At an industry level, the demand for sterile injectable manufacturing capability is evident and industry publications regularly publish indicators of growth in the market. There are many factors driving this including increasing trends for development of oncology therapies and the increasing relative number of large molecule drugs in development which consequently require an injectable route of administration. Additional data generated by absolute bioavailability studies to support regulatory submissions where a proven relationship exists between the pharmacodynamics and the pharmacokinetics at therapeutic dose further drive this.
Market growth and increasing demand has resulted in some high profile activity in recent months. The acquisition of the Aptuit fill/finish facility in Glasgow by AMRI although interesting, is unlikely to significantly affect the UK or European market given neither the number of drug development companies or the number of manufacturing facilities providing sterile injectable manufacturing services will actually change as a result of that acquisition.
There is no doubt this deal is evidence of further consolidation in the aseptic manufacturingspace following the acquisition of OsoBio by AMRI last year, however the wider market still remains relatively fragmented.
Moving forward, I expect to see other large contract development and manufacturing organisations (CDMOs) prompt further deals of this type as the competitive landscape continues to change, but again, I’m not convinced the market will significantly change other than clients potentially having fewer options – crystallised as the choice between large one-stop CDMOs or specialist sterile service providers like Symbiosis.
The competitive landscape includes specialist contract manufacturing organisation (CMO) players such as ourselves here at Symbiosis who have an operational flexibility to move our clients through the clinical development stages more quickly than the larger, more cumbersome, CMOs/CDMOs.
Interestingly, given the recent corporate activity by the larger CMO/CDMOs, it appears that the “all-under-one-roof drug development capability organisational model” similar to the one which the big pharma companies had in-house a generation ago and prior to the advent of the more efficient modern drug development outsourcing model we know now – is in danger of being resurrected.
Having said that, as the market continues to develop, I would argue it’s not just about organisational size but more about the level of service excellence you can deliver to your customers that may translate into how quickly you can offer them access to your services, or the ability to demonstrate absolute regulatory compliance to the highest standards. Size really doesn’t matter in this sense.
For the smaller providers of sterile fill/finish services, the key to growth will be to retain a clear focus on what they are good at and delivering exactly what their customers need.
The requirements of any drug development project change and so the freedom to choose from a number of smaller drug development service providers with true expertise in their field may be the most time-efficient and cost-effective way of not only successfully achieving drug development milestones but of generating value for stakeholders. This will continue to drive the growth of specialist, smaller players in the market and ensure healthy competition.
So yes, the sterile manufacturing market is certainly changing and will continue to do so, but as ever, customers are faced with the choice of engaging a one-stop-shop service provider or electing to go with a smaller, more specialist, flexible and time-conscious partner like Symbiosis. Ultimately for clients, it’s about getting to clinical trials in the safest and quickest route they possibly can and Symbiosis has positioned itself perfectly to assist its clients in achieving exactly that.