Fatty Acid Oxidation Disorder Drugs Market Size, Share, Industry, Forecast and Outlook (2024-2031)

Global Fatty Acid Oxidation Disorder Drugs Market is segmented By Type (Short-Chain FAODs, Medium-Chain FAODs, Long-Chain FAODs, Very Long-Chain FAODs) By Drug Type (Levocarnitine, Triheptanoin, Dextrose, Riboflavin, Others) By Route of Administration (Oral, Intravenous) By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) and By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Report Overview

The Global Fatty Acid Oxidation Disorder Drugs Market reached US$ YY billion in 2023 and is expected to reach US$ YY billion by 2031 growing with a CAGR of YY% during the forecast period 2024-2031. 

Fatty Acid Oxidation Disorders (FAOD), also known as fatty acid oxidation deficits or fatty acid metabolism disorders, are a category of rare hereditary metabolic diseases that halt the body's ability to break down and turn fats into energy. Normally, the body uses fatty acids as its primary source of energy, especially when fasting or engaging in intense physical exercise. Individuals with FAODs, on the other hand, are deficient in one or more of the enzymes or transport proteins involved in the fatty acid oxidation pathway.

Fatty Acid Oxidation Disorders (FAOD) drugs are pharmaceutical treatments and therapies that are used to manage and mitigate the symptoms and consequences associated with FAOD. These medications are intended to enhance energy production, prevent toxic metabolite buildup, and treat symptoms such as muscle weakness, hypoglycemia, and metabolic crises.

Market Scope

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Market Dynamics: Drivers and Restraints

The increasing number of product approvals 

The increasing number of product approvals is expected to drive the fatty acid oxidation disorder (FAOD) drug market, as each approval extends treatment options, improves patient access, encourages competition, and boosts investor confidence. These approvals are the outcome of rigorous clinical trials, which provide patients with cutting-edge medicines while also driving additional R&D investments.

For instance, in January 2023, Reneo Pharmaceuticals, Inc., a clinical-stage pharmaceutical company that focuses on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, stated that the US Food and Drug Administration (FDA) has granted mavodelpar (REN001) Fast Track designation for long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, one of the predominant genotypes in patients with long-chain fatty acid oxidation disorder (LC-FAOD). Thus, owing to the above factors the market is expected to drive over the forecast period.

Market Dynamics: Restraint

The limited patient pool is a major restraint to the fatty acid oxidation disorders (FAOD) drugs market. In comparison to more prevalent diseases, these uncommon hereditary metabolic abnormalities affect a small percentage of people. As a result, pharmaceutical companies face difficulties in establishing economies of scale and profitability in the research, development, and production of FAOD-specific drugs and therapies. Due to restricted competition and economies of scale, the small market size reduces financial incentives for companies to invest significant resources in FAOD drug research, potentially resulting in fewer treatment options and higher costs for patients.

Segment Analysis

The global fatty acid oxidation disorder drugs market is segmented based on type, drug type, route of administration, distribution channel and region.

The triheptanoin segment accounted for approximately 31.2% of the fatty acid oxidation disorder drugs market share

Triheptanoin segment is expected to dominate the fatty acid oxidation disorder (FAOD) drug market with market share of 31.2%. Triheptanoin, a metabolic modulator, has received considerable interest as a potentially effective treatment for long-chain FAODs and other forms of FAODs. It serves as an alternative energy source and aids in avoiding the metabolic problems caused by FAODs.

Furthermore, the increasing number product approvals and collaboration between the companies for this drug is expected to fuel the segment growth. For instance, in July 2020, Ultragenyx Pharmaceutical Inc. partnered with Orsini Pharmaceutical Services, a prominent independent national specialty pharmacy specializing in patients with rare and difficult disorders, as a limited distribution specialty pharmacy partner for Dojolvi (triheptanoin). Dojolvi is approved for the treatment of pediatric and adult patients with molecularly proven long-chain fatty acid oxidation disorders (LC-FAOD) as a source of calories and fatty acids. Thus, owing to the above factors the segment is expected to dominate over the forecast period.

Geographical Penetration

North America accounted for approximately 37.4% of the market share in 2023

The North America region particulary the U.S. is expected to dominate the market owing to the factors such as, rise in product approvals, increasing number of clinical trial, and presence of key market players in this region

For instance, in June 2020, Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, received FDA approval for Dojolvi (triheptanoin) as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD) as the first approved therapy.

Moreover, the increasing healthcare spending and growing population and awareness in Asia Pacific countries and government initiatives to promote awareness, and rise in the demand for the treatment are some of the other factors responsible for revenue growth of the market in the Asia Pacific region.

COVID-19 Impact Analysis

The COVID-19 pandemic has had a major impact on the market for Fatty Acid Oxidation Disorder (FAOD) drugs. It caused delays in patient enrollment and data collecting in ongoing clinical trials. Manufacturing and distribution of FAOD medications were hampered by supply chain issues, potentially leading to shortages. Healthcare priorities have evolved, with resources allocated to COVID-19 management, affecting attention and funding for uncommon diseases such as FAODs. Due to lockdowns and limitations, diagnoses and treatments were delayed, creating hazards to FAOD patients. 

FAOD patients, many of whom had underlying medical issues, faced additional risks and disturbances in their everyday lives. However, A study found that pharmacological inhibition of fatty acid synthesis blocks SARS-CoV-2 replication, and identified fatty acid synthase inhibitors as drug candidates for the prevention and treatment of COVID-19.

Competitive Landscape

The major global players in the fatty acid oxidation disorder drugs market include Pfizer Inc., Leadiant Biosciences, Inc., Ultragenyx Pharmaceutical Inc., Vitane Pharmaceuticals, Inc., Laboratorios Casasco, NEXTWELL PHARMACEUTICAL PRIVATE LIMITED, Action Labs, Inolex, Inc., Lonza Group Ltd, Northeast Pharmaceutical Group Co., Ltd., and among others. 

Key Developments

• On January 31, 2023, Reneo Pharmaceuticals, Inc., a clinical-stage pharmaceutical company that focuses on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, stated that the US Food and Drug Administration (FDA) has granted mavodelpar (REN001) Fast Track designation for long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, one of the predominant genotypes in patients with long-chain fatty acid oxidation disorder (LC-FAOD).

Why Purchase the Report?

• To visualize the global fatty acid oxidation disorder drugs market segmentation based on type, drug type, 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 fatty acid oxidation disorder drugs market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in Excel consisting of key products of all the major players.

The global fatty acid oxidation disorder drugs market report would provide approximately 69 tables, 69 figures and 195 Pages.

Target Audience 2024

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