Octreotide

Chronic diseases such as neuroendocrine tumors and acromegaly have long been faced with the dilemma of limited clinical treatment options. As a synthetic analog of natural somatostatin, octreotide is the core drug in the treatment field of such diseases. Its mechanism of action is to specifically bind to somatostatin receptors to inhibit the pathological excessive secretion of growth hormone, thyroid-stimulating hormone, as well as gastrointestinal and pancreatic endocrine hormones, and at the same time reduce visceral blood flow and inhibit gastrointestinal peristalsis. In addition to the long-acting dosage form used for the long-term control of acromegaly and gastroenteropancreatic endocrine tumors, the short-acting dosage form is also widely used in the emergency treatment of acute pancreatitis and bleeding from ruptured esophagogastric varices, covering the full-scenario medication demand from emergency treatment to chronic disease management.

The global octreotide market size has maintained a steady growth trend in recent years, with the market size reaching approximately USD 1.8 billion in 2023, among which the Chinese market accounts for about 16%, and the compound annual growth rate is maintained at around 7%. The competitive landscape presents a coexistence of original research drugs and generics. The market share of domestic generic drug enterprises has gradually increased after passing the consistency evaluation. At present, more than 10 enterprises have obtained approval for the marketing of octreotide preparations. The accessibility of drugs has been greatly improved after the centralized procurement at the terminals of public medical institutions, driving the continuous rise in the demand for APIs, and the production capacity supply of domestic API enterprises has accounted for more than 60% of the global generic market.

The original research enterprise of octreotide is Novartis, and the original research trade names are Sandostatin (short-acting injection) and Sandostatin LAR (long-acting microsphere injection). Among them, the compound patent of short-acting octreotide expired globally in 2003, the patent of long-acting microsphere preparation expired in the European and American markets in 2021, and the core preparation patent in China expired in 2024. The main dosage forms of the original research drug include 0.1mg/1ml short-acting injection and 20mg/vial long-acting microsphere injection. Both dosage forms have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also listed as FDA reference preparations. As of now, more than 20 domestic enterprises have completed the registration of octreotide APIs in CDE and obtained the A status identifier, more than 15 enterprises have obtained approval for the marketing of octreotide injection, and 3 domestic enterprises have obtained approval for long-acting microsphere preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for octreotide APIs. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production.