North America Companion Diagnostics Devices Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The North America Companion Diagnostics Devices Market is segmented by Technology, Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Leukemia, Melanoma, Other Indications), and Geography.

Market Snapshot

NA Companion Diagnostics Market _Image 1
Study Period: 2018 - 2026
Base Year: 2021
CAGR: 18.5 %

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Market Overview

The North American 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 increasing demand and awareness for personalized medicine and targeted therapy, increasing cases of adverse drug reactions, and technological demands.

The United States takes an exceptional approach in regulating the innovative companion diagnostic devices. The US FDA approved diagnostic assays play an important 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.

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.

Immunohistochemistry (IHC)
Polymerase Chain Reaction (PCR)
In-situ Hybridization (ISH)
Real-time PCR (RT-PCR)
Gene Sequencing
Other Technologies
Lung Cancer
Breast Cancer
Colorectal Cancer
Other Indications
North America
United States

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Key Market Trends

The In-situ Hybridization (ISH) Segment is Expected to Exhibit the 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 American 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, and Thermo Fisher Scientific Inc., among others, hold the substantial market share in the companion diagnostics devices market.

Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Demand and Awareness for Personalized Medicine and Targeted Therapy

      2. 4.2.2 Increasing Cases of Adverse Drug Reactions

      3. 4.2.3 Technological Advancements in the Devices

    3. 4.3 Market Restraints

      1. 4.3.1 High Cost of Drug Development and Associated Clinical Trials

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 Technology

      1. 5.1.1 Immunohistochemistry (IHC)

      2. 5.1.2 Polymerase Chain Reaction (PCR)

      3. 5.1.3 In-situ Hybridization (ISH)

      4. 5.1.4 Real-time PCR (RT-PCR)

      5. 5.1.5 Gene Sequencing

      6. 5.1.6 Other Technologies

    2. 5.2 Indication

      1. 5.2.1 Lung Cancer

      2. 5.2.2 Breast Cancer

      3. 5.2.3 Colorectal Cancer

      4. 5.2.4 Leukemia

      5. 5.2.5 Melanoma

      6. 5.2.6 Other Indications

    3. 5.3 Geography

      1. 5.3.1 North America

        1. United States

        2. Canada

        3. Mexico


    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories

      2. 6.1.2 Agilent Technologies Inc.

      3. 6.1.3 Biomerieux SA

      4. 6.1.4 Danaher Corporation (Beckman Coulter Inc.)

      5. 6.1.5 F. Hoffmann-La Roche Ltd

      6. 6.1.6 Qiagen NV

      7. 6.1.7 Siemens Healthcare

      8. 6.1.8 Thermo Fisher Scientific Inc.

    2. *List Not Exhaustive

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The North America Companion Diagnostics Devices Market market is studied from 2018 - 2026.

The North America Companion Diagnostics Devices Market is growing at a CAGR of 18.5% over the next 5 years.

Abbott, F. Hoffmann-La Roche Ltd, Biomerieux SA, Qiagen NV, Agilent Technologies Inc. are the major companies operating in North America Companion Diagnostics Devices Market.

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