Global Minimal Residual Disease (MRD) Testing Markets 2021-2027: Potential Long-Term Cost Savings / Increasing Market Access in Emerging Economies / Technological Evolution of Testing

DUBLIN, June 23, 2022 /PRNewswire/ -- The "Global MRD Testing Market: Focus on Technology, Application, End User, Region - Analysis and Forecast, 2022-2027" report has been added to ResearchAndMarkets.com's offering.

The minimal residual disease (MRD) testing market is projected to reach $2,611.2 million by 2027 from $1,089.3 million in 2021, at a CAGR of 14.53%.

The market is driven by certain factors, such as the rising incidence of hematologic malignancies, increasing consumer awareness for tailored therapy, increasing research funding from the National Cancer Institute and increasing disposable income in emerging economies.

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.

Market Lifecycle Stage

The global MRD testing market is in the rapidly evolving and dynamic stage, which opens ample opportunities for diagnostic and life science companies.

Also, companies that are already in the development phase for MRD tests are trying to match themselves with modern technologies in the market to improve the overall system of MRD testing, from diagnostic assays and kits development to commercialization.

The companies operating in the global MRD testing market are now focusing more on disease-specific and personalized diagnostic kits to enhance testing and improve detection outcomes.

Also, major players such as ARUP Laboratories, Adaptive Biotechnologies Corporation, Bio-Rad Laboratories, Inc., Cergentis B.V, F. Hoffmann-La Roche Ltd, and Guardant Health are investing heavily in research and development for their respective testing products.

Impact

With an increased worldwide focus on treating hematological malignancies, the major market players are developing novel diagnostic tests, which are significantly impacting the growth of the MRD testing market. Diagnostic evolution in the form of companion diagnostics and liquid biopsy through molecular techniques such as PCR and NGS has enabled molecular diagnostic juggernauts to enter this market seamlessly.

Following FDA approvals of clonoSEQ and 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 35 significant synergistic developments during the time period between January 2018 and May 2022.

In addition to this, in November 2021, Palmetto GBA's Molecular Diagnostics Program (MolDX) has confirmed a local coverage determination that supported the Medicare coverage for Adaptive Biotechnologies clonoSEQ in patients with B-cell acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL) for monitoring minimal residual disease. The above activities created a global impact and contributed to an increase in MRD testing market.

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.

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

Total Number of Companies Profiled: 15 (11 public companies and 4 private companies)

• Adaptive Biotechnologies Corporation
• Arup Laboratories
• Bio-Rad Laboratories, Inc.
• Cergentis B.V.
• F. Hoffmann- La Roche Ltd
• Guardant Health
• ICON plc
• Invivoscribe, Inc.
• Laboratory Corporation of America Holdings
• Mission Bio, Inc.
• Natera, Inc.
• NeoGenomics Laboratories, Inc.
• Opko Health, Inc.
• Quest Diagnostics Incorporated
• Sysmex Corporation

Key Topics Covered:

1 Market

2 Research Methodology

3 Market Overview
3.1 MRD Testing: Introduction
3.2 MRD Testing: Solid Tumor vs. Hematological Malignancy
3.3 Market Footprint
3.4 Market Size and Future Growth Potential

4 Market Dynamics
4.1 Impact Analysis
4.2 Market Drivers
4.2.1 Rising Incidence of Hematological Malignancies
4.2.2 Increasing Consumer Awareness for Tailored Therapy
4.2.3 Increase in Research Funding from National Cancer Institute
4.2.4 Increasing Disposable Income in Emerging Economies
4.3 Market Restraints
4.3.1 False Negatives and Positives
4.3.2 Uncertain Reimbursement and Regulatory Policies
4.3.3 Lack of Trained Professionals
4.3.4 Lack of Established Treatment Protocols for High-Value Tests in Emerging Economies
4.4 Market Opportunities
4.4.1 Potential Long-Term Cost Savings
4.4.2 Increasing Market Access in Emerging Economies
4.4.3 Technological Evolution of Testing
4.4.3.1 10- and 12-Color Flow Cytometry
4.4.3.2 PCR for Gene Rearrangements
4.4.3.3 NGS and Multiplexing

5 Industry Insights
5.1 Approval Scenario
5.2 Financing Scenario
5.3 Regulatory Framework
5.4 Reimbursement Scenario
5.5 Supply Chain Analysis
5.6 Price Sensitivity Analysis (Elasticity)

6 Global Minimal Residual Disease Testing Market: Competitive Insights
6.1 Overview
6.2 Synergistic Activities
6.3 Product Approvals
6.4 Product Launches and Updates
6.5 Merger and Acquisition Activities
6.6 Business Expansion and Funding Activities
6.7 Other Developments
6.8 Market Share Analysis, 2020-2021
6.9 Growth-Share Analysis

7 Global Minimal Residual Disease Testing Market: Stakeholder Analysis (N=30-40)
7.1 Physicians' Perception
7.1.1 Stage of the Treatment Use for MRD
7.1.2 Frequency of Receiving MRD Testing
7.1.3 Average Treatment Duration for Patients Diagnosed with MRD
7.1.4 Adoption and Barriers to MRD Testing
7.2 Payors' Perception
7.2.1 Reimbursement vs. Patient Out-of-Pocket Expense
7.3 Investors' Perception
7.3.1 Price vs. Sensitivity vs. Turnaround time

8 Global Minimal Residual Testing Market (by Technology), 2021-2027
8.1 Overview
8.2 Flow Cytometry
8.3 Polymerase Chain Reaction (PCR)
8.4 Next-Generation Sequencing (NGS)
8.5 Other Technologies

9 Global Minimal Residual Testing Market (by Application), 2021-2027
9.1 Overview
9.2 Hematological Malignancy
9.2.1 Non-Hodgkin's Lymphoma (NHL)
9.2.2 Multiple Myeloma (MM)
9.2.3 Acute Lymphoblastic Leukemia (ALL)
9.2.4 Chronic Lymphocytic Leukemia (CLL)
9.2.5 Acute Myeloid Leukemia (AML)
9.2.6 Chronic Myeloid Leukemia (CML)
9.2.7 Hodgkin's Lymphoma (HL)
9.2.8 Other Leukemia

10 Global Minimal Residual Disease Testing Market (by End User), 2021-2027
10.1 Overview
10.2 Hospitals and Specialty Clinics
10.3 Diagnostic Laboratories
10.4 Research Institutions
10.5 Other End Users

11 Global Minimal Residual Disease Testing Market (by Region), 2021-2027

12 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/h9yd9n

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