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市场调查报告书
商品编码
1801159
自体免疫疾病诊断市场规模、份额、趋势及预测(按产品类型、疾病类型、检测类型、最终用户和地区),2025 年至 2033 年Autoimmune Disease Diagnosis Market Size, Share, Trends and Forecast by Product Type, Disease Type, Test Type, End-User, and Region, 2025-2033 |
2024年,全球自体免疫疾病诊断市场规模达34亿美元。展望未来, IMARC Group预测,到2033年,市场规模将达到55亿美元,2025-2033年期间的复合年增长率为5.57%。北美市场占据主导地位,2024年市占率超过39.7%。对改善患者预后的日益关注、诊断技术的进步、主要参与者之间的合作与伙伴关係以及对精准诊断解决方案的需求,是影响自体免疫疾病诊断市场份额的一些因素。
市场成长得益于几个关键驱动因素。类风湿性关节炎、红斑性狼疮和多发性硬化症等自体免疫疾病在全球的发生率不断上升,这增加了对准确诊断的需求。患者和医疗保健提供者的认知度有所提高,促使人们更早进行检测和治疗。技术进步,尤其是在生物标记发现和成像方面的进步,使得检测速度更快、更精确。老化人口更容易罹患自体免疫疾病,这进一步刺激了需求。研发投入的增加也带来了更优诊断工具的出现。新兴市场医疗基础设施的扩展改善了检测服务的可近性。此外,实验室中即时检测和自动化技术的日益普及有助于缩短週转时间,并提高诊断效率。这些因素共同推动市场的发展,并鼓励诊断平台的创新。
在美国,透过新的多生物标记检测,改善狼疮和类风湿性关节炎等自体免疫疾病的早期检测的努力正在加速推进。这些工具旨在透过靶向TC4d、TIgG和TIgM等标记物来提高诊断灵敏度,这标誌着临床免疫学正转向更精准的血液检测方法。例如,2025年1月,Exagen Inc.获得纽约州卫生部的有条件批准,允许其开发新的生物标记检测方法,以增强狼疮和类风湿性关节炎的检测。这些即将添加到AVISE CTD平台的检测方法旨在利用TC4d、TIgG和TIgM等生物标记来提高诊断灵敏度。
诊断技术的进步
人们发现了诸如自体抗体之类的新型生物标记物,可用于诊断狼疮、类风湿性关节炎和乳糜泻等特定自体免疫疾病。例如,流行病学研究表明,全球自体免疫疾病的发生率(新发病例率)每年上升19.1%,其中干燥症和狼疮等风湿病的发生率每年上升7.1%。生物标记可以对自体免疫疾病进行更精确的分类和早期识别。由于蛋白质体学和代谢组学的发展,更个人化的诊断方法使得人们能够发现与自体免疫疾病相关的独特蛋白质特征或代谢谱。此外,微阵列技术可以同时检测多种生物标记物,这使得诊断涉及多种遗传或蛋白质因素的复杂自体免疫疾病变得更加容易。此外,各公司正在推出尖端产品和新技术,这对自体免疫疾病诊断市场前景产生了积极影响。例如,2024年3月25日,艾伯维公司(AbbVie Inc.)与Landos Biopharma, Inc.宣布达成最终协议,艾伯维将收购Landos。 Landos是一家临床阶段生物製药公司,专注于开发针对自体免疫疾病患者的新型口服疗法。 Landos的主要在研药物是NX-13,这是一款具有双峰作用机制(MOA)的首创口服NLRX1激动剂。
日益关注改善患者治疗效果
美国食品药物管理局 (FDA) 于2023年10月16日批准了Werfen公司Aptiva结缔组织疾病 (CTD) 必需试剂的510(k)上市许可。新试剂有助于加快诊断速度,并改善难以诊断的自体免疫疾病患者的预后。根据自体免疫疾病诊断市场预测,为改善患者护理而不断加强早期和精准检测的努力可能会刺激需求。此外,自体免疫疾病的早期诊断使医护人员能够迅速启动治疗,同时预防或延缓多发性硬化症、红斑性狼疮和类风湿性关节炎等疾病的发生。
关键参与者之间的合作与伙伴关係
2023 年 1 月 10 日,ScipherMedicine 收购了位于费城的资料、分析和软体公司 CrossBridge,以增强其资料和分析能力。这使得能够更细緻、更即时地了解患者的治疗途径。软体即服务 (SaaS) 以价值为基础的照护平台有助于降低医疗成本,同时改善病患的治疗效果。透过各种合作,各公司结合其在免疫学、分子生物学和生物资讯学方面的专业知识,支持自体免疫疾病诊断市场的成长。许多製药公司正在与诊断公司合作,提供伴随诊断测试,旨在确定哪些患者将从特定治疗中受益最多。例如,2025 年 4 月共进行了 15 项关键诊断测试中的 2,399,600 次。这比 2024 年 4 月增加了 70,600 次(3.0%),按工作日调整后增加了 8.2%。这些诊断技术有助于为患者配对最佳的自体免疫疾病生物疗法,从而提高疗效并减少治疗选择的反覆试验。这些合作也涉及治疗方法和诊断工具的共同发展。例如,製药公司可以与诊断公司合作,开发监测疗效的测试,帮助医生即时调整治疗方案,进而改善患者的治疗效果。
The global autoimmune disease diagnosis market size was valued at USD 3.4 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 5.5 Billion by 2033, exhibiting a CAGR of 5.57% during 2025-2033. North America dominated the market, holding a significant market share of over 39.7% in 2024. Rising focus on improving patient outcomes, advancements in diagnostic technologies, collaborations and partnerships among major players, and the need for accurate diagnostic solutions represent some of the factors contributing to the autoimmune disease diagnosis market share.
The market is growing due to several key drivers. The rising global incidence of autoimmune disorders like rheumatoid arthritis, lupus, and multiple sclerosis has increased the need for accurate diagnosis. Awareness among patients and healthcare providers has improved, prompting earlier testing and treatment. Technological advancements, especially in biomarker discovery and imaging, allow faster and more precise detection. Aging populations are more prone to autoimmune conditions, which further fuels demand. There's also increased investment in research and development, leading to better diagnostic tools. Expansion of healthcare infrastructure in emerging markets has improved access to testing services. In addition, the growing use of point-of-care testing and automation in labs helps reduce turnaround time, making diagnosis more efficient. These combined factors are pushing the market forward and encouraging innovation across diagnostic platforms.
In the United States, efforts to improve early detection of autoimmune disorders like lupus and rheumatoid arthritis are gaining pace through new multi-biomarker assays. These tools aim to raise diagnostic sensitivity by targeting markers such as TC4d, TIgG, and TIgM, signaling a shift toward more precise, blood-based testing methods in clinical immunology. For instance, in January 2025, Exagen Inc. received conditional approval from the New York State Department of Health for its new biomarker assays to enhance the detection of lupus and rheumatoid arthritis. The assays, set to be added to the AVISE CTD platform, were designed to improve diagnostic sensitivity using biomarkers like TC4d, TIgG, and TIgM.
Advancements in Diagnostic Technologies
New biomarkers like autoantibodies are discovered to diagnose specific autoimmune diseases like lupus, rheumatoid arthritis, and celiac disease. For instance, epidemiological studies have shown that the incidence (rate of new cases) of global autoimmune diseases has risen yearly by 19.1% with rheumatological diseases such as Sjogren's and lupus rising 7.1% per year. Biomarkers can provide more precise classification and early identification of autoimmune diseases. More individualized diagnostics are allowing for the discovery of distinct protein signatures or metabolic profiles linked to autoimmune disorders only because of developments in proteomics and metabolomics. Furthermore, microarray technology allows simultaneous testing of multiple biomarkers, which makes it easier to diagnose complex autoimmune diseases involving multiple genetic or protein factors. Additionally, companies are launching cutting-edge products and new technologies, which is positively influencing the autoimmune disease diagnosis market outlook. For instance, on 25 March 2024, AbbVie Inc. and Landos Biopharma, Inc. announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel and oral therapeutics for patients with autoimmune diseases. The main investigational asset of Landos is NX-13, a first-in-class, oral NLRX1 agonist with a bimodal mechanism of action (MOA).
Rising Focus on Improving Patient Outcomes
The US Food and Drug Administration (FDA) provided clearance for Werfen's Aptiva connective tissue disease (CTD) essential reagent under 510(k) on October 16, 2023. New reagents benefit in speeding up diagnosis and enhancing patient outcomes in difficult-to-diagnose autoimmune disorders. As per the autoimmune disease diagnosis market forecast, rising efforts to enhance early and precise detection for improved patient care are likely to boost demand. Apart from this, early diagnosis of autoimmune disorders enables medical professionals to start treatment quickly while preventing or delaying the onset of diseases, including multiple sclerosis, lupus, and rheumatoid arthritis.
Collaborations and Partnerships among Key Players
On January 10, 2023, ScipherMedicine acquired CrossBridge, a Philadelphia-based data, analytics, and software company, to enhance its data and analytics capabilities. This enables a more granular and real time understanding of patients' treatment pathways. The software as a service (SaaS) value-based care platform aids in lowering healthcare costs while enhancing patient outcomes. Through various collaborations, companies combine their expertise in immunology, molecular biology, and bioinformatics, which supports the autoimmune disease diagnosis market growth. A large number of pharmaceutical companies are collaborating with diagnostic companies to provide companion diagnostics tests that are intended to determine which patients will benefit the most from particular treatments. For instance, in total 2,399,600 of the 15 key diagnostic tests were performed during April 2025. This is an increase of 70,600 (3.0%) from April 2024, which is 8.2% when adjusted for working days. These diagnostics aid in matching patients with the best biologic therapy for autoimmune illnesses, enhancing results while decreasing treatment selection trial and error. These partnerships also involve the co-development of treatments and diagnostic tools. For instance, pharmaceutical companies might work with diagnostics firms to create tests that monitor treatment efficacy, helping doctors adjust therapies in real time to improve patient outcomes.
Consumables and assay kits stood as the largest product type in 2024, holding around 72.8% of the market. Diagnostic laboratories and hospitals require a continuous supply of consumables and assay kits for routine testing and monitoring of autoimmune diseases. Since autoimmune conditions often require long-term monitoring, the demand for consumables remains high. They are used in a variety of diagnostic procedures, including immunohistochemistry, flow cytometry, Western blot, and enzyme-linked immunosorbent assay (ELISA). They play a vital role in identifying autoantibodies connected to celiac disease, multiple sclerosis, lupus, and rheumatoid arthritis. Assay kits and consumables have a shorter lifespan as compared to diagnostic devices.
Localized autoimmune disease led the market with around 51.7% of market share in 2024. Localized autoimmune diseases are far more common as compared to systemic autoimmune illnesses. Localized autoimmune disease diagnostic procedures are more precise and targeted. Additionally, companies are developing products that aid in the treatment of various illnesses. For example, on June 9, 2023, AstraZeneca and Quell Therapeutics entered in a license agreement to develop multiple engineered T-regulator (Treg) cell therapies with the potential to be curative for both type 1 diabetes (T1D) and inflammatory bowel disease (IBD) indications. Autologous multi-modular Treg cell therapy candidates for key autoimmune disease indications will be developed using Quell's patented toolbox of Treg cell engineering modules. This is expected to provide a positive autoimmune disease diagnosis market forecast.
Autoantibodies and immunologic tests led the market with around 35.3% of market share in 2024. The growing use of autoantibodies and immunologic tests is pushing demand in the autoimmune disease diagnosis market. These tests help detect early-stage autoimmune disorders by identifying specific autoantibodies linked to diseases like rheumatoid arthritis, lupus, and type 1 diabetes. Their accuracy makes them a preferred first-line diagnostic tool among clinicians. With more awareness, patients are seeking earlier evaluation, especially when symptoms are vague. Labs and diagnostics companies are expanding panels to include newer biomarkers, which are now being validated at a faster rate due to advances in immunology. Also, insurance coverage for these tests has improved, reducing out-of-pocket costs and encouraging broader adoption. As autoimmune conditions become more widely recognized and better understood, the use of immunologic assays continues to increase, helping drive both clinical demand and revenue in this segment.
Hospitals led the market with around 53.6% of market share in 2024. In the autoimmune disease diagnosis market, hospitals are a major demand driver due to their role as primary diagnostic and treatment centers. They handle a large share of autoimmune cases, especially moderate to severe ones that require specialized testing. Hospitals typically invest in advanced diagnostic tools, such as autoantibody panels, ANA testing, and flow cytometry, because of the need for accuracy in complex cases. These facilities often house multidisciplinary teams, including immunologists, rheumatologists, and lab technicians, who rely on high-throughput and integrated diagnostic systems. The increasing number of autoimmune disorders being diagnosed in hospital settings, combined with a rise in hospital-based outpatient services, also adds to the volume. Further, hospitals tend to adopt newer diagnostic technologies earlier than small labs or clinics, which helps boost market growth through faster adoption and higher procurement volumes.
In 2024, North America accounted for the largest market share of over 39.7%. North America, particularly the United States, has a high prevalence of autoimmune diseases among individuals. The region benefits from a highly developed healthcare system with widespread access to advanced diagnostic technologies. Clinical laboratories, hospitals, and specialized diagnostic centers have the latest molecular diagnostics and imaging techniques, enabling efficient and accurate diagnosis of autoimmune diseases. Besides this, autoimmune disease diagnosis companies in the region are focusing on introducing solutions that provide enhanced care to individuals suffering from autoimmune diseases. For example, on October 03, 2023, WellTheory, a first-of-its-kind virtual solution for the 50 Million Americans suffering from autoimmune disease, launched an enterprise solution that will enable employers and payers to offer autoimmune care through WellTheory. Through its new enterprise solution, WellTheory will be able to tackle the unseen costs and productivity impacts of untreated autoimmune diseases across the entire healthcare ecosystem.
United States Autoimmune Disease Diagnosis Market Analysis
In 2024, the United States accounted for 91.50% of the market share in North America. United States is witnessing increased autoimmune disease diagnosis adoption due to the sharp rise of autoimmune diseases across various age groups. Over 50 Million Americans (8% of the U.S. population) are affected by autoimmune diseases and current data suggests that the prevalence of autoimmune diseases is rising. The growing prevalence of conditions such as multiple sclerosis and rheumatoid arthritis has prompted healthcare providers to invest in advanced testing tools. The rise of autoimmune diseases has created pressure on public health systems, leading to enhanced diagnostic programs and early intervention strategies. Hospitals and clinics are emphasizing personalized diagnostics, which is accelerating the adoption of specialized screening tools. Growing awareness, availability of advanced diagnostic technologies, and integration of electronic health records further support early detection. In addition, insurance coverage for autoimmune disease-related tests has improved access to diagnosis. Rising clinical research initiatives are also contributing to the adoption of advanced autoimmune disease diagnosis tools nationwide.
Asia Pacific Autoimmune Disease Diagnosis Market Analysis
Asia-Pacific is experiencing growing autoimmune disease diagnosis adoption primarily due to the increasing number of Type 1 Diabetes patients. For instance, the estimated number of individuals with diabetes in India was 32 Million in the year 2000, which rose to 63 Million by 2012, 74 Million in 2021, and it is now 101 Million, according to the ICMR-INDIAB Study. This autoimmune disorder, commonly diagnosed in children and young adults, has seen a notable surge across urban and semi-urban populations. The rising incidence of Type 1 Diabetes is prompting significant investments in early diagnostic platforms, with a focus on improving glycemic control and disease monitoring. Healthcare systems are expanding their diagnostic infrastructure to manage growing pediatric and adolescent cases. The increase in Type 1 Diabetes patients is also driving innovation in test kits, especially those supporting rapid and accurate detection.
Europe Autoimmune Disease Diagnosis Market Analysis
Europe is seeing a rising prevalence of thyroid-related autoimmune disorders, particularly Hashimoto's thyroiditis and Graves' disease, which is leading to greater reliance on diagnostic technologies. Expansion of healthcare infrastructure across urban and rural areas is improving access to advanced autoimmune disease diagnostic services. For instance, Germany has more than 1,900 hospitals, including over 30 elite university hospitals, combining top-level patient care with research and innovation. Public health campaigns targeting thyroid awareness and increased physician focus on autoimmune symptoms are enhancing early detection. New investments in immunology labs and academic research centres are aiding diagnosis accuracy. Technological upgrades in laboratories and clinical support systems are boosting adoption further. Rising healthcare expenditure and the aging population are also contributing to broader diagnosis initiatives. With growing thyroid cases and investment on healthcare infrastructure in Europe, the region continues to strengthen its position in autoimmune disease diagnostics.
Latin America Autoimmune Disease Diagnosis Market Analysis
Latin America is witnessing increased autoimmune disease diagnosis adoption driven by rising incidences of lupus, rheumatoid arthritis, and celiac disease. Awareness campaigns and support from medical societies are prompting early clinical consultations. Expanding diagnostic facilities and greater availability of trained professionals are improving accessibility. For instance, Novo Nordisk plans to invest USD 1.09 Billion to boost Ozempic, Wegovy production in Brazil. As autoimmune diseases like lupus, rheumatoid arthritis, and celiac disease gain attention, diagnostic procedures are becoming more widespread. Rising focus on public healthcare support is contributing to enhanced diagnosis practices.
Middle East and Africa Autoimmune Disease Diagnosis Market Analysis
Middle East and Africa are undergoing rapid improvements in healthcare systems, leading to broader autoimmune disease diagnosis adoption. Growing healthcare facilities are increasing the availability of diagnostics in both urban and semi-urban areas. For the 2025 fiscal year, the UAE allocated AED 5.7 Billion, equivalent to 8% of the federal budget, to healthcare and community prevention services, reflecting its sustained commitment to developing the health sector. With more hospitals and laboratories being equipped for autoimmune screenings, patients now have better access to early-stage diagnostics. Expansion of medical infrastructure continues to support effective diagnosis in the region.
The autoimmune disease diagnostics market is seeing steady activity across product development, research, and collaborations. Diagnostic tools are becoming more precise, with new technologies enabling earlier and less invasive detection. Research groups and labs are working closely with diagnostics firms to bring innovations into clinical use more quickly. AI and machine learning are starting to influence test development, especially in pattern recognition and predictive diagnostics. Governments are showing more interest through national health strategies and dedicated funding for autoimmune conditions. Product launches and R&D remain the most consistent forms of progress, while formal partnerships and agreements are also frequent. Compared to others, large-scale fundraising or private investment announcements are less common right now. Most movement is driven by research and collaboration.