Non-alcoholic Steatohepatitis Clinical Trials Market (By Phase: Phase I, Phase II, Phase III, Phase IV; By Study Design: Interventional, Observational, Expanded Access) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook 20222030

The global non-alcoholic steatohepatitis clinical trials market size was valued at USD 2.40 billion in 2020, and is predicted to be worth around USD 4.1 billion by 2030, registering a CAGR of 6.4% during the forecast period 2022 to 2030.

Growth Factors

Rising healthcare expenditure, cases of obesity, and prevalence of non-alcoholic steatohepatitis (NASH) are the factors driving the growth of this market. Due to the COVID-19 pandemic, enrollment in new drug clinical trials for NASH patients was halted, but people shifted to alternate means of data collecting methods, like virtual visits. Non-alcoholic Steatohepatitis is a fatty liver disease that causes scarring and damage to the liver.

The growth can be attributed to factors, such as increased drug R&D, rising prevalence of obesity & diabetes mainly due to sedentary lifestyles, and unmet medical needs. The COVID-19 pandemic and the FDA’s request for further post-interim safety and effectiveness data have slowed the final approval of phase III trial evaluating obeticholic acid for non-alcoholic Steatohepatitis (NASH), drug development. The COVID-19 pandemic in 2020 drew attention to the various vulnerabilities of those living with conditions, such as diabetes and obesity. The largest risk of COVID-19 is associated with NASH.

Report Coverage

By Phase Analysis

The segment of phase III accounted for more than 39.5% of the global revenue share in 2021. The phase III trials are associated with high costs. For instance, a single phase 3 study costs around USD 100 million.

A Phase III trial gathers further data on the drug’s safety and effectiveness by evaluating different populations and dosages, as well as using it in conjunction with other drugs. 

The most successful and cost-effective way to identify and monitor NASH patients for clinical trials is to use smart, quantitative imaging in combination with other clinical markers for NASH. According to current FDA guidelines, all Phase 3 NASH trials must involve at least two liver biopsies.

One at the start of the study to verify the patient’s eligibility, and another at the end to assess treatment efficacy. The complete cost of a liver biopsy, including the procedure, processing, and pathologist read, is expected to be USD 7,000 or more.

By Study Design Analysis

The interventional segment dominated the market with the largest share of more than 45.5% in 2021. In December 2019, there were 84 ongoing interventional studies with patients enrolled to evaluate the therapeutic efficacy of therapies for NASH. 

The FDA and the EMA recognized that the reliable way to diagnose NASH is through a histopathological analysis of a tissue sample obtained from a liver biopsy. Biomarkers are a point of contention between the EMA and the FDA.

In phase 2 of a trial, the FDA strongly recommends the use of a biomarker signature method. The EMA does not forbid such a strategy from being used in phase 2, but it also does not necessitate it to be used in phase 2. 

As no satisfactory therapies are available, it could be a viable option for patients with significant disease conditions to receive treatment outside of a clinical trial. The expanded access trials market is expected to be driven by increasing innovation in NASH clinical trial approaches.

By Regional Analysis

Asia Pacific region is anticipated to register the fastest growth rate of 7.6% over the forecast period. The high prevalence of diabetes and obesity, as well as the growing number of people affected by these disorders (which is anticipated to rise by 30-fold by 2030), are driving the region’s growth.

Around 5% of patients with NAFLD are likely to have NASH. In India, there are no standardized NAFLD screening guidelines. Because the majority of noncirrhotic NAFLD and NASH patients are asymptomatic, fatty liver is usually diagnosed based on an ultrasound finding and/or increased liver enzymes. Newer

Newer and better imaging modalities for assessing fatty liver and fibrosis, such as magnetic resonance imaging derived proton density fat fraction and MR elastography, have been developed in recent technological advances and are being used in early-phase NASH trials to assess liver fat content and fibrosis stage. 

Key Players

• Pfizer Inc.

• Novartis AG

• Icon Plc

• LabCorp

•  Allergan Plc

• Cadila Healthcare Ltd.

• Shire Plc (Takeda Pharmaceuticals)

• Eli Lilly

• Novo Nordisk

• Gilead Sciences Inc.

• Glaxosmith Kline

• Arrowhead Pharmaceuticals 

Market Segmentation

• By Phase 

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• By Study Design

  • Interventional

  • Observational

  • Expanded Access

• Regional

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

The non-alcoholic steatohepatitis clinical trials market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of non-alcoholic steatohepatitis clinical trials market for the base year 2021 and the forecast between 2022 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global non-alcoholic steatohepatitis clinical trials market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the non-alcoholic steatohepatitis clinical trials market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted non-alcoholic steatohepatitis clinical trials market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the non-alcoholic steatohepatitis clinical trials capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of non-alcoholic steatohepatitis clinical trials by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global non-alcoholic steatohepatitis clinical trials market. These figures have been provided in terms of both revenue and volume for the period 2019 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major non-alcoholic steatohepatitis clinical trials market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of non-alcoholic steatohepatitis clinical trials market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the non-alcoholic steatohepatitis clinical trials industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

non-alcoholic steatohepatitis clinical trials market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to non-alcoholic steatohepatitis clinical trials market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of non-alcoholic steatohepatitis clinical trials market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new non-alcoholic steatohepatitis clinical trials market. These factors have benefited the growth of the global market for non-alcoholic steatohepatitis clinical trials. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for non-alcoholic steatohepatitis clinical trials. The global market is segmented on the basis of region, application, end-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of non-alcoholic steatohepatitis clinical trials are as follows:

• History Year: 2019-2020

• Base Year: 2021

• Forecast Year 2022  to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2019-2021) and forecast (2022-2030);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.