Non-alcoholic Steatohepatitis Clinical Trials Market Expanding in Worldwide With Size, Share, Trend & Forecast 2030

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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.

Non-alcoholic Steatohepatitis Clinical Trials Industry Overview

The global non-alcoholic steatohepatitis clinical trials market size was valued at USD 2.42 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2022 to 2030 The growth can be attributed to factors, such as increased drug RD, 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.

 

Gather more insights about the market drivers, restrains and growth of the Global Non-alcoholic Steatohepatitis Clinical Trials Market

 

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.

 

Browse through Grand View Research's Medical Devices Industry Research Reports

  • Medical Device Regulatory Affairs Market: The global medical device regulatory affairs market was valued at USD 5.6 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 10.1% from 2023 to 2030.
  • Biopsy Devices Market: The global biopsy devices market size was valued at USD 2.11 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 7.1% from 2023 to 2030.

 

Non-alcoholic Steatohepatitis Clinical Trials Market Segmentation

Grand View Research has segmented the global non-alcoholic steatohepatitis clinical trials market based on phase, study design, and region:

NASH Clinical Trials Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

NASH Clinical Trials Study Design Outlook (Revenue, USD Million, 2018 - 2030)

  • Interventional
  • Observational
  • Expanded Access

NASH Clinical Trials Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East Africa

 

Market Share Insights

  • 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.
  • March 2021: Gilead Sciences, Inc. and Novo Nordisk announced that their trial partnership in non-alcoholic steatohepatitis has been expanded. 

 

Key Companies Profile

Some of the prominent players in the global non-alcoholic steatohepatitis clinical trials market are:

  • Pfizer Inc.
  • Novartis AG
  • Icon Plc
  • LabCorp
  • Allergan Plc
  • Cadila Healthcare Ltd.
  • Shire Plc (Takeda Pharmaceuticals)
  • Eli Lilly
  • Novo Nordisk
  • Gilead Sciences Inc.
  • Glaxosmith Kline
  • Arrowhead Pharmaceuticals

 

Order a free sample PDF of Non-alcoholic Steatohepatitis Clinical Trials Market Intelligence Study, published by Grand View Research.

 

 

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