MRD 검사 시장 - 세계 및 지역 분석 : 기술, 표적 탐지, 최종 사용자 및 지역별 분석 및 예측(2023-2033년)

The Global MRD Testing Market Expected to Reach $6.67 Billion by 2033

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

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.

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.

Table of Contents

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