Non-Alcoholic Steatohepatitis (NASH) - Market Insights, Epidemiology and Market Forecast - 2032

Key Highlights:

• Total diagnosed prevalent cases of Non-Alcoholic Steatohepatitis (NASH) were estimated at nearly 2.5 million in 2022 in Japan.
• Among the 7MM, estimations showed that Japan had the second highest number of cases of Non-Alcoholic Steatohepatitis (NASH) diagnosed patients, preceded by the US in 2022.
• The market size of NASH in Japan was approximately USD 200 million in 2022, which is anticipated to increase by 2032.
• The current treatment market for Non-Alcoholic Steatohepatitis (NASH) includes vitamin E, antifibrotic, antiviral, immunosuppressant, beta-blockers, and others used off-label.
• The total market size of the Non-Alcoholic Steatohepatitis (NASH) is anticipated to upsurge during the forecast period due to the expected entry of emerging therapies that includes MGL-3196 (Resmetirom), Lanifibranor/ IVA337, Efruxifermin, and others.
• The distribution of Non-Alcoholic Steatohepatitis (NASH) by severity-specific diagnosed prevalent cases was estimated for F0-F4 Stages and showed that F1 Stage has the highest burden in Japan.

DelveInsight's "Non-Alcoholic Steatohepatitis (NASH) - Market Insights, Epidemiology and Market Forecast - 2032" report delivers an in-depth understanding of the Non-Alcoholic Steatohepatitis (NASH), historical and forecasted epidemiology, and the Non-Alcoholic Steatohepatitis (NASH) market trends in Japan.

The Non-Alcoholic Steatohepatitis (NASH) market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted in Japan, Non-Alcoholic Steatohepatitis (NASH) market size from 2019 to 2032. The report also covers current Non-Alcoholic Steatohepatitis (NASH) treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered:

• Japan

Study Period: 2019-2032.

Disease Understanding and Treatment Algorithm

NASH Overview

NASH is the most common chronic respiratory disease all over the globe. It affects the airways in the lungs, which become inflamed and narrowed due to various triggers, making it harder for air to flow out. A complex activity between airway inflammation and remodeling results in airway hyper-responsiveness (AHR), leading to variable and excessive airway contraction. The symptoms of Non-Alcoholic Steatohepatitis (NASH) include wheezing, shortness of breath, cough, a sensation of tightness in the chest, straining of neck and chest muscles, rapid breathing, and changes in heart rate.

NASH Diagnosis

Diagnosing Non-Alcoholic Steatohepatitis (NASH) generally includes a medical history, physical exam, and lung tests. The main tests used to help diagnose Non-Alcoholic Steatohepatitis (NASH) are the FeNO test - that measures the level of nitric oxide in the breath, which is a sign of inflammation in the lungs, and spirometry - which measures how fast one can breathe out and how much air he/she can hold in the lungs.

Organizations like the Japanese Society of Gastroenterology (JSGE), and others have published criteria for diagnosing Non-Alcoholic Steatohepatitis (NASH).

Further details related to country-based variations are provided in the report

NASH Treatment

The current treatment of Non-Alcoholic Steatohepatitis (NASH) focuses on lifestyle modifications and managing the underlying risk factors associated with the disease. These include weight loss through a combination of diet and exercise, as obesity and insulin resistance are key contributors to Non-Alcoholic Steatohepatitis (NASH) development. Additionally, managing comorbid conditions such as diabetes, dyslipidemia, and hypertension is crucial. While there is no specific medication approved for the treatment of Non-Alcoholic Steatohepatitis (NASH), several promising drugs are undergoing clinical trials, targeting different aspects of the disease including metabolic pathways, inflammation, and fibrosis. These potential therapies offer hope for the future management of Non-Alcoholic Steatohepatitis (NASH), but currently, lifestyle interventions and risk factor management remain the cornerstone of Non-Alcoholic Steatohepatitis (NASH) treatment.

With recent development in disease understanding, tailored therapies are given based on the type of Non-Alcoholic Steatohepatitis (NASH). Besides medication, lifestyle changes are recommended. In some cases, bronchial thermoplasty might be recommended.

NASH Epidemiology

As the market is derived using the patient-based model, the Non-Alcoholic Steatohepatitis (NASH) epidemiology chapter in the report provides historical as well as forecasted epidemiology of total diagnosed prevalent cases of Non-Alcoholic Steatohepatitis (NASH) segmented by gender and severity in Japan, from 2019 to 2032. The total diagnosed prevalent cases of Non-Alcoholic Steatohepatitis (NASH) in Japan comprised approximately 2.5 million cases in 2022 and are projected to increase during the forecast period.

• Japan accounted for 2.5 million diagnosed prevalent cases of Non-Alcoholic Steatohepatitis (NASH) in 2022.
• According to DelveInsight's estimates, the distribution of diagnosed prevalent cases of NASH in Japan by gender reveals that males outnumber females, constituting 55% of the cases.
• Based on severity-specific segmentation as F0, F1, F2, F3, and F4. F1 stage is the most prevalent one in Japan, accounting for approximately 0.9 million cases in 2022.

Non-Alcoholic Steatohepatitis (NASH) Drug Chapters

The drug chapter segment of the Non-Alcoholic Steatohepatitis (NASH) report encloses a detailed analysis of Non-Alcoholic Steatohepatitis (NASH) marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands the Non-Alcoholic Steatohepatitis (NASH) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Emerging Drugs

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

Resmetirom (formerly MGL-3196) is a thyroid hormone receptor B-agonist. In December 2022, Madrigal announced topline results from the pivotal Phase III MAESTRO-NASH biopsy study of resmetirom. In addition, this study has the potential to support an additional indication for resmetirom in patients with well-compensated Non-Alcoholic Steatohepatitis (NASH) cirrhosis.

Efruxifermin (AKR-001): Akero Therapeutics, Inc.

Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for Non-Alcoholic Steatohepatitis (NASH). EFX is designed to offer convenient once-weekly SC dosing. EFX is currently being evaluated in two Phase II clinical trials in patients with biopsy-confirmed F1-F3 and F4 Non-Alcoholic Steatohepatitis (NASH) patients.

Note: Detailed emerging therapies assessment will be provided in the final report of Non-Alcoholic Steatohepatitis (NASH).

Drug Class Insights

The most popular drug classes used to treat Non-Alcoholic Steatohepatitis (NASH) include antivirals, antibiotics, antifibrotics, etc. For individuals with severe decompensated cirrhosis, early antiviral therapy is crucial. Antiviral therapy for Chronic Hepatitis B's primary objective is to reduce hepatic dysfunction and save patients from death. Interferon alpha (IFN) and nucleos(t)ide analogs are antiviral medications that are clinically used.

Non-Alcoholic Steatohepatitis (NASH) Market Outlook

To date, no drug has received approval from FDA, EMA, or PMDA (Pharmaceuticals and Medical Devices Agency) for treating Non-Alcoholic Steatohepatitis (NASH). The current front-line treatment includes lifestyle modifications, such as diet and exercise. Aside from lifestyle modifications, additional treatment options for Non-Alcoholic Steatohepatitis (NASH) have included off-label use of vitamin E and anti-diabetes agents (e.g., pioglitazone and liraglutide). Because of the complexity of the different potential pathways involved in the pathogenesis of Non-Alcoholic Steatohepatitis (NASH), treatment may have to target several key elements in cellular and molecular events to achieve meaningful results.

The launch of emerging therapies, such as Resmetirom (Madrigal Pharmaceuticals, Inc.) Efruxifermin (Akero Therapeutics, Inc), and others are expected to impact the market positively.

• The total market size of Non-Alcoholic Steatohepatitis (NASH) in Japan was around USD 200 million in 2022. This is estimated to increase by 2032 at a significant CAGR.
• Among the forecasted emerging therapies, MGL-3196 (Resmetirom) is expected to capture the highest market in Japan by 2032.
• Innovative therapeutic classes like FXR agonists, THR-B agonists, FGF modulators, PPAR modulators, GLP-1 receptor agonists, FASN inhibitors, CCR5 antagonists, FFAR4 agonists, and others are reshaping the pharmaceutical landscape. Expected regulatory approvals indicate substantial market expansion, fueled by the potential of these advanced treatments to address diverse medical conditions, paving the way for significant post-approval market growth.

Non-Alcoholic Steatohepatitis (NASH) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2019-2032. For example, for BIO89-100 (Pegozafermin), in Japan we expect the drug uptake to be slow-medium with a probability-adjusted peak share of around 3%, and years to the peak is expected to be 7 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report…

Non-Alcoholic Steatohepatitis (NASH) Pipeline Development Activities

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

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Non-Alcoholic Steatohepatitis (NASH) emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Non-Alcoholic Steatohepatitis (NASH) evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from the Department of Gastroenterology, Kobe Asahi Hospital; Liver Center, Saga University Hospital, Saga University, Saga, Japan; The Japanese Society of Gastroenterology (JSGE), Tokyo, and others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in Japan. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Non-Alcoholic Steatohepatitis (NASH) market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The cost of newly approved medications is usually high; patients can escape from proper treatment or opt for off-label and cheap medications. It affects access to newly launched medications in the market, and reimbursement is crucial. Often, the decision to reimburse comes down to the drug's price relative to the benefit it produces in treated patients. Market access and reimbursement options can differ depending on regulatory status, target population size, care setting, unmet need, the magnitude of incremental benefit claims, and costs.

The days of fee-for-service medicine may soon be over, and the healthcare market is steadily moving toward value-based payment models. In most of the country, insurance carriers are increasingly assembling narrow provider networks to try and rein in costs.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, descriptive overview of Non-Alcoholic Steatohepatitis (NASH), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the Non-Alcoholic Steatohepatitis (NASH) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering Japan drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive Japan Non-Alcoholic Steatohepatitis (NASH) market.

Non-Alcoholic Steatohepatitis (NASH) Report Insights

• Patient Population
• Therapeutic Approaches
• NASH Pipeline Analysis
• NASH Market Size and Trends
• Existing and Future Market Opportunity

Non-Alcoholic Steatohepatitis (NASH) Report Key Strengths

• 10 Years Forecast
• Japan Coverage
• NASH Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Non-Alcoholic Steatohepatitis (NASH) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

Market Insights

• What were the Non-Alcoholic Steatohepatitis (NASH) total market size, the market size by therapies, and market share (%) distribution in 2019, and how would it all look in 2032? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of Non-Alcoholic Steatohepatitis (NASH)?
• What will be the impact of the Resmetirom patent expiry in the market?
• How will Efruxifermin compete with the existing therapies for Non-Alcoholic Steatohepatitis (NASH) after approval?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risk, burdens, and unmet needs of Non-Alcoholic Steatohepatitis (NASH)? What will be the growth opportunities around Japan concerning the patient population of Non-Alcoholic Steatohepatitis (NASH)?
• What is the historical and forecasted Non-Alcoholic Steatohepatitis (NASH) patient pool Japan?
• Why do only limited patients appear for diagnosis?
• Which type of Non-Alcoholic Steatohepatitis (NASH) is more prevalent and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Non-Alcoholic Steatohepatitis (NASH)? What are the current guidelines for treating Non-Alcoholic Steatohepatitis (NASH) in Japan?
• How many companies are developing therapies for treating Non-Alcoholic Steatohepatitis (NASH)?
• How many emerging therapies are in the mid-stage and late stage of development for treating Non-Alcoholic Steatohepatitis (NASH)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Non-Alcoholic Steatohepatitis (NASH)?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are Japan historical and forecasted markets of Non-Alcoholic Steatohepatitis (NASH)?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Non-Alcoholic Steatohepatitis (NASH) Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in Japan.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions

1. How does the prevalence of NASH in Japan compare globally?

• While the United States leads in the number of diagnosed NASH cases, Japan ranks significantly in the global landscape, showcasing the worldwide impact of this liver disease.

2. What factors contribute to the growth of the NASH market in Japan post-approval?

• Anticipated regulatory approvals for novel treatments suggest a potential surge in the NASH market in Japan, driven by the demand for effective therapies addressing diverse medical conditions associated with NASH.

3. What is the current market scenario for NASH treatments in Japan?

• The NASH market in Japan is evolving, with a focus on innovative therapeutic classes. Emerging treatments like FXR agonists and others are gaining attention and undergoing regulatory evaluations.

4. What is the key driver of the NASH market?

• The NASH market is driven by the increasing global prevalence of the disease, fueled by rising awareness and a growing number of risk factors like obesity and diabetes. This has led to a heightened demand for effective treatments, spurring pharmaceutical R&D efforts, especially in innovative therapeutic classes, and potential regulatory approvals. The key driver is the convergence of rising NASH cases and the ongoing pursuit of novel treatment solutions.