CDMOs to benefit from BTDs, orphan drugs, fast track status
The arrival of patient-centric CDMO’s predicted by CPhI Annual Report
Frankfurt, 05th November 2019: CPhI Worldwide – the world’s largest pharma event taking place in Frankfurt (5th – 7th November 2019) – has released the fourth part of its eponymous 2019 annual Report. Experts Peter Soelkner, Managing Director, Vetter Pharma International GmbH, Stewart Needleman, Chief Commercial Officer, Piramal Pharma Solutions and Adam Bradbury, Industry Analyst, Pharmsource (a GlobalData product) discuss the future of patient centric CDMOs.
In his piece, Bradbury explores how the changing drugs pipeline and increasing diversity of innovators are creating opportunities for the CDMO sector. He asserts that the increase in drug approvals and priority reviews are likely to be beneficial to the CMO industry in the next few years, as manufacturing of these products is often outsourced.
According to Bradbury’s analysis, 23 NMEs were approved with Fast Track status in 2018. This was significantly more than in 2017. Of these products, 70% of them were outsourced, which represents a five-year increase average of 58%. Due to this, the rising number of priority review designations and small cap companies gaining FDA approvals can only be a positive sign for dose CMOs. Similarly, outsourcing percentages for CDMOs of Breakthrough Therapy Designation (BTD) has never been so high. Demand also remains for high potency APIs, of which around 60% are developed for oncology – and we continue to see rising demand for CDMOs with containment facilities.
In other new implications for the contract services sector, Vetter’s Peter Soelkner predicts that new drugs will have to be produced using a more patient-centric methodology. Soelkner emphasizes that the use of personalized medicines will mean increasingly individualized dosages and packaging. But he also forewarns that this will necessitate that contract providers and the industry adapt to help reduce the costs per patient.
Soelkner states that personalized medicines will require new logistics and manufacturing systems, as each therapy is tailored specifically to an individual’s own genetic profile. Looked at more broadly, nearly 400% of current FDA new drug approvals already involves injectables, and often for smaller patient cohorts. This will continue to present manufacturing challenges, as companies switch from systems designed for larger batches.
Stuart Needleman, Chief Commercial Officer, Piramal Pharma Solutions, explores how the patient-centric journey will operate through the pharmaceutical supply chain. He states that there will be a progressive trend across the pharmaceutical industry, with a shift towards lower volume targeted therapies. This has been driven by an increasing amount of research into more complex drugs and compounds.
Needleman argues that one approach (advocated by Piramal Pharma Solutions) is to deliver new ways of motivating the workers so that they have a real understanding of the importance of their work and the effect on real world patients.