Global Metabolic Dysfunction-Associated Steatohepatitis (MASH) Treatment - 2024-2031

Report Overview

The Global Metabolic Dysfunction-Associated Steatohepatitis (MASH) Treatment Market reached US$ 1.67 billion in 2023 and is expected to reach US$ 7.64 billion by 2031, growing at a CAGR of 21.8% during the forecast period 2024-2031.

Metabolic dysfunction-associated steatohepatitis is the advanced stage of metabolic dysfunction-associated steatotic liver disease (MASLD). This condition causes inflammation and damages the patient's liver - again, despite low alcohol use. If one has steatotic (fatty) liver disease, the body will begin to store excess fat in the liver. This doesn't always cause problems for people. But when it does, it's called steatohepatitis.

Metabolic dysfunction-associated steatohepatitis, formerly known as nonalcoholic steatohepatitis or NASH) is a type of fatty liver disease. It often develops due to a metabolic disorder, such as obesity or diabetes, resulting in a toxic buildup of fat in the liver. MASH symptoms are often silent or nonspecific, making it difficult to diagnose. As a result, MASH patients can remain unaware of their condition until the late stages of the disease. For most people, a buildup of fat in the liver, while not ideal, causes no problems. But in some people, the fat can become toxic to liver cells, causing inflammation and cell damage.

Market Dynamics: Drivers

Increasing prevalence of metabolic dysfunction-associated steatotic liver disease

The demand for the global metabolic dysfunction-associated steatohepatitis (MASH) treatment market is driven by multiple factors. The rising prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) propels the market growth.

Furthermore, the demand for treatment will be fueled by the increase in technological advancements. For instance, according to nih.gov, MASLD has been estimated to affect 30% of the adult population worldwide. The increasing prevalence of MASLD parallels the increasing prevalence of obesity and obesity-related diseases. Metabolic dysfunction-associated steatohepatitis is the more severe form of MASLD, is defined histologically by the presence of lobular inflammation and hepatocyte ballooning, and is associated with a greater risk of fibrosis progression.

MASH has been found in 63% of patients with MASLD undergoing liver biopsy in an Asian multi-center cohort. Among patients with MASLD without an indication for liver biopsy, the prevalence of MASH is 7%. While CVD is the leading cause of mortality in patients with MASLD, those with more severe liver fibrosis are at increased risk of liver-related mortality, with the risk increasing exponentially with fibrosis stage. Steatotic liver disease (SLD) contributes significantly to the burden of chronic liver disease. While 62% of patients seen in our liver clinic had MASLD, 47% of patients with other chronic liver diseases had significant hepatic steatosis.

In the United States, MASH has become one of the leading causes of adult liver transplantation and among patients with HCC undergoing liver transplantation. The burden of MASLD and its complications, including HCC, is projected to continue to increase in the coming years.

Restraints

Factors such as the high cost associated with the treatment, lack of awareness among people, and stringent regulatory requirements for the approval of new treatments are expected to hamper the market.

Market Segment Analysis

The global metabolic dysfunction-associated steatohepatitis treatment market is segmented based on treatment, end-user, and region.

The segment by drug accounted for approximately 54.3% of the global metabolic dysfunction-associated steatohepatitis treatment market share

The drugs segment is expected to hold the largest market share over the forecast period. In this segment, the technological developments, and rising funds for private manufacturers for drug treatment clinical trials would drive this market. The drug that is used for the treatment of metabolic dysfunction-associated steatohepatitis is rezdiffra and three drugs were approved recently for the usage of treatment.

For instance, in March 2024, the FDA approved the first drug for metabolic dysfunction-associated steatohepatitis treatment. Its approval sets the bar for many other companies that are also eying the field, which is estimated to affect about 5% of adults in the U.S. Rezdiffra was the first drug to have met both goals of MASH resolution and fibrosis improvement in a phase 3 trial.

Market Geographical Share

North America accounted for approximately 43.2% of the global metabolic dysfunction-associated steatohepatitis treatment market share

North America region is expected to hold the largest market share over the forecast period. The technological advancements, and funding allotted for research works, help to propel the market.

For instance, in June 2024, Eli Lilly announced that they achieved an absence of metabolic dysfunction-associated steatohepatitis without the worsening of fibrosis in more than 50% of patients in a mid-stage study from their Phase II SYNERGY-NASH study. At 52 weeks, 51.8% of patients treated with 5-mg tirzepatide saw an absence of metabolic dysfunction-associated steatohepatitis (MASH) without the worsening of fibrosis. This proportion increased to 62.8% and 73.3% in the 10-mg and 15-mg dose groups, respectively, while only 13.2% of placebo counterparts reached the endpoint.

Moreover, in May 2024, US-based biopharmaceutical company 89bio began the Phase III ENLIGHTEN-Cirrhosis clinical trial of pegozafermin for treating metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis.

Market Segmentation

By Treatment

• By Drug
• Rezdiffra
• By Therapy
• Phytic Acid Based Nano-Medicine Therapy
• Weight Management
• Diabetes Control
• Regular Exercise
• Others

By End-User

• Hospitals
• Specialty Clinics
• Homecare
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Market Competitive Landscape

The major global players in the global metabolic dysfunction-associated steatohepatitis treatment market include Madrigal Pharmaceuticals, Simson Pharma Limited, Dr. Reddy's Laboratories Ltd., Thermo Fisher Scientific Inc., Biosynth, Affgility Solutions, Conscientia Industrial Co. Ltd., Smolecule Inc., 89 Bio Inc., and Sandoo Pharmaceuticals and Chemicals Co. Ltd. among others.

Key Developments

• In August 2024, Altimmune's experimental therapy with pemvidutide significantly reduced liver fat and inflammation, as well as body weight, among overweight or obese people with metabolic dysfunction-associated steatotic liver disease (MASLD), a form of fatty liver disease as a part of Phase I clinical trials. A Phase 2b trial called IMPACT (NCT05989711) now is testing pemvidutide against a placebo in up to 190 adults with metabolic dysfunction-associated steatohepatitis (MASH).
• In July 2024, according to a research paper published by the Qu Yongquan/Tian Zhimin team from Northwestern Polytechnical University, and the Liu Lei/Zhao Junlong team from Air Force Medical University, phytic acid-based nanomedicine shows promise for metabolic dysfunction-associated sttraileatohepatitis therapy. Due to cerium's significant antioxidant and anti-inflammatory activities, as well as its hepatophilicity and good biosafety, it shows great potential in liver disease treatment.
• In July 2024, Monocyte-derived macrophages have been implicated in MASH-associated liver fibrosis, yet their precise roles and the underlying differentiation mechanisms remain elusive. In this study, a key orchestrator of this process is unveiled: long chain saturated fatty acid-Egr2 pathway. The findings identify the transcription factor Egr2 as the driving force behind monocyte differentiation into hepatic lipid-associated macrophages (hLAMs) within MASH liver.

Why Purchase the Report?

• To visualize the global metabolic dysfunction-associated steatohepatitis treatment market segmentation based on treatment, end-user, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of global metabolic dysfunction-associated steatohepatitis (MASH) treatment market level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in Excel consisting of key products of all the major players.

The global metabolic dysfunction-associated steatohepatitis treatment market report would provide approximately 51 tables, 54 figures, and 181 Pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies