Carglumic Acid Market to Reach an Opportunity of US$ 187.0 Mn by the End of 2026

Carglumic acid is an orphan drug that is utilized for treatment of patients with hyperammonemia, which implies deficiency of N-acetylglutamate (NAG) synthase. Well known as N-carbamoyl-L-glutamic acid (NCGA) or Carbaglu, carglumic acid stimulates the initial enzyme in urea cycle, which helps in detoxification and removal of ammonia from blood cells. Carglumic acid is on the verge of becoming an indispensable therapeutic tool for managing life-threating & rare inborn metabolic disorders that affect the urea cycle.

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Carglumic Acid holds Potential in Accelerating Cancer Cell Suppression and Promoting Apoptosis

Analysis of in vivo models have showcased carglumic acid to stimulate liver carbamoyl phosphate synthetase. Although carbamoyl phosphate synthetase has a relatively lower affinity for carglumic acid than N-acetylglutamate (NAG), carglumic acid has been represented in vitro to activate carbamoyl phosphate synthetase, being much more effective in preventing ammonia intoxication. This orphan drug is currently gaining huge traction in treating patients with hyperammonemia, a rare congenital disorder caused by genetic defects pertaining to urea cycle enzymes. Carglumic acid also holds potential in accelerating cancer cell suppression, thereby promoting apoptosis in various types of cancers such as lung cancer and pancreatic ductal adenocarcinoma. These Factors will determine the future expansion of the market for carglumic acid across the globe.

Researchers across the globe are working on the development of “whole exome sequencing” procedure, with an aim of preventing intellectual disability in children through the combination of metabolomics analysis of carglumic acid and genome sequencing. Carglumic acid is further being utilized for application in enhancing ammonia detoxification in patients with organic acidurias. Transparency Market Research’s new report states that the global carglumic acid market will reflect an impressive expansion through the forecast period (2017-2026). Worldwide sales of carglumic acid is estimated to reach revenues worth nearly US$ 190 Mn by 2026-end.

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North America to Remain Dominant in Global Carglumic Acid Market

North America will continue to dominate the global carglumic acid market, accounting for more than one-third market revenue share during the forecast period. Carglumic acid has gained significant traction among North American healthcare professionals for treating hyperammonemia. Researchers in the region are focusing on adjunctive treatment and maintenance therapy associated with acute hyperammonemia and chronic hyperammonemia, which are caused by deficiency of N-acetylglutamate synthase (NAGS) in elder population and pediatric patients. Regulatory bodies and pharmaceutical companies in the region are also focusing on patient education concerned with dosage and use of carglumic acid, so as to prevent patients from any side effects.

Tablet for suspension is anticipated to remain the most lucrative delivery format of carglumic acid, with sales estimated to exceed US$ 100 Mn by 2026-end. This delivery format of carglumic acid will witness a robust expansion in sales through 2026. In addition, sales of carglumic acid in the delivery format of orally disintegrating tablets will exhibit an impressive expansion through 2026.

Although hospital pharmacies are expected to remain the largest distribution channels for carglumic acid, sales in e-commerce is likely to witness a relatively faster expansion through 2026. Retail pharmacies will witness a comparatively faster expansion than hospital pharmacies in the market, however market revenue share of the former will remain relatively lower than the latter throughout the forecast period.

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Competition Landscape

The global market for carglumic acid is dominated by few well-established players, who are continuously working on developing new formulations for carglumic acid. This has further created challenges for new market entrants in terms of product differentiation and quality. Key players profiled by TMR’s report include Recordati S.p.A, Civentichem LLC, and Dipharma Francis S.r.l. These players are continuous working on developing new formulations of carglumic acid to stay at the market’s forefront. For example – Dipharma, s Swiss pharmaceutical company, has recently announced its development of new & fast-dissolving formulation of the carglumic acid tablets, which remain stable at room temperature. In addition, Recordati S.p.A has announced inclusion of its Canadian affiliate, named Recordati Rare Diseases Canada Inc, thereby expanding its market presence.

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