Personalized medicine continues to transform the field of clinical oncology across the spectrum of patient care. Oncology biomarker testing is now used for applications including treatment selection, prognosis, and monitoring drug response / tumor progression. We forecast that the cancer biomarker testing market size will grow at ~11% p.a. from ~$2.7B in 2017 to ~$3.7B in 2020. The near-term growth is driven primarily by the global personalized medicine initiatives and evolving regulatory and reimbursement landscapes in the U.S. that are designed to make biomarker-based diagnostic tests more accessible to patients. While treatment selection is the most established application within oncology biomarker testing, advances in technology and increasing shift of focus to blood-based biopsies are expected to continue to drive developments in other areas of unmet needs such as screening and early detection of cancer.

The first edition of this report reviews the market size, segmentation, growth and trends of the oncology biomarker test manufacturer / provider (i.e., excluding instruments and service fees associated with labor and shipping) market. We assess the oncology biomarker testing market across 4 segments:

• Technology: Immunohistochemistry (IHC), ISH/FISH/CISH, PCR/qPCR/dPCR, Sanger sequencing/CE sequencing Flow cytometry, ELISA, NGS, and others***
• Indication: Breast cancer, Lung cancer, Prostate cancer, Colorectal cancer, Pan-cancer, and others
• Regulatory status: In vitro diagnostics (IVD), Lab developed tests (LDT)
• Geography: U.S., Europe, Japan, Asia/Pacific, and Rest of the world (RoW)

For each of these segments, we provide the market size and growth from 2017 to 2020, as well as commentary on key growth drivers and moderators.

Major factors driving future growth include:

• Increased adoption driven by guideline inclusions (e.g., NCCN, ACP, NICE) and growing evidence of clinical utility
• Increased number of diagnostic-enabled immuno-oncology drugs and targeted therapies
• Increased pharma spending on companion diagnostic test commercialization
• Evolving regulatory framework for NGS-based comprehensive tumor profiling tests
• Evolving Medicare coverage landscape broadening patient access to NGS-based tests
• Shift towards more expensive multiplex panels from low-cost, single-gene tests
• Increased adoption of liquid-biopsy assays to track and monitor drug response
• Growing role of personalized medicine outside the U.S., particularly in Japan and China