mRNA Vaccine and Therapeutics Market

mRNA Vaccine and Therapeutics Market (2nd Edition) by Route of Administration, Therapeutic Area, and Geography: Global Trends and Industry Analysis, 2022-2035

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mRNA Vaccine and Therapeutics Market Overview

The global mRNA vaccine and therapeutics market size was estimated to be worth over USD 51 billion in 2022; non COVID-19 indications will drive the market growth during the forecast period 2023-2035. Messenger ribonucleic acid (mRNA) is a type of single-stranded ribonucleic acid (RNA), which helps in transferring genetic information in order to produce proteins.

The mRNA encoding instructions for protein synthesis are transferred from a strand of DNA to the ribosomes, where these instructions are translated and processed into functional proteins. mRNA therapeutics and mRNA vaccines have emerged as a promising alternative to conventional treatment approaches. Post the onset of the COVID-19 pandemic, mRNA therapeutics and mRNA vaccine have garnered significant attention as they have evolved as a revolutionary novel drug class for the treatment of COVID-19, as well as several other diseases, such as infectious diseases, cancer, genetic disorders and other disorders.

Till date, three mRNA-based vaccines have received approval for the treatment of COVID-19, while a number of such candidates are being evaluated as potential therapies. Moreover, BioNTech and Pfizer have signed contracts to deliver 2.4 billion doses of its approved vaccine, Comirnaty®, by the end of 2022. The overall success of the mRNA-based therapies and vaccines against COVID-19 has attracted the interest of several investors, specifically towards small and emerging mRNA focused biotechnology companies. 

The mRNA Vaccine and Therapeutics Market (2nd Edition), 2022-2035: Distribution by Route of Administration (Intravenous, Intramuscular, Intranasal and Others), Therapeutic Area (Infectious Diseases, Oncological Disorders and Other Disorders), and Geography (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa) report features an extensive study of the current market overview and future potential of the mRNA therapeutics and vaccines market, over the forecast period. The study also features an in-depth analysis, highlighting the capabilities of various mRNA companies engaged in this field. Amongst other elements, the market research report analyzes the mRNA market from the perspective of drugs developers, manufacturers, mRNA technology companies and investors.

mRNA Therapeutics Market Context mRNA Therapeutics Market, Development Pipeline mRNA Therapeutics Market, Distribution by Phase of Development

Key mRNA Vaccine and Therapeutics Market Insights

New Drug Modality: mRNA Therapeutics and mRNA Vaccines

The ongoing research and development efforts being undertaken in the mRNA vaccine and therapeutics market are primarily being driven by the various advantages offered by these molecules, including higher biological efficacy, enhanced potent immunogenicity and versatile delivery platforms at reduced toxicity levels, over other therapeutic modalities. Recent reports highlight the potential benefits related to the use of mRNA; for instance, such products pose no undesirable risk of inadvertent infection and insertional mutagenesis. 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, the manufacturing of mRNA candidates is believed to be cost-effective, rapid and scalable. 

Pipeline Analysis: More Than 190 mRNA Therapeutics and mRNA Vaccine in Various Stages of Development

With the approval of the first mRNA vaccine under emergency use authorization (EUA), Comirnaty®, in 2020, the field has witnessed a further surge in activity. Since then, two more mRNA-based therapies 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 stages of clinical trials for the treatment of multitude of disease indications.  Amongst the mRNA-based products, majority of the development is focused on mRNA vaccines. However, mRNA companies such as Moderna, BioNTech and Arcturus Therapeutics, are also developing mRNA therapeutics. Till July 2022, AstraZeneca was developing a mRNA-based protein replacement therapy, AZD8601 (a mRNA expressing vascular endothelial growth factor (VEGF-A)), for treatment of cardiovascular disease. However, the rights for the drug were returned to Moderna, which is evaluating the next steps for the program.

Additionally, the companies are evaluating various mRNA delivery technology to ensure efficient and safe delivery of the oligonucleotide. These details along with the route of administration have been analyzed in this market report.

mRNA Companies Analysis: Big Pharma Partnering to Enter the mRNA Vaccine and Therapeutics Market

Presently, over 35 companies are engaged in the evaluation of more than 195 mRNA therapeutics and mRNA vaccines, across various stages of development, for a myriad of disease indications. Further, over the coming decade, several promising leads, specifically those exhibiting enhanced efficacy, are anticipated to be commercially launched. Big pharmaceutical companies such as Merck, Sanofi and Daiichi Sankyo have partnered with smaller, dedicated mRNA-based therapeutics and vaccines developers to expand their respective capabilities in this upcoming field of therapy. In September 2021, Sanofi became the first big pharma to acquire a mRNA therapeutics company, Translate Bio. The active involvement of big pharma players, as well as the presence of new entrants, will drive the market growth during the forecast period.

Indication Analysis: Infectious Diseases Segment Will Continue to Hold the Largest mRNA Vaccine and Therapeutics Market Share 

In 2022, the mRNA vaccine and therapeutics market was driven by sales of three approved mRNA vaccine for infectious diseases, particularly COVID-19. However, mRNA drugs have shown safety and efficacy against a myriad of other infectious diseases such as Respiratory Syncytial Virus Infection, Cytomegalovirus Infection and Influenza. In addition, companies such as BioNTech are also working on development of mRNA-based vaccine for mosquito-borne infectious disease, Malaria. According to the World Health Organization (WHO), there were an estimated 247 million cases of malaria in 2021 and only a single recombinant protein-based vaccine from GSK marketed to date.

Additionally, it is worth noting that the global market is likely to see the launch of first mRNA cancer vaccine by 2030. Recently, Moderna received Breakthrough Therapy Designation for its melanoma vaccine being tested in phase II clinical trial in combination with Merck’s Keytruda. Cancer targeting indications other than COVID-19 are estimated to witness lucrative market growth during the forecast period 2025-2035. This will also be driven by an increase in the incidence of cancer across the globe as well as the need to develop precision cancer therapy.

Regional Analysis: North America Holds the Largest Share of the mRNA Vaccine and Therapeutics Market

The global market for mRNA therapeutics is currently dominated by North America and this trend is unlikely to change during the forecast period. National Institutes of Health (NIH) has been supporting mRNA therapeutics research through provision of grants even before the COVID-19 pandemic. mRNA vaccine development not only requires support for the clinical development of the vaccines, but also development of delivery technologies and expansion of the manufacturing capabilities. Governments of the US and Canada are actively supporting the domestic manufacturing projects. In April 2022, Moderna announced its plan to set up a mRNA vaccine manufacturing facility in Quebec under a strategic partnership with the Government of Canada. Additionally, in September 2022, the US President signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative, supporting domestic manufacturing.  Such initiatives will continue to ensure government support for mRNA technologies and sustain the North American market share during the forecast period.

Trends Analysis: Partnerships, Funding, Clinical Trials and More

It is worth highlighting that close to 150 collaborations have been inked between industry / academic stakeholders to advance the development of their proprietary pipeline candidates. A number of big pharma companies have been part of these partnerships and have acted as active investors in emerging mRNA vaccine companies. The mRNA vaccine and therapeutics market has attracted huge investments, specifically in 2020, when over USD 5 billion was invested in mRNA therapeutics companies. The raised funds are not solely focused on the development of mRNA therapeutics for infectious diseases, but cancer focused mRNA drug development efforts have also generated interest amongst the venture community.

During the period 2017-2021, the number of clinical trials registered for evaluation of mRNA-based products increased at a compounded annual growth rate (CAGR) of more than 60%. There was a significant increase in the number of patients recruited in trial studies evaluating mRNA-therapeutics, driven by the development of COVID-19 vaccine and new mRNA therapeutics and mRNA vaccines entering the clinical phase of development. Driven by the growing interest of various stakeholders and encouraging clinical research results, the overall mRNA therapeutics and mRNA vaccines market is anticipated to witness consistent market growth during the forecast period.

Recent Developments in mRNA Therapeutics and mRNA Vaccines Market

Several recent developments have taken place in the field of mRNA therapeutics and mRNA vaccines. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In August 2023, Moderna entered into a collaboration with CARsgen Therapeutics to combine their respective mRNA therapeutic cancer vaccine with a solid tumor CAR-T cell therapy with an aim to treat multiple cancers. 
  • In June 2023, Providence Therapeutics announced a collaboration with University Health Network (UHN) to develop mRNA-based vaccines and therapeutics for the treatment of patients suffering from cancers and infectious diseases. 
  • In April 2023, Moderna collaborated with IBM to explore next generation technologies, including quantum computing and artificial intelligence, in order to advance and accelerate mRNA research and science. 
mRNA Therapeutics Market, Competitiveness Analysis mRNA Therapeutics Market, Clinical Trial Analysis mRNA Therapeutics Market, Partnerships and Collaborations

Scope of the mRNA Vaccine and Therapeutics Market Report

mRNA Vaccine and Therapeutics Market: Market Segmentations

Report Attribute Details

Forecast Period

2022 – 2035

Base Year 2021
Market Size 2022 $51 billion

Area of Expertise

mRNA therapeutics, mRNA vaccines

Route of Administration

Intravenous, Intramuscular, Intranasal, Others

Therapeutic Areas

Infectious diseases, Oncological disorders, Others

Key Geographical Regions

North America, Europe, Asia-Pacific, MENA, Latin America and Rest of the World

The market research report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report features: 

  • A detailed overview of the overall market landscape of mRNA therapeutics and mRNA vaccines, based on several relevant parameters, such as phase of development (marketed, phase III, phase II, phase I / II, phase I, preclinical and discovery), type of drug candidate (mRNA therapeutic and mRNA vaccine), therapeutic area (infectious diseases, oncological disorders, genetic disorders, pulmonary disorders, autoimmune disorders and other disorders), type of delivery system used (lipid nanoparticles, lipopolyplex, liposomes, direct transfer, self-amplifying RNA platform and others), type of molecule encoded (spike protein, glycoprotein, antigen, cytokine, protein coding gene, tumor neoantigen, enzyme, tumor antigen and others) and route of administration (intramuscular, intravenous, intranasal and others).
  • A detailed overview of the current market of players engaged in the development of mRNA therapeutics and mRNA vaccines, along with information on their year of establishment, company size (in terms of number of employees), location of headquarters, regional landscape and key players engaged in this domain.
  • An in-depth company competitiveness analysis of mRNA therapeutics and mRNA vaccine companies based on their portfolio strength (in terms of year of establishment and company size), pipeline strength (in terms of its pipeline maturity and drug administration route) and number of therapeutic areas targeted.
  • Detailed profiles of marketed and late stage (phase III) mRNA therapeutics and mRNA vaccines, along with information on the development timeline of the therapy, current development status, primary target indication, therapeutic area, type of molecule encoded, type of delivery system used, affiliated technology, recent partnerships associated with the drug, clinical trial results related to the drug and other recent developmental.
  • A review of the various mRNA-focused initiatives undertaken by big pharma players (shortlisted on the basis of the revenues generated in 2021), featuring a [A] heat map representation that highlights mRNA therapeutics and mRNA vaccines under development (in partnership with core mRNA-focused entities), along with information on funding amount raised, partnership activity, and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)), as well as [B] a spider web representation, comparing the initiatives of big pharmaceutical players on the basis of multiple relevant parameters.
  • An analysis of start-ups (established between 2016-2022) engaged in this domain, based on several relevant parameters, such as number of candidates in discovery, preclinical and clinical phases of development, amount raised, number of investors and number of deals inked.
  • An analysis of completed, ongoing and planned clinical studies of mRNA therapeutics and mRNA vaccines, based on several relevant parameters, such as trial registration year, trial status, trial phase, target therapeutic area, study design, type of sponsor / collaborator, leading industry players (in terms of number of trials conducted), enrolled patient population and key geographical regions.
  • An analysis of recent collaborations and partnerships within the mRNA therapeutics and mRNA vaccines industry, based on several relevant parameters, such as year of partnership, type of partnership, targeted therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have been undertaken in this domain, during the period 2013-2022.
  • A detailed analysis of various investments made by players engaged in this domain, during the period 2013-2022, based on several relevant parameters, such as year of funding, type of funding (seed financing, venture capital, IPOs, secondary offerings, debt, grants and other offerings), amount invested, therapeutic area, most active players (in terms of number of funding instances and amount invested) and key investors (in terms of number of funding instances). 
  • An in-depth analysis of the various patents that have been filed / granted related to mRNA therapeutics and mRNA vaccines domain, since 2016, based on several relevant parameters, such as type of patent (granted patents, patent applications and others), publication year, geographical region, CPC symbols, leading industry players (in terms of the number of patents filed / granted) and patent valuation.

One of the key objectives of this market research report was to estimate the existing market size and the future growth potential of the mRNA therapeutics and mRNA vaccines market over the forecast period. We have provided an informed estimate on the likely financial evolution of the market in the short to mid-term and long term, for the period 2022-2035. Additionally, the report features the likely distribution of the current and upcoming opportunity segmented across important parameters, such as [A] route of administration (intravenous, intramuscular, intranasal and others), [B] therapeutic area (infectious diseases, oncological disorders and other disorders), and [C] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa).

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, portraying the conservative, base and optimistic scenarios of the industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

mRNA Therapeutics Market, Funding and Investments mRNA Therapeutics Market, Big Pharma Players mRNA Therapeutics Market, Future Opportunity

Frequently Asked Questions

Question 1: What are mRNA therapeutics and mRNA vaccines?

Answer: mRNA stands for messenger ribonucleic acid and it is a single stranded copy of the gene that carries the code for expressing a protein. mRNA therapeutics and mRNA vaccines deliver mRNA coding for specific proteins or antigens into the cells of a patient either naked or using a delivery vehicle.

Question 2: What is the current market size of mRNA therapeutics market?

Answer: The global mRNA therapeutics and mRNA vaccine market size was estimated to be worth over USD 51 billion in 2022

Question 3: Which segment will drive the mRNA therapeutics market growth?

Answer: mRNA therapeutics targeting infectious diseases, which presently capture a significant share of the global market (in terms of sales-based revenues) will continue to hold the largest share during the forecast period; however, drugs targeting cancer are likely to witness the highest market growth.

Question 4: What are the key challenges faced by mRNA companies?

Answer: mRNA-based product developers often face challenges related to the stability and targeted delivery of their drug candidates. Some of the other key concerns faced by drug developers include limited availability of expertise, lack of specialized infrastructure, requirement for exorbitant capital investment, and constraints associated with ensuring compliance to good manufacturing practices (GMP).

Question 5: What are the key drivers in the mRNA therapeutics and mRNA vaccine market?

Answer: The key value drivers in the mRNA therapeutics and mRNA vaccines market include a significant rise in the overall healthcare expenditure, increased R&D spending, a surge in mRNA-focused research initiatives and a plethora of mRNA technological advancements in the recent past.

Question 6: Who are the key players in the mRNA therapeutics and mRNA vaccine market?

Answer: Examples of key players engaged in this industry (which have also been captured in this report) include BioNTec, Chimeron Bio, CureVac, eTheRNA, IMMORNA, Moderna, Omega Therapeutics, RNACure and Stemirna Therapeutics.

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