비알코올성 지방간염(NASH) : 신규 요법, 미충족 수요 및 TPP 인사이트 보고서(2026년)

Non-Alcoholic Steatohepatitis (NASH) Emerging Therapy and TPP Insights

Thelansis's "Non-Alcoholic Steatohepatitis (NASH) Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Non-Alcoholic Steatohepatitis (NASH) Overview

Non-alcoholic steatohepatitis, now more accurately referred to in current clinical and regulatory guidance as metabolic dysfunction associated steatohepatitis, is a progressive liver disease that develops when fat buildup in the liver, closely tied to obesity, insulin resistance, and related metabolic conditions, advances into inflammation and scarring that can eventually lead to cirrhosis and liver failure. That naming shift reflects a broader move away from defining the disease by what it is not, namely alcohol related, toward defining it by its actual metabolic drivers, a change now widely adopted across scientific literature, regulatory filings, and drug labeling. Clinically, treatment has evolved just as significantly, moving from a landscape with no approved pharmacologic therapy toward one featuring a liver-targeted oral therapy that activates a specific thyroid hormone receptor pathway, followed by a GLP-1 receptor agonist already established in diabetes and obesity care extending its benefits into liver health. Diagnosis has also evolved, increasingly relying on non-invasive blood-based and imaging tools to stage fibrosis rather than defaulting to biopsy.

Key Highlights

• In Germany, the prevalent NASH population is projected to increase from 3,705,760 in 2025 to 4,772,710 by 2035.
• NASH is a progressive liver disease that can lead to fibrosis, cirrhosis, and liver failure if left untreated.
• Rising obesity and type 2 diabetes prevalence continue to drive disease burden.
• Significant unmet need remains for therapies that slow disease progression and improve liver outcomes.

Market Overview

• The Italy NASH market is projected to grow from $95M in 2025 to $850M by 2035.
• Market growth is driven by:
• Increasing adoption of emerging disease-modifying therapies
• Improved diagnosis and growing awareness of chronic liver disease
• Future growth will depend on therapies that effectively reduce fibrosis and prevent disease progression.

Insights driven by surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• Novo Nordisk A/S
• Inipharm Australia Pty Ltd.
• Madrigal Pharmaceuticals, Inc.
• Xiamen Amoytop Biotech Co., Ltd.
• Arrowhead Pharmaceuticals
• Sunshine Lake Pharma Co., Ltd.
• Haisco Pharmaceutical Group Co., Ltd.
• Altimmune, Inc.
• Hoffmann-La Roche
• Corcept Therapeutics
• AstraZeneca
• Boehringer Ingelheim
• Merck Sharp & Dohme LLC
• Akero Therapeutics, Inc.
• 89bio, Inc.
• Terns, Inc.
• NGM Biopharmaceuticals, Inc.
• Inventiva Pharma
• Hanmi Pharmaceutical Company Limited
• Sinew Pharma Inc.
• Eli Lilly and Company
• Gilead Sciences
• Zydus Therapeutics Inc.
• HighTide Biopharma Pty Ltd.
• Hudson Biotech
• Regeneron Pharmaceuticals
• Neuraly, Inc.

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risk, etc.

2. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key emerging therapies - profiles and KOL insights

3. Product Attribute Analysis

• Key takeaways
• Scientific attributes
• Commercial attributes
• Product positioning

4. Primary Market Research

• Current treatment landscape
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Current challenges
• Unmet needs
• Emerging therapies
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Unmet needs and KOL expectations

5. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

6. Regulatory and Reimbursement Environments (by country and payer insights)

7. Appendix (e.g., bibliography, methodology)