The polysorbate market continues to grow, but product quality varies

Polysorbate (Tween, PS) is a family of amphiphilic nonionic surfactants derived from ethoxylated sorbitan or isosorbide (derivatives of sorbitol) esterified with fatty acids. The appearance of polysorbate is a light yellow to orange viscous liquid with a slight odor and a slightly bitter taste. Polysorbate has the characteristics of solubilizing, emulsifying, wetting, and good stability. Its downstream applications involve food, Pharmaceutical, daily chemical, textile and other fields.

There are many polysorbate series products, including polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, polysorbate 85, etc. Among them, polysorbate 80 is the most widely used surfactant in biological preparations. agent. Polysorbate 80 has the characteristics of biocompatibility, low toxicity, and can prevent protein aggregation. In biological preparations, polysorbate 80 is mostly used as a protein stabilizer.

The main component of polysorbate 80 is polyoxyethylene sorbitan monooleate. According to the different oleic acid content, polysorbate 80 for injection can be divided into two levels: multi-pharmacopoeia grade MC and Chinese Pharmacopoeia grade CP. Polysorbate 80 has a complex structure and high production technology requirements, so there are few global suppliers, including Nanjing Weil, Renfu Pharmaceutical, NOF, Croda, Sigma, etc.

According to the “2023-2028 China Polysorbate Industry Market In-depth Research and Development Prospects Forecast Report released by the Industrial Research Center, my country is a major producer and consumer of polysorbate. In 2021, the global polysorbate market size will be approximately 4.47 billion yuan, of which my country’s market size will be approximately 1.43 billion yuan, accounting for approximately 32.0% of the global market. It is expected that from 2023 to 2027, driven by the upgrading of the pharmaceutical industry and the accelerated aging process, the polysorbate market will expand steadily, with an average annual compound growth rate of more than 5.5%.

Stability and effectiveness are key features of drug development and production. Affected by production processes, raw materials, product properties, etc., the quality and ingredients of polysorbate series products improved by different suppliers are also inconsistent, resulting in poor quality of polysorbate series products. The unevenness greatly limits its application in the biologics industry.

Nanjing Weil is the leader in domestic injection-grade excipients. The company’s polysorbate 80 production technology and standards are at the internationally advanced level. In 2022, polysorbate 80 (II) will complete the FDA’s DMF filing. In addition, it has also obtained approval from the European Drug Quality Management European Pharmacopoeia Suitability Certificate (CEP Certificate) issued by the European Pharmacopoeia.

Industry analysts said that polysorbate has the characteristics of solubilizing, emulsifying, wetting and good stability. It is widely used in medicine and food. It is widely used in , daily chemicals, textile and other fields, and the market size will maintain a growth trend in the future. There are many polysorbate series products, but due to the production process and product performance, the quality of polysorbate currently available on the market is uneven, which limits its market development under certain circumstances.