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The global RNA Vaccines and RNA Therapeutics market is estimated to be worth over USD 948 million in 2035 and is expected to grow at compounded annual growth rate (CAGR) of 68% during the forecast period (2028-2035). In the past few years, RNA based therapeutics have emerged as one of the key therapeutic modalities in the modern healthcare industry. These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. In addition, they offer enhanced therapeutic and safety profiles as compared to traditional treatment approaches. However, there are some concerns associated with the highly unstable nature of such molecules and their delivery at adequate concentrations. Therefore, in order to address the challenges pertaining to the use of RNA therapeutics and RNA vaccines, several industry players have been engaged in the development / deployment of novel technologies for the design, development and manufacturing of next generation RNA-based therapeutics / vaccines, offering the healthcare sector a promising disease management recourse.
The next generation RNA therapeutics and RNA vaccines are modified treatment molecules aimed at specifically targeting and treating diseases that were earlier considered undruggable. Among these, innovative modalities, such as circular RNA (circRNA), endless RNA (eRNA), self activating RNA (sacRNA), self amplifying RNA (saRNA), self amplifying mRNA (samRNA), replicating RNA (repRNA) and transfer RNA (tRNA) have emerged as popular targeted therapeutics. The success of these next generation RNA therapeutics and RNA vaccines can be attributed to their structural stability, expression specificity, targeted delivery, non-immunogenic nature, high efficiency and ability to target a wide range of therapeutic modalities, including influenza, COVID-19 infection, breast cancer and interstitial lung disease, among others. Further, owing to their self-replicating nature, such RNA based therapeutics offer prolonged therapeutic effects at relatively low and less frequent doses, as compared to traditional methods.
Given the ongoing pace of innovation in this field, encouraging clinical trial results, accelerated approvals, and the continuous efforts of both industry and non-industry players, the next generation RNA Therapeutics market is likely to witness significant growth during the forecast period.
The RNA Vaccines and RNA Therapeutics Market: Distribution by Type of Modality (RNA Therapeutics and RNA Vaccines), Type of Molecule (replicating RNA, self amplifying RNA, self activating RNA, self amplifying mRNA and transfer RNA), Therapeutic Areas (Infectious Diseases, Oncological Disorders and Pulmonary Disorders), Route of Administration (Intradermal, Intramuscular and Intravenous), Key Geographical Regions (North America, Europe and Asia-Pacific) and Leading Players: Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunities associated with the RNA vaccines and RNA therapeutics market, during the given forecast period. Further, the market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the RNA vaccines and RNA therapeutics market are briefly discussed below.
The next generation RNA vaccines and RNA therapeutics market landscape is concentrated with the presence of over 35 large, mid-sized and small companies. Of these, 50% of the companies were established during the period 2016-2020, indicating significant start-up activity in this therapeutic market segment. Examples of companies (established in 2019 and 2020, in alphabetical order) include Chimerna Therapeutics, Orna Therapeutics, Replicate Bioscience, Transine Therapeutics, VaxEquity, VLP Therapeutics and Ziphius Vaccines. Further, more than 70% of the companies are based in North America. Within Europe, the UK has emerged as the hub of players engaged in the development of next generation RNA therapeutics and RNA vaccines.
It is worth mentioning that, currently, over 100 next generation RNA therapeutics and RNA vaccines are either approved or being evaluated in various stages of development; of these, nearly 25% of the drug candidates are being evaluated in clinical trials. Further, 40% and 32% of the drug candidates are being investigated for the treatment of infectious diseases and oncological disorders, respectively, across different phases of development. These drug candidates have emerged as popular targeted therapy among therapy developers.
Recent advancements in the healthcare industry in the last few years have led to the development of various novel drug modalities. Interestingly, the industry is evaluating next generation RNA therapeutics and RNA vaccines, which have surfaced as possible targeted therapies for a wide range of therapeutic indications.
It is important to highlight that a therapeutic modality, ATYR1923, developed by aTyr Pharma, is currently being investigated in phase III, targeting Pulmonary Sarcoidosis. Recently, in August 2022, the drug received fast track designation from the USFDA. Over 1,160 clinical trial initiatives focused on various next generation drug modalities, such as circular RNA (circRNA), endless RNA (eRNA), self-activating RNA (sacRNA), self amplifying RNA (saRNA), self amplifying mRNA (samRNA), replicating RNA (repRNA) and transfer RNA (tRNA), long non coding RNA and others have been undertaken since 2019, indicating the substantial research efforts being made in this industry.
Since 2021, 18 clinical trials have been registered for the evaluation of next generation RNA therapeutics and vaccines. Of these, 72% of the trials were focused on infectious diseases. This can be attributed to the enhanced activity of industry players towards the development of therapies targeting COVID-19. Interestingly, 27% of these trials have advanced to the late stages of development (phase II and above). As the next generation RNA therapeutics and RNA vaccines move along the clinical development trajectory, we expect the market to grow at a favorable CAGR during the forecast period.
RNA vaccines have caught the attention of the pharmaceutical industry, specifically during the COVID-19 pandemic, when the first generation mRNA based COVID vaccine received approval from regulatory authorities. Prior to mRNA vaccines, other modalities, such as antisense RNA, siRNA and RNA aptamers were evaluated as therapeutics. Gemcovac®, developed by HDT Bio was the first self amplifying mRNA (saRNA) based COVID vaccine to receive emergency use approval in India, in June 2022. Notably, this COVID vaccine is currently being evaluated in clinical trials in the US, Brazil and South Korea. According to the pivotal trial results, Gemcovac® demonstrated a much lower rate of adverse events as compared to the COVID vaccine, developed by Moderna and Pfizer. The immunological response of the therapy was comparable to that developed by AstraZeneca. Additionally, Gemcovac® is supplied in lyophilized powder form and requires storage in a normal refrigerator. This self amplifying mRNA vaccine is delivered intradermally, unlike most of the COVID vaccines that are administered intramuscularly. Owing to their highly stable structure, enhanced therapeutic profile and low concentration administration, the next generation RNA therapeutics and RNA vaccines have emerged as a potential alternative to conventional RNA-based approaches.
Another player, Arcturus Therapeutics is developing the COVID vaccine using its proprietary self amplifying mRNA technology platform. In April 2023, its collaboration partner, Meiji Seika Pharma, submitted an NDA to commercialize the vaccine, ARCT-154, in Japan. The launch of more such self amplifying mRNA vaccines will drive the market growth over the forecast period.
The pandemic offered a major thrust to RNA-based therapies. Since then, industry stakeholders are actively being engaged in the development of therapies that are long lasting and can target a wide range of therapeutic targets, giving rise to the development of next generation RNA therapeutics and RNA vaccines using various approaches.
One such approach involves the use of transfer RNA (tRNA), being engineered by US-based Alltrna, in order to correct gene code and ultimately gene expression. The company raised USD 50 million in Series A funding in 2020. However, Alltrna is not the sole company working on tRNA technology. Other companies include ReCode Therapeutics, ShapeTX, Tevard Biosciences and hC Bioscience. The current tRNA market landscape features the presence of close to ten therapies, of which, majority are still in early stages of development. These therapies are primarily being developed to target indications, such as Cystic Fibrosis, Duchenne Muscular Dystrophy and Pulmonary Sarcoidosis.
Circular RNA is a covalently bonded closed-loop RNA structure, engineered from linear RNAs by circularization. These structures confer higher stability to the RNA molecules, protecting the molecule from rapid degradation by exonucleases. Recently, the next generation RNA therapeutics and vaccines domain has witnessed the emergence of industry players engaged in the development of circular RNA therapies, owing to the vast potential and high stability of such therapies. Examples of some players include (in alphabetical order) Chimerna Therapeutics, Esperovax, Flagship Pioneering’s Laronde, Ginkgo Bioworks, Orna Therapeutics, Ring Code Biotech, Circio and Therorna. Notably, since 2019, more than USD 380 million has been raised / invested by companies engaged in the development of circular RNA, reflecting significant funding activity for circular RNA-based therapies in this domain.
It is worth highlighting that industry players are actively collaborating with circular RNA therapy developers in order to support the discovery, development and delivery of circRNA molecules. For instance, Renagade Therapeutics has entered into a collaboration with Orna Therapeutics in order to support the delivery of circular RNA therapies being discovered by Orna Therapeutics. Considering the potential of these therapies, several industry stakeholders are actively engaging in the development of such therapeutics. The support from venture capitalists and big pharmaceutical companies will continue to drive the development of circular RNA therapeutics and market growth over the forecast period.
Many stakeholders are undertaking initiatives to forge alliances with other industry / non-industry players. Of the strategic partnerships focused on next generation RNA therapeutics and RNA vaccines that have been inked since 2019, close to 22% of partnerships are research and development agreements, indicating that the stakeholders are actively engaged in research and development of these next generation RNA therapeutics and RNA vaccines. Interestingly, it was observed that many big pharma players, such as Merck, Gilead Sciences, AstraZeneca and others have partnered with several next generation RNA therapeutics and RNA vaccines players, in order to expand their respective portfolios. It is worth highlighting that a sum of $2.9 billion has been raised / invested by players engaged in the development of RNA therapeutics and RNA vaccines, indicating the interest of stakeholders in this market.
Given the inclination towards development of novel next generation RNA therapeutics and RNA vaccines, along with the engagement of big pharma players and high investments, we believe that the next generation RNA Therapeutics market is likely to evolve at a rapid pace over the forecast period.
Driven by the rising interest in R&D activities and growing demand for effective therapies for rare and oncological disorders, the next generation RNA therapeutics and RNA vaccines market is anticipated to witness an annualized growth rate (CAGR) of over 50%, during the forecast period (2026-2035). Specifically, in terms of type of molecule, the global market for next generation RNA therapeutics and RNA vaccines is anticipated to be driven by self amplifying mRNAs. Likewise, in terms of therapeutic area, the market is anticipated to be dominated by the RNA therapeutics and RNA vaccines targeting oncological disorders and pulmonary disorders.
In addition, close to 94% of the market share in 2035 is captured by the players based in North America. However, it is worth highlighting that the next generation RNA therapeutics and RNA vaccines market in Asia-Pacific is anticipated to grow at a higher CAGR, during the forecast period (2030-2035).
Recently, the increasing number of orphan and fast track designations granted by the regulatory authorities, such as the USFDA and the EMA, has intrigued interest and increased the confidence of the pharmaceutical industry in these novel targeted therapies. All the above factors will contribute to a healthy market growth of the next generation RNA therapeutics market during the forecast period.
Examples of key companies engaged in the next generation RNA therapeutics and RNA vaccines development (which have also been captured in this market report, arranged in alphabetical order) include Alphavax, Arcturus Therapeutics, Atyr Pharma, Flagship Pioneering, Forge Therapeutics, Gingko Bioworks, Gritstone Bio, HDT Bio, Laronde Therapeutics, MiNA Therapeutics, Orna Therapeutics, Recode Therapeutics, Renegade Therapeutics, Replicate Bioscience, Shape Therapeutics and VLP Therapeutics. This market report includes an easily searchable excel database of all the companies developing next generation RNA therapeutics and RNA vaccines, worldwide.
Several recent developments have taken place in the field of next generation RNA vaccines and RNA therapeutics, some of which have been outlined below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we’ve outlined in our analysis.
The market report presents an in-depth analysis of the various firms / organizations that are engaged in this market, across different segments, as defined in the below table:
|Key Report Attributes
Type of Modality
Type of Molecule
Route of Administration
|Key Geographical Regions
|Key Companies Profiled
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The market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market report includes:
One of the key objectives of this market report was to estimate the current market size and the future growth potential of the next generation RNA therapeutics and RNA vaccines over the forecast period. Based on several parameters, such as region-specific adoption rates and expected prices of such modalities, we have developed informed estimates of the likely evolution of the next generation RNA vaccines and RNA therapeutics market over the forecast period 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of modality (therapeutics and vaccines), type of molecule (repRNA, saRNA, sacRNA, samRNA and tRNA), therapeutic area (infectious diseases, oncological disorders and pulmonary disorders), route of administration (intradermal, intramuscular and intravenous), key geographical regions (North America, Europe and Asia-Pacific) and leading players. 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, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.
All actual figures have been sourced and analyzed from publicly available information forums and secondary research. Financial figures mentioned in this report are in USD, unless otherwise specified.