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Global Companion Diagnostics (CDx) Market

Global Companion Diagnostics (CDx) Market: Focus on Technology, Indication, Country-wise Analysis, Regulatory Framework, and Competitive Landscape - Analysis and Forecast, 2018-2025

The global companion diagnostics market is expected to reach $4.1 billion by 2025. With increasing demand for NGS-based companion diagnostics, the global CDx market is expected to witness double digit growth rate during the forecast period 2018-2025.

SKU: BH067A
Published Year: 2018
 
 

In the era of precision medicine, the healthcare industry is focused on the development of advanced biomarker-based diagnostics to deliver improved patient care and enhance treatment outcome. The increasing prevalence of chronic disorders and improving regulatory framework for supporting drug-diagnostic co-development models are promoting the growth of the companion diagnostics market. Thereby, the advent of precision medicine approach and development of precision diagnostics are improving quality of life of the patients and reducing economic, societal, and clinical burden.

Presently, companion diagnostic (CDx) solutions are developed based on four technologies which include Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR). Till date, the healthcare industry has witnessed a number of successful procedures for parallel development of drug and its companion diagnostic, but mostly for oncology. However, successful commercialization and approval of companion diagnostics for multiple cancer types, including lung cancer, breast cancer, leukemia, colorectal cancer, gastric cancer, ovarian cancer, and melanoma, have further drawn the attention of several pharmaceutical and diagnostic companies to venture into this lucrative market by developing CDx solutions for non-oncology indications, including neurodegenerative diseases, infectious diseases, metabolic disorders, and cardiovascular diseases. Further, several players are now focusing on the development of multiple biomarker-based CDx development, which is anticipated to enhance the growth of NGS-based companion diagnostics market.

The purpose of this study is to gain a holistic view of the companion diagnostics market in terms of various influencing factors, such as recent trends, regulatory frameworks, and technological advancements in the market. The scope of this report constitutes a detailed study of the technologies associated with the global companion diagnostics market. The market has been segmented into ‘technology’, ‘indication’, and ‘region’. The report presents the reader with an opportunity to unlock comprehensive insights with respect to the market and helps in forming well-informed strategic decisions. The research uncovers some of the substantial parameters that must be taken into consideration before entering into the market.

This research report aims at answering various aspects of the global companion diagnostics market with the help of the key factors driving the market, the restraints, and the challenges that can possibly inhibit the overall market growth, and the current growth opportunities that are going to shape the future trajectory of the market expansion. The report includes an in-depth examination of the key players and recent developments taking place in this market. Moreover, the report includes chapters on market dynamics (market drivers, opportunities, and challenges) and industry analysis as well.

The research study highlights the factors governing the industry attractiveness with Porter’s Five Forces for a comprehensive understanding of the global companion diagnostics market. Moreover, the study includes detailed product mapping, market estimation, and analysis of key trends in multiple geographical regions, growth of companion diagnostics market in each region for different cancer types, and the key strategies and developments by the prominent companion diagnostics manufacturers.

The answers to the following key questions can be derived from this report:

•    What are the major market drivers, challenges, and opportunities in the global companion diagnostics market?
•    What are the underlying structures resulting in the emerging trends within the companion diagnostics industry?
•    What was the market value of the leading segments and sub-segments of the global companion diagnostics systems market in 2017?
•    How will each segment of the global companion diagnostics market grow during the forecast period and what will be the revenue generated by each of the segments by the end of 2025?
•    What are the influencing factors that may affect the market share of the key players?
•    How will the industry evolve during the forecast period 2018- 2025?
•    What are the key developmental strategies which are being implemented by the key players to sustain in this competitive market?
•    What are the key technologies in companion diagnostics market? What are the major benefits of each technology?
•    How has the market been segmented on the basis of indication? Which indication is dominating the global companion diagnostics market and its reason? 
•    What is the market share of the companies by CDx technologies which include Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR)?
•    Who are the key manufacturers in the companion diagnostics market and what are their contributions?
•    What is the scope of each companion diagnostic technology in North America, Europe, and Asia-Pacific?
•    What are the key regulatory implications in developed and developing regions for companion diagnostics?
•    What is the growth potential of companion diagnostics in each region?
•    Which companion diagnostic technology is having most promising growth and in which indication type? 

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

   Executive Summary
   1   Market Overview
        1.1   Classification of Companion Diagnostics (CDx)
        1.2   CDx in a Historical Perspective
        1.3   Constituents for Companion Diagnostics (CDx) Development
        1.4   Significant Applications of Companion Diagnostics (CDx)
        1.5   Companion Diagnostics (CDx): Future Potential
 
   2   Market Dynamics
        2.1   Overview
        2.2   Iceberg Analysis
        2.3   Impact Analysis
        2.4   Market Drivers
                2.4.1   Growing Incidence of Cancer
                           2.4.1.1   Better Treatment Assurance
                           2.4.1.2   Diagnostic and Treatment Availability for All Forms of Cancer
                2.4.2   Growing Demand of Precision Medicine
                           2.4.2.1   Adverse Drug Reactions
                           2.4.2.2   Boost in Predictive Biomarker Discovery
                2.4.3   Co-Development of Drugs and Diagnostics
        2.5   Market Restraints
                2.5.1   Uncertain Reimbursement Scenario
                2.5.2   Companion Diagnostics Leakage in Oncology
                2.5.3   Weak Synchronization between Therapeutics and Diagnostics in Marketing and Distribution Channels
        2.6   Opportunities within the Market
                2.6.1   New Indication Areas
                2.6.2   Next Generation Sequencing Accelerating Targeted Gene Therapy
                2.6.3   Data Science for Companion Diagnostics Applications
 
   3   Competitive Insights
        3.1   Key Strategies and Developments
        3.2   Joint Ventures, Partnerships, and Collaborations
        3.3   Product Approvals
        3.4   Acquisitions
        3.5   Product Launches and Other Developments
        3.6   Market Share Analysis
        3.7   Growth Share Analysis
                3.7.1   Growth Share Analysis by Technology
                3.7.2   Growth Share Analysis by Indication
                3.7.3   Growth Share Analysis by Region
                3.7.4   Industry Attractiveness
                           3.7.4.1   Bargaining Power of Suppliers
                           3.7.4.2   Bargaining Power of Buyer
                           3.7.4.3   Threat of New Entrants
                           3.7.4.4   Threat of Substitute Products
                           3.7.4.5   Intensity of Competitive Rivalry
 
   4   Regulatory Framework
        4.1   Legal Requirements and Framework by the FDA
        4.2   Legal Requirements and Framework by the EMA
        4.3   Legal Requirements and Framework by the MHLW
 
   5   Global Companion Diagnostics Market: Analysis and Forecast
        5.1   Assumptions & Limitations for Market Size Calculations
        5.2   Market Overview
 
   6   Global Companion Diagnostics Market (by Technology)
        6.1   Overview
        6.2   Polymerase Chain Reaction (PCR)
        6.3   Immunohistochemistry (IHC)
        6.4   In-situ Hybridization (ISH)
        6.5   Next Generation Sequencing (NGS)
 
   7   Global Companion Diagnostics Market (by Indication)
        7.1   Overview
        7.2   Lung Cancer
        7.3   Breast Cancer
        7.4   Colorectal Cancer
        7.5   Stomach Cancer
        7.6   Leukemia
        7.7   Melanoma
        7.8   Others
        7.9   Non-Oncology Diseases
 
   8   Global Companion Diagnostics Market (by Region)
        8.1   Overview
        8.2   North America
                8.2.1   The U.S.
                8.2.2   Canada
        8.3   Europe
                8.3.1   The U.K.
                8.3.2   Germany
                8.3.3   France
                8.3.4   Italy
                8.3.5   Spain
                8.3.6   Rest-of-Europe
        8.4   Asia-Pacific
                8.4.1   China
                8.4.2   Japan
                8.4.3   India
                8.4.4   Australia
                8.4.5   Singapore
                8.4.6   Rest-of-APAC
        8.5   Rest-of-the-World
 
   9   Company Profiles
        9.1   Overview
        9.2   Abbott Laboratories
                9.2.1   Company Overview
                9.2.2   Overall Product Portfolio
                9.2.3   Product Offering in CDx
                9.2.4   Financials
                           9.2.4.1   Financial Summary
                9.2.5   Global Presence
                9.2.6   Recent Developments
                9.2.7   SWOT Analysis
        9.3   Agilent Technologies, Inc.
                9.3.1   Company Overview
                9.3.2   Overall Product Portfolio
                9.3.3   Financials
                           9.3.3.1   Financial Summary
                9.3.4   Global Presence
                9.3.5   Recent Developments
                9.3.6   SWOT Analysis
        9.4   ARUP Laboratories
                9.4.1   Company Overview
                9.4.2   Overall Product Portfolio
                9.4.3   Product Offering
                9.4.4   Corporate Summary
                9.4.5   Recent Developments
                9.4.6   SWOT Analysis
        9.5   bioMérieux SA
                9.5.1   Company Overview
                9.5.2   Overall Product Portfolio
                9.5.3   Product Offering
                9.5.4   Financials
                           9.5.4.1   Financial Summary
                9.5.5   Global Presence
                9.5.6   Recent Developments
                9.5.7   SWOT Analysis
        9.6   Danaher Corporation
                9.6.1   Company Overview
                9.6.2   Overall Product Portfolio
                9.6.3   Product Offering
                9.6.4   Financials
                           9.6.4.1   Financial Summary
                9.6.5   Global Presence
                9.6.6   Recent Developments
                9.6.7   SWOT Analysis
        9.7   F. Hoffmann-La Roche AG
                9.7.1   Company Overview
                9.7.2   Overall Product Portfolio
                9.7.3   Product Offering
                9.7.4   Financials
                           9.7.4.1   Financial Summary
                9.7.5   Global Presence
                9.7.6   Recent Developments
                9.7.7   SWOT Analysis
        9.8   Illumina, Inc.
                9.8.1   Company Overview
                9.8.2   Overall Product Portfolio
                9.8.3   Product Offering
                9.8.4   Financials
                           9.8.4.1   Financial Summary
                9.8.5   Global Presence
                9.8.6   Recent Developments
                9.8.7   SWOT Analysis
         9.9  Invivoscribe Technologies, Inc.
                9.9.1   Company Overview
                9.9.2   Overall Product Portfolio
                9.9.3   Product Offering
                9.9.4   Corporate Summary
                9.9.5   Recent Developments
                9.9.6   SWOT Analysis
       9.10  MolecularMD Corporation
                9.10.1   Company Overview
                9.10.2   Overall Product Portfolio
                9.10.3   Product Offering
                9.10.4   Corporate Summary
                9.10.5   Recent Developments
                9.10.6   SWOT Analysis
       9.11  Myriad Genetics, Inc.
                9.11.1   Company Overview
                9.11.2   Overall Product Portfolio
                9.11.3   Product Offering
                9.11.4   Financials
                             9.11.4.1   Financial Summary
                9.11.5   Global Presence
                9.11.6   Recent Developments
       9.12  QIAGEN N.V.
                9.12.1   Company Overview
                9.12.2   Overall Product Portfolio
                9.12.3   Product Offering
                9.12.4   Financials
                             9.12.4.1   Financial Summary
                9.12.5   Global Presence
                9.12.6   Recent Developments
                9.12.7   SWOT Analysis
       9.13  Thermo Fisher Scientific Inc.
                 9.13.1   Company Overview
                 9.13.2   Overall Product Portfolio
                 9.13.3   Product Offering
                 9.13.4   Financials
                              9.13.4.1   Financial Summary
                 9.13.5   Global Presence
                 9.13.6   Recent Developments
                 9.13.7   SWOT Analysis
       9.14   ArcherDx, Inc.
                 9.14.1   Company Overview
                 9.14.2   Corporate Summary
                 9.14.3   Recent Developments
       9.15   Exosome Diagnostics, Inc.
                 9.15.1   Company Overview
                 9.15.2   Corporate Summary
                 9.15.3   Recent Developments
       9.16   NeoGenomics, Inc.
                 9.16.1   Company Overview
                 9.16.2   Corporate Summary
                 9.16.3   Recent Developments
      9.17   MDxHealth, Inc.
                9.17.1   Company Overview
                9.17.2   Corporate Summary
                9.17.3   Recent Developments
      9.18   NanoString Technologies, Inc.
                9.18.1   Company Overview
                9.18.2   Corporate Summary
                9.18.3   Recent Developments
 
   10   Research Scope and Methodology
          10.1   Report Scope
          10.2   Companion Diagnostics Market: Research Methodology
 
List of Tables

Table 2.1    Impact Analysis of Market Drivers
Table 2.2    Impact Analysis of Market Restraints
Table 2.3    Impact Analysis of Market Opportunities
Table 3.1    R&D Revenue of Major CDx Companies (as of FY2017)
Table 6.1    PCR-Based Companion Diagnostics Manufacturers
Table 6.2    PCR-Based Companion Diagnostics Service Providers
Table 6.3    IHC-Based Companion Diagnostics Manufacturers
Table 6.4    IHC-Based Companion Diagnostics Service Providers
Table 6.5    ISH-Based Companion Diagnostics Manufacturers
Table 6.6    ISH-Based Companion Diagnostics Service Providers
Table 6.7    NGS-Based Companion Diagnostics Manufacturers
Table 6.8    NGS-Based Companion Diagnostics Service Providers
Table 7.1    Cancer Type- Incidence and Mortality
Table 7.2    Available Companion Diagnostic Tests for Lung Cancer
Table 7.3    Available Companion Diagnostic Tests for Breast Cancer
Table 7.4    Available Companion Diagnostic Tests for Colorectal Cancer
Table 7.5    Available Companion Diagnostic Tests for Stomach Cancer
Table 7.6    Available Companion Diagnostic Tests for Leukemia
Table 7.7    Available Companion Diagnostic Tests for Melanoma
Table 7.8    Available Companion Diagnostics for Others
Table 9.1    Abbott Laboratories: Partnerships, Agreements, and Collaborations
Table 9.2    Abbott Laboratories: Product Approvals
Table 9.3    Agilent Technologies, Inc.: Acquisition
Table 9.4    Agilent Technologies, Inc.: Collaborations
Table 9.5    ARUP Laboratories: Collaboration
Table 9.6    bioMérieux SA: Approval
Table 9.7    Danaher Corporation: Collaborations and Partnership
Table 9.8    F. Hoffmann-La Roche AG: Collaborations, Agreements, and Partnerships
Table 9.9    F. Hoffmann-La Roche AG: Product Approvals
Table 9.10    Illumina, Inc.: Collaborations, Agreements, and Partnerships
Table 9.11    Illumina, Inc.: Acquisition
Table 9.12    Illumina, Inc.: Product Approval
Table 9.13    Invivoscribe Technologies, Inc.: Product Approval
Table 9.14    MolecularMD Corporation: Agreement and Partnership
Table 9.15    Invivoscribe Technologies, Inc.: Product Approval
Table 9.16    Myriad Genetics, Inc.: Collaborations and Agreements
Table 9.17    Illumina, Inc.: Product Approval
Table 9.18    QIAGEN N.V.: Acquisition
Table 9.19    QIAGEN N.V.: Collaborations, Partnership, and Agreement
Table 9.20    QIAGEN N.V.: Product Approval
Table 9.21    Thermo Fisher Scientific Inc.: Collaborations, Partnership, and Agreement
Table 9.22    Thermo Fisher Scientific Inc.: Product Approval
Table 9.23    ArcherDX, Inc.: Collaborations, Partnership, and Agreement
Table 9.24    Exosome Diagnostics, Inc.: Collaborations and Partnerships
Table 9.25    NeoGenomics, Inc.: Acquisition
Table 9.26    NeoGenomics, Inc.: Collaboration and Agreement
Table 9.27    NeoGenomics, Inc.: Product Launch
Table 9.28    MDxHealth, Inc.: Partnerships and Agreements
Table 9.29    NanoString Technologies, Inc.: Partnership, Collaboration and Agreement

List of Figures

Figure 1    Escalating Healthcare Expenditure, 2016-2020
Figure 2    Impact of Market Drivers and Market Restraints, 2017 and 2025
Figure 3    Global Companion Diagnostics (CDx) Market Snapshot
Figure 4    Dominating Segments of Global Companion Diagnostics Market, 2017 and 2025
Figure 5    Global Companion Diagnostics Market (by Technology), 2017 and 2025
Figure 6    Global Companion Diagnostics Market (by Indication), 2017 and 2025
Figure 7    Global Companion Diagnostics Market (by Region), 2017 and 2025
Figure 8    Growth Share Matrix for Global Companion Diagnostics Market (by Country), 2018 and 2025
Figure 9    Market Statistics
Figure 10    Market Share Analysis: Global Companion Diagnostics Market (2017)
Figure 11    Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2017
Figure 1.1    Classification of Companion Diagnostics (CDx)
Figure 1.2    Evolution of Companion Diagnostics (CDx)
Figure 1.3    Components Required to Develop Companion Diagnostics
Figure 1.4    Applications of Companion Diagnostics (CDx)
Figure 1.5    Potential of Companion Diagnostics (CDx)
Figure 2.1    Market Dynamics
Figure 2.2    Iceberg Analysis
Figure 2.3    Cancer Incidence by WHO Region (2012) per 100,000
Figure 2.4    Fully Aligned Drug-Diagnostic Co-Development
Figure 2.5    CDx Leakage for Oncology
Figure 3.1    Competitive Landscape (January 2014-July 2018)
Figure 3.2    Share of Key Developments and Strategies (January 2014-July 2018)
Figure 3.3    Joint Venture, Partnership, and Collaboration Share by Companies (January 2014-July 2018)
Figure 3.4    Product Approval Share by Companies (January 2014-July 2018)
Figure 3.5    Acquisition Share by Companies (January 2014-July 2018)
Figure 3.6    Market Share Analysis for the Global Companion Diagnostics Market (2016)
Figure 3.7    Market Share Analysis for the Global Companion Diagnostics Market (2017)
Figure 3.8    Growth Share Matrix for Global Companion Diagnostics Market (by Technology), 2017
Figure 3.9    Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2017
Figure 3.10    Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2018 and 2025
Figure 3.11    Industy Attractieness (Porter’s Five Forces Analysis)
Figure 3.12    Bargaining Power of Suppliers: Overall Impact
Figure 3.13    Bargaining Power of Buyers: Overall Impact
Figure 3.14    Threat of New Entrants: Overall Impact
Figure 3.15    Threat of Substitute Products: Overall Impact
Figure 3.16    Intensity of Competitive Rivalry: Overall Impact
Figure 4.1    FDA Guidelines for CDx Approval
Figure 5.1    Global Companion Diagnostics Market, 2017-2025
Figure 6.1    Companion Diagnostics Market (by Technology)
Figure 6.2    Global Companion Diagnostics Market (by Technology), 2017-2025
Figure 6.3    Global Companion Diagnostics Market (by PCR Technology), 2017-2025
Figure 6.4    Global Companion Diagnostics Market (by IHC Technology), 2017-2025
Figure 6.5    Global Companion Diagnostics Market (by ISH Technology), 2017-2025
Figure 6.6    Global Companion Diagnostics Market (by NGS Technology), 2017-2025
Figure 7.1    Global Companion Diagnostics Market (by Indication), 2017-2025
Figure 7.2    Global Companion Diagnostics Market (by Lung Cancer), 2017-2025
Figure 7.3    Total Market Size for Lung Cancer Companion Diagnostics (2017 and 2020)
Figure 7.4    Global Companion Diagnostic Market (by Breast Cancer), 2017-2025
Figure 7.5    Total Market Size for Breast Cancer Companion Diagnostics (2017 and 2020)
Figure 7.6    Global Companion Diagnostics Market (by Colorectal Cancer), 2017-2025
Figure 7.7    Total Market Size for Colorectal Cancer Companion Diagnostics (2017 and 2020)
Figure 7.8    Global Companion Diagnostics Market (by Stomach Cancer), 2017-2025
Figure 7.9    Total Market Size for Stomach Cancer Companion Diagnostics (2017 and 2020)
Figure 7.10    Global Companion Diagnostics Market (by Leukemia), 2017-2025
Figure 7.11    Total Market Size for Leukemia Companion Diagnostics (2017 and 2020)
Figure 7.12    Global Companion Diagnostics Market (by Melanoma), 2017-2025
Figure 7.13    Total Market Size for Melanoma Companion Diagnostics (2017 and 2020)
Figure 7.14    Global Companion Diagnostics Market (by Others), 2017-2025
Figure 7.15    Total Market Size for Others Companion Diagnostics (2017 and 2020)
Figure 8.1    Global Companion Diagnostics Market (by Region), 2017 and 2025
Figure 8.2    Global Companion Diagnostics Market (by Region), 2017-2025
Figure 8.3    Global Companion Diagnostics Market Share (by Region), 2017
Figure 8.4    Global Companion Diagnostics Market Share (by Region), 2025
Figure 8.5    North America Companion Diagnostics Market, 2017-2025
Figure 8.6    North America: Market Dynamics
Figure 8.7    North America Companion Diagnostics Market (by Country), 2017-2025
Figure 8.8    North America Companion Diagnostics Market (by Indication), 2017-2025
Figure 8.9    The U.S. Companion Diagnostics Market, 2017-2025
Figure 8.10    Canada Companion Diagnostics Market, 2017-2025
Figure 8.11    Overview of Reimbursement Policies across Europe
Figure 8.12    Europe Companion Diagnostics Market, 2017-2025
Figure 8.13    Europe: Market Dynamics
Figure 8.14    Europe Companion Diagnostics Market (by Country), 2017-2025
Figure 8.15    Europe Companion Diagnostics Market (by Indication), 2017-2025
Figure 8.16    The U.K. Companion Diagnostics Market, 2017-2025
Figure 8.17    Germany Companion Diagnostics Market, 2017-2025
Figure 8.18    France Companion Diagnostics Market, 2017-2025
Figure 8.19    Italy Companion Diagnostics Market, 2017-2025
Figure 8.20    Spain Companion Diagnostics Market, 2017-2025
Figure 8.21    Rest-of-Europe Companion Diagnostics Market, 2017-2025
Figure 8.22    APAC Companion Diagnostics Market, 2017-2025
Figure 8.23    APAC: Market Dynamics
Figure 8.24    APAC Companion Diagnostics Market (by Country), 2017-2025
Figure 8.25    APAC Companion Diagnostics Market (by Indication), 2017-2025
Figure 8.26    China Companion Diagnostics Market, 2017-2025
Figure 8.27    Japan Companion Diagnostics Market, 2017-2025
Figure 8.28    India Companion Diagnostics Market, 2017-2025
Figure 8.29    Australia Companion Diagnostics Market, 2017-2025
Figure 8.30    Singapore Companion Diagnostics Market, 2017-2025
Figure 8.31    Rest-of-APAC Companion Diagnostics Market, 2017-2025
Figure 8.32    Rest-of-the-World Companion Diagnostics Market, 2017-2025
Figure 9.1    Total Number of Company Profiles
Figure 9.2    Abbott Laboratories: Overall Product Portfolio
Figure 9.3    Abbott Laboratories: Product Portfolio for Companion Diagnostics Market
Figure 9.4    Abbott Laboratories: Overall Financials, 2015-2017
Figure 9.5    Abbott Laboratories: Revenue (by Segment), 2015-2017
Figure 9.6    Abbott Laboratories: Revenue (by Region), 2015-2017
Figure 9.7    Abbott Laboratories: Global Presence
Figure 9.8    SWOT Analysis: Abbott Laboratories
Figure 9.9    Agilent Technologies, Inc.: Overall Product Portfolio
Figure 9.10    Agilent Technology, Inc.: Product Portfolio for Companion Diagnostics Market
Figure 9.11    Agilent Technologies, Inc.: Overall Financials, 2015-2017
Figure 9.12    Agilent Technologies, Inc.: Revenue (by Region), 2015-2017
Figure 9.13    Agilent Technologies, Inc.: Revenue (by Segment), 2015-2017
Figure 9.14    Agilent Technologies, Inc.: Global Presence
Figure 9.15    Agilent Technologies, Inc. SWOT Analysis
Figure 9.16    ARUP Laboratories: Overall Product Portfolio
Figure 9.17    ARUP Laboratories: Product Portfolio for Companion Diagnostics Market
Figure 9.18    ARUP Laboratories: SWOT Analysis
Figure 9.19    bioMérieux SA: Overall Product Portfolio
Figure 9.20    bioMérieux SA: Product Portfolio for Companion Diagnostics Market
Figure 9.21    bioMérieux SA: Overall Financials, 2015-2017
Figure 9.22    bioMérieux SA: Revenue (by Segment), 2015-2017
Figure 9.23    bioMérieux SA: Revenue (by Region), 2015-2017
Figure 9.24    bioMérieux SA: Global Presence
Figure 9.25    bioMérieux SA: SWOT Analysis
Figure 9.26    Danaher Corporation: Overall Product Portfolio
Figure 9.27    Danaher Corporation: Product Portfolio for Companion Diagnostics Market
Figure 9.28    Danaher Corporation: Overall Financials, 2015-2017
Figure 9.29    Danaher Corporation: Net Revenue (by Region), 2015-2017
Figure 9.30    Danaher Corporation: Net Revenue (by Business Segment), 2015-2017
Figure 9.31    Danaher Corporation: Global Presence
Figure 9.32    Danaher Corporation: SWOT Analysis
Figure 9.33    F. Hoffmann-La Roche AG: Overall Product Portfolio
Figure 9.34    F. Hoffmann-La Roche AG: Product Portfolio for Companion Diagnostics Market
Figure 9.35    F. Hoffmann-La Roche AG: Overall Financials, 2015-2017
Figure 9.36    F. Hoffmann-La Roche AG: Net Revenue (by Region), 2015-2017
Figure 9.37    F. Hoffmann-La Roche AG: Net Revenue (by Business Segment), 2015-2017
Figure 9.38    F. Hoffmann-La Roche AG: Global Presence
Figure 9.39    F. Hoffmann-La Roche AG: SWOT Analysis
Figure 9.40    Illumina, Inc.: Overall Product Portfolio
Figure 9.41    Illumina, Inc.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.42    Illumina, Inc.: Overall Financials, 2015-2017
Figure 9.43    Illumina, Inc.: Net Revenue (by Region), 2015-2017
Figure 9.44    Illumina, Inc.: Net Revenue (by Business Segment), 2015-2017
Figure 9.45    Illumina, Inc.: Global Presence
Figure 9.46    Illumina, Inc.: SWOT Analysis
Figure 9.47    Invivoscribe Technologies, Inc.: Overall Product Portfolio
Figure 9.48    Invivoscribe Technologies, Inc.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.49    Invivoscribe Technologies, Inc.: SWOT Analysis
Figure 9.50    MolecularMD Corporation: Overall Product Portfolio
Figure 9.51    MolecularMD Corporation: Product Portfolio for Global Companion Diagnostics Market
Figure 9.52    MolecularMD Corporation: SWOT Analysis
Figure 9.53    Myriad Genetics, Inc.: Overall Product Portfolio
Figure 9.54    Myriad Genetics, Inc.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.55    Myriad Genetics, Inc.: Overall Financials, 2015-2017
Figure 9.56    Myriad Genetics, Inc.: Net Revenue (by Business Segment), 2015-2017
Figure 9.57    Myriad Genetics, Inc.: Global Presence
Figure 9.58    Myriad Genetics, Inc.: SWOT Analysis
Figure 9.59    QIAGEN N.V.: Overall Product Portfolio
Figure 9.60    QIAGEN N.V.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.61    QIAGEN N.V.: Overall Financials, 2015-2017
Figure 9.62    QIAGEN N.V.: Net Revenue (by Business Segment), 2015-2017
Figure 9.63    QIAGEN N.V.: Net Revenue (by Region), 2015-2017
Figure 9.64    QIAGEN N.V.: Global Presence
Figure 9.65    QIAGEN N.V.: SWOT Analysis
Figure 9.66    Thermo Fisher Scientific Inc.: Overall Product Portfolio
Figure 9.67    Thermo Fisher Scientific Inc.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.68    Thermo Fisher Scientific Inc.: Overall Financials, 2015-2017
Figure 9.69    Thermo Fisher Scientific Inc.: Net Revenue (by Business Segment), 2015-2017
Figure 9.70    Thermo Fisher Scientific Inc.: Net Revenue (by Region), 2015-2017
Figure 9.71    Thermo Fisher Scientific Inc.: Global Presence
Figure 9.72    Thermo Fisher Scientific Inc.: SWOT Analysis
Figure 10.1    Global Companion Diagnostics Market Segmentation
Figure 10.2    Global Companion Diagnostics Market Research Methodology
Figure 10.3    Primary Research
Figure 10.4    Secondary Research
Figure 10.5    Data Triangulation
Figure 10.6    Bottom-Up Approach (Segment-Wise Analysis)
Figure 10.7    Top-Down Approach (Segment-Wise Analysis)
Figure 10.8    Assumptions and Limitations
Figure 10.9    Considered Factors for Data Prediction and Modeling

The global healthcare expenditure was valued approximately $7 trillion in 2015 and is expected to reach over $8.5 trillion by 2020, owing to the increasing prevalence of chronic diseases, such as cancer, diabetes, cardiovascular diseases, and respiratory diseases, among others. In addition, the rise in global geriatric population and the increase in incidence of communicable diseases, neurodegenerative diseases, and infectious diseases, among others are escalating the economic, social, and clinical burden, across the globe, thereby increasing pricing pressure on the pharmaceutical as well as diagnostic companies. Acknowledging the criticality of the situation, government bodies of several nations have been restructuring their regulatory framework and norms to help companies in reducing treatment costs and expand accessibility to advance healthcare solutions. On the other hand, the healthcare companies are trying to reduce the unnecessary healthcare expenditure by enabling novel treatment approaches and developing cost-effective products based on advanced technologies. Advent of precision medicine, a patient-centric treatment approach based on biomarker study, is perceived to be promising in driving a paradigm shift in the healthcare industry. This biomarker-based, targeted medication would not only facilitate in eliminating the uncertainty of trial and error method of medications, but also eliminate unnecessary healthcare expenditure.

In the era of precision medicine, the number of commercialized predictive biomarker assays has increased tremendously, especially in case of chronic diseases, to facilitate the development of targeted therapeutics. These biomarker-based assays, known as companion diagnostics (CDx), not only aid in parallel development of targeted drugs, but also provide essential information for patient stratification to enable effective and safe use of corresponding treatment. Till date, healthcare industry has witnessed several successful drug-diagnostic co-developments mostly for oncology. However, successful commercialization and approval of CDx for multiple cancer types, including lung cancer, breast cancer, leukemia, colorectal cancer, gastric cancer, ovarian cancer, and melanoma, have further drawn attention of several pharmaceutical and diagnostic companies to venture into this lucrative market by developing non-oncology CDx solutions, especially for indications such as neurodegenerative diseases, infectious diseases, metabolic disorders, and cardiovascular diseases, thereby enhancing the growth of global CDx market. The global companion diagnostics market is expected to reach $4.1 billion by 2025. With increasing demand for NGS-based companion diagnostics, the global CDx market is expected to witness double digit growth rate during the forecast period 2018-2025. In addition, PCR-based companion diagnostics is expected to be dominating among the other technology-based products, in 2025. In 2017, companion diagnostics for lung cancer was responsible for a 27.20% share of the global market value.

The purpose of the study is to gain a holistic view of the global companion diagnostics market in terms of various factors such as recent trends and technological advancements, influencing the market. The scope of this report is centered upon conducting a detailed study of the products allied with the companion diagnostics market, which includes various technology-based products such as Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR). However, the market estimation only comprises manufacturers of companion diagnostics. The companion diagnostics market is segmented into three different parts namely technology, indication, and region. The global market value was estimated using these three different approaches and was validated with one another. These segments are further segmented into several sub-segments to ease the market estimation and to gain a holistic view of the market.

Based on the region, the global companion diagnostics market is segmented into North America, Europe, Asia-Pacific, and Rest-of-the-World (RoW). North America is the leading contributor to the global companion diagnostics market and was responsible for a 52.53% share of the global market values in 2017. However, Asia-Pacific is expected to grow at a CAGR of 32.06% during the forecast period 2018-2025.

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

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In the era of precision medicine, the healthcare industry is focused on the development of advanced biomarker-based diagnostics to deliver improved patient care and enhance treatment outcome. The increasing prevalence of chronic disorders and improving regulatory framework for supporting drug-diagnostic co-development models are promoting the growth of the companion diagnostics market. Thereby, the advent of precision medicine approach and development of precision diagnostics are improving quality of life of the patients and reducing economic, societal, and clinical burden.

Presently, companion diagnostic (CDx) solutions are developed based on four technologies which include Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR). Till date, the healthcare industry has witnessed a number of successful procedures for parallel development of drug and its companion diagnostic, but mostly for oncology. However, successful commercialization and approval of companion diagnostics for multiple cancer types, including lung cancer, breast cancer, leukemia, colorectal cancer, gastric cancer, ovarian cancer, and melanoma, have further drawn the attention of several pharmaceutical and diagnostic companies to venture into this lucrative market by developing CDx solutions for non-oncology indications, including neurodegenerative diseases, infectious diseases, metabolic disorders, and cardiovascular diseases. Further, several players are now focusing on the development of multiple biomarker-based CDx development, which is anticipated to enhance the growth of NGS-based companion diagnostics market.

The purpose of this study is to gain a holistic view of the companion diagnostics market in terms of various influencing factors, such as recent trends, regulatory frameworks, and technological advancements in the market. The scope of this report constitutes a detailed study of the technologies associated with the global companion diagnostics market. The market has been segmented into ‘technology’, ‘indication’, and ‘region’. The report presents the reader with an opportunity to unlock comprehensive insights with respect to the market and helps in forming well-informed strategic decisions. The research uncovers some of the substantial parameters that must be taken into consideration before entering into the market.

This research report aims at answering various aspects of the global companion diagnostics market with the help of the key factors driving the market, the restraints, and the challenges that can possibly inhibit the overall market growth, and the current growth opportunities that are going to shape the future trajectory of the market expansion. The report includes an in-depth examination of the key players and recent developments taking place in this market. Moreover, the report includes chapters on market dynamics (market drivers, opportunities, and challenges) and industry analysis as well.

The research study highlights the factors governing the industry attractiveness with Porter’s Five Forces for a comprehensive understanding of the global companion diagnostics market. Moreover, the study includes detailed product mapping, market estimation, and analysis of key trends in multiple geographical regions, growth of companion diagnostics market in each region for different cancer types, and the key strategies and developments by the prominent companion diagnostics manufacturers.

The answers to the following key questions can be derived from this report:

•    What are the major market drivers, challenges, and opportunities in the global companion diagnostics market?
•    What are the underlying structures resulting in the emerging trends within the companion diagnostics industry?
•    What was the market value of the leading segments and sub-segments of the global companion diagnostics systems market in 2017?
•    How will each segment of the global companion diagnostics market grow during the forecast period and what will be the revenue generated by each of the segments by the end of 2025?
•    What are the influencing factors that may affect the market share of the key players?
•    How will the industry evolve during the forecast period 2018- 2025?
•    What are the key developmental strategies which are being implemented by the key players to sustain in this competitive market?
•    What are the key technologies in companion diagnostics market? What are the major benefits of each technology?
•    How has the market been segmented on the basis of indication? Which indication is dominating the global companion diagnostics market and its reason? 
•    What is the market share of the companies by CDx technologies which include Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR)?
•    Who are the key manufacturers in the companion diagnostics market and what are their contributions?
•    What is the scope of each companion diagnostic technology in North America, Europe, and Asia-Pacific?
•    What are the key regulatory implications in developed and developing regions for companion diagnostics?
•    What is the growth potential of companion diagnostics in each region?
•    Which companion diagnostic technology is having most promising growth and in which indication type? 

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

   Executive Summary
   1   Market Overview
        1.1   Classification of Companion Diagnostics (CDx)
        1.2   CDx in a Historical Perspective
        1.3   Constituents for Companion Diagnostics (CDx) Development
        1.4   Significant Applications of Companion Diagnostics (CDx)
        1.5   Companion Diagnostics (CDx): Future Potential
 
   2   Market Dynamics
        2.1   Overview
        2.2   Iceberg Analysis
        2.3   Impact Analysis
        2.4   Market Drivers
                2.4.1   Growing Incidence of Cancer
                           2.4.1.1   Better Treatment Assurance
                           2.4.1.2   Diagnostic and Treatment Availability for All Forms of Cancer
                2.4.2   Growing Demand of Precision Medicine
                           2.4.2.1   Adverse Drug Reactions
                           2.4.2.2   Boost in Predictive Biomarker Discovery
                2.4.3   Co-Development of Drugs and Diagnostics
        2.5   Market Restraints
                2.5.1   Uncertain Reimbursement Scenario
                2.5.2   Companion Diagnostics Leakage in Oncology
                2.5.3   Weak Synchronization between Therapeutics and Diagnostics in Marketing and Distribution Channels
        2.6   Opportunities within the Market
                2.6.1   New Indication Areas
                2.6.2   Next Generation Sequencing Accelerating Targeted Gene Therapy
                2.6.3   Data Science for Companion Diagnostics Applications
 
   3   Competitive Insights
        3.1   Key Strategies and Developments
        3.2   Joint Ventures, Partnerships, and Collaborations
        3.3   Product Approvals
        3.4   Acquisitions
        3.5   Product Launches and Other Developments
        3.6   Market Share Analysis
        3.7   Growth Share Analysis
                3.7.1   Growth Share Analysis by Technology
                3.7.2   Growth Share Analysis by Indication
                3.7.3   Growth Share Analysis by Region
                3.7.4   Industry Attractiveness
                           3.7.4.1   Bargaining Power of Suppliers
                           3.7.4.2   Bargaining Power of Buyer
                           3.7.4.3   Threat of New Entrants
                           3.7.4.4   Threat of Substitute Products
                           3.7.4.5   Intensity of Competitive Rivalry
 
   4   Regulatory Framework
        4.1   Legal Requirements and Framework by the FDA
        4.2   Legal Requirements and Framework by the EMA
        4.3   Legal Requirements and Framework by the MHLW
 
   5   Global Companion Diagnostics Market: Analysis and Forecast
        5.1   Assumptions & Limitations for Market Size Calculations
        5.2   Market Overview
 
   6   Global Companion Diagnostics Market (by Technology)
        6.1   Overview
        6.2   Polymerase Chain Reaction (PCR)
        6.3   Immunohistochemistry (IHC)
        6.4   In-situ Hybridization (ISH)
        6.5   Next Generation Sequencing (NGS)
 
   7   Global Companion Diagnostics Market (by Indication)
        7.1   Overview
        7.2   Lung Cancer
        7.3   Breast Cancer
        7.4   Colorectal Cancer
        7.5   Stomach Cancer
        7.6   Leukemia
        7.7   Melanoma
        7.8   Others
        7.9   Non-Oncology Diseases
 
   8   Global Companion Diagnostics Market (by Region)
        8.1   Overview
        8.2   North America
                8.2.1   The U.S.
                8.2.2   Canada
        8.3   Europe
                8.3.1   The U.K.
                8.3.2   Germany
                8.3.3   France
                8.3.4   Italy
                8.3.5   Spain
                8.3.6   Rest-of-Europe
        8.4   Asia-Pacific
                8.4.1   China
                8.4.2   Japan
                8.4.3   India
                8.4.4   Australia
                8.4.5   Singapore
                8.4.6   Rest-of-APAC
        8.5   Rest-of-the-World
 
   9   Company Profiles
        9.1   Overview
        9.2   Abbott Laboratories
                9.2.1   Company Overview
                9.2.2   Overall Product Portfolio
                9.2.3   Product Offering in CDx
                9.2.4   Financials
                           9.2.4.1   Financial Summary
                9.2.5   Global Presence
                9.2.6   Recent Developments
                9.2.7   SWOT Analysis
        9.3   Agilent Technologies, Inc.
                9.3.1   Company Overview
                9.3.2   Overall Product Portfolio
                9.3.3   Financials
                           9.3.3.1   Financial Summary
                9.3.4   Global Presence
                9.3.5   Recent Developments
                9.3.6   SWOT Analysis
        9.4   ARUP Laboratories
                9.4.1   Company Overview
                9.4.2   Overall Product Portfolio
                9.4.3   Product Offering
                9.4.4   Corporate Summary
                9.4.5   Recent Developments
                9.4.6   SWOT Analysis
        9.5   bioMérieux SA
                9.5.1   Company Overview
                9.5.2   Overall Product Portfolio
                9.5.3   Product Offering
                9.5.4   Financials
                           9.5.4.1   Financial Summary
                9.5.5   Global Presence
                9.5.6   Recent Developments
                9.5.7   SWOT Analysis
        9.6   Danaher Corporation
                9.6.1   Company Overview
                9.6.2   Overall Product Portfolio
                9.6.3   Product Offering
                9.6.4   Financials
                           9.6.4.1   Financial Summary
                9.6.5   Global Presence
                9.6.6   Recent Developments
                9.6.7   SWOT Analysis
        9.7   F. Hoffmann-La Roche AG
                9.7.1   Company Overview
                9.7.2   Overall Product Portfolio
                9.7.3   Product Offering
                9.7.4   Financials
                           9.7.4.1   Financial Summary
                9.7.5   Global Presence
                9.7.6   Recent Developments
                9.7.7   SWOT Analysis
        9.8   Illumina, Inc.
                9.8.1   Company Overview
                9.8.2   Overall Product Portfolio
                9.8.3   Product Offering
                9.8.4   Financials
                           9.8.4.1   Financial Summary
                9.8.5   Global Presence
                9.8.6   Recent Developments
                9.8.7   SWOT Analysis
         9.9  Invivoscribe Technologies, Inc.
                9.9.1   Company Overview
                9.9.2   Overall Product Portfolio
                9.9.3   Product Offering
                9.9.4   Corporate Summary
                9.9.5   Recent Developments
                9.9.6   SWOT Analysis
       9.10  MolecularMD Corporation
                9.10.1   Company Overview
                9.10.2   Overall Product Portfolio
                9.10.3   Product Offering
                9.10.4   Corporate Summary
                9.10.5   Recent Developments
                9.10.6   SWOT Analysis
       9.11  Myriad Genetics, Inc.
                9.11.1   Company Overview
                9.11.2   Overall Product Portfolio
                9.11.3   Product Offering
                9.11.4   Financials
                             9.11.4.1   Financial Summary
                9.11.5   Global Presence
                9.11.6   Recent Developments
       9.12  QIAGEN N.V.
                9.12.1   Company Overview
                9.12.2   Overall Product Portfolio
                9.12.3   Product Offering
                9.12.4   Financials
                             9.12.4.1   Financial Summary
                9.12.5   Global Presence
                9.12.6   Recent Developments
                9.12.7   SWOT Analysis
       9.13  Thermo Fisher Scientific Inc.
                 9.13.1   Company Overview
                 9.13.2   Overall Product Portfolio
                 9.13.3   Product Offering
                 9.13.4   Financials
                              9.13.4.1   Financial Summary
                 9.13.5   Global Presence
                 9.13.6   Recent Developments
                 9.13.7   SWOT Analysis
       9.14   ArcherDx, Inc.
                 9.14.1   Company Overview
                 9.14.2   Corporate Summary
                 9.14.3   Recent Developments
       9.15   Exosome Diagnostics, Inc.
                 9.15.1   Company Overview
                 9.15.2   Corporate Summary
                 9.15.3   Recent Developments
       9.16   NeoGenomics, Inc.
                 9.16.1   Company Overview
                 9.16.2   Corporate Summary
                 9.16.3   Recent Developments
      9.17   MDxHealth, Inc.
                9.17.1   Company Overview
                9.17.2   Corporate Summary
                9.17.3   Recent Developments
      9.18   NanoString Technologies, Inc.
                9.18.1   Company Overview
                9.18.2   Corporate Summary
                9.18.3   Recent Developments
 
   10   Research Scope and Methodology
          10.1   Report Scope
          10.2   Companion Diagnostics Market: Research Methodology
 
List of Tables

Table 2.1    Impact Analysis of Market Drivers
Table 2.2    Impact Analysis of Market Restraints
Table 2.3    Impact Analysis of Market Opportunities
Table 3.1    R&D Revenue of Major CDx Companies (as of FY2017)
Table 6.1    PCR-Based Companion Diagnostics Manufacturers
Table 6.2    PCR-Based Companion Diagnostics Service Providers
Table 6.3    IHC-Based Companion Diagnostics Manufacturers
Table 6.4    IHC-Based Companion Diagnostics Service Providers
Table 6.5    ISH-Based Companion Diagnostics Manufacturers
Table 6.6    ISH-Based Companion Diagnostics Service Providers
Table 6.7    NGS-Based Companion Diagnostics Manufacturers
Table 6.8    NGS-Based Companion Diagnostics Service Providers
Table 7.1    Cancer Type- Incidence and Mortality
Table 7.2    Available Companion Diagnostic Tests for Lung Cancer
Table 7.3    Available Companion Diagnostic Tests for Breast Cancer
Table 7.4    Available Companion Diagnostic Tests for Colorectal Cancer
Table 7.5    Available Companion Diagnostic Tests for Stomach Cancer
Table 7.6    Available Companion Diagnostic Tests for Leukemia
Table 7.7    Available Companion Diagnostic Tests for Melanoma
Table 7.8    Available Companion Diagnostics for Others
Table 9.1    Abbott Laboratories: Partnerships, Agreements, and Collaborations
Table 9.2    Abbott Laboratories: Product Approvals
Table 9.3    Agilent Technologies, Inc.: Acquisition
Table 9.4    Agilent Technologies, Inc.: Collaborations
Table 9.5    ARUP Laboratories: Collaboration
Table 9.6    bioMérieux SA: Approval
Table 9.7    Danaher Corporation: Collaborations and Partnership
Table 9.8    F. Hoffmann-La Roche AG: Collaborations, Agreements, and Partnerships
Table 9.9    F. Hoffmann-La Roche AG: Product Approvals
Table 9.10    Illumina, Inc.: Collaborations, Agreements, and Partnerships
Table 9.11    Illumina, Inc.: Acquisition
Table 9.12    Illumina, Inc.: Product Approval
Table 9.13    Invivoscribe Technologies, Inc.: Product Approval
Table 9.14    MolecularMD Corporation: Agreement and Partnership
Table 9.15    Invivoscribe Technologies, Inc.: Product Approval
Table 9.16    Myriad Genetics, Inc.: Collaborations and Agreements
Table 9.17    Illumina, Inc.: Product Approval
Table 9.18    QIAGEN N.V.: Acquisition
Table 9.19    QIAGEN N.V.: Collaborations, Partnership, and Agreement
Table 9.20    QIAGEN N.V.: Product Approval
Table 9.21    Thermo Fisher Scientific Inc.: Collaborations, Partnership, and Agreement
Table 9.22    Thermo Fisher Scientific Inc.: Product Approval
Table 9.23    ArcherDX, Inc.: Collaborations, Partnership, and Agreement
Table 9.24    Exosome Diagnostics, Inc.: Collaborations and Partnerships
Table 9.25    NeoGenomics, Inc.: Acquisition
Table 9.26    NeoGenomics, Inc.: Collaboration and Agreement
Table 9.27    NeoGenomics, Inc.: Product Launch
Table 9.28    MDxHealth, Inc.: Partnerships and Agreements
Table 9.29    NanoString Technologies, Inc.: Partnership, Collaboration and Agreement

List of Figures

Figure 1    Escalating Healthcare Expenditure, 2016-2020
Figure 2    Impact of Market Drivers and Market Restraints, 2017 and 2025
Figure 3    Global Companion Diagnostics (CDx) Market Snapshot
Figure 4    Dominating Segments of Global Companion Diagnostics Market, 2017 and 2025
Figure 5    Global Companion Diagnostics Market (by Technology), 2017 and 2025
Figure 6    Global Companion Diagnostics Market (by Indication), 2017 and 2025
Figure 7    Global Companion Diagnostics Market (by Region), 2017 and 2025
Figure 8    Growth Share Matrix for Global Companion Diagnostics Market (by Country), 2018 and 2025
Figure 9    Market Statistics
Figure 10    Market Share Analysis: Global Companion Diagnostics Market (2017)
Figure 11    Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2017
Figure 1.1    Classification of Companion Diagnostics (CDx)
Figure 1.2    Evolution of Companion Diagnostics (CDx)
Figure 1.3    Components Required to Develop Companion Diagnostics
Figure 1.4    Applications of Companion Diagnostics (CDx)
Figure 1.5    Potential of Companion Diagnostics (CDx)
Figure 2.1    Market Dynamics
Figure 2.2    Iceberg Analysis
Figure 2.3    Cancer Incidence by WHO Region (2012) per 100,000
Figure 2.4    Fully Aligned Drug-Diagnostic Co-Development
Figure 2.5    CDx Leakage for Oncology
Figure 3.1    Competitive Landscape (January 2014-July 2018)
Figure 3.2    Share of Key Developments and Strategies (January 2014-July 2018)
Figure 3.3    Joint Venture, Partnership, and Collaboration Share by Companies (January 2014-July 2018)
Figure 3.4    Product Approval Share by Companies (January 2014-July 2018)
Figure 3.5    Acquisition Share by Companies (January 2014-July 2018)
Figure 3.6    Market Share Analysis for the Global Companion Diagnostics Market (2016)
Figure 3.7    Market Share Analysis for the Global Companion Diagnostics Market (2017)
Figure 3.8    Growth Share Matrix for Global Companion Diagnostics Market (by Technology), 2017
Figure 3.9    Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2017
Figure 3.10    Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2018 and 2025
Figure 3.11    Industy Attractieness (Porter’s Five Forces Analysis)
Figure 3.12    Bargaining Power of Suppliers: Overall Impact
Figure 3.13    Bargaining Power of Buyers: Overall Impact
Figure 3.14    Threat of New Entrants: Overall Impact
Figure 3.15    Threat of Substitute Products: Overall Impact
Figure 3.16    Intensity of Competitive Rivalry: Overall Impact
Figure 4.1    FDA Guidelines for CDx Approval
Figure 5.1    Global Companion Diagnostics Market, 2017-2025
Figure 6.1    Companion Diagnostics Market (by Technology)
Figure 6.2    Global Companion Diagnostics Market (by Technology), 2017-2025
Figure 6.3    Global Companion Diagnostics Market (by PCR Technology), 2017-2025
Figure 6.4    Global Companion Diagnostics Market (by IHC Technology), 2017-2025
Figure 6.5    Global Companion Diagnostics Market (by ISH Technology), 2017-2025
Figure 6.6    Global Companion Diagnostics Market (by NGS Technology), 2017-2025
Figure 7.1    Global Companion Diagnostics Market (by Indication), 2017-2025
Figure 7.2    Global Companion Diagnostics Market (by Lung Cancer), 2017-2025
Figure 7.3    Total Market Size for Lung Cancer Companion Diagnostics (2017 and 2020)
Figure 7.4    Global Companion Diagnostic Market (by Breast Cancer), 2017-2025
Figure 7.5    Total Market Size for Breast Cancer Companion Diagnostics (2017 and 2020)
Figure 7.6    Global Companion Diagnostics Market (by Colorectal Cancer), 2017-2025
Figure 7.7    Total Market Size for Colorectal Cancer Companion Diagnostics (2017 and 2020)
Figure 7.8    Global Companion Diagnostics Market (by Stomach Cancer), 2017-2025
Figure 7.9    Total Market Size for Stomach Cancer Companion Diagnostics (2017 and 2020)
Figure 7.10    Global Companion Diagnostics Market (by Leukemia), 2017-2025
Figure 7.11    Total Market Size for Leukemia Companion Diagnostics (2017 and 2020)
Figure 7.12    Global Companion Diagnostics Market (by Melanoma), 2017-2025
Figure 7.13    Total Market Size for Melanoma Companion Diagnostics (2017 and 2020)
Figure 7.14    Global Companion Diagnostics Market (by Others), 2017-2025
Figure 7.15    Total Market Size for Others Companion Diagnostics (2017 and 2020)
Figure 8.1    Global Companion Diagnostics Market (by Region), 2017 and 2025
Figure 8.2    Global Companion Diagnostics Market (by Region), 2017-2025
Figure 8.3    Global Companion Diagnostics Market Share (by Region), 2017
Figure 8.4    Global Companion Diagnostics Market Share (by Region), 2025
Figure 8.5    North America Companion Diagnostics Market, 2017-2025
Figure 8.6    North America: Market Dynamics
Figure 8.7    North America Companion Diagnostics Market (by Country), 2017-2025
Figure 8.8    North America Companion Diagnostics Market (by Indication), 2017-2025
Figure 8.9    The U.S. Companion Diagnostics Market, 2017-2025
Figure 8.10    Canada Companion Diagnostics Market, 2017-2025
Figure 8.11    Overview of Reimbursement Policies across Europe
Figure 8.12    Europe Companion Diagnostics Market, 2017-2025
Figure 8.13    Europe: Market Dynamics
Figure 8.14    Europe Companion Diagnostics Market (by Country), 2017-2025
Figure 8.15    Europe Companion Diagnostics Market (by Indication), 2017-2025
Figure 8.16    The U.K. Companion Diagnostics Market, 2017-2025
Figure 8.17    Germany Companion Diagnostics Market, 2017-2025
Figure 8.18    France Companion Diagnostics Market, 2017-2025
Figure 8.19    Italy Companion Diagnostics Market, 2017-2025
Figure 8.20    Spain Companion Diagnostics Market, 2017-2025
Figure 8.21    Rest-of-Europe Companion Diagnostics Market, 2017-2025
Figure 8.22    APAC Companion Diagnostics Market, 2017-2025
Figure 8.23    APAC: Market Dynamics
Figure 8.24    APAC Companion Diagnostics Market (by Country), 2017-2025
Figure 8.25    APAC Companion Diagnostics Market (by Indication), 2017-2025
Figure 8.26    China Companion Diagnostics Market, 2017-2025
Figure 8.27    Japan Companion Diagnostics Market, 2017-2025
Figure 8.28    India Companion Diagnostics Market, 2017-2025
Figure 8.29    Australia Companion Diagnostics Market, 2017-2025
Figure 8.30    Singapore Companion Diagnostics Market, 2017-2025
Figure 8.31    Rest-of-APAC Companion Diagnostics Market, 2017-2025
Figure 8.32    Rest-of-the-World Companion Diagnostics Market, 2017-2025
Figure 9.1    Total Number of Company Profiles
Figure 9.2    Abbott Laboratories: Overall Product Portfolio
Figure 9.3    Abbott Laboratories: Product Portfolio for Companion Diagnostics Market
Figure 9.4    Abbott Laboratories: Overall Financials, 2015-2017
Figure 9.5    Abbott Laboratories: Revenue (by Segment), 2015-2017
Figure 9.6    Abbott Laboratories: Revenue (by Region), 2015-2017
Figure 9.7    Abbott Laboratories: Global Presence
Figure 9.8    SWOT Analysis: Abbott Laboratories
Figure 9.9    Agilent Technologies, Inc.: Overall Product Portfolio
Figure 9.10    Agilent Technology, Inc.: Product Portfolio for Companion Diagnostics Market
Figure 9.11    Agilent Technologies, Inc.: Overall Financials, 2015-2017
Figure 9.12    Agilent Technologies, Inc.: Revenue (by Region), 2015-2017
Figure 9.13    Agilent Technologies, Inc.: Revenue (by Segment), 2015-2017
Figure 9.14    Agilent Technologies, Inc.: Global Presence
Figure 9.15    Agilent Technologies, Inc. SWOT Analysis
Figure 9.16    ARUP Laboratories: Overall Product Portfolio
Figure 9.17    ARUP Laboratories: Product Portfolio for Companion Diagnostics Market
Figure 9.18    ARUP Laboratories: SWOT Analysis
Figure 9.19    bioMérieux SA: Overall Product Portfolio
Figure 9.20    bioMérieux SA: Product Portfolio for Companion Diagnostics Market
Figure 9.21    bioMérieux SA: Overall Financials, 2015-2017
Figure 9.22    bioMérieux SA: Revenue (by Segment), 2015-2017
Figure 9.23    bioMérieux SA: Revenue (by Region), 2015-2017
Figure 9.24    bioMérieux SA: Global Presence
Figure 9.25    bioMérieux SA: SWOT Analysis
Figure 9.26    Danaher Corporation: Overall Product Portfolio
Figure 9.27    Danaher Corporation: Product Portfolio for Companion Diagnostics Market
Figure 9.28    Danaher Corporation: Overall Financials, 2015-2017
Figure 9.29    Danaher Corporation: Net Revenue (by Region), 2015-2017
Figure 9.30    Danaher Corporation: Net Revenue (by Business Segment), 2015-2017
Figure 9.31    Danaher Corporation: Global Presence
Figure 9.32    Danaher Corporation: SWOT Analysis
Figure 9.33    F. Hoffmann-La Roche AG: Overall Product Portfolio
Figure 9.34    F. Hoffmann-La Roche AG: Product Portfolio for Companion Diagnostics Market
Figure 9.35    F. Hoffmann-La Roche AG: Overall Financials, 2015-2017
Figure 9.36    F. Hoffmann-La Roche AG: Net Revenue (by Region), 2015-2017
Figure 9.37    F. Hoffmann-La Roche AG: Net Revenue (by Business Segment), 2015-2017
Figure 9.38    F. Hoffmann-La Roche AG: Global Presence
Figure 9.39    F. Hoffmann-La Roche AG: SWOT Analysis
Figure 9.40    Illumina, Inc.: Overall Product Portfolio
Figure 9.41    Illumina, Inc.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.42    Illumina, Inc.: Overall Financials, 2015-2017
Figure 9.43    Illumina, Inc.: Net Revenue (by Region), 2015-2017
Figure 9.44    Illumina, Inc.: Net Revenue (by Business Segment), 2015-2017
Figure 9.45    Illumina, Inc.: Global Presence
Figure 9.46    Illumina, Inc.: SWOT Analysis
Figure 9.47    Invivoscribe Technologies, Inc.: Overall Product Portfolio
Figure 9.48    Invivoscribe Technologies, Inc.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.49    Invivoscribe Technologies, Inc.: SWOT Analysis
Figure 9.50    MolecularMD Corporation: Overall Product Portfolio
Figure 9.51    MolecularMD Corporation: Product Portfolio for Global Companion Diagnostics Market
Figure 9.52    MolecularMD Corporation: SWOT Analysis
Figure 9.53    Myriad Genetics, Inc.: Overall Product Portfolio
Figure 9.54    Myriad Genetics, Inc.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.55    Myriad Genetics, Inc.: Overall Financials, 2015-2017
Figure 9.56    Myriad Genetics, Inc.: Net Revenue (by Business Segment), 2015-2017
Figure 9.57    Myriad Genetics, Inc.: Global Presence
Figure 9.58    Myriad Genetics, Inc.: SWOT Analysis
Figure 9.59    QIAGEN N.V.: Overall Product Portfolio
Figure 9.60    QIAGEN N.V.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.61    QIAGEN N.V.: Overall Financials, 2015-2017
Figure 9.62    QIAGEN N.V.: Net Revenue (by Business Segment), 2015-2017
Figure 9.63    QIAGEN N.V.: Net Revenue (by Region), 2015-2017
Figure 9.64    QIAGEN N.V.: Global Presence
Figure 9.65    QIAGEN N.V.: SWOT Analysis
Figure 9.66    Thermo Fisher Scientific Inc.: Overall Product Portfolio
Figure 9.67    Thermo Fisher Scientific Inc.: Product Portfolio for Global Companion Diagnostics Market
Figure 9.68    Thermo Fisher Scientific Inc.: Overall Financials, 2015-2017
Figure 9.69    Thermo Fisher Scientific Inc.: Net Revenue (by Business Segment), 2015-2017
Figure 9.70    Thermo Fisher Scientific Inc.: Net Revenue (by Region), 2015-2017
Figure 9.71    Thermo Fisher Scientific Inc.: Global Presence
Figure 9.72    Thermo Fisher Scientific Inc.: SWOT Analysis
Figure 10.1    Global Companion Diagnostics Market Segmentation
Figure 10.2    Global Companion Diagnostics Market Research Methodology
Figure 10.3    Primary Research
Figure 10.4    Secondary Research
Figure 10.5    Data Triangulation
Figure 10.6    Bottom-Up Approach (Segment-Wise Analysis)
Figure 10.7    Top-Down Approach (Segment-Wise Analysis)
Figure 10.8    Assumptions and Limitations
Figure 10.9    Considered Factors for Data Prediction and Modeling

The global healthcare expenditure was valued approximately $7 trillion in 2015 and is expected to reach over $8.5 trillion by 2020, owing to the increasing prevalence of chronic diseases, such as cancer, diabetes, cardiovascular diseases, and respiratory diseases, among others. In addition, the rise in global geriatric population and the increase in incidence of communicable diseases, neurodegenerative diseases, and infectious diseases, among others are escalating the economic, social, and clinical burden, across the globe, thereby increasing pricing pressure on the pharmaceutical as well as diagnostic companies. Acknowledging the criticality of the situation, government bodies of several nations have been restructuring their regulatory framework and norms to help companies in reducing treatment costs and expand accessibility to advance healthcare solutions. On the other hand, the healthcare companies are trying to reduce the unnecessary healthcare expenditure by enabling novel treatment approaches and developing cost-effective products based on advanced technologies. Advent of precision medicine, a patient-centric treatment approach based on biomarker study, is perceived to be promising in driving a paradigm shift in the healthcare industry. This biomarker-based, targeted medication would not only facilitate in eliminating the uncertainty of trial and error method of medications, but also eliminate unnecessary healthcare expenditure.

In the era of precision medicine, the number of commercialized predictive biomarker assays has increased tremendously, especially in case of chronic diseases, to facilitate the development of targeted therapeutics. These biomarker-based assays, known as companion diagnostics (CDx), not only aid in parallel development of targeted drugs, but also provide essential information for patient stratification to enable effective and safe use of corresponding treatment. Till date, healthcare industry has witnessed several successful drug-diagnostic co-developments mostly for oncology. However, successful commercialization and approval of CDx for multiple cancer types, including lung cancer, breast cancer, leukemia, colorectal cancer, gastric cancer, ovarian cancer, and melanoma, have further drawn attention of several pharmaceutical and diagnostic companies to venture into this lucrative market by developing non-oncology CDx solutions, especially for indications such as neurodegenerative diseases, infectious diseases, metabolic disorders, and cardiovascular diseases, thereby enhancing the growth of global CDx market. The global companion diagnostics market is expected to reach $4.1 billion by 2025. With increasing demand for NGS-based companion diagnostics, the global CDx market is expected to witness double digit growth rate during the forecast period 2018-2025. In addition, PCR-based companion diagnostics is expected to be dominating among the other technology-based products, in 2025. In 2017, companion diagnostics for lung cancer was responsible for a 27.20% share of the global market value.

The purpose of the study is to gain a holistic view of the global companion diagnostics market in terms of various factors such as recent trends and technological advancements, influencing the market. The scope of this report is centered upon conducting a detailed study of the products allied with the companion diagnostics market, which includes various technology-based products such as Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR). However, the market estimation only comprises manufacturers of companion diagnostics. The companion diagnostics market is segmented into three different parts namely technology, indication, and region. The global market value was estimated using these three different approaches and was validated with one another. These segments are further segmented into several sub-segments to ease the market estimation and to gain a holistic view of the market.

Based on the region, the global companion diagnostics market is segmented into North America, Europe, Asia-Pacific, and Rest-of-the-World (RoW). North America is the leading contributor to the global companion diagnostics market and was responsible for a 52.53% share of the global market values in 2017. However, Asia-Pacific is expected to grow at a CAGR of 32.06% during the forecast period 2018-2025.

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

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