DUBLIN–(BUSINESS WIRE)–The “mRNA Synthesis and Manufacturing Services Market by Type of Products, Application Areas, Scale of Operation, Geographical Regions: Industry Trends and Global Forecasts, 2021-2030” report has been added to ResearchAndMarkets.com’s offering.
The “mRNA Synthesis and Manufacturing Market, 2021-2030” report features an extensive study of the current market landscape and future opportunity for the players involved in the synthesis of research- and GMP-grade mRNA for use in development of therapeutics and vaccines. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographies.
One of the key objectives of the report was to estimate the future growth potential of mRNA synthesis services market, over the coming decade. Based on multiple parameters, such as mRNA products market, cost of goods sold, manufacturing cost and share of outsourcing, we have provided an informed estimate on the evolution of the market for the period 2021-2030.
The applications of RNA, in both basic research and clinical R&D, have increased after advances in the field of molecular biology have significantly improved the in vitro stability of such molecules. Presently, there are more than 150 therapeutics and vaccines, either based on mRNA molecules, or involve the use of mRNA in their respective production processes, which are being evaluated for the treatment of a wide variety of indications.
It is worth highlighting that most of the aforementioned product candidates are in the preclinical stages of development. Prominent examples include dendritic cell vaccines, T cell therapies, other anti-cancer therapies/vaccines, and stem cell therapies, which are modified in vitro using transgenes encoded into mRNA vectors; on the other hand, there are certain novel therapeutic paradigms that are exploring the in vivo transformation of cells using stable mRNAs (carrying therapeutic gene segments) that are delivered via viable nanocarriers.
In fact, the first two of the vaccines to be approved (Pfizer / BioNTech’s BNT-162 and Moderna’s mRNA-1273) against the SARS-CoV-2 viral pathogen, were based on mRNA and have recently been approved for use across various global regions. According to the CDC, more than 374 million doses of vaccines have been delivered in the US alone.
The success of the anti-COVID-19 vaccines has created an enormous need for consistent supply of these new vaccines; for instance, Pfizer needs to deliver 1.6 billion doses and Moderna needs to produce between 800 million to 1 billion doses of their respective products by the end of 2021. As a result, there is an evident increase in demand for mRNA manufacturing capacity.
Fundamentally, the production of this biomolecule is complex, cost intensive and requires specialized expertise. In addition, scaling up the manufacturing of RNA is also associated with a number of challenges, mostly related to process development, and maintaining purity and stability.
Referring to scaling up of manufacturing activities to meet pandemic level requirements, Tanya Alcorn, Vice President of Pfizer’s biopharmaceutical global supply chain, recently identified the need for harmony in the efforts of the various stakeholders (suppliers and manufacturing teams) in order to adequately amplify production output.
Moreover, some of the processes associated with mRNA production, such as the purification step, involve the use of hazardous solvents/materials. Once manufactured, mRNA therapeutics need to be stored in conditions that do not compromise their stability (thereby, requiring specialized facilities and cold chain transportation); 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 leaning on contract service providers. Moreover, the COVID-19 pandemic has caused a notable surge in outsourcing activity, with vaccines developers entering into strategic deals with contract service providers to cater to the urgent global demand. The services landscape features a mix of large, mid-sized and small companies, which claim to have mRNA-related capabilities.
Recent developments in this segment of the biopharmaceutical industry indicate that service providers are upgrading their capabilities and infrastructure to accommodate the current and anticipated demand for this novel class of biologics. In the foreseen future, as more of such RNA-based leads mature and move into the clinic and/or the market, we anticipate the mRNA synthesis service providers market to witness healthy growth.
Key Questions Answered
- Who are the key service providers engaged in the custom synthesis of research-grade mRNA?
- Who are the key service providers engaged in the manufacturing, formulation and fill/finish of GMP-grade mRNA?
- Which regions are current hubs for GMP grade production of mRNA?
- Which companies are actively involved in conducting clinical trials for their mRNA-based therapeutics and vaccines?
- Which regions are leading the enrollment of patients in mRNA-based therapeutics and vaccines clinical trials?
- Which partnership models are commonly adopted by stakeholders engaged in this domain?
- Which factors are likely to influence the evolution of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
Key Topics Covered:
1. PREFACE
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Structure of Mature mRNA
3.2. Chemical Synthesis of mRNA
3.3. Drawbacks of Chemical Synthesis
3.4. In vitro Synthesis of mRNA
3.5. Purification of Synthesized mRNA
3.6. Applications of in vitro Synthesized mRNA
3.7. Commonly Outsourced Manufacturing Operations
3.8. Advantages of Outsourcing Manufacturing Operations
4. MARKET LANDSCAPE
4.1. Market Landscape of mRNA Synthesis Custom Service Providers
4.2. Market Landscape of cGMP Service Providers
4.3. Market Landscape of mRNA Synthesis Kits
5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Methodology
5.2. Competitiveness Analysis
6 CLINICAL TRIAL ANALYSIS
6.1. Methodology
6.2 mRNA-based Products: Clinical Trial Analysis
7. PARTNERSHIPS AND COLLABORATIONS
7.1. Analysis by Year of Partnership
7.2. Analysis by Type of Partnership Model
7.3. Most Active Players: Analysis by Number of Partnerships
7.4. Intercontinental and Intracontinental Agreements
7.5. Local and International Agreements
7.6. Top Partners: Analysis by Number of Partnerships
8. BIG PHARMA INITIATIVES
8.1. Analysis by Type of Initiative
8.2. Analysis by Therapeutic Focus
8.3. Analysis by Number of Partnerships
9. COMPANY PROFILES
9.1. Eurogentec
9.2. Aldevron
9.3. eTheRNA
9.4. bioSYNTHESIS
9.5. TriLink BioTechnologies
9.6. Biomay
9.7 Jena Biosciences
9.8 APExBIO
9.9. CELLSCRIPT
9.10. Thermo Fisher Scientific
9.11. New England Biolabs
10. DEMAND ANALYSIS
10.1. Methodology and Assumption
10.2. Global mRNA Demand: Clinical and Commercial, 2021
10.3. Global Commercial Demand for mRNA, 2020 and 2021
10.4. Global Clinical Demand for mRNA, 2020 and 2021
11. MARKET FORECAST
11.1. Methodology and Assumption
11.2. Overall mRNA Synthesis and Manufacturing Market, 2021-2030
12. APPENDIX 1: TABULATED DATA
13. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
For more information about this report visit https://www.researchandmarkets.com/r/v4kxpn
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