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Minimal Residual Disease Testing Market Size, Share, Forecast, & Trends Analysis by Offering, Technology (PCR, Flow Cytometry, NGS), Application (Lymphoma, Leukemia, Multiple Myeloma, Solid Tumor), Sample (Blood, Bone Marrow) - Global Forecast to 2031
Report ID: MRHC - 1041385 Pages: 265 Nov-2024 Formats*: PDF Category: Healthcare Delivery: 2 to 4 Hours Download Free Sample ReportThe growth of the minimal residual disease testing market is driven by the growing incidence of cancer, the increasing application of MRD in hematological malignancies, the high recurrence rates of some cancers, and increasing investments and funding for MRD testing. Moreover, emerging economies, the rising adoption of personalized treatments & targeted therapies in the field of oncology, and the growing use of MRD testing in cases of solid tumors are expected to generate market growth opportunities.
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The growing awareness regarding cancer screening and early diagnosis has led to diagnoses of cancer at earlier stages, increasing survival rates further supported by advances in treatments. Surviving cancer patients are at constant risk of relapse and cancer recurrence. These patients require regular monitoring to identify signs of relapse and start early treatment. According to the International Agency for Research on Cancer, the estimated number of new cancer cases is expected to increase to 24.5 million in 2030 from 19.2 million cases in 2020.
The field of minimal residual disease testing has gained traction in recent years owing to the rising cancer burden and the need to improve patient outcomes. The players operating in this market are raising funds for MRD test development and commercialization. Additionally, governments around the globe are offering grants and research funding to advance minimal residual disease testing. For instance, in February 2024, Freenome Holdings, Inc. (U.S.), a biotech company involved in the development of blood tests for early cancer detection, received an investment of $254 million to advance the pipeline of single-cancer and tailored multi-cancer early detection tests built on its multiomics platform. This platform is also being evaluated for minimal residual disease testing with the support of biological insights derived from the company’s multiomics platform. Similarly, in September 2023, Adela, Inc. (U.S.) received an investment of $48 million from several venture capitalists and diagnostic service providers to advance its technology platform and commercialize its first product for MRD monitoring.
Digital PCR (dPCR) is one of the significant technological advancements in Minimal Residual Disease (MRD) testing. Unlike conventional PCR methods that provide quantitative results based on amplification cycles, dPCR divides a sample into thousands of individual reactions for more precise quantification of nucleic acids, which enables the detection of low levels of residual disease with improved sensitivity and accuracy for monitoring patients with blood cancers.
The implementation of dPCR in clinical practices can also be attributed to its relatively simpler workflow, which requires less hands-on time compared to other advanced techniques. Due to continuous technological advancements, dPCR is expected to become more widely adopted for MRD testing.
Single-cell multiomics assays simultaneously conduct the genotypic and immunophenotypic assessment of MRD across thousands of individual cells, providing clonal insight in tandem with the immunophenotype from rare residual disease cells. These high-resolution, integrated molecular profiles provide valuable insights and information regarding the complex biology of cancer MRD, which can lead to the identification of new markers for early cancer recurrence. The application of Artificial Intelligence (AI) and advanced bioinformatics tools in MRD testing is a more recent development that has enabled the analysis of vast amounts of data generated through NGS and dPCR techniques. AI-driven algorithms can identify subtle patterns in genetic data, improving the accuracy of MRD detection and predicting patient outcomes more effectively.
The growth in MRD testing is supported by advancements in technologies enabling real-time monitoring and personalized treatment. With advances in single-cell sequencing and the integration of artificial intelligence, the next generation of MRD tests could offer deeper insights into cancer recurrence, treatment resistance mechanisms, and treatment efficacy.
Traditionally, MRD testing has been more established and used in blood cancers, but recent advancements and research have accelerated the application of MRD testing in solid tumors. As research on MRD continues, the potential of MRD testing in informing treatment decisions for solid tumor patients is expected to improve in the future. Moreover, diagnostic companies’ focus on launching MRD tests for solid tumors indicates the growing demand for MRD testing for solid tumors. For instance, in October 2023, Personalis, Inc. (U.S.), a provider of MRD testing services for patients and clinicians, launched NeXT Personal Dx, an MRD test for clinical use to detect MRD in lung and breast cancer.
Furthermore, MRD testing can provide oncologists with valuable information, fulfilling their need for precise and accurate data to assess treatment response and recurrence risk. The ability to detect even small amounts of residual disease after surgical interventions or therapies can lead to more personalized follow-up strategies, improving patient outcomes. With ongoing research and clinical trials, the growing acceptance and implementation of MRD testing in solid tumors is expected to create opportunities for the players operating in the market.
Based on offering, the minimal residual disease testing market is segmented into assays & reagents, instruments, and software & services. In 2024, the assays & reagents segment is expected to account for the largest share of 76.7% of the minimal residual disease testing market. The segment’s large market share is attributed to the recurrent use of assays & reagents, increasing research & development in the field of oncology leading to the emergence of new MRD tests, market players’ focus on introducing new assays for minimal residual disease testing, and the rising adoption of MRD testing in clinical trials.
Moreover, the assays & reagent segment is projected to record the highest growth rate of 15.4% during the forecast period 2024–2031. The growth of this segment is driven by the rising cancer incidence, key players’ focus on introducing new MRD tests for different types of cancer, and growing research and development for the development of new MRD tests.
Based on technology, the minimal residual disease testing market is segmented into flow cytometry, polymerase chain reaction, next-generation sequencing, and other technologies. In 2024, the flow cytometry segment is expected to account for the largest share of 42.7% of the minimal residual disease testing market. The segment’s large market share is attributed to flow cytometry technology’s ability to provide real-time, quantitative data on the number and type of cancer cells in a sample, the wide availability of flow cytometers, and the relatively lower costs of flow cytometry consumables compared to more advanced technologies such as Next-generation Sequencing (NGS).
However, the polymerase chain reaction segment is projected to record the highest CAGR of 16.6% during the forecast period. The growth of this segment is driven by PCR technology’s high specificity in targeting known genetic markers and its capacity to detect disease at the molecular level, often before clinical symptoms reappear, facilitating earlier interventions and potentially improving patient outcomes. Moreover, PCR is well-suited for detecting minimal residual disease in patients, which often requires tracking of specific mutations.
Based on application, the minimal residual disease testing market is segmented into blood cancers and solid tumors. In 2024, the blood cancers segment is expected to account for the larger share of the minimal residual disease testing market. The segment’s large market share is attributed to the growing incidence of blood cancers, the advent of new diagnostic technologies, the rising focus on precision oncology, high investments in MRD testing for blood cancers, and the wide availability of MRD testing solutions for blood cancers.
Moreover, the blood cancers segment is projected to record the higher CAGR during the forecast period 2024-2031. The growth of this segment is driven by the growing availability of MRD tests for blood cancers, the growing focus of MRD test providers on different types of blood cancers, and the rising incidence of blood cancers.
Based on sample type, the minimal residual disease testing market is segmented into blood, bone marrow, and other sample types. In 2024, the blood segment is expected to account for the largest share of the minimal residual disease testing market. The segment’s large market share is attributed to the growing cancer incidence, the noninvasiveness of procedures used to obtain blood samples, and better patient compliance in the case of regular blood-based MRD monitoring.
Moreover, the blood segment is projected to record the highest CAGR during the forecast period 2024-2031. The growth of this segment is driven by the focus of market players on launching blood-based MRD tests, growing awareness regarding MRD testing, and the convenience of blood sample collection, leading to better patient compliance.
Based on customer type, the minimal residual disease testing market is segmented into hospitals, diagnostic laboratories, academic & research organizations/institutions, and pharmaceutical & biopharmaceutical companies. In 2024, the pharmaceutical & biopharmaceutical companies segment is expected to account for the largest share of the minimal residual disease testing market. The segment’s large market share is attributed to the high adoption of MRD testing in clinical trials for oncology therapies, high investments in oncology drug development and research, and supportive initiatives by regulatory authorities to promote MRD testing in drug trials.
Moreover, the pharmaceutical & biopharmaceutical companies segment is projected to record the highest CAGR during the forecast period 2024-2031. The growth of this segment is driven by the growing adoption of MRD testing in clinical trials for oncology therapies, increasing R&D investments by pharmaceutical & biopharmaceutical companies, and the growing adoption of MRD testing to validate the efficacy of drugs.
In 2024, North America is expected to account for the largest share of 38.8% of the minimal residual disease testing market. Furthermore, in 2024, the U.S. is expected to account for the major share of the minimal residual disease testing market in North America. North America’s large market share is attributed to the rising incidence of cancer, funding for the development of MRD tests, the presence of key market players, and the rising focus on cancer screening in the region.
However, Asia-Pacific is slated to register the highest CAGR of 15.5% during the forecast period. Asia-Pacific is becoming an increasingly active market for healthcare product manufacturers and service providers due to improving healthcare infrastructure in the region. Asia-Pacific’s growing population is the key factor driving the region’s healthcare sector. This growth is attracting investments from private and public organizations in the development of MRD testing solutions. The rising incidence of cancer, improving healthcare infrastructure, the growing focus on personalized therapies, increasing cancer screening initiatives, and the availability of funding for cancer research are driving market growth in Asia-Pacific.
The report offers a competitive analysis based on an extensive assessment of the leading players’ product portfolios, geographic presence, and key growth strategies adopted in the last 3–4 years. The key players operating in the minimal residual disease testing market are Illumina, Inc. (U.S.), Qiagen N.V. (Netherlands), F. Hoffmann-La Roche Ltd. (Switzerland), Thermo Fisher Scientific, Inc. (U.S.), Natera Inc (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Adaptive Biotechnologies Corporation (U.S.), Sysmex Corporation, (Japan), Integrated DNA Technologies, Inc. (U.S.), Twist Bioscience Corporation (U.S.), and Invivoscribe Inc. (U.S.).
Particulars |
Details |
No. of Pages |
265 |
Format |
|
Forecast Period |
2024-2031 |
Base Year |
2023 |
CAGR |
14.6% |
Market Size (Value) |
$4.45 Billion by 2031 |
Segments Covered |
By Offering
By Technology
By Application
By Sample Type
By Customer Type
|
Countries Covered |
North America (U.S. and Canada), Europe (Germany, France, U.K., Spain, Italy, Switzerland, Netherlands, and Rest of Europe), Asia-Pacific (China, Japan, India, Australia, South Korea, and Rest of APAC), Latin America (Brazil, Mexico, and Rest of Latin America), and the Middle East & Africa |
Key Companies |
Illumina, Inc. (U.S.), Qiagen N.V. (Netherlands), F. Hoffmann-La Roche Ltd. (Switzerland), Thermo Fisher Scientific, Inc. (U.S.), Natera Inc (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Adaptive Biotechnologies Corporation (U.S.), Sysmex Corporation, (Japan), Integrated DNA Technologies, Inc. (U.S.), Twist Bioscience Corporation (U.S.), and Invivoscribe Inc. (U.S.) |
The minimal residual disease testing market is expected to reach $4.45 billion in 2031.
The market is projected to grow from an estimated $1.72 billion in 2024 to $4.45 billion by 2031.
The minimal residual disease testing market analysis indicates significant growth, with the market expected to reach $4.45 billion by 2031 at a Compound Annual Growth Rate (CAGR) of 14.6% from 2024 to 2031.
The key companies operating in this market include Illumina, Inc. (U.S.), Qiagen N.V. (Netherlands), F. Hoffmann-La Roche Ltd. (Switzerland), Thermo Fisher Scientific, Inc. (U.S.), Natera Inc (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Adaptive Biotechnologies Corporation (U.S.), Sysmex Corporation, (Japan), Integrated DNA Technologies, Inc. (U.S.), Twist Bioscience Corporation (U.S.), and Invivoscribe Inc. (U.S.).
Single-cell multiomics and artificial intelligence are key trends in this market. Single-cell multiomics assays simultaneously conduct the genotypic and immunophenotypic assessment of MRD across thousands of individual cells, providing clonal insight in tandem with immunophenotypes from rare residual disease cells. These high-resolution, integrated molecular profiles provide valuable insights and information regarding the complex biology of cancer MRD, which can lead to the identification of new markers for early cancer recurrence.
By product type, the reagents & assays segment is forecasted to hold the largest market share. By application, the blood cancers segment is expected to dominate the market. By technology, the flow cytometry segment is expected to dominate the market. By sample type, the blood segment is expected to dominate the market. By customer type, the pharmaceutical & biopharmaceutical companies segment is poised to hold the dominant position in the market. By geography, North America is slated to hold the largest market share.
By region, North America is expected to hold the largest share of the minimal residual disease testing market in 2024. However, Asia-Pacific is expected to record the highest CAGR during the forecast period, driven by the rising incidence of cancer, improving healthcare infrastructure, the growing focus on personalized therapies, increasing cancer screening initiatives, and the availability of funding for cancer research.
The primary drivers for the minimal residual disease testing market include the growing incidence of cancer, the increasing application of MRD in hematological malignancies, the high recurrence rates of some cancers, and increasing investments and funding for MRD testing.
Published Date: Jul-2024
Published Date: Jun-2024
Published Date: Apr-2023
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