mRNA Synthesis and Manufacturing Services Market (2nd Edition), 2022-2035

mRNA Synthesis and Manufacturing Services Market (2nd Edition), 2022-2035

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 vaccines 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 manufacturing capacity. 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, as more of such RNA-based leads mature and move into the clinic and / or get commercialized, we anticipate the mRNA synthesis and manufacturing services market to witness healthy growth.

The “mRNA Synthesis and Manufacturing Services Market (2nd Edition), 2022-2035: Distribution by Type of Product (Drug Substances (APIs) and Drug Products (FDFs)), Application Area(s) (mRNA-based Vaccines and mRNA-based 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” report features an extensive study of the current market landscape and future opportunity for the players involved in the synthesis and manufacturing of research- and GMP-grade mRNA for use in the development of therapeutics and vaccines. The report answers many key questions related to this domain.

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. It is worth highlighting that mRNA therapeutics / mRNA vaccines are anticipated to become a powerful therapeutic modality for the treatment of a variety of refractory diseases, including oncological disorders, metabolic disorders, infectious diseases, cardiovascular disorders, cerebrovascular diseases and other diseases.

Need for Outsourcing mRNA Synthesis and Manufacturing Services to Contract Manufacturers

The synthesis and manufacturing of mRNA therapeutics and mRNA vaccines is fraught with several challenges as the production of such biomolecules is complex, cost intensive and requires specialized expertise. Scaling up the manufacturing of mRNA is associated with a number of challenges, mostly related to process development, 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). Given such technical and operational challenges associated with the production of RNA-based products, innovators in the biopharmaceutical industry are increasingly relying on the contract service providers. The COVID-19 pandemic caused a notable surge in the outsourcing activity, with vaccine developers entering into strategic deals with contract service providers to cater to the urgent global demand.

Current Market Landscape of mRNA Synthesis and Manufacturing Service Providers

The mRNA synthesis and 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 various services for the synthesis and manufacturing of mRNAs across different scales of operations, worldwide. 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 service providers are upgrading their capabilities and infrastructure to accommodate the current and anticipated demand for this novel class of biologics.

Key Drivers in the mRNA Synthesis and Manufacturing Services Market

The success of anti-COVID-19 vaccines has created an enormous need for the consistent supply of these novel vaccines. In the coming decade, several promising leads, specifically those exhibiting enhanced efficacy, are anticipated to be commercially launched. Moreover, considering the active involvement of big pharma players, as well as new entrants, the development pipeline of mRNA drugs is likely to grow further. The big pharma players have undertaken several initiatives, including strengthening mRNA-based product portfolio, entering into strategic deals and making significant financial investments. Therefore, 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.

Market Size of the mRNA Synthesis and Manufacturing Services Market

Driven by the rising interest in R&D activities and the demand for mRNA-based products, the future opportunities and growth associated with the mRNA synthesis and manufacturing market is anticipated to witness a noteworthy growth in the foreseen future. Specifically, in terms of type of product, the market is anticipated to be driven by contract manufacturing of mRNA vaccines. In addition to this, presently, close to 70% of the market is captured by players based in North America and Europe.

Who are the Key Players in the mRNA Synthesis and Manufacturing Services Market

Examples of key players engaged in this domain (which have also been captured in this report) include Aldevron, APExBIO, Biomay, BioNTech, CELLSCRIPT, CureVac, bioSYNTHESIS, eTheRNA, Eurogentec, Jena Biosciences, Moderna, New England Biolabs, Thermo Fisher Scientific and TriLink BioTechnologies.

evolution.

SCOPE OF THE REPORT

mRNA Synthesis and Manufacturing Services Market: Report Attribute

Report Attribute Details

Forecast Period 2022 – 2035

Type of Product Drug Substance (APIs)

Drug Product (FDFs)

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.

Customization Scope 15% Free Customization Option (equivalent to 5

analyst working days)

Excel Data Packs (Complimentary) 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

Source: Roots Analysis

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

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.

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, 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 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)).

One of the key objectives of the report was to estimate the current opportunity and the future growth potential of the mRNA synthesis and contract manufacturing services market over the coming years. We have provided an informed estimates on the likely evolution of the market for the period, 2022-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as type of product (drug substances (APIs) and drug products (FDFs)), application areas (mRNA-based 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.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

FREQUENTLY ASKED QUESTIONS

Question 1: What are the factors driving mRNA synthesis and 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 2: 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 3: How many players are offering mRNA contract manufacturing services for commercial purposes?

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

Question 4: 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 5: 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 6: 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 7: What is the partnership and collaboration trends in mRNA synthesis and manufacturing domain?

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.

CHAPTER OUTLINES

Chapter 2 Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the mRNA synthesis and contract manufacturing services market and its likely evolution in the short to mid-term and long term.

Chapter 3 provides 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.

Chapter 4 includes 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.

Chapter 5 presents 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).

Chapter 6 includes a comprehensive assessment of the overall market landscape of 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, 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).

Chapter 7 features an in-depth company competitiveness analysis of mRNA contract manufacturing service providers based in North America, Europe and Asia-Pacific. The analysis compares the contract service providers on the basis of various parameters, such as their supply strength (based on their experience in this field) and service portfolio strength (based on type of service(s) offered, scale of operation, type of product manufactured and number of facilities).

Chapter 8 provides a detailed overview of the current market landscape of companies engaged in the development of mRNA synthesis kits, 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 mRNA kit developers landscape based on year of establishment, company size (in terms of number of employees), location of headquarters. Further, it also highlights the leading players (in terms of number of mRNA synthesis kits offered) in this domain.

Chapter 9 presents 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).

Chapter 10 features profiles of the key players offering services for the synthesis and manufacturing of mRNA (shortlisted based on service portfolio strength). Each profile includes a brief overview of the company, details on mRNA synthesis focused service portfolio, recent developments and an informed future outlook.

Chapter 11 includes profiles of the key mRNA synthesis kit providers (shortlisted based on the number of mRNA synthesis kits offered). Each profile includes a brief overview of the company, along with information on the mRNA synthesis kits portfolio.

Chapter 12 features a detailed 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.

Chapter 13 features an analysis of 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.

Chapter 14 features a comprehensive 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.

Chapter 15 provides the list of 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)).

Chapter 16 presents a comprehensive market forecast analysis, highlighting the future potential of the market till 2035. We have segregated the current and upcoming opportunity based on type of product (drug substances (APIs) and drug products (FDFs)), application areas (mRNA-based 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).

Chapter 17 provides the transcripts of interviews conducted with key stakeholders in the industry.

Chapter 18 is an appendix, which contains tabulated data and numbers for all the figures included in this report.

Chapter 19 is an appendix, which contains a list of companies and organizations mentioned in this report.