For pharmaceutical companies, the path from product concept to commercialization has become more complicated, more expensive and more strategically important than ever. The old model was relatively straightforward: When a company wanted to bring a new product to market, it developed the product, filed the FDA applications, waited for approvals, and then either scaled it up at its own manufacturing site or transferred it to a CMO if it wanted to use contract manufacturing. 

Today the paradigm has shifted. Companies are balancing speed to market, regulatory risk, development investment, intellectual property strategy, supply reliability and dosage-form differentiation. Branded companies may not have the flexibility to wait several years and spend millions of dollars to commercialize a new product. A company with an approved drug product may need a new manufacturing partner, but the transfer may also present…