Nonalcoholic Steatohepatitis Market Insights, Epidemiology and Market Forecast-2028
DelveInsight’s
‘Nonalcoholic
Steatohepatitis Market Insights, Epidemiology and Market Forecast-2028’ NASH Market report delivers an
in-depth understanding of the disease, historical & forecasted epidemiology
as well as the NASH market trends in the United States, EU5 (Germany, Spain, Italy,
France and United Kingdom), and Japan.
The Report
provides the current nonalcoholic steatohepatitis treatment practices, emerging
drugs, NASH market share of the individual therapies, current and forecasted
market size of Nonalcoholic Steatohepatitis from 2016 to 2028 segmented by
seven major markets. The Report also covers current treatment
practice/algorithm, market drivers, market barriers and unmet medical needs to
curate best of the opportunities and assess underlying potential of the market.
- The United States
- EU5 (Germany, France, Italy,
Spain and the United Kingdom)
- Japan
Study
Period: 2016-2028
Nonalcoholic
Steatohepatitis (NASH) is the progressive form of liver injury that carries a
risk of progressive fibrosis, cirrhosis, and end-stage liver disease. It is an
advanced form of non-alcoholic fatty liver disease (NAFLD), caused by buildup
of fat in the liver. When this buildup causes inflammation and damage, it is
known as NASH, which can lead to scarring of the liver. Scarring of the liver
is a potentially life-threatening condition called cirrhosis. Nonalcoholic
Steatohepatitis usually comes under the category of silent diseases
that has very few or no symptoms typically because it doesn’t cause any
symptoms until it’s too late.
The
classification of fibrosis stages of NASH is as follows: No Fibrosis (F0), NASH
Fibrosis (F1, F2 and F3), and NASH Cirrhosis (F4). According to various
studies, such as Schuppan D et.al. [2019], Siddharth Singh et.al. [2014], and
others NASH has been defined to keep progressing from early stages (F0 and F1)
to advanced stages (F2, F3, F4) over time. The development of NASH with
cirrhosis increases the risk of NASH
Decompensated Cirrhosis and ultimately to death.
The
DelveInsight Nonalcoholic Steatohepatitis market report gives the thorough
understanding of the NASH by including details such as disease definition,
classification, symptoms, etiology, pathophysiology, diagnostic trends. It also
provides treatment algorithms and treatment guidelines for NASH in the US,
Europe, and Japan.
The NASH
Epidemiology division provide the insights about historical and current patient
pool and forecasted trend for every 8 major countries. It helps to recognize
the causes of current and forecasted trends by exploring numerous studies and
views of key opinion leaders. This part of the DelveInsight report also
provides the diagnosed patient pool and their trends along with assumptions
undertaken.
The disease
epidemiology covered in the report provides historical as well as forecasted
epidemiology [segmented by Total Prevalent Cases of Non-Alcoholic Fatty Liver
Disease, Total Prevalent cases of Nonalcoholic Steatohepatitis and Nonalcoholic
Steatohepatitis Segmentation by Fibrosis Stage] scenario of Nonalcoholic
Steatohepatitis in the 7MM countries covering United States, EU5 countries
(Germany, Spain, Italy, France and United Kingdom), and Japan from 2016-2028.
According to
DelveInsight, increase in obesity, diabetes population will significantly
increase the prevalent cases of NAFLD with the CAGR of 1.02% for the study
period i.e. 2016-2028 in the 7MM. Of all the prevalent cases of NAFLD in the
7MM, approximately 19% of the population fulfilled the criteria for NASH. These
cases are expected to increase throughout the study period [2016-2028],
reaching nearly 47 million cases in 2028. We estimate highest prevalence of
NASH in the United States, accounting for almost 50% of the total prevalent
cases, followed by Japan. On the other hand, it is assessed that among the
European countries, Germany accounted for the highest prevalent population,
followed by Italy. Among all the 7MM countries, Spain had the lowest prevalent
population.
This segment
of the Nonalcoholic
Steatohepatitis report encloses the detailed analysis of marketed drugs
and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to
understand the 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.
NASH treatment
depends on the stage of the disease. Currently, there is no approved therapy
for the treatment of NASH, yet doctors prescribe certain off-label drugs
(supportive therapies) for its management. Lifestyle modifications are however
the first line treatment. Lifestyle modifications include going for weight loss
combined with active exercise program. Diet is also planned accordingly.
Medications
are then prescribed in the later stages when lifestyle modifications do not
produce significant results. Insulin sensitizing agents are prescribed in
certain cases, however, metformin produced good results but on a temporary
basis, due to which it is not recommended much. Pioglitazone is recommended in
selected cases for patients already suffering with type II diabetes.
Vitamin E
produces very significant results and is prescribed in most cases. Vitamin E is
a first line therapy only for patients without diabetes. It is not recommended
for patients with diabetes, NASH cirrhosis or cryptogenic cirrhosis. Statins
are also prescribed in cases when a person has the cardiovascular risk
associated with NASH. Statins are not recommended until histologic data are
available.
Detailed
chapters of upcoming therapies such as Elafibranor (Genfit), OCA (Intercept
Pharmaceuticals), Selonsertib (Gilead Sciences), Cenicriviroc (Allergan-
Tobira), GS-9674 (Gilead Sciences), Aramchol_005 (Galmed), MSDC-0602K (Cirius
Therapeutics), Emricasan (Conatus Pharmaceuticals), and others which are
expected to launch during the nonalcoholic steatohepatitis market forecast
period [2019-2028] have also been covered in the report.
The Nonalcoholic
Steatohepatitis market outlook of the report helps to build the
detailed comprehension of the historic, current and forecasted trend of the
market by analyzing the impact of current therapies on the market, unmet needs,
drivers and barriers and demand of better technology.
This segment
gives a through detail of market trend of each marketed drug and late-stage
pipeline therapy by evaluating their impact based on annual cost of therapy,
inclusion and exclusion criteria’s, mechanism of action, compliance rate,
growing need of the market, increasing patient pool, covered patient segment,
expected launch year, competition with other therapies, brand value, their
impact on the market and view of the key opinion leaders. The calculated market
data are presented with relevant tables and graphs to give a clear view of the
market at first sight.
Nonalcoholic
Steatohepatitis market treatment will experience significant annual growth over
the 2016-2028 study period, as major-market sales increase up to USD 30,096.1
million by 2028. As the number of effective treatments for the NASH increases
during the forecast period, the supportive therapies (off-label) market share
will start to decrease, from a peak of 100% in 2016 to ~11% in 2028.
Elafibranor (Genfit) will be the first drug for the NASH treatment which will
targeting the NASH Fibrosis (F1, F2 & F3) patients and Obeticholic acid (OCA;
Intercept Pharmaceutical) will give competition to Elafibranor.
Intercept’s OCA is expected to grab maximum nonalcoholic steatohepatitis market
share, owing to its development to target all stages of NASH (F1 to F4), except
F0 and with the increasing demand for therapies to treat advanced stage of
NASH, i.e. cirrhosis.
This section
focusses on the rate of uptake of the potential NASH drugs recently launched in
the market or will get launched in the market during the study period from
2016-2028. The analysis covers 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 on the basis of
market share and size which again will be useful in investigating factors
important in market uptake and in making financial and regulatory decisions.
The leading
companies in NASH market are Genfit, Intercept Pharmaceuticals, Gilead
Sciences, Allergan (Tobira Therapeutics), Galmed Pharmaceuticals, Bristol-Myers
Squibb, Cirius Therapeutics, Conatus Pharmaceuticals, Galectin Therapeutics,
Immuron, NGM Biopharmaceuticals, Akcea Therapeutics and others. We expect that
the launch of emerging therapies will fill the treatment void in the near
future. The targeted therapies will have stronger penetration than the
off-label therapies and the market is expected to reach in billions.
Intercept’s
Obeticholic Acid (OCA) is expected to grab maximum market share, owing to its
development to target all stages of NASH (F1 to F4), except F0 and with the
increasing demand for therapies to treat advanced stage of NASH, i.e.
cirrhosis, this drug is expected to influence the market size with a greater
percentage.
Apart from
OCA, Selonsertib, and Emricasan, two other drugs which are expected to enter
the NASH therapeutic market targeting cirrhosis stage of NASH, include GR-MD-02
by Galectin Therapeutics and Immuron’s IMM-124E. Both of these drugs are
expected will grab a significant proportion in the market size.
Furthermore,
the expected launch of drugs, which are in the Phase II stage of clinical
development shall significantly drive the market size forward. Emricasan
(IDN-6556; Conatus Pharmaceuticals) is one of the drugs currently in Phase II,
which will occupy more share in the therapeutic market of NASH as compared to
two of the drugs in the Phase III, i.e. Cenicriviroc and Selonsertib.
It is
expected that the NASH market size of currently available off-label therapies
for the treatment shall decrease, owing to the launch of upcoming therapies in
NASH market forecast period [2019-2028]. Moreover, the ratio of drugs that will
target all the NASH stages (F1 to F4) to those that are restricted towards the
treatment of only one-or two of the stages, will be significant. Overall, the
increasing prevalence, awareness of the disease and promising emerging
nonalcoholic steatohepatitis pipeline therapies will fuel the market size
during the forecasted period of 2019-2028.
- Nonalcoholic Steatohepatitis
Patient Population
- Nonalcoholic Steatohepatitis
Therapeutic Approaches
- NASH Pipeline Analysis
- Nonalcoholic Steatohepatitis
Market Size and Nonalcoholic Steatohepatitis Market Trends
- NASH Market Opportunities
- Impact of upcoming Nonalcoholic
Steatohepatitis Therapies
- 10 Years Nonalcoholic
Steatohepatitis Forecast
- NASH 7MM Coverage
- Nonalcoholic Steatohepatitis
Epidemiology Segmentation
- Nonalcoholic Steatohepatitis Key
Cross Competition
- Nonalcoholic Steatohepatitis
Market Size by Therapies
- NASH Drugs Uptake
- NASH Pipeline Product Profiles
- Nonalcoholic Steatohepatitis Key
Products and Nonalcoholic Steatohepatitis Key Players
- NASH Market Drivers and NASH
Market Barriers
- This DelveInsight report will
help to develop Business Strategies by understanding the trends shaping
and driving Nonalcoholic Steatohepatitis market
- Organize NASH sales forecasting
and marketing efforts by identifying the best opportunities for Nonalcoholic
Steatohepatitis market
- To understand the future market
competition in the Nonalcoholic Steatohepatitis market.
1. Key Insights
2. Non-Alcoholic
Steatohepatitis (NASH) Market Overview at a Glance
2.1. Market Share (%) Distribution of NASH
in 2016
2.2. Market Share (%) Distribution of NASH
in 2028
3. Disease Background and
Overview: Non-Alcoholic Steatohepatitis
3.1. Introduction
3.2. Signs and Symptoms of NASH
3.3. Causes and Risk Factors
3.4. Classification of NASH
3.5. Pathophysiology
3.5.1. Pathogenesis
3.5.2. Hedgehog signaling
3.6. Diagnosis
3.6.1. Physical examination
3.6.2. Laboratory examination
3.6.3. Blood tests
3.6.4. Imaging tests
3.6.5. Liver biopsy
3.6.6. Current diagnostic Trends (Noninvasive fibrosis tests)
3.6.7. Functional Diagnostic tools of NASH
4. Epidemiology and
Patient Population
4.1. Key Findings
5. 7MM Epidemiology
5.1. Total Prevalent Cases of NAFLD in 7MM
5.2. Total Prevalent cases of NASH in 7MM
6. United States
Epidemiology
6.1. Assumptions and Rationale
6.2. Total Prevalent Cases of NAFLD in the
United States
6.3. Total Prevalent cases of NASH in the
United States
6.4. NASH Segmentation by Fibrosis Stage in
the United States
7. EU5 Epidemiology
7.1. Germany Epidemiology
7.1.1. Assumptions and Rationale
7.1.2. Total Prevalent Cases of NAFLD in Germany
7.1.3. Total Prevalent cases of NASH in Germany
7.1.4. NASH Segmentation by Fibrosis Stage in Germany
7.2. France Epidemiology
7.2.1. Assumptions and Rationale
7.2.2. Total Prevalent Cases of NAFLD in France
7.2.3. Total Prevalent cases of NASH in France
7.2.4. NASH Segmentation by Fibrosis Stage in France
7.3. Italy Epidemiology
7.3.1. Assumptions and Rationale
7.3.2. Total Prevalent Cases of NAFLD in Italy
7.3.3. Total Prevalent Cases of NASH in Italy
7.3.4. NASH Segmentation by Fibrosis Stage in Italy
7.4. Spain Epidemiology
7.4.1. Assumptions and Rationale
7.4.2. Total Prevalent Cases of NAFLD in Spain
7.4.3. Total Prevalent cases of NASH in Spain
7.4.4. NASH Segmentation by Fibrosis Stage in Spain
7.5. United Kingdom Epidemiology
7.5.1. Assumptions and Rationale
7.5.2. Total Prevalent Cases of NAFLD in the United Kingdom
7.5.3. Total Prevalent cases of NASH in the United Kingdom
7.5.4. NASH Segmentation by Fibrosis Stage in the United
Kingdom
7.6. Japan Epidemiology
7.6.1. Assumptions and Rationale
7.6.2. Total Prevalent Cases of NAFLD in Japan
7.6.3. Total Prevalent cases of NASH in Japan
7.6.4. NASH Segmentation by Fibrosis Stage in Japan
8. Treatment Goals
9. Treatment Algorithm
10. Experts Opinions for Off-Label
(Supportive Therapies) drugs for the treatment of NASH
11. Treatment Guidelines
11.1. American Association for the Study of Liver
Diseases (AASLD) Current Recommendations for NAFLD/NASH
11.2. EASL–EASD–EASO* Clinical Practice Guidelines for
the management of non-alcoholic fatty liver disease
11.3. Guideline for NAFLD/NASH, by the Japanese Society
of Gastroenterology (JSG) in cooperation with “The Japan Society of Hepatology”
12. Unmet needs
13. Key Cross Competitors
14. Emerging Drugs
14.1. Elafibranor (GFT505): Genfit
14.1.1. Drug Description
14.1.2. Other Development Activities
14.1.3. Advantages & Disadvantages
14.1.4. Clinical Development
14.1.5. Clinical Trials Information
14.1.6. Safety and Efficacy
14.1.7. Product Profile
14.2. Obeticholic Acid (OCA, Ocaliva): Intercept
Pharmaceuticals
14.2.1. Drug Description
14.2.2. Other Development Activities
14.2.3. Advantages & Disadvantages
14.2.4. Clinical Development
14.2.5. Clinical Trials Information
14.2.6. Safety and Efficacy
14.2.7. Product Profile
14.3. Selonsertib (SEL, Formerly GS-4997): Gilead
Sciences
14.3.1. Drug Description
14.3.2. Other Development Activities
14.3.3. Advantages & Disadvantages
14.3.4. Clinical Development
14.3.5. Clinical Trials Information
14.3.6. Safety and Efficacy
14.3.7. Product Profile
14.4. Cenicriviroc (CVC): Allergan (Tobira
Therapeutics)
14.4.1. Drug Description
14.4.2. Other Development Activities
14.4.3. Advantages and Disadvantages
14.4.4. Clinical Development
14.4.5. Clinical Trials Information
14.4.6. Safety and Efficacy
14.4.7. Product Profile
14.5. GS-9674: Gilead Sciences
14.5.1. Drug Description
14.5.2. Other Developmental Activities
14.5.3. Clinical Development
14.5.4. Clinical Trials Information
14.5.5. Safety and Efficacy
14.5.6. Product Profile
14.6. GS-0976: Gilead Sciences
14.6.1. Drug Description
14.6.2. Other Development Activities
14.6.3. Clinical Development
14.6.4. Clinical Trials Information
14.6.5. Safety and Efficacy
14.6.6. Product Profile
14.7. Aramchol_005: Galmed Pharmaceuticals Ltd.
14.7.1. Drug Description
14.7.2. Other Development Activities
14.7.3. Clinical Development
14.7.4. Clinical Trials Information
14.7.5. Safety and Efficacy
14.7.6. Product Profile
14.8. BMS-986036 (Pegylated FGF21): Bristol-Myers
Squibb (BMS)
14.8.1. Drug Description
14.8.2. Other Development Activities
14.8.3. Clinical Development
14.8.4. Clinical Trials Information
14.8.5. Safety and Efficacy
14.8.6. Product Profile
14.9. IMM-124E: Immuron
14.9.1. Drug Description
14.9.2. Other Developmental Activities
14.9.3. Clinical Development
14.9.4. Clinical Trials Information
14.9.5. Safety and Efficacy
14.9.6. Product Profile
14.10. GR-MD-02: Galectin Therapeutics
14.10.1. Drug
Description
14.10.2.
Other Developmental Activities
14.10.3.
Clinical Development
14.10.4.
Clinical Trials Information
14.10.5.
Safety and Efficacy
14.10.6.
Product Profile
14.11. Emricasan (IDN-6556): Conatus Pharmaceuticals
14.11.1. Drug
Description
14.11.2.
Other Developmental Activities
14.11.3.
Clinical Development
14.11.4.
Clinical Trials Information
14.11.5.
Safety and Efficacy
14.11.6.
Product Profile
14.12. MSDC-0602K: Cirius Therapeutics
14.12.1. Drug
Description
14.12.2.
Other Developmental Activities
14.12.3.
Clinical Development
14.12.4.
Clinical Trials Information
14.12.5.
Safety and Efficacy
14.12.6.
Product Profile
14.13. NGM282: NGM Biopharmaceuticals
14.13.1. Drug
Description
14.13.2. Other
Developmental Activities
14.13.3.
Clinical Development
14.13.4.
Clinical Trials Information
14.13.5.
Safety and Efficacy
14.13.6.
Product Profile
14.14. JKB-121 (Nalmefene): TaiwanJ Pharmaceuticals
14.14.1. Drug
Description
14.14.2.
Other Developmental Activities
14.14.3.
Clinical Development
14.14.4.
Clinical Trials Information
14.14.5.
Safety and Efficacy
14.14.6.
Product Profile
14.15. Semaglutide: Novo Nordisk
14.15.1. Drug
Description
14.15.2.
Other Developmental Activities
14.15.3.
Clinical Development
14.15.4.
Clinical Trials Information
14.15.5.
Product Profile
14.16. LMB763: Novartis Pharmaceuticals
14.16.1.
Product Description
14.16.2.
Other Developmental Activities
14.16.3.
Clinical Development
14.16.4.
Clinical Trials Information
14.16.5.
Product Profile
14.17. LJN452 (Tropifexor): Novartis Pharmaceuticals
14.17.1. Drug
Description
14.17.2.
Other Developmental Activities
14.17.3.
Clinical Development
14.17.4.
Clinical Trials Information
14.17.5.
Product Profile
14.18. MT-3995 (Apararenone): Mitsubishi Tanabe Pharma
14.18.1. Drug
Description
14.18.2.
Clinical Development
14.18.3.
Clinical Trials Information
14.18.4.
Product Profile
14.19. MN-001 (Tipelukast): MediciNova
14.19.1. Drug
Description
14.19.2.
Other Developmental Activities
14.19.3.
Clinical Development
14.19.4.
Clinical Trials Information
14.19.5.
Safety and Efficacy
14.19.6.
Product Profile
14.20. MGL-3196: Madrigal Pharmaceuticals
14.20.1. Drug
Description
14.20.2.
Other Developmental Activities
14.20.3.
Clinical Development
14.20.4.
Clinical Trials Information
14.20.5.
Safety and Efficacy
14.20.6.
Product Profile
14.21. Lanifibranor (IVA33): Inventiva Pharma
14.21.1. Drug
Description
14.21.2.
Other Developmental Activities
14.21.3.
Clinical Development
14.21.4.
Clinical Trials Information
14.21.5.
Safety and Efficacy
14.21.6.
Product Profile
14.22. Solithromycin (CEM-101): Cempra Inc (Melinta Therapeuctics)
14.22.1. Drug
Description
14.22.2.
Other Development Activities
14.22.3.
Clinical Development
14.22.4.
Clinical Trials Information
14.22.5.
Safety and Efficacy
14.22.6.
Product Profile
14.23. CF102 (Namodenoson): Can-Fite BioPharma
14.23.1. Drug
Description
14.23.2.
Other Developmental Activities
14.23.3.
Clinical Development
14.23.4.
Clinical Trials Information
14.23.5.
Safety and Efficacy
14.23.6.
Product Profile
15. Nonalcoholic Steatohepatitis
(NASH): 7 Major Market Analysis
15.1. Key Findings
15.2. Market Size: Assumptions and Forecast Parameters
15.3. Market Size of Nonalcoholic Steatohepatitis
(NASH) in 7MM
15.4. Market Distribution (%) of Nonalcoholic
Steatohepatitis (NASH), in 2016, 2022 and 2028, in the 7MM
16. The United States: Market Outlook
16.1. The United States Market Size
16.1.1. Total Market size of NASH
16.1.2. Market Size of NASH by Therapies
17. EU5: Market Outlook
17.1. Germany Market Size
17.1.1. Total Market size of NASH
17.1.2. Market Size of NASH by Therapies
17.2. France Market Size
17.2.1. Total Market size of NASH
17.2.2. Market Size of NASH by Therapies
17.3. Italy Market Size
17.3.1. Total Market size of NASH
17.3.2. Market Size of NASH by Therapies
17.4. Spain Market Size
17.4.1. Total Market size of NASH
17.4.2. Market Size of NASH by Therapies
17.5. The United Kingdom Market Size
17.5.1. Total Market size of NASH
17.5.2. Market Size of NASH by Therapies
18. Japan: Market Outlook
18.1. Japan Market Size
18.1.1. Total Market size of NASH
18.1.2. Market Size of NASH by Therapies
19. Market Drivers
20. Market Barriers
21. Appendix
21.1. Report Methodology
22. DelveInsight Capabilities
23. Disclaimer
24. About DelveInsight
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