Market Report

Global Oncology Liquid Biopsy Manufacturing Market (2018-2023) and Stakeholder Toolkit

January 2, 2019

112 pages

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.

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

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

Precision Medicine is evolving at a rapid pace

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