Companion Diagnostics: Technologies and Markets

Table of Contents

Chapter 1 Introduction

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

Chapter 2 Summary and Highlights

Summary
Key Highlights

Chapter 3 Market and Technology Background

Personalized Medicine and Biomarkers

• Predictive Biomarkers

Companion Diagnostics and Complementary Diagnostics

• Companion Diagnostic Development
• CDx Stakeholders
• Technologies Used in CDx
• Applications of CDx
• Regulatory Aspects of CDx

Chapter 4 Market Breakdown by Solution and Type of Test

Global Market for Companion Diagnostic by Type of Test

• Market Overview

Global Market for Companion Diagnostics by Solution

• Market Overview

Global Market for Companion Diagnostic Solutions by Region

• Instruments
• Consumables
• Services

Chapter 5 Market Breakdown by Technology

Global Market for Companion Diagnostics by Technology

• Market Overview

Global Market for Companion Diagnostic Technologies by Region

• Market Shares
• Immunohistochemistry
• In Situ Hybridization
• Polymerase Chain Reaction
• Next-Generation Sequencing
• Genotyping
• Others
• CDx Development Services

Chapter 6 Market Breakdown by Application

Global Market for Companion Diagnostic Applications

• Market Overview

Global Market for Companion Diagnostic Applications by Region

• Market Shares
• Cancer
• Pharmacogenetics
• Cystic Fibrosis
• HIV
• LDT-CDx by Application

CDx in Non-oncology Areas

Chapter 7 Industry Structure

Stakeholders in Companion Diagnostics
Driving Trends in Companion Diagnostics
Business Models of Companion Diagnostics
Grants and Funding in Companion Diagnostics
Collaborations and Partnerships
Mergers and Acquisitions
Leading Market Players in Companion Diagnostics Market

• Leading Market Players in IHC Market
• Leading Market Players in ISH Market
• Leading Market Players in PCR Market
• Leading Market Players in NGS Market
• Leading Market Players in Genotyping Market
• Leading Market Players in Other CDx Technologies Market

Chapter 8 Patent Review

Patents in Companion Diagnostics Market
Patent Analysis

• Patents by Year
• Patents by Application
• Patents by Company
• Patents by Country
• Patents by Assignee

Chapter 9 Clinical Trials Analysis

Clinical Trials and CDx
Clinical Trials Analysis

• Clinical Trials Analysis by Type of Study
• Clinical Trials Analysis by Status
• Clinical Trials Analysis by Phase
• Clinical Trials Analysis by Technology
• Clinical Trial Analysis by Application
• Clinical Trial Analysis by Therapeutic Area
• Companies with Companion Diagnostics in Clinical Trials

Chapter 10 Analysis of Market Opportunities

Market Dynamics

• Strengths
• Challenges
• Opportunities
• Threats

Chapter 11 Company Profiles

ABBOTT LABORATORIES INC.
ABNOVA CORP.
ADAPTIVE BIOTECHNOLOGIES CORP.
ADVANCED CELL DIAGNOSTICS INC.
AGILENT TECHNOLOGIES INC.
AMOY DIAGNOSTICS CO., LTD.
ALMAC GROUP LTD.
ARUP LABORATORIES
ASURAGEN INC.
AUTOGENOMICS INC. (ACQUIRED BY PRESCIENT MEDICINE)
BIOCARTIS NV
BIODESIX, INC.
BIOFLUIDICA
BIOMERIEUX SA
CERBA RESEARCH
CIRCULOGENE
CLINICAL MICRO SENSORS INC. (NOW GENMARK DIAGNOSTICS INC.)
EXACT SCIENCES CORP.
EXOSOMEDX, INC.
F. HOFFMANN-LA ROCHE LTD.
FOUNDATION MEDICINE INC.
GUARDANT HEALTH INC.
HOLOGIC INC.
ICON PLC
ILLUMINA INC.
INVIVOSCRIBE, INC.
LEICA BIOSYSTEMS (DIVISION OF LEICA MICROSYSTEMS INC.)
LUMINEX MOLECULAR DIAGNOSTICS INC. (LUMINEX CORP.)
MAZE THERAPEUTICS
MONOGRAM BIOSCIENCES INC. (PART OF LABCORP)
MYRIAD GENETICS INC.
NEOGENOMICS LABORATORIES
PROMETHEUS BIOSCIENCES
QIAGEN GMBH
QUEST DIAGNOSTICS INC.
RESOLUTION BIOSCIENCE INC.
RESONANCE HEALTH LTD.
SIEMENS HEALTHINEERS AG
SPARTAN BIOSCIENCE INC.
SYSMEX CORP.
THERMO FISHER SCIENTIFIC INC.
TRIMGEN CORP.
VELA DIAGNOSTICS INC.
Chapter 12 Appendix: Acronyms

List of Tables

Summary Table : Global Market for Companion Diagnostics, by Technology, Through 2026
Table 1 : Examples of Predictive Biomarkers
Table 2 : Biomarkers Used in Companion Diagnostics
Table 3 : Commercial CDx vs. LDT-CDx
Table 4 : Examples of Technologies Used in Different CDx
Table 5 : FDA List of Pharmacogenetic Associations for which the Data Support Therapeutic Management Recommendations
Table 6 : Different Agents Used for Chemotherapy and Targeted Therapy
Table 7 : Comparison between Chemotherapy and Targeted Therapy
Table 8 : Differences between PMA, HDE and 510(k) Applications for CDx
Table 9 : CLIA Categorization Criteria
Table 10 : Regulatory Approvals Granted for CDx
Table 11 : Global Market for Companion Diagnostics, by Type of Test, Through 2026
Table 12 : Global Market Shares of Companion Diagnostics, by Type of Test, 2020
Table 13 : Global Market for Companion Diagnostics, by Solution, Through 2026
Table 14 : Global Market Shares of Companion Diagnostics, by Solution, 2020
Table 15 : Global Market for Companion Diagnostic Solutions, by Region, Through 2026
Table 16 : Global Market Shares of Companion Diagnostic Solutions, by Region, 2020
Table 17 : Global Market for Companion Diagnostic Instruments, by Region, Through 2026
Table 18 : Global Market for Companion Diagnostic Consumables, by Region, Through 2026
Table 19 : Global Market for Companion Diagnostic Services, by Region, Through 2026
Table 20 : FDA-Approved CDx Technologies, by Year, 2000-June 2021
Table 21 : Number and Percentage of FDA-Approved CDx Tests, by Technology, 2000-June 2021
Table 22 : Global Market for Companion Diagnostics, by Technology, Through 2026
Table 23 : Global Market Shares of Companion Diagnostics, by Technology, 2020
Table 24 : Global Market for Companion Diagnostic Technologies, by Region, Through 2026
Table 25 : Global Market Shares of Companion Diagnostic Technologies, by Region, 2020
Table 26 : FDA-Approved IHC-CDx
Table 27 : Global Market for Immunohistochemistry CDx, by Region, Through 2026
Table 28 : FDA-Approved ISH-CDx
Table 29 : Global Market for In Situ Hybridization CDx, by Region, Through 2026
Table 30 : FDA-Approved PCR-CDx
Table 31 : Global Market for Polymerase Chain Reaction CDx, by Region, Through 2026
Table 32 : FDA-Approved NGS-CDx
Table 33 : Foundation Medicine CDx Indications-Biomarkers
Table 34 : Global Market for Next-Generation Sequencing CDx, by Region, Through 2026
Table 35 : FDA-Cleared Pharmacogenetic Tests
Table 36 : Global Market for Genotyping CDx, by Region, Through 2026
Table 37 : Global Market for Other CDx Technologies, by Region, Through 2026
Table 38 : Technological Expertise in CDx Services Sector
Table 39 : Global Market for Companion Diagnostic Services, by Region, Through 2026
Table 40 : Global Market for Companion Diagnostics, by Application, Through 2026
Table 41 : Global Market Shares of Companion Diagnostics, by Application, 2020
Table 42 : Global Market for Companion Diagnostic Applications, by Region, Through 2026
Table 43 : Global Market Shares of Companion Diagnostic Applications, by Region, 2020
Table 44 : Drugs with Approved Companion Diagnostics
Table 45 : Global Market for Companion Diagnostics in Cancer Applications, by Region, Through 2026
Table 46 : Total Number of Drugs with Approved CDx, by Cancer Type, 2018
Table 47 : Global Market for Companion Diagnostics in Cancer Applications, by Cancer Type, Through 2026
Table 48 : Global Market Shares of Companion Diagnostics in Cancer Applications, by Cancer Type, 2020
Table 49 : Examples of Drugs with CYP450 Pharmacogenomic Biomarkers in Drug Labeling
Table 50 : Examples of Drugs with Pharmacogenomic Biomarkers in Drug Labeling
Table 51 : Global Market for Companion Diagnostics in Pharmacogenetic Applications, by Region, Through 2026
Table 52 : Global Market for Companion Diagnostics in Cystic Fibrosis Applications, by Region, Through 2026
Table 53 : Classes of ART
Table 54 : Global Market for Companion Diagnostics in HIV Applications, by Region, Through 2026
Table 55 : Global Market for LDT-CDx, by Application, Through 2026
Table 56 : Grants and Funding in Companion Diagnostics, 2019-July 15th, 2020
Table 57 : Collaborations and Partnerships in the Global Companion Diagnostics Market, 2018-July 15, 2020
Table 58 : Mergers and Acquisitions in the Global Companion Diagnostics Market, 2018-July 15th, 2020
Table 59 : Leading Developers of IHC Companion Diagnostics, 2020
Table 60 : Global Market Shares of Leading Developers of IHC Companion Diagnostics, 2020
Table 61 : Leading Developers of ISH Companion Diagnostics, 2020
Table 62 : Global Market Shares of Leading Developers of ISH Companion Diagnostics, 2020
Table 63 : Leading Developers of PCR Companion Diagnostics, 2020
Table 64 : Global Market Shares of Leading Developers of PCR Companion Diagnostics, 2020
Table 65 : Leading Developers of NGS Companion Diagnostics, 2020
Table 66 : Global Market Shares of Leading Developers of NGS Companion Diagnostics, 2020
Table 67 : Leading Developers of Genotyping Companion Diagnostics, 2020
Table 68 : Global Market Shares of Leading Developers of Genotyping Companion Diagnostics, 2020
Table 69 : Leading Developers of Other Companion Diagnostics, 2020
Table 70 : Global Market Shares of Leading Developers of Other Companion Diagnostics, 2020
Table 71 : Basic Aspects of Patents
Table 72 : Representative Patents in Companion Diagnostics, 2018-June 2021
Table 73 : Patents Issued for Companion Diagnostics, by Year, 2018-June 2021
Table 74 : Patents Issued for Companion Diagnostics, by Application, 2018-June 2021
Table 75 : Patents Issued for Companion Diagnostics, by Company, 2018-June 2021
Table 76 : Patents Issued for Companion Diagnostics, by Country, 2018-June 2021
Table 77 : Patents Issued for Companion Diagnostics, by Assignee, 2018-June 2021
Table 78 : Clinical Trials in Companion Diagnostics, by Type of Study
Table 79 : Clinical Trials in Companion Diagnostics, by Status
Table 80 : Clinical Trials in Companion Diagnostics, by Phase
Table 81 : Clinical Trials in Companion Diagnostics, by Technology
Table 82 : Clinical Trials on Companion Diagnostics, by Application
Table 83 : Clinical Trials in Companion Diagnostics, by Therapeutic Area
Table 84 : Companies with CDx in Clinical Trials
Table 85 : Companion Diagnostics and Approved Drugs, 2017-2020
Table 86 : FoundationOne CDx Approved Indications
Table 87 : Common Inefficiencies in Clinical Testing Landscape
Table 88 : Initiatives Towards Harmonization of Commercial and LDT-CDx
Table 89 : All of Us Research Program Highlights
Table 90 : Foundation Medicine: List of Pipeline Companion Diagnostics
Table 91 : Guardant Health: List of Pipeline Companion Diagnostics
Table 92 : Myriad Genetics' List of Pipeline Companion Diagnostics
Table 93 : Prometheus Biosciences' List of Pipeline Companion Diagnostics
Table 94 : Qiagen GmbH's List of Pipeline Companion Diagnostics
Table 95 : Thermo Fisher Scientific Inc.: List of Pipeline Companion Diagnostics
Table 96 : Acronyms Used in This Report

List of Figures

Summary Figure : Global Market for Companion Diagnostics, by Technology, 2019-2026
Figure 1 : Companion Diagnostic Co-development Process from Biomarker Discovery to Regulatory Approval
Figure 2 : Global Market for Companion Diagnostics, by Type of Test, 2019-2026
Figure 3 : Global Market Shares of Companion Diagnostics, by Type of Test, 2020
Figure 4 : Global Market for Companion Diagnostics, by Solution, 2019-2026
Figure 5 : Global Market Shares of Companion Diagnostics, by Solution, 2020
Figure 6 : Global Market for Companion Diagnostic Solutions, by Region, 2019-2026
Figure 7 : Global Market Shares of Companion Diagnostic Solutions, by Region, 2020
Figure 8 : Global Market for Companion Diagnostic Instruments, by Region, 2019-2026
Figure 9 : Global Market for Companion Diagnostic Consumables, by Region, 2019-2026
Figure 10 : Global Market for Companion Diagnostic Services, by Region, 2019-2026
Figure 11 : Share of FDA-Approved CDx Tests, by Technology, 2000-June 2021
Figure 12 : Global Market for Companion Diagnostics, by Technology, 2019-2026
Figure 13 : Global Market Shares of Companion Diagnostics, by Technology, 2020
Figure 14 : Global Market for Companion Diagnostic Technologies, by Region, 2019-2026
Figure 15 : Global Market Shares of Companion Diagnostic Technologies, by Region, 2020
Figure 16 : Global Market for Immunohistochemistry CDx, by Region, 2019-2026
Figure 17 : Global Market for In Situ Hybridization CDx, by Region, 2019-2026
Figure 18 : Global Market for Polymerase Chain Reaction CDx, by Region, 2019-2026
Figure 19 : Global Market for Next-Generation Sequencing CDx, by Region, 2019-2026
Figure 20 : Global Market for Genotyping CDx, by Region, 2019-2026
Figure 21 : Global Market for Other CDx Technologies, by Region, 2019-2026
Figure 22 : Global Market for Companion Diagnostic Services, by Region, 2019-2026
Figure 23 : Global Market for Companion Diagnostics, by Application, 2019-2026
Figure 24 : Global Market Shares of Companion Diagnostics, by Application, 2020
Figure 25 : Global Market for Companion Diagnostic Applications, by Region, 2019-2026
Figure 26 : Global Market Shares of Diagnostic Applications, by Region, 2020
Figure 27 : Global Market for Companion Diagnostics in Cancer Applications, by Region, 2019-2026
Figure 28 : Global Market for Companion Diagnostics in Cancer Applications, by Type, 2019-2026
Figure 29 : Global Market Shares of Companion Diagnostics in Cancer Applications, by Cancer Type, 2020
Figure 30 : Global Market for Companion Diagnostics in Pharmacogenetic Applications, by Region, 2019-2026
Figure 31 : Global Market for Companion Diagnostics in Cystic Fibrosis Applications, by Region, 2019-2026
Figure 32 : Global Market for Companion Diagnostics in HIV Applications, by Region, 2019-2026
Figure 33 : Global Market for LDT-CDx, by Application, 2019-2026
Figure 34 : Perspective of Different Stakeholders in CDx Market
Figure 35 : Companion Diagnostic Business Models
Figure 36 : Global Market Shares of Leading Developers of IHC Companion Diagnostics, 2020
Figure 37 : Global Market Shares of Leading Developers of ISH Companion Diagnostics, 2020
Figure 38 : Global Market Shares of Leading Developers of PCR Companion Diagnostics, 2020
Figure 39 : Global Market Shares of Leading Developers of NGS Companion Diagnostics, 2020
Figure 40 : Global Market Shares of Leading Developers of Genotyping Companion Diagnostics, 2020
Figure 41 : Global Market Shares of Leading Developers of Other Companion Diagnostics, 2020
Figure 42 : Share of Patents Issued for Companion Diagnostics, by Year, 2018–June 2021
Figure 43 : Patents Issued for Companion Diagnostics, by Application, 2018-June 2021
Figure 44 : Patents Issued for Companion Diagnostics, by Assignee, 2018-June 2021
Figure 45 : Clinical Trials in Companion Diagnostics, by Type of Study
Figure 46 : Clinical Trials in Companion Diagnostics, by Status
Figure 47 : Clinical Trials in Companion Diagnostics, by Phase
Figure 48 : Clinical Trials in Companion Diagnostics, by Technology
Figure 49 : Clinical Trials on Companion Diagnostics, by Application
Figure 50 : Share of Clinical Trials in Companion Diagnostics, by Therapeutic Area
Figure 51 : SWOT Analysis of the Global Companion Diagnostics Market

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