Lowest Price Guaranteed From USD 4,799
The global mRNA manufacturing and mRNA synthesis market (for services) is estimated to be worth USD 1.95 billion in 2023. The global market is anticipated to decline at a CAGR of -1.7% during the forecast period.
The decline in the market size over the next decade is likely to be the result of a dip in the demand for COVID vaccines till 2035. In the past few years, messenger ribonucleic acid (mRNA) has emerged as one of the key therapeutic modalities in the modern healthcare industry. Post the onset of the COVID-19 pandemic, mRNA therapeutics and mRNA vaccine manufacturing 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 oncological disorders, infectious diseases and genetic disorders. Presently, more than 195 mRNA therapeutics / mRNA vaccines are under development or commercialized for the treatment of a variety of indications. As a result, there is an evident increase in the demand for mRNA production capacity. Fundamentally, mRNA therapeutic / mRNA vaccine manufacturing is complex and cost intensive process that requires specialized expertise. Therefore, mRNA vaccine / therapeutic developers are actively exploring avenues that enable them to overcome the existing challenges. Amongst other alternatives, outsourcing to mRNA CDMO has emerged as a lucrative option for mRNA vaccine / therapeutic developers. In the foreseen future, as more of such RNA-based leads mature and move into the clinic and / or get commercialized, we anticipate the mRNA synthesis and mRNA manufacturing market to witness healthy market growth during the forecast period.
The mRNA Synthesis and mRNA Manufacturing Market (2nd Edition), 2022-2035: Distribution by Type of Product (Drug Substances (APIs) and Drug Products (FDFs)), Application Area(s) (mRNA Vaccines and mRNA Therapeutics), Therapeutic Area(s) (Infectious Diseases, Oncological Disorders and Other Diseases) and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World): Industry Trends and Global Forecasts market report features an extensive study of the current market landscape, market size, market forecast and future opportunities associated with the players involved in the mRNA synthesis and mRNA manufacturing of research- and GMP-grade mRNAs for use in the development of therapeutics and vaccines. The market research report highlights efforts of several mRNA CDMO engaged in this rapidly emerging market segment of the pharmaceutical and biopharmaceuticals industry. Key takeaways of the mRNA manufacturing and mRNA synthesis market research report are briefly discussed below.
mRNA therapeutics and mRNA vaccines (such as COVID vaccine) have emerged as a promising alternative over conventional treatment approaches owing to their multiple benefits, including shorter development timelines, higher biological efficiency, and versatile delivery platforms at reduced toxicity levels. It is worth highlighting that these next generation mRNA therapeutics / mRNA vaccines are anticipated to become a powerful therapeutic modality for the treatment of a variety of refractory diseases, including infectious diseases, oncological disorders, metabolic disorders, cardiovascular disorders, cerebrovascular diseases and other diseases. In 2020, Food and Drug Administration (FDA) gave emergency use authorization to two mRNA vaccines - developed by Pfizer and BioNTech, Comirnaty® was the first COVID vaccine to receive authorization followed by Moderna’s Spikevax®. However, now in 2023, the COVID vaccine manufacturers have witnessed decline in their sales. In the near future, growth in the mRNA therapeutics and mRNA vaccines market will be driven by the launch of products for infectious diseases such as respiratory syncytial virus (RSV) infection and personalized cancer vaccines.
The manufacturing process of mRNA vaccines and mRNA therapeutics is fraught with several challenges as the mRNA production is complex, cost intensive and requires specialized expertise. Large scale mRNA manufacturing is associated with a number of challenges, mostly related to process development, technology transfer and maintaining purity and stability. Moreover, some of the processes associated with mRNA production, such as purification, involve the use of hazardous solvents / materials. Once manufactured, mRNA therapeutics / mRNA vaccines need to be stored in conditions that do not compromise their stability (thereby, requiring specialized facilities and cold chain transportation). Further, they also require appropriate drug delivery systems to efficiently administer the intervention (in a manner that they can avoid degradation by cellular endonucleases). It is worth highlighting that, currently, lipid nanoparticles (LNPs) are the most commonly used drug delivery systems in mRNA vaccines owing their capability to encapsulate and deliver genetic material to the target cells.
Given such technical and operational challenges associated with the GMP manufacturing of mRNA vaccines and mRNA therapeutics, innovators in the biopharmaceutical industry are increasingly relying on the mRNA CDMO / mRNA synthesis service providers. Further, the COVID-19 pandemic caused a notable surge in the outsourcing activity, with mRNA vaccine developers entering into strategic deals with contract service providers to cater to the urgent global demand.
The mRNA synthesis and mRNA manufacturing service providers landscape features a mix of over 70 large, mid-sized and small companies, which claim to have the required expertise to offer mRNA synthesis service across different scales of operations, worldwide. Most of the (~50%) manufacturing facilities are located in Europe, followed by North America; prominent manufacturing hubs in the Europe include Germany, France, the UK, the Netherlands, Spain and Belgium. In addition to this, more than 95 mRNA synthesis kits, that contain reagents for the synthesis of research grade mRNAs, are currently available in the market.
Recent developments in this segment of the biopharmaceutical industry indicate that the mRNA synthesis service providers are upgrading their capabilities and infrastructure to accommodate the current and anticipated demand for mRNA GMP manufacturing. In August 2022, Samsung Biologics and GreenLight Biosciences announced the successful completion of the first commercial-scale engineering run for the companies’ mRNA COVID vaccine manufacturing. However, more recently the leading mRNA companies have announced setting up of in-house facilities for mRNA manufacturing. 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. However, the company will continue to depend on the mRNA CDMO till the facilities are open for operation. Daiichi Sankyo is also setting up a facility near Tokyo to meet the production demand for its mRNA COVID vaccine, which received PMDA approval in August 2023.
However, we strongly believe that the several small to mid-sized mRNA companies will continue to depend on the mRNA CDMO network for fulfilling their clinical and commercial mRNA demand. As such, the mRNA CDMO will continue to enter into capacity expansions, driving the market growth for mRNA manufacturing and mRNA synthesis, though not at the scale necessitated by the COVID pandemic.
The global market for mRNA synthesis and mRNA manufacturing services is estimated to be worth USD 1.95 billion in 2023. The market growth will be driven by the rising interest in R&D activities and the demand for non-COVID mRNA-based products. However, owing to the global decline in demand for COVID vaccines, the global market associated with the mRNA synthesis and mRNA manufacturing market is anticipated to witness a CAGR of -1.7% over the forecast period. The decline in the market size over the next decade is likely to be the result of a dip in the demand for COVID vaccines till 2035. Specifically, in terms of type of product, the market is anticipated to be driven by contract manufacturing of mRNA vaccines, followed by mRNA therapeutics. In addition to this, presently, close to 70% of the market is captured by players based in North America and Europe.
Majority of the companies offering mRNA synthesis services and mRNA vaccine manufacturing services are headquartered in North America and Europe. Consequently, presently, North America and Europe capture over 70% market share of the overall mRNA synthesis and mRNA manufacturing market. In recent years, demand for mRNA products, such as mRNA vaccines, in the North America region has witnessed a tremendous increase. However, in the coming years, owing to the anticipated mRNA-based drug approvals and growing need for GMP manufacturing of such products, Asia-Pacific region is likely to grow at a much faster rate as compared to other geographies.
Examples of key mRNA CDMO engaged in mRNA synthesis and mRNA manufacturing market (which have also been profiled in this market report; the complete list of players is available in the full report) include Aldevron, APExBIO, Biomay, BioNTech, CELLSCRIPT, CureVac, bioSYNTHESIS, eTheRNA, Eurogentec, Jena Biosciences, Moderna, New England Biolabs, Thermo Fisher Scientific and TriLink BioTechnologies. It is interesting to note that in October 2022, Thermo Fisher Scientific introduced a customized Dynabeads® solutions to support mRNA synthesis and purification for mRNA vaccine manufacturing and development. Such portfolio additions are expected to drive mRNA synthesis and mRNA manufacturing market growth during the forecast period.
Several recent developments have taken place in the field of mRNA synthesis and mRNA manufacturing market, 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 have outlined in our analysis.
The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments as defined in the below table:
|2023 – 2035
|Market Size 2023
|$ 1.95 Billion
|Type of Product
|Key Geographical Regions
|Key Companies Profiled
(Full list of 80+ companies captured is available in the report)
|PowerPoint Presentation (Complimentary)
|Excel Data Packs (Complimentary)
The market report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry. Amongst other elements, the market research report includes:
One of the key objectives of this mRNA synthesis and mRNA manufacturing market report was to estimate current market size and the future opportunity in the mRNA synthesis and mRNA manufacturing market over the forecast period. Based on multiple parameters, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the forecast period 2023-2035. In order to provide a detailed future outlook, year-wise projections of the current and future opportunity have been further segmented on the basis of relevant parameters, such as type of product (drug substances (APIs) and drug products (FDFs)), application areas (mRNA vaccines and mRNA-based therapeutics), target indications (infectious diseases, oncological disorders and other diseases), and key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World). 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 report are in USD, unless otherwise specified.