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市场调查报告书
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1355176
肌酸酐检测市场 - 2018-2028F 全球产业规模、份额、趋势、机会和预测,按测试类型、产品、样品、最终用户、地区、竞争细分Creatinine Assay Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028F Segmented By Test Type, By Product, By Sample, By End User, By Region, Competition |
The Global Creatinine Assay Market was valued at USD 360.12 million in 2022 and is expected to exhibit robust growth in the forecast period, with a CAGR of 6.6% through 2028. The measurement of creatinine is a vital test conducted to evaluate renal function in the human身体.肌酸酐是肌肉产生能量后产生的一种化合物,保留在体内。评估血液和尿液样本中的肌酸酐水平可以确定肾臟滤除肌酸酐时的肾臟状态。对于成人,肌酸酐测量的正常范围是每分升血液 0.5 至 1.2 毫克。肌酸酐水平升高表示肾臟状况不健康。肾臟疾病的盛行率不断上升,特别是在发展中国家,由于生活条件不利,导致对肌酸酐测量测试的需求不断增长。此外,市场成长是由测试套件和试剂的成本效益和广泛可用性所推动的。
市场概况 | |
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预测期 | 2018-2028 |
2022 年市场规模 | 54025万美元 |
2028 年市场规模 | 77395万美元 |
2023-2028 年复合年增长率 | 6.04% |
成长最快的细分市场 | 试剂 |
最大的市场 | 北美洲 |
肾臟疾病,包括慢性肾臟病 (CKD),对全球死亡率有重大影响。早期诊断和适当的治疗对于预防併发症起着至关重要的作用。肌酸酐测试方法用于评估肾功能。市场参与者优先生产高品质的产品,以满足不断增长的需求。此外,该领域研究活动的增加有助于全球市场的扩大。越来越多的人被诊断出患有肾臟相关疾病,导致对肌酸酐检测以评估肾功能和监测疾病进展的需求更高。对于肾病患者来说,定期监测肾功能,包括肌酸酐水平是必要的。这种持续监测推动了频繁肌酸酐测试的需要。医院、诊所和医疗机构通常会进行肌酸酐测定,以评估患有肾臟相关问题或正在接受可能影响肾功能的治疗的患者的肾功能。由于需要快速获得结果和立即做出临床决策,从而能够及时管理患者,在重症监护环境中越来越多地采用床边肌酸酐检测。在製药业,肌酸酐测定用于临床前和临床研究,以评估新药对肾功能和潜在肾毒性的影响。人们对肾臟健康的认识不断增强,导致常规健康检查的增加,其中包括肌酸酐检测,以检测肾功能障碍的早期迹象,从而推动了全球肌酸酐检测市场的发展。
老年人口的增加以及随后与年龄相关的健康状况的增加极大地推动了对肌酸酐测定的需求。随着年龄的增长,肾臟相关疾病和肾功能受损的风险往往会增加。老年人群的肾功能评估和肾臟健康监测在很大程度上依赖肌酸酐测定的关键作用。肾臟自然发生与年龄相关的变化,导致肾功能下降和肾小球滤过率(GFR)下降。检测老年人的肾功能障碍至关重要,肌酸酐测定是此过程中的基本工具。老年人经常需要多种药物来治疗慢性病,这强调了肾功能在清除体内药物方面的重要性。透过促进适当的药物剂量调整,肌酸酐测定可帮助医疗保健提供者预防老年患者的潜在毒性和不良反应。定期肌酸酐检测可以及早发现老年人的肾臟疾病,从而及时进行干预和管理,以防止疾病进展和併发症。随着老年人口的持续增长,对肌酸酐测定的需求预计将保持在较高水平。确保肾臟健康和早期发现肾臟疾病对于管理老年族群的健康和福祉至关重要,使肌酸酐检测成为老年护理和医学中不可或缺的工具。
许多患者可能缺乏肌酸酐检测在评估肾功能及其对整体健康影响的重要性的认识。不同的医疗机构可能采用不同的肌酸酐测试方法,导致患者和医疗保健提供者对结果的准确性和可靠性产生困惑。在某些情况下,医疗保健提供者可能会优先考虑其他健康参数而不是肌酸酐测试,这可能会错过肾功能障碍的早期迹象。公共卫生措施和宣传活动可能无法充分解决肾臟健康和肌酸酐检测在促进整体健康方面的重要性。
IVD 中肌酸酐检测试剂盒的可用性或使用有限可能会导致医疗保健提供者和患者获得这些诊断测试的机会受到限制。这可能会导致肾臟相关疾病的诊断不足或延迟诊断。肌酸酐检测试剂盒的使用有限也可能导致不同医疗机构的肌酸酐检测缺乏标准化。标准化对于确保一致和可靠的结果至关重要,而缺乏广泛使用的检测试剂盒可能会阻碍此过程。医疗保健提供者可能会探索评估肾功能的替代诊断方法,例如即时检测或其他生物标记物,这可能会转移对传统肌酸酐测定的需求。肌酸酐检测试剂盒的製造商可能会遇到对其产品的需求减少,从而影响他们的收入和获利能力。反过来,这可能会影响他们投资研发或改进检测试剂盒的能力。
POCT 可以在患者床边、门诊诊所甚至偏远或资源有限的地区进行。它消除了患者前往集中实验室进行肌酸酐检测的需要,从而提高了诊断服务的可近性。对于患有慢性肾病(CKD)或正在接受可能影响肾功能的治疗的患者,POCT可以频繁、方便地监测肌酸酐水平,从而能够及时调整治疗计划。在远距医疗或远距医疗保健环境中,肌酸酐 POCT 可以远端监测肾功能,促进护理的连续性和个人化治疗计划。此外,POCT 可以减少多次访问或样品运输到集中实验室的需要,从而节省成本。
随着新兴市场医疗保健服务的改善,对具有成本效益且用户友好的肌酸酐试剂盒的需求预计将会增加。製造商可能会专注于为这些市场开发负担得起且可靠的解决方案。新兴市场医疗基础设施的改善和医疗服务范围的扩大意味着更多的人可以接受定期健康检查,包括肾功能评估。人们越来越认识到预防性医疗保健的重要性,鼓励个人定期进行筛检,包括肌酸酐检测,以发现肾功能障碍的早期迹象。政府为提高医疗保健可及性和品质而采取的倡议,以及解决非传染性疾病 (NCD) 的努力,可以进一步推动对肌酸酐检测的需求。
根据测试类型,Jaffe 的动力学方法成为市场的主导部分。这主要是因为它是测量肌酸酐最古老、最传统的方法,因而拥有最大的市场份额。 Jaffe 法采用简单的比色测定,肌酸酐在碱性条件下与苦味酸反应,形成红橙色髮色团。颜色变化的强度与肌酸酐的浓度成正比,使其成为方便的测量方法。 Jaffe 方法在临床实验室中被广泛接受和标准化,使其成为肌酸酐检测的参考方法。它在临床试验和研究中的广泛应用进一步确立了其可信度。其他占据该细分市场重要份额的因素包括 Jaffe 动力学测试套件的广泛可用性和成本效益。
其中,血液样本占据肌酸酐检测试剂盒市场的主导地位。由于血液样本的可及性,该细分市场占有最大的市场份额。血液通常用于肌酸酐检测,因为肌酸酐是肌肉代谢的废物,会释放到血流中,随后被肾臟过滤。血液中肌酸酐的浓度保持相对稳定,可作为肾功能的指标,特别是肾小球滤过率(GFR)。然而,由于越来越多地使用尿液样本进行肌酸酐测量,特别是在肾功能评估中,尿液样本部分正在经历快速增长。尿液肌酸酐通常用于计算肌酸酐清除率,这是估计 GFR 的另一种方法。然而,值得注意的是,尿液肌酸酐测定通常与血液肌酸酐测量结合使用,进一步确定了样本部分中血液样本的主导地位。
预计北美市场在预测期内将占据重要的收入份额。这可归因于肾衰竭和慢性肾臟疾病的盛行率不断上升,以及肌酸酐检测方法的进步和该地区医疗基础设施的改善。此外,有利的报销政策预计将进一步推动市场成长。 2022 年,在主要参与者实施各种策略以扩大收入机会和地理影响力的推动下,亚太市场出现了快速成长。由于人们对肌酸酐检测方法的认识不断提高、患有糖尿病和肾臟疾病等慢性病的老年人口不断增加,以及医疗保健领域的研发活动不断增加等因素,亚太地区市场的收入正在快速增长。
全球肌酸酐测定市场报告以及给定的市场资料,技术科学研究根据公司的具体需求提供客製化服务。该报告可以使用以下自订选项:
The Global Creatinine Assay Market was valued at USD 360.12 million in 2022 and is expected to exhibit robust growth in the forecast period, with a CAGR of 6.6% through 2028. The measurement of creatinine is a vital test conducted to evaluate renal function in the human body. Creatinine, a chemical compound produced after muscle energy production, remains in the body. Assessing creatinine levels in blood and urine samples enables the determination of kidney status as the kidneys filter out creatinine. In adults, the normal range for creatinine measurement is 0.5 to 1.2 milligrams per deciliter of blood. Elevated creatinine levels indicate unhealthy kidney conditions. The increasing prevalence of kidney diseases, particularly in developing countries due to unfavorable living conditions, has resulted in a growing demand for creatinine measurement tests. Moreover, the market growth is driven by the cost-effectiveness and widespread availability of test kits and reagents.
Market Overview | |
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Forecast Period | 2018-2028 |
Market Size 2022 | USD 540.25 Million |
Market Size 2028 | USD 773.95 Million |
CAGR 2023-2028 | 6.04% |
Fastest Growing Segment | Reagents |
Largest Market | North America |
Kidney disorders, including chronic kidney disease (CKD), contribute significantly to global mortality rates. Early diagnosis and appropriate treatment play a crucial role in preventing complications. Creatinine testing methods are utilized to evaluate renal functionality. Market players prioritize the production of high-quality products to meet the rising demand. Furthermore, increased research activities in this field contribute to the expansion of the global market. The growing number of individuals diagnosed with kidney-related diseases has led to a higher demand for creatinine testing to assess kidney function and monitor disease progression. Regular monitoring of kidney function, including creatinine levels, is necessary for patients with kidney diseases. This continuous monitoring drives the need for frequent creatinine testing. Creatinine assays are routinely performed in hospitals, clinics, and healthcare facilities to evaluate kidney function in patients admitted with kidney-related issues or undergoing treatments that may impact kidney function. The adoption of point-of-care creatinine testing has increased in critical care settings due to the need for rapid results and immediate clinical decision-making, which enables timely patient management. In the pharmaceutical industry, creatinine assays are used in pre-clinical and clinical research to assess the impact of new drugs on kidney function and potential nephrotoxicity. The growing awareness about kidney health has led to an increase in routine health check-ups that include creatinine testing to detect early signs of kidney dysfunction, thereby boosting the global creatinine assay market.
The growing demand for rapid diagnostic techniques and procedures to measure creatinine levels in blood and urine is a key driver of market growth. The prevalence of diabetes, which has a negative impact on kidney health, along with the increasing incidence of chronic kidney disorders among the aging population and the rising number of patients with kidney cancer, glomerulonephritis, and renal failures, among others, are fueling the need for rapid diagnostic procedures to measure creatinine levels. Creatinine, an endogenous waste product formed during the breakdown of creatine found in muscles, is used by clinical laboratories to assess health and kidney function by testing glomerular filtration rate (GFR) and blood urea nitrogen (BUN).
Technological advancements in creatinine detection have led to the development of a biosensor construction based on a single-mode fiber-multicore fiber-multimode fiber-single-mode fiber (SMFMCF-MMF-SMF) configuration. This construction is characterized by simplicity, portability, and high sensitivity. To enhance the generation of strong evanescent waves, the diameter of the sensing probe has been reduced to 90m using chemical etching. The sensor probe is functionalized with graphene oxide (GO), gold nanoparticles (AuNPs), molybdenum disulfide nanoparticles (MoS2-NPs), and the creatininase (CA) enzyme. Fiber optic localized surface plasmon resonance (LSPR) is employed to assess the concentration of creatinine. Two-dimensional (2D) materials, such as GO and MoS2-NPs, are used to enhance biocompatibility, while CA increases the probe's specificity. The use of evanescent waves (EWs) enhances the impact of AuNPs on LSPR.
Moreover, high-resolution transmission electron microscopy (HR-TEM) and UV-visible spectroscopy are utilized to analyze and evaluate the shape and absorption spectra of nanoparticles (NPs). Scanning electron microscopy (SEM) is used to characterize NPs adsorbed on the surface of the fiber probe. The performance of the sensor probe is evaluated in terms of reusability, repeatability, stability, selectivity, and pH tests. The suggested sensor exhibits a sensitivity of 0.0025 nm/M, a standard deviation of 0.107, and a detection limit of 128.4m within a linear detection range of 0 - 2000m. Based on these findings, significant market growth is anticipated in the forecast period.
The increasing geriatric population and the subsequent rise in age-related health conditions significantly drive the demand for creatinine assay. With advancing age, the risk of kidney-related diseases and impairments in kidney function tends to escalate. The assessment of kidney function and monitoring renal health in the elderly population heavily relies on the crucial role of the creatinine assay. Age-related changes naturally occur in the kidneys, leading to reduced kidney function and a decline in the glomerular filtration rate (GFR). Detecting kidney dysfunction in older adults is vital, and the creatinine assay serves as a fundamental tool in this process. Elderly individuals often require multiple medications to manage chronic conditions, emphasizing the importance of kidney function in clearing drugs from the body. By facilitating appropriate drug dosage adjustments, creatinine assays help healthcare providers prevent potential toxicity and adverse effects in older patients. Regular creatinine testing enables early detection of kidney disease in older adults, allowing for timely interventions and management to prevent disease progression and complications. As the geriatric population continues to grow, the demand for creatinine assay is expected to remain high. Ensuring kidney health and early detection of kidney diseases will be paramount in managing the health and well-being of the elderly population, making creatinine testing an indispensable tool in geriatric care and medicine.
Many patients may lack awareness of the importance of creatinine testing in evaluating kidney function and its impact on overall health. Different healthcare settings may employ various methods for creatinine testing, leading to confusion among patients and healthcare providers regarding the accuracy and reliability of results. In some cases, healthcare providers may prioritize other health parameters over creatinine testing, potentially missing early signs of kidney dysfunction. Public health initiatives and awareness campaigns may not adequately address the significance of kidney health and creatinine testing in promoting overall well-being.
Limited availability or usage of creatinine assay kits in IVD can result in restricted access to these diagnostic tests for healthcare providers and patients. This could potentially lead to underdiagnosis or delayed diagnosis of kidney-related conditions. Limited usage of creatinine assay kits may also contribute to a lack of standardization in creatinine testing across different healthcare settings. Standardization is crucial for ensuring consistent and reliable results, and the absence of widely used assay kits can hinder this process. Healthcare providers may explore alternative diagnostic methods for assessing kidney function, such as point-of-care tests or other biomarkers, potentially diverting demand away from traditional creatinine assays. Manufacturers of creatinine assay kits might experience reduced demand for their products, affecting their revenue and profitability. This, in turn, could impact their ability to invest in research and development or improvements to their assay kits.
POCT can be conducted at the patient's bedside, in outpatient clinics, or even in remote or resource-limited areas. It eliminates the need for patients to visit a centralized laboratory for creatinine testing, thereby enhancing accessibility to diagnostic services. For patients with chronic kidney disease (CKD) or those undergoing treatments that may affect kidney function, POCT allows for frequent and convenient monitoring of creatinine levels, enabling timely adjustments to treatment plans. In telemedicine or remote healthcare settings, POCT of creatinine enables remote monitoring of kidney function, promoting continuity of care and personalized treatment plans. Furthermore, POCT can lead to cost savings by reducing the need for multiple visits or sample transportation to centralized laboratories.
As access to healthcare improves in emerging markets, the demand for cost-effective and user-friendly creatinine kits is expected to increase. Manufacturers are likely to focus on developing affordable and reliable solutions for these markets. The improvement of healthcare infrastructure and expanded access to medical services in emerging markets mean that more individuals can undergo regular health check-ups, including assessments of kidney function. Growing awareness about the importance of preventive healthcare is encouraging individuals to seek regular screenings, including creatinine testing, to detect early signs of kidney dysfunction. Government initiatives to enhance healthcare access and quality, along with efforts to address non-communicable diseases (NCDs), can further drive the demand for creatinine assays.
Based on the test types, Jaffe's Kinetic method emerged as the dominant segment in the market. This is primarily due to its status as the oldest and most traditional method for measuring creatinine, resulting in the largest market share. The Jaffe method utilizes a simple colorimetric assay, where creatinine reacts with picric acid under alkaline conditions, forming a red-orange chromophore. The intensity of the color change is directly proportional to the concentration of creatinine, making it a convenient measurement method. The Jaffe method is widely accepted and standardized in clinical laboratories, making it a reference method for creatinine testing. Its credibility is further established by its extensive use in clinical trials and research studies. Other contributing factors to the significant share of this segment include the wide availability and cost-effectiveness of Jaffe's Kinetic Test Kits.
Among the sample, blood samples dominate the Creatinine Assay Kits Market. This segment holds the largest market share due to the accessibility of blood samples. Blood is commonly used for creatinine testing because creatinine, a waste product of muscle metabolism, is released into the bloodstream and subsequently filtered by the kidneys. The concentration of creatinine in blood remains relatively stable and serves as an indicator of kidney function, specifically the glomerular filtration rate (GFR). However, the urine sample segment is experiencing rapid growth, driven by the increasing use of urine samples for creatinine measurements, particularly in the assessment of kidney function. Urine creatinine is often used to calculate creatinine clearance, an additional method for estimating GFR. However, it is important to note that urine creatinine assays are typically used in conjunction with blood creatinine measurements, further establishing the dominance of blood samples in the sample segment.
The North America market is projected to hold a significant revenue share during the forecast period. This can be attributed to the increasing prevalence of renal failure and chronic kidney diseases, as well as advancements in creatinine testing methods and improved healthcare infrastructure in the region. Furthermore, favorable reimbursement policies are expected to further drive market growth. In 2022, the Asia Pacific market witnessed a rapid growth rate, fueled by major players implementing various strategies to expand their revenue opportunities and geographic presence. The market in the Asia Pacific region is experiencing rapid revenue growth due to factors such as growing awareness about creatinine testing methods, a rising geriatric population with chronic diseases like diabetes and kidney disorders, and increased research and development activities in the healthcare sector.
In this report, the Global Creatinine Assay Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Creatinine Assay Market.
Global Creatinine Assay market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report: