According to Vision Research Reports, the non-alcoholic steatohepatitis clinical trials market size is predicted to hit around USD 4.1 billion by 2030, registering a CAGR of 6.4% during the forecast period 2022 to 2030.
According to Vision Research Reports, the non-alcoholic steatohepatitis clinical trials market size is predicted to hit around USD 4.1 billion by 2030, registering a CAGR of 6.4% during the forecast period 2022 to 2030.
Growth Factors
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.
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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. 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.
Report Coverage
| Report Scope | Details |
| Market Size | US$ 4.1 billion by 2030 |
| Growth Rate | CAGR of 6.4% From 2022 to 2030 |
| Largest Market | Asia Pacific |
| Base Year | 2021 |
| Forecast Period | 2022 to 2030 |
| Segments Covered | Phase, Study design |
| Regional Scope | North America, Europe, Asia Pacific, Latin America, Middle East & Africa |
| Companies Mentioned | 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 |
By Phase Analysis
The segment of phase III accounted for more than 39.5% of the global revenue share in 2021. The phase III trials are associated with high costs. For instance, a single phase 3 study costs around USD 100 million.
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.
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By Study Design Analysis
The interventional segment dominated the market with the largest share of more than 45.5% in 2021. In December 2019, there were 84 ongoing interventional studies with patients enrolled to evaluate the therapeutic efficacy of therapies 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 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.
By Regional Analysis
Asia Pacific region is anticipated to register the fastest growth rate of 7.6% 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.
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
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.
Key Players
- 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
Market Segmentation
- By Phase
- Phase I
- Phase II
- Phase III
- Phase IV
- By Study Design
- Interventional
- Observational
- Expanded Access
- Regional
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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