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Market Research Report
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1068410

Companion Diagnostic Markets, The Future of Diagnostics By Application, Technology and Funding. With Customized Forecasting/Analysis, and Executive and Consultant Guides 2022-2026

Published: | Howe Sound Research | 465 Pages | Delivery time: 1-2 business days

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Companion Diagnostic Markets, The Future of Diagnostics By Application, Technology and Funding. With Customized Forecasting/Analysis, and Executive and Consultant Guides 2022-2026
Published: April 4, 2022
Howe Sound Research
Content info: 465 Pages
Delivery time: 1-2 business days
  • Description
  • Table of Contents
  • List of Tables

OVERVIEW:

Companion Diagnostics are poised to revolutionize the diagnostics industry. The market is moving out of the lab and into the clinic. Oncology, especially immune-oncology is leading the way. And the FDA is holding the door open for this diagnostic technology of the future. Find out the latest outlook for this important market.

Will Personalized Companion Diagnostics become the norm for diagnostics?

Learn all about how diagnostic players are jockeying for position with their pharmaceutical counterparts and creating new and significant business opportunities. And some players are already taking the lead. It is a dynamic market situation with enormous opportunity. Diagnostic companies are trying to back the right horse. The science is racing forward. And the cost of molecular diagnostics continues to fall.

"Companion Diagnostic Markets, the future of diagnostics. By Application, Technology and Funding with customized forecasting/analysis and Executive and Consultant Guides 2021-2025" provides data that analysts and planners can use.

The report includes detailed breakouts for 18 Countries and 4 Regions. A detailed breakout for any country or specific area in the world is available to purchasers of the report.

ABOUT THE LEAD AUTHOR:

Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years. Mr. Powell's education includes:

  • B.Sc. (Chemistry) University of BC
  • M.B.A. (Finance and Policy) University of BC
  • Market Research Seminar - Burke Institute
  • Finance for Senior Executives - Harvard Business School

Table of Contents

1 Market Guides

  • 1.1 Companion Diagnostic Market - Strategic Situation Analysis
  • 1.2 Guide for Executives, Marketing, Sales and Business Development Staff
  • 1.3 Guide for Management Consultants and Investment Advisors

2 Introduction and Market Definition

  • 2.1 What are Companion Diagnostics?
  • 2.2 The Personalized Medicine Revolution
  • 2.3 Market Definition
    • 2.3.1 Revenue Market Size.
  • 2.4 Methodology
    • 2.4.1 Authors
    • 2.4.2 Sources
  • 2.5 Perspective: Healthcare, the IVD Industry, and the COVID-19 Pandemic
    • 2.5.1 Global Healthcare Spending
    • 2.5.2 Spending on Diagnostics
    • 2.5.3 Important Role of Insurance for Diagnostics

3 Market Overview

  • 3.1 Players in a Dynamic Market
    • 3.1.1 Academic Research Lab
    • 3.1.2 Diagnostic Test Developer
    • 3.1.3 Instrumentation Supplier
    • 3.1.4 Distributor and Reagent Supplier
    • 3.1.5 Independent Testing Lab
    • 3.1.6 Public National/regional lab
    • 3.1.7 Hospital lab
    • 3.1.8 Physician Office Labs
    • 3.1.9 Audit Body
    • 3.1.10 Certification Body
  • 3.2 Personalized Medicine and Companion Diagnostics
    • 3.2.1 Basics
    • 3.2.2 Method
    • 3.2.3 Disease risk assessment
    • 3.2.4 Applications
    • 3.2.5 Diagnosis and intervention
      • 3.2.5.1 Companion Diagnostics
    • 3.2.6 Drug development and usage
    • 3.2.7 Respiratory proteomics
    • 3.2.8 Cancer genomics
    • 3.2.9 Population screening
    • 3.2.10 Challenges
    • 3.2.11 Regulatory oversight
    • 3.2.12 Intellectual property rights
    • 3.2.13 Reimbursement policies
    • 3.2.14 Patient privacy and confidentiality
  • 3.3 Chromosomes, Genes and Epigenetics
    • 3.3.1 Chromosomes
    • 3.3.2 Genes
    • 3.3.3 Epigenetics
  • 3.4 Cancer Genes
    • 3.4.1 Germline vs Somatic
    • 3.4.2 Changing Clinical Role
  • 3.5 Structure of Industry Plays a Part
    • 3.5.1 New Pharmaceutical Funding Market
    • 3.5.2 Economies of Scale
      • 3.5.2.1 Hospital vs. Central Lab
    • 3.5.3 Physician Office Labs
    • 3.5.4 Physicians and POCT

4 Market Trends

  • 4.1 Factors Driving Growth
    • 4.1.1 Level of Care.
    • 4.1.2 Immuno-oncology.
    • 4.1.3 Liability.
    • 4.1.4 Aging Population
  • 4.2 Factors Limiting Growth
    • 4.2.1 State of knowledge.
    • 4.2.2 Genetic Blizzard.
    • 4.2.3 Protocol Resistance.
    • 4.2.4 Regulation and coverage.
  • 4.3 Instrumentation and Automation
    • 4.3.1 Instruments Key to Market Share
    • 4.3.2 Bioinformatics Plays a Role
  • 4.4 Diagnostic Technology Development
    • 4.4.1 Next Generation Sequencing Fuels a Revolution.
    • 4.4.2 Single Cell Genomics Changes the Picture.
    • 4.4.3 Pharmacogenomics Blurs Diagnosis and Treatment.
    • 4.4.4 CGES Testing, A Brave New World.
    • 4.4.5 Biochips/Giant magneto resistance based assay.

5 Companion Diagnostics Recent Developments

  • 5.1 Recent Developments - Importance and How to Use This Section
    • 5.1.1 Importance of These Developments
    • 5.1.2 How to Use This Section
  • 5.2 Burning Rock Secures Lung Cancer NGS Test Approval in China
  • 5.3 TenSixteen Bio Developing Drugs, Companion NGS Tests
  • 5.4 Guardant Health Plans New Comprehensive Assay
  • 5.5 Thermo Fisher, Oncocyte Ink Comarketing Deal for Cancer IVDs
  • 5.6 Qiagen, Denovo Biopharma to Develop Liquid Biopsy CDx Test
  • 5.7 Japanese Approves Thermo Fisher Scientific Oncomine Assay as CDx
  • 5.8 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug
  • 5.9 Natera Aims to Lead Market in Solid Tumor Adjuvant CDx
  • 5.10 Oncocyte Details Expansions Plans
  • 5.11 Agilent Acquires Resolution Biosciences
  • 5.12 Qiagen, Inovio Expand CDx Partnership
  • 5.13 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance
  • 5.14 NeoGenomics to Grow Through CDx Agreements, Acquisitions
  • 5.15 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction
  • 5.16 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform
  • 5.17 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies
  • 5.18 Promega to Develop MSI Assay as CDx
  • 5.19 Guardant Health to Develop CDx for Janssen
  • 5.20 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx
  • 5.21 FDA Approval for FoundationOne®CDx
  • 5.22 FDA finalizes CDx Guidance
  • 5.23 QIAGEN Launches CDx Therascreen BRAF Test

6 Profiles of Key Players

  • 6.1 10x Genomics, Inc.
  • 6.2 Abbott Diagnostics
  • 6.3 AccuraGen Inc.
  • 6.4 Adaptive Biotechnologies
  • 6.5 Aethlon Medical
  • 6.6 Agena Bioscience, Inc.
  • 6.7 Agilent
  • 6.8 Anchor Dx
  • 6.9 ANGLE plc
  • 6.10 ApoCell, Inc.
  • 6.11 ArcherDx, Inc.
  • 6.12 ARUP Laboratories
  • 6.13 Asuragen
  • 6.14 AVIVA Biosciences
  • 6.15 Baylor Miraca Genetics Laboratories
  • 6.16 Beckman Coulter Diagnostics
  • 6.17 Becton, Dickinson and Company
  • 6.18 BGI Genomics Co. Ltd
  • 6.19 Bioarray Genetics
  • 6.20 Biocartis
  • 6.21 Biocept, Inc.
  • 6.22 Biodesix Inc.
  • 6.23 BioFluidica
  • 6.24 BioGenex
  • 6.25 BioIVT
  • 6.26 Biolidics Ltd
  • 6.27 bioMérieux Diagnostics
  • 6.28 Bioneer Corporation
  • 6.29 Bio-Rad Laboratories, Inc
  • 6.30 Bio-Reference Laboratories
  • 6.31 Bio-Techne
  • 6.32 Bioview
  • 6.33 Bolidics
  • 6.34 Boreal Genomics
  • 6.35 Bristol-Myers Squibb
  • 6.36 Cancer Genetics
  • 6.37 Caris Molecular Diagnostics
  • 6.38 Castle Biosciences, Inc.
  • 6.39 CellMax Life
  • 6.40 Cepheid (now Danaher)
  • 6.41 Charles River Laboratories
  • 6.42 Chronix Biomedical
  • 6.43 Circulogene
  • 6.44 Clinical Genomics
  • 6.45 Cynvenio
  • 6.46 Cytolumina Technologies Corp.
  • 6.47 CytoTrack
  • 6.48 Datar Cancer Genetics Limited
  • 6.49 Diagnologix LLC
  • 6.50 Diasorin S.p.A.
  • 6.51 Enzo Life Sciences, Inc.
  • 6.52 Epic Sciences
  • 6.53 Epigenomics AG
  • 6.54 Eurofins Scientific
  • 6.55 Exosome Diagnostics
  • 6.56 Exosome Sciences
  • 6.57 Fabric Genomics
  • 6.58 Fluidigm Corp
  • 6.59 Fluxion Biosciences
  • 6.60 Foundation Medicine
  • 6.61 Freenome
  • 6.62 GeneFirst Ltd.
  • 6.63 Genetron Health (Beijing) Co., Ltd.
  • 6.64 Genomic Health
  • 6.65 GenomOncology
  • 6.66 GILUPI Nanomedizin
  • 6.67 Grail, Inc.
  • 6.68 Guardant Health
  • 6.69 HalioDx
  • 6.70 HansaBiomed
  • 6.71 HeiScreen
  • 6.72 Helomics
  • 6.73 Horizon Discovery
  • 6.74 HTG Molecular Diagnostics
  • 6.75 iCellate
  • 6.76 Illumina
  • 6.77 Incell Dx
  • 6.78 Inivata
  • 6.79 Integrated Diagnostics
  • 6.80 Invivogen
  • 6.81 Invivoscribe
  • 6.82 Janssen Diagnostics
  • 6.83 MDNA Life SCIENCES, Inc.
  • 6.84 MDx Health
  • 6.85 Menarini Silicon Biosystems
  • 6.86 Millipore Sigma
  • 6.87 Miltenyi Biotec
  • 6.88 MIODx
  • 6.89 miR Scientific
  • 6.90 Molecular MD
  • 6.91 MyCartis
  • 6.92 Myriad Genetics/Myriad RBM
  • 6.93 NantHealth, Inc.
  • 6.94 Natera
  • 6.95 NeoGenomics
  • 6.96 New Oncology
  • 6.97 Novogene Bioinformatics Technology Co., Ltd.
  • 6.98 Oncocyte
  • 6.99 OncoDNA
  • 6.100 Ortho Clinical Diagnostics
  • 6.101 Oxford Nanopore Technologies
  • 6.102 Panagene
  • 6.103 Perkin Elmer
  • 6.104 Personal Genome Diagnostics
  • 6.105 Personalis
  • 6.106 Precipio
  • 6.107 PrecisionMed
  • 6.108 Promega
  • 6.109 Qiagen Gmbh
  • 6.110 Rarecells SAS
  • 6.111 RareCyte
  • 6.112 Roche Molecular Diagnostics
  • 6.113 Screencell
  • 6.114 Sense Biodetection.
  • 6.115 Serametrix
  • 6.116 Siemens Healthineers
  • 6.117 Silicon Biosystems
  • 6.118 simfo GmbH
  • 6.119 Singlera Genomics Inc.
  • 6.120 Singulomics
  • 6.121 SkylineDx
  • 6.122 Stratos Genomics
  • 6.123 Sysmex Inostics
  • 6.124 Tempus Labs, Inc.
  • 6.125 Thermo Fisher Scientific Inc.
  • 6.126 Thrive Earlier Detection
  • 6.127 Todos Medical
  • 6.128 Trovagene
  • 6.129 Volition
  • 6.130 Vortex Biosciences

7 The Global Market for Companion Diagnostics

  • 7.1 Global Market Overview by Country
    • 7.1.1 Table - Global Market by Country
    • 7.1.2 Chart - Global Market by Country
  • 7.2 Global Market by Application - Overview
    • 7.2.1 Table - Global Market by Application
    • 7.2.2 Chart - Global Market by Application - Base/Final Year Comparison
    • 7.2.3 Chart - Global Market by Application - Base Year
    • 7.2.4 Chart - Global Market by Application - Final Year
    • 7.2.5 Chart - Global Market by Application - Share by Year
  • 7.3 Global Market Funding Source - Overview
    • 7.3.1 Table - Global Market by Funding Source
    • 7.3.2 Chart - Global Market Funding Source - Base/Final Year Comparison
    • 7.3.3 Chart - Global Market Funding Source - Base Year
    • 7.3.4 Chart - Global Market Funding Source - Final Year
    • 7.3.5 Chart - Global Market Funding Source - Share by Year
  • 7.4 Global Market Technology - Overview
    • 7.4.1 Table - Global Market by Technology
    • 7.4.2 Chart - Global Market Technology - Base/Final Year Comparison
    • 7.4.3 Chart - Global Market Technology - Base Year
    • 7.4.4 Chart - Global Market Technology - Final Year
    • 7.4.5 Chart - Global Market Technology - Share by Year

8 Global Companion Diagnostic Markets - By Application

  • 8.1 Oncology
    • 8.1.1 Table Oncology - by Country
    • 8.1.2 Chart - Oncology Growth
  • 8.2 Neurology
    • 8.2.1 Table Neurology - by Country
    • 8.2.2 Chart - Neurology Growth
  • 8.3 Cardiology
    • 8.3.1 Table Cardiology - by Country
    • 8.3.2 Chart - Cardiology Growth
  • 8.4 Other Application
    • 8.4.1 Table Other Application - by Country
    • 8.4.2 Chart - Other Application Growth

9 Global Companion Diagnostic Markets - Funding Source

  • 9.1 Global Market Pharmaceutical
    • 9.1.1 Table Pharmaceutical - by Country
    • 9.1.2 Chart - Pharmaceutical Growth
  • 9.2 Global Market Venture
    • 9.2.1 Table Venture - by Country
    • 9.2.2 Chart - Venture Growth
  • 9.3 Global Market Clinical
    • 9.3.1 Table Clinical - by Country
    • 9.3.2 Chart - Clinical Growth
  • 9.4 Global Market Other Funding
    • 9.4.1 Table Other Funding - by Country
    • 9.4.2 Chart - Other Funding Growth

10 Global Companion Diagnostic Markets - Technology

  • 10.1 Global Market Next Generation Sequencing
    • 10.1.1 Table Next Generation Sequencing - by Country
    • 10.1.2 Chart - Next Generation Sequencing Growth
  • 10.2 Global Market PCR
    • 10.2.1 Table PCR - by Country
    • 10.2.2 Chart - PCR Growth
  • 10.3 Global Market IHC/ISH
    • 10.3.1 Table IHC/ISH - by Country
    • 10.3.2 Chart - IHC/ISH Growth
  • 10.4 Global Market Other Technology
    • 10.4.1 Table Other Technology - by Country
    • 10.4.2 Chart - Other Technology Growth

11 Appendices

  • 11.1 United States Medicare System: January 2022 Clinical Laboratory Fees Schedule
  • 11.2 Pharmacogenomic Biomarkers in Drug Labeling

Table of Tables

  • Table 1: Market Players by Type
  • Table 2: The Base Pairs
  • Table 3: Five Factors Driving Growth
  • Table 4: Four Factors Limiting Growth
  • Table 5: Key Diagnostic Laboratory Technology Trends
  • Table 6: Next Generation Sequencing Technologies - Speed and Cost
  • Table 7: Global Companion Diagnostic Market by Region
  • Table 8: Global Market by Application
  • Table 9: Global Market by Funding Source
  • Table 10: Global Market by Technology
  • Table 11: Oncology by Country
  • Table 12: Neurology by Country
  • Table 13: Cardiology by Country
  • Table 14: Other Application by Country
  • Table 15: Pharmaceutical by Country
  • Table 16: Venture by Country
  • Table 17: Clinical by Country
  • Table 18: Other Funding by Country
  • Table 19: Next Generation Sequencing by Country
  • Table 20: PCR by Country
  • Table 21: IHC/ISH by Country
  • Table 22: Other Technology by Country
  • Table 23: 2022 Clinical Laboratory Fee Schedule
  • Table 24: Pharmacogenomic Biomarkers

Table of Figures

  • Figure 1: FDA Approved Companion Diagnostics
  • Figure 2: Global Health Care Spending
  • Figure 3: The Lab Testing Pie
  • Figure 4: DNA Strands and Chromosomes
  • Figure 5: Karyogram of Human Chromosomes
  • Figure 6: Size of Various Genomes
  • Figure 7: Germline vs Somatic Mutations
  • Figure 8: Comparing Genomic Diagnostic and Traditional Testing
  • Figure 9: Percentage of World Population Over 65
  • Figure 10: Base Year Country Market Share Chart
  • Figure 11: CDx Market by Application - Base vs. Final Year
  • Figure 12: CDx Market by Application Base Year
  • Figure 13: CDx Market by Application Final Year
  • Figure 14: Application Type Share by Year
  • Figure 15: Funding Source - Base vs. Final Year
  • Figure 16: Funding Source Market Base Year
  • Figure 17: Funding Source Market Final Year
  • Figure 18: Funding Source Share by Year
  • Figure 19: Technology - Base vs. Final Year
  • Figure 20: Technology Market Base Year
  • Figure 21: Technology Market Final Year
  • Figure 22: Technology Share by Year
  • Figure 23: Oncology Growth
  • Figure 24: Neurology Growth
  • Figure 25: Cardiology Growth
  • Figure 26: Other Application Growth
  • Figure 27: Pharmaceutical Growth
  • Figure 28: Venture Growth
  • Figure 29: Clinical Growth
  • Figure 30: Other Funding Growth
  • Figure 31: Next Generation Sequencing Growth
  • Figure 32: PCR Growth
  • Figure 33: IHC/ISH Growth
  • Figure 34: Other Technology Growth