1. Biotech

Market Analysis Report of mRNA Vaccine

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Principle of mRNA Vaccine

Most vaccines are designed to cause the body to spontaneously develop a specific immune response by delivering antigens. After forming an immune memory, if the body is attacked by a pathogen, the acquired immune response will quickly destroy the pathogen and susceptible cells before the pathogen infects other cells on a large scale.

mRNA vaccines are nucleic acid vaccines that produce antigens by injecting a portion of the mRNA fragment of the virus into human cells, which in turn stimulates a specific immune response and creates an immune memory effect.

The principle of mRNA vaccine therapy refers that the mRNA-encoding antigen is delivered to human cells through different delivery methods, and the corresponding antigen protein is produced after translation in the cell to effectively stimulate cellular immunity and humoral immunity.

Advantages of mRNA Vaccine

  1. Short development cycle and low R&D costs. The development cycle of an mRNA vaccine is about 1 year, and its cost can be controlled at under $200 million. Traditional vaccines generally require more than 8 years with a cost of $200 million to $1 million. DNA vaccines can be done faster but it also usually takes 4 to 7 years.
  2. High safety. mRNA vaccines can be naturally degraded after entering the body and the side effects can be more precisely controlled. Additionally, there's no risk of integration, induced gene mutation, or exogenous viral infection.
  3. Good water solubility and easy to turn into medicine.
  4. Flexible design. mRNA vaccines can deliver a variety of antigens and can be targeted for delivery to DC cells as well.
  5. Quick preparation. Traditional vaccines usually take at least 6 months to produce while mRNA vaccines can be developed within 30 days under standardized production due to their high yield of in vitro transcription reaction and the characteristics of rapid preparation. The timeliness of vaccines is especially important when dealing with sudden outbreaks, especially virus mutations.

Market Analysis of mRNA

The size of the market for mRNA products depends in the short term on COVID-19 vaccine sales. Between 2023 and 2025, though with the support of booster vaccine approval and wider global use, this number will go down to about $20 billion due to a decline in mainstream demand for COVID-19 vaccines and a lack of new product launches. It is estimated that the mRNA drug market is expected to grow from 2028 and reach $23 billion in 2035 with the introduction of other preventive and therapeutic vaccine products. Among them, preventive vaccines will remain the cornerstone, accounting for more than 50% of the market by 2035. Therapeutic vaccines for cancer account for about 30% and therapeutic drugs for less than 20%.

mRNA Industry Process

The upstream of the mRNA industry mainly includes equipment and raw materials such as DNA plasmid, enzymes, lipids, separation, and purification materials. The R&D and production enterprises of drugs and vaccines are in the middle process. Downstream covers the cold chain transport, hospitals, and patients.

The upstream encompassing the preparation of DNA plasmid template and mRNA stock solution and the production of raw materials is the part with the highest proportion of production cost in the whole mRNA industry process since it requires high-standard raw materials and production environment.

  • Plasmids

Large-scale production of DNA takes plasmid as the carrier with the core technology lying in plasmid design, strain selection, fermentation method, plasmid purification, and so on. Mass production of DNA is similar to antibody production in that it relies on cell expansion.

  • mRNA transcription and modification

mRNA modifications include pseudoUridine etc.

  • Raw materials for LNP production

The raw materials required for LNP include cationic lipids, auxiliary lipids, cholesterol, and particles with a stable composition of polyethylene glycol (PEG) modified lipids, accounting for 8% of the total cost.

  • Equipment and consumables

The requirements of LNP production equipment and technology are very high and purification reaction requires sets of equipment.

Summary

At present, Pfizer's mRNA vaccine products have verified their commercial value and international pharmaceutical giants also have other mRNA product layouts in their R&D pipelines. For example, BioNTech has a rich pipeline layout in the field of the tumor, with indications including head and neck squamous cell carcinoma, melanoma, and prostate cancer, which confirms the recognition of mRNA technology. It's believed that mRNA technology can play a significant role in the cause of human health.

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