mRNA Therapeutics and mRNA Vaccines Market by Route of Administration, Therapeutic Area, and Geography: Global Trends and Industry Analysis, 2022-2035

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. 

Q1. How is the research and development (R&D) activity evolving in the mRNA-based drugs industry?

mRNA therapeutics and mRNA 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 novel drug class for the treatment of COVID-19, as well as several other diseases, such as infectious diseases, oncological disorders, genetic disorders and other disorders. Subsequently, upon the approval of the first mRNA vaccine under emergency use authorization (EUA), Comirnaty®, in 2020, the field has witnessed a further surge in activity. Since then, two more mRNA-based drugs under EUA, namely (in chronological order of approval year) Spikevax® (December 2020) and GEMCOVAC™-19 (June 2022) have been approved by regulatory authorities. In addition, over 1,000 mRNA therapeutics are being evaluated in various stages of clinical trials for the treatment of multitude of disease indications. This demonstrates remarkable scientific advancement and therapeutic promise of these ground-breaking drug candidates.

Q2. What are the key advantages offered by mRNA therapeutics and mRNA vaccines?

The ongoing research and development efforts being undertaken in this domain are primarily being driven by the various advantages offered by these molecules, including higher biological efficacy, enhanced potent immunogenicity and versatile delivery platforms at reduced toxicity levels, over other therapeutic modalities. Recent reports highlight the potential benefits related to the use of mRNA; for instance, such products pose no undesirable risk of inadvertent infection and insertional mutagenesis. Additionally, the in vivo half-life of mRNA can be regulated by deploying different modifications and delivery techniques in order to make the drugs more stable and highly translatable, as it is usually degraded by typical cellular activities. Moreover, owing to the high yields of in vitro transcription reactions, the manufacturing of mRNA candidates is believed to be cost-effective, rapid and scalable. 

Q3. What are the current opportunities in the mRNA vaccines and mRNA therapeutics market?

In the past few years, the field of mRNA therapeutics and mRNA vaccines has evolved at a steady pace. In fact, a significant amount of preclinical data has been gathered and multiple human clinical trials have been initiated. Further, over the past decade, major technological innovations and substantial investments have enabled mRNA to become a promising therapeutic tool in the field of vaccine development and protein replacement therapy. With the advent of several mRNA-based technologies, there has been a rise in the development of these therapeutics to target a myriad of disease indications. 

In addition, it is important to highlight the recent opportunities that have been created in this market, post the onset of the COVID-19 pandemic. As mentioned earlier, till date, three 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, BioNTech and Pfizer have signed contracts to deliver 2.4 billion doses of its approved vaccine, Comirnaty®, by the end of 2022. The overall success of the mRNA-based therapies and mRNA vaccines against COVID-19 has attracted the interest of several investors, specifically towards small and emerging mRNA focused biotechnology companies. Further, along with drug developers, the mRNA technology and platform providers are streamlining their existing capabilities to offer a wide range of services to their clients. 

Q4. What are the recent developments and expected trends in the mRNA vaccines and mRNA therapeutics market?

Presently, over 35 companies are engaged in the evaluation of more than 195 mRNA therapeutics and mRNA vaccines, 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. Moreover, considering the active involvement of big pharma players, as well as new entrants, the development pipeline of mRNA drugs is likely to grow further. It is also worth highlighting that close to 150 collaborations have been inked between industry / academic stakeholders to advance the development of their proprietary pipeline candidates. Driven by the growing interest of various stakeholders and encouraging clinical research results, the overall mRNA therapeutics and mRNA vaccines market is anticipated to witness consistent growth, till 2035.

Q5. What are the key challenges faced by mRNA drug developers?

Despite the numerous benefits offered by mRNA therapies, developers of these novel products often face challenges related to the stability and targeted delivery of their drug candidates. Some of the other key concerns faced by drug developers include limited availability of expertise, lack of specialized infrastructure, requirement for exorbitant capital investment, and constraints associated with ensuring compliance to good manufacturing practices (GMP). , 

Q6. What are the key value drivers in the mRNA vaccines and mRNA therapeutics market? 

The key value drivers in the mRNA therapeutics and mRNA vaccines market include a significant rise in the overall healthcare expenditure, increased R&D spending, a surge in mRNA-focused research initiatives and a plethora of mRNA technological advancements in the recent past. 

Q7. How is the revenue generation potential associated with mRNA therapeutics and mRNA vaccines likely to evolve in the coming years?

The revenue generation potential associated with the mRNA therapeutics and mRNA vaccines is anticipated to witness a steady growth in the foreseen future. Specifically, in terms of route of administration, the current market is expected to be driven by sales of mRNA therapeutics designed for administration via the intramuscular route, and this trend is unlikely to change in the foreseen future as well. Further, another key segment is represented by mRNA-based therapies targeting infectious diseases, which presently capture a significant share of the global market (in terms of sales-based revenues). 

Q8. Who are the key players engaged in the mRNA therapeutics and mRNA vaccines market?

Examples of key players engaged in this domain (which have also been captured in this report) include BioNTec, Chimeron Bio, CureVac, eTheRNA, IMMORNA, Moderna, Omega Therapeutics, RNACure and Stemirna Therapeutics.

Scope of the Report

The “mRNA Therapeutics and mRNA Vaccines Market (2nd Edition) by Route of Administration (Intravenous, Intramuscular, Intranasal and Others), Therapeutic Area (Infectious Diseases, Oncological Disorders and Other Disorders), and Geography (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Global Trends and Industry Analysis, 2022-2035” report features an extensive study of the current market overview and future potential of the mRNA therapeutics and mRNA vaccines market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Amongst other elements, the report features: 

• A detailed overview of the overall market landscape of mRNA therapeutics and mRNA vaccines, based on several relevant parameters, such as phase of development (marketed, phase III, phase II, phase I / II, phase I, preclinical and discovery), type of drug candidate (mRNA therapeutic and mRNA vaccine), therapeutic area (infectious diseases, oncological disorders, genetic disorders, pulmonary disorders, autoimmune disorders and other disorders), type of delivery system used (lipid nanoparticles, lipopolyplex, liposomes, direct transfer, self-amplifying RNA platform and others), type of molecule encoded (spike protein, glycoprotein, antigen, cytokine, protein coding gene, tumor neoantigen, enzyme, tumor antigen and others) and route of administration (intramuscular, intravenous, intranasal and others).
• A detailed overview of the current market of players engaged in the development of mRNA therapeutics and mRNA vaccines, along with information on their year of establishment, company size (in terms of number of employees), location of headquarters, regional landscape and key players engaged in this domain.
• An in-depth company competitiveness analysis of mRNA therapeutics and mRNA vaccines developers based on their portfolio strength (in terms of year of establishment and company size), pipeline strength (in terms of its pipeline maturity and drug administration route) and number of therapeutic areas targeted.
• Detailed profiles of marketed and late stage (phase III) mRNA therapeutics and mRNA vaccines, along with information on the development timeline of the therapy, current development status, primary target indication, therapeutic area, type of molecule encoded, type of delivery system used, affiliated technology, recent partnerships associated with the drug, clinical trial results related to the drug and other recent developmental.
• A review of the various mRNA-focused initiatives undertaken by big pharma players (shortlisted on the basis of the revenues generated in 2021), featuring a [A] heat map representation that highlights mRNA therapeutics and mRNA vaccines under development (in partnership with core mRNA-focused entities), along with information on funding amount raised, partnership activity, and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)), as well as [B] a spider web representation, comparing the initiatives of big pharmaceutical players on the basis of multiple relevant parameters.
• An analysis of start-ups (established between 2016-2022) engaged in this domain, based on several relevant parameters, such as number of candidates in discovery, preclinical and clinical phases of development, amount raised, number of investors and number of deals inked.
• An analysis of completed, ongoing and planned clinical studies of mRNA therapeutics and mRNA vaccines, based on several relevant parameters, such as trial registration year, trial status, trial phase, target therapeutic area, study design, type of sponsor / collaborator, leading industry players (in terms of number of trials conducted), enrolled patient population and key geographical regions.
• An analysis of recent collaborations and partnerships within the mRNA therapeutics and mRNA vaccines industry, based on several relevant parameters, such as year of partnership, type of partnership, targeted therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have been undertaken in this domain, during the period 2013-2022.
• A detailed analysis of various investments made by players engaged in this domain, during the period 2013-2022, based on several relevant parameters, such as year of funding, type of funding (seed financing, venture capital, IPOs, secondary offerings, debt, grants and other offerings), amount invested, therapeutic area, most active players (in terms of number of funding instances and amount invested) and key investors (in terms of number of funding instances). 
• An in-depth analysis of the various patents that have been filed / granted related to mRNA therapeutics and mRNA vaccines domain, since 2016, based on several relevant parameters, such as type of patent (granted patents, patent applications and others), publication year, geographical region, CPC symbols, leading industry players (in terms of the number of patents filed / granted) and patent valuation.

One of the key objectives of this report was to estimate the existing market opportunity and the future growth potential of the mRNA therapeutics and mRNA vaccines market over the coming years. We have provided an informed estimate on the likely financial evolution of the market in the short to mid-term and long term, for the period 2022-2035. Additionally, the report features the likely distribution of the current and upcoming opportunity segmented across important parameters, such as [A] route of administration (intravenous, intramuscular, intranasal and others), [B] therapeutic area (infectious diseases, oncological disorders and other disorders), and [C] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa).

In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

• Which are the key players engaged in the development of mRNA therapeutics and mRNA vaccines?
• Which mRNA drug candidates are being evaluated across early and late stages of clinical development?
• Which are the key therapeutic areas targeted by mRNA therapeutics and mRNA vaccines?
• Which type of delivery systems are primarily being used for the delivery of mRNA therapeutics and mRNA vaccines?
• Which are the most active trial sites (in terms of number of clinical studies being conducted) related to mRNA therapeutics and mRNA vaccines?
• Which companies are actively filing patents in order to drive innovation in the field of mRNA therapeutics and mRNA vaccines?
• What type of partnership models are commonly adopted by stakeholders in the mRNA therapeutics and vaccine domain?
• Which are the companies that are investing heavily in this domain?
• How is the current and future market opportunity likely to be distributed across the various key market segments?