Job Description

Despite the growth of biologic drugs, medicines based on small molecules remain important in the treatment of all types of diseases. Small molecule injectable drugs are often necessary for the treatment of hospital patients. Production of sterile injectable projects is much more complex and challenging than oral dose manufacturing. A commitment to quality, robust processes and knowledge of the end user are essential for CDMOs providing these services.
Don't Count Out Small Molecules
These days small molecule drugs don't seem to receive the attention that biologics do. They are just as relevant today as they ever have been, however. In fact, they account for approximately two-thirds of drugs in the pharmaceutical industry pipeline.1
In addition, the majority of FDA new drug approvals have gone to small molecule
drugs in the past several years. Specifically, in 2015, 33 of the 45 new drugs approved by FDA were small molecules,2 while in 2016, 15 out of 22 newly approved products were based on chemical active pharmaceutical ingredients (APIs).3 Furthermore, as recently as 2014, small molecule drugs accounted for 84% of pharmaceutical industry revenues.4 Five of the top 10 drugs in terms of revenue, and nine out of the top 10 most-prescribed drugs, were based on small molecule APIs.5
It is also worth noting that the global market for small molecule APIs is expected to grow at an annual rate of approximately 7% from 2016 to 2027, reaching $279.7 billion.6
Small Molecule Injectables' Important Niche
Within the small molecule drug market, the vast majority of products are formulated for oral administration. Oral dosage forms are generally the easiest for patients to take and the least costly for manufacturers to produce. There is a real need, however, for parenteral formulations of small molecule drugs.