biologic development internally , meaning that they outsource more small molecule development . In addition , small molecule manufacture will become more sophisticated , using state-of-the-art biocatalysis and flow chemistry technologies , which must be part of a successful CDMO ’ s armoury . Barr agreed , saying that in the future , “ major CDMOs will have to straddle both large and small molecule ” to ensure success , while Besançon agreed that CDMOs ’ capabilities will increase . Consolidation and ‘ one-stop shops ’ would be more and more prevalent , with the knock-on effect of raising the barrier to entry into the small molecule CDMO space . As CDMOs start to buy up sites that Big Pharma is offloading and companies move ever closer to the holy grail of continuous manufacturing , CDMOs could begin to consolidate their influence in the small molecule market . This is a very visible shift as CDMOs buy up these sites .
Future impact of biologics
Surely , though , biologics will have an impact be on the CDMO market
– and , if so , how big will it be ? “ An increase in biologic drugs has the potential to offer more personalised medicines which can be better targeted to both the disease and the patient , potentially with fewer side effects and improved outcomes ,” Robinson said . This seems a tantalising prospect . However , these benefits come at a huge financial cost , which will minimise the impact that biologics have on the market , at least for the short term . Robinson added : “ It is worth noting that biologics only make up around 2 % of US prescription drug sales by volume but around 35 % of the total expenditure ”. The point is further emphasised by the fact that massively increased investment is not reflected in many more discoveries . As Van Nieuwenhove noted , small molecules made up 38 of the 48 NMEs developed last year . So , it seems that biologics production will alter , or perhaps tilt , the CDMO market rather than dominate it . Biologic treatments have the potential to cure a condition in one dose rather than prolonged , generic courses of treatment . This potential cannot be understated .
But neither can the huge associated costs or the regulatory hurdles that also persist . So , is biologics the end of small molecule ? No , but we already knew that . Does it have a part to play ? Yes , and that part will only increase . As Van Nieuwenhove said , ultimately the aim of a CDMO is not just to provide the best solution for the client but to “ guarantee the best supply for the patient as well ”. The continued rise of biologics will push small molecule treatments further , to the benefit of the market while also created solutions to medical problems that small molecule simply cannot . If businesses can maintain the balance across both areas , considering the patient as well as the customer then the future is a very exciting one for everyone associated with the pharmaceutical industry . •
Jack Shute
ASSOCIATE DIRECTOR & HEAD OF CM LIFE SCIENCE
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