비알코올성 지방간염(NASH) : 세계 시장 전망, 역학, 경쟁 구도, 시장 예측 보고서(주요 32개 시장, 2025-2035년)

Global Non-Alcoholic Steatohepatitis (NASH) Market Outlook

Thelansis's "Global Non-Alcoholic Steatohepatitis (NASH) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report (Top 32 Markets) - 2025 To 2035" covers disease overview, epidemiology, kidney biopsy cases, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential NASH treatment modalities options for the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America).

Non-Alcoholic Steatohepatitis (NASH) Overview

Metabolic dysfunction-associated steatohepatitis (MASH), formerly non-alcoholic steatohepatitis (NASH), is a progressive inflammatory liver disease characterized by hepatic steatosis, lobular inflammation, hepatocyte ballooning, and progressive fibrosis. Driven by lipotoxicity, oxidative stress, and metabolic drivers like type 2 diabetes and obesity, advanced stages pose significant risks of cirrhosis and hepatocellular carcinoma. Diagnosis combines liver biopsy as the histological standard with non-invasive elastography and FIB-4 scoring. While sustained weight reduction remains foundational, the therapeutic paradigm has fundamentally shifted away from purely lifestyle interventions. Care is anchored by two major regulatory approvals: the thyroid hormone receptor beta agonist Rezdiffra (resmetirom) for non-cirrhotic MASH with moderate-to-advanced fibrosis, and the newly approved GLP-1 receptor agonist Wegovy (semaglutide), indicated for pre-cirrhotic phenotypes following landmark Phase 3 trials. Conversely, historical candidates like the farnesoid X receptor agonist obeticholic acid have been completely abandoned following definitive regulatory rejections due to safety risks. The active late-stage pipeline relies on alternative pathways, led by the oral pan-PPAR agonist lanifibranor, which is completing Phase 3 NATiV3 validation, alongside advanced dual/triple incretins like tirzepatide. Regular non-invasive tracking is mandatory to guide lifelong management.

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.

Market Definition:

• North America (United States, Canada)
• Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
• Middle East (Saudi Arabia, UAE, Kuwait, Turkey)
• Asia Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam)
• Africa (Egypt, Nigeria, South Africa, Morocco)
• South / Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru)

Insights driven by robust research, including:

• In-depth interviews with leading KOLs and payers
• Physician surveys
• RWE analysis for claims and EHR datasets
• Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

• Detailed Report (PDF)
• Market Forecast Model (MS Excel-based automated dashboard)
• Epidemiology (MS Excel; interactive tool)
• Executive Insights (PowerPoint presentation)
• Others: regular updates, customizations, consultant support
• As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

• 10-year market forecast (2025-2035)
• Bottom-up patient-based market forecasts validated through the top-down sales methodology
• Covers clinically and commercially-relevant patient populations/ line of therapies
• Annualized drug-level sales and patient share projections
• Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
• Detailed methodology/sources & assumptions
• Graphical and tabular outputs
• Users can customize the model based on requirements

Key business questions answered:

• How can drug development and lifecycle management strategies be optimized across the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America)?
• How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
• What is the 10-year market outlook for sales and patient share?
• Which events will have the greatest impact on the market's trajectory?
• What insights do interviewed experts provide on current and emerging treatments?
• Which pipeline products show the most promise, and what is their potential for launch and future positioning?
• What are the key unmet needs and KOL expectations for target profiles?
• What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

• North America (United States, Canada)
• Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
• Middle Ea

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 risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
• Notable early-phase pipeline

6. Unmet Need and TPP Analysis

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

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

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