Dublin, April 09, 2025 (GLOBE NEWSWIRE) -- The "Liver Fibrosis & NASH/MASH Drugs Market Report 2025-2035" has been added to ResearchAndMarkets.com's offering.
World revenue for the Liver Fibrosis & NASH/MASH Drugs Market is set to surpass US$18 billion in 2025, with strong revenue growth through to 2035.
NASH/MASH is an escalating public health crisis, with the disease progressively leading to liver fibrosis and cirrhosis. MASH is primarily associated with type 2 diabetes and cardiovascular diseases. During clinical trials, NASH drugs must demonstrate their ability to delay disease progression and prevent its onset by measuring composite endpoints related to liver-associated outcomes.
However, due to the absence of effective treatments currently available for NASH, the U.S. FDA has provided an alternative approval pathway. This pathway relies on histopathological assessment of disease progression through liver biopsies as surrogate endpoints, along with positive clinical outcomes during trials. Consequently, the U.S. FDA approves drugs that meet the primary endpoints by either demonstrating an improvement of ,a.1 stage in fibrosis with no worsening of MASH or achieving MASH resolution without worsening fibrosis.
In contrast, the European Medicines Agency (EMA) has different regulatory requirements compared to the U.S. FDA. The EMA mandates that both primary endpoints be met, requiring complete resolution of NASH along with improvement in fibrosis. The lack of uniformity in clinical trial requirements at a global level poses a significant challenge for pharmaceutical companies.
Beyond meeting these endpoints, the effects of new therapies must also be evaluated for their impact on type 2 diabetes and cardiovascular risks. For complete regulatory approval, clinical outcomes should include mortality rates, cirrhosis progression reports, and other liver-related events. This necessitates long-term patient monitoring and follow-up during clinical trials, with the added risk of product failure in confirmatory trials. Additionally, patients receiving a placebo may be required to wait despite the drug being commercially available.
Thus, the lack of regulatory uniformity and the complexity of NASH as a disease hinder the timely commercialization of these drugs.
Key Questions Answered
- How is the Liver Fibrosis & NASH/MASH Drugs market evolving?
- What is driving and restraining the Liver Fibrosis & NASH/MASH Drugs market?
- How will each Liver Fibrosis & NASH/MASH Drugs submarket segment grow over the forecast period and how much revenue will these submarkets account for in 2035?
- How will the market shares for each Liver Fibrosis & NASH/MASH Drugs submarket develop from 2025 to 2035?
- What will be the main driver for the overall market from 2025 to 2035?
- Will leading Liver Fibrosis & NASH/MASH Drugs markets broadly follow the macroeconomic dynamics, or will individual national markets outperform others?
- How will the market shares of the national markets change by 2035 and which geographical region will lead the market in 2035?
- Who are the leading players and what are their prospects over the forecast period?
- What are the Liver Fibrosis & NASH/MASH Drugs projects for these leading companies?
- How will the industry evolve during the period between 2025 and 2035? What are the implications of
- Liver Fibrosis & NASH/MASH Drugs projects taking place now and over the next 10 years?
- Is there a greater need for product commercialisation to further scale the Liver Fibrosis & NASH/MASH Drugs market?
- Where is the Liver Fibrosis & NASH/MASH Drugs market heading and how can you ensure you are at the forefront of the market?
- What are the best investment options for new product and service lines?
- What are the key prospects for moving companies into a new growth path and C-suite?
Forecasts to 2035 and other analyses reveal commercial prospects
- In addition to revenue forecasting to 2035, the new study provides you with recent results, growth rates, and market shares.
- You will find original analyses, with business outlooks and developments.
- Discover qualitative analyses (including market dynamics, drivers, opportunities, and restraints), Porter's Five Forces Analysis, PEST Analysis and recent developments.
In addition to the revenue predictions for the overall world market and segments, you will also find revenue forecasts for five regional and 20 leading national markets.
The report also includes profiles for some of the leading companies in the Liver Fibrosis & NASH/MASH Drugs Market, with a focus on this segment of these companies' operations.
Leading companies and the potential for market growth
- List of Companies Profiled in the Report
- Madrigal Pharmaceuticals
- Novo Nordisk
- Eli Lilly
- Gilead Sciences Inc.
- Galectin Therapeutics
- Galmed Pharmaceuticals
- Akero Therapeutics
- AstraZeneca plc
- Altimmune
- Boehringer Ingelheim
How will the Liver Fibrosis & NASH/MASH Drugs Market report help you?
In summary, the report provides you with the following knowledge:
- Revenue forecasts to 2035 for Liver Fibrosis & NASH/MASH Drugs Market 2025 to 2035, with forecasts for Type and Indication, each forecast at a global and regional level - discover the industry's prospects, finding the most lucrative places for investments and revenues.
- Revenue forecasts to 2035 for five regional and 20 key national markets - See forecasts for the Liver Fibrosis & NASH/MASH Drugs Market market in North America, Europe, Asia-Pacific, Latin America, and MEA. Also forecasted is the market in the US, Canada, Mexico, Brazil, Germany, France, UK, Italy, Spain, China, India, Japan, South Korea and Australia among other prominent economies.
- Prospects for established firms and those seeking to enter the market - including company profiles for 11 of the major companies involved in the Liver Fibrosis & NASH/MASH Drugs Market.
Key Topics Covered:
1 Report Overview
2 Executive Summary
3 Market Overview
3.1 Key Findings
3.2 Market Dynamics
3.3 Impact Analysis
3.3.1 Market Driving Factors
3.3.1.1 Rise in Prevalence of Liver Diseases
3.3.1.2 Rise in diabetes and obesity pandemic consequently leading to rise in MASH
3.3.1.3 Early diagnosis via adoption of Non-invasive diagnostics tests
3.3.1.4 Growing adoption of Artificial Intelligence for Liver Disease Diagnosis
3.3.2 Market Restraining Factors
3.3.2.1 High Cost of Diagnosis & Drugs Limits the Growth of the Market
3.3.2.2 Delayed Diagnosis of MASH & Fibrosis
3.3.2.3 Regulatory Hurdles
3.3.3 Market Opportunities
3.3.3.1 Diagnostic & Biopharma Partnerships
3.3.3.2 Nano-Particle Based Drug Delivery
3.4 Regulatory Framework
3.5 Porter's Five Forces Analysis
3.6 PEST Analysis
4 Liver Fibrosis Drugs Market Analysis, by Disease Type
4.1 Key Findings
4.2 Product Type Segment: Market Attractiveness Index
4.3 Liver Fibrosis / NASH / MASH drugs market Size Estimation and Forecast by Drug Type
4.4 Antivirals
4.5 Alcoholic Liver Disease (ALD)
4.6 Autoimmune Liver Disease
4.7 Anti-Oxidant Modulators
4.8 Drug Induced Liver Injury (DILI)
5 NASH / MASH Drugs Market Analysis
5.1 Key Findings
5.2 Liver Fibrosis / NASH / MASH Drugs Market Size Estimation and Forecast by Drugs
5.3 Vitamin E & Pioglitazone
5.4 Rezdiffra
5.5 Semaglutide (Ozempic)
5.6 Tirzepatide
5.7 Pemvidutide
5.8 Lanifibranor
5.9 Belapectin
5.10 Efruxifermin
5.11 Pegozafermin
5.12 Denifanstat
5.13 Combination Therapies
6 NASH / MASH Drugs Market Analysis by Pipeline Drugs
6.1 Key Findings
6.2 Number of NASH/MASH Pipeline in Various Clinical Trial Stage,2024
6.3 Phase III Clinical Trials : NASH/MASH Market
6.4 Phase II Clinical Trials : NASH/MASH Market
6.5 Pipeline Combination Therapies: NASH/MASH Market
6.6 Pipeline Combination Therapies: NASH/MASH Market with Cirrhosis
6.7 New Entrants / New Technology Clinical Trials : NASH/MASH Market
6.8 Clinical Trials : Repurposing Drugs Liver Fibrosis Market
7 NASH / MASH Drugs Market Analysis by Major Countries
7.1 Key Findings
7.2 NASH/MASH Market : By Stage of Fibrosis (%)
7.3 NASH/MASH Geographic Analysis : By Market Share (%)
7.3.1 Market Size by Region, 2025-2035 (US$ Billion)
7.4 U.S.
7.5 UK
7.6 France
7.7 Italy
7.8 Spain
7.9 Germany
7.10 Japan
7.11 China
8 Liver Fibrosis Drugs Market Analysis by End-users
8.1 Key Findings
8.2 End-users Segment: Market Attractiveness Index
8.3 Liver Fibrosis drugs market Size Estimation and Forecast by End-users
8.4 Hospital Pharmacies
8.5 Speciality Pharmacies
8.6 Other Pharmacies
9 Liver Fibrosis / NASH / MASH Drugs Market Analysis by Region
9.1 Key Findings
9.2 Regional Market Size Estimation and Forecast
10 North America Liver Fibrosis Market Analysis
11 Europe Liver Fibrosis / NASH / MASH Drugs Market Analysis
12 Asia Pacific Liver Fibrosis Drugs Market Analysis
13 Latin America Liver Fibrosis Drugs Market Analysis
14 MEA Liver fibrosis Drugs Market Analysis
15 Company Profiles
- Madrigal Pharmaceuticals
- Novo Nordisk.
- Eli Lilly and Company
- Gilead Sciences
- Inventiva Pharma
- Galectin Therapeutics
- Galmed Pharmaceutical
- Akero Therapeutics
- AstraZeneca
- Altimmune
- Boehringer Ingelheim
For more information about this report visit https://www.researchandmarkets.com/r/2f8lha
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