mRNA: How To Build A Custom Program Using CDMO Services

By Dieter Kramer and Christoph Winterhalter, AGC Biologics

The global mRNA vaccine and therapeutic market is estimated to swell to $29.67 billion in 2025, driven not only by its applicability to COVID-19 vaccination and oncology therapies, but its promise in treating chronic and infectious diseases (e.g., diabetes and HIV). The market has developed differently from traditional therapeutics markets. Typically, a therapy spends a long time in the clinical phase, then is pushed to market. However, in response to the COVID-19 pandemic, Moderna and Pfizer-BioNTech developed vaccines that essentially created an mRNA market before the platform was broadly established.

Now, competition has exploded as numerous companies strive to develop new mRNA concepts and principles in hopes of replicating that success. This, in turn, has created demand for CMO/CDMO partners capable of producing the mRNA and helping these organizations progress through clinical studies based on their in-house expertise and entry points into the market, among other factors.

To take advantage of this opportunity, pharmaceutical and biopharma organizations are well-served by a CDMO partner that offers shared expertise and resources across a network of sites, as well as shared manufacturing capacity available immediately for production at various scales (serving different stages of the product lifecycle).