Meeting the need for innovative small molecule APIs
Scott Mohler , director of business development at Aceto , discusses the CDMO ’ s role in meeting the growing demand for innovative APIs
In today ’ s world of pharmaceutical manufacturing , the demands for creating APIs have changed significantly in the past 10 to 15 years and continue to change . With the rise in precision medicine approaches , targeted therapies , biologics and RNA therapies , the challenges to effectively manufacture drugs have never been greater . Many of the headlines in drug development today are focused on biologics , a $ 285 billion market in 2020 that is expected to increase to more than $ 421 billion by 2025 , with a large portion of these new drug candidates targetting a range of indications in cancer . 1 Yet while these new classes of drugs hold great potential to alter the course not only of cancer but also of other genetically driven diseases , small molecule drug candidates continue to fill pharma companies ’ pipelines and still represent the bulk of drug approvals . This is unlikely to change any time soon . According to research from September 2021 published in Bioorganic & Medicinal Chemistry , of the 53 FDA approvals in 2020 , 40 were for small molecule drugs , indicating that the need for innovative small molecule API manufacturing is strong . 2
Demand keeps growing
In the past 20 years , the number of new molecular entities ( NMEs ) approved by the FDA each year has nearly doubled . In 2001-2 , the agency approved 30 NMEs and by 2020-21 that number was 76 , according to statistics compiled by Nature Reviews and published in January 2022.3 Approved NMEs are less than half of the story , however . Over the past ten years ( 2011-2020 ), the likelihood of approval for all development candidates entering Phase I clinical trials is 7.9 %, according to the 2021 report from Informa Pharma Intelligence , BIO and QLS Advisors . 4 Extrapolating the data for candidates that moved from Phase I to post-marketing approval , approximately 1,000 drug candidates entered clinical trials to yield the 76 approved during 2020 and 2021 , all of which would have required teams dedicated to research , development and manufacturing . While many of the top pharma companies run their own operations to develop and manufacture the APIs for their own approved drugs and drug candidates , they only account for roughly one-third of all New Drug Applications ( NDAs ). The trend , especially for clinical phases , continues to skew toward smaller
biopharmaceutical developers who lack the full internal teams and facilities to develop and manufacture their drug candidates . This has led to an increased demand for outsourced R & D and manufacturing with CDMOs , which has come as the CDMO industry has undergone consolidation over the last decade . Additionally , a variety of shipping disruptions , regulatory restrictions and geopolitical considerations have caused a shift to manufacturing closer to end markets , disrupting the pre-COVID global sourcing paradigm . Combined , these factors can limit the development and manufacturing capacity available to smaller biopharmaceutical companies . The result is that , with demand for the development of innovative APIs increasing and fewer qualified contracting options available , drug sponsors looking to outsource their API work need to carefully plan their supply chains and evaluate which CDMO partners to choose in order to maintain their aggressive timelines through development and commercialisation .
26 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981