthcare systems prioritize chronic disease management, demand for accessible, personalized diabetes diagnostics continues to surge. This segment's rapid growth reflects its critical role in preventive and long-term care.
During the forecast period, the Asia Pacific region is expected to hold the largest market share, due to rising healthcare demand, expanding middle-class populations, and government initiatives to improve medical access. Countries like China, India, and Japan are investing in decentralized healthcare infrastructure and affordable diagnostic solutions. The region's strong manufacturing base and increasing adoption of mobile health technologies further support market expansion. Asia Pacific's dynamic healthcare landscape positions it as a leader in point-of-care innovation and deployment.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, owing to advanced healthcare infrastructure, strong R&D investment, and high demand for rapid diagnostics. The region's focus on personalized medicine, telehealth, and chronic disease management supports widespread adoption of POC technologies. Regulatory support and reimbursement frameworks also encourage innovation and market entry. With leading manufacturers and early adopters, North America continues to set the pace for technological advancement and market growth in point-of-care diagnostics.
Key players in the market
Some of the key players in Point-of-Care Diagnostics Market include Abbott Laboratories, F. Hoffmann-La Roche Ltd., Siemens Healthineers, Danaher Corporation, Becton, Dickinson and Company (BD), QuidelOrtho Corporation, Thermo Fisher Scientific, bioMerieux SA, Bio-Rad Laboratories, Hologic, Inc., LumiraDx Ltd., SD Biosensor, Nova Biomedical Corporation, Trinity Biotech plc, and Werfen.
In June 2025, Abbott and MSD Pharmaceuticals (Merck & Co.) have forged a strategic distribution partnership in India for MSD's oral anti-diabetic drugs Sitagliptin, its fixed-dose combination with metformin and the extended-release version marketed under the names Januvia, Janumet and Janumet XR.
In March 2025, Cadrenal Therapeutics and Abbott have entered collaboration for the "TECH-LVAD" trial to evaluate Tecarfarin in patients using the HeartMate 3 left ventricular assist device (LVAD).
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.