자가면역성 간염 진단 및 치료 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측 : 유형별, 진단별, 치료 유형별, 지역별＆경쟁(2021-2031년)

The Global Autoimmune Hepatitis Diagnosis And Treatment Market is projected to expand from USD 12.56 Billion in 2025 to USD 16.31 Billion by 2031, reflecting a compound annual growth rate of 4.45%. Autoimmune Hepatitis (AIH), a chronic inflammatory condition where the immune system targets liver cells, necessitates accurate serological identification and long-term immunosuppressive therapy. The market's growth is primarily driven by the increasing global prevalence of autoimmune disorders and heightened clinical awareness, which supports earlier detection and intervention. Furthermore, the availability of reliable diagnostic biomarkers helps differentiate AIH from other liver conditions. Underscoring the disease's burden, a 2024 patient survey by the British Liver Trust indicated that 16.7% of respondents with a liver condition were diagnosed specifically with autoimmune hepatitis.

However, market expansion is hindered by the complexity of diagnosis and the frequent misclassification of the disease. AIH often manifests with vague symptoms or mimics other liver pathologies, resulting in delays in diagnosis and the start of treatment. This ambiguity, coupled with the significant side effects linked to standard corticosteroid therapies, often leads to poor patient compliance. These factors complicate the effective long-term management strategies required to sustain continuous market growth.

Market Driver

The emergence of novel biologics and targeted immunotherapies is fundamentally transforming the market by providing alternatives to traditional corticosteroid treatments. This transition is bolstered by substantial industry consolidation and financial investments aimed at broadening autoimmune product lines. For instance, in May 2024, Incyte completed its $750 million acquisition of Escient Pharmaceuticals to obtain advanced small molecule antagonists for systemic immune disorders. This strong investment environment is accelerating specific clinical programs for liver autoimmunity; notably, Kezar Life Sciences shifted its focus in October 2024 to the PORTOLA Phase 2a clinical trial for autoimmune hepatitis, utilizing a cash balance of approximately $148 million to advance its selective immunoproteasome inhibitor.

Simultaneously, advancements in non-invasive diagnostic imaging and biomarker technologies are addressing historical issues related to disease misclassification and delayed detection. Identifying precise metabolic signatures is becoming essential for distinguishing this pathology from other liver conditions without relying solely on invasive biopsies. A study published in the journal Hepatology in September 2024 validated a new metabolic profile comprising 15 metabolites capable of differentiating autoimmune hepatitis from other hepatic diseases with 95% sensitivity. These diagnostic breakthroughs are crucial for facilitating early intervention and ensuring patients receive appropriate, targeted therapies, thereby driving market growth through enhanced clinical management.

Market Challenge

The intricate nature of diagnosing Autoimmune Hepatitis (AIH) and the high rate of misclassification act as significant restraints on global market growth. Because the disease does not present a single definitive marker, healthcare providers frequently struggle to distinguish AIH from other hepatic disorders, such as viral hepatitis or metabolic liver conditions, without conducting extensive testing. This uncertainty results in prolonged diagnostic timelines, which delays the administration of essential immunosuppressive therapies and lowers prescription volumes during the early, treatable stages of the disease. Consequently, the window for effective pharmacological intervention often narrows, limiting the revenue potential for drug manufacturers.

The consequences of these diagnostic delays are substantial, as missed early diagnoses allow the pathology to progress to irreversible stages where standard drug regimens are less effective. Data from the American Association for the Study of Liver Diseases in 2024 estimates that 28% to 33% of adults with Autoimmune Hepatitis already present with cirrhosis at the time of their initial clinical assessment. This high incidence of late-stage diagnosis suggests that a significant portion of the patient population is missing the primary phase of chronic disease management, thereby impeding the consistent expansion of the therapeutic market.

Market Trends

The incorporation of Artificial Intelligence into diagnostic algorithms is revolutionizing the assessment of liver autoimmunity by addressing histological variability. Deep learning models are being utilized to automate the recognition of microscopic features on biopsy slides, thereby standardizing interpretation and reducing the inter-observer variability that complicates diagnosis. This algorithmic precision is especially valuable for distinguishing the disease from overlapping cholestatic conditions. For example, a study presented at the European Association for the Study of the Liver (EASL) annual congress in June 2024 demonstrated that a new AI-based neural estimator distinguished autoimmune hepatitis from primary biliary cholangitis with an area under the receiver operating characteristic curve (AUROC) of 0.81, enhancing diagnostic accuracy and reducing misclassification.

Concurrent with diagnostic advancements, the increasing utilization of B-cell depleting agents is reshaping the management of refractory disease. Clinicians are rapidly adopting anti-CD20 monoclonal antibodies for patients who do not respond to standard corticosteroids, directly targeting the immune cells responsible for producing pathogenic autoantibodies. A registry analysis published in the official journal of the International Association for the Study of the Liver in May 2024 indicated that 89% of patients treated with Rituximab achieved or maintained a complete biochemical response. This shift toward targeted B-cell depletion marks a critical evolution in therapeutic strategies, ensuring effective management for difficult-to-treat patient cohorts where conventional immunosuppressants fail.

Key Market Players

• AbbVie, Inc.
• ADC Therapeutics SA
• AstraZeneca PLC
• Genentech, Inc.
• Genmab A/S
• Gilead Sciences, Inc.
• GlaxoSmithKline PLC
• Pfizer, Inc.
• Hiedelberg Pharma A/G
• Takeda Pharmaceutical Company Limited

Report Scope

In this report, the Global Autoimmune Hepatitis Diagnosis And Treatment Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Autoimmune Hepatitis Diagnosis And Treatment Market, By Type

• Type 1
• Type 2

Autoimmune Hepatitis Diagnosis And Treatment Market, By Diagnosis

• Blood Tests
• Liver Biopsy
• Imaging Tests

Autoimmune Hepatitis Diagnosis And Treatment Market, By Treatment Type

• Medications
• Surgery
• Liver Transplant
• Others

Autoimmune Hepatitis Diagnosis And Treatment Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Autoimmune Hepatitis Diagnosis And Treatment Market.

Available Customizations:

Global Autoimmune Hepatitis Diagnosis And Treatment Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Autoimmune Hepatitis Diagnosis And Treatment Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Type (Type 1, Type 2)
  • 5.2.2. By Diagnosis (Blood Tests, Liver Biopsy, Imaging Tests)
  • 5.2.3. By Treatment Type (Medications, Surgery, Liver Transplant, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2025)
• 5.3. Market Map

6. North America Autoimmune Hepatitis Diagnosis And Treatment Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Type
  • 6.2.2. By Diagnosis
  • 6.2.3. By Treatment Type
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Type
      • 6.3.1.2.2. By Diagnosis
      • 6.3.1.2.3. By Treatment Type
  • 6.3.2. Canada Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Type
      • 6.3.2.2.2. By Diagnosis
      • 6.3.2.2.3. By Treatment Type
  • 6.3.3. Mexico Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Type
      • 6.3.3.2.2. By Diagnosis
      • 6.3.3.2.3. By Treatment Type

7. Europe Autoimmune Hepatitis Diagnosis And Treatment Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Type
  • 7.2.2. By Diagnosis
  • 7.2.3. By Treatment Type
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Type
      • 7.3.1.2.2. By Diagnosis
      • 7.3.1.2.3. By Treatment Type
  • 7.3.2. France Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Type
      • 7.3.2.2.2. By Diagnosis
      • 7.3.2.2.3. By Treatment Type
  • 7.3.3. United Kingdom Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Type
      • 7.3.3.2.2. By Diagnosis
      • 7.3.3.2.3. By Treatment Type
  • 7.3.4. Italy Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Type
      • 7.3.4.2.2. By Diagnosis
      • 7.3.4.2.3. By Treatment Type
  • 7.3.5. Spain Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Type
      • 7.3.5.2.2. By Diagnosis
      • 7.3.5.2.3. By Treatment Type

8. Asia Pacific Autoimmune Hepatitis Diagnosis And Treatment Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Type
  • 8.2.2. By Diagnosis
  • 8.2.3. By Treatment Type
  • 8.2.4. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Type
      • 8.3.1.2.2. By Diagnosis
      • 8.3.1.2.3. By Treatment Type
  • 8.3.2. India Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Type
      • 8.3.2.2.2. By Diagnosis
      • 8.3.2.2.3. By Treatment Type
  • 8.3.3. Japan Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Type
      • 8.3.3.2.2. By Diagnosis
      • 8.3.3.2.3. By Treatment Type
  • 8.3.4. South Korea Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Type
      • 8.3.4.2.2. By Diagnosis
      • 8.3.4.2.3. By Treatment Type
  • 8.3.5. Australia Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Type
      • 8.3.5.2.2. By Diagnosis
      • 8.3.5.2.3. By Treatment Type

9. Middle East & Africa Autoimmune Hepatitis Diagnosis And Treatment Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Type
  • 9.2.2. By Diagnosis
  • 9.2.3. By Treatment Type
  • 9.2.4. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Type
      • 9.3.1.2.2. By Diagnosis
      • 9.3.1.2.3. By Treatment Type
  • 9.3.2. UAE Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Type
      • 9.3.2.2.2. By Diagnosis
      • 9.3.2.2.3. By Treatment Type
  • 9.3.3. South Africa Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Type
      • 9.3.3.2.2. By Diagnosis
      • 9.3.3.2.3. By Treatment Type

10. South America Autoimmune Hepatitis Diagnosis And Treatment Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Type
  • 10.2.2. By Diagnosis
  • 10.2.3. By Treatment Type
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Type
      • 10.3.1.2.2. By Diagnosis
      • 10.3.1.2.3. By Treatment Type
  • 10.3.2. Colombia Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Type
      • 10.3.2.2.2. By Diagnosis
      • 10.3.2.2.3. By Treatment Type
  • 10.3.3. Argentina Autoimmune Hepatitis Diagnosis And Treatment Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Type
      • 10.3.3.2.2. By Diagnosis
      • 10.3.3.2.3. By Treatment Type

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Autoimmune Hepatitis Diagnosis And Treatment Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. AbbVie, Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. ADC Therapeutics SA
• 15.3. AstraZeneca PLC
• 15.4. Genentech, Inc.
• 15.5. Genmab A/S
• 15.6. Gilead Sciences, Inc.
• 15.7. GlaxoSmithKline PLC
• 15.8. Pfizer, Inc.
• 15.9. Hiedelberg Pharma A/G
• 15.10. Takeda Pharmaceutical Company Limited

16. Strategic Recommendations

17. About Us & Disclaimer