Liquid Biopsy with Emphasis on NIPT: Global Markets to 2023

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 noninvasive 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 noninvasive and carries little, if any, risks of side effects. Noninvasive 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 nextgeneration 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 noninvasive 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.


Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of the Report
Information Sources
Methodology
Geographic Breakdown
Analysts Credentials
BCC Custom Research
Related BCC Research 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 Mothers Age
Figure 18 : Global NIPT Market Share, by Key Players, 2018
Figure 19 : Thermo Fisher Scientific: Market Share, by Business Segments, 2018 (Q1)


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