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Market Research Report

North America Companion Diagnostics Devices Market - Growth, Trends, and Forecast (2019 - 2024)

Published by Mordor Intelligence LLP Product code 871448
Published Content info 70 Pages
Delivery time: 2-3 business days
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North America Companion Diagnostics Devices Market - Growth, Trends, and Forecast (2019 - 2024)
Published: June 1, 2019 Content info: 70 Pages

Market Overview

North America Companion Diagnostics Devices market is expected to witness a CAGR of 18.5% during the forecast period. Certain factors that are driving the market growth include rising demand and awareness for personalized medicine and targeted therapy, increasing cases of adverse drug reactions, technological demands.

The United States takes an exceptional approach to regulate innovative companion diagnostic devices. The US Food and Drug Administration (FDA)-approved diagnostic assays play an ever more common role in managing patients to extend lifespan while also enhancing the quality of life. Diagnostic assays have been found to be essential for the safe and effective use of therapeutics (companion diagnostic).

Scope of the Report

Companion diagnostic tests provide information that is essential for the safe and effective use of a corresponding drug or biological product. As per the scope of the report, the market studied has been segmented by technology, indications, and geography. By technology, the market studied has been further segmented into immunohistochemistry, polymerase chain reaction, in-situ hybridization, real time-polymerase chain reaction, gene sequencing, and other technologies.

Key Market Trends

In-situ Hybridization (ISH) Segment is Expected to Exhibit Fastest Growth Rate Over the Forecast Period

In-situ hybridization (ISH), especially fluorescence in-situ hybridization (FISH), is a reliable, reproducible, sensitive, and accurate procedure, which is less affected by tissue fixation and analytical variables, in comparison to immunochemistry and other techniques. It offers the benefit of simultaneous evaluation of morphology and gene amplification. FISH has been the method of choice for use in companion diagnostics for several cancer therapies, such as trastuzumab, lapatinib, and criotinib, which have been already approved by FDA and other therapies, like everolimus, ridaforolimus, bicatulamide, TBD, and other drugs, that are yet to obtain regulatory approval.

Competitive Landscape

The North America Companion Diagnostics Devices market is highly competitive and consists of a few major players. Companies like Abbott, Agilent Technologies Inc., Biomerieux SA, Danaher Corporation (Beckman Coulter Inc.), F. Hoffmann-La Roche Ltd, Qiagen NV, Siemens Healthcare, Thermo Fisher Scientific Inc., among others, hold the substantial market share in the Companion Diagnostics Devices market.

Reasons to Purchase this report:

  • The market estimate (ME) sheet in Excel format
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Table of Contents
Product Code: 57114

Table of Contents


  • 1.1 Study Deliverables
  • 1.2 Study Assumptions
  • 1.3 Scope of the Study




  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Demand and Awareness for Personalized Medicine and Targeted Therapy
    • 4.2.2 Increasing Cases of Adverse Drug Reactions
    • 4.2.3 Technological Demands
  • 4.3 Market Restraints
    • 4.3.1 High Cost of Drug Development and Associated Clinical Trials
  • 4.4 Porter's Five Force Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry


  • 5.1 Technology
    • 5.1.1 Immunohistochemistry (IHC)
    • 5.1.2 Polymerase Chain Reaction (PCR)
    • 5.1.3 In-situ Hybridization (ISH)
    • 5.1.4 Real-time PCR (RT-PCR)
    • 5.1.5 Gene Sequencing
    • 5.1.6 Other Technologies
  • 5.2 Indication
    • 5.2.1 Lung Cancer
    • 5.2.2 Breast Cancer
    • 5.2.3 Colorectal Cancer
    • 5.2.4 Leukemia
    • 5.2.5 Melanoma
    • 5.2.6 Other Indications
  • 5.3 Geography
    • 5.3.1 North America
      • US
      • Canada
      • Mexico


  • 6.1 Company Profiles
    • 6.1.1 Abbott
    • 6.1.2 Agilent Technologies Inc.
    • 6.1.3 Biomerieux SA
    • 6.1.4 Danaher Corporation (Beckman Coulter Inc.)
    • 6.1.5 F. Hoffmann-La Roche Ltd
    • 6.1.6 Qiagen NV
    • 6.1.7 Siemens Healthcare
    • 6.1.8 Thermo Fisher Scientific Inc.


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