Carglumic Acid Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The Carglumic Acid Market is Segmented by Dosage Form (Orally Disintegrating Tablets, Dispersible Tablets, and Others), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and E-Commerce Channel), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Carglumic Acid Market Size

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Carglumic Acid Market Summary
Study Period 2019 - 2029
Base Year For Estimation 2023
CAGR 7.20 %
Fastest Growing Market Asia-Pacific
Largest Market North America
Market Concentration Low

Major Players

Carglumic Acid Market Major Players

*Disclaimer: Major Players sorted in no particular order


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Carglumic Acid Market Analysis

The Carglumic Acid Market is projected to register a CAGR of 7.2% during the forecast period.

COVID-19 brought a high infection rate among the population across the globe.The medical emergency known as hyperammonemia results in cerebral edema and neurologic impairment. Due to hyperammonemia from a disseminated cryptococcal infection, respiratory distress syndrome in COVID-19 patients may be the cause of such an infection.A rare genetic condition characterized by a lack of N-acetylglutamate synthase (NAGS) can be treated with the orphan medication carglumic acid, which aids in converting ammonia into urea in patients. This condition is creating a demand for carglumic acid medications for patients suffering from COVID-19 infections. Due to a deficit in the hepatic enzyme NAGS, it was utilized as a supplementary therapy for the treatment of acute hyperammonemia and as a maintenance therapy for chronic hyperammonemia. Hence, the COVID-19 pandemic significantly impacted the market.

The main things that are driving the growth of the carglumic acid market are the rise in cancers caused by drinking, smoking, and being inactive, as well as the rise in metabolic disorders like hepatic encephalopathy, Reye's syndrome, and cirrhosis around the world.WHO's key facts, which were last updated in May 2022, say that drinking too much can cause more than 200 diseases and injuries.According to the same source as above, alcohol-related disabilities caused 5.1% of the world's disease and injury burden in 2022.The amount of ammonia in the blood rises as people drink more alcohol. Carglumic acid is used and prescribed to lower the amount of ammonia in the blood.This is expected to drive the market.

In the same way, more people smoking and the problems that come with smoking are likely to increase the use of carglumic acid and help the market grow.For instance, according to the Office on Smoking and Health and the Chronic Disease Center (NCCDPHP), whose data was updated in March 2022, nearly 13 of every 100 United States adults aged 18 years or older (12.5%) smoked cigarettes in 2020. This means an estimated 30.8 million adults in the United States currently smoke cigarettes. More than 16 million Americans live with a smoking-related disease. Therefore, the smoking-related disease burden is anticipated to create demand for arglumic acid products, further fueling the market's growth.

In addition, hepatic encephalopathy (HE) is a nervous system disorder that is caused by severe liver disease and is often treated with carglumic acid. The number of people with covert hepatic encephalopathy (CHE) goes up to 54% when minimal hepatic encephalopathy (MHE) is found, according to an article in the Clinical Gastroenterology and Hepatology journal from August 2022.This burden of HE is expected to drive market growth. Additionally, according to the National Institute of Neurological Disorders and Stroke (NINDS) data published in February 2022, an estimated two children per year in the United States develop Reye's syndrome. This is expected to accumulate ammonia in the blood and thereby increase growth. Also, carglumic acid has shown potential for anti-tumor activity in breast cancer, along with various applications in cosmetics and chemicals, which are expected to fuel the global carglumic acid market during the forecast period.

But the market isn't growing as fast as it could because there are more problems in the development stage, patented products are expensive, and carglumic acid medicines can have serious side effects.

Carglumic Acid Market Trends

This section covers the major market trends shaping the Carglumic Acid Market according to our research experts:

Dispersible Tablets Segment is Expected to Hold a Significant Market Share

The dispersible tablets disintegrate quickly in water or disperse immediately in the mouth. The tablets can be administered quickly and help patients such as pediatrics, stroke patients, and elderly people who have difficulty swallowing other dosage forms. Thus, the demand for these dosage forms is increasing, and the segment is expected to witness growth.

According to an article published by Pharmaoffer in August 2022, people with high levels of ammonia in their blood are given a tablet called carbaglu. This is the first and only drug approved by the FDA to treat acute hyperammonemia caused by propionic acidemia (PA) or methylmalonic acidemia (MMA).The same source above also stated that the dosage per kilogram of body mass varies daily from 100 mg to 250 mg, depending on how severe the problem is. Because the dosage form is good for both young and old patients, the drug is becoming more popular.As a result, the carbaglu dispersible tablet is expected to boost segmental growth.

Segmental growth is likely to be driven by the growing number of people with NAGS syndrome, cancer, and metabolic disorders like hepatic encephalopathy, Reye's syndrome, and cirrhosis around the world. Orphanet's update from November 2022 says that hyperammonemia caused by N-acetylglutamate synthase deficiency is a rare autosomal recessive disorder of urea cycle metabolism that makes it hard to get rid of ammonia and make arginine. It affects less than 1 out of every 1,000,000 people.The disease's presence in the population creates a need for new ways to treat it, which in turn creates more opportunities for dispersible tablets.Thus, it is expected to drive segmental growth.

As a result, during the forecast period, the aforementioned factors are likely to be the main drivers of the segment's growth.

Carglumic Acid Market:  11Year Survival Rate for Hyperammonemia (in Percentage), United States, By COnset Type, 2021

North America is Anticipated to Grow Significantly Over the Forecast Period

North America is expected to hold the largest share of the carglumic acid market throughout the forecast period. Several factors such as increasing incidences of various cancers like breast cancer, lung cancer, and hyperammonemia in North America led to high demand for carglumic acid in the region. Also, key pharmaceutical companies investing in research activities to develop novel products to treat cancers using carglumic acid are creating opportunities for the market to be studied. In addition, regulatory bodies such as the USFDA create awareness about carglumic acid products, along with their dosage and use in the region. Thus, the availability of such regulatory bodies ensures the safety of the products and contributes to the market's growth.

According to a 2022 update by National Organization for Rare Disorders (NORD), hepatic encephalopathy is most often associated with cirrhosis, which is estimated to affect nearly 5.5 million people in the United States, and nearly 70% of individuals with cirrhosis may develop symptoms of hepatic encephalopathy in 2022. As carglumic acid is used for the treatment of severe hyperammonemia that occurs due to a deficiency of hepatic NAGS the demand for carglumic acid is expected to grow for treatment. This is expected to create a huge demand and opportunities for carglumic acid, fueling the market growth in the region.

Further, as per an article published in March 2022 in NCBI, urea cycle disorders is one of the causes of hyperammonemia and a gross estimate of the incidence of urea cycle disorders is 1 in 250,000 live births in the United States. Thus, the burden of hyperammonemia creates demand for the usage of carglumic acid. This is expected to accelerate the market in the country.

Therefore, the above-mentioned factors are expected to drive the market in the region during the forecast period.

Carglumic Acid Market Growth Rate by Region

Carglumic Acid Industry Overview

The global carboxylic acid market is moderately competitive and consists of several major players. In terms of market revenue, a few prominent players are currently dominating the market and are applying various strategies, like acquiring products or other companies, to consolidate their market positions across the globe. Some of the companies that are currently dominating the market are Apothecon Pharmaceuticals Pvt. Ltd., Manus Aktteva Biopharma LLP, Recordati Rare Diseases Inc., Dipharma Francis S.r.l., and Civentichem LLC, among others.

Carglumic Acid Market Leaders

  1. Apothecon Pharmaceuticals Pvt. Ltd

  2. Manus Aktteva Biopharma LLP

  3. Recordati Rare Diseases Inc

  4. Civentichem LLC

  5. Dipharma Francis S.r.l

*Disclaimer: Major Players sorted in no particular order

Carglumic Acid Market Concentration
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Carglumic Acid Market News

  • December 2021: Eton Pharmaceuticals, Inc and ANI Pharmaceuticals, Inc commercially launched Carglumic Acid tablets. The product is expected to be marketed by Eton Pharmaceuticals and is the first and only USFDA-approved generic version of Carbaglu.
  • January 2021: Recordati Rare Diseases Inc. received approval from the USFDA for a new indication for CARBAGLU (carglumic acid) tablets 200mg as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) in pediatric and adult patients.

Carglumic Acid Market Report - Table of Contents


    1. 1.1 Study Assumptions and Market Definitions

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Global Prevalence of N-acetylglutamate Synthase (NAGS) Syndrome and Cancer Cases

      2. 4.2.2 Rise in New Product Approvals due to Accelerated Drug Approval Initiative by USFDA

    3. 4.3 Market Restraints

      1. 4.3.1 Severe Adverse Effects Associated with Carglumic Acid Medication

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Dosage Form

      1. 5.1.1 Orally Disintegrating Tablets

      2. 5.1.2 Dispersible Tablets

      3. 5.1.3 Other Dosage Forms

    2. 5.2 By Distribution Channel

      1. 5.2.1 Hospital Pharmacies

      2. 5.2.2 Retail Pharmacies

      3. 5.2.3 E-Commerce Channel

    3. 5.3 Geography

      1. 5.3.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.3.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.3.4 Middle East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East and Africa

      5. 5.3.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Apothecon Pharmaceuticals Pvt Ltd

      2. 6.1.2 Manus Aktteva Biopharma LLP

      3. 6.1.3 Recordati Rare Diseases Inc

      4. 6.1.4 Dipharma Francis S r l

      5. 6.1.5 Civentichem LLC

      6. 6.1.6 NURAY CHEMICALS

      7. 6.1.7 NOVITIUM PHARMA LLC

      8. 6.1.8 Suven Life Sciences Limited

      9. 6.1.9 Biophore India Pharmaceuticals Pvt Ltd.

      10. 6.1.10 Rhyme Organics and Chemicals Ltd.

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments
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Carglumic Acid Industry Segmentation

As per the scope of the report, carglumic acid is an orphan drug used to treat hyperammonemia also known as NAGS Syndrome, a rare genetic disorder that occurs due to the lack of an enzyme called N-acetyl glutamate synthase (NAGS) in the liver, that results in elevated levels of ammonia in the blood causing hyperammonemia. The Carglumic Acid Market is segmented by Dosage Form (Orally Disintegrating Tablets, Dispersible Tablets, and Others), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and E-Commerce Channel), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Dosage Form
Orally Disintegrating Tablets
Dispersible Tablets
Other Dosage Forms
By Distribution Channel
Hospital Pharmacies
Retail Pharmacies
E-Commerce Channel
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle East and Africa
South Africa
Rest of Middle East and Africa
South America
Rest of South America
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Carglumic Acid Market Research FAQs

The Carglumic Acid Market is projected to register a CAGR of 7.20% during the forecast period (2024-2029)

Apothecon Pharmaceuticals Pvt. Ltd, Manus Aktteva Biopharma LLP, Recordati Rare Diseases Inc, Civentichem LLC and Dipharma Francis S.r.l are the major companies operating in the Carglumic Acid Market.

Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Carglumic Acid Market.

The report covers the Carglumic Acid Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Carglumic Acid Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Carglumic Acid Industry Report

Statistics for the 2024 Carglumic Acid market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Carglumic Acid analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Carglumic Acid Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)