Global Nonalcoholic Fatty Liver Disease (NAFLD) Market - 2023-2030

Overview

Non-alcoholic fatty liver disease (NAFLD) is the term for a spectrum of conditions caused by a build-up of fat in the liver. It's usually seen in people who are overweight or obese. A healthy liver should contain little or no fat. It is assessed that nearly 1 in out of 3 individuals in the UK has premature phases of NAFLD where there exist little quantities of fat in their liver. Early-stage NAFLD does not usually induce any harm, but it can direct to severe liver damage, including cirrhosis if it gets worse.

Presently, insulin sensitizers (thiazolidinediones) and antioxidants (vitamin E) appear to be the highly advantageous therapeutic agents for NAFLD/NASH, and lipid-lowering drugs, Insulin sensitizers, angiotensin receptor blockers, and n-3 polyunsaturated fatty acids also have been employed in the treatment.

Market Dynamics: Drivers & Restraints

High Prevalence of Condition

The high prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) is expected to boost the global market growth during the forecast period. For instance, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) NAFLD is highly typical in individuals who have certain diseases and disorders, such as obesity, and conditions that may be linked to obesity, including type 2 diabetes. Investigations indicate that one-third to two-thirds of individuals with type 2 diabetes have NAFLD. Research also indicates that NAFLD is present in around 75% of individuals who are overweight and in over 90% of individuals who have severe obesity.

Moreover, according to the American Liver Foundation, approximately 100 million people in the United States are assessed to have nonalcoholic fatty liver disease. Nonalcoholic Fatty Liver Disease (NAFLD), is the most typical condition of liver disorder in children and has increased two folds over the past 20 years.

Stringent Regulatory Authorities

The stringent regulatory authorities authorizing the new drug treatments are expected to hamper the global market growth. Furthermore, high drug development costs and treatment side effects are also expected to hamper the global market growth in the forecast period.

Segment Analysis

The global Nonalcoholic Fatty Liver Disease (NAFLD) market is segmented based on drug class, disease stage, route of administration, distribution channel and region.

Non-Alcoholic Steatohepatitis (NASH) Stage of NAFLD is Expected to Dominate Market

Owing to the increasing research approval from the FDA the Non-Alcoholic Steatohepatitis (NASH) Stage of NAFLD is expected to dominate the global market during the forecast period. For instance, in September 2023 Madrigal Pharmaceuticals, Inc., a clinical-stage biopharmaceutical corporation pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), obtained the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) award for resmethrin to treat adult patients with NASH with liver fibrosis.

Moreover, in June 2023, Merck, obtained Fast Track Designation from the U.S. Food and Drug for Efinopegdutide, a technology transferred from the South Korean pharmaceutical corporation Hanmi Pharmaceutical Co., to treat nonalcoholic steatohepatitis (NASH). Similarly, in May 2022, Pfizer Inc. acquired the U.S. Food and Drug Administration (FDA) Fast Track designation for its investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis.

Geographical Analysis

North America is Expected to Dominate the Global Market

The increasing research funding and investments in North America are expected to boost the regional market growth, thereby dominating the global market in the forecast period. For instance, in September 2022, Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical corporation committed to enhancing cardio-metabolic health, secured a $132 million Series B financing conducted by RA Capital Management with participation from Bain Capital Life Sciences, BB Biotech AG and existing investors Longitude Capital, Medicxi and RxCapital. This financing is expected to additionally sustain the clinical advance of principal nominee HU6, a first-in-class Controlled Metabolic Accelerator (CMA) developed for the treatment of cardio-metabolic disorder by managing obesity, a direct driver of disorder.

Moreover, since there are no medications authorized by the U.S. Food and Drug Administration (FDA) for the treatment of NAFLD. A recent $9.57 million funding granted to researchers with the UC San Diego NAFLD Research Center at the University of California San Diego School of Medicine is expected to aid in the clinical trial to investigate new threatment choices for individuals with the condition.

COVID-19 Impact Analysis

The pandemic is estimated to have positively impacted the global market growth owing to an increase in treatment demand as Plasminogen activator inhibitor-1 is observed to be advanced in COVID-19 patients. While the level of PAI-1 is significantly elevated in fibrotic tissues, the lack of PAI-1 protects different organs from fibrosis in response to injury-related profibrotic signals.

Thus, PAI-1 is implicated in the pathology of fibrosis in different organs including the heart, lung, kidney, liver, and skin. This role of PAI-1 in COVID-19 liver injury is potentially interesting, especially in NAFLD patients, as elevated PAI-1 has been associated with NAFLD and NASH therefore, COVID-19-induced PAI-1 elevation aggravated NAFLD.

Market Segmentation

By Drug Class

• Antioxidants
• Lipid-Lowering Drugs
• Insulin sensitizers
• Pentoxifylline
• Angiotensin receptor blockers
• Others

By Disease Stage

• Non-Alcoholic Steatohepatitis (NASH)
• Cirrhosis
• Fibrosis

By Route of Administration

• Injectable
• Oral
• Other

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Key Developments

• In April 2022, Oramed Pharmaceuticals Inc. acquired the patent termed "Methods and Compositions for Treating NAFLD, Hepatic Steatosis, and Sequelae Thereof" from the European Patent Office. They have produced oral protein delivery platform technology which protects therapeutic proteins in the digestive system.
• In March 2023 Akero Therapeutics, Inc., a clinical-stage corporation designing transformational therapies for patients with serious metabolic disorders and high unmet medical needs, declared positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and details of the anticipated SYNCHRONY Phase 3 efruxifermin schedule for the treatment of nonalcoholic steatohepatitis (NASH).

Competitive Landscape

The major global players in the market include: Pfizer Inc., AstraZeneca, Novartis AG, Takeda Pharmaceutical Company Limited., Intercept Pharmaceuticals, Inc., F. Hoffmann-La Roche Ag, Merck & Co., Inc., Abbvie Inc., And Gilead Sciences, Inc. among others.

Why Purchase the Report?

• To visualize the global Nonalcoholic Fatty Liver Disease (NAFLD) market segmentation based on drug class, disease stage, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of Nonalcoholic Fatty Liver Disease (NAFLD) market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global Nonalcoholic Fatty Liver Disease (NAFLD) market report would provide approximately 64 tables, 61 figures and 186 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies