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Report
Companion Diagnostics: Technologies and Markets
Market Research Report I 2024-04-23 I 121 Pages I BCC Research
Description
Report Scope
The current report provides detailed coverage of the companion diagnostics market. This report highlights the current and future market potential of companion diagnostics, and it includes a detailed analysis of the drivers, opportunities, restraints, and challenges in the market. The report details the companion diagnostics market share based on product and service, type of test, technology, and application. The market's products and services is segmented into instruments, consumables, and services. It is categorized based on the type of test into commercial CDx and lab-developed tests (LDT)-CDx. Based on technology, the market is segmented into polymerase chain reaction, immunohistochemistry, next-generation sequencing, in situ hybridization, genotyping, immunoassays, exosomes, others, and services market. Based on application, the CDx market is categorized into cancer, neurologic disorders, cardiovascular disease, infectious disease, and others. Based on end users, the companion diagnostics market is segmented into clinical laboratories, pharmaceutical companies, contract research organizations (CROs), and other end users. The report also includes company profiles of the major players in the companion diagnostics market, with details about each company's business segments, financials, product portfolios, and recent developments.
By geographical region, the market is segmented into North America, Europe, Asia-Pacific, and the Rest of the World. The North America region includes the U.S. and Canada; Europe includes Germany, the U.K., Italy, France, and the Rest of Europe; Asia-Pacific includes China, India, Japan, and the Rest of Asia-Pacific. For market estimates, data has been provided for 2020 and 2021 as the historic years, 2022 as the base year, and 2028 as the forecast year.
Report Includes
- 54 data tables and 59 additional tables
- Overview and an analysis of the global markets for companion diagnostics (CDx).
- Analyses of the global market trends, with historical market revenue data (sales figures) from 2021 to 2022, estimates for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028.
- A look at the current and future market potential of companion diagnostics along with the market dynamics, competitive landscape and regulatory scenario.
- Estimate of the market size and revenue forecast for the global CDx market, and corresponding market share analysis based on product and services, test type, technology, application, end user and region.
- Discussion of the market opportunities for CDx products by identification of high-growth applications in different therapeutic areas, with a focus on the largest and fastest-expanding markets for diseases.
- Analysis of recent market developments and clinical trials, as well as the leading companies engaged in R&D and product developments in CDx reagents.
- Discussion of the importance of ESG in the CDx industry, including consumer attitudes, the impact of ESG on company performance, ESG score analysis, and ESG practices followed by leading companies.
- Review of key patent grants and patent applications related to CDx.
- Identification of the major vendors along with an analysis of the competitive intelligence, including companies' market shares, recent M&A activity, and venture funding outlook.
- Company profiles of major players within the industry, including F. Hoffmann-La Roche Ltd., Agilent Technologies Inc., and QIAGEN
Executive Summary
Summary:
The global market for companion diagnostics is estimated to increase from $7.6 billion in 2023 to reach $15.4 billion by 2028, at a compound annual growth rate (CAGR) of 15.2% from 2023 through 2028.
Table of Contents
Chapter 1 Executive Summary
Market Outlook
Scope of Report
Market Summary
Highlights of the Market for Companion Diagnostics (CDx)
Chapter 2 Market Overview
Introduction
History
Regulatory Landscape
Companion Diagnostics Regulations in the U.S.
Companion Diagnostics Regulations Outside the U.S.
LDT-CDx Regulation
Chapter 3 Market Dynamics
Market Dynamics
Market Drivers
Market Restraints
Market Opportunities
Market Challenges
Chapter 4 Emerging Technologies and Developments
Emerging Technologies
Multiplex Testing
Next-Generation Sequencing (NGS)
Digital PCR
Liquid Biopsy
Artificial Intelligence
Chapter 5 Market Segmentation Analysis
Segmental Breakdown
Global Market for Companion Diagnostics by Product and Service
Market Share and Forecast
Instruments
Consumables
Services
Global Market for Companion Diagnostics by Type of Test
Market Share and Forecast
LDT-CDx
Commercial CDx
Global Market for Companion Diagnostics by Technology
Market Share and Forecast
Polymerase Chain Reaction
Immunohistochemistry
Next-Generation Sequencing
In Situ Hybridization
Genotyping
Immunoassays
Exosomes
Others
Services
Global Market for Companion Diagnostics by Application
Market Share and Forecast
Cancer
Market for the Application of CDx in Cancer by Type
Neurologic Disorders
Cardiovascular Disease
Infectious Diseases
Other Diseases
Market Breakdown by End User
Market Share and Forecast
Clinical Laboratories
Pharmaceutical Companies
Contract Research Organizations (CROs)
Other End Users
Geographic Breakdown
Global Market for Companion Diagnostics by Region
North America
The U.S.
Canada
Europe
Germany
The U.K.
France
Italy
Rest of Europe
Asia-Pacific
China
Japan
India
Rest of Asia-Pacific
Rest of the World
Chapter 6 Competitive Intelligence
Market Share Analysis
Leading Market Players in Companion Diagnostics Market, by Technology
Grants and Funding in Companion Diagnostics
Recent Developments of Key Market Players
Clinical Trials Analysis
Clinical Trials Analysis, by Type of Study
Clinical Trials Analysis, by Status
Clinical Trials Analysis, by Phase
Clinical Trials Analysis, by Region
Patent Analysis
Patents, by Year
Patents, by Top Applicant
Patents, by Top Owner
Patents, by Jurisdiction
Chapter 7 Sustainability in Companion Diagnostics: ESG Perspective
Introduction to ESG
Sustainability in the Companion Diagnostics Industry: An ESG Perspective
Key ESG Issues
Concluding Remarks from BCC
Chapter 8 Appendix
Methodology
References
Company Profiles
ABBOTT
AGILENT TECHNOLOGIES INC.
ARUP LABORATORIES
BIOMERIEUX
DANAHER CORP.
F. HOFFMANN-LA ROCHE LTD.
ILLUMINA INC.
MYRIAD GENETICS INC.
QIAGEN
THERMO FISHER SCIENTIFIC INC.
List of Tables
Summary Table A : Global Market for Companion Diagnostics, by Product, Through 2028
Summary Table B : Global Market for Companion Diagnostics, by Region, Through 2028
Table 1 : Expanded/New CDx Testing for Personalized Medicine in 2022
Table 2 : Global Market for Companion Diagnostics, by Product and Service, Through 2028
Table 3 : Companion Diagnostics Instruments
Table 4 : Global Market for Companion Diagnostics Instruments, by Region, Through 2028
Table 5 : Global Market for Companion Diagnostics Consumables, by Region, Through 2028
Table 6 : Global Market for Companion Diagnostics Services, by Region, Through 2028
Table 7 : Global Market for Companion Diagnostics, by Type of Test, Through 2028
Table 8 : Global Market for Laboratory Developed Test (LDT)-CDx, by Region, Through 2028
Table 9 : List of FDA-Approved Companion Diagnostics, by Company, as of December 2023
Table 10 : Global Market for Commercial-CDx, by Region, Through 2028
Table 11 : FDA-Approved CDx Tests, by Technology, as of December 2023
Table 12 : Global Market for Companion Diagnostics, by Technology, Through 2028
Table 13 : List of FDA-Approved PCR-CDx, by Company, as of December 2023
Table 14 : Global Market for Polymerase Chain Reaction CDx, by Region, Through 2028
Table 15 : Global Market for Polymerase Chain Reaction CDx, by Application, Through 2028
Table 16 : List of FDA-Approved IHC-CDx, by Company, as of December 2023
Table 17 : Global Market for Immunohistochemistry CDx, by Region, Through 2028
Table 18 : Global Market for Immunohistochemistry CDx, by Application, Through 2028
Table 19 : List of FDA-Approved NGS-CDx, by Company, as of December 2023
Table 20 : Global Market for Next-Generation Sequencing CDx, by Region, Through 2028
Table 21 : Global Market for Next-Generation Sequencing CDx, by Application, Through 2028
Table 22 : List of FDA-Approved ISH-CDx, by Company, as of December 2023
Table 23 : Global Market for In Situ Hybridization CDx, by Region, Through 2028
Table 24 : Global Market for In Situ Hybridization CDx, by Application, Through 2028
Table 25 : Global Market for Genotyping CDx, by Region, Through 2028
Table 26 : Global Market for Genotyping CDx, by Application, Through 2028
Table 27 : Global Market for Immunoassays CDx, by Region, Through 2028
Table 28 : Global Market for Immunoassays CDx, by Application, Through 2028
Table 29 : Global Market for Exosome CDx, by Region, Through 2028
Table 30 : Global Market for Exosomes CDx, by Application, Through 2028
Table 31 : Global Market for Other CDx, by Region, Through 2028
Table 32 : Global Market for Other CDx, by Application, Through 2028
Table 33 : Technological Expertise in the CDx Services Sector
Table 34 : Global Market for CDx Services, by Region, Through 2028
Table 35 : Global Market for CDx Services, by Application, Through 2028
Table 36 : Global Market for Companion Diagnostics, by Application, Through 2028
Table 37 : Global Market for Companion Diagnostics in Cancer Applications, by Region, Through 2028
Table 38 : Cancer Incidence, Global, by Cancer Type, 2022
Table 39 : Approved CDx Drugs for Cancer Treatment, by Cancer Type, 2023
Table 40 : Global Market for Companion Diagnostics in Cancer Applications, by Cancer Type, Through 2028
Table 41 : Global Market for Companion Diagnostics in Neurologic Disorder Applications, by Region, Through 2028
Table 42 : Global Market for Companion Diagnostics in Neurologic Disorder Applications, by Type, Through 2028
Table 43 : Global Market for Companion Diagnostics in Cardiovascular Disease Applications, by Region, Through 2028
Table 44 : Global Market for Companion Diagnostics in Infectious Disease Applications, by Region, Through 2028
Table 45 : Global Market for Companion Diagnostics in Other Disease Applications, by Region, Through 2028
Table 46 : Global Market for Companion Diagnostics, by End User, Through 2028
Table 47 : Global Market for Companion Diagnostics in Clinical Laboratories, by Region, Through 2028
Table 48 : Recent Collaborations and Partnerships in the Companion Diagnostics Market, 2022 and 2023
Table 49 : Global Market for Companion Diagnostics in Pharmaceutical Companies, by Region, Through 2028
Table 50 : Global Market for Companion Diagnostics in Contract Research Organizations, by Region, Through 2028
Table 51 : Global Market for Companion Diagnostics in Other End Users, by Region, Through 2028
Table 52 : Global Market for Companion Diagnostics, by Region, Through 2028
Table 53 : North American Market for Companion Diagnostics, by Country, Through 2028
Table 54 : European Market for Companion Diagnostics, by Country, Through 2028
Table 55 : Asia-Pacific Market for Companion Diagnostics, by Country, Through 2028
Table 56 : FDA Approved CDx, by Company, as of December 2023
Table 57 : Companion Diagnostics: Market Share Analysis, 2023
Table 58 : Leading Companies in the Companion Diagnostics Market, by Technology
Table 59 : Companion Diagnostics: Market Ranking, by Major Technology
Table 60 : Grants and Funding in Companion Diagnostics, 2020-2022
Table 61 : Recent Developments in the Companion Diagnostics Market, 2023
Table 62 : Clinical Trials in Companion Diagnostics, by Type of Study, January 2024
Table 63 : Clinical Trials in Companion Diagnostics, by Status, January 2024
Table 64 : Clinical Trials in Companion Diagnostics, by Phase, January 2024
Table 65 : Clinical Trials in Companion Diagnostics, by Region, January 2024
Table 66 : Patents Granted on Companion Diagnostics, by Top Applicant, 2019-2023
Table 67 : Patents Granted on Companion Diagnostics, by Top Owner, 2019-2023
Table 68 : Patents Granted for Companion Diagnostics, by Jurisdiction, 2019-2023
Table 69 : ESG Risk Rankings for Companion Diagnostic Companies, 2024*
Table 70 : ESG: Environmental Overview
Table 71 : ESG: Social Overview
Table 72 : ESG: Governance Overview
Table 73 : Acronyms Used in This Report
Table 74 : Abbott: Company Snapshot
Table 75 : Abbott: Financial Performance, FY 2022 and 2023
Table 76 : Abbott: Product Portfolio
Table 77 : Agilent Technologies Inc.: Company Snapshot
Table 78 : Agilent Technologies Inc.: Financial Performance, FY 2022 and 2023
Table 79 : Agilent Technologies Inc.: Product Portfolio
Table 80 : Agilent Technologies Inc.: News/Key Developments, 2021-2023
Table 81 : ARUP Laboratories: Company Snapshot
Table 82 : ARUP Laboratories: Product Portfolio
Table 83 : ARUP Laboratories: News/Key Developments, 2023
Table 84 : bioMerieux: Company Snapshot
Table 85 : bioMerieux: Financial Performance, FY 2021 and 2022
Table 86 : bioMerieux: Product Portfolio
Table 87 : bioMerieux: News/Key Developments, 2021
Table 88 : Danaher Corp.: Company Snapshot
Table 89 : Danaher Corp.: Financial Performance, FY 2022 and 2023
Table 90 : Danaher Corp.: Product Portfolio
Table 91 : Danaher Corp.: News/Key Developments, 2021-2023
Table 92 : F. Hoffmann-La Roche Ltd.: Company Snapshot
Table 93 : F. Hoffmann-La Roche Ltd.: Financial Performance, FY 2021 and 2022
Table 94 : F. Hoffmann-La Roche Ltd.: Product Portfolio
Table 95 : F. Hoffmann-La Roche Ltd.: News/Key Developments, 2021-2023
Table 96 : Illumina Inc.: Company Snapshot
Table 97 : Illumina Inc.: Financial Performance, FY 2022 and 2023
Table 98 : Illumina Inc.: Product Portfolio
Table 99 : Illumina Inc.: News/Key Developments, 2021 and 2022
Table 100 : Myriad Genetics Inc.: Company Snapshot
Table 101 : Myriad Genetics Inc.: Financial Performance, FY 2022 and 2023
Table 102 : Myriad Genetics Inc.: Product Portfolio
Table 103 : Myriad Genetics Inc.: News/Key Developments, 2020 and 2023
Table 104 : QIAGEN: Company Snapshot
Table 105 : QIAGEN: Financial Performance, FY 2021 and 2022
Table 106 : QIAGEN: Product Portfolio
Table 107 : QIAGEN: News/Key Developments, 2021-2023
Table 108 : Thermo Fisher Scientific Inc.: Company Snapshot
Table 109 : Thermo Fisher Scientific Inc.: Financial Performance, FY 2022 and 2023
Table 110 : Thermo Fisher Scientific Inc.: Product Portfolio
Table 111 : Thermo Fisher Scientific Inc.: News/Key Developments, 2020-2023
List of Figures
Summary Figure A : Global Market for Companion Diagnostics, by Product, 2020-2028
Summary Figure B : Global Market for Companion Diagnostics, by Region, 2020-2028
Figure 1 : Companion Diagnostics: Timeline, 1990s-Present
Figure 2 : Timeline of FDA Guidance Release for Companion Diagnostics (CDx), as of 2023
Figure 3 : Market Dynamics of Companion Diagnostics
Figure 4 : Share of Global Cancer Incidence for Both Sexes, by Region, 2022
Figure 5 : Companion Diagnostics: Growing Share in Total New Molecular Entities (NMEs), 2019-2022
Figure 6 : Emerging Trends/Technologies in the Companion Diagnostics Market
Figure 7 : Patents Granted for Companion Diagnostics, by Year, 2019-2023
Figure 8 : ESG Pillars
Figure 9 : Abbott: Revenue Share, by Business Unit, FY 2023
Figure 10 : Abbott: Revenue Share, by Country/Region, FY 2023
Figure 11 : Agilent: Revenue Share, by Business Unit, FY 2023
Figure 12 : Agilent: Revenue Share, by Country/Region, FY 2023
Figure 13 : bioMerieux: Market Share, by Business Unit, FY 2022
Figure 14 : bioMerieux: Revenue Share, by Country/Region, FY 2022
Figure 15 : Danaher Corp.: Market Share, by Business Unit, FY 2023
Figure 16 : Danaher Corp.: Revenue Share, by Country/Region, FY 2023
Figure 17 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Business Unit, FY 2022
Figure 18 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Country/Region, FY 2022
Figure 19 : Illumina Inc.: Revenue Share, by Business Unit, FY 2022
Figure 20 : Illumina Inc.: Revenue Shares, by Country/Region, FY 2022
Figure 21 : Myriad Genetics Inc.: Revenue Share, by Business Unit, FY 2023
Figure 22 : Myriad Genetics Inc.: Revenue Share, by Country/Region, FY 2023
Figure 23 : QIAGEN: Market Share, by Business Unit, FY 2022
Figure 24 : QIAGEN: Revenue Share, by Country/Region, FY 2022
Figure 25 : Thermo Fisher Scientific Inc.: Market Share, by Business Unit, FY 2023
Figure 26 : Thermo Fisher Scientific Inc.: Revenue Share, by Country/Region, FY 2023
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