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市場調查報告書
商品編碼
1801150
2025 年至 2033 年即時診斷市場規模、佔有率、趨勢及預測(按產品類型、平台、處方模式、最終用戶和地區)Point-of-Care Diagnostics Market Size, Share, Trends and Forecast by Product Type, Platform, Prescription Mode, End-User, and Region, 2025-2033 |
2024年,全球即時診斷市場規模達531.1億美元。展望未來, IMARC Group預測,到2033年,該市場規模將達到1,024億美元,2025-2033年期間的複合年成長率為7.6%。目前,北美在2024年佔據市場主導地位。對更快捷、更便捷的診斷解決方案的需求日益成長,全球傳染病的發病率不斷上升,以及技術和小型化的進步,是推動市場發展的一些關鍵因素。
全球市場主要受慢性病和傳染病的流行所驅動,這些疾病需要更快、更準確的診斷解決方案才能有效管理。此外,緊急情況和偏遠地區對快速檢測試劑盒的需求不斷成長,也促進了即時診斷的普及,從而提升了醫療服務的可近性。此外,將生物感測器和微流體等先進技術融入簡化診斷流程中,從而提高效率和可靠性,也推動了市場的發展。此外,醫療基礎設施的持續改善,以及對疾病早期發現和及時干預的日益重視,正在創造積極的市場前景。此外,創新診斷解決方案的研發支出也推動了即時診斷技術的發展。對數位平台和診斷連接性日益成長的需求也使資料管理變得更加容易,從而改善了患者的整體預後。此外,即時診斷在腫瘤學、心臟病學和傳染病管理等領域的應用日益增多,也增強了該市場的成長。
隨著慢性病和傳染病在人群中日益流行,美國成為重要的區域市場。此外,對家用和攜帶式檢測設備的需求不斷成長,也為患者提供了更大的便利,從而推動了即時診斷市場的發展。此外,人工智慧和生物感測器等先進技術在診斷領域的應用日益廣泛,簡化了流程,提高了準確性和效率,為市場創造了豐厚的商機。此外,積極的監管政策推動創新,增加了所有醫療環境中產品的可用性,也推動市場的發展。自 2024 年 2 月 22 日起,FDA 的診斷數據計劃啟動了一項計劃,旨在支持開發創新方法,用於收集、協調、傳輸和分析在傳統實驗室以外進行的測試的診斷資料。這將有助於將非實驗室資料流與實驗室數據流結合,以改善公共衛生決策。此外,與美國國立衛生研究院(NIH)的ITAP和RADx計畫等聯邦機構的策略合作,透過制定標準化評估方案和資料報告機制,正在促進家庭檢測的授權。此外,醫療基礎設施投資的增加顯著擴大了獲得先進診斷解決方案的管道,從而推動了市場成長。
慢性病盛行率不斷上升
根據世界衛生組織 (WHO) 的數據,非傳染性疾病(也稱為慢性病)每年導致 4,100 萬人死亡,佔全球死亡人數的 74%。同樣,愛滋病毒等傳染病仍然是一項重大的健康挑戰。根據 WHO 估計,2022 年全球愛滋病毒感染者人數約 3,900 萬人,當年全球約有 130 萬人感染愛滋病毒。全球慢性病的增加推動了對即時診斷 (POC) 服務的需求。糖尿病、心血管疾病和呼吸系統疾病等慢性病在人群中日益普遍,對全球醫療保健系統構成了巨大挑戰。即時診斷為自發性檢測和持續監測這些健康併發症提供了一種寶貴的工具,有助於及時介入和有效的疾病管理。即時檢測的便利性和易用性進一步促進了慢性病的管理,尤其是在偏遠或農村地區,這些地區傳統實驗室設施有限或無法取得。
各種技術進步
技術創新與整合在支援即時診斷市場成長方面發揮著至關重要的作用。微型化、生物感測器和連接性方面的創新和研究,正在推動各種智慧型攜帶式診斷設備和系統的誕生。這些即時診斷設備能夠執行各種高精度測試,而傳統的實驗室方法往往無法做到這一點。它們通常還整合了擴展的測試選單,從而無需使用多台設備,並縮短了獲取測試結果的周轉時間。例如,2023年2月,Huwel Lifesciences開發了一款攜帶式RT-PCR設備,可以檢測多種病毒。該公司表示,該測試大約需要30分鐘,並且可以透過血液和胃腸道樣本識別呼吸道和其他感染。同樣,雅培於2020年推出了ID NOW,這是世界上速度最快的分子即時診斷測試,只需13分鐘即可得出COVID-19的結果。該設備廣泛應用於分散的醫療機構,例如醫生辦公室和緊急護理診所。 2023年5月,丹納赫公司推出了Dxl 9000 Access免疫分析分析儀,該分析儀每小時可進行高達215次檢測,顯著擴展了該公司的即時診斷產品線。各公司亦計劃生產體積小巧、檢測設施齊全的即時診斷系統。主要市場參與者也與其他公司合作,提供獨特可靠的診斷解決方案,以徹底改變醫療保健服務。 Molbio Diagnostics於2023年宣布與SigTuple合作,共同開發多種常規和診斷檢測的下一代人工智慧攜帶式設備。
個人化醫療日益受到重視
大眾對個人化醫療日益成長的需求推動了市場的成長。美國國家癌症研究所 (NCI) 啟動了一項大型精準醫療癌症計劃,旨在研究使用各種新型藥物組合治療兒童和成人的有效性。此外,隨著醫療保健產業向更以患者為中心的模式轉型,個人化醫療的普及也促進了根據患者需求制定治療方案。世界衛生組織 (WHO) 報告稱,2020 年各收入水準的政府衛生支出大幅增加,推動全球衛生支出達到 9 兆美元的新高,約佔全球 GDP 的 11%。投資的成長反映了人們對包括精準醫療在內的先進醫療保健解決方案日益成長的關注。即時診斷 (POC) 在這過程中發揮關鍵作用,因為它能夠提供快速、有針對性的診斷解決方案,有助於精準識別和監測疾病。即時診斷讓患者對自己的治療和整體健康狀況感到安心,這也是其廣泛認可的原因。此外,根據 Coriell Life Sciences 的研究,精準醫療已達到全球應用的臨界點。
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.