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Liver Fibrosis & NASH/MASH Drugs Market Report 2025-2035
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The global Liver Fibrosis & NASH/MASH Drugs Market Report 2025-2035 market is estimated at US$18.3 billion in 2025 and is projected to grow at a CAGR of 10.0% during the forecast period 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 ,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.

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

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

Segments Covered in the Report

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, 2025 to 2035, with a focus on this segment of these companies' operations.

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.

Table of Contents

1 Report Overview

2 Executive Summary

3 Market Overview

4 Liver Fibrosis Drugs Market Analysis, by Disease Type

5 NASH / MASH Drugs Market Analysis

6 NASH / MASH Drugs Market Analysis by Pipeline Drugs

7 NASH / MASH Drugs Market Analysis by Major Countries

8 Liver Fibrosis Drugs Market Analysis by End-users

9 Liver Fibrosis / NASH / MASH Drugs Market Analysis by Region

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

16 Conclusion and Recommendations

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