Nonalcoholic Steatohepatitis (NASH) Market is poised for growth in the upcoming years, driven by the rising incidence of NASH in the 7MM (Seven Major Markets) and the forthcoming introduction of innovative therapies.
Global companies are actively engaged in the development of novel treatment modalities, achieving significant progress over time. Among the prominent contributors to drug development for Non-Alcoholic Steatohepatitis are Inventiva Pharma, Novo Nordisk, Intercept Pharmaceuticals, Madrigal Pharmaceuticals, Inc., and others.
The current pipeline of NASH consists of plenty of drugs. FXR Agonists, FGF21 Stimulants, FGF19 Analog, Glucagon-like Peptide-1 (GLP-1) Agonist, Peroxisome Proliferator-activated Receptor (PPAR) Regulators, THR-β Agonist, and some others are the most highlighted class of this indication. Ongoing research and current trials can potentially change the Nonalcoholic Steatohepatitis (NASH) treatment scenario in the coming years.
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 (NASH) 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 Nonalcoholic Steatohepatitis (NASH) market report covers emerging drugs, current treatment practices, market share of individual therapies, and current & forecasted market size from 2019 to 2032. It also evaluates the current 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) Overview
Non-alcoholic fatty liver disease (NAFLD) serves as a comprehensive term encompassing the entire spectrum of fatty liver conditions, ranging from simple steatosis to more advanced stages involving hepatitis, fibrosis, cirrhosis, and, in severe instances, hepatocellular carcinoma.
Within the NAFLD spectrum, Nonalcoholic Steatohepatitis (NASH) represents the progressive form of liver injury, posing risks of advancing fibrosis, cirrhosis, and eventual liver failure. This prevalent chronic liver ailment is characterized by liver inflammation and damage induced by fat accumulation. Children, under certain unhealthy conditions, may also develop NAFLD and NASH, mirroring occurrences in adults. The precise reasons behind why some children with NAFLD develop simple fatty liver while others progress to NASH remain unclear.
Treatment for NASH lacks a standardized approach; however, lifestyle modifications have demonstrated efficacy in influencing disease progression. These lifestyle adjustments may entail weight loss, adhering to a balanced diet, and managing underlying health conditions such as hypothyroidism and diabetes. In cases where NASH coexists with cirrhosis, treatment may involve medications and potentially surgical interventions. Individuals with NASH complications, such as liver cancer or liver failure, may necessitate liver transplantation.
Nonalcoholic Steatohepatitis (NASH) Market Key Facts
In the US, there were approximately 20 million prevalent cases of NASH in 2021, which is anticipated to rise by 2032.
In 2021, 57% of males and around 43% of females were found to be affected by NASH in the US.
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.
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.
It is observed that males are slightly more likely to get affected by NASH than females in the 7MM.
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).
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.
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).
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) Market
The market outlook section of the report helps to build a detailed comprehension of the historical, current and forecasted Nonalcoholic Steatohepatitis (NASH) market size by analyzing the impact of current and emerging pipeline therapies. It also provides a thorough assessment of the market drivers & barriers, unmet needs, and emerging technologies set to impact the market dynamics.
The report gives complete detail of the Nonalcoholic Steatohepatitis (NASH) market trend for each marketed 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 epidemiology trends in the seven major countries (7MM) from 2019 to 2032. It helps to recognize the causes of current and forecasted epidemiology trends by exploring numerous studies and research. The epidemiology section also provides a detailed analysis of diagnosed and prevalent patient pool, future trends, and views of key opinion leaders.
Report Covers the Nonalcoholic Steatohepatitis (NASH) Epidemiology, Segmented by –
Gender-specific Diagnosed Prevalent Cases of Non-Alcoholic Steatohepatitis (NASH) in the 7MM (2019-32)
Total Diagnosed Prevalent Cases of Non-Alcoholic Steatohepatitis (NASH) in the 7MM (2019-32)
Total Prevalent Cases of Non-Alcoholic Steatohepatitis (NASH) in the 7MM (2019-32)
Severity-specific Diagnosed Prevalent Cases of Non-Alcoholic Steatohepatitis (NASH) (F0, F1, F2, F3, and F4 (Cirrhosis)) in the 7MM [2019–2032]
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 rate of uptake of the potential drugs recently launched in the Nonalcoholic Steatohepatitis (NASH) market or expected to be launched during the study period. The analysis covers the Nonalcoholic Steatohepatitis (NASH) market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Nonalcoholic Steatohepatitis (NASH) pipeline development activities. It provides valuable insights about different therapeutic candidates in various stages and the key 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
At present, no medications have received approval from the FDA, EMA, or PMDA (Pharmaceuticals and Medical Devices Agency) specifically for treating NASH. However, ongoing research is exploring potential drugs to address this condition. The primary approach to managing NASH currently involves lifestyle adjustments, including dietary changes and physical activity. In addition to these modifications, other treatment possibilities for NASH encompass the off-label utilization of vitamin E and anti-diabetic medications such as pioglitazone and liraglutide. Numerous prominent companies are actively engaged in advancing treatments within the Nonalcoholic Steatohepatitis (NASH) Therapeutics Market to enhance treatment options.
Madrigal Pharmaceuticals currently leads the therapeutics market, advancing Nonalcoholic Steatohepatitis drug candidates in the most advanced stages of clinical development.
The Leading Pharma and Biotech Companies in the Nonalcoholic Steatohepatitis (NASH) 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 various others.
Nonalcoholic Steatohepatitis Therapies Covered in the Report Include:
Resmetirom: Madrigal Pharmaceuticals
ION224: Ionis Pharmaceuticals
MSDC-0602K: Cirius Therapeutics
HU 6: Rivus Pharmaceuticals
HTD 1801: HighTide Biopharma
EDP-305: Enanta Pharmaceuticals
Lanifibranor: Inventiva Pharma
Saroglitazar Magnesium: Zydus Therapeutics
Semaglutide: Novo Nordisk A/S
Tirzepatide: Eli Lilly and Company
MGL-3196 (Resmetirom): Madrigal Pharmaceuticals, Inc
TERN-501: Terns, Inc.
Obeticholic acid (OCA): Intercept Pharmaceuticals
Vonafexor (EYP001): Enyo Pharma
Pegozafermin: 89bio, Inc.
Efruxifermin (EFX): Akero Therapeutics, Inc
EA3571: EA Pharma
And Many More
Report Covers the In-depth Assessment of the Emerging Drugs & Key Companies. Download the Sample Report to Learn More @ https://www.delveinsight.com/sample-request/nonalcoholic-steatohepatitis-nash-market
Table of Contents
1. Key Insights
2. Executive Summary
3. Nonalcoholic Steatohepatitis (NASH) Competitive Intelligence Analysis
4. Nonalcoholic Steatohepatitis (NASH) Market Overview at a Glance
5. Nonalcoholic Steatohepatitis (NASH) Disease Background and Overview
6. Nonalcoholic Steatohepatitis (NASH) Patient Journey
7. Nonalcoholic Steatohepatitis (NASH) Epidemiology and Patient Population (In the US, EU5, and Japan)
8. Nonalcoholic Steatohepatitis (NASH) 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 Drugs and Latest Therapeutic Advances
13. Nonalcoholic Steatohepatitis (NASH) Seven Major Market Analysis
14. Attribute Analysis
15. Nonalcoholic Steatohepatitis (NASH) Market Outlook (In US, EU5, and Japan)
16. Nonalcoholic Steatohepatitis (NASH) Access and Reimbursement Overview
17. KOL Views on the Nonalcoholic Steatohepatitis (NASH) Market
18. Nonalcoholic Steatohepatitis (NASH) Market Drivers
19. Nonalcoholic Steatohepatitis (NASH) Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
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