Oncology Liquid Biopsy (LBx) Market Report 2024 - 2029

Liquid biopsies (LBx), which, to-date, have been used largely for genomic profiling and therapy selection, are finding new applications throughout the patient journey and within pharma research.  Less invasive and faster to process than tissue samples, liquid biopsies provide both clinicians and researchers with an effective tool for biomarker testing, especially serially.  Liquid biopsies can also be used to detect the earliest signs of cancer, providing an alternative to existing screening methods, or a new option for many cancers without any screening protocols at all.  The increasing clinical validation of liquid biopsies, emerging applications, and technological improvements are expected to drive significant growth of the LBx market in the near-midterm.  Even so, the markets for early cancer detection and MRD / monitoring will still be immature by the end of the forecast window for this report, with significant growth in the decades ahead.

This third-edition of DeciBio’s liquid biopsy report takes an updated look at the LBx landscape, accounting for technological, clinical, and commercial developments since the last report was published in 2022.  Informed by a combination of primary research (38 interviews with oncology and pharma stakeholders; EDx survey with >200 primary care physicians), secondary research, proprietary DeciBio databases and tools, and years of consulting experience in the precision medicine market, this report provides a quantitative and qualitative assessment of the key LBx clinical markets (e.g., early cancer detection, therapy selection, and MRD /monitoring) and the LBx pharma clinical trial and translational research market.  Qualitatively, we assess key market players, assays, and technologies, as well as the market drivers, moderators, and trends.  We also provide quotes from our interview campaign to illustrate a diversity of perspectives.  Quantitatively, we provide a 5-year (2024 –2029) market forecast segmented by application (early cancer detection, therapy selection, MRD, monitoring / surveillance, pharma research), geography (U.S., Europe, APAC, ROW), tumor type (lung cancer, breast cancer, colorectal cancer, others), business model (kits vs. services), and, at a high-level, competitor.

The LBx market is evolving rapidly, and there is much development and strategy that happens outside of the public domain.  The assessments and projections made in this report are based only off information that is available in the public domain through Jun. 2024, as well as gathered from primary market research.

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Table of Contents

• Introduction & Methodology
• Executive Summary
• Therapy Selection
• MRD / Monitoring
• Early Cancer Detection
• Biopharma Trials & Research
• Company Profiles
• Primary Vendor Feedback (Available as part of the Global license only)
• Appendix

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3^rd Edition: This version of the LBx report has been updated to account for recent developments and the expanding applications and complexity of the LBx space.

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Updated Content

• Incorporated the latest trends in the LBx market, based on interviews (N = 38) with experts, a clinical EDx-focused survey (N = 207) and extensive secondary research
• Assessed new / current offerings and expected future portfolio developments
• Provided verbatim quotes from primary research to illustrate a variety of viewpoints and experiences
• Updated our database of LBx companies and their offerings, evaluated the latest performance data from key players
• Updated market sizing, segmentation, and forecast based on primary research findings and publicly-available financials
• Evaluated emerging, high-growth applications in depth, elucidating both quantitative and qualitative market divers, moderators, and trends: (Minimal residual disease / monitoring, Early cancer detection)
• Updated and added new deep-dive profiles of select key competitors
• Included primary vendor feedback on perceived strengths and weaknesses, as well as stakeholder familiarity and satisfaction scores as part of the Global Report License

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Updated Market Numbers

• Updated four market models to estimate the different segments of the LBxmarket; triangulated the market estimates against publicly available data(e.g., from SEC filings)
• Informed model assumptions with primary and secondary research, as well as DeciBio domain expertise
• Assessed market sizes for each of the market segments analyzed, including:
  • Customer type (clinical, pharma)
  • Indication
  • Application
  • Competitor
  • Geography
• Projected revenues for each market segment from current year (2024) through 2029

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Report Scope

Technologies and Revenues Included:

• Liquid biopsies, in which a bodily fluid, primarily blood, is taken to detect molecular biomarkers
• Any soluble analyte (e.g., cfDNA, cfRNA, CTCs, exosomes, methylation)
• LBx testing done in routine clinical care and as part of biopharma trials and translational research
• Oncology-focused applications including cancer early detection (EDx), therapy (Tx) selection, and minimum residual disease (MRD) / monitoring
• Kits / reagents (e.g., off the shelf assays and LBx library prep) used in the testing of blood-based oncology biomarkers; the revenue captured is there venue to the kit manufacturer
• Send-out services in which a sample is sent to a centralized testing location; the revenue captured is the revenue to the service provider

Technologies and Revenues Excluded:

• Germline testing, prognostic testing, or any other kind of testing performed on analytes extracted from peripheral blood cells
• Academic trials and research (i.e., non-industry sponsored)
• Applications outside of solid tumor oncology such as organ transplant, reproductive health, prenatal screening, routine bloodwork
• Sequencing reagents used to perform the assay
• Instruments and platforms used to run / analyze LBx samples (e.g., NGS, PCR machines)
• Software or bioinformatics support used in the analysis of LBx assays
• CDx licensing and development deals revenue, even if the licensing / deal involved LBx

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Early Cancer Detection Survey Scope

The focus of this survey was to characterize the current clinical use (or lack thereof) of blood-based early cancer detection (EDx)tests. Respondents were asked about use of EDx tests within routine clinical practice within the past 12 months, as well as expectations for potential future use over the next 12 months

The survey was distributed randomly to PCPs and specialists. Respondents were not screened or eliminated from the survey based on whether they have used blood-based EDx testing.

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Survey participants were asked about:

• Preferred use cases of EDx tests and testing approaches (e.g., single-cancer vs. multi-cancer testing)
• Test volumes across cancer types, different use cases, and patient populations
• Ordering patterns across vendors, satisfaction with different test characteristics, and drivers of assay selectionest coverage / reimbursement patterns
• Patient vs. clinician role in testing decisions
• Minimum test performance requirements for expanded adoption across different patient populations and cancer types
• Estimated out-of-pocket price limits for broader adoption
• Projected timeframe for when clinicians expect to order LBx tests for the majority of eligible patients

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Liquid Biopsy Discovery Portal

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DeciBio’s Liquid Biopsy Discovery Portal is an easy-to-navigate dashboard, offering real-time data and analysis of liquid biopsy publications and conference abstracts.

The Liquid Biopsy Discovery Portal curates all liquid biopsy related publications and major conference abstracts from 2023 - July 2024 (e.g., ASCO, AACR, EMSO),which can be filtered and analyzed by:

• Liquid biopsy application (therapy selection, MRD, monitoring, early cancer detection)
• Cancer type
• Analyte assessed
• Author / company affiliations
• Clinical trial phase

Key Features

• AI Chat Pro: The dashboard is AI-powered, offering content curation and a lightning-fast chat bot for quick and easy answers.
• Partnerships: The Discovery Portal allows fast identification of authors’ affiliations, facilitating the identification of potential partners
• KOL / Expert Identification: Facilitate and streamline the KOL and expert identification process for advisor or C-suite searches
• Product & Competitor Tracking: Gain insight into how products are being used across different applications and how use changes over time

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