Minimal Residual Disease (MRD) Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (Flow Cytometry, Polymerase Chain Reaction, Next Generation Sequencing, Others), By Application (Leukemia, Lymphoma, Multiple Myeloma, Others), By End User (Hospitals & Specialty Clinics, Academic & Research Institutions, Clinical Laboratories, Others), By Region and Competition, 2020-2030F

Market Overview

The Global Minimal Residual Disease (MRD) Testing Market, valued at USD 1.45 Billion in 2024, is projected to experience a CAGR of 8.70% to reach USD 2.39 Billion by 2030. Minimal residual disease (MRD) testing identifies minute quantities of cancer cells remaining in a patient's body post-treatment, often undetectable by conventional methods, which significantly predict disease relapse. This global market's expansion is fundamentally driven by the rising incidence of various hematological malignancies and continuous advancements in diagnostic technologies, such as next-generation sequencing and highly sensitive flow cytometry. For instance, according to the American Society of Hematology, in 2024, Multiple Myeloma constituted approximately 1.8% of all newly diagnosed cancer cases in the United States, underscoring the persistent burden of these conditions that necessitate advanced monitoring solutions.

A significant impediment to the market's broader expansion remains the high cost associated with these advanced MRD testing technologies. This economic factor, coupled with variations in reimbursement policies across different regions, can limit patient access and widespread adoption of these crucial diagnostic tools.

Key Market Drivers

The escalating global incidence of cancer and hematological malignancies represents a primary force propelling the minimal residual disease testing market. As the population grows and ages, the number of new cancer diagnoses continues to rise, directly increasing the patient pool requiring sophisticated monitoring tools throughout their treatment journey and follow-up. MRD testing becomes crucial in managing these conditions by offering precise detection of residual disease after therapy, guiding subsequent treatment decisions, and identifying patients at high risk of relapse. According to the International Agency for Research on Cancer, in February 2024, the GLOBOCAN 2022 report estimated approximately 20 million new cancer cases globally in 2022, highlighting the substantial and persistent disease burden driving demand for sensitive diagnostic methods in oncology and hematology.

Concurrent advancements in molecular diagnostics and testing technologies form another pivotal driver, enhancing the sensitivity, specificity, and accessibility of MRD assays. Innovations in techniques such as next-generation sequencing, digital PCR, and highly sensitive flow cytometry have significantly improved the ability to detect extremely low levels of cancer cells, which were previously undetectable. These technological strides enable more accurate risk stratification and personalized treatment adjustments. For example, Adaptive Biotechnologies announced in December 2023 its clonoSEQ® Assay is available for clinical use as a laboratory-developed test for MRD assessment in diffuse large B-cell lymphoma, demonstrating expanding clinical utility and regulatory acceptance of advanced molecular tests. Further emphasizing the sector’s growth, The Leukemia & Lymphoma Society announced in September 2023 a new $50 million commitment to advance research in blood cancers, underscoring sustained investment in areas directly benefiting from MRD testing.

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Key Market Challenges

The high cost associated with advanced minimal residual disease testing technologies represents a significant impediment to market expansion. These economic considerations directly limit patient access and hinder widespread adoption, especially in healthcare systems facing budget constraints or where high patient out-of-pocket expenses are prevalent. The advanced methodologies and specialized infrastructure required for these tests contribute to their elevated cost, thereby making them less attainable for a wider patient demographic.

Adding to this challenge are the varied reimbursement policies across different regions and among insurance providers. This inconsistency creates an unpredictable financial environment for both healthcare providers and patients, directly influencing the uptake of these essential diagnostic tools. For example, according to the American Cancer Society Cancer Action Network, as of August 2025, while twenty states have enacted laws expanding insurance coverage of comprehensive biomarker testing across disease areas, many jurisdictions still operate without such specific policies. This uneven coverage restricts the widespread application of MRD tests, impeding market penetration and consequently limiting the growth trajectory of the global minimal residual disease testing market.

Key Market Trends

The expanding clinical utility of minimal residual disease (MRD) testing in solid tumors represents a significant market trend, moving beyond its established role in hematological malignancies. This shift is driven by the clear need for more precise post-treatment monitoring and recurrence prediction in a broader patient population. According to the American Cancer Society, in 2023, an estimated 1,958,310 new cancer cases were projected to occur in the United States, with solid tumors constituting the vast majority of these diagnoses, highlighting a substantial and underserved patient base for advanced monitoring solutions. This expansion is further underscored by industry developments, such as Illumina Inc. 's announcement in January 2024 of a collaboration with Janssen Research & Development, LLC to develop a novel molecular residual disease assay. This whole-genome sequencing multi-cancer research solution is specifically designed to detect circulating tumor DNA for various solid tumor indications, signaling growing investment and technological application in this area.

The development and adoption of liquid biopsy for MRD detection also stands as a crucial trend, offering a less invasive and more dynamic approach to disease monitoring. This method, primarily using circulating tumor DNA from blood samples, enables repeated assessments and earlier detection of recurrence compared to traditional imaging. The scale of this trend is evidenced by major clinical research initiatives; a multicenter observational study, presented as an ASCO Meeting Abstract in May 2025, outlined plans to enroll approximately 1,350 patients across 30 Flatiron Research Network community oncology sites to explore MRD in early stage solid tumors using blood samples. Furthermore, advancements in this space are continually being introduced, with Personalis, Inc. announcing in March 2024 that data for its NeXT Personal® whole genome-based, tumor-informed assay for ultra-sensitive circulating tumor DNA detection would be featured at the American Association for Cancer Research (AACR) Annual Meeting. This consistent innovation and integration into large-scale studies demonstrate liquid biopsy's increasing role in enhancing MRD detection capabilities.

Segmental Insights

The Next Generation Sequencing (NGS) segment is experiencing rapid growth in the Global Minimal Residual Disease (MRD) Testing Market due to its superior analytical capabilities for detecting residual cancer cells. NGS offers high sensitivity and comprehensive detection, enabling the identification of a broad spectrum of genetic alterations and providing detailed insights into tumor heterogeneity and clonal evolution, surpassing the limitations of conventional methods. This advanced technology allows for the precise monitoring of treatment response and relapse risk, crucial for personalized patient management. Furthermore, regulatory bodies, such as the U. S. Food and Drug Administration, have recognized and approved NGS-based MRD tests, thereby increasing clinical adoption and driving market expansion.

Regional Insights

North America leads the Global Minimal Residual Disease (MRD) Testing Market due to its well-established healthcare infrastructure and the early, widespread adoption of advanced diagnostic technologies, including next-generation sequencing and polymerase chain reaction. The region benefits from substantial investments in research and development for precision medicine, driving innovation in MRD testing methods. Furthermore, supportive regulatory frameworks, such as clearances and approvals from the U. S. Food and Drug Administration (FDA), alongside a favorable reimbursement landscape, significantly bolster market growth and clinical integration. The increasing prevalence of hematological malignancies also fuels demand for precise monitoring tools, contributing to North America's dominance.

Recent Developments

• In August 2025, Quest Diagnostics received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Haystack MRD® test. This designation was granted for identifying minimal residual disease (MRD)-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy. The Haystack MRD test is a highly sensitive liquid biopsy designed to uncover low levels of circulating tumor DNA. This regulatory recognition underscores the test's potential to provide earlier detection of cancer recurrence, thereby supporting more precise and personalized monitoring and treatment decisions in oncology.

• In January 2025, Natera unveiled significant advancements in its oncology innovation roadmap, including the introduction of an enhanced version of its Signatera assay, leveraging the genome. This new Signatera Genome assay, made available for research and clinical use, facilitates bespoke assay design from a patient's whole genome sequence. Additionally, Natera introduced a new tissue-free molecular residual disease (MRD) capability, developed through its growing expertise in methylation-based technologies. This development expands Natera's portfolio of MRD assays, offering more comprehensive tools for advanced cancer detection and monitoring, with an initial launch in colorectal cancer anticipated in mid-2025.

• In October 2024, Myriad Genetics announced a series of ongoing research collaborations to study the utilization of its Precise® MRD test in breast cancer management. These partnerships with various health institutions are designed to evaluate the use of molecular residual disease (MRD) testing for monitoring treatment response in breast cancer patients. The Precise MRD test is a whole-genome sequencing-based assay that monitors numerous tumor-specific variants to quantify circulating tumor DNA. These collaborative research efforts represent a step in advancing the clinical application of next-generation MRD testing for more effective patient treatment and surveillance.

• In January 2024, Illumina expanded its collaboration with Janssen Research & Development, LLC, focusing on the development of Illumina's novel molecular residual disease (MRD) assay. This assay utilizes whole-genome sequencing to detect circulating tumor DNA, aiming to better understand disease persistence or recurrence after clinical intervention. The collaboration is a strategic initiative to advance precision oncology, particularly for solid tumors where current disease-monitoring tools have shown limitations. This partnership aims to deliver a sensitive, accurate, and accessible whole-genome sequencing MRD assay, enhancing clinical research in oncology by providing earlier insights into a patient's disease status.

Key Market Players

• ICON plc
• F. Hoffmann-La Roche AG
• Bio-Rad Laboratories, Inc.
• Laboratory Corporation of America Holdings
• Natera, Inc.
• Cergentis B.V.
• OPKO Health, Inc.
• Sysmex Corporation
• Mission Bio, Inc.
• Invivoscribe, Inc.

Report Scope:

In this report, the Global Minimal Residual Disease (MRD) Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Minimal Residual Disease (MRD) Testing Market, By Technology:

o   Flow Cytometry

o   Polymerase Chain Reaction

o   Next Generation Sequencing

o   Others

• Minimal Residual Disease (MRD) Testing Market, By Application:

o   Leukemia

o   Lymphoma

o   Multiple Myeloma

o   Others

• Minimal Residual Disease (MRD) Testing Market, By End User:

o   Hospitals & Specialty Clinics

o   Academic & Research Institutions

o   Clinical Laboratories

o   Others

• Minimal Residual Disease (MRD) Testing Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Minimal Residual Disease (MRD) Testing Market.

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Company Information

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