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At the end of 2020, companies represented by Moderna and BioNTech were authorized by regulatory agencies for their mRNA new coronary pneumonia vaccines.
Vaccines and drugs based on mRNA technology that are currently being developed can be divided into three major application directions according to their potential mechanisms of action: preventive vaccines, therapeutic vaccines and therapeutic drugs.
1 preventive vaccine
1 preventive vaccinePreventive vaccines will continue to dominate the mRNA field in the next 15 years, because preventive vaccines currently have a large number of research and development pipelines, higher probability of success (POS), and mRNA advantages over other vaccine technologies
The current mRNA industry research and development activities are also mainly focused on preventive vaccines.
Although many indications have already been marketed products, and the competition for vaccines may be fierce, mRNA has obvious advantages over other technologies in terms of speed of development, at least in terms of the protection rate of new coronary pneumonia
Taking into account the target population penetration rate, pricing and competition in the main indications, it is estimated that the average peak sales value of each research and development pipeline project of the global preventive mRNA vaccine is about 800 million US dollars (for products other than the new coronary pneumonia vaccine).
2 Therapeutic vaccines
2 Therapeutic vaccinesTherapeutic vaccines are likely to be a niche space for mRNA products, but due to the size of the patient population and the possible dominant position in therapies for multiple tumor-associated antigens, they have huge market potential
The development of mRNA therapeutic vaccines is currently mainly focused on immuno-oncology (IO), and candidate vaccines can be classified according to whether they target a single or multiple antigens
Single-antigen vaccines provide a new way to target difficult-to-treat drug targets.
Currently, most mRNA therapeutic vaccines (19 out of 26 known targets) are multi-antigen vaccines, such as personalized cancer vaccines (PCV), where mRNA is superior to peptide vaccines
The industry is paying more and more attention to joint strategies with immuno-oncology drugs (such as PD1/PDL1 blockers) for early treatment of patients with low disease burden and still effective immune systems
However, mRNA therapeutic vaccines face several challenges
Taking into account the above factors, as well as the size of the target population, competition between and within the model, pricing, market penetration, and higher risks, it is estimated that the average peak sales of personalized cancer vaccine products are about 5 billion US dollars, while a single target The product of the disease is approximately $1.
3 therapeutic drugs
3 therapeutic drugsTherapeutic drugs will be the opportunistic field of mRNA products, involving multiple indications, but compared with other therapies, whether it has clinical advantages is still unclear, and there are also higher clinical risks
For protein replacement therapy, in some cases, compared with standard recombinant protein strategies, the mRNA platform may have delivery advantages, but there is no clear solution to the technical challenges faced in the near future, including the lack of organ selectivity and the potential demand for frequent delivery And high immunogenicity
In view of the above situation, therapeutic drugs account for about 10-30% of the mRNA share, and the success probability of mRNA therapeutic drugs in each treatment field will also be lower than the average level
In the short term, the mRNA market is only supported by the new coronary pneumonia vaccine, and its market is estimated to exceed US$50 billion in 2021
.
Between 2023 and 2025, due to reduced demand for the new crown pneumonia vaccine in major markets and lack of new product launches, a decline is expected, and enhanced injections and wider global use may support approximately US$20 billion in sales of this technology.
Uh
.
As other preventive vaccines and therapeutic vaccines of mRNA enter the market, the market is expected to rebound from 2028 and reach US$23 billion by 2035
.
It is expected that preventive vaccines will remain the cornerstone of the mRNA field, and the market share will exceed 50% by 2035.
Therapeutic vaccines for cancer are about 30%, while the proportion of therapeutic drugs is less than 20%
.
In short, with the further advancement of drug delivery system improvement and stability, mRNA has the potential to compete as a type of technology for a wide range of clinical applications
.