In the fast-changing world of pharmaceuticals new molecular entities (NMEs) are more complex than ever before and are targeted at smaller patient groups. As a result, there is an increasing trend for more products but in smaller volumes. Meanwhile, compliance requirements are extending into the non-GMP key starting material (KSM) supply chain with impurity tracking and tracing now taking centre stage. The resulting cost increases and the capacity and technology misfit, however, offer an opportunity for the more nimble CMOs. Furthermore, novel collaborative partnering models and concepts will have to be considered to make the best of the situation for the pharmaceutical industry and the patient.
Pharma innovation is accelerating through classic pharma innovators as well as emerging virtual pharma innovators but with increased focus on unmet medical need and more narrowly defined therapeutic areas – truly ‘pinpointed’ patient solutions.
New blockbuster drugs will still occur, but a new lean burn engine of growth has emerged that demands better value to cater for both an explosion in demand and customer expectation. Innovation pipelines are once again growing but with more complex molecules and lower volume indications after launch compared with the previous period.
This is having a profound effect on the future supply chain for active pharmaceutical ingredients (APIs) and their registered starting materials.
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