mRNA has completely revolutionized the field of medicine and significantly influenced the study and treatment of human diseases. The success of COVID-19 vaccines paved the path for mRNA-based drug products. Safety, efficacy and rapid production of mRNA drives the interest in this domain. However, synthesis and manufacturing of mRNA is fraught with several challenges as the production of such biomolecules is complex, cost intensive, requires specialized expertise and dedicated equipment. Additionally scaling up the manufacturing of mRNA is associated with a number of challenges, such as lack of experience, knowledge in scaling up mRNA processes and regulatory uncertainties. 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 manufacturing service providers to cater to the urgent global demand.
Market Landscape of mRNA Custom Synthesis and Contract Manufacturing Service Providers
The mRNA synthesis and contract 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.
Market Landscape of mRNA Synthesis Kits
Presently more than 95 mRNA synthesis kits, that contain reagents for the synthesis of research grade mRNAs with yield range up to 50,000 µg, are currently available in the market.
Close to 70% of mRNA synthesis kits contain capping enzymes; of these, 96% use T7 RNA polymerase as a preferred enzyme mix for the synthesis of modified mRNAs
Several deals are Inked between Industry and Non-industry Stakeholders Reflecting Rising Interest in this field
In the past few years, a number of stakeholders engaged in this domain have partnered with various industry players / research institutes for the manufacturing of mRNA. The growing interest is evident from the rise in partnership activity; in fact, the maximum number of collaborations related to mRNA-based drug manufacturing were inked in 2020 and 2021.
Future Opportunities for mRNA Synthesis and Manufacturing Service Providers
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 contract manufacturing market is anticipated to witness a noteworthy growth in the foreseen future.
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 commercialised, we anticipate the mRNA synthesis and manufacturing services market to witness healthy growth.