ABSTRACT
The use of outsourcing in clinical trial biomarker research and development has become increasingly common as pharmaceutical companies have become more and more virtual. This section describes the advantages and disadvantages of outsourcing biomarker work with respect to resources, access to novel technologies, expertise, quality, turnaround, and costs as well as discussing issues such as confidentiality and continuity of supply.
The Contract Research Organization (CRO) biomarker outsourcing market has witnessed significant growth in the past decade. In 2016, the global biomarker discovery outsourcing service market was estimated to be worth $2.7 billion, and the global biomarker market is expected to reach $45.5 billion by 2020. The growth in outsourced biomarker studies is primarily due to the increased use of biomarkers in clinical trials as well as a rise in the amount of outsourcing being carried out by pharmaceutical companies. The use of CROs in clinical trials was originally born out of resourcing and capacity issues experienced by pharmaceutical company’s internal departments; this relationship has since matured, with CROs effectively acting as an extension of the pharmaceutical company’s own laboratories.
