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市场调查报告书
商品编码
1828064
2025年全球免疫检测市场报告Immunoassay Global Market Report 2025 |
近年来,免疫检测市场稳定成长,从2024年的358.1亿美元成长到2025年的373.2亿美元,复合年增长率为4.2%。预测期内的成长主要受疾病流行、人口老化、感染疾病爆发、就地检验、研究经费增加等因素所驱动。
预计未来几年免疫检测市场规模将强劲成长,到2029年将达到494亿美元,复合年增长率为7.3%。预测期内的成长可归因于个人化医疗、新兴市场的扩张、疫情防治、癌症诊断以及向居家检测的转变。预测期内的主要趋势包括监管协调、多用途免疫检测、客製化检测服务、与穿戴式装置的整合以及检测法的微型化。
免疫检测是一种生物分析测试,利用抗体与抗原的结合来检测和定量特定化学物质,在疾病诊断中发挥重要作用。免疫检测测试结果的资讯可用于制定适当的治疗策略。免疫检测测试依赖高特异性抗分析物抗体上有限数量的受体与大多数标记和未标记样本分析物之间的竞争性结合反应。
免疫检测产品的主要类型包括试剂和套件、分析仪和设备以及软体和服务。试剂是促进反应的物质或产品,常用于各种测试。免疫检测样本包括血液、唾液和尿液,检体包括治疗监测、肿瘤学、循环系统、内分泌学、传染病检查和自体免疫疾病。免疫检测产品的最终用户多种多样,包括研究和学术实验室、居家医疗机构、製药和生物技术公司、委外研发机构(CRO)、血库、医院和诊所以及临床实验室。
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价格上涨,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、加强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,该系列提供免疫检测市场统计数据,例如免疫检测行业的全球市场规模、各地区市场份额、免疫检测测定市场份额的竞争对手、详细的免疫检测市场细分、市场趋势和机会,以及您在免疫检测行业取得成功所需的数据。本免疫检测市场研究报告对该行业的现状和未来趋势进行了详细分析,为您提供所需的一切观点。
未来五年7.3%的预测成长率比我们先前对该市场的预测略有下降,下降了0.2%。下降的主要原因是美国与其他国家之间关税的影响。美国可能会直接感受到这种影响,因为酵素连结抗体和微孔盘洗板机的供应链中断,这些产品来自瑞士和荷兰等主要地区,这可能导致传染病检查延迟和诊断实验室成本增加。此外,这种影响可能会透过互惠关税以及贸易紧张局势和限制加剧对全球经济和贸易的负面影响,在更广泛的范围内显现。
感染疾病和慢性病的流行预计将在不久的将来推动免疫检测市场的成长。慢性病通常被定义为持续一年以上、需要持续治疗、限制日常活动或两者兼而有之的疾病。感染疾病是由细菌、病毒、真菌和寄生虫等生物引起的疾病。许多生物在人体内和人与人之间共存,有些感染疾病可以在人与人之间传播。免疫检测用于检测各种感染疾病和慢性病。例如,根据美国生物医学研究机构国立卫生研究院 (NIH) 的报告,预计到 2023 年,美国50 岁及以上患有至少一种慢性病的人数将增加 99.5%,从 2020 年的 71,522,000 人增加到 2050 年的 142,660,000 人。此外,患有多种疾病的人数预计将增加 91.16%,从 2020 年的 7,834,000 人增加到 2050 年的 14,968,000 人。因此,感染疾病和慢性病的日益普及正在推动市场的成长。
预计政府主导的医疗保健研究和开发倡议将在未来几年支持免疫检测市场的成长。这些措施是指各级政府当局(地方、区域、国家和国际)为解决具体问题、实现具体目标和带来计划积极变化而采取的具体行动、计划、措施和项目。这些倡议旨在改善诊断测试的可近性、提高医疗保健品质和应对公共卫生挑战,从而推动对免疫测量的需求。例如,2022 年,英国政府机构卫生和社会保障部宣布资助 2.6 亿英镑(2.7065 亿美元)加强医疗保健研究和製造。 BEIS 和 DHSC 的这项承诺旨在透过新的隐私保护平台和临床研究服务支持美国主导的诊断和治疗健康研究,并拨款 6,000 万英镑(6,360 万美元)支持英国生命科学製造业的扩张。因此,政府在医疗保健领域的倡议的成长正在推动免疫检测市场的发展。
产品创新是发展势头强劲的关键趋势,领先企业正努力透过提供尖端产品来巩固其市场地位。例如,中国生物技术公司Getein BIoTech Inc.在2022年德国慕尼黑国际医学展览会上推出了MAGICL 6000。这款可携式化学冷光免疫检测分析仪专为中高容量工作流程的实验室设计,提供一步式化学冷光解决方案。该设备以其高效、紧凑、全自动和快速评估频率而脱颖而出,为诊断实验室提供了一个技术先进的选择。
免疫检测市场包括供应免疫检测套件、分析仪和试剂的营业单位所获得的收益。市场规模还包括服务供应商销售或包含在其服务产品中的相关商品的价值。仅包括营业单位之间交易或销售给最终消费者的商品和服务。
Immunoassay is a bioanalytical test that utilizes the binding of antibodies to antigens to detect and quantify specific chemicals, playing a crucial role in the diagnosis of diseases. Information derived from immunoassay test results can be used to establish appropriate courses of therapy. This method relies on a competitive binding reaction between a limited number of receptors on a highly specific anti-analyte antibody, labeled versions of an analyte, and a significant portion of an unlabeled sample analyte.
The main types of immunoassay products include reagents and kits, analyzers or instruments, and software and services. Reagents are substances or products that accelerate a reaction and are commonly used in various tests. Immunoassay specimens include blood, saliva, urine, and others, and the technique is applied in therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing, autoimmune diseases, and more. The end users of immunoassay products are diverse and include research and academic laboratories, home care settings, pharmaceutical and biotechnology companies, Contract Research Organizations (CROs), blood banks, hospitals and clinics, and clinical laboratories.
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 immunoassay market research report is one of a series of new reports from The Business Research Company that provides immunoassay market statistics, including immunoassay industry global market size, regional shares, competitors with a immunoassay market share, detailed immunoassay market segments, market trends and opportunities, and any further data you may need to thrive in the immunoassay industry. This immunoassay market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The immunoassay market size has grown steadily in recent years. It will grow from $35.81 billion in 2024 to $37.32 billion in 2025 at a compound annual growth rate (CAGR) of 4.2%. The growth in the historic period can be attributed to disease prevalence, aging population, infectious disease outbreaks, point-of-care testing, increased research funding.
The immunoassay market size is expected to see strong growth in the next few years. It will grow to $49.4 billion in 2029 at a compound annual growth rate (CAGR) of 7.3%. The growth in the forecast period can be attributed to personalized medicine, expansion in emerging markets, pandemic preparedness, cancer diagnostics, shift to home-based testing. Major trends in the forecast period include regulatory harmonization efforts, multipurpose immunoassays, customized assay services, integration with wearable devices, and miniaturization of assays.
The forecast of 7.3% growth over the next five years indicates a slight reduction of 0.2% from the previous estimate 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 enzyme-conjugated antibodies and microplate washers, sourced from key regions such as Switzerland and the Netherlands, which could lead to slower infectious disease testing and increased diagnostic laboratory costs.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 growing prevalence of infectious and chronic diseases is expected to drive the growth of the immunoassay market in the near future. Chronic illnesses are generally defined as conditions that last for a year or longer, require ongoing medical attention, restrict daily activities, or both. Infectious diseases are illnesses caused by organisms such as bacteria, viruses, fungi, or parasites. Numerous organisms coexist within and on the human body, and several infectious diseases can be transmitted from one person to another. Immunoassays are utilized to detect various infectious and chronic diseases. For example, a report from the National Institutes of Health (NIH), a US-based biomedical research agency, stated that in 2023, the number of individuals aged 50 and older in the United States with at least one chronic illness is projected to increase by 99.5%, from 71.522 million in 2020 to 142.66 million by 2050. Moreover, the number of people with multimorbidity is expected to rise by 91.16%, from 7.8304 million in 2020 to 14.968 million by 2050. Therefore, the increasing incidence of infectious and chronic diseases is driving market growth.
Government-led research and development initiatives in healthcare are anticipated to support the growth of the immunoassay market in the future. These initiatives refer to specific actions, programs, policies, or projects undertaken by government authorities at various levels-local, regional, national, or international-to tackle specific issues, achieve certain objectives, or foster positive changes in society. Such initiatives have aimed at improving access to diagnostic testing, enhancing healthcare quality, and addressing public health challenges, thereby driving demand for immunoassays. For instance, in 2022, the Department of Health and Social Care, a UK government authority, announced £260 million (US$270.65 million) in funding to enhance healthcare research and manufacturing. This commitment, made by BEIS and DHSC, was aimed at supporting NHS-led health research into diagnostics and treatment through new privacy-preserving platforms and clinical research services, along with £60 million (US$63.60 million) to aid in expanding life sciences manufacturing in the UK. Consequently, the growth of government initiatives in healthcare is driving the immunoassay market.
A key trend gaining momentum is product innovation, with major companies striving to strengthen their market position through cutting-edge offerings. For instance, Getein Biotech Inc., a China-based biotechnological company, introduced the MAGICL 6000 at MEDICA 2022. This portable chemiluminescence immunoassay analyzer is designed for labs with mid- to high-workflow requirements, providing a one-step chemiluminescence solution. The instrument stands out for its efficiency, compact size, complete automation, and rapid assessment frequency, offering a technologically advanced option for diagnostic laboratories.
Major players in the immunoassay market are introducing innovative immunoassay analyzers to gain a competitive advantage. These analyzers automate the detection and quantification of biological molecules, such as proteins or hormones, through immunological reactions. Beckman Coulter Diagnostics launched the DxI 9000 Access Immunoassay Analyzer in May 2023, addressing the needs of clinical laboratories for speed, reliability, reproducibility, and expanded menu options. The analyzer incorporates advanced features such as new analyte processing and detection technology, precision sensors, smart algorithms, and remote real-time system monitoring. Its distinctive feature includes no daily maintenance, enhancing its efficiency in diagnostic workflows.
In January 2023, Heska Corporation, a US-based biotechnology firm, acquired MBio Diagnostics, Inc. for an undisclosed sum. This acquisition is intended to strengthen Heska Corporation's research, development, and manufacturing capabilities, primarily by incorporating LightDeck's innovative point-of-care technology. This integration will facilitate the launch of advanced diagnostic platforms, including a product for canine cancer screening. MBio Diagnostics, Inc. is a US-based company that specializes in immunoassays.
Major companies operating in the immunoassay market include Siemens Healthineers GmbH, bioMerieux, Abbott, Beckman Coulter Inc., Quidel Corporation, Ortho Clinical Diagnostics, Sysmex Corporation, Bio-Rad Laboratories Inc., Becton Dickinson and Company, F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Merck KGaA, Agilent Technologies Inc., PerkinElmer Inc, WAK-Chemie Medical GmbH, J Mitra & Co Pvt Ltd, Kamiya Biomedical Company, Tosoh Corporation, Gyros Protein Technologies AB, BioCheck Inc., Bio-Techn, DiaSorin S.p.A, Meso Scale Diagnostics LLC, QIAGE, Randox Laboratories Ltd., Shenzhen Mindray Bio-Medical Electronics Co Ltd, Danaher Corporation, Hologic Inc., Tecan Trading AG, Eurofins Scientific, Abcam plc, Enzo Biochem Inc., Luminex Corporation, Quanterix Corporation, Roche Diagnostics, ZEUS Scientific Inc.
North America was the largest region in the immunoassay market in 2024. Asia-Pacific is expected to be the fastest-growing region in the immunoassay market report during the forecast period. The regions covered in the immunoassay market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa
The countries covered in the immunoassay market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The immunoassay market includes revenues earned by entities by supplying immunoassay kits, analyzers, and reagents. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
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.
Immunoassay 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 immunoassay 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 immunoassay ? 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 immunoassay 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.