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市场调查报告书
商品编码
1250771
乳胶凝集测试套件市场预测到 2028 年-按测试类型、样本类型、适应症、产品类型、应用、最终用户、按地区进行全球分析Latex Agglutination Test Kits Market Forecasts to 2028 - Global Analysis By Test Type, By Sample Type (Urine, Blood, Cerebrospinal Fluid, Sperm and Other Sample Types), By Indication, By Product, By Application, By End User and By Geography |
根据 Stratistics MRC 的数据,2022 年全球乳胶凝集检测试剂盒市场规模将达到 4.754 亿美元,预计到 2028 年将达到 6.859 亿美元,预测期内復合年增长率为 6.3%。
通常使用乳胶凝集检测试剂盒来鑑定脑脊液 (CSF)、血液、尿液和唾液等体液中的抗体和抗原。该测试套件由涂有抗原或抗体的基于乳胶珠的人造载体颗粒组成。自身免疫性疾病和传染病的日益流行,以及这些试剂盒的广泛使用,帮助推动了产品的采用。
根据美国国立卫生研究院 (NIH) 的数据,2021 年全球脑膜炎发病率估计为每 10 万人 20.0 例,相当于约 120 万例。
乳胶凝集检测试剂盒的多元化应用领域
肝炎、脑膜炎、类风湿性关节炎、扁桃体炎和其他链球菌感染经常使用乳胶凝集试验试剂盒进行诊断。使用这些试剂盒诊断各种病毒和自身免疫性疾病是该领域的光明前景。Wellcogen Strep B Rapid Latex Agglutination Test、Wellcogen Strep B 30 Pk for Staphylococcus、Waaler Rose Latex Kits for rheumatoid arthritis、E. coli O157 Latex Test for E. coli、ASI Rubella test for Rubella Virus是市售产品的示例。
新的可靠替代诊断的出现
儘管乳胶凝集检测试剂盒在诊断医学方面具有诸多优势,但创新和可靠的替代诊断方法的开发显着阻碍了市场增长,尤其是在美国和欧洲等高增长市场。这些测试套件非常快速、简单且价格实惠。此外,需要标准化以防止人为的阳性反应。由于此类检测试剂盒的局限性和传染病诊断技术的进步,预计市场增长潜力有限。
传染病和自身免疫性疾病的患病率上升
对于脑膜炎、肺炎、肝炎、流感嗜血桿菌、伤寒和肺结核等常见感染,我们提供乳胶凝集试剂盒。由于这些检测试剂盒能够快速诊断,某些传染病流行率的增加预计将推动对产品的需求。此外,狼疮和类风湿性关节炎等自身免疫性疾病的日益流行,以及发展中国家检测试剂盒的可用性,正在推动产品的快速普及。
解释结果时的人为错误
免疫凝集测定没有终点,因此在实验设计中必须考虑反应时间分析。较长的反应时间还会导致液体干燥和颗粒沉降,使结果难以阅读并增加假阳性解释的可能性。该检测只能由在该领域工作的训练有素的专业人员分类为强阳性、中等阳性或弱阳性。此外,更先进的测试,如□联免疫吸附测定和化学发光免疫测定,可提供比 LAT 更准确、更快速的结果。
COVID-19 的影响
由于我们在 COVID-19 大流行期间进行的特定测试(CRP、D-二聚体)的增加,大流行产生了积极影响。就诊次数减少,大肠桿菌、肺炎和自身免疫性疾病等其他疾病的诊断也有所减少。这对市场产生了负面影响。由于供应链在 COVID-19 大流行期间中断,乳胶凝集检测试剂盒製造商的处境岌岌可危。这种下降是由多种因素推动的,包括对自身免疫性疾病、大肠桿菌和肺炎的检测减少,患者就诊和诊断的总体下降,以及医院对 COVID-19 以外疾病的诊断能力下降。 .
预计在预测期内抗原检测部分将是最大的
由于患有细菌、病毒、真菌等各种传染病的患者数量巨大,抗原检测领域在全球乳胶凝集检测试剂盒市场中占有最大份额。对于大多数患有这些感染的患者,建议进行抗原检测以进行疾病诊断。2020 年,根据临床实验室分析杂誌(中国杭州),该研究在浙江大学医学院儿童医院进行。结果表明,该试验结果良好,可有效检测轮状病毒和腺病毒抗原。该测试的轮状病毒检测灵敏度为 81.0%,特异性为 97.4%。
预计血液学部分在预测期内的复合年增长率最高
由于其在抗原和抗体乳胶凝集检测试剂盒中的广泛使用,预计血液学部分在预测期内将实现有利可图的增长。许多细菌和真菌的检测需要血液或血清样本。这些因素正在推动这一细分市场的增长。例如,根据 2020 年美国国立卫生研究院 (NIH) 的一份报告,一项对 Barnes-Jewish 医院 2002 年至 2019 年隐球菌病患者的回顾性分析评估了血清 CrAg 乳胶凝集的敏感性为 94.7%。
市场占有率最高的地区
由于使用检测试剂盒的疾病种类繁多且市场进入者数量众多,预计北美在预测期内将主导全球市场。此外,这些测试套件的广泛应用和越来越多的临床实验室改进法案 (CLIA) 认可的实验室预计将推动该地区的市场扩张。
由于亚太地区在全球传染病负担中所占比例很高,因此预计在预测期内其复合年增长率最高。医院和独立实验室的发展也将推动乳胶凝集试验的采用。此外,增加研发计划以评估这些试剂盒的功效,以及增加政府在患者诊断护理方面的支出,也是推动该地区市场扩张的因素。
2022 年 7 月,Bio-Rad Laboratories, Inc. 推出两款产品:针对蜱传、脑膜炎/脑炎和性传播疾病产品的 Synthetic Negative Run Control,以及针对医院相关感染产品的 HAI Negative Run Control。
2022 年 6 月,Thermo Fisher Scientific 将与 Diagnostic BioSystems (DBS) 合作,在美国提供广谱一抗。
2022 年 4 月,Bio-Rad 实验室参加了 2022 年第 32 届欧洲临床微生物学和传染病会议 (ECCMID)。该公司展示了全系列的传染病检测系统、试剂和质量控制产品,以优化检测工作流程。
2021年10月,Hardy Diagnostics发布“HardyCHROM Candida+Auris”。这是一种用于选择性分离和鑑别念珠菌属物种的显色培养基。
2021 年 8 月,Hardy Diagnostics 推出了 HardyCHROM A 组链球菌琼脂。它是一种显色培养基,用于从临床标本中选择性培养和分化 A 组链球菌(S. pyogenes)。
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根据产品组合、地域分布和战略联盟对主要参与者进行基准测试
According to Stratistics MRC, the Global Latex Agglutination Test Kits Market is accounted for $475.4 million in 2022 and is expected to reach $685.9 million by 2028 growing at a CAGR of 6.3% during the forecast period. The identification of antibodies or antigens in body fluids such as cerebrospinal fluid (CSF), blood, urine, and saliva is usually done using latex agglutination test kits. The test kits include coating either an antigen or an antibody on a latex bead-based artificial carrier particle. The increasing prevalence of autoimmune and infectious disorders as well as the wide range of applications for these kits help to drive adoption of the product.
According to the National Institutes of Health (NIH) in 2021, the global incidence of meningitis is estimated to be 20.0 cases per 100,000 people, representing about 1.2 million cases.
Diverse application areas of latex agglutination test kits
Hepatitis, meningitis, rheumatoid arthritis, tonsillitis, and other streptococcal diseases are frequently diagnosed with latex agglutination test kits. The use of these kits to diagnose a variety of viral and autoimmune diseases leads to a bright future for this sector. The Wellcogen Strep B Rapid Latex Agglutination Test, the Wellcogen Strep B 30 Pk for Staphylococcus, the Waaler Rose Latex Kits for rheumatoid arthritis, the E. coli O157 Latex Test for E. coli, and the ASI Rubella test for Rubella Virus are a few instances of commercially accessible products.
Emergence of new and reliable alternate diagnostics
Despite the fact that latex agglutination test kits have a number of benefits for diagnostic care, the development of innovative and trustworthy alternative diagnostics, particularly in high-growing markets like the United States and Europe, has significantly hampered market growth. These test kits are very rapid, simple, and affordable. Standardization is also required to prevent artificially positive results. The market is anticipated to have limited growth possibilities due to the limitations of these kits and higher technological advancements in infectious diseases diagnostics.
Rising prevalence of infectious and autoimmune diseases
For common infectious diseases such as meningitis, pneumonia, hepatitis, Haemophilus influenzae, typhoid, and tuberculosis, latex agglutination kits are provided. Since these test kits offer quick diagnosis, the increasing prevalence of certain infectious diseases will drive demand for products. Additionally, the rise in autoimmune disorders like lupus and rheumatoid arthritis cases, as well as the accessibility of these kits in developing countries, encourage the rapid uptake of the products.
Human error in interpretation of results
Because immunoagglutination assays do not have an endpoint, reaction time analysis must be taken into consideration while designing an experiment. Also, as the reaction time increases, the liquid dries and the particles settle, making it more difficult to read the results and increasing the likelihood of false-positive interpretations. This assay can only be classified as a strong, intermediate, or weak positive by trained specialists working in the field. In addition, compared to LAT, other more sophisticated tests, including enzyme-linked immunosorbent assays and chemiluminescence immunoassays, give results that are more accurate and rapid.
Covid-19 Impact:
Due to an increase in specific tests (C-reactive protein (CRP) and D-dimer) performed during the COVID-19 pandemic, the pandemic had a favorable effect. As patient visits to healthcare institutions decreased, fewer diagnoses of other diseases, including E. coli, pneumonia, and autoimmune disease, occurred. This had a detrimental influence on the market. Due to supply chain disruptions during the COVID-19 pandemic, the situation for businesses that manufacture latex agglutination test kits was unpredictable. The decrease was seen as a result of a number of factors, including a decrease in the number of autoimmune, E. coli, and pneumonia tests performed, a decrease in overall patient visits to hospitals and diagnoses, a reduction in the ability of hospitals to diagnose diseases other than COVID-19, and others.
The antigen testing segment is expected to be the largest during the forecast period
Due to the enormous number of patients affected by diverse bacterial, viral, and fungal infections, the antigen testing segment held the largest share of the global market for latex agglutination test kits. Antigen testing is recommended for the majority of these infectious disease patients in order to diagnose the illness. In 2020, a study was carried out at the Children's Hospital of Zhejiang University, School of Medicine, according to the Journal of Clinical Laboratory Analysis (Hangzhou, China). It was discovered that this test had favorable outcomes and was effective in detecting rotavirus and adenovirus antigens. This test had a rotavirus detection sensitivity of 81.0% and a specificity of 97.4%.
The blood segment is expected to have the highest CAGR during the forecast period
Because of its widespread use in test kits for antigen and antibody latex agglutination, the blood segment is anticipated to have lucrative expansion throughout the forecast period. Blood or serum samples are required for a number of bacterial and fungal detections. These elements boosted the segment's growth. For instance, a retrospective analysis of patients with cryptococcosis from 2002 to 2019 at Barnes-Jewish Hospital indicated that the sensitivity for serum CrAg latex agglutination was assessed to be 94.7%, according to a report by the National Institutes of Health (NIH) in 2020.
Region with largest share:
Due to the wide range of diseases for which these kits are used, as well as the presence of significant market participants in North America, it is predicted that the region would dominate the global market during the projection period. Moreover, the broad use of these test kits and the rising number of labs with Clinical Laboratory Improvement Amendments (CLIA) certification are anticipated to fuel market expansion in the region.
Owing to the region's significant share of the worldwide burden of infectious diseases, Asia-Pacific is predicted to experience the highest CAGR during the forecast period. Moreover, the promotion of latex agglutination testing will be aided by the growth of hospital-based laboratories and independent laboratories. Furthermore, increasing R&D initiatives to evaluate the effectiveness of these kits and rising government spending on patient diagnostic care are other factors driving market expansion in this region.
Some of the key players in Latex Agglutination Test Kits market include Arlington Scientific, Inc., Atlas Medical GmbH, BioLegend, Bio-Rad Laboratories, Inc., Biotec (Novacyt), Creative Diagnostics, Hardy Diagnostics, HiMedia Laboratories, Liofilchem S.r.l., Pro Lab Diagnostics Inc. and Thermo Fisher Scientific Inc..
In July 2022, Bio-Rad Laboratories, Inc. launched two products, the Synthetic Negative Run Control for tick-borne, meningitis/encephalitis, and sexually-transmitted infections products, and HAI Negative Run Control for hospital-associated infections products.
In June 2022, Thermo Fisher Scientific partnered with Diagnostic BioSystems (DBS) to offer a wide spectrum of primary antibodies in the U.S.
In April 2022, Bio-Rad Laboratories, Inc. participated in the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022. The company showcased its complete range of infectious disease testing systems, reagents, and quality controls for optimizing testing workflows.
In October 2021, Hardy Diagnostics launched the HardyCHROM Candida + Auris. It is a chromogenic media for the selective isolation and differential identification of Candida species.
In August 2021, Hardy Diagnostics launched the HardyCHROM Group A Strep agar. It is a chromogenic medium for the selective cultivation and differentiation of Group A Streptococcus (S. pyogenes) from clinical specimens.
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All the customers of this report will be entitled to receive one of the following free customization options:
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.