Non-Alcoholic Steatohepatitis (NASH) – Market Outlook, Epidemiology, Market Forecast and Competitive Landscape Report – 2023 To 2033

Non-Alcoholic Steatohepatitis (NASH) Market Outlook

Thelansis’s “Non-Alcoholic Steatohepatitis (NASH) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Non-Alcoholic Steatohepatitis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Non-Alcoholic Steatohepatitis (NASH) Overview

Nonalcoholic fatty liver disease (NAFLD) is characterized by fat accumulation within the liver. A more severe variant of NAFLD is known as nonalcoholic steatohepatitis (NASH), which leads to liver inflammation and damage. NASH typically develops in individuals who are overweight or obese have diabetes, high cholesterol, or elevated triglyceride levels. Nevertheless, some individuals may develop NASH even without these risk factors. NASH progresses through three distinct stages:

1. Stage 1, called compensated cirrhosis or NASH without fibrosis, denotes a stage where the liver's function remains intact despite some compromise. The liver exhibits slight enlargement, inflammation, and fat accumulation exceeding 5% (steatosis).
2. Stage 2, known as NASH with fibrosis, encompasses the features of Stage 1 and involves the development of liver scarring (fibrosis). This fibrosis stage has four degrees, with Stage 2 corresponding to fibrosis levels 1 to 3.
3. Stage 3 signifies the severe stage of NASH, where extensive liver cirrhosis or liver cancer may occur. At this point, the only viable treatment option is a liver transplant. The damage inflicted by NASH poses a significant risk to the cardiovascular system, as it releases harmful free radicals into the bloodstream.

The progression of NASH is driven by factors such as obesity, insulin resistance, and type 2 diabetes mellitus (non-insulin-dependent), leading to increased fatty acid flux within the liver and hypertension and dyslipidemia. Sedentary lifestyles, poor dietary habits, and unhealthy eating patterns contribute to the prevalence of obesity and insulin resistance, exacerbating liver dysfunction. Additional risk factors for NASH include a poor diet, polycystic ovarian disease (PCOD), hypothyroidism, high cholesterol, obstructive sleep apnea, small bowel bacterial overgrowth, and high triglyceride levels. NASH can also have a hereditary component, and individuals with family members affected by NASH or NAFLD are at a higher risk. The pathogenesis of NASH is often described using a "two-hit" hypothesis, where the initial "hit" leads to steatosis and subsequent progression to steatohepatitis. NASH results from a combination of factors, including oxidative stress (caused by free radicals during fatty acid oxidation), the release of tumor necrosis factor-alpha (a cytokine), immune factors, direct lipotoxicity, gut-derived endotoxin, and endoplasmic reticulum stress. Over an average follow-up period of 13.7 years, NASH has been associated with a tenfold increased risk of liver-related mortality and a doubling cardiovascular risk. Currently, there is no approved therapy for NASH. The typical age range for NASH patients is between 40 and 50 years, with the development of NASH-related cirrhosis occurring between 50 and 60, even without alcohol consumption. Childhood obesity is becoming increasingly prevalent, indicating that NASH now affects younger individuals. NASH is often asymptomatic in its early stages, earning it the moniker of a "silent disease."

• It is more prevalent among women than men, and many individuals may have NASH for years before experiencing noticeable symptoms. NASH is one of the primary causes of cirrhosis in adults in the United States, with up to 25% of adults with NASH ultimately developing cirrhosis.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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