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Global Non-alcoholic Steatohepatitis (NASH) Treatment Market Share, Size, Growth, Analysis, Forecast: By Drug Classification: Insulin Sensitizer, Ocaliva Thiazolidinediones, Biguanides, Gucagon-Like Peptide-1 Receptor Agonists, Others; By Diagnosis; By Sales Channel; By Treatment Channel; Regional Analysis; Supplier Landscape; 2023-2031

Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market Outlook

The non-alcoholic steatohepatitis (NASH) treatment market size attained a value of USD 6.2 billion in 2022. The market value is likely to rise at a CAGR of 5.7% during the forecast period of 2023-2031 to reach a value of about USD 10.3 billion by 2031. The growth can be attributed to the advanced study for diagnosis and drug development therapies.

 

Non-Alcoholic Steatohepatitis (NASH) Treatment Market: Insights

Non-Alcoholic Steatohepatitis (NASH) refers to the liver inflammation caused by the accumulation of fat in the liver. It is one of several disorders known as non-alcoholic fatty liver disease (NAFLD). The fat accumulation in the liver promotes inflammation and destroys liver cells, making it difficult for the liver to function efficiently.

 

NASH can further progress to scarring of the liver, which leads to cirrhosis, which is a chronic liver disease that causes degeneration of cells and fibrous thickening of tissue, among other severities. However, the condition does not always worsen. NASH is identical to the type of liver disease induced by chronic, excessive drinking. However, NASH can also happen to people who do not consume alcohol.

 

Chronic liver inflammation can harm the organ, leading to cirrhosis and finally liver failure, if not treated timely. In order to treat NASH, it is important to address its causes and risk factors, which include reducing body fat. Diabetes type 2 and metabolic syndrome, high cholesterol, high triglycerides, and obesity are some the key factors that lead to NASH and liver damage.

 

Non-alcoholic steatohepatitis (NASH) treatment market is expected to grow significantly due to the increasing prevalence of obesity and diabetes due to sedentary lifestyles, increased consumption of processed food and alcohol.

 

Diagnosis of the Disease

A physical exam and a study of the patient's medical history are initially done for the diagnosis. If NAFLD or NASH is suspected, blood tests will be performed to establish how well the liver is functioning. Magnetic resonance imaging (MRI) or ultrasound may also be utilised to aid the diagnosis. 

 

A liver biopsy will also be performed if NASH is suspected. A needle is used to extract a small bit of tissue from the liver, which is subsequently inspected under a microscope. This allows the doctor to see if there is any scarring or inflammation of the liver tissue. During the liver biopsy, patients are usually anaesthetised since it is an invasive process.

 

The Fatty Liver Program additionally employs MR-EFF (Elastography Fat Fraction) technology to evaluate the quantity of fat and scarring present. This non-invasive diagnostic technology has the potential to eliminate the necessity for a liver biopsy.

 

According to the global non-steatohepatitis (NASH) treatment market research report, the market can be categorised into the following segments: 

 

Market Breakup by Drug Classification

  • Insulin Sensitizer
    • Ocaliva Thiazolidinediones
    • Biguanides 
    • Gucagon-like Peptide-1 Receptor Agonists
    • Dipeptidyl Peptidase IV Inhibitors
  • Farnesoid X Receptor Agonists
    • Ocaliva
  • Phenylimidazoles
    • Selonsertib
  • Vitamin E and Pioglitazone
  • Elafibranor
  • Cencicriviroc
  • Others

 

Market Breakup by Diagnosis

  • Blood Tests
  • CT Scan
  • MRI Scan
  • Abdominal Ultrasound
  • Liver Biopsy

 

Market Breakup by Sales Channel

  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Provider

 

Market Breakup by Treatment Channel

  • Public
  • Private

 

Market Breakup by Region

  • North America
    • United States of America
    • Canada
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Others
  • Asia Pacific
    • China
    • Japan
    • India
    • ASEAN
    • Australia
    • Others
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • United Arab Emirates
    • Nigeria
    • South Africa
    • Others

 

Global Non-Alcoholic Steatohepatitis Epidemiology

Non-alcoholic fatty liver disease is widespread. According to researchers, up to 25.2% of adults globally have NAFLD, although only 1.5-6.45% of those have NASH. 

 

NAFLD and NASH were found in 54% and 65.26% of type 2 diabetes mellitus patients, respectively. The global prevalence of NAFLD is relatively high, yet it disproportionately affects people of Hispanic descent, notably Mexicans. The increased frequency of obesity and metabolic syndrome in the context of high genetic vulnerability could explain this.

 

Global Non-Alcoholic Steatohepatitis Market Drivers

A rise in medical costs and rise in obesity and diabetes are the major factors influencing the non-alcoholic steatohepatitis market growth during the forecast period. Lack of access to medical care and inactive lifestyle will further accelerate the growth of the non-alcoholic steatohepatitis treatment market. 

 

As part of ongoing research projects and advanced study for diagnosis and drug development therapies, the growth of the non-alcoholic steatohepatitis treatment market is also expected to propel further during the forecast period. It is also possible that in the near future, more precise methods of diagnosing NASH and NAFLD will lead to the expansion of the non-alcoholic steatohepatitis treatment market.

 

The slow drug approval process is one of the primary factors that is restraining the growth of the market. 

 

Asia Pacific is Dominating the Global Non-Alcoholic Steatohepatitis Treatment Market

North America accounted for the largest share of the global market, almost 79.62%, in 2021. This can be attributed to the region's high disease burden, higher healthcare expenditure, improved patient awareness. The United States had the greatest prevalence of NASH cases, followed by Japan.

 

Among the European countries, Spain had the lowest prevalence of NASH, whereas Germany had the highest. The Asia Pacific region is predicted to witness significant growth during the forecast period. This is particularly common in nations with a high prevalence of NASH, such as Japan.

 

Therapeutic Landscape

NASH is characterised by lobular inflammation and hepatocellular distension, which can lead to liver cirrhosis.

 

In most patients, diet and lifestyle changes are not possible, so NASH needs to be treated with drugs. The progression of disease is characterised by insulin resistance, oxidative stress, and activation of inflammatory cytokines.

 

NASH was first treated with Thiazolidinediones like Pioglitazone and antioxidants like vitamin E. It is caused by a number of different pathways, including metabolic homeostasis, inflammation, oxidative stress, and liver fibrosis. Several new molecules have been developed in recent years that target these pathways. 

 

Placebo-controlled phase IIb clinical trial, Obeticholic acid (INT-747) and Elafibranor (GFT-505) showed promising results. A phase III study is currently taking place to determine whether they are safe and effective. There are phase 1 and phase 2 trials currently being conducted for potential treatments for NASH.

 

Emerging Therapies and Clinical trials

Non-alcoholic steatohepatitis (NASH) does not currently have FDA approved treatment but various companies are working to develop new drugs using organic and inorganic methods. There are currently more than 50 pipeline candidates.

 

Due to the issues such as the lack of licenced medications, the high disease burden, and difficult diagnostic techniques, the NASH therapeutic market has significant unmet needs. Off-label medications such as Pioglitazone and Vitamin E currently dominate the global market. These are regularly recommended medications in this field around the world. To meet the unmet need, prominent market participants are investing extensively in R&D operations to discover innovative therapies for NASH treatment. 

 

A key factor supporting the growth of the pipeline for non-alcoholic steatohepatitis treatments is the increase in research incentives and funding. It is expected that several clinical candidates will reach the global market within the next eight years after they reach the final stages of development.

 

Clinical Trials:

  • In a phase 3 metacenter trial, Intercept Pharmaceuticals is testing its lead molecule, a farnesoid X receptor agonist.
  • Genfit's Elafranor is a phase 3 drug that is a peroxisome-activated receptor alpha/delta. Two other drugs are also in phase 3 trials, Tobira Therapeutics' Cenicriviroc and Gilead's selonsertib. In the pipeline of drugs for non-alcoholic steatohepatitis, late-phase failures carry huge financial costs to their sponsors.
  • In May 2022, Pfizer Inc., a pharmaceutical and biotechnology company, said that the FDA has approved ervogastat and clesacostat for the treatment of non-alcoholic steatohepatitis (NASH). A combination therapy called Fast Track, presented by Pfizer, is being tested in patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis. In its decision, the FDA considered Pfizer's nonclinical studies and the results of the Phase 2a clinical trial of ervogastat/clesacostat and concluded that treatment with it reduced liver fat with a favourable safety and tolerability profile. An ongoing Pfizer study of ervogastat/clesacostat aims to evaluate the therapy's efficacy in improving non-alcoholic steatohepatitis or liver fibrosis. The study is expected to be completed by 2024.

 

Research and development investment and increasing interest in growth strategies by industry experts will create favorable conditions for global non- steatohepatitis treatment market expansion during the forecast period.

 

Competitive Landscape

The report gives an in-depth analysis of the key players involved in the global non-alcoholic steatohepatitis (NASH) treatment market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows: 

 

  • Genfit S.A.
  • Allergan Plc. (AbbVie Inc.)
  • Zydus Lifesciences Ltd.
  • Conatus Pharmaceuticals, Inc.
  • Galmed Pharmaceuticals Ltd.
  • NeuroBo Pharmaceuticals Ltd.
  • Gilead Sciences, Inc.
  • Pfizer Inc.
  • Takeda Pharmaceutical Company Limited.
  • Novartis AG
  • Icon Plc.
  • Novo Nordisk A/S
  • GlaxoSmithKline Plc

 

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2022
Historical Period 2016-2022
Forecast Period 2023-2031
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Drug Classification
  • Diagnosis
  • Sales Channel
  • Treatment Channel
  • Region
Breakup by Drug Classification
  • Insulin Sensitizer
  • Ocaliva Thiazolidinediones
  • Biguanides
  • Gucagon-Like Peptide-1 Receptor Agonists
  • Dipeptidyl Peptidase IV Inhibitors
  • Farnesoid X Receptor Agonists
  • Phenylimidazoles
  • Vitamin E and Pioglitazone
  • Others
Breakup by Diagnosis
  • Blood Tests
  • CT Scan
  • MRI Scan
  • Abdominal Ultrasound
  • Liver Biopsy
Breakup by Sales Channel
  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Provider
Breakup by Treatment Channel
  • Public
  • Private
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • SWOT
  • Porter's Five Forces
  • Key Indicators for Demand
  • Key Indicators for Price
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Company Overview
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • Genfit S.A.
  • Allergan Plc. (AbbVie Inc.)
  • Zydus Lifesciences Ltd.
  • Conatus Pharmaceuticals, Inc. (Histogen)
  • Galmed Pharmaceuticals Ltd.
  • NeuroBo Pharmaceuticals
  • Gilead Sciences, Inc.
  • Pfizer Inc.
  • Takeda Pharmaceutical Company Limited
  • Novartis AG
  • Icon Plc.
  • Novo Nordisk A/S
  • GlaxoSmithKline Plc.

 

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1    Preface
    1.1    Objectives of the Study
        1.1.1    Research Objectives
        1.1.2    Key Findings of the Report
    1.2    Limitations of the Study and Scope for Future Research
2    Research Methodology
3    Executive Summary
4    Global Non-Alcoholic Steatohepatitis Overview 

    4.1    Guidelines and Stages
    4.2    Pathophysiology
    4.3    Screening and Diagnosis
    4.4    Treatment Pathway 
5    Patient Profile
    5.1    Patient Profile Overview 
    5.2    Patient Psychology and Emotional Impact Factors 
    5.3    Risk Assessment and Treatment Success Rate 
6    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market
    6.1    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market Overview
    6.2    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market Analysis 
        6.2.1     Market Overview
            6.2.1.1    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market Historical Value (2016-2022) 
            6.2.1.2    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market Forecast Value (2023-2031)
    6.3    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market by Drug Classification
        6.3.1    Market Overview
            6.3.1.1    Insulin Sensitizer
            6.3.1.2    Ocaliva Thiazolidinediones
            6.3.1.3    Biguanides 
            6.3.1.4    Gucagon-Like Peptide-1 Receptor Agonists
            6.3.1.5    Dipeptidyl Peptidase IV Inhibitors
            6.3.1.6    Farnesoid X Receptor Agonists
                6.3.1.6.1    Ocaliva
            6.3.1.7    Phenylimidazoles
                6.3.1.7.1    Selonsertib
            6.3.1.8    Vitamin E and Pioglitazone
            6.3.1.9    Others
                6.3.1.9.1    Elafibranor
                6.3.1.9.2    Cencicriviroc
    6.4    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market by Diagnosis
        6.4.1    Market Overview
            6.4.1.1    Blood Tests
            6.4.1.2    CT Scan
            6.4.1.3    MRI Scan
            6.4.1.4    Abdominal Ultrasound 
            6.4.1.5    Liver Biopsy
    6.5    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market by Sales Channel
        6.5.1    Market Overview
            6.5.1.1    Hospital Pharmacy
            6.5.1.2    Retail Pharmacy
            6.5.1.3    Online Provider
    6.6    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market by Treatment Channel
        6.6.1    Public
        6.6.2    Private
    6.7    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market by Region
        6.7.1    Market Overview
            6.7.1.1    North America 
                6.7.1.1.1    Historical Trend (2016-2022)
                6.7.1.1.2    Forecast Trend (2023-2031)
            6.7.1.2    Europe
                6.7.1.2.1    Historical Trend (2016-2022)
                6.7.1.2.2    Forecast Trend (2023-2031)
            6.7.1.3    Asia Pacific
                6.7.1.3.1    Historical Trend (2016-2022)
                6.7.1.3.2    Forecast Trend (2023-2031)
            6.7.1.4    Latin America
                6.7.1.4.1    Historical Trend (2016-2022)
                6.7.1.4.2    Forecast Trend (2023-2031)
            6.7.1.5    Middle East and Africa
                6.7.1.5.1     Historical Trend (2016-2022)
                6.7.1.5.2    Forecast Trend (2023-2031)
7    North America Non-Alcoholic Steatohepatitis (NASH) Treatment Market
    7.1    United States of America
        7.1.1    Historical Trend (2016-2022)
        7.1.2    Forecast Trend (2023-2031)
    7.2    Canada 
        7.2.1    Historical Trend (2016-2022)
        7.2.2    Forecast Trend (2023-2031)
8    Europe Non-Alcoholic Steatohepatitis (NASH) Treatment Market
    8.1    United Kingdom
        8.1.1    Historical Trend (2016-2022)
        8.1.2    Forecast Trend (2023-2031)
    8.2    Germany
        8.2.1    Historical Trend (2016-2022)
        8.2.2    Forecast Trend (2023-2031)
    8.3    France
        8.3.1    Historical Trend (2016-2022)
        8.3.2    Forecast Trend (2023-2031)
    8.4    Italy
        8.4.1    Historical Trend (2016-2022)
        8.4.2    Forecast Trend (2023-2031)
9    Asia Pacific Non-Alcoholic Steatohepatitis (NASH) Treatment Market
    9.1    China
        9.1.1    Historical Trend (2016-2022)
        9.1.2    Forecast Trend (2023-2031)
    9.2    Japan
        9.2.1    Historical Trend (2016-2022)
        9.2.2    Forecast Trend (2023-2031)
    9.3    India
        9.3.1    Historical Trend (2016-2022)
        9.3.2    Forecast Trend (2023-2031)
    9.4    ASEAN
        9.4.1    Historical Trend (2016-2022)
        9.4.2    Forecast Trend (2023-2031)
    9.5    Australia
        9.5.1    Historical Trend (2016-2022)
        9.5.2    Forecast Trend (2023-2031)
10    Latin America Non-Alcoholic Steatohepatitis (NASH) Treatment Market
    10.1    Brazil
        10.1.1    Historical Trend (2016-2022)
        10.1.2    Forecast Trend (2023-2031)
    10.2    Argentina
        10.2.1    Historical Trend (2016-2022)
        10.2.2    Forecast Trend (2023-2031)
    10.3    Mexico
        10.3.1    Historical Trend (2016-2022)
        10.3.2    Forecast Trend (2023-2031)
11    Middle East and Africa Non-Alcoholic Steatohepatitis (NASH) Treatment Market
    11.1    Saudi Arabia
        11.1.1    Historical Trend (2016-2022)
        11.1.2    Forecast Trend (2023-2031)
    11.2    United Arab Emirates
        11.2.1    Historical Trend (2016-2022)
        11.2.2    Forecast Trend (2023-2031)
    11.3    Nigeria
        11.3.1    Historical Trend (2016-2022)
        11.3.2    Forecast Trend (2023-2031)
    11.4    South Africa
        11.4.1    Historical Trend (2016-2022)
        11.4.2    Forecast Trend (2023-2031)
12    Current Scenario Evaluation and Regulatory Framework
    12.1    Emerging Therapies and Clinical Trials Synopsis
    12.2    Patent Landscape
        12.2.1    Patent Overview
            12.2.1.1    Patent Status and Expiry
            12.2.1.2    Timelines from Drug Development to Commercial Launch
            12.2.1.3    New Drug Application
                12.2.1.3.1    Documentation and Approval Process
    12.3    Cost of Treatment
    12.4    Regulatory Framework
        12.4.1    Regulatory Overview
            12.4.1.1    US FDA
            12.4.1.2    EU EMA
            12.4.1.3    INDIA CDSCO
            12.4.1.4    JAPAN PMDA
            12.4.1.5    Others
13    Challenges and Unmet Needs
    13.1    Treatment Pathway Challenges
    13.2    Compliance and Drop - Out Analysis
    13.3    Awareness and Prevention Gaps
14    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market Dynamics
    14.1    Market Drivers and Constraints
    14.2    SWOT Analysis
    14.3    Porter’s Five Forces Model
    14.4    Key Demand Indicators
    14.5    Key Price Indicators
    14.6    Industry Events, Initiatives and Trends
    14.7    Value Chain Analysis
15    Supplier Landscape
    15.1    Genfit S.A.
        15.1.1    Company Overview
        15.1.2    Product Portfolio
        15.1.3    Demographic Reach and Achievements
        15.1.4    Mergers and Acquisitions
        15.1.5    Certifications
    15.2    Allergan Plc. (AbbVie Inc.)
        15.2.1    Company Overview
        15.2.2    Product Portfolio
        15.2.3    Demographic Reach and Achievements
        15.2.4    Mergers and Acquisitions
        15.2.5    Certifications
    15.3     Zydus Lifesciences Ltd.
        15.3.1    Company Overview
        15.3.2    Product Portfolio
        15.3.3    Demographic Reach and Achievements
        15.3.4    Mergers and Acquisitions
        15.3.5     Certifications
    15.4    Conatus Pharmaceuticals, Inc. (Histogen) 
        15.4.1    Company Overview
        15.4.2    Product Portfolio
        15.4.3    Demographic Reach and Achievements
        15.4.4    Mergers and Acquisitions
        15.4.5    Certifications
    15.5     Galmed Pharmaceuticals Ltd.
        15.5.1    Company Overview
        15.5.2    Product Portfolio
        15.5.3    Demographic Reach and Achievements
        15.5.4    Mergers and Acquisitions
        15.5.5    Certifications
    15.6    NeuroBo Pharmaceuticals
        15.6.1    Company Overview
        15.6.2    Product Portfolio
        15.6.3    Demographic Reach and Achievements
        15.6.4    Mergers and Acquisitions
        15.6.5    Certifications
    15.7    Gilead Sciences, Inc.
        15.7.1    Company Overview
        15.7.2    Product Portfolio
        15.7.3    Demographic Reach and Achievements
        15.7.4    Mergers and Acquisitions
        15.7.5    Certifications
    15.8    Pfizer Inc.
        15.8.1    Company Overview
        15.8.2    Product Portfolio
        15.8.3    Demographic Reach and Achievements
        15.8.4    Mergers and Acquisitions
        15.8.5    Certifications
    15.9    Takeda Pharmaceutical Company Limited
        15.9.1    Company Overview
        15.9.2    Product Portfolio
        15.9.3    Demographic Reach and Achievements
        15.9.4    Mergers and Acquisitions
        15.9.5    Certifications
    15.10    Novartis AG
        15.10.1    Company Overview
        15.10.2    Product Portfolio
        15.10.3    Demographic Reach and Achievements
        15.10.4    Mergers and Acquisitions
        15.10.5    Certifications
    15.11    Icon Plc.
        15.11.1    Company Overview
        15.11.2    Product Portfolio
        15.11.3    Demographic Reach and Achievements
        15.11.4    Mergers and Acquisitions
        15.11.5    Certifications
    15.12    Novo Nordisk A/S
        15.12.1    Company Overview
        15.12.2    Product Portfolio
        15.12.3    Demographic Reach and Achievements
        15.12.4    Mergers and Acquisitions
        15.12.5    Certifications
    15.13    GlaxoSmithKline Plc.
        15.13.1    Company Overview
        15.13.2    Product Portfolio
        15.13.3    Demographic Reach and Achievements
        15.13.4    Mergers and Acquisitions
        15.13.5    Certifications
16    Recommendations and Discussion
17    Global Non-Alcoholic Steatohepatitis (NASH) Treatment Drugs Distribution Model (Additional Insight)

    17.1    Overview 
    17.2    Potential Distributors 
    17.3    Key Parameters for Distribution Partner Assessment 
18    Payment Methods (Additional Insight)
    18.1    Government Funded
    18.2    Private Insurance
    18.3    Out-of-Pocket

 

*Additional insights provided are customisable as per client requirements.

Key Questions Answered in the Report

The market size attained a value of USD 9.3 billion in 2022.

The market is likely to grow at a CAGR of 56.7% during the forecast period of 2023-2031.

The market is expected to reach a value of USD 529.3 billion by 2031.

The high prevalence of obesity and diabetes, increasing number of patients and presence of major players focused on development, and marketing of technologically advanced products will drive the market growth during the forecast period.

Asia Pacific is the dominating region in the global market owing to the rising cases of liver issues due to increased alcoholism.

Genfit S.A., Allergan Plc. (AbbVie Inc.), Zydus Lifesciences Ltd., Conatus Pharmaceuticals, Inc., Galmed Pharmaceuticals Ltd., NeuroBo Pharmaceuticals Ltd., Gilead Sciences, Inc., Pfizer Inc., Takeda Pharmaceutical Company Limited., Novartis AG, Icon Plc., Novo Nordisk A/S, and GlaxoSmithKline Plc, among others are the key players in the market.

Lack of awareness of the treatment and slow drug approval will restrain the growth of non-alcoholic steatohepatitis (NASH) treatment market.

Excess fat cells in liver, diabetes type 2 and metabolic syndrome, high cholesterol, high triglycerides, and obesity are among the key factors that lead to NASH and liver damage.

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