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    US Minimal Residual Disease Testing Market

    ID: MRFR/HC/15223-HCR
    100 Pages
    Garvit Vyas
    October 2025

    US Minimal Residual Disease Testing Market Research Report By Technology (Flow Cytometry, Polymerase Chain Reaction (PCR), Next-generation Sequencing (NGS), Others), By Application (Lymphoma, Leukemia, Solid Tumors, Others) and By End User (Hospitals & Clinics, Diagnostic Laboratories, Others) - Forecast to 2035

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    US Minimal Residual Disease Testing Market Summary

    As per MRFR analysis, the minimal residual-disease-testing market size was estimated at 507.48 USD Million in 2024. The minimal residual-disease-testing market is projected to grow from 565.13 USD Million in 2025 to 1657.77 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 11.36% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The US minimal residual-disease-testing market is poised for substantial growth driven by technological advancements and increasing demand for personalized medicine.

    • Technological advancements are enhancing the accuracy and efficiency of minimal residual disease testing.
    • The shift towards personalized medicine is driving the demand for tailored treatment approaches in oncology.
    • The largest segment in this market is the hematological malignancies segment, while the solid tumors segment is the fastest-growing.
    • Rising incidence of cancer and advancements in diagnostic technologies are key drivers propelling market growth.

    Market Size & Forecast

    2024 Market Size 507.48 (USD Million)
    2035 Market Size 1657.77 (USD Million)

    Major Players

    Roche Diagnostics (CH), Abbott Laboratories (US), Thermo Fisher Scientific (US), Qiagen N.V. (NL), Bristol-Myers Squibb (US), Amgen Inc. (US), Illumina Inc. (US), Myriad Genetics Inc. (US)

    US Minimal Residual Disease Testing Market Trends

    The minimal residual-disease-testing market is currently experiencing notable advancements, driven by increasing awareness of the importance of early detection and monitoring of residual disease in patients. This market is characterized by a growing demand for precise and sensitive testing methods, which are essential for improving patient outcomes in various hematological malignancies. The integration of advanced technologies, such as next-generation sequencing and digital PCR, appears to enhance the accuracy of these tests, thereby fostering greater adoption among healthcare providers. Furthermore, the emphasis on personalized medicine is likely to propel the development of tailored testing solutions that cater to individual patient needs, potentially transforming treatment protocols. In addition, regulatory support and funding initiatives from government bodies are contributing to the growth of the minimal residual-disease-testing market. These efforts aim to facilitate research and development, ensuring that innovative testing methods are accessible to a broader patient population. As healthcare systems increasingly prioritize cost-effective solutions, the market may witness a shift towards more affordable testing options without compromising quality. Overall, the landscape of the minimal residual-disease-testing market is evolving, with a focus on enhancing diagnostic capabilities and improving patient care through innovative approaches.

    Technological Advancements

    The minimal residual-disease-testing market is witnessing rapid technological innovations, particularly in the realm of molecular diagnostics. Techniques such as next-generation sequencing and digital PCR are becoming more prevalent, offering enhanced sensitivity and specificity. These advancements are likely to improve the accuracy of residual disease detection, thereby influencing treatment decisions and patient management.

    Regulatory Support

    Regulatory bodies are increasingly recognizing the importance of minimal residual-disease testing in clinical practice. This support is manifesting through streamlined approval processes for new testing methods and increased funding for research initiatives. Such measures may facilitate the introduction of novel diagnostic tools, ultimately benefiting patient care.

    Shift Towards Personalized Medicine

    There is a growing trend towards personalized medicine within the minimal residual-disease-testing market. Tailored testing solutions that consider individual patient profiles are becoming more common. This shift is expected to enhance treatment efficacy and optimize patient outcomes, as healthcare providers seek to deliver more targeted therapies.

    US Minimal Residual Disease Testing Market Drivers

    Rising Incidence of Cancer

    The increasing incidence of cancer in the US is a primary driver for the minimal residual-disease-testing market. According to the National Cancer Institute, approximately 1.9 million new cancer cases are expected to be diagnosed in 2025. This surge in cancer cases necessitates advanced diagnostic tools to monitor treatment efficacy and detect residual disease. As healthcare providers seek to improve patient outcomes, the demand for minimal residual disease testing is likely to rise. This market is projected to grow at a CAGR of around 12% from 2025 to 2030, reflecting the urgent need for effective monitoring solutions in oncology. The minimal residual-disease-testing market is thus positioned to expand significantly in response to these trends.

    Advancements in Diagnostic Technologies

    Technological innovations in diagnostic methodologies are propelling the minimal residual-disease-testing market forward. The introduction of highly sensitive techniques such as next-generation sequencing (NGS) and digital PCR has enhanced the ability to detect minimal residual disease with greater accuracy. These advancements allow for the identification of cancer cells at very low levels, which is crucial for timely intervention. The market for these technologies is expected to reach $2 billion by 2027, driven by their increasing adoption in clinical settings. As healthcare providers aim to implement cutting-edge solutions, the minimal residual-disease-testing market is likely to benefit from these technological advancements, leading to improved patient management and outcomes.

    Increased Investment in Cancer Research

    The minimal residual-disease-testing market is also being driven by increased investment in cancer research and development. Government funding and private sector investments are focusing on innovative diagnostic solutions that can enhance cancer treatment outcomes. The National Institutes of Health (NIH) has allocated substantial resources towards cancer research, which includes the development of advanced testing methodologies. This financial support is expected to foster innovation within the minimal residual-disease-testing market, leading to the introduction of new products and services. As research progresses, the market is likely to experience a surge in demand for effective testing solutions that can aid in the early detection of residual disease.

    Regulatory Approvals and Reimbursement Policies

    The evolving landscape of regulatory approvals and reimbursement policies is shaping the minimal residual-disease-testing market. Recent changes in healthcare regulations have streamlined the approval process for new diagnostic tests, making it easier for innovative solutions to enter the market. Additionally, favorable reimbursement policies are encouraging healthcare providers to adopt these tests as part of routine cancer care. As insurance coverage for minimal residual disease testing expands, patient access to these critical diagnostics is likely to improve. This trend is expected to drive market growth, with projections indicating a potential increase in market size by 15% over the next few years. The minimal residual-disease-testing market is thus poised for expansion as regulatory and reimbursement frameworks evolve.

    Growing Awareness Among Healthcare Professionals

    There is a notable increase in awareness among healthcare professionals regarding the importance of minimal residual disease testing in cancer management. Educational initiatives and clinical guidelines are emphasizing the role of these tests in personalizing treatment plans and improving patient prognoses. As oncologists and hematologists become more informed about the benefits of minimal residual disease testing, the demand for these services is expected to rise. This shift in professional attitudes is likely to contribute to a market growth rate of approximately 10% annually over the next five years. The minimal residual-disease-testing market stands to gain from this heightened awareness, as more practitioners incorporate these tests into standard care protocols.

    Market Segment Insights

    By Technology: Flow Cytometry (Largest) vs. Next-generation Sequencing (Fastest-Growing)

    In the US minimal residual-disease-testing market, Flow Cytometry holds the largest share among technologies, attributed to its widespread adoption in clinical settings for real-time cell analysis. In contrast, Next-generation Sequencing (NGS) is rapidly gaining traction, driven by advancements in genomic technologies and decreasing costs that enhance its accessibility for various medical applications. The growth trends in this segment reflect a shift toward precision medicine and personalized healthcare, where NGS is emerging as a game-changer. Its ability to provide comprehensive genetic insights supports targeted therapy decisions, fostering its popularity. Conversely, Flow Cytometry continues to dominate due to its established methods and reliability, although NGS's rapid advancements position it as a compelling alternative for the future.

    Technology: Flow Cytometry (Dominant) vs. Next-generation Sequencing (Emerging)

    Flow Cytometry is characterized by its ability to analyze multiple parameters of individual cells quickly, making it crucial in minimal residual disease detection due to its sensitivity and specificity. It serves as a cornerstone technology in many laboratories due to its established protocols and extensive clinical validation. In comparison, Next-generation Sequencing offers a high-throughput method for sequencing DNA and RNA, providing detailed genetic profiles that aid in understanding disease progression and treatment response. Its emerging status reflects the increasing demand for precision medicine, as healthcare providers strive for more accurate and personalized treatment plans. While Flow Cytometry remains a dominant force, NGS is expected to disrupt the market with its innovative capabilities.

    By Application: Lymphoma (Largest) vs. Leukemia (Fastest-Growing)

    The market share distribution among the application segments reveals that Lymphoma holds the largest share in the US minimal residual-disease-testing market. It is followed by Leukemia, which is gaining traction due to increasing awareness and advancements in diagnostic technologies. Solid Tumors and Others segments also contribute to the market but occupy relatively smaller shares, reflecting the concentrated focus on blood cancers. Growth trends within this segment indicate a significant upward trajectory for leukemia testing, fueled by innovation in treatment methodologies and heightened clinical adoption. The rising prevalence of hematologic malignancies further enhances demand, while regulatory support for new tests and growing investments in oncology research catalyze market expansion, particularly for the leukemia segment.

    Lymphoma: Dominant vs. Leukemia: Emerging

    Lymphoma stands out as the dominant application in the US minimal residual-disease-testing market, characterized by robust testing protocols and established treatment pathways. Its prominence can be attributed to a higher diagnosis rate and effective monitoring capabilities, enabling healthcare providers to strategize treatment effectively. In contrast, the leukemia segment, while emerging, is rapidly expanding due to technological advancements and improved therapeutic options. This segment is witnessing increased investments in R&D, aiming to enhance diagnostic accuracy and treatment personalization. As awareness grows and screening becomes more commonplace, leukemia testing is set to capture a larger portion of the market, creating a competitive dynamic between these two crucial applications.

    By End User: Hospitals & Clinics (Largest) vs. Diagnostic Laboratories (Fastest-Growing)

    In the US minimal residual-disease-testing market, Hospitals & Clinics command the largest share, playing a pivotal role in diagnostics and patient management. Their extensive reach and established infrastructure enable them to provide comprehensive testing services, which significantly contribute to their market dominance. Diagnostic Laboratories, while smaller in market share, are rapidly gaining traction, driven by their specialized services and ability to offer quick turnaround times. This competitive dynamic drives innovation and efficiency within the sector. The growth trends observed in this segment indicate robust expansion for Diagnostic Laboratories, fueled by increased demand for precise and timely testing solutions. Factors such as technological advancements, increasing funding for healthcare initiatives, and the ongoing focus on personalized medicine are accelerating growth. As healthcare providers strive for better patient outcomes, the reliance on specialized diagnostics is expected to trend upward, positioning Diagnostic Laboratories as a key player in the future landscape of the US minimal residual-disease-testing market.

    Hospitals & Clinics (Dominant) vs. Diagnostic Laboratories (Emerging)

    Hospitals & Clinics represent the dominant force in this segment, characterized by their extensive networks and capability to perform a wide range of medical services under one roof. They provide essential minimal residual disease testing and often integrate these services with patient care pathways. This holistic approach not only enhances patient convenience but also promotes timely diagnosis and treatment. In contrast, Diagnostic Laboratories are emerging as significant players by leveraging cutting-edge technologies and specializing in complex testing services. Their agility in adapting to new testing methodologies and the growing demand for rapid results is enabling them to capture a larger market share. The competition between these two segments fosters innovation and drives improvements in diagnostic accuracy and service delivery.

    Get more detailed insights about US Minimal Residual Disease Testing Market

    Key Players and Competitive Insights

    The minimal residual-disease-testing market is characterized by a dynamic competitive landscape, driven by advancements in technology and increasing demand for precision medicine. Key players such as Roche Diagnostics (CH), Abbott Laboratories (US), and Thermo Fisher Scientific (US) are at the forefront, each adopting distinct strategies to enhance their market presence. Roche Diagnostics (CH) focuses on innovation through the development of next-generation sequencing technologies, which are pivotal in improving the accuracy of minimal residual disease detection. Meanwhile, Abbott Laboratories (US) emphasizes strategic partnerships with healthcare providers to expand its testing capabilities and reach a broader patient population. Thermo Fisher Scientific (US) is leveraging its extensive portfolio to integrate digital solutions into its testing processes, thereby enhancing operational efficiency and customer engagement. Collectively, these strategies contribute to a competitive environment that is increasingly centered around technological advancement and collaborative growth.

    In terms of business tactics, companies are localizing manufacturing and optimizing supply chains to enhance responsiveness to market demands. The market structure appears moderately fragmented, with several key players exerting influence while also allowing for niche entrants. This fragmentation fosters innovation, as companies strive to differentiate their offerings in a crowded marketplace. The collective influence of these major players shapes the competitive dynamics, as they continuously adapt to emerging trends and consumer needs.

    In October 2025, Roche Diagnostics (CH) announced the launch of a new liquid biopsy test designed to detect minimal residual disease in hematological malignancies. This strategic move is significant as it positions Roche at the cutting edge of non-invasive testing, potentially increasing patient compliance and expanding its market share. The introduction of this test aligns with the growing trend towards personalized medicine, where tailored treatment plans are based on precise diagnostic information.

    In September 2025, Abbott Laboratories (US) entered into a collaboration with a leading oncology research institute to develop advanced biomarkers for minimal residual disease detection. This partnership is crucial as it not only enhances Abbott's research capabilities but also accelerates the development of innovative testing solutions. By aligning with academic institutions, Abbott is likely to strengthen its position in the market and foster a culture of innovation that could lead to breakthrough discoveries.

    In August 2025, Thermo Fisher Scientific (US) unveiled a new cloud-based platform that integrates artificial intelligence into its testing workflows. This platform aims to streamline data analysis and improve the accuracy of minimal residual disease assessments. The strategic importance of this development lies in its potential to enhance operational efficiency and provide healthcare professionals with actionable insights, thereby improving patient outcomes. As AI continues to permeate the healthcare sector, Thermo Fisher's initiative may set a benchmark for future innovations in the industry.

    As of November 2025, current competitive trends are increasingly defined by digitalization, sustainability, and the integration of artificial intelligence. Strategic alliances are becoming more prevalent, as companies recognize the value of collaboration in driving innovation and expanding market reach. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on technological innovation, reliability in supply chains, and the ability to deliver personalized healthcare solutions. This shift underscores the importance of adaptability and forward-thinking strategies in navigating the complexities of the minimal residual-disease-testing market.

    Key Companies in the US Minimal Residual Disease Testing Market market include

    Industry Developments

    The US Minimal Residual Disease Testing Market has seen significant activity recently, with growing recognition of the crucial role these tests play in monitoring cancer treatment effectiveness. Notably, in August 2023, Illumina announced expanded collaborations to enhance genetic testing capabilities, potentially influencing Minimal Residual Disease diagnostics.

    Similarly, Exact Sciences has made strides in developing more accurate testing methodologies, addressing the demand for precision in cancer care. In November 2022, Abbott Laboratories launched a new blood test geared toward minimal residual disease, which is anticipated to impact patient management decisions significantly.

    Mergers and acquisitions have also been pivotal, particularly Takeda Pharmaceutical's acquisition of a smaller biotech firm in June 2023, aiming to bolster its testing portfolio related to oncology. The market is benefiting from a substantial valuation growth trend, with major companies like Thermo Fisher Scientific and F. Hoffmann-La Roche investing heavily in Research and Development for advanced testing solutions.

    Over the past couple of years, from ongoing regulatory approvals to innovative partnerships, the landscape of the US Minimal Residual Disease Testing Market has evolved rapidly, highlighting the importance of continuous advancements in technology and collaboration among industry leaders.

    Future Outlook

    US Minimal Residual Disease Testing Market Future Outlook

    The minimal residual-disease-testing market is projected to grow at 11.36% CAGR from 2024 to 2035, driven by technological advancements and increasing demand for precision medicine.

    New opportunities lie in:

    • Development of portable testing devices for remote patient monitoring.
    • Integration of AI algorithms for enhanced diagnostic accuracy.
    • Expansion of partnerships with oncology clinics for comprehensive testing services.

    By 2035, the market is expected to achieve substantial growth, positioning itself as a leader in precision diagnostics.

    Market Segmentation

    US Minimal Residual Disease Testing Market End User Outlook

    • Hospitals & Clinics
    • Diagnostic Laboratories
    • Others

    US Minimal Residual Disease Testing Market Technology Outlook

    • Flow Cytometry
    • Polymerase Chain Reaction (PCR)
    • Next-generation Sequencing (NGS)
    • Others

    US Minimal Residual Disease Testing Market Application Outlook

    • Lymphoma
    • Leukemia
    • Solid Tumors
    • Others

    Report Scope

    MARKET SIZE 2024 507.48(USD Million)
    MARKET SIZE 2025 565.13(USD Million)
    MARKET SIZE 2035 1657.77(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 11.36% (2024 - 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 Million
    Key Companies Profiled Roche Diagnostics (CH), Abbott Laboratories (US), Thermo Fisher Scientific (US), Qiagen N.V. (NL), Bristol-Myers Squibb (US), Amgen Inc. (US), Illumina Inc. (US), Myriad Genetics Inc. (US)
    Segments Covered Technology, Application, End User
    Key Market Opportunities Advancements in liquid biopsy technologies enhance detection capabilities in the minimal residual-disease-testing market.
    Key Market Dynamics Technological advancements drive innovation in minimal residual disease testing, enhancing accuracy and patient outcomes.
    Countries Covered US

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    FAQs

    What is the projected market size of the US Minimal Residual Disease Testing Market in 2024?

    The US Minimal Residual Disease Testing Market is projected to be valued at 508.2 million USD in 2024.

    What is the expected market size of the US Minimal Residual Disease Testing Market by 2035?

    The expected market size of the US Minimal Residual Disease Testing Market by 2035 is estimated to reach 1658.0 million USD.

    What is the expected compound annual growth rate (CAGR) for the US Minimal Residual Disease Testing Market from 2025 to 2035?

    The expected CAGR for the US Minimal Residual Disease Testing Market from 2025 to 2035 is 11.349%.

    Which technology segment is projected to dominate the US Minimal Residual Disease Testing Market in 2024?

    In 2024, the Flow Cytometry segment is projected to dominate the US Minimal Residual Disease Testing Market with a value of 150.0 million USD.

    What is the market size for Polymerase Chain Reaction (PCR) in the US Minimal Residual Disease Testing Market by 2024?

    The market size for Polymerase Chain Reaction (PCR) in the US Minimal Residual Disease Testing Market is valued at 180.0 million USD in 2024.

    Which companies are considered key players in the US Minimal Residual Disease Testing Market?

    Key players in the US Minimal Residual Disease Testing Market include Illumina, Exact Sciences, BioRad Laboratories, and Abbott Laboratories.

    What will the revenue for Next-generation Sequencing (NGS) be in the US Minimal Residual Disease Testing Market by 2035?

    The revenue for Next-generation Sequencing (NGS) in the US Minimal Residual Disease Testing Market is expected to reach 460.0 million USD by 2035.

    What challenges does the US Minimal Residual Disease Testing Market face?

    Challenges in the US Minimal Residual Disease Testing Market include regulatory hurdles and the need for standardization across testing technologies.

    What growth drivers are influencing the US Minimal Residual Disease Testing Market?

    Growth drivers for the US Minimal Residual Disease Testing Market include advancements in technology and increasing awareness of early disease detection.

    What is the expected market value of the 'Others' technology segment in the US Minimal Residual Disease Testing Market by 2035?

    The expected market value of the 'Others' technology segment in the US Minimal Residual Disease Testing Market is projected to reach 84.0 million USD by 2035.

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