With the increasing difficulty of small molecule drug research and development, the global biopharmaceutical research and development speed is accelerating and ushering in the outbreak period. Among them, liraglutide and grantirel, which have annual sales of several billion dollars, have become a hot research and development hotspot in the world.
Compared with the global research and development trend of peptide drugs, China is still in the growth stage in the field of peptide drugs, and it is urgent to innovate in varieties and delivery methods.
Leading the trend of new drug research and development
Peptide drugs are often between small molecular drugs and macromolecular protein / antibody drugs. They balance the advantages of small molecular drugs and macromolecular protein drugs. They have the characteristics of good curative effect, quick effect, strong specificity, predictable side effects, low toxicity and predictable metabolic pathway.
From 2007 to 2017, the global peptide drug preparation market scale grew rapidly, reaching about US $34.1 billion in 2017, with a 10-year compound growth rate of 11%. The United States, the United Kingdom, France, Spain, Italy and Germany are the most important markets for peptide drugs, accounting for more than 70% of the market share. At present, nearly 70 peptide drugs have been approved for marketing worldwide,
involving the treatment of digestive tract, blood, cardiovascular, genitourinary, central nervous system, respiratory and sensory organ diseases, as well as anti-tumor and immune regulation, systemic hormones, anti infection and other fields, among which systemic sex hormones, anti-tumor and immune modulators are the majority.
With the rapid development of biotechnology and genetic engineering technology, peptide drugs have become one of the important directions of new drug research and development in many companies. There are abundant polypeptide drug pipelines all over the world, and there are varieties entering phase III clinical trials in many disease fields, among which the research and development of tumor and metabolism related drugs is the most active.
China has a huge market potential
In 2017, the market scale of peptide drugs in China was about 1.74 billion US dollars, accounting for 1.4% of the overall pharmaceutical market in China, far lower than the mature international market. Among them, about 60% of peptide products are antitumor and immunomodulators, and most of them are adjuvant drugs with low clinical value, such as thymopentin and thymosin.
In contrast, Germany and other developed countries and regions lead the sales list of peptide drugs with clear clinical benefits, such as hypoglycemic drugs liraglutide and dulaglycopeptide, antitumor drugs leuprorelin and goserelin, and anti osteoporosis drug tripatide.
From the perspective of market share, China’s polypeptide drug industry is already a red sea, with more than 100 enterprises competing in the same field. In addition to leuprorelin microsphere, the number of top 5 peptide drug preparation sales enterprises in the top five are all double-digit.
Although there are many competitors, there are still a few leading enterprises that have carved up most of the market share of peptide drugs in China. Among them, the top 15 enterprises (including multinational enterprises and local pharmaceutical enterprises) accounted for 73% of the market share;
In recent years, although local enterprises continue to make efforts in the research and development of products with high clinical value, most of them still produce fewer high-end and sophisticated products. It can be seen that the field of peptide drugs in China is still in its infancy and growth stage, with great development potential.
At present, nearly half of the peptide drugs listed in the world have not yet been listed in China, and the utilization rate of the top 10 peptide products in China is relatively low. The first reason is that many local enterprises are unable to copy the relevant drugs due to the original research patents and the extension of the patent period of foreign manufacturers.
Two, the difference between Chinese and foreign disease spectrum is large, and some diseases are low incidence rate in China. For example, the number of patients with multiple sclerosis in China is relatively small, although the treatment of the disease in the global sales of similar drugs ranked first, but its commercial advantages in China can not be exerted. Third, high technical barriers to R & D and production.
Compared with small molecular drugs, the patents of peptide drugs have all-round technical barriers in terms of production process and mass production mode. Due to the gap in technology, equipment and process, the R & D and production capacity of some original high-end peptide drug preparations is limited in China.
The market expects innovative drugs
The peak period of peptide drugs in China was in the 1990s. At present, 16 of the more than 30 polypeptide drugs were listed before 2000, and all the 8 products with the largest sales volume were listed before 1999. It is urgent for fresh blood to join the peptide drug market in China.
With the increasingly fierce competition in the domestic drug market in recent years, many local pharmaceutical enterprises have seen the high cost performance advantage of peptide drugs. The production / acquisition of peptide drug pipelines or enterprises has become one of the choices for many pharmaceutical enterprises in strategic transformation.
Deepening the reform of drug review and approval system and the introduction of the newly revised “Drug Administration Law” all encourage innovation and research from the policy point of view. Foreign listed new drugs with clear clinical efficacy, including polypeptide drugs, have also accelerated their listing in China.
In 2018, etibant, produced by shire and used for cardiovascular and cerebrovascular diseases, was included in the list of 48 overseas listed clinical urgently needed new drugs published by the drug evaluation center. In January and February this year, two kinds of peptide drugs with definite clinical efficacy, linalopide and dulaglycopeptide, were approved for marketing in China.
Strict restrictions on the use of adjuvant drugs also make room for the development of innovative drugs. In July this year, after the National Health Commission and other departments released the first batch of national key monitoring and rational drug use list (chemical and biological products), the use and management of adjuvant drugs in various regions has been more strict, and the sales of some peptide products, such as thymopentin and thymosin, have shown negative growth for a long time.
In recent years, some multinational enterprises with innovative drug molecules and mechanism of action have performed strongly in the peptide drug market and maintained a double-digit growth rate. This shows that only enterprises that have developed innovative preparations and delivery methods can have a place in this field in the future.
From the perspective of product innovation, peptide coupling, cell penetrating peptide and new antimicrobial peptides are the hot research and development directions at home and abroad. Among them, the application of peptide coupling is more, its purpose is usually to form double / multi receptor agonists, such as GLP-1 multifunctional receptor agonist;
cell penetrating peptide can directly and innocuously cross the cell membrane into the cell, and can mediate and promote the ingestion of nanoparticles, small molecules and other substances by the cell; antibacterial peptide can make the cell membrane imbalance, so as to achieve the effect of killing bacteria And it is not easy to make the pathogen resistant to it. Antimicrobial peptides are more effective and broad-spectrum than traditional antimicrobial agents.
From the perspective of the innovation of drug delivery mode, the structure of peptide molecules in the digestive tract is unstable and can be hydrolyzed rapidly. In addition, the first pass metabolic effect of liver and the possibility of forming polymer result in low oral bioavailability. At present, the administration of polypeptide drugs is relatively single, mainly by intravenous injection or drip.
New non-invasive administration methods can improve the safety, compliance and convenience of patients. For example, cyclopeptide drugs are mostly oral or inhaled. As of 2017, only 4% of polypeptide drugs can be taken orally or inhaled in China (see Figure). It is expected that the upgrading of administration mode will further enhance the competitiveness of enterprises
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