Table of Content


Executive Summary

1 Markets
1.1 Product Definition
1.2 Inclusion and Exclusion Criteria
1.3 Market Scope
1.3.1 Scope of the Study
1.3.2 Key Questions Answered in the Report
1.4 Research Methodology
1.4.1 Global MRD Testing Market: Research Methodology
1.4.2 Data Sources
1.4.2.1 Primary Data Sources
1.4.2.2 Secondary Data Sources
1.5 Market Estimation Model
1.5.1 Criteria for Company Profiling

2 Market Overview
2.1 MRD Testing Workflow Analysis
2.2 MRD Testing: Solid Tumor vs. Hematological Malignancy
2.3 Evolution of MRD Testing
2.4 Market Footprint
2.5 Market Size and Future Growth Potential

3 Industry Insights
3.1 Legal and Regulatory Framework of MRD Tests
3.1.1 U.S.
3.1.2 Europe
3.1.3 Asia-Pacific
3.1.3.1 Japan
3.1.3.2 China
3.1.3.3 India
3.2 Reimbursement Scenario
3.2.1 North America
3.2.2 European Union
3.2.3 Asia-Pacific
3.3 Supply Chain Analysis
3.3.1 For Laboratory Developed Tests (LDTs)
3.3.2 For In-Vitro Diagnostics (IVDs)

4 Market Dynamics
4.1 Overview
4.2 Market Drivers
4.2.1 Advent of MRD Testing and its Awareness among Consumers
4.2.2 Increasing Incidence of Cancer Cases Demanding MRD Testing
4.2.3 Rise in Administration of Solid Tumor Diagnosis in MRD Testing Ecosystem
4.2.4 Expanding Medicare Coverage for MRD Testing
4.3 Market Challenges
4.3.1 Early-Risk of Progression and Relapse due to MRD Negative Results
4.3.2 Substantially High Cost of MRD Testing
4.4 Market Opportunities
4.4.1 Advancements in the Development of Companion Diagnostics
4.4.2 Rising Number of Clinical Trials in Prolonged MRD-Negative Treatment Decisions

5 Competitive Insights
5.1 Overview
5.2 Key Strategies and Developments
5.2.1 Synergistic Activities
5.2.2 Product Launches, Upgradations, and Approvals
5.2.3 Business Expansion
5.2.4 Mergers and Acquisitions
5.2.5 Funding and Other Activities
5.3 Company Share Analysis
5.4 Growth Share Analysis

6 Global Minimal Residual Testing Market (by Technology), 2022-2033
6.1 Overview
6.2 Flow Cytometry
6.3 Polymerase Chain Reaction (PCR)
6.4 Next-Generation Sequencing (NGS)
6.5 Other Technologies

7 Global Minimal Residual Testing Market (by Target Detection), 2022-2033
7.1 Overview
7.2 Leukemia
7.2.1 Multiple Myeloma
7.2.2 Acute Lymphoblastic Leukemia
7.2.3 Chronic Lymphocytic Leukemia
7.2.4 Acute Myeloid Leukemia
7.2.5 Chronic Myeloid Leukemia
7.2.6 Other Leukemia
7.3 Lymphoma
7.3.1 Non-Hodgkin’s Lymphoma
7.3.2 Hodgkin’s Lymphoma
7.4 Solid Tumor
7.4.1 Colorectal Cancer
7.4.2 Breast Cancer
7.4.3 Lung Cancer
7.4.4 Other Cancer

8 Global Minimal Residual Disease Testing Market (by End User), 2022-2033
8.1 Overview
8.2 Hospitals and Specialty Clinics
8.3 Diagnostic Laboratories
8.4 Research Institutions
8.5 Others

9 Global Minimal Residual Disease Testing Market (by Region), 2022-2033
9.1 Overview
9.2 North America
9.2.1 North America MRD Testing Market, by End User
9.2.2 North America MRD Testing Market, by Country
9.2.2.1 U.S.
9.2.2.2 Canada
9.3 Europe
9.3.1 Europe MRD Testing Market, by End User
9.3.2 Europe MRD Testing Market, by Country
9.3.2.1 Germany
9.3.2.2 France
9.3.2.3 U.K.
9.3.2.4 Italy
9.3.2.5 Spain
9.3.2.6 Rest-of-Europe
9.4 Asia-Pacific
9.4.1 Asia-Pacific MRD Testing Market, by End User
9.4.2 Asia-Pacific MRD Testing Market, by Country
9.4.2.1 China
9.4.2.2 India
9.4.2.3 Japan
9.4.2.4 South Korea
9.4.2.5 Australia
9.4.2.6 Singapore
9.4.2.7 Rest-of-Asia-Pacific
9.5 Latin America and Middle East
9.5.1 Latin America and Middle East MRD Testing Market, by End User
9.5.2 Latin America and Middle East MRD Testing Market, by Country
9.5.2.1 Brazil
9.5.2.2 Mexico
9.5.2.3 Saudi Arabia
9.5.2.4 Rest-of-Latin America (RoLATAM) and Middle East
9.6 Rest-of-the-World (RoW)
9.6.1 Rest-of-the-World MRD Testing Market, by End User

10 Company Profiles
10.1 Overview
10.2 MRD Testing Ecosystem Active Players
10.3 Adaptive Biotechnologies
10.3.1 Company Overview
10.3.2 Role of Adaptive Biotechnologies in the Global MRD Testing Market
10.3.3 Financials
10.3.4 Recent Developments
10.3.5 Analyst Perspective
10.4 ARUP Laboratories
10.4.1 Company Overview
10.4.2 Role of ARUP Laboratories in the Global MRD Testing Market
10.4.3 Recent Developments
10.4.4 Analyst Perspective
10.5 Bio-Rad Laboratories, Inc.
10.5.1 Company Overview
10.5.2 Role of Bio-Rad Laboratories, Inc. in the Global MRD Testing Market
10.5.3 Financials
10.5.4 Recent Developments
10.5.5 Analyst Perspective
10.6 Cergentis B.V.
10.6.1 Company Overview
10.6.2 Role of Cergentis B.V. in the Global MRD Testing Market
10.6.3 Analyst Perspective
10.7 F. Hoffmann-La Roche Ltd
10.7.1 Company Overview
10.7.2 Role of F. Hoffmann-La Roche Ltd in the Global MRD Testing Market
10.7.3 Financials
10.7.4 Recent Developments
10.7.5 Analyst Perspective
10.8 Guardant Health, Inc.
10.8.1 Company Overview
10.8.2 Role of Guardant Health, Inc. in the Global MRD Testing Market
10.8.3 Financials
10.8.4 Recent Developments
10.8.5 Analyst Perspective
10.9 Invivoscribe, Inc.
10.9.1 Company Overview
10.9.2 Role of Invivoscribe, Inc. in the Global MRD Testing Market
10.9.3 Analyst Perspective
10.10 Laboratory Corporation of America Holdings
10.10.1 Company Overview
10.10.2 Role of Laboratory Corporation of America Holdings in the Global MRD Testing Market
10.10.3 Financials
10.10.4 Recent Developments
10.10.5 Analyst Perspective
10.11 Mission Bio, Inc.
10.11.1 Company Overview
10.11.2 Role of Mission Bio, Inc. in the Global Minimal Residual Disease Testing Market
10.11.3 Recent Developments
10.11.4 Analyst Perspective
10.12 ICON plc
10.12.1 Company Overview
10.12.2 Role of ICON plc in the Global MRD Testing Market
10.12.3 Financials
10.12.4 Analyst Perspective
10.13 Natera, Inc.
10.13.1 Company Overview
10.13.2 Role of Natera, Inc. in the Global MRD Testing Market
10.13.3 Financials
10.13.4 Recent Developments
10.13.5 Analyst Perspective
10.14 NeoGenomics Laboratories, Inc.
10.14.1 Company Overview
10.14.2 Role of NeoGenomics Laboratories, Inc. in the Global MRD Testing Market
10.14.3 Financials
10.14.4 Recent Developments
10.14.5 Analyst Perspective
10.15 OPKO Health, Inc.
10.15.1 Company Overview
10.15.2 Role of OPKO Health, Inc. in the Global MRD Testing Market
10.15.3 Financials
10.15.4 Recent Developments
10.15.5 Analyst Perspective
10.16 Quest Diagnostics Incorporated
10.16.1 Company Overview
10.16.2 Role of Quest Diagnostics Incorporated in the Global MRD Testing Market
10.16.3 Financials
10.16.4 Recent Developments
10.16.5 Analyst Perspective
10.17 Sysmex Corporation
10.17.1 Company Overview
10.17.2 Role of Sysmex Corporation in the Global MRD Testing Market
10.17.3 Financials
10.17.4 Analyst Perspective
List of Figures
Figure 1: Global MRD Testing Market, $Billion, 2022 and 2033
Figure 2: Share of Global MRD Testing Market (by Technology), $Billion, 2022 and 2033
Figure 3: Share of Global MRD Testing Market (by Target Detection), $Billion, 2022 and 2033
Figure 4: Share of Global MRD Testing Market (by End User), $Billion, 2022 and 2033
Figure 5: Share of Global MRD Testing Market (by Region), 2022
Figure 6: Global MRD Testing Market Segmentation
Figure 7: Global MRD Testing Market: Research Methodology
Figure 8: Primary Research Methodology
Figure 9: Bottom-Up Approach (Segment-Wise Analysis)
Figure 10: Top-Down Approach (Segment-Wise Analysis)
Figure 11: MRD Testing Workflow
Figure 12: Evolution of the MRD Testing Market
Figure 13: Global MRD Testing Market Potential, $Billion, 2022-2033
Figure 14: Biomarker Evaluation and Evidentiary Considerations
Figure 15: Regulatory Submissions for the Use of Minimal Residual Disease as a Biomarker
Figure 16: Laboratory Methods for MRD Detection
Figure 17: Methods to Achieve Coverage
Figure 18: Supply Chain Analysis of Laboratory-Developed Tests
Figure 19: Supply Chain Analysis of In-Vitro Diagnostics
Figure 20: Global MRD Testing Market Dynamics
Figure 21: Growth of MRD Solutions Showcasing Increasing Number of Tests
Figure 22: Estimated New Cancer Cases and Deaths in the U.S., 2022
Figure 23: Patents Related to Companion Diagnostics Products Involved in MRD Testing, 2019-2023
Figure 24: Clinical Trials Undertaken by Adaptive Biotechnologies for MRD Testing, 2022
Figure 25: Share of Key Developments and Strategies, January 2020-January 2024
Figure 26: Share of Synergistic Activities (by Company), January 2020-January 2024
Figure 27: Share of Product Launches and Product Approvals (by Company), January 2020-January 2024
Figure 28: Share of Business Expansion (by Company), January 2020-January 2024
Figure 29: Merger and Acquisition (by Company), January 2020-January 2024
Figure 30: Share of Funding and Other Activities (by Company), January 2020-January 2024
Figure 31: Global MRD Testing Market, Company Share Analysis, 2022
Figure 32: Global MRD Testing Market, Growth Share Analysis, (by Technology), 2023-2033
Figure 33: Global MRD Testing Market (by Technology), $Billion, 2022-2033
Figure 34: Global MRD Testing Market (by Technology), Thousand Units, 2022-2033
Figure 35: MRD Detection by Multiparametric Flow Cytometry (MFC)
Figure 36: Global MRD Testing Market (Flow Cytometry), $Billion, 2022-2033
Figure 37: Global MRD Testing Market (Flow Cytometry), Thousand Units, 2022-2033
Figure 38: Global Minimal Residual Disease Testing Market (PCR), $Billion, 2022-2033
Figure 39: Global MRD Testing Market (PCR), Thousand Units, 2022-2033
Figure 40: Global MRD Testing Market (NGS), $Billion, 2022-2033
Figure 41: High-Throughput Sequencing Workflow for MRD Monitoring
Figure 42: Global MRD Testing Market (NGS), Thousand Units, 2022-2033
Figure 43: Global MRD Testing Market (Other Technologies), $Billion, 2022-2033
Figure 44: Global MRD Testing Market (Other Technologies), Thousand Units, 2022-2033
Figure 45: Global MRD Testing Market (by Target Detection)
Figure 46: Global MRD Testing Market (by Target Detection), $Billion, 2022-2033
Figure 47: Global MRD Testing Market (by Target Detection), $Billion, 2022-2033
Figure 48: Global MRD Testing Market (by Target Detection), Thousand Units, 2022-2033
Figure 49: Global MRD Testing Market (Leukemia), $Billion, 2022-2033
Figure 50: Global MRD Testing Market (Multiple Myeloma), $Million, 2022-2033
Figure 51: Global MRD Testing Market (Acute Lymphoblastic Leukemia), $Million, 2022-2033
Figure 52: Global MRD Testing Market (Chronic Lymphoblastic Leukemia), $Million, 2022-2033
Figure 53: Global MRD Testing Market (Acute Myeloid Leukemia), $Million, 2022-2033
Figure 54: Global MRD Testing Market (Chronic Myeloid Leukemia), $Million, 2022-2033
Figure 55: Global MRD Testing Market (Other Leukemia), $Million, 2022-2033
Figure 56: Global MRD Testing Market (Lymphoma), $Billion, 2022-2033
Figure 57: Global MRD Testing Market (Non-Hodgkin’s Lymphoma), $Million, 2022-2033
Figure 58: Global MRD Testing Market (HL), $Million, 2022-2033
Figure 59: Global MRD Testing Market (Solid Tumor), $Billion, 2022-2033
Figure 60: Global MRD Testing Market (Solid Tumor), Thousand Units, 2022-2033
Figure 61: Global MRD Testing Market (Colorectal Cancer), $Million, 2022-2033
Figure 62: Global MRD Testing Market (Breast Cancer), $Million, 2022-2033
Figure 63: Global MRD Testing Market (Lung Cancer), $Million, 2022-2033
Figure 64: Global MRD Testing Market (Other Cancer), $Million, 2022-2033
Figure 65: Global MRD Testing Market (by End User), $Billion, 2022-2033
Figure 66: Global MRD Testing Market (by End User), Thousand Units, 2022-2033
Figure 67: Global MRD Testing Market (Hospitals and Specialty Clinics), $Billion, 2022-2033
Figure 68: Global MRD Testing Market (Hospitals and Specialty Clinics), Thousand Units, 2022-2033
Figure 69: Global MRD Testing Market (Diagnostic Laboratories), $Billion, 2022-2033
Figure 70: Global MRD Testing Market (Diagnostic Laboratories), Thousand Units, 2022-2033
Figure 71: Global MRD Testing Market (Research Institutions), $Billion, 2022-2033
Figure 72: Global MRD Testing Market (Research Institutions), Thousand Units, 2022-2033
Figure 73: Global MRD Testing Market (Others), $Billion, 2022-2033
Figure 74: Global MRD Testing Market (Others), Thousand Units, 2022-2033
Figure 75: Global MRD Testing Market Snapshot (by Region)
Figure 76: Global MRD Testing Market (by Region), Thousand Units, 2022-2033
Figure 77: North America MRD Testing Market, $Billion, 2023-2033
Figure 78: North America: Market Dynamics
Figure 79: North America MRD Testing Market (by End User), $Million, 2022-2033
Figure 80: North America MRD Testing Market (by Country), $Million, 2022-2033
Figure 81: U.S. MRD Testing Market, $Million, 2022-2033
Figure 82: Canada MRD Testing Market, $Million, 2022-2033
Figure 83: Europe MRD Testing Market, $Billion, 2022-2033
Figure 84: Europe: Market Dynamics
Figure 85: Europe MRD Testing Market (by End User), $Million, 2022-2033
Figure 86: Europe MRD Testing Market (by Country), $Million, 2022-2033
Figure 87: Germany MRD Testing Market, $Million, 2022-2033
Figure 88: France MRD Testing Market, $Million, 2022-2033
Figure 89: U.K. MRD Testing Market, $Million, 2022-2033
Figure 90: Italy MRD Testing Market, $Million, 2022-2033
Figure 91: Spain MRD Testing Market, $Million, 2022-2033
Figure 92: Rest-of-Europe MRD Testing Market, $Million, 2022-2033
Figure 93: Asia-Pacific: Market Dynamics
Figure 94: Asia-Pacific MRD Testing Market, $Billion, 2022-2033
Figure 95: Asia-Pacific MRD Testing Market (by End User), $Million, 2022-2033
Figure 96: Asia-Pacific MRD Testing Market (by Country), $Million, 2022-2033
Figure 97: China MRD Testing Market, $Million, 2022-2033
Figure 98: India MRD Testing Market, $Million, 2022-2033
Figure 99: Japan MRD Testing Market, $Million, 2022-2033
Figure 100: South Korea MRD Testing Market, $Million, 2022-2033
Figure 101: Australia MRD Testing Market, $Million, 2022-2033
Figure 102: Singapore MRD Testing Market, $Million, 2022-2033
Figure 103: Rest-of-Asia-Pacific MRD Testing Market, $Million, 2022-2033
Figure 104: Latin America: Market Dynamics
Figure 105: Latin-America and Middle East MRD Testing Market, $Billion, 2022-2033
Figure 106: Latin America and Middle East MRD Testing Market (by End User), $Million, 2022-2033
Figure 107: Latin America and Middle East MRD Testing Market (by Country), $Million, 2022-2033
Figure 108: Brazil MRD Testing Market, $Million, 2022-2033
Figure 109: Mexico MRD Testing Market, $Million, 2022-2033
Figure 110: Saudi Arabia MRD Testing Market, $Million, 2022-2033
Figure 111: Rest-of-Latin America and Middle East MRD Testing Market, $Million, 2022-2033
Figure 112: Rest-of-the-World MRD Testing Market, $Billion, 2022-2033
Figure 113: Rest-of-the-World MRD Testing Market (by End User), $Million, 2022-2033
Figure 114: Global MRD Testing Market, Total Number of Companies Profiled
Figure 115: Adaptive Biotechnologies: Product Portfolio
Figure 116: Adaptive Biotechnologies: Overall Financials, $Million, 2020-2022
Figure 117: Adaptive Biotechnologies: R&D Expenditure, $Million, 2020-2022
Figure 118: ARUP Laboratories: Product Portfolio
Figure 119: Bio-Rad Laboratories, Inc.: Product Portfolio
Figure 120: Bio-Rad Laboratories, Inc.: Overall Financials, $Million, 2020-2022
Figure 121: Bio-Rad Laboratories, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 122: Cergentis B.V.: Product Portfolio
Figure 123: F. Hoffmann-La Roche Ltd: Product Portfolio
Figure 124: F. Hoffmann-La Roche Ltd: Overall Financials, 2020-2022
Figure 125: F. Hoffmann-La Roche Ltd: R&D Expenditure, 2020-2022
Figure 126: Guardant Health, Inc.: Product Portfolio
Figure 127: Guardant Health, Inc.: Overall Financials, $Million, 2020-2022
Figure 128: Guardant Health, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 129: Invivoscribe, Inc.: Product Portfolio
Figure 130: Laboratory Corporation of America Holdings.: Product Portfolio
Figure 131: Laboratory Corporation of America Holdings.: Overall Financials, $Million, 2020-2022
Figure 132: Mission Bio, Inc.: Product Portfolio
Figure 133: ICON plc: Product Portfolio
Figure 134: ICON plc: Overall Financials, $Million, 2020-2022
Figure 135: Natera, Inc.: Portfolio
Figure 136: Natera, Inc.: Overall Financials, $Million, 2020-2022
Figure 137: Natera, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 138: NeoGenomics Laboratories, Inc.: Portfolio
Figure 139: NeoGenomics Laboratories, Inc.: Overall Financials, $Million, 2020-2022
Figure 140: NeoGenomics Laboratories, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 141: OPKO Health, Inc.: Product Portfolio
Figure 142: OPKO Health, Inc.: Overall Financials, $Million, 2020-2022
Figure 143: OPKO Health, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 144: Quest Diagnostics Incorporated.: Product Portfolio
Figure 145: Quest Diagnostics Incorporated: Overall Financials, $Million, 2020-2022
Figure 146: Sysmex Corporation: Product Portfolio
Figure 147: Sysmex Corporation: Overall Financials, $Million, 2020-2022
Figure 148: Sysmex Corporation: R&D Expenditure, $Million, 2020-2022
List of Tables
Table 1: Impact Analysis of Market Drivers, Challenges, and Opportunities in the Global MRD Testing Market
Table 2: Comparison of Solid Tumor and Hematological Malignancy for MRD Testing
Table 3: Comparison of FDA and EMA Draft Guidance
Table 4: Registration Criteria for IVD Medical Devices as per CFDA
Table 5: Key Coverage Providers for Hematologic Malignancies Testing
Table 6: Products used for Solid Tumor MRD Diagnosis
Table 7: Expansion of Medicare Coverage for MRD Tests by Companies
Table 8: Classification of MRD Test Results by True Relapse State Without Further Treatment in 2019
Table 9: Average Price of MRD Testing
Table 10: Comparison of Different Methods for Minimal Residual Disease Testing
Table 11: Key Products Offered by Companies Based on Flow Cytometry
Table 12: Key Products Offered by the Companies Based on PCR
Table 13: Key Products Offered by Companies Based on NGS
Table 14: Ongoing Initiatives to Generate Evidence for MRD Test in AML Patients
Table 15: Molecular Techniques used for MRD Assessment in NHL Patients
Table 16: Few Examples of Facilities Conducting MRD Testing