A quick peek into the report
Table of Contents
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
2.1 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
3.1 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)
4.1 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
5.1 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
6.1 Overview
6.2 Flow Cytometry
6.3 Polymerase Chain Reaction (PCR)
6.4 Next-Generation Sequencing (NGS)
6.5 Other Technologies
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
8.1 Overview
8.2 Hospitals and Specialty Clinics
8.3 Diagnostic Laboratories
8.4 Research Institutions
8.5 Others
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
10.1 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
10.1 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
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
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
MRD Testing Market Report Coverage
|
MRD Testing Market |
|||
|
Base Year |
2022 |
Market Size in 2023 |
$1.67 Billion |
|
Forecast Period |
2023-2033 |
Value Projection and Estimation by 2033 |
$6.67 Billion |
|
CAGR During Forecast Period |
14.81% |
Number of Pages |
202 |
| Number of Tables | 16 |
Number of Figures |
148 |
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.
The top segment players leading in the market include 11 public companies that capture around 73.33% of the market share. On the other hand, there are four private players, including Invivoscribe, Inc. and Mission Bio, among others, which account for approximately 26.67% of the market presence.
Some prominent names established in this market are:
• Adaptive Biotechnologies
• Laboratory Corporation of America Holdings
• NeoGenomics Laboratories, Inc.
• Quest Diagnostics Incorporated
• QIAGEN N.V.
• Thermo Fisher Scientific, Inc.
• Sysmex Corporation
• Mission Bio, Inc.
• OPKO Health, Inc.
• Bio-Rad Laboratories, Inc.
• ICON plc
• F. Hoffmann-La Roche Ltd
• Invivoscribe, Inc.
• ARUP Laboratories
• Guardant Health, Inc.
How can this report add value to an organization?
Product/Innovation Strategy: The technology segment helps the reader understand the different types of technologies for currently available tests and their global potential. Moreover, the study provides the reader with a detailed understanding of the global MRD testing market based on end-user, technology, and target detection.
Growth/Marketing Strategy: The MRD testing market has seen major development by key players operating in the market, such as business expansions, partnerships, collaborations, and joint ventures. The favored strategy for the companies has been partnerships and collaborations to strengthen their position in the MRD testing market. For instance, in April 2023, Bio-Rad Laboratories enhanced the pace of measurable residual disease (MRD) research by engaging in over six partnerships with institutions and companies, utilizing their latest QX600 Droplet Digital PCR System.
Competitive Strategy: Key players analyzed and profiled in the MRD testing market study involve major residual testing-based companies and test manufacturers. Moreover, a detailed competitive benchmarking of the players operating in the 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.
Methodology
Key Considerations and Assumptions in Market Engineering and Validation
• Detailed secondary research has been done to ensure maximum coverage of manufacturers/suppliers operational in a country.
• Exact revenue information, up to a certain extent, has been extracted for each company from secondary sources and databases. Revenues specific to product/service/technology were then estimated for each market player based on fact-based proxy indicators as well as primary inputs.
• Based on the classification, the average selling price (ASP) has been calculated using the weighted average method.
• The currency conversion rate has been taken from the historical exchange rate of Oanda and/or other relevant websites.
• Any economic downturn in the future has not been taken into consideration for the market estimation and forecast.
• The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations, considering the average conversion rate for that particular year.
• The term “product” in this document may refer to “service” or “technology” as and where relevant.
• The term “manufacturers/suppliers” may refer to “service providers” or “technology providers” as and where relevant.
Primary Research
The key data points taken from the primary research include:
• Validation and triangulation of all the numbers and graphs
• Validation of the report’s segmentation and key qualitative findings
• Understanding of the numbers of the various markets for market type
• Percentage split of individual markets for regional analysis
Secondary Research
The key data points taken from the secondary research include:
• segmentations, split-ups, and percentage shares
• data for market value
• quantitative data for mathematical and statistical calculations
• key industry trends of the top players in the market
• qualitative insights into the market trends given in addition to emerging areas of innovation.
Market Introduction
Minimal residual disease (MRD) testing is a technique used to detect and quantify the small number of cancer cells that remain in a patient's body after treatment. It involves sensitive technologies such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and flow cytometry to identify residual disease at a molecular level. MRD testing is clinically important as it helps to monitor treatment response, predict relapse risk, guide personalized therapies, and serve as an endpoint in clinical trials. By identifying and addressing MRD, healthcare providers can strive for better treatment outcomes and improved patient survival rates.
The MRD testing market was valued at $1.67 billion in 2023 and is expected to reach $6.67 billion by 2033, growing at a CAGR of 14.81% between 2023 and 2033. The MRD testing market is driven by several factors, including the expansion in medicare coverage for MRD testing and the administration of solid tumor diagnosis. In recent years, as consumer awareness has grown, there has been an increasing demand for MRD testing. Healthcare providers and researchers are recognizing this trend and striving to meet the expectations of patients by integrating MRD testing into clinical practices.
Market Lifecycle Stage
The global MRD testing market is a rapidly growing segment in the healthcare industry, driven by the increasing demand for accurate and sensitive methods to monitor and manage cancer patients. This market focuses on technologies such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and flow cytometry that enable the detection and quantification of minimal residual disease (MRD) in cancer patients. With its clinical significance in treatment response monitoring, prognostic assessment, and personalized treatment approaches, the minimal residual testing market offers immense opportunities for diagnostic companies, pharmaceutical manufacturers, and research institutions to develop innovative solutions and contribute to improving patient outcomes and survival rates.
Industrial Impact
Minimal residual disease (MRD) assessment is an adjunctive method used to identify exceedingly low levels of blood cancer cells and solid tumors after the treatment of conditions such as acute and chronic leukemia, lymphoma, and multiple myeloma. MRD refers specifically to the small population of cancer cells that remain in the body despite achieving complete remission (CR) following treatments such as chemotherapy or stem cell transplantation. Detecting these residual cancer cells, which often go unnoticed through traditional microscopic examination of the bone marrow, requires more sensitive techniques for accurate evaluation.
By enabling early detection, guiding treatment decisions, and providing a sensitive assessment of minimal residual disease (MRD) testing contributes to improved patient outcomes, supports precision medicine approaches, and plays a vital role in research and clinical trials. Furthermore, the rising incidence of cancer has spurred research and technological advancements in the field of MRD testing. Efforts to enhance the sensitivity, accuracy, and efficiency of MRD testing methods have been driven by the need to address the diagnostic challenges posed by increasing cancer rates. These aforementioned advancements in minimal residual disease testing have resulted in the development of new technologies, improved laboratory protocols, and novel approaches.
In recent years, in March 2023, Providence and GRAIL strengthened their collaboration to enhance the availability of the Galleri multi-cancer early detection screening, with an intent to broaden its accessibility. Similarly, in December 2022, IDT (Integrated DNA Technologies) acquired the ArcherDX Next Generation Sequencing Research Assays from Invitae Corporation. This acquisition of the NGS research assays is in line with Integrated DNA Technologies, Inc.'s goal of expanding scientific discovery and establishing itself as a prominent provider of oncology research solutions in the industry.
Market Segmentation:
Segmentation 1: by Technology
• Flow Cytometry
• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• Other Technologies
Flow Cytometry to Continue its Dominance as Leading Technology Segment
The global MRD testing market has been led by flow cytometry in the technology segment, which held a 35.14% share in 2022. The market growth is attributed to recent technological innovations in multiparametric flow cytometry, such as the development of high-sensitivity 10-color and 12-color flow cytometry assay for the identification of leukemia-associated phenotypes (LAPs) and estimation of the prognostic significance of treatment in MRD patients.
MRD testing uses highly sensitive methods such as flow cytometry, PCR, NGS, and others. These tests use bone marrow samples and/or peripheral blood cells (taken through a vein). Significant advancements 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. Techniques such as karyotyping and classical microscopy have lesser value in MRD detection due to their low sensitivity.
Segmentation 2: by Target Detection
• Solid Tumor
• Leukemia
• Lymphoma
As of 2022, the global MRD testing market (by target detection) was dominated by the leukemia segment, holding a 52.71% market share.
Segmentation 3: by End User
• Hospitals and Speciality Clinics
• Research Institutions
• Diagnostic Laboratories
• Other End Users
Hospitals and Speciality Clinics to Witness the Highest Growth between 2023 and 2033
The global MRD testing market is estimated to be led by the hospitals and specialty clinics in the end user segment, which held a share of 44.38% in 2022. Hospitals are at the forefront of providing MRD testing kits and services to detect residual cells in solid tumors and hematological malignancies in routine healthcare procedures. There has been a high adoption of various testing assays by hospitals, particularly in the field of oncology. Moreover, hospitals, particularly in leading regions such as North America and Europe, and also to a certain extent in Asia-Pacific (APAC), have incorporated extensive molecular diagnostics test portfolios to provide superior care to patients. Other end users, such as outpatient clinics and cancer clinics, also contribute significantly to the global MRD testing market.
Segmentation 4: by Region
• North America - U.S. and Canada
• Europe - Germany, France, U.K., Italy, Spain, and Rest-of-Europe
• Asia-Pacific - China, India, Japan, South Korea, Australia, Singapore, and Rest-of-Asia-Pacific
• Latin America - Brazil, Mexico, Saudi Arabia, Rest-of-Latin America and Middle East
• Rest-of-the-World (RoW)
China to Continue its Dominance as the Leading Country in Asia-Pacific Region
China dominated the Asia-Pacific MRD testing market in 2022 with a share of 36.08%. Although the market is expected to remain in a strong growth phase due to the massively growing number of cancer cases and the rising health-related awareness among people in Asia-Pacific, a significant barrier to the increasing adoption is an uneven economic balance among countries within the region. However, the growth in MRD testing is expected to be tremendous in the regional market due to the substantial commercial growth of emerging companies, high-profile publications, and the establishment of multidisciplinary consortiums aiming to accelerate standardization and harmonization of regulatory consensus for an emerging field.
Recent Developments in the MRD Testing Market:
• In April 2023, Quest Diagnostics acquired Haystack Oncology, expanding its oncology portfolio with the inclusion of advanced liquid biopsy technology. This addition aimed to enhance personalized cancer care by offering highly sensitive diagnostic capabilities.
• In April 2023, Integrated DNA Technologies launched the Archer FUSIONPlex Core Solid Tumor Panel, a pioneering cancer research testing solution that has been enhanced and fine-tuned to include a broader range of single nucleotide variant (SNV) and indel coverage.
• In April 2023, Adaptive Biotechnologies collaborated on a translational partnership with Takeda to employ its clonoSEQ assay throughout Takeda's range of hematologic malignancy treatments, enabling the measurement of minimal residual disease.
Demand – Drivers and Limitations
Market Demand Drivers:
• Advent of MRD Testing and its Awareness among Consumers
• Increasing Incidence of Cancer Cases Demanding MRD Testing
• Expanding Medicare Coverage for MRD Testing
• Rise in Administration of Solid Tumor Diagnosis in MRD Testing Ecosystem
Market Challenges:
• Substantially High Cost of MRD Tests
• Early-Risk of Progression and Relapse due to MRD Negative Result
Market Opportunities:
• Advancements in the Development of Companion Diagnostics
• Rising Number of Clinical Trials in Prolonged MRD-Negative Treatment Decisions
Analyst’s Thoughts
According to Revti Bhaskar, Senior Research Analyst, BIS Research, "The escalating prevalence of various cancers globally, such as leukemia, lymphoma, and solid tumors, has contributed to the growing demand for MRD testing. Healthcare providers and researchers recognize the clinical utility of MRD assessment in monitoring treatment response, predicting relapse, and guiding therapeutic interventions. As MRD testing continues to evolve and establish itself as a crucial tool in cancer management, market players must focus on innovation, standardization, and accessibility to capitalize on the lucrative opportunities that lie ahead.”
MRD Testing Market - Global and Regional Analysis
Focus on Technology, Target Detection, End User and Region Analysis - Analysis and Forecast, 2023-2033
Frequently Asked Questions
Minimal residual disease (MRD) testing is a supplementary approach to detect extremely low levels of blood cancer cells and solid tumors following the treatment of conditions such as acute and chronic leukemia, lymphoma, or multiple myeloma. MRD specifically pertains to the minute population of cancer cells that persist in the body despite achieving complete remission (CR) through chemotherapy or stem cell transplantation.
Synergistic activities and product launches/approvals accounted for the maximum number of key developments, which was more than 50% of the total developments in the global MRD market as of May 2023. Key players such as Adaptive Biotechnologies collaborated on a translational partnership with Takeda to employ its clonoSEQ assay throughout Takeda's range of hematologic malignancy treatments, enabling the measurement of minimal residual disease.
The global MRD testing market is currently witnessing several developments, primarily aimed at introducing new products and services. Major manufacturers of MRD testing products, along with the service providers, are actively undertaking significant business strategies to translate success in research and development into the commercial clinical setting.
A new entrant can focus on various MRD testing product offerings by established players. The market is fragmented, with established market leaders such as Bio-Rad Laboratories, Inc., ARUP Laboratories, and Guardant Health, Inc., among others, who have had their presence in the market for many years. The new entrants can focus on strategies such as product launches and global expansions for MRD testing.
The following can be termed as some of the USPs of this report:
• Breakdown of hematological malignancy and solid tumors to its key target detections along with test volume
• Current market scenario of MRD testing with company share analysis
• Technology used for MRD Testing and its current trend in the market
• Legal and regulatory framework, along with the reimbursement scenarios
• Country-wise and region-wise analysis of the market, including market forecast of segments
• Test volume of technologies, target indication, and end user of the MRD testing market
Companies manufacturing and distributing different tests, assays, and panels used for MRD testing in leukemia, lymphoma, and solid tumors, as well as startups looking to enter the MRD market, can buy this report.