Abstract

The first FDA-approved liquid biopsy assay, Roche’s Cobas EGFR v600 assay, launched in 2016. Since then, significant investment in liquid biopsy companies has led to rapid growth within the diagnostics market. The subsequent proliferation of liquid biopsy companies (>100 companies globally) has drawn both attention and skepticism over the future state of the market. To help predict the future state of the market, we have developed an evaluation framework to identify and assess areas of growth within the liquid biopsy market. Market segmentations include:

This market report also includes a “stakeholder toolkit” to help the following parties manage the challenges and realize the growth opportunities that exist within the liquid biopsy space:

• Entrepreneurs
• Investors
• Regulatory and reimbursement (payers)
• Biopharma partners

Select Liquid Biopsy Companies Profiled in Report

Major Trends

Drivers

• Improvement of high sensitivity technologies (e.g., dPCR, next-generation sequencing (NGS) to accurately detect circulating nucleic acids, tumor cells, and exosomes
• Demonstration of clinical utility in particular use cases (e.g., T790M resistance monitoring)
• Inclusion in NCCN guidelines for metastatic if repeat tissue biopsy is not feasible
• Improved reimbursement prospects given the final CMS NGS NCD and Guardant360’s LCD by Palmetto GBA

Moderators

• Variability in the level of circulating analytes by cancer type and stage
• Limited / low frequency events of circulating analytes
• Lack of large studies demonstrating clinical utility for certain use cases
• Limited or delayed reimbursement by commercial payers

Authors

Dr. Stephane Budel specializes in the market analysis of private to mid-cap companies with emerging to established technologies in the life science research tools and diagnostic spaces. He has deep genomics expertise, especially as it relates to clinical NGS. He has supported clients facing a broad range of challenging business issues, including R&D prioritization, evaluation of disruptive technologies, and commercial due diligences.

Jessica Lee has extensive knowledge of market segments including neuromodulation, in-vitro diagnostics and molecular diagnostics. She has co-authored numerous market reports including DeciBio’s liquid biopsy, oncology biomarkers and NGS reports. Jessica completed her Master’s of Bioscience with a focus in Clinical & Regulatory Affairs at the Keck Graduate Institute (KGI) where she was a recipient of the Allergan Foundation Scholarship.