Autoimmune Hepatitis (AIH) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032

Autoimmune Hepatitis (AIH) Market Outlook

Thelansis’s “Autoimmune Hepatitis (AIH) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Autoimmune Hepatitis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Autoimmune Hepatitis (AIH) Overview

Autoimmune Hepatitis (AIH) is a rare liver disorder characterized by immune-mediated inflammation of the liver, which can manifest as acute or chronic inflammation. Clinically, it often appears as cryptogenic hepatitis and is identified by interface hepatitis upon histological examination. Patients typically exhibit elevated serum aminotransferase levels and increased levels of immunoglobulin G (IgG) or hypergammaglobulinemia, either with or without specific circulating autoantibodies. Patients with AIH may display various symptoms, from being asymptomatic to experiencing chronic illness or acute liver failure. It is not uncommon for individuals with AIH to have concurrent autoimmune diseases. This disease can affect pediatric and adult patients, and its presentation varies widely. About 25% of patients experience an acute onset or an acute-on-chronic disease course. Some individuals have a severe form of the disease at diagnosis, which can quickly progress to liver failure. The most common clinical presentation, observed in two-thirds of patients, involves a gradual onset of symptoms that may be nonspecific. These symptoms can include fatigue, overall malaise, right upper quadrant pain, lethargy, anorexia, weight loss, nausea, itching, fluctuating jaundice, and joint pain in small joints without arthritis. Researchers believe that a combination of environmental factors, genetic predisposition, and dysfunction in immunoregulatory networks contribute to the development of AIH. Diagnosing AIH is challenging and relies on diagnostic criteria incorporating typical yet largely nonspecific findings. These criteria encompass the presence of autoantibodies (although testing methods are not standardized), hypergammaglobulinemia or elevated IgG levels, the histological pattern of interface hepatitis, the exclusion of other liver diseases, and, ultimately, the response to steroid treatment. The standard approach to treatment involves initiating therapy with steroids to induce remission, followed by a maintenance regimen typically consisting of prednisolone and azathioprine. Immunosuppressive treatment is often required for the long term to manage AIH effectively.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2021-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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