The global non-alcoholic steatohepatitis clinical trials market size was estimated at USD 2.68 billion in 2022 and is expected to surpass around USD 5.07 billion by 2032 and poised to grow at a compound annual growth rate (CAGR) of 6.6% during the forecast period 2023 to 2032.
Key Takeaways:
Non-alcoholic Steatohepatitis Clinical Trials Market Report Scope
Report Coverage | Details |
Market Size in 2023 | USD 2.85 Billion |
Market Size by 2032 | USD 5.07 Billion |
Growth Rate From 2023 to 2032 | CAGR of 6.6% |
Base Year | 2022 |
Forecast Period | 2023 to 2032 |
Segments Covered | Phase, Study design, Region |
Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
Regional Scope | North America; Europe; Asia Pacific; Central and South America; the Middle East and Africa |
Key Companies Profiled | Pfizer Inc.; Novartis AG; Icon Plc; LabCorp; Allergan Plc; Cadila Healthcare Ltd.; Shire Plc (Takeda Pharmaceuticals); Eli Lilly; Novo Nordisk; Glaxo Smith Kline; Gilead Sciences Inc.; Arrowhead Pharmaceuticals |
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.
The pandemic resulted in halts in the trials due to limited patient involvement in the clinical trials and supply chain disruptions. However, some companies managed to complete the trials through virtual participants and screening with proper COVID guidelines. For instance, Novartis successfully finished the phase 2 trial of semaglutide in non-alcoholic steatohepatitis as semaglutide was designated as a breakthrough therapy in the U.S. In 2021, semaglutide will be started in phase 3a in NASH patients. The results of a phase 2 proof-of-concept trial in NASH were given by Novo Nordisk and Gilead Sciences. In the U.S., NASH is the second most common reason for a liver transplant. Recent studies have also emphasized the possibility of developing hepatocellular carcinoma as a result of NASH.
Patients with NAFLD may have it for years before developing NASH. The lack of sensitive, non-invasive diagnostic methods and a limited understanding of the disease mechanism have impeded the development of clinically useful animal models and pharmaceutical therapies for NASH. In NASH trials, categorizing patients into distinct fibrosis stages can be tricky due to pathologist bias. To achieve more consistent biopsy analysis, Sagimet Biosciences is adopting digital pathology in its Phase IIb nonalcoholic steatohepatitis (NASH) trial. Digital pathology in NASH involves histological imaging of biopsy samples, which are ultimately analyzed using Artificial Intelligence (AI) to detect fibrosis alterations. Sagimet is collaborating with HistoIndex, a Singapore-based digital pathology company in the Phase IIb FASCINATE-2 trial (NCT04906421), to investigate TVB-2640.
PathAI and Summit Clinical Research, both based in the U.S., are partnering to develop AI-powered tools for assessing liver pathology. There are 1,000 MR Elastography (MREs) deployed around the world, but the difficulty is that they have not reached the places with the highest number of NASH clinical trial patients. The considerable cost of upgrading MR elastography is its restriction. Finally, the typical cost of upgrading a unit to MR elastography, whether in Europe or the U.S., is around $100,000. The barrier to adoption is not just the cost of the technology, but also the fact that, even though MRE scans are more expensive than regular MRI scans, medical insurers do not currently provide additional reimbursements.
Phase Insights
The segment of phase III accounted for more than 40.16% of the global revenue share in 2022. The phase III trials are associated with high costs. For instance, a single phase 3 study costs around USD 111 million. Hence, the failure of such trials causes a major financial impact on the sponsors. 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. In addition to the economic costs of a liver biopsy, the method’s low precision and subjective nature are inherent in the operation. Despite the well-known limitations of liver biopsy, the need that it be included in a NASH study could lead sponsors to be hesitant to add more quantitative measurements in a clinical trial. However, even in Phase 2 and Phase 3 studies that entail liver biopsy, careful use of LiverMultiScan as a screening tool can minimize enrollment costs by avoiding costly, unneeded biopsies.
Study Design Insights
The interventional segment dominated the market with the largest share of more than 46.9% in 2022. In December 2019, there were 84 ongoing interventional studies with patients enrolled to evaluate the therapeutic efficacy of therapies for NASH. The majority of these trials are investigating novel drugs as monotherapies, with some exploring into combination therapy 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 a result, interventional trialists are in high demand. Expanded access trials, also known as compassionate use trials, are expected to grow at the fastest CAGR of 6.9% during the forecast period. 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.
Regional Insights
Asia Pacific region is anticipated to register the fastest growth rate of 7.7% 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. NASH cases are projected to account for 20 to 25% of all NAFLD cases in 2019, with prevalence ranging from 5.9% (4.8%-7.3%) in Singapore in the general population (all ages). During the 2019-2030 timeframe, the number of prevalent NASH cases is expected to rise 20% in Hong Kong and South Korea, 25% in Taiwan, and 35% in Singapore. In India, the incidence and prevalence of NAFLD are comparable to global estimates, with the majority of cases occurring in people aged 30 to 50 years.
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 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. These are accessible in a few specialized centers; but, expensive costs and a lack of reimbursements may limit their use, especially when clinically necessary trials.
Key Companies & Market Share Insights
Market players are undertaking various strategic initiatives, such as the signing of the new partnership agreement, collaborations, mergers & acquisitions, geographic expansion, aiming to strengthen their services, & manufacturing capacities, thus providing a competitive advantage. In March 2021, Gilead Sciences, Inc. and Novo Nordisk announced that their trial partnership in non-alcoholic steatohepatitis has been expanded. In people with compensated cirrhosis (F4) due to NASH, the companies would perform a Phase 2b double-blind, placebo-controlled study to assess the safety and efficacy of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist.
In November 2021, GlaxoSmithKline announced it is making its first massive effort into treating the fatty liver disease known as nonalcoholic steatohepatitis (NASH) with a USD 1 billion asset deal with Arrowhead Pharmaceuticals. In October 2019, Novartis added another non-alcoholic steatohepatitis therapeutic candidate to its pipeline with a USD 80 million license agreement with Pliant Therapeutics.
The deal focuses on PLN-1474, a preclinical drug that acts as a small-molecule inhibitor of integrin V1, a target suspected to be implicated in the development of fibrotic (scar) tissue in the livers of persons with NASH. In January 2021, Terns Pharmaceuticals introduced two NASH candidates in clinical trials. The company received USD 87 million in investment from Eli Lilly and Deerfield Management after leasing three NASH candidates. Some of the prominent players in the global non-alcoholic steatohepatitis clinical trials market are:
Segments Covered in the Report
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2020 to 2032. For this study, Nova one advisor, Inc. has segmented the global Non-alcoholic Steatohepatitis Clinical Trials market.
By Phase
By Study Design
By Region
Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 Estimates and forecast timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased database
1.3.2 Nova one advisor’s internal database
1.3.3 Secondary sources
1.3.4 Primary research
1.3.5 Details of primary research
1.4 Information or Data Analysis
1.4.1 Data analysis models
1.5 Market Formulation & Validation
1.6 Region Wise Market Calculation
1.6.1 Region Wise Market: Base Estimates
1.6.2 Global Market: CAGR Calculation
1.7 List of Secondary Sources
1.8 Objectives
1.8.1 Objective - 1: Understanding market dynamics
1.8.2 Objective - 2: Understanding market estimates and forecasts
1.8.3 Objective - 3: Understanding attributes such as strategy framework and competitor categorization
1.8.4 Objective - 4: Understanding the key service and application scopes to conclude on the market size.
Chapter 2 Executive Summary
2.1 Market Outlook
Chapter 3 Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market: Variables, Trends, & Scope
3.1 Market Segmentation and Scope
3.2 Market Dynamics
3.2.1 Market Driver Analysis
3.2.1.1 Increasing pharmaceutical R&D investment
3.2.1.2 Rising diabetic population & Obesity
3.2.1.3 Rising Healthcare expenditure
3.2.2 Market Restraint Analysis
3.2.2.1 Lack of Awareness
3.2.2.2 Barriers to enrollment
3.2.2.3 Lethargic drug approval process
3.3 Penetration & Growth Prospect Mapping
3.4 COVID-19 Impact on the Market
3.5 Major Deals and Strategic Alliances Analysis
3.6 NASH Clinical Trials: Market Analysis Tools
3.6.1 Industry Analysis - Porter’s
3.6.3 PESTEL Analysis
Chapter 4 Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market: Phase Segment Analysis
4.1 Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market: Phase Market Share Analysis, 2021 & 2030
4.2 Phase I
4.2.1 Phase I Market, 2020 - 2032
4.3 Phase II
4.3.1 Phase II Market, 2020 - 2032
4.4 Phase III
4.4.1 Phase III Market, 2020 - 2032
4.5 Phase IV
4.5.1 Phase IV, 2020 - 2032
Chapter 5 Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market: Study Design Segment Analysis
5.1 Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market: Study Design Market Share Analysis, 2021 & 2030
5.2 Interventional
5.2.1 Interventional Non-alcoholic Steatohepatitis (NASH) Clinical Trials market, 2020 - 2032
5.3 Observational
5.3.1 Observational Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
5.4 Expanded Access
5.4.1 Expanded Access Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
Chapter 6 Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market: Regional Analysis
6.1 Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market: Regional Market Share Analysis, 2020 & 2028
6.2 North America
6.2.1 North America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.2.2 U.S.
6.2.2.1 U.S. Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.2.3 Canada
6.2.3.1 Canada Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.3 Europe
6.3.1 Europe Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.3.2 U.K.
6.3.2.1 U.K. Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.3.3 Germany
6.3.3.1 Germany Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.3.4 France
6.3.4.1 France Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.3.5 Italy
6.3.5.1 Italy Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.3.6 Spain
6.3.6.1 Spain Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.4 Asia Pacific
6.4.1 Asia Pacific Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.4.2 Japan
6.4.2.1 Japan Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.4.3 China
6.4.3.1 China Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.4.4 India
6.4.4.1 India Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.4.5 Australia
6.4.5.1 Australia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.4.6 South Korea
6.4.6.1 South Korea Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.5 Latin America
6.5.1 Latin America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.5.2 Brazil
6.5.2.1 Brazil Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.5.3 Mexico
6.5.3.1 Mexico Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.5.4 Argentina
6.5.4.1 Argentina Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.5.5 Colombia
6.5.5.1 Colombia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.6 MEA
6.6.1 MEA Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.6.2 South Africa
6.6.2.1 South Africa Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.6.3 Saudi Arabia
6.6.3.1 Saudi Arabia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
6.6.4 UAE
6.6.4.1 UAE Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2020 - 2032
Chapter 7 Company Profiles
7.1 Pfizer Inc
7.1.1 Company Overview
7.1.2 Financial Performance
7.1.3 Service Benchmarking
7.1.4Strategic Initiatives
7.2 Shire Plc
7.2.1 Company Overview
7.2.2 Financial Performance
7.2.3 Service Benchmarking
7.2.4Strategic Initiatives
7.3 Novartis AG
7.3.1 Company Overview
7.3.2 Financial Performance
7.3.3 Service Benchmarking
7.3.4 Strategic Initiatives
7.4 Icon Plc.
7.4.1 Company Overview
7.4.2 Financial Performance
7.4.3 Service Benchmarking
7.4.4 Strategic Initiative
7.5 LabCorp
7.5.1 Company Overview
7.5.2 Financial Performance
7.5.3 Service Benchmarking
7.5.4 Strategic Initiatives
7.6 Allergan Plc
7.6.1 Company Overview
7.6.2 Financial Performance
7.6.3 Service Benchmarking
7.6.4 Strategic Initiatives
7.7 Cadila Healthcare Ltd.
7.7.1 Company Overview
7.7.2 Financial Performance
7.7.3 Service Benchmarking
7.7.4 Strategic Initiatives
7.8 Eli Lilly
7.8.1 Company Overview
7.8.2 Financial Performance
7.8.3 Service Benchmarking
7.8.4 Strategic Initiatives
7.9 Novo Nordisk
7.9.1 Company Overview
7.9.2 Financial Performance
7.9.3 Service Benchmarking
7.9.4 Strategic Initiatives
7.10 Glaxosmith Kline
7.10.1 Company Overview
7.10.2 Financial Performance
7.10.3 Service Benchmarking
7.10.4 Strategic Initiatives