RNA-based therapeutics have completely revolutionized the healthcare segment, greatly influencing the study and treatment of human diseases by conferring precise targeting ability to therapeutic modalities. Further, the enhanced safety and efficacy of treatment using RNA-based therapeutics has surpassed the safety profiles of the conventional treatment approaches. Considering their vast potential, stakeholders are actively engaged in developing novel RNA-based therapeutics, that have the capacity to circumvent the few challenges associated with the traditional approaches. In this context, several industry players have demonstrated high inclination towards supporting and advancing the development of next generation RNA-based therapeutics, vaccine and technologies. Additionally, the support from venture capitalists and big pharmaceutical companies is expected to continue to drive the development of next generation RNA-based therapeutics and market growth over the forecast period. The below given figure provides an illustrative summary of the benefits of next generation RNA-based vaccines and RNA-based therapeutics market.
RNA-based therapeutics and RNA-based vaccines– Current Market Landscape
Presently, more than 100 RNA-based therapeutics and RNA-based vaccines are being investigated across various stages of development for the treatment of a myriad of disease indications; one such drug product has already received emergency use approval. The below figure presents the distribution of next generation RNA-based therapeutics and RNA-based vaccines, based on type of molecule.
It is worth highlighting that close to 40% of the self-amplifying RNA therapies re in the preclinical phase; among the next generation molecules, only one self-amplifying RNA based therapy, Gemcovac, has been marketed, till date. Examples of players developing self-amplifying RNA therapeutics include Arcturus Therapeutics, Replicate Bioscience and VLP therapeutics. Circular RNA has emerged as the second most prominent type of next generation RNA-based molecule. This can be attributed to the highly stable, closed-loop structure of the molecule. Examples of players engaged in the development of circular RNA-based therapeutics include Chimerna Therapeutics, Orna Therapeutics, Targovax and Therorna.
Next Generation RNA Technologies: Advancing the Design, Development, Manufacturing and Delivery of Next Generation RNA-based therapeutics and Vaccines
Over the years, RNA-based therapeutics and RNA-based vaccines domain has witnessed significant advancements in terms of development of technologies / platforms to aid in the development and manufacturing of RNA-based therapeutics and vaccines. It is worth highlighting that more than 41% of the technologies are being deployed for self-amplifying RNA based molecules, owing to their greater therapeutic efficacy at low dose concentrations. Further, around 14% of the next generation RNA technologies / platforms are capable to support the research and discovery, development, and delivery of the RNA therapies / vaccines. The below figure presents the distribution of next generation RNA technologies, based on their capabilities.
Clinical Trial Activity: Demonstrating entry of next generation RNA-based therapeutics and RNA-based vaccines in clinical stages of development
Majority of the trials focused on RNA-based therapeutics and vaccines were registered in 2022. It is worth highlighting that in 2022 alone, over 58% of the overall patients were enrolled in clinical trials evaluating next generation RNA therapies and vaccines, across different geographical regions. Further, more than 70% of these studies have either been completed / are currently recruiting patients across different locations. The below figure presents the distribution of clinical trials evaluating next generation RNA-based therapeutics and RNA-based vaccines, based on the trial status.
Patent Analysis: Reflective of the significant intellectual capability expansion activity of players engaged in the RNA-based therapeutics and RNA-based vaccines market
Over the past decade, industry stakeholders have been extensively working towards improving the treatment options related to next generation RNA and RNA-based vaccines. Most of the innovations in this domain have been focused on developing drugs for the treatment of various indications, including oncological and infectious diseases, and developing innovative delivery technologies to ensure the proper delivery of next generation RNA therapeutics and RNA-based vaccines. As a result, close to 1,170 patents have been filed / granted for next generation RNA-based therapeutics and vaccines, by industry and non-industry players, to protect intellectual property generated within this field. The below figure presents the distribution of filed / granted patents, based on the year and type of patent.
It is worth highlighting that player such as MiNA Therapeutics, Flagship Pioneering, Orna Therapeutics have emerged as the leading industry patent applicants.
Partnerships and Collaborations: Exhibiting high activity of players engaged in this domain
Stakeholders engaged in the RNA therapeutics and RNA vaccines domain are known to adopt a variety of partnership models to collaborate with other companies / organizations for specific purposes. Such deals are inked to not only allow companies to expand their respective product / service portfolios, but also gain additional capabilities related to emerging technologies. During our research, we came across more than 40 partnerships and collaborations that have been established between various stakeholders engaged in this domain. The below figure presents the distribution of partnerships and collaborations, based on the focus of partnership.
Funding and Investment Initiatives: Indicative of the Increasing Interest among Players
Over the years, monetary assistance from angel investors, venture capitalists, and funding schemes of various public and private organizations / funds, along with assistance from regulatory authorities, have allowed start-ups / small companies to further their R&D efforts related to the development of next generation RNA therapeutics and RNA-based vaccines. During our research, we came across more than 70 funding instances focused on next generation RNA therapeutics and RNA-based vaccines, during the period 2019-2023, which amounted to a total of more than USD 2.7 billion. It is worth highlighting that Grants emerged as the most popular type of funding, followed by venture capital; in 2022, more than USD 468 million was raised across five venture capital funding rounds. The below figure presents the distribution of funding instances, based on the type of funding.
In a nutshell, the growing pipeline of RNA-based therapeutic modalities and favorable clinical trial results have encouraged several industry players and big pharma players to undertake initiatives for the development and advancement of RNA-based therapeutics / vaccines. Further, considering the potential advantages of these therapies over conventional treatment approaches such as self-amplification capability possessed by self-amplifying RNA, self-amplifying messenger RNA and replicating RNA and highly stable structure (circular RNA and endless RNA), these therapeutic modalities are anticipated to contribute significantly to the market growth and revolutionize the healthcare and medical sector.