DUBLIN, October 11, 2021– (BUSINESS WIRE) – The report “MRNA Synthesis and Manufacturing Services Market by Product Type, Application Areas, Operation Scale, Geographical Regions: Industry Trends and Global Forecast, 2021 -2030 »has been added to ResearchAndMarkets.com offer.
The report “mRNA Synthesis and Manufacturing Market, 2021-2030” presents an in-depth study of the current market landscape and future opportunities for players involved in the synthesis of research-grade mRNA and GMP for use in the development. therapeutic products and vaccines. The study presents an in-depth analysis, highlighting the capacities of the different stakeholders involved in this field, in different geographical areas.
One of the main objectives of the report was to estimate the future growth potential of the mRNA synthesis services market, over the next decade. Based on several parameters, such as mRNA product market, cost of goods sold, cost of manufacturing and share of outsourcing, we have provided an educated estimate of how the market will develop for the period. 2021-2030.
The applications of RNA, both in basic research and in clinical R&D, have mushroomed after advances in molecular biology dramatically improved the in vitro stability of these molecules. Currently, there are over 150 therapeutics and vaccines, either based on mRNA molecules or involving the use of mRNA in their respective production processes, which are being evaluated for the treatment of a wide variety of indications. .
It should be noted that most of the above product candidates are in the preclinical stages of development. Important examples include dendritic cell vaccines, T cell therapies, other cancer therapies / vaccines and stem cell therapies, which are modified in vitro using transgenes encoded in mRNA vectors; on the other hand, there are some new therapeutic paradigms which explore the in vivo transformation of cells using stable mRNAs (carriers of therapeutic gene segments) which are delivered via viable nanocarriers.
In fact, the first two vaccines to be approved (BNT-162 from Pfizer / BioNTech and mRNA-1273 from Moderna) against the viral pathogen SARS-CoV-2, were based on mRNA and were recently approved for use in various regions of the world. . According to the CDC, more than 374 million doses of the vaccine have been delivered to the United States alone.
The success of COVID-19 vaccines has created a huge need for constant supply of these new vaccines; for example, Pfizer is to deliver 1.6 billion doses and Moderna is expected to produce between 800 million and 1 billion doses of their respective products by the end of 2021. As a result, there is a clear increase in demand for capacity. mRNA manufacturing process.
Basically, the production of this biomolecule is complex, expensive and requires specialized expertise. In addition, the intensification of RNA manufacturing is also associated with a number of challenges, mainly related to process development and maintaining purity and stability.
Referring to the intensification of manufacturing activities to meet pandemic level requirements, Tanya Alcorn, VP of Global Biopharmaceutical Supply Chain at Pfizer, recently identified the need for harmony in the efforts of different stakeholders. (suppliers and manufacturing teams) in order to adequately amplify the production going out.
Additionally, some of the processes associated with mRNA production, such as the purification step, involve the use of hazardous solvents / materials. Once manufactured, mRNA-based therapeutic products must be stored under conditions which do not compromise their stability (which requires specialized facilities and cold chain transport); they also require appropriate drug delivery systems to effectively deliver the intervention (so as to avoid degradation by cellular endonucleases).
In view of these technical and operational challenges associated with the production of RNA-based products, innovators in the biopharmaceutical industry are increasingly relying on contract service providers. Additionally, the COVID-19 pandemic has caused a noticeable increase in outsourcing activity, with vaccine developers entering into strategic deals with contracted service providers to meet urgent global demand. The services landscape includes a mix of large, medium and small businesses, which claim to have mRNA related capabilities.
Recent developments in this segment of the biopharmaceutical industry indicate that service providers are improving their capabilities and infrastructure to meet the current and expected demand for this new class of biologics. For the foreseeable future, as more and more such RNA-based leads mature and enter the clinical and / or marketplace, we anticipate that the market for mRNA synthesis service providers will experience a boom. healthy growth.
Answers to key questions
Who are the major service providers engaged in the personalized synthesis of research-grade mRNA?
Who are the major service providers engaged in the manufacture, formulation and filling / finishing of GMP grade mRNA?
Which regions are currently hubs for the production of GMP-grade mRNA?
Which companies are actively involved in conducting clinical trials for their mRNA-based therapies and vaccines?
Which regions are leading the recruitment of patients in clinical trials of mRNA-based therapies and vaccines?
What partnership models are commonly adopted by the actors involved in this field?
What factors are likely to influence the evolution of this market?
How are current and future market opportunities likely to be distributed among key market segments?
Main topics covered:
2. EXECUTIVE SUMMARY
3.1. Structure of mature mRNA
3.2. Chemical synthesis of mRNA
3.3. Disadvantages of chemical synthesis
3.4. In vitro synthesis of mRNA
3.5. Purification of the synthesized mRNA
3.6. Applications of mRNA synthesized in vitro
3.7. Commonly outsourced manufacturing operations
3.8. Benefits of outsourcing manufacturing operations
4. MARKET LANDSCAPE
4.1. Custom mRNA Synthesis Service Provider Market Landscape
4.2. CGMP Service Provider Market Landscape
4.3. MRNA Synthesis Kits Market Landscape
5. ANALYSIS OF THE COMPETITIVENESS OF THE COMPANY
5.2. Competitiveness analysis
6 ANALYSIS OF CLINICAL TRIALS
6.2 mRNA products: analysis of clinical trials
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. Main partners: analysis by number of partnerships
8. MAJOR PHARMACEUTICAL INITIATIVES
8.1. Analysis by type of initiative
8.2. Analysis by therapeutic orientation
8.3. Analysis by number of partnerships
9. COMPANY PROFILES
9.5. Biotechnologies TriLink
9.7 Jena Biosciences
9.9. CELLULAR SCRIPT
9.10. Thermo Fisher Scientific
9.11. New England Biolabs
10. ANALYSIS OF THE REQUEST
10.1. Methodology and hypothesis
10.2. Global mRNA demand: clinical and commercial, 2021
10.3. Global mRNA trade demand, 2020 and 2021
10.4. Global clinical demand for mRNA, 2020 and 2021
11. MARKET FORECASTS
11.1. Methodology and hypothesis
11.2. Global mRNA Synthesis and Manufacturing Market, 2021-2030
12. APPENDIX 1: TABULATED DATA
13. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
For more information on this report, visit https://www.researchandmarkets.com/r/v4kxpn
See the source version on businesswire.com: https://www.businesswire.com/news/home/20211011005618/en/
Laura Wood, Senior Press Director
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