In recent years, the global peptide drug market as a whole is in a rising period, with a compound growth rate of more than 12% and a market size of nearly 20 billion US dollars. According to the report released by transparency market research, the global peptide drug market is expected to reach 23.7 billion US dollars by 2020. Peptide drugs have also become one of the important directions of new drug research and development.
Peptide analogues are hot spots in research and development
Peptide usually refers to a peptide chain composed of no more than 50 amino acids, which is between small molecular drugs (molecular weight < 500) and protein drugs (molecular weight > 5000). Because peptides are involved in many physiological functions as signaling molecules in the body, peptide drugs often act as alternative therapy to compensate for the lack of endogenous peptide hormones.
Peptide drugs have been widely recognized and widely used in clinical practice from the isolation and extraction of early automatic tissue to modern artificial synthesis.
For a long time, the number of natural peptide research and development projects is small, but the pharmaceutical industry has always been enthusiastic about the research and development of peptide analogues. In particular, the number of heterologous peptides has been increasing since 2000, which also reflects the development and changes of peptide synthesis technology.
The essence of peptide synthesis (peptide chain synthesis) is to arrange amino acid units according to the structure of natural amino acids. In order to synthesize polypeptides in a specific sequence, only directed peptide synthesis method can be used, that is, the amino or carboxyl groups that do not need to be reacted are protected with appropriate groups, and then the ligation reaction is carried out. At present, the main methods of peptide synthesis are chemical synthesis and biological synthesis.
The chemical synthesis methods mainly include solid-phase synthesis and liquid-phase synthesis, and the biological synthesis methods mainly include fermentation and enzymatic hydrolysis. With the development of bioengineering technology, the genetic engineering method dominated by DNA recombination technology has also been applied to peptide synthesis.
In the 1980s, almost all peptides in clinical trials were less than 10 amino acids in length. In the next 10 years, the average length of peptides gradually increased, which was mainly due to the continuous maturity and improvement of peptide synthesis technology. At present, the long peptide chain with length of 40 amino acids can also be successfully developed, which indicates that the length of peptide chain is no longer the difficulty in the development of peptide drugs.
Advantages and disadvantages of peptide drugs
From natural extraction to artificial synthesis, polypeptide as a new drug shows unique advantages in clinical application and production methods. In clinical practice, polypeptide drugs are similar to recombinant protein drugs and monoclonal antibody drugs, with strong specificity and good curative effect;
in the production and preparation methods, peptide drugs are close to small molecular drugs, with high purity, controllable quality and easy to determine the structure. Therefore, polypeptide therapy has been considered as a potential therapy with high selectivity, effectiveness and relative safety.
Although peptide therapy has a bright future, it is not perfect. Due to the existence of polypeptidase, the half-life of polypeptide hormones is usually short. This instability has a negative impact on drug development and clinical treatment. Another technical bottleneck of peptide drugs is the low oral utilization rate.
In order to overcome the above technical problems, a new peptide synthesis strategy has emerged in recent years. By adjusting pharmacokinetic characteristics, modifying amino acid skeleton, adding unnatural amino acids, conjugating groups with extended half-life and improving solubility, researchers can reduce the injection frequency of peptide drugs and improve their stability and other physical properties.
Among them, conjugated linker has become an important means to change the properties of peptide drugs. Since 2010, about 30% of peptide drugs in clinical trials are conjugates, such as structural coupling with polyethylene glycol, lipids and proteins. Studies have shown that the conjugated Fc fragment can prolong the half-life of polypeptide, and the peptide drug conjugate can also be used as the payload and carrier of cytotoxic agents (see table for some common peptide drug conjugates).
Rapid development of peptide drug market
In recent years, with the rapid development of global peptide drug market, peptide drugs have become an important direction of new drug research and development at home and abroad. Such as Pfizer, Merck, Roche, Lilly, Novartis, Sanofi, Bayer and other large multinational pharmaceutical enterprises have increased their investment in peptide drug research and development through acquisition or merger, and have harvested a lot of listed drugs. The world’s representative polypeptide drugs are laluride, dulaglutide, glatellare, leuprorelin, octreotide, goserelin and exenatide.
According to the research analysis and development trend forecast report of China’s polypeptide drug industry from 2019 to 2025 released by China industry research network, the market scale of polypeptide drugs in China has also shown an upward trend in recent years, reaching 63.05 billion yuan in 2017 (see Figure). This is due to the large population base, the aggravation of aging, and the existence of a large number of cancer and chronic disease patients. It is expected that the market demand will continue to expand in the future, and there is still room for substantial growth of peptide drugs.
Compared with the developed countries and regions, there is still a big gap in the field of peptide drugs in China, and the product structure is also different. Among them, the products of immune enhancement are the majority, while the products for cancer, diabetes and rare diseases account for a relatively small proportion. The market is not mature and far from saturated.
According to the cortellis database, as of May 7, 2019, there were 1153 kinds of peptide synthetic drugs in the world, and 198 polypeptide drugs were listed in 2018, with a wide range of indications, including tumors, cardiovascular diseases, endocrine and metabolic diseases and other major diseases or more common diseases, of which the number of drugs targeting tumors was the largest.
In general, peptide drugs have many advantages over traditional drugs, and the global clinical market demand is growing. It can be predicted that with the progress of modern synthesis technology, more and more new peptide drugs will be put on the market in the future, which will bring good news to the majority of patients.
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