Outsourcing vaccines, biologics and biosimilars remains an area of high activity within the industry. In fact, there are indications that the market for injectables has expanded to account for seven of the top ten marketed pharmaceuticals, as opposed to just one in the top ten a decade ago.1
The market lifespan for biologically derived drugs is longer than it is for small molecule drugs. Gaining regulatory approval for biosimilars is very complex, and the commercial impact of biosimilars on the original product is less than what is seen on blockbusters by small molecule generic competition.
Consequently, market prices for biosimilars remain high when compared with those of small molecule generics; but, both types of drug represent good business opportunities for contract manufacturing organisations (CMOs) and contract development and manufacturing organisations (CDMOs) that provide aseptic fill/finish solutions.