Non-Alcoholic Fatty Liver Disease (NAFLD) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Non-Alcoholic Fatty Liver Disease (NAFLD) Market Outlook

Thelansis’s “Non-Alcoholic Fatty Liver Disease (NAFLD) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" 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 Fatty Liver Disease treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Non-Alcoholic Fatty Liver Disease (NAFLD) Overview

Non-alcoholic fatty liver disease (NAFLD) is a prevalent condition where excess fat accumulates in the liver of individuals who consume minimal or no alcohol. The most common type of NAFLD is referred to as fatty liver, which is generally not considered a serious ailment. In fatty liver, fat accumulates within the liver cells. A smaller subset of people with NAFLD may experience a more severe condition known as non-alcoholic steatohepatitis (NASH). NASH is characterized by fat accumulation accompanied by inflammation of liver cells and varying degrees of scarring. This condition poses a potential threat as it can progress to severe liver scarring and cirrhosis. Cirrhosis occurs when the liver undergoes significant damage, gradually replaced by scar tissue, impairing its proper functioning. Most individuals with NAFLD do not exhibit symptoms and pass a normal physical examination. Symptoms like abdominal pain (typically in the center or upper right abdomen) and occasional fatigue may be observed in children. However, it is essential to consider other potential causes of abdominal pain and fatigue. During a physical examination, the liver may be slightly enlarged, and some children may display patchy, dark skin discoloration, most commonly seen in the neck and underarm area, known as acanthosis nigricans. NAFLD is part of the metabolic syndrome, which includes diabetes or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids such as cholesterol and triglycerides, and high blood pressure. It's important to note that not all patients exhibit all aspects of the metabolic syndrome. The exact causes of NASH development are not fully understood, but several factors may contribute to its onset. These factors encompass oxidative stress (an imbalance between pro-oxidant and anti-oxidant chemicals leading to liver cell damage), the production and release of inflammatory proteins (cytokines) by the patient's inflammatory cells, liver cells, or fat cells, liver cell necrosis or apoptosis, inflammation, and infiltration of adipose tissue (fat tissue) by white blood cells, and the potential role of gut microbiota (intestinal bacteria) in liver inflammation. NAFLD can lead to liver inflammation, resulting in liver swelling (steatohepatitis), which may progress to scarring (cirrhosis) over time and, in severe cases, lead to liver cancer or liver failure. NAFLD progresses through four primary stages, with most individuals remaining in the initial stage without realizing it. In a small percentage of cases, it may advance and potentially lead to liver damage if left undetected and untreated. The primary stages of NAFLD include:

1. Simple fatty liver (steatosis): This stage involves a mostly harmless fat accumulation within the liver cells, often detected incidentally during other medical tests.
2. Non-alcoholic steatohepatitis (NASH): NASH represents a more severe form of NAFLD characterized by liver inflammation, affecting an estimated 5% of the UK population.
3. Fibrosis: Persistent inflammation leads to the formation of scar tissue around the liver and nearby blood vessels, but the liver can still function normally at this stage.
4. Cirrhosis: This is the most advanced stage, after years of inflammation, resulting in liver shrinkage, scarring, and a lumpy appearance. Cirrhosis leads to permanent liver damage, resulting in liver failure and liver cancer.

Initial suspicion of non-alcoholic fatty liver disease arises when blood tests show elevated liver enzyme levels. However, additional tests are conducted to rule out other liver diseases. An ultrasound is often employed to confirm the diagnosis of NAFLD. Currently, there is no specific medication available for the treatment of NAFLD.

• It is estimated that approximately 25% of adults in the United States have NAFLD, with about 20% of those individuals having NASH (equivalent to 5% of all adults in the U.S.).

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: 2022-2032

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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