PHARMA SPECIAL
even in manufacturing , but there is no sharing of the burden when it comes to the cost structure . How we respond to this challenge will shape the industry in the next few years .”
The industry has been talking about outsourcing more to CDMOs at the life-cycle management stage for both drug product ( DP ) and drug substance ( DS ). However , Yu said , probably fewer than ten companies worldwide offer every service from early development to DS . A huge amount of consolidation will be necessary to change this , although there some is logic in doing this at the end of patent life . As Spaene noted , large CDMOs like Siegfried are already looking at their partners ’ Scope III emissions .
“ They would have to be pretty comfortable with their partner if they outsource their final stages because the next person touching the product is the consumer ” Keay said . “ Any mistakes would damage their brand , so it ’ s a big step to take .”
Spread the risk
“ There will be scant few one-stop shops and it would not necessarily be beneficial to the value chain if there were ,” added Hedrick . Spreading the cost structure of development over multiple companies so that they all focus on what they are best at is the best way , in his view . “ If you have everything under one umbrella , it is very difficult to maintain any kind of cost structure .”
In addition , said Yu , those few who can theoretically do everything from CRO to DP , even competing with innovator pharma companies , outsource some aspects where they lack expertise . However good the idea sounds in theory “ it is not efficient to have everything in one shop , no matter how good you are ”.
“ The other point is risk management ,” added Kaus . “ At the end of the day , would a pharma company want to go with just one CDMO ?” As to the alternative Spaene mooted of using a handful of fully back-integrated suppliers , he joked : “ Then you ’ re back to Pfizer ”.
Dyke – Advanced materials another growing market
Dr David Molyneux , VP of business development at Sterling Pharma Solutions , said that the way large pharma companies are structured also makes working with a single CDMO difficult . “ They ’ ve got their DP guys and their DS guys , and these are further sub-divided into pre-clinical , clinical and commercial . To get everything in one place requires buy-in from six to eight discrete , independent teams .”
This is , of course different in biotechs where typically one person will look after the whole value chain . They can get more value out of having one company manage it from beginning to end . It would clearly be an advantage , for instance , to make the four parts of the antibody-drug conjugate ( ADC ) all in one place . “ It ’ s about balancing these things in the future ,” he said . Who knows which way it ’ s going to go but it ’ s an interesting time .”
There have , of course , been repeated forecasts of consolidation in this sector for nearly 30 years . Why , if at all , would it be different this time ? Keay replied that it may not alter that much , despite an ageing world population needing more and more drugs of all sorts . Cost will remain paramount and the name of the game will still be “ to find something you ’ re good at , where you ’ re differentiating and which helps you maintain the value into just this one project ”.
Hedrick – Big Pharma making moves into AI
Is dual sourcing the answer ?
The unwillingness of pharma companies to change a registered process has certainly impeded a transition from batch to continuous manufacture and the use of flow chemistry , even where the latter is a measurably better option . This is also a roadblock to greater sustainability .
However , Spaene said , ever more small new molecules are in development – about 17,000 are currently in Phases I-III - and there was much talk during COVID of moving towards more dual sourcing from Phase II onwards , with one supplier in the innovator ’ s home region and another in Asia . This has not materialised yet but is it a likely trend for the future to avoid re-registration ?
Yu said that she had not seen any such indication . At the end of the day , innovators want to get their product to launch as fast as possible . Only then will they look at different chemistry . Saving a short amount of time in the clinic can be a big money earner . “ I think dual sourcing will be a trend for the long term ,” added Elizabeth Becker , pharma product manager at Actylis . “ Qualifying a new supplier takes a long time .”
Dr Alan Dyke , global VP of business development at ProChem , said that the only thing slowing down greater
20 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981