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Minimal Residual Disease Testing Market by Type, Technology, End User, and by Region - Global Forecast to 2022-2033

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    Report

  • 200 Pages
  • January 2023
  • Region: Global
  • Quintana Research and Consulting
  • ID: 5717219
The minimal residual disease testing market size is estimated to be USD 1.98 million in 2022 and is expected to witness a CAGR of 11.75% during the forecast period 2023-2033. Surge in incidence of cancer, rising consumer awareness of treatment options, growing funding for research, and higher disposable income in emerging nations are factors contributing to the market growth. Furthermore, growing research in the areas of MRD diagnostics and monitoring and rising emphasis on treating hematological malignancies globally are other factors supporting the market growth. However, high price of minimal residual disease testing kits is expected to hinder the growth.

Surge in incidence of cancer is expected to fuel the market growth during the forecast period. Cancer is the second-leading reason for death worldwide, according to the WHO. 19.3 million new cases of cancer were reported in 2020, while 9.96 million people died from cancer-related diseases. The International Agency for Research on Cancer estimates that by 2025, there will be 21.9 million new cases of cancer, and by 2030, there will be 24.6 million. It is anticipated that this increase in cancer cases would force governments to launch new programmes for population-wide cancer screening.

Rising emphasis on treating hematological malignancies globally is predicted to propel the market growth during the projected period. Major companies are currently aiming to invest in the field of MRD, focusing largely on the foundation created for hematological malignancies, as a result of the FDA's approval of clonoSEQ and Signatera. Between January 2018 and May 2022, there were about 35 key synergistic innovations that the market witnessed. In economically developed countries, hematologic malignancies represent approximately 6.5% of all cancers and are the fourth most common type of cancer found in both men and women.

Segmentation

By Type

The market is categorized into next generation sequencing (NGS), flow cytometry, polymerase chain reaction (PCR), and others. In 2022, the flow cytometry segment accounted for the highest revenue share due to the flow cytometry's greater sensitivity and wide range of MRD testing applications. Using flow cytometry, it is possible to assess each individual cell by examining the surface of the cell for the presence of particular protein markers. A recent bone marrow sample is required for accurate results. On the bone marrow sample, specialised antibodies are applied, and they only bind to cells that have a certain protein on them. One cancer cell can be found with this technology out of 10,000 to 100,000 healthy bone marrow cells, depending on the flow cytometry setting. Results can be available in less time than a day. The polymerase chain reaction (PCR) technology segment is anticipated to increase profitably during the projected period. This approach allows for the identification of cancer cells based on specific genetic anomalies, such as mutations or chromosomal changes. Essentially, PCR 'amplifies' or 'enhances' small amounts of DNA or RNA fragments in order to increase their detectability and countability. As a result, even in the existence of very few cancer cells, PCR can detect genetic anomalies. The test uses bone marrow or blood cells. PCR can identify one cancer cell out of 100,000 normal cells. Test results can take between 5 and 14 days to become accessible.

By Technology

The market is categorized into solid tumors and hematological malignancy. In the global market, the hematological malignancy segment accounted for the largest revenue share in 2022 owing to growing use of MRD testing in hematological tumors as a diagnostic and monitoring tool. Hematological cancers start in immune system cells or blood-forming organs. Leukemia, lymphoma, and multiple myeloma are the three main types of haematological malignancies. For the use of NGS technology in bone marrow samples from patients with multiple myeloma, the ClonoSEQ assay has received FDA approval. Additionally, the prevalence of haematological malignancies in the general population has grown. The solid tumours market is anticipated to grow profitably throughout the anticipated period. This can be ascribed to continuing studies being done for the evaluation of patients with solid tumors. There are presently no approved recommendations for the use of MRD testing in nonhematologic malignancies. Clinical trial design, translational research projects, and traditional clinical care are all rapidly implementing the use of circulating tumor-derived DNA (ctDNA) as a predictive biomarker for molecular residual disease (MRD) after therapy for solid tumors. Despite the rapid advancement of ctDNA detection technology, the low sensitivity of current detection methods reduces their usefulness for detecting MRD across a variety of clinical applications.

By End User

The market is segmented into academic and research institutes, hospitals and specialty clinics, diagnostic laboratories, others. In 2022, the hospitals and specialty clinics segment accounted for the largest revenue share owing to rising prevalence of the target disease, availability of a variety of testing alternatives, and introduction of novel tests for a better and more extensive screening of patients. The academic and research institutes segment is anticipated to increase profitably during the projection period. MRD testing for multiple myeloma is widely used in clinical trials to evaluate the disease response and as a prediction technique to determine the duration of the response. According to preliminary data, MRD positivity after therapy is associated with a higher chance of relapse, while MRD negativity is associated with a higher progression-free survival (PFS). Studies are also being conducted to evaluate the value of sequentially monitoring MRD in patients receiving therapy.

Regional Markets

In 2022, North America region accounted for the highest revenue in the minimal residual disease testing market and is expected to maintain its dominance during the forecast period. This is attributed to the government initiatives to prevent the spread of diseases. The U.S. and Canada are North America's two main markets for cancer screening due to increasing patient and physician awareness of the advantages of screening. Additionally, a number of initiatives are being taken to offer MRD testing in the area. For instance, in November 2022, Natera was awarded a contract for national MRD testing by the National Precision Oncology Program of the U.S. Department of Veterans Affairs (VA) to provide MRD and monitoring services using the company's Signetera MRD test. Asia Pacific is anticipated to exhibit the fastest growth during the projection period. Japan is anticipated to be the region's largest market due to rising screening-related investment and the existence of favourable reimbursement rules. Additionally, MRD testing is required due to the high occurrence of hematological malignancies in the region. The market's major players are concentrating on research to provide new tests. Additionally, the region's market is expanding due to the rising demand for cancer surveillance and the enabling of new MRD technologies.

Competitor Insights

Some of the key players operating in the minimal residual disease testing market are
GRAIL, LLC, QIAGEN, Natera, Inc., FOUNDATION MEDICINE, INC., Veracyte, Inc., F. Hoffmann-La Roche Ltd, Exact Sciences Corporation, mdxhealth, Guardant Health, and Bio-Techne.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

For instance, Adaptive Biotechnologies Corporation introduced the clonoSEQ assay for the detection of MRD in blood for individuals with diffuse large B-cell lymphoma in December 2022.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including type, technology, and end user from 2023 to 2033.

Segmentation: Minimal Residual Disease Testing Market Report 2022 - 2033

Type (Revenue, USD Million), 2022 - 2033

  • Next Generation Sequencing (NGS)
  • Flow Cytometry
  • Polymerase Chain Reaction (PCR)
  • Others

Technology (Revenue, USD Million), 2022 - 2033

  • Solid Tumors

Hematological Malignancy

  • Leukemia
  • Lymphoma

End user (Revenue, USD Million), 2022 - 2033

  • Academic and Research Institutes
  • Hospitals and Specialty Clinics
  • Diagnostic Laboratories
  • Others

By Region (Revenue, USD Million), 2022 - 2033

North America

  • U.S.
  • Canada

Europe

  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Rest of Europe

Asia Pacific

  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC

Latin America

  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM

Middle East & Africa

  • South Africa
  • GCC
  • Rest of MEA

Table of Contents

1. Research Methodology
1.1. Study Objectives
1.2. Study Scope
1.3. Research Framework
1.3.1. Research Models
1.3.1.1. Bottom-up Approach
1.3.1.2. Top-down Approach
1.3.1.3. Data Triangulation
1.3.2. Data Analysis
1.3.2.1. Data Validation
1.3.2.2. Market Size Estimation
1.3.2.3. Market Forecast Model

2. Introduction: Minimal Residual Disease Testing

3. Executive Summary

4. Market Dynamics
4.1. Market Drivers
4.1.1. Driver 1
4.1.2. Driver 2
4.1.3. Driver 3
4.1.4. Driver 4
4.2. Market Restraint
4.2.1. Restraint 1
4.2.2. Restraint 2
4.2.3. Restraint 3
4.3. Market Opportunities
4.3.1. Opportunity 1
4.3.2. Opportunity 2
4.3.3. Opportunity 3
4.4. Market Trends
4.4.1. Trend 1
4.4.2. Trend 2
4.4.3. Trend 3
4.5. Market Challenges
4.5.1. Challenge 1
4.5.2. Challenge 2
4.5.3. Challenge 3

5. Market Environment Analysis
5.1. Porter’s 5 Forces Analysis
5.2. PESTEL Analysis
5.3. SWOT Analysis

6. COVID-19 Impact Analysis: Minimal Residual Disease Testing Market

7. Market Analysis by Type
7.1. Next Generation Sequencing (NGS)
7.1.1. Next Generation Sequencing (NGS) Market Forecast, 2022-2033 (USD Million)
7.2. Flow Cytometry
7.2.1. Flow Cytometry Market Forecast, 2022-2033 (USD Million)
7.3. Polymerase Chain Reaction (PCR)
7.3.1. Polymerase Chain Reaction (PCR) Market Forecast, 2022-2033 (USD Million)
7.4. Others
7.4.1. Others Market Forecast, 2022-2033 (USD Million)

8. Market Analysis by Technology
8.1. Solid Tumors
8.1.1. Solid Tumors Market Forecast, 2022-2033 (USD Million)
8.2. Hematological Malignancy
8.2.1. Hematological Malignancy Market Forecast, 2022-2033 (USD Million)
8.2.1.1. Leukemia
8.2.1.1.1. Leukemia Market Forecast, 2022-2033 (USD Million)
8.2.1.2. Lymphoma
8.2.1.2.1. Lymphoma Market Forecast, 2022-2033 (USD Million)

9. Market Analysis by End User
9.1. Academic and Research Institutes
9.1.1. Academic and Research Institutes Market Forecast, 2022-2033 (USD Million)
9.2. Hospitals and Specialty Clinics
9.2.1. Hospitals and Specialty Clinics Market Forecast, 2022-2033 (USD Million)
9.3. Diagnostic Laboratories
9.3.1. Diagnostic Laboratories Market Forecast, 2022-2033 (USD Million)
9.4. Others
9.4.1. Others Market Forecast, 2022-2033 (USD Million)

8. Regional Market Analysis
8.1. Regional Market Trends Analysis

9. North America Minimal Residual Disease Testing Market
9.1. North America Minimal Residual Disease Testing Market
9.1.1. North America Market Size and Forecast, 2022-2033 (USD Million)
9.1.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
9.1.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
9.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
9.2. U.S. Minimal Residual Disease Testing Market
9.2.1. U.S. Market Size and Forecast, 2022-2033 (USD Million)
9.2.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
9.2.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
9.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
9.3. Canada Minimal Residual Disease Testing Market
9.3.1. Canada Market Size and Forecast, 2022-2033 (USD Million)
9.3.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
9.3.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
9.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

10. Europe Minimal Residual Disease Testing Market
10.1. Europe Minimal Residual Disease Testing Market
10.1.1. Europe Market Size and Forecast, 2022-2033 (USD Million)
10.1.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
10.1.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.2. Germany Minimal Residual Disease Testing Market
10.2.1. Germany Market Size and Forecast, 2022-2033 (USD Million)
10.2.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
10.2.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.3. UK Minimal Residual Disease Testing Market
10.3.1. UK Market Size and Forecast, 2022-2033 (USD Million)
10.3.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
10.3.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.4. France Minimal Residual Disease Testing Market
10.4.1. France Market Size and Forecast, 2022-2033 (USD Million)
10.4.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
10.4.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.4.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.5. Spain Minimal Residual Disease Testing Market
10.5.1. Spain Market Size and Forecast, 2022-2033 (USD Million)
10.5.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
10.5.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.5.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.6. Italy Minimal Residual Disease Testing Market
10.6.1. Italy Market Size and Forecast, 2022-2033 (USD Million)
10.6.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
10.6.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.6.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.7. Rest of Europe Minimal Residual Disease Testing Market
10.7.1. Rest of Europe Market Size and Forecast, 2022-2033 (USD Million)
10.7.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
10.7.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.7.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

11. Asia Pacific Minimal Residual Disease Testing Market
11.1. Asia Pacific Minimal Residual Disease Testing Market
11.1.1. Asia Pacific Market Size and Forecast, 2022-2033 (USD Million)
11.1.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
11.1.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.2. Japan Minimal Residual Disease Testing Market
11.2.1. Japan Market Size and Forecast, 2022-2033 (USD Million)
11.2.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
11.2.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.3. China Minimal Residual Disease Testing Market
11.3.1. China Market Size and Forecast, 2022-2033 (USD Million)
11.3.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
11.3.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.4. India Minimal Residual Disease Testing Market
11.4.1. India Market Size and Forecast, 2022-2033 (USD Million)
11.4.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
11.4.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.4.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.5. South Korea Minimal Residual Disease Testing Market
11.5.1. South Korea Market Size and Forecast, 2022-2033 (USD Million)
11.5.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
11.5.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.5.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.6. Australia Minimal Residual Disease Testing Market
11.6.1. Australia Market Size and Forecast, 2022-2033 (USD Million)
11.6.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
11.6.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.6.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.7. Rest of Asia Pacific Minimal Residual Disease Testing Market
11.7.1. Rest of Asia Pacific Market Size and Forecast, 2022-2033 (USD Million)
11.7.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
11.7.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.7.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

12. Latin America Minimal Residual Disease Testing Market
12.1. Latin America Minimal Residual Disease Testing Market
12.1.1. Latin America Market Size and Forecast, 2022-2033 (USD Million)
12.1.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
12.1.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
12.2. Brazil Minimal Residual Disease Testing Market
12.2.1. Brazil Market Size and Forecast, 2022-2033 (USD Million)
12.2.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
12.2.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
12.3. Mexico Minimal Residual Disease Testing Market
12.3.1. Mexico Market Size and Forecast, 2022-2033 (USD Million)
12.3.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
12.3.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
12.4. Argentina Minimal Residual Disease Testing Market
12.4.1. Argentina Market Size and Forecast, 2022-2033 (USD Million)
12.4.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
12.4.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.4.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
12.5. Rest of Latin America Minimal Residual Disease Testing Market
12.5.1. Rest of Latin America Market Size and Forecast, 2022-2033 (USD Million)
12.5.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
12.5.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.5.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

13. MEA Minimal Residual Disease Testing Market
13.1. MEA Minimal Residual Disease Testing Market
13.1.1. MEA Market Size and Forecast, 2022-2033 (USD Million)
13.1.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
13.1.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
13.2. GCC Minimal Residual Disease Testing Market
13.2.1. GCC Market Size and Forecast, 2022-2033 (USD Million)
13.2.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
13.2.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
13.3. South Africa Minimal Residual Disease Testing Market
13.3.1. South Africa Market Size and Forecast, 2022-2033 (USD Million)
13.3.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
13.3.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
13.4. Rest of MEA Minimal Residual Disease Testing Market
13.4.1. Rest of MEA Market Size and Forecast, 2022-2033 (USD Million)
13.4.1.1. Market Size and Forecast by Type, 2022-2033 (USD Million)
13.4.1.2. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.4.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

14. Competitor Analysis
14.1. Market Share Analysis, 2022
14.2. Major Recent Developments, 2019-2022

15. Company Profiles
15.1. GRAIL, LLC
15.1.1. Company Snapshot
15.1.2. Company Overview
15.1.3. Financial Analysis
15.1.4. Product Benchmarking
15.1.5. Recent Developments
15.2. QIAGEN
15.2.1. Company Snapshot
15.2.2. Company Overview
15.2.3. Financial Analysis
15.2.4. Product Benchmarking
15.2.5. Recent Developments
15.3. Natera, Inc.
15.3.1. Company Snapshot
15.3.2. Company Overview
15.3.3. Financial Analysis
15.3.4. Product Benchmarking
15.3.5. Recent Developments
15.4. FOUNDATION MEDICINE, INC.
15.4.1. Company Snapshot
15.4.2. Company Overview
15.4.3. Financial Analysis
15.4.4. Product Benchmarking
15.4.5. Recent Developments
15.5. Veracyte, Inc
15.5.1. Company Snapshot
15.5.2. Company Overview
15.5.3. Financial Analysis
15.5.4. Product Benchmarking
15.5.5. Recent Developments
15.6. F. Hoffmann-La Roche Ltd
15.6.1. Company Snapshot
15.6.2. Company Overview
15.6.3. Financial Analysis
15.6.4. Product Benchmarking
15.6.5. Recent Developments
15.7. Exact Sciences Corporation
15.7.1. Company Snapshot
15.7.2. Company Overview
15.7.3. Financial Analysis
15.7.4. Product Benchmarking
15.7.5. Recent Developments
15.8. mdxhealth
15.8.1. Company Snapshot
15.8.2. Company Overview
15.8.3. Financial Analysis
15.8.4. Product Benchmarking
15.8.5. Recent Developments
15.9. Guardant Health
15.9.1. Company Snapshot
15.9.2. Company Overview
15.9.3. Financial Analysis
15.9.4. Product Benchmarking
15.9.5. Recent Developments
15.10. Bio-Techne
15.10.1. Company Snapshot
15.10.2. Company Overview
15.10.3. Financial Analysis
15.10.4. Product Benchmarking
15.10.5. Recent Developments
15.11. Company 11
15.11.1. Company Snapshot
15.11.2. Company Overview
15.11.3. Financial Analysis
15.11.4. Product Benchmarking
15.11.5. Recent Developments
15.12. Company 12
15.12.1. Company Snapshot
15.12.2. Company Overview
15.12.3. Financial Analysis
15.12.4. Product Benchmarking
15.12.5. Recent Developments
15.13. Company 13
15.13.1. Company Snapshot
15.13.2. Company Overview
15.13.3. Financial Analysis
15.13.4. Product Benchmarking
15.13.5. Recent Developments
15.14. Company 14
15.14.1. Company Snapshot
15.14.2. Company Overview
15.14.3. Financial Analysis
15.14.4. Product Benchmarking
15.14.5. Recent Developments
15.15. Company 15
15.15.1. Company Snapshot
15.15.2. Company Overview
15.15.3. Financial Analysis
15.15.4. Product Benchmarking
15.15.5. Recent Developments

16. Conclusion

17. Recommendations

Companies Mentioned

A selection of companies mentioned in this report includes:

  • GRAIL LLC
  • QIAGEN
  • Natera Inc.
  • FOUNDATION MEDICINE Inc.
  • Veracyte Inc.
  • F. Hoffmann-La Roche Ltd
  • Exact Sciences Corporation
  • mdxhealth
  • Guardant Health
  • Bio-Techne