![]() |
市场调查报告书
商品编码
2021653
即时诊断设备市场预测至2034年-按产品类型、检体类型、技术、应用、最终用户和地区分類的全球分析Point-of-Care Diagnostic Devices Market Forecasts to 2034 - Global Analysis By Product Type, Sample Type, Technology, Application, End User and By Geography |
||||||
根据 Stratistics MRC 的数据,预计到 2026 年,全球即时诊断设备市场规模将达到 480 亿美元,并在预测期内以 7.5% 的复合年增长率增长,到 2034 年将达到 850 亿美元。
即时诊断设备是携带式医疗设备,用于在患者就诊地点或附近进行诊断测试。这些设备能够快速检测感染疾病、血糖值和心臟标记等疾病,从而支持即时的临床决策。它们还能减少对中心检查室检测的需求,并提高医疗服务的效率。即时诊断设备广泛应用于医院、诊所和家庭环境中,支援早期诊断、及时治疗和改善患者预后,尤其是在急诊和远端医疗环境中。
慢性病增多
随着糖尿病、心血管疾病和感染疾病的日益流行,对快速、准确且便捷的诊断解决方案的需求激增。即时检测设备能够实现即时检测和结果回馈,从而支持及时的临床决策并减少患者就诊次数。其便携性和易用性使其不仅适用于临床环境,也适用于家庭环境。医疗专业人员正越来越多地采用这些设备来改善患者预后并减轻中心检查室的负担。鑑于慢性病在全球范围内日益加重,对即时诊断的需求预计将持续强劲。
监理核准的挑战
对临床检验、安全性和准确性的严格要求常常导致产品上市延迟。製造商面临着复杂且因地区而异的核准流程,这增加了成本并减缓了全球推广。中小企业尤其难以克服这些监管障碍,限制了创新。医疗机构在获得全面监管批准之前可能犹豫是否要引入新设备,这进一步延缓了产品的普及。儘管监管机构旨在确保病患安全,但漫长的核准週期却阻碍了产品的快速商业化。
与数位健康平台集成
将医疗设备与行动应用、电子健康记录和远端医疗平台集成,可改善数据存取和病患监测。医生可以远端追踪患者的检测结果,从而实现预防性介入和个人化治疗方案。检测结果可以即时共用给医疗服务提供者,使患者受益,并提高就医便利性和参与度。这种整合还支援大规模社区健康管理和慢性病监测。为了顺应数位化医疗的发展趋势,各公司正在增加对互联诊断技术的投资。随着医疗系统采用数位化优先模式,这些整合机会有望推动显着成长。
低成本设备带来的价格压力
新兴经济体的许多本土製造商正在提供价格亲民的即时检测(PoC)解决方案,这对老牌大型企业构成了挑战。在价格敏感的市场中,成本往往优先于先进功能,从而限制了高级产品的利润空间。这种竞争环境迫使企业在创新与价格可负担之间寻求平衡。医疗服务提供者可能会选择更便宜的替代方案,即使这些方案缺乏先进的连接性或分析能力。商品化的威胁在血糖值监测和快速感染疾病检测等领域尤为突出。
新冠疫情显着加速了即时诊断设备的应用。快速检测对于控制疫情传播至关重要,由此产生了对携带式诊断解决方案前所未有的需求。疫情期间,各国政府和医疗系统对即时检测基础设施进行了大量投资。疫情也凸显了分散式诊断的重要性,有助于减少对集中式检查室的依赖。疫情过后,随着医疗服务提供者认识到快速诊断在慢性病管理和急诊医学的价值,这一趋势仍在持续。製造商正利用从新冠疫情中汲取的经验教训,拓展产品系列併加强供应链。
在预测期内,免疫检测领域预计将占据最大的市场份额。
随着慢性病盛行率的不断上升,对快速、准确的生物标记检测的需求日益增长,预计在预测期内,免疫检测领域将占据最大的市场份额。免疫检测广泛应用于感染疾病诊断、慢性病监测和癌症标记检测。由于其多功能性和可靠性,免疫检测是即时诊断的基础。微流体技术和携带式平台的进步正在提高免疫检测的效率。医院、诊所和居家医疗机构越来越依赖这些检测来进行快速决策。已开发市场和新兴市场对该领域的强劲需求都支撑着这一细分市场的发展。
在预测期内,居家照护环境细分市场预计将呈现最高的复合年增长率。
在预测期内,受慢性病患病率上升以及由此产生的对便捷家庭诊断解决方案的需求推动,居家照护环境领域预计将呈现最高的增长率。糖尿病、心血管疾病和呼吸系统疾病患者越来越依赖即时检测设备进行自我管理。家庭诊断可以减少就医次数,提高治疗顺从性,并帮助患者更好地掌控自身健康。这一领域受益于可与行动应用程式和远端医疗平台整合的连网型设备的日益普及。不断上涨的医疗保健成本和人口老化进一步推动了居家照护的转型。製造商正致力于开发用户友好、便于携带且针对家庭使用进行最佳化的设备。
在预测期内,北美预计将占据最大的市场份额,这主要得益于其先进的医疗保健基础设施以及慢性病在总人口中日益普遍的患病率。美国在即时诊断技术的核准方面处于主导地位,这得益于其健全的报销体系和监管审批。市场主要企业总部均设在该地区,推动创新和商业化进程。糖尿病、心血管疾病和癌症的高发生率推动了对快速诊断的需求。该地区还受益于数位健康平台和即时诊断设备的深度整合。对研发和临床试验的持续投入进一步巩固了其市场领导地位。
在预测期内,亚太地区预计将呈现最高的复合年增长率,这主要得益于医疗保健的快速数位化以及新兴经济体慢性病盛行率的上升。中国、印度和东南亚等国家对价格合理且易于取得的诊断服务的需求日益增长。各国政府正在加大对医疗基础设施的投资,并推广分散式检查以增强医疗公平性。本土製造商提供高性价比的解决方案,促进了价格敏感型市场的普及。智慧型手机普及率的提高和远端医疗措施正在推动即时检测设备与数位平台的整合。预防医学意识的增强也进一步推动了市场扩张。
According to Stratistics MRC, the Global Point-of-Care Diagnostic Devices Market is accounted for $48 billion in 2026 and is expected to reach $85 billion by 2034 growing at a CAGR of 7.5% during the forecast period. Point-of-Care Diagnostic Devices are portable medical tools used to perform diagnostic tests at or near the site of patient care. These devices provide rapid results for conditions such as infections, blood glucose levels, cardiac markers, and more, enabling immediate clinical decisions. They reduce the need for centralized laboratory testing and improve efficiency in healthcare delivery. Widely used in hospitals, clinics, and home settings, point-of-care devices support early diagnosis, timely treatment, and improved patient outcomes, particularly in emergency and remote care environments.
Increasing prevalence of chronic diseases
Rising cases of diabetes, cardiovascular disorders, and infectious diseases have created urgent demand for rapid, accurate, and accessible diagnostic solutions. Point-of-care devices enable immediate testing and results, supporting timely clinical decisions and reducing hospital visits. Their portability and ease of use make them suitable for both clinical and home settings. Healthcare providers are increasingly adopting these devices to improve patient outcomes and reduce the burden on centralized laboratories. The growing global burden of chronic illnesses is expected to sustain strong demand for point-of-care diagnostics.
Regulatory approval challenges
Stringent requirements for clinical validation, safety, and accuracy often delay product launches. Manufacturers face complex approval processes across different regions, which increases costs and slow global expansion. Smaller companies, in particular, struggle to navigate these regulatory hurdles, limiting innovation. Healthcare providers may hesitate to adopt new devices until they receive full regulatory clearance, further slowing uptake. While regulatory bodies aim to ensure patient safety, the lengthy approval timelines remain a barrier to rapid commercialization.
Integration with digital health platforms
Linking devices with mobile apps, electronic health records, and telehealth platforms enhances data accessibility and patient monitoring. Physicians can remotely track patient results, enabling proactive interventions and personalized treatment plans. Patients benefit from improved convenience and engagement, as results can be shared instantly with healthcare providers. This integration also supports population health management and chronic disease monitoring at scale. Companies are increasingly investing in connected diagnostics to align with digital health trends. As healthcare systems embrace digital-first models, integration opportunities are expected to drive significant growth.
Pricing pressure from low-cost devices
Many local manufacturers in emerging economies offer affordable point-of-care solutions, challenging established players. Price-sensitive markets often prioritize cost over advanced features, limiting margins for premium products. This competitive environment forces companies to balance innovation with affordability. Healthcare providers may opt for cheaper alternatives, even if they lack advanced connectivity or analytics. The threat of commoditization is particularly strong in segments such as glucose monitoring and rapid infectious disease tests.
The COVID-19 pandemic significantly accelerated the adoption of point-of-care diagnostic devices. Rapid testing became essential for managing infection spread, driving unprecedented demand for portable diagnostic solutions. Governments and healthcare systems invested heavily in point-of-care testing infrastructure during the crisis. The pandemic also highlighted the importance of decentralized diagnostics, reducing reliance on centralized laboratories. Post-pandemic, the momentum continues as healthcare providers recognize the value of rapid diagnostics for chronic disease management and emergency care. Manufacturers are leveraging lessons from COVID-19 to expand product portfolios and strengthen supply chains.
The immunoassays segment is expected to be the largest during the forecast period
The immunoassays segment is expected to account for the largest market share during the forecast period as the increasing prevalence of chronic diseases has heightened demand for rapid and accurate biomarker detection. Immunoassays are widely used for diagnosing infectious diseases, monitoring chronic conditions, and detecting cancer markers. Their versatility and reliability make them a cornerstone of point-of-care diagnostics. Advances in microfluidics and portable platforms are enhancing the efficiency of immunoassays. Hospitals, clinics, and home care settings increasingly rely on these tests for immediate decision-making. The segment benefits from strong demand across both developed and emerging markets.
The home care settings segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the home care settings segment is predicted to witness the highest growth rate due to the increasing prevalence of chronic diseases, which has driven demand for convenient, at-home diagnostic solutions. Patients with diabetes, cardiovascular disorders, and respiratory conditions increasingly rely on point-of-care devices for self-monitoring. Home-based diagnostics reduce hospital visits, improve adherence, and empower patients to manage their health. The segment benefits from growing adoption of connected devices that integrate with mobile apps and telehealth platforms. Rising healthcare costs and aging populations further support the shift toward home care. Manufacturers are focusing on user-friendly, portable devices tailored for home use.
During the forecast period, the North America region is expected to hold the largest market share owing to advanced healthcare infrastructure and the increasing prevalence of chronic diseases across the population. The U.S. leads in adoption of point-of-care diagnostics, supported by strong reimbursement frameworks and regulatory approvals. Major players in the market are headquartered in the region, driving innovation and commercialization. High incidence of diabetes, cardiovascular disorders, and cancer fuels demand for rapid diagnostics. The region also benefits from strong integration of digital health platforms with point-of-care devices. Ongoing investments in R&D and clinical trials further strengthen market leadership.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR driven by rapid healthcare digitization and the increasing prevalence of chronic diseases in emerging economies. Countries such as China, India, and Southeast Asia are witnessing rising demand for affordable and accessible diagnostics. Governments are investing in healthcare infrastructure and promoting decentralized testing to improve equity. Local manufacturers are offering cost-effective solutions, boosting adoption in price-sensitive markets. Growing smartphone penetration and telehealth initiatives enhance integration of point-of-care devices with digital platforms. Rising awareness of preventive healthcare further supports market expansion.
Key players in the market
Some of the key players in Point-of-Care Diagnostic Devices Market include Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, Danaher Corporation, Becton Dickinson and Company, Bio-Rad Laboratories, QuidelOrtho Corporation, PerkinElmer Inc., Sekisui Diagnostics, Trinity Biotech, Arkray Inc., SD Biosensor Inc., Werfen, Hologic Inc. and Fujifilm Holdings Corporation.
In March 2026, Arkray launched a portable HbA1c analyzer for diabetes management in outpatient clinics. The device provides immediate results, enabling clinicians to adjust treatment plans during patient visits. Arkray's innovation reinforces its focus on chronic disease management through point-of-care solutions.
In September 2025, Bio-Rad introduced a compact immunoassay analyzer for decentralized oncology testing. The system supports biomarker-guided therapy decisions, offering clinicians rapid results outside central labs. Bio-Rad's innovation reflects its focus on precision diagnostics and expanding access to personalized medicine tools.
In June 2025, Sekisui Diagnostics launched a rapid point-of-care test for C-reactive protein (CRP), supporting infection and inflammation management. The device offers results in under five minutes, aiding primary care decision-making. Sekisui's expansion into portable immunoassays strengthens its role in frontline diagnostics.
Note: Tables for North America, Europe, APAC, South America, and Rest of the World (RoW) are also represented in the same manner as above.