Liver Fibrosis & NASH/MASH Drugs Market Report 2025-2035

The Liver Fibrosis & NASH/MASH Drugs Market Report 2025-2035: This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.

Regulatory Challenges and Market Barriers in NASH/MASH Drug Approval

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 ‚â•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.

What Questions Should You Ask before Buying a Market Research Report?

• 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?

You need to discover how this will impact the Liver Fibrosis & NASH/MASH Drugs market today, and over the next 10 years:

• Our 245-page report provides 112 tables, 138 charts exclusively to you.
• The report highlights key lucrative areas in the industry so you can target them – NOW.
• It contains in-depth analysis of global, regional and national sales and growth.
• It highlights for you the key successful trends, changes and revenue projections made by your competitors.

Forecasts to 2035 and other analyses reveal commercial prospects

• In addition to revenue forecasting to 2035, our 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.

Segments Covered in the Report

Liver Fibrosis Disease Drug Type

• Antiviral
• Alcoholic Liver Disease
• Antioxidants
• Immunosuppressants
• Drug Induced Liver Injury

NASH/MASH Market by Drugs by Type

• Vitamin E & Pioglitazone
• Rezdiffra
• Semaglutide
• Tirzepatide
• Pemvidutide
• Lanifibranor
• Belapectin
• Efruxifermin
• Pegozafermin
• Denifanstat
• Combination Therapies

NASH/MASH Drugs by Clinical Pipeline

• Phase III
• Phase II
• New Entrants
• Combination Therapies
• Repurposing Drugs

Liver Fibrosis Drugs Market by End Users

• Hospital Pharmacies
• Specialty Pharmacies
• Online Pharmacies

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:

North America

• U.S.
• Canada

Europe

• Germany
• UK
• France
• Italy
• Spain
• Rest of Europe

Asia Pacific

• Japan
• China
• India
• Australia
• South Korea
• Rest of Asia Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

MEA

• GCC
• South Africa
• Rest of MEA

The report also includes profiles for some of the leading companies in the Liver Fibrosis & NASH/MASH Drugs Market, 2025 to 2035, 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

Overall world revenue for Liver Fibrosis & NASH/MASH Drugs Market, 2025 to 2035 in terms of value the market will surpass US$18.0 billion in 2025, our work calculates. We predict strong revenue growth through to 2035. Our work identifies which organizations hold the greatest potential. Discover their capabilities, progress, and commercial prospects, helping you stay ahead.

How will the Liver Fibrosis & NASH/MASH Drugs Market, 2025 to 2035 report help you?

In summary, our 240+ page 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, 2025 to 2035 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, 2025 to 2035.

Find quantitative and qualitative analyses with independent predictions. Receive information that only our report contains, staying informed with invaluable business intelligence.

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