Non-Alcoholic Steatohepatitis Clinical Trials Market Analysis report by Future Market Insights shows that global sales in 2021 were held at USD 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) | USD 2.6 billion |
| Global Non-Alcoholic Steatohepatitis Clinical Trials Market (2032) | USD 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) | USD 943.3 million |
| Key Companies Profiled | Pfizer Inc.; Novartis AG; Icon Plc; LabCorp; Allergan Plc; Cadila Healthcare Ltd.; Shire Plc; Eli Lilly; Novo Nordisk; Gilead Sciences Inc.; Glaxosmith Kline; Arrowhead Pharmaceuticals |
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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 USD 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 USD 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 USD 100 million in 2021. With a CAGR of 7.6%, the market is projected to reach a valuation of USD 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 USD 116 million, which is expected to swell to USD 211 million by 2032.
The market for Non-Alcoholic Steatohepatitis Clinical Trials in South Korea accounted for USD 48.3 million. With an absolute dollar opportunity of around USD 50 million from 2022 to 2032, the market is projected to reach a valuation of USD 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 USD 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 USD 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 2. Market Overview 3. Market Risks and Trends Assessment 4. Market Background and Foundation Data Points 5. Key Success Factors 6. Global Market Demand Analysis 2017 to 2021 and Forecast, 2022 to 2032 7. Global Market Value Analysis 2017 to 2021 and Forecast, 2022 to 2032 8. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Study Design 8.1. Interventional 8.2. Observational 8.3. Expanded Access 9. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Phase 9.1. Phase 1 9.2. Phase 2 9.3. Phase 3 9.4. Phase 4 10. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Region 10.1. North America 10.2. Latin America 10.3. Europe 10.4. Asia Pacific 10.5. Middle East and Africa (MEA) 11. North America Market Analysis 2017 to 2021 and Forecast 2022 to 2032 12. Latin America Market Analysis 2017 to 2021 and Forecast 2022 to 2032 13. Europe Market Analysis 2017 to 2021 and Forecast 2022 to 2032 14. Asia Pacific Market Analysis 2017 to 2021 and Forecast 2022 to 2032 15. Middle East and Africa Market Analysis 2017 to 2021 and Forecast 2022 to 2032 16. Key Countries Market Analysis 2017 to 2021 and Forecast 2022 to 2032 17. Market Structure Analysis 18. Competition Analysis 18.1. Pfizer Inc. 18.2. Novartis AG 18.3. Icon Plc 18.4. LabCorp 18.5. Allergan Plc 18.6. Cadila Healthcare Ltd. 18.7. Shire Plc 18.8. Eli Lilly 18.9. Novo Nordisk 18.10. Gilead Sciences Inc. 18.11. GlaxoSmithKline 18.12. Arrowhead Pharmaceuticals 19. Assumptions and Acronyms Used 20. Research Methodology
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Non-Alcoholic Steatohepatitis Clinical Trials Market
