The market growth is attributed to the surging prevalence of cancer and the increasing use of next-generation sequencing technology. Further, rising investments and research and development (R&D) by companies are likely to offer opportunities for the market growth. However, complex regulatory framework, high cost, and unclear reimbursement scenarios and policies hinder the minimal residue disease testing market growth.
Patients achieving complete hematologic remission after blood cancer treatment may foster residual cancer cells in the bone marrow or peripheral blood. These cells can result in relapse, as they persist at levels so low that they cannot be detected by conventional cytomorphology. Similar is the case with several other cancer conditions, including solid tumors and multiple myeloma. Minimal residual disease testing is employed to detect and quantify cancer cells existing in small numbers in a patient's body. This testing is performed by using sensitive technologies such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and flow cytometry to identify measurable residual disease at the molecular level. Minimal residual disease testing is clinically important because it helps monitor response to treatment, predicts risk of relapse, guides personalized therapies, and serves as an endpoint in clinical trials.
North America accounted for a major share of the global minimal residual disease testing market in 2023. The North America minimal residual disease testing market is segmented into the US, Canada, and Mexico. The key factors driving the market growth in this region is the increasing incidence and prevalence of hematologic cancer in the US are likely to reflect the high risk of survivors having residual cancer cells. According to statistics published by the American Cancer Society, in 2022, there were 34,470 new cases of multiple myeloma and about 6,660 new cases of acute lymphoblastic leukemia (ALL) in the US. The Leukemia and Lymphoma Society estimated ~90,390 new diagnoses of lymphoma in the US in 2021, including 8,830 cases of Hodgkin's lymphoma and 81,560 cases of non-Hodgkin's lymphoma. In November 2022, Natera received a national minimal residual disease testing contract from the US Department of Veterans Affairs (VA) National Precision Oncology Program to provide MRD and monitoring services using the company's Signetera MRD test. In February 2022, the Biomarkers Consortium (BC) of the Foundation for the National Institutes of Health (FNIH) launched a project to validate new methods for quantifying and detecting MRDs. The strong MRD reimbursement framework further facilitates the rollout of new testing products in the region.
Increasing Investments and R&D by Companies to Provide Market Opportunities in Future
In April 2023, Foresight Diagnostics closed a Series B financing round led by Foresite Capital and raised US$ 58.75 million to commercialize a highly sensitive liquid biopsy minimal residue disease testing platform. The financing round was headed by Foresite Capital, with the involvement of Bluebird Ventures, Civilization Ventures, Pear Ventures, Stanford University, Agent Capital, and the University of Colorado Healthcare Innovation Fund. Adela, Inc., an innovator in blood testing to monitor minimal residual disease and detect cancer in early stages through a genome-wide methylome approach, announced the closing of the financing of US$ 48 million in September 2023. This financing round included existing investors F-Prime Capital, Deerfield Management, Decheng Capital, OrbiMed, and RA Capital Management, along with Labcorp, a global leader in innovative and comprehensive laboratory services, as a new investor-bringing the company's total capital to US$ 108 million.
Cancer research centers are also involved in detecting MRD in cancer patients. For example, in September 2023, Myriad Genetics collaborated with Memorial Sloan Kettering (MSK) Cancer Center to evaluate the use of minimum residual disease testing in breast cancer patients. The research project was planned with the utilization of Myriad's MRD testing platform, a tumor-informed high-resolution assay based on whole-genome sequencing, for achieving high sensitivity and specificity for circulating tumor DNA (ctDNA). Thus, the increasing research funding in the area of minimal residue disease testing, as well as the participation of companies in investment initiatives, is expected to boost market growth in the coming years.
Technique -Based Insights
Based on technique, the minimal residue disease testing market is divided into flow cytometry, PCR, NGS, and others. The flow cytometry segment held the largest market share in 2023, and the PCR segment is likely to register the highest CAGR of 12.39% during 2023-2031.
The largest market share of the flow cytometry segment is due to its high sensitivity and wide applicability for minimal residual disease testing. Evaluating individual cells using flow cytometry determines whether certain protein markers are present on the cell surface. Reliable results need a recent bone marrow sample. Specific antibodies are applied to the bone marrow sample that binds to cells with a specific protein. The sensitivity of this method is evident from its ability to detect a cancer cell from 10,000-100,000 healthy bone marrow cells, subject to the configuration of the flow cytometry. Availability of results may take less than a day.
Cancer Type -Based Insights
Based on cancer type, the minimal residue disease testing market is segmented into leukemia, lymphoma, solid tumors, and multiple myeloma. The solid tumors segment held the largest market share in 2023, and the same segment is estimated to grow at the fastest CAGR during 2023-2031. The lymphoma segment held the second largest market share in 2023.
The lymphoma segment held the second largest share in the market owing to the increasing prevalence of lymphoma. According to the American Cancer Society, approximately 90,300 people were diagnosed with lymphoma in the US in 2021; the disease burden is expected to increase with each passing year. The most common symptoms of lymphoma include swelling of the lymph nodes in the neck, armpits, or groin.
End User -Based Insights
The market is categorized into hospitals, specialty clinics, diagnostic laboratories, and others based on end users. The hospitals segment held the largest minimal residue disease testing market share in 2022, which is anticipated to register the highest CAGR of 12.79% from 2023-2031.
Leading players are implementing strategies such as expansion, partnership, launch of new products, and acquisition of a new customer base for tapping prevailing business opportunities.
The US Food and Drug Administration, Centers for Disease Control and Prevention (CDC), and Global Burden of Disease Study are among the primary and secondary sources referred to while preparing the minimal residue disease testing market report.