세계의 미세잔존질환(MRD) 검사 시장(2022-2027년) : 기술, 용도, 최종사용자, 지역별

“Global Minimal Residual Disease (MRD) Testing Market to Reach $2,611.2 Million by 2027.”

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.

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
  • U.S.
  • Canada

• Europe
  • Germany
  • Italy
  • France
  • U.K.
  • Spain
  • Rest-of-Europe

• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Australia
  • Singapore
  • Rest-of-APAC (RoAPAC)

• Latin America and Middle East
  • Brazil
  • Mexico
  • Saudi Arabia
  • 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

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.

Key Market Players and Competition Synopsis

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

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

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.

Table of Contents

1 Market

• 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 Research Methodology

• 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 Market Overview

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

4 Market Dynamics

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

5 Industry Insights

• 5.1 Approval Scenario
  • 5.1.1 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 Global Minimal Residual Disease Testing Market: Competitive Insights

• 6.1 Overview
• 6.2 Synergistic Activities
• 6.3 Product Approvals
• 6.4 Product Launches and Updates
• 6.5 Merger and Acquisition Activities
• 6.6 Business Expansion and Funding Activities
• 6.7 Other Developments
• 6.8 Market Share Analysis, 2020-2021
• 6.9 Growth-Share Analysis
  • 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 Global Minimal Residual Disease Testing Market: Stakeholder Analysis (N=30-40)

• 7.1 Physicians' Perception
  • 7.1.1 Stage of the Treatment Use for MRD
  • 7.1.2 Frequency of Receiving MRD Testing
  • 7.1.3 Average Treatment Duration for Patients Diagnosed with MRD
  • 7.1.4 Adoption and Barriers to MRD Testing
• 7.2 Payors' Perception
  • 7.2.1 Reimbursement vs. Patient Out-of-Pocket Expense
• 7.3 Investors' Perception
  • 7.3.1 Price vs. Sensitivity vs. Turnaround time

8 Global Minimal Residual Testing Market (by Technology), 2021-2027

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

9 Global Minimal Residual Testing Market (by Application), 2021-2027

• 9.1 Overview
• 9.2 Hematological Malignancy
  • 9.2.1 Non-Hodgkin's Lymphoma (NHL)
    • 9.2.1.1 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 Global Minimal Residual Disease Testing Market (by End User), 2021-2027

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

• 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 Company Profiles

• 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
• 12.1 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