Carglumic acid is an orphan drug used for the treatment of hyperammonemia. Hyperammonemia is a rare genetic disorder characterized by elevated level of ammonia in the blood. Increased entry of ammonia is a primary cause of neurological disorders such as congenital deficiencies of urea cycle enzymes, hepatic encephalopathy, Reye’s syndrome, several other metabolic disorders, and some toxic encephalopathy.
Global Carglumic Acid Market Drivers

Increasing research and development is expected to drive the global carglumic acid market growth. For instance, in April 2017, Dipharma S.A, a Swiss pharmaceutical company, developed fast dissolving formulation of carglumic acid tablets. These tablets are stable at room temperature and are used for the treatment and management of rare, life threatening inborn metabolic disorders affecting the urea cycle. Furthermore, increasing approvals is expected to boost the global carglumic acid market value. For instance, in September 2015, Orphan Europe announced that carbaglu (carglumic acid) is approved by the Health Canada, as an adjunctive therapy for the treatment and improvement of acute hyperammonemia or as maintenance therapy for chronic hyperammonemia.

Global Carglumic Acid Market Restraints

High cost of carglumic acid tablet is expected to hamper the global carglumic acid market growth. For instance, in April 2017, according to P&T Community report, Carbaglu (containing Carglumic acid) is an expensive prescription medicine in the world. This drug costs around US$ 1042.12 for 5 tablets. Furthermore, side effects associated with carglumic acid is expected to the hinder the global carglumic acid market growth. For instance, in May 2018, according to Drugs@FDA, carglumic acid can cause serious side effects such as ear infection, anemia, somnolence, pneumonia, influenza, hyperhidrosis, asthenia, anorexia.

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Global Carglumic Acid Market regional Analysis

North America is expected to hold dominant position in the carglumic acid market over the forecast period, owing to increasing collaborations by key players. For instance, in April 2017, Recordati Rare Diseases Canada, Inc. partnered with the Italy-based Recordati group, which is exclusive provider of several rare disease treatment including Carbaglu (Carglumic acid), Cystadane (Betaine anhydrous), and Cosmegen (Dactinomycin) in Canada. Furthermore, Asia Pacific is also projected to witness significant growth in the global carglumic acid market, owing to increasing initiatives by government to offer better healthcare facilities. For instance, in February 2019, China announced the collaborative network with various hospitals for the rare disease diagnosis and treatment. Under this network, 324 hospitals are selected according to their capacity and experience in treating patients with rare diseases. This collaboration will facilitate the timely transfer of difficult and complicated cases of rare diseases such as hyperammonemia between hospitals and provide the quality medical resources to them.

Key players operating in the global carglumic acid include Manus Aktteva Biopharma LLP., Civentichem LLC., Recoedati S.p.A, and Dipharma Francis S.r.I

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