Autoimmune Hepatitis Diagnosis And Treatment Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Type 1 and Type 2), By Diagnosis (Blood Tests, Liver Biopsy, and Imaging Tests), By Treatment Type (Medications, Surgery, Liver Transplant, and Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 12.56 Billion
CAGR (2026-2031)	4.45%
Fastest Growing Segment	Type 1
Largest Market	North America
Market Size (2031)	USD 16.31 Billion

Market Overview

The Global Autoimmune Hepatitis Diagnosis And Treatment Market will grow from USD 12.56 Billion in 2025 to USD 16.31 Billion by 2031 at a 4.45% CAGR. Autoimmune Hepatitis (AIH) is a chronic inflammatory liver disease characterized by the immune system targeting hepatic cells, necessitating precise serological diagnosis and sustained immunosuppressive therapy. The market is fundamentally driven by the rising global incidence of autoimmune disorders and improved clinical vigilance, which facilitates earlier detection and intervention strategies. These drivers are further supported by the increasing availability of reliable diagnostic biomarkers that distinguish AIH from other hepatic conditions. According to the British Liver Trust, in 2024, a comprehensive patient survey revealed that 16.7% of respondents diagnosed with a liver condition were suffering specifically from autoimmune hepatitis, highlighting the significant burden of this pathology within hepatology caseloads.

However, a major challenge impeding market expansion is the diagnostic complexity and frequent misclassification of the disease. AIH often presents with non-specific symptoms or overlaps with other liver pathologies, leading to delayed diagnosis and treatment initiation. This ambiguity, combined with the substantial side effects associated with standard corticosteroid regimens, often results in poor patient adherence and complicates the effective long-term management required to sustain market growth.

Key Market Drivers

The rising development of novel biologics and targeted immunotherapies is fundamentally reshaping the market by offering alternatives to standard corticosteroid treatments. This shift is supported by significant industry consolidation and financial backing intended to expand autoimmune portfolios. According to Incyte, in May 2024, the company finalized its acquisition of Escient Pharmaceuticals for $750 million to secure advanced small molecule antagonists for systemic immune disorders. This robust investment climate is accelerating specific clinical programs for liver autoimmunity. For instance, according to Kezar Life Sciences, in October 2024, the company strategically pivoted to focus on its PORTOLA Phase 2a clinical trial for autoimmune hepatitis, supported by a cash balance of approximately $148 million to drive the development of its selective immunoproteasome inhibitor.

Advancements in non-invasive diagnostic imaging and biomarker technologies are simultaneously overcoming the historic challenges of disease misclassification and delayed detection. The identification of precise metabolic signatures is proving essential for distinguishing this pathology from other liver conditions without sole reliance on invasive biopsies. According to a study published in the journal Hepatology, in September 2024, researchers validated a novel metabolic profile consisting of 15 metabolites that could differentiate autoimmune hepatitis from other hepatic diseases with 95% sensitivity. These diagnostic breakthroughs are critical for facilitating early intervention and ensuring patients receive appropriate, targeted therapies, thereby driving market growth through improved clinical management.

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Key Market Challenges

The diagnostic complexity and frequent misclassification of Autoimmune Hepatitis (AIH) constitute a significant restraint on the growth of the global market. Since the disease lacks a single pathognomonic marker, healthcare providers often struggle to differentiate AIH from other hepatic disorders such as viral hepatitis or metabolic liver conditions without extensive testing. This ambiguity leads to a prolonged diagnostic timeline, which directly delays the uptake of essential immunosuppressive therapies and reduces the volume of prescriptions generated 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 market impact of these diagnostic delays is profound, as missed early diagnoses allow the pathology to advance to irreversible stages where standard drug regimens are less effective. According to the American Association for the Study of Liver Diseases, in 2024, an estimated 28% to 33% of adults with Autoimmune Hepatitis already had cirrhosis at the time of their initial clinical presentation. This high rate of late-stage diagnosis indicates that a substantial portion of the patient population is bypassing the primary phase of chronic disease management, thereby hampering the consistent expansion of the therapeutic market.

Key Market Trends

The Integration of Artificial Intelligence in Diagnostic Algorithms is revolutionizing the assessment of liver autoimmunity by addressing histological heterogeneity. Deep learning models are being deployed to automate the recognition of microscopic features from biopsy slides, thereby standardizing interpretation and minimizing the inter-observer variability that often complicates diagnosis. This algorithmic precision is particularly valuable for differentiating the disease from overlapping cholestatic conditions. According to the European Association for the Study of the Liver (EASL), June 2024, a study presented at their annual congress showed 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. This technology enhances diagnostic accuracy, offering objective metrics that complement traditional serological methods to reduce misclassification rates.

Simultaneously, 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 unresponsive to standard corticosteroids, directly targeting the immune cells responsible for pathogenic autoantibody production. According to the International Association for the Study of the Liver, May 2024, a registry analysis published in their official journal indicated that 89% of patients treated with Rituximab achieved or maintained a complete biochemical response. This shift towards targeted B-cell depletion represents a critical evolution in therapeutic strategies, ensuring effective management for difficult-to-treat cohorts where conventional immunosuppressants fail to induce remission.

Segmental Insights

The Type 1 segment is currently positioning itself as the fastest-growing category within the global autoimmune hepatitis diagnosis and treatment market. This expansion is primarily driven by the significantly higher prevalence of this form, which accounts for the vast majority of clinical cases and affects a wide demographic ranging from children to older adults. The segment’s growth is further accelerated by established diagnostic protocols that effectively detect anti-nuclear and smooth muscle antibodies, facilitating higher patient identification rates. Consequently, the consistent demand for therapeutic interventions specifically tailored to manage this dominant variant is fueling its rapid market development.

Regional Insights

North America maintains a leading position in the global autoimmune hepatitis diagnosis and treatment market, driven by established healthcare infrastructure and a rising prevalence of autoimmune liver conditions. This dominance is supported by the presence of key pharmaceutical manufacturers and favorable reimbursement policies that improve patient access to therapies. Additionally, regulatory support from bodies like the U.S. Food and Drug Administration accelerates the approval process for new treatments. Growing awareness among healthcare providers regarding early diagnosis further strengthens the market standing of the United States and Canada within this sector.

Recent Developments

• In March 2025, Kezar Life Sciences reported positive topline results from its Phase 2a PORTOLA clinical trial evaluating zetomipzomib in patients with autoimmune hepatitis who had not responded sufficiently to standard of care. The data revealed that 50 percent of patients treated with zetomipzomib achieved a complete biochemical response, measured by the normalization of liver enzymes and immunoglobulin G levels, compared to 37.5 percent of patients in the placebo group. Additionally, the study showed that a higher proportion of patients in the treatment arm achieved a complete response while tapering corticosteroids.
• In July 2024, Parvus Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to its lead drug candidate, PVT201, for the treatment of primary biliary cholangitis. In the announcement, the company highlighted that PVT201, which utilizes their proprietary Navacim platform technology to trigger the endogenous generation of antigen-specific regulatory T cells, had also demonstrated disease modification and hepatoprotection in preclinical models of autoimmune hepatitis. This designation marked a key regulatory milestone for the company's platform in addressing autoimmune liver diseases.
• In May 2024, Novartis AG completed the acquisition of MorphoSys AG, a Germany-based biopharmaceutical company, strengthening its oncology and immunology pipeline. Through this transaction, Novartis gained full rights to ianalumab (VAY736), a monoclonal antibody targeting the B-cell activating factor receptor (BAFF-R) that MorphoSys had originally discovered and licensed to Novartis. Ianalumab is currently in clinical development for several autoimmune diseases, including autoimmune hepatitis, where it aims to deplete B cells and block BAFF-R signaling to reduce disease activity.
• In February 2024, Xencor, Inc. announced plans to conclude ongoing clinical studies of XmAb564, a monovalent interleukin-2 Fc fusion protein, and pause its further development in autoimmune diseases. The company disclosed this decision as part of a strategic reprioritization to focus resources on its solid tumor programs and other high-potential candidates. XmAb564 had been in evaluation for its potential to selectively activate and expand regulatory T cells in patients with autoimmune conditions, including those with autoimmune liver diseases.

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

By Type	By Diagnosis	By Treatment Type	By Region
Type 1 and Type 2	Blood Tests Liver Biopsy and Imaging Tests	Medications Surgery Liver Transplant and Others	North America Europe Asia Pacific South America Middle East & Africa

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 and Type 2

• Autoimmune Hepatitis Diagnosis And Treatment Market, By Diagnosis:

• Blood Tests
• Liver Biopsy
• and Imaging Tests

• Autoimmune Hepatitis Diagnosis And Treatment Market, By Treatment Type:

• Medications
• Surgery
• Liver Transplant
• and 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