Global Companion Diagnostics Market

Global Companion Diagnostics Market:

Focus on Technology, Application Area, Country Data (12 Countries), and Competitive Landscape - Analysis and Forecast, 2020-2030

The companion diagnostics industry analysis by BIS Research projects the market to grow at a significant CAGR of 12.45% during the forecast period, 2020-2030.

SKU: BH067B
Published Year: 2020
 

Key Questions Answered in this Report:

•    What are the long-term and short-term impacts of companion diagnostics on the human health continuum?
•    What are the major market drivers, challenges, and opportunities in the global companion diagnostics market?
•    What are the key development strategies which are implemented by the major players in order to sustain in the competitive market? 
•    What are the key regulatory implications in developed and developing regions for the global companion diagnostics market?
•    How is the patent landscape in the industry shaping up future technological trends?
•    How is each segment of the market expected to grow during the forecast period from 2020 to 2030?
•    Who are the leading players with significant offerings to the global companion diagnostics market? What is the expected market dominance for each of these leading players? 
•    Which companies are anticipated to be highly disruptive in the future, and why?
•    What are challenges that are yet to be met by the global companion diagnostics market? 

Global Companion Diagnostics Market Forecast, 2020-2030

Global Companion Diagnostics Market

The companion diagnostics industry analysis by BIS Research projects the market to grow at a significant CAGR of 12.45% during the forecast period, 2020-2030. The global companion diagnostics market generated $1,764.7 million revenue in 2019, in terms of value. The global companion diagnostics market growth has been primarily attributed to the major drivers in this market such as growing incidence of cancer, growing demand for precision medicine, and co development of drug and diagnostics. However, there are significant challenges which are restraining the market growth. These challenges include uncertain reimbursement scenario, weak synchronization between therapeutics and diagnostics in marketing and distribution channels.

Expert Quote

“North America is the leading contributor in the global companion diagnostics market and contributed approximately 56.69% to the global market value in 2019. This region is anticipated to grow at a significant CAGR during the forecast period 2020-2030 and continue dominating the global market in 2030. However, the Asia-Pacific region is expected to grow at the highest CAGR of 20.99% during the forecast period. In addition, the region of Europe also contributed a significant share of 25.95% to the global market in 2019.”

Scope of the Market Intelligence on the Global Companion Diagnostics Market

The companion diagnostics research provides a holistic view of the market in terms of various factors influencing it, including regulatory reforms, and technological advancements.

The scope of the report primarily evaluates FDA-approved companion diagnostics products that are commercialized in the U.S. as well as other regions. In addition, the study also includes companion diagnostics products that have received approvals for commercialization from the European Medicines Agency (EMA), Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), and National Medical Products Administration (NMPA; formerly known as China Food and Drug Administration or the CFDA). 

Market Segmentation

The global companion diagnostics market segmentation (on the basis of manufacturing) is further segmented on the basis of technology, application, and region.

The global companion diagnostics market segmentation (on the basis of technology) is segmented into polymerase chain reaction (PCR), immunohistochemistry (IHC), in-situ hybridization (ISH), and next-generation sequencing (NGS).

The global companion diagnostics market segmentation (on the basis of application) is segmented into lung cancer, breast cancer, colorectal cancer, leukemia, stomach cancer, and melanoma.

The global companion diagnostics market segmentation (on the basis of region) is segmented into North America, Europe, Asia-Pacific, and Rest-of-the-World.

Key Companies in the Global Companion Diagnostics Market

The key manufacturers who have been contributing significantly to the global companion diagnostics market include Abbott Laboratories, Agilent Technologies, Inc., ARUP Laboratories, bioMérieux S.A., Danaher Corporation , DiaCarta, Inc., F. Hoffmann-La Roche Ltd, ICON plc, Illumina, Inc., Invivoscribe Technologies, Inc. , Myriad Genetics, Inc. , Novogene Corporation, QIAGEN N.V. , Thermo Fisher Scientific Inc among others.

 Executive Summary
 1    Product Definition
       1.1    Inclusion and Exclusion
 
 2    Research Scope
       2.1    Scope of the Study
       2.2    Key Questions Answered in the Report
       2.3    Global Companion Diagnostics Market: Research Methodology
 
 3    Research Methodology
       3.1    Primary Data Sources
       3.2    Secondary Data Sources
       3.3    Market Estimation Model
 
 4    Market Dynamics
       4.1    Overview
       4.2    Iceberg Analysis - Global Companion Diagnostics Market
       4.3    Impact Analysis
       4.4    Market Drivers
                4.4.1    Growing Incidence of Cancer
                            4.4.1.1    Better Treatment Assurance
                            4.4.1.2    Diagnostic and Treatment Availability for All Forms of Cancer
                4.4.2    Growing Demand for Precision Medicine
                            4.4.2.1    Adverse Drug Reactions
                            4.4.2.2    Boost in Predictive Biomarker Discovery
                4.4.3    Co-Development of Drugs and Diagnostics
       4.5    Market Restraints
                4.5.1    Uncertain Reimbursement Scenario
                4.5.2    Companion Diagnostics Leakage in Oncology
                4.5.3    Weak Synchronization between Therapeutics and Diagnostics in Marketing and Distribution Channels
       4.6    Market Opportunities
                4.6.1    New Indication Areas
                4.6.2    Next-Generation Sequencing Accelerating Targeted Gene Therapy
                4.6.3    Data Science for Companion Diagnostics Applications
 
 5    Industry Insights
       5.1    Legal Requirements and Framework by the FDA
       5.2    Legal Requirements and Framework by the EMA
       5.3    Legal Requirements and Framework by the MHLW
 
 6    Competitive Landscape
       6.1    Mergers and Acquisitions
       6.2    Product Launches and Product Updates
       6.3    Synergistic Activities
       6.4    Business Expansion Activities and Others
       6.5    Product Approvals
       6.6    Market Share Analysis
       6.7    Opportunity Mapping
                6.7.1    By Technology
                6.7.2    By Application Area
                6.7.3    By Region
 
 7    Global Companion Diagnostics Market Overview
       7.1    Classification of Companion Diagnostics (CDx)
       7.2    CDx in a Historical Perspective
       7.3    Constituents for Companion Diagnostics (CDx) Development
       7.4    Significant Applications of Companion Diagnostics (CDx)
       7.5    Companion Diagnostics (CDx): Future Potential
 
 8    Global Companion Diagnostics Market (by Technology)
       8.1    Overview
       8.2    Polymerase Chain Reaction (PCR)
       8.3    Immunohistochemistry (IHC)
       8.4    In-Situ Hybridization (ISH)
       8.5    Next Generation Sequencing (NGS)
 
 9    Global Companion Diagnostics Market (by Application Area)
       9.1    Overview
       9.2    Lung Cancer
       9.3    Breast Cancer
       9.4    Colorectal Cancer
       9.5    Leukemia
       9.6    Stomach Cancer
       9.7    Melanoma
       9.8    Other Application Areas
 
 10    Global Companion Diagnostics Market, (by Region)
         10.1    Overview
         10.2    North America
                    10.2.1    Key Products Marketed
                    10.2.2    U.S.
                    10.2.3    Canada
         10.3    Europe
                    10.3.1    Key Products Marketed
                    10.3.2    Germany
                    10.3.3    France
                    10.3.4    U.K.
                    10.3.5    Italy
                    10.3.6    Spain
                    10.3.7    Rest-of-Europe
         10.4    Asia-Pacific
                    10.4.1    Key Products Marketed
                    10.4.2    China
                    10.4.3    Japan
                    10.4.4    Australia
                    10.4.5    India
                    10.4.6    Singapore
                    10.4.7    Rest-of-APAC
          10.5    Rest-of-the-World
 
 11    Company Profiles
         11.1    Overview
         11.2    Abbott Laboratories
                    11.2.1    Company Overview
                    11.2.2    Role of Abbott Laboratories in the Global Companion Diagnostics Market
                    11.2.3    Financials
                    11.2.4    Key Insights About Financial Health of the Company
                    11.2.5    SWOT Analysis
          11.3    Agilent Technologies, Inc.
                    11.3.1    Company Overview
                    11.3.2    Role of Agilent Technologies, Inc. in the Global Companion Diagnostics Market
                    11.3.3    Financials
                    11.3.4    Key Insights About Financial Health of the Company
                    11.3.5    SWOT Analysis
          11.4    ARUP Laboratories
                    11.4.1    Company Overview
                    11.4.2    Role of ARUP Laboratories in the Global Companion Diagnostics Market
                    11.4.3    SWOT Analysis
          11.5    bioMérieux S.A.
                    11.5.1    Company Overview
                    11.5.2    Role of bioMérieux S.A. in the Global Companion Diagnostics Market
                    11.5.3    Financials
                    11.5.4    Key Insights About Financial Health of the Company
                    11.5.5    SWOT Analysis
         11.6    Danaher Corporation
                    11.6.1    Company Overview
                    11.6.2    Role of Danaher Corporation in the Global Companion Diagnostics Market
                    11.6.3    Financials
                    11.6.4    Key Insights About Financial Health of the Company
                    11.6.5    SWOT Analysis
          11.7    DiaCarta, Inc.
                    11.7.1    Company Overview
                    11.7.2    Role of DiaCarta, Inc. in the Global Companion Diagnostics Market
                    11.7.3    SWOT Analysis
          11.8    F. Hoffmann-La Roche Ltd
                    11.8.1    Company Overview
                    11.8.2    Role of F. Hoffmann-La Roche Ltd in the Global Companion Diagnostics Market
                    11.8.3    Financials
                    11.8.4    Key Insights About Financial Health of the Company
                    11.8.5    SWOT Analysis
          11.9    ICON plc (MolecularMD Corporation)
                    11.9.1    Company Overview
                    11.9.2    Role of ICON plc in the Global Companion Diagnostics Market
                    11.9.3    Financials
                    11.9.4    SWOT Analysis
         11.10   Illumina, Inc.
                    11.10.1    Company Overview
                    11.10.2    Role of Illumina, Inc. in the Global Companion Diagnostics Market
                    11.10.3    Financials
                    11.10.4    Key Insights About Financial Health of the Company
                    11.10.5    SWOT Analysis
         11.11   Invivoscribe Technologies, Inc.
                    11.11.1    Company Overview
                    11.11.2    Role of Invivoscribe Technologies, Inc. in the Global Companion Diagnostics Market
                    11.11.3    SWOT Analysis
        11.12   Myriad Genetics, Inc.
                    11.12.1    Company Overview
                    11.12.2    Role of Myriad Genetics, Inc. in the Global Companion Diagnostics Market
                    11.12.3    Financials
                    11.12.4    SWOT Analysis
         11.13   Novogene Corporation
                    11.13.1    Company Overview
                    11.13.2    Role of Novogene Corporation in the Global Companion Diagnostics Market
                    11.13.3    SWOT Analysis
        11.14   QIAGEN N.V.
                    11.14.1    Company Overview
                    11.14.2    Role of QIAGEN N.V. in the Global Companion Diagnostics Market
                    11.14.3    Financials
                    11.14.4    Key Insights About Financial Health of the Company
                    11.14.5    SWOT Analysis
         11.15   Thermo Fisher Scientific Inc.
                    11.15.1    Company Overview
                    11.15.2    Role of Thermo Fisher Scientific Inc. in the Global Companion Diagnostics Market
                    11.15.3    Financials
                    11.15.4    Key Insights About Financial Health of the Company
                    11.15.5    SWOT Analysis
 

List of Tables

Table 8.1:    PCR-Based Companion Diagnostics Manufacturers
Table 8.2:    PCR-Based Companion Diagnostics Service Providers
Table 8.3:    IHC-Based Companion Diagnostics Manufacturers
Table 8.4:    IHC-Based Companion Diagnostics Service Providers
Table 8.5:    ISH-Based Companion Diagnostics Manufacturers
Table 8.6:    ISH-Based Companion Diagnostics Service Providers
Table 8.7:    NGS-Based Companion Diagnostics Manufacturers
Table 8.8:    NGS-Based Companion Diagnostics Service Providers
Table 9.1:    Cancer Type - Incidence and Mortality
Table 9.2:    Available Companion Diagnostic Tests for Lung Cancer
Table 9.3:    Available Companion Diagnostic Tests for Breast Cancer
Table 9.4:    Available Companion Diagnostic Tests for Colorectal Cancer
Table 9.5:    Available Companion Diagnostic Tests for Leukemia
Table 9.6:    Available Companion Diagnostic Tests for Stomach Cancer
Table 9.7:    Available Companion Diagnostic Tests for Melanoma
Table 9.8:    Available Companion Diagnostic Tests for Other Application Areas
Table 10.1:    List of Cleared or Approved Companion Diagnostic Devices
Table 10.2:    List of Cleared or Approved Companion Diagnostic Devices
Table 10.3:    List of Cleared or Approved Companion Diagnostic Devices

List of Figures

Figure 1:    Decreasing Cost and Increasing Output (TB) of Genome Sequencing (2009-2025)
Figure 2:    Impact Analysis of Market Drivers and Market Challenges on the Global Companion Diagnostics Market
Figure 3:    Global Companion Diagnostics Market (by Technology), 2019 vs. 2030 ($Million)
Figure 4:    Global Companion Diagnostics Market (by Application Area), 2019 vs. 2030 ($Million)
Figure 5:    Global Companion Diagnostics Market Snapshot
Figure 2.1:    Global Companion Diagnostics Market Segmentation
Figure 2.2:    Global Companion Diagnostics Market Methodology Primary Research Methodology
Figure 3.1:    Bottom-Up Approach (Segment-Wise Analysis)
Figure 3.2:    Top-Down Approach (Segment-Wise Analysis)
Figure 4.1:    Iceberg Analysis - Global Companion Diagnostics Market
Figure 4.2:    Impact Analysis
Figure 4.3:    Cancer Incidence by WHO Region (2012) per 100,000
Figure 4.4:    Decreasing Cost and Increasing Output (TB) of Genome Sequencing (2009-2025)
Figure 4.5:    Fully Aligned Drug-Diagnostic Co-Development
Figure 4.6:    CDx Leakage for Oncology
Figure 5.1:    FDA Guidelines for CDx Approval
Figure 6.1:    Share of Key Developments and Strategies, January 2014–February 2020
Figure 6.2:    Product Launches Share (by Company), January 2014–February 2020
Figure 6.3:    Synergistic Activities Share (by Company), January 2014–February 2020
Figure 6.4:    Market Share Analysis for the Global Companion Diagnostics Market, 2019
Figure 6.5:    Opportunity Mapping for Global Companion Diagnostics Market (by Technology), 2019-2030
Figure 6.6:    Opportunity Mapping for Global Companion Diagnostics Market (by Application Area), 2019-2030
Figure 6.7:    Opportunity Mapping for Global Companion Diagnostics Market (by Region), 2019-2030
Figure 7.1:    Classification of Companion Diagnostics (CDx)
Figure 7.2:    Evolution of Companion Diagnostics (CDx)
Figure 7.3:    Components Required to Develop Companion Diagnostics
Figure 7.4:    Applications of Companion Diagnostics (CDx)
Figure 7.5:    Potential of Companion Diagnostics (CDx)
Figure 8.1:    Global Companion Diagnostics Market (by Technology)
Figure 8.2:    Global Companion Diagnostics Market (PCR Technology), 2019-2030
Figure 8.3:    Total Market Size for PCR Companion Diagnostics (by Application Area), 2019 and 2030
Figure 8.4:    Total Market Size for Immunohistochemistry (by Application Area),  2019 and 2030
Figure 8.5:    Global Companion Diagnostics Market (IHC Technology), 2019-2030
Figure 8.6    Global Companion Diagnostics Market (ISH Technology), 2019-2030
Figure 8.7:    Total Market Size for In-situ Hybridization (by Application Area), 2019 and 2030
Figure 8.8:    Global Companion Diagnostics Market (NGS Technology), 2019-2030
Figure 8.9:    Total Market Size for Next Generation Sequencing (by Application Area), 2019 and 2030
Figure 9.1:    Global Companion Diagnostics Market (by Application Area), 2019-2030
Figure 9.2:    Global Companion Diagnostics Market (Lung Cancer), 2019-2030
Figure 9.3:    Total Market Size for Lung Cancer Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.4:    Global Companion Diagnostics Market (Breast Cancer), 2019-2030
Figure 9.5:    Total Market Size for Breast Cancer Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.6:    Global Companion Diagnostics Market (Colorectal Cancer), 2019-2030
Figure 9.7:    Total Market Size for Colorectal Cancer Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.8:    Global Companion Diagnostics Market (Leukemia), 2019-2030
Figure 9.9:    Total Market Size for Leukemia Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.10:    Global Companion Diagnostics Market (Stomach Cancer), 2019-2030
Figure 9.11:    Total Market Size for Stomach Cancer Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.12:    Global Companion Diagnostics Market (Melanoma), 2019-2030
Figure 9.13:    Total Market Size for Melanoma Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.14:    Global Companion Diagnostics Market (by Other Application Areas), 2019-2030
Figure 10.1:    Global Companion Diagnostics Market (by Region), 2019 and 2030
Figure 10.2:    Global Companion Diagnostics Market (by Region), 2019-2030
Figure 10.3:    Global Companion Diagnostics Market Share (by Region), 2019
Figure 10.4:    Global Companion Diagnostics Market Share (by Region), 2030
Figure 10.5:    North America Companion Diagnostics Market, 2019-2030
Figure 10.6:    North America: Market Dynamics
Figure 10.7:    North America Companion Diagnostics Market (by Country), 2019-2030
Figure 10.8:    U.S. Companion Diagnostics Market, 2019-2030
Figure 10.9:    Canada Companion Diagnostics Market, 2019-2030
Figure 10.10:    Europe Companion Diagnostics Market, 2019-2030
Figure 10.11:    Europe: Market Dynamics
Figure 10.12:    Europe Companion Diagnostics Market (by Country), 2019-2028
Figure 10.13:    Germany Companion Diagnostics Market, 2019-2030
Figure 10.14:    France Companion Diagnostics Market, 2019-2030
Figure 10.15:    U.K. Companion Diagnostics Market, 2019-2030
Figure 10.16:    Italy Companion Diagnostics Market, 2019-2030
Figure 10.17:    Spain Companion Diagnostics Market, 2019-2030
Figure 10.18:    Rest-of-Europe Companion Diagnostics Market, 2019-2030
Figure 10.19:    Asia-Pacific Companion Diagnostics Market, 2019-2030
Figure 10.20:    APAC: Market Dynamics
Figure 10.21:    APAC Companion Diagnostics Market (by Country), 2019-2030
Figure 10.22:    China Companion Diagnostics Market, 2019-2030
Figure 10.23:    Japan Companion Diagnostics Market, 2019-2030
Figure 10.24:    Australia Companion Diagnostics Market, 2019-2030
Figure 10.25:    India Companion Diagnostics Market, 2019-2030
Figure 10.26:    Singapore Companion Diagnostics Market, 2019-2030
Figure 10.27:    RoAPAC Companion Diagnostics Market, 2019-2030
Figure 10.28:    RoW Companion Diagnostics Market, 2019-2030
Figure 11.1:    Total Number of Companies Profiled
Figure 11.2:    Abbott Laboratories: Product Portfolio
Figure 11.3:    Abbott Laboratories: Overall Financials, 2017-2019
Figure 11.4:    Abbott Laboratories: Revenue (by Segment), 2017-2019
Figure 11.5:    Abbott Laboratories: Revenue (by Region), 2017-2019
Figure 11.6:    Abbott Laboratories: R&D Expenditure, 2017-2019
Figure 11.7:    Abbott Laboratories: SWOT Analysis
Figure 11.8:    Agilent Technologies, Inc.: Product Portfolio
Figure 11.9:    Agilent Technologies, Inc.: Overall Financials, 2017-2019
Figure 11.10:    Agilent Technologies, Inc.: Revenue (by Segment), 2017-2019
Figure 11.11:    Agilent Technologies, Inc.: Revenue (by Region), 2016-2018
Figure 11.12:    Agilent Technologies, Inc.: R&D Expenditure, 2017-2019
Figure 11.13:    Agilent Technologies, Inc.: SWOT Analysis
Figure 11.14:    ARUP Laboratories: Product Portfolio
Figure 11.15:    ARUP Laboratories: SWOT Analysis
Figure 11.16:    bioMérieux S.A.: Product Portfolio
Figure 11.17:    bioMérieux S.A.: Overall Financials, 2016-2018
Figure 11.18:    bioMérieux S.A.: Revenue (by Segment), 2016-2018
Figure 11.19:    bioMérieux S.A.: Revenue (by Region), 2016-2018
Figure 11.20:    bioMérieux S.A.: R&D Expenditure, 2016-2018
Figure 11.21:    bioMérieux S.A.: SWOT Analysis
Figure 11.22:    Danaher Corporation: Product Portfolio
Figure 11.23:    Danaher Corporation: Overall Financials, 2016-2018
Figure 11.24:    Danaher Corporation: Revenue (by Business Segment), 2016-2018
Figure 11.25:    Danaher Corporation: Revenue (by Region), 2016-2018
Figure 11.26:    Danaher Corporation: R&D Expenditure, 2016-2018
Figure 11.27:    Danaher Corporation: SWOT Analysis
Figure 11.28:    DiaCarta, Inc.: Product Portfolio
Figure 11.29:    DiaCarta, Inc.: SWOT Analysis
Figure 11.30:    F. Hoffmann-La Roche Ltd: Product Portfolio
Figure 11.31:    F. Hoffmann-La Roche Ltd: Overall Financials, 2017-2019
Figure 11.32:    F. Hoffmann-La Roche Ltd: Revenue (by Segment), 2017-2019
Figure 11.33:    F. Hoffmann-La Roche Ltd: Revenue (by Region), 2017-2019
Figure 11.34:    F. Hoffmann-La Roche Ltd: R&D Expenditure, 2017-2019
Figure 11.35:    F. Hoffmann-La Roche Ltd: SWOT Analysis
Figure 11.36:    ICON plc: Product Portfolio
Figure 11.37:    ICON plc: Overall Financials, 2016-2018
Figure 11.38:    ICON plc: Revenue (by Region), 2016-2018
Figure 11.39:    ICON plc: SWOT Analysis
Figure 11.40:    Illumina, Inc.: Product Portfolio
Figure 11.41:    Illumina, Inc.: Overall Financials, 2017-2019
Figure 11.42:    Illumina, Inc.: Revenue (by Segment), 2017-2019
Figure 11.43:    Illumina, Inc.: Revenue (by Region), 2016-2018
Figure 11.44:    Illumina, Inc.: R&D Expenditure, 2016-2018
Figure 11.45:    Illumina, Inc.: SWOT Analysis
Figure 11.46:    Invivoscribe Technologies, Inc.: Product Portfolio
Figure 11.47:    Invivoscribe Technologies, Inc.: SWOT Analysis
Figure 11.48:    Myriad Genetics, Inc.: Product Portfolio
Figure 11.49:    Myriad Genetics, Inc.: Overall Financials, 2016-2018
Figure 11.50:    Myriad Genetics, Inc.: Revenue (by Business Segment), 2016-2018
Figure 11.51:    Myriad Genetics, Inc.: SWOT Analysis
Figure 11.52:    Novogene Corporation.: Product Portfolio
Figure 11.53:    Novogene Corporation: SWOT Analysis
Figure 11.54:    QIAGEN N.V.: Product Portfolio
Figure 11.55:    QIAGEN N.V.: Overall Financials, 2016-2018
Figure 11.56:    QIAGEN N.V.: Revenue (by Segment), 2016-2018
Figure 11.57:    QIAGEN N.V.: Revenue (by Region), 2016-2018
Figure 11.58:    QIAGEN N.V.: R&D Expenditure, 2016-2018
Figure 11.59:    QIAGEN N.V.: SWOT Analysis
Figure 11.60:    Thermo Fisher Scientific Inc.: Product Portfolio
Figure 11.61:    Thermo Fisher Scientific Inc.: Overall Financials, 2016-2018
Figure 11.62:    Thermo Fisher Scientific Inc.: Revenue (by Segment), 2016-2018
Figure 11.63:    Thermo Fisher Scientific Inc.: Revenue (by Region), 2016-2018
Figure 11.64:    Thermo Fisher Scientific Inc.: R&D Expenditure, 2016-2018
Figure 11.65:    Thermo Fisher Scientific Inc.: SWOT Analysis

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Key Questions Answered in this Report:

•    What are the long-term and short-term impacts of companion diagnostics on the human health continuum?
•    What are the major market drivers, challenges, and opportunities in the global companion diagnostics market?
•    What are the key development strategies which are implemented by the major players in order to sustain in the competitive market? 
•    What are the key regulatory implications in developed and developing regions for the global companion diagnostics market?
•    How is the patent landscape in the industry shaping up future technological trends?
•    How is each segment of the market expected to grow during the forecast period from 2020 to 2030?
•    Who are the leading players with significant offerings to the global companion diagnostics market? What is the expected market dominance for each of these leading players? 
•    Which companies are anticipated to be highly disruptive in the future, and why?
•    What are challenges that are yet to be met by the global companion diagnostics market? 

Global Companion Diagnostics Market Forecast, 2020-2030

Global Companion Diagnostics Market

The companion diagnostics industry analysis by BIS Research projects the market to grow at a significant CAGR of 12.45% during the forecast period, 2020-2030. The global companion diagnostics market generated $1,764.7 million revenue in 2019, in terms of value. The global companion diagnostics market growth has been primarily attributed to the major drivers in this market such as growing incidence of cancer, growing demand for precision medicine, and co development of drug and diagnostics. However, there are significant challenges which are restraining the market growth. These challenges include uncertain reimbursement scenario, weak synchronization between therapeutics and diagnostics in marketing and distribution channels.

Expert Quote

“North America is the leading contributor in the global companion diagnostics market and contributed approximately 56.69% to the global market value in 2019. This region is anticipated to grow at a significant CAGR during the forecast period 2020-2030 and continue dominating the global market in 2030. However, the Asia-Pacific region is expected to grow at the highest CAGR of 20.99% during the forecast period. In addition, the region of Europe also contributed a significant share of 25.95% to the global market in 2019.”

Scope of the Market Intelligence on the Global Companion Diagnostics Market

The companion diagnostics research provides a holistic view of the market in terms of various factors influencing it, including regulatory reforms, and technological advancements.

The scope of the report primarily evaluates FDA-approved companion diagnostics products that are commercialized in the U.S. as well as other regions. In addition, the study also includes companion diagnostics products that have received approvals for commercialization from the European Medicines Agency (EMA), Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), and National Medical Products Administration (NMPA; formerly known as China Food and Drug Administration or the CFDA). 

Market Segmentation

The global companion diagnostics market segmentation (on the basis of manufacturing) is further segmented on the basis of technology, application, and region.

The global companion diagnostics market segmentation (on the basis of technology) is segmented into polymerase chain reaction (PCR), immunohistochemistry (IHC), in-situ hybridization (ISH), and next-generation sequencing (NGS).

The global companion diagnostics market segmentation (on the basis of application) is segmented into lung cancer, breast cancer, colorectal cancer, leukemia, stomach cancer, and melanoma.

The global companion diagnostics market segmentation (on the basis of region) is segmented into North America, Europe, Asia-Pacific, and Rest-of-the-World.

Key Companies in the Global Companion Diagnostics Market

The key manufacturers who have been contributing significantly to the global companion diagnostics market include Abbott Laboratories, Agilent Technologies, Inc., ARUP Laboratories, bioMérieux S.A., Danaher Corporation , DiaCarta, Inc., F. Hoffmann-La Roche Ltd, ICON plc, Illumina, Inc., Invivoscribe Technologies, Inc. , Myriad Genetics, Inc. , Novogene Corporation, QIAGEN N.V. , Thermo Fisher Scientific Inc among others.

 Executive Summary
 1    Product Definition
       1.1    Inclusion and Exclusion
 
 2    Research Scope
       2.1    Scope of the Study
       2.2    Key Questions Answered in the Report
       2.3    Global Companion Diagnostics Market: Research Methodology
 
 3    Research Methodology
       3.1    Primary Data Sources
       3.2    Secondary Data Sources
       3.3    Market Estimation Model
 
 4    Market Dynamics
       4.1    Overview
       4.2    Iceberg Analysis - Global Companion Diagnostics Market
       4.3    Impact Analysis
       4.4    Market Drivers
                4.4.1    Growing Incidence of Cancer
                            4.4.1.1    Better Treatment Assurance
                            4.4.1.2    Diagnostic and Treatment Availability for All Forms of Cancer
                4.4.2    Growing Demand for Precision Medicine
                            4.4.2.1    Adverse Drug Reactions
                            4.4.2.2    Boost in Predictive Biomarker Discovery
                4.4.3    Co-Development of Drugs and Diagnostics
       4.5    Market Restraints
                4.5.1    Uncertain Reimbursement Scenario
                4.5.2    Companion Diagnostics Leakage in Oncology
                4.5.3    Weak Synchronization between Therapeutics and Diagnostics in Marketing and Distribution Channels
       4.6    Market Opportunities
                4.6.1    New Indication Areas
                4.6.2    Next-Generation Sequencing Accelerating Targeted Gene Therapy
                4.6.3    Data Science for Companion Diagnostics Applications
 
 5    Industry Insights
       5.1    Legal Requirements and Framework by the FDA
       5.2    Legal Requirements and Framework by the EMA
       5.3    Legal Requirements and Framework by the MHLW
 
 6    Competitive Landscape
       6.1    Mergers and Acquisitions
       6.2    Product Launches and Product Updates
       6.3    Synergistic Activities
       6.4    Business Expansion Activities and Others
       6.5    Product Approvals
       6.6    Market Share Analysis
       6.7    Opportunity Mapping
                6.7.1    By Technology
                6.7.2    By Application Area
                6.7.3    By Region
 
 7    Global Companion Diagnostics Market Overview
       7.1    Classification of Companion Diagnostics (CDx)
       7.2    CDx in a Historical Perspective
       7.3    Constituents for Companion Diagnostics (CDx) Development
       7.4    Significant Applications of Companion Diagnostics (CDx)
       7.5    Companion Diagnostics (CDx): Future Potential
 
 8    Global Companion Diagnostics Market (by Technology)
       8.1    Overview
       8.2    Polymerase Chain Reaction (PCR)
       8.3    Immunohistochemistry (IHC)
       8.4    In-Situ Hybridization (ISH)
       8.5    Next Generation Sequencing (NGS)
 
 9    Global Companion Diagnostics Market (by Application Area)
       9.1    Overview
       9.2    Lung Cancer
       9.3    Breast Cancer
       9.4    Colorectal Cancer
       9.5    Leukemia
       9.6    Stomach Cancer
       9.7    Melanoma
       9.8    Other Application Areas
 
 10    Global Companion Diagnostics Market, (by Region)
         10.1    Overview
         10.2    North America
                    10.2.1    Key Products Marketed
                    10.2.2    U.S.
                    10.2.3    Canada
         10.3    Europe
                    10.3.1    Key Products Marketed
                    10.3.2    Germany
                    10.3.3    France
                    10.3.4    U.K.
                    10.3.5    Italy
                    10.3.6    Spain
                    10.3.7    Rest-of-Europe
         10.4    Asia-Pacific
                    10.4.1    Key Products Marketed
                    10.4.2    China
                    10.4.3    Japan
                    10.4.4    Australia
                    10.4.5    India
                    10.4.6    Singapore
                    10.4.7    Rest-of-APAC
          10.5    Rest-of-the-World
 
 11    Company Profiles
         11.1    Overview
         11.2    Abbott Laboratories
                    11.2.1    Company Overview
                    11.2.2    Role of Abbott Laboratories in the Global Companion Diagnostics Market
                    11.2.3    Financials
                    11.2.4    Key Insights About Financial Health of the Company
                    11.2.5    SWOT Analysis
          11.3    Agilent Technologies, Inc.
                    11.3.1    Company Overview
                    11.3.2    Role of Agilent Technologies, Inc. in the Global Companion Diagnostics Market
                    11.3.3    Financials
                    11.3.4    Key Insights About Financial Health of the Company
                    11.3.5    SWOT Analysis
          11.4    ARUP Laboratories
                    11.4.1    Company Overview
                    11.4.2    Role of ARUP Laboratories in the Global Companion Diagnostics Market
                    11.4.3    SWOT Analysis
          11.5    bioMérieux S.A.
                    11.5.1    Company Overview
                    11.5.2    Role of bioMérieux S.A. in the Global Companion Diagnostics Market
                    11.5.3    Financials
                    11.5.4    Key Insights About Financial Health of the Company
                    11.5.5    SWOT Analysis
         11.6    Danaher Corporation
                    11.6.1    Company Overview
                    11.6.2    Role of Danaher Corporation in the Global Companion Diagnostics Market
                    11.6.3    Financials
                    11.6.4    Key Insights About Financial Health of the Company
                    11.6.5    SWOT Analysis
          11.7    DiaCarta, Inc.
                    11.7.1    Company Overview
                    11.7.2    Role of DiaCarta, Inc. in the Global Companion Diagnostics Market
                    11.7.3    SWOT Analysis
          11.8    F. Hoffmann-La Roche Ltd
                    11.8.1    Company Overview
                    11.8.2    Role of F. Hoffmann-La Roche Ltd in the Global Companion Diagnostics Market
                    11.8.3    Financials
                    11.8.4    Key Insights About Financial Health of the Company
                    11.8.5    SWOT Analysis
          11.9    ICON plc (MolecularMD Corporation)
                    11.9.1    Company Overview
                    11.9.2    Role of ICON plc in the Global Companion Diagnostics Market
                    11.9.3    Financials
                    11.9.4    SWOT Analysis
         11.10   Illumina, Inc.
                    11.10.1    Company Overview
                    11.10.2    Role of Illumina, Inc. in the Global Companion Diagnostics Market
                    11.10.3    Financials
                    11.10.4    Key Insights About Financial Health of the Company
                    11.10.5    SWOT Analysis
         11.11   Invivoscribe Technologies, Inc.
                    11.11.1    Company Overview
                    11.11.2    Role of Invivoscribe Technologies, Inc. in the Global Companion Diagnostics Market
                    11.11.3    SWOT Analysis
        11.12   Myriad Genetics, Inc.
                    11.12.1    Company Overview
                    11.12.2    Role of Myriad Genetics, Inc. in the Global Companion Diagnostics Market
                    11.12.3    Financials
                    11.12.4    SWOT Analysis
         11.13   Novogene Corporation
                    11.13.1    Company Overview
                    11.13.2    Role of Novogene Corporation in the Global Companion Diagnostics Market
                    11.13.3    SWOT Analysis
        11.14   QIAGEN N.V.
                    11.14.1    Company Overview
                    11.14.2    Role of QIAGEN N.V. in the Global Companion Diagnostics Market
                    11.14.3    Financials
                    11.14.4    Key Insights About Financial Health of the Company
                    11.14.5    SWOT Analysis
         11.15   Thermo Fisher Scientific Inc.
                    11.15.1    Company Overview
                    11.15.2    Role of Thermo Fisher Scientific Inc. in the Global Companion Diagnostics Market
                    11.15.3    Financials
                    11.15.4    Key Insights About Financial Health of the Company
                    11.15.5    SWOT Analysis
 

List of Tables

Table 8.1:    PCR-Based Companion Diagnostics Manufacturers
Table 8.2:    PCR-Based Companion Diagnostics Service Providers
Table 8.3:    IHC-Based Companion Diagnostics Manufacturers
Table 8.4:    IHC-Based Companion Diagnostics Service Providers
Table 8.5:    ISH-Based Companion Diagnostics Manufacturers
Table 8.6:    ISH-Based Companion Diagnostics Service Providers
Table 8.7:    NGS-Based Companion Diagnostics Manufacturers
Table 8.8:    NGS-Based Companion Diagnostics Service Providers
Table 9.1:    Cancer Type - Incidence and Mortality
Table 9.2:    Available Companion Diagnostic Tests for Lung Cancer
Table 9.3:    Available Companion Diagnostic Tests for Breast Cancer
Table 9.4:    Available Companion Diagnostic Tests for Colorectal Cancer
Table 9.5:    Available Companion Diagnostic Tests for Leukemia
Table 9.6:    Available Companion Diagnostic Tests for Stomach Cancer
Table 9.7:    Available Companion Diagnostic Tests for Melanoma
Table 9.8:    Available Companion Diagnostic Tests for Other Application Areas
Table 10.1:    List of Cleared or Approved Companion Diagnostic Devices
Table 10.2:    List of Cleared or Approved Companion Diagnostic Devices
Table 10.3:    List of Cleared or Approved Companion Diagnostic Devices

List of Figures

Figure 1:    Decreasing Cost and Increasing Output (TB) of Genome Sequencing (2009-2025)
Figure 2:    Impact Analysis of Market Drivers and Market Challenges on the Global Companion Diagnostics Market
Figure 3:    Global Companion Diagnostics Market (by Technology), 2019 vs. 2030 ($Million)
Figure 4:    Global Companion Diagnostics Market (by Application Area), 2019 vs. 2030 ($Million)
Figure 5:    Global Companion Diagnostics Market Snapshot
Figure 2.1:    Global Companion Diagnostics Market Segmentation
Figure 2.2:    Global Companion Diagnostics Market Methodology Primary Research Methodology
Figure 3.1:    Bottom-Up Approach (Segment-Wise Analysis)
Figure 3.2:    Top-Down Approach (Segment-Wise Analysis)
Figure 4.1:    Iceberg Analysis - Global Companion Diagnostics Market
Figure 4.2:    Impact Analysis
Figure 4.3:    Cancer Incidence by WHO Region (2012) per 100,000
Figure 4.4:    Decreasing Cost and Increasing Output (TB) of Genome Sequencing (2009-2025)
Figure 4.5:    Fully Aligned Drug-Diagnostic Co-Development
Figure 4.6:    CDx Leakage for Oncology
Figure 5.1:    FDA Guidelines for CDx Approval
Figure 6.1:    Share of Key Developments and Strategies, January 2014–February 2020
Figure 6.2:    Product Launches Share (by Company), January 2014–February 2020
Figure 6.3:    Synergistic Activities Share (by Company), January 2014–February 2020
Figure 6.4:    Market Share Analysis for the Global Companion Diagnostics Market, 2019
Figure 6.5:    Opportunity Mapping for Global Companion Diagnostics Market (by Technology), 2019-2030
Figure 6.6:    Opportunity Mapping for Global Companion Diagnostics Market (by Application Area), 2019-2030
Figure 6.7:    Opportunity Mapping for Global Companion Diagnostics Market (by Region), 2019-2030
Figure 7.1:    Classification of Companion Diagnostics (CDx)
Figure 7.2:    Evolution of Companion Diagnostics (CDx)
Figure 7.3:    Components Required to Develop Companion Diagnostics
Figure 7.4:    Applications of Companion Diagnostics (CDx)
Figure 7.5:    Potential of Companion Diagnostics (CDx)
Figure 8.1:    Global Companion Diagnostics Market (by Technology)
Figure 8.2:    Global Companion Diagnostics Market (PCR Technology), 2019-2030
Figure 8.3:    Total Market Size for PCR Companion Diagnostics (by Application Area), 2019 and 2030
Figure 8.4:    Total Market Size for Immunohistochemistry (by Application Area),  2019 and 2030
Figure 8.5:    Global Companion Diagnostics Market (IHC Technology), 2019-2030
Figure 8.6    Global Companion Diagnostics Market (ISH Technology), 2019-2030
Figure 8.7:    Total Market Size for In-situ Hybridization (by Application Area), 2019 and 2030
Figure 8.8:    Global Companion Diagnostics Market (NGS Technology), 2019-2030
Figure 8.9:    Total Market Size for Next Generation Sequencing (by Application Area), 2019 and 2030
Figure 9.1:    Global Companion Diagnostics Market (by Application Area), 2019-2030
Figure 9.2:    Global Companion Diagnostics Market (Lung Cancer), 2019-2030
Figure 9.3:    Total Market Size for Lung Cancer Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.4:    Global Companion Diagnostics Market (Breast Cancer), 2019-2030
Figure 9.5:    Total Market Size for Breast Cancer Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.6:    Global Companion Diagnostics Market (Colorectal Cancer), 2019-2030
Figure 9.7:    Total Market Size for Colorectal Cancer Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.8:    Global Companion Diagnostics Market (Leukemia), 2019-2030
Figure 9.9:    Total Market Size for Leukemia Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.10:    Global Companion Diagnostics Market (Stomach Cancer), 2019-2030
Figure 9.11:    Total Market Size for Stomach Cancer Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.12:    Global Companion Diagnostics Market (Melanoma), 2019-2030
Figure 9.13:    Total Market Size for Melanoma Companion Diagnostics (by Technology), 2019 and 2030
Figure 9.14:    Global Companion Diagnostics Market (by Other Application Areas), 2019-2030
Figure 10.1:    Global Companion Diagnostics Market (by Region), 2019 and 2030
Figure 10.2:    Global Companion Diagnostics Market (by Region), 2019-2030
Figure 10.3:    Global Companion Diagnostics Market Share (by Region), 2019
Figure 10.4:    Global Companion Diagnostics Market Share (by Region), 2030
Figure 10.5:    North America Companion Diagnostics Market, 2019-2030
Figure 10.6:    North America: Market Dynamics
Figure 10.7:    North America Companion Diagnostics Market (by Country), 2019-2030
Figure 10.8:    U.S. Companion Diagnostics Market, 2019-2030
Figure 10.9:    Canada Companion Diagnostics Market, 2019-2030
Figure 10.10:    Europe Companion Diagnostics Market, 2019-2030
Figure 10.11:    Europe: Market Dynamics
Figure 10.12:    Europe Companion Diagnostics Market (by Country), 2019-2028
Figure 10.13:    Germany Companion Diagnostics Market, 2019-2030
Figure 10.14:    France Companion Diagnostics Market, 2019-2030
Figure 10.15:    U.K. Companion Diagnostics Market, 2019-2030
Figure 10.16:    Italy Companion Diagnostics Market, 2019-2030
Figure 10.17:    Spain Companion Diagnostics Market, 2019-2030
Figure 10.18:    Rest-of-Europe Companion Diagnostics Market, 2019-2030
Figure 10.19:    Asia-Pacific Companion Diagnostics Market, 2019-2030
Figure 10.20:    APAC: Market Dynamics
Figure 10.21:    APAC Companion Diagnostics Market (by Country), 2019-2030
Figure 10.22:    China Companion Diagnostics Market, 2019-2030
Figure 10.23:    Japan Companion Diagnostics Market, 2019-2030
Figure 10.24:    Australia Companion Diagnostics Market, 2019-2030
Figure 10.25:    India Companion Diagnostics Market, 2019-2030
Figure 10.26:    Singapore Companion Diagnostics Market, 2019-2030
Figure 10.27:    RoAPAC Companion Diagnostics Market, 2019-2030
Figure 10.28:    RoW Companion Diagnostics Market, 2019-2030
Figure 11.1:    Total Number of Companies Profiled
Figure 11.2:    Abbott Laboratories: Product Portfolio
Figure 11.3:    Abbott Laboratories: Overall Financials, 2017-2019
Figure 11.4:    Abbott Laboratories: Revenue (by Segment), 2017-2019
Figure 11.5:    Abbott Laboratories: Revenue (by Region), 2017-2019
Figure 11.6:    Abbott Laboratories: R&D Expenditure, 2017-2019
Figure 11.7:    Abbott Laboratories: SWOT Analysis
Figure 11.8:    Agilent Technologies, Inc.: Product Portfolio
Figure 11.9:    Agilent Technologies, Inc.: Overall Financials, 2017-2019
Figure 11.10:    Agilent Technologies, Inc.: Revenue (by Segment), 2017-2019
Figure 11.11:    Agilent Technologies, Inc.: Revenue (by Region), 2016-2018
Figure 11.12:    Agilent Technologies, Inc.: R&D Expenditure, 2017-2019
Figure 11.13:    Agilent Technologies, Inc.: SWOT Analysis
Figure 11.14:    ARUP Laboratories: Product Portfolio
Figure 11.15:    ARUP Laboratories: SWOT Analysis
Figure 11.16:    bioMérieux S.A.: Product Portfolio
Figure 11.17:    bioMérieux S.A.: Overall Financials, 2016-2018
Figure 11.18:    bioMérieux S.A.: Revenue (by Segment), 2016-2018
Figure 11.19:    bioMérieux S.A.: Revenue (by Region), 2016-2018
Figure 11.20:    bioMérieux S.A.: R&D Expenditure, 2016-2018
Figure 11.21:    bioMérieux S.A.: SWOT Analysis
Figure 11.22:    Danaher Corporation: Product Portfolio
Figure 11.23:    Danaher Corporation: Overall Financials, 2016-2018
Figure 11.24:    Danaher Corporation: Revenue (by Business Segment), 2016-2018
Figure 11.25:    Danaher Corporation: Revenue (by Region), 2016-2018
Figure 11.26:    Danaher Corporation: R&D Expenditure, 2016-2018
Figure 11.27:    Danaher Corporation: SWOT Analysis
Figure 11.28:    DiaCarta, Inc.: Product Portfolio
Figure 11.29:    DiaCarta, Inc.: SWOT Analysis
Figure 11.30:    F. Hoffmann-La Roche Ltd: Product Portfolio
Figure 11.31:    F. Hoffmann-La Roche Ltd: Overall Financials, 2017-2019
Figure 11.32:    F. Hoffmann-La Roche Ltd: Revenue (by Segment), 2017-2019
Figure 11.33:    F. Hoffmann-La Roche Ltd: Revenue (by Region), 2017-2019
Figure 11.34:    F. Hoffmann-La Roche Ltd: R&D Expenditure, 2017-2019
Figure 11.35:    F. Hoffmann-La Roche Ltd: SWOT Analysis
Figure 11.36:    ICON plc: Product Portfolio
Figure 11.37:    ICON plc: Overall Financials, 2016-2018
Figure 11.38:    ICON plc: Revenue (by Region), 2016-2018
Figure 11.39:    ICON plc: SWOT Analysis
Figure 11.40:    Illumina, Inc.: Product Portfolio
Figure 11.41:    Illumina, Inc.: Overall Financials, 2017-2019
Figure 11.42:    Illumina, Inc.: Revenue (by Segment), 2017-2019
Figure 11.43:    Illumina, Inc.: Revenue (by Region), 2016-2018
Figure 11.44:    Illumina, Inc.: R&D Expenditure, 2016-2018
Figure 11.45:    Illumina, Inc.: SWOT Analysis
Figure 11.46:    Invivoscribe Technologies, Inc.: Product Portfolio
Figure 11.47:    Invivoscribe Technologies, Inc.: SWOT Analysis
Figure 11.48:    Myriad Genetics, Inc.: Product Portfolio
Figure 11.49:    Myriad Genetics, Inc.: Overall Financials, 2016-2018
Figure 11.50:    Myriad Genetics, Inc.: Revenue (by Business Segment), 2016-2018
Figure 11.51:    Myriad Genetics, Inc.: SWOT Analysis
Figure 11.52:    Novogene Corporation.: Product Portfolio
Figure 11.53:    Novogene Corporation: SWOT Analysis
Figure 11.54:    QIAGEN N.V.: Product Portfolio
Figure 11.55:    QIAGEN N.V.: Overall Financials, 2016-2018
Figure 11.56:    QIAGEN N.V.: Revenue (by Segment), 2016-2018
Figure 11.57:    QIAGEN N.V.: Revenue (by Region), 2016-2018
Figure 11.58:    QIAGEN N.V.: R&D Expenditure, 2016-2018
Figure 11.59:    QIAGEN N.V.: SWOT Analysis
Figure 11.60:    Thermo Fisher Scientific Inc.: Product Portfolio
Figure 11.61:    Thermo Fisher Scientific Inc.: Overall Financials, 2016-2018
Figure 11.62:    Thermo Fisher Scientific Inc.: Revenue (by Segment), 2016-2018
Figure 11.63:    Thermo Fisher Scientific Inc.: Revenue (by Region), 2016-2018
Figure 11.64:    Thermo Fisher Scientific Inc.: R&D Expenditure, 2016-2018
Figure 11.65:    Thermo Fisher Scientific Inc.: SWOT Analysis

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