PHARMACEUTICALS
New technologies in the custom development & manufacturing industry
Matthew J . Jones and Peter Poechlauer of Thermo Fisher Scientific look at some of the key challenges CDMOs must address , notably continuous processing and crystallisation *
Changes in the way new APIs are identified have led to changes in the way they are developed into medications reaching patients as marketed drugs . Most notably , the annual number of new drugs launched is increasing , while the development time from concept to launch , the product volume and the market volume per drug are all decreasing . New technologies are needed that can work under these boundary conditions . To define which technologies are useful in this context we will first discuss technical and commercial factors affecting today ’ s drug development .
An increasing proportion of new therapeutic concepts has been discovered by small companies .
Who develops new drugs ?
The high attrition rate of pharmaceutical development projects and a steep increase in development costs have caused large pharmaceutical houses to change their strategies . Instead of doing in-house basic research on new therapeutic concepts , they acquire projects with potentially successful new therapeutic concepts that have been discovered by small companies once they have reached a certain degree of maturity . Thus , the proportion of NCEs developed by small innovators rose from 31 % in 2009 to 64 % in 2018 . 1 In 2020 , ten of the 35 new small
16 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981