mRNA Synthesis: Manufacturing Process of Modern Revolutionary Molecule Messenger ribonucleic acid (mRNA) is a single-stranded molecule, which carries coding sequence and plays a prominent role in protein synthesis. It transfers genetic information form to DNA to ribosomes, a specialized structure, or organelle, which decodes genetic information into a protein. Structure of mRNA Post the onset of the COVID-19 pandemic mRNA has emerged as promising therapeutic tool in modern healthcare industry. With the help of genetic engineering, synthetic mRNAs can express proteins, as they structurally resemble a natural mRNA. 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. Application of Synthetic mRNA Several studies conducted by healthcare companies and research institutions have demonstrated the potential of mRNA. Contract Manufacturing in mRNA Synthesis AND Manufacturing Service Domain The synthesis and manufacturing process of mRNA-based therapeutics / vaccines is complex and associated with several challenges. The production of such drug products requires skilled labor, stringent manufacturing protocols and specialized expertise. Further, the biggest challenge in this domain is the purification which involve the use of hazardous solvents / materials and stability of drug products (thereby, requiring specialized facilities and cold chain transportation). Additionally, they also require appropriate drug delivery systems to efficiently administer the intervention (in a manner that they can avoid degradation by cellular endonucleases). However, because of such operational and technical challenges associated with the production of RNA-based products innovators in the biopharmaceutical industry are increasingly relying on the contract service providers. Players Engaged in mRNA Synthesis and Manufacturing Domain Presently, 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. Concluding Remarks Currently, dozens of preclinical and clinical reports demonstrating the efficacy of these platforms have been published in the last two years alone. However, owing to the several challenges associated with the production of mRNA-based therapeutics / vaccines, majority of the pharmaceutical companies prefer to outsource their manufacturing operations. 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 market to witness healthy growth. For additional details, please visit https://www.rootsanalysis.com/blog/mrna-synthesis-and-manufacturing/ or email sales@rootsanalysis.com You may also be interested in the following titles: 1. Smart Labels Market: Industry Trends and Global Forecasts, 2022-2035 2. 4D Bioprinting Market : Industry Trends and Global Forecasts, 2022-2035 About Roots Analysis Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. Contact: Ben Johnson +1 (415) 800 3415 Ben.johnson@rootsanalysis.com

The mRNA synthesis and manufacturing market is projected to be worth USD 1.5 billion by 2035, claims Roots Analysis Given the current technical and operational challenges associated with the manufacturing of mRNA-based products, innovators in the biopharmaceutical industry are increasingly relying on the mRNA synthesis and contract manufacturing service providers. Roots Analysis has announced the addition of “mRNA Synthesis and Manufacturing Services Market (2nd Edition), 2022–2035” report to its list of offerings. Owing to the recent success and growing pipeline of mRNA-based products in the market, mRNA, as a therapeutic agent, has gained significant traction from the medical community. However, due to challenges, such as high capital requirement, stringent regulations and lack of technical expertise, outsourcing has become a preferred business model and CMOs are upgrading their existing capabilities and service portfolios to meet the increased demand for mRNA-based products. To request a sample copy / brochure of this report, please visit https://www.rootsanalysis.com/reports/mrna-synthesis-and-manufacturing-market/request-sample.html Key Market Insights Presently, 30+ companies claim to offer custom synthesis services for mRNA, globally. Majority of the service providers are mid-sized players (44%), followed by small (35%), large (12%) and very large players (9%). Additionally, more than 25% of the stakeholders were established post 2010. It is also worth mentioning that over 50% of the total players are based in North America, specifically in the US. More than 40 companies, across the globe, claim to provide contract manufacturing and fill / finish services for mRNA vaccines / therapeutics. Of the aforementioned players, nearly 85% of the contract manufacturing service providers are based in North America and Europe. Notably, more than 50% of the total players engaged in this space offer services for drug substance (APIs) manufacturing. Currently, more than 95 mRNA synthesis kits are available in the market. Close to 70% of the mRNA synthesis kits contain capping enzymes; of these, 96% use T7 RNA polymerase enzyme mix for the synthesis of modified mRNAs. It is worth highlighting that majority (54%) of the kit developers are small players. More than 170 clinical trials have been registered for the evaluation of mRNA-based therapeutics / vaccines, worldwide. The clinical research activity, in terms of number of trials registered, is reported to have increased at a steady CAGR of 44%, during the period 2017-2022. Of the total number of trials registered, close to 22% have already been completed, while 46% of the studies are actively recruiting participants. Partnership activity within this domain has grown at a CAGR of 60%, between 2019 and 2022. Nearly 34% of the deals were inked in 2021. Majority of the instances captured in the report were manufacturing agreements, representing 22% of the total partnerships. Further, most of the intercontinental deals have been inked by players based in North America. North America and Europe are anticipated to capture close to 65% of the global market share, by 2035. The market in Asia Pacific is likely to grow at the highest CAGR during the period 2022-2035. In terms of type of product, drug substance (APIs) is expected to occupy a larger share (70%) of the overall mRNA synthesis and manufacturing service market in 2035. For additional details, please visit https://www.rootsanalysis.com/reports/mrna-synthesis-and-manufacturing-market.html or email sales@rootsanalysis.com You may also be interested in the following titles: 1. Smart Labels Market: Industry Trends and Global Forecasts, 2022-2035 2. AI-based Digital Pathology / AI Pathology Market: Industry Trends and Global Forecasts, 2022-2035 About Roots Analysis Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. Contact: Ben Johnson +1 (415) 800 3415 Ben.johnson@rootsanalysis.com