(Albany, US), September 11, 2026 – DelveInsight’s report “Nonalcoholic Steatohepatitis Diagnostics Market Insights, Epidemiology, and Market Forecast-2034” provides a comprehensive analysis of the Nonalcoholic Steatohepatitis landscape. The report presents historical and projected epidemiological data covering Total Nonalcoholic Steatohepatitis Prevalence Cases, Total Nonalcoholic Steatohepatitis Diagnosed Prevalence Cases, Nonalcoholic Steatohepatitis Gender-specific Diagnosed Prevalence Cases, and Nonalcoholic Steatohepatitis Severity-specific Diagnosed Prevalence Cases.

Additionally, the market report encompasses various aspects related to the patient population, including the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in Nonalcoholic Steatohepatitis. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions, enabling stakeholders to make well-informed decisions regarding product development and strategic planning.

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Some of the key facts of the Nonalcoholic Steatohepatitis Market Report:

• The NASH Market Size in the 7MM was approximately ~USD 2,114 million in 2023 and is projected to increase during the forecast period (2024–2034) in the leading countries (US, EU4, UK, and Japan).

• In 2023, the NASH Market Size was highest in the US among the 7MM, accounting for approximately USD 1,519 million, which is further expected to increase by 2034.

• In 2023, there were an estimated 42 million NASH Prevalence Cases in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM.

• In the United States, a higher number of cases were observed in the F1 stage compared to others, comprising around 38% of the total diagnosed cases in 2023.

• In 2023, of the Nonalcoholic Steatohepatitis Gender-specific Diagnosed Prevalent Cases in EU4 and the UK, nearly 2,018 thousand cases occurred in males and 1,656 thousand cases among females. It is projected that by 2034, the number of cases will increase more significantly in males compared to females.

• In November 2024, Novo Nordisk announced positive results for semaglutide in treating Nonalcoholic Steatohepatitis. In the Phase 3 ESSENCE trial, a once-weekly 2.4 mg dose of semaglutide improved liver fibrosis and resolved steatohepatitis without worsening liver fibrosis in NASH patients with stage 2 or stage 3 fibrosis, meeting the primary endpoints.

• In October 2024, Sagimet Biosciences (SGMT) announced that it has successfully completed end-of-Phase 2 interactions with the FDA, paving the way for denifanstat to advance into Phase 3 trials for metabolic dysfunction-associated steatohepatitis.

• In March 2024, Madrigal Pharmaceuticals’ groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic NASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis.

• The emerging drug Pegozafermin is expected to launch in the US NASH market by 2026; the drug has the potential to reduce the disease burden of Nonalcoholic Steatohepatitis in the forecasted years.

• Key Nonalcoholic Steatohepatitis Companies: Inventiva Pharma, Zydus Therapeutics, Novo Nordisk A/S, Eli Lilly and Company, Madrigal Pharmaceuticals, Inc, Terns, Inc., Intercept Pharmaceuticals, Enyo Pharma, 89bio, Inc., Akero Therapeutics, Inc, and others.

• Key Nonalcoholic Steatohepatitis Therapies: REZDIFFRA (resmetirom), Pegozafermin, Efruxifermin (EFX), Belapectin

• The Nonalcoholic Steatohepatitis market is expected to experience notable changes with a robust pipeline of emerging fibrosis- and metabolism-targeted therapies. Key market players, including 89bio, Inc., Akero Therapeutics, Inc., and Galectin Therapeutics, have demonstrated a keen interest in this progressive liver condition and are actively pursuing the development of potential treatments.

Nonalcoholic Steatohepatitis Overview

Nonalcoholic Steatohepatitis is the progressive form of liver injury that carries a risk of progressive fibrosis, cirrhosis, and end-stage liver disease. It is a common chronic liver disease and is defined as liver inflammation and damage caused by buildup of fat in the liver. Much like adults, children who have certain unhealthy conditions may also develop NAFLD and NASH. It is still not known why some children with NAFLD have simple fatty liver while others have NASH.

Many people have a buildup of fat in the liver, and for most people there are usually no symptoms and no problems, whereas, in some people, the fat causes inflammation and damages the cells in the liver, and because of this damage, the liver is unable to work as it should. NASH is similar to the kind of liver disease that is caused by long-term, heavy drinking, and if someone has NASH, their liver has a high percentage of fat with swollen sustained damage, causing fibrosis, or scarring. If the scarring is remarkably significant, it may lead to cirrhosis, a condition that causes permanent liver damage.

According to the American Liver Foundation, the exact cause of NAFLD is not known. The likely cause to develop NAFLD – either simple fatty liver or NASH – is in case of overweight or obesity, type 2 diabetes or pre-diabetes, abnormal levels of fats reported in blood, and others.

To know in detail about the Nonalcoholic Steatohepatitis market outlook, drug uptake, treatment scenario, and epidemiology trends, Click here; Nonalcoholic Steatohepatitis Market Forecast

Nonalcoholic Steatohepatitis Diagnosis and Treatment Algorithm

This segment of the report covers the detailed diagnostic methods or tests for Nonalcoholic Steatohepatitis.

It covers the details of conventional and current medical therapies available in the NASH Market for the treatment of the condition. It also provides Nonalcoholic Steatohepatitis treatment algorithms and guidelines in the United States, Europe, and Japan.

Until mid-March, the Nonalcoholic Steatohepatitis Therapeutics Market Landscape lacked FDA, EMA, or PMDA-approved medications, relying primarily on lifestyle adjustments like diet and exercise. Supplemental interventions encompassed off-label usage of vitamin E and antidiabetic agents (e.g., pioglitazone, liraglutide) and liver transplantation in case of severe stages. Given NASH’s multifaceted pathogenesis, effective treatment demands comprehensive targeting of various cellular and molecular pathways.

The Nonalcoholic Steatohepatitis Incidence is significantly associated with T2DM and obesity, especially in patients with a higher body mass index (BMI). In contrast, the Nonalcoholic Steatohepatitis Incidence is decreased in patients with T2DM who received treatments such as SGLT2 Inhibitors, GLP-1 receptor antagonists, and insulin. Vitamin E, known for its antioxidant effects, is considered a first-line pharmacological treatment in managing NASH, especially when diet and other lifestyle changes are insufficient. Antifibrotic reagents can prevent the progression of liver fibrosis and MASLD to fibrotic NASH. Other targets for MASLD and NASH treatments include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRa), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery (BS) or weight loss surgery is the most effective way to treat obesity and diabetes by reducing food absorption and modulating gut hormone secretion and metabolic dysfunction.

The American Association for the Study of Liver Diseases (AASLD) MASLD practice guidance statement recommends off-label use of vitamin E in noncirrhotic, non-diabetic patients with biopsy-proven NASH and pioglitazone for the management of diabetic patients with biopsy-proven NASH.

Nonalcoholic Steatohepatitis Epidemiology

The Nonalcoholic Steatohepatitis epidemiology section provides insights about the historical and current Nonalcoholic Steatohepatitis patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the NASH Market report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings:

• Based on DelveInsight’s estimates, the United States had the highest number of Nonalcoholic Steatohepatitis Diagnosed Prevalence Cases in 2023, with a total of ~9.4 million cases. Following the US, EU4 and the UK had ~3.6 million cases, while Japan had ~2.5 million cases.

• The categorization based on gender showed that Nonalcoholic Steatohepatitis diagnosed prevalent cases in males were higher than in females in the 7MM. The male-diagnosed prevalent cases accounted for 56% of the total cases in the 7MM.

• Japan accounted for approximately 16% of the total NASH Diagnosed Prevalent Cases in the 7MM in 2023. These cases are expected to increase in the study period (2020–2034).

Download the report to understand which factors are driving Nonalcoholic Steatohepatitis epidemiology trends @ Nonalcoholic Steatohepatitis Epidemiology Forecast

Nonalcoholic Steatohepatitis Market Outlook

The primary treatment goal for Nonalcoholic Steatohepatitis is to improve patient quality of life by reducing liver inflammation and fibrosis progression while managing the underlying metabolic drivers of the disease.

In conclusion, the advent of REZDIFFRA marks a significant breakthrough in NASH treatment, offering hope and promise to millions affected by this complex liver condition. As the pioneering FDA-approved therapy for NASH, REZDIFFRA leads innovation, transforming treatment. While other emerging therapies such as lanifibranor, VK2809, Semaglutide, and others show promise in addressing NASH, REZDIFFRA’s unique efficacy and safety profile position it as the cornerstone of NASH management. As the field navigates this dynamic era of medical advancement, REZDIFFRA stands as a guiding light, illuminating the path toward a future where effective treatment and improved outcomes are within reach for all those affected by NASH.

Nonalcoholic Steatohepatitis Drug ChaptersNonalcoholic Steatohepatitis Marketed Drugs

• REZDIFFRA (resmetirom): Madrigal Pharmaceuticals

REZDIFFRA is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The emergence of the inaugural medication for NASH is a true game-changer for healthcare providers, the research community, and, most importantly, patients living with this serious liver condition. Based on the robust efficacy and safety data generated in two large Phase III MAESTRO studies, it is believed that REZDIFFRA will become the foundational therapy for patients with NASH with moderate to advanced liver fibrosis. Now that the FDA has approved REZDIFFRA for NASH, NASH companies will have a better understanding of the thresholds they must meet to get future approvals.

Physicians hope that REZDIFFRA’s approval “energizes” the field and leads to more treatment advances. Madrigal Pharmaceuticals has already garnered widespread support among physicians. A significant portion of gastroenterologists plan to incorporate the brand into their practice within six months of its launch. They estimate that over a third of their patients with NASH could benefit from the drug, suggesting rapid adoption and utilization. Physicians are hopeful that insurance providers will cover the cost of REZDIFFRA and are poised to offer it to eligible NASH patients once it becomes available.

Emerging NASH Drugs

• Pegozafermin: 89bio, Inc

Pegozafermin, or BIO89-100, is a compound that specifically targets and activates a receptor known as fibroblast growth factor 21 (FGF21). FGF21 is a hormone involved in regulating glucose and lipid metabolism, and it has been shown to have potential therapeutic effects in NASH.

Preclinical studies and early-stage clinical trials of BIO89-100 have shown promising results in improving metabolic parameters and reducing liver fat accumulation in patients with NASH.

• In May 2024, 89bio initiated the Phase III ENLIGHTEN-Cirrhosis Trial of Pegozafermin in NASH patients with compensated cirrhosis.

• In October 2024, 89bio, Inc. reported that new analyses from the Phase IIb ENLIVEN trial, which investigates the efficacy of pegozafermin in patients with NASH and fibrosis, would be presented in four poster sessions at the 75th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2024 in November 2024 in San Diego, California.

• Efruxifermin (EFX): Akero Therapeutics, Inc.

Efruxifermin (EFX) is Akero’s lead product candidate for NASH. It is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is designed to offer convenient once-weekly SC dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treating NASH.

In June 2024, the company initiated the SYNCHRONY Outcomes study, a Phase III trial evaluating the efficacy and safety of efruxifermin (EFX) in patients with compensated cirrhosis, F4 due to NASH.

• Belapectin: Galectin Therapeutics

Belapectin, a complex carbohydrate drug, targets galectin-3, a critical protein in fatty liver disease and fibrosis pathogenesis. Galectin-3 plays a major role in organ-scarring diseases, including the liver, lung, kidney, heart, and vascular systems fibrotic disorders. The drug binds to galectin-3 proteins and disrupts its function.

In April 2024, the company reported the positive outcome of its fifth independent data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, Phase IIb/III study of belapectin in patients with cirrhotic portal hypertension caused by NASH. The topline results from the interim analysis of the Phase IIb (Stage 1) portion of NAVIGATE were expected in the fourth quarter of 2024.

Discover more about therapies set to grab major Nonalcoholic Steatohepatitis market share @ Nonalcoholic Steatohepatitis Treatment Landscape

Nonalcoholic Steatohepatitis Market Segmentation

DelveInsight’s ‘Nonalcoholic Steatohepatitis Diagnostics Market Insights, Epidemiology, and Market Forecast-2034’ report provides a detailed outlook of the current and future Nonalcoholic Steatohepatitis market, segmented within countries, by therapies, and by class. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Nonalcoholic Steatohepatitis Market Size by Countries

The Nonalcoholic Steatohepatitis market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2023, the US accounted for the largest share of the market at USD 1,519 million. Among European countries, Germany accounted for the maximum Nonalcoholic Steatohepatitis Market Size of USD 89 million in 2023, while Spain occupied the bottom of the ladder in the same year with USD 50 million. The Nonalcoholic Steatohepatitis Market Size in Japan was nearly USD 260 million in 2023, which is further expected to increase by 2034.

Nonalcoholic Steatohepatitis Market Size by Therapies

Nonalcoholic Steatohepatitis Market Size by Therapies is categorized into current and emerging markets for the study period 2020–2034. This section focuses on the uptake rate of potential NASH drugs expected to launch in the NASH market during 2020–2034. For example, Lanifibranor/IVA337 in the US is expected to be launched by 2027 with a peak share of 2.9%. HPG1860 is anticipated to take 7 years to peak with slow-medium uptake. Nonalcoholic Steatohepatitis Drugs Uptake helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs on the basis of NASH Market Share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Scope of the Nonalcoholic Steatohepatitis Market Report

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]

• Key Nonalcoholic Steatohepatitis Companies: Inventiva Pharma, Zydus Therapeutics, Novo Nordisk A/S, Eli Lilly and Company, Madrigal Pharmaceuticals, Inc, Terns, Inc., Intercept Pharmaceuticals, Enyo Pharma, 89bio, Inc., Akero Therapeutics, Inc, and others

• Key Nonalcoholic Steatohepatitis Therapies: REZDIFFRA (resmetirom), Pegozafermin, Efruxifermin (EFX), Belapectin

• Nonalcoholic Steatohepatitis Therapeutic Assessment: Nonalcoholic Steatohepatitis current marketed and Nonalcoholic Steatohepatitis emerging therapies

• Nonalcoholic Steatohepatitis Market Dynamics: Nonalcoholic Steatohepatitis market drivers and Nonalcoholic Steatohepatitis market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Nonalcoholic Steatohepatitis Unmet Needs, KOL’s views, Analyst’s views, Nonalcoholic Steatohepatitis Market Access and Reimbursement

To know more about Nonalcoholic Steatohepatitis companies working in the treatment market, visit @ Nonalcoholic Steatohepatitis Clinical Trials and Therapeutic Assessment

Table of Contents

1. Key Insights

2. Executive Summary of Nonalcoholic Steatohepatitis (NASH)

3. Competitive Intelligence Analysis for Nonalcoholic Steatohepatitis (NASH)

4. Nonalcoholic Steatohepatitis (NASH): Market Overview at a Glance

5. Nonalcoholic Steatohepatitis (NASH): Disease Background and Overview

6. Nonalcoholic Steatohepatitis Patient Journey

7. Nonalcoholic Steatohepatitis (NASH) Epidemiology and Patient Population

8. Nonalcoholic Steatohepatitis Treatment Algorithm, Current Treatment, and Medical Practices

9. Nonalcoholic Steatohepatitis (NASH) Unmet Needs

10. Key Endpoints of Nonalcoholic Steatohepatitis (NASH) Treatment

11. Nonalcoholic Steatohepatitis (NASH) Marketed Products

12. Nonalcoholic Steatohepatitis (NASH) Emerging Therapies

13. Nonalcoholic Steatohepatitis (NASH): Seven Major Market Analysis

14. Attribute Analysis

15. 7MM: Nonalcoholic Steatohepatitis Market Outlook

16. Access and Reimbursement Overview of Nonalcoholic Steatohepatitis (NASH)

17. KOL Views

18. Nonalcoholic Steatohepatitis Market Drivers

19. Nonalcoholic Steatohepatitis Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

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