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Famotidine market triples 2 years after ranitidine issue
by Chon, Seung-Hyun Feb 09, 2022 06:09am
The H2 receptor antagonist market had fluctuated with the ban of the ranitidine ingredient in antiulcer drugs. The gap made by the exit of ranitidine initially shrunk the market into nearly half its size. Famotidine enjoyed the most reflective benefits with its market size increasing nearly threefold after the ranitidine impurity issue. Also, nizatidine, which also experienced an impurity issue, recently showed strong growth. According to the market research institution UBIST on the 8th, outpatient prescriptions of H2 receptor antagonists last year recorded ₩151.8 billion, an 11.2% increase from the previous year. This is the first time in 3 years the market showed year-on-year (YoY) growth. H2 receptor antagonists such as ranitidine, famotidine, nizatidine, lafutidine, roxatidine, and cimetidine are used for gastric and duodenal ulcers and reflux esophagitis. The H2 receptor antagonist market had significantly shrunk for two consecutive years since recording ₩346.5 billion in prescriptions in 2018. Its prescription market shrunk 60.6% in two years to record ₩136.5 billion in 2020. The market took a hard blow with the ban of its leading ingredient, ranitidine. In September 2019, the Ministry of Food and Safety decided to ban sales of all products containing ranitidine due to an excessive amount of a carcinogenic substance, ‘n-nitrosodimethylamine (NDMA),' being detected in the products. At the time, prescriptions of ranitidine-containing pharmaceuticals had accounted for 77.7% of the H2 receptor antagonist market, bringing in ₩269.2 billion in prescriptions in 2018. Although the H2 receptor antagonist market took a hard blow with the exit of ranitidine, the market has been making a rebound recently with the increase in prescriptions of other ingredients of the same class. Outpatient prescriptions of H2 receptor antagonists other than ranitidine recorded ₩151.7 billion last year, an 11.2% increase from the previous year. This is more than twice an increase from the ₩77.2 billion made by the same ingredients in 2018, before the ranitidine impurity issue. Among the ingredients, the famotidine market has shown the strongest growth. Prescriptions of famotidine recorded ₩60.5 billion last year, an 8.9% growth from the previous year. Compared to the ₩13.7 billion made in 2018, its market expanded by over threefold in three years. In 2018, famotidine’s sales had been on a downward trend, showing a 44.4% decrease YoY. However, its sales took an upward turn with the exit of ranitidine from the market. Famotidine had only accounted for 4.9% of the market in 2018, but its share surged 39.9% last year. Dong-A ST’s Dong-A Gaster drove the growth. Dong-A Gaster sold ₩12.5 billion last year, a fourfold increase from the ₩3.1 billion 3 years ago. Nizatidine, which had once been embroiled in impurity issues, has also shown strong growth. Nizatidine’s prescriptions recorded ₩46.1 billion last year, which is a 32.9% increase from the previous year. Also, its sales expanded 50.0% in two years from the ₩30.8 billion in 2019. The MFDS had suspended sales of 13 nizatidine products in October 2019 due to excessive level of impurities detected in the products. The industry’s analysis was that the permit to sell the nizatidine products that were not found to have impurity issues had allowed the products to enjoy reflective benefits from the ban of the ranitidine ingredient. Nizatidine had ranked third in the H2 receptor antagonist market after famotidine and lafutidine but then jumped to rank second with the surge in its prescriptions. Prescription of lafutidine products recorded ₩36.1 billion last year, a 2.3% increase from the previous year. This is also an 11.5% increase from the ₩16.8 billion 3 years ago. Although its growth had slowed down somewhat recently, its overall market size had grown significantly since ranitidine’s exit. Sales of roxatidine products had also nearly doubled from ₩2.6 billion in 2018 to ₩5.1 billion last year. The only major H2 receptor antagonist ingredient that did not enjoy reflective benefits from the ranitidine ban was cimetidine. Prescription of cimetidine products fell to ₩3.9 billion, a 75.2% drop from 3 years ago. Such reduction in prescriptions is analyzed to have been due to the prolonged unavailability of key products that arose due to disruptions in the supply of its raw materials.