The core data of this paper: application field, competition pattern and market scale.
Racers on CXO racetrack have launched peptides one after another.
In the 20021semi-annual report, while consolidating the main track of small molecule CDMO, Gloria Ying actively expanded its CDMO capabilities to new business areas: chemical macromolecules such as peptides and oligonucleotides. In addition, WuXi PharmaTech also indicated that it will continue to invest heavily to further strengthen its service capacity for new molecular types such as PROTAC, oligonucleotide drugs, polypeptide drugs, antibody-coupled drugs (ADC), double antibodies, cells and gene therapy.
Definition: Polypeptide drugs combine the advantages of small molecule drugs and protein drugs.
Polypeptide is a bioactive substance that participates in various cell functions in organisms and is an indispensable participant in life activities. At present, more than 7000 kinds of natural peptides have been found, involving hormones, nerves, cell growth and reproduction. , widely participate in and regulate the functional activities of various human systems, organs and cells, as well as various endocrine hormones, such as thyroxine, insulin, pituitary hormone, neuropeptide, enkephalin, growth factor and luteinizing hormone. From the application field, peptides have been widely used in medicine, food, health care products, cosmetics, biomaterials, biological pesticides and many other fields. Among them, the application of polypeptide in medical field mainly includes polypeptide drugs, polypeptide vaccines, polypeptide diagnostic reagents and so on.
Polypeptide drugs refer to polypeptides with specific therapeutic effects extracted from plants and animals through chemical synthesis and gene recombination, and are specific applications of polypeptides in the medical field. Polypeptide drugs are mainly derived from endogenous peptides or other natural peptides, with clear structure and clear mechanism of action. Compared with ordinary small molecule drugs, they have higher activity and stronger selectivity, and have obvious advantages in treating complex diseases. Moreover, because polypeptide itself is a compound composed of amino acids, its metabolites are amino acids, which generally have no or few side effects on human body. Compared with protein drugs, polypeptide drugs have relatively good stability, high purity, low production cost, low or no immunogenicity, and the quality control level is close to that of traditional small molecule drugs. In the stage of drug research and development, chemical modification can also improve the affinity, solubility, pharmacokinetic properties (stability) and toxicity of candidate drugs, and support the rapid screening of candidate drugs.
In a word, polypeptide drugs combine the advantages of small molecule drugs and protein drugs, and have the advantages of good stability, strong specificity, low impurities, good curative effect and little toxic and side effects, and can be widely used in endocrine system, immune system, digestive system, cardiovascular system, blood system, musculoskeletal system and so on.
Application field: mainly distributed in 7 major disease treatment fields.
Polypeptide drugs mainly treat chronic diseases. At present, international polypeptide drugs are mainly distributed in seven major disease treatment fields, including rare diseases, tumors, diabetes, gastrointestinal tract, orthopedics, immunity, cardiovascular diseases and so on. Among them, rare diseases, tumors and diabetes are the "troika" to drive the polypeptide drug market, and many heavy varieties are also listed in the other four fields. Representative varieties are liraglutide, dulaglutide, somarutide, leuprorelin, etc.
Market size: the market is developing slowly.
At present, the main peptide drug developers are the world's leading pharmaceutical companies, including Novo Nordisk and EliLilly. According to Jost Sullivan, the two leading peptide drug developers adopt completely different development and production strategies. Novo Nordisk produces most of its own products and often avoids establishing cooperative relations with CMO/CDMO. Instead, EliLily uses a third-party service provider to produce and refine some active ingredients.
However, pharmaceutical and biotechnology companies that do not have technical expertise and internal production facilities to meet regulatory requirements also rely on peptide CDMO to produce peptide APIs. In addition, outsourcing the development and production of peptides to external service providers can provide certain advantages for peptide pharmaceutical companies seeking to achieve efficient production in peptide drug research and development projects. R&D service providers of exopeptide drugs have professional talents and knowledge, advanced equipment and methods, customized development and production capacity, and the advantages of quality, cost and risk control system. Therefore, due to the increasing demand for peptide CDMO services, it is expected that the trend of outsourcing the development and production of peptide drugs to external service providers will continue in the next few years.
According to Jost Sullivan's data, the market size of peptide CDMO in China fluctuated from $20 16 to $20 1 0 in 2020, far below the global growth rate.
Prospect forecast: In 2030, the market size of China will reach US$ 654.38 billion, which is higher than the global growth rate.
Driven by the continuous growth of the global peptide drug market, the increase of overall drug R&D expenditure, technological progress, increased penetration rate and the emergence of emerging biotechnology companies, the global peptide CDMO service market has achieved sustained growth in the past few years, and it is expected to maintain the same trend in the next few years. More and more pharmaceutical companies outsource process development and peptide production to CDMO in order to focus on their core competitiveness in drug discovery, clinical development and commercialization. Especially some large pharmaceutical companies (such as Lilly and Janssen Pharmaceutical Company). It is more inclined to use CDMO for the production and finishing of peptide raw materials, because CDMO has the production capacity and technology that cannot be obtained in China, so that pharmaceutical companies can produce peptide raw materials in a more cost-effective way. It is expected that more companies will use CDMO services to prevent or reduce internal technical challenges in peptide production.
According to Jost Sullivan's forecast, the global peptide CDMO market will grow from $2 billion in 2020 to $4.4 billion in 2025, with a compound annual growth rate of 17.7% from 2020 to 2025, and will further grow to $7.9 billion in 2030 and12 from 2025 to 2030. In China market, peptide CDMO will increase from $6,543.8+0 billion in 2020 to $400 million in 2025, with a compound annual growth rate of 26.6%. It will further rise to $654.38 billion in 2030, with a compound annual growth rate of 21%; Far exceeding the global growth rate.