Non-Alcoholic Steatohepatitis Market Forecast (2024-2031)
The non-alcoholic steatohepatitis market size is projected to reach US$ 77.42 billion by 2031 from US$ 3.53 billion in 2023. The market is expected to register a CAGR of 47.10% during 2023–2031. Growing clinical trials involving combination studies of drugs will likely remain a key trend in the market.
Non-Alcoholic Steatohepatitis Market Analysis
The rising incidence of NASH disorders is expected to propel the market for NASH treatments to more significant growth. The main factors driving the market's growth are the biotechnology industry's expansion and rising R&D spending in the area. Shortly, there will be plenty of lucrative opportunities due to the increasing adoption of NASH diagnosis, with Asia Pacific predicted to grow at the fastest rate. Several initiatives, both inorganic and organic, have been implemented by the businesses to support its expansion. Companies have been using various organic strategies to expand their businesses, such as product launches. The enterprises have used inorganic tactics like partnerships, mergers, and acquisitions. For example, Intercept Pharmaceuticals, Inc. announced in July 2021 that several abstracts on the use of obeticholic acid (OCA) to treat primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) will be presented at the 56th Annual Meeting of the European Association for the Study of the Liver (EASL), which will take place virtually from June 23 to June 26, 2021.
Non-Alcoholic Steatohepatitis Market Overview
The potentially deadly condition known as non-alcoholic steatohepatitis (NASH) results in severe liver cirrhosis and scarring. The most prevalent chronic liver disease worldwide is non-alcoholic fatty liver disease (NAFLD). A progressive type of NAFLD known as NASH is increasingly taking the lead in end-stage liver diseases and liver transplantation. The Global Liver Institute released data on June 12, 2019, which indicates that non-alcoholic steatohepatitis (NASH) is considered an epidemic. Moreover, it is a kind of non-alcoholic fatty liver disease (NAFLD) that progresses over time, affecting approximately 115 million individuals currently, with an estimated 357 million by 2030. Significant risk factors for NAFLD and NASH include obesity, type 2 diabetes, and hyperlipidemia; over 70% of the population is obese, 75% has type 2 diabetes, and 20–80% has hyperlipidemia. If NASH is not treated, it can lead to liver cancer, cirrhosis, and the requirement for a liver transplant.
NAFLD/NASH is becoming more common, but it is still an underdiagnosed condition, and preventing its progression and the consequences that go along with it requires early detection. Therefore, it is anticipated that the rising prevalence of NASH will drive the non-alcoholic steatohepatitis (NASH) market.
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Non-Alcoholic Steatohepatitis Market: Strategic Insights
Market Size Value in US$ 1,631.92 million in 2021 Market Size Value by US$ 24,266.81 million by 2028 Growth rate CAGR of 47.1% from 2021 to 2028. Forecast Period 2021- 2028 Base Year 2021
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Non-Alcoholic Steatohepatitis Market: Strategic Insights
| Market Size Value in | US$ 1,631.92 million in 2021 |
| Market Size Value by | US$ 24,266.81 million by 2028 |
| Growth rate | CAGR of 47.1% from 2021 to 2028. |
| Forecast Period | 2021- 2028 |
| Base Year | 2021 |
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Non-Alcoholic Steatohepatitis Market Drivers and Opportunities
Increasing Initiatives for the Awareness of NASH Favors the Market Growth
NASH is a disease that is not well understood. A systematic referral pathway and early detection of this disease depend on raising public and primary care physician (PCP) awareness of it. The patient pool can be increased by identifying more people and sending them to specialists for additional evaluation by creating a clear patient pathway for referrals and patient awareness campaigns. On June 12, 2018, "International NASH Day," the NASH Education Program launched a public education campaign to increase public knowledge of non-alcoholic fatty liver disease (NAFLD), which affects over 115 million people, and its more advanced form, NASH.
On June 12, 2019, International NASH Day, NASH 24X7, a digital platform dedicated to increasing exposure and awareness regarding the NASH epidemic, took a few actions, including HCP support patient awareness. NASH Crusaders of NASH 24X7 teamed up with leading HCPs (gastroenterologists and hepatologists) throughout India to spread awareness on International NASH Day. Regarding patient education, the NASH Crusaders of NASH 24X7 worked with healthcare professionals all over India to organize numerous small- and large-scale awareness- and education-raising workshops on liver health and the importance of leading a healthy lifestyle to prevent NAFLD/NASH. Several initiatives were launched to reach the general public on International NASH Day, including press releases and television programs that used print and digital media.
For International NASH Day on June 12, 2020, the American Liver Foundation joined a global community to raise awareness about NASH with support from the Allergan Foundation. American Liver Foundation (ALF) is now piloting a NASH Text Messaging Program, wherein people can sign up to receive three weekly messages for ten weeks. Messages include hyperlinks to NASH resources, facts, interactive quizzes, and sensible pointers for everyday self-management. ALF will open this system to the general public when the pilot is finished and evaluated. It collaborated with the Global Liver Institute (GLI) for International NASH Day and shared a few social media posts with links to GLI posts and the International NASH Day page.
Thus, rising initiatives for the awareness of NASH are driving the non-alcoholic steatohepatitis (NASH) market.
High Competition among Market Players to Manufacture the First Marketed NASH Drug Creates Global Sales Opportunity
According to Back Bay Life Science Advisors, at its peak, the global NASH market is anticipated to hit an average of USD 13 billion yearly by 2030. As of June 2020, the NASH pipeline of first-wave drugs holds 54 medical candidates in development by 47 companies evaluating 29 unique mechanisms of action. Over the last decades, the NASH pipeline witnessed many late-degree programs fail to reveal clinical efficacy after focusing on a broad range of mechanisms of action. Competition to manufacture the first marketed NASH drug stays high among market players, with numerous late-stage candidates vying for opportunities to launch the first marketed NASH drug. Below are a few companies in drug development's 3rd and 2nd phases. Market players are racing to be the first ones to launch drugs in the market, creating a more significant opportunity to generate sales in the global market.
Non-Alcoholic Steatohepatitis Market Report Segmentation Analysis
Key segments that contributed to the derivation of the non-alcoholic steatohepatitis market analysis are product, application, and sales channel.
- Based on product, the non-alcoholic steatohepatitis market is segmented into vitamin E and pioglitazone, elafibranor, ocaliva, selonsertib & cenicriviroc, and others. The other segment held the most significant market share in 2023.
- By application, the market is divided into treatment and diagnosis. The treatment segment held the largest share of the market in 2023.
- By sales channel, the market is segmented into hospital pharmacy, online provider, and retail pharmacy. The retail pharmacy segment held the largest share of the market in 2023.
Non-Alcoholic Steatohepatitis Market Share Analysis by Geography
The geographic scope of the non-alcoholic steatohepatitis market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South & Central America.
North America consists of three countries: the US, Canada, and Mexico. The US is the largest market for non-alcoholic steatohepatitis, followed by Canada and Mexico. The non-alcoholic steatohepatitis market is expected to grow at a faster rate due to rising research and development activities and increased adoption of technological advancements. Large healthcare organizations and the rising prevalence of non-alcoholic steatohepatitis also fuel the market's growth in this area. Overweight fat accumulates in the liver in a condition known as non-alcoholic fatty liver disease (NAFLD). Heavy alcohol use is not the cause of this fat accumulation. Alcohol-associated liver disease is the term for a condition where the accumulation of fat in the liver is brought on by heavy alcohol consumption. Non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) are the two forms of NAFLD. In the US, NAFLD is one of the most frequent causes of liver disease. NAFL is present in most NAFLD patients. NASH is only present in a tiny percentage of NAFLD patients. According to experts, 1.5% to 6.5% of American adults have NASH, and roughly 24% of adult Americans have NAFLD.
NASH is characterized by fat accumulation, inflammation, and cellular damage; it can also lead to cirrhosis and hepatocellular carcinoma. According to a US prevalence study, in 2016 there were 17.3 million NASH cases and 85.3 million NAFLD cases in the US. Due to these conditions, the nation's healthcare expenses are incurred in billions of dollars. Furthermore, NAFLD is a risk factor for cardiovascular disease on its own. As a result, NAFLD and NASH are becoming increasingly essential disease states for payers to oversee.
Non-Alcoholic Steatohepatitis Market Report Scope
Non-Alcoholic Steatohepatitis Market News and Recent Developments
The non-alcoholic steatohepatitis market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the non-alcoholic steatohepatitis market are listed below:
- Novartis announced that it had signed an agreement with Carisma Therapeutic to manufacture the HER 2 targeted CAR-M cell therapy, tested in initial trials to treat solid tumors. (Source: Novartis AG, Press Release, March 2022)
- Siemens Healthineers announced the launch of the Enhanced Liver Fibrosis (ELF) Test in US. This is the first time the test is commercially available in the U.S., following De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) in August 2021. (Source: Siemens Healthineers AG, Press Release, January 2022)
Non-Alcoholic Steatohepatitis Market Report Coverage and Deliverables
The “Non-Alcoholic Steatohepatitis Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:
- Non-alcoholic steatohepatitis market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- Non-alcoholic steatohepatitis market trends as well as market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST/Porter’s Five Forces and SWOT analysis
- Non-alcoholic steatohepatitis market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments.
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the non-alcoholic steatohepatitis market
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Product, Application, and Sales Channel
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
The market is expected to register a CAGR of 47.1% during 2023–2031.
Genfit SA, Cadila Pharmaceuticals Ltd., One Way Liver, S.L., BioPredictive S.A.S., Siemens Healthineers AG, Intercept Pharmaceuticals, Inc., Prometheus Laboratories, Novartis AG, Galmed Pharmaceuticals, Laboratory Corporation of America Holdings
Key factors driving the market are the Rising Prevalence of NASH and Increasing Initiatives for the Awareness of NASH.
Growing clinical trials involving combination studies of drugs will likely remain a key trend in the market.
North America dominated the non-alcoholic steatohepatitis market in 2023
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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