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至 2030 年 ELISA 测试市场预测:按类型、技术、应用、最终用户和地区分類的全球分析Elisa Tests Market Forecasts to 2030 - Global Analysis By Type (Indirect ELISA, Sandwich ELISA, Competitive ELISA and Multiple and Portable ELISA), Technology (Chemiluminescent, Colorimetric and Fluorescent), Application, End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球 ELISA 检测市场规模为 25.5 亿美元,预计在预测期内将以 8.9% 的年复合成长率增长,并在 2030 年达到 46.4 亿美元。
酵素结合免疫吸附测定法是一种标准测定技术,用于识别和定量血液中的抗体、荷尔蒙、胜肽和蛋白质。 ELISA 测试常用于药物品管测试,例如内毒素测定和蛋白质定量,对于许多病毒性疾病的诊断至关重要。 ELISA是植物病理学和医学中的诊断技术,也是许多不同领域的品管测试。酵素结合免疫吸附检测法(ELISA) 测试经常在医学和植物病理学等各个领域用作品质保证测试和筛选仪器。
根据世界卫生组织 (WHO) 统计,2020 年约有 3,770 万人感染爱滋病毒。
有效的疾病管理和治疗依赖早期和准确的诊断。 ELISA 测试的高灵敏度和特异性使医疗保健专业人员能够识别和检测患者样本中的特定生物标记。早期诊断可以立即开始治疗并显着改善患者的治疗效果。此外,对这些生物标誌物的快速识别使医护人员能够进行干预并快速实施有效的治疗技术。由于对早期准确诊断的需求,ELISA 检测市场正在扩大。
诊断药物的行销很困难,因为有些产品被归类为医疗设备,儘管它们的目的是供医生用于诊断。如果没有成功的临床试验,这类设备就无法推出,这是一个耗时、昂贵且不确定的过程。不同国家对这些设备的认证有不同的规则,这对国际公司来说是一个重大挑战。此外,如果各种法规机构(例如 FDA)在产品开发过程中改变法规,则可能会出现潜在的产品推出延迟。这些严格的政府法规是市场成长的主要障碍。
ELISA 测试市场受益于技术发展,例如自动化系统的创建、多重功能以及检测灵敏度和特异性的改进。技术进步创造了自动化 ELISA 系统,消除了体力劳动并提高了效率。自动化平台可以同时处理多个样品,从而简化测试程序并提高吞吐量。此外,透过减少週转时间并提高实验室效率,该技术使医护人员能够有效地进行大量测试。由于这些新兴市场的开拓提高了功效、准确性和生产力,从而推动了市场需求,ELISA 测试在许多医疗保健环境中已广泛应用。
即时检测 (POCT) 设备、次世代定序(NGS) 和分子诊断技术(例如 PCR)等替代诊断技术与市场上的 ELISA 检测竞争。这些创新具有快速週转时间、更高的灵敏度以及同时检测多种分析物的能力等优点。随着这些技术的发展和变得更加广泛应用,它们可能会取代 ELISA 测试或与 ELISA 测试竞争,特别是在分子诊断具有明显优势的领域。 ELISA 检测市场可能会受到这些替代技术的可用性和普及的威胁。
最初,在 COVID-19 爆发期间,没有特定的诊断测试来识别患者的疾病。最初尝试了替代诊断方法,但成效有限。此外,某些 COVID-19 诊断测试的无法提供为诊断试剂盒製造商提供了销售 COVID-19 诊断产品的有利可图的机会。利用这个机会,许多老字型大小企业以及来自各国的新兴企业不仅向当地市场而且还向全球市场提供了COVID-19诊断试剂盒。
夹心 ELISA 部分估计占据最大份额。使用由两层抗体(捕获抗体和检测抗体)组成的夹心 ELISA检测抗原。标靶抗原上的两个抗原位点已准备好与抗体结合。在夹心ELISA方法中,使用单株或多株抗体来捕捉和辨识抗体。夹心 ELISA 最适合检测免疫反应,这一事实正在推动市场的扩张。夹心ELISA利用多种抗体来辨识和检测相同抗原,也是最灵敏的检测方法。它也非常弹性和具体。
预计感染疾病领域在预测期内将出现良好成长。由于慢性病和传染病的盛行率不断增加,感染疾病目前主导着ELISA市场的应用领域。酵素结合免疫吸附和观察ELISA 测试占主导地位,因为它们是自动化的、易于执行,并且不需要放射性材料或昂贵的辐射设备。
由于其高度发达的医疗保健系统和不断增长的医疗设备可用性,北美在预测期内占据了最大的市场占有率。製药公司和政府机构针对糖尿病和慢性病等疾病的研发支出的增加也有助于预测期内该地区 ELISA 检测市场的成长。
由于新兴经济体可支配所得和医疗保健支出的增加,预计欧洲在预测期内将出现盈利成长。由于已开发国家医疗设备的使用不断增加,ELISA 检测市场预计在未来年度将成长。此外,由于老年人口众多以及研发投入庞大,预计在预测期内欧洲大陆非传染性疾病的发生率也会增加,从而增加对 ELISA 检测的需求。
According to Stratistics MRC, the Global Elisa Tests Market is accounted for $2.55 billion in 2023 and is expected to reach $4.64 billion by 2030 growing at a CAGR of 8.9% during the forecast period. The enzyme-linked immune sorbent assay is the standard assay technique used to identify and quantify antibodies, hormones, peptides, and proteins in the blood. The ELISA test is often used in pharmaceutical quality control tests like endotoxin assays and protein quantification and is crucial in the diagnosis of a number of viral diseases. ELISA is a diagnostic technique in plant pathology and medicine as well as a quality control checks in many different sectors. Enzyme-linked immune sorbent assay (ELISA) testing is frequently used as a quality assurance check and screening instrument in a variety of fields, including medicine and plant pathology.
According to the World Health Organization (WHO), around 37.7 million people had HIV in 2020.
Effective illness management and therapy rely on early and precise diagnosis. The high sensitivity and specificity of Elisa testing enable medical personnel to identify and measure particular biomarkers in patient samples. Early diagnosis enables quick treatment beginning, which can greatly enhance patient results. Additionally, healthcare practitioners can intervene and swiftly implement effective treatment techniques by quickly recognizing these biomarkers. The market for Elisa testing is expanding due to the demand for early and accurate diagnosis.
The marketing of diagnostic products is difficult because some products are categorized as medical devices even though they are intended for use in diagnostic procedures by doctors. Without successfully completing clinical trials, which are a time-consuming, expensive, and uncertain process, such devices cannot be launched. The reality that different countries have different rules for these devices' certification is a significant challenge for international corporations. Additionally, any modifications to rules made by various regulatory agencies, like the FDA, during the product development process may cause a delay in the introduction of potential products. These stringent government regulations are the major barriers to market growth.
The market for Elisa testing has benefited from technological developments such as the creation of automated systems, the ability to multiplex and enhanced sensitivity and specificity of assays. Technological improvements have led to the creation of automated Elisa systems, excluding manual labor and enhancing efficiency. Multiple samples can be handled simultaneously by automated platforms, streamlining the testing procedure and boosting throughput. Furthermore, by speeding up turnaround times and increasing laboratory efficiency, this technology enables healthcare practitioners to efficiently perform a higher volume of tests. Elisa tests are becoming more widely used in many healthcare settings as a result of these developments, which improve their effectiveness, accuracy, and productivity, which drives market demand.
Alternative diagnostic technologies, such as point-of-care testing (POCT) devices, next-generation sequencing (NGS), and molecular diagnostic techniques (e.g., PCR), compete with Elisa tests on the market. These innovations have benefits like quicker turnaround times, greater sensitivity, and the capacity to detect multiple analytes at once. Elisa tests may be replaced or competed with as these technologies develop and become more widely available, especially in areas where molecular diagnostics have clear advantages. The market for Elisa tests may be threatened by the availability and uptake of these substitute technologies.
Initially, in the COVID-19 epidemic, there were no particular diagnostic tests available to identify the illness in patients. Initially, alternative diagnostic procedures were attempted, but they were not very successful. Additionally, due to the unavailability of certain COVID-19 diagnostic tests, diagnostic kit manufacturers had profitable chances to market their COVID-19 diagnostic products. Utilizing this chance, many established companies as well as a few start-ups from different nations offered COVID-19 diagnostic kits to local as well as global markets.
The sandwich ELISA segment is estimated to hold the largest share. Antigen is measured using a sandwich ELISA, which consists of two layers of antibodies (the capture antibody and the detection antibody). Two antigenic sites on the target antigens are ready to bind to the antibodies. In sandwich ELISA techniques, monoclonal or polyclonal antibodies are employed to capture and recognize antibodies. Sandwich ELISA works the best for detecting immunological responses, and this fact is promoting market expansion. Sandwich ELISA, which uses a variety of antibodies to bind to the same antigen for recognition or detection, is also the most sensitive test available. It also has a high degree of flexibility and higher specificity.
The infectious diseases segment is anticipated to have lucrative growth during the forecast period, due to an increase in the prevalence of chronic illnesses and infectious disorders, infectious diseases are now leading the ELISA market's application sector. HIV, HBV, HCV, HTLV, Diphtheria, Giardiasis, and several other infectious blood-borne illnesses The application sector of the enzyme-linked immune sorbent assay (ELISA) testing market is dominated by ELISA tests because they provide quick and accurate findings, have high sensitivity, are automated and simple to perform, and do not require radioactive materials or expensive radiation gear.
North America commanded the largest market share during the extrapolated period due to the highly developed healthcare system and the growing use of medical gadgets. Rising R&D expenditures by pharmaceutical firms and government organizations for disorders and diseases, including diabetes and chronic illnesses, would also contribute to the market growth for ELISA tests in this region during the projected period.
Europe is expected to witness profitable growth over the projection period due to the rising disposable income and healthcare expenditure in emerging nations. The market for ELISA tests is anticipated to grow in the coming years as a result of the rising use of medical equipment in developed nations. Additionally, due to the large geriatric population and significant investment in research and development, in the projected time frame, it is also anticipated that the rising frequency of non-communicable diseases on the European continent will increase demand for ELISA testing.
Some of the key players in the Elisa Tests Market include: Abbott Laboratories, Danaher Corporation, BioMerieux SA, Quidel Corporation, Siemens Healthineers, Sysmex Corporation, Bio-Rad Laboratories, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Inc., ZEUS Scientific, Inc., Hoffmann-La Roche AG, PerkinElmer, Inc., Enzo Life Sciences, Inc., Agilent Technologies, Inc., R&D Systems, Inc., Bruker, Eurofins Scientific, ELISA Technologies, Inc and BioLegend, Inc.
In May 2023, Abbott, a global leader in health care and nutrition, has partnered with Real Madrid, one of the most successful and popular football clubs in the world, to inaugurate the Abbott-Real Madrid Innovation Lab, a space for collaboration and research on the future of sports physiology and nutrition.
In March 2023, Thermo Fisher Scientific, the world leader in serving science, and Arsenal Biosciences, Inc. (ArsenalBio), a clinical-stage cell therapy company engineering advanced chimeric antigen receptor (CAR)-T cell therapies for solid tumors, announced an update to their strategic collaboration to further the development of manufacturing processes for new cancer treatments.
In November 2020, Siemens Healthineers announced that its SARS-CoV-2 IgG Antibody Test has proven to evaluate neutralizing antibodies and has gained CE Marking. This test is the better version of its previously launched COVID-19 antibody test.