Currently, the global messenger RNA (mRNA) vaccines market consists entirely of vaccines for Covid-19. The rapid sequencing of the SARS-CoV-2 viral genome and the subsequent development of mRNA vaccines in response to the Covid-19 pandemic led to the authorisation of the first of these vaccines in December 2020. However, several pharmaceutical companies have mRNA vaccines in late-stage development for other infectious diseases, demonstrating the strong potential for growth and diversification of this market.

GlobalData’s latest report, mRNA Vaccines in Infectious Diseases Market Outlook and Trends by Opportunities, Challenges, Unmet Needs, and Competitive Landscape, identified several late-stage pipeline products developed for various infectious disease indications, such as influenza, respiratory syncytial virus (RSV), and cytomegalovirus, as well as Covid-19.

Most of the current late-stage Covid-19 pipeline is focused on developing boosters against emerging Covid-19 variants globally. However, in the upcoming years, mRNA vaccines will likely be approved in other infectious diseases, especially in influenza, where there are currently 11 different pipeline products in Phase II and III clinical trials.

While many companies, especially large pharmaceutical companies, have a stake in mRNA vaccines development, Moderna dominates above all of them in terms of R&D investment. The company has a Phase III pipeline candidate across four different indications (Covid-19, influenza, RSV, and cytomegalovirus), and is also developing a Phase III combination vaccine against Covid-19 and influenza.
In addition to Moderna’s strong Phase III pipeline, the company also possess many different unique candidates in Phase II, exploring the potential use of mRNA vaccines in indications such as Zika virus, Mpox, and herpes, as well as the bacterial infection Lyme disease. Moderna is the only company in the late-stage pipeline that is targeting mRNA vaccines against bacterial pathogens.

Moderna is already a key company in the mRNA vaccines space. The company’s Covid-19 vaccine Spikevax (elasomeran) is recommended by the World Health Organization as a safe and effective vaccine for everyone older than age six months. Although Spikevax sales are projected to decline sharply from 2023 onwards, as the company has stakes in many different pipeline agents, it will remain a major player in this market in the coming years.

Pfizer, in collaboration with BioNTech, also has several assets in the pipeline. These include a new Covid-19 booster and an influenza vaccine, which are currently in Phase III clinical trials, as well as vaccines for Mpox, herpes, and a combination vaccine for Covid-19 and influenza, all of which are currently in Phase II clinical trials. There is also a heavy presence from Sanofi and GSK in Phase II clinical development for influenza, with GSK currently having one pipeline product in development and Sanofi having three. Sanofi is also developing one mRNA vaccine for RSV. With the popularity of the mRNA platform significantly growing in recent years, there are also many mid-range to smaller pharmaceutical companies interested in their development, especially in the field of Covid-19.

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Despite the success of mRNA vaccines in the Covid-19 space, key opinion leaders (KOLs) interviewed by GlobalData expect the commercial performance of mRNA vaccines in other indications to vary greatly depending on the current competition and unmet needs within each space.

According to KOLs, mRNA vaccines may face tough competition within influenza, as the influenza vaccines that are currently available on the market are safe, reliable, and hold a strong position within the market itself. However, indications such as cytomegalovirus may greatly benefit from the approval of mRNA vaccines, especially as there are currently no approved vaccines available to protect immunocompromised patients from the infection. KOLs also noted the need for more combination vaccines, especially those targeting Covid-19, influenza, and RSV.

Another important commercial unmet need highlighted by KOLs is the distrust among the general public towards mRNA vaccines due to the unclear messaging during the Covid-19 pandemic and the swift development of these vaccines. It is therefore necessary to improve the clarity of communication regarding their benefits, efficacy, side effects, and research process to improve the uptake of mRNA vaccines in the future.