Liver Fibrosis - Market Insight, Epidemiology and Market Forecast - 2032

DelveInsight's, 'Liver Fibrosis-Market Insights, Epidemiology, and Market Forecast-2032' report delivers 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 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.

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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.

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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.

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 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 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.

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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 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 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.

Pipeline Development Activities

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

Reimbursement Scenario in Liver Fibrosis

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.

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.

Scope of the Report:

• 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.

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 Report Insights

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

Liver Fibrosis Report Key Strengths

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

Liver Fibrosis 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.