The growth of this market can be largely attributed to the rising incidence of cancer and the growing adoption of next-generation sequencing (NGS) technologies. Additionally, increased investments and research and development (R&D) efforts by various companies are anticipated to create further opportunities for market expansion. However, challenges such as a complex regulatory environment, high costs, and ambiguous reimbursement policies may impede the growth of the minimal residue disease testing market.
Patients who achieve complete hematologic remission following treatment for blood cancers may still harbor residual cancer cells in their bone marrow or peripheral blood. These residual cells can lead to relapse, as they exist at levels too low to be detected by traditional cytomorphology methods. This scenario is also applicable to various other cancer types, including solid tumors and multiple myeloma. Minimal residual disease testing is utilized to identify and quantify these low levels of cancer cells within a patient?s body. This testing employs advanced technologies such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and flow cytometry to detect measurable residual disease at a molecular level. The clinical significance of minimal residual disease testing lies in its ability to monitor treatment responses, predict relapse risks, guide personalized treatment strategies, and serve as endpoints in clinical trials.
In 2023, North America held a significant share of the global minimal residual disease testing market. This market is further divided into the US, Canada, and Mexico. The primary drivers of market growth in this region include the rising incidence of hematologic cancers in the US, which indicates a high risk of residual cancer cells among survivors. According to the American Cancer Society, in 2022, there were 34,470 new cases of multiple myeloma and approximately 6,660 new cases of acute lymphoblastic leukemia (ALL) reported in the US. The Leukemia and Lymphoma Society estimated around 90,390 new lymphoma diagnoses in the US in 2021, which included 8,830 cases of Hodgkin's lymphoma and 81,560 cases of non-Hodgkin's lymphoma. In November 2022, Natera secured a national contract from the US Department of Veterans Affairs (VA) National Precision Oncology Program to provide MRD testing and monitoring services using its Signetera MRD test. Furthermore, in February 2022, the Biomarkers Consortium (BC) of the Foundation for the National Institutes of Health (FNIH) initiated a project aimed at validating new methods for quantifying and detecting MRDs. The robust reimbursement framework for MRD testing in this region further supports the introduction of new testing products.
The increasing investments and R&D initiatives by companies are expected to create future market opportunities. For instance, in April 2023, Foresight Diagnostics completed a Series B financing round led by Foresite Capital, raising US$ 58.75 million to commercialize a highly sensitive liquid biopsy platform for minimal residue disease testing. This financing round included participation from Bluebird Ventures, Civilization Ventures, Pear Ventures, Stanford University, Agent Capital, and the University of Colorado Healthcare Innovation Fund. Additionally, Adela, Inc., which focuses on blood testing for minimal residual disease and early cancer detection through a genome-wide methylome approach, announced the closure of a US$ 48 million financing round in September 2023, bringing its total capital to US$ 108 million.
Cancer research institutions are also actively engaged in MRD detection. For example, in September 2023, Myriad Genetics partnered with Memorial Sloan Kettering (MSK) Cancer Center to assess the application of minimal residual disease testing in breast cancer patients. This research project utilized Myriad's MRD testing platform, which is based on whole-genome sequencing, to achieve high sensitivity and specificity for circulating tumor DNA (ctDNA). Thus, the growing research funding in minimal residue disease testing, along with corporate investment initiatives, is expected to propel market growth in the upcoming years.
From a technique perspective, the minimal residue disease testing market is categorized into flow cytometry, PCR, NGS, and others. The flow cytometry segment dominated the market in 2023, while the PCR segment is projected to exhibit the highest CAGR of 12.39% from 2023 to 2031. The flow cytometry segment's leading market share is due to its high sensitivity and broad applicability in minimal residual disease testing. This technique evaluates individual cells to determine the presence of specific protein markers on their surfaces, requiring a recent bone marrow sample for reliable results. Specific antibodies are used to bind to cells with particular proteins, allowing for the detection of cancer cells among 10,000 to 100,000 healthy bone marrow cells, depending on the flow cytometry configuration. Results can often be obtained in less than a day.
In terms of cancer types, the minimal residue disease testing market is divided into leukemia, lymphoma, solid tumors, and multiple myeloma. The solid tumors segment held the largest market share in 2023 and is expected to grow at the fastest CAGR during the forecast period. The lymphoma segment ranked second in market share due to the increasing prevalence of lymphoma, with approximately 90,300 diagnoses reported in the US in 2021, a figure that is expected to rise annually. Common symptoms of lymphoma include swollen lymph nodes in the neck, armpits, or groin.
The market is also segmented by end users, including hospitals, specialty clinics, diagnostic laboratories, and others. The hospitals segment accounted for the largest share of the minimal residue disease testing market in 2022 and is anticipated to register the highest CAGR of 12.79% from 2023 to 2031.
Key players in the market are pursuing strategies such as expansion, partnerships, new product launches, and customer base acquisitions to capitalize on existing business opportunities.
The US Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), and the Global Burden of Disease Study are among the primary and secondary sources referenced in the preparation of the minimal residue disease testing market report.