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
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: bioMérieux SA: Total Revenue, 2019-2021
Figure 81: bioMérieux SA: Market Share, by Business Segment, 2021
Figure 82: bioMérieux 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