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Growing Need for Outsourcing mRNA Synthesis and Manufacturing Services to Contract Manufacturers


DUBLIN , Jan. 22, 2023 /PRNewswire/ — The “mRNA Synthesis and Manufacturing Services Market by Type of Product and Drug Products, Application Area, Therapeutic Area and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035” report has been added to  ResearchAndMarkets.com’s offering.

The “mRNA Synthesis and Manufacturing Services Market (2nd Edition), 2022-2035” 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.

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.

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.

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.

Key Market Insights

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.

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. An Overview of mRNA
3.2. Structure of mRNA
3.3. Evolution of mRNA Vaccines
3.4. mRNA Manufacturing Process
3.5. Applications of Chemically / in vitro Synthesized mRNA
3.6. Challenges Associated with mRNA Synthesis
3.7. Commonly Outsourced Manufacturing Operations
3.8. Advantages of Outsourcing Manufacturing Operations

4. MARKET LANDSCAPE: mRNA CUSTOM SYNTHESIS SERVICE PROVIDERS
4.1. mRNA Custom Synthesis Service Providers: Overall Market Landscape

5. mRNA CUSTOM SYNTHESIS SERVICE PROVIDERS: COMPANY COMPETITIVENESS ANALYSIS
5.1. Key Parameters and Scores
5.2. Methodology
5.3. Competitiveness Analysis: Small Companies
5.4. Competitiveness Analysis: Mid-Sized Companies
5.5. Competitiveness Analysis: Large Companies

6. MARKET LANDSCAPE: mRNA CONTRACT MANUFACTURING SERVICE PROVIDERS
6.1. mRNA Contract Manufacturing Service Providers: Overall Market Landscape

7. mRNA CONTRACT MANUFACTURING SERVICE PROVIDERS: COMPANY COMPETITIVENESS ANALYSIS
7.1. Methodology
7.2. Company Competitiveness Analysis: mRNA Contract Manufacturing Service Providers

8. MARKET LANDSCAPE: mRNA SYNTHESIS KIT PROVIDERS
8.1. mRNA Synthesis Kits: Overall Market Landscape
8.2. mRNA Synthesis Kits: Developer Landscape

9. mRNA SYNTHESIS KITS: PRODUCT COMPETITIVENESS ANALYSIS
9.1. Methodology
9.2. Product Competitiveness Analysis: mRNA Synthesis Kits

10. COMPANY PROFILES: mRNA SYNTHESIS AND MANUFACTURING SERVICE PROVIDERS
10.1. Aldevron
10.2. Biomay
10.3. bioSYNTHESIS
10.4. eTheRNA
10.5. Eurogentec
10.6. TriLink BioTechnologies

11. COMPANY PROFILES: mRNA SYNTHESIS KIT PROVIDERS
11.1. APExBIO
11.2. CELLSCRIPT
11.3. Jena Biosciences
11.4. New England Biolabs
11.5. Thermo Fisher Scientific

12. CLINICAL TRIAL ANALYSIS
12.1. Methodology
12.2. mRNA-based Therapeutics / Vaccines: Clinical Trial Analysis

13. PARTNERSHIP AND COLLABORATIONS
13.1. Partnership Models
13.2. mRNA Synthesis and Manufacturing: Partnerships and Collaborations

14. LIKELY PARTNERS ANALYSIS
14.1. Methodology

15. BIG PHARMA INITIATIVES
15.1. Methodology
15.2. Big Pharma Players: List of mRNA-based Therapeutics / Vaccines Focused Initiatives
15.3. Competitive Benchmarking of Big Pharma Players
15.3.1. Harvey Ball Analysis
15.3.2. Spider Web Analysis

16. MARKET FORECAST
16.1. Chapter Overview
16.2. Key Assumptions and Forecast Methodology
16.3. Global mRNA Synthesis and Manufacturing Market, 2022-2035)

17. EXECUTIVE INSIGHTS

18. APPENDIX 1: TABULATED DATA

19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/5e4ynd

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