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市场调查报告书
商品编码
1828130
2025年全球免疫诊断市场报告Immunodiagnostics Global Market Report 2025 |
近年来,免疫诊断市场呈现强劲成长势头,规模将从2024年的228.8亿美元增加到2025年的243.2亿美元,复合年增长率为6.3%。预测期内的成长主要受以下因素驱动:感染疾病率上升、自体免疫疾病发生率上升、癌症诊断和监测、感染疾病全球化、公共卫生措施以及筛检计画。
预计未来几年免疫诊断市场规模将强劲成长,2029年将达到328.9亿美元,复合年增长率为7.8%。预测期内的成长可归因于疫情防治、个人化医疗和生物标记发现、新兴市场医疗基础设施的不断完善、与实验室资讯系统的整合以及慢性病负担的日益加重。预测期内的主要趋势包括多重技术、就地检验(POCT)、生物标记发现和个人化医疗、数位免疫诊断的兴起以及向液态切片的转变。
免疫诊断试剂是主要依赖抗原抗体反应检测血清胰岛素的诊断方法。这些检测已被用于识别抗体和寄生虫抗原。
免疫诊断部门的主要产品包括试剂和耗材、仪器和软体以及服务。试剂是用于与其他物质发生化学反应以检测特定物质存在的物质,而耗材是指用于执行分析技术的可追溯物品。相关技术包括酵素结合免疫吸附检测法、化学冷光免疫检测、萤光免疫分析、免疫检测和快速检测。这些技术应用于各种医疗保健领域,包括感染疾病、肿瘤学、内分泌学、骨矿疾病、自体免疫疾病、心臟生物标记和药物监测。研究的最终用户包括医院、诊所、诊断实验室和学术研究机构。
2025年春季美国关税的突然上调及其引发的贸易摩擦对医疗设备行业产生了重大影响,尤其对用于诊断影像设备的进口零件、手术用不銹钢和一次性塑胶製品产生了重大影响。由于医院和诊所抵制涨价,製造商面临利润压力。监管挑战使情况更加复杂,因为由于关税而更换供应商通常需要重新认证医疗设备,导致市场进入延迟。为此,企业正在透过双重采购关键零件、增加标准化产品的国内生产以及加快寻找更具成本效益的材料来降低风险。
本研究报告是商业研究公司 (The Business Research Company) 新报告系列的一部分,该系列提供免疫诊断试剂市场统计数据,例如全球市场规模、区域份额、竞争对手的市场份额、详细的免疫诊断试剂市场细分、市场趋势和商业机会,为您提供在免疫诊断试剂行业取得成功所需的数据。本免疫诊断试剂市场研究报告透过对产业现状和未来趋势的详细分析,全面展望了您所需的一切。
我们对该市场未来五年7.8%的成长率预测与先前的预测一致。下降的主要原因是美国与其他国家之间关税的影响。这种影响可能会直接影响美国,因为来自瑞典和台湾等主要地区的多重微球阵列和侧流硝酸纤维素膜的供应链中断,可能导致自体免疫疾病检测的延迟和专业检测成本的增加。这种影响可能会透过互惠关税以及日益加剧的贸易紧张局势和限制对全球经济和贸易的负面影响,更广泛地体现出来。
预计未来几年,感染疾病的盛行率将推动免疫诊断市场的成长。感染疾病是由病毒、细菌、真菌、寄生虫和其他可在人与人之间传播的微生物引起的疾病。免疫诊断检测用于检测血液样本中是否有病毒。例如,美国政府机构疾病管制与预防中心 (CDC) 在 2024 年 3 月报告称,结核病病例数将从 2022 年的 8,320 例增加到 2023 年的 9,615 例,增加 1,295 例。因此,预计感染疾病的盛行率将显着推动免疫诊断市场的发展。
预计不断增长的医疗保健支出将推动免疫诊断试剂市场的未来成长。医疗保健支出是指医疗保健的总支出,涵盖特定医疗保健系统或经济体在医疗保健相关商品和服务上的所有支出。这些支出对于促进免疫诊断解决方案的开发和应用至关重要。例如,2023年11月,总部位于加拿大的非营利组织加拿大卫生资讯研究所预测,2023年医疗保健总支出将达到3,440亿美元,较去年同期成长2.8%。因此,医疗保健成本的上涨正在推动免疫诊断试剂市场的扩张。
免疫诊断市场的主要企业正致力于创造创新解决方案,例如肺炎链球菌抗原免疫诊断检测,这有助于诊断肺炎球菌肺炎感染。此检验用于检测体液中是否存在肺炎球菌抗原,有助于诊断肺炎链球菌感染。例如,2024 年 9 月,义大利生物技术公司 DiaSorin SpA 推出了 LIAISON 肺炎球菌抗原免疫诊断检测。此诊断测试专门用于定性检测疑似患有肺炎球菌肺炎的成人尿液检体中的肺炎球菌抗原。该测试提供了一种高性能解决方案,使医疗保健提供者能够快速诊断肺炎球菌肺炎并将其与其他呼吸道感染疾病分开来。与 LIAISON CLIA 分析仪一起使用时,只需 35 分钟即可获得结果,从而可以及时、有针对性地进行抗生素治疗。此外,识别 91 种血清型的能力增强了临床决策能力,支持有效的抗生素管理,并且是社区获得性肺炎免疫诊断领域的重大进步。
免疫诊断市场的主要企业正在越来越多地建立伙伴关係,以推动收益成长。医疗专家、学术机构和IT公司之间的合作将显着促进市场扩张,促进创新并加速免疫诊断药物的临床应用。例如,2022年10月,澳洲放射性药物公司Telix Pharmaceuticals Limited与美国医疗科技公司GE Healthcare合作,将Telix的在临床实验PET成像放射性示踪剂与GE Healthcare的免疫诊断产品组合结合。此次合作旨在改善免疫治疗测试中的治疗方法选择和患者监测。
2023年5月,美国生技公司Freenome收购了Oncimmune,收购金额未揭露。此次收购旨在整合Oncimmune的创新技术和免疫分析专业知识,并增强Freenome在早期癌症检测方面的能力。此次收购旨在巩固Freenome在癌症诊断市场的地位,并扩展其液态切片解决方案组合。 Oncimmune总部位于英国,专注于开发有助于癌症诊断和监测的免疫分析和生物标记发现技术。
免疫诊断市场的主要企业包括:雅培实验室、Arkray Inc.、bioMerieux Inc.、Immunodiagnostic Systems Holdings Plc (IDS)、Bio-Rad Laboratories Inc.、DiaSorin SpA、F. Hoffmann-La Roche Ltd.、强生服务公司、西门子股份公司、Sysmex Corporation、Sysmex Corporation, 世界飞纳赫尔科技公司、Sysmeding ? AG、珀金埃尔默公司、默克集团、Becton Dickinson and Company、Grifols SA、Ortho Clinical Diagnostics、贝克曼库尔特公司、Bio-Techne Corporation、Creative Diagnostics、Fujire Holdings Inc.、Gold Standard Diagnostics Corp.、Hologic Inc.、Lumin Corporation、Fujire Holdings Inc.、Gold Standard Diagnostics Corp.、Hologic Inc.、Lumin Corporation., Inc., 阿联酋 Corporation, el开镜。
2024年免疫诊断试剂市场最大的地区是北美。免疫诊断试剂市场报告涵盖的地区包括亚太地区、西欧、东欧、北美、南美以及中东和非洲。
免疫诊断试剂市场报告涵盖的国家:澳洲、巴西、中国、法国、德国、印度、印尼、日本、俄罗斯、韩国、英国、美国、加拿大、义大利、西班牙
免疫诊断市场由提供凝集、比浊法、免疫沉淀和放射免疫扩散检测服务的营业单位所获得的收益所构成。市场规模包括服务提供者销售或包含在其服务产品中的相关产品的价值。免疫诊断市场还包括抗链球菌溶血素-O乳胶、传染性单核球增多症增多症玻片、类风湿因子和梅毒血清试剂的销售。此市场的价值是指“出厂价”,即商品製造商或生产商向其他营业单位(包括下游製造商、批发商、经销商和零售商)或直接向最终客户销售的商品价值。该市场中的商品价值还包括商品製造商销售的任何相关服务。
Immunodiagnostics is a diagnostic approach that relies primarily on the antigen-antibody response for detecting serum insulin. These tests are employed to identify antibodies and parasite antigens.
The principal products in the field of immunodiagnostics include reagents and consumables, instruments and software, and services. Reagents are substances used to initiate chemical reactions with other substances to detect the presence of specific substances, while consumables refer to traceable items utilized in the execution of analysis techniques. The technologies involved encompass enzyme-linked immunosorbent assay, chemiluminescence immunoassay, fluorescent immunoassay, radioimmunoassay, rapid tests, and others. These technologies find applications in various medical fields such as infectious diseases, oncology, endocrinology, bone and mineral diseases, autoimmunity disorders, cardiac biomarkers, drug monitoring, and more. The end-users of immunodiagnostics include hospitals, clinics, diagnostic laboratories, academic and research institutes, among others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sharp increase in U.S. tariffs and resulting trade tensions in spring 2025 are significantly impacting the medical equipment sector, especially for imported components used in imaging machines, surgical-grade stainless steel, and disposable plastics. With hospitals and clinics pushing back against price increases, manufacturers are facing margin pressure. The situation is further complicated by regulatory challenges, as switching suppliers due to tariffs often necessitates re-certification of medical devices, leading to delays in market entry. In response, companies are mitigating risks by dual-sourcing key components, ramping up domestic production of standardized items, and accelerating research into more cost-effective materials.
The immunodiagnostics market research report is one of a series of new reports from The Business Research Company that provides immunodiagnostics market statistics, including immunodiagnostics industry global market size, regional shares, competitors with immunodiagnostics market share, detailed immunodiagnostics market segments, market trends, and opportunities, and any further data you may need to thrive in the immunodiagnostics industry. This immunodiagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The immunodiagnostics market size has grown strongly in recent years. It will grow from $22.88 billion in 2024 to $24.32 billion in 2025 at a compound annual growth rate (CAGR) of 6.3%. The growth in the historic period can be attributed to the increasing incidence of infectious diseases, rise in autoimmune diseases, cancer diagnosis and monitoring, globalization of infectious diseases, public health initiatives, and screening programs.
The immunodiagnostics market size is expected to see strong growth in the next few years. It will grow to $32.89 billion in 2029 at a compound annual growth rate (CAGR) of 7.8%. The growth in the forecast period can be attributed to pandemic preparedness and response, personalized medicine and biomarker discovery, growing healthcare infrastructure in emerging markets, integration with laboratory information systems, rising burden of chronic diseases. Major trends in the forecast period include multiplexing technologies, point-of-care testing (POCT), biomarker discovery and personalized medicine, the rise of digital immunodiagnostics, shift toward liquid biopsy.
The forecast of 7.8% growth over the next five years remains unchanged from the previous projection for this market.This reduction is primarily due to the impact of tariffs between the US and other countries. This is likely to directly affect the US through supply chain disruptions for multiplex bead arrays and lateral flow nitrocellulose membranes, sourced from key regions such as Sweden and Taiwan, which could lead to delayed autoimmune disease detection and increased costs for specialty testing.The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The rising prevalence of infectious diseases is anticipated to drive the growth of the immunodiagnostics market in the coming years. Infectious diseases are illnesses caused by germs such as viruses, bacteria, fungi, or parasites that can be transmitted between individuals. Immunodiagnostic assays are utilized to detect the presence of viruses in blood samples. For example, in March 2024, the Centers for Disease Control and Prevention (CDC), a U.S. government agency, reported that the number of tuberculosis cases increased from 8,320 in 2022 to 9,615 in 2023, representing an increase of 1,295 cases. Therefore, the growing prevalence of infectious diseases is expected to significantly boost the immunodiagnostics market.
The increasing healthcare expenditure is expected to propel the growth of the immunodiagnostics market in the future. Healthcare expenditure refers to the total spending on healthcare costs, encompassing all money spent on healthcare-related goods and services within a specific healthcare system or economy. This expenditure is vital for fostering the development and accessibility of immunodiagnostic solutions. For example, in November 2023, the Canadian Institute for Health Information, a non-profit organization based in Canada, projected that total health expenditure would reach $344 billion in 2023, indicating a modest growth of 2.8% compared to the previous year. Therefore, the rising healthcare expenditure is driving the expansion of the immunodiagnostics market.
Leading companies in the immunodiagnostics market are focused on creating innovative solutions, such as the S. pneumoniae antigen immunodiagnostic assay, to assist in diagnosing pneumococcal pneumonia infections. This assay is used to detect the presence of Streptococcus pneumoniae antigens in bodily fluids, facilitating the diagnosis of pneumococcal infections. For instance, in September 2024, DiaSorin S.p.A., an Italy-based biotechnology company, introduced the LIAISON S. pneumoniae antigen immunodiagnostic assay. This diagnostic test is specifically designed for the qualitative detection of Streptococcus pneumoniae antigens in urine samples from adults suspected of having pneumococcal pneumonia. The assay provides a high-throughput solution, enabling healthcare providers to rapidly diagnose and differentiate pneumococcal pneumonia from other respiratory infections. When utilized with LIAISON CLIA analyzers, the test delivers results in just 35 minutes, promoting timely and targeted antimicrobial therapy. Additionally, its capability to identify 91 serotypes enhances clinical decision-making and supports effective antibiotic stewardship, representing a significant advancement in the immunodiagnostics field for community-acquired pneumonia.
Major companies in the immunodiagnostics market are increasingly forming partnerships to drive revenues. Collaborations involving medical experts, academic entities, and IT firms can significantly contribute to market expansion by fostering innovation and accelerating clinical immunodiagnostics. For example, in October 2022, Telix Pharmaceuticals Limited, an Australia-based radiopharmaceutical company, partnered with GE Healthcare, a US-based medical technology company, to combine Telix's investigational PET imaging radiotracers with GE Healthcare's immuno-diagnostic range. This collaboration aims to improve therapy selection and patient monitoring in immunotherapy trials.
In May 2023, Freenome, a biotechnology company based in the U.S., acquired Oncimmune for an undisclosed amount. This acquisition is intended to enhance Freenome's capabilities in early cancer detection by incorporating Oncimmune's innovative technology and expertise in immune profiling. The move aims to strengthen Freenome's position in the oncology diagnostics market and expand its portfolio of liquid biopsy solutions. Oncimmune, located in the UK, specializes in developing technologies for immune profiling and biomarker discovery to aid in cancer diagnosis and monitoring.
Major companies operating in the immunodiagnostics market include Abbott Laboratories, Arkray Inc., bioMerieux Inc., Immunodiagnostic Systems Holdings Plc (IDS), Bio-Rad Laboratories Inc., DiaSorin S.p.A., F. Hoffmann-La Roche Ltd., Johnson & Johnson Services Inc., Siemens AG, Sysmex Corporation, Thermo Fisher Scientific Inc., Danaher Corporation, Qiagen N.V., Tecan Trading AG, PerkinElmer Inc., Merck KGaA, Becton Dickinson and Company, Grifols S.A., Ortho Clinical Diagnostics, Beckman Coulter Inc., Bio-Techne Corporation, Creative Diagnostics, Fujirebio Holdings Inc., Gold Standard Diagnostics Corp., Hologic Inc., Luminex Corporation, Myriad Genetics Inc., Natera Inc., OraSure Technologies Inc., Quidel Corporation
North America was the largest region in the immunodiagnostics market in 2024. The regions covered in the immunodiagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa
The countries covered in the immunodiagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain
The immunodiagnostics market consists of revenues earned by entities by providing agglutination, nephelometry, immunoprecipitation, and radial immunodiffusion test services. The market value includes the value of related goods sold by the service provider or included within the service offering. The immunodiagnostics market also includes sales of anti-streptolysin-O latex, infectious mononucleosis slide, rheumatoid factor, and syphilis serology reagent. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Immunodiagnostics Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on immunodiagnostics market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for immunodiagnostics ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The immunodiagnostics market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.