The global minimal residual disease testing market was valued at USD 1.09 billion in 2021 and it is predicted to surpass around USD 3.70 billion by 2030 with a CAGR of 14.53% from 2022 to 2030.
The global minimal residual disease testing market was valued at USD 1.09 billion in 2021 and it is predicted to surpass around USD 3.70 billion by 2030 with a CAGR of 14.53% from 2022 to 2030.
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MRD testing is essentially used in clinical and research applications for the detection of a residual disease condition. These tests are used for the detection of either hematological malignancies or solid tumors. Continuous monitoring of residual cancer cells throughout the core treatment and during the remission stage fetches the oncologists with personalized insights on the efficacy of the used therapy. It also precisely predicts the risk of a possible relapse of the condition. MRD testing influences treatment choices to yield better therapeutic outcomes.
The use of MRD testing as a novel prognostic and diagnostic assay facilitates robust moderation of treatment regimes to treat all kinds of hematological malignancies. It generates important molecular information to better understand the cancer conditions and ultimately work towards leveraging treatment outcomes. For instance, in February 2022, the Foundation for National Institutes of Health’s Biomarkers Consortium launched a project for the validation of novel detection and quantification methods to effectively detect the trace amounts of carcinogenic cells left out in the body after a full-fledged anti-cancer therapy, and in cases of acute myeloid leukemia.
Scope of The Report
Report Coverage | Details |
Market Size in 2021 | USD 1.09 billion |
Revenue Forecast by 2030 | USD 3.70 billion |
Growth rate from 2022 to 2030 | CAGR of 14.53% |
Base Year | 2021 |
Forecast Period | 2022 to 2030 |
Segmentation | Technology, Cancer Type, End use, Region |
Companies Covered | Adaptive Biotechnologies Corporation, Bio-Rad Laboratories, Inc., Arup Laboratories, F. Hoffmann- La Roche Ltd, Cergentis B.V., Guardant Health, ICON plc, Laboratory Corporation of America Holdings, Invivoscribe, Inc., Mission Bio, Inc., Opko Health, Natera, Inc., NeoGenomics Laboratories, Inc., Sysmex Corporation, Quest Diagnostics Incorporated |
Measurement of therapeutic outcomes are critical for the successful adoption of a given cancer therapeutic regime. Therefore, MRD testing is increasingly used as an end-point analysis step in numerous clinical trial studies for oncology-based research and also effectively records the variations in outcomes due to individual genetic characteristics. For instance, in November 2020, Adaptive Biotechnologies Corporation, entered into a collaboration with GlaxoSmithKline plc., to use its clonoSEQ assay for the assessment of residual cancer cells after treatment with GSK’s hematology therapeutics.
Surgical removal of a tumor with other associative therapies does not essentially mean, that the cancerous cells are removed completely. Traces of cancer can still remain in the body parts and bloodstream. The diagnosis of such residual cells are crucial for deciding upon the need for further rounds of chemotherapy and radiation. Researchers are devising non-invasive tests to effectively detect MRD. For instance, in February 2022, a blood test from C2i Genomics quantified the residual cancer cells after surgical oncology procedures. The C2inform test also achieved the CE mark clearance and is offered as a ‘software-as-a-medical-device’ MRD test in Europe.
Potential MRD diagnostics play a crucial role to make effective individual and long-term clinical decisions after the core cancer therapy. Moreover, MRD diagnostics efficiency is also important for healthcare insurance companies to effectively offer financial assistance to cancer survivors across the globe. For instance, in November 2021, Palmetto GBA’s Molecular Diagnostics Program (MolDX) determined a medical expense cover that supported patients with multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and B-cell acute lymphoblastic leukemia (ALL) for effectively monitoring the presence of residual cancer cells using the clonoSEQ platform.
Numerous MRD tests for the detection of residual solid tumors require tissue biopsy samples and deployment of patient-specific assays, which consumes longer turn-around time. Therefore, blood sample-based MRD detection assays are preferred. For instance, in January 2021 GRAIL, Inc., signed into a collaboration with Amgen, AstraZeneca, and Bristol Myers Squibb for evaluation of its MRD detection technology that is based on methylation.
Cancer therapeutics are effectively moderated to avoid leaving a residue of tumorous cells using the most relevant clinical evidence and are also personalized based on specific progression profiles in an individual. Numerous research studies are rising the need for consideration of individual genetic characteristics for effective treatment. For instance, in February 2021, Natera Inc., collaborated with Personalis Inc., to understand the outcomes of personalized cancer care by integrating the NeXT tumor profiling (by Personalis) and the personalized ctDNA platform Signatera’s diagnostic products (by Natera, Inc.,) for effectively designing the treatment monitoring regime and assessment of MRD.
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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.
Key Questions
- What are the major market drivers, challenges, and opportunities and their respective impacts in the global MRD testing market?
- What is the potential impact of biotechnological advancement in the diagnostic industry among end users, such as physicians, researchers, pathologists, and laboratory technicians?
- What is the current market demand along with future expected demand for the global MRD testing market?
- Has MRD testing penetrated major countries facing an immense burden from hematological malignancies?
- What are the key regulatory hurdles for industry players looking to enter this highly dynamic market?
- What are the key development strategies that are implemented by the major players in order to sustain in the competitive market?
- How is each segment of the market expected to grow during the forecast period from 2020 to 2025 based on each segment?
- Technology (flow cytometry, PCR, NGS, and other technologies)
- Application (hematological malignancy and solid tumor)
- End user (specialty clinics and hospitals, diagnostic laboratories, research institutions, and other end users)
- Region (North America, Europe, Asia-Pacific, Latin America & Middle East, and Rest-of-the-World)
- Which are the leading players with significant offerings to the global MRD testing market? What is the expected market dominance for each of these leading players?
- Which emerging companies are anticipated to be highly disruptive in the future, and what are their key strategies for sustainable growth in the global MRD testing market?
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Key Players
- Adaptive Biotechnologies Corporation
- Bio-Rad Laboratories, Inc.
- Arup Laboratories
- F. Hoffmann- La Roche Ltd
- Cergentis B.V.
- Guardant Health
- ICON plc
- Laboratory Corporation of America Holdings
- Invivoscribe, Inc.
- Mission Bio, Inc.
- Opko Health
- Natera, Inc.
- NeoGenomics Laboratories, Inc.
- Sysmex Corporation
- Quest Diagnostics Incorporated
Market Segmentation
By Technology
- Next Generation Sequencing (NGS)
- Polymerase Chain Reaction (PCR)
- Flow Cytometry
- Others
By Cancer Type
- Haematological Malignancy
- Solid Tumour
By End use
- Hospitals & Diagnostic Laboratories
- Academic & Research Institutes
- Others
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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