미세잔존질환 시장 예측( -2030년) : 제공별, 샘플 유형별, 임상적 유용성별, 기술별, 최종사용자별, 지역별 세계 분석

According to Stratistics MRC, the Global Minimal Residual Disease Market is accounted for $1.96 billion in 2024 and is expected to reach $4.51 billion by 2030 growing at a CAGR of 14.88% during the forecast period. Minimal Residual Disease (MRD) is an important marker in hematologic cancers like leukemia, lymphoma, and multiple myeloma. It helps doctors figure out how well treatment is working and make decisions about future care. Advanced techniques like flow cytometry, polymerase chain reaction (PCR), and next-generation sequencing (NGS) enable highly sensitive detection of MRD, allowing for personalized treatment adjustments, early intervention, and improved long-term patient outcomes. Moreover, MRD is the small number of cancer cells that remain in a patient's body after treatment, which are undetectable through conventional imaging or laboratory tests but can still cause relapse.

According to BD Biosciences, MRD is a crucial biomarker in clinical trials for blood cancers such as acute lymphoblastic leukemia and multiple myeloma, with sensitivity and specificity values often exceeding 95%.

Market Dynamics:

Driver:

Increasing personalized medicine adoption

The need for MRD testing is growing as precision oncology becomes more prevalent. MRD tests enable individualized treatment modifications by precisely identifying residual disease, such as lowering treatment intensity for patients with a low risk of relapse or increasing therapy for high-risk patients. This method reduces the negative effects and financial burden of needless treatments while also improving patient outcomes. Additionally, the market is expanding as a result of MRD testing's incorporation into precision medicine frameworks.

Restraint:

Expensive MRD testing

The high expense of MRD testing is one of the main obstacles preventing its widespread use. Advanced methods like digital PCR, multi-parameter flow cytometry, and next-generation sequencing (NGS) are costly because they call for specialized equipment, chemicals, and skilled workers. Depending on the technology employed and the quantity of markers examined, MRD testing can cost anywhere from hundreds to thousands of dollars per test. Affordability is still a problem for healthcare systems with little funding, especially in developing nations. Furthermore, regular MRD monitoring for cancer patients receiving long-term therapy raises costs even more and restricts access.

Opportunity:

Extension of MRD examination in solid cancers

The use of minimal residual disease (MRD) testing in solid tumors offers a substantial growth opportunity, despite the fact that it has been extensively adopted in hematologic malignancies. A promising method for identifying MRD in solid tumors like prostate, colorectal, lung, and breast cancers is circulating tumor DNA (ctDNA) analysis. In contrast to conventional imaging methods, ctDNA-based MRD detection enables earlier intervention by detecting molecular recurrence before tumors appear on scans. Moreover, research and commercial expansion into new cancer types are being fueled by investments made in MRD assays for solid tumors by companies such as Foundation Medicine, Natera, and Guardant Health.

Threat:

Tough regulatory conditions

MRD testing is subject to strict regulatory oversight, as its clinical applications involve critical cancer treatment decisions. Before approving MRD assays, regulatory bodies like the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other international health authorities demand thorough clinical validation. The lengthy and expensive regulatory approval process can postpone new products' release onto the market. Additionally, businesses looking to expand internationally face compliance issues due to regional differences in regulatory frameworks. Product recalls, penalties, or limitations on market access may arise from noncompliance with changing regulatory requirements.

Covid-19 Impact:

The COVID-19 pandemic had a mixed effect on the market for minimal residual disease (MRD). At first, lockdowns and overburdened healthcare systems disrupted clinical trials, cancer screenings, and diagnostic procedures. Testing volumes decreased as a result of the deprioritization or delay of numerous non-urgent cancer monitoring tests, such as MRD evaluations. But the pandemic also spurred interest in non-invasive MRD detection techniques like circulating tumor DNA (ctDNA) analysis by speeding up developments in remote monitoring, liquid biopsy adoption, and decentralized clinical trials. Furthermore, the significance of MRD testing has also been reaffirmed by the post-pandemic increased focus on precision medicine and oncology research, which has resulted in new investments, regulatory support, and technological developments that propel market expansion.

The Assay Kits & Reagents segment is expected to be the largest during the forecast period

The Assay Kits & Reagents segment is expected to account for the largest market share during the forecast period. These assay kits and reagents are necessary for methods that are frequently employed in MRD testing, including flow cytometry, polymerase chain reaction (PCR), and next-generation sequencing (NGS). Their recurrent nature guarantees ongoing use in hospitals, research facilities, and diagnostic labs, supporting their continued market dominance. Moreover, this segment's growth is further fueled by developments in highly sensitive and specific reagents for detecting traces of remaining cancer cells, which makes it a significant source of revenue for the MRD market.

The Treatment Response Assessment segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the Treatment Response Assessment segment is predicted to witness the highest growth rate. The growing use of MRD testing to assess the efficacy of immunotherapy's, targeted therapies, and chemotherapy regimens is what is driving this market. Clinicians can now modify treatment in real time based on MRD status thanks to developments in digital PCR and next-generation sequencing (NGS), which enhances patient outcomes and lowers needless treatment toxicity. Additionally, growth in this market is also being fueled by regulatory approvals for MRD as a biomarker in clinical trials and drug development, which is speeding up its incorporation into oncology treatment protocols.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, driven by advanced healthcare infrastructure, high adoption of precision medicine, and strong investments in cancer research. The area benefits from a high incidence of hematologic malignancies, reputable diagnostic labs, and easy access to state-of-the-art technologies like digital PCR for MRD detection and next-generation sequencing (NGS). Furthermore, the U.S. FDA's supportive regulations, the rise in clinical trials using MRD as a biomarker, and the expansion of pharmaceutical and diagnostic company partnerships all contribute to North America's market dominance in MRD.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR because of the increased incidence of cancer, the development of better healthcare facilities, and the growing use of cutting-edge diagnostic tools. The need for MRD testing is being driven by significant investments being made in precision medicine and oncology research by nations like China, India, and Japan. Moreover, the market is also growing faster due to government initiatives to improve cancer diagnostics, rising healthcare spending, and increased awareness of early cancer detection. Increased partnerships between foreign diagnostic firms and regional healthcare providers are also taking place in the area, which will increase MRD technology adoption and accessibility.

Key players in the market

Some of the key players in Minimal Residual Disease market include Adaptive Biotechnologies Corporation, F. Hoffmann-La Roche Ltd, Natera Inc., Guardant Health, QIAGEN N.V., Bio-Rad Laboratories Inc., Exact Sciences Corporation, Sysmex Corporation, NeoGenomics Inc., Illumina Inc., Thermo Fisher Scientific Inc., Bio-Techne Corporation, Invitae Corporation, Invivoscribe Inc., Quest Diagnostics, PerkinElmer Inc., Agilent Technologies Inc. and Laboratory Corporation of America Holdings.

Key Developments:

In February 2025, Bio-Rad Laboratories, Inc launched its TrailBlazer Tag and TrailBlazer StarBright Dye Label Kits. The new kits are designed to offer a convenient method to label any antibody with one of Bio-Rad's StarBright Dyes, for use in either flow cytometry or fluorescent western blot experiments.

In November 2024, Roche announced that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc., a public clinical-stage biopharmaceutical company pioneering donor-derived CAR-T cell therapies. Poseida's R&D portfolio includes pre-clinical and clinical-stage off-the-shelf CAR-T therapies across several therapeutic areas including haematological malignancies, solid tumours, and autoimmune disease, as well as manufacturing capabilities and technology platforms.

In March 2024, Sysmex Corporation and CellaVision AB will be working together to advance hematology solutions by expanding its portfolio, including next-generation cell morphology analyzers. Going forward, the companies will work to further increase efficiency and standardization of the testing workflow in the hematology field, increase the precision of cell morphology classification, and provide value in supporting diagnosis.

Offerings Covered:

• Assay Kits & Reagents
• Instruments/Platforms
• Software/Data Analysis Solutions
• Services

Disease Types Covered:

• Hematological Malignancies
• Solid Tumors

Sample Types Covered:

• Blood
• Bone Marrow
• Other Sample Types

Clinical Utilities Covered:

• MRD Monitoring & Detection
• Treatment Response Assessment
• Prognosis & Risk Stratification

Technologies Covered:

• Flow Cytometry
• Polymerase Chain Reaction (PCR)
• Next Generation Sequencing (NGS)
• Fluorescence In Situ Hybridization (FISH)
• Mass Spectrometry

End Users Covered:

• Hospitals & Specialty Clinics
• Diagnostic Laboratories
• Academic & Research Institutes
• Pharmaceutical & Biotech Companies
• Contract Research Organizations (CROs)

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2022, 2023, 2024, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Technology Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Minimal Residual Disease Market, By Offering

• 5.1 Introduction
• 5.2 Assay Kits & Reagents
• 5.3 Instruments/Platforms
• 5.4 Software/Data Analysis Solutions
• 5.5 Services

6 Global Minimal Residual Disease Market, By Disease Type

• 6.1 Introduction
• 6.2 Hematological Malignancies
  • 6.2.1 Leukemia
  • 6.2.2 Lymphoma
  • 6.2.3 Multiple Myeloma
  • 6.2.4 Myelodysplastic Syndromes (MDS)
• 6.3 Solid Tumors
  • 6.3.1 Breast Cancer
  • 6.3.2 Colorectal Cancer
  • 6.3.3 Lung Cancer
  • 6.3.4 Other Solid Tumors

7 Global Minimal Residual Disease Market, By Sample Type

• 7.1 Introduction
• 7.2 Blood
• 7.3 Bone Marrow
• 7.4 Other Sample Types

8 Global Minimal Residual Disease Market, By Clinical Utility

• 8.1 Introduction
• 8.2 MRD Monitoring & Detection
• 8.3 Treatment Response Assessment
• 8.4 Prognosis & Risk Stratification

9 Global Minimal Residual Disease Market, By Technology

• 9.1 Introduction
• 9.2 Flow Cytometry
• 9.3 Polymerase Chain Reaction (PCR)
  • 9.3.1 Quantitative PCR (qPCR)
  • 9.3.2 Digital PCR (dPCR)
• 9.4 Next Generation Sequencing (NGS)
• 9.5 Fluorescence In Situ Hybridization (FISH)
• 9.6 Mass Spectrometry

10 Global Minimal Residual Disease Market, By End User

• 10.1 Introduction
• 10.2 Hospitals & Specialty Clinics
• 10.3 Diagnostic Laboratories
• 10.4 Academic & Research Institutes
• 10.5 Pharmaceutical & Biotech Companies
• 10.6 Contract Research Organizations (CROs)

11 Global Minimal Residual Disease Market, By Geography

• 11.1 Introduction
• 11.2 North America
  • 11.2.1 US
  • 11.2.2 Canada
  • 11.2.3 Mexico
• 11.3 Europe
  • 11.3.1 Germany
  • 11.3.2 UK
  • 11.3.3 Italy
  • 11.3.4 France
  • 11.3.5 Spain
  • 11.3.6 Rest of Europe
• 11.4 Asia Pacific
  • 11.4.1 Japan
  • 11.4.2 China
  • 11.4.3 India
  • 11.4.4 Australia
  • 11.4.5 New Zealand
  • 11.4.6 South Korea
  • 11.4.7 Rest of Asia Pacific
• 11.5 South America
  • 11.5.1 Argentina
  • 11.5.2 Brazil
  • 11.5.3 Chile
  • 11.5.4 Rest of South America
• 11.6 Middle East & Africa
  • 11.6.1 Saudi Arabia
  • 11.6.2 UAE
  • 11.6.3 Qatar
  • 11.6.4 South Africa
  • 11.6.5 Rest of Middle East & Africa

12 Key Developments

• 12.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 12.2 Acquisitions & Mergers
• 12.3 New Product Launch
• 12.4 Expansions
• 12.5 Other Key Strategies

13 Company Profiling

• 13.1 Adaptive Biotechnologies Corporation
• 13.2 F. Hoffmann-La Roche Ltd
• 13.3 Natera Inc.
• 13.4 Guardant Health
• 13.5 QIAGEN N.V.
• 13.6 Bio-Rad Laboratories Inc.
• 13.7 Exact Sciences Corporation
• 13.8 Sysmex Corporation
• 13.9 NeoGenomics Inc.
• 13.10 Illumina Inc.
• 13.11 Thermo Fisher Scientific Inc.
• 13.12 Bio-Techne Corporation
• 13.13 Invitae Corporation
• 13.14 Invivoscribe Inc.
• 13.15 Quest Diagnostics
• 13.16 PerkinElmer Inc.
• 13.17 Agilent Technologies Inc.
• 13.18 Laboratory Corporation of America Holdings