Traditionally, the contract development and manufacturing organization (CDMO) market was for pharmaceutical services, including drug compound development and manufacturing. Over time, many pharmaceutical companies expanded into offering services for biopharmaceuticals and biologics as well, and a companies went as far as to specialize in cell therapy CDMO services.
According to the U.S. FDA, biologics are defined as “any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of diseases or injuries of humans.” Biologics include vaccines, blood and blood products, and human cells and tissues used for transplantation, as well as gene and cell therapies.
Most biopharmaceuticals are classed and regulated by the FDA as biologics. However, due to similarity to products historically regulated as drugs, some simple biopharmaceuticals are still regulated as drugs, for example, insulin and human growth hormone.
Importantly, companies offering CMDO services for pharmaceuticals and biologics are not cell therapy CDMOs.
Nonetheless, there is a spectrum that exists such that CDMOs may gradually expand from one of these manufacturing areas into other related areas of manufacturing.
For example, KBI Biopharma, Inc. (KBI) started as a traditional pharmaceutical CDMO in 1996, then signed an agreement with Merck & Co., Inc. (known as Merck in the United States and Canada) to acquire Merck’s microbial process development and manufacturing operations in Boulder, Colorado, in May 2014. That expanded KBI’s manufacturing operations from pharmaceuticals to biologics. Next, KBI acquired the laboratory and manufacturing facilities of Opexa Therapeutics in February 2017 to expand into cell therapy manufacturing.
A similar path was followed by WuXi PharmaTech, which began as a Shanghai, China based pharmaceutical CDMO. Originally, AppTec Laboratory Services operated as an independent service provider for the biopharmaceutical and medical device industries, offering testing, contract research and development, and biologics cGMP manufacturing services.
By acquiring AppTec Laboratory Services in January 2008, WuXi PharmaTech then formed WuXi AppTec, instantly expanding its reach into U.S. based biopharmaceutical CDMO services. With the construction of specialized labs in Philadelphia, WuXi AppTec later expanded into specialized cell therapy CDMO services.
Although the cell therapy CDMO market does not include the pharmaceutical CDMO market and is closely related to the biologics CDMO market, it is a unique and distinguishable market segment. Clearly, expansion from pharmaceutical to biological to cell therapy CDMO services is a natural progression.