Non-Alcoholic Steatohepatitis Clinical Trials Market Analysis report by Future Market Insights shows that global sales in 2021 were held at US$ 2.5 billion. With 7%, the projected market growth from 2022 to 2032 is expected to be significantly higher than the historical growth. Phase 3 is expected to be the highest revenue generating for the Non-Alcoholic Steatohepatitis Clinical Trials Market, with a CAGR of around 11.2% from 2022 to 2032.
| Attribute | Details |
|---|---|
| Global Non-Alcoholic Steatohepatitis Clinical Trials Market (2022) | US$ 2.6 billion |
| Global Non-Alcoholic Steatohepatitis Clinical Trials Market (2032) | US$ 5.1 billion |
| Global Non-Alcoholic Steatohepatitis Clinical Trials Market (2022 to 2032) | 7% |
| North America Non-Alcoholic Steatohepatitis Clinical Trials Market Share (2022) | 40% |
| The USA Non-Alcoholic Steatohepatitis Clinical Trials Market (2022) | US$ 943.3 million |
| Key Companies Profiled |
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As per the Non-Alcoholic Steatohepatitis Clinical Trials Market research by Future Market Insights - a market research and competitive intelligence provider, historically, from 2017 to 2021, the market value of the Non-Alcoholic Steatohepatitis Clinical Trials Market increased at around 6.2% CAGR, wherein, countries such as the USA, the United Kingdom, China, and Japan held a significant share in the global market.
Additionally, rising technical developments and the rising prevalence of chronic diseases, the rise in the number of surgical procedures, and the aging population are the key factors driving the growth. Owing to this, Non-Alcoholic Steatohepatitis Clinical Trials Market is projected to grow at a CAGR of 7% over the coming 10 years.
Due to reduced patient participation in clinical studies and supply chain interruptions, trials were halted as a result of the pandemic. However, some organizations were able to finish the studies using virtual participants and COVID-compliant screening. Novartis, for example, completed a phase two trial of a specific substance in non-alcoholic steatohepatitis after the drug was identified as a groundbreaking therapy in the United States. Semaglutide will be initiated in non-alcoholic steatohepatitis (NASH) patients in phase 3a in 2021. Novo Nordisk and Gilead Sciences presented the findings of a phase two proof-of-concept experiment in NASH. NASH is the second-leading cause of liver transplants in the United States. NASH is also linked to the development of hepatocellular carcinoma, according to recent research.
Due to pathologist bias, classifying patients into discrete fibrosis phases in NASH trials can be difficult. Sagimet Biosciences is using digital histopathology in its Stage IIb non-alcoholic steatohepatitis (NASH) experiment to achieve better consistent biopsy analysis. In the case of NASH, digital pathology entails histological imaging of biopsy samples, which are then evaluated using Ai Technology (AI) to detect fibrosis changes. In the Phase IIb FASCINATE-2 trial (NCT04906421), Sagimet is cooperating with HistoIndex, a Singapore-based diagnostic business, to investigate TVB-2640.
PathAI and Summit Clinical Research, each based in the United States, are collaborating to create AI-powered tools for evaluating liver pathology. There are 1,000 MR Elastography (MRE) machines in use around the world, however, they have yet to reach the areas with the highest number of NASH clinical trial participants. Its limitation is the high expense of improving MR elastography. Finally, whether it be in Europe or the United States, converting a machine to MR elastography costs roughly $100,000. The cost of the technology is a barrier to adoption, as is the fact that, despite the fact that MRE scans are much more expensive than ordinary Mris, medical insurance does not currently pay additional reimbursements.
Principal Consultant
Over the projected period, the market in Asia Pacific is expected to grow at the fastest rate of 7.6%. The region's expansion is being fueled by the incidence of diabetes, obesity, and the expanding number of deaths caused by these diseases (which is expected to increase 30-fold by 2030). In 2019, NASH cases are expected to account for 20 to 25 percent of all NAFLD cases, with a prevalence of approximately 5.9% (4.8 percent -7.3 percent) inside the general population in Singapore (all ages). The number of prevalent NASH cases is anticipated to increase by 20% in Hong Kong and South Korea, 25% in Taiwan, and 35% in Singapore between 2019 and 2030. The incidence rates of NAFLD in India are similar to global figures.
NASH is present in around 5% of people with NAFLD. There are no standardized NAFLD screening protocols in India. Fatty liver is usually identified primarily on an ultrasound finding and/or elevated liver enzymes as bulk in noncirrhotic NAFLD and NASH patients who remain asymptomatic. Recent technological advances have resulted in the development of newer as well as better image analysis modes for assessing hyperlipidemia and fibrosis, including magnetic resonance-derived proton density fat portion and MR elastography, which are now being used during early-phase NASH trials to assess the liver amount of fat and fibrosis stage. These are available at a few specialized centers; nevertheless, high costs as well as a paucity of reimbursement can limit their use, particularly in clinical studies.
NAFLD is one of the most common chronic liver conditions in the USA It is estimated that about 25% of adults in The USA have NAFLD and of them, about 20% have NASH. With these alarming statistics, the Non-Alcoholic Steatohepatitis Clinical Trials market in The USA is expected to reach a valuation of US$ 1.9 billion by 2032, at a CAGR of 7.5% from 2022 to 2032.
A Study indicates that one in eight adults in the United Kingdom may have NASH. It indicates that the prevalence of non-alcohol-related steatohepatitis in the United Kingdom adults could be as high as 12%. Owing to these figures, the market for Non-Alcoholic Steatohepatitis Clinical Trials Market in the United Kingdom stood at around US$ 100 million in 2021. With a CAGR of 7.6%, the market is projected to reach a valuation of US$ 222.2 million by 2032.
The prevalence of NAFLD in the Japanese population rose from 12.6 - 12.9% of the population in the early 1990s to 24.6 - 34.7% of the population in the early 2000s. At present, the prevalence of NASH in Japan is estimated to be 1.9 - 2.7%. In 2021, Non-Alcoholic Steatohepatitis Clinical Trials Market in Japan was held at US$ 116 million, which is expected to swell to US$ 211 million by 2032.
The market for Non-Alcoholic Steatohepatitis Clinical Trials in South Korea accounted for US$ 48.3 million. With an absolute dollar opportunity of around US$ 50 million from 2022 to 2032, the market is projected to reach a valuation of US$ 102 million by 2032.
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In 2021, phase III clinical trials accounted for around 40% of global sales. Phase III studies are known for their high expenditures. A single phase III study, for example, costs around US$ 100 million. As a result, the failure of these studies has a significant economic impact just on sponsors. A Phase III trial collects further information on the drug's safety and efficacy by evaluating additional populations and doses, as well as combining it with other medications. Intelligent, quantitative radiography in association with other diagnostic markers for NASH is the most effective and cost-effective technique to identify and follow NASH patients for clinical trials. All Phase 3 NASH studies must include at least two people, according to existing FDA standards.
In 2021, the interventional category led the market with a share of around 45.5%. There were 84 active intervention studies involving patients enrolled in December 2019 to examine the treatment effectiveness of NASH treatments. The bulk of these trials is looking into innovative medications as targeted therapies, with some looking into NASH treatment in combination. The FDA and the EMA recognized that a histopathological study of cell samples taken from a liver biopsy is the most reliable technique to diagnose NASH. Biomarkers are a subject of controversy between the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
The FDA highly advises using a biomarker signature technique in phase 2 of a trial. The EMA neither prohibits nor requires the implementation of such a method in stage 2, but it does not require it. Intervention trialists are all in high demand as a result. During the projection period, expanded access trials, also called compassionate use tests, are predicted to rise at the fastest CAGR of 7.7%. Patients with serious illness conditions may be able to receive treatment even in a clinical trial if no satisfactory medicines are available. Increased development in NASH clinical trial methodologies is projected to drive the expanded entry trials market.
Some of the key companies operating in the Non-Alcoholic Steatohepatitis Clinical Trials Market include Pfizer Inc., Novartis AG, Icon Plc, LabCorp, Allergan Plc, Cadila Healthcare Ltd., Shire Plc, Eli Lilly, Novo Nordisk, Gilead Sciences Inc., Glaxosmith Kline, and Arrowhead Pharmaceuticals.
Market participants are pursuing a number of strategic activities, including new partnership agreements, collaborations, mergers and acquisitions, geographic expansion, and strengthening their services and production facilities in order to gain a competitive advantage.
Some of the key developments in the Non-Alcoholic Steatohepatitis Clinical Trials Market are:
The Non-Alcoholic Steatohepatitis Clinical Trials Market is worth more than US$ 2.6 billion at present.
The value of the Non-Alcoholic Steatohepatitis Clinical Trials Market is projected to increase at a CAGR of around 7% from 2022 to 2032.
The value of the Non-Alcoholic Steatohepatitis Clinical Trials Market increased at a CAGR of around 6.2% from 2017 to 2021.
Phase III Non-Alcoholic Steatohepatitis Clinical Trials are expected to get augmented in the forthcoming years.
The top 5 countries are the USA, the United Kingdom, China, Japan, and South Korea
1. Executive Summary | Non-Alcoholic Steatohepatitis Clinical Trials Market
1.1. Global Market Outlook
1.2. Summary of Statistics
1.3. Key Market Characteristics & Attributes
1.4. Fact.MR Analysis and Recommendations
2. Market Overview
2.1. Market Coverage / Taxonomy
2.2. Market Definition / Scope / Limitations
3. Market Risks and Trends Assessment
3.1. Risk Assessment
3.1.1. COVID-19 Crisis and Impact on the Market
3.1.2. COVID-19 Impact Benchmark with Previous Crisis
3.1.3. Impact on Market Value (US$ million)
3.1.4. Assessment by Key Countries
3.1.5. Assessment by Key Market Segments
3.1.6. Action Points and Recommendation for Suppliers
3.2. Key Trends Impacting the Market
3.3. Formulation and Product Development Trends
4. Market Background and Foundation Data Points
4.1. Global Market (US$ million)
4.2. Market Opportunity Assessment (US$ million)
4.2.1. Total Available Market
4.2.2. Serviceable Addressable Market
4.2.3. Serviceable Obtainable Market
4.3. Market Scenario Forecast
4.3.1. Demand in optimistic Scenario
4.3.2. Demand in Likely Scenario
4.3.3. Demand in Conservative Scenario
4.4. Investment Feasibility Analysis
4.4.1. Investment in Established Markets
4.4.1.1. In Short Term
4.4.1.2. In Long Term
4.4.2. Investment in Emerging Markets
4.4.2.1. In Short Term
4.4.2.2. In Long Term
4.5. Forecast Factors - Relevance & Impact
4.5.1. Top Companies Historical Growth
4.5.2. Global Market Growth
4.5.3. Adoption Rate, By Country
4.6. Market Dynamics
4.6.1. Market Driving Factors and Impact Assessment
4.6.2. Prominent Market Challenges and Impact Assessment
4.6.3. Market Opportunities
4.6.4. Prominent Trends in the Global Market & Their Impact Assessment
5. Key Success Factors
5.1. Manufacturers’ Focus on Low Penetration High Growth Markets
5.2. Banking on with Segments High Incremental Opportunity
5.3. Peer Benchmarking
6. Global Market Demand Analysis 2017 to 2021 and Forecast, 2022 to 2032
6.1. Historical Market Analysis, 2017 to 2021
6.2. Current and Future Market Projections, 2022 to 2032
6.3. Y-o-Y Growth Trend Analysis
7. Global Market Value Analysis 2017 to 2021 and Forecast, 2022 to 2032
7.1. Historical Market Value (US$ million) Analysis, 2017 to 2021
7.2. Current and Future Market Value (US$ million) Projections, 2022 to 2032
7.2.1. Y-o-Y Growth Trend Analysis
7.2.2. Absolute $ Opportunity Analysis
8. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Study Design
8.1. Introduction / Key Findings
8.2. Historical Market Size (US$ million) Analysis By Study Design, 2017 to 2021
8.3. Current and Future Market Size (US$ million) Analysis and Forecast By Study Design, 2022 to 2032
8.3.1. Interventional
8.3.2. Observational
8.3.3. Expanded Access
8.4. Market Attractiveness Analysis By Study Design
9. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Phase
9.1. Introduction / Key Findings
9.2. Historical Market Size (US$ million) Analysis By Phase, 2017 to 2021
9.3. Current and Future Market Size (US$ million) Analysis and Forecast By Phase, 2022 to 2032
9.3.1. Phase 1
9.3.2. Phase 2
9.3.3. Phase 3
9.3.4. Phase 4
9.4. Market Attractiveness Analysis By Phase
10. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Region
10.1. Introduction
10.2. Historical Market Size (US$ million) Analysis By Region, 2017 to 2021
10.3. Current Market Size (US$ million) & Analysis and Forecast By Region, 2022 to 2032
10.3.1. North America
10.3.2. Latin America
10.3.3. Europe
10.3.4. Asia Pacific
10.3.5. Middle East and Africa (MEA)
10.4. Market Attractiveness Analysis By Region
11. North America Market Analysis 2017 to 2021 and Forecast 2022 to 2032
11.1. Introduction
11.2. Pricing Analysis
11.3. Historical Market Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
11.4. Market Value (US$ million) & Forecast By Market Taxonomy, 2022 to 2032
11.4.1. By Country
11.4.1.1. The USA
11.4.1.2. Canada
11.4.1.3. Rest of North America
11.4.2. By Study Design
11.4.3. By Phase
11.5. Market Attractiveness Analysis
11.5.1. By Country
11.5.2. By Study Design
11.5.3. By Phase
12. Latin America Market Analysis 2017 to 2021 and Forecast 2022 to 2032
12.1. Introduction
12.2. Pricing Analysis
12.3. Historical Market Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
12.4. Market Value (US$ million) & Forecast By Market Taxonomy, 2022 to 2032
12.4.1. By Country
12.4.1.1. Brazil
12.4.1.2. Mexico
12.4.1.3. Rest of Latin America
12.4.2. By Study Design
12.4.3. By Phase
12.5. Market Attractiveness Analysis
12.5.1. By Country
12.5.2. By Study Design
12.5.3. By Phase
13. Europe Market Analysis 2017 to 2021 and Forecast 2022 to 2032
13.1. Introduction
13.2. Pricing Analysis
13.3. Historical Market Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
13.4. Market Value (US$ million) & Forecast By Market Taxonomy, 2022 to 2032
13.4.1. By Country
13.4.1.1. Germany
13.4.1.2. France
13.4.1.3. The United Kingdom.
13.4.1.4. Italy
13.4.1.5. Benelux
13.4.1.6. Nordic Countries
13.4.1.7. Rest of Europe
13.4.2. By Study Design
13.4.3. By Phase
13.5. Market Attractiveness Analysis
13.5.1. By Country
13.5.2. By Study Design
13.5.3. By Phase
14. Asia Pacific Market Analysis 2017 to 2021 and Forecast 2022 to 2032
14.1. Introduction
14.2. Pricing Analysis
14.3. Historical Market Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
14.4. Market Value (US$ million) & Forecast By Market Taxonomy, 2022 to 2032
14.4.1. By Country
14.4.1.1. China
14.4.1.2. Japan
14.4.1.3. South Korea
14.4.1.4. Rest of Asia Pacific
14.4.2. By Study Design
14.4.3. By Phase
14.5. Market Attractiveness Analysis
14.5.1. By Country
14.5.2. By Study Design
14.5.3. By Phase
15. Middle East and Africa Market Analysis 2017 to 2021 and Forecast 2022 to 2032
15.1. Introduction
15.2. Pricing Analysis
15.3. Historical Market Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
15.4. Market Value (US$ million) & Forecast By Market Taxonomy, 2022 to 2032
15.4.1. By Country
15.4.1.1. GCC Countries
15.4.1.2. South Africa
15.4.1.3. Turkey
15.4.1.4. Rest of Middle East and Africa
15.4.2. By Study Design
15.4.3. By Phase
15.5. Market Attractiveness Analysis
15.5.1. By Country
15.5.2. By Study Design
15.5.3. By Phase
16. Key Countries Market Analysis 2017 to 2021 and Forecast 2022 to 2032
16.1. Introduction
16.1.1. Market Value Proportion Analysis, By Key Countries
16.1.2. Global Vs. Country Growth Comparison
16.2. US Market Analysis
16.2.1. Value Proportion Analysis by Market Taxonomy
16.2.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.2.2.1. By Study Design
16.2.2.2. By Phase
16.3. Canada Market Analysis
16.3.1. Value Proportion Analysis by Market Taxonomy
16.3.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.3.2.1. By Study Design
16.3.2.2. By Phase
16.4. Mexico Market Analysis
16.4.1. Value Proportion Analysis by Market Taxonomy
16.4.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.4.2.1. By Study Design
16.4.2.2. By Phase
16.5. Brazil Market Analysis
16.5.1. Value Proportion Analysis by Market Taxonomy
16.5.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.5.2.1. By Study Design
16.5.2.2. By Phase
16.6. Germany Market Analysis
16.6.1. Value Proportion Analysis by Market Taxonomy
16.6.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.6.2.1. By Study Design
16.6.2.2. By Phase
16.7. France Market Analysis
16.7.1. Value Proportion Analysis by Market Taxonomy
16.7.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.7.2.1. By Study Design
16.7.2.2. By Phase
16.8. Italy Market Analysis
16.8.1. Value Proportion Analysis by Market Taxonomy
16.8.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.8.2.1. By Study Design
16.8.2.2. By Phase
16.9. BENELUX Market Analysis
16.9.1. Value Proportion Analysis by Market Taxonomy
16.9.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.9.2.1. By Study Design
16.9.2.2. By Phase
16.10. UK Market Analysis
16.10.1. Value Proportion Analysis by Market Taxonomy
16.10.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.10.2.1. By Study Design
16.10.2.2. By Phase
16.11. Nordic Countries Market Analysis
16.11.1. Value Proportion Analysis by Market Taxonomy
16.11.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.11.2.1. By Study Design
16.11.2.2. By Phase
16.12. China Market Analysis
16.12.1. Value Proportion Analysis by Market Taxonomy
16.12.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.12.2.1. By Study Design
16.12.2.2. By Phase
16.13. Japan Market Analysis
16.13.1. Value Proportion Analysis by Market Taxonomy
16.13.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.13.2.1. By Study Design
16.13.2.2. By Phase
16.14. South Korea Market Analysis
16.14.1. Value Proportion Analysis by Market Taxonomy
16.14.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.14.2.1. By Study Design
16.14.2.2. By Phase
16.15. GCC Countries Market Analysis
16.15.1. Value Proportion Analysis by Market Taxonomy
16.15.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.15.2.1. By Study Design
16.15.2.2. By Phase
16.16. South Africa Market Analysis
16.16.1. Value Proportion Analysis by Market Taxonomy
16.16.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.16.2.1. By Study Design
16.16.2.2. By Phase
16.17. Turkey Market Analysis
16.17.1. Value Proportion Analysis by Market Taxonomy
16.17.2. Value & Analysis and Forecast by Market Taxonomy, 2017 to 2032
16.17.2.1. By Study Design
16.17.2.2. By Phase
16.17.3. Competition Landscape and Player Concentration in the Country
17. Market Structure Analysis
17.1. Market Analysis by Tier of Companies
17.2. Market Concentration
17.3. Market Share Analysis of Top Players
17.4. Market Presence Analysis
17.4.1. By Regional footprint of Players
17.4.2. Product footprint by Players
18. Competition Analysis
18.1. Competition Dashboard
18.2. Competition Benchmarking
18.3. Competition Deep Dive
18.3.1. Pfizer Inc.
18.3.1.1. Overview
18.3.1.2. Product Portfolio
18.3.1.3. Sales Footprint
18.3.1.4. Strategy Overview
18.3.2. Novartis AG
18.3.3. Icon Plc
18.3.4. LabCorp
18.3.5. Allergan Plc
18.3.6. Cadila Healthcare Ltd.
18.3.7. Shire Plc
18.3.8. Eli Lilly
18.3.9. Novo Nordisk
18.3.10. Gilead Sciences Inc.
18.3.11. Glaxosmith Kline
18.3.12. Arrowhead Pharmaceuticals
19. Assumptions and Acronyms Used
20. Research Methodology
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Non-Alcoholic Steatohepatitis Clinical Trials Market
