MRD Testing Market - Global and Regional Analysis: Focus on Technology, Target Detection, End User and Region Analysis - Analysis and Forecast, 2023-2033

Jun 2023| BIS452C| BIS Research

Report Highlights

Global MRD Testing Market 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 global MRD testing market is projected to reach $6.67 billion by 2033 from $1.47 billion in 2022, growing at a CAGR of 14.81% during the forecast period 2023-2033. 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 practice.

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 expansion of 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 is led by flow cytometry in the technology segment, with a 41.14% 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 other methods. 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

  • Leukemia
  • Lymphoma
  • Solid Tumor

Solid Tumor-Based Target Detection to Witness the Highest Growth between 2023 and 2033

The global MRD testing market is estimated to be led by the solid tumor in the target detection segment, with a share of 15.09% in 2022, owing to the increasing number of companies entering the market with a focus on solid tumor based MRD testing. The assessment of minimal residual disease (MRD) is a crucial prognostic indicator, and the application of circulating tumor DNA (ctDNA) analysis for evaluating MRD in solid tumors after curative treatment and prior to disease recurrence has shown great therapeutic potential. This promising advancement is a key driving force behind the growth of ctDNA analysis in the field.

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, with 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 is 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 and Middle East - Brazil, Mexico, Saudi Arabia, and Rest-of-Latin America and Middle East
  • Rest-of-the-World (RoW)

North America’s minimal residual disease testing market is expected to reach $2.75 billion in 2033 and is currently the leading contributor to the market. The rising incidence of hematological malignancies such as leukemia and lymphoma, coupled with the development of innovative tests, are key factors that contribute to North America's dominance in the global MRD testing market. However, the Asia-Pacific region, constituting several emerging economies, is expected to register the highest CAGR of 16.06% during the forecast period 2023-2033.

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.

Report Synopsis

Report Metrics Details
Base year considered 2023
Forecast period considered 2023-2033
Base year market size $1.68 Billion in 2023
Market size forecast $6.67 Billion by 2033
Growth rate 14.81%
Units considered $ Billion
Segments covered by Technology, by Target Detection, by End User, by Region
Industry covered BIS Healthcare
Regions covered North America, Europe, Asia-Pacific, Latin America and Middle
Countries covered U.S., Canada, Germany, Italy, France, U.K., Spain, Rest-of-Europe, China, Japan, India, South Korea, Australia, Singapore, Rest-of-Asia-Pacific East Brazil Mexico Saudi Arabia Rest-of-Latin America and Middle EastRest-of-the-World (RoW)
Companies studied
  • Adaptive Biotechnologies
  • Sysmex Corporation
  • ARUP Laboratories
  • Bio-Rad Laboratories, Inc.
  • Cergentis B.V.
  • F. Hoffmann-La Roche Ltd
  • Guardant Health, Inc.
  • Invivoscribe, Inc.
  • Laboratory Corporation of America Holdings
  • Mission Bio, Inc.
  • ICON plc
  • Natera, Inc.
  • NeoGenomics Laboratories, Inc.
  • OPKO Health, Inc.
  • Quest Diagnostics Incorporated

Demand – Drivers and Limitations

Market Demand Drivers:

  • Advent of MRD Testing and its Awareness among Consumers
  • Increasing Incidence of Cancer Cases Demanding MRD Testing
  • Rise in Administration of Solid Tumor Diagnosis in MRD Testing Ecosystem
  • Expanding Medicare Coverage for MRD Testing

Market Challenges:

  • Early-Risk of Progression and Relapse due to MRD Negative Results
  • Substantially High Cost of MRD Testing

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 available for currently available tests and their potential globally. Moreover, the study provides the reader with a detailed understanding of the global MRD testing market by end-user application (hospitals and specialty clinics, research institutions, diagnostic laboratories, and other end users), by technology (flow cytometry, polymerase chain reaction (PCR), next-generation sequencing (NGS), and Other technologies), and by target detection (leukemia, lymphoma, and solid tumor).

Growth/Marketing Strategy: The MRD testing market has seen major development by key players operating in the market, such as business expansion, partnership, collaboration, and joint venture. 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 is enhancing 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 in the MRD testing market analyzed and profiled in the 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.

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 presence in the market. 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 presence in the market.

Key Companies Profiled:

  • Adaptive Biotechnologies
  • ARUP Laboratories
  • Bio-Rad Laboratories, Inc.
  • Cergentis B.V.
  • F. Hoffmann-La Roche Ltd
  • Guardant Health, Inc.
  • Invivoscribe, Inc.
  • Laboratory Corporation of America Holdings
  • Mission Bio, Inc.
  • ICON plc
  • Natera, Inc.
  • NeoGenomics Laboratories, Inc.
  • OPKO Health, Inc.
  • Quest Diagnostics Incorporated
  • Sysmex Corporation

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