DelveInsight’s “Nonalcoholic Steatohepatitis (NASH) Market Insights, Epidemiology, and Market Forecast 2032” report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the Nonalcoholic Steatohepatitis market size, share, trends, and growth opportunities in the seven major markets (7MM) (i.e., the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom and Japan).
The report covers emerging Nonalcoholic Steatohepatitis drugs, current treatment practices, market share of individual therapies, and current & forecasted market size from 2019 to 2032. It also evaluates the current Nonalcoholic Steatohepatitis treatment practice/algorithm, key drivers & barriers impacting the market growth, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Nonalcoholic Steatohepatitis (NASH): An Overview
Non-alcoholic fatty liver disease (NAFLD) is an umbrella term that encompasses the entire spectrum of fatty liver disease, from simple steatosis to more progressive steatosis with associated hepatitis, fibrosis, cirrhosis, and in some cases, hepatocellular carcinoma.
Under NAFLD, Nonalcoholic Steatohepatitis (NASH) 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 the buildup of fat in the liver. Children with certain unhealthy conditions may also develop NAFLD and NASH like adults. It is still unknown why some children with NAFLD have simple fatty liver while others have NASH.
There is no standard treatment for NASH patients; lifestyle changes have been shown to affect its progression. This may include losing weight, maintaining a healthy diet, or addressing underlying conditions such as hypothyroidism and diabetes. If a person with NASH also has cirrhosis, the treatment may include medications and possibly surgery. People with NASH who develop liver cancer or liver failure may require a transplant.
Nonalcoholic Steatohepatitis (NASH) Market Key Facts
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In the US, there were approximately 20 million prevalent cases of NASH in 2021, which is anticipated to rise by 2032.
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In 2021, 57% of males and around 43% of females were found to be affected by NASH in the US.
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According to a study by Petta et al. (2019), NAFLD is one of the most frequent causes of chronic liver disease worldwide, affecting around 24% of the global population. In Italy, NAFLD prevalence ranges between 20%-30%. Nonalcoholic steatohepatitis (NASH) comprises nearly 25% of NAFLD patients.
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Park et al. (2021), in their study, found that the overall prevalence of NAFLD was 31.46%. NASH prevalence was 52%, but <15% had significant fibrosis.
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It is observed that males are slightly more likely to get affected by NASH than females in the 7MM.
Nonalcoholic Steatohepatitis (NASH) Market
The market outlook section of the report helps to build a detailed comprehension of the historical, current, and forecasted market size by analyzing the impact of current and emerging Nonalcoholic Steatohepatitis pipeline therapies. It also thoroughly assesses the Nonalcoholic Steatohepatitis market drivers & barriers, unmet needs, and emerging technologies set to impact the market dynamics.
The report gives complete details of the market trend for each marketed Nonalcoholic Steatohepatitis drug and mid & late-stage pipeline therapies by evaluating their impact based on the annual cost of therapy, their Mechanism of Action (MOA), Route of Administration (ROA), molecule types, competition with other therapies, brand value, and their impact on the market.
Nonalcoholic Steatohepatitis (NASH) Epidemiology Assessment
The epidemiology section provides insights into the historical, current, and forecasted Nonalcoholic Steatohepatitis epidemiology trends in the seven major countries (7MM) from 2019 to 2032. It helps to recognize the causes of current and forecasted Nonalcoholic Steatohepatitis epidemiology trends by exploring numerous studies and research. The epidemiology section also provides a detailed analysis of diagnosed and prevalent patient pools, future trends, and views of key opinion leaders.
The Report Covers the Nonalcoholic Steatohepatitis (NASH) Epidemiology, Segmented as –
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Gender-specific Diagnosed Prevalent Cases of Non-Alcoholic Steatohepatitis (NASH) in the 7MM (2019-32)
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Total Diagnosed Prevalent Cases of Non-Alcoholic Steatohepatitis (NASH) in the 7MM (2019-32)
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Total Prevalent Cases of Non-Alcoholic Steatohepatitis (NASH) in the 7MM (2019-32)
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Severity-specific Diagnosed Prevalent Cases of Non-Alcoholic Steatohepatitis (NASH) (F0, F1, F2, F3, and F4 (Cirrhosis)) in the 7MM [2019–2032]
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Treatable Cases of Non-Alcoholic Steatohepatitis (NASH) in the 7MM (2019-32)
Nonalcoholic Steatohepatitis (NASH) Drugs Uptake and Pipeline Development Activities
The drug uptake section focuses on the uptake rate of potential drugs recently launched in the Nonalcoholic Steatohepatitis market or expected to be launched during the study period. The analysis covers the Nonalcoholic Steatohepatitis market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the market dynamics by drug sales, the most rapid drug uptake, and the reasons behind the maximal use of particular drugs. Additionally, it compares the non-alcoholic steatohepatitis drugs based on their sale and market share.
The report also covers the Nonalcoholic Steatohepatitis pipeline development activities. It provides valuable insights about different therapeutic candidates in various stages and the key Nonalcoholic Steatohepatitis companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
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Nonalcoholic Steatohepatitis (NASH) Therapeutics Analysis
Presently, no FDA, EMA, or PMDA (Pharmaceuticals and Medical Devices Agency) is approved for the treatment of NASH; however, researchers are studying medicines that may improve these conditions. The current treatment The current front-line treatment consists of lifestyle modifications, such as diet and exercise. Aside from lifestyle modifications, additional treatment options for NASH have included off-label use of vitamin E and anti-diabetes agents (e.g., pioglitazone and liraglutide). Several key companies are actively working in the Nonalcoholic Steatohepatitis (NASH) Therapeutics Market to improve the treatment scenario further.
Currently, Madrigal Pharmaceuticals is leading the therapeutics market with its Nonalcoholic Steatohepatitis drug candidates in the most advanced stage of clinical development.
Nonalcoholic Steatohepatitis (NASH) Therapeutics Development Activities
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On January 20, 2023, Intercept Pharmaceuticals, Inc. announced that the FDA had accepted the company’s new drug application (NDA) for obeticholic acid (OCA) that seeks accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).
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On January 4, 2023, SFA Therapeutics announced that it had received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with non-alcoholic steatohepatitis (NASH) with or without fibrosis. SFA-001N is designed to act on multiple pathways involved in the pathogenesis of NASH.
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On December 08, 2022, Akero Therapeutics, Inc. (Nasdaq: AKRO) announced that efruxifermin (EFX) had received a Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of nonalcoholic steatohepatitis (NASH).
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On May 26, 2022, Pfizer Inc. (NYSE: PFE) announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer’s investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi).
Nonalcoholic Steatohepatitis (NASH) Companies Actively Working in the Therapeutics Market Include
Madrigal Pharmaceuticals, Cirius Therapeutics, AstraZeneca, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Akero Therapeutics, Merck Sharp & Dohme LLC, Enanta Pharmaceuticals, TaiwanJ Pharmaceuticals, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, GSK plc., Amgen, Altimmune, Inc., Sciwind Biosciences, SCOHIA PHARMA, Galecto Biotech, J2H Biotech, Tiziana Life Sciences, Palobiofarma, Bird Rock Bio, Ascletis, Liminal BioSciences, ARTham Therapeutics, Pliant Therapeutics, Guangdong Zhongsheng Pharmaceutical, Pharmaxis, Melior Pharmaceuticals, TransThera Biosciences, Cerenis Therapeutics, DURECT Corporation, Enzychem Lifesciences, Ildong Pharmaceutical, LG Chem Life sciences, Gmax Biopharm, Albireo Pharma, InorbitTX, Viking Therapeutics, Ildong Pharmaceutical, Thoth Science, and others.
Emerging and Marketed Nonalcoholic Steatohepatitis (NASH) Therapies Covered in the Report Include:
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Resmetirom: Madrigal Pharmaceuticals
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ION224: Ionis Pharmaceuticals
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MSDC-0602K: Cirius Therapeutics
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HU 6: Rivus Pharmaceuticals
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HTD 1801: HighTide Biopharma
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EDP-305: Enanta Pharmaceuticals
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Lanifibranor: Inventiva Pharma
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Saroglitazar Magnesium: Zydus Therapeutics
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Semaglutide: Novo Nordisk A/S
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Tirzepatide: Eli Lilly and Company
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MGL-3196 (Resmetirom): Madrigal Pharmaceuticals, Inc
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TERN-501: Terns, Inc.
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Obeticholic acid (OCA): Intercept Pharmaceuticals
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Vonafexor (EYP001): Enyo Pharma
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Pegozafermin: 89bio, Inc.
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Efruxifermin (EFX): Akero Therapeutics, Inc
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EA3571: EA Pharma
And Many More
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Table of Content (TOC)
1. Key Insights
2. Executive Summary
3. Nonalcoholic Steatohepatitis Competitive Intelligence Analysis
4. Nonalcoholic Steatohepatitis Market Overview at a Glance
5. Nonalcoholic Steatohepatitis Disease Background and Overview
6. Nonalcoholic Steatohepatitis Patient Journey
7. Nonalcoholic Steatohepatitis Patient Population and Epidemiology Trends (In the US, EU5, and Japan)
8. Nonalcoholic Steatohepatitis Treatment Algorithm, Current Treatment, and Medical Practices
9. Nonalcoholic Steatohepatitis Unmet Needs
10. Key Endpoints of Nonalcoholic Steatohepatitis Treatment
11. Nonalcoholic Steatohepatitis Marketed Therapies
12. Nonalcoholic Steatohepatitis Emerging Drugs and Latest Therapeutic Advances
13. Nonalcoholic Steatohepatitis Seven Major Market Analysis
14. Attribute Analysis
15. Nonalcoholic Steatohepatitis Market Outlook (In US, EU5, and Japan)
16. Nonalcoholic Steatohepatitis Companies Active in the Market
17. Nonalcoholic Steatohepatitis Access and Reimbursement Overview
18. KOL Views on the Nonalcoholic Steatohepatitis Market
19. Nonalcoholic Steatohepatitis Market Drivers
20. Nonalcoholic Steatohepatitis Market Barriers
21. Appendix
22. DelveInsight Capabilities
23. Disclaimer
*The Table of Contents (TOC) is not exhaustive; the final content may vary. Refer to the sample report for the complete table of contents.
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About DelveInsight
DelveInsight is a leading Business Consultant and Market Research Firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.
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