Drug delivery trends in clinical trials and translational medicine: growth in biologic molecule development and impact on rheumatoid arthritis, Crohn's disease, and colitis.

There are 94,709 clinical trials across 179 countries. Approximately half (47,467) are related to the three categories within the scope of the free online resource "Drug Delivery Trends in Clinical Trials and Translational Medicine," which are (1) drug delivery technology and systems, (2) biological molecule platforms, and (3) pharmacokinetic and pharmacodynamic interactions. In this commentary, trends in biological molecule platforms and their impacts are discussed. The sales of top 15 biologic drugs have reached over $63 billion in 2010. In the past 10 years, major pharmaceutical companies have acquired biological molecule platforms and have become integrated biopharmaceutical companies, highlighting the role of biotechnology in driving new therapeutic product development. The top three products--Remicade, Enbrel, and Humira--indicated for arthritis and colitis and targeted to tumor necrosis factor-alpha (TNF-α), each generated over $6 billion in annual sales. In addition to TNF-α, biologic candidates targeted to other inflammatory molecules are in clinical development, partly driven by commercial interests and medical need. Although clinical experience indicates that all the anti-TNF-α molecular platforms are effective for rheumatoid arthritis, Crohn's disease, and colitis, whether the new agents can provide additional relief or cures remains to be seen.