The global RNA Vaccines and RNA Therapeutics market is estimated to be worth over USD 1.1 billion in 2035 and is expected to grow at compounded annual growth rate (CAGR) of 50% during the forecast period (2026-2035). 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 vaccines and RNA therapeutics market is likely to witness significant growth during the forecast period.
Key Market Insights
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.
Current Market Landscape: Next Generation RNA Therapeutics and RNA Vaccines Offering Efficient Treatment Recourse
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.
Clinical Trials Analysis: A number of RNA Therapeutics and RNA Vaccines are Being Evaluated in Clinical Trials
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.
Self Amplifying mRNA Vaccines Offer Several Advantages Over the First Generation mRNA Vaccines
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.
Potential of tRNA Therapeutics is Being Explored by Few Key Companies
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 Therapeutics Market is Witnessing a number of Start Ups and Funding Activity
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.
Key Trends in the Next Generation RNA Therapeutics and RNA Vaccines Market
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 and RNA vaccines market is likely to evolve at a rapid pace over the forecast period.
Next Generation RNA Vaccines and RNA Therapeutics Market Size: North America to Hold the Largest Market Share
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 and RNA vaccines market during the forecast period.
Leading Next Generation RNA Therapeutics and RNA Vaccines Developers
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.
Recent Developments in the Next Generation RNA Vaccines and RNA Therapeutics Market
- 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.
- In February 2023, Tevard Biosciences entered into a research and development agreement with Vertex Pharmaceuticals for the development of novel tRNA based therapies, intended for the treatment of Duchenne Muscular Dystrophy.
- In January 2023, Esperovax entered into a product development agreement with Gingko Bioworks for the development of circular RNA therapeutics, specifically targeting colorectal cancer.
- Further, in January 2023, HDT Bio entered into a technology utilization agreement with the Pan African Cancer Research Institute (PACRI), in order to develop self-amplifying RNA vaccines and therapeutics.
Scope of the Report
The market report presents an in-depth analysis of the various firms / organizations that are engaged in this market, across different segments.
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:
- A preface providing an introduction to the full report, RNA Therapeutics and RNA Vaccines Market, 2023-2035.
- An outline of the systematic research methodology adopted to conduct the study on next generation RNA therapeutics and RNA vaccines market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
- An overview of economic factors that impact the overall next generation RNA therapeutics and RNA vaccines market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
- An executive summary of the insights captured during our research, offering a high-level view of the current state of the next generation RNA therapeutics and RNA vaccines market and its likely evolution in the mid-to-long term.
- A brief introduction to the next generation RNA therapeutics and RNA vaccines, highlighting their historical background, as well as information on their types, key aspects, key challenges and the advantages of using next generation RNA modalities.
- A detailed assessment of the market landscape of more than 100 next generation RNA therapeutics and RNA vaccines that are either approved or being evaluated in different stages of development, based on several relevant parameters, such as type of modality (therapeutics and vaccines), type of molecule (saRNA, circRNA, tRNA, sacRNA, ARC, SINEUPs, eRNA and lamRNA), type of delivery vehicle (lipid nanoparticles, viral vectors, non-lipid nanoparticles, non-viral vectors and polymers), phase of development (discovery, preclinical, phase I, phase I / II, phase II, phase II / III, phase III and emergency use approval), therapeutic area (infectious diseases, oncological disorders, genetic disorders, neurological disorders, immunological disorders and other disorders). Further, the chapter features analysis on key niche market segments (circRNA and saRNA). In addition, the chapter features analysis of various next generation RNA therapeutic and RNA vaccine developers, based on their year of establishment, company size, location of headquarters and most active players (in terms of number of therapies).
- A detailed assessment of the market landscape of more than 35 technologies that are being developed / deployed to support the development of next generation RNA therapeutics and RNA vaccines, based on several relevant parameters, such as class of molecule (therapeutics and vaccines), type of molecule (saRNA, circRNA, tRNA, sacRNA, ARC, SINEUPs, eRNA and lamRNA), capabilities of the technology (development, delivery, research and discovery, design and manufacturing), therapeutic area (oncological disorders, infectious diseases, genetic disorders, neurological disorders, immunological disorders, cardiovascular disorders, inflammatory disorders, ophthalmic disorders, rare disorders, pulmonary disorders, unspecified and other disorders) and highest phase of development (discovery, preclinical, clinical and commercial). In addition, the chapter features analysis of various next generation RNA therapeutic and RNA vaccine technology developers, based on their year of establishment, company size, location of headquarters and operational model.
- Elaborate profiles of drug candidates that are in advanced stages of development (Phase II, III and above). Each drug profile features details on its developer, drug overview, clinical trial information, clinical trial endpoints, clinical trial results and estimated sales.
- An in-depth analysis of completed and ongoing clinical trials of various next generation RNA therapeutics and RNA vaccines, based on several relevant parameters, such as trial registration year, trial status, trial phase, patients enrolled, type of sponsor, therapeutic area, study design, leading organizations (in terms of number of trials), focus area and geography.
- An in-depth analysis of patents related to next generation RNA therapeutics and RNA vaccines, filed / granted, since 2019, based on several relevant parameters, such as type of patent (granted patents, patent applications and others), patent publication year, patent jurisdiction, CPC symbols, emerging focus areas, patent age, leading industry / non-industry players (in terms of number of patents filed / granted), and patent valuation.
- An in-depth analysis of partnerships that have been inked between various stakeholders, since 2019, based on several relevant parameters, such as the year of partnership, type of partnership, type of molecule, focus of partnership, purpose of partnership, therapeutic area and most active players (in terms of number of partnerships). It also highlights the regional distribution of partnership activity in this market.
- A detailed analysis of various investments made by companies engaged in this industry, since 2019, based on several relevant parameters, such as year of funding, type of funding (grants, seed, venture capital, initial public offering, secondary offerings, private equity and debt financing), type of molecule, amount invested, geography, purpose of funding, stage of development, therapeutic area, most active players (in terms of number and amount of funding instances) and leading investors (in terms of number of funding instances).
- An in-depth analysis of the various next generation RNA therapeutics and RNA vaccines focused initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, type of initiative, purpose of initiative, focus of initiative and location of headquarters of the big pharma players.
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.
Frequently Asked Questions
Question 1: What are RNA-based therapeutics?
Answer: RNA-based molecules are a class of therapeutics that utilize RNA molecules for specifically targeting genes in order to regulate their function and expression. The altered gene expression aids in the management of several disease indications by producing the desired therapeutic effect.
Question 2: What is self replicating RNA mechanism? What are self-amplifying mRNA vaccines?
Answer: The self replicating property of RNA molecules enables them to create multiple copies of themselves within the cell without using additional cellular machinery, such as proteins and DNA. The mechanism involves the use of a short RNA strand as the template guide to synthesize a complementary copy of itself, thereby generating a new RNA molecule. The two new molecules then segregate to act as the template guides for further replication.
Question 3: What are self-amplifying mRNA vaccines?
Answer: Self-amplifying mRNA vaccines utilize a strand of messenger RNA designed to self-replicate and elicit a sustained immune response when administered to the human body. Owing to the self-replicating nature, the vaccine would not require frequent administration and would lead to a higher expression of proteins even at low dose concentration.
Question 4: Are RNA-based therapies approved by the FDA?
Answer: RNA-based therapies are continuously being evaluated in clinical trials for their safety and efficacy in the treatment of a wide range of therapeutic indications. It is worth noting that the first clinical trial of an mRNA-based vaccine was conducted in 2008. However, the first mRNA vaccine received the FDA approval for the treatment of COVID in 2021.
Question 5: What RNA drugs are FDA approved?
Answer: Interestingly, close to 10 RNA therapeutics have been approved till date. Of these, the primary types of therapies include those based on antisense oligonucleotides and small interfering RNA molecules. Further, Gemcovac®, a self amplifying RNA vaccine, has been granted emergency use approval as a COVID vaccine in India.
Question 6: How big is the next generation RNA vaccines and RNA therapeutics market?
Answer: The market size for the next generation RNA therapeutics and RNA vaccines market is estimated to be USD 1.1 billion in 2035.
Question 7: What is the likely market growth rate (CAGR) for the next generation RNA vaccines and RNA therapeutics market?
Answer: The market size for next generation RNA therapeutics and RNA vaccines is projected to grow at an annualized rate (CAGR) of ~50%, during the forecast period (2026-2035).
Question 8: Who are the leading companies in the next generation RNA therapeutics and RNA vaccines market?
Answer: Some of the leading 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 Arcturus Therapeutics, Flagship Pioneering, Forge Therapeutics, Gingko Bioworks, Laronde Therapeutics, Orna Therapeutics, Recode Therapeutics, Renegade Therapeutics, Replicate Bioscience and Shape Therapeutics.
Table of Contents
Companies Mentioned
- 4SR Biosciences
- 8VC
- Alexandria Real Estate Equities
- Alltrna
- AlphaVax
- aMoon
- Apple Tree Partners
- Arcturus Therapeutics
- Aspire Capital
- AstraZeneca
- Atlas Special Opportunities
- aTyr Pharma
- Aurora Vaccines
- Avidity Partners
- AyurMaya Capital Management Fund
- BeiGene
- MPM BioImpact
- BioNTech
- Camford Capital
- Catalent
- Charles River
- Chimerna Therapeutics
- Chimeron Bio
- Circio
- Circularis
- Coalition for Epidemic Preparedness Innovations (CEPI)
- Colt Ventures
- Cowen Healthcare Investments
- Creative Biolabs
- CSL Behring
- CSL Seqirus
- CureVac
- Curia
- Dualsystems Biotech
- Duke-NUS Medical School
- EcoR1 Capital
- Eli Lilly
- Elixirgen Therapeutics
- Epidarex
- Esperovax
- F2 Ventures
- Flagship Pioneering
- FPV Ventures
- Frazier Life Sciences
- Friends of FSH Research
- FUJIFILM
- FUJIFILM Diosynth Biotechnologies
- Genevant Sciences
- George Mason University
- Gilead Sciences
- Ginkgo Bioworks
- GlaxoSmithKline
- Gritstone bio
- hC Bioscience
- HDT Bio
- Hercules Capital
- ImmunityBio
- Imperial College London
- Israeli Ministry of Health
- Japanese Ministry of Economy, Trade and Industry (METI)
- K2 HealthVentures
- Konishiyasu
- KYORIN Pharmaceutical
- Laronde
- Leaps by Bayer
- Levatio Therapeutics
- Maryland Industrial Partnerships
- thisMerck
- Michigan Rise
- MiNA Therapeutics
- miRecule
- Miyako Capital
- MPM Capital
- MSA Capital
- MUFG Bank
- National Cancer Institute (NCI)
- National Institutes of Health
- Nobelpharma
- Oncorus
- OrbiMed
- Orbital Therapeutics
- Orna Therapeutics
- Pan African Cancer Research Institute (PACRI)
- Panacea Venture
- Perceptive Advisors
- Pfizer
- Playground Global
- Precision NanoSystems
- Quanchuang Capital
- Recipharm
- ReCode Therapeutics
- Redmile Group
- Replicate Bioscience
- Ring Code Biotech
- Sanofi
- Servier
- ShapeTX
- Silicon Valley Bank
- Simnova
- SK Impact Fund
- Sojitz
- Solve FSHD
- Strand Therapeutics
- SYTE.bio
- Taiho Ventures
- Takeda Ventures
- Tevard Biosciences
- Biomedical Advanced Research and Development Authority (BARDA)
- Coalition for Epidemic Preparedness Innovations (CEPI)
- National Institute of Allergy and Infectious Diseases
- The National University Cancer Institute, Singapore (NCIS)
- University of Nebraska Medical Center
- The University of Texas Medical Branch (UTMB)
- Therorna
- Transine Therapeutics
- TriLink BioTechnologies
- University of Antwerp
- UZ Gent
- VaxEquity
- Vertex Pharmaceuticals
- Vida Ventures
- Vingroup
- VLP Therapeutics
- Ziphius Vaccines
- Zogenix (Acquired by UCB)
- Zoic Capital
Methodology
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