The global autoimmune hepatitis market size is estimated to be valued at USD 134.7 Million in 2025. It can reach a valuation of USD 199.9 Million by 2032, by exhibiting a CAGR of 5.8% throughout the forecast period (2025-2032).
The alarming surge in autoimmune hepatitis (AIH) cases and improvements in early diagnostic capabilities can drive the market growth significantly. The advancements in biologics and the fast-track of approvals of drugs with minimum side effects can further facilitate the market growth.
However, the high treatment costs of combination therapies can create hurdles for the market growth.
Key Market Insights
The autoimmune hepatitis market is shaped by investments in biologics and monoclonal antibodies. The development of biomarkers and the introduction of precision medicine can open new growth opportunities.
- By therapeutics, the corticosteroids segment is expected to capture a 43% share of the market in 2025. This can be attributed to anti-inflammatory medications being the first line of treatment for stalling disease progression.
- By drug pipeline, the late-stage drugs segment is expected to capture a 41.9% share of the market in 2025. The investment in investigational therapies for AIH beyond Phase II can drive the segment’s growth over the forecast period. This can be exemplified by Intercept Pharmaceuticals’ FXR agonist being evaluated for immune modulation.
- By disease progression, the chronic autoimmune hepatitis segment is anticipated to retain 39.9% market share in 2025. The advances in non-invasive fibrosis assessment and biomarker monitoring can drive the segment’s demand.
- By region, the North America region is touted to lead the autoimmune hepatitis market in 2025. This can be attributed to high disease awareness and the U.S. leading in research and clinical trials.
The full report is now available for purchase: https://www.coherentmi.com/industry-reports/autoimmune-hepatitis-market
Autoimmune Hepatitis Market Report Coverage
Report Coverage |
Details |
Market Revenue in 2025 |
USD 134.7 Million |
Estimated Value by 2032 |
USD 199.9 Million |
Growth Rate |
5.8% |
Historical Data |
2020–2024 |
Forecast Period |
2025–2032 |
Forecast Units |
Value (USD Million) |
Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
Segments Covered |
|
Geographies Covered |
North America (U.S. and Canada), Latin America (Brazil, Argentina, Mexico, and Rest of Latin America), Europe (Italy, Spain, U.K., Germany, France, Russia, and Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific), Middle East (GCC Countries, Israel, and Rest of Middle East), and Africa (South Africa, North Africa, and Central Africa) |
Growth Drivers |
|
Opportunities |
|
Trends |
|
Restraints & Challenges |
|
Market Dynamics
The application of biomarkers in AIH can improve the diagnosis and treatment plan for patients. The identification of novel biomarkers that differentiate AIH from other chronic liver diseases can drive the market growth significantly. The increased healthcare funding by governments across regions of Latin America, Asia Pacific, and the Middle East & Africa and collaborations with regional healthcare ecosystems can bode well for the market.
The introduction of AI-based imaging systems for the assessment of liver fibrosis and inflammation can open new market opportunities. On January 24, 2025, Siemens Healthineers launched a range of AI-powered diagnostic solutions that support clinicians with faster diagnosis.
Market Opportunity: Monoclonal Antibodies as Adjunct Therapy
The potential of monoclonal antibodies like Belimumab in improving liver function tests in AIH can drive its demand in the market. Although the drug was approved by systemic lupus erythematosus (SLE), its promise for AIH patients with overlapping autoimmune conditions can bode well for the market. The drug manufactured by GlaxoSmithKline (GSK) has been successful in reducing systemic inflammation and improvement in Circulating B cell activating factor (BAFF) levels.
Market Challenge: Complexity in Diagnosis
The complexity in the accurate diagnosis of AIH can pose a challenge to market growth. The paucity of precise diagnostic tests for the assessment of AIH can create hurdles for the market. While an early diagnosis requires immunosuppression, an early diagnosis requires the detection of histologic abnormalities and laboratory findings with specific antibodies. However, seronegative AIH being accountable for only 5-20% of AIH cases overall presents a challenge.
Analyst’s View
- The high number of cases of AIH among middle-aged women is expected to drive the autoimmune hepatitis market growth.
- The late-stage drugs segment has potential for growth owing to a lack of successful drugs.
- Key players are likely to focus on early biomarker integration and clinical trials to release early versions of their drugs.
Recent Developments
Kezar Life Sciences’ drug zetomipzomib has shown disease remission in adults with treatment-resistant autoimmune hepatitis according to their clinical trial results on March 25, 2025.
Competitor Insights
- Gilead Sciences
- Pfizer
- Novartis
- Merck & Co.
- Bristol-Myers Squibb
- TaiwanJ Pharmaceuticals
Market Segmentation
- By Therapeutics
- Immunosuppressive Drugs
- Corticosteroids
- Biologics
- By Drug Pipeline
- Early-stage Drugs
- Late-stage Drugs
- By Drug Progression
- Acute Autoimmune Hepatitis
- Chronic Autoimmune Hepatitis
Regional Insights
- North America
- U.S.
- Canada
- Latin America
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Italy
- Germany
- U.K.
- Spain
- Russia
- France
- Rest of Europe
- Asia Pacific
- South Korea
- India
- China
- Japan
- Australia
- ASEAN
- Rest of Asia Pacific
- Middle East
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- South Africa
- North Africa
- Central Africa