mRNA Synthesis and mRNA Manufacturing Market

mRNA Synthesis and mRNA Manufacturing Market (2nd Edition): Distribution by Type of Product, Application Areas, Therapeutic Areas and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035

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mRNA Manufacturing and mRNA Synthesis Market Overview

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.

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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.

mRNA Synthesis and mRNA Manufacturing Market, Type of Product

Key Market Insights

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.

Market is Expected to Witness Approvals for mRNA Vaccines and mRNA Therapeutics for non-COVID Indications

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.

Need for Outsourcing mRNA Manufacturing and mRNA Synthesis Services to mRNA CDMO

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. 

Competitive Landscape of mRNA Synthesis and mRNA Manufacturing Companies

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. 

Market Trends Analysis: In 2023, mRNA CDMO Expansions Are Outnumbered by In-House Expansions

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 image provides context of mRNA synthesis and manufacturing. Given the current technical and operational challenges associated with the manufacturing of mRNA-based products, innovators in the biopharmaceutical industry are increasingly relying on the mRNA synthesis and contract manufacturing service providers This image provides list of mRNA Custom Synthesis Service Providers and mRNA Contract Manufacturing Service Providers. Presently, more than 70 companies claim to have the required expertise to offer various services for the synthesis and manufacturing of mRNAs across different scales of operations, worldwide The image looks at the competitive landscape across manufacturing organizations. In pursuit of building a competitive edge, service providers are actively upgrading their existing capabilities to enhance their respective portfolios and comply with the evolving industry benchmarks

Market Analysis: Market Size of the mRNA Synthesis and mRNA Manufacturing Market

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.

Regional Analysis: North America and Europe Emerge as the Hubs for mRNA synthesis and mRNA manufacturing; Asia-Pacific to be the Fastest Growing Market

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.

Leading Companies Engaged in mRNA Synthesis and mRNA Manufacturing Market

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.

Recent Developments in mRNA Synthesis and mRNA Manufacturing Market

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.

  • In August 2023, AstraZeneca signed a mRNA manufacturing agreement with CanSino Biologics, a China based mRNA CDMO. As per the agreeemnt, CanSino Biologics will use its mRNA manufacturing platform to support AstraZeneca on the R&D of certain mRNA vaccines. The partners may further collaborate on R&D and commercialization in the future. 
  • In May 2023, TriLink BioTechnologies announced the expansion of its mRNA manufacturing capabilities to serve late-phase mRNA drug developers. 
  • In April 2023, Arranta Bio and Massachusetts Institute of Technology (MIT) signed a contract for development of continuous manufacturing process for mRNA therapeutics.
  • In March 2023, Moderna entered into an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. This mRNA manufacturing facility in Africa is expected to have the capacity to produce up to 500 million mRNA vaccine doses annually. 
The image provides details on the current mRNA synthesis and manufacturing market landscape. Leveraging their expertise, stakeholders in this domain are providing contract manufacturing services for a myriad of mRNA-based products This image provides list of mRNA synthesis kits. Presently, more than 95 kits are available in the market for the synthesis of research grade mRNAs used for various applications with yield range upto 50,000 µgs The image provides details on the mRNA synthesis kits market landscape. Close to 50% of mRNA synthesis kits contain all the components, including enzyme mix, buffers and other reagents, required for the synthesis of varying quantity of modified mRNAs at affordable prices


Scope of the Report

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:

mRNA Synthesis and Manufacturing Services: Report Attributes / Market Segmentations

Report Attribute Details
Base Year

2023

Forecast Period 2023 – 2035
Market Size 2023 $ 1.95 Billion
CAGR 1.7%
Type of Product
  • Drug Substance (APIs) 
  • Drug Product (FDFs)
Application Area
  • mRNA Vaccines
  • mRNA Therapeutics
Therapeutic Areas
  • Infectious Diseases
  • Oncological Disorders
  • Other Diseases
Key Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and North Africa
  • Rest of the World
Key Companies Profiled
  • Aldevron
  • APExBIO
  • Biomay
  • BioNTech
  • CELLSCRIPT
  • CureVac
  • biosynthesis
  • eTheRNA, Eurogentec
  • Jena Biosciences
  • Moderna
  • New England Biolabs
  • Thermo Fisher Scientific
  • TriLink BioTechnologies.

(Full list of 80+ companies captured is available in the report)
 

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  • Market Landscape Analysis
  • Company Competitiveness Analysis
  • Product Competitiveness Analysis
  • Partnership and Collaboration Analysis
  • Clinical Trial Analysis
  • Likely Partners Analysis
  • Big Pharma Initiative
  • Market Forecast an Opportunity Analysis

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:

  • A preface providing an introduction to the full report, mRNA Synthesis and mRNA Manufacturing Market, 2022-2035. 
  • An outline of the systematic research methodology adopted to conduct the study on mRNA synthesis and mRNA manufacturing market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
  • A summary of the key insights captured in our research, offering a high-level view on the likely evolution of the mRNA synthesis and mRNA manufacturing market in the short to mid-term, and long term.
  • A general overview of mRNA, highlighting details on its structure and the historical evolution of mRNA vaccines. It also presents information on the in-vitro synthesis of mRNA, its applications in various therapeutic modalities and the challenges associated with the process. Additionally, it features a discussion on the commonly outsourced manufacturing operations and their advantages.
  • A detailed assessment of the overall market landscape of the companies offering mRNA custom synthesis services, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of service(s) offered (custom synthesis, modification, purification, process development, scale-up / manufacturing and fill / finish), input for synthesis (plasmid DNA, mRNA sequence, PCR fragments and other(s)), structural modification (3’ modification, 5’ modification and base modification), type of purification method(s) (precipitation, chromatography, electrophoresis and other(s)), application area(s) (research and therapeutics / vaccines), scale of operation (research / preclinical, clinical, and commercial) and GMP compliance. It also features information on the mRNA synthesis / manufacturing capacity of the mRNA custom synthesis service providers, highlighting the length of the mRNA manufactured.
The image looks at the competitive landscape across mRNA synthesis kits. mRNA synthesis kit providers are steadily expanding their capabilities in order to enhance their existing capabilities and augment their respective kit portfolios This image looks at the details of clinical trials related to mRNA-based Therapeutics / Vaccines. A considerable increase in the number of clinical trials registered for mRNA-based therapeutics / vaccines shows growing demand for such therapeutic / preventive intervention This infographic looks at the various partnership deals inked by stakeholders in mRNA synthesis and manufacturing domain. The growing interest is evident from the rise in partnership activity; in fact, the maximum number of collaborations related to mRNA-based drug manufacturing were inked in 2020 and 2021
  • A detailed competitiveness analysis of mRNA custom synthesis service providers based on supplier strength (in terms of years of experience) and service strength (considering type of service(s) offered, type of modification, scale of operation, GMP compliance and application areas). 
  • A comprehensive assessment of the overall market landscape of mRNA contract manufacturing service providers (mRNA CDMO), based on several relevant parameters, including year of establishment, company size (in terms of number of employees), location of headquarters, location of manufacturing facilities, type of product(s) manufactured (drug products (FDFs) and drug substances (APIs)), type of service(s) offered (fill / finish, formulation development, purification, process development, analytical testing, and regulatory support) and scale of operation (research / preclinical, clinical and commercial).
  • An in-depth company competitiveness analysis of mRNA contract manufacturing service providers (mRNA CDMO) based in North America, Europe and Asia-Pacific. The analysis compares the contract service providers based on supply strength (in terms of years of experience) and service portfolio strength (considering type of service(s) offered, scale of operation, type of product manufactured and number of facilities).
  • A detailed overview of the current market landscape of kits available for mRNA synthesis, based on several relevant parameters, such as type of enzyme, kit components, type of enzyme mix used, mRNA component modified, yield per reaction, number of reactions, reaction run time and kit price. It also features a list of players engaged in the development of mRNA kits, along with analysis based on year of establishment, company size (in terms of number of employees) and location of headquarters.  Additionally, it highlights the leading players (in terms of number of mRNA synthesis kits offered) in this domain.  
  • A product competitiveness analysis of the mRNA synthesis kits, based on supplier power (in terms of the experience of the developer) and product competitiveness (in terms of type of enzyme, number of kit component(s), type of mRNA component modified, yield, number of reaction(s) and price).
  • Elaborate profiles of key players engaged in the synthesis and manufacturing of mRNA (shortlisted based on strength of service portfolio). Each profile includes a brief overview of the company, along with information on mRNA synthesis service portfolio, additional services offered, recent developments and an informed future outlook. 
  • Detailed profiles of the key mRNA synthesis kit providers (shortlisted based on strength of product portfolio). Each profile includes a brief overview of the company, along with information on the mRNA synthesis kits portfolio.
  • An analysis of completed, ongoing and planned clinical studies of mRNA therapeutics and vaccines, based on several relevant parameters, such as trial registration year, trial status, trial phase, target patient population, therapeutic area, type of sponsor / collaborator, leading industry players (in terms of number of trials conducted), and regional distribution of trials.
  • A detailed analysis of the recent partnerships inked between stakeholders engaged in this domain, since 2014, covering acquisitions, manufacturing agreements, fill / finish service agreements, supply agreements, service alliance, and other relevant deals. 
  • An in-depth analysis of over 35 mRNA-based therapeutics / vaccines developers that are likely to partner with mRNA contract manufacturing service providers. These players have been shortlisted based on several relevant parameters, such as developer strength (which takes into account the company’s experience), company size, (in terms of number of employees), pipeline strength (based on the number of mRNA-based drugs in pipeline), highest phase of development, therapeutic area, route of administration and type of candidate being developed.
  • A review of the various mRNA-focused initiatives undertaken by big pharma players (shortlisted on the basis of the revenues generated in 2021), featuring various insightful representations, such as Harvey ball analysis, spider web analysis, based on several relevant parameters such as funding amount raised, partnership activity, and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)).
This image provides the list of likely partners with mRNA synthesis and manufacturing service providers. Close to 35 mRNA-based therapeutic / vaccine developers across the world are anticipated to forge strategic alliances with mRNA synthesis and manufacturing service providers, to further augment their drug portfolio This image provides details on various initiatives taken by big pharma players related to mRNA synthesis and manufacturing. In order to tap the lucrative opportunity in this rapidly growing market, big pharma players have undertaken several initiatives, including strengthening product portfolio, agreements, and investments This image provides details on mRNA synthesis and manufacturing market size. The market’s evolution is likely to be driven by the need for novel mRNA therapeutics; we expect the future opportunity to be well distributed across various types of product, therapeutic areas, and key geographical regions

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.

Frequently Asked Questions

Question 1: How is synthetic mRNA produced?

Answer: mRNA is made from a DNA template during the process of transcription. During transcription, the DNA of a gene serves as a template for complementary base-pairing, and an enzyme called RNA polymerase II catalyzes the formation of a pre-mRNA molecule, which is then processed to form mature mRNA.

Question 2: Who is the producer of mRNA vaccine?

Answer: Examples of some companies that manufacture mRNA vaccine include AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer.

Question 3: What is mRNA vaccine made out of?

Answer: mRNA vaccine contains mRNA created in a laboratory to train cells in the body to make a protein that can trigger an immune response.

Question 4: What is the function of the mRNA?

Answer: mRNAs carry protein information from the DNA in a cell nucleus to the cytoplasm, where the protein-making machinery reads the mRNA sequence and translates each three-base codon into its corresponding amino acid in a growing protein chain.

Question 5: What are the factors driving mRNA synthesis and mRNA manufacturing market?

Answer: The growing demand for mRNA as a drug agent, lack of manufacturing capabilities and the need for independent geographical supply chains has prompted the mRNA drug developers to outsource various operations involved in mRNA synthesis to the service providers.

Question 6: How many players are providing services for custom synthesis of mRNAs?

Answer: Presently, more than 30 companies claim to offer various custom mRNA synthesis services which include mRNA modification, mRNA purification, manufacturing / scale-up, fill / finish and process development related services.

Question 7: How many companies are offering mRNA contract manufacturing services for commercial purposes?

Answer: Close to 70% of the players involved in this industry claim to offer mRNA contract manufacturing services at commercial scale; notable examples include Catalent, Curia, Baxter BioPharma Solutions.

Question 8: How many kits are available in the market for the synthesis of mRNA?

Answer: Currently, more than 95 kits available in the market contain the required components for the synthesis of research grade mRNAs used for various applications.

Question 9: Which geographical segment has the highest growth rate in mRNA synthesis and manufacturing market?

Answer: Asia Pacific is likely to grow at the highest CAGR during the period 2022- 2035.

Question 10: Which segment, in terms of type of product, accounts for the largest mRNA synthesis and manufacturing market share?

Answer: Drug substance (APIs), presently, dominates the mRNA synthesis and manufacturing market with a share of close to 70% in 2022. This is attributable to the rising interest in R&D activities and growing demand for the consistent supply of these novel therapeutic / prophylactic interventions for various disease indications.

Question 11: What is the partnership and collaboration trends in mRNA synthesis and manufacturing market?

Answer: Currently, manufacturing agreements, fill / finish service agreements and supply agreements are common types of partnerships inked by stakeholders in the mRNA synthesis and manufacturing domain.

Question 12: How big is the global mRNA synthesis and mRNA manufacturing market?

Answer: The global market size of mRNA synthesis and mRNA manufacturing market is estimated to be USD 1.95 billion in 2023.

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