The global non-alcoholic steatohepatitis drugs pipeline market is expected to enjoy a valuation of USD 0.27 Billion by the end of the year 2023, and further expand at a CAGR (2023 to 2033) of 33.3% to reach a valuation of ~USD 51.36 Billion by the year 2033. According to a recent study by Future Market Insights, mid-stage products (phase II) are leading the non-alcoholic steatohepatitis drugs pipeline market with a share of about 66.7% in the year 2022.
Market Outlook:
| Data Points | Market Insights |
|---|---|
| Market Value 2022 | USD 0.26 Billion |
| Market Value 2023 | USD 0.27 Billion |
| Market Value 2033 | USD 51.36 Billion |
| CAGR 2023 to 2033 | 33.3% |
| Key Market Players | Pfizer Inc.; Merck & Co., Inc.; Zydus Lifesciences Ltd. (Cadila Pharmaceuticals); GSK plc.; AstraZeneca; Novartis AG; F. Hoffmann-La Roche Ltd (Genentech, Inc. (Jecure Therapeutics, Inc.)); Novo Nordisk A/S; Gilead Sciences; Viking Therapeutics; ENYO Pharma SA; Enanta Pharmaceuticals, Inc.; Oramed; Intercept Pharmaceuticals, Inc.; Melinta Therapeutics LLC; Boston Pharmaceuticals; CytoDyn Inc.; Akero Therapeutics, Inc.; SINEW PHARMA INC.; AbbVie (Allergan (Tobira Therapeutics Inc.); Eli Lilly & Co.; Bristol Myers Squibb Co.; Boehringer Ingelheim International GmbH; NGM Biopharmaceuticals; Sagimet Biosciences; Madrigal Pharmaceuticals; Axcella Therapeutics; TaiwanJ Pharmaceuticals Co., Ltd.; Kowa Group (Kowa Company, Ltd.); Hepion Pharmaceuticals; HighTide Therapeutics Inc.; Cirius Therapeutics; Gmax Biopharm; TERNS PHARMACEUTICALS, INC.; NuSirt Biopharma; Galmed Pharmaceuticals; Ionis Pharmaceuticals, Inc. (Akcea Therapeutics); Inventiva and Histogen, Inc. (Conatuspharma.com) |
Pharmaceutical companies are investing heavily in the research and development of drugs to treat NASH and have recognized the potential market opportunities. This has led to the development of several promising drug candidates that are in various stages of clinical trials.
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The market value for non-alcoholic steatohepatitis drugs pipeline was around 1.4% of the overall ~USD 18.3 Billion of the global Non-Alcoholic Fatty Liver Disease (NAFLD) drug market in 2022.
NASH (Non-Alcoholic Steatohepatitis) is becoming a public health burden and has a significant impact on overall morbidity and mortality. The increasing prevalence of obesity, diabetes, and other lifestyle-related diseases is contributing to the rising incidence of NASH, which is driving the demand for drugs to treat this condition. The prevalence of NASH is increasing worldwide due to sedentary lifestyles, unhealthy eating habits, and rising obesity rates. Obesity is a major risk factor for NASH. As the prevalence of obesity increases worldwide, so does the number of people with NASH.
According to the American Liver Foundation in 2020, Non-Alcoholic Fatty Liver Disease (NAFLD) tops the chronic liver disease in the United States. About 25% of adults in the United States are thought to have NAFLD and about 20% of people with NAFLD also have NASH (5% of American adults). This indicates the increasing demand for disease-specific treatments and would therefore have a positive impact on this market. This is one of the major drivers of the non-alcoholic steatohepatitis drugs pipeline market and will positively impact the growth of this market in the upcoming future.
Overall, the global non-alcoholic steatohepatitis drugs pipeline market is projected to expand at a CAGR of 33.3% during the forecast period (2023 to 2033).
Currently, there are no approved drugs for the treatment of NASH, and available treatments focus on lifestyle changes and the management of comorbidities such as diabetes and obesity. This presents a great opportunity for drug developers to bring new and effective therapies to market. This lack of approved drugs is an opportunity for companies to develop new therapies for NASH. The first company that succeeds in bringing an FDA-approved NASH drug to market can gain a significant competitive advantage, as there is a large and growing patient population in need of effective treatments.
As the prevalence of NASH continues to rise, the economic burden of the disease is also increasing, which is driving demand for new treatments that can reduce the healthcare costs associated with the disease. As per one of the articles published by the Annals of Hepatology in September 2022, it was anticipated that NASH patients' lifetime expenses in the USA will be USD 222.6 Billion in 2017, with advanced NASH patients' costs coming in at USD 95.4 Billion. Thus, NASH imposes a significant economic burden on the USA. This points out the increasing demand for novel therapies for the treatment of NASH.
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There are several challenges in the clinical trials of NASH drugs, which include Biopsies are required to define participants and are also needed to demonstrate efficacy, many trials have a high failure rate when it comes to screening the trials due to stricter inclusion criteria and others. Clinical trials for NASH drugs are complex and expensive, requiring large numbers of patients and long follow-up periods to demonstrate safety and efficacy. This can make it difficult for small biotech companies with limited resources to develop and bring NASH drugs to market.
Apart from this, the exact mechanisms that cause NASH are not well understood, making it difficult for drug developers to find effective drug targets. This lack of understanding is a major obstacle to the development of new and effective NASH drugs. These factors are negatively impacting the growth of the non-alcoholic steatohepatitis drugs pipeline.
Currently, the share of phase 2 products is much more than the other phases of the clinical trials when it comes to the pipeline of NASH drugs. This held around 66.7% share of the pipeline assessment.
Phase 2 clinical trials of NASH drugs are designed to evaluate the safety and efficacy of investigational drugs in a small group of patients with NASH. Phase 2 clinical trials of NASH drugs typically enroll patients with biopsy-proven NASH and evidence of liver fibrosis. Patients are usually required to have certain liver function test results and other clinical criteria to be eligible for enrolment. As observed from the clinicaltrials.gov the number of drugs which are in phase 2 for the treatment of NASH is more than in other phases.
The oral route of administration is dominating segment in the route of administration in the NASH drugs pipeline, with a share of 53.7% of the NASH drugs pipeline market in 2022.
Many NASH drugs in the pipeline are being developed as oral medications. Oral administration is a convenient and non-invasive route of administration, and it allows for self-administration by patients. The choice of route of administration for a NASH drug depends on several factors, including the drug's properties, the target patient population, and the desired pharmacokinetic profile. Ultimately, the goal is to choose a route of administration that maximizes the drug's efficacy and safety while minimizing patient burden and adverse events.
The small molecules segment is leading the global market with share of around 64.5% in 2022 in terms of ongoing pipeline assessment. Small molecules are dominating segment in the molecules category in the NASH Pipeline Assessment. Small molecule drugs are one of the approaches being pursued in the development of treatments for NASH.
For example, Aramchol is a synthetic fatty acid derivative that is being developed by Galmed Pharmaceuticals. It is designed to reduce liver fat and inflammation by modulating lipid metabolism in the liver. Aramchol has shown promise in Phase II trials, with some patients experiencing improvements in liver fat and inflammation.
PF-05221304 is a small molecule inhibitor of acetyl-CoA carboxylase (ACC) that is being developed by Pfizer. ACC is an enzyme that plays a role in lipid metabolism in the liver. PF-05221304 has shown promise in preclinical studies. As observed from the clinicaltrials.gov the number of small molecules being tested for the treatment of NASH is more than the other types of molecules.
Receptor Agonist is dominating segment in the mechanism of action in the NASH Pipeline Assessment, with a share of 44.4%. Despite focusing on a wide range of mechanisms of action, several late-stage programs in the NASH pipeline have failed to demonstrate clinical success during the past 20 years. There are several receptor agonists under various phases of clinical trials which include Peroxisome proliferator-activated receptors (PPARs), Farnesoid X receptors (FXRs), Thyroid hormone receptor-β agonists, and others.
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Key market players are actively investing in significant research and development to develop novel therapies. Manufacturers are focused on regulatory approval. As a result of this, there is a promising product pipeline. Therefore, the presence of treatment solutions with the potential for commercialization is anticipated to boost market expansion and aid the players in fortifying their positions within this market.
A few of the recent instances include:
| Attribute | Details |
|---|---|
| Forecast Period | 2023 to 2032 |
| Historical Data Available for | 2021 to 2022 |
| Market Analysis | USD Million for Value |
| Key Regions Covered | North America; Europe; Latin America; East Asia and South Asia & Pacific |
| Key Market Segments Covered | Phases, Drugs, Route of Administration, Molecules, Mechanism of Action and Region |
| Key Companies Profiled | Pfizer Inc.; Merck & Co., Inc.; Zydus Lifesciences Ltd. (Cadila Pharmaceuticals); GSK plc.; AstraZeneca; Novartis AG; F. Hoffmann-La Roche Ltd (Genentech, Inc. (Jecure Therapeutics, Inc.)); Novo Nordisk A/S; Gilead Sciences; Viking Therapeutics; ENYO Pharma SA; Enanta Pharmaceuticals, Inc.; Oramed; Intercept Pharmaceuticals Inc.; Melinta Therapeutics LLC; Boston Pharmaceuticals; CytoDyn Inc.; Akero Therapeutics, Inc.; SINEW PHARMA INC.; AbbVie (Allergan (Tobira Therapeutics Inc.); Eli Lilly & Co.; Bristol Myers Squibb Co.; Boehringer Ingelheim International ; GmbH; NGM Biopharmaceuticals; Sagimet Biosciences; Madrigal Pharmaceuticals; Axcella Therapeutics; TaiwanJ Pharmaceuticals Co., Ltd.; Kowa Group (Kowa Company, Ltd.); Hepion Pharmaceuticals; HighTide Therapeutics Inc.; Cirius Therapeutics; Gmax Biopharm; TERNS PHARMACEUTICALS, INC.; NuSirt Biopharma; Galmed Pharmaceuticals; Ionis Pharmaceuticals, Inc. (Akcea Therapeutics); Inventiva; Histogen, Inc. (Conatuspharma.com) |
| Report Coverage | Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives |
| Pricing | Available upon Request |
The growth potential of the market is 33.3% through 2033.
Pharmaceutical companies are investing in research and development.
The oral route of administration is a dominating segment in 2022.
The market valuation in 2023 is USD 0.27 billion.
The increasing prevalence of obesity and diabetes drives sales.
1. Executive Summary | Non-alcoholic Steatohepatitis Drugs Pipeline Market 2. Market Overview 3. Key Market Trends 4. Market Background 5. Value Added Insights 6. Global Market Overview 6.1. Global Assessment, By Phases 6.1.1. Pre-clinical and Discovery stage candidates 6.1.2. Early-stage product (Phase I) 6.1.3. Mid-stage products (Phase II) 6.1.4. Late stage products (Phase III) 6.2. Global Assessment, By Drugs 6.2.1. Saroglitazar Magnesium 6.2.2. VK-1430 6.2.3. GMA-107 6.2.4. Resmetirom (MGL-3196) 6.2.5. MSDC-0602K 6.2.6. ION-224 6.2.7. HTD 1801 6.2.8. JKB-121 6.2.9. EDP-305 6.2.10. TERN-101 6.2.11. EYP001 6.2.12. SNP-610 6.2.13. SNP-630 6.2.14. Lanifibranor 6.2.15. Firsocostat 6.2.16. Tirzepatide 6.2.17. Others 6.3. Global Assessment, By Route of Administration 6.3.1. Oral 6.3.2. Subcutaneous 6.3.3. Others 6.4. Global Assessment, By Molecules 6.4.1. Small Molecules 6.4.2. Biologics 6.4.3. Oligonucleotides 6.5. Global Assessment, By Mechanism of Action 6.5.1. Receptor Agonist 6.5.2. Enzyme Inhibitor 6.5.3. Protein & Peptide Inhibitor 6.5.4. Receptor Antagonist 6.5.5. Others 6.6. Global Assessment, By Region 6.6.1. North America 6.6.2. Europe 6.6.3. Latin America 6.6.4. East Asia 6.6.5. South Asia & Pacific 7. Competition Analysis 7.1. Pfizer Inc. 7.2. Merck & Co., Inc. 7.3. Zydus Lifesciences Ltd. (Cadila Pharmaceuticals) 7.4. GSK plc. 7.5. AstraZeneca 7.6. Novartis AG 7.7. F. Hoffmann-La Roche Ltd (Genentech, Inc. (Jecure Therapeutics, Inc.)) 7.8. Novo Nordisk A/S 7.9. Gilead Sciences 7.10. Viking Therapeutics 7.11. ENYO Pharma SA 7.12. Enanta Pharmaceuticals, Inc. 7.13. Oramed 7.14. Intercept Pharmaceuticals, Inc. 7.15. Melinta Therapeutics LLC 7.16. Boston Pharmaceuticals 7.17. CytoDyn Inc. 7.18. Akero Therapeutics, Inc. 7.19. SINEW PHARMA INC. 7.20. AbbVie (Allergan (Tobira Therapeutics Inc.)) 7.21. Eli Lilly & Co. 7.22. Bristol Myers Squibb Co. 7.23. Boehringer Ingelheim International GmbH 7.24. NGM Biopharmaceuticals 7.25. Sagimet Biosciences 7.26. Madrigal Pharmaceuticals 7.27. Axcella Therapeutics 7.28. TaiwanJ Pharmaceuticals Co., Ltd 7.29. Kowa Group (Kowa Company, Ltd.) 7.30. Hepion Pharmaceuticals 7.31. HighTide Therapeutics Inc. 7.32. Cirius Therapeutics 7.33. Gmax Biopharm 7.34. TERNS PHARMACEUTICALS, INC. 7.35. NuSirt Biopharma 7.36. Galmed Pharmaceuticals 7.37. Ionis Pharmaceuticals, Inc. (Akcea Therapeutics) 7.38. Inventiva 7.39. Histogen, Inc. (Conatuspharma.com) 8. Nonalcoholic Steatohepatitis- Future Perspectives and Conclusion 9. Nonalcoholic Steatohepatitis Analyst Views 10. Assumptions and Acronyms Used 11. Research Methodology
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Non-alcoholic Steatohepatitis Drugs Pipeline Market
