mRNA Synthesis and Manufacturing Market: Industry Trends and Global Forecasts, till 2035 - Distribution by Type of Product, Application Area, Therapeutic Area and Key Geographical Regions

30% of Recent Industry Partnerships in Cell and Gene Therapy Inked in Last Two Years, Highlighting Manufacturing and Service Agreements

The global mRNA synthesis and manufacturing market is estimated to be worth $1.06 billion in 2024 and is likely to be $0.58 billion in 2035.

Ribonucleic acid (RNA) is a molecule which is present in all living cells and translates genetic information to various proteins in order to perform various cellular processes. Notably, RNA can be of different types, including messenger RNA (mRNA), transfer RNA (tRNA) and ribosomal RNA (rRNA); of these, mRNA has emerged as one of the key therapeutic modalities in the modern healthcare industry. mRNA is a single-stranded molecule, which carries the genetic information present in the DNA to produce proteins. The genetic coding which is present on mRNA gets translated into amino acids, which further gets processed into a functional product (proteins). Post the onset of the COVID-19 pandemic, mRNA vaccine and therapeutics manufacturing have garnered significant attention as they have evolved as a next generation drug class for the treatment of COVID-19, as well as several other diseases, such as oncological disorders, infectious diseases and genetic disorders.

Fundamentally, the production of mRNA therapeutics / mRNA vaccines is complex, cost intensive and requires specialized expertise. Therefore, mRNA therapeutic / vaccine developers are actively exploring avenues that enable them to overcome the existing challenges. Amongst other alternatives, outsourcing has emerged as a lucrative option for mRNA therapeutic / vaccine developers. In the foreseen future, owing to the rising incidence of chronic diseases, increasing demand for gene therapy, maturation of RNA-based leads into the clinic and / or commercialized stage, and development of advanced technologies, we anticipate the mRNA synthesis and mRNA manufacturing market to witness healthy growth.

mRNA Synthesis and Manufacturing Market Share Insights

The mRNA synthesis and manufacturing market research report presents an in-depth analysis of the various companies in the global mRNA synthesis and mRNA manufacturing services industry, across different segments, as defined below:

• Historical Trend: 2019-2023
• Base Year: 2023
• Forecast Period: 2024-2035
• Market Size in 2024: $1.06 Billion
• Type of Product
  • Drug Substance (APIs)
  • Drug Product (FDFs)
• Application Area
  • mRNA-based Vaccines
  • mRNA-based Therapeutics
• Therapeutic Area
  • Infectious Diseases
  • Oncological Disorders
  • Other Diseases
• Key Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
• Key Companies Profiled
  • Aldevron
  • APExBIO
  • Aurigene Pharmaceutical Services
  • Biomay
  • CELLSCRIPT
  • Curia
  • eTheRNA
  • Enzynomics
  • Eurogentec
  • Genscript
  • Jena Bioscience
  • Merck KGaA
  • New England Biolabs
  • Vernal Biosciences
  • ST Pharm
  • Thermo Fisher Scientific
  • TriLink BioTechnologies
  • WuXi Biologics
  • (Full list of 70+ companies captured is available in the report)
• PowerPoint Presentation (Complimentary)
• Customization Scope: 15% Free Customization
• Excel Data Packs (Complimentary) 
  • Market Landscape (mRNA custom synthesis service providers)
  • Market Landscape (mRNA contract manufacturing service providers)
  • Market Landscape (mRNA synthesis kit providers)
  • Company Competitiveness Analysis (mRNA custom synthesis service providers)
  • Company Competitiveness Analysis (mRNA contract manufacturing service providers)
  • Product Competitiveness Analysis (mRNA synthesis kit providers)
  • Partnerships and Collaborations
  • Likely Partner Analysis
  • Big Pharma Initiatives
  • Market Forecast and Opportunity Analysis

mRNA Synthesis and Manufacturing Market Segmentation Overview

Market Share by Type of Product

The global mRNA synthesis and manufacturing market highlights the market segmentation based on the type of product, such as drug substances (APIs) and drug products (FDFs). Currently, the bulk drug substances (APIs) segment captures maximum share (~86%) of the overall market and is likely to dominate the market in the future as well.

Market Share by Application Area

The global mRNA synthesis and manufacturing market is categorized into mRNA-based vaccines and mRNA-based therapeutics, based on their application area. Currently, the market is driven by mRNA vaccines; however, in the coming future, we anticipate the mRNA therapeutics market segment to grow at a significant pace.

Market Share by Therapeutic Area

The global mRNA synthesis and manufacturing market is segmented based on therapeutic area into infectious diseases, oncological disorders and other disorders. The infectious diseases market segment dominates the 2024 market; further, the mRNA being developed for treating oncological disorders is expected to witness substantial market growth in the next decade.

Market Share by Key Geographical Regions

This segment highlights the distribution of mRNA synthesis and manufacturing market across various geographies, such as North America, Europe, Asia-Pacific and Rest of the World. According to the projections, North America is likely to capture the majority (~50%) of the current mRNA synthesis and manufacturing market share, and this trend is unlikely to change in the future.

mRNA Synthesis and Manufacturing Market Key Insights

The market report features an extensive study of the current market landscape, market size and future opportunities within the mRNA synthesis and manufacturing services industry, during the given forecast period. The market report highlights the efforts of several stakeholders engaged in this rapidly emerging market segmentation of the pharmaceutical industry. Key takeaways of the global mRNA synthesis and manufacturing market report have been briefly discussed below.

Benefits and Growing Demand for mRNA Therapeutics/mRNA Vaccines

mRNA therapeutics and mRNA vaccines 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. Some examples of mRNA COVID vaccines include (arranged in alphabetical order) AstraZeneca-Oxford University (ChAdOx1 nCoV-19), CanSino Biologicals (Ad5-nCoV), Moderna (mRNA-1273) and Pfizer-BioNTech (BNT162b2/COMIRNATY). It is worth mentioning that the COVID vaccine developed by BioNTech-Pfizer and Moderna demonstrated a preventive efficiency of about 95% and were the first mRNA vaccines to receive Emergency Use Authorization by the US FDA (in December 2020) as well as European Medicines Agency (EMA) (in January 2020).

Competitive Landscape of mRNA Synthesis and Manufacturing Service Providers

The current market landscape features a mix of over 70 very large, large, mid-sized and small companies, which claim to have the required expertise to offer various services for the synthesis and manufacturing of mRNAs, across different scales of operation. Majority (95%) of the service providers offer mRNA purification services (primarily chromatography), followed by mRNA modification services (93%) (primarily 5’ modification). In addition, around 50% of the players claim to offer contract services for mRNA as well as mRNA-based products (vaccines and therapeutics).

Competitive Landscape of mRNA Synthesis Kits

The current market landscape features the presence of more than 95 kits that are used in the synthesis of mRNA. Most (85%) of the companies in mRNA synthesis kits industry offer enzymes (for capping and tailing) in their kits. Notably, more than 30% of the kits are capable of carrying out 15 reactions (per kit).

Further, there are around 15 mRNA synthesis kit providers (established as well as start-ups), across the globe. Notably, close to 65% of the companies in this domain are based in North America, followed by Europe (22%).

Market Trends: Partnerships and Collaborations on the Rise for mRNA Synthesis

In recent years, several partnerships have been inked by industry stakeholders, in order to consolidate their presence in this field. It is worth highlighting that 30% of deals were forged in the past two years. Interestingly, most of the inked were instances of manufacturing agreements (~25%), followed by service agreements (17%). In July 2023, Vernal Biosciences entered into an agreement with Reprocell to provide mRNA services for research and clinical applications.

Market Size: mRNA Vaccines Market Segment to Hold the Largest Share of the Market

The global mRNA synthesis and manufacturing market size is estimated to be worth $ 1.06 billion in 2024. Further, the piqued interest of stakeholders in R&D activities and the demand for mRNA-based products is likely to drive growth of this market. Specifically, in terms of type of product, the market is anticipated to be driven by contract manufacturing of mRNA vaccines.

Regional Analysis: North America to Hold the Largest Market Share in mRNA Synthesis and Manufacturing Market

Majority of the mRNA synthesis and manufacturing service providers are headquartered in North America and Europe. Notably, the global mRNA synthesis and manufacturing market in 2035 is anticipated to be dominated by players based in North America, while ~30% share is anticipated to be captured by players based in Europe.

Key Players in the mRNA Synthesis and Manufacturing Market

Examples of key players engaged in this industry (which have also been captured in this report) include Aldevron, Aurigene Pharmaceutical Services, Biomay, Curia, eTheRNA, Eurogentec, Genscript, Merck KGaA, TriLink BioTechnologies, Vernal Biosciences and WuXi Biologics.

Further, examples of other key players offering mRNA synthesis kits include (in alphabetical order) APExBIO, CELLSCRIPT, Enzynomics, Jena Bioscience, New England Biolabs and Thermo Fisher Scientific.

Recent Developments in mRNA Synthesis and Manufacturing Market

Several recent developments have taken place in the field of mRNA synthesis and manufacturing, some of which have been outlined below. These developments, even if they took place post the release of the market report, substantiate the overall mRNA synthesis and manufacturing market trends that the analyst has outlined in the analysis.

• In December 2023, Katalin Karikó (affiliated to the Szeged University, Szeged, Hungary and University of Pennsylvania, US) and Drew Weissman (affiliated to the Penn Institute for RNA Innovations, University of Pennsylvania, US) were jointly awarded the 2023 Nobel Prize in Physiology or Medicine, for their discoveries related to nucleoside base modifications that were useful in the development of effective mRNA vaccines during the pandemic.
• In November 2023, TriLink BioTechnologies entered into a partnership with Intellia Therapeutics to supply products (including certain cap analogs) useful in the manufacturing of mRNA.
• In October 2023, AGC Biologics expanded its pDNA and mRNA production facility located in Heidelberg, Germany.
• In August 2023, researchers from Penn University developed a scalable microfluidics platform that has the potential to transform the production of mRNA therapeutics and mRNA vaccines.
• In June 2023, Eurofins Genomics Blue Heron launched its in-vitro transcription (IVT) mRNA synthesis services; the new synthesis service has the capability to handle different applications (including molecular biology, drug discovery, gene therapy and vaccine development).
• In May 2023, Aldevron announced the expansion of its mRNA production capabilities, with the inclusion of lipid nanoparticles?(LNP) encapsulation and aseptic fill-finish capabilities.
• In April 2023, Arranta Bio entered into a collaboration with MIT to develop a continuous manufacturing technology for mRNA therapeutics.

mRNA Synthesis and Manufacturing Market Report Coverage

The market report presents an in-depth analysis, highlighting the capabilities of various stakeholders in this industry, across different geographies. Amongst other elements, the market report includes:

• A preface providing an introduction to the full report, mRNA Synthesis and Manufacturing Market (3rd Edition), till 2035.
• An outline of the systematic research methodology adopted to conduct the study on global mRNA synthesis and manufacturing market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of the findings.
• An overview of economic factors that impact the overall mRNA synthesis and manufacturing industry, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the key insights captured during the research, offering a high-level view of the current state of the mRNA synthesis and manufacturing services and its likely evolution in the short to mid 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 synthetic mRNA production (chemical / in-vitro), its applications in various therapeutic modalities and the challenges associated with the synthesis and mRNA manufacturing process. Additionally, it features a discussion on the commonly outsourced manufacturing operations and their advantages.
• A detailed assessment of mRNA custom synthesis service providers, based on several relevant parameters, including year of establishment, company size (in terms of number of employees), location of headquarters (North America, Europe and Asia Pacific), type of services offered (mRNA modification, mRNA purification, scale-up, process development and fill / finish), starting material (plasmid DNA, mRNA sequence and PCR fragments), structural modification (5’ modification, 3’ modification, ribonucleotide base modification and others), type of purification method (chromatography, electrophoresis, desalting / precipitation and others), application area (vaccine production, therapeutic production and others) and scale of operation (preclinical / research, clinical and commercial). Further, the chapter also features information on the length of the mRNA manufactured and mRNA production capacity of the stakeholders.
• An insightful competitiveness analysis of mRNA custom synthesis service providers (across key geographical regions), based on supplier strength (in terms of years of experience and company size), and service strength (in terms of number of type of services offered, number of type of modifications, scale of operation, GMP compliance and area of application).
• A comprehensive assessment of the mRNA contract manufacturing service providers, based on several relevant parameters, including year of establishment, company size (in terms of number of employees), location of headquarters (North America, Europe and Asia Pacific), location of manufacturing facilities, type of additional services offered (formulation development, analytical testing, process development, mRNA purification, fill / finish, scale-up, regulatory support and others) type of product manufactured (drug substances (APIs) and drug products (FDFs)) and scale of operation (preclinical / research, clinical and commercial).
• An in-depth company competitiveness analysis of mRNA contract manufacturing service providers (across key geographical regions), based on supplier strength (in terms of years of experience and company size) and service portfolio strength (in terms of number of facilities, type of product manufactured, number of type of services offered and scale of operation).
• A detailed assessment of the current market landscape of mRNA synthesis kits based on several relevant parameters, such as kit components (enzyme mix, reagents, buffer and others), type of enzyme (capping enzyme and tailing enzyme), type of enzyme mix used (T7 polymerase, SP6 polymerase and T3 polymerase), mRNA component modified (cap, base and tail), number of reactions (5 reactions, 10 reactions, 15 reactions, 16 reactions, 20 reactions, 25 reactions, 48 reactions and 50 reactions), yield per reaction (less than 31µg, 31-60 µg, 61-90 µg and more than 90 µg), reaction run time (less than 61 minutes, 61-120 minutes and more than 120 minutes) and kit price (less than USD 500, USD 501-USD 700, USD 701-USD 900 USD, USD 901-USD 1,200 and more than 1,200 USD). In addition, the chapter provides a detailed analysis of mRNA synthesis kit providers, along with information on their year of establishment, company size (in terms of employees count), location of headquarters and most active players (in terms of number of mRNA synthesis kits offered).
• An insightful analysis of mRNA synthesis kits, based on supplier strength (in terms of years of experience and company size) and product strength (in terms of number of kit components, number of type of enzyme, number of type of mRNA component modified, yield, number of reactions, reaction run time and price of the kit).
• Elaborate profiles of leading mRNA manufacturing companies (shortlisted based on service portfolio strength). Each profile features a brief overview of the company (including information on year of establishment, location of headquarters, number of employees and key executive), details related to mRNA synthesis and manufacturing service portfolio, recent developments and an informed future outlook. In addition to the leading service providers for synthesis and manufacturing of mRNA, some other prominent players have also been profiled, for which information on company overview and mRNA synthesis and manufacturing service portfolio has been provided.
• Detailed profiles of the key mRNA synthesis kit providers (shortlisted based on product portfolio strength). Each profile includes a brief overview of the company, along with information on the mRNA synthesis kits portfolio.
• A detailed analysis of the partnerships inked between stakeholders engaged in this industry, during the period 2019-2023, based on several parameters, such as year of partnership, type of partnership, type of product, type of partner and most active players (in terms of the number of partnerships signed). It also provides for the regional distribution of the companies involved in these agreements.
• 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 (in terms of 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 2023 revenues), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative and therapeutic area.
• An in-depth analysis of the factors that can impact the growth of mRNA synthesis and manufacturing market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
• A detailed mRNA synthesis and manufacturing market forecast analysis in order to estimate the existing market size and future opportunity in the market, till the year 2035. Based on multiple parameters, such as likely adoption trends and thorough primary validations, the analyst has provided an informed estimate on the market evolution during the forecast period 2024-2035. The report also features the likely distribution of the current and forecasted opportunity within the mRNA synthesis and manufacturing market. Further, in order to account for future uncertainties and to add robustness to the model, the analyst has provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
• Detailed projections of the current and future mRNA synthesis and manufacturing market across type of product, such as drug substances and drug products.
• Detailed projections of the current and future mRNA synthesis and manufacturing market across application area, such as mRNA-based vaccines and mRNA-based therapeutics.
• Detailed projections of the current and future mRNA synthesis and mRNA manufacturing market across therapeutic area, such as infectious diseases, oncological disorders and other disorders.
• Detailed projections of the current and future mRNA synthesis and manufacturing market across key geographies, such as North America, Europe, Asia-Pacific, and Rest of the World.

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential of the global mRNA synthesis and manufacturing market, over the forecast period. the analyst has provided informed estimates on the likely evolution of the market for the forecast period, 2024-2035.

the year-wise projections of the current and future opportunity for the mRNA synthesis and manufacturing market have been segmented based on relevant parameters, such as type of product (drug substances (APIs) and drug products (FDFs)), application area (mRNA-based vaccines and mRNA-based therapeutics), therapeutic area (infectious diseases, oncological disorders and other disorders) and key geographical regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa and Rest of the World)

In order to account for future uncertainties associated with some of the key parameters and to add robustness to the model, the analyst has provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution. Further, the opinions and insights presented in the mRNA synthesis and manufacturing market report were influenced by discussions held with various stakeholders in the industry.

Further, 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.

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