Landscape of mRNA-Based Therapeutics and Vaccines: Growth Opportunities and Future Outlook

Messenger ribonucleic acid (mRNA) is a type of single-stranded ribonucleic acid (RNA), which helps in transferring genetic information in order to produce proteins. The mRNA encoding instructions for protein synthesis are transferred from a strand of DNA to the ribosomes, where these instructions are translated and processed into functional proteins. mRNA-based therapeutics and vaccines have emerged as a promising alternative to conventional treatment approaches. Post the onset of the COVID-19 pandemic, mRNA therapeutics and mRNA vaccines have garnered significant attention as they have evolved as a revolutionary drug class for the treatment of COVID-19, as well as several other diseases, such as infectious diseases, cancer, genetic disorders and other disorders.

Till date, four mRNA-based vaccines have received approval for the treatment of COVID-19, while a number of such candidates are being evaluated as potential therapies. Moreover, the overall success of the mRNA-based therapeutics and vaccines against COVID-19 has attracted the interest of several investors, specifically towards small and emerging mRNA focused biotechnology companies.

The success of mRNA-based therapeutics and vaccines has increased the research activity in novel / next generation RNA therapeutics market. The rich pipeline of products are also driving growth in the mRNA synthesis and manufacturing market, as the drug developers are seeking contract services to scale-up the manufacturing of mRNA-based drugs.

mRNA-based Therapeutics and Vaccine: Market Landscape

With the approval of the first mRNA-based vaccine under Emergency Use Authorization (EUA), Comirnaty®, in 2020, the field has witnessed a further surge in research and development activity. Since then, two more mRNA-based vaccines under EUA have been approved by regulatory authorities, which includes (in chronological order of approval year) Spikevax® (December 2020) and GEMCOVAC™-19 (June 2022).

Pipeline Analysis: More Than 230 mRNA-based Therapeutics and Vaccines in Various Stages of Development

The current market landscape features the presence of more than 230 mRNA based drugs and vaccines. While the primary focus lies on mRNA-based vaccines, mRNA therapeutic companies such as Moderna, BioNTech and Arcturus Therapeutics, are also engaged in actively developing mRNA-based therapeutics. Additionally, the companies are evaluating various mRNA delivery technologies in order to ensure efficient and safe delivery of mRNA-based drugs.

The following figure presents the distribution of the pipeline based on the type of drug candidate and type of delivery system.

mRNA Companies Analysis: Big Pharma Companies Partnering to Enter the Market

Presently, over 45 companies are engaged in the market with products across various stages of development, for a myriad of disease indications. Further, over the coming decade, several promising leads, specifically those exhibiting enhanced efficacy, are anticipated to be commercially launched.

Big pharmaceutical companies, such as Merck, Sanofi and Daiichi Sankyo have partnered with smaller, dedicated mRNA-based drug developers to expand their respective capabilities in this upcoming field of therapy. In September 2021, Sanofi became the first big pharma to acquire a mRNA-based therapeutics company, Translate Bio. The active involvement of big pharma players, as well as the presence of new entrants, will drive the market growth during the forecast period.

Regional Analysis: North America Holds the Largest Share of the mRNA Vaccine and Therapeutics Market

The global market for mRNA therapeutics is currently dominated by North America and this trend is unlikely to change during the forecast period. National Institutes of Health (NIH) has been supporting mRNA therapeutics research through provision of grants even before the COVID-19 pandemic. mRNA vaccine development not only requires support for the clinical development of the vaccines, but also development of delivery technologies and expansion of the manufacturing capabilities. Governments of the US and Canada are actively supporting the domestic manufacturing projects. In April 2022, Moderna announced its plan to set up a mRNA vaccine manufacturing facility in Quebec under a strategic partnership with the Government of Canada. Additionally, in September 2022, the US President signed an Executive Order to launch National Biotechnology and Biomanufacturing Initiative, supporting domestic manufacturing. Such initiatives will continue to ensure government support for mRNA technologies and sustain the North American market share during the forecast period.

Future Perspectives and Conclusion

The advent of mRNA-based therapeutics and vaccines has made it possible to address the challenges faced by conventional therapeutics and vaccines. The known antigen, gene and protein targets for various diseases can be directly targeted by the mRNA sequences designed in-silico. This focused approach significantly enhanced the interest of pharmaceutical industry players to develop and advance mRNA-based research. In the recent years, several established players, as well as start-ups, have emerged in this domain to provide various types of mRNA therapeutics and vaccines, targeting several indications, such as cancer, COVID-19, influenza, and other infectious / non-infectious diseases.

Further, as the technology matures and manufacturing processes become more efficient, mRNA vaccines and therapeutics are expected to become more affordable and widely available, especially in developing countries. This could have a significant global impact, improving access to life-saving treatments and contributing to better health outcomes worldwide.

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