CPhI Worldwide, part of UBM Live’s Pharmaceutical Portfolio, has announced the findings of its Pharma Insights report on manufacturing. Overall the report indicates that the industry is aware of the need to continue to improve manufacturing practices, processes and efficiencies to dive down costs and improve profits and drug quality. However, the report warns that industry must more actively take the lead if we are to see these vital changes driven through- currently, the inertia of the existing model is impeding innovation and preventing wide spread adoption.
CPhI adds that most of the sector now states that they are utilising continuous process improvements to drive efficiency savings, but more could be done to revolutionise practices. CPhI findings show that 26 per cent are using ‘statistical process control’, 21 per cent using ‘process capability analysis’, 16 per cent QbD, 12 per cent ‘six sigma’ and 11 per cent using both ‘lean/kaizen’ and ‘PAT’. Furthermore, many are building for the future and making essential upgrades to existing equipment with 70 per cent actively investing in manufacturing.
In the medium to long term, we should see a cross-pollination of process improvements from generics (where costs savings can still be made) though CMOs and ultimately into big pharma’s patented products. The advantage here is that lower cost patented products would open huge new markets, whilst reducing the attractiveness of counterfeits.
For cost savings to be made, however, the report clearly states further improvements must come from the industry itself and not the regulator, as this will only increase costs.
Girish Malhotra, CPhI panel member and President EPCOT International said, “Not much will change in the current processes as the needed regulatory approval will come in the way of any improvement of existing processes. Success to exceed regulations will only come from process inception stage along with command of the process as they become commercial. ‘Process centricity’ has to overtake the current ‘regulation centricity’ if pharma wants to see cost reductions in new and existing processes.”
In terms of the industry’s economic strength, the findings show the sector is in good health with 59 per cent planning to increase headcount this year and only four per cent planning reductions. In outsourcing we continue to see increases with 41 per cent outsourcing more of their manufacturing. Going forward, if manufacturers want to improve product quality, they must find a supplier that aligns with their own GMP compliance expectation.
Additionally, nearly 50 per cent of the industry stated they introduced more than three products last year, with a further 41 per cent adding one to three products.
The biggest manufacturing goals are to ‘increase efficiencies’ and ‘safety’ and already 89 per cent are testing raw material sourced- with ‘compendial testing’ by far the most favoured method (81 per cent).
Chris Kilbee, Group Director, CPhI Pharma Portfolio said, “With the majority of the industry now committed to process improvements and increased product quality the next few years will hopefully see more new manufacturing methods coming to market, with tighter process controls these should ultimately reduce costs and increase profits for the industry.”
CPhI believes that if one major pharma company starts reaping the benefits of implementing process perfection from initial development to commercialisation others will follow. Drawing all these findings together the report concludes that the industry has made great strides and with new efficient techniques drugs should be more available globally at reduced cost, enabling developing countries increased access.
Kilbee added, “The desire to modernise processes across the industry is clearly there and taking a long-term view we can see that the way we conduct development work right through to commercialisation has the chance to revolutionise the business model. Patented products will be opened up to a wider number of the globe’s seven billion inhabitants, which is a real human goal, but also one that will see the industry become more sustainable and increase profits. I believe that with these commitments we see a situation where industry actively drives improvements and takes these new methods to the regulator- cost savings and improved quality should go hand in hand.”
EP News Bureau – Mumbai