Liver Fibrosis Market

DelveInsight’s ‘Liver Fibrosis-Market Insights, Epidemiology, and Market Forecast–2032’ report deliver an in-depth understanding of the Liver Fibrosis, historical and forecasted epidemiology as well as the Liver Fibrosis market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

 

The Liver Fibrosis market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Liver Fibrosis market size from 2019 to 2032. The Report also covers current Liver Fibrosis treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

 

Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan

Study Period: 2019–2032

 

Liver Fibrosis Market Disease Understanding and Treatment Algorithm

Liver fibrosis results in the accumulation of extracellular matrix (ECM) proteins, mostly collagens Type I and Type III, followed by the formation of fibrous scar, which can ultimately compromise normal liver function. The main causes of liver fibrosis include alcohol abuse, chronic HCV infection, Non-alcoholic fatty liver disease, and NASH (Fatty Liver not due to alcohol use).

 

Regardless of the etiology, liver fibrosis is characterized by common molecular mechanisms such as hepatocyte death, chronic inflammation with cytokine release, activation of HSCs, and disruption of the epithelial or endothelial barrier.

 

Liver Fibrosis Diagnosis

Fibrosis is a precursor to cirrhosis, and establishing the severity of liver fibrosis helps predict liver-related morbidity and mortality and the emergence of complications of portal hypertension. Noninvasive methods to estimate hepatic fibrosis are commonly used in clinical practice as a safer, more accessible, and less costly strategy than liver biopsy for stratifying persons according to risk. These methods include indirect biomarkers, direct biomarkers, and elastography. If a combination of noninvasive methods provides a clear-cut assessment of hepatic fibrosis, further assessment with liver biopsy is generally not needed. Although liver biopsy with histologic analysis has long been considered the gold standard evaluation of hepatic fibrosis, it is now infrequently used to evaluate liver fibrosis in persons with chronic HCV. In the current era, the optimal approach to fibrosis assessment is to use noninvasive serum markers/tests in conjunction with transient elastography.

Continued in the report…..

 

Liver Fibrosis Treatment

Though, there is no approved drug for the treatment of this condition but various mechanism of action, such as inhibiting HSC activation, promoting HSC phenotypic conversion, immunological clearance of HSC, promoting HSC death, and inducing HSC senescence are a few of the methods that can repair liver fibrosis. According to the guidelines of the American Liver Foundation, Vitamin E is commonly prescribed to patients with Liver fibrosis (NASH) and works by reducing or neutralizing the damage caused by inflammation. However, both vitamin E as an antioxidant and pioglitazone as an insulin sensitizer have shown some efficacy against NASH in randomized controlled trials (RCTs). In recent years, ongoing research has paved the way for the development of pharmacological treatment. Several new emerging drugs such as lanifibranor, AXA1125, LPCN 1144, and others, are medications with a novel mechanism of action, currently being investigated in FDA trials to treat Liver Fibrosis specifically for NASH.

Continued in the report…..

 

Liver Fibrosis Epidemiology 

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent cases of Liver Fibrosis, Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH), Total Diagnosed Prevalent cases of Liver Fibrosis in NASH in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

 

Liver Fibrosis Key Findings

  • In the assessment done by DelveInsight, the estimated total diagnosed prevalent cases of Liver Fibrosis in the 7MM were 19,126,579 in 2021.
  • The highest diagnosed prevalent cases of Liver fibrosis were accounted by the US in 2021 (9,488,135 cases), which are expected to show a rise in the future.
  • Among the European countries, Germany had the highest diagnosed prevalent cases of Liver fibrosis with 1,641,162 cases, followed by Italy, which had diagnosed population of 1,532,651 in 2021. On the other hand, Spain had the lowest diagnosed population (1,307,582 cases).
  • Japan had 2,299,149 diagnosed cases of Liver fibrosis for in 2021, accounting for approximately 12% in 7MM.

 

Liver Fibrosis Market

 

Country-Wise Liver Fibrosis Epidemiology

The epidemiology segment also provides the Liver Fibrosis epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom),and Japan.

 

Liver Fibrosis Drug Chapters

The drug chapter segment of the Liver Fibrosis report encloses the detailed analysis of Liver Fibrosis drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Liver Fibrosis clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.

 

Liver Fibrosis Emerging Drugs

 

Lanifibranor: Inventiva Pharma

Lanifibranor is an orally-available small molecule that induces anti-fibrotic, anti-inflammatory, and beneficial metabolic changes in the body by activating each of the three PPAR isoforms, known as PPARα, PPARδ, and PPARɣ. PPARs are ligand-activated transcription factors belonging to the nuclear hormone receptor family that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ and partial activation of PPARɣ, while other PPAR agonists target only one or two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in clinical development. Fast Track Designation previously granted to Lanifibranol in NASH, on September 21, 2021, includes the treatment of NASH patients with compensatory cirrhosis by the Food and Drug Administration (FDA)

Products detail in the report…

 

Aramchol: Galmed Research and Development

Aramchol (arachidyl amido cholanoic acid) is a first-in-class, novel synthetic small molecule, a conjugate of cholic acid and arachidic acid, liver-targeted stearoyl-CoA desaturase 1 (SCD1) modulator, developed as an oral therapy to treat NASH -and fibrosis. It can modulate hepatic lipid metabolism which was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation, and fibrosis. The effect of Aramchol on fibrosis is mediated by the downregulation of steatosis and directly on human collagen-producing cells. Aramchol has been granted Fast Track Designation status by the FDA to treat NASH.

Products detail in the report…

List to be continued in the report…

 

Liver Fibrosis Market

 

Liver Fibrosis Market Outlook

Liver fibrosis is the result of excessive accumulation of the extracellular matrix of the liver due to chronic liver injury, and fibrosis is considered as a model for the wound healing response. This process is associated with an inflammatory response in which extracellular matrix (ECM) deposition is restricted. Persistent liver damage causes liver regeneration to fail and hepatocytes are replaced by large amounts of ECM, including collagen.

 

There is growing optimism that new medications that favor the natural history of the disease are likely to emerge within the next 3-5 years.

 

Due to the lack of standard treatment, liver transplantation is the only treatment option available for severe and advanced cases of fibrosis. No drug has been approved by the FDA for fibrosis and NASH, but few studies have shown promising results. According to the guidelines of the American Liver Foundation, Vitamin E is commonly prescribed to patients with NAFLD / NASH and works by reducing or neutralizing the damage caused by inflammation. However, both vitamin E as an antioxidant and pioglitazone as an insulin sensitizer have shown some efficacy against NASH in randomized controlled trials (RCTs).

 

In upcoming drug scenario, there are plethora of companies investigating agents for use in NASH based Fibrosis which are Inventiva Pharma, Galmed Pharmaceuticals, Madrigal pharma, Galectin therapeutics, Intercept Pharmaceuticals, Galectin Therapeutics Inc., Zydus Therapeutic. There are many more pharma companies which are conducting clinical trials for therapies of liver fibrosis or NASH.

Continued in the report…..

 

Liver Fibrosis Key Findings

  • The therapeutic market of Liver Fibrosis (NASH) in the 7MM was USD 2,225 million in 2021.
  • The United States accounts for the highest market size of Liver Fibrosis (NASH) approximately 79% of the total market size in 7MM in 2021, in comparison to the other major markets i.e., EU5 countries (the United Kingdom, Germany, Italy, France, and Spain),and Japan.
  • Among the EU5 countries, Germany had the highest market size with USD 94 million in 2021, while Spain had the lowest market size of Liver Fibrosis (NASH) with USD 55 million in 2021.
  • The market size for Liver Fibrosis (NASH) in Japan was estimated to be USD 108 Million in 2021, which accounts for 5% of the total 7MM market.
  • With the expected launch of upcoming therapies, such as Resmetirom, Lanifibranor, Aramchol, and others the total market of Liver Fibrosis (NASH) is expected to show change in upcoming years.

 

The United States Market Outlook

This section provides the total Liver Fibrosis (NASH) market size and; market size by therapies in the United States.

 

EU-5 Market Outlook

The total Liver Fibrosis (NASH) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

 

Japan Market Outlook

The total Liver Fibrosis (NASH) market size and market size by therapies in Japan are provided.

 

Liver Fibrosis Market

 

Liver Fibrosis Market Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Liver Fibrosis market (NASH) or expected to get launched in the market during the study period 2019–2032. The analysis covers Liver Fibrosis (NASH) market uptake by drugs; patient uptake by therapies; and sales of each drug. 

 

This 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 based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

 

Liver Fibrosis Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages. It also analyzes key players involved in developing targeted therapeutics.

 

Liver Fibrosis Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Liver Fibrosis emerging therapies.

 

Liver Fibrosis Reimbursement Scenario

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

 

Liver Fibrosis Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Liver Fibrosis market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

 

Report Metrics

Details

Study Period

2019 to 2032

Base Year

2021

Forecast Period

2022 to 2032

CAGR

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Market Size

USD 2,225 Million in 2021

Key Companies

Inventiva Pharma, Galmed Research and Development, Ltd., Madrigal Pharmaceuticals, Inc., Intercept Pharmaceuticals, Galectin Therapeutics Inc., Zydus Therapeutics, Axcella Therapeutics, Akero Therapeutics Inc, Lipocine Inc., Enyo Pharma, Sagimet Biosciences Inc., 89bio Inc., HighTide Biopharma, Rivus Pharmaceuticals Inc, Novo Nordisk A/S, and others

 

Liver Fibrosis Market Report Scope

  • The report covers the descriptive overview of Liver Fibrosis, explaining its signs and symptoms, causes, classification, and currently available therapies.
  • Comprehensive insight has been provided into the Liver Fibrosis epidemiology and treatment.
  • Additionally, an all-inclusive account of both the current and emerging therapies for Liver Fibrosis (NASH) is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of the Liver Fibrosis (NASH) market; historical and forecasted is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Liver Fibrosis (NASH) market.

 

Liver Fibrosis Market Report Highlights

  • The robust pipeline with novel MOA and oral ROA and increasing prevalence will positively drive the Liver Fibrosis market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Liver Fibrosis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition and underlying cause.
  • Major players are involved in developing therapies for Liver Fibrosis. The launch of emerging therapies will significantly impact the Liver Fibrosis market.
  • Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

 

Liver Fibrosis Market Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Liver Fibrosis Pipeline Analysis
  • Liver Fibrosis Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

 

Liver Fibrosis Market Report Key Strengths

  • 11-Years Forecast
  • 7MM Coverage
  • Liver Fibrosis Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

 

Liver Fibrosis Market Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Market Drivers and Barriers
  • SWOT analysis

 

Key Questions

Market Insights:

  • What was the Liver Fibrosis market share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the Liver Fibrosis total market size as well as market size by therapies across the 7MM during the forecast period (2022–2032)?
  • What are the key findings pertaining to the market across the 7MM and which country will have the largest Liver Fibrosis market size during the forecast period (2022–2032)?
  • At what CAGR, the Liver Fibrosis market is expected to grow at the 7MM level during the forecast period (2022–2032)?
  • What would be the Liver Fibrosis market outlook across the 7MM during the forecast period (2022–2032)?
  • What would be the Liver Fibrosis market growth till 2032 and what will be the resultant market size in the year 2032?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

 

Epidemiology Insights:

  • What is the disease risk, burden, and unmet needs of Liver Fibrosis?
  • What is the historical Liver Fibrosis patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
  • What would be the forecasted patient population of Liver Fibrosis at the 7MM level?
  • What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Liver Fibrosis?
  • Out of the above-mentioned countries, which country would have the highest prevalent population of Liver Fibrosis during the forecast period (2022–2032)?
  • At what CAGR the population is expected to grow across the 7MM during the forecast period (2022–2032)?

 

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

  • What are the current options for the treatment of Liver Fibrosis along with the approved therapy?
  • What are the current treatment guidelines for the treatment of Liver Fibrosis in the US, Europe, And Japan?
  • What are the Liver Fibrosis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
  • How many companies are developing therapies for the treatment of Liver Fibrosis?
  • How many emerging therapies are in the mid-stage and late stages of development for the treatment of Liver Fibrosis?
  • What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Liver Fibrosis therapies?
  • What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Liver Fibrosis and their status?
  • What are the key designations that have been granted for the emerging therapies for Liver Fibrosis?
  • What are the 7MM historical and forecasted market of Liver Fibrosis?

 

Reasons to buy

  • The report will help in developing business strategies by understanding trends shaping and driving the Liver Fibrosis.
  • To understand the future market competition in the Liver Fibrosis market and an Insightful review of the key market drivers and barriers.
  • Organize sales and marketing efforts by identifying the best opportunities for Liver Fibrosis in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
  • Organize sales and marketing efforts by identifying the best opportunities for the Liver Fibrosis market.
  • To understand the future market competition in the Liver Fibrosis market.

 

Frequently Asked Questions

What is the Liver Fibrosis?
Liver fibrosis results in the accumulation of extracellular matrix (ECM) proteins, mostly collagens Type I and Type III, followed by the formation of fibrous scar, which can ultimately compromise normal liver function. The main causes of liver fibrosis include alcohol abuse, chronic HCV infection, Non-alcoholic fatty liver disease, and NASH (Fatty Liver not due to alcohol use).
Who are the leading companies in the Liver Fibrosis Market Landscape?
Some of the key players of Liver Fibrosis Market includes Inventiva Pharma, Galmed Research and Development, Ltd., Madrigal Pharmaceuticals, Inc., Intercept Pharmaceuticals, Galectin Therapeutics Inc., Zydus Therapeutics, Axcella Therapeutics, Akero Therapeutics, Inc, Lipocine Inc., Enyo Pharma, Sagimet Biosciences Inc., 89bio Inc., HighTide Biopharma, Rivus Pharmaceuticals Inc, Novo Nordisk A/S, and others
What are the key strengths of Liver Fibrosis Market Report?
Key strengths of Liver Fibrosis Market Report are 11 Years Forecast, 7MM Coverage, Epidemiology Segmentation, Market Size, Drug Uptake, Pipeline Therapies, Market Drivers and Market Barriers.
Which country is expected to account for the most significant prevalent cases for Liver Fibrosis in the 7MM?
The US is expected to account for the highest Liver Fibrosis prevalent cases.

1. Key Insights

2. Report Introduction

3. Liver Fibrosis Market Overview at a Glance

3.1. Market Share (%) Distribution of Liver Fibrosis by Therapies in 2019

3.2. Market Share (%) Distribution of Liver Fibrosis by Therapies in 2032

4. Liver Fibrosis Market: Future Perspective

5. Executive Summary of Liver Fibrosis

6. Key Events

7. Disease Background and Overview: Liver Fibrosis

7.1. Introduction of Liver Fibrosis

7.2. Fibrogenesis in Liver Fibrosis

7.3. Etiology of Liver Fibrosis

7.3.1. Metabolic disorders: Non-alcoholic fatty liver disease and non-alcoholic steatohepatitis

7.3.2. Genetic disorders

7.3.3. Alcohol

7.3.4. Drugs

7.3.5. Cholestasis

7.3.6. Viral hepatitis

7.3.7. Parasitic infections

7.3.8. Cryptogenic causes

7.4. Pathophysiology of Liver Fibrosis

7.4.1. Cell types in liver fibrosis

7.5. Diagnostic Approach for Liver Fibrosis

7.5.1. General approach to evaluate liver fibrosis

7.5.2. Liver biopsy and histologic assessment of the liver

7.5.3. Classification of liver histology

7.5.4. Indirect markers of fibrosis

7.5.5. Direct markers of fibrosis

7.5.6. Radiologic Modalities to Estimate Fibrosis

7.6. Treatment

7.6.1. Treatment Algorithm

7.6.2. Treatment Guidelines

7.6.3. American Gastroenterological Association (AGA)

7.6.4. EASL-ALEH Clinical Practice Guidelines (European Association for the Study of the Liver)

7.6.5. Japanese Society of Gastroenterology in Conjunction With the Japan Society of Hepatology

8. Epidemiology and Patient Population

8.1. Key Findings

8.2. Methodology of Epidemiology

8.3. Assumptions and Rationale: 7MM

8.3.1. United States

8.3.2. EU-5 Countries

8.3.3. Japan

8.4. Total Diagnosed Prevalent cases of Liver Fibrosis in the 7MM

8.5. The United States

8.5.1. Total diagnosed prevalent cases of Liver fibrosis in the United States

8.5.2. Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in the United States

8.5.3. Total Diagnosed Prevalent cases of Liver fibrosis in NASH in the United States

8.6. Major Five European Countries

8.6.1. Total diagnosed prevalent cases of Liver fibrosis in the EU-5

8.6.2. Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in the EU-5

8.6.3. Total Diagnosed Prevalent cases of Liver fibrosis in NASH in the  EU-5

8.7. Japan

8.7.1. Total diagnosed prevalent cases of Liver fibrosis in Japan

8.7.2. Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in Japan

8.7.3. Total Diagnosed Prevalent cases of Liver fibrosis in NASH in Japan

9. Patient Journey

10 .Emerging Drugs

10.1. Key Competitors

10.2. Lanifibranor: Inventiva Pharma

10.2.1. Product description

10.2.2. Other development activities

10.2.3. Clinical development

10.2.4. Clinical trials information

10.2.5. Safety and efficacy

10.2.6. Product profile

10.2.7. Analyst views

10.3. Aramchol: Galmed Research and Development, Ltd.

10.3.1. Product description

10.3.2. Other development activities

10.3.3. Clinical development

10.3.4. Clinical Trials Information

10.3.5. Safety and efficacy

10.3.6. Product profile

10.3.7. Analyst views

10.4. MGL-3196 (Resmetirom): Madrigal Pharmaceuticals, Inc.

10.4.1. Product description

10.4.2. Other development activities

10.4.3. Clinical development

10.4.4. Clinical trials information

10.4.5. Safety and efficacy

10.4.6. Product profile

10.4.7. Analyst views

10.5. Obeticholic Acid (Ocaliva): Intercept Pharmaceuticals

10.5.1. Product description

10.5.2. Other development activities

10.5.3. Clinical development

10.5.4. Clinical trials information

10.5.5. Safety and efficacy

10.5.6. Product profile

10.5.7. Analyst views

10.6. GR-MD-02 (Belapectin): Galectin Therapeutics Inc.

10.6.1. Product description

10.6.2. Other development activities

10.6.3. Clinical development

10.6.4. Clinical trials information

10.6.5. Safety and Efficacy

10.6.6. Product profile

10.6.7. Analyst views

10.7. Saroglitazar Magnesium: Zydus Therapeutics

10.7.1. Product description

10.7.2. Clinical development

10.7.3. Clinical trials information

10.7.4. Safety and efficacy

10.7.5. Product profile

10.7.6. Analyst views

10.8. AXA1125: Axcella Therapeutics

10.8.1. Product description

10.8.2. Other development activities

10.8.3. Clinical development

10.8.4. Clinical trials information

10.8.5. Safety and efficacy

10.8.6. Product profile

10.8.7. Analyst views

10.9. EFX: Akero Therapeutics, Inc

10.9.1. Product Description

10.9.2. Other Development Activities

10.9.3. Clinical Development

10.9.4. Clinical Trials Information

10.9.5. Safety and Efficacy

10.9.6. Product Profile

10.9.7. Analysts’ Views

10.10. LPCN 1144: Lipocine Inc.

10.10.1. Product Description

10.10.2. Other Development Activities

10.10.3. Clinical Development

10.10.4. Clinical Trials Information

10.10.5. Safety and Efficacy

10.10.6. Product Profile

10.10.7. Analysts’ Views

10.11. EYP001a (Vonafexor): Enyo Pharma

10.11.1. Product description

10.11.2. Other development activities

10.11.3. Clinical development

10.11.4. Clinical trials information

10.11.5. Safety and efficacy

10.11.6. Product profile

10.11.7. Analyst views

10.12. TVB-2640 (Denifanstat): Sagimet Biosciences Inc.

10.12.1. Product description

10.12.2. Other development activities

10.12.3. Clinical development

10.12.4. Clinical trials information

10.12.5. Safety and efficacy

10.12.6. Product profile

10.12.7. Analyst views

10.13. Pegozafermin (BIO89-100): 89bio, Inc.

10.13.1. Drug description

10.13.2. Other development activities

10.13.3. Clinical development

10.13.4. Clinical trials information

10.13.5. Safety and efficacy

10.13.6. Product profile

10.14. HTD1801: HighTide Biopharma

10.14.1. Product Description

10.14.2. Other Development Activities

10.14.3. Clinical Development

10.14.4. Clinical Trials Information

10.14.5. Safety and Efficacy

10.14.6. Product Profile

10.14.7. Analysts’ Views

10.15. HU6: Rivus Pharmaceuticals, Inc.

10.15.1. Product Description

10.15.2. Clinical Development

10.15.3. Clinical Trials Information

10.15.4. Safety and Efficacy

10.15.5. Product Profile

10.15.6. Analysts’ Views

10.16. Semaglutide: Novo Nordisk A/S

10.16.1. Product Description

10.16.2. Other Development Activities

10.16.3. Clinical Development

10.16.4. Clinical Trials Information

10.16.5. Safety and Efficacy

10.16.6. Product Profile

10.16.7. Analysts’ Views

11. Liver Fibrosis: Seven Major Market Analysis

11.1. Key Findings

11.2. Methodology of Liver Fibrosis Market

11.3. Market Outlook

11.4. Potential of Emerging Therapies

11.5. Attribute Analysis

11.6. Key Market Forecast Assumptions

11.7. Market Size of Liver Fibrosis (NASH) in the 7MM

11.8. Market Size of Liver Fibrosis (NASH) by Therapies in the 7MM

11.9. Market Size of Liver Fibrosis (NASH) in the United States

11.9.1. Total Market Size of Liver Fibrosis (NASH)

11.9.2. Market Size of Liver Fibrosis by Therapies

11.10. Market Size of Liver Fibrosis (NASH) in the EU-5

11.10.1. Total Market Size of Liver Fibrosis

11.10.2. Market Size of Liver Fibrosis by Therapies

11.11. Market Size of Liver Fibrosis (NASH) in Japan

11.11.1. Total Market Size of Liver Fibrosis (NASH)

11.11.2. Market Size of Liver Fibrosis by Therapies

12. Key Opinion Leaders’ Views

13. Market Drivers

14. Market Barriers

15. SWOT Analysis

16. Unmet Needs

17. Reimbursement and Market Access

18. Appendix

18.1. Bibliography

18.2. List of Abbreviations

19. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

List of Table

Table 1: Summary of Liver Fibrosis Market and Epidemiology (2019–2032)

Table 2: Key Events

Table 3: Comparative Scoring System for Histologic Grade (Inflammation)

Table 4: Comparative Scoring System for Histologic Grade (Fibrosis)

Table 5: Total Diagnosed Prevalent cases of Liver Fibrosis in the 7MM (2019–2032)

Table 6: Total Diagnosed Prevalent Cases of Liver Fibrosis in the US (2019–2032)

Table 7: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in the US (2019–2032)

Table 8: Total Diagnosed Prevalent Cases of Liver Fibrosis in NASH in the US (2019–2032)

Table 9: Total Diagnosed Prevalent Cases of Liver Fibrosis in the EU-5 (2019–2032)

Table 10: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in the EU-5 (2019–2032)

Table 11: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in Germany (2019–2032)

Table 12: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in France (2019–2032)

Table 13: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in Italy (2019–2032)

Table 14: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in Spain (2019–2032)

Table 15: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in the UK (2019–2032)

Table 16: Total Diagnosed Prevalent cases of Liver fibrosis in NASH in EU-5 (2019–2032)

Table 17: Total Diagnosed Prevalent Cases of Liver Fibrosis in Japan (2019–2032)

Table 18: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in Japan (2019–2032)

Table 19: Total Diagnosed Prevalent cases of Liver fibrosis in NASH in Japan (2019–2032)

Table 20: Comparison of Approved Drugs for Liver Fibrosis

Table 21: Lanifibranor, Clinical Trial Description, 2022

Table 22: Aramchol, Clinical Trial Description, 2022

Table 23: MGL-3196, Clinical Trial Description, 2022

Table 24: Obeticholic Acid, Clinical Trial Description, 2022

Table 25: GR-MD-02, Clinical Trial Description, 2022

Table 26: Saroglitazar Magnesium, Clinical Trial Description, 2022

Table 27: AXA1125, Clinical Trial Description, 2022

Table 28: EFX, Clinical Trial Description, 2022

Table 29: LPCN 1144, Clinical Trial Description, 2022

Table 30: Vonafexor (EYP001), Clinical Trial Description, 2022

Table 31: TVB-2640 (Denifanstat), Clinical Trial Description, 2022

Table 32: HTD1801, Clinical Trial Description, 2022

Table 33: HU6, Clinical Trial Description, 2022

Table 34: Semaglutide, Clinical Trial Description, 2022

Table 35: Key Market Forecast Assumptions for Lanifibranor

Table 36: Key Market Forecast Assumptions for Aramchol

Table 37: Key Market Forecast Assumptions for MGL-3196 (Resmetirom)

Table 38: Key Market Forecast Assumptions for Obeticholic acid

Table 39: Key Market Forecast Assumptions for Pegozafermin

Table 40: Key Market Forecast Assumptions for Saroglitazar Magnesium

Table 41: Key Market Forecast Assumptions for AXA1125

Table 42: Key Market Forecast Assumptions for HU6

Table 43: Key Market Forecast Assumptions for LPCN 1144

Table 44: Key Market Forecast Assumptions for Semaglutide

Table 45: Key Market Forecast Assumptions for HTD1801

Table 46: Key Market Forecast Assumptions for Efruxifermin (EFX)

Table 47: Key Market Forecast Assumptions for Vonafexor

Table 48: Key Market Forecast Assumptions for TVB-2640

Table 49: Market Size of Liver Fibrosis (NASH) in the 7MM in USD Million (2019–2032)

Table 50: Market Size of Liver Fibrosis (NASH) by Therapies in the 7MM in USD Million (2019–2032)

Table 51: The United States Market Size of Liver Fibrosis (NASH) in USD Million (2019–2032)

Table 52: Market Size of Liver Fibrosis (NASH) by Therapies in the US in USD Million (2019–2032)

Table 53: The EU-5 Market Size of Liver Fibrosis (NASH), in USD Million (2019–2032)

Table 54: Market Size of Liver Fibrosis (NASH) by Therapies in Germany in USD Million (2019–2032)

Table 55: Market Size of Liver Fibrosis (NASH) by Therapies in France in USD Million (2019–2032)

Table 56: Market Size of Liver Fibrosis (NASH) by Therapies in Italy in USD Million (2019–2032)

Table 57: Market Size of Liver Fibrosis (NASH) by Therapies in Spain in USD Million (2019–2032)

Table 58: Market Size of Liver Fibrosis (NASH) by Therapies in the UK in USD Million (2019–2032)

Table 59: Market Size of Liver Fibrosis (NASH) by Therapies in the EU-5 in USD Million (2019–2032)

Table 60: Market Size of Liver Fibrosis (NASH) in Japan, in USD Million (2019–2032)

Table 61: Market Size of Liver Fibrosis (NASH) by Therapies in Japan in USD Million (2019–2032)

Table 62: List of abbreviations

List of Figures

Figure 1: Liver Architecture in Healthy Liver and Fibrosis. (A) Normal liver (B) Injury to hepatocytes due to any of Several Causes, Such as Alcohol, Drug, Genetic Predisposition, etc., Activates the Wound Healing Fibrogenic Response

Figure 2: Drivers Predisposing the Liver to Fibrosis

Figure 3: The TGF-β Signaling Pathway in Hepatic Stellate Cells

Figure 4: Summary of Important Pathways in the Progression of NAFLD to NASH

Figure 5: Alcohol Metabolism in the Liver

Figure 6: Metabolism of Drugs and Other Xenobiotics in the Liver

Figure 7: Pathophysiology of Liver Fibrosis

Figure 8: Aspartate Aminotransferase-to-Platelet-Ratio Index (APRI)

Figure 9: The Fib4 Represents an Easy-to-use Test for Predicting Severe Hepatic Fibrosis or Cirrhosis.

Figure 10: The FibroIndex is a Complicated Calculation That Requires a Platelet Count, Aspartate Aminotransferase (AST) Level, and Gamma Globulin Level.

Figure 11: The Forns Index Incorporates Easy-to-obtain Parameters but Requires a Highly Complicated Calculation

Figure 12: HepaScore (FibroScore)

Figure 13:  Castera Transient Elastography Cutoffs Correlating With Metavir Fibrosis

Figure 14: Castera Transient Elastography Cutoffs Correlating With Metavir Fibrosis

Figure 15: Ziols Transient Elastography Cutoffs Correlating with Metavir Fibrosis

Figure 16: Ziols Transient Elastography Cutoffs Correlating with Metavir Fibrosis

Figure 17: Castera and Ziol Cut-offs for Metavir F3 Fibrosis Score

Figure 18: Management of NAFLD with advanced fibrosis

Figure 19: Total Diagnosed Prevalent Cases of Liver Fibrosis in the 7MM (2019–2032)

Figure 20: Total Diagnosed Prevalent Cases of Liver Fibrosis in the US (2019–2032)

Figure 21: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in the US (2019–2032)

Figure 22: Total Diagnosed Prevalent cases of Liver fibrosis in NASH in the US (2019–2032)

Figure 23: Total Diagnosed Prevalent Cases of Liver Fibrosis in the EU-5 (2019–2032)

Figure 24: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in the EU-5 (2019–2032)

Figure 25: Total Diagnosed Prevalent cases of Liver fibrosis in NASH in the EU-5 (2019–2032)

Figure 26: Total Diagnosed Prevalent Cases of Liver Fibrosis in Japan (2019–2032)

Figure 27: Severity-specific Diagnosed cases of Non Alcoholic Steatohepatitis (NASH) in Japan (2019–2032)

Figure 28: Total Diagnosed Prevalent cases of Liver fibrosis in NASH in Japan (2019–2032)

Figure 29: Patient Journey

Figure 30: Overview of Treatment-emergent Adverse Events – Intention-to-treat (ITT) Subjects

Figure 31: Summary of Related or Possibly Related Treatment-Emergent Adverse Events by System Organ Class and Preferred Term – Intention-to-treat (ITT) Subjects

Figure 32: Summary of Moderate or Severe Treatment-emergent Adverse Events – Intention-to-treat (ITT) Subjects

Figure 33: Possible Potential of Emerging Therapy

Figure 34: Market Size of Liver Fibrosis (NASH) in the 7MM, in USD Million (2019–2032)

Figure 35: Market Size of Liver Fibrosis (NASH) by Therapies in the 7MM in USD Million (2019–2032)

Figure 36: Market Size of Liver Fibrosis (NASH) in the United States, USD Million (2019–2032)

Figure 37: Market Size of Liver Fibrosis (NASH) by Therapies in the United States, in USD Million (2019–2032)

Figure 38: Market Size of Liver Fibrosis (NASH) in the EU-5, USD Million (2019–2032)

Figure 39: Market Size of Liver Fibrosis (NASH) by Therapies, in the EU-5, in USD Million (2019–2032)

Figure 40: Market Size of Liver Fibrosis (NASH) in Japan, USD Million (2019–2032)

Figure 41: Market Size of Liver Fibrosis (NASH) by Therapies in Japan, in USD Million (2019–2032)

Figure 42: Market Drivers

Figure 43: Market Barriers

Figure 44: SWOT Analysis

Figure 45: Unmet Needs

Figure 46: European Pharmaceutical Markets

Inventiva Pharma
Galmed Research and Development, Ltd.
Madrigal Pharmaceuticals, Inc.
Intercept Pharmaceuticals
Galectin Therapeutics Inc.
Zydus Therapeutics
Axcella Therapeutics
Akero Therapeutics, Inc
Lipocine Inc.
Enyo Pharma
Sagimet Biosciences Inc.
89bio, Inc.
HighTide Biopharma
Rivus Pharmaceuticals, Inc.
Novo Nordisk A/S

 

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