Next-generation Sequencing: Emerging Clinical Applications and Global Markets

Table of Contents

Chapter 1 Introduction

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

Chapter 2 Summary and Highlights

Chapter 3 Overview

Introduction
Liquid and Tissue Biopsy
Clinical NGS Testing Market
Growth Drivers of Clinical NGS
Key Trends
Industry

Chapter 4 Technology Background

Importance of DNA
Genetic Variation and Analysis
Genetic Analysis Technologies
Sequencing in Clinical Applications
Sequencing Technologies

• History of DNA Sequencing
• Sanger Sequencing Technology
• NGS Platforms
• Short-Read Platforms
• Long-Read Platforms

Informatics Technologies
Base Calling
Mapping to a Reference Sequence
Variant Analysis
Artificial Intelligence Technologies
Clinical Sequencing Technology Challenges

Chapter 5 Clinical NGS Initiatives

R&D Initiatives and Programs

• 1+ Million Genomes
• Access to Treatment and Testing (ACTT)
• Access to Comprehensive Genomic Profiling Coalition (ACGP)
• Africa Pathogen Genomics Initiative
• Blood Profiling Atlas
• Cancer-ID
• Cancer Moon Shots Program
• China Precision Medicine Initiative
• ClinGen
• CTC Trap Consortium
• diaRNAgnosis Project
• Early Cancer Detection Consortium
• EpiFemCare
• France Genomic Medicine Plan
• Friends of Cancer Research Project
• Genomic Medicine Sweden
• HCA-Organoid
• Human Cell Atlas
• Human Immunomics Initiative
• Immunomonitor Consortium
• Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy Program
• Intervene
• Liquid Biopsies and Imaging for Improved Cancer Care
• Liquid Biopsy-Based Malignant Tumor Early Screening Technology Research and Development Project
• Liver Cancer Early Screening Comprehensive Prevention and Control Project
• Lung Cancer Genomic Screening Project for Individualized Medicine in Asia
• Million Veteran Program
• Medical Genome Initiative
• MedSeq
• Precision Medicine Initiative
• Prompt
• QuIP Project
• SPHERES
• Target ALS Diagnosis Initiative
• TopMed
• Treehouse Childhood Cancer Initiative
• Very Rare Cancer Consortium
• Worldwide Innovative Networking (WIN) Consortium

Single-Cell Research

• Cambridge Single-Cell Analysis Core Facility
• Harvard Medical School Single-Cell Core
• Mayo Medical Genome Facility
• National Center for Single-Cell Biology
• Next-Generation Single-Cell Analysis Program
• Single-Cell Analysis Core
• UC San Francisco Single-Cell Analysis Center

Population Sequencing Projects

Chapter 6 Clinical NGS Applications

Introduction
Cancer Applications

• Precision Medicine
• Liquid Biopsy Biomarkers

Mendelian Disorders Applications
Reproductive Health Applications

• Noninvasive Prenatal Testing
• Newborn Screening

Microbiology and Infectious Disease Applications
Complex Disorders Applications

Chapter 7 Clinical NGS Industry

Sequencing Instrument Industry

• Companies

Third-Generation Sequencing Industry
Sequencing Informatics Industry
Target Enrichment and Amplification Industry
CTC Capture and Detection Industry
Liquid Biopsy Assay Industry
Liquid Biopsy Cancer Screening/Early Detection Industry
Health-Focused DTC Genetic Testing Industry: Two Market Models
DTC Clinical Health Genetic Testing Industry
Noninvasive Prenatal Testing (NIPT) Industry

Chapter 8 Acquisitions and Strategic Alliances

Acquisitions
Strategic Alliances

• Key Trends

Chapter 9 Clinical NGS Markets

Market Dynamics

• Market Drivers
• Impact of COVID-19 on the Clinical NGS Markets

Clinical NGS Market by Disease Category

• Oncology
• Cardiology
• NGS Mendelian Disorders
• Metabolic/Immune Disorders
• Neurology
• Reproductive Health
• Microbiology and Infectious Diseases
• Transplantation

Geographical Markets

• Global Market for NGS in Oncology by Region
• Global Market for NGS in Reproductive Health by Region

Chapter 10 Patent Review

Patents on Circulating Tumor Cells
Patents on Exosomes
Patents on Cell-Free DNA
Patents Related to Biomarkers
Patent Considerations for the Use of Artificial Intelligence in Cancer Diagnostics
Liquid Biopsy Patent Litigation

Chapter 11 Company Profiles

ACCURAGEN INC.
ADAPTIVE BIOTECHNOLOGIES INC.
AGILENT TECHNOLOGIES INC.
ALCEDIAG
AMBRY GENETICS
AMOY DIAGNOSTICS CO. LTD.
ANGLE PLC
APOCELL INC.
APOSTLE INC.
ARCEDI BIOTECH APS
ARCHER DX
ARMONICA TECHNOLOGIES INC.
ARUP LABORATORIES
ASURAGEN INC.
AVIVA BIOMED INC.
AVIVA BIOSCIENCES
BARD1 LIFE SCIENCES LTD.
BASE GENOMICS
BAYLOR GENETICS
BECTON, DICKINSON AND CO.
BERRY GENOMICS CO. LTD.
BGI SHENZHEN
BIOCAPTIVA LTD.
BIOCEPT INC.
BIODESIX INC.
BIOFLUIDICA INC.
BIOLIDICS LTD.
BIOLOGICAL DYNAMICS INC.
BIONANO GENOMICS
BIO-TECHNE CORP.
BITBIOME, INC.
BLUESTAR GENOMICS INC.
BURNING ROCK BIOTECH LTD.
C2I GENOMICS
CAMBRIDGE EPIGENETIX
CANCER GENETICS INC.
CANEXIA HEALTH
CAPIO BIOSCIENCES
CAPTIS DIAGNOSTICS INC.
CAREDX INC.
CARIS LIFE SCIENCE
CEGAT GMBH
CELLMAX LIFE
CELL MICROSYSTEMS INC.
CELSEE DIAGNOSTICS
CENTRILLION GENOMICS TECHNOLOGIES
CHRONIX BIOMEDICAL
CIRCULOGENE THERANOSTICS
CLARET BIOSCIENCE
CLINICAL GENOMICS TECHNOLOGIES
CODIAK BIOSCIENCES
COGENICA
CRADLE GENOMICS
CYCLOMICS
CYGNUS BIOSCIENCES CO. LTD.
CYTOTRACK APS
DANAHER CORP.
DANTE LABS
DATAR CANCER GENETICS LTD.
DELFI DIAGNOSTICS
DIACARTA INC.
DIAGNOLOGIX LLC
DIAGNOMICS
DIAMIR BIO
DNALYTICS
DNANEXUS INC.
DOVETAIL GENOMICS LLC
EARLYDX INC.
EONE-DIAGNOMICS GENOME CENTER
ENCRYPGEN
EPIC SCIENCES INC.
EPIGENOMICS AG
EUROFINS SCIENTIFIC
EXACT SCIENCES CORP.
EXOSOME SCIENCES INC.
EXOSOMICS SPA
EXOPERT
EZLIFE BIO INC.
FABRIC GENOMICS
FLUXION BIOSCIENCES INC.
FREENOME INC.
FULGENT GENETICS INC.
FULL GENOMES CORP. INC.
GENAPSYS INC.
GENE BY GENE LTD.
GENEDX INC.
GENETRON HEALTH TECHNOLOGIES
GENESEQ BIOSCIENCES PTY LTD.
GENEXOSOME TECHNOLOGIES INC.
GENOMICTREE
GENOMONCOLOGY
GENOSABER
GENOSITY
GRAIL INC.
GUARDANT HEALTH INC.
HELIO HEALTH
HELIX OPCO LLC
HITGEN
HTG MOLECULAR DIAGNOSTICS INC.
ID SOLUTIONS
ILLUMINA INC.
INCELLDX INC.
INEX INNOVATE PTE. LTD.
INIVATA LTD.
INSITOME INC.
INTERPACE BIOSCIENCES INC.
INVITAE INC.
INVIVOSCRIBE INC.
JABREHOO MEDTECH CO., LTD.
JBS SCIENCE INC.
JUMPCODE GENOMICS INC.
KONINKLIJKE PHILIPS N.V.
LABORATORY CORP. OF AMERICA INC.
LABGENOMICS CO., LTD.
LABRINTH BIOTECH INC.
LARIAT BIOSCIENCES INC.
LIQUID BIOPSY LABS
LUCENCE DIAGNOSTICS PTE. LTD.
LUNGLIFE AI INC.
MACROGEN INC.
MAPMYGENOME
MDXHEALTH INC.
MEDGENOME INC.
MENARINI SILICON BIOSYSTEMS SPA
MERCK KGAA
MICAREO RARE CELL DIAGNOSTICS
MICRONOMA
MIR SCIENTIFIC
MUTANTDX
MYRIAD GENETICS INC.
NAMOCELL INC.
NANOSTRING TECHNOLOGIES INC.
NANOVIEW BIOSCIENCES INC.
NATERA INC.
NEBULA GENOMICS
NEOGENOMICS LABORATORIES
NEO NEW ONCOLOGY GMBH
NEW ENGLAND BIOLABS
NEW HORIZON HEALTH LTD.
NIPD GENETICS
NOVIGENIX SA
NOVOGENE CO. LTD.
NRICHDX INC.
NUPROBE INC.
NX PRENATAL INC.
ONCIMMUNE HOLDINGS PLC
ONCOCYTE CORP.
ONCODNA S.A.
OPKO HEALTH
ORCHID HEALTH INC.
OXFORD NANOPORE TECHNOLOGIES LTD.
PACIFIC BIOSCIENCES OF CALIFORNIA INC.
PANGAEA ONCOLOGY
PERSONAL GENOME DIAGNOSTICS INC.
PERSONALIS INC.
PFDENA INC.
PHASE SCIENTIFIC
PHOSPHORUS INC.
PIERIANDX
PWNHEALTH
PREDICINE INC.
PRENETICS GROUP
QCDX LLC
QIAGEN NV
QUANTAPORE INC.
QUANTGENE INC.
QUANTUM BIOSYSTEMS INC.
QUANTUMDX
QUEST DIAGNOSTICS INC.
RARECELLS SAS
RAVGEN
REAL TIME GENOMICS INC.
RESOLUTION BIOSCIENCE INC.
ROCHE HOLDING AG
SAGA DIAGNOSTICS AB
SANO GENETICS
SANOMICS LTD.
SCREENCELL
SEEKIN
SERACARE LIFE SCIENCES INC.
SEQUENCING.COM
SEVEN BRIDGES GENOMICS INC.
SINGLE TECHNOLOGIES
SINGLERA GENOMICS INC.
SMARTCACTCH
STAGE ZERO LIFE SCIENCES
STRAND LIFE SCIENCES PVT. LTD.
STRATA ONCOLOGY
STRATOS GENOMICS INC.
SYAPSE
SYSMEX INOSTICS GMBH
TAILAI BIOSCIENCES CO., LTD.
TAKARA BIO INC.
TELEXOS GMBH
THERMO FISHER SCIENTIFIC INC.
TWINSTRAND BIOSCIENCES
TWIST BIOSCIENCE
UBIQUITY GENOMICS INC.
UNIVERSAL DIAGNOSTICS SL
VELA DIAGNOSTICS
VERACYTE
VOLITIONRX
VORTEX BIOSCIENCES
XING TECHNOLOGIES LLC
YOURGENE HEALTH PLC
YIKON GENOMICS CO. LTD.

List of Tables

Summary Table : Global Market for Clinical Next-Generation Sequencing, by Disease Class, Through 2025
Table 1 : Scope of the Report
Table 2 : Global Market for Clinical NGS Testing, by Disease Type, Through 2025
Table 3 : Forces Influencing Growth in the Clinical NGS Testing Market
Table 4 : Key Trends in the Clinical NGS Testing Market
Table 5 : Clinical NGS Industry Subsectors
Table 6 : DNA Chemical Building Blocks
Table 7 : DNA Translation and Transcription
Table 8 : Long-Range DNA Structure
Table 9 : Genetic Variant Types
Table 10 : Molecular Diagnostic Technology Platforms
Table 11 : Genome Coverage of PCR, Microarray and NGS Technology Platforms
Table 12 : Genetic Testing Coverage
Table 13 : Key Near- to Mid-Term Segments of NGS Diagnostics
Table 14 : DNA Sequencing Historical Timeline
Table 15 : Sequencing Technology Development, 1990-2020
Table 16 : Cost of Sequencing a Single Human Genome, 2001-2021
Table 17 : Summary of Sanger Sequencing
Table 18 : Improvements in Sanger Sequencing
Table 19 : NGS Technologies
Table 20 : Illumina NGS Workflow
Table 21 : Thermo Fisher Scientific NGS Workflow
Table 22 : NGS Bioinformatics Workflow
Table 23 : Sequence Annotation Steps
Table 24 : Types of AI in Healthcare
Table 25 : Future Challenges in Implementing Clinical NGS
Table 26 : Clinical NGS Research and Development Initiatives and Programs
Table 27 : Single-Cell Core Research Facilities
Table 28 : Population Sequencing Projects
Table 29 : Clinical NGS Near- to Mid-term Applications
Table 30 : Personalized Medicine Driven, by Common Cancer Genetic Mutations
Table 31 : Liquid Biopsy Biomarkers
Table 32 : NGS-Based Cancer Diagnostics Market Segments
Table 33 : Mendelian Disorders Applications
Table 34 : Reproductive Health Screening Applications
Table 35 : Ethical Issues Associated with NIPT
Table 36 : Microbiology/Infectious Disease Applications
Table 37 : Complex Disorders Applications
Table 38 : Key Segments and Trends in the Clinical NGS Industry
Table 39 : NGS and 3GS Industry Company Positioning
Table 40 : Long-Read Sequencing Industry
Table 41 : Sequencing Informatics Industry
Table 42 : NGS Target Enrichment Industry
Table 43 : CTC Separations Industry
Table 44 : Liquid Biopsy Assay Industry: Company Focus
Table 45 : Examples of NGS-Based Liquid Biopsy Market Differentiation
Table 46 : Multi-Cancer Screening Test Desired Features
Table 47 : Shed Rates of Various Cancers
Table 48 : Cancer Screening Liquid Biopsy Industry
Table 49 : Thrive Earlier Detection (Exact Sciences) Cancer Targets
Table 50 : Colorectal Cancer Early Detection/Screening Liquid Biopsy Industry
Table 51 : Key Clinical Trials on Single- and Multi-Cancer Liquid Biopsy Assays
Table 52 : Clinical-Grade Health DTC Genetic Testing Companies
Table 53 : NIPT Industry
Table 54 : Clinical NGS Industry Acquisitions, January 2019–April 2021
Table 55 : Strategic Alliances in Clinical NGS, January 2019–April 2021
Table 56 : Key Forces Driving Growth in Clinical NGS and Their Implications
Table 57 : Global Market for Clinical Sequencing, by Disease Category, Through 2025
Table 58 : Global Market for Clinical NGS, by Test Complexity, Through 2025
Table 59 : Global Market for Clinical NGS, by Purpose of Test, Through 2025
Table 60 : Limitations of Tissue Biopsy in Cancer Applications
Table 61 : Low-Frequency Mutation Detection
Table 62 : Global Market for Clinical NGS in Oncology, by Indication, Through 2025
Table 63 : Five-Year Survival Rate for Ovarian Cancer
Table 64 : National Institutes of Health Liquid Biopsy Early Detection Initiative
Table 65 : Clinical Trials on Lung Cancer Liquid Biopsies
Table 66 : Global Market for Clinical NGS in Oncology, by Purpose of Test, Through 2025
Table 67 : MRI and Liquid Biopsy Methods
Table 68 : Early Detection Tissue of Origin Approaches
Table 69 : Global Market for Clinical NGS in Oncology, by Test Complexity, Through 2025
Table 70 : European Society of Medical Oncology NGS Recommendations for Metastatic Cancers, August 2020
Table 71 : Global Market for Clinical NGS in Cardiology Diagnostics, by Purpose of Test, Through 2025
Table 72 : NGS-Based Dilated Cardiomyopathy Test Providers
Table 73 : Global Market for Clinical NGS in Cardiology Diagnostics, by Test Complexity, Through 2025
Table 74 : Global Market for Clinical NGS in Mendelian Disorder Diagnostics, by Purpose of Test, Through 2025
Table 75 : Global Market for Clinical NGS in Mendelian Disorder Diagnostics, by Test Complexity, Through 2025
Table 76 : Global Market for Clinical NGS in Metabolic and Immune Disorder Diagnostics, by Purpose of Test, Through 2025
Table 77 : Multiple Sclerosis Diagnostic Technologies
Table 78 : Global Market for Clinical NGS in Metabolic and Immune Disorder Diagnostics, by Test Complexity, Through 2025
Table 79 : Global Market for Clinical NGS in Neurological Diagnostics, by Purpose of Test, Through 2025
Table 80 : Global Market for Clinical NGS in Neurological Diagnostics, by Test Complexity, Through 2025
Table 81 : Global Market for Clinical NGS in Reproductive Health, by Application, Through 2025
Table 82 : Global NGS-Based NIPT Market, by Risk Type, Through 2025
Table 83 : Global Market for Clinical NGS in Reproductive Health, by Purpose of Test, Through 2025
Table 84 : Global Market for Clinical NGS in Reproductive Health, by Test Complexity, Through 2025Global Market for Clinical NGS in Reproductive Health, by Test Complexity, Through 2025
Table 85 : NGS-Based Infectious Disease Landscape
Table 86 : Global Market for Clinical NGS-Based Microbiology and Infectious Disease Diagnostics, by Purpose of Test, Through 2025
Table 87 : Global Market for Clinical NGS-Based Microbiology and Infectious Disease Diagnostics, by Test Complexity, Through 2025
Table 88 : NGS in Infectious Disease Diagnostics
Table 89 : Global Market for Clinical NGS in Transplantations, by Organ, Through 2025
Table 90 : Transplant Procedures Performed in the U.S., by Organ, 2018-2020
Table 91 : Global Market for Clinical NGS in Transplantation, by Purpose of Test, Through 2025
Table 92 : Global Market for Clinical NGS in Transplantation, by Test Complexity, Through 2025
Table 93 : Global Market for Clinical NGS, by Region, Through 2025
Table 94 : Global Market for Clinical NGS in Oncology, by Region, Through 2025
Table 95 : Global Market for NGS in Reproductive Health, by Region, Through 2025
Table 96 : Global Market for Clinical NGS in Transplantation, by Region, Through 2025
Table 97 : Patent Activity on Circulating Tumor Cells (CTCs), by Country/Region, January 2010–June 2020
Table 98 : Patent Activity on Exosomes, by Country/Region, January 2010–December 2020
Table 99 : Patent Activity on Cell-Free DNA, by Country/Region, January 2010–December 2020
Table 100 : Patent Activity on Cancer Biomarkers, by Country/Region, January 2010–December 2020
Table 101 : Status of NGS-Based Liquid Biopsy Patent Disputes

List of Figures

Summary Figure : Global Market for Clinical Next-Generation Sequencing, by Disease Class, 2019-2025

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