The pharmaceutical and biotech industry is under severe pressure.
Research & Development (R&D) costs are spiralling, development timelines are growing, payer pushback is increasing and consumers are becoming increasingly knowledgeable about care options.
The industry is responding by driving time out of development, becoming smarter with stopping projects early in the development cycle, and increasing efficiency through rationalisation or outsourcing of non-core activities.
As scientific advances enable the industry to move from a ‘one-size-fits-all’ approach to care to one of segmentation, personalisation and wellness, so the supply chain will need to evolve. The supply chain of the future will be built around flexibility, responsiveness and reliability shifting the supply paradigm from a stock-based model to an order-based model.
Its characteristics will include:
Since structural changes to the supply chain model will have tax implications, it is imperative that organisations carefully balance operational and financial efficiencies when designing supply chains.
Manufacturing operations continue to invest in new technologies targeting cost savings and flexibility, to address historically inefficient, low yield batch processes with inconsistent quality outcomes. The regulatory landscape covering the adoption of these new techniques is maturing, due to the International Conference on Harmonisation (ICH) initiative and more recently with the new FDA draft guidance on process validation.
The thorough evaluation of the appropriate innovative technologies, like process analytical technology (PAT) and real-time product release, continuous, disposable and miniaturised manufacturing and new process development methods like Quality by Design (QbD), in line with the future manufacturing vision, will be key as manufacturers prepare for the future.
Many pharmaceutical companies are considering transitioning non-core manufacturing from traditional strong-holds in Europe to the emerging markets (e.g. China and India). But such usage of external supply networks will require companies to employ new and more evolved tools of tech transfer and virtual supply chain management – from operations to finance to tax planning.
PwC’ offers a wide array of industry-focussed supply chain management services that address the challenges facing pharmaceutical and healthcare products companies, including: