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Non-alcoholic Steatohepatitis Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, II, III, IV), by Study Design (Interventional, Expanded Access), by Region (APAC, Europe), and Segment Forecasts, 2022-2030

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    Report

  • 100 Pages
  • January 2022
  • Region: Global
  • Grand View Research
  • ID: 5534083
The global non-alcoholic steatohepatitis clinical trials market size is expected to reach USD 4.2 billion by 2030, registering a CAGR of 6.5% over the forecast period. 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.



NASH has no FDA-approved treatment and can proceed to the point where patients need a liver transplant in extreme situations. NASH, like diabetes, is linked to obesity and a high-sugar diet. Some pharmaceutical companies are testing whether diabetes drugs could help NASH patients. However, the COVID-19 pandemic has thrown a wrench into every element of NASH clinical trials, from patient recruiting to IP administration and safety monitoring to data integrity. As clinical research monitors are not allowed to travel, remote electronic monitoring is a viable alternative to traditional on-site monitoring. Monitors could receive information from research locations by paper mail, e-mail (allowing direct access to electronic medical records), or remote monitoring systems.

In December, the FDA issued guidance urging the pharmaceutical sector to develop and confirm improved biomarkers for the diagnosis and progression of NASH. In many aspects, getting past the biopsy barrier is significant compared to a lack of general awareness of NASH, that’s why it is critical for pharmaceutical companies to invest in innovations (such as a variety of imaging techniques) to alleviate this patient burden, and then persuade the FDA with positive data to accept those advancements as appropriate end-point markers for clinical trials.

Non-alcoholic Steatohepatitis Clinical Trials Market Report Highlights


  • The phase III segment dominated the global market in 2021. These trials cost more than USD 100 million
  • The interventional study design segment held the largest revenue share in 2021. There were 84 ongoing interventional studies with patients enrolled in December 2019 to evaluate the therapeutic efficacy of treatments for NASH
  • North America dominated the global market in 2021 due to the increased number of NASH patients in the region
  • According to the U.S. National Library of Medicine 2018, instances of NASH in the U.S. are expected to increase 63% from 16.52 million to 27.00 million cases by 2030
  • Asia Pacific is projected to register the fastest CAGR over the forecast period owing to the increasing incidence of associated risk factors, such as obesity, type 2 diabetes (T2D), dyslipidemia, and other metabolic diseases with substantial diagnostic improvements using ultrasound and biomarkers

Table of Contents

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 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
3.6.1Industry 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, 2018 - 2030 (USD Million)
4.3 Phase II
4.3.1 Phase II Market, 2018 - 2030 (USD Million)
4.4 Phase III
4.4.1 Phase III Market, 2018 - 2030 (USD Million)
4.5 Phase IV
4.5.1 Phase IV, 2018 - 2030 (USD Million)
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, 2018 - 2030 (USD Million)
5.3 Observational
5.3.1 Observational Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
5.4 Expanded Access
5.4.1 Expanded Access Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
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, 2018 - 2030 (USD Million)
6.2.2 U.S.
6.2.2.1 U.S. Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.2.3 Canada
6.2.3.1 Canada Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.3 Europe
6.3.1 Europe Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.3.2 U.K.
6.3.2.1 U.K. Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.3.3 Germany
6.3.3.1 Germany Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.3.4 France
6.3.4.1 France Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.3.5 Italy
6.3.5.1 Italy Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.3.6 Spain
6.3.6.1 Spain Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.4 Asia Pacific
6.4.1 Asia Pacific Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.4.2 Japan
6.4.2.1 Japan Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.4.3 China
6.4.3.1 China Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.4.4 India
6.4.4.1 India Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.4.5 Australia
6.4.5.1 Australia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.4.6 South Korea
6.4.6.1 South Korea Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.5 Latin America
6.5.1 Latin America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.5.2 Brazil
6.5.2.1 Brazil Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.5.3 Mexico
6.5.3.1 Mexico Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.5.4 Argentina
6.5.4.1 Argentina Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.5.5 Colombia
6.5.5.1 Colombia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.6 MEA
6.6.1 MEA Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.6.2 South Africa
6.6.2.1 South Africa Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.6.3 Saudi Arabia
6.6.3.1 Saudi Arabia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
6.6.4 UAE
6.6.4.1 UAE Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, 2018 - 2030 (USD Million)
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
List of Tables
Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 Global Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by region, 2018 - 2030 (USD Million)
Table 4 Global Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 5 Global Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 6 North America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Country, 2018 - 2030 (USD Million)
Table 7 North America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 8 North America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 9 U.S. Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 10 U.S. Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 11 Canada Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 12 Canada Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 13 Europe Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Country, 2018 - 2030 (USD Million)
Table 14 Europe Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 15 Europe Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 16 U.K. Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 17 U.K. Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 18 Germany Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 19 Germany Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 20 France Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 21 France Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 22 Italy Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 23 Italy Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 24 Spain Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 25 Spain Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 26 France Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 27 France Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 28 Asia Pacific Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Country, 2018 - 2030 (USD Million)
Table 29 Asia Pacific Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 30 Asia Pacific Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 31 India Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 32 India Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 33 Japan Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 34 Japan Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 35 China Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 36 China Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 37 Australia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 38 Australia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 39 South Korea Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 40 South Korea Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 41 Latin America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Country, 2018 - 2030 (USD Million)
Table 42 Latin America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 43 Latin America Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 44 Brazil Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 45 Brazil Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 46 Mexico Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 47 Mexico Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 48 Argentina Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 49 Argentina Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 50 Colombia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 51 Colombia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 52 MEA Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Country, 2018 - 2030 (USD Million)
Table 53 MEA Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 54 MEA Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 55 South Africa Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 56 South Africa Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 57 South Arabia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 58 South Arabia Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
Table 59 UAE Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Phase, 2018 - 2030 (USD Million)
Table 60 UAE Non-alcoholic Steatohepatitis (NASH) Clinical Trials Market, by Study Design, 2018 - 2030 (USD Million)
List of Figures
Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Secondary research pattern
Fig. 4 Market research approaches
Fig. 5 Value-chain-based sizing & forecasting
Fig. 6 QFD modeling for market share assessment
Fig. 7 Market formulation & validation
Fig. 8 Non-alcoholic Steatohepatitis (NASH) Clinical Trials market snapshot (2021)
Fig. 9 Non-alcoholic Steatohepatitis (NASH) Clinical Trials market segmentation
Fig. 10 Market driver relevance analysis (Current & future impact)
Fig. 11 Market restraint relevance analysis (Current & future impact)
Fig. 12 Penetration & growth prospect mapping
Fig. 13 Porter’s five forces analysis
Fig. 14 PESTEL analysis
Fig. 15 Non-alcoholic Steatohepatitis (NASH) Clinical Trials market Phase outlook: Segment dashboard
Fig. 16 Non-alcoholic Steatohepatitis (NASH) Clinical Trials market: Phase movement analysis
Fig. 17 Phase I market, 2018 - 2030 (USD Million)
Fig. 18 Phase II market, 2018 - 2030 (USD Million)
Fig. 19 Phase III market, 2018 - 2030 (USD Million)
Fig. 20 Phase IV market, 2018 - 2030 (USD Million)
Fig. 21 Non-alcoholic Steatohepatitis (NASH) Clinical Trials market Study Design outlook: Segment dashboard
Fig. 22 Non-alcoholic Steatohepatitis (NASH) Clinical Trials market: Study Design movement analysis
Fig. 23 Interventional based Non-alcoholic Steatohepatitis (NASH) Clinical Trials market, 2018 - 2030 (USD Million)
Fig. 24 Observational based Non-alcoholic Steatohepatitis (NASH) Clinical Trials market, 2018 - 2030 (USD Million)
Fig. 25 Expanded Access-based Non-alcoholic Steatohepatitis (NASH) Clinical Trials market, 2018 - 2030 (USD Million)
Fig. 26 Regional market: Key takeaways
Fig. 27 Regional outlook, 2020 & 2028
Fig. 28 North America market, 2018 - 2030 (USD Million)
Fig. 29 U.S. market, 2018 - 2030 (USD Million)
Fig. 30 Canada market, 2018 - 2030 (USD Million)
Fig. 31 Europe market, 2018 - 2030 (USD Million)
Fig. 32 U.K. market, 2018 - 2030 (USD Million)
Fig. 33 Germany market, 2018 - 2030 (USD Million)
Fig. 34 France market, 2018 - 2030 (USD Million)
Fig. 35 Italy market, 2018 - 2030 (USD Million)
Fig. 36 Spain market, 2018 - 2030 (USD Million)
Fig. 37 Asia Pacific market, 2018 - 2030 (USD Million)
Fig. 38 Japan market, 2018 - 2030 (USD Million)
Fig. 39 China market, 2018 - 2030 (USD Million)
Fig. 40 India market, 2018 - 2030 (USD Million)
Fig. 41 Australia market, 2018 - 2030 (USD Million)
Fig. 42 SouthKorea market, 2018 - 2030 (USD Million)
Fig. 43 Latin America market, 2018 - 2030 (USD Million)
Fig. 44 Brazil market, 2018 - 2030 (USD Million)
Fig. 45 Mexico market, 2018 - 2030 (USD Million)
Fig. 46 Argentina market, 2018 - 2030 (USD Million)
Fig. 47 Colombia market, 2018 - 2030 (USD Million)
Fig. 48 MEA market, 2018 - 2030 (USD Million)
Fig. 49 South Africa market, 2018 - 2030 (USD Million)
Fig. 50 Saudi Arabia market, 2018 - 2030 (USD Million)
Fig. 51 UAE market, 2018 - 2030 (USD Million)

Companies Mentioned

  • Pfizer Inc
  • Shire Plc
  • Novartis AG
  • Icon Plc.
  • LabCorp
  • Allergan Plc
  • Cadila Healthcare Ltd.
  • Eli Lilly
  • Novo Nordisk
  • Glaxosmith Kline

Methodology

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