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Liquid Biopsy with Emphasis on NIPT: Global Markets to 2023

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    Report

  • 359 Pages
  • April 2019
  • Region: Global
  • BCC Research
  • ID: 4769725
UP TO OFF until Aug 31st 2033

Report Scope:

The scope of the report includes liquid biopsy technologies, applications, industry sub-segments, biomarker technologies, major funding initiatives, NIPT methods, patents for both liquid biopsy and NIPT, and company profiles. The market sizes for liquid biopsy diagnostics with emphasis on NIPT are given for the years 2017, 2018 (estimated) and 2023 (forecasted).

This report reviews liquid biopsy biomarkers and technologies and provides background on why liquid biopsy is increasingly viewed as a replacement for, or a companion to, tissue biopsy. It then discusses several of the significant large-scale research initiatives that are contributing to liquid biopsy development. Market-driving forces are also discussed.

In addition to this, the report examines the markets by NIPT methods, high-risk and low-risk pregnancies and geography. The end-user segment of this market is based on disease area and healthcare setting. Disease areas include trisomy 21, 18 and 13 and Turner syndrome (a sex chromosome aneuploidy). Healthcare settings include diagnostic laboratories and hospitals. Market dynamics such as drivers and restraints for the NIPT market are also discussed.

The structure of several important industry subsectors was reviewed. The industry subsectors that are analyzed include next-generation sequencing (NGS) instruments, droplet digital PCR, target enrichment and amplification, single-cell DNA polymerase, prenatal screening, liquid biopsy, direct to consumer, and clinical laboratory.

The market for liquid biopsy diagnostics is analyzed by application (cancer, reproductive health, transplant), biomarker type (nucleic acids, cells, extracellular vesicles, proteins), analysis platform (microarray, NGS, PCR, proteomics and others), analysis purpose (screening/early detection, diagnosis, therapy guidance, monitoring) and geography (North America, Europe, Asia-Pacific, Rest of World). Similarly, the market size of non-cancer applications of liquid biopsy, NIPT, is analyzed based on risk-type, analysis purpose, biomarker class, analysis method, NIPT methods, high- and low-risk pregnancies, and geography.

Market data cover the years 2017, 2018 (estimated) and 2023 (forecasted).

More than 165 companies in the liquid biopsy industry are profiled in this report. Nearly 18 companies in the NIPT market have been profiled in detail.

This provides a summary of the main industry acquisitions and strategic alliances from January 2016 until December 2018, including key alliance trends.

Report Includes:


  • 45 data tables and 94 additional tables
  • An overview of liquid biopsy and non-invasive prenatal tests (NIPT) market
  • Analyses of global market trends with data from 2017, 2018 and projections of compound annual growth rates (CAGRs) through 2023
  • Country specific data and analysis for China, Japan, India, South Korea, UK, Germany, France, Italy, Spain and USA
  • Comparative study of liquid biopsy with conventional biopsy and coverage of their respective biomarkers
  • Snapshot of key liquid biopsy research and development programs
  • Information on NIPT available in market such as NIFTY, Verifi prenatal test, Harmony prenatal test, Panorama, MaterniT21 and IONA test
  • Description of chromosomal diseases where NIPT plays a vital role in detection and screening i.e. Down’s Syndrome, Edwards Syndrome (Trisomy 18), Patau syndrome (Trisomy 13) and Turner syndrome
  • Comprehensive company profiles of major players, including Agilent Technologies, Illumina, Natera, Oxford Nanopore, QIAGEN, and Thermo Fisher

Table of Contents

Chapter 1 Introduction
  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Scope of the Report
  • Information Sources
  • Methodology
  • Geographic Breakdown
  • Analyst's Credentials
  • Custom Research
  • Related Reports



Chapter 2 Summary and Highlights
Chapter 3 Market and Technology Background
  • Liquid Biopsy Overview
  • Liquid Biopsy versus Traditional Biopsy
  • Liquid Biopsy Biomarkers
  • Cancer Genomics
  • Noninvasive Prenatal Testing
  • Circulating Tumor Cell Technologies
  • CTC Workflow
  • Cell Isolation Technologies
  • CTC Sample Preparation Technologies
  • CTC Downstream Analysis Technologies
  • Comparison of Liquid Biopsy with Conventional Biopsy
  • Cancer Testing
  • Prenatal Testing
  • Growth Driving Forces
  • Key Trends
  • Key Developments in Liquid Biopsy



Chapter 4 Liquid Biopsy Initiatives
  • Blood Profiling Atlas
  • Cambridge Single Cell Analysis Core Facility
  • Cancer-ID
  • CTCTrap Consortium
  • Early Cancer Detection Consortium
  • Hematologic Oncology Consortium
  • National Center for Single-Cell Biology
  • Precancer Genome Atlas
  • Precision Medicine Initiative
  • Single Cell Analysis Program
  • TopMed
  • Worldwide Innovative Networking (WIN) Consortium
  • NIPT for Cancer Detection
  • Research Studies on NIPT for Cancer Detection



Chapter 5 Liquid Biopsy Applications
  • Introduction
  • Cancer Applications
  • Precision Medicine
  • Cancer Biomarker Status
  • Cancer Market Segments
  • Reproductive Health Applications
  • Transplant Diagnostics Applications



Chapter 6 Liquid Biopsy Subindustries
  • Introduction
  • Advanced Sequencing Instruments Industry
  • NGS Instrument Industry
  • MiSeq
  • NextSeq
  • MiniSeq
  • ISeq 100
  • Ion Torrent
  • PromethION
  • MinION
  • GridION X5
  • Third-Generation Sequencing Industry
  • Droplet Digital PCR Industry
  • Target Enrichment and Amplification Industry
  • Single-Cell DNA Polymerase Industry
  • NGS Clinical Informatics Industry
  • Testing Services Industry
  • Noninvasive Prenatal Testing Industry
  • Fetal Cell NIPT Industry
  • CTC Capture and Detection Industry
  • Liquid Biopsy Industry
  • Direct-to-Consumer Genetic Testing Industry



Chapter 7 Liquid Biopsy Industry
  • Growth Driving Forces
  • Liquid Biopsy Market by Application
  • Liquid Biopsy Market by Biomarker Type
  • Liquid Biopsy Market by Analysis Platform
  • Liquid Biopsy Market by Analysis Purpose
  • Geographical Market



Chapter 8 Market Breakdown by Indication-Cancer and Transplant
  • Cancer Markets
  • Cancer Market by Indication
  • Cancer Market by Analysis Purpose
  • Cancer Market by Biomarker Class
  • Cancer Market by Analysis Method
  • Breast Cancer Market
  • Colorectal Cancer Market
  • Hematological Cancer Market
  • Lung Cancer Market
  • Pan-Cancer Market
  • Geographical Market
  • Transplant Markets
  • Geographical Market



Chapter 9 NIPT Industry
  • NIPT-Introduction and Technology Overview
  • Other Conventional Prenatal Testing Methods
  • Advantages of NIPT
  • Positive Predictive Value
  • Implementation of NIPT Process
  • In-house Testing
  • As a Service
  • Factors Driving NIPT Market
  • Average Risk NIPT
  • Favorable Reimbursement
  • New Advances in Genomic Technologies
  • Preference for Noninvasive Techniques over Invasive Methods
  • Patient Counseling and Awareness
  • Increasing Collaborations with Local Entities
  • Increasing Mean Maternal Age
  • Restraints
  • Legal and Regulatory Issues
  • Access to Advancing Technologies
  • Current Market Scenario
  • Cost of NIPT
  • NGS-Based NIPT
  • NGS Sequencers for NIPT
  • VeriSeq NIPT Solution
  • MiSeqDx
  • NextSeq 550x
  • NextSeq 550AR
  • Noninvasive Prenatal Tests Available in Market
  • NIFTY
  • Verifi Prenatal Test
  • Harmony Prenatal Test
  • Panorama
  • MaterniT21
  • IONA Test
  • Iona Test Workflow
  • Bambni Test
  • informaSeq
  • Prena Test
  • VisibiliT
  • VERACITY
  • Geographical Market
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World



Chapter 10 Liquid Biopsy-NIPT End Users
  • By Disease Area
  • Down Syndrome (Trisomy 21)
  • Edwards Syndrome (Trisomy 18)
  • Patau Syndrome (Trisomy 13)
  • Turner Syndrome
  • Others
  • By Healthcare Setting
  • Diagnostic Laboratories
  • Hospitals



Chapter 11 Patent Review/ New Developments
  • Patent Review by Year
  • Circulating Tumor Cell Patents
  • Cell-Free DNA Patents
  • Liquid Biopsy- and Sequencing-Related Patent Issues



Chapter 12 Analysis of Market Opportunities
  • Market Share Analysis
  • PEST Analysis
  • Political
  • Economical
  • Social
  • Technological



Chapter 13 Competitive Landscape
  • Mergers and Acquisitions
  • New Product Launches
  • Agreements, Collaborations and Partnerships
  • Pipeline Analysis



Chapter 14 Company Profiles
  • Key Players in NIPT Industry
  • 10X Genomics
  • Agilent Technologies Inc.
  • Berry Genomics
  • BGI (Beijing Genomics Institute)
  • Eurofins Gatc Biotech
  • Eurofins Gatc-Lifecodexx Ag
  • Illumina Inc.
  • Knome Inc./Tute Genomics/Pierian Dx
  • Labcorp
  • Labcorp-Sequenom Laboratories
  • Natera Inc.
  • Nipd Genetics
  • Oxford Nanopore Technologies Ltd.
  • Pacific Biosciences Of California
  • Pieriandx Inc.
  • Perkinelmer Inc.
  • Qiagen N.V.
  • Roche Holding Ag
  • Thermo Fisher Scientific Inc.
  • Players In The Liquid Biopsy Industry
  • 3D Signatures
  • Adaptive Biotechnologies Inc.
  • Alcediag
  • Ambry Genetics
  • Angle Plc
  • Apocell Inc.
  • Arup Laboratories
  • Asuragen Inc.
  • Atreca Inc.
  • Aviva Biosciences
  • Baylor Miraca Genetics Laboratories Inc.
  • Becton, Dickinson And Co.
  • Bellwether Bio Inc.
  • Biocartis Nv
  • Biocept Inc.
  • Biodesix Inc.
  • Biofluidica Inc.
  • Biogazelle
  • Biomarx Inc.
  • Bio-Rad Laboratories Inc.
  • Bio-Techne Ltd.
  • Biovendor-Laboratorni Medicina A.S.
  • Boreal Genomics
  • Cancer Genetics
  • Cegat Gmbh
  • Cellmax Life
  • Cell Microsystems Inc.
  • Celsee Diagnostics
  • Chronix Biomedical
  • Circulogene Theranostics
  • Circulomics Inc.
  • Clinomics Co. Ltd.
  • Codiak Biosciences
  • Color Genomics
  • Coopersurgical Inc.
  • Coriell Life Sciences Inc.
  • Cynvenio Biosystems Inc.
  • Cytotrack Aps
  • Danaher Corp. /Hach Co.
  • Diacarta Inc.
  • Diagnologix Llc
  • Diagnomics
  • Diploid
  • DNA Electronics Ltd.
  • Dnalytics
  • Dnanexus Inc.
  • Edico Genome
  • Envision Genomics
  • Epic Sciences
  • Exact Sciences Corp.
  • Exosome Diagnostics Inc.
  • Fabric Genomics Inc.
  • Fluxion Biosciences Inc.
  • Foundation Medicine Inc.
  • Freenome Inc.
  • Genapsys Inc.
  • Genedx Inc.
  • Genomatix Software Gmbh
  • Genomic Health Inc.
  • Genomoncology
  • Genospace
  • Gigagen Inc.
  • Good Start Genetics Inc.
  • Golden Helix
  • Grail
  • Guardant Health Inc.
  • Helitec
  • Helix Opco Llc
  • Htg Molecular Diagnostics Inc.
  • Human Longevity Inc.
  • Inex Innovations Exchange Pte Ltd.
  • Inivata Ltd.
  • Interpace Diagnostics Llc
  • Invitae
  • Invivoscribe Inc.
  • Irepertoire Inc.
  • Kellbenx Inc.
  • Laboratory Corp. Of America Inc.
  • Mdna Life Sciences Inc.
  • Mdx Health Inc.
  • Medgenome Labs Pvt. Ltd.
  • Menarini Silicon Biosystems
  • Merck Kgaa
  • Molecular Health Gmbh
  • Myriad Genetics Inc.
  • Namocell Inc.
  • Nanostring Technologies Inc.
  • Neogenomics Inc.
  • New England Biolabs
  • New Oncology Gmbh
  • N-Of-One Inc.
  • Novogene Corp.
  • Nugen Technologies Inc.
  • Nx Prenatal Inc.
  • Oncocyte Corp.
  • Oncodna Sa
  • Pangaea Oncology
  • Paradigm Diagnostics Inc.
  • Parseq Lab S.R.O.
  • Pathway Genomics Corp.
  • Personal Genome Diagnostics Inc.
  • Portable Genomics Llc
  • Predicine Inc.
  • Prenetics
  • Provista Diagnostics Inc.
  • Quantapore Inc.
  • Quantum Biosystems Inc.
  • Quantumdx
  • Quest Diagnostics Inc.
  • Rarecells Sas
  • Rarecyte Inc.
  • Real Time Genomics Inc.
  • Resolution Bioscience Inc.
  • Screencell
  • Sengenics International Pte Ltd.
  • Sequencing.Com
  • Seven Bridges Genomics Inc.
  • Singlera Genomics
  • Sophia Genetics
  • Spera Medical
  • Sphere Fluidics Ltd.
  • Station X Inc.
  • Stilla Technologies
  • Strand Life Sciences Pvt. Ltd.
  • Stratec Biomedical Ag
  • Stratos Genomics Inc.
  • Syapse
  • Sygnis Ag
  • Sysmex Inostics Gmbh
  • TAI Diagnostics Inc.
  • Takara Bio Inc.
  • Thorne Diagnostics Inc.
  • Trovagene Inc.
  • Transgenomic Inc.
  • Twinstrand Biosciences
  • Two Pore Guys Inc.
  • Ubiquity Genomics Inc.
  • Vela Diagnostics
  • Volitionrx
  • Xcell Biosciences Inc.
  • Yikon Genomics Co. Ltd.
  • Yourgene Health Plc
  • ZS Genetics Inc.



List of Tables
Summary Table: Global Liquid Biopsy Market, by Disease Class, Through 2023
Table 1: Liquid Biopsy Sample Types
Table 2: Liquid Biopsy Biomarker Classes
Table 3: Clinical Implications of CTCs
Table 4: Key Applications of Circulating Tumor DNA (ctDNA)
Table 5: Comparison between Applications of ctDNA, CTCs and Exosomes
Table 6: Single-Cell Analysis to Identify Cancer Driver Mutations
Table 7: Genomics-Based Oncology Workflow
Table 8: Unique Challenges of CTC Capture and Analysis
Table 9: CTC Workflow
Table 10: Cell Differentiators
Table 11: Cell Isolation Technologies
Table 12: CTC-Isolating Markers
Table 13: CTC Sample Preparation Technologies
Table 14: Single-Cell Analysis Technologies
Table 15: Difference between Liquid Biopsy and Traditional Biopsy
Table 16: Estimated Annual Solid Biopsy Procedures Performed in the U.S. for Selected Cancers
Table 17: Main Risks for Needle-Based Tissue Biopsies
Table 18: Factors in Tissue Biopsy
Table 19: Prenatal Invasive Testing Technologies
Table 20: Invasive versus Noninvasive Prenatal Technologies
Table 21: Growth Driving Forces
Table 22: Key Trends in Liquid Biopsy Market
Table 23: Key Liquid Biopsy Research and Development Programs
Table 24: Source of Foreign Biomarkers for Liquid Biopsy Applications
Table 25: Personalized Medicine Driven by Cancer Common Genetic Mutations
Table 26: Cancer Liquid Biopsy Biomarker Clinical Status
Table 27: Cancer Liquid Biopsy Market Segments
Table 28: Reproductive Health Screening Application
Table 29: Ethical Issues Associated with NIPT
Table 30: Transplant Diagnostics Application
Table 31: Key Segments within the Liquid Biopsy Industry
Table 32: Advanced Sequencing Industry Company Positioning
Table 33: End-to-End Sequencing Approaches
Table 34: Next-Generation Sequencing Instrument Companies
Table 35: NGS Instruments
Table 36: Benchtop and Handheld Sequencer Platforms
Table 37: 3GS Industry, by Tier Status
Table 38: Advantages of Droplet Digital PCR for Single-Cell Analysis
Table 39: Droplet Digital PCR Industry
Table 40: Target Enrichment Industry
Table 41: Single-Cell DNA Polymerase Industry
Table 42: Next-Generation Sequencing Clinical Informatics Company Positioning
Table 43: Selected NGS Clinical Testing Laboratories
Table 44: NIPT Industry
Table 45: Estimated Market Share for NIPT, 2018
Table 46: German NGS-Based Noninvasive Prenatal Diagnostic Companies, 2017
Table 47: NIPT Test Licensing, by Country
Table 48: Fetal Cell NIPT Industry
Table 49: CTC Capture and Detection Industry
Table 50: Liquid Biopsy Industry by Company Focus
Table 51: Example of NGS-Based Liquid Biopsy Market Differentiation
Table 52: Key Competitors in the Direct-to-Consumer Genetic Testing Industry
Table 53: Liquid Biopsy Key Growth Driving Forces
Table 54: Global Liquid Biopsy Market, by Application, Through 2023
Table 55: Global Liquid Biopsy Market, by Biomarker Type, Through 2023
Table 56: FDA-Approved or CE-Marked Tests with Epigenetic Component
Table 57: Global Liquid Biopsy Market, by Analysis Platform, Through 2023
Table 58: Global Liquid Biopsy Market, by Analysis Purpose, Through 2023
Table 59: Global Liquid Biopsy Market, by Region, Through 2023
Table 60: Limitations of Solid Biopsy in Cancer Applications
Table 61: Low-Frequency Mutation Detection
Table 62: Global Liquid Biopsy Cancer Market, by Indication, Through 2023
Table 63: Five-Year Survival Rate for Ovarian Cancer
Table 64: National Institutes of Health Liquid Biopsy Early Detection Initiative
Table 65: Molecular Thyroid Nodule Classifier Test Company Positioning
Table 66: Global Liquid Biopsy Cancer Market, by Analysis Purpose, Through 2023
Table 67: MRI and Liquid Biopsy Methods
Table 68: Early Detection Tissue of Origin Approaches
Table 69: Global Liquid Biopsy Cancer Market, by Biomarker Class, Through 2023
Table 70: Global Liquid Biopsy Cancer Market, by Analysis Method, Through 2023
Table 71: Global Breast Cancer Liquid Biopsy Market, by Analysis Method, Through 2023
Table 72: Global Colorectal Cancer Liquid Biopsy Market, by Analysis Method, Through 2023
Table 73: Global Hematological Cancer Market, by Analysis Method, Through 2023
Table 74: Global Lung Cancer Liquid Biopsy Market, by Analysis Method, Through 2023
Table 75: Global Pan-Cancer Liquid Biopsy Market, by Analysis Method, Through 2023
Table 76: Global Cancer Liquid Biopsy Market, by Region, Through 2023
Table 77: Global Liquid Biopsy Transplant Market, by Analysis Purpose, Through 2023
Table 78: Global Liquid Biopsy Transplant Market, by Organ Type, Through 2023
Table 79: Transplant Procedures Performed in the U.S., 2016-Sept. 30, 2018
Table 80: Global Liquid Biopsy Transplant Market, by Analysis Method, Through 2023
Table 81: Global Liquid Biopsy Transplant Market, by Biomarker Class, Through 2023
Table 82: Global Transplant Liquid Biopsy Market, by Region, Through 2023
Table 83: NIPT Test Prices Across the Globe, 2017
Table 84: Global NIPT Market, by Analysis Purpose, Through 2023
Table 85: Global NIPT Market, by Risk Type, Through 2023
Table 86: Global NIPT Market, by Biomarker Class, Through 2023
Table 87: Global NIPT Market, by Analysis Method, Through 2023
Table 88: NGS NIPT Industry
Table 89: Number of Tests and Market for NIPT, by Region and Company, 2015
Table 90: Germany NGS-Based Noninvasive Prenatal Diagnostic Companies
Table 91: Global NIPT Market, by Method, Through 2023
Table 92: NIPTs Offered by Various Companies
Table 93: Positive Predictive Values for High- and Average-Risk Cohorts
Table 94: Comparison with Other NIPTs That are Based on Counting Technologies
Table 95: Global Iona Test Market, by Country/Region, 2016 and 2017
Table 96: informaSeq Tests
Table 97: informaSeq Test Performance in the Most Common Chromosomal Aneuploidies
Table 98: informaSeq Test Performance in the Most Common Sex Chromosomes
Table 99: VisibiliT Test Performance
Table 100: Global NIPT Market, by Region, Through 2023
Table 101: North American NIPT Market, by Country, Through 2023
Table 102: Commercial Landscape of Noninvasive Prenatal Testing for Fetal Aneuploidy in the U.S.
Table 103: U.S. Patents and Applications for Institutions Commercializing Noninvasive Prenatal Tests, 2012
Table 104: European NIPT Market, by Country, Through 2023
Table 105: Asia-Pacific NIPT Market, by Country, Through 2023
Table 106: NIPT Technology Transfers, by Country
Table 107: Patent Review of NIPT, by Year, 2010-2018
Table 108: CTC-Related Patents, by Region, 2007-2019*
Table 109: Cell-Free DNA-Related Patents, by Region, 2007-2017
Table 110: Status of Liquid Biopsy- and Sequencing-Related Patent Disputes
Table 111: Mergers and Acquisitions of Key Players, 2016-2018
Table 112: New Products Launched by Key Players of NGS-NIPT Industry, 2017 and 2018
Table 113: Agreements, Collaborations and Partnerships among Liquid Biopsy-NIPT Key Players, 2017 and 2018
Table 114: Pipeline Analysis of Liquid Biopsy Industry, 2017 and 2018
Table 115: 10x Genomics: Products and Services
Table 116: Agilent Technologies: Financials, 2016-2017
Table 117: Agilent Technologies: Products and Services
Table 118: Berry Genomics: Products and Services
Table 119: BGI: Products and Services
Table 120: LifeCodexx: Products and Services
Table 121: Illumina: Financials, 2016-2017
Table 122: Illumina: Products and Services
Table 123: LabCorp: Financials, 2016-2017
Table 124: LabCorp: Products and Services
Table 125: Natera: Financials, 2016-2017
Table 126: Natera: Products and Services
Table 127: Oxford Nanopore Technologies: Products and Services
Table 128: Pacific Biosciences: Financials, 2016-2017
Table 129: PacBio: Products and Services
Table 130: PDx: Products and Services
Table 131: QIAGEN: Financials, 2016-2017
Table 132: QIAGEN: Products and Services
Table 133: Roche Diagnostics: Division Sales, 2016-2017
Table 134: Roche Diagnostics: Products and Services
Table 135: Thermo Fisher: Financials, 2016-2017
Table 136: Thermo Fisher: Products and Services
List of Figures
Summary Figure: Global Liquid Biopsy Market, by Disease Class, 2017-2023
Figure 1: Timeline of Liquid Biopsy Development
Figure 2: Molecular Applications of Biomarkers as Liquid Biopsy for Personalized Medicine
Figure 3: How Cancer Genomics Drives Liquid Biopsy
Figure 4: Clinical Applications of Liquid Biopsy for Precision Medicine
Figure 5: NIPT Using Massively Parallel Sequencing (MPS)
Figure 6: Global NIPT Market, by Risk Type, 2017-2023
Figure 7: Clinical Performance of NIFTY Test
Figure 8: Clinical Performance of Harmony Test
Figure 9: Clinical Performance of Panorama Test
Figure 10: North American NIPT Market, 2017-2023
Figure 11: European NIPT Market, 2017-2023
Figure 12: European NIPT Market Share, 2017
Figure 13: Mean Maternal Age in Five EU Countries, 2016
Figure 14: Total Number of Pregnancies and NIPT Procedures in Five EU Countries, 2016
Figure 15: Asia-Pacific NIPT Market, 2017-2023
Figure 16: RoW NIPT Market, 2017-2023
Figure 17: Prevalence of Down Syndrome by Mother's Age
Figure 18: Global NIPT Market Share, by Key Players, 2018
Figure 19: Thermo Fisher Scientific: Market Share, by Business Segments, 2018 (Q1)

Executive Summary

Liquid biopsy is an attractive option as a supplement or alternative to doing a tissue biopsy for applications in reproductive health, cancer and transplant medicine.

Ongoing advances in sensitive molecular technologies such as next-generation DNA sequencing (NGS) and digital polymerase chain reaction (dPCR) enable the detection of biomarkers that are present in fluids at very low concentrations.

The biomarker types garnering the most interest include cell-free DNA (cfDNA), circulating tumor cells (CTCs) and exosomes.

When compared with conventional tissue biopsy, liquid biopsy tests address a significant medical need for a biopsy that is non-invasive and has little or no risk of medical complications. The validation of this testing platform and the demonstration of clinical utility first occurred in the high-risk pregnancy segment of the NIPT industry, resulting in high market penetration. Substantial progress is being made in the average-risk pregnancy NIPT market segment and in some applications in cancer and transplant medicine.

Reasons for Doing This Study

Traditional biopsy methods are often invasive, uncomfortable and carry risks of side effects. Liquid biopsy addresses these issues because it is non-invasive and carries little, if any, risks of side effects. Non-invasive prenatal testing (NIPT) is a liquid biopsy approach that has revolutionized medical genetics. NIPT is a blood test that detects with remarkable accuracy the risk of a fetus developing chromosomal abnormalities like Down syndrome, Edwards syndrome or Patau syndrome, as well as abnormalities with the X and Y sex chromosomes. NIPT involves a simple blood draw, unlike invasive methods such as chorionic villus sampling (CVS) or amniocentesis, each of which also has a small chance of miscarriage. NIPT comes with no risk of miscarriage.

In the age of genomics and personalized medicine, it is critical for clinicians to have diagnostic tools that can be used on a regular basis to screen, monitor, conduct surveillance, guide treatment or otherwise give valuable genomic information about a disease. Liquid biopsy provides this capability and thus is of high interest to the medical community. NIPT is used as a first screen for identifying high-risk pregnancies and will, in the future, be used for low-risk pregnancies as well.

Liquid-biopsy-enabling technologies are coming to the forefront and provide significant market growth momentum to the industry. Downstream analysis technologies like next-generation sequencing (NGS) and digital polymerase chain reaction (PCR) are progressing in terms of their capabilities, efficiency and costs. Upstream technologies like microfluidics, cell-free deoxyribonucleic acid (DNA) capture and isolation, cell capture, and DNA amplification are also making significant progress. The use of next generation sequencing technologies in NIPT opened exciting new market applications. By 2017, the costs of sequencing rapidly reduced to the point where it is now feasible for complex NGS tests to be
priced in the range of other multiplex genetic tests. More than 85 clinical laboratories are now offering NGS-based testing services. For many applications, the clinical benefits have been proven.

Liquid biopsy is also gaining significant traction with key opinion leaders, medical societies and insurance payers. As a result, liquid biopsy is penetrating into attractive clinical applications, including average-risk non-invasive prenatal testing and cancer therapy guidance and monitoring.

Based on these trends, liquid biopsy markets are rapidly emerging and the need for industry and market characterization is great.

The outstanding growth potential for liquid biopsy diagnostics and the future growth potential for NIPTNGS diagnostics make the preparation of this updated report particularly timely.

Companies Mentioned

  • 10X Genomics
  • 3D Signatures
  • Adaptive Biotechnologies Inc.
  • Agilent Technologies Inc.
  • Alcediag
  • Ambry Genetics
  • Angle Plc
  • Apocell Inc.
  • Arup Laboratories
  • Asuragen Inc.
  • Atreca Inc.
  • Aviva Biosciences
  • Baylor Miraca Genetics Laboratories Inc.
  • Becton, Dickinson And Co.
  • Bellwether Bio Inc.
  • Berry Genomics
  • BGI (Beijing Genomics Institute)
  • Bio-Rad Laboratories Inc.
  • Bio-Techne Ltd.
  • Biocartis Nv
  • Biocept Inc.
  • Biodesix Inc.
  • Biofluidica Inc.
  • Biogazelle
  • Biomarx Inc.
  • Biovendor–Laboratorni Medicina A.S.
  • Boreal Genomics
  • Cancer Genetics
  • Cegat Gmbh
  • Cell Microsystems Inc.
  • Cellmax Life
  • Celsee Diagnostics
  • Chronix Biomedical
  • Circulogene Theranostics
  • Circulomics Inc.
  • Clinomics Co. Ltd.
  • Codiak Biosciences
  • Color Genomics
  • Coopersurgical Inc.
  • Coriell Life Sciences Inc.
  • Cynvenio Biosystems Inc.
  • Cytotrack Aps
  • Danaher Corp. /Hach Co.
  • Diacarta Inc.
  • Diagnologix Llc
  • Diagnomics
  • Diploid
  • DNA Electronics Ltd.
  • Dnalytics
  • Dnanexus Inc.
  • Edico Genome
  • Envision Genomics
  • Epic Sciences
  • Eurofins Gatc Biotech
  • Eurofins Gatc—Lifecodexx Ag
  • Exact Sciences Corp.
  • Exosome Diagnostics Inc.
  • Fabric Genomics Inc.
  • Fluxion Biosciences Inc.
  • Foundation Medicine Inc.
  • Freenome Inc.
  • Genapsys Inc.
  • Genedx Inc.
  • Genomatix Software Gmbh
  • Genomic Health Inc.
  • Genomoncology
  • Genospace
  • Gigagen Inc.
  • Golden Helix
  • Good Start Genetics Inc.
  • Grail
  • Guardant Health Inc.
  • Helitec
  • Helix Opco Llc
  • Htg Molecular Diagnostics Inc.
  • Human Longevity Inc.
  • Illumina Inc.
  • Inex Innovations Exchange Pte Ltd.
  • Inivata Ltd.
  • Interpace Diagnostics Llc
  • Invitae
  • Invivoscribe Inc.
  • Irepertoire Inc.
  • Kellbenx Inc.
  • Knome Inc./Tute Genomics/Pierian Dx
  • Labcorp
  • Labcorp—Sequenom Laboratories
  • Laboratory Corp. Of America Inc.
  • Mdna Life Sciences Inc.
  • Mdx Health Inc.
  • Medgenome Labs Pvt. Ltd.
  • Menarini Silicon Biosystems
  • Merck Kgaa
  • Molecular Health Gmbh
  • Myriad Genetics Inc.
  • N-Of-One Inc.
  • Namocell Inc.
  • Nanostring Technologies Inc.
  • Natera Inc.
  • Neogenomics Inc.
  • New England Biolabs
  • New Oncology Gmbh
  • Nipd Genetics
  • Novogene Corp.
  • Nugen Technologies Inc.
  • Nx Prenatal Inc.
  • Oncocyte Corp.
  • Oncodna Sa
  • Oxford Nanopore Technologies Ltd.
  • Pacific Biosciences Of California
  • Pangaea Oncology
  • Paradigm Diagnostics Inc.
  • Parseq Lab S.R.O.
  • Pathway Genomics Corp.
  • Perkinelmer Inc.
  • Personal Genome Diagnostics Inc.
  • Pieriandx Inc.
  • Portable Genomics Llc
  • Predicine Inc.
  • Prenetics
  • Provista Diagnostics Inc.
  • Qiagen N.V.
  • Quantapore Inc.
  • Quantum Biosystems Inc.
  • Quantumdx
  • Quest Diagnostics Inc.
  • Rarecells Sas
  • Rarecyte Inc.
  • Real Time Genomics Inc.
  • Resolution Bioscience Inc.
  • Roche Holding Ag
  • Screencell
  • Sengenics International Pte Ltd.
  • Sequencing.Com
  • Seven Bridges Genomics Inc.
  • Singlera Genomics
  • Sophia Genetics
  • Spera Medical
  • Sphere Fluidics Ltd.
  • Station X Inc.
  • Stilla Technologies
  • Strand Life Sciences Pvt. Ltd.
  • Stratec Biomedical Ag
  • Stratos Genomics Inc.
  • Syapse
  • Sygnis Ag
  • Sysmex Inostics Gmbh
  • TAI Diagnostics Inc.
  • Takara Bio Inc.
  • Thermo Fisher Scientific Inc.
  • Thorne Diagnostics Inc.
  • Transgenomic Inc.
  • Trovagene Inc.
  • Twinstrand Biosciences
  • Two Pore Guys Inc.
  • Ubiquity Genomics Inc.
  • Vela Diagnostics
  • Volitionrx
  • Xcell Biosciences Inc.
  • Yikon Genomics Co. Ltd.
  • Yourgene Health Plc
  • ZS Genetics Inc.