市場調查報告書
商品編碼
1250771
乳膠凝集測試套件市場預測到 2028 年-按測試類型、樣本類型、適應症、產品類型、應用、最終用戶、按地區進行全球分析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 |
根據 Stratistics MRC 的數據,2022 年全球乳膠凝集檢測試劑盒市場規模將達到 4.754 億美元,預計到 2028 年將達到 6.859 億美元,預測期內復合年增長率為 6.3%。
通常使用乳膠凝集檢測試劑盒來鑑定腦脊液 (CSF)、血液、尿液和唾液等體液中的抗體和抗原。該測試套件由塗有抗原或抗體的基於乳膠珠的人造載體顆粒組成。自身免疫性疾病和傳染病的日益流行,以及這些試劑盒的廣泛使用,幫助推動了產品的採用。
根據美國國立衛生研究院 (NIH) 的數據,2021 年全球腦膜炎發病率估計為每 10 萬人 20.0 例,相當於約 120 萬例。
乳膠凝集檢測試劑盒的多元化應用領域
肝炎、腦膜炎、類風濕性關節炎、扁桃體炎和其他鏈球菌感染經常使用乳膠凝集試驗試劑盒進行診斷。使用這些試劑盒診斷各種病毒和自身免疫性疾病是該領域的光明前景。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是市售產品的示例。
新的可靠替代診斷的出現
儘管乳膠凝集檢測試劑盒在診斷醫學方面具有諸多優勢,但創新和可靠的替代診斷方法的開發顯著阻礙了市場增長,尤其是在美國和歐洲等高增長市場。這些測試套件非常快速、簡單且價格實惠。此外,需要標準化以防止人為的陽性反應。由於此類檢測試劑盒的局限性和傳染病診斷技術的進步,預計市場增長潛力有限。
傳染病和自身免疫性疾病的患病率上升
對於腦膜炎、肺炎、肝炎、流感嗜血桿菌、傷寒和肺結核等常見感染,我們提供乳膠凝集試劑盒。由於這些檢測試劑盒能夠快速診斷,某些傳染病流行率的增加預計將推動對產品的需求。此外,狼瘡和類風濕性關節炎等自身免疫性疾病的日益流行,以及發展中國家檢測試劑盒的可用性,正在推動產品的快速普及。
解釋結果時的人為錯誤
免疫凝集測定沒有終點,因此在實驗設計中必須考慮反應時間分析。較長的反應時間還會導致液體乾燥和顆粒沉降,使結果難以閱讀並增加假陽性解釋的可能性。該檢測只能由在該領域工作的訓練有素的專業人員分類為強陽性、中等陽性或弱陽性。此外,更先進的測試,如□聯免疫吸附測定和化學發光免疫測定,可提供比 LAT 更準確、更快速的結果。
COVID-19 的影響
由於我們在 COVID-19 大流行期間進行的特定測試(CRP、D-二聚體)的增加,大流行產生了積極影響。就診次數減少,大腸桿菌、肺炎和自身免疫性疾病等其他疾病的診斷也有所減少。這對市場產生了負面影響。由於供應鏈在 COVID-19 大流行期間中斷,乳膠凝集檢測試劑盒製造商的處境岌岌可危。這種下降是由多種因素推動的,包括對自身免疫性疾病、大腸桿菌和肺炎的檢測減少,患者就診和診斷的總體下降,以及醫院對 COVID-19 以外疾病的診斷能力下降。 .
預計在預測期內抗原檢測部分將是最大的
由於患有細菌、病毒、真菌等各種傳染病的患者數量巨大,抗原檢測領域在全球乳膠凝集檢測試劑盒市場中佔有最大份額。對於大多數患有這些感染的患者,建議進行抗原檢測以進行疾病診斷。2020 年,根據臨床實驗室分析雜誌(中國杭州),該研究在浙江大學醫學院兒童醫院進行。結果表明,該試驗結果良好,可有效檢測輪狀病毒和腺病毒抗原。該測試的輪狀病毒檢測靈敏度為 81.0%,特異性為 97.4%。
預計血液學部分在預測期內的複合年增長率最高
由於其在抗原和抗體乳膠凝集檢測試劑盒中的廣泛使用,預計血液學部分在預測期內將實現有利可圖的增長。許多細菌和真菌的檢測需要血液或血清樣本。這些因素正在推動這一細分市場的增長。例如,根據 2020 年美國國立衛生研究院 (NIH) 的一份報告,一項對 Barnes-Jewish 醫院 2002 年至 2019 年隱球菌病患者的回顧性分析評估了血清 CrAg 乳膠凝集的敏感性為 94.7%。
市場佔有率最高的地區
由於使用檢測試劑盒的疾病種類繁多且市場進入者數量眾多,預計北美在預測期內將主導全球市場。此外,這些測試套件的廣泛應用和越來越多的臨床實驗室改進法案 (CLIA) 認可的實驗室預計將推動該地區的市場擴張。
由於亞太地區在全球傳染病負擔中所佔比例很高,因此預計在預測期內其複合年增長率最高。醫院和獨立實驗室的發展也將推動乳膠凝集試驗的採用。此外,增加研發計劃以評估這些試劑盒的功效,以及增加政府在患者診斷護理方面的支出,也是推動該地區市場擴張的因素。
2022 年 7 月,Bio-Rad Laboratories, Inc. 推出兩款產品:針對蜱傳、腦膜炎/腦炎和性傳播疾病產品的 Synthetic Negative Run Control,以及針對醫院相關感染產品的 HAI Negative Run Control。
2022 年 6 月,Thermo Fisher Scientific 將與 Diagnostic BioSystems (DBS) 合作,在美國提供廣譜一抗。
2022 年 4 月,Bio-Rad 實驗室參加了 2022 年第 32 屆歐洲臨床微生物學和傳染病會議 (ECCMID)。該公司展示了全系列的傳染病檢測系統、試劑和質量控制產品,以優化檢測工作流程。
2021年10月,Hardy Diagnostics發布“HardyCHROM Candida+Auris”。這是一種用於選擇性分離和鑑別念珠菌屬物種的顯色培養基。
2021 年 8 月,Hardy Diagnostics 推出了 HardyCHROM A 組鏈球菌瓊脂。它是一種顯色培養基,用於從臨床標本中選擇性培養和分化 A 組鏈球菌(S. pyogenes)。
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根據產品組合、地域分佈和戰略聯盟對主要參與者進行基準測試
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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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.