North America Companion Diagnostics Devices Market Size (2024 - 2029)

The North American companion diagnostics devices market is projected to expand significantly over the forecast period, driven by increasing demand for personalized medicine and targeted therapies, as well as technological advancements in diagnostic devices. The market's growth is further supported by the rising awareness and adoption of companion diagnostics, particularly in response to the COVID-19 pandemic and the emergence of treatment-resistant variants. Strategic collaborations and partnerships aimed at enhancing access to personalized medicines are also contributing to market expansion. Despite these positive trends, the high costs associated with drug development and clinical trials may pose challenges to market growth.

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Market Size of North America Companion Diagnostics Devices Industry

North America Companion Diagnostics Devices Market Summary
Study Period 2019 - 2029
Base Year For Estimation 2023
Forecast Data Period 2024 - 2029
Historical Data Period 2019 - 2022
CAGR 18.50 %
Market Concentration Medium

Major Players

North America Companion Diagnostics Devices Market Major Players

*Disclaimer: Major Players sorted in no particular order

North America Companion Diagnostics Devices Market Analysis

The North American companion diagnostics devices market is expected to witness a CAGR of 18.5% over the forecast period.

COVID-19 has impacted the growth of the companion diagnostics devices market. For instance, according to an article published by Systematic Reviews in Pharmacy, in May 2022, serological antibody tests were used as SARS-CoV-2 vaccination companion diagnostics to enhance COVID-19 immunization schedules. In addition, as per the same source, SARS-CoV-2 vaccination companion diagnostics offered several advantages, including long-lasting, dependable immune protection through monitoring with a particular test combination and, consequently, medical security against COVID-19. This has increased the demand for companion diagnostics during the pandemic. Moreover, the emerging new or treatment-resistant variants has increased the demand for alternative therapies and rapid companion diagnostics for combatting acute infections as well as to understand the short- and long-term impact of variants on health. Thus, the studied market has witness significant growth and is expected to grow over the forecast period.

Factors such as the increasing demand and awareness for personalized medicines and targeted therapy, increasing cases of adverse drug reactions, and technological advancements in the devices are expected to boost market growth over the forecast period.

The growing company's focus on adopting various key strategies such as collaboration, partnerships, and others to improve access to personalized medicines as well as increasing awareness regarding targeted therapies among the population is expected to increase the adoption of companion diagnostic tests. This in turn is anticipated to fuel market growth. For instance, in May 2021, Hoffmann-La Roche Limited, Canada, signed a joint initiative with BC Cancer and the Canadian Personalized Healthcare Innovation Network (CPHIN) to co-create a real-world evidence (RWE) framework in British Columbia. The PREDiCT initiative generates and assesses RWE, which can be used to shape new sustainable reimbursement pathways for personalized cancer treatments.

Furthermore, a surge in research and development of targeted therapies is also expected to increase the demand for companion diagnostics tests and devices, hence contributing to the market growth. For instance, in May 2021, the United States FDA approved Rybrevant (amivantamab) as a targeted therapy for treating adult patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Moreover, the growing company activities in developing technologically advanced products, and increasing new product launches and approvals are also expected to bolster the market growth in the region over the forecast period. For instance, in July 2021, Labcorp launched therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib). Similarly, in May 2021, QIAGEN N.V. launched an expanded scope of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit after the United States as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRAST approval.

Therefore, owing to the aforementioned factors, the studied market is anticipated to grow over the forecast period. However, the high cost of drug development and associated clinical trials are likely to impede the growth of the companion diagnostics devices market over the forecast period.

North America Companion Diagnostics Devices Industry Segmentation

As per the 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. The North America Companion Diagnostics Devices Market is Segmented by Technology (Immunohistochemistry (IHC), Polymerase Chain Reaction (PCR), In-situ Hybridization (ISH), Real-time PCR (RT-PCR), Gene Sequencing, and Other Technologies), Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Leukemia, Melanoma, and Other Indications) and Geography. The report offers the value (in USD million) for the above segments.

Technology
Immunohistochemistry (IHC)
Polymerase Chain Reaction (PCR)
In-situ Hybridization (ISH)
Real-time PCR (RT-PCR)
Gene Sequencing
Other Technologies
Indication
Lung Cancer
Breast Cancer
Colorectal Cancer
Leukemia
Melanoma
Other Indications
Geography
North America
United States
Canada
Mexico
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North America Companion Diagnostics Devices Market Size Summary

The North American companion diagnostics devices market is poised for significant growth, driven by the increasing demand for personalized medicine and targeted therapies. The market is experiencing a surge in interest due to the rising prevalence of cancer and the need for effective treatment strategies that minimize adverse drug reactions. Technological advancements in diagnostic devices are further propelling market expansion. The COVID-19 pandemic has also played a role in boosting the market, as companion diagnostics were utilized to enhance vaccination strategies and monitor immune responses. Companies are actively engaging in collaborations and partnerships to improve access to these diagnostics, which is expected to further fuel market growth.

The United States is anticipated to hold a substantial share of the North American market, supported by high healthcare expenditure and a strong focus on technological innovation in diagnostics. The increasing incidence of various cancers necessitates early detection and personalized treatment approaches, driving demand for companion diagnostics. The market is characterized by the presence of numerous key players, including Abbott Laboratories, Agilent Technologies Inc., and Thermo Fisher Scientific Inc., who are continuously launching new products and seeking regulatory approvals to enhance their offerings. Despite the high costs associated with drug development and clinical trials, the market is expected to grow, with breast cancer diagnostics anticipated to see significant advancements due to rising awareness and new product approvals.

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North America Companion Diagnostics Devices Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing Demand and Awareness for Personalized Medicine and Targeted Therapy

      2. 1.2.2 Increasing Cases of Adverse Drug Reactions

      3. 1.2.3 Technological Advancements in the Devices

    3. 1.3 Market Restraints

      1. 1.3.1 High Cost of Drug Development and Associated Clinical Trials

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size by Value - USD Million)

    1. 2.1 Technology

      1. 2.1.1 Immunohistochemistry (IHC)

      2. 2.1.2 Polymerase Chain Reaction (PCR)

      3. 2.1.3 In-situ Hybridization (ISH)

      4. 2.1.4 Real-time PCR (RT-PCR)

      5. 2.1.5 Gene Sequencing

      6. 2.1.6 Other Technologies

    2. 2.2 Indication

      1. 2.2.1 Lung Cancer

      2. 2.2.2 Breast Cancer

      3. 2.2.3 Colorectal Cancer

      4. 2.2.4 Leukemia

      5. 2.2.5 Melanoma

      6. 2.2.6 Other Indications

    3. 2.3 Geography

      1. 2.3.1 North America

        1. 2.3.1.1 United States

        2. 2.3.1.2 Canada

        3. 2.3.1.3 Mexico

North America Companion Diagnostics Devices Market Size FAQs

The North America Companion Diagnostics Devices Market is projected to register a CAGR of 18.5% during the forecast period (2024-2029)

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

North America Companion Diagnostics Devices Report Snapshots

North America Companion Diagnostics Devices Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)