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Carglumic Acid Market - By Dosage Form (Orally Disintegrating Tablets, Dispersible Tablets), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), & Global Forecast 2024 – 2032

  • Report ID: GMI8505
  • Published Date: Mar 2024
  • Report Format: PDF

Carglumic Acid Market Size

Carglumic Acid Market size was valued at around USD 148.6 million in 2023 and is expected to reach around USD 280 million by 2032 at a CAGR of 7.1% during the forecast period. The growing prevalence of metabolic diseases is anticipated to be among primary factor propelling the growth of the market.

Carglumic Acid Market

The rising incidences of metabolic diseases globally, including metabolic syndrome, type 2 diabetes mellitus, hypertension, and non-alcoholic fatty liver disease (NAFLD) are a growing concern, with significant increases observed in prevalence rates over the years. According to the Centers for Disease Control and Prevention (CDC), nearly half of adults in the U.S. have hypertension, affecting an estimated 119.9 million adults.

Additionally, the World Health Organization (WHO) emphasizes the importance of early diagnosis through regular check-ups and blood tests to prevent the worst effects of type 2 diabetes. This rise in the prevalence of such metabolic conditions is anticipated as a key factor contributing to the growth of the market.

Carglumic acid is a medication used for the treatment of hyperammonemia, a condition characterized by elevated levels of ammonia in the blood. Hyperammonemia can be caused by various metabolic disorders, including urea cycle disorders. Carglumic acid works by promoting the excretion of ammonia in the urine, thereby reducing its concentration in the blood.

Carglumic Acid Market Trends

The rise in awareness coupled with surging research and development (R&D) activities by key industry players is crucial in addressing metabolic diseases. Industry organizations are actively involved in the development of treatments and solutions for metabolic disorders.

  • The manufacturing key industry players have been actively engaged in surging research and development (R&D) activities to advance treatments and solutions for metabolic disorders. For instance, Eton Pharmaceuticals, Inc. and ANI Pharmaceuticals, Inc. commercially launched Carglumic Acid tablets in December 2021, marking the first USFDA-approved generic version of this medication. Such activities are increasing the awareness of carglumic acid treatment among people and ultimately propelling their demand.
  • Additionally, Recordati Rare Diseases Inc. received approval from the U.S. FDA for a new indication of CARBAGLU (carglumic acid) tablets 200mg as adjunctive therapy in January 2021. These initiatives highlight the commitment of industry leaders to drive innovation and improve therapeutic options for individuals affected by metabolic disorders like N-acetylglutamate Synthase (NAGS) Syndrome and anticipates propelling the market growth.

Carglumic Acid Market Analysis

Carglumic Acid Market, By Dosage Form, 2021 – 2032 (USD Million)

Based on dosage form, the carglumic acid market is segmented into orally disintegrating tablets, dispersible tablets, and other dosage forms. The dispersible tablets segment held leading revenue share in 2023 and is anticipated to reach USD 164.5 million by 2032.

  • Dispersible tablets offer convenience for patients who may have difficulty swallowing traditional tablets or capsules. This ease of administration, even for pediatric and geriatric patients, can lead to better patient adherence to treatment regimens.  
  • Moreover, with an increasing focus on patient-centric healthcare and the rising prevalence of conditions requiring carglumic acid treatment, there is a growing demand for convenient dosage forms such as dispersible tablets due to their convenient dosing features.   
Carglumic Acid Market, By Distribution Channel (2023)

The carglumic acid market by distribution channel is categorized into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment dominates the market with the revenue of around USD 77 million in 2023.

  • Hospital pharmacies are equipped to handle the distribution of medications for complex conditions such as hyperammonemia, ensuring that patients receive the necessary treatment in a timely manner, making them major distribution channel of carglumic acid.
  • Moreover, hospital pharmacies are staffed with pharmacists and healthcare professionals who have expertise in managing complex medication regimens and monitoring for potential drug interactions or adverse effects. This ensures safe and effective administration of carglumic acid to patients.
North America Carglumic Acid Market, 2020 – 2032 (USD Million)

North America carglumic acid market accounted for USD 60.4 million revenue in 2023 and is predicted to witness substantial market growth.

  • The rising healthcare expenditure in North America, coupled with a growing emphasis on specialty care and rare diseases treatment, creates a conducive environment for the growth of medications like carglumic acid. Healthcare systems' willingness to invest in innovative therapies for rare conditions is anticipates driving the uptake of carglumic acid in the region.
  • Furthermore, the increasing prevalence of cancer in North America is indeed a significant factor that could indirectly impact the growth of carglumic acid usage. Certain cancers may lead to hyperammonemia as a complication, contributing to its rising prevalence in the region and ultimately anticipating the growing demand for the market in the region.

Carglumic Acid Market Share

The carglumic acid industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced product based on different technologies is among a key market strategy.

Carglumic Acid Market Companies

Some of the eminent market participants operating in the carglumic acid industry include:

  • Apothecon Pharmaceuticals Pvt. Ltd.
  • Biophore India Pharmaceuticals Pvt Ltd.
  • Dipharma Francis S.r.l.
  • Eton Pharmaceuticals
  • Merck KGaA
  • Recordati Rare Diseases Inc.
  • Suven Life Sciences Limited.

Carglumic Acid Industry News:

  • In December 2021, Eton Pharmaceuticals and ANI Pharmaceuticals have announced the commercial availability of Carglumic acid tablets, which represent the first and only FDA-approved generic version of Carbaglu (carglumic acid). This strategy expanded the company’s customer base and its reputation in the market.  

Carglumic acid market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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Market, By Dosage Form

  • Orally disintegrating tablets
  • Dispersible tablets
  • Other dosage forms

Market, By Distribution Channel

  • Hospital pharmacies
  • Retail pharmacies
  • Online pharmacies

The above information is provided for the following regions and countries:

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


Authors: Mariam Faizullabhoy, Gauri Wani

Frequently Asked Questions (FAQ) :

The global carglumic acid industry was valued at around USD 148.6 million in 2023 and is expected to reach around USD 280 million by 2032 at a CAGR of 7.1%, driven by the growing prevalence of metabolic diseases.

The hospital pharmacies segment accounted for a revenue of around USD 77 million in 2023, as they handle the distribution of medications for complex conditions such as hyperammonemia, ensuring that patients receive the necessary treatment.

North America carglumic acid market accounted for USD 60.4 million in 2023, attributed to the rising healthcare expenditure in the region, associated with a growing emphasis on specialty care and rare diseases treatment.

Apothecon Pharmaceuticals Pvt. Ltd., Biophore India Pharmaceuticals Pvt Ltd., Dipharma Francis S.r.l., Eton Pharmaceuticals, KAVYA PHARMA, MANUS AKTTEVA BIOPHARMA LLP, Merck KGaA, NOVITIUM PHARMA LLC, NURAY CHEMICALS, Recordati Rare Diseases Inc., and Suven Life Sciences Limited.

Carglumic Acid Market Scope

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Premium Report Details

  • Base Year: 2023
  • Companies covered: 11
  • Tables & Figures: 136
  • Countries covered: 22
  • Pages: 100
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