サンプル依頼リスト カート
  • English
デフォルト表紙
市場調査レポート
商品コード
1801159

自己免疫疾患診断の市場規模、シェア、動向、予測：製品タイプ、疾患タイプ、検査タイプ、エンドユーザー、地域別、2025年～2033年

Autoimmune Disease Diagnosis Market Size, Share, Trends and Forecast by Product Type, Disease Type, Test Type, End-User, and Region, 2025-2033

出版日
発行
IMARC
ページ情報
英文 149 Pages
納期
2～3営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=149.25円
自己免疫疾患診断の市場規模、シェア、動向、予測：製品タイプ、疾患タイプ、検査タイプ、エンドユーザー、地域別、2025年～2033年
出版日: 2025年08月01日
発行: IMARC
ページ情報: 英文 149 Pages
納期: 2～3営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

自己免疫疾患診断の世界市場規模は2024年に34億米ドルとなりました。今後、IMARC Groupは、同市場が2033年には55億米ドルに達し、2025～2033年のCAGRは5.57％になると予測しています。北米が市場を独占し、2024年には39.7%以上の大きな市場シェアを占める。患者の転帰改善への注目の高まり、診断技術の進歩、主要企業間の提携やパートナーシップ、正確な診断ソリューションの必要性などが、自己免疫疾患診断市場シェアに寄与している要因の一例です。

市場はいくつかの主要促進要因によって成長しています。関節リウマチ、ループス、多発性硬化症などの自己免疫疾患の世界の罹患率の上昇により、正確な診断の必要性が高まっています。患者やヘルスケア提供者の意識が向上し、早期の検査と治療が促されています。特にバイオマーカーの発見と画像診断における技術の進歩は、より迅速で正確な検出を可能にしています。高齢化社会は自己免疫疾患に罹患しやすく、これがさらに需要を促進しています。研究開発への投資も増加しており、より優れた診断ツールが開発されています。新興市場におけるヘルスケアインフラの拡充は、検査サービスへのアクセスを向上させています。加えて、ポイントオブケア検査の普及と検査室の自動化により、診断にかかる時間が短縮され、診断の効率化が進んでいます。こうした複合的な要因が市場を押し上げ、診断プラットフォーム全体の技術革新を促しています。

米国では、ループスや関節リウマチのような自己免疫疾患の早期発見を改善する取り組みが、新しいマルチバイオマーカーアッセイによって加速しています。これらのツールは、TC4d、TIgG、TIgMなどのマーカーを標的とすることで診断感度を上げることを目的としており、臨床免疫学においてより精密な血液ベースの検査法へのシフトを示唆しています。例えば、2025年1月、エクサジェン社は、ニューヨーク州保健局から、ループスと関節リウマチの検出を強化するための新しいバイオマーカー測定法について条件付き承認を受けた。AVISE CTDプラットフォームに追加されるこのアッセイは、TC4d、TIgG、TIgMのようなバイオマーカーを用いて診断感度を向上させるように設計されています。

自己免疫疾患診断市場動向：

診断技術の進歩

ループス、関節リウマチ、セリアック病のような特定の自己免疫疾患を診断するために、自己抗体のような新しいバイオマーカーが発見されています。例えば、疫学調査によると、世界の自己免疫疾患の発症率（新規発症率）は毎年19.1%上昇しており、シェーグレンやループスなどのリウマチ性疾患は毎年7.1%上昇しています。バイオマーカーは、自己免疫疾患のより正確な分類と早期発見を可能にします。プロテオミクスとメタボロミクスの開発により、より個別化された診断が可能になり、自己免疫疾患と関連する明確なタンパク質シグネチャーや代謝プロファイルが発見されつつあります。さらに、マイクロアレイ技術により複数のバイオマーカーの同時検査が可能になり、複数の遺伝的要因やタンパク質要因が関与する複雑な自己免疫疾患の診断が容易になりました。さらに、企業は最先端の製品や新技術を発表しており、これが自己免疫疾患診断市場の見通しにプラスの影響を与えています。例えば、2024年3月25日、アッヴィインクとランドスバイオファーマインクは、アッヴィが自己免疫疾患患者のための新規経口治療薬の開発に注力する臨床段階のバイオ医薬品企業であるランドスを買収する正式契約を発表しました。ランドス社の主な治験資産はNX-13で、ファーストインクラスの経口NLRX1作動薬であり、二峰性の作用機序（MOA）を有します。

患者の転帰改善への注目の高まり

米国食品医薬品局（FDA）は2023年10月16日、Werfen社のAptiva結合組織病（CTD）必須試薬について510（k）の認可を与えました。新しい試薬は、診断が困難な自己免疫疾患の診断を迅速化し、患者の予後を改善するのに役立ちます。自己免疫疾患診断の市場予測によると、患者ケアの向上のために早期かつ正確な検出を強化する取り組みの高まりが需要を押し上げる可能性が高いです。これとは別に、自己免疫疾患の早期診断により、医療専門家は、多発性硬化症、ループス、関節リウマチなどの疾患の発症を予防または遅延させながら、迅速に治療を開始することができます。

主要企業間の協力とパートナーシップ

2023年1月10日、サイファーメディシンはフィラデルフィアを拠点とするデータ、分析、ソフトウェア企業のCrossBridgeを買収し、データと分析能力を強化しました。これにより、患者の治療経路をよりきめ細かくリアルタイムで理解できるようになります。SaaS（Software as a Service）型のバリューベースケアプラットフォームは、患者の転帰を改善しながら医療費の削減を支援します。様々なコラボレーションを通じて、企業は免疫学、分子生物学、バイオインフォマティクスにおける専門知識を結集し、自己免疫疾患診断市場の成長を支えています。多くの製薬企業が診断薬企業と提携し、コンパニオン診断テストを提供しています。コンパニオン診断テストは、どの患者が特定の治療から最も恩恵を受けるかを判断することを目的としています。例えば、2025年4月中に実施された15の主要診断検査の総数は239万9,600件でした。これは2024年4月から7万600件（3.0％）の増加であり、労働日数で調整すると8.2％の増加です。これらの診断薬は、自己免疫疾患に対する最適な生物学的製剤治療と患者のマッチングを支援し、治療選択の試行錯誤を減らしつつ結果を向上させる。このようなパートナーシップには、治療や診断ツールの共同開発も含まれます。例えば、製薬会社は診断会社と協力して、治療効果をモニターする検査を開発し、医師がリアルタイムで治療法を調整し、患者の転帰を改善するのを助けるかもしれないです。

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査の目的
  • ステークホルダー
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

第5章 世界の自己免疫疾患診断市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場予測

第6章 市場内訳：製品タイプ別

  • 消耗品およびアッセイキット
  • 機器

第7章 市場内訳：疾患タイプ別

  • 全身性自己免疫疾患
    • 市場内訳：タイプ別
      • 関節リウマチ
      • 乾癬
      • 全身性エリテマトーデス（SLE）
      • 多発性硬化症
      • その他
  • 局所性自己免疫疾患
    • 市場内訳：タイプ別
      • 炎症性腸疾患
      • 1型糖尿病
      • 甲状腺
      • その他

第8章 市場内訳：検査タイプ別

  • 定期的な臨床検査
  • 炎症マーカー
  • 自己抗体と免疫学的検査
  • その他

第9章 市場内訳：エンドユーザー別

  • 臨床検査室
  • 病院
  • その他

第10章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • アジア太平洋地域
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • インドネシア
    • その他
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • ロシア
    • その他
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • その他
  • 中東・アフリカ

第11章 SWOT分析

第12章 バリューチェーン分析

第13章 ポーターのファイブフォース分析

第14章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • Abbott Laboratories
    • AESKU.GROUP
    • Danaher Corp.
    • bioMerieux SA
    • Bio-Rad Laboratories Inc.
    • PerkinElmer Inc.
    • Hemagen Diagnostics, Inc.
    • Inova Diagnostics, Inc.
    • Myriad Genetics, Inc.
    • Quest Diagnostics Incorporated
    • Siemens Healthineers AG
    • SQI Diagnostics
    • Thermo Fisher Scientific Inc.
    • Trinity Biotech plc
図表

List of Figures

  • Figure 1: Global: Autoimmune Disease Diagnosis Market: Major Drivers and Challenges
  • Figure 2: Global: Autoimmune Disease Diagnosis Market: Sales Value (in Billion USD), 2019-2024
  • Figure 3: Global: Autoimmune Disease Diagnosis Market: Breakup by Product Type (in %), 2024
  • Figure 4: Global: Autoimmune Disease Diagnosis Market: Breakup by Disease Type (in %), 2024
  • Figure 5: Global: Autoimmune Disease Diagnosis Market: Breakup by Test Type (in %), 2024
  • Figure 6: Global: Autoimmune Disease Diagnosis Market: Breakup by End-User (in %), 2024
  • Figure 7: Global: Autoimmune Disease Diagnosis Market: Breakup by Region (in %), 2024
  • Figure 8: Global: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Billion USD), 2025-2033
  • Figure 9: Global: Autoimmune Disease Diagnosis (Consumables and Assay Kits) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 10: Global: Autoimmune Disease Diagnosis (Consumables and Assay Kits) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 11: Global: Autoimmune Disease Diagnosis (Instruments) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 12: Global: Autoimmune Disease Diagnosis (Instruments) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 13: Global: Autoimmune Disease Diagnosis (Systemic Autoimmune Disease) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 14: Global: Autoimmune Disease Diagnosis (Systemic Autoimmune Disease) Market: Breakup by Disease Type (in %), 2024
  • Figure 15: Global: Autoimmune Disease Diagnosis (Systemic Autoimmune Disease) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 16: Global: Autoimmune Disease Diagnosis (Localized Autoimmune Disease) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 17: Global: Autoimmune Disease Diagnosis (Localized Autoimmune Disease) Market: Breakup by Disease Type (in %), 2024
  • Figure 18: Global: Autoimmune Disease Diagnosis (Localized Autoimmune Disease) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 19: Global: Autoimmune Disease Diagnosis (Routine Laboratory Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 20: Global: Autoimmune Disease Diagnosis (Routine Laboratory Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 21: Global: Autoimmune Disease Diagnosis (Inflammatory Markers) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 22: Global: Autoimmune Disease Diagnosis (Inflammatory Markers) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 23: Global: Autoimmune Disease Diagnosis (Autoantibodies and Immunologic Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 24: Global: Autoimmune Disease Diagnosis (Autoantibodies and Immunologic Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 25: Global: Autoimmune Disease Diagnosis (Other Test Types) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 26: Global: Autoimmune Disease Diagnosis (Other Test Types) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 27: Global: Autoimmune Disease Diagnosis (Clinical Laboratories) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 28: Global: Autoimmune Disease Diagnosis (Clinical Laboratories) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 29: Global: Autoimmune Disease Diagnosis (Hospitals) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 30: Global: Autoimmune Disease Diagnosis (Hospitals) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 31: Global: Autoimmune Disease Diagnosis (Other End-Users) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 32: Global: Autoimmune Disease Diagnosis (Other End-Users) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 33: North America: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 34: North America: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 35: United States: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 36: United States: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 37: Canada: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 38: Canada: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 39: Asia Pacific: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 40: Asia Pacific: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 41: China: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 42: China: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 43: Japan: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 44: Japan: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 45: India: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 46: India: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 47: South Korea: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 48: South Korea: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 49: Australia: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 50: Australia: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 51: Indonesia: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 52: Indonesia: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 53: Others: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 54: Others: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 55: Europe: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 56: Europe: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 57: Germany: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 58: Germany: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 59: France: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 60: France: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 61: United Kingdom: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 62: United Kingdom: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 63: Italy: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 64: Italy: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 65: Spain: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 66: Spain: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 67: Russia: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 68: Russia: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 69: Others: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 70: Others: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 71: Latin America: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 72: Latin America: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 73: Brazil: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 74: Brazil: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 75: Mexico: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 76: Mexico: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 77: Others: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 78: Others: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 79: Middle East and Africa: Autoimmune Disease Diagnosis Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 80: Middle East and Africa: Autoimmune Disease Diagnosis Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 81: Global: Autoimmune Disease Diagnosis Industry: SWOT Analysis
  • Figure 82: Global: Autoimmune Disease Diagnosis Industry: Value Chain Analysis
  • Figure 83: Global: Autoimmune Disease Diagnosis Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Autoimmune Disease Diagnosis Market: Key Industry Highlights, 2024 and 2033
  • Table 2: Global: Autoimmune Disease Diagnosis Market Forecast: Breakup by Product Type (in Million USD), 2025-2033
  • Table 3: Global: Autoimmune Disease Diagnosis Market Forecast: Breakup by Disease Type (in Million USD), 2025-2033
  • Table 4: Global: Autoimmune Disease Diagnosis Market Forecast: Breakup by Test Type (in Million USD), 2025-2033
  • Table 5: Global: Autoimmune Disease Diagnosis Market Forecast: Breakup by End-User (in Million USD), 2025-2033
  • Table 6: Global: Autoimmune Disease Diagnosis Market Forecast: Breakup by Region (in Million USD), 2025-2033
  • Table 7: Global: Autoimmune Disease Diagnosis Market Structure
  • Table 8: Global: Autoimmune Disease Diagnosis Market: Key Players
目次
Product Code: SR112025A2250

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.

Autoimmune Disease Diagnosis Market Trends:

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.

Autoimmune Disease Diagnosis Industry Segmentation:

Analysis by Product Type:

  • Consumables and Assay Kits
  • Instruments

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.

Analysis by Disease Type:

  • Systemic Autoimmune Disease
    • Rheumatoid Arthritis
    • Psoriasis
    • Systemic Lupus Erythematosus (SLE)
    • Multiple Sclerosis
    • Others
  • Localized Autoimmune Disease
    • Inflammatory Bowel Disease
    • Type 1 Diabetes
    • Thyroid
    • Others

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.

Analysis by Test Type:

  • Routine Laboratory Tests
  • Inflammatory Markers
  • Autoantibodies and Immunologic Tests
  • Others

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.

Analysis by End-User:

  • Clinical Laboratories
  • Hospitals
  • Others

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.

Regional Analysis:

  • North America
    • United States
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

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.

Key Regional Takeaways:

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.

Competitive Landscape:

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.

The report provides a comprehensive analysis of the competitive landscape in the autoimmune disease diagnosis market with detailed profiles of all major companies, including:

  • Abbott Laboratories
  • AESKU.GROUP
  • Danaher Corp.
  • bioMerieux SA
  • Bio-Rad Laboratories, Inc.
  • PerkinElmer Inc.
  • Hemagen Diagnostics, Inc.
  • Inova Diagnostics, Inc.
  • Myriad Genetics, Inc.
  • Quest Diagnostics Incorporated
  • Siemens Healthineers AG
  • SQI Diagnostics
  • Thermo Fisher Scientific Inc.
  • Trinity Biotech plc

Key Questions Answered in This Report

  • 1.How big is the autoimmune disease diagnosis market?
  • 2.What is the future outlook of autoimmune disease diagnosis market?
  • 3.What are the key factors driving the autoimmune disease diagnosis market?
  • 4.Which region accounts for the largest autoimmune disease diagnosis market share?
  • 5.Which are the leading companies in the global autoimmune disease diagnosis market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Autoimmune Disease Diagnosis Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Product Type

  • 6.1 Consumables and Assay Kits
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Instruments
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast

7 Market Breakup by Disease Type

  • 7.1 Systemic Autoimmune Disease
    • 7.1.1 Market Trends
    • 7.1.2 Market Breakup by Type
      • 7.1.2.1 Rheumatoid Arthritis
      • 7.1.2.2 Psoriasis
      • 7.1.2.3 Systemic Lupus Erythematosus (SLE)
      • 7.1.2.4 Multiple Sclerosis
      • 7.1.2.5 Others
    • 7.1.3 Market Forecast
  • 7.2 Localized Autoimmune Disease
    • 7.2.1 Market Trends
    • 7.2.2 Market Breakup by Type
      • 7.2.2.1 Inflammatory Bowel Disease
      • 7.2.2.2 Type 1 Diabetes
      • 7.2.2.3 Thyroid
      • 7.2.2.4 Others
    • 7.2.3 Market Forecast

8 Market Breakup by Test Type

  • 8.1 Routine Laboratory Tests
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Inflammatory Markers
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Autoantibodies and Immunologic Tests
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Others
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast

9 Market Breakup by End-User

  • 9.1 Clinical Laboratories
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Hospitals
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Others
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast

10 Market Breakup by Region

  • 10.1 North America
    • 10.1.1 United States
      • 10.1.1.1 Market Trends
      • 10.1.1.2 Market Forecast
    • 10.1.2 Canada
      • 10.1.2.1 Market Trends
      • 10.1.2.2 Market Forecast
  • 10.2 Asia Pacific
    • 10.2.1 China
      • 10.2.1.1 Market Trends
      • 10.2.1.2 Market Forecast
    • 10.2.2 Japan
      • 10.2.2.1 Market Trends
      • 10.2.2.2 Market Forecast
    • 10.2.3 India
      • 10.2.3.1 Market Trends
      • 10.2.3.2 Market Forecast
    • 10.2.4 South Korea
      • 10.2.4.1 Market Trends
      • 10.2.4.2 Market Forecast
    • 10.2.5 Australia
      • 10.2.5.1 Market Trends
      • 10.2.5.2 Market Forecast
    • 10.2.6 Indonesia
      • 10.2.6.1 Market Trends
      • 10.2.6.2 Market Forecast
    • 10.2.7 Others
      • 10.2.7.1 Market Trends
      • 10.2.7.2 Market Forecast
  • 10.3 Europe
    • 10.3.1 Germany
      • 10.3.1.1 Market Trends
      • 10.3.1.2 Market Forecast
    • 10.3.2 France
      • 10.3.2.1 Market Trends
      • 10.3.2.2 Market Forecast
    • 10.3.3 United Kingdom
      • 10.3.3.1 Market Trends
      • 10.3.3.2 Market Forecast
    • 10.3.4 Italy
      • 10.3.4.1 Market Trends
      • 10.3.4.2 Market Forecast
    • 10.3.5 Spain
      • 10.3.5.1 Market Trends
      • 10.3.5.2 Market Forecast
    • 10.3.6 Russia
      • 10.3.6.1 Market Trends
      • 10.3.6.2 Market Forecast
    • 10.3.7 Others
      • 10.3.7.1 Market Trends
      • 10.3.7.2 Market Forecast
  • 10.4 Latin America
    • 10.4.1 Brazil
      • 10.4.1.1 Market Trends
      • 10.4.1.2 Market Forecast
    • 10.4.2 Mexico
      • 10.4.2.1 Market Trends
      • 10.4.2.2 Market Forecast
    • 10.4.3 Others
      • 10.4.3.1 Market Trends
      • 10.4.3.2 Market Forecast
  • 10.5 Middle East and Africa
    • 10.5.1 Market Trends
    • 10.5.2 Market Breakup by Country
    • 10.5.3 Market Forecast

11 SWOT Analysis

  • 11.1 Overview
  • 11.2 Strengths
  • 11.3 Weaknesses
  • 11.4 Opportunities
  • 11.5 Threats

12 Value Chain Analysis

13 Porters Five Forces Analysis

  • 13.1 Overview
  • 13.2 Bargaining Power of Buyers
  • 13.3 Bargaining Power of Suppliers
  • 13.4 Degree of Competition
  • 13.5 Threat of New Entrants
  • 13.6 Threat of Substitutes

14 Competitive Landscape

  • 14.1 Market Structure
  • 14.2 Key Players
  • 14.3 Profiles of Key Players
    • 14.3.1 Abbott Laboratories
      • 14.3.1.1 Company Overview
      • 14.3.1.2 Product Portfolio
      • 14.3.1.3 Financials
      • 14.3.1.4 SWOT Analysis
    • 14.3.2 AESKU.GROUP
      • 14.3.2.1 Company Overview
      • 14.3.2.2 Product Portfolio
    • 14.3.3 Danaher Corp.
      • 14.3.3.1 Company Overview
      • 14.3.3.2 Product Portfolio
      • 14.3.3.3 SWOT Analysis
    • 14.3.4 bioMerieux SA
      • 14.3.4.1 Company Overview
      • 14.3.4.2 Product Portfolio
      • 14.3.4.3 Financials
      • 14.3.4.4 SWOT Analysis
    • 14.3.5 Bio-Rad Laboratories Inc.
      • 14.3.5.1 Company Overview
      • 14.3.5.2 Product Portfolio
      • 14.3.5.3 Financials
      • 14.3.5.4 SWOT Analysis
    • 14.3.6 PerkinElmer Inc.
      • 14.3.6.1 Company Overview
      • 14.3.6.2 Product Portfolio
      • 14.3.6.3 Financials
    • 14.3.7 Hemagen Diagnostics, Inc.
      • 14.3.7.1 Company Overview
      • 14.3.7.2 Product Portfolio
    • 14.3.8 Inova Diagnostics, Inc.
      • 14.3.8.1 Company Overview
      • 14.3.8.2 Product Portfolio
    • 14.3.9 Myriad Genetics, Inc.
      • 14.3.9.1 Company Overview
      • 14.3.9.2 Product Portfolio
      • 14.3.9.3 Financials
      • 14.3.9.4 SWOT Analysis
    • 14.3.10 Quest Diagnostics Incorporated
      • 14.3.10.1 Company Overview
      • 14.3.10.2 Product Portfolio
      • 14.3.10.3 Financials
      • 14.3.10.4 SWOT Analysis
    • 14.3.11 Siemens Healthineers AG
      • 14.3.11.1 Company Overview
      • 14.3.11.2 Product Portfolio
      • 14.3.11.3 Financials
    • 14.3.12 SQI Diagnostics
      • 14.3.12.1 Company Overview
      • 14.3.12.2 Product Portfolio
      • 14.3.12.3 Financials
    • 14.3.13 Thermo Fisher Scientific Inc.
      • 14.3.13.1 Company Overview
      • 14.3.13.2 Product Portfolio
      • 14.3.13.3 Financials
      • 14.3.13.4 SWOT Analysis
    • 14.3.14 Trinity Biotech plc
      • 14.3.14.1 Company Overview
      • 14.3.14.2 Product Portfolio
      • 14.3.14.3 Financials
      • 14.3.14.4 SWOT Analysis