Minimal Residual Disease (MRD) Testing Market - A Global and Country Analysis

Focus on Technology, Application, End User, Region - Analysis and Forecast, 2022-2027

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A quick peek into the report

Market Report Coverage

MRD Testing Market
Forecast Period: 2022-2027
CAGR During Forecast Period: 14.53%

MRD Testing Market

Base Year

2021

Market Size in 2021

$1,089.3 Million

Forecast Period

2022-2027

Value Projection and Estimation by 2027

$2,611.2 Million

CAGR During Forecast Period

14.53%

Number of Tables

15

Number of Pages

281

Number of Figures

235

 

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.

Minimal Residual Disease Testing Market

Public companies include ICON plc, Bio-Rad Laboratories, Inc., Adaptive Biotechnologies Corporation, Sysmex Corporation, Quest Diagnostics Incorporated, Opko Health, Inc., NeoGenomics Laboratories, Inc., Natera, Inc., Laboratory Corporation of America Holdings, F. Hoffmann-La Roche, and Guardant Health. The private company profiled are ARUP Laboratories, Cergentis B.V., Invivoscribe, Inc., and Mission Bio, Inc.

How can this report add value to an organization?

The technology segment helps the reader understand the different technology based on MRD testing present in the market.

Technology/Innovation Strategy: The technology segment helps the reader understand the different technology based on MRD testing present in the market. Moreover, the study provides the reader with a detailed understanding of two different applications including hematologic malignancy and solid tumor.

Growth/Marketing Strategy: The global MRD testing market has seen major development by key players operating in the market, such as synergistic activities, product approvals, product launches and updates, mergers and acquisitions, business expansion and funding, and other developments (Medicare coverage). The favored strategy for the companies has been regulatory and legal activities along with product approvals to strengthen their position in the market.

Competitive Strategy: Key players in the global MRD testing market have been analyzed and profiled in the study. Moreover, a detailed competitive benchmarking of players operating in the global MRD testing market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Industry & Technology Overview

The 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%.

Global MRD Testing Market: Industry Overview

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.

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.

Figure: Global MRD Testing Market

MRD Testing Market

Source: BIS Research Analysis

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.

Market Segmentation

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    U.S.
        o    Canada
•    Europe
        o    Germany
        o    Italy
        o    France
        o    U.K.
        o    Spain
        o    Rest-of-Europe
•    Asia-Pacific
        o    China 
        o    India
        o    Japan
        o    South Korea
        o    Australia
        o    Singapore
        o    Rest-of-APAC (RoAPAC)
•    Latin America and Middle East
        o    Brazil
        o    Mexico
        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.

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

Analyst Thoughts

According to Vaishali Chauhan, Research Analyst, BIS Research, “The global MRD testing market is in a dynamic stage. The NGS technology used in the detection of MRD is novel with high sensitivity, which will lead to immense scope in the testing market. This opens ample opportunities which will reduce the cost of NGS technology for MRD detection. Although most diagnostic products for the testing of MRD include clonoSEQ, QXDx BCR-ABL %IS Kit, Oncomine BCR IGH SR Assay, DNA, and AVENIO ctDNA Surveillance Kits; there is a massive need for more testing products that are extremely sensitive, specific, and cost-effective, and not limited to research used but available on a commercial scale.”

Table of Contents

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1.1    Product Definition and Market Scope
1.2    Inclusion and Exclusion
1.3    Scope of Work
1.4    Key Questions Answered in the Report

2.1    Global MRD Testing Market: Research Methodology
2.2    Primary Data Sources
2.3    Secondary Data Sources
2.4    Market Estimation Model
2.5    Criteria for Company Profiling

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

4.1    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

5.1    Approval Scenario
         5.1.1    Approved Minimal Residual Disease Tests by Major Players
         5.1.2    Launched Minimal Residual Disease Tests (by Major Players)
5.2    Financing Scenario
         5.2.1    Key Players’ Stratification (as Per Raised Financing Value)
         5.2.2    Key Players’ Financing Analysis (FY2019-2021)
5.3    Regulatory Framework
         5.3.1    Legal Requirements and Framework in the U.S.
         5.3.2    Legal Requirements and Framework in Europe
         5.3.3    Legal Requirements and Framework in Asia-Pacific
                     5.3.3.1    Japan
                     5.3.3.2    China
                     5.3.3.3    India
5.4    Reimbursement Scenario
         5.4.1    North America
                     5.4.1.1    Outpatient Department (OPD) vs. Inpatient Department (IPD)
         5.4.2    European Union
                     5.4.2.1    OPD vs. IPD
         5.4.3    Asia-Pacific
5.5    Supply Chain Analysis
         5.5.1    For Laboratory Developed Tests (LDTs)
         5.5.2    For In-Vitro Diagnostics (IVDs)
5.6    Price Sensitivity Analysis (Elasticity)
         5.6.1    Physicians’ Perception
                     5.6.1.1    Turnaround Time (TAT)
                     5.6.1.2    Test Sensitivity
         5.6.2    Investors’ Perception
                     5.6.2.1    Turnaround Time (TAT)
                     5.6.2.2    Test Sensitivity
         5.6.3    Payors’ Perception
                     5.6.3.1    Turnaround Time (TAT)
                     5.6.3.2    Test Sensitivity

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
         6.9.1    Growth-Share Analysis (by Company)
         6.9.2    Growth-Share Analysis (by Technology)
         6.9.3    Growth-Share Analysis (by Application)
         6.9.4    Growth-Share Analysis (by End User)

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

8.1    Overview
8.2    Flow Cytometry
8.3    Polymerase Chain Reaction (PCR)
8.4    Next-Generation Sequencing (NGS)
8.5    Other Technologies

9.1    Overview
9.2    Hematological Malignancy
         9.2.1    Non-Hodgkin’s Lymphoma (NHL)
                     9.2.1.1    Non-Hodgkin’s Lymphoma (NHL) (by Type)
                     9.2.1.2    Non-Hodgkin’s Lymphoma (NHL) (by Age)
         9.2.2    Multiple Myeloma (MM)
                     9.2.2.1    Multiple Myeloma (MM) (by Age)
         9.2.3    Acute Lymphoblastic Leukemia (ALL)
                     9.2.3.1    Acute Lymphoblastic Leukemia (ALL) (by Age)
         9.2.4    Chronic Lymphocytic Leukemia (CLL)
                     9.2.4.1    Chronic Lymphocytic Leukemia (CLL) (by Age)
         9.2.5    Acute Myeloid Leukemia (AML)
                     9.2.5.1    Acute Myeloid Leukemia (AML) (by Age)
         9.2.6    Chronic Myeloid Leukemia (CML)
                     9.2.6.1    Chronic Myeloid Leukemia (CML) (by Age)
         9.2.7    Hodgkin’s Lymphoma (HL)
                     9.2.7.1    Hodgkin’s Lymphoma (HL) (by Age)
9.2.8    Other Leukemia

10.1    Overview
10.2    Hospitals and Specialty Clinics
           10.2.1    Hospitals and Specialty Clinics (by Technology)
10.3    Diagnostic Laboratories
           10.3.1    Diagnostic Laboratories (by Technology)
10.4    Research Institutions
           10.4.1    Research Institutions (by Technology)
10.5    Other End Users
           10.5.1    Other End Users (by Technology)

11.1    Overview
11.2    North America
           11.2.1    U.S.
                        11.2.1.1    U.S. Minimal Residual Disease Testing Market (by Application)
           11.2.2    Canada
                        11.2.2.1    Canada Minimal Residual Disease Testing Market (by Application)
11.3    Europe
           11.3.1    Germany
                         11.3.1.1    Germany Minimal Residual Disease Testing Market (by Application)
           11.3.2    Italy
                        11.3.2.1    Italy Minimal Residual Disease Testing Market (by Application)
           11.3.3    France
                         11.3.3.1    France Minimal Residual Disease Testing Market (by Application)
           11.3.4    U.K.
                        11.3.4.1    U.K. Minimal Residual Disease Testing Market (by Application)
           11.3.5    Spain
                        11.3.5.1    Spain Minimal Residual Disease Testing Market (by Application)
           11.3.6    Rest-of-Europe
                         11.3.6.1    Rest-of-Europe Minimal Residual Disease Testing Market (by Application)
11.4    Asia-Pacific
           11.4.1    China
                         11.4.1.1    China Minimal Residual Disease Testing Market (by Application)
           11.4.2    India
                        11.4.2.1    India Minimal Residual Disease Testing Market (by Application)
           11.4.3    Japan
                        11.4.3.1    Japan Minimal Residual Disease Testing Market (by Application)
           11.4.4    South Korea
                         11.4.4.1    South Korea MRD Testing Market (by Application)
           11.4.5    Australia
                        11.4.5.1    Australia Minimal Residual Disease Testing Market (by Application)
           11.4.6    Singapore
                        11.4.6.1    Singapore Minimal Residual Disease Testing Market (by Application)
           11.4.7    Rest-of-APAC (RoAPAC)
                         11.4.7.1    Rest-of-APAC Minimal Residual Disease Testing Market (by Application)
11.5    Latin America and Middle East
           11.5.1    Brazil
                         11.5.1.1    Brazil Minimal Residual Disease Testing Market (by Application)
           11.5.2    Mexico
                         11.5.2.1    Mexico Minimal Residual Disease Testing Market (by Application)
           11.5.3    Saudi Arabia
                        11.5.3.1    Saudi Arabia Minimal Residual Disease Testing Market (by Application)
           11.5.4    Rest-of-Latin America and Middle East
                         11.5.4.1    Rest-of-Latin America and Middle East Minimal Residual Disease Testing Market (by Application)
11.6    Rest-of-the-World (RoW)
           11.6.1.1    Rest-of-the-World Minimal Residual Disease Testing Market (by Application)

12.1    Overview
12.2    ICON plc
          12.2.1    Company Overview
          12.2.2    Role of ICON plc in Global Minimal Residual Disease Testing Market
          12.2.3    Key Customers of the Company
          12.2.4    Key Competitors of the Company
          12.2.5    Financials
          12.2.6    Analyst’s Perspective
12.3    ARUP Laboratories
          12.3.1    Company Overview
          12.3.2    Role of ARUP Laboratories in Global Minimal Residual Disease Testing Market
          12.3.3    Key Customers of the Company
          12.3.4    Key Competitors of the Company
          12.3.5    Analyst’s Perspective
12.4    Cergentis B.V.
          12.4.1    Company Overview
          12.4.2    Role of Cergentis B.V. in Global Minimal Residual Disease Testing Market
          12.4.3    Key Customers of the Company
          12.4.4    Key Competitors of the Company
          12.4.5    Analyst’s Perspective
12.5    Bio-Rad Laboratories, Inc.
          12.5.1    Company Overview
          12.5.2    Role of Bio-Rad Laboratories, Inc. in Global Minimal Residual Disease Testing Market
          12.5.3    Key Customers of the Company
          12.5.4    Key Competitors of the Company
          12.5.5    Financials
          12.5.6    Key Insights About Financial Health of the Company
          12.5.7    Analyst’s Perspective
12.6    Mission Bio, Inc.
          12.6.1    Company Overview
          12.6.2    Role of Mission Bio, Inc. in Global Minimal Residual Disease Testing Market
          12.6.3    Key Customers of the Company
          12.6.4    Key Competitors of the Company
          12.6.5    Recent Developments
          12.6.6    Analyst’s Perspective
12.7    Guardant Health
          12.7.1    Company Overview
          12.7.2    Role of Guardant Health in Global Minimal Residual Disease Testing Market
          12.7.3    Key Customers of the Company
          12.7.4    Key Competitors of the Company
          12.7.5    Financials
          12.7.6    Key Insights About Financial Health of the Company
          12.7.7    Recent Developments
          12.7.8    Analyst’s Perspective
12.8    Invivoscribe, Inc.
          12.8.1    Company Overview
          12.8.2    Role of Invivoscribe, Inc. in Global Minimal Residual Disease Testing Market
          12.8.3    Key Customers of the Company
          12.8.4    Key Competitors of the Company
          12.8.5    Recent Developments
          12.8.6    Analyst’s Perspective
12.9    Laboratory Corporation of America Holdings
          12.9.1    Company Overview
          12.9.2    Role of Laboratory Corporation of America Holdings in Global Minimal Residual Disease Testing Market
          12.9.3    Key Customers of the Company
          12.9.4    Key Competitors of the Company
          12.9.5    Financials
          12.9.6    Analyst’s Perspective
12.10    Natera, Inc.
             12.10.1    Company Overview
             12.10.2    Role of Natera, Inc. in Global Minimal Residual Testing Market
             12.10.3    Key Customers of the Company
             12.10.4    Key Competitors of the Company
             12.10.5    Financials
             12.10.6    Key Insights About Financial Health of the Company
             12.10.7    Recent Developments
             12.10.8    Analyst’s Perspective
12.11    NeoGenomics Laboratories, Inc.
             12.11.1    Company Overview
             12.11.2    Role of NeoGenomics Laboratories, Inc. in Global Minimal Residual Testing Market
             12.11.3    Key Customers of the Company
             12.11.4    Key Competitors of the Company
             12.11.5    Financials
             12.11.6    Key Insights About Financial Health of the Company
             12.11.7    Recent Developments
             12.11.8    Analyst’s Perspective
12.12    Opko Health, Inc.
             12.12.1    Company Overview
             12.12.2    Role of Opko Health, Inc. in Global Minimal Residual Disease Testing Market
             12.12.3    Key Customers of the Company
             12.12.4    Key Competitors of the Company
             12.12.5    Financials
             12.12.6    Key Insights About Financial Health of the Company
             12.12.7    Analyst’s Perspective
12.13    Quest Diagnostics Incorporated
             12.13.1    Company Overview
             12.13.2    Role of Quest Diagnostics Incorporated in Global Minimal Residual Disease Testing Market
             12.13.3    Key Customers of the Company
             12.13.4    Key Competitors of the Company
             12.13.5    Financials
             12.13.6    Analyst’s Perspective
12.14    Sysmex Corporation
             12.14.1    Company Overview
             12.14.2    Role of Sysmex Corporation in Global Minimal Residual Disease Testing Market
             12.14.3    Key Customers of the Company
             12.14.4    Key Competitors of the Company
             12.14.5    Financials
             12.14.6    Key Insights About Financial Health of the Company
             12.14.7    Analyst’s Perspective
12.15    Adaptive Biotechnologies Corporation
             12.15.1    Company Overview
             12.15.2    Role of Adaptive Biotechnologies Corporation in Global Minimal Residual Disease Testing Market
             12.15.3    Key Competitors of the Company
             12.15.4    Financials
             12.15.5    Key Insights About Financial Health of the Company
             12.15.6    Recent Developments
             12.15.7    Analyst’s Perspective
12.16    F. Hoffmann- La Roche Ltd
             12.16.1    Company Overview
             12.16.2    Role of F. Hoffmann-La Roche Ltd in Global Minimal Residual Disease Testing Market
             12.16.3    Key Customers of the Company
             12.16.4    Key Competitors of the Company
             12.16.5    Financials
             12.16.6    Key Insights About Financial Health of the Company
             12.16.7    Analyst’s Perspective

Table 1:    Likert Scale
Table 2:    Impact Analysis of Market Drivers
Table 3:    Impact Analysis of Market Restraints
Table 4:    Current Research Grants and Funding in the U.S., 2021
Table 5:    MRD False Positive and Negative (by Relapse State)
Table 6:    List of Approved MRD Tests by Major Players
Table 7:    List of Launched MRD Tests (by Major Players)
Table 8:    Key Notable Developments
Table 9:    Key Notable Developments
Table 10:    Comparison of FDA and EMA Draft Guidance
Table 11:    Registration Criteria for IVD Medical Devices as per CFDA
Table 12:    Key Coverage Providers for Hematologic Malignancies Testing
Table 13:    Key Products Offered Based on Flow Cytometry
Table 14:    Key Products Offered Based on PCR
Table 15:    Key Products Offered Based on NGS

Figure 1:    Global Cancer Incidence, 2020
Figure 2:    New Lymphoma Cases Expected in the U.S., 2022
Figure 3:    Prevalence of Different Hematological Malignancies Across the U.S. (2018-2021)
Figure 4:    Global Minimal Residual Disease Testing Market, Impact Analysis
Figure 5:    Global MRD Testing Market (by Application), $Million, 2021 vs. 2027
Figure 6:    Global MRD Testing Market (by Hematological Malignancy), $Million, 2021 vs. 2027
Figure 7:    Global Minimal Residual Disease Testing Market (by Technology), $Million, 2021 vs. 2027
Figure 8:    Global Minimal Residual Disease Testing Market (by End User), $Million, 2021 vs. 2027
Figure 9:    Global Minimal Residual Disease Testing Market Snapshot
Figure 10:    Global MRD Testing Market Segments
Figure 11:    Global MRD Testing Market: Methodology
Figure 12:    Primary Research Methodology
Figure 13:    Bottom-Up Approach (Segment-Wise Analysis)
Figure 14:    Top-Down Approach (Segment-Wise Analysis)
Figure 15:    Global MRD Testing Market, $Million, 2021-2027
Figure 16:    Global MRD Testing Market Potential, $Million, 2021-2027
Figure 17:    Global Incidence and Mortality Rate for Individual Hematological Conditions, 2020
Figure 18:    Global Incidence of Leukemia (by Region), 2020
Figure 19:    Incidence of Hematological Malignancies in the U.S. (by Type), 2021
Figure 20:    New Cases of Hematological Cancer in the U.S. (by Sex), 2021
Figure 21:    Biomarker Evaluation and Evidentiary Considerations
Figure 22:    Regulatory Submissions for the Use of Minimal Residual Disease as a Biomarker
Figure 23:    Laboratory Methods for MRD Detection
Figure 24:    Classification of In-Vitro Diagnostics in India
Figure 25:    Methods to Achieve Coverage
Figure 26:    Supply Chain Analysis of Laboratory Developed Tests
Figure 27:    Supply Chain Analysis of In-Vitro Diagnostics
Figure 28:    Share of Key Developments and Strategies, January 2018-May 2022
Figure 29:    Synergistic Activities Share (by Company), January 2018-May 2022
Figure 30:    Product Approvals Share (by Company), January 2018-May 2022
Figure 31:    Product Launches and Updates Share (by Company), January 2018-May 2022
Figure 32:    Merger and Acquisition Activities Share (by Company), January 2018-May 2022
Figure 33:    Business Expansion and Funding Activities Share (by Company), January 2018-May 2022
Figure 34:    Market Share Analysis for Global MRD Testing Market, 2020 and 2021
Figure 35:    Growth-Share Analysis for Global MRD Testing Market (by Company), 2019
Figure 36:    Growth-Share Analysis for Global MRD Testing Market (by Technology), 2021-2027
Figure 37:    Growth-Share Analysis for Global MRD Testing Market (by Application), 2021-2027
Figure 38:    Growth-Share Analysis for Global MRD Testing Market (by End User), 2021-2027
Figure 39:    Treatment Stage for MRD Testing
Figure 40:    Average Number of MRD Tests Per Patient Per Year
Figure 41:    Average Treatment Duration
Figure 42:    Perceived Importance of Key Drivers to Improve MRD Testing Adoption
Figure 43:    Agreement Level with Key Barriers to MRD Testing Adoption
Figure 44:    Reimbursement Scenario with respect to MRD Testing
Figure 45:    Price vs. Sensitivity vs. Turnaround Time
Figure 46:    Global Minimal Residual Disease Testing Market (by Technology), $Million, 2021-2027
Figure 47:    Global Minimal Residual Disease Testing Market (Flow Cytometry), $Million, 2021-2027
Figure 48:    Global Minimal Residual Disease Testing Market (Flow Cytometry), Thousand Units, 2021-2027
Figure 49:    Global Minimal Residual Disease Testing Market (PCR), $Million, 2021-2027
Figure 50:    Global Minimal Residual Disease Testing Market (PCR), Thousand Units, 2021-2027
Figure 51:    Global Minimal Residual Disease Testing Market (NGS), $Million, 2021-2027
Figure 52:    Global Minimal Residual Disease Testing Market (by NGS), Thousand Units, 2021-2027
Figure 53:    Global Minimal Residual Disease Testing Market (Other Technologies), $Million, 2021-2027
Figure 54:    Global Minimal Residual Disease Testing Market (Other Technologies), Thousand Units, 2021-2027
Figure 55:    Global MRD Testing Market (by Application)
Figure 56:    Global MRD Testing Market (by Application), 2021-2027
Figure 57:    Global MRD Testing Market (by Hematological Malignancy), 2021 vs. 2027
Figure 58:    Global Minimal Residual Disease Testing Market (Non-Hodgkin’s Lymphoma), $Million, 2021-2027
Figure 59:    Global Minimal Residual Disease Testing Market (by Non-Hodgkin’s Lymphoma Type), $Million, 2021 vs. 2027
Figure 60:    Global NHL MRD Testing Market (by Age), $Million, 2021 vs. 2027
Figure 61:    Global Minimal Residual Disease Testing Market (Multiple Myeloma), $Million, 2021-2027
Figure 62:    Global MM MRD Testing Market (by Age), $Million, 2021 vs. 2027
Figure 63:    Global Minimal Residual Disease Testing Market (Acute Lymphoblastic Leukemia), $Million, 2021-2027
Figure 64:    Global ALL MRD Testing Market (by Age), $Million, 2021 vs. 2027
Figure 65:    Global Minimal Residual Disease Testing Market (Chronic Lymphocytic Leukemia), $Million, 2021-2027
Figure 66:    Global CLL MRD Testing Market (by Age), $Million, 2021 vs. 2027
Figure 67:    Global Minimal Residual Disease Testing Market (Acute Myeloid Leukemia), $Million, 2021-2027
Figure 68:    Global AML MRD Testing Market (by Age), $Million, 2021 vs. 2027
Figure 69:    Global Minimal Residual Disease Testing Market (Chronic Myeloid Leukemia), $Million, 2021-2027
Figure 70:    Global CML MRD Testing Market (by Age), $Million, 2021 vs. 2027
Figure 71:    Global Minimal Residual Disease Testing Market (Hodgkin’s Lymphoma), $Million, 2021-2027
Figure 72:    Global HL MRD Testing Market (by Age), $Million, 2021 vs. 2027
Figure 73:    Global Minimal Residual Disease Testing Market (Other Leukemia), $Million, 2021-2027
Figure 74:    Global Minimal Residual Disease Testing Market (by End User), $Million, 2021-2027
Figure 75:    Global Minimal Residual Disease Testing Market (Hospitals and Specialty Clinics), $Million, 2021-2027
Figure 76:    Global Minimal Residual Disease Testing Market (Hospitals and Specialty Clinics), Thousand Units, 2021-2027
Figure 77:    Global Minimal Residual Disease Testing Market (Hospitals and Specialty Clinics) (by Technology), $Million, 2021 vs. 2027
Figure 78:    Global Minimal Residual Disease Testing Market (Hospitals and Specialty Clinics) (by Technology), Thousand Units, 2021 vs. 2027
Figure 79:    Global Minimal Residual Disease Testing Market (Diagnostic Laboratories), $Million, 2021-2027
Figure 80:    Global Minimal Residual Disease Testing Market (Diagnostic Laboratories), Thousand Units, 2021-2027
Figure 81:    Global Minimal Residual Disease Testing Market (Diagnostic Laboratories) (by Technology), $Million, 2021 vs. 2027
Figure 82:    Global Minimal Residual Disease Testing Market (Diagnostic Laboratories) (by Technology), Thousand Units, 2021 vs. 2027
Figure 83:    Global Minimal Residual Disease Testing Market (Research Institutions), $Million, 2021-2027
Figure 84:    Global Minimal Residual Disease Testing Market (Research Institutions), Thousand Units, 2021-2027
Figure 85:    Global Minimal Residual Disease Testing Market (Research Institutions) (by Technology), $Million, 2021 vs. 2027
Figure 86:    Global Minimal Residual Disease Testing Market (Research Institutions) (by Technology), Thousand Units, 2021 vs. 2027
Figure 87:    Global Minimal Residual Disease Testing Market (Other End Users), $Million, 2021-2027
Figure 88:    Global Minimal Residual Disease Testing Market (Other End Users), Thousand Units, 2021-2027
Figure 89:    Global Minimal Residual Disease Testing Market (Other End Users) (by Technology), $Million, 2021 vs.2027
Figure 90:    Global Minimal Residual Disease Testing Market (Other End Users) (by Technology), Thousand Units, 2021 vs. 2027
Figure 91:    Global Minimal Residual Disease Testing Market (by Region), $Million,  2021 and 2027
Figure 92:    North America: Market Dynamics
Figure 93:    North America Minimal Residual Disease Testing Market, $Million,  2021-2027
Figure 94:    North America Minimal Residual Disease Testing Market (by Country), $Million, 2021 vs. 2027
Figure 95:    U.S. Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 96:    U.S. Minimal Residual Disease Testing Market (by Application), $Million,  2021-2027
Figure 97:    U.S. Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 98:    Growth-Share Analysis for the U.S. Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 99:    Canada Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 100:    Canada Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 101:    Canada Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 102:    Growth-Share Analysis for Canada Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 103:    Europe: Market Dynamics
Figure 104:    Europe Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 105:    Europe Minimal Residual Disease Testing Market (by Country), $Million,  2021 vs. 2027
Figure 106:    Germany Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 107:    Germany Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 108:    Germany Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 109:    Growth-Share Analysis for Germany Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 110:    Italy Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 111:    Italy Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 112:    Italy Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 113:    Growth-Share Analysis for Italy Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 114:    France Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 115:    France Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 116:    France Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 117:    Growth-Share Analysis for France Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 118:    U.K. Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 119:    U.K. Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 120:    U.K. Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 121:    Growth-Share Analysis for the U.K. Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 122:    Spain Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 123:    Spain Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 124:    Spain Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 125:    Growth-Share Analysis for Spain Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 126:    Rest-of-Europe Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 127:    Rest-of-Europe Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 128:    Rest-of-Europe Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 129:    Growth-Share Analysis for Rest-of-Europe Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 130:    Asia-Pacific: Market Dynamics
Figure 131:    Asia-Pacific Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 132:    Asia-Pacific Minimal Residual Disease Testing Market (by Country), $Million, 2019 vs. 2027
Figure 133:    China Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 134:    China Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 135:    China Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 136:    Growth-Share Analysis for China Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 137:    India Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 138:    India Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 139:    India Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 140:    Growth-Share Analysis for India Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 141:    Japan Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 142:    Japan Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 143:    Japan Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 144:    Growth-Share Analysis for Japan Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 145:    South Korea Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 146:    South Korea Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 147:    South Korea Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 148:    Growth Share Analysis for South Korea MRD Testing Market (by Application), 2021-2027
Figure 149:    Australia Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 150:    Australia Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 151:    Australia Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 152:    Growth-Share Analysis for Australia Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 153:    Singapore Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 154:    Singapore Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 155:    Singapore Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 156:    Growth-Share Analysis for Singapore Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 157:    Rest-of-APAC Minimal Residual Disease Testing Market, $Million,  2021-2027
Figure 158:    Rest-of-APAC Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 159:    Rest-of-APAC Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 160:    Growth-Share Analysis for Rest-of-APAC Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 161:    Latin America: Market Dynamics
Figure 162:    Latin America and Middle East Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 163:    Latin America and Middle East Minimal Residual Disease Testing Market (by Country), $Million, 2021 vs. 2027
Figure 164:    Brazil Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 165:    Brazil Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 166:    Brazil Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 167:    Growth-Share Analysis for Brazil Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 168:    Mexico Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 169:    Mexico Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 170:    Mexico Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 171:    Growth-Share Analysis for Mexico Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 172:    Saudi Arabia Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 173:    Saudi Arabia Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 174:    Saudi Arabia Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 175:    Growth-Share Analysis for Saudi Arabia Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 176:    Rest-of-Latin America and Middle East Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 177:    Rest-of-Latin America and Middle East Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 178:    Rest-of-Latin America and Middle East Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 179:    Growth-Share Analysis for Rest-of-Latin America and Middle East Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 180:    Rest-of-the-World Minimal Residual Disease Testing Market, $Million, 2021-2027
Figure 181:    Rest-of-the-World Minimal Residual Disease Testing Market (by Application), $Million, 2021-2027
Figure 182:    Rest-of-the-World Minimal Residual Disease Testing Market (by Hematological Malignancy), $Million, 2021-2027
Figure 183:    Growth-Share Analysis for Rest-of-the-World Minimal Residual Disease Testing Market (by Application), 2021-2027
Figure 184:    Total Number of Companies Profiled
Figure 185:    ICON plc: Overall Product Portfolio
Figure 186:    ICON plc: Overall Financials, $Million, 2019-2021
Figure 187:    ICON plc: Revenue (by Region), $Million, 2019-2021
Figure 188:    ARUP Laboratories: Product Portfolio
Figure 189:    Cergentis B.V.: Product Portfolio
Figure 190:    Bio-Rad Laboratories, Inc.: Product Portfolio
Figure 191:    Bio-Rad Laboratories, Inc.: Overall Financials, $Million, 2019-2021
Figure 192:    Bio-Rad Laboratories, Inc.: Revenue (by Segment), $Million, 2019-2021
Figure 193:    Bio-Rad Laboratories, Inc.: Revenue (by Region), $Million, 2019-2021
Figure 194:    Bio-Rad Laboratories, Inc.: R&D Expenditure, $Million, 2019-2021
Figure 195:    Mission Bio, Inc.: Product Portfolio
Figure 196:    Guardant Health: Portfolio
Figure 197:    Guardant Health: Overall Financials, $Million, 2019-2021
Figure 198:    Guardant Health: Revenue (by Segment), $Million, 2019-2021
Figure 199:    Guardant Health: Revenue (by Region), $Million, 2019-2021
Figure 200:    Guardant Health: R&D Expenditure, $Million, 2019-2021
Figure 201:    Invivoscribe, Inc.: Product Portfolio
Figure 202:    Laboratory Corporation of America Holdings: Product Portfolio
Figure 203:    Laboratory Corporation of America Holdings: Overall Financials, $Million, 2019-2021
Figure 204:    Laboratory Corporation of America Holdings: Revenue (by Segment), $Million, 2019-2021
Figure 205:    Laboratory Corporation of America Holdings: Revenue (by Region), $Million, 2019-2021
Figure 206:    Natera, Inc.: Portfolio
Figure 207:    Natera, Inc.: Overall Financials, $Million, 2019-2021
Figure 208:    Natera, Inc.: Revenue (by Segment), $Million, 2019-2021
Figure 209:    Natera, Inc.: Sales (by Region), $Million, 2019-2021
Figure 210:    Natera, Inc.: R&D Expenditure, $Million, 2019-2021
Figure 211:    NeoGenomics Laboratories, Inc.: Portfolio
Figure 212:    NeoGenomics Laboratories, Inc.: Overall Financials, $Million, 2019-2021
Figure 213:    NeoGenomics Laboratories, Inc.: Revenue (by Segment), $Million, 2019-2021
Figure 214:    NeoGenomics Laboratories, Inc.: R&D Expenditure, $Million, 2019-2021
Figure 215:    Opko Health: Portfolio
Figure 216:    Opko Health, Inc.: Overall Financials, $Million, 2019-2021
Figure 217:    Opko Health, Inc.: Revenue (by Segment), $Million, 2019-2021
Figure 218:    Opko Health, Inc.: R&D Expenditure, $Million, 2019-2021
Figure 219:    Quest Diagnostics Incorporated: Product Portfolio
Figure 220:    Quest Diagnostics Incorporated: Overall Financials, $Million, 2019-2021
Figure 221:    Quest Diagnostics Incorporated: Revenue (by Segment), $Million, 2019-2021
Figure 222:    Sysmex Corporation: Product Portfolio
Figure 223:    Sysmex Corporation: Overall Financials, $Million, 2019-2021
Figure 224:    Sysmex Corporation: Revenue (by Business Segment), $Million, 2019-2021
Figure 225:    Sysmex Corporation: Revenue (by Region), $Million, 2019-2021
Figure 226:    Sysmex Corporation R&D Expenditure, $Million, 2019-2021
Figure 227:    Adaptive Biotechnologies Corporation: Product Portfolio
Figure 228:    Adaptive Biotechnologies Corporation: Overall Financials, $Million, 2019-2021
Figure 229:    Adaptive Biotechnologies Corporation: Revenue (by Business Segment), $Million, 2019-2021
Figure 230:    Adaptive Biotechnologies Corporation R&D Expenditure, $Million, 2019-2021
Figure 231:    F. Hoffmann-La Roche Ltd: Portfolio
Figure 232:    F. Hoffmann-La Roche Ltd: Overall Financials, $Million, 2019-2021
Figure 233:    F. Hoffmann-La Roche Ltd: Revenue (by Segment), $Million, 2019-2021
Figure 234:    F. Hoffmann-La Roche Ltd: Revenue (by Region), $Million, 2019-2021
Figure 235:    F. Hoffmann-La Roche Ltd: R&D Expenditure, $Million, 2019-2021

Market Report Coverage

MRD Testing Market

Base Year

2021

Market Size in 2021

$1,089.3 Million

Forecast Period

2022-2027

Value Projection and Estimation by 2027

$2,611.2 Million

CAGR During Forecast Period

14.53%

Number of Tables

15

Number of Pages

281

Number of Figures

235

 

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.

Minimal Residual Disease Testing Market

Public companies include ICON plc, Bio-Rad Laboratories, Inc., Adaptive Biotechnologies Corporation, Sysmex Corporation, Quest Diagnostics Incorporated, Opko Health, Inc., NeoGenomics Laboratories, Inc., Natera, Inc., Laboratory Corporation of America Holdings, F. Hoffmann-La Roche, and Guardant Health. The private company profiled are ARUP Laboratories, Cergentis B.V., Invivoscribe, Inc., and Mission Bio, Inc.

How can this report add value to an organization?

Technology/Innovation Strategy: The technology segment helps the reader understand the different technology based on MRD testing present in the market. Moreover, the study provides the reader with a detailed understanding of two different applications including hematologic malignancy and solid tumor.

Growth/Marketing Strategy: The global MRD testing market has seen major development by key players operating in the market, such as synergistic activities, product approvals, product launches and updates, mergers and acquisitions, business expansion and funding, and other developments (Medicare coverage). The favored strategy for the companies has been regulatory and legal activities along with product approvals to strengthen their position in the market.

Competitive Strategy: Key players in the global MRD testing market have been analyzed and profiled in the study. Moreover, a detailed competitive benchmarking of players operating in the global MRD testing market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Industry & Technology Overview

Global MRD Testing Market: Industry Overview

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.

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.

Figure: Global MRD Testing Market

MRD Testing Market

Source: BIS Research Analysis

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.

Market Segmentation

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    U.S.
        o    Canada
•    Europe
        o    Germany
        o    Italy
        o    France
        o    U.K.
        o    Spain
        o    Rest-of-Europe
•    Asia-Pacific
        o    China 
        o    India
        o    Japan
        o    South Korea
        o    Australia
        o    Singapore
        o    Rest-of-APAC (RoAPAC)
•    Latin America and Middle East
        o    Brazil
        o    Mexico
        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.

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

Analyst Thoughts

According to Vaishali Chauhan, Research Analyst, BIS Research, “The global MRD testing market is in a dynamic stage. The NGS technology used in the detection of MRD is novel with high sensitivity, which will lead to immense scope in the testing market. This opens ample opportunities which will reduce the cost of NGS technology for MRD detection. Although most diagnostic products for the testing of MRD include clonoSEQ, QXDx BCR-ABL %IS Kit, Oncomine BCR IGH SR Assay, DNA, and AVENIO ctDNA Surveillance Kits; there is a massive need for more testing products that are extremely sensitive, specific, and cost-effective, and not limited to research used but available on a commercial scale.”

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