Published: September 2023
Success of the currently approved mRNA-based therapies and novel vaccine candidates, specifically against COVID-19 infection, has encouraged industry stakeholders to explore the therapeutic potential of such drugs for several other diseases, such as infectious diseases, cancer, genetic disorders and other disorders. We analyzed close to 40 mRNA companies that are engaged in the development of over 190 mRNA therapeutics and mRNA vaccines, across different stages of development. In this article, discover 5 leading mRNA companies and their capabilities in this industry.
With the approval of the first mRNA vaccine under emergency use authorization (EUA), Comirnaty®, in 2020, the mRNA therapeutics and vaccines market came abuzz with activity; industry players have forged several strategic alliances and received significant financial support from investors. This can be attributed to the various benefits offered by these therapeutic modalities, such as ease of administration, higher biological efficacy, enhanced potent immunogenicity and versatile delivery platforms at reduced toxicity levels. 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, mRNA manufacturing is believed to be cost-effective, rapid and scalable.
Since the approval of the first mRNA vaccine, two more mRNA vaccines 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 70 mRNA therapeutics and mRNA vaccines are being evaluated in various clinical trials for the treatment of multitude of disease indications. Amongst the mRNA-based products, majority of the development is focused on mRNA vaccines. It is worth noting that the companies are evaluating various mRNA delivery technology to ensure efficient and safe delivery of the oligonucleotide.
Roots Analysis has conducted an exhaustive study on mRNA Therapeutics and mRNA Vaccines Market featuring the current market landscape and future opportunity associated with mRNA therapies and mRNA vaccines, respectively, over the period 2022-2035.
In the table below, we have listed (in decreasing order of funding amount raised), the top 5 mRNA companies.
Table: Top mRNA Companies
|Company||YoE||Headquarters||Company Size (Employees)||Funding Amount (USD Million)1|
|GreenLight Biosciences||2008||California, US||51-500||359|
|Arcturus Therapeutics||2013||Massachusetts, US||51-500||343|
Abbreviation: YoE: Year of Establishment
Note 1: The funding instances have been considered till 2022
Source: Roots Analysis
Interested in exploring the funding and investment activity for all 35+ mRNA Companies?
This article highlights the top mRNA companies to watch out for in 2023. These companies were chosen based on the amount of funding raised in capital investment; these companies have the required funds to advance the development of their drug products. It is essential to note that the selection of top players can differ substantially according to the defined criteria.
Moderna is a US-based biotechnology company that is dedicatedly working for the development of new generation of transformative medicines for patients. In 2015, the company initiated first-in-human dose of its mRNA vaccine candidate, mRNA-1440, targeting H10N8 flu. However, its first breakthrough came when in January 2022, the company received FDA approval for Spikevax® for the treatment of COVID-19. As of August 2023, the company has 47 development programs with six in phase III and seven in phase II trials.
In January 2023, the company made its first acquisition since its establishment to strengthen its mRNA manufacturing technology. It acquired Japan based OriCiro Genomics for USD 85 million. OriCiro Genomics, which is now renamed as Moderna Enzymatics, has developed a technology for cell free amplification of plasmid DNA, which is an essential component for mRNA manufacturing.
Additionally, Moderna is also setting up its own manufacturing network. In May 2023, Moderna announced investment of USD 322 million in setting up a new mRNA manufacturing facility in Massachusetts, US. This came after March 2023 announcement from the company to set up a mRNA manufacturing facility in Kenya. Till 2022, Moderna had entered into several partnerships with mRNA CDMO to manufacture its COVID vaccine; however, with a rich pipeline of non-COVID mRNA therapeutics and vaccines, the company is now setting up its own manufacturing network.
Moderna is engaged in the development of following mRNA therapies:
Market Capitalization (as of August 2023): USD 42.02 billion
Total Funds Raised: USD 4,659 million
In July 2023, Moderna initiated phase III study to evaluate V940 (mrna-4157) in combination with Merck’s Keytruda (pembrolizumab) for adjuvant treatment of patients with resected high-risk (stage IIB-IV) melanoma.
In the same month, Moderna submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency, Swissmedic, and the Therapeutic Goods Administration in Australia. This was based on mRNA-1345 meeting the primary efficacy endpoints, demonstrating vaccine efficacy of 83.7% against RSV lower respiratory tract disease in the phase III pivotal efficacy trial. The company has also initiated a rolling submission of a Biologics License Application to the U.S. Food and Drug Administration for mRNA-1345 and plans further regulatory submissions for mRNA-1345, worldwide.
Key Strengths and Future Outlook:
The company has one of the largest mRNA-based clinical pipeline, with at least two launch expected till 2025. This includes the launch of mRNA-1345 in 2024 and mRNA-4157 in 2025.1 Moderna has started with pre-launch activity of mRNA-1345 for RSV. It is manufacturing prefilled syringe format for its RSV product. Additionally, within the personalized mRNA cancer vaccine market segment, Moderna’s mRNA-4157 is currently in the lead.
As of 30 June 2023, the company has cash, cash equivalents and investments of USD 14.6 billion. As such, it is in a good position to launch its approved products as well as continue to reinvest in R&D, licensing or acquisitions, and building capabilities for in-house manufacturing.
With more than 20 years of experience, CureVac claims to be one of the leading global biotechnology company that is engaged in the development of mRNA-based therapies to combat various diseases. The company aims to leverage its unique proprietary mRNA technology to provide life-saving solutions for patients in order to enable the body to make its own prophylactic and therapeutic drugs. Additionally, CureVac is focused on creating specific carrier molecules either in-house or in collaboration with strategic partners to support its mRNA products and to ensure that the products can enter the cells of the body to carry out the labor-intensive process of protein expression.
With respect to manufacturing, CureVac is constructing its GMP IV facility, with capabilities for industrial scale manufacturing of mRNA based products. It is also driving innovation in mRNA manufacturing through its focus on an automated end to end manufacturing system for mRNA therapeutics and mRNA vaccines. The system called The RNA Printer® is being developed in collaboration with Tesla, who is the manufacturing partner for the printer.2 The company is underway to get regulatory approval for the mobile mRNA manufacturing system.
CureVac is engaged in the development of following mRNA therapies:
Market Capitalization (as of August 2023): USD 1.97 billion
Total Funds Raised: USD 2,269 million
In June 2023, the company announced that it has dosed the first patient with its investigational cancer vaccine, CVGBM, targeting glioblastoma in a phase I study. In February 2023, the company raised USD 250 million through public offering.
Key Strengths and Future Outlook:
With the positive extended preliminary data from ongoing phase I clinical programs in COVID-19 and seasonal flu that were conducted in collaboration with GSK, the company has been able to prove the strength of its mRNA technology. Further, the aforementioned data supports its decision to advance the updated versions of the modified mRNA vaccine constructs to the next stage of clinical testing in 2023.
As of 31 March 2023, the company has cash, cash equivalents and investments of EUR 617.5 million, which will help the company sustain the product development in 2023 and beyond.
With its extensive portfolio of cutting-edge technology and decades of profound immunology expertise, BioNTech is collaborating with various industry stakeholders to eradicate life-threatening diseases like cancer, COVID-19, malaria and tuberculosis. In December 2020, the company received approval for its first mRNA vaccine, Comirnaty, targeting COVID-19 that was developed in its production facility in Mainz, Germany.
The company is also focused on accelerating its oncology pipeline, which includes antibody candidates and cell therapies, in addition to mRNA-based cancer vaccine. There are four mRNA based drugs in phase II clinical trials for oncological indications.
BioNTech is engaged in the development of following mRNA therapies:
Market Capitalization (as of August 2023): USD 25.30 billion
Total Funds Raised: USD 1,638 million
In July 2023, the company acquired InstaDeep to strengthen its AI-driven drug discovery and drug development capabilities for the production of next-generation immunotherapies and vaccines. In the same month, BioNTech also signed a long-term partnership agreement with the UK Government which aims to provide personalized mRNA-based cancer immunotherapies to up to 10,000 patients by 2030 as part of clinical trials.3
Key Strengths and Future Outlook:
In June 2023, the company in collaboration with Pfizer submitted regulatory applications to the U.S. Food and Drug Administration for Omicron XBB.1.5-adapted monovalent COVID-19 vaccine candidate for individuals of age 6 months and older. Following the regulatory approval, the companies anticipates to supply the adapted vaccines immediately.4
As of 30 June 2023, the company has cash, cash equivalents and investments of EUR 16.8 billion, which will be used for the launch of its adapted vaccine as well support the progress of the oncology pipeline.
GreenLight Biosciences aims to harness the power of RNA to combat some of humanity’s most pressing problems, such as pandemics, rare diseases, biodiversity loss and climate change. The company is engaged in the development of multiple types of RNA by employing a unique manufacturing platform. With its expertise, the company strives to launch RNA products quicky and in a cost-effective manner.
GreenLight Biosciences is engaged in the development of following mRNA therapies:
Market Capitalization (as of August 2023): USD 0.04 billion
Total Funds Raised: USD 359 million
In July 2023, GreenLight Biosciences announced the completion of its merger with SW Merger and SW Parent from a syndicate of investors led by Fall Line Capital.
In January 2023, GreenLight Biosciences entered into an agreement with EpiVax Therapeutics in order to develop and commercialize mRNA-based vaccine candidates for cancers. The effort will combine GreenLight’s mRNA design and manufacturing expertise with EpiVax’s advanced Ancer® pipeline for personalized cancer vaccine design.
Key Strengths and Future Outlook:
In February 2023, GreenLight Biosciences received regulatory approval from the Rwanda Food and Drugs Administration to initiate a phase I/II clinical trial of its vaccine candidate against COVID-19 as a booster to previously vaccinated individuals. The company’s efforts to initiate this clinical study in Rwanda demonstrate its unwavering commitment in supporting Africa to achieve affordable vaccine self-sufficiency.
As of 31 March 2023, the company had USD 32.4 million in cash, cash equivalents, and marketable securities. GreenLight Biosciences recent downsizing is likely a result of its plans to become more capital efficient and focus on the unmet medical needs. This is also visible in its collaboration with EpiVax Therapeutics, marking its entry into the mRNA based cancer vaccines segment.
Arcturus Therapeutics is a US-based firm that specializes in the development and commercialization of late-stage clinical messenger RNA vaccines. In order to develop high-quality RNA medicines, the company leverages LUNAR® platform for diseases with significant unmet medical needs and accelerated clinical paths.
The company’s COVID 19 and Influenza vaccine are partnered programs; however, the mRNA therapeutics for rare diseases are being developed in-house.
Arcturus Therapeutics is engaged in the development of following mRNA therapies:
Market Capitalization (as of August 2023): USD 0.90 billion
Total Funds Raised: USD 343 million
In August 2023, Arcturus Therapeutics announced that ARCALIS, its manufacturing joint venture in Japan, has been awarded USD115 million in two separate grants from the Japanese government. The grants received by the company will be used to fund the construction of a factory and the purchase of capital equipment to support cGMP production of mRNA drug substance and mRNA drug product operations.
In May 2023, the company announced that Meiji Seika Pharma submitted regulatory applications to the Japanese PMDA to manufacture and market LUNAR®-COV19 for primary immunization in order to prevent COVID-19 in adults.
In January 2023, the company received approval to proceed into a phase I clinical study in New Zealand for ARCT-032, an inhaled investigational mRNA therapy to treat cystic fibrosis. Further in December 2022, Arcturus Therapeutics entered into a technology utilization agreement with CSL for the purpose of leveraging former company’s self-amplifying mRNA vaccine technology to develop drug candidates for COVID-19, influenza and other respiratory pathogens.
Key Strengths and Future Outlook:
In June 2023, Arcturus Therapeutics received U.S. Food and Drug Administration fast track designation for ARCT-810, a mRNA therapy for ornithine transcarbamylase (OTC) deficiency. The company anticipates to hold more regular interactions with the FDA and to accelerate the development of ARCT 810 as a potential novel therapeutic option that targets the underlying cause of OTC deficiency.
As of 30 June 2023, the company had cash, cash equivalents and restricted cash of USD 380.6 million, which will be used to support the ongoing development of COVID and flu pipeline.
The above presentation features five mRNA therapy companies selected from a pool of over 35 companies that we have compiled. If you are interested, you can download the Sample Report on this topic by Roots Analysis. Further, Investor Series: Opportunities in RNA Therapeutics Market report offers a technical and financial perspective on how the opportunity in this industry is likely to evolve, in terms of future business success, over the coming decade. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don’t hesitate to reach out to us at firstname.lastname@example.org.
With an experience of over 4 years with Roots Analysis, Jasmeet is adept at generating useful insights from unstructured / structured datasets. As a senior analyst at Roots Analysis, she has assisted several clients across multiple industry verticals within the healthcare industry. These verticals include contract services, devices / technologies, and drugs / disease indications. Since the findings of the research are aimed at supporting the clients to make thoughtful decisions for their business, she has hands-on experience on competitive landscape assessment, benchmarking, market sizing and forecasting, as well as several quantitative / qualitative / strategic frameworks.
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