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市场调查报告书
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1190483

肌酐检测试剂盒市场——增长、趋势、COVID-19 的影响和预测 (2023-2028)

Creatinine Assay Kits Market - Growth, Trends, and Forecasts (2023 - 2028)
出版日期: | 出版商: Mordor Intelligence | 英文 110 Pages | 商品交期: 2-3个工作天内

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简介目录

在预测期内，肌酐检测试剂盒市场的复合年增长率预计为 5.3%。

主要亮点

  • 已确认 COVID-19 对市场产生了重大影响。 这主要是由于 COVID-19 患者中肾臟疾病的发生。 发生 COVID-19 的患者表现出急性肾损伤 (AKI) 风险增加、估计肾小球滤过率 (eGFR) 下降、终末期肾病 (ESKD) 和主要肾臟不良事件 (MAKE) 下降。 肾臟结局的风险（和负担）随着急性感染的严重程度而增加。 因此，COVID-19的高流行增加了全球肾臟疾病的负担，推动了对用于检测和诊断肾臟疾病的肌酐测量试剂盒的需求，推动了被调查市场的增长。然而，我们研究的市场现在正处于大流行前的步伐，因为 COVID-19 的疾病和相关影响已经减弱。
  • 肾臟病和其他慢性病的发病率上升、肾臟疾病生物医学研究的重大技术发展以及研发计划的增加是肌酐测量套件市场的主要驱动力。 肌酐测定试剂盒测量血清/血浆、尿液和其他生物样本中的肌酐浓度。 肌酐测定用于分析体内蛋白质代谢，肌酐水平会受到肌肉质量、怀孕、癌症等变化的影响。 如果肾臟状况不好，血液中的肌酐水平就会升高，血液检查就会出现偏差。 肌酐测试是使用特定的肌酐测量套件完成的，可以针对多种情况进行，例如高血压、糖尿病和癌症。
  • 根据国际肾臟病学会 2021 年的数据，全球每年约有 1330 万例急性肾损伤 (AKI)，新兴国家除外，年发病率为 1130 万例。估计 因此，随着肾臟疾病负担的增加，用于诊断目的的肌酐检测试剂盒的需求也在增加，这是全球市场增长的驱动因素。
  • 此外，据 Globocan 称，到 2040 年，癌症负担预计将达到 605,726 例。 肾癌的高负担正在推动肾臟疾病的早期检测，从而推动肾臟生物标誌物市场的发展。 根据 2021 年 4 月发表的题为终末期肾病 (ESKD) 的全球流行病学和肾臟替代疗法的差异的研究，终末期肾病 (ESKD) 是对健康和医疗保健的全球威胁。负担正在迅速增长，全球平均每百万普通人口中有 144 例新的 ESKD 诊断。 因此，预计用于检测和诊断 ESKD 的肾臟生物标誌物的需求将增加，这可能会促进被调查市场的增长。
  • 然而，新型肾臟生物标誌物的鑑定和肌酐测定试剂盒在体外诊断设备中的有限使用是抑制全球市场增长的因素。

主要市场趋势

预计血液和血清业务在预测期内将快速增长

血清肌酐是最广泛使用的肾功能测试之一。 它用于推导出作为肾功能指标的估计肾小球滤过率 (eGFR)。 它还被用作确定慢性肾病的最佳指标。 血液中的肌酐浓度与肾小球滤过率 (GFR) 呈负相关，是肾功能的理想指标。 然而不幸的是，测量 GFR 非常耗时，因此 GFR 通常是根据考虑了血清肌酐 (sCr) 等内源性滤过标记物的公式来估算的。

慢性肾病患病率上升、研发活动增加、主要参与者采取重大战略举措以及血清肌酐测试的推出和进步正在推动市场增长。 根据 2022 年 2 月发布的 PubMed 数据，亚洲中低收入国家的慢性肾病患病率明显更高，约为 11.2%。 出于这个原因，对肌酐测试的需求正在增加，推动了市场。

此外，全球范围内该领域不同机构对血清肌酐的研究和研究合作越来越多。 例如，2021 年 9 月，美国国家肾臟基金会 (NKF) 和美国肾臟病学会 (ASN) 工作组宣布采用新的 eGFR 2021 CKD EPI（慢性肾臟病流行病学伙伴关係）肌酐公式来估计肾功能，不分种族变量。我们制定了法规 工作组还建议扩大使用胱抑素 C 联合血清（血液）肌酐作为肾功能的确认评估。 这些努力将增加对血清肌酐生物标誌物测试的需求。

预计北美目前和预测期内将占据很大的市场份额

由于该地区肾臟疾病和其他影响肾功能的慢性疾病的发病率不断增加，以及肾臟疾病生物医学研究的技术进步，北美在全球肌酐检测试剂盒市场中占有很大份额。

根据 2021 年 3 月 CDC 数据，估计约有 3700 万人（占美国成年人的 15%）患有慢性肾病 (CKD)。 据估计，慢性肾臟病 (CKD) 在女性 (16%) 中比在男性 (13%) 中更常见。 此外，有利的保险报销政策和完善的医疗基础设施正在极大地推动整个地区的市场增长。

此外，新产品在该国的推出以及主要市场参与者越来越多地采用扩张战略也有望提振市场。 2022 年 7 月，莫菲特癌症中心的研究人员确定了肾细胞癌的生物标誌物。 基于他们的生物标誌物表达，我们开发了一种工具来指示哪些患者预后不良的风险很高。 预计这些研发活动将在预测期内促进肾臟疾病生物标誌物测试的发展。 同样，2021 年 4 月，Renalytix AI PLC 与乔斯林糖尿病中心签订了独家选择权协议，为肾臟疾病的某些其他新型生物标誌物申请专利，以便在 KidneyIntelXin 体外预后平台上进行开发和部署。 这表明开发肾臟疾病生物标誌物测试的研发活动有所增加，这正在推动市场增长。

竞争格局

肌酐检测试剂盒市场是一个高度分散且竞争激烈的市场，由几家大型企业组成。 从市场份额的角度来看，目前大多数玩家占据了市场主导地位。 目前主导市场的公司包括 Abbott Laboratories、Thermo Fisher Scientific、Merck KGaA、Quidel Corporation、Cell Biolabs Inc、Genway Biotech、Randox Laboratories Ltd、ACON Laboratories、Nova Biomedical 和 Sysmex India Pvt。

其他好处

  • Excel 格式的市场预测 (ME) 表
  • 三个月的分析师支持

内容

第一章介绍

  • 研究假设和市场定义
  • 调查范围

第二章研究方法论

第 3 章执行摘要

第四章市场动态

  • 市场概览
  • 市场驱动因素
    • 肾臟和其他影响肾功能的慢性疾病的发病率增加
    • 肾臟疾病生物医学研究的技术进展
    • 增加研发计划
  • 市场製约因素
    • 鑑定新型肾功能障碍生物标誌物
    • 关于在体外诊断 (IVD) 中使用肌酐测定试剂盒的限制
  • 波特的五力分析
    • 新进入者的威胁
    • 买方/消费者议价能力
    • 供应商的议价能力
    • 替代品的威胁
    • 竞争公司之间的敌对关係

第 5 章市场细分（市场规模:百万美元）

  • 按类型
    • Jaffe 法动力学测试试剂盒
    • 肌酐-PAP 检测试剂盒
    • ELISA 检测试剂盒
  • 按样本类型
    • 血液/血清
    • 尿液
    • 其他样本
  • 按地区列出
    • 北美
      • 美国
      • 加拿大
      • 墨西哥
    • 欧洲
      • 德国
      • 英国
      • 法国
      • 意大利
      • 西班牙
      • 其他欧洲地区
    • 亚太地区
      • 中国
      • 日本
      • 印度
      • 澳大利亚
      • 韩国
      • 其他亚太地区
    • 中东和非洲
      • 海湾合作委员会
      • 南非
      • 其他中东地区
    • 南美洲地区
      • 巴西
      • 阿根廷
      • 其他南美洲

第六章竞争格局

  • 公司简介
    • Abbott Laboratories
    • Thermo Fisher Scientific
    • Merck KGaA
    • Quidel Corporation
    • Cell Biolabs, Inc
    • Genway Biotech（Aviva Systems Biology LLC）
    • Randox Laboratories Ltd
    • ACON Laboratories
    • Nova Biomedical
    • Sysmex Corporation

第7章 市场机会今后动向

简介目录
Product Code: 67729

The creatinine assay kits market is expected to register a CAGR of 5.3% during the forecast period.

Key Highlights

  • There was a significant COVID-19 impact observed on the market studied. This was majorly attributed to the occurrence of kidney diseases among the individuals who suffered from COVID-19. The patients who survived COVID-19 exhibited an increased risk of acute kidney injury (AKI), estimated glomerular filtration rate (eGFR) declined, end-stage kidney disease (ESKD), and significant adverse kidney events (MAKE). The risks (and burdens) of kidney outcomes increased according to the severity of the acute infection. Thus, due to the high incidence rate of COVID-19, the burden of kidney diseases increased worldwide, which propelled the demand for creatinine assay kits to detect and diagnose kidney diseases and boosted the growth of the market studied. However, the market studied is currently performing at a pre-pandemic pace as COVID-19 illness and its associated impact have declined.
  • The increasing incidence of renal and other chronic disorders, technological advancements in biomedical research about kidney disorders, and increasing research and development initiatives are the key driving factors in the creatinine assay kits market. Creatinine assay kits measure creatinine levels in serum/plasma, urine, and other biological samples. Creatinine assay is used to analyze the protein metabolism in the body, and the creatinine levels can be affected by changes in muscle mass, pregnancy, cancer, etc. Creatinine levels in the blood will increase and deflect in the blood test if the kidney is not in good condition. The creatinine test is performed by using a specific creatinine assay kit and can be performed for different conditions like hypertension, diabetes, and cancers.
  • According to the International Society of Nephrology 2021 data, yearly, approximately 13.3 million cases of acute kidney injury (AKI) globally are exceptionally high in emerging countries, where annual incidence is estimated to be 11.3 million. Hence, with the increasing burden of kidney diseases, there is a growing demand for creatinine assay kits for diagnosis purposes, fueling the market growth worldwide.
  • Furthermore, as per Globocan, the burden of cancer is expected to reach 605,726 cases by 2040. The high burden of kidney cancer boosted the early detection of kidney diseases, thereby driving the renal biomarkers market. According to the research study published in April 2021, titled, Global epidemiology of end-stage kidney disease (ESKD) and disparities in kidney replacement therapy, end-stage kidney disease (ESKD) was a rapidly increasing global health and healthcare burden, and the average number of new ESKD diagnoses worldwide was 144 individuals per million general population. Thus, the demand for renal biomarkers for detecting and diagnosing ESKD is expected to increase, likely to boost the growth in the market studied.
  • However, identifying novel renal biomarkers and the limited usage of creatinine assay kits in in-vitro diagnostic devices hinder the global market growth.

Key Market Trends

Blood/Serum Segment is Expected to Witness Rapid Growth over the Forecast Period

Serum creatinine is one of the most widely used laboratory tests for kidney function. It is used to derive the estimated glomerular filtration rate (eGFR) as an indicator of kidney function. It is also used as an ideal indicator for the determination of chronic kidney diseases. The creatinine concentration in blood is inversely proportional to the glomerular filtration rate (GFR), which is an ideal marker of kidney function. Unfortunately, measuring GFR is time-consuming, and therefore GFR is usually estimated from equations that consider endogenous filtration markers like serum creatinine (sCr).

The growing incidence of chronic kidney disease, rising R&D activities, adoption of key strategic initiatives by major players, and the growing launches and advancement in serum creatinine tests are boosting the market growth. As per the PubMed data published in February 2022, the prevalence of chronic kidney disease in Asia in low- and middle-income countries was around 11.2%, which was significantly high. This increases the demand for creatinine tests, thereby driving the market.

Additionally, the research on serum creatinine and the collaborations by various organizations in this area are increasing worldwide. For instance, in September 2021, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) Task Force rolled out regulations for the adoption of the new eGFR 2021 CKD EPI (chronic kidney disease epidemiology collaboration) creatinine equation that estimated kidney function without a race variable. The task force also recommended increased use of cystatin C combined with serum (blood) creatinine as a confirmatory assessment of kidney function. Such initiatives are likely to boost the demand for serum creatinine biomarker tests.

North America is Expected to Hold a Significant Share in the Market Currently and During the Forecast Period

North America is expected to hold a significant share in the global creatinine assay kits market due to the increasing incidence of renal disorders and other chronic disorders impacting renal function and technological advancements in biomedical research about kidney disorders in this region.

According to the CDC data from March 2021, approximately 37 million people, or 15% of US adults, are estimated to have chronic kidney disease (CKD). Chronic kidney disease (CKD) is estimated to be more common in women (16%) than in men (13%). Furthermore, favorable reimbursement policies and well-established healthcare infrastructure are fueling the growth of the overall regional market to a large extent.

Furthermore, the launch of new products in the country and the rising adoption of expansion strategies by key market players are expected to boost the market. In July 2022, Moffitt Cancer Center researchers identified biomarkers for renal cell carcinoma. Based on its biomarker expression, it developed a tool to indicate which patients are at high risk of poor outcomes. Such R&D activities are expected to boost the development of biomarker tests for kidney diseases during the forecast period. Similarly, in April 2021, Renalytix AI PLC entered an exclusive option agreement with Joslin Diabetes Center for patent filings on specific additional novel biomarkers in kidney disease for development and deployment in the KidneyIntelXin Vitro prognostic platform. This indicates the rise in R&D activities for developing biomarkers tests for kidney diseases, thereby driving the market growth.

Competitive Landscape

The creatinine assay kits market is highly fragmented and competitive and consists of several major players. In terms of market share, the majority of the players are currently dominating the market. Some of the companies which are currently dominating the market are Abbott Laboratories, Thermo Fisher Scientific, Merck KGaA, Quidel Corporation, Cell Biolabs Inc., Genway Biotech, Randox Laboratories Ltd, ACON Laboratories, Nova Biomedical, and Sysmex India Pvt. Ltd.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Increasing Incidence of Renal and Other Chronic Disorders Impacting Renal Function
    • 4.2.2 Technological Advancements in Biomedical Research Pertaining to Kidney Disorders
    • 4.2.3 Increasing Research and Development Initiatives
  • 4.3 Market Restraints
    • 4.3.1 Identification of Novel Renal Dysfunction Biomarkers
    • 4.3.2 Limited Usage of Creatinine Assay Kits in Invitro Diagnostic Device (IVD)
  • 4.4 Porter's Five Force Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size - in USD million)

  • 5.1 By Type
    • 5.1.1 Jaffe's Kinetic Test kits
    • 5.1.2 Creatinine-PAP Test kits
    • 5.1.3 ELISA Test kits
  • 5.2 By Type of Sample
    • 5.2.1 Blood/Serum
    • 5.2.2 Urine
    • 5.2.3 Other Samples
  • 5.3 By Geography
    • 5.3.1 North America
      • 5.3.1.1 United States
      • 5.3.1.2 Canada
      • 5.3.1.3 Mexico
    • 5.3.2 Europe
      • 5.3.2.1 Germany
      • 5.3.2.2 United Kingdom
      • 5.3.2.3 France
      • 5.3.2.4 Italy
      • 5.3.2.5 Spain
      • 5.3.2.6 Rest of Europe
    • 5.3.3 Asia-Pacific
      • 5.3.3.1 China
      • 5.3.3.2 Japan
      • 5.3.3.3 India
      • 5.3.3.4 Australia
      • 5.3.3.5 South Korea
      • 5.3.3.6 Rest of Asia-Pacific
    • 5.3.4 Middle East and Africa
      • 5.3.4.1 GCC
      • 5.3.4.2 South Africa
      • 5.3.4.3 Rest of Middle East and Africa
    • 5.3.5 South America
      • 5.3.5.1 Brazil
      • 5.3.5.2 Argentina
      • 5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Abbott Laboratories
    • 6.1.2 Thermo Fisher Scientific
    • 6.1.3 Merck KGaA
    • 6.1.4 Quidel Corporation
    • 6.1.5 Cell Biolabs, Inc
    • 6.1.6 Genway Biotech (Aviva Systems Biology LLC)
    • 6.1.7 Randox Laboratories Ltd
    • 6.1.8 ACON Laboratories
    • 6.1.9 Nova Biomedical
    • 6.1.10 Sysmex Corporation

7 MARKET OPPORTUNITIES AND FUTURE TRENDS