市场调查报告书
商品编码
1402490
北美免疫诊断市场预测至 2030 年 - 区域分析 - 按产品(酶联免疫吸附测定、化学发光免疫测定、放射免疫测定等)、临床适应症和最终用户North America Immunodiagnostics Market Forecast to 2030 - Regional Analysis - by Product (Enzyme-Linked Immunosorbent Assays, Chemiluminescence Immunoassays, Radioimmunoassays, and Others), By Clinical Indication, and End User |
北美免疫诊断市场预计将从2023年的104.6348亿美元成长到2030年的173.991亿美元。预计2023年至2030年CAGR为7.5%。
床边免疫诊断的使用不断增长推动北美工业机器人市场
由于需要快速诊断结果来确定准确、更快的治疗方法,床边检测 (POCT) 已成为以患者为中心的医疗保健的关键。从集中式现场护理测试到分散式测试的转变使得可以轻鬆存取这些诊断。免疫测定测试有助于监测慢性病并检测病原体,例如细菌和病毒。先进的护理点设备能够从单一样本中快速筛选多达三种成分。此外,倾向于行动医疗 (mH) 智慧型装置的护理点诊断 (POCD) 可能会彻底改变个人化医疗监控和管理,为下一代 POCT 铺平道路。 POCT 可以显着改善传染病的管理,特别是在难以获得及时医疗服务且医疗基础设施陈旧且稀少的发展中国家。此外,技术开发的诊断试剂盒减少了手动错误,推动了免疫诊断市场的发展。一些市场参与者正在开发创新的免疫诊断产品。例如,赛默飞世尔科技(Thermo Fisher Scientific) 开发了酵素连结免疫(ELISA) 试剂和缓衝液、抗体和检测探针、连接机制、封闭缓衝液和去污剂、检测底物和捕获表面等免疫诊断产品,以及生物共轭等服务和检测。此外,2020年9月,罗氏推出了SARS-CoV-2快速抗原检测,该检测用于POC环境中,帮助医疗保健专业人员在15分钟内识别疑似病毒携带者的感染情况。
2021 年 4 月,DiaSorin 推出了 LIAISON IQ(一种新型免疫诊断即时护理 (POC) 阅读器)以及 LIAISON QuickDetect COVID TrimericS Ab 测试,该测试与 Lumos Diagnostics 为接受 CE 标誌的国家开发。 LIAISON IQ 的这项测试使用人体毛细血管血的指尖血,在 10 分钟内识别出针对 SARS-CoV-2 刺突蛋白的特异性 IgG 抗体。
2021 年 4 月,Chembio Diagnostics, Inc. 推出了 FDA 紧急使用授权批准的、获得许可的快速护理点 COVID-19/Flu A&B 测试,用于传统和分散的测试环境。快速免疫检测无需仪器,15 分钟内即可得出结果。
世卫组织讚扬检测试剂盒开发商在 COVID-19 危机期间为创新和满足群众需求所做的努力。据美国临床病理学会称,2020 年 3 月,Cepheid Xpert Xpress SARS-CoV-2 检测成为第一个获得美国食品和药物管理局 (FDA) 紧急使用授权 (EUA) 的 POC COVID-19 检测方法。
同样,免疫诊断在癌症治疗的应用也在增加。在肿瘤学中,免疫诊断测试可以透过检测已知的肿瘤相关抗原或抗体来确认实体肿瘤的存在。这些优势和适应症正在推动免疫诊断市场的发展。
北美免疫诊断市场概况
该国的癌症盛行率正在以惊人的速度增加,导致对癌症诊断的需求增加。根据美国癌症协会 (ASC) 对 2023 年癌症事实和数字的估计,美国登记了近 190 万个新癌症病例。进一步预测,到 2023 年,该国将有 609,360 人死于癌症,即每天约 1,670 人死亡。然而,诊断的增加减少了与癌症相关的死亡人数。根据 ASC 的数据,在过去 28 年里,男性和女性癌症死亡率从 1991 年的高峰到 2019 年下降了 32%。死亡率下降的原因是早期和晚期癌症诊断。人们对诊断技术进步的认识不断增强。因此,它导致了美国免疫分析市场的显着成长。同样,糖尿病在美国老年族群的盛行率也很高。许多公司正在提供糖尿病免疫测定试剂盒。例如,Bio-Rad Laboratories, Inc. 提供 Bio-Plex Pro 人类糖尿病免疫测定法,该方法对于研究人类糖尿病和肥胖标记物可靠且方便。它们有助于管理和治疗糖尿病患者的糖尿病。由于美国公民糖尿病盛行率的上升,预计该市场将显着增长。根据美国疾病管制与预防中心(CDC)在2023年全国糖尿病统计报告中公布的资料,美国有3,730万人患有糖尿病,占美国总人口的11.3%。此外,报告也指出,18岁或以上的人有9,600万处于糖尿病前期,占美国人口的38%。因此,考虑到该国糖尿病的盛行率,预计免疫诊断的需求将会增加,从而导致市场成长。近年来,创新和改进的医疗技术出现了前所未有的成长。结果,先进诊断和整个医疗保健行业取得了发展。此外,美国拥有多家公司开发用于现场诊断的尖端产品,为免疫诊断市场的成长铺平了道路。 2020 年 4 月,Bio-Rad 实验室推出了一种基于血液的免疫测定试剂盒,用于识别 SARS-CoV-2 抗体。
北美免疫诊断市场收入及 2030 年预测(百万美元)
北美免疫诊断市场细分
北美免疫诊断市场分为产品、临床适应症、最终用户和国家。
根据产品,北美免疫诊断市场分为酵素连结免疫吸附测定(ELISA)、化学发光免疫测定(CLIA)、放射免疫测定(RIA)等。 2023年,酵素连结免疫吸附测定(ELISA)领域在北美免疫诊断市场中占据最大份额。化学发光免疫分析 (CLIA) 领域进一步细分为维生素 D 分析市场、HIV 检测市场、HIV ag/ab 组合分析市场和其他测试。
根据临床适应症,北美免疫诊断市场分为传染病、肝炎+HIV、内分泌、胃肠道、代谢等。 2023年,传染病领域在北美免疫诊断市场中占据最大份额。传染病部分进一步细分为 COVID-19、结核病、莱姆病、感染管理、寨卡病毒、密螺旋体、火炬、麻疹和腮腺炎、水痘带状疱疹病毒和 EB 病毒。内分泌科进一步细分为高血压、生长、糖尿病、甲状腺和生殖内分泌。
根据最终用户,北美免疫诊断市场分为医院、诊所、诊断实验室、学术和研究机构等。 2023年,医院细分市场在北美免疫诊断市场中占据最大份额。
根据国家/地区,北美免疫诊断市场分为美国、加拿大、墨西哥。 2023年,美国在北美免疫诊断市场中占据最大份额。
雅培实验室;生物梅里埃公司;丹纳赫公司; DiaSorin SpA; F.霍夫曼-拉罗氏有限公司;珀金埃尔默公司;深圳迈瑞生物医疗电子有限公司;西门子医疗保健有限公司;斯瓦尔生命科学公司;和 Thermo Fisher Scientific Inc 是北美免疫诊断市场上的一些领先公司。
The North America immunodiagnostics market is expected to grow from US$ 10,463.48 million in 2023 to US$ 17,399.10 million by 2030. It is estimated to grow at a CAGR of 7.5% from 2023 to 2030.
Growing Use of Point-of-Care Immunodiagnostics Drive North America Industrial Robotics Market
Point-of-care testing (POCT) has become critical to patient-centric healthcare due to the need for rapid diagnostic results to determine accurate and faster treatments. A shift from centralized point-of-care testing to decentralized testing has resulted in easy access to these diagnostics. Immunoassay testing helps monitor chronic conditions and detect pathogens, such as bacteria and viruses. Advanced point-of-care devices enable rapid screening of up to three components from a single sample. Also, the point-of-care diagnostics (POCD) inclined toward mobile healthcare (mH) smart devices could revolutionize personalized healthcare monitoring and management, paving the way for next-generation POCTs. The management of infectious diseases can be significantly improved by POCTs, particularly in developing countries where access to timely medical care is challenging and healthcare infrastructure is outdated and sparse. Additionally, the technologically developed diagnostic kits leading to fewer manual errors propel the immunodiagnostics market. Several market players are developing innovative immunodiagnostics products. For instance, Thermo Fisher Scientific has developed immunodiagnostics products such as enzyme-linked immunoassay (ELISA) reagents and buffers, antibodies and detection probes, linking mechanisms, blocking buffers and detergents, detection substrates, and capture surfaces, as well as services such as bioconjugation and detection. Further, in September 2020, Roche launched the SARS-CoV-2 Rapid Antigen Test, which is used in POC settings to help healthcare professionals identify the infection within 15 minutes in people suspected of carrying the virus.
In April 2021, DiaSorin introduced the LIAISON IQ, a new immunodiagnostics Point-of-Care (POC) reader, and the LIAISON QuickDetect COVID TrimericS Ab test, developed with Lumos Diagnostics for countries accepting the CE Mark. Using a fingerstick of human capillary blood, this test for the LIAISON IQ identifies specific IgG antibodies against SARS-CoV-2 Spike Protein in 10 minutes.
In April 2021, Chembio Diagnostics, Inc. launched an FDA Emergency Use Authorization-approved, in-licensed rapid point-of-care COVID-19/Flu A&B test for use in traditional and decentralized testing settings. The rapid immunoassay test requires no instrumentation and produces results in 15 minutes.
WHO applauded the test kit developers for efforts taken to innovate and respond to the masses' requirements during the COVID-19 crisis. According to the American Society for Clinical Pathology, in March 2020, the Cepheid Xpert Xpress SARS-CoV-2 test became the first POC COVID-19 detection assay to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
Likewise, the use of immunodiagnostics in cancer treatment is increasing. In oncology, an immunodiagnostics test can confirm the presence of a solid tumor by detecting known tumor-associated antigens or antibodies. These advantages and indications are driving the immunodiagnostics market.
North America Immunodiagnostics Market Overview
The prevalence of cancer is increasing in the country at an alarming rate, leading to the rising demand for cancer diagnoses. According to the American Cancer Society's (ASC) cancer facts & figures estimates for 2023, nearly 1.9 million new cancer cases were registered in the US. It is further projected that in 2023, the country will register 609,360 deaths from cancer, which is ~1,670 deaths a day. However, the increased diagnostics have reduced the number of cancer-linked deaths. As per the ASC, in the past 28 years, the death rate from cancer in men and women has fallen 32% from its peak in 1991 to 2019. The fall in death rates was found to be because of early and advanced cancer diagnoses. The awareness of the advancements in diagnostic technology has grown among people. Therefore, it has resulted in the significant growth of the immunoassay market in the US. Similarly, diabetes is prevailing at a high rate in the geriatric population in the US. Many companies are providing immunoassay kits for diabetes. For instance, Bio-Rad Laboratories, Inc. offers Bio-Plex Pro human diabetes immunoassays, which are reliable and convenient for studying human diabetes and obesity markers. They help in managing and treating diabetes in diabetic patients. The market is expected to witness significant growth due to the rising prevalence of diabetes among US citizens. According to the data published by the Centers for Disease Control and Prevention (CDC) in the 2023 National Diabetes Statistics Report, 37.3 million people have diabetes in the US, which accounts for 11.3% of the total US population. Also, the reports state that 96 million people aged 18 years or above are prediabetic, accounting for 38% of the US population. Thus, considering the prevalence of diabetes in the country, an increased demand for immunodiagnostics is anticipated, leading to market growth. There has been unprecedented growth in innovative and improved medical technologies in recent years. As a result, there have been developments in advanced diagnostics and the overall healthcare industry. Moreover, the US houses various companies developing cutting-edge products for point-of-care diagnosis, paving the way for the growth of the immunodiagnostics market. In April 2020, Bio-Rad Laboratories launched a blood-based immunoassay kit to identify antibodies to the SARS-CoV-2.
North America Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
North America Immunodiagnostics Market Segmentation
The North America immunodiagnostics market is segmented into product, clinical indication, end user, and country.
Based on product, the North America immunodiagnostics market is segmented into enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), radioimmunoassays (RIA), and others. In 2023, the enzyme-linked immunosorbent assays (ELISA) segment registered the largest share in the North America immunodiagnostics market. The chemiluminescence immunoassays (CLIA) segment is further segmented into vitamin D assay market, HIV detection market, HIV ag/ab combo assay market, and other tests.
Based on clinical indication, the North America immunodiagnostics market is segmented into infectious diseases, hepatitis+HIV, endocrinology, gastrointestinal, metabolics, and others. In 2023, the infectious diseases segment registered the largest share in the North America immunodiagnostics market. The infectious diseases segment is further segmented into COVID-19, tuberculosis, lyme, infection management, zika, treponema, torch, measles and mumps, VZV, and EBV. The endocrinology segment is further segmented into hypertension, growth, diabetes, thyroid, and reproductive endocrinology.
Based on end user, the North America immunodiagnostics market is segmented into hospitals, clinics, diagnostic laboratories, academic & research institutes, and others. In 2023, the hospitals segment registered the largest share in the North America immunodiagnostics market.
Based on country, the North America immunodiagnostics market is segmented into the US, Canada, Mexico. In 2023, the US registered the largest share in the North America immunodiagnostics market.
Abbott Laboratories; bioMerieux SA; Danaher Corp; DiaSorin SpA; F. Hoffmann-La Roche Ltd; PerkinElmer Inc; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; Siemens Healthcare GmbH; Svar Life Science AB; and Thermo Fisher Scientific Inc are some of the leading companies operating in the North America immunodiagnostics market.