The market for biologics and biosimilars is expected to grow significantly throughout this decade. Given this growth, it becomes essential that contract research labs are able to predict trends and add capabilities and capacity, and that development firms are able to effectively tap into those capabilities.
Examining predictions of how this market may grow was a March 2014 article in Drug Development & Delivery magazine, Analytical Testing of Biologics and Biosimilars, featuring contributions from key thought leaders in the contract analytical research field including PBL's VP of Analytical Testing, Erik Foehr.
Anyone working on the development of biosimilars can benefit from reading this article - especially those involved in outsourcing. Some key points:
"U.S. demand for biologics is expected to grow 6.5% per year to $102 billion in 2015, up from $74.3 billion in 2011, according to Freedonia Group."
"...the most commonly outsourced activity is analytical testing because of the need for highly specialized staff and equipment required to perform assays as well as regulatory agencies wanting more characterization and other data about products. On average, facilities outsource 32% of their analytical testing/bioassays..."
Dr. Foehr: "Start-ups may not have had the opportunity to learn from mistakes or successes of other innovators - contract labs share in the experience of a multitude of clients. Therefore, the experienced contract labs can be a tremendous resource to the pharmaceutical industry. As Big Pharma sheds R&D resources and virtual start-ups become the norm, in-house analytical experience and technical capabilities dry up. One of the last pools of experienced, well-resourced chemists is now found in the contract lab sector."
Pacific BioLabs is a contract research organization providing in vivo testing, as well as bioanalytical laboratory services.