In order to enhance the entire system of MRD testing, from the development of diagnostic assays and kits to commercialization, businesses that are already in the development phase for MRD tests are attempting to align themselves with contemporary technologies in the market. The global minimal residual disease MRD testing market is expected to witness massive growth owing to the high demand for the sensitivity of assays, particularly witnessed in the U.S. With an increasing number of companies attempting to establish synergies in order to enter the market and an increasing number of products acquiring approvals from regulatory bodies; this market will witness tremendous dynamicity. According to the optimistic approach, the market is expected to grow at a CAGR of 17.61% during the forecast period, 2020-2025.
Factors considered include high adoption among patients for existing, approved MRD tests, as well as a high rate of return to testing normalcy after the pandemic. In addition, other factors such as the optimum influence of coverage decision and high physician driven MRD testing for patients have also been considered. According to the realistic approach, the market is expected to grow at a CAGR of 15.64% during the forecast period, 2020-2025. This approach considers factors such as delayed return to testing for existing patients due to the pandemic, limited adoption among patients for existing, approved MRD tests, particularly for NGS-based testing. Other factors such as the affordability of molecular-MRD tests and limited support from physicians have also been considered.
Recent Developments in the Global MRD Testing Market
• In November 2021, Palmetto GBA’s Molecular Diagnostics Program (MolDX) confirmed a local coverage determination that supported the Medicare coverage for clonoSEQ in patients with B-cell acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). ) for monitoring minimal residual disease.
• In February 2021, Natera, Inc. and Personalis, Inc. partnered in the field of personalized oncology by combining Personalis’ NeXT tumor profiling and diagnostic products with Natera’s personalized ctDNA platform Signatera for treatment monitoring and molecular residual disease assessment.
• In May 2021, Invivoscribe, Inc. announced licensing of key software and two new MRD clinical services. The company’s LymphoTrack Enterprise Software supported high volume customers to meet ever-increasing testing demands.
• In October 2021, Inivata Limited, a subsidiary of NeoGenomics, Inc. entered a clinical collaboration with the Princess Margaret Cancer Center in Toronto, Canada, for the use of Inivata’s InVisionFirst-Lung and RaDaR liquid biopsy assays in two separate studies.
Segmentation 1: by Technology
• Flow Cytometry
• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• Other Technologies
Due to recent developments in molecular diagnostic technologies, the turnaround time and overall cost have been reduced with increased sensitivity and accuracy of results. Significant advances are being witnessed in the development of highly sensitive, quantitative, and multiplex assays. Some of the new technologies include NGS and low-cost PCR devices available in the form of multiparameter assays and multiplexing devices for MRD testing.
Segmentation 2: by Application
• Hematological Malignancy
• Solid Tumor
The global MRD testing market (by application) is broadly segmented into hematological malignancy and solid tumor applications. The global MRD testing market (by application) is dominated by hematological malignancy, which held a share of 94.39% in 2021.
Segmentation 3: by End User
• Hospital and Specialty Clinics
• Diagnostic Laboratories
• Research Institutions
• Other End Users
End users of the MRD market typically include hospitals and specialty clinics, research institutions, diagnostic laboratories, and others. Although hospitals and specialty clinics have been at the forefront of developing advanced technologies that incorporate several ancillaries for superior biological and chemical research, the applicability of MRD tests has been widespread among research institutions. Other end users, such as out-patient clinics and cancer clinics, also contribute significantly to the global MRD testing market.
Segmentation 4: by Region
• North America
o South Korea
o Rest-of-APAC (RoAPAC)
• Latin America and Middle East
o Saudi Arabia
o Rest-of-Latin America and Middle East
• Rest-of-the-World (RoW)
In 2021, North America accounted for a share of 42.92% of the global minimal residual disease testing market. The segment is expected to reach $1,016.8 million in 2027 from $467.5 million in 2021 at a CAGR of 12.68% during the forecast period 2022-2027.
Demand – Drivers and Limitations
Following are the demand drivers for the global MRD testing market:
• Rising Incidence of Hematological Malignancies
• Increasing Consumer Awareness for Tailored Therapy
• Increase in Research Funding from National Cancer Institute
• Increasing Disposable Income in Emerging Economies
The market is expected to face some limitations too due to the following challenges:
• False Negatives and Positives
• Uncertain Reimbursement and Regulatory Policies
• Lack of Trained Professionals
• Lack of Established Treatment Protocols for High-Value Tests in Emerging Economies
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Key Questions Answered in the Report
- What are the major market drivers, challenges, and opportunities and their respective impacts in the global MRD testing market?
- What is the potential impact of biotechnological advancement in the diagnostic industry among the end users, such as physicians, researchers, pathologists, and laboratory technicians?
- What is the current market demand along with future expected demand for the global MRD testing market?
- Has MRD testing penetrated major countries facing an immense burden from hematological malignancies?
- What are the key regulatory hurdles for industry players looking to enter this highly dynamic market?
- What are the key development strategies that are implemented by the major players in order to sustain the competitive market?
- How is each segment of the market expected to grow during the forecast period from 2022 to 2027 based on each segment?
Following are each segment type:
- End User
- Region, namely, North America, Europe, Asia-Pacific, Latin America and Middle East, and Rest-of-the-World (RoW)
- Who are the leading players with significant offerings to the global MRD testing market, and what is the expected market dominance for each of these leading players?
- Which emerging companies are anticipated to be highly disruptive in the future, and what are their key strategies for sustainable growth in the global MRD testing market?
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