Pharma innovation is accelerating again and is now focusing increasingly on true unmet medical need and more narrowly defined therapeutic areas.
While new blockbusters are still likely, the majority of pharma executives I have met over the past year are confirming the new trend: Innovation pipelines are growing again but with more complex molecules and lower volume indications once launched, compared with the previous period’.
This will have a profound effect on the future supply chain for active pharmaceutical ingredients and their registered starting materials.
Rather than needing high volume, dedicated capacities for a product or class of products, more versatile, multipurpose, medium sized GMP and non-GMP plants will be required.
Rather than needing high volume, dedicated capacities for a product or class of products, more versatile, multipurpose, medium sized GMP and non-GMP plants will be required
This suggests a certain level of capacity ‘misfit’ with the prevailing industry assets and an increasing demand for medium scale multi-purpose plants to cope with this new supply chain complexity.
Furthermore, the development intensity and technical support required to scale-up and launch more complex molecules pose a new challenge as well; skill and the right scale will have to go hand-in-hand.
Ensuring compliance and change control in this web of increasing complexity will not only challenge the pharma innovators but also their current models of preferred suppliers.
The myriad smaller niche players, along with a fairly stable pool of large capacity CMOs, will have to rethink their behaviours and embrace more collaborative business models.
The myriad smaller niche players, along with a fairly stable pool of large capacity CMOs, will have to rethink their behaviours and embrace more collaborative business models
This refers specifically to the current competitive and highly over-rated ‘one-stop-shop’ offering, which does not balance well with the reality of well in excess of 2,500 APIs and counting, which are becoming increas-ingly complex.
Taking on the future challenge in the pharma supply chain will require companies to seek rational partnerships that complement both technical and production skill sets and manage at least a part of this complexity for a reducing number of global pharma majors.
Sai Life Sciences is completing its ‘plus 1’ skill and scale strategy to meet these future challenges and offers a collaborative long term mind-set that can add up to a solution for this new trend.
