Table of Content


Chapter 1 Introduction
1.1 Overview
1.2 Study Goals and Objectives
1.3 Reasons for Doing This Study
1.4 What’s New in This Update?
1.5 Scope of Report
1.6 Information Sources
1.7 Research Methodology
1.8 Geographic Breakdown
1.9 Analyst’s Credentials
Chapter 2 Summary and Highlights
2.1 Highlights of the Market for Companion Diagnostics (CDx)
Chapter 3 Market and Technology Background
3.1 Introduction
3.2 Personalized Medicine and Biomarkers
3.2.1 Predictive Biomarkers
3.3 Companion Diagnostics and Complementary Diagnostics
3.3.1 Companion Diagnostics Development
3.3.2 CDx Stakeholders
3.3.3 Technologies Used in CDx
3.3.4 Applications of CDx
3.3.5 Regulatory Aspects of CDx
Chapter 4 Global Market for Companion Diagnostics by Product and Service
4.1 Market Overview
4.2 Market Share and Forecast
4.2.1 Instruments
4.2.2 Consumables
4.2.3 Services
Chapter 5 Global Market for Companion Diagnostics by Type of Test
5.1 Market Overview
5.2 Market Share and Forecast
5.2.1 LDT-CDx
5.2.2 Commercial CDx
Chapter 6 Global Market for Companion Diagnostics by Technology
6.1 Market Overview
6.2 Market Share and Forecast
6.2.1 Immunohistochemistry
6.2.2 In Situ Hybridization
6.2.3 Polymerase Chain Reaction
6.2.4 Next-Generation Sequencing
6.2.5 Genotyping
6.2.6 Others
6.2.7 Services
Chapter 7 Global Market for Companion Diagnostics by Application
7.1 Market Overview
7.2 Market Share and Forecast
7.2.1 Cancer
7.2.2 Market for the Application of CDx in Cancer by Type
7.2.3 Neurologic Disorders
7.2.4 Cardiovascular Disease
7.2.5 Infectious Disease
7.2.6 Other Diseases
Chapter 8 Global Market for Companion Diagnostics by Region
8.1 North America
8.1.1 U.S.
8.1.2 Canada
8.2 Europe
8.2.1 Germany
8.2.2 U.K.
8.2.3 France
8.2.4 Italy
8.2.5 Rest of Europe
8.3 Asia-Pacific
8.3.1 China
8.3.2 Japan
8.3.3 India
8.3.4 Rest of Asia-Pacific
8.4 Rest of the World
Chapter 9 Industry Structure
9.1 Overview
9.2 Stakeholders in Companion Diagnostics
9.3 Driving Trends in Companion Diagnostics
9.4 Business Models of Companion Diagnostics
9.5 Grants and Funding in Companion Diagnostics
9.6 Collaborations and Partnerships
9.7 Mergers and Acquisitions
9.7.1 Market Share Analysis
9.8 Leading Market Players in Companion Diagnostics Market, by Technology
9.8.1 Leading Market Players in IHC Market
9.8.2 Leading Market Players in ISH Market
9.8.3 Leading Market Players in PCR Market
9.8.4 Leading Market Players in NGS Market
9.8.5 Leading Market Players in Genotyping Market
9.8.6 Leading Market Players in Others (Tropism, MRI) CDx Market
Chapter 10 Patent Review
10.1 Introduction
10.2 Patents on Companion Diagnostics Market
10.3 Patent Analysis
10.3.1 Patents by Year
10.3.2 Patents by Top Applicant
10.3.3 Patents by Top Owner
10.3.4 Patents by Jurisdiction
Chapter 11 Clinical Trials Analysis
11.1 Introduction
11.2 Clinical Trials and CDx
11.3 Clinical Trials Analysis
11.3.1 Clinical Trials Analysis, by Type of Study
11.3.2 Clinical Trials Analysis, by Status
11.3.3 Clinical Trials Analysis, by Phase
11.3.4 Clinical Trials Analysis, by Region
11.3.5 Clinical Trials Analysis, by Application
11.3.6 Companies with Companion Diagnostics in Clinical Trials
Chapter 12 Analysis of Market Opportunities
12.1 Introduction
12.2 Market Dynamics
12.2.1 Strengths
12.2.2 Challenges
12.2.3 Opportunities
12.2.4 Threats
12.3 Impact of the COVID-19 Pandemic
Chapter 13 Company Profiles
ABBOTT
ADAPTIVE BIOTECHNOLOGIES CORP.
AGILENT TECHNOLOGIES INC.
AMOY DIAGNOSTICS CO., LTD.
ALMAC GROUP LTD.
ARUP LABORATORIES
AUTOGENOMICS INC. (ACQUIRED BY PRESCIENT MEDICINE)
BIOCARTIS
BIODESIX INC.
BIOFLUIDICA
BIOMERIEUX SA
BIO-TECHNE
CERBA RESEARCH
CIRCULOGENE
DANAHER
DIASORIN S.P.A.
EXACT SCIENCES CORP.
F. HOFFMANN-LA ROCHE LTD.
GUARDANT HEALTH INC.
HOLOGIC INC.
ICON PLC
ILLUMINA INC.
INVIVOSCRIBE INC.
MAZE THERAPEUTICS
MYRIAD GENETICS INC.
NEOGENOMICS LABORATORIES
QIAGEN
QUEST DIAGNOSTICS INC.
RESONANCE HEALTH LTD.
SIEMENS HEALTHINEERS AG
SPARTAN BIOSCIENCE INC.
SYSMEX CORP.
THERMO FISHER SCIENTIFIC INC.
TRIMGEN CORP.
VELA DIAGNOSTICS INC.
Chapter 14 Appendix: Acronyms



List of Figures

List of Figures
Summary Figure A : Global Market for Companion Diagnostics, by Product and Service, 2019-2027
Summary Figure B : Global Market for Companion Diagnostics, by Region, 2019-2027
Figure 1 : Companion Diagnostics Co-development Process from Biomarker Discovery to Regulatory Approval
Figure 2 : Overview of the Key Priorities/Needs for CDx Tests Across Stakeholders
Figure 3 : Global Market for Companion Diagnostics, by Product and Service, 2019-2027
Figure 4 : Global Market Shares of Companion Diagnostics, by Product and Service, 2021
Figure 5 : Global Market for Companion Diagnostics Instruments, by Region, 2019-2027
Figure 6 : Global Market for Companion Diagnostics Consumables, by Region, 2019-2027
Figure 7 : Global Market for Companion Diagnostics Services, by Region, 2019-2027
Figure 8 : Global Market for Companion Diagnostics, by Type of Test, 2019-2027
Figure 9 : Global Market Shares of Companion Diagnostics, by Type of Test, 2021
Figure 10 : Global Market for Laboratory Developed Test (LDT)-CDx, by Region, 2019-2027
Figure 11 : Global Market for Commercial-CDx, by Region, 2019-2027
Figure 12 : Share of FDA-Approved CDx Tests, by Technology, 2000–June 2021
Figure 13 : Global Market for Companion Diagnostics, by Technology, 2019-2027
Figure 14 : Global Market Shares of Companion Diagnostics, by Technology, 2021
Figure 15 : Global Market for Immunohistochemistry CDx, by Region, 2019-2027
Figure 16 : Global Market for In Situ Hybridization CDx, by Region, 2019-2027
Figure 17 : Global Market for Polymerase Chain Reaction CDx, by Region, 2019-2027
Figure 18 : Global Market for Next-Generation Sequencing CDx, by Region, 2019-2027
Figure 19 : Global Market for Genotyping CDx, by Region, 2019-2027
Figure 20 : Global Market for Other CDx Technologies, by Region, 2019-2027
Figure 21 : Global Market for CDx Services, by Region, 2019-2027
Figure 22 : Global Market for Companion Diagnostics, by Application, 2019-2027
Figure 23 : Global Market Shares of Companion Diagnostics, by Application, 2021
Figure 24 : Global Market for Companion Diagnostics in Cancer Applications, by Region, 2019-2027
Figure 25 : Global Market for Companion Diagnostics in Cancer Applications, by Cancer Type, 2019-2027
Figure 26 : Global Market Shares of Companion Diagnostics in Cancer Applications, by Cancer Type, 2021
Figure 27 : Global Market for Companion Diagnostics in Neurologic Disorders Applications, by Region, 2019-2027
Figure 28 : Global Market for Companion Diagnostics in Cardiovascular Disease Application, by Region, 2019-2027
Figure 29 : Global Market for Companion Diagnostics in Infectious Disease Application, by Region, 2019-2027
Figure 30 : Global Market for Companion Diagnostics in Other Disease Applications, by Region, 2019-2027
Figure 31 : Global Market for Companion Diagnostics, by Region, 2019-2027
Figure 32 : Global Market Shares of Companion Diagnostics, by Region, 2021
Figure 33 : North American Market for Companion Diagnostics, by Country, 2019-2027
Figure 34 : North American Market Shares of Companion Diagnostics, by Country, 2021
Figure 35 : U.S. Market for Companion Diagnostics, 2019-2027
Figure 36 : Canadian Market for Companion Diagnostics, 2019-2027
Figure 37 : European Market for Companion Diagnostics, by Country, 2019-2027
Figure 38 : European Market Shares of Companion Diagnostics, by Country, 2021
Figure 39 : German Market for Companion Diagnostics, 2019-2027
Figure 40 : U.K. Market for Companion Diagnostics, 2019-2027
Figure 41 : French Market for Companion Diagnostics, 2019-2027
Figure 42 : Cancer Incidence in Italy, by Cancer Type, 2020
Figure 43 : Italian Market for Companion Diagnostics, 2019-2027
Figure 44 : Rest of the European Market for Companion Diagnostics, 2019-2027
Figure 45 : Asia-Pacific Market for Companion Diagnostics, by Country, 2019-2027
Figure 46 : Asia-Pacific Market Shares of Companion Diagnostics, by Country, 2021
Figure 47 : Cancer Incidence in China, by Cancer Type,2020
Figure 48 : Distribution Share of Cancer Incidence in China, by Cancer Type, 2020
Figure 49 : Chinese Market for Companion Diagnostics, 2019-2027
Figure 50 : Japanese Market for Companion Diagnostics, 2019-2027
Figure 51 : Indian Market for Companion Diagnostics, 2019-2027
Figure 52 : Rest of Asia-Pacific Market for Companion Diagnostics, 2019-2027
Figure 53 : RoW Market for Companion Diagnostics, 2019-2027
Figure 54 : Perspective of Different Stakeholders in CDx Market
Figure 55 : Companion Diagnostics Business Models
Figure 56 : Number of Patents Issued on Companion Diagnostics, by Year, 2018-2022
Figure 57 : Number of Patents Issued on Companion Diagnostics, by Top Applicant, 2018-2022
Figure 58 : Number of Patents Issued on Companion Diagnostics, by Top Owner, 2018-2022
Figure 59 : Clinical Trials on Companion Diagnostics, by Type of Study, March 2023
Figure 60 : Clinical Trials on Companion Diagnostics, by Status, March 2023
Figure 61 : Clinical Trials on Companion Diagnostics, by Phase, March 2023
Figure 62 : SWOT Analysis of the Global Companion Diagnostics Market
Figure 63 : Distribution Share of Global Cancer Incidence, by Region, 2020
Figure 64 : Estimated Global Cancer Incidence, by Region, 2020 vs. 2040
Figure 65 : Number of Personalized Medicines in the Global Drug Market, 2008-2020
Figure 66 : Abbott: Diagnostics Annual Revenue, 2019-2021
Figure 67 : Abbott: Diagnostics Market Share, by Business Segment, 2021
Figure 68 : Abbott: Diagnostics Market Share, by Region, 2021
Figure 69 : Adaptive Biotechnologies Corp.: Total Revenue, 2019-2021
Figure 70 : Adaptive Biotechnologies Corp.: Market Share, by Business Segment, 2021
Figure 71 : Agilent Technologies Inc.: Diagnostics and Genomics Revenue, 2019-2021
Figure 72 : Agilent Technologies Inc.: Market Share, by Business Segment, 2021
Figure 73 : Agilent Technologies Inc.: Market Share, by Region, 2021
Figure 74 : Biocartis: Total Revenue, 2019-2021
Figure 75 : Biocartis: Market Share, by Business Segment, 2021
Figure 76 : Biocartis: Market Share, by Geography, 2021
Figure 77 : Biodesix Inc.: Total Revenue, 2019-2021
Figure 78 : Biodesix Inc.: Market Share, by Business Segment, 2021
Figure 79 : Biodesix Inc.: Market Share, by Region, 2021
Figure 80 : bioM?rieux SA: Total Revenue, 2019-2021
Figure 81 : bioM?rieux SA : Market Share, by Business Segment, 2021
Figure 82 : bioM?rieux SA : Market Share, by Region, 2021
Figure 83 : Bio-Techne Corp.: Total Revenue, 2019-2021
Figure 84 : Bio-Techne Corp.: Market Share, by Business Segment, 2021
Figure 85 : Bio-Techne Corp.: Market Share, Diagnostics, by Geography, 2021
Figure 86 : Danaher Corp.: Annual Revenue, 2019-2021
Figure 87 : Danaher Corp.: Market Share, by Business Segment, 2021
Figure 88 : Danaher: Market Share, by Geography, 2021
Figure 89 : F. Hoffmann-La Roche Ltd.: Total Revenue, 2019-2021
Figure 90 : F. Hoffmann-La Roche Ltd.: Market Share, by Business Segment, 2021
Figure 91 : F. Hoffmann-La Roche Ltd.: Market Share, by Region, 2021
Figure 92 : Hologic Inc.: Annual Revenue, 2019-2021
Figure 93 : Hologic Inc.: Market Share, by Business Segment, 2021
Figure 94 : Hologic Inc.: Market Share, by Region, 2021
Figure 95 : Illumina Inc.: Annual Revenue, 2019-2021
Figure 96 : Illumina Inc.: Market Share, by Business Segment, 2021
Figure 97 : Illumina Inc.: Market Share, by Region, 2021
Figure 98 : Qiagen NV: Annual Revenue, 2019-2021
Figure 99 : Qiagen NV: Market Share, by Business Segment, 2021
Figure 100 : Qiagen NV: Market Share, by Region, 2021
Figure 101 : Siemens Healthineers AG: Annual Revenue, 2019-2021
Figure 102 : Siemens Healthineers AG: Market Share, by Business Segment, 2021
Figure 103 : Siemens Healthineers AG: Market Share, by Region, 2021
Figure 104 : Sysmex Corp.: Annual Revenue, 2019-2021
Figure 105 : Sysmex Corp.: Market Share, by Business Segment, 2021
Figure 106 : Sysmex Corp.: Market Share, by Region, 2021
Figure 107 : Thermo Fisher Scientific Inc.: Annual Revenue, 2019-2021
Figure 108 : Thermo Fisher Scientific Inc.: Market Share, by Region, 2021
Figure 109 : Thermo Fisher Scientific Inc.: Market Share, by Business Segment, 2021

List of Tables

List of Tables
Summary Table A : Global Market for Companion Diagnostics, by Product and Service, Through 2027
Summary Table B : Global Market for Companion Diagnostics, by Region, Through 2027
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 Among 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 Product and Service, Through 2027
Table 12 : Companion Diagnostics Instruments
Table 13 : Global Market for Companion Diagnostics Instruments, by Region, Through 2027
Table 14 : Global Market for Companion Diagnostics Consumables, by Region, Through 2027
Table 15 : Global Market for Companion Diagnostics Services, by Region, Through 2027
Table 16 : Global Market for Companion Diagnostics, by Type of Test, Through 2027
Table 17 : Laboratory Developed Test (LDT) Assays Approved by the FDA as a Companion Diagnostics (CDx)
Table 18 : Global Market for Laboratory Developed Test (LDT)-CDx, by Region, Through 2027
Table 19 : FDA Approved Companion Diagnostics, March 2023
Table 20 : Global Market for Commercial-CDx, by Region, Through 2027
Table 21 : FDA-Approved CDx Technologies, by Year, 2000–June 2021
Table 22 : Number and Percentage of FDA-Approved CDx Tests, by Technology, 2000–June 2021
Table 23 : Global Market for Companion Diagnostics, by Technology, Through 2027
Table 24 : FDA-Approved IHC-CDx
Table 25 : Global Market for Immunohistochemistry CDx, by Region, Through 2027
Table 26 : FDA-Approved ISH-CDx
Table 27 : Global Market for In Situ Hybridization CDx, by Region, Through 2027
Table 28 : FDA-Approved PCR-CDx
Table 29 : Global Market for Polymerase Chain Reaction CDx, by Region, Through 2027
Table 30 : FDA-Approved NGS-CDx
Table 31 : Foundation Medicine CDx: Indications and Biomarkers
Table 32 : Global Market for Next-Generation Sequencing CDx, by Region, Through 2027
Table 33 : FDA-Cleared Pharmacogenetic Tests
Table 34 : Global Market for Genotyping CDx, by Region, Through 2027
Table 35 : Global Market for Other CDx Technologies, by Region, Through 2026
Table 36 : Technological Expertise in CDx Services Sector
Table 37 : Global Market for CDx Services, by Region, Through 2027
Table 38 : Global Market for Companion Diagnostics, by Application, Through 2027
Table 39 : Drugs with Approved Companion Diagnostics
Table 40 : Global Market for Companion Diagnostics in Cancer Applications, by Region, Through 2027
Table 41 : Cancer Incidence, Global, by Cancer Type, 2020
Table 42 : Total Number of Drugs with Approved CDx, by Cancer Type, 2021
Table 43 : Global Market for Companion Diagnostics in Cancer Applications, by Cancer Type, Through 2027
Table 44 : Global Market for Companion Diagnostics in Neurologic Disorders Applications, by Region, Through 2027
Table 45 : Estimated Deaths Due to Cardiovascular Disease, by Gender and Disease, 2019
Table 46 : Global Market for Companion Diagnostics in Cardiovascular Disease Application, by Region, Through 2027
Table 47 : Classes of ART
Table 48 : Global Market for Companion Diagnostics in Infectious Disease Application, by Region, Through 2027
Table 49 : Global Market for Companion Diagnostics in Other Disease Applications, by Region, Through 2027
Table 50 : Global Market for Companion Diagnostics, by Region, Through 2027
Table 51 : North American Market for Companion Diagnostics, by Country, Through 2027
Table 52 : U.S. Estimated Number of New Cancer Cases, by Cancer Site, 2021
Table 53 : European Market for Companion Diagnostics, by Country, Through 2027
Table 54 : Asia-Pacific Market for Companion Diagnostics, by Country, Through 2027
Table 55 : Grants and Funding in Companion Diagnostics, 2019–July 15, 2020
Table 56 : Collaborations and Partnerships in the Global Companion Diagnostics Market, 2019–February 2023
Table 57 : Mergers and Acquisitions in the Global Companion Diagnostics Market, 2019-2020
Table 58 : Companion Diagnostics: Market Share Analysis
Table 59 : IHC Companion Diagnostics, Product
Table 60 : Leading Market Players of IHC Companion Diagnostics, 2021
Table 61 : ISH Companion Diagnostics, Product
Table 62 : Leading Market Players of ISH Companion Diagnostics, 2021
Table 63 : PCR Companion Diagnostics, Product
Table 64 : Leading Market Players of PCR Companion Diagnostics, 2021
Table 65 : NGS Companion Diagnostics, Products
Table 66 : Leading Market Players of NGS Companion Diagnostics, 2021
Table 67 : Genotyping Companion Diagnostics, Products
Table 68 : Leading Market Players of Genotyping Companion Diagnostics, 2021
Table 69 : Other Companion Diagnostics, Products
Table 70 : Leading Market Players of Other Companion Diagnostics, 2021
Table 71 : Basic Aspects of Patents
Table 72 : Representative Patents on Companion Diagnostics, 2018–June 2021
Table 73 : Number of Patents Issued on Companion Diagnostics, by Top Applicant, 2018-2022
Table 74 : Number of Patents Issued on Companion Diagnostics, by Top Owner, 2018-2022
Table 75 : Number of Patents Issued on Companion Diagnostics, by Jurisdiction, 2017-2022
Table 76 : Clinical Trials on Companion Diagnostics, by Type of Study, March 2023
Table 77 : Clinical Trials on Companion Diagnostics, by Status, March 2023
Table 78 : Clinical Trials on Companion Diagnostics, by Phase, March 2023
Table 79 : Clinical Trials on Companion Diagnostics, by Region, March 2023
Table 80 : Clinical Trials on Companion Diagnostics, by Application, March 2023
Table 81 : Companies with CDx in Clinical Trials, March 2023
Table 82 : Companion Diagnostics and Approved Drugs, 2020-2022
Table 83 : FoundationOne CDx Approved Indications
Table 84 : Common Inefficiencies in Clinical Testing Landscape
Table 85 : Initiatives Towards Harmonization of Commercial and LDT-CDx
Table 86 : All of Us Research Program Highlights
Table 87 : Abbott: Product Portfolio
Table 88 : Agilent Technologies Inc.: Product Portfolio
Table 89 : Agilent Technologies Inc: Key Developments, 2021-2023
Table 90 : Amoy Diagnostics: Key Developments, 2020-2022
Table 91 : Biocartis: Key Developments, 2020-2023
Table 92 : Danaher Corp.: Key Developments, 2021-2022
Table 93 : F. Hoffmann-La Roche Ltd.: Key Developments, 2021-2023
Table 94 : Guardant Health Inc.: Key Developments, 2021-2022
Table 95 : Hologic Inc.: Key Developments, 2021
Table 96 : Illumina Inc.: Key Developments, 2021-2022
Table 97 : Invivoscribe: Key Developments, 2020-2022
Table 98 : Qiagen NV: Key Developments, 2021-2022
Table 99 : Thermo Fisher Scientific Inc.: List of Pipeline Companion Diagnostics
Table 100 : Thermo Fisher Scientific Inc.: Key Developments, 2021-2023
Table 101 : Acronyms Used in This Report