The era of personalized medicine is already well established in oncology. Biomarker-driven targeted therapies are among the top-selling oncology products today, and the impact of molecular biomarker testing on the oncology therapy market remains strong. The influence of biomarker testing can be evaluated on multiple levels: the market share of leading targeted therapies, the R&D pipelines of top pharmaceutical companies, the NMEs approved by the FDA in 2013 for oncology that use biomarkers, and the oncology agents granted breakthrough therapy designation by the FDA in 2013 that have companion biomarkers.
The ability to identify appropriate patients for treatment based on molecular biomarkers created the flourishing targeted therapy oncology market. Numerous indications, including breast cancer, gastric cancer, colorectal cancer, non-small-cell lung cancer (NSCLC), malignant melanoma, and chronic myeloid leukemia, have all benefited from validated molecular biomarkers as a companion to the therapeutic agent. Emerging biomarkers and associated targeted therapies reaching the oncology market in the near term are expected to continue fueling the growth of this market segment. However, as additional biomarkers are added, their developers will have to differentiate them to ensure their acceptance and reimbursement. Other clinical challenges in biomarker development include the need for biomarker assays with a faster turnaround time, the ability to test only small amounts of tissue, and the ability to test for several biomarkers at once (i.e., a multiplex panel).