Carglumic Acid Market

Carglumic Acid Market Analysis by Dispersible Tablets and Orally Disintegrating Tablets from 2023 to 2033

Analysis of Carglumic Acid Market Covering 30+ Countries Including Analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Carglumic Acid Market Growth Outlook (2023 to 2033)

Fact.MR forecasts the global carglumic acid market to grow from US$ 152.5 million in 2023 to US$ 314.4 million in 2033. This represents a CAGR of over 7.5% from 2023 to 2033.

Carglumic acid is derived from N-acetyl glutamate which helps in the removal of ammonia and detoxification by activating the first enzyme in the urea cycle. This drug is particularly used for the treatment of rare diseases such as propionic academia and methyl-malonic academia which are autosomal recessive disease and often requires lifelong medical treatment to maintain normal well-being.

Report Attributes


Carglumic Acid Market Size (2022A)

US$ 141.9 Million

Estimated Market Value (2023E)

US$ 152.5 Million

Forecasted Market Value (2033F)

US$ 314.4 Million

Global Market Growth Rate (2023–2033)

7.5% CAGR

North America Market Share (2022)


Key Companies Profiled

  • Apothecon Pharmaceuticals Pvt Ltd.
  • Manus Aktteva Biopharma LLP
  • Civentichem LLC
  • Dipharma Francis S.r.l
  • Recordati Rare Diseases

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Historic to Future Path of Carglumic Acid Market

Carglumic acid is used for therapeutic treatment that enhances the quality of life, and as a result, the market for therapeutic drugs is expected to rise significantly between 2023 and 2033. Manufacturers are emphasizing on developing new formulations of carglumic acid to manage life-threatening, rare congenital metabolic disorders that result in ammonia deficiency in humans.

A sedentary lifestyle, rising alcohol consumption, and smoking-related diseases to further enhance the demand for carglumic acid as these habits result in the accumulation of ammonia in the blood.

  • Growth Factors for Short Term (2023–2026): The rise of cancers brought on by alcohol, tobacco, and inactivity, as well as the rise of metabolic diseases like cirrhosis, Reye's syndrome, and hepatic encephalopathy globally, are the main factors propelling the growth of the carglumic acid market.
  • Factors for Medium-Term Growth (2026–2029): Carglumic acid has the potential to promote apoptosis and speed up the suppression of cancer cells in a variety of cancers, including pancreatic ductal adenocarcinoma and lung cancer.
  • Long-Term Growth Opportunities (2029–2033): Efforts led by market players to curb the demand pool and gain high-profit margins are likely to drive the carglumic acid market.

According to Fact.MR, the market for carglumic acid has grown at a CAGR of 4.8% from 2018 to 2022 and is expected to grow at a CAGR of 7.5% from 2023 to 2033.

Factor’s Contributing to the Expansion of the Carglumic Acid Market

“Apoptosis and Cancer Cell Suppression Are Potential Benefits of Carglumic Acid”

Drug repurposing has remained a popular therapeutic strategy, which applies to drug development for the treatment of multiple diseases on the basis of new therapeutic functions.

Carglumic acid has grown in popularity as a result of its versatility in treating a variety of diseases, including hyperammonemia, and cancer. The chemical is also used to prevent ammonia intoxication, promote apoptosis in cancer cells, avoid brain injury, and more.

Repurposing carglumic acid as an anti-cancer agent has depicted its potential in inhibiting cancer cell proliferation and inducing apoptosis in various cancers, including lung cancer, hepatoma, triple-negative breast cancer (TNBC), and pancreatic ductal adenocarcinoma. The usage of this orphan medicine is currently gaining enormous traction in the treatment of patients with hyperammonemia, a rare congenital condition brought on by urea cycle enzyme-related genetic abnormalities.

“Carglumic Acid Market to Reach Substantial Revenues Due to Exome Sequencing System Development”

The global prevalence of metabolic disorders such as cirrhosis, Reye's illness, and hepatic encephalopathy, as well as rising alcohol consumption, smoking, and sedentary lifestyles that induce different cancers are the main drivers of the carglumic acid market.

This increases the appeal for treatment by increasing the amount of smelling salts in the blood. Moreover, carglumic acid has demonstrated potential for inhibiting tumor growth in breast cancer, in addition to other uses in cosmetics and synthetics, which are anticipated to drive the global carglumic acid market throughout the anticipated time period.

The development of the "whole exome sequencing" procedure is being pursued by scientists worldwide, with the goal of preventing intellectual disability in children by combining genomic sequencing with metabolomics research of carglumic acid. Further applications of carglumic acid include improving ammonia detoxification in patients with organic acidurias.

“Factors Creating a Roadblock for Carglumic Acid Market Growth”

High raw material procurement cost coupled with additional capital investment for final product processing and some side effects related to carglumic acid medications has limited the expansion of carglumic acid use. Additionally, increasing research and development expenditures along with the high cost of medicine has increased the cost of overall production, driving customers to hunt for alternatives.

Additionally, the shelf life of the medicine carglumic acid is less than a month, thus bottles must be thrown away after opening. Over the course of the forecast period, these issues are anticipated to limit the growth of carglumic acid sales.

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Country-wise Insights

What is the Demand Outlook for Carglumic Acid in the U.S.?

The U.S. is anticipated to rule the global market for carglumic acid consumption during the forecast period. The prevalence of breast cancer, lung cancer, and hyperammonemia patients in the United States creates a high demand for carglumic acid in the country.

Additionally, pharmaceutical companies' investments in research to establish novel cancer treatments employing carglumic acid, as well as regulatory agencies like the USFDA initiating campaigns to raise awareness regarding the substance's use and dose in the area, all contribute to the market's expansion.

Moreover, healthcare spending in the U.S. accounts for around 17% of the country’s GDP, thus providing a positive outlook to the market for carglumic acid.

What are the Growth Opportunities for Carglumic Acid Market Across U.K.?

The first medication accepted by the Food and Drug Administration (FDA) for the treatment of NAGS deficiency is Carbaglu (carglumic acid), which was created by Orphan Europe, a major European company in orphan medicine.

One of the most severe disorders affecting people in Europe is NAGS insufficiency, according to experts. Numerous newborns in the area have displayed NAGS deficient signs, necessitating prompt & efficient medical attention to restore elevated ammonium levels to normal.

The U.K. carglumic market is expected to grow at a CAGR of 7.2% and offer an absolute dollar opportunity worth US$ 16.4 million during the forecast period as a result of the aforementioned factors.

Category-wise Insights

Why Consumption of Oral Dispersible Tablets Stimulates Market Growth?

The dispersible tablets segment holds a prominent share in the market as carbaglu oral dispersible tablet is the only approved drug. The dispersible tablets dissolve instantly in water or in the mouth. Patients having trouble swallowing traditional dosage forms, such as children, stroke patients, and the elderly benefit from the tablets' speedy administration.

Furthermore, the increased cost of the tablets is anticipated to result in their greatest revenue, which will support the market for the foreseeable future.

Which Distribution Channel is Projected to Bolster Carglumic Acid Market Growth?

Hospital pharmacies account for around half of the total carglumic acid market. This is mostly attributable to established hospital infrastructure, quick access to medications, patient convenience, preference for the purchase of medications, and the simplicity and dependability of pharmacy outlets.

Owing to the above-mentioned factors, the hospital pharmacies are set to grow during the projected period creating an absolute $ opportunity of US$ 67.2 million between 2023-2033.

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Key Strategies by Manufacturers

Prominent carglumic acid manufacturers are Apothecon Pharmaceuticals Pvt Ltd, Manus Aktteva Biopharma LLP, Civentichem LLC, Dipharma Francis S.r.l, Recordati Rare Diseases, and many more.

The global market for carglumic acid has a few significant competitors and is moderately competitive. A few of the major players are now leading the market in terms of sales and are employing a variety of techniques, such as acquiring other businesses to strengthen their market positions globally.

Numerous players are focusing on getting approval for generic products. For instance, the growth of API producers like Suven and Apothecan in India creates income by delivering the API to satisfy the need for carglumic acid, which propels the market growth.

  • In December 2021, ANI Pharmaceuticals and Eton Pharmaceuticals announced the commercial availability of carglumic acid tablets. The drug is the first and only generic version of Carbaglu that is approved by the FDA. The FDA gave it the go-ahead to treat acute and chronic hyperammonemia brought on by a lack of N-acetyl glutamate synthase (NAGS).

Fact.MR has provided detailed information about the price points of key manufacturers of carglumic acid positioned across regions, sales growth, production capacity, and speculative technological expansion, in the recently published report.

Segmentation of Carglumic Acid Market

  • By Dosage :

    • Dispersible Tablets
    • Oral Disintegrating Tablets
    • Others
  • By Distribution Channel :

    • Hospital Pharmacies
    • Retail Pharmacies
    • E-Commerce
  • By Region :

    • North America
    • Latin America
    • Europe
    • East Asia
    • South Asia & Oceania
    • MEA

- FAQs -

What Was the Global Carglumic Acid Market Size Reported by Fact.MR for 2022?

In 2022, the global market for carglumic acid was worth US$ 141.9 million.

What Is the Carglumic Acid Market Size in 2023?

The market is expected to reach a valuation of US$ 152.5 million by 2023.

What is the Projected CAGR for the Carglumic Acid Market from 2023 to 2033?

The market is expected to grow at a CAGR of 7.5% by the end of the forecast period.

What Dosage Type Market Accounts for A Leading Market Share?

Oral disintegrating tablets account for more than 50% of the market share over the other two dosage forms.

Which Region Accounts for the Significant Demand for Carglumic Acid?

North America accounts for more than 40.4% of revenue generated in the global carglumic acid market.

Carglumic Acid Market

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