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.
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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
Healthcare
May 2018
REP-GB-6719
April 2023
290 pages
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Non-Alcoholic Steatohepatitis Clinical Trials Market
