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 molecularMRD 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.

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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Fastest-growing application in the global MRD testing market

For hematological malignancies, various applications exist for both myeloid and lymphoid malignancies. Although lymphoid malignancies segment dominates the market, there is tremendous opportunity in the myeloid segment with companies such as Invivoscribe, Inc., NeoGenomics Laboratories, Inc., and Quest Diagnostics dominating the field with their expansive product portfolios. The global MRD testing market (by hematological malignancies) is estimated tobe dominated by Non-Hodgkin’s lymphoma (NHL), growing at a CAGR of 14.93% during the forecast period, 2020-2025. However, owing to the increasing incidence and fatality observed in patients being diagnosed with multiple myeloma (MM), it is expected that this sub-segment will witness the highest CAGR of 17.02% during the forecast period, holding a 15.74% share of the market in 2025.

Fastest-growing region in the global MRD testing market

North America is currently the leading contributor to the global MRD testing market. The growing incidences of hematologic malignancies, such as leukemia and lymphoma, and the development of novel assay kits are among the major factors that lead to the dominance of North America in the global minimal residual disease (MRD) testing market. However, the Asia-Pacific (APAC) region, constituting several emerging economies, is expected to register the highest CAGR of 17.65% during the forecast period 2020-2025. As of 2020, China is the leading contributor to the APAC minimal residual disease testing market and is expected to grow at a CAGR of 17.12% during the forecast period, 2020-2025.

Key competitors in the global MRD testing market

The global MRD testing market has been dominated significantly by companies Invivoscribe, Inc., NeoGenomics Laboratories, Inc., and Quest Diagnostics, owing to their expansive product portfolios. However, due to emerging industry-academia collaborations and the increasing influx of funds into smaller companies, the market is extremely dynamic. The market is witnessing the emergence of a huge number of smaller companies and larger companies adopting strategic measures to establish their dominance. Companies such as ArcherDx, Inc., ARUP Laboratories, Asuragen, Inc., Sysmex Corporation, MissionBio, Inc., and Inivata Ltd. have also been instrumental in propelling growth in the global MRD testing market.

Key growth strategies in the global MRD testing market

Following FDA approvals of Adaptive Biotechnology’s clonoSEQ and Natera’s Signatera, major companies are now looking to invest in the field of MRD, focusing primarily on the foundation laid for hematological malignancies. The market witnessed approximately 37 significant key developments in the three years (January 2018-December 2020). Key players such as Adaptive Biotechnologies Corporation and Natera, Inc. led the most synergic developments witnessed by the market. Other companies such as MissionBio, Inc., Guardant Health, Sysmex Inostics, and Guardant Health have also established synergies with leading companies.

Key end-user perceptions in the global MRD testing market?

PHYSICIAN’S PERCEPTION:

In developed economies, the adoption of advanced diagnostic tests accounts for favorable reimbursement scenarios, shift toward technologically advanced diagnostic tests in hospitals and clinics and increasing awareness among patients for early diagnosis of cancer, particularly hematologic malignancies. However, physicians in the developing economies still prefer to use traditional testing methods for malignancy detection, which is primarily attributed to unfavorable reimbursement scenarios, high maintenance cost, and lack of technical support and robustness, among others.

INVESTOR’S PERCEPTION:

The investors have similar concerns as physicians or clinicians. During the development of a diagnostic, it is very imperative that the end-product delivers effective results with cost, time, and effort. The investors are more inclined toward better-quality diagnostics available at a reduced cost in order to have greater market penetration globally.

PAYOR’S PERCEPTION:

Payors’ concerns are majorly related to the high cost of diagnostics, delay in approval due to the lack of evidence-based data, and required funding mechanisms, including annuity payments and risk-sharing schemes. The lack of development in reimbursement policies for MRD test assays is majorly due to the unavailability of the clinical trial data and physicians’ acceptance of MRD tests with lower benefits.

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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:

• Technology
• Application
• 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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