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Carglumic Acid Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028)

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  • 85 Pages
  • April 2023
  • Region: Global
  • Mordor Intelligence
  • ID: 4987274
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

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.

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 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.

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Table of Contents

1.1 Study Assumptions and Market Definitions
1.2 Scope of the Study
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Global Prevalence of N-acetylglutamate Synthase (NAGS) Syndrome and Cancer Cases
4.2.2 Rise in New Product Approvals due to Accelerated Drug Approval Initiative by USFDA
4.3 Market Restraints
4.3.1 Severe Adverse Effects Associated with Carglumic Acid Medication
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size by Value - USD million)
5.1 By Dosage Form
5.1.1 Orally Disintegrating Tablets
5.1.2 Dispersible Tablets
5.1.3 Other Dosage Forms
5.2 By Distribution Channel
5.2.1 Hospital Pharmacies
5.2.2 Retail Pharmacies
5.2.3 E-Commerce Channel
5.3 Geography
5.3.1 North America United States Canada Mexico
5.3.2 Europe Germany United Kingdom France Italy Spain Rest of Europe
5.3.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
5.3.4 Middle East and Africa GCC South Africa Rest of Middle East and Africa
5.3.5 South America Brazil Argentina Rest of South America
6.1 Company Profiles
6.1.1 Apothecon Pharmaceuticals Pvt Ltd
6.1.2 Manus Aktteva Biopharma LLP
6.1.3 Recordati Rare Diseases Inc
6.1.4 Dipharma Francis S r l
6.1.5 Civentichem LLC
6.1.8 Suven Life Sciences Limited
6.1.9 Biophore India Pharmaceuticals Pvt Ltd.
6.1.10 Rhyme Organics and Chemicals Ltd.

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Apothecon Pharmaceuticals Pvt Ltd
  • Manus Aktteva Biopharma LLP
  • Recordati Rare Diseases Inc
  • Dipharma Francis S r l
  • Civentichem LLC
  • Suven Life Sciences Limited
  • Biophore India Pharmaceuticals Pvt Ltd.
  • Rhyme Organics and Chemicals Ltd.