This “Liquid Biopsy for Cancer Diagnostics - Competitive Landscape and Pipeline Analysis, 2022,” 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: 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?
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
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.
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
- Guardant Health
- Roche
- Neo Genomics
- Qiagen
- ArcherDX
- Bio-Techne
- Resolution Bioscience
- Personal Genome Diagnostics
- Laboratory for Advanced Medicine (LAM)
- 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:
- Analysis by Market Status
- Marketed
- Emerging
- Analysis by Number of Industry Collaborations
- 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
- Analysis by Turnaround Time
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
- Liquid Biopsy Cancer Test: GRAIL Inc.
- Parsortix: Angle Plc
- DNA methylation based liquid biopsy test: Exact Sciences
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.
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 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?
Table of Contents
1 Key Insights2 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
4.1 Guardant360 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: Laboratory for Advanced Medicine (LAM)
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 . 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 Publisher Capabilities
12 Disclaimer
13 About the PublisherList of Tables
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 ProductsList 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
Figure 7
Figure 8 Analysis by Biomarker Type
Market Drivers
Market Barriers
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Guardant Health
- Roche
- Neo Genomics
- Qiagen
- ArcherDX
- Bio-Techne
- Resolution Bioscience
- Personal Genome Diagnostics
- Laboratory for Advanced Medicine (LAM)
- 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
