Carglumic Acid Market Size, Share & Trends Analysis Report By Dosage Form (Orally Disintegrating Tablets, Dispersible Tablets), By Distribution Channel, By Region and Segment Forecasts, 2024 - 2030

Carglumic Acid Market Size & Trends

The global carglumic acid market was valued at USD 137.2 million in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 7.43% from 2024 to 2030. The growth of the carglumic acid market is attributed to several factors, including the increased prevalence of several cancer diseases related to lifestyle factors such as excessive alcohol consumption, tobacco use, and sedentary behavior. For instance, according to the World Health Organization (WHO), in 2022, excessive alcohol consumption is a major risk factor for over 200 diseases and injuries. The report also stated that high alcohol consumption accounted for more than 10% of the global non-communicable disease burden, including several ailments such as pancreatitis, cirrhosis, cancer, and hypertension, among others.

Additionally, the growing incidence rate of metabolic disorders such as hepatic encephalopathy, Reye's syndrome, and cirrhosis around the world is projected to boost overall market demand. Carglumic acid is a medication that plays a pivotal role in reducing ammonia concentrations in the bloodstream and is expected to drive the carglumic acid market growth over the analysis timeline.

The outbreak of the COVID-19 pandemic moderately impacted the carglumic acid industry growth. The market growth is owing to the increased incidence of several infectious diseases worldwide, including hyperammonemia-related concern among COVID-19 patients. This led to a growing demand for carglumic acid in disease management. Furthermore, heightened awareness about numerous metabolic disorders and diagnostics and treatment accelerated market demand during the pandemic.

Upsurge in research and development activities by well-established industry leaders to develop novel orphan drugs is anticipated to propel the global carglumic acid market. Growing awareness regarding rare diseases and enhanced applications of carglumic acid is expected to spur market growth potential. Furthermore, growing government initiatives and awareness campaigns regarding several metabolic disorders, including hyperammonemia disease management and treatment, are predicted to drive market demand in the near future.

Dosage Form Insights

Based on the dosage form, the carglumic acid market is segmented into dispersible tablets, orally disintegrating tablets, and others. The dispersible tablets segment held the largest market share in 2023. Dispersible tablets are designed to disintegrate in water or dissolve instantly in the mouth rapidly. These tablets offer a convenient means of administration, particularly benefiting patients such as stroke patients, pediatrics, and the elderly who may encounter difficulties in swallowing other forms of medication. Consequently, there is an escalating demand for dispersible tablets is anticipated to witness substantial segment growth.

Distribution Channel Insights

Based on end-use, the carglumic acid market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment held the largest market share in 2022 and is predicted to witness substantial market growth over the forecast period.

Expanding healthcare infrastructure, along with the availability of specialized healthcare professionals for effective treatment in clinical facilities, positively impacts segment growth. Growing patient preference towards hospital pharmacies owing to large availability and accessibility to diverse product offerings, driving segment demand.

Regional Insights

North America dominated the market in 2022. The increasing metabolic disease burden and the strong presence of numerous industry participants are estimated to accelerate regional market growth. The adoption of a sedentary lifestyle and excessive alcohol consumption among the population in the region leads to several metabolic disorders, such as cirrhosis and hyperammonemia, among others, accelerating the product demand.  

Asia-Pacific is predicted to witness the fastest CAGR over the forecast period. Rapidly growing awareness regarding metabolic ailments, the rising geriatric population that is highly prone to several chronic diseases, and the increasing government initiatives are a few key factors driving the Asia Pacific carglumic acid market.

Competitive Insights

Key players operating in the market are Apothecon Pharmaceuticals Pvt. Ltd., Recordati Rare Diseases Inc., Manus Aktteva Biopharma LLP, Dipharma Francis S.r.l., NURAY CHEMICALS, NOVITIUM PHARMA LLC, Suven Life Sciences Limited, Biophore India Pharmaceuticals Pvt Ltd., Rhyme Organics and Chemicals Ltd., Aktteva Biopharma LLP., and Civentichem LLC. The market participants are continuously undertaking new product development, M&A activities, and other strategic alliances to gain new market avenues. The following are some instances of such initiatives.

• In December 2021, Eton Pharmaceuticals collaborated with ANI Pharmaceuticals and launched FDA-approved generic carglumic Acid tablets to treat acute and chronic hyperammonemia. These tablets are marketed as an alternative to the Carbaglu tablet. This product launch strengthened the company’s product portfolio in rare diseases.

• In January 2021, Recordati Rare Diseases Inc. received U.S. FDA approval for CARBAGLU 200 mg tablets as adjunctive therapy to treat acute hyperammonemia due to methylmalonic academia (MMA) or propionic acidemia (PA) among pediatric and adult patients. This has broadened the company’s product offerings for several applications and offered a competitive edge over its peers.