• Cat-intel
  • MedIntelliX
  • Resources
  • About Us
  • Request Free Sample ×

    Kindly complete the form below to receive a free sample of this Report

    Leading companies partner with us for data-driven Insights

    clients tt-cursor

    US Companion Diagnostic Market

    ID: MRFR/MED/13122-HCR
    100 Pages
    Rahul Gotadki
    September 2025

    US Companion Diagnostic Market Research Report By Product & Service (Assays, Kits, Reagents, Software, Services), By Technology (Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Others), By Indication (Cancer, Neurological Diseases, Infectious Diseases, Cardiovascular Diseases, Others) and By End User (Pharmaceutical & Biopharmaceutical Companies, Contract Research Organizations, Laboratories, Others) - Forecast to 2035

    Share:
    Download PDF ×

    We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.

    US Companion Diagnostic Market Infographic
    Purchase Options
    $ 4,950.0
    $ 5,950.0
    $ 7,250.0

    US Companion Diagnostic Market Summary

    The US Companion Diagnostic market is projected to grow significantly from 9.01 USD Billion in 2024 to 60.9 USD Billion by 2035.

    Key Market Trends & Highlights

    US Companion Diagnostic Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 18.96 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 60.9 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 9.01 USD Billion, reflecting the current demand for companion diagnostics in the United States.
    • Growing adoption of personalized medicine due to increased awareness of targeted therapies is a major market driver.

    Market Size & Forecast

    2024 Market Size 9.01 (USD Billion)
    2035 Market Size 60.9 (USD Billion)
    CAGR (2025-2035) 18.96%

    Major Players

    Illumina, Novartis, BioRad Laboratories, Merck, Myriad Genetics, QIAGEN, Abbott Laboratories, Foundation Medicine, BristolMyers Squibb, Thermo Fisher Scientific, Agilent Technologies, Pfizer, Amgen, Roche, GSK

    US Companion Diagnostic Market Trends

    The US Companion Diagnostic Market is experiencing significant growth driven by the increasing adoption of personalized medicine and advancements in genomics. Regulatory agencies, particularly the FDA, have been supportive of the development of companion diagnostics, which enhances the approval process of targeted therapies. This supportive regulatory environment is a crucial market driver as it encourages manufacturers to invest in developing innovative diagnostic tools. Furthermore, the rise in cancer prevalence and the growing demand for personalized treatment options are propelling the need for companion diagnostics, particularly in oncology.

    There are also numerous opportunities to be explored within the US market. The increasing collaboration between diagnostic companies and pharmaceutical firms presents an avenue for developing novel companion diagnostics that can significantly improve patient outcomes. Additionally, the integration of artificial intelligence and machine learning into diagnostic processes can streamline the workflow and enhance accuracy, offering a promising area for growth. The trend toward increased precision in medical treatments aligns well with these technological advancements.

    Market Segment Insights

    Companion Diagnostic Market Product & Service Insights

    The US Companion Diagnostic Market within the Product and Service segment is a significant aspect of the healthcare landscape, particularly as it gears towards personalized medicine. This segment encompasses various critical components, including assays, kits, reagents, software, and services that facilitate the efficient identification of the right therapies for patients based on their individual genetic profiles. Assays play a crucial role by providing the necessary testing methodologies that allow for the reliable detection of biomarkers, which are vital for determining patient-specific treatment plans.

    Kits and reagents support these assays by ensuring they are accessible and user-friendly while delivering accurate results in a timely manner, making them indispensable in clinical settings.

    Software solutions within the Product and Service segment enhance laboratory workflows and improve data management and analysis, thus facilitating better decision-making in treatment pathways. Furthermore, the Services category provides essential support, including consultation and guidance on the best diagnostic practices, as well as the implementation of these advanced technologies in clinical environments. This tight integration among assays, kits, reagents, software, and services not only strengthens the functionality of diagnostics but also promotes a patient-centered approach in the US healthcare system.

    The demand for these products and services is driven by various factors, including an increasing prevalence of chronic diseases, advancements in genomic technologies, and a growing emphasis on tailored therapies that promise better patient outcomes. Moreover, the regulatory landscape in the US is evolving, with health authorities actively encouraging the development and integration of companion diagnostics to align treatments with patient genetic profiles. This trend is likely to create a robust support system for the Product and Service segment, offering ample opportunities for innovation and expansion.

    Despite the potential and momentum of this market segment, challenges such as reimbursement issues for diagnostic tests and the complexity of regulatory approvals remain pertinent. Nevertheless, the ongoing efforts to establish comprehensive guidelines and collaborative frameworks between diagnostic manufacturers and healthcare providers signify proactive measures to overcome these hurdles. As the US Companion Diagnostic Market continues to grow, a focus on enhancing the quality and accessibility of these essential products and services will be paramount in ensuring that patients receive the most effective and tailored therapeutic interventions.

    Companion Diagnostic Market Technology Insights

    The Technology segment of the US Companion Diagnostic Market plays a vital role in advancing personalized medicine. This segment includes various techniques, such as Polymerase Chain Reaction, which is widely utilized for its accuracy in amplifying specific DNA sequences, making it crucial for genetic testing. Next-Generation Sequencing stands out due to its high throughput and ability to analyze multiple genes simultaneously, thereby enhancing patient-specific therapies. In Situ Hybridization is noteworthy for its application in visualizing specific nucleic acid sequences within fixed tissues, providing essential insights into cellular environments.

    Immunohistochemistry remains a dominant method for determining protein expressions in various cancers, facilitating targeted treatment approaches. Lastly, other technologies contribute to innovation and diversification within the market, allowing for the integration of new methodologies into clinical applications. The continuous advancements and adoption of these technologies underline the critical role they play in shaping the landscape of the US Companion Diagnostic Market, ultimately impacting patient outcomes and treatment efficiency.

    Companion Diagnostic Market Indication Insights

    The US Companion Diagnostic Market is a rapidly evolving field, primarily focused on improving patient outcomes through tailored therapies based on individual patient data. Within this market, indication segments such as Cancer, Neurological Diseases, Infectious Diseases, and Cardiovascular Diseases play a critical role, with significant implications for patient management. Cancer diagnostics dominate this segment due to the rising incidence of various cancers and the necessity for personalized treatment plans, which drive demand for precise biomarkers.

    Neurological diseases have also gained attention owing to advancements in diagnostic technologies that help in early detection, crucial for conditions like Alzheimer's and Parkinson's disease. Infectious diseases have seen increased relevance, especially in light of global health challenges, emphasizing the need for rapid and accurate testing methods. Cardiovascular diseases remain a critical focus because they contribute to a high mortality rate, thus highlighting the need for effective diagnostic tools to guide treatment strategies.

    The segmentation of the US Companion Diagnostic Market is shaped by these conditions, driving innovation and growth opportunities while addressing distinct healthcare challenges faced in the region.As the landscape continues to develop, ongoing Research and Development efforts are likely to lead to new opportunities across these segments, ensuring improved healthcare outcomes for patients in the US.

    Companion Diagnostic Market End User Insights

    The End User segment of the US Companion Diagnostic Market plays a pivotal role in the broader landscape of personalized medicine. Pharmaceutical and Biopharmaceutical Companies are increasingly investing in companion diagnostics to enhance their drug development processes, ensuring that therapies are tailored to the right patient populations. This segment is crucial for driving innovation as these companies utilize companion diagnostics to identify biomarkers and improve patient outcomes. Contract Research Organizations are also integral to this market segment, providing necessary expertise and resources to facilitate clinical trials and validation processes.

    Their ability to streamline research and development efforts allows for faster time to market for diagnostic products. Laboratories represent another key component, often acting as the frontline for testing and deploying companion diagnostics in clinical settings; their role in interpreting test results and providing actionable insights is critical in treatment decisions. The Others category encompasses various stakeholders, indicating the diverse ecosystem of entities contributing to the efficacy of companion diagnostics in the US.

    Overall, the segmentation of the End User market reflects a robust framework that supports the ongoing growth and development of the US Companion Diagnostic Market, with each segment playing an essential role in augmenting patient care and advancing healthcare solutions.

    Get more detailed insights about US Companion Diagnostic Market Research Report - Forecast to 2035

    Key Players and Competitive Insights

    The US Companion Diagnostic Market is characterized by a dynamic competitive landscape, which has evolved significantly due to rapid advancements in technology and the increasing emphasis on personalized medicine. Companion diagnostics are essential tools that enable clinicians to identify the most suitable therapies for patients based on their unique genetic profiles or other biomarkers. This market is heavily influenced by innovation, regulatory approvals, and collaborations between diagnostic companies and pharmaceutical firms. The competitive insights reflect an ongoing trend toward integrating diagnostic testing with targeted therapies, creating a synergy that benefits both patients and healthcare providers.

    As the market expands, companies are focusing on developing novel diagnostics that complement existing therapies and improve patient outcomes, which is leading to an intensified competitive environment.

    Key Players Analysis

    Illumina holds a strong position within the US Companion Diagnostic Market, renowned for its cutting-edge sequencing technologies that facilitate genomic analysis. The company’s prowess in next-generation sequencing (NGS) has established it as a leader in the field, providing robust solutions for precision medicine and oncology. Illumina’s offerings enable the identification of specific mutations or biomarkers that are crucial for selecting appropriate treatments, contributing to increased adoption among healthcare professionals.

    The company continues to capitalize on the growing demand for personalized healthcare by expanding its partnerships with pharmaceutical companies and actively participating in clinical trials to validate its diagnostic tests. Its extensive market presence is bolstered by a reputation for reliability and accuracy, promoting its diagnostics as indispensable tools in crafting effective treatment plans tailored to individual patients.

    Novartis is another significant player in the US Companion Diagnostic Market, integrating diagnostics with its pharmaceutical innovations to enhance therapeutic effectiveness. The company’s strategy includes the development of companion diagnostics alongside its targeted therapies, allowing for substance-specific drug interactions that optimize treatment options for various conditions, particularly in oncology. Key products within its portfolio focus on aiding in the selection of treatments that correspond with specific genetic profiles.

    Novartis has also pursued strategic mergers and acquisitions to bolster its capabilities in the diagnostics domain and improve its market reach in the US. This commitment not only strengthens its position in the market but also allows for a more comprehensive approach to patient care, ensuring that the therapies it develops are used in conjunction with the appropriate diagnostic tests. By aligning its product development with the latest advancements in genetics, Novartis remains a formidable contender in shaping the future of personalized medicine in the United States.

    Key Companies in the US Companion Diagnostic Market market include

    Industry Developments

    In recent developments, the US Companion Diagnostic Market has witnessed significant advancements, particularly among key players such as Illumina, Novartis, and Roche. For instance, in April 2023, Illumina announced a partnership with Merck to develop companion diagnostics for immune-oncology therapies, expanding their genomic sequencing capabilities. In June 2023, BioRad Laboratories launched a new product line aimed explicitly at enhancing the accuracy of companion diagnostics in oncology, reflecting the growing demand for personalized medicine. Merger and acquisition activity has also been notable; in May 2023, Thermo Fisher Scientific acquired MGI Tech, enhancing its genetic sequencing and diagnostic offerings.

    The US market continues to grow, driven by increased adoption of targeted therapies and advancements in precision medicine. Companies such as Myriad Genetics and Foundation Medicine are actively enhancing their product portfolios to meet healthcare providers' needs for accurate diagnostics. Growth trends in the market indicate a strong valuation increase for these companies, attributed to ongoing investments in Research and Development, technology innovations, and expansions in regulatory approvals for companion diagnostic tests, highlighting the dynamic nature of this sector in the US healthcare landscape.

    Market Segmentation

    Companion Diagnostic Market End User Outlook

    • Pharmaceutical & Biopharmaceutical Companies
    • Contract Research Organizations
    • Laboratories
    • Others

    Companion Diagnostic Market Indication Outlook

    • Cancer
    • Neurological Diseases
    • Infectious Diseases
    • Cardiovascular Diseases
    • Others

    Companion Diagnostic Market Technology Outlook

    • Polymerase Chain Reaction
    • Next-Generation Sequencing
    • In Situ Hybridization
    • Immunohistochemistry
    • Others

    Companion Diagnostic Market Product & Service Outlook

    • Assays
    • Kits
    • Reagents
    • Software
    • Services

    Report Scope

    Report Attribute/Metric Source: Details
    MARKET SIZE 2018 7.28(USD Billion)
    MARKET SIZE 2024 9.01(USD Billion)
    MARKET SIZE 2035 60.85(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 18.962% (2025 - 2035)
    REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR 2024
    MARKET FORECAST PERIOD 2025 - 2035
    HISTORICAL DATA 2019 - 2024
    MARKET FORECAST UNITS USD Billion
    KEY COMPANIES PROFILED Illumina, Novartis, BioRad Laboratories, Merck, Myriad Genetics, QIAGEN, Abbott Laboratories, Foundation Medicine, BristolMyers Squibb, Thermo Fisher Scientific, Agilent Technologies, Pfizer, Amgen, Roche, GSK
    SEGMENTS COVERED Product & Service, Technology, Indication, End User
    KEY MARKET OPPORTUNITIES Increasing prevalence of cancer, Rising personalized medicine adoption, Advancements in genetic testing, Collaborations between diagnostics and pharma, Expanding regulatory support for diagnostics
    KEY MARKET DYNAMICS Regulatory support and collaboration, Increasing precision medicine adoption, Growing cancer prevalence, Advancements in biomarker discovery, Rising healthcare expenditure
    COUNTRIES COVERED US

    FAQs

    What is the projected market size of the US Companion Diagnostic Market in 2024?

    The US Companion Diagnostic Market is expected to be valued at approximately 9.01 billion USD in 2024.

    How much is the US Companion Diagnostic Market expected to grow by 2035?

    By 2035, the market is anticipated to grow significantly, reaching an estimated value of 60.85 billion USD.

    What is the expected CAGR of the US Companion Diagnostic Market from 2025 to 2035?

    The market is expected to grow at a compound annual growth rate of 18.962% from 2025 to 2035.

    Which segment of the US Companion Diagnostic Market holds the highest value in 2024?

    The Assays segment is expected to hold the highest market value at approximately 3.5 billion USD in 2024.

    What will be the market size of the Kits segment in 2035?

    The Kits segment is projected to reach a market size of about 17.68 billion USD by 2035.

    Who are the major players in the US Companion Diagnostic Market?

    Key players in the market include Illumina, Novartis, BioRad Laboratories, Merck, and Myriad Genetics.

    What is the market value of the Reagents segment in 2024?

    In 2024, the market value for the Reagents segment is expected to be around 1.4 billion USD.

    How much is the Software segment expected to be worth in 2035?

    The Software segment is anticipated to reach a market value of approximately 5.59 billion USD by 2035.

    What challenges are the US Companion Diagnostic Market likely to face?

    Challenges may include regulatory hurdles and complexity in the integration of diagnostic testing with therapeutic treatments.

    Which region is predicted to dominate the US Companion Diagnostic Market?

    The US market is projected to dominate the Companion Diagnostic space, presenting significant opportunities for growth across various segments.

    US Companion Diagnostic Market Research Report - Forecast to 2035 Infographic
    Free Sample Request

    Kindly complete the form below to receive a free sample of this Report

    Customer Stories

    “I am very pleased with how market segments have been defined in a relevant way for my purposes (such as "Portable Freezers & refrigerators" and "last-mile"). In general the report is well structured. Thanks very much for your efforts.”

    Victoria Milne Founder
    Case Study
    Chemicals and Materials