Liquid Biopsy Market Size, Growth and Trends (2018-2023)
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Author: Stephane Budel, Jessica Lee, Mika Wang
Date: January 2, 2019
Price: $5300
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:
Purpose of analysis for research or clinical use including:
• Early detection
• Diagnosis
• Therapy selection
• Surveillance monitoring
Substance being measured and analyzed using liquid biopsy including:
• Cell-free nucleic acid (cfDNA/cfRNA)
• Circulating tumor cells (CTCs)
• Exosomes
• Other
Method of investigation including:
• NGS
• PCR (qPCR, dPCR)
• Other (e.g., microarray, sanger, immunoassay)
• Kit
• Send-out service
• U.S.
• EU-5
• China
• Rest-of-the-world (ROW)
• Guardant Health
• Foundation Medicine (Roche Pharma)
• Thermo Fisher
• Qiagen
• Roche Diagnostics
• Others
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
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
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
Dr. Stephane BudelDr. 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 LeeJessica Lee has an 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.