Despite an economic downturn for many business sectors across the globe since 2020, the biotech industry persevered, not only significantly outperforming small molecule pharmaceuticals but also a wide range of consumer goods and technologies. The result was a record-breaking run of venture-capital funding, deals, and IPOs.1 And while many different products are emerging from the companies driving this growth, mammalian-based biopharmaceuticals have continually increased and are now the dominant, commercially marketed product type at approximately 65% as well as the largest product type for all phases of development.2 A recent report from CPhI outlining supply and demand trends indicates that, although the current installed capacity is able to meet the typical manufacturing demand for these products, several factors may affect accessibility, leading to a potential constraint that could prevent current and future drugs from reaching patients in need.2
Given the resources and risks associated with establishing in-house manufacturing capabilities, drug manufacturers have historically turned to CDMOs to supplement expertise and capacity. A market-sizing analysis by Frost & Sullivan found that clinical-stage and virtual biopharma companies lacking funding and advanced development and manufacturing expertise will continue to be key drivers for growth in the CDMO market, which is expected to reach a value of $20.31 billion by 2026 at a 10.1% CAGR.3 However, being able to accommodate the flow of customers looking for a qualified CDMO will require outsourcing partners to invest in innovative strategies that can provide commercial-ready solutions.
In this article, Bruce Frazier, Vice President of business development and sales at Bionova Scientific, a biologics CDMO focused on developing and manufacturing recombinant protein products via mammalian cell culture, discusses the decision behind his company’s business case for expansion and what factors to consider when selecting a CDMO in the midst of so many unknowns.