MINIMAL RESIDUAL DISEASE TESTING MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024 - 2031)

Market Size and Trends

The minimal residual disease testing market is estimated to be valued at USD 2.31 Bn in 2024 and is expected to reach USD 4.97 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 11.6% from 2024 to 2031.

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The minimal residual disease testing market is expected to witness significant growth over the forecast period. This can be primarily attributed to rising cancer prevalence worldwide coupled with increasing adoption of minimal residual disease testing in healthcare facilities for accurate prognosis prediction. MRD technologies enable detection of residual tumor cells which helps determine appropriate treatment approach and chance of relapse. With benefits such as real-time disease monitoring and treatment optimization, the demand for MRD tests is expected to surge substantially in the coming years. Additionally, ongoing efforts by market players to develop highly sensitive technologies will further aid the market expansion through the forecast period.

Rising Prevalence of Blood Cancer and Improved Treatment Outcomes

The increasing incidence and prevalence of various types of hematological malignancies including leukemia, lymphoma, and multiple myeloma across the world has been a major factor fueling the demand for minimal residual disease testing. According to key opinion leaders, the early and accurate detection of residual cancer cells after initial treatment is critical in blood cancers in order to assess treatment response and make adjustments to therapy if needed. MRD testing allows physicians to closely monitor patients and customize their treatment approach. For instance, in August 2022, according to data published by Blood Cancer UK Research, it was stated that blood cancer is the fifth most common cancer in the U.K., with over 41,000 people being diagnosed with it every year. With advancements in treatment options such as targeted therapies, immunotherapy, and stem cell transplantation, more patients are achieving remission and long-term survival. However, the risk of relapse persists if residual cancer cells remain present even at low levels after primary treatment. MRD testing helps identify such residual disease that may not be detected by conventional imaging and ensures patients receive timely and appropriate intervention such as additional chemotherapy cycles or stem cell transplant. This is expected to improve long term outcomes. The ability of MRD to predict relapse and guide treatment strategies non-invasively without the need for invasive biopsies provides a significant advantage. With growing success rates of initial treatments, monitoring of MRD will become an important tool helping clinicians effectively manage blood cancer patients over the long term.

Market Concentration and Competitive Landscape

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There is a growing trend in the oncology field towards more personalized and precision medicine based on a patient’s specific disease characteristics and risk factors. Advanced MRD technologies allow the quantitative assessment of the tumor burden right down to a single cancer cell. Key opinion leaders note that MRD status is already used to personalize post-remission therapy decisions in some blood cancer types. For example, in acute myeloid leukemia, an MRD negative status may allow stopping further treatment whereas MRD positivity could warrant a stem cell transplant. Researchers are also exploring use of MRD for predicting survival outcomes and tailoring surveillance schedules accordingly. As clinical studies establish MRD as a reliable biomarker, its use for personalized risk stratification and subsequent personalization of treatment regimens is expected to increase tremendously. This drives the need for the wider adoption of sensitive and standardized MRD testing methods across the continuum of care.

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The minimal residual disease testing market faces various challenges. Healthcare providers are still adopting these molecular diagnostic tests due to their high cost. Additionally, lack of expertise and complex workflow processes also hinder the growth of this market. Reimbursement issues pose another challenge as many payers do not provide coverage for these advanced tests. Standardization of techniques and result interpretation remains an area that needs more research efforts.

Market Opportunities – Strategic Collaborations Between Companies and Research Institutes

Strategic collaborations between companies and research institutes could be a great opportunity in the minimal residual disease testing market. When companies partner with academic institutions and leverage their research expertise, it helps accelerate the development of novel and improved testing technologies. For instance, in June 2023, Myriad Genetics, Inc., a biotechnology company, announced a collaboration agreement with The University of Texas MD Anderson Cancer Center to support research focused on metastatic renal cell carcinoma treatment selection and response. The project will use Myriad Genetics, Inc.’s minimal residual disease (MRD) testing platform, a tumor-informed high-definition assay that detects circulating tumor DNA (ctDNA).

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The technology segment includes flow cytometry, polymerase chain reaction (PCR), and next generation sequencing. The flow cytometry segment is estimated to hold 41.9% share of the market in 2024 owing to its unmatched sensitivity in detecting rare tumor cells at very low concentrations. Flow cytometry relies on fluorescent dye or antibody labelling of cells to uniquely identify malignant cells present at frequencies as low as one in a million. This extreme sensitivity enables detection of minimal residual disease that may exist post-treatment and enable early identification of relapse risk. The ability to sensitively detect rare cancer cells circulating in blood or bone marrow aspirates at the single cell level is crucial for monitoring treatment response and tailoring further therapy. The technology's multi-parameter analysis capabilities also allow identification of multiple tumor-associated markers simultaneously, enhancing accuracy. This multi-dimensional analysis differentiates malignant cells from normal cells based on unique expression profiles detected across several markers. The heterogeneity of blood and tissue samples poses challenges for PCR and NGS methods, but flow cytometry can efficiently sort through complex sample matrices to pinpoint rare tumor populations. Advances in instrumentation have increased throughput while maintaining exquisite analytical sensitivity. Overall, flow cytometry remains the gold standard for minimal residual disease testing due to its unparalleled single cell sensitivity and specificity for detection of rare tumor populations.

Insights, By Application: Lymphoma Monitoring Relies on MRD Testing

The application segment includes lymphoma, solid tumors, and others. The lymphoma segment is estimated to hold 51.3% share of the market in 2024 due to the clinical need to closely monitor the treatment response and relapse risk in these cancers. Lymphoma includes both Hodgkin's and non-Hodgkin's subtypes that are generally treated via chemotherapy with or without stem cell transplantation. Achieving a complete response to initial therapy is a strong prognostic indicator, but minimal residual disease may persist in some patients and subsequently cause relapse. MRD testing provides crucial post-treatment surveillance for lymphomas, as it can identify patients who are not fully cleared of disease and are at higher risk. This enables preemptive interventions such as adjustment of maintenance therapies or closer follow up monitoring. The sensitivity to detect one lymphoma cell among a million normal cells allows identification of minimal residual disease before clinical or imagistic relapse. Numerous studies have demonstrated the power of MRD status for refining risk stratification and prognosis in aggressive lymphomas such as diffuse large B-cell lymphoma. Adopting MRD monitoring as a standard of care improves treatment outcomes by targeting higher risk patients for consolidated therapies or enrollment in clinical trials of new drugs. Overall, close surveillance of lymphoma response to therapy drives extensive use of MRD testing in this disease segment.

Insights, By End User: Hospitals Lead MRD Testing due to Infrastructure

The end user segment includes hospitals, clinics, research laboratories, and others. The hospital subsegment is expected to have 36.9% of the market share in 2024 owing to institutional infrastructure advantages. MRD testing requires specialized laboratory equipment, trained technicians, and multi-disciplinary collaboration between pathology, hematology and oncology specialties. Most hospitals have centralized pathology labs with flow cytometers, PCR machines and the capacity to perform complex genomic analyses. This efficient concentration of analyzers and expertise enables high volume, standardized testing. Additionally, hospitals treat the majority of cancer patients receiving chemotherapy or stem cell transplants. This consolidates sample collection locally and facilitates utilizing MRD status to guide clinical management and follow up care within the same organization. Hospitals also employ hematopathologists and oncologists who can properly select patients for MRD monitoring, integrate results into patient care, and conduct further translational research. Commercialization of testing services has emerged but remains supplementary to hospital laboratories forming the core infrastructure. Efforts to decentralize testing to community clinics and physician offices are limited by complex assay requirements. As a result, hospitals play the lead role in fulfilling clinical needs for minimal residual disease monitoring.

Regional Insights

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North America remains the dominant region in the global minimal residual disease testing market and is anticipated to hold 34.5% of the market share in 2024. North America has established itself as the leading region in the global minimal residual disease testing market. The presence of some of the top pharmaceutical and biotechnology companies along with advanced healthcare infrastructure and high healthcare spending have fueled market growth. The U.S. accounts for the largest share due to the growing adoption of MRD testing in clinical trials and patient monitoring practices. Several hospitals and laboratories in the country are well-equipped with modern testing technologies and skilled professionals to perform these tests routinely.

Asia Pacific is recognized as the fastest-growing market for MRD testing globally. The growth can be attributed to improving healthcare infrastructure, expanding patient pool of hematological cancers, and growing medical tourism across India, China, and other countries. Various initiatives by governments to promote localization of production are also encouraging international companies to tap into opportunities. While the market is still in the growth phase, improving purchasing power and demand for advanced diagnostic technologies will likely aid regional expansion in the coming years.

Market Report Scope

Key Developments

• In September 2023, Guardant Health, Inc., a precision oncology company, announced that Geisinger Health Plan offers coverage for the Guardant Reveal minimal residual disease (MRD) test. Guardant Reveal is a blood test that detects circulating tumor DNA (ctDNA) in blood after treatment, including surgery, to help oncologists identify cancer patients with residual or recurring disease who may benefit most from adjuvant therapy or surveillance. It is the first blood-only liquid biopsy test commercially available for MRD testing.
• In April 2023, Sebia, a provider of clinical protein electrophoresis equipment and reagents, announced the launch of Minimal Residual Disease (MRD) test for monitoring in multiple myeloma. M-inSight is a Laboratory Developed Test (LDT) being offered by Corgenix, College of American Pathologists (CAP)-accredited, Clinical Laboratory Improvement Amendments (CLIA) -licensed clinical laboratory and part of the Sebia Group.
• In December 2022, Adaptive Biotechnologies, a biotechnology company, announced the launch of its clonoSEQ Assay to detect minimal residual disease (MRD) in blood for patients with diffuse large B-cell lymphoma (DLBCL)
• In January 2021, GRAIL, Inc., a healthcare company, announced collaborations with Amgen Inc., a biopharmaceutical company, and AstraZeneca and Bristol Myers Squibb, to evaluate GRAIL Inc.’s methylation-based technology for the detection of minimal residual disease (MRD)

*Definition:

Minimal residual disease (MRD) testing is a highly sensitive method for detecting cancer cells in patients with blood cancers such as myeloma, lymphoma, and leukemia. MRD testing is used to determine if cancer cells have been killed by chemotherapy or other cancer treatments. It can help determine if a patient is in full remission, at risk of relapse, or if further treatment is needed.

Market Segmentation

• Technology Insights (Revenue, USD Bn, 2019 - 2031)
  • Flow Cytometry
  • Polymerase chain reaction (PCR)
  • Next generation sequencing
•  Application Insights (Revenue, USD Bn, 2019 - 2031)
  • Lymphoma 
  • Solid Tumors
  • Others
•  End User Insights (Revenue, USD Bn, 2019 - 2031)
  • Hospitals
  • Clinics
  • Research Laboratories
  • Others
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Bio-Rad Laboratories, Inc.
  • F. Hoffmann-La Roche Ltd
  • Guardant Health, Inc.
  • Adaptive Biotechnologies
  • Invitae Corporation
  • ASURAGEN, INC.
  • Invivoscribe, Inc. 
  • Laboratory Corporation of America Holdings
  • Natera, Inc.
  • Sysmex Inostics, Inc.
  • Amgen Inc.
  • FOUNDATION MEDICINE, INC.
  • Sebia
  • Myriad Genetics, Inc.