Liquid Biopsy For Cancer Diagnostics Pipeline Insight

DelveInsight’s, “Liquid Biopsy for Cancer Diagnostics – Competitive Landscape and Pipeline Analysis, 2021,” report provides an understanding of the current competition, pipeline products, and changing market dynamics of the Liquid Biopsy for Cancer Diagnostics market in the 7 major pharmaceutical markets. The report also gives a brief competitive analysis of both the current and emerging products, to help understand the competition in the market.

Liquid Biopsy for Cancer Diagnostics Understanding

Liquid Biopsy: Overview

Liquid biopsy is a revolutionary technique that consists of the detection and isolation of circulating tumor cells (CTCs), circulating tumor DNA (ctDNA) and exosomes, as a source of genomic and proteomic information in patients with cancer. The major advantages of liquid biopsy in cancer diagnosis is that the technique is minimally-invasive, painless, does not have risk of complications, and gives faster results as compared to tumor biopsies. Some disadvantages and limitations of liquid biopsy include its lower accuracy and sensitivity as compared to tumor biopsies, and a lack of standardized protocols for isolation of components from the blood for mutation analysis.

Why use Liquid Biopsy instead of Tissue Biopsy?

  • Minimal invasiveness
  • No pain
  • No risk of complications
  • More compatibility with Longitudinal monitoring

Key Players

  • Guardant Health
  • Roche
  • Neo Genomics
  • Qiagen
  • ArcherDX
  • Bio-Techne
  • Resolution Bioscience
  • Personal Genome Diagnostics
  • Helio Health
  • Lucence Diagnostics
  • Foundation Medicine Inc
  • Biocept
  • Sysmex Ionostics Inc
  • Veridex LLC (Janssen Diagnostics)
  • Biodesix
  • Pathway Genomics
  • Exact Sciences
  • Angle Plc
  • GRAIL Inc.
  • NuProbe
  • OncoCell MDx Inc
  • Merck
  • AmoyDx

Liquid Biopsy: Competitive Assessment

This segment of the report provides a brief competitive analysis of both the current and emerging products, to help understand the competition in the market It has been segregated based on following parameters that define the scope of the report, such as:


DelveInsight’s report covers around approx. 20 major products segregated under marketed and emerging

  • Marketed
  • Emerging
  • Analysis by Number of Industry Collaborations


DelveInsight’s Liquid Biopsy for cancer diagnostics report provides a complete analysis of all the major collaborations done by the key players for the development of the liquid biopsy test devices

  • Snapshot of some key collaborations in the liquid Biopsy Market
  • Guardant360 Cdx Assay (Guardant Health): 3 collaborations
  • ArcherMET (ArcherDx): 2 collaborations
  • Invisionfirst (Inviata): 1 collaboration

Further collaboration details are provided in the report…….


 Products have been categorized under various turnaround time such as:

  • Less than 2 days
  • Less than 10 days
  • Less than 5 days
  • More than 10 days
  • Analysis by Indication


Products have been categorized under different indications under the Cancer therapeutics such as:

  • NSCLC
  • Breast Cancer
  • Prostate Cancer
  • All Solid Tumors
  • Liver Cancer
  • Blood Cancer
  • NTRK fusion Cancer
  • Hepatocellular Carcinoma
  • Head and Neck Cancer
  • Many types of Cancer
  • Analysis by Biomarker Type


Products have been classified according to the different biomarker types used in the detection of cancer through liquid Biopsy technique:

  • CtDNA and cfDNA
  • Exosomes in Urine
  • Methylated ctDNA
  • CTCs and ctDNA
  • CTCs

Major Players in Liquid Biopsy Market

There are approx. 20+ key companies which are developing the products for liquid biopsy products.


  • Liquid Biopsy Cancer Test: GRAIL Inc.

Grail is developing multi-cancer early detection liquid biopsy test or blood test which can detect up to 50 types of cancer and is committed to is committed to develop a deep understanding of cancer biology. GRAIL is poised to detect cancer early by combining high-intensity sequencing of unprecedented breadth and depth with the techniques of modern data science. GRAIL is creating vast datasets to develop evidence supporting their products.


  • Parsortix: Angle Plc

ANGLE’s Parsortix system has the potential to deliver profound improvements in clinical and health economic outcomes in the treatment and diagnosis of various forms of cancer.


Parsortix is different from many of its rivals as, rather than testing for fragments of dead cancer cells, it detects and captures circulating tumour cells (CTCs). CTCs provide the tell-tale signs of cancer and their capture can allow doctors to more accurately assess treatment options. This method is seen as more reliable because other tests have shown that fragments of dead cancer cells are present in around a quarter of people over 65 who do not have cancer. CTCs, on the other hand, give a complete picture because they can only be found in people with cancer.


  • DNA methylation based liquid biopsy test: Exact Sciences

Exact’s DNA methylation based liquid biopsy test detects 80% of hepatocellular carcinoma (HCC) cases across all stages and 71% of early stage cases. It has shown better performance than the most commonly used marker for HCC, serum alpha-fetoprotein (AFP).


  • Liquid Biopsy for Cancer Diagnostics: Commercialization Activity

This segment of the report provides a detailed list of any commercial activity in the field of liquid biopsy products ranging from collaboration, mergers and acquisition, recent breakthrough among others.

Development Activities

  • In November 2020, Grail has announced a commercial partnership with the UK's National Health Service to make its early cancer liquid biopsy test available starting in 2021
  • In June 22nd 2020, NuProbe and Weigao Group had announced a strategic collaboration to use NuProbe's proprietary blocker displacement amplification (BDA) technology to develop a liquid biopsy next-generation sequencing panel for non-small cell lung cancer for the Chinese market.

Further commercial activities are provided in the report……..

Liquid Biopsy for Cancer Diagnostics: Regulatory Pathway

Liquid Biopsy: Regulatory Overview

The regulatory pathway for diagnostic is an alternative NDA process for approving a new diagnostic device. This segment provides an overview of how the regulatory bodies such as the FDA the diagnostics products, by classifying them into different classes which are Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness.

Report Highlights

  • The report covers Introduction of liquid biopsy for cancer diagnostics, including its applications, advantages, disadvantages and limitations, and technological considerations
  • The report provides detailed product profiles for marketed products as well as pipeline products consisting of product description, regulatory milestones, research and development activities, along with product development activities
  • The report gives a brief competitive analysis of both the current and emerging products, to help understand the competition in the market
  • The report also reviews the driving and restraining factors for Liquid Biopsy for Cancer Diagnostics market in 7 MM
  • The report helps in developing business strategies by understanding trends shaping and driving the global Liquid Biopsy for Cancer Diagnostics market

Liquid Biopsy Report Insights

  • Liquid Biopsy in Cancer Diagnostic Overview
  • Regulatory Overview
  • Competitive Assessment
  • Key Driver and Barriers
  • Key strategic developments

Liquid Biopsy Report Assessment

  • Marketed Product profiles
  • Pipeline Product Profiles
  • Industry Collaborations assessment
  • Turnaround Time assessment
  • Oncology Indication Assessment
  • Biomarker Type Assessment

Key Questions

  • How many companies are developing Liquid Biopsy Diagnostic devices?
  • How many Liquid Biopsy Diagnostic devices are developed by each company?
  • How many emerging liquid biopsy devices are there?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the liquid Biopsy in Cancer diagnostics market?
  • What are the other key developments and happenings going on for the liquid Biopsy in Cancer diagnostic market domain and their status?
  • What are the key designations that have been granted to the emerging diagnostic devices?

 

1 Key Insights

2 Executive Summary of Liquid Biopsy for Cancer Diagnostics

3 Liquid Biopsy for Cancer Diagnostics: Background and Overview

3.1 Introduction

3.2 Tumor Circulome

3.2.1 Circulating Tumor-Derived Proteins

3.2.2 Circulating Tumor DNA

3.2.3 Circulating Tumor Cells

3.2.4 Circulating Tumor RNA

3.2.5 Extracellular Vesicles

3.2.6 Tumor-Educated Platelets

3.3 Applications of Liquid Biopsy in Cancer Diagnosis

3.3.1 Screening and early diagnosis

3.3.2 Treatment selection and prognosis

3.3.3 Residual disease and risk of relapse

3.4 Advantages of Liquid Biopsy over conventional Tissue Biopsies

3.5 Disadvantages of Liquid Biopsy over conventional Tissue Biopsies

3.6 Limitation of Liquid Biopsy Components and its Solutions

3.7 Technological Considerations

3.8 Liquid Biopsies of Biological Specimens other than Blood

3.9 Regulatory Pathways for Diagnostics

3.10 Reimbursement Scenario

4 Marketed Product Profiles

4.1Guardant360 CDx Assay: Guardant Health

4.1.1 Product Description

4.1.2 Regulatory Milestones

4.1.3 Research and Development

4.1.4 Product Development and Commercialization Activities

4.2 Cobas EGFR Mutation Test v2: Roche

4.2.1 Product Description

4.2.2 Regulatory Milestones

4.2.3 Research and Development

4.3 InVisionFirst: Neo Genomics

4.3.1 Product Description

4.3.2 Research and Development

4.3.3 Product Development and Commercialization Activities

4.4 Therascreen PIK3CA test: Qiagen

4.4.1 Product Description

4.4.2 Regulatory Milestones

4.4.3 Research and Development

4.4.4 Product Development Activities

4.5 Archer MET Companion Diagnostic: ArcherDX

4.5.1 Product Description

4.5.2 Regulatory Milestones

4.5.3 Research and Development

4.5.4 Product Development Activities

4.6 ExoDx Prostate Test: Bio-Techne

4.6.1 Product Description

4.6.2 Regulatory Milestones

4.6.3 Research and Development

4.6.4 Product Development Activities

4.7 Resolution ctDx Lung Assay: Resolution Bioscience

4.7.1 Product Description

4.7.2 Regulatory Milestones

4.7.3 Research and Development

4.7.4 Product Development Activities

4.8 PlasmaSELECT 64: Personal Genome Diagnostics

4.8.1 Product Description

4.8.2 Regulatory Milestones

4.8.3 Product Development Activities

4.9 IvyGene DX Liver Cancer Test: Helio Health

4.9.1 Product Description

4.9.2 Regulatory Milestones

4.9.3 Research and Development

4.10 LiquidHALLMARK Test: Lucence Diagnostics

4.10.1 Product Description

4.10.2 Regulatory Milestones

4.10.3 Research and Development

4.10.4 Product Development Activities

4.11 FoundationOne Liquid: Foundation Medicine Inc.

4.11.1 Product Description

4.11.2 Regulatory Milestones

4.11.3 Research and Development

4.11.4 Product Development Activities

4.12 Target Selector pan-TRK assay: Biocept

4.12.1 Product Description

4.12.2 Regulatory Milestones

4.12.3 Product Development Activities

4.13 OncoBEAM Liquid Biopsy Test: Sysmex Ionostics Inc.

4.13.1 Product Description

4.13.2 Regulatory Milestones

4.13.3 Research and Development

4.13.4 Product Development Activities

4.14 CellSearch CTC Test: Veridex LLC (Janssen Diagnostics)

4.14.1 Product Description

4.14.2 Regulatory Milestones

4.14.3 Research and Development

4.14.4 Product Development Activities

4.15 GeneStrat Liquid Biopsy Lung Cancer Test: Biodesix

4.15.1 Product Description

4.15.2 Regulatory Milestones

4.15.3 Research and Development

4.15.4 Product Development Activities

5 Pipeline Products Profiles

5.1 CancerIntercept Detect: Pathway Genomics

5.1.1 Product Description

5.1.2 Research and Development

5.2 DNA methylation based liquid biopsy test: Exact Sciences

5.2.1 Product Description

5.2.2 Regulatory Milestones

5.2.3 Research and Development

5.3 Parsortix: Angle Plc

5.3.1 Product Description

5.3.2 Regulatory Milestones

5.3.3 Research and Development

5.4 Liquid Biopsy Cancer Test: GRAIL Inc.

5.4.1 Product Description

5.4.2 Research and Development

5.4.3 Product Development Activities

6 .Other Developments in Liquid Biopsy

6.1 Liquid biopsy next-generation sequencing panel: NuProbe

6.2 Liquid Biopsy Test for Prostate Cancer: OncoCell MDx Inc.

6.3 Liquid biopsy RAS biomarker test: Merck/AmoyDx

7 Competitive Analysis

7.1 Analysis by Market Status

7.2 Analysis by Number of Industry Collaborations

7.3 Anlaysis by Turnaround Time

7.4 Analysis by Indication

7.5 Analysis by Biomarker Type

8 .DelveInsight’s Analytical Perspective

    8.1 PEST Analysis

    8.2 PORTER’s Five Forces

    8.3 SWOT Analysis

8 Market Drivers

9 Market Barriers

10 Appendix

10.1 Bibliography

10.2 Report Methodology

11 DelveInsight Capabilities

12 Disclaimer

13 About DelveInsight

List of Table

Table 1 Advantages of Liquid Biopsy

Table 2 Disadvantages of Liquid Biopsy

Table 3 Limitation of Liquid Biopsy components and its solutions

Table 4 List of Marketed Products

Table 5 Clinical Trials Description: Guardant360 CDx assay

Table 6 List of Pipeline Products

List of Figures

Figure 1 Components of Tumor Circulome

Figure 2 Analysis by Market Status

Figure 3 Analysis by Number of Industry Collaborations

Figure 4 Analysis by Turnaround Time

Figure 5 Analysis by Indication

Figure 6 Market Drivers

Figure 7 Market Barriers

Figure 8 Analysis by Biomarker Type



• Guardant Health

• Roche

• Neo Genomics

• Qiagen

• ArcherDX

• Bio-Techne

• Resolution Bioscience

• Personal Genome Diagnostics

Helio Health

• Lucence Diagnostics

• Foundation Medicine Inc

• Biocept

• Sysmex Ionostics Inc

• Veridex LLC (Janssen Diagnostics)

• Biodesix

• Pathway Genomics

• Exact Sciences

• Angle Plc

• GRAIL Inc.

• NuProbe

• OncoCell MDx Inc

• Merck

• AmoyDx

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