Original title: Analysis of the current status and development trends of the mRNA drug industry in 2022, mRNA therapy application scenarios are broad. "Picture"
1. mRNA product overview
1. mRNA therapy application
mRNA products can be divided into mRNA vaccines and mRNA drugs. Messenger RNA (mRNA) is a single-stranded long ribonucleic acid that can transmit genetic information in DNA and synthesize proteins after translation. After mRNA enters the body, specific proteins can be expressed by autologous cells, avoiding the influence of in vitro factors; it can regulate the human immune system through endogenous expression of functional proteins and eliminate autologous threats, including cancer cells. The mRNA vaccine encoding the antigen sequence is introduced into the cells through delivery platforms such as lipid nanocarriers, and then the human cells generate antigens through translation to activate the immune response. The main applications of mRNA therapy are infectious disease vaccines, therapeutic cancer vaccines, immuno-oncology vaccines and protein replacement.
mRNA therapy application
Source: Public information compilation
2, mRNA therapy advantages
mRNA4mRNA was discovered in 1961. Due to its low stability, it did not receive much attention at the time. As people's understanding of mRNA gradually deepens, it has now become an ideal platform for the treatment of many diseases. mRNA therapy has unique advantages over traditional therapies, and mRNA-based treatment platforms have broad market prospects. At present, many leading pharmaceutical companies are actively planning and developing.
mRNA therapy advantages
Source: Public information sorting
2. Background of mRNA drug development
From a technical perspective, the pain point that mRNA technology needs to solve is to reduce its own immunogenicity , the efficiency of protein expression in the body and the final large-scale production. The resulting core technical challenges are: 1) Design and synthesis: Mastering platform-based computing power is the core competitiveness, and the 5’ end capping and UTR region nucleotide modification is the key. 2) Modification technology: Chemical modification is carried out to improve drug stability and reduce toxicity. 3) Delivery system synthesis design: Among them, the synthesis technology of lipid nanoparticle particle mRNA-LNP is the focus of research and development in the field of mRNA. Amplified production of mRNA vaccines or drugs has strong replicability, and the core is successful sequence modification and delivery system assembly. The upstream and downstream industrial chains of amplification of production are also particularly important. Taking raw materials as an example alone, hundreds of types such as enzymes, nucleotides, liposomes, , etc., which have many technical challenges such as mass production of raw materials and high barriers to production equipment.
mRNA drug core R&D technology challenges
Source: Public information sorting
Related report: "2023-2028 China mRNA vaccine industry market in-depth analysis and future development trend forecast report" released by Huajing Industry Research Institute
III. mRNA drug industry chain
1, industrial chain
mRNA drug industry chain covers the preparation of upstream raw materials, midstream includes the research and development and production of biopharmaceutical companies, and downstream includes all links of vaccination and final recipient users.
mRNA drug industry chain
Source: Public information sorting
2, upstream raw material cost structure
weighted average with Moderna and BioNTech new crown vaccine sales, enzymes and modified substrates occupy the main raw material costs, and there is a broad space for domestic substitution. DNA templates account for 4%, corresponding to the market size of plasmid is about 1.592 billion yuan; Cap analog, T7 RNA polymerase , inorganic pyrophosphatase and other mRNA synthesis account for 74%, corresponding to the market size of 29.452 billion yuan; nucleotides and modified nucleoside NTP account for 7%, corresponding to the market size of 2.786 billion yuan; cation lipids, cholesterol , etc. are required to synthesize LNP account for 5%, corresponding to the market size of 2 billion yuan.
The cost structure of the new crown mRNA vaccine raw material
Source: Public information sorting
4. Current status of the mRNA drug industry
1, mRNA drug clinical pipeline type
From the perspective of global mRNA drug pipeline types, mRNA vaccines are currently the main research direction in the industry, accounting for 84%, and mRNA drugs account for 14%.
Type distribution of global mRNA drug clinical pipeline in 2022
Source: Sullivan, public information sorted
2, mRNA vaccine sales
From the perspective of mRNA vaccine sales, vaccine sales in 2020 were US$350 million. Due to the global COVID-19 epidemic epidemic, mRNA vaccine sales rose rapidly in 2021, with sales reaching US$58.7 billion.
2020-2021 The total sales of the two mRNA vaccines
Source: Sullivan, public information sorted
3, COVID-19 vaccine revenue
Specifically, looking at the revenue of COVID-19 vaccines, there are four major companies that have launched COVID-19 vaccines in the world, Pfizer, BioNTech, Moderna, AstraZeneca and Janssen, and the revenue of the new crown vaccine was US$41 billion, US$17.7 billion, US$3.92 billion and US$2.39 billion, respectively.
Globally listed COVID-19 vaccine revenue in 2021
Source: Sullivan, public information sorted
5. mRNA drug competitive landscape
1, global market
From the perspective of the global mRNA drug market, the two mRNA products currently on the market are mainly used to treat novel coronavirus pneumonia . In December 2020, the FDA approved the emergency use of two mRNA new crown vaccines of Pfizer , BioNtech and Moderna, and these two products were officially approved in 2021 and 2022 respectively.
mRNA products that have been launched worldwide
Source: Sullivan, public information sorted
2, Chinese market
From the perspective of the domestic market, since the outbreak of the new crown epidemic, domestic listed pharmaceutical companies have set off a wave of cooperation with mRNA companies to develop vaccines. In terms of COVID-19 vaccines, the domestic Watson/Aibo/AMCAS ARCoV is in phase III clinical, Fosun Pharma and BioNTech are in phase II clinical, smith microbiology and Zhuhai Livanda are in phase I clinical, and the domestic vaccine industry is expected to compete with overseas markets; most other indication fields are in the preclinical/early stage. At present, the domestic mRNA research field is mainly COVID-19 vaccines, and global mRNA drug indications are also distributed in genetic diseases and other infectious diseases other than COVID-19 . In comparison, there is a lot of room for future indications for domestic mRNA drugs to expand.
Domestic mRNA drug clinical research pipeline
Source: Sullivan, public information sorting
6. Difficulties and development trends of mRNA drug technology
1. Technical difficulties
1. Technical difficulties
mRNA technology mainly faces challenges in sequence optimization and synthesis, delivery systems, and large-scale preparations and storage. The continuous optimization of technology will continue to promote the rapid expansion of the mRNA market. In mRNA synthesis and sequence optimization, since the half-life of mRNA is relatively short, its sequence optimization requires improving its stability and expression efficiency, and mRNA can induce intrinsic immunogenicity, further sequence improvement is needed to control immunogenicity. In terms of delivery systems, liposome nanoparticles are currently the preferred mRNA delivery system, which is almost toxic to most cells, but in some cases it will still have side effects on the liver, and future delivery systems need to be further optimized. In terms of large-scale preparation and storage, although the mRNA production process is not complicated, in the early stages of development in this field, a stable and controllable large-scale production supply chain has not yet been formed. For mRNA products with ultra-low temperature transportation and storage requirements, breakthroughs in their storage methods will promote their rapid development.
mRNA technology difficulties
Source: Sullivan, public information sorting
2, development trend
(1) Expand the field of treatment
mRNA is a revolutionary platform that uses cells to produce antigens or drugs, suitable for most vaccine products. There is a mature mRNA vaccine platform, and manufacturers can apply it to other diseases by simply changing the mRNA sequence. Therefore, mRNA-based therapies can be rapidly expanded to a variety of other diseases. mRNA therapy is also a potential alternative to many future protein-based drugs such as cytokine and even antibodies, and mRNA-based treatments may further expand to many other disease treatments. In addition, mRNA drug development can also target some targets that are difficult to produce drugs, further expanding the therapeutic field.
(2) Rapid development of the entire industrial chain
The outbreak of the new crown epidemic in 2020 has accelerated the popularization and commercialization of mRNA technology. Countries have increased their investment in mRNA technology, which has also given rise to the birth of mRNA biotechnology companies, promoted the construction and improvement of mRNA and drug technology platforms, and brought about the outbreak opportunities in the upstream and downstream of the mRNA industry chain, and promoted the rapid development of upstream and downstream circulation and transportation, including upstream raw materials, midstream R&D and production links, and downstream circulation and transportation.
(3) R&D system is gradually complete
At present, mRNA pharmaceutical companies have formed complete mRNA vaccine teams to optimize mRNA high-throughput synthesis platform, improve patent systems, enrich mRNA pipelines and advanced processes, develop leading mRNA delivery technology, and gradually release large-scale production technologies. In the future, the mRNA industry will make breakthroughs in drug development technology and gradually improve in various aspects such as product line, preparation technology, patent layout and production technology.
Original title: Analysis of the current status and development trend of the mRNA drug industry in 2022, mRNA therapy application scenarios are broad. "Picture"
Huajing Industry Research Institute conducted an in-depth analysis of the current development status of China's mRNA drug industry, upstream and downstream industrial chains, competitive landscapes and key enterprises, to minimize corporate investment risks and operating costs and improve corporate competitiveness; and use a variety of data analysis technologies to predict the industry's development trends so that enterprises can seize the market opportunities in a timely manner; for more detailed content, please pay attention to the "2023-2028 China mRNA Vaccine Industry Market In-depth Analysis and Future Development Trend Forecast Report" published by Huajing Industry Research Institute.
