Compared with general small molecular drugs, the molecular structure of peptide drugs is relatively complex, and the synthesis cost is higher;
however, the activity of peptide drugs is better, the dosage is low, and the production demand of peptide raw materials is not high.
Therefore, the efficient synthesis technology of peptide drugs is only mastered by a few specialized enterprises. In the development and production of peptide drugs, peptide synthesis is often outsourced to cro or CMO enterprises.
According to the data of Lonza company, the global market scale of peptide drugs in 2011 was 11.7 billion US dollars, of which the market scale of polypeptide raw materials was 1 billion US dollars, which required 1400 kg peptide raw materials.
The market of peptide API produced by outsourcing is 440 million US dollars, nearly half of the total market. According to the annual compound growth rate of about 6.5%, the global market scale of outsourcing production of polypeptide API in 2017 is about US $700 million. The outsourcing production of polypeptide API has a clear market division, and has formed a three echelon of cro, CMO and API.
Market distribution of peptide drugs
Small new drug companies and scientific research institutions need a large number of peptide compounds with different structures and small dosage for screening the activity of peptide compounds and conducting preclinical research of peptide drugs to the early stage of phase I clinical trial, which are mainly provided by cro company.
This group of companies are mainly concentrated in developing countries, such as sinobio’s “customer peptide” business, which synthesizes peptide compounds with customer specified structure, and orders products are usually less than 100g.
Large new drug research and development companies carry out clinical research on peptide drugs. The general dosage of drugs is at the level of kg, and the cost of synthesis by our company is often too high.
Therefore, CMO company, a professional peptide drug company, is usually selected to provide specific drugs. After the new drugs are put on the market, the original CMO company has become the API supplier of patent drugs directly by virtue of its mature production process.
Due to geographical advantages, customer relations and policy barriers, European and American polypeptide CMO companies have basically monopolized the CMO business of patent peptide drugs, accounting for more than half of the outsourcing production market.
The main representative companies include Bachem, Lonza, Zealand and polypeptide. They can also carry out the research on new peptide drugs of the company.
Large generic pharmaceutical companies can produce peptide raw materials by themselves after their polypeptide generic drugs (or patent drugs) come into the market, such as Israel Teva, India sun pharmaceutical, etc. However, small and medium-sized generic drug companies usually choose CMO company to produce API of generic polypeptide drugs.
Manufacturers of generic API are mainly concentrated in developing countries, represented by Chengdu suno, etc. After passing the cGMP certification and obtaining the DMF documents, the corresponding manufacturing enterprises can enter the European and American markets, and vigorously develop the non-standard markets, so as to enhance the competitiveness.
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