Biotin

As a key member of the B-vitamin family, biotin (vitamin B7) is an indispensable water-soluble micronutrient that maintains the normal substance metabolism and physiological functions of the human body. Its mechanism of action lies in acting as a coenzyme for a variety of carboxylases, participating in the metabolic processes of the three major nutrients: carbohydrates, fats and proteins, and playing an important role in cell signal transduction and gene expression regulation. Clinical indications cover alopecia, dry skin and neurological dysfunction caused by biotin deficiency. It is also widely used in nutritional supplementation during pregnancy, replacement therapy for congenital biotinidase deficiency, and adjuvant blood glucose regulation for diabetic patients. The applicable population spans the general nutritional supplementation population, patients with special diseases and maternal groups.

The global biotin market size exceeded USD 380 million in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 6.2%. Feed additives account for more than 60% of the downstream demand, and the proportion of the pharmaceutical and health food sectors has increased year by year to 28%. The competitive landscape shows obvious characteristics of industrial agglomeration. China is the world's largest biotin producer and exporter, with production capacity accounting for more than 90% of the global total supply. Leading production enterprises occupy the main market share by virtue of their fermentation process advantages, while the terminal preparation market is dominated by the joint competition between original research brands and generic drugs.

The original research enterprise of biotin is Roche Group, and the original research trade name is "Rovimix Biotin". Its core compound patent has expired globally. At present, the main dosage forms in circulation on the market include oral tablets, injections and multivitamin preparations, with common specifications of 10μg, 50μg, 1mg, 5mg, etc. Relevant preparations have been included in the FDA Reference Listed Drug Catalog and the Chinese *List of Chemical Drugs*. Up to now, there are dozens of biotin API registration numbers on the CDE API registration platform in China, most of which are in A status and can be directly associated with domestic preparation declarations. A number of biotin single-agent and compound preparations have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for biotin API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable impurity reference standard support for pharmaceutical enterprises in the R&D, quality research and registration of biotin APIs.