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市场调查报告书
商品编码
1801150
2025 年至 2033 年即时诊断市场规模、份额、趋势及预测(按产品类型、平台、处方模式、最终用户和地区)Point-of-Care Diagnostics Market Size, Share, Trends and Forecast by Product Type, Platform, Prescription Mode, End-User, and Region, 2025-2033 |
2024年,全球即时诊断市场规模达531.1亿美元。展望未来, IMARC Group预测,到2033年,该市场规模将达到1,024亿美元,2025-2033年期间的复合年增长率为7.6%。目前,北美在2024年占据市场主导地位。对更快捷、更便捷的诊断解决方案的需求日益增长,全球传染病的发病率不断上升,以及技术和小型化的进步,是推动市场发展的一些关键因素。
全球市场主要受慢性病和传染病的流行所驱动,这些疾病需要更快、更准确的诊断解决方案才能有效管理。此外,紧急情况和偏远地区对快速检测试剂盒的需求不断增长,也促进了即时诊断的普及,从而提升了医疗服务的可近性。此外,将生物感测器和微流体等先进技术融入简化诊断流程中,从而提高效率和可靠性,也推动了市场的发展。此外,医疗基础设施的持续改善,以及对疾病早期发现和及时干预的日益重视,正在创造积极的市场前景。此外,创新诊断解决方案的研发支出也推动了即时诊断技术的发展。对数位平台和诊断连接性日益增长的需求也使资料管理变得更加容易,从而改善了患者的整体预后。此外,即时诊断在肿瘤学、心臟病学和传染病管理等领域的应用日益增多,也增强了该市场的成长。
随着慢性病和传染病在人群中日益流行,美国成为重要的区域市场。此外,对家用和便携式检测设备的需求不断增长,也为患者提供了更大的便利,从而推动了即时诊断市场的发展。此外,人工智慧和生物感测器等先进技术在诊断领域的应用日益广泛,简化了流程,提高了准确性和效率,为市场创造了丰厚的商机。此外,积极的监管政策推动创新,增加了所有医疗环境中产品的可用性,也推动市场的发展。自 2024 年 2 月 22 日起,FDA 的诊断数据计划启动了一项计划,旨在支持开发创新方法,用于收集、协调、传输和分析在传统实验室以外进行的测试的诊断资料。这将有助于将非实验室资料流与实验室数据流结合,以改善公共卫生决策。此外,与美国国立卫生研究院(NIH)的ITAP和RADx计画等联邦机构的策略合作,透过制定标准化评估方案和资料报告机制,正在促进家庭检测的授权。此外,医疗基础设施投资的增加显着扩大了获得先进诊断解决方案的管道,从而推动了市场成长。
慢性病盛行率不断上升
根据世界卫生组织 (WHO) 的数据,非传染性疾病(也称为慢性病)每年导致 4,100 万人死亡,占全球死亡人数的 74%。同样,爱滋病毒等传染病仍然是一项重大的健康挑战。根据 WHO 估计,2022 年全球爱滋病毒感染者人数约 3,900 万人,当年全球约有 130 万人感染爱滋病毒。全球慢性病的增加推动了对即时诊断 (POC) 服务的需求。糖尿病、心血管疾病和呼吸系统疾病等慢性病在人群中日益普遍,对全球医疗保健系统构成了巨大挑战。即时诊断为自发性检测和持续监测这些健康併发症提供了一种宝贵的工具,有助于及时介入和有效的疾病管理。即时检测的便利性和易用性进一步促进了慢性病的管理,尤其是在偏远或农村地区,这些地区传统实验室设施有限或无法取得。
各种技术进步
技术创新与整合在支援即时诊断市场成长方面发挥着至关重要的作用。微型化、生物感测器和连接性方面的创新和研究,正在推动各种智慧型便携式诊断设备和系统的诞生。这些即时诊断设备能够执行各种高精度测试,而传统的实验室方法往往无法做到这一点。它们通常还整合了扩展的测试选单,从而无需使用多台设备,并缩短了获取测试结果的周转时间。例如,2023年2月,Huwel Lifesciences开发了一款便携式RT-PCR设备,可以检测多种病毒。该公司表示,该测试大约需要30分钟,并且可以透过血液和胃肠道样本识别呼吸道和其他感染。同样,雅培于2020年推出了ID NOW,这是世界上速度最快的分子即时诊断测试,只需13分钟即可得出COVID-19的结果。该设备广泛应用于分散的医疗机构,例如医生办公室和紧急护理诊所。 2023年5月,丹纳赫公司推出了Dxl 9000 Access免疫分析分析仪,该分析仪每小时可进行高达215次检测,显着扩展了该公司的即时诊断产品线。各公司亦计划生产体积小巧、检测设施齐全的即时诊断系统。主要市场参与者也与其他公司合作,提供独特可靠的诊断解决方案,以彻底改变医疗保健服务。 Molbio Diagnostics于2023年宣布与SigTuple合作,共同开发多种常规和诊断检测的下一代人工智慧便携式设备。
个人化医疗日益受到重视
大众对个人化医疗日益增长的需求推动了市场的成长。美国国家癌症研究所 (NCI) 启动了一项大型精准医疗癌症计划,旨在研究使用各种新型药物组合治疗儿童和成人的有效性。此外,随着医疗保健产业向更以患者为中心的模式转型,个人化医疗的普及也促进了根据患者需求制定治疗方案。世界卫生组织 (WHO) 报告称,2020 年各收入水准的政府卫生支出大幅增加,推动全球卫生支出达到 9 兆美元的新高,约占全球 GDP 的 11%。投资的成长反映了人们对包括精准医疗在内的先进医疗保健解决方案日益增长的关注。即时诊断 (POC) 在这过程中发挥关键作用,因为它能够提供快速、有针对性的诊断解决方案,有助于精准识别和监测疾病。即时诊断让患者对自己的治疗和整体健康状况感到安心,这也是其广泛认可的原因。此外,根据 Coriell Life Sciences 的研究,精准医疗已达到全球应用的临界点。
The global point-of-care diagnostics market size was valued at USD 53.11 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 102.4 Billion by 2033, exhibiting a CAGR of 7.6% during 2025-2033. North America currently dominates the market in 2024. The increasing demand for faster and more convenient diagnostic solutions, rising prevalence of infectious diseases across the globe, and advancements in technology and miniaturization represent some of the key factors driving the market.
The global market is majorly driven by the prevalence of chronic and infectious diseases requiring faster and accurate diagnostic solutions for effective management. In addition to this, increasing demand for rapid testing kits in emergency and remote settings is augmenting the adoption of point-of-care diagnostics, thereby promoting the accessibility of healthcare services. Furthermore, the integration of sophisticated technologies, including biosensors and microfluidics, into the processes for streamlining diagnosis, resulting in increased efficiency and reliability, is propelling the market. Moreover, continual improvements the healthcare infrastructure, along with an increasing focus on early detection of diseases for timely intervention, are creating a positive market outlook. Besides this, research and development (R&D) expenditures for innovative diagnostic solutions are encouraging the growth in point-of-care technologies. The increasing demand for digital platforms and connectivity in diagnostics is also making it easier to manage data and consequently improving overall outcomes for the patient. Furthermore, the increased applications of point-of-care diagnostics in such areas as oncology, cardiology, and infectious disease management have strengthened the growth of this market.
The United States stands out as a key regional market, driven by the increasing prevalence of chronic and infectious diseases among the masses. Besides, the accelerating demand for home-based and portable testing devices is also propelling the point-of-care diagnostics market by facilitating greater patient convenience. Also, the increasing usage of advanced technologies such as AI and biosensors in diagnostics has streamlined the process and helped in better accuracy and efficiency, which is creating lucrative opportunities in the market. In addition, positive regulatory policies driving innovation and increasing the availability of products in all healthcare settings is impelling the market. As of February 22, 2024, the FDA's Diagnostic Data Program launched an initiative that aimed to support the development of innovative methods for collecting, harmonizing, transmitting, and analyzing diagnostic data from tests performed outside traditional laboratories. This will help integrate non-laboratory-based data streams with lab-based ones to improve public health decision-making. Also, strategic collaborations with federal agencies, such as NIH's ITAP and RADx programs, are facilitating the authorization of at-home tests by developing standardized evaluation protocols and data reporting mechanisms. Furthermore, increased investments in healthcare infrastructure is significantly expanding access to sophisticated diagnostic solutions, which is driving market growth.
The Growing Prevalence of Chronic Diseases
According to the World Health Organization (WHO), non-communicable diseases, also called chronic diseases, kills 41 million people each year, which is equivalent to 74% of all deaths globally. Similarly, infectious diseases such as HIV remain a major health challenge, with an estimated 39.0 million people living with HIV in 2022 and approximately 1.3 million acquiring the infection globally that year, according to WHO. The global rise in chronic diseases is driving the demand for POC diagnostic services. Chronic conditions, such as diabetes, cardiovascular diseases, and respiratory disorders, are becoming increasingly prevalent among the masses, posing substantial challenges to healthcare systems worldwide. POC diagnostics offer a valuable tool for spontaneous detection and continuous monitoring of these health complications, facilitating timely interventions and effective disease management. The convenience and easy availability of POC testing further contributes to the management of chronic diseases, especially in remote or rural areas where access to traditional laboratory facilities is limited or not available.
Various Technological Advancements
Technological innovations and integration play a crucial role in supporting the point-of-care diagnostics market growth. Initiatives and research in miniaturization, biosensors, and connectivity are leading to the creation of various smart and portable diagnostic devices and systems. These POC devices can perform a wide range of tests with high accuracy, which traditional laboratory-based methods often fail to deliver. They are also often integrated with expanded test menus to eliminate the need for multiple devices and reduce turnaround time for getting the test results. For instance, in February 2023, Huwel Lifesciences developed a portable RT-PCR device that can test multiple viruses. The company stated the test takes about 30 minutes and can identify respiratory and other infections using blood and gastrointestinal samples. Similarly, Abbott launched ID NOW in 2020, which is the world's fastest molecular POC test. It delivers COVID-19 results in just 13 minutes. This device is widely used in dispersed healthcare settings such as doctor's offices and urgent care clinics. In May 2023, Danaher Corporation introduced the Dxl 9000 Access Immunoassay Analyzer, capable of running up to 215 tests per hour, significantly expanding the company's POC diagnostics offerings. Companies are also planning to produce POC diagnostics systems which are compact in size and offer comprehensive testing facilities. Key market players are also collaborating with other firms to offer unique and reliable diagnostic solutions to revolutionize healthcare delivery. Molbio Diagnostics declared its partnership with SigTuple in 2023 to develop next-generation AI-enabled portable devices for many routine and diagnostic tests.
The Growing Emphasis on Personalized Medicine
The increasing need for personalized medicine among the masses is propelling the growth of the market. The National Cancer Institute (NCI) has launched a large precision medicine cancer initiative to examine the effectiveness of treating children and adults with various novel drug combinations. Moreover, as the healthcare sector is transitioning towards a more patient-centric approach, the acceptance of personalized medicine is facilitating the creation of treatment plans according to the needs of patients. The World Health Organization (WHO) reported that sharp increases in government spending on health at all income levels in 2020 underpinned a rise in global health expenditure to a new high of USD 9 Trillion, accounting for approximately 11% of global GDP. This increase in investment reflects the growing focus on advanced healthcare solutions, including precision medicine. POC diagnostics play a pivotal part in this procedure as it offers rapid and targeted diagnostic solutions that aid in precise disease identification and monitoring. They provide a sense of assurance to patients regarding their treatment and overall wellbeing, which is also responsible for their high acceptance among patients. Moreover, according to research done by Coriell Life Sciences, it is confirmed that precision medicine has reached a global tipping position for adoption.
Blood- glucose monitoring kit leads the market in 2024. Blood-glucose monitoring kits are designed to be user-friendly, allowing patients to perform tests themselves without the need for specialized medical training. The simplicity and convenience of these kits are contributing to their widespread adoption, making them accessible to a broad spectrum of patients, including those in remote or underserved areas. Moreover, blood-glucose monitoring kits are often compact and portable, enabling patients to carry them wherever they go, thereby offering a favorable point-of-care diagnostics market outlook. Furthermore, based on the predictions and research by the Institute for Health Metrics and Evaluation, global diabetes cases will increase from 529 million to 1.3 billion by 2050. The US Food and Drug Administration cleared the first over the counter (OTC) continuous glucose monitoring system (CGM) in the US -- the Dexcom Stelo Glucose Biosensor System. This will help people with Type 2 diabetes who don't need insulin to track their blood sugar for nonmedical purposes.
Lateral flow assays lead the market in 2024. Lateral flow assays are known for their simplicity and user-friendly design. They are easy to use, requiring minimal training for both healthcare professionals and patients. The test procedure typically involves incorporating a sample such as blood, saliva, and urine to a test strip, and the results are visually interpreted through the appearance of colored lines, eliminating the need for complex laboratory equipment. They offer stability over a wide range of environmental conditions and have a long shelf life. They also require a small sample volume to conduct tests. As a result, various organizations and institutions are investing in the development of advanced lateral flow assays. For instance, iiCON announced in 2021 that it will support Liverpool SME to develop advanced lateral flow tests, which can be performed with and without the addition of the Nano Biosols reagent.
Prescription-based testing leads the market in 2024. Prescription-based testing involves diagnostic tests that require a healthcare professional's order or prescription before they can be performed. These tests often undergo rigorous regulatory approval processes to ensure their safety, efficacy, and accuracy. The involvement of healthcare professionals in prescribing these tests ensures appropriate medical supervision and interpretation of the results, leading to better patient care and treatment decisions. Prescription-based testing is essential for the accurate detection, staging, and monitoring of diseases such as cancer, infectious diseases, cardiovascular disorders, and autoimmune conditions. As per the reports of WHO, over 35 million new cancer cases will arise by 2050. This will further increase the need for prescription-based testing solutions.
Professional diagnostics centers lead the market in 2024. Professional diagnostic centers offer a wide range of POC diagnostic tests, catering to various medical specialties and healthcare needs. These centers often have advanced equipment and well-trained personnel, allowing them to perform a diverse set of tests, including blood tests, rapid infectious disease testing, urinalysis, pregnancy tests, and more. The availability of comprehensive testing services makes professional diagnostic centers a preferred choice for both patients and healthcare providers. Moreover, professional diagnostic centers are staffed by qualified healthcare professionals, including medical technologists, clinical laboratory scientists, and physicians. For instance, according to a report by the United Nations Economic and Social Commission for Asia and the Pacific (ESCAP), from 2008 to 2021, the pharmaceutical sector received the largest share of foreign direct investment, totaling USD 32 Billion. This amount notably surpassed the FDI attracted by the medical devices sector, which stood at USD 20 billion, the biotechnology industry (USD 17 billion), and healthcare (USD 10.8 Billion) subsectors. This further increased the number of professional diagnostic centers providing comprehensive healthcare services.
In 2024, North America accounted for the largest market share. North America has a highly developed healthcare infrastructure with well-established medical facilities, laboratories, and diagnostic centers. The robust healthcare system of the region enables widespread adoption and integration of POC diagnostics into routine medical practice, contributing to their market dominance. Besides this, the high prevalence of chronic diseases, such as diabetes, cardiovascular disorders, and respiratory conditions, is driving the demand for comprehensive testing services. POC diagnostics play a crucial role in the early detection, monitoring, and management of these chronic conditions. For instance, as per a press release by the Centers for Disease Control and Prevention, the number of Americans with diabetes will range between 1 in 3 to 1 in 5 by 2050. This will further increase the demand for point-of-care testing solutions in the region.
United States Point-of-Care Diagnostics Market Analysis
The increasing cancer incidence in the United States is a strong growth factor for the point-of-care diagnostics market in the country. Early detection of cancer improves patient outcomes and the demand for advanced diagnostic solutions is on the rise. According to Cancer.org 2021 data, approximately 1.9 million new cancer cases were diagnosed in the U.S., with 608,570 deaths reported. These alarming statistics call for some innovative diagnostic technologies that should enable timely and accurate disease detection. Moreover, the market leaders have been bringing innovative products due to growing demand for this emerging need. For instance, last October 2022, F. Hoffmann-La Roche Ltd. received its first companion diagnostic, which allows the identification of patients suffering from HER2-low metastatic breast cancer, eligible to receive ENHERTU. This diagnostic breakthrough would mark an important step ahead in cancer care, and it is the role of point-of-care diagnostics that becomes vital in providing patient-specific and targeted solutions. Such innovation will most likely propel the U.S. POC diagnostics market since they respond to the growing need for customized and accurate health care.
Europe Point-of-Care Diagnostics Market Analysis
The increasing prevalence of chronic diseases in Europe is a key growth driver for this region's point-of-care diagnostics market. The International Diabetes Federation (IDF) reports that the prevalence of diabetes in the European region is going to increase by 13%. The number of people afflicted with this disease will reach 61 million by 2045. This growing diabetes burden increases the demand for POC diagnostic solutions to monitor glucose levels and manage the disease effectively. Also, cardiovascular diseases (CVD), which are the cause of death in Europe, also drive the POC diagnostics market. The National Institutes of Health reported that CVD accounts for 45% of all deaths in the region, with over 4 million deaths annually, primarily from coronary heart disease and stroke. With a rising incidence of these conditions, there is a need for prompt, on-site diagnostic solutions to detect early, manage, and monitor. POC diagnostics offer an efficient way to address these healthcare challenges, contributing to the market's growth.
Asia Pacific Point-of-Care Diagnostics Market Analysis
One major driving force for the POC diagnostics market in Asia Pacific is the accelerating patients with chronic diseases. Notably, the OECD 2021 states that, out of 227 million people living with type 2 diabetes in the Asia-Pacific region, close to half remain undiagnosed or without realizing their long-term complications. This increase in trend is leading to an escalating demand for early detection and monitoring and thereby propelling the utilization of POC diagnostics. Additionally, the miniaturized diagnostic models and the measures undertaken in hospitals and clinics to reduce the duration of hospital and clinic stay will further propel the demand for POC devices. Moreover, improving health outcomes require accessible and efficient solutions for diagnostics, especially in rural and underserved areas. Also, the market is also being driven by rapid technological advancements, high prevalence of both chronic and infectious diseases, and continuous efforts by local companies and organizations to improve healthcare access. For instance, in January 2023, Cipla Limited launched Cippoint, a POC device capable of testing a wide range of parameters, including diabetes, cardiac markers, fertility, and infectious diseases. This innovation reflects the growing trend of comprehensive, multi-disease diagnostics in the region, further boosting the adoption of POC technologies.
Latin America Point-of-Care Diagnostics Market Analysis
This market is gaining momentum in Latin America, primarily due to the increase in prevalence of chronic diseases, along with the growth need for early disease diagnosis. The World Cancer Research Fund International reported that nearly 101,703 cancer cases were diagnosed in Mexico in 2022, which points out the growing demand for appropriate and easily accessible diagnostic devices. POC diagnostics are highly important as early detection of a condition, such as cancer or any other dangerous disease, can lead to positive health outcomes and lessen further health burdens. The rising chronic diseases, including diabetes and cardiovascular diseases, have been stimulating the demand for POC devices as it can offer an immediate and cost-effective diagnosis that results in proper and efficient care of these patients. Also, increasing healthcare technologies and an increase in the awareness levels for preventive health are also significant growth-inducing factors for the market across this region.
Middle East and Africa Point-of-Care Diagnostics Market Analysis
The World Heart Federation says that CVD is the leading cause of death in the MENA region, accounting for more than one-third of all deaths or approximately 1.4 million fatalities annually. In 2024, the percentage of CVD deaths varies from country to country in the region, which ranges from 40 percent of total deaths in Oman to 10 percent in Somalia. High prevalence rates of cardiovascular diseases will fuel point-of-care diagnostics growth in Middle East and Africa. POC diagnostics in the management of cardiovascular disease ensure early detection, monitoring, and management of this type of disease, making a timely intervention possible. Growing cardiovascular diseases weigh much on the region. Adoption of POC technologies across the region is likely to gain momentum because of an increasing demand for accessible, rapid, and cost-effective diagnostic solutions. MENA region healthcare systems that have prioritized efficient and preventive care are also going to create an even greater need for POC diagnostics, hence accelerating market growth.
The competitive landscape of the market comprises a wide variety of players, which comprises established companies, emerging startups, and specialized firms. Major players are focusing significant investment on R&D innovation and development of the latest POC diagnostic solutions. Also, they are placing their emphasis on accuracy, sensitivity, and speed of the tests. Top companies expand the range of analytes and diseases detectable by POC devices. R&D activities also encompass the design of innovative technologies, such as biosensors, microfluidics, and systems that are lab-on-a-chip, in pursuit of improving the performance capabilities of POC diagnostics. In addition, they adjust the designs of their products to meet specific health needs and regulatory requirements in various countries. For instance, the company Cipla expanded its product portfolio with the launch of a point-of-care testing device for different forms of non-communicable diseases and other diseases/health conditions. The point-of-care diagnostics market statistics clearly show a very strong growth trajectory, led by higher demands for rapid testing, new technologies, and increasing attention to decentralized healthcare.