Companion Diagnostics Market - Global Forecast to 2026, by Application (Lung Cancer, Breast Cancer, Colorectal Cancer, Gastric Cancer, Melanoma, and Others), by Technology (Real Time PCR, Gene Sequencing, Fluorescence In Situ Hybridization, and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Trends, and Forecast 2018 - 2026

  • Published On : Jul 2019 |
  • Pages : 191 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Global Companion Diagnostics Market – Growing Preference for Precision Medicine

Companion diagnostics play a major role in advanced healthcare, as it aids in targeting biomarker identification, reducing clinical trial cost, and time to market the product. Also, encouragement from the regulatory bodies such as the U.S Food and Drug Administration (FDA) in terms of providing a defined structure for companion diagnostic development is driving research activities in companion diagnostics.

The global companion diagnostics market size was valued at US$ 2,040.0 million in 2017, and is expected to exhibit a CAGR of 19.5 % over the forecast period (2018–2026).

Figure 1. Global Companion Diagnostics Market Value (US$ Mn), by Region, 2017

                                                                 Source: Coherent Market Insights Analysis (2019)

Increasing incidences of cancer is expected to propel growth of the global companion diagnostics market

Increasing incidences of cancer cases is expected to drive the global companion diagnostics market growth. For instance, according to GLOBOCAN 2018, around 18.1 million new cancer cases and 9.6 million cancer deaths were recorded worldwide in 2018. Furthermore, according to the same source, in 2018, around 2,093,876 new lung cancer cases were recorded.

Moreover, increasing government initiatives for development of companion diagnostics and therapies used in the treatment of cancer patients is expected to propel growth of global companion diagnostics market. For instance, in 2015, the U.S. government announced the launch of Precision Medicine Initiative, which has led to powerful new discoveries and several new treatments that are tailored for specific characteristic such as person’s genetic makeup or genetic profile of an individual tumor that helps to transform the way of treatment.

However, narrow labelling of companion diagnostics is expected to be the major factor hindering the market growth.

Figure 2. Global Companion Diagnostics Market Share (%), by Application, 2018 and 2026

                                     

Source: Coherent Market Insights Analysis (2019)

Increasing cancer cases and presence of well-established manufacturers, which are engaged in providing advanced companion diagnostics in the North America are expected to bolster the market growth

North America holds dominant position in the global companion diagnostics market, owing to presence of well-established manufacturers, which are focused in product approval for offering advanced companion diagnostic. For instance, in June 2018, Agilent Technologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay. PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test for determining PD-L1 expression in cervical cancer and is the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with KEYTRUDA. Moreover, increasing cancer cases in the region is propelling growth of the market. For instance, according to the National Cancer Institute (NCI), in April 2018, an estimated around 1,735,350 new cancer cases and 609,640 deaths due to cancer in the U.S. were recorded. Moreover, according to the same source, the most common cancers in 2018, were breast cancer, prostate cancer, melanoma, bladder cancer, pancreatic cancer, liver cancer, and other cancers, and the number of new cancer cases reported were around 439.2 per 100,000 men and women per year in the U.S. (based on 2011 to 2015 cases).

Key Players

Major players operating in the global companion diagnostics market include Abbott Laboratories, Agilent Technologies Inc., Danaher Corporation, Qiagen N.V., F. Hoffmann-La Roche AG, bioMerieux S.A., Illumina, Inc., GE Healthcare, Myriad Genetics Inc., and Siemens Healthineers.

Companion diagnostics (CDx) is a diagnostic tool used to determine the suitability of a drug therapy to the patient. It has become a critical part of targeted cancer therapy that allows development of personalized therapy that can be developed and administered to the patient. Whole blood samples, tissues samples, or buccal samples are collected and tested for diagnosis and identification of targeted disease biomarker. Generally, CDx is utilized in identifying genetic mutations and the health and treatment approach implications.

Market Dynamics

Increasing prevalence of cancer cases is a major factor driving global companion diagnostics market growth. According to a National Cancer Institute, in 2016, an estimated 16.8 million new cases of cancer were diagnosed in the U.S., with around 595,690 deaths from the disease. The number of people with cancer is expected to rise to 19 million by 2024 in the U.S. according to the same source.

Furthermore, inorganic strategies adopted by key players for offering best products in the market is expected to drive the market growth. For instance, in May 2018, Foundation Medicine, Inc., announced collaboration with Merck for development of companion diagnostic test to use with KEYTRUDA (pembrolizumab), Merck’s first immunotherapy for solid tumors. Similarly, in June 2016, MolecularMD Corporation, announced collaboration with Illumina, Inc., for the development and commercialization of sequencing-based companion diagnostics. The agreement combines MolecularMD’s companion diagnostic development and with Illumina’s NGS technology.

Key features of the study:

  • This report provides in-depth analysis of the companion diagnostics market and provides market size (US$ million) and compound annual growth rate (CAGR%) for the forecast period (2018–2026), considering 2017 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategy adopted by key players
  • It profiles key players in the global companion diagnostics market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Abbott Laboratories, Agilent Technologies Inc., Danaher Corporation, F. Hoffmann-La Roche AG, Qiagen N.V., bioMerieux S.A., Illumina, Inc., GE Healthcare, Myriad Genetics Inc., and Siemens Healthineers
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics.
  • The global companion diagnostics market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global companion diagnostics market

Detailed Segmentation:

  • Global Companion diagnostics market, By Application:
    • Lung Cancer
    • Breast Cancer
    • Colorectal Cancer
    • Gastric Cancer
    • Melanoma
    • Others
  • Global Companion diagnostics market, By Technology:
    • Real Time PCR
    • Gene Sequencing
    • Fluorescence In Situ Hybridization (FISH)
    • Others
  • Global Companion diagnostics market, By Region:
    • North America
      • By Application:
        • Lung Cancer
        • Breast Cancer
        • Colorectal Cancer
        • Gastric Cancer
        • Melanoma
        • Others
      • By Technology:
        • Real Time PCR
        • Gene Sequencing
        • Fluorescence In Situ Hybridization (FISH)
        • Others
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Application:
        • Lung Cancer
        • Breast Cancer
        • Colorectal Cancer
        • Gastric Cancer
        • Melanoma
        • Others
      • By Technology:
        • Real Time PCR
        • Gene Sequencing
        • Fluorescence In Situ Hybridization (FISH)
        • Others
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Application:
        • Lung Cancer
        • Breast Cancer
        • Colorectal Cancer
        • Gastric Cancer
        • Melanoma
        • Others
      • By Technology:
        • Real Time PCR
        • Gene Sequencing
        • Fluorescence In Situ Hybridization (FISH)
        • Others
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Application:
        • Lung Cancer
        • Breast Cancer
        • Colorectal Cancer
        • Gastric Cancer
        • Melanoma
        • Others
      • By Technology:
        • Real Time PCR
        • Gene Sequencing
        • Fluorescence In Situ Hybridization (FISH)
        • Others
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Application:
        • Lung Cancer
        • Breast Cancer
        • Colorectal Cancer
        • Gastric Cancer
        • Melanoma
        • Others
      • By Technology:
        • Real Time PCR
        • Gene Sequencing
        • Fluorescence In Situ Hybridization (FISH)
        • Others
      • By Country/Region:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Application:
        • Lung Cancer
        • Breast Cancer
        • Colorectal Cancer
        • Gastric Cancer
        • Melanoma
        • Others
      • By Technology:
        • Real Time PCR
        • Gene Sequencing
        • Fluorescence In Situ Hybridization (FISH)
        • Others
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Abbott Laboratories*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • Agilent Technologies Inc.
    • Danaher Corporation
    • F. Hoffmann-La Roche AG
    • Qiagen N.V.
    • bioMerieux S.A.
    • Illumina, Inc.
    • GE Healthcare
    • Myriad Genetics Inc.
    • Siemens Healthineers

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Application
      • Market Snippet, By Technology
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Collaborations and Acquisitions
    • Regulatory Scenario
    • Reimbursement Scenario
    • PEST Analysis
    • Porter’s Analysis
    • Epidemiology
    • Market Trends
  4. Global Companion Diagnostics Market, By Application, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Lung Cancer
      •  Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Breast Cancer
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Colorectal Cancer
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Gastric Cancer
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Melanoma
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  5. Global Companion Diagnostics Market, By Technology, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Real Time PCR
      •  Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Gene Sequencing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Fluorescence In Situ Hybridization (FISH)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  6. Global Companion Diagnostics Market, By Region, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
    • North America
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Technology, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • U.S.
        • Canada
    • Latin America
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Technology, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Technology, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • Germany
        • U.K.
        • France        
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Technology, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of APAC
    • Middle East
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Technology, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country/Region, 2016 – 2026, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Technology, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country/Region, 2016 – 2026, (US$ Mn)
        • South Africa
        • Central Africa
        • North Africa
  7. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Abbott Laboratories
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Agilent Technologies Inc.
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Danaher Corporation
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • F. Hoffmann-La Roche AG
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      •  Qiagen N.V.
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • bioMerieux S.A.
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Illumina, Inc.
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • GE Healthcare
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Myriad Genetics Inc.
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Siemens Healthineers
        • Company Overview
        • Product Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
    • Analyst Views
  8. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 33 market data tables and 26 figures on "Companion Diagnostics Market - Global forecast to 2026”.

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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