Minimal Residual Disease Testing Market Size Analysis:

The Minimal Residual Disease Testing Market was valued at USD 2.16 billion in 2023 and is expected to reach USD 5.74 billion by 2032, growing at a CAGR of 11.50% over the forecast period of 2024-2032. This report emphasizes the world burden of MRD, examining incidence and prevalence trends that fuel the need for sophisticated diagnostic solutions. The research examines MRD testing patterns in different technologies, such as NGS and flow cytometry, which are becoming must-haves in disease monitoring. Moreover, it considers market penetration and the dynamic reimbursement environment where policies from regulations and insurance play an important role in accessibility as well as affordability. The study further explores clinical trials and drug development with the integration of MRD testing where more pharmaceuticals are using the tests to analyze the effectiveness of their treatments as well as advance the outcomes for their patients.

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The U.S. Minimal Residual Disease Testing Market was valued at USD 0.65 billion in 2023 and is expected to reach USD 1.58 billion by 2032, growing at a CAGR of 10.38% over the forecast period of 2024-2032. Within the U.S., the MRD testing market is growing with the increasing prevalence of cancer, broader uptake of personalized medicine, and rising investments in precision oncology, which are encouraged by supportive regulatory environments and healthcare reimbursement schemes.

Minimal Residual Disease Testing Market Dynamics

Drivers

• The MRD testing market is being driven by increasing cancer prevalence, rising adoption of precision medicine, and advancements in molecular diagnostics.

By 2040, cancer incidence is estimated to increase by 47% worldwide, driving the need for sophisticated monitoring technologies such as MRD testing, states the WHO. The move toward individualized treatment approaches in cancer therapy has rendered MRD testing an indispensable instrument in planning therapy and forecasting relapse. Next-generation sequencing (NGS) and digital PCR technologies have greatly enhanced test sensitivity, with residual disease being detected earlier. In addition, the increasing use of MRD testing in drug development clinical trials is hastening its adoption. The rise in regulatory approvals, including the FDA's clearance of Adaptive Biotechnologies' ClonoSEQ assay for the detection of MRD in multiple myeloma and lymphoid malignancies, is also propelling market growth. Further, increasing insurance coverage and reimbursement policies in various countries are increasing access to MRD testing for patients. The intense interest of pharma firms in applying MRD as an immunotherapy and targeted therapy effectiveness biomarker further propels market growth. Rising awareness among hematologists and oncologists about the value of MRD testing for better patient outcomes is likely to continue at this pace over the coming years.

Restraints

• The MRD testing market faces key restraints, including high costs, limited standardization, and regulatory hurdles.

MRD testing by NGS or digital PCR is costly, with test prices between USD 1,000 and USD 5,000 per patient, and hence less accessible in low-income groups. Furthermore, the absence of universal standardization across MRD detection techniques results in heterogeneity of test results, reducing clinical confidence in its extensive use. Although flow cytometry is still the most popular technique, it is less sensitive than molecular-based methods, introducing discrepancies in MRD measurement. Regulatory hurdles also present a challenge since MRD assay approvals vary by region, resulting in delayed commercialization. For instance, although ClonoSEQ has obtained FDA approval, other MRD assays are still going through intense regulatory scrutiny in other markets. In addition, reimbursement policies are quite different, with some insurers reimbursing MRD testing for only certain indications, which restricts its wider clinical application. There is also limited awareness and training among healthcare providers for interpreting MRD results, which prevents its inclusion in routine clinical practice. The need for specialized laboratory facilities and expertise to conduct MRD testing also limits its widespread use, particularly in resource-limited healthcare systems.

Opportunities

• The expansion of MRD applications in solid tumors, advancements in liquid biopsy technology, and increasing collaborations between biotech companies and pharmaceutical firms.

Although MRD testing has been most commonly applied in hematologic malignancies, recent studies indicate its promise in solid tumors like breast, colorectal, and lung cancers. MRD detection using circulating tumor DNA (ctDNA) analysis has been demonstrated to predict relapse several months before traditional imaging, paving the way for market expansion. Another huge opportunity comes from the increased use of liquid biopsy-based MRD tests that are non-invasive, ultra-sensitive, and in real time to monitor the recurrence of cancer. Guardant Health and Natera, among other firms, are developing liquid biopsies as MRD detectors. The escalating use of MRD testing within pharma R&D for measuring the response of treatments in immunotherapy and targeted therapy trials also drives demand. The increasing focus on AI and machine learning for improving MRD test accuracy and automation adds to the market potential even more. Furthermore, increasing government funding and private investment in cancer diagnostics are preparing a conducive climate for the development and commercialization of advanced MRD assays, which are making early detection more accessible and economical.

Challenges

• The MRD testing market faces significant challenges, including technical limitations, sample collection difficulties, and clinical validation issues.

One of the significant challenges is the need for sensitive and specific detection techniques to detect minimal residual disease accurately. Although NGS and digital PCR provide high sensitivity, they demand good-quality DNA/RNA samples, which are not always easy to obtain, particularly in solid tumors. Moreover, the heterogeneity of MRD levels among patients poses challenges in establishing standardized cut-offs for therapeutic decisions. A major hurdle in MRD testing is the problem of false positives or false negatives, which can affect clinical decision-making and result in overtreatment or undertreatment. The collection and processing of samples also present logistical problems since MRD determination necessitates serial testing over time to follow disease progression. The deficiency of long-term clinical proof-of-concept studies that show the effect of MRD-directed treatment decisions on overall survival also hinders adoption. Additionally, the hesitancy of some oncologists to embrace MRD testing as a routine part of their clinical practice because of test accuracy and interpretability concerns constitutes another source of resistance. Overcoming these technical, clinical, and operational issues will be essential to ensure the wider use of MRD testing in oncology.

Minimal Residual Disease Testing Market Segmentation Analysis

By Technology

In 2023, the Flow Cytometry segment led the MRD testing market with a market share of more than 40%. This was mainly because it had become very popular in hospital and laboratory environments, was less expensive and easily accessible compared to molecular approaches, and has been traditionally used in hematologic malignancies for residual disease burden detection. The standardized processes and established regulatory approvals for MRD testing using flow cytometry also helped it be at the leadership level.

The Polymerase Chain Reaction (PCR) segment is also expected to be the largest-growing technology in the forecast period. This is due to the higher sensitivity of PCR than that of flow cytometry, greater adoption of real-time and digital PCR technologies, and its growing application in hematologic and solid tumors. With the growing number of FDA-approved PCR-based MRD assays and their capacity to deliver quantifiable and standardized results, they become a preferred choice for clinical as well as research purposes.

By Cancer Type

Hematological Malignancies was the dominant segment in 2023, capturing more than 60% of the overall MRD testing market. This is due to the widespread prevalence of leukemia, lymphoma, and multiple myeloma cases, for which MRD testing is already widely established as a standard tool in disease surveillance and treatment. The availability of well-defined MRD testing guidelines in hematologic cancers and robust reimbursement mechanisms further consolidated this segment's leadership.

The Solid Tumors segment is likely to be the most rapidly growing category in the future. The increasing use of MRD testing in cancers like breast, lung, and colorectal tumors is driving this growth, led by the development of liquid biopsy and next-generation sequencing (NGS) technologies. The growing emphasis on early relapse detection and treatment optimization in solid tumors is broadening the application of MRD testing beyond hematologic cancers.

By Business

The Hospitals and Specialty Clinics segment was the largest market contributor in 2023, with a 45% market share. This was attributed to the large volume of MRD testing in hospital labs, the adoption of MRD testing as a standard part of clinical workflows, and the availability of specialized oncology facilities that are dependent on MRD diagnostics for monitoring treatment. Strong hospital infrastructure and the availability of sophisticated diagnostic technologies also helped this segment lead the market.

The Academic and Research Institutes segment is expected to experience the fastest expansion in the coming years. Growing numbers of MRD-centric clinical trials, growth in government and private sources of funding for cancer research, and innovation in the development of new MRD detection technologies are major drivers propelling the growth of this segment. The contribution of academic institutions in affirming new MRD approaches and their partnerships with biotech firms are also driving growth.

Minimal Residual Disease Testing Market Regional Insights

North America led the Minimal Residual Disease (MRD) Testing Market in 2023, with a market share of more than 39.9% globally. The region's leadership was fueled mainly by the prevalence of hematologic malignancies, the robust established reimbursement structures, and the availability of the major market players like Adaptive Biotechnologies, Natera, and Invitae. The U.S. dominated the region with increased investments in oncology diagnostics, high adoption rates of next-generation sequencing (NGS) technologies, and enhanced clinical trial activity incorporating MRD testing. Further, the surging need for precision medicine and strict regulatory clearance by the FDA also bolstered North America's dominance in the MRD market.

Asia-Pacific is anticipated to be the region with the highest growth rate, with a forecast growth rate outpacing other regions during the forecast period. This growth is boosted by the expanding cancer burden, increasing uptake of sophisticated molecular diagnostic technologies, and increasing healthcare infrastructure in nations such as China, Japan, and India. Further, increasing government support, favorable reimbursement environments, and the emergence of international diagnostics players in APAC regions are fueling adoption. The growing trend toward individualized medicine and the rising recognition of liquid biopsy-based MRD testing are additionally driving market expansion in the region.

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Minimal Residual Disease Testing Market Key Players 

• Exact Sciences Corporation – Oncotype MAP

• GRAIL, LLC – Galleri (Developing MRD applications)

• Veracyte, Inc.

• Natera, Inc. – Signatera

• Guardant Health – Guardant Reveal

• F. Hoffmann-La Roche Ltd – AVENIO Tumor Tissue Analysis (Exploring MRD applications)

• FOUNDATION MEDICINE, INC. – FoundationOne Tracker

• QIAGEN – ipsogen MRD Tests

• mdxhealth

• Bio-Techne – Asuragen QuantideX qPCR Assays

Recent Developments in the Minimal Residual Disease Testing Market

• In March 2025, Veracyte, Inc. announced the presentation of multiple abstracts at the 40th Annual European Association of Urology Congress (EAU25), highlighting the clinical performance of its Decipher tests for prostate and bladder cancer.