Calcitonin

The high incidence of metabolic bone diseases has driven the expansion of clinical demand for bone regulatory drugs. As a core category of calcium metabolism regulating drugs, calcitonin specifically binds to receptors on the surface of osteoclasts to inhibit osteoclast activity and reduce bone resorption, while promoting bone formation and regulating blood calcium levels. Clinically, it is mainly used for the treatment of postmenopausal osteoporosis, senile osteoporosis, Paget's disease of bone, and hypercalcemia caused by bone metastasis of malignant tumors, etc. It is especially suitable for osteoporosis patients who are intolerant to bisphosphonates, and can quickly relieve bone pain symptoms and improve the quality of life of patients.

The global market size of calcitonin has maintained a steady growth trend for a long time. In 2023, the market size was approximately USD 1.27 billion, with a compound annual growth rate of around 3.5%. In terms of the domestic market, the sales volume in sample hospitals in 2024 was approximately RMB 320 million, of which salmon calcitonin accounted for nearly 85% of the market share, and eel calcitonin accounted for about 14%. The current market competition is dominated by generic drugs, with the market share of original research products being less than 20%. More than 30 domestic enterprises have obtained approval for related preparations. After the centralized procurement, the product price has dropped by more than 60%, the clinical accessibility has been greatly improved, and the demand in the primary market is gradually released.

The original research enterprise of calcitonin is Novartis, and the original trade name is Miacalcic. The core patent of its salmon calcitonin compound expired globally around 1990. The main dosage forms approved for the original research product include injections (1ml:50IU, 1ml:100IU) and nasal sprays (2ml:4400IU, 200IU per spray). All related dosage forms have been included in the FDA Reference Listed Drug Catalogue, and are also included in China's *Catalogue of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, 4 enterprises have obtained approval for salmon calcitonin API through CDE registration and launched the products, and more than 20 related preparation products have been approved for sale in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of calcitonin impurity reference standards, covering all categories such as synthetic process impurities and degradation impurities. Most products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various needs in the stages of API R&D, quality research and declaration.