mRNA Vaccines

Overview

Medical researchers first began evaluating mRNA as a therapeutic modality in the 1990s. The clinical use of mRNA is presently being evaluated in both therapeutic (protein replacement therapies, and as an alternative to classical gene therapies) and preventive (mRNA vaccines) roles. There are over 65 mRNA therapeutics and more than 85 vaccines currently in the development pipeline. As a biomolecule, mRNA is well tolerated in vivo, and (depending on the encoded protein) is capable of inducing humoral and cell-mediated immune responses. Moreover, using this approach, researchers have demonstrated that it is possible to deliver adequate amounts of tumor antigens (bearing patient-specific molecular signatures), and provide the necessary costimulatory signals to mount an effective anticancer immune response. As indicated earlier, mRNA-based interventions are also being evaluated as protein replacement therapies and alternatives to classical gene therapies; however, research on the aforementioned modalities is still in its infancy, with several potential leads in the preclinical stages. Such therapies are predominantly being developed for treating rare disorders. On the other hand, using mRNA, it is possible to develop both personalized (for various cancer) and general-use vaccines (for infectious diseases). Interestingly, mRNA vaccines have shorter development and manufacturing timelines, compared to their traditional counterparts. In fact, Pfizer and BioNtech’s recently approved vaccine (BNT-162) and Moderna’s late phase candidate (mRNA-1273) against the novel coronavirus strain, are both mRNA-based preventive solutions.

Despite the potential benefits, there are, however, several challenges that limit the use of mRNA as a therapeutic. One of the major concerns is related to the short cytoplasmic half-life of the molecule, which compromises its efficacy as a therapeutic / vaccine. Other known setbacks of using mRNA as a therapy include its large size and inherent antigenicity, which complicate therapy administration and immune tolerance, respectively. Over the years, manipulation of the chemical structure of mRNA has enabled medical researchers and therapy developers to address some of the aforementioned challenges. Similarly, with regards to therapy delivery, lipoplexes and lipid-based nanoparticles are now preferred vehicles (among other contemporary nucleic acid delivery methods) for the targeted, intracellular delivery of therapeutic mRNA. However, companies (mostly startups and small firms) engaged in this field still claim to be in pursuit of better drug delivery strategies. In the last five years alone, close to USD 8 billion has been invested into companies that are engaged in developing mRNA-based therapeutics and vaccines; a significant proportion of the capital has come from public sector investors / state-backed institutes. Further, over the last few years, there has been noticeable consolidation, with stakeholders entering into strategic partnerships to support ongoing R&D initiatives. In the foreseen future, as more mRNA-based therapeutic / vaccine leads demonstrate proof-of-concept, enter into clinical testing and are eventually marketed, the opportunity for stakeholders engaged in this niche industry segment is anticipated to witness substantial growth.

Scope of the Report

The “mRNA Therapeutics and Vaccines Market, 2020-2030” report features an extensive study of the current market landscape and future potential of the players engaged in the development of mRNA-based therapeutics and vaccines for the treatment of a variety of disease conditions. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report features:

• A detailed assessment of the current market landscape of mRNA therapeutics and vaccines, along with information on type of product candidate, phase of development, type of development program, type of delivery vehicle, target disease indication, target therapeutic area and route of administration. It also includes details related to year of establishment, company size (in terms of number of employees) and location of headquarters of the drug developers. Further, it presents an elaborate analysis of the contemporary trends, presented using two schematic representations, including [A] logo landscape, highlighting the distribution of drug developers based on company size and location of their headquarters, and [B] grid analysis, presenting the distribution of drugs based on target disease indication, type of development program and type of candidate. It also provides a detailed analysis of key therapeutic areas, such as oncological disorders and infectious diseases, for which mRNA-based therapeutics and vaccines are being developed.
• A competitiveness analysis of key players engaged in this domain. The analysis is presented in the form of spider web representations, which take into consideration several important parameters, such as number of early stage candidates, number of late stage candidates, number of deals signed, amount raised through funding, company size (in terms of number of employees) and years of experience in the industry. 
• Detailed profiles of drug candidates that are in advanced stages of development. Each profile features an overview of the drug and respective developer, details related to type of candidate, route of administration, phase of development, target disease indication and therapeutic area, mechanism of action, technology used, and recent developments (including information of partnerships, clinical trials and results and special review designations awarded).
• An analysis of the completed, ongoing and planned clinical studies for mRNA therapeutics and vaccines. The trials considered in the analysis were analyzed on the basis of various relevant parameters, such as trial registration year, trial recruitment status, number of patients enrolled, study design, target patient segment, trial focus area, target therapeutic area, geographical location of trials and leading organizations.
• An in-depth analysis of the various patents that have been filed / granted related to mRNA delivery technologies / methods, since 2017. The analysis also highlights the key parameters associated with the patents, including information on patent application year, patent publication year, geographical location / patent jurisdiction, IPCR symbols, emerging focus areas and leading players. In addition, it includes detailed patent benchmarking analysis based on leading players. Further, it features a patent valuation analysis which evaluates the qualitative and quantitative aspects of the patents.
• An analysis of the partnerships that have been inked by stakeholders engaged in the development of mRNA-based therapeutics and vaccines, during the period 2013-2020, including research agreements, research and development agreements, contract manufacturing agreements, licensing agreements, and other relevant types of deals. 
• An analysis of the investments made, including award / grant, seed financing, venture capital financing, debt financing and others, in companies that are engaged in the development of mRNA-based therapeutics and vaccines
• A discussion on the affiliated trends, key drivers and challenges which are likely to impact the industry’s evolution, under an elaborate SWOT framework. It also includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.  

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the mRNA therapeutics and vaccines market, over the coming decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the financial evolution of the market for the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] key therapeutic areas (infectious diseases and oncological disorders), [B] route of administration (intravenous and intramuscular) and [D] key geographical regions (North America, Europe, Asia Pacific, MENA and LATAM regions). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

Key Questions Answered

• Who are the leading players engaged in the development of mRNA therapeutics and vaccines?
• Which key clinical conditions can be treated by mRNA drugs?
• What are the investment trends in this industry?
• Which partnership models are commonly adopted by stakeholders engaged in this domain?
• Which regions have emerged as the key hubs for conducting clinical studies focused on mRNA drugs?
• How has the intellectual property landscape in this market evolved over the years?
• Which factors are likely to influence the evolution of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?