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市場調查報告書
商品編碼
1801159
自體免疫疾病診斷市場規模、佔有率、趨勢及預測(按產品類型、疾病類型、檢測類型、最終用戶和地區),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,全球自體免疫疾病診斷市場規模達34億美元。展望未來, IMARC Group預測,到2033年,市場規模將達到55億美元,2025-2033年期間的複合年成長率為5.57%。北美市場佔據主導地位,2024年市佔率超過39.7%。對改善患者預後的日益關注、診斷技術的進步、主要參與者之間的合作與夥伴關係以及對精準診斷解決方案的需求,是影響自體免疫疾病診斷市場佔有率的一些因素。
市場成長得益於幾個關鍵促進因素。類風濕性關節炎、紅斑性狼瘡和多發性硬化症等自體免疫疾病在全球的發生率不斷上升,這增加了對準確診斷的需求。患者和醫療保健提供者的認知度有所提高,促使人們更早進行檢測和治療。技術進步,尤其是在生物標記發現和成像方面的進步,使得檢測速度更快、更精確。老化人口更容易罹患自體免疫疾病,這進一步刺激了需求。研發投入的增加也帶來了更優診斷工具的出現。新興市場醫療基礎設施的擴展改善了檢測服務的可近性。此外,實驗室中即時檢測和自動化技術的日益普及有助於縮短週轉時間,並提高診斷效率。這些因素共同推動市場的發展,並鼓勵診斷平台的創新。
在美國,透過新的多生物標記檢測,改善狼瘡和類風濕性關節炎等自體免疫疾病的早期檢測的努力正在加速推進。這些工具旨在透過靶向TC4d、TIgG和TIgM等標記物來提高診斷靈敏度,這標誌著臨床免疫學正轉向更精準的血液檢測方法。例如,2025年1月,Exagen Inc.獲得紐約州衛生部的有條件批准,允許其開發新的生物標記檢測方法,以增強狼瘡和類風濕性關節炎的檢測。這些即將添加到AVISE CTD平台的檢測方法旨在利用TC4d、TIgG和TIgM等生物標記來提高診斷靈敏度。
診斷技術的進步
人們發現了諸如自體抗體之類的新型生物標記物,可用於診斷狼瘡、類風濕性關節炎和乳糜瀉等特定自體免疫疾病。例如,流行病學研究表明,全球自體免疫疾病的發生率(新發病例率)每年上升19.1%,其中乾燥症和狼瘡等風濕病的發生率每年上升7.1%。生物標記可以對自體免疫疾病進行更精確的分類和早期識別。由於蛋白質體學和代謝組學的發展,更個人化的診斷方法使得人們能夠發現與自體免疫疾病相關的獨特蛋白質特徵或代謝譜。此外,微陣列技術可以同時檢測多種生物標記物,這使得診斷涉及多種遺傳或蛋白質因素的複雜自體免疫疾病變得更加容易。此外,各公司正在推出尖端產品和新技術,這對自體免疫疾病診斷市場前景產生了積極影響。例如,2024年3月25日,艾伯維公司(AbbVie Inc.)與Landos Biopharma, Inc.宣布達成最終協議,艾伯維將收購Landos。 Landos是一家臨床階段生物製藥公司,專注於開發針對自體免疫疾病患者的新型口服療法。 Landos的主要在研藥物是NX-13,這是一款具有雙峰作用機制(MOA)的首創口服NLRX1激動劑。
日益關注改善患者治療效果
美國食品藥物管理局 (FDA) 於2023年10月16日批准了Werfen公司Aptiva結締組織疾病 (CTD) 必需試劑的510(k)上市許可。新試劑有助於加快診斷速度,並改善難以診斷的自體免疫疾病患者的預後。根據自體免疫疾病診斷市場預測,為改善患者護理而不斷加強早期和精準檢測的努力可能會刺激需求。此外,自體免疫疾病的早期診斷使醫護人員能夠迅速啟動治療,同時預防或延緩多發性硬化症、紅斑性狼瘡和類風濕性關節炎等疾病的發生。
關鍵參與者之間的合作與夥伴關係
2023 年 1 月 10 日,ScipherMedicine 收購了位於費城的資料、分析和軟體公司 CrossBridge,以增強其資料和分析能力。這使得能夠更細緻、更即時地了解患者的治療途徑。軟體即服務 (SaaS) 以價值為基礎的照護平台有助於降低醫療成本,同時改善病患的治療效果。透過各種合作,各公司結合其在免疫學、分子生物學和生物資訊學方面的專業知識,支持自體免疫疾病診斷市場的成長。許多製藥公司正在與診斷公司合作,提供伴隨診斷測試,旨在確定哪些患者將從特定治療中受益最多。例如,2025 年 4 月共進行了 15 項關鍵診斷測試中的 2,399,600 次。這比 2024 年 4 月增加了 70,600 次(3.0%),按工作日調整後增加了 8.2%。這些診斷技術有助於為患者配對最佳的自體免疫疾病生物療法,從而提高療效並減少治療選擇的反覆試驗。這些合作也涉及治療方法和診斷工具的共同發展。例如,製藥公司可以與診斷公司合作,開發監測療效的測試,幫助醫生即時調整治療方案,進而改善患者的治療效果。
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.