MRD検査市場 - 世界および地域の分析：技術・ターゲット検出・エンドユーザー・地域別の分析・予測 (2023-2033年)

世界のMRD検査の市場規模は、2023年に16億7,000万米ドルから、予測期間中は14.81%のCAGRで推移し、2033年には66億7,000万米ドルに成長すると予測されています。

MRD検査の市場は、医療保険の適用拡大や固形癌診断の行政管理など、いくつかの要因によって牽引されています。近年、消費者の意識が高まるにつれ、MRD検査に対する需要が増加しています。ヘルスケアプロバイダーや研究者はこの動向を認識し、MRD検査を臨床診療に組み込むことで患者の期待に応えようと努力しています。

市場の分類

セグメンテーション1：技術別

• フローサイトメトリー
• ポリメラーゼ連鎖反応 (PCR)
• 次世代シーケンシング(NGS)
• その他の技術

技術別では、フローサイトメトリーの部門が2022年に35.14%のシェアを示し、優位性を示しています。同部門の成長は、白血病関連表現型 (LAP) の同定やMRD患者における治療の予後的意義の推定のための高感度10色および12色フローサイトメトリーアッセイの開発など、マルチパラメトリックフローサイトメトリーにおける最近の技術革新によるものです。

セグメンテーション2：ターゲット検出別

• 固形腫瘍
• 白血病
• リンパ腫

ターゲット検出別では、白血病の部門が2022年に52.71％のシェアを示しています。

セグメンテーション3：エンドユーザー別

• 病院および専門クリニック
• 研究機関
• 診断ラボ
• その他のエンドユーザー

エンドユーザー別では、病院および専門クリニックの部門が2022年に44.38%のシェアを示し、予測期間中は最大の成長を示すと予測されています。病院は、日常的な医療処置において固形癌や血液悪性腫瘍の残存細胞を検出するために、MRD検査キットやサービスを多く使用しています。特に腫瘍の分野では、病院によるさまざまな検査アッセイの採用が進んでいます。

セグメンテーション4：地域別

• 北米：米国、カナダ
• 欧州：ドイツ、フランス、英国、イタリア、スペイン、その他
• アジア太平洋：中国、インド、日本、韓国、オーストラリア、シンガポール、その他
• ラテンアメリカ：ブラジル、メキシコ、サウジアラビア、その他・中東
• その他の地域

地域別では、中国がアジア太平洋地域の主要国として優位を保っています。2022年のアジア太平洋地域のMRD検査市場では、中国が36.08％のシェアを占めました。アジア太平洋地域の癌患者数の大幅な増加や人々の健康関連意識の高まりにより、市場は力強い成長局面を維持すると予想されています。

当レポートでは、世界のMRD検査の市場を調査し、市場概要、市場影響因子の分析、法規制・償還環境、市場規模の推移・予測、各種区分・地域別の詳細分析、競合情勢、主要企業の分析などをまとめています。

目次

エグゼクティブサマリー

第1章 市場

第2章 市場概要

• MRDテストのワークフロー分析
• MRD検査：固形腫瘍 vs 血液悪性腫瘍
• MRD検査の進化
• 市場フットプリント
• 市場規模と今後の成長可能性

第3章 業界考察

• MRD検査の法的および規制の枠組み
• 償還シナリオ
• サプライチェーン分析

第4章 市場力学

• 概要
• 市場促進要因
• 市場の課題
• 市場機会

第5章 競合考察

• 概要
• 主要な戦略と展開
• 企業シェア分析
• 成長シェア分析

第6章 世界のMRD (微小残存病変) 検査市場：技術別

• 概要
• フローサイトメトリー
• ポリメラーゼ連鎖反応 (PCR)
• 次世代シーケンス (NGS)
• その他の技術

第7章 世界のMRD (微小残存病変) 検査市場：ターゲット検出別

• 概要
• 白血病
  • 多発性骨髄腫
  • 急性リンパ性白血病
  • 慢性リンパ性白血病
  • 急性骨髄性白血病
  • 慢性骨髄性白血病
  • その他の白血病
• リンパ腫
  • 非ホジキンリンパ腫
  • ホジキンリンパ腫
• 固形腫瘍
  • 結腸直腸癌
  • 乳癌
  • 肺癌
  • その他の癌

第8章 世界のMRD (微小残存病変) 検査市場：エンドユーザー別

• 概要
• 病院・専門クリニック
• 診断ラボ
• 研究機関
• その他

第9章 世界のMRD (微小残存病変) 検査市場：地域別

• 概要
• 北米
• 欧州
• アジア太平洋
• ラテンアメリカ・中東
• その他の地域

第10章 企業プロファイル

• MRD Testing Ecosystem Active Players
• 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

List of Figures

• Figure 1: Global MRD Testing Market, $Billion, 2022 and 2033
• Figure 2: Share of Global MRD Testing Market (by Technology), $Billion, 2022 and 2033
• Figure 3: Share of Global MRD Testing Market (by Target Detection), $Billion, 2022 and 2033
• Figure 4: Share of Global MRD Testing Market (by End User), $Billion, 2022 and 2033
• Figure 5: Share of Global MRD Testing Market (by Region), 2022
• Figure 6: Global MRD Testing Market Segmentation
• Figure 7: Global MRD Testing Market: Research Methodology
• Figure 8: Primary Research Methodology
• Figure 9: Bottom-Up Approach (Segment-Wise Analysis)
• Figure 10: Top-Down Approach (Segment-Wise Analysis)
• Figure 11: MRD Testing Workflow
• Figure 12: Evolution of the MRD Testing Market
• Figure 13: Global MRD Testing Market Potential, $Billion, 2022-2033
• Figure 14: Biomarker Evaluation and Evidentiary Considerations
• Figure 15: Regulatory Submissions for the Use of Minimal Residual Disease as a Biomarker
• Figure 16: Laboratory Methods for MRD Detection
• Figure 17: Methods to Achieve Coverage
• Figure 18: Supply Chain Analysis of Laboratory-Developed Tests
• Figure 19: Supply Chain Analysis of In-Vitro Diagnostics
• Figure 20: Global MRD Testing Market Dynamics
• Figure 21: Growth of MRD Solutions Showcasing Increasing Number of Tests
• Figure 22: Estimated New Cancer Cases and Deaths in the U.S., 2022
• Figure 23: Patents Related to Companion Diagnostics Products Involved in MRD Testing, 2019-2023
• Figure 24: Clinical Trials Undertaken by Adaptive Biotechnologies for MRD Testing, 2022
• Figure 25: Share of Key Developments and Strategies, January 2020-January 2024
• Figure 26: Share of Synergistic Activities (by Company), January 2020-January 2024
• Figure 27: Share of Product Launches and Product Approvals (by Company), January 2020-January 2024
• Figure 28: Share of Business Expansion (by Company), January 2020-January 2024
• Figure 29: Merger and Acquisition (by Company), January 2020-January 2024
• Figure 30: Share of Funding and Other Activities (by Company), January 2020-January 2024
• Figure 31: Global MRD Testing Market, Company Share Analysis, 2022
• Figure 32: Global MRD Testing Market, Growth Share Analysis, (by Technology), 2023-2033
• Figure 33: Global MRD Testing Market (by Technology), $Billion, 2022-2033
• Figure 34: Global MRD Testing Market (by Technology), Thousand Units, 2022-2033
• Figure 35: MRD Detection by Multiparametric Flow Cytometry (MFC)
• Figure 36: Global MRD Testing Market (Flow Cytometry), $Billion, 2022-2033
• Figure 37: Global MRD Testing Market (Flow Cytometry), Thousand Units, 2022-2033
• Figure 38: Global Minimal Residual Disease Testing Market (PCR), $Billion, 2022-2033
• Figure 39: Global MRD Testing Market (PCR), Thousand Units, 2022-2033
• Figure 40: Global MRD Testing Market (NGS), $Billion, 2022-2033
• Figure 41: High-Throughput Sequencing Workflow for MRD Monitoring
• Figure 42: Global MRD Testing Market (NGS), Thousand Units, 2022-2033
• Figure 43: Global MRD Testing Market (Other Technologies), $Billion, 2022-2033
• Figure 44: Global MRD Testing Market (Other Technologies), Thousand Units, 2022-2033
• Figure 45: Global MRD Testing Market (by Target Detection)
• Figure 46: Global MRD Testing Market (by Target Detection), $Billion, 2022-2033
• Figure 47: Global MRD Testing Market (by Target Detection), $Billion, 2022-2033
• Figure 48: Global MRD Testing Market (by Target Detection), Thousand Units, 2022-2033
• Figure 49: Global MRD Testing Market (Leukemia), $Billion, 2022-2033
• Figure 50: Global MRD Testing Market (Multiple Myeloma), $Million, 2022-2033
• Figure 51: Global MRD Testing Market (Acute Lymphoblastic Leukemia), $Million, 2022-2033
• Figure 52: Global MRD Testing Market (Chronic Lymphoblastic Leukemia), $Million, 2022-2033
• Figure 53: Global MRD Testing Market (Acute Myeloid Leukemia), $Million, 2022-2033
• Figure 54: Global MRD Testing Market (Chronic Myeloid Leukemia), $Million, 2022-2033
• Figure 55: Global MRD Testing Market (Other Leukemia), $Million, 2022-2033
• Figure 56: Global MRD Testing Market (Lymphoma), $Billion, 2022-2033
• Figure 57: Global MRD Testing Market (Non-Hodgkin's Lymphoma), $Million, 2022-2033
• Figure 58: Global MRD Testing Market (HL), $Million, 2022-2033
• Figure 59: Global MRD Testing Market (Solid Tumor), $Billion, 2022-2033
• Figure 60: Global MRD Testing Market (Solid Tumor), Thousand Units, 2022-2033
• Figure 61: Global MRD Testing Market (Colorectal Cancer), $Million, 2022-2033
• Figure 62: Global MRD Testing Market (Breast Cancer), $Million, 2022-2033
• Figure 63: Global MRD Testing Market (Lung Cancer), $Million, 2022-2033
• Figure 64: Global MRD Testing Market (Other Cancer), $Million, 2022-2033
• Figure 65: Global MRD Testing Market (by End User), $Billion, 2022-2033
• Figure 66: Global MRD Testing Market (by End User), Thousand Units, 2022-2033
• Figure 67: Global MRD Testing Market (Hospitals and Specialty Clinics), $Billion, 2022-2033
• Figure 68: Global MRD Testing Market (Hospitals and Specialty Clinics), Thousand Units, 2022-2033
• Figure 69: Global MRD Testing Market (Diagnostic Laboratories), $Billion, 2022-2033
• Figure 70: Global MRD Testing Market (Diagnostic Laboratories), Thousand Units, 2022-2033
• Figure 71: Global MRD Testing Market (Research Institutions), $Billion, 2022-2033
• Figure 72: Global MRD Testing Market (Research Institutions), Thousand Units, 2022-2033
• Figure 73: Global MRD Testing Market (Others), $Billion, 2022-2033
• Figure 74: Global MRD Testing Market (Others), Thousand Units, 2022-2033
• Figure 75: Global MRD Testing Market Snapshot (by Region)
• Figure 76: Global MRD Testing Market (by Region), Thousand Units, 2022-2033
• Figure 77: North America MRD Testing Market, $Billion, 2023-2033
• Figure 78: North America: Market Dynamics
• Figure 79: North America MRD Testing Market (by End User), $Million, 2022-2033
• Figure 80: North America MRD Testing Market (by Country), $Million, 2022-2033
• Figure 81: U.S. MRD Testing Market, $Million, 2022-2033
• Figure 82: Canada MRD Testing Market, $Million, 2022-2033
• Figure 83: Europe MRD Testing Market, $Billion, 2022-2033
• Figure 84: Europe: Market Dynamics
• Figure 85: Europe MRD Testing Market (by End User), $Million, 2022-2033
• Figure 86: Europe MRD Testing Market (by Country), $Million, 2022-2033
• Figure 87: Germany MRD Testing Market, $Million, 2022-2033
• Figure 88: France MRD Testing Market, $Million, 2022-2033
• Figure 89: U.K. MRD Testing Market, $Million, 2022-2033
• Figure 90: Italy MRD Testing Market, $Million, 2022-2033
• Figure 91: Spain MRD Testing Market, $Million, 2022-2033
• Figure 92: Rest-of-Europe MRD Testing Market, $Million, 2022-2033
• Figure 93: Asia-Pacific: Market Dynamics
• Figure 94: Asia-Pacific MRD Testing Market, $Billion, 2022-2033
• Figure 95: Asia-Pacific MRD Testing Market (by End User), $Million, 2022-2033
• Figure 96: Asia-Pacific MRD Testing Market (by Country), $Million, 2022-2033
• Figure 97: China MRD Testing Market, $Million, 2022-2033
• Figure 98: India MRD Testing Market, $Million, 2022-2033
• Figure 99: Japan MRD Testing Market, $Million, 2022-2033
• Figure 100: South Korea MRD Testing Market, $Million, 2022-2033
• Figure 101: Australia MRD Testing Market, $Million, 2022-2033
• Figure 102: Singapore MRD Testing Market, $Million, 2022-2033
• Figure 103: Rest-of-Asia-Pacific MRD Testing Market, $Million, 2022-2033
• Figure 104: Latin America: Market Dynamics
• Figure 105: Latin-America and Middle East MRD Testing Market, $Billion, 2022-2033
• Figure 106: Latin America and Middle East MRD Testing Market (by End User), $Million, 2022-2033
• Figure 107: Latin America and Middle East MRD Testing Market (by Country), $Million, 2022-2033
• Figure 108: Brazil MRD Testing Market, $Million, 2022-2033
• Figure 109: Mexico MRD Testing Market, $Million, 2022-2033
• Figure 110: Saudi Arabia MRD Testing Market, $Million, 2022-2033
• Figure 111: Rest-of-Latin America and Middle East MRD Testing Market, $Million, 2022-2033
• Figure 112: Rest-of-the-World MRD Testing Market, $Billion, 2022-2033
• Figure 113: Rest-of-the-World MRD Testing Market (by End User), $Million, 2022-2033
• Figure 114: Global MRD Testing Market, Total Number of Companies Profiled
• Figure 115: Adaptive Biotechnologies: Product Portfolio
• Figure 116: Adaptive Biotechnologies: Overall Financials, $Million, 2020-2022
• Figure 117: Adaptive Biotechnologies: R&D Expenditure, $Million, 2020-2022
• Figure 118: ARUP Laboratories: Product Portfolio
• Figure 119: Bio-Rad Laboratories, Inc.: Product Portfolio
• Figure 120: Bio-Rad Laboratories, Inc.: Overall Financials, $Million, 2020-2022
• Figure 121: Bio-Rad Laboratories, Inc.: R&D Expenditure, $Million, 2020-2022
• Figure 122: Cergentis B.V.: Product Portfolio
• Figure 123: F. Hoffmann-La Roche Ltd: Product Portfolio
• Figure 124: F. Hoffmann-La Roche Ltd: Overall Financials, 2020-2022
• Figure 125: F. Hoffmann-La Roche Ltd: R&D Expenditure, 2020-2022
• Figure 126: Guardant Health, Inc.: Product Portfolio
• Figure 127: Guardant Health, Inc.: Overall Financials, $Million, 2020-2022
• Figure 128: Guardant Health, Inc.: R&D Expenditure, $Million, 2020-2022
• Figure 129: Invivoscribe, Inc.: Product Portfolio
• Figure 130: Laboratory Corporation of America Holdings.: Product Portfolio
• Figure 131: Laboratory Corporation of America Holdings.: Overall Financials, $Million, 2020-2022
• Figure 132: Mission Bio, Inc.: Product Portfolio
• Figure 133: ICON plc: Product Portfolio
• Figure 134: ICON plc: Overall Financials, $Million, 2020-2022
• Figure 135: Natera, Inc.: Portfolio
• Figure 136: Natera, Inc.: Overall Financials, $Million, 2020-2022
• Figure 137: Natera, Inc.: R&D Expenditure, $Million, 2020-2022
• Figure 138: NeoGenomics Laboratories, Inc.: Portfolio
• Figure 139: NeoGenomics Laboratories, Inc.: Overall Financials, $Million, 2020-2022
• Figure 140: NeoGenomics Laboratories, Inc.: R&D Expenditure, $Million, 2020-2022
• Figure 141: OPKO Health, Inc.: Product Portfolio
• Figure 142: OPKO Health, Inc.: Overall Financials, $Million, 2020-2022
• Figure 143: OPKO Health, Inc.: R&D Expenditure, $Million, 2020-2022
• Figure 144: Quest Diagnostics Incorporated.: Product Portfolio
• Figure 145: Quest Diagnostics Incorporated: Overall Financials, $Million, 2020-2022
• Figure 146: Sysmex Corporation: Product Portfolio
• Figure 147: Sysmex Corporation: Overall Financials, $Million, 2020-2022
• Figure 148: Sysmex Corporation: R&D Expenditure, $Million, 2020-2022

List of Tables

• Table 1: Impact Analysis of Market Drivers, Challenges, and Opportunities in the Global MRD Testing Market
• Table 2: Comparison of Solid Tumor and Hematological Malignancy for MRD Testing
• Table 3: Comparison of FDA and EMA Draft Guidance
• Table 4: Registration Criteria for IVD Medical Devices as per CFDA
• Table 5: Key Coverage Providers for Hematologic Malignancies Testing
• Table 6: Products used for Solid Tumor MRD Diagnosis
• Table 7: Expansion of Medicare Coverage for MRD Tests by Companies
• Table 8: Classification of MRD Test Results by True Relapse State Without Further Treatment in 2019
• Table 9: Average Price of MRD Testing
• Table 10: Comparison of Different Methods for Minimal Residual Disease Testing
• Table 11: Key Products Offered by Companies Based on Flow Cytometry
• Table 12: Key Products Offered by the Companies Based on PCR
• Table 13: Key Products Offered by Companies Based on NGS
• Table 14: Ongoing Initiatives to Generate Evidence for MRD Test in AML Patients
• Table 15: Molecular Techniques used for MRD Assessment in NHL Patients
• Table 16: Few Examples of Facilities Conducting MRD Testing

The Global MRD Testing Market Expected 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 MRD testing market was valued at $1.67 billion in 2023 and is expected to reach $6.67 billion by 2033, growing at a CAGR of 14.81% between 2023 and 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 practices.

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 expanding 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 has been led by flow cytometry in the technology segment, which held a 35.14% 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 others. 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

• Solid Tumor
• Leukemia
• Lymphoma

As of 2022, the global MRD testing market (by target detection) was dominated by the leukemia segment, holding a 52.71% market share.

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, which held 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 has been a 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 - Brazil, Mexico, Saudi Arabia, Rest-of-Latin America and Middle East
• Rest-of-the-World (RoW)

China to Continue its Dominance as the Leading Country in Asia-Pacific Region

China dominated the Asia-Pacific MRD testing market in 2022 with a share of 36.08%. Although the market is expected to remain in a strong growth phase due to the massively growing number of cancer cases and the rising health-related awareness among people in Asia-Pacific, a significant barrier to the increasing adoption is an uneven economic balance among countries within the region. However, the growth in MRD testing is expected to be tremendous in the regional market due to the substantial commercial growth of emerging companies, high-profile publications, and the establishment of multidisciplinary consortiums aiming to accelerate standardization and harmonization of regulatory consensus for an emerging field.

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.

Demand - Drivers and Limitations

Market Demand Drivers:

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

Market Challenges:

• Substantially High Cost of MRD Tests
• Early-Risk of Progression and Relapse due to MRD Negative Result

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 for currently available tests and their global potential. Moreover, the study provides the reader with a detailed understanding of the global MRD testing market based on end-user, technology, and target detection.

Growth/Marketing Strategy: The MRD testing market has seen major development by key players operating in the market, such as business expansions, partnerships, collaborations, and joint ventures. 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 enhanced 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 analyzed and profiled in the MRD testing market 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.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

• Detailed secondary research has been done to ensure maximum coverage of manufacturers/suppliers operational in a country.
• Exact revenue information, up to a certain extent, has been extracted for each company from secondary sources and databases. Revenues specific to product/service/technology were then estimated for each market player based on fact-based proxy indicators as well as primary inputs.
• Based on the classification, the average selling price (ASP) has been calculated using the weighted average method.
• The currency conversion rate has been taken from the historical exchange rate of Oanda and/or other relevant websites.
• Any economic downturn in the future has not been taken into consideration for the market estimation and forecast.
• The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations, considering the average conversion rate for that particular year.
• The term "product" in this document may refer to "service" or "technology" as and where relevant.
• The term "manufacturers/suppliers" may refer to "service providers" or "technology providers" as and where relevant.

Primary Research

The key data points taken from the primary research include:

• Validation and triangulation of all the numbers and graphs
• Validation of the report's segmentation and key qualitative findings
• Understanding of the numbers of the various markets for market type
• Percentage split of individual markets for regional analysis

Secondary Research

The key data points taken from the secondary research include:

• segmentations, split-ups, and percentage shares
• data for market value
• quantitative data for mathematical and statistical calculations
• key industry trends of the top players in the market
• qualitative insights into the market trends given in addition to emerging areas of innovation.

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 market share. 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 market presence.

Some prominent names established in this market are:

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

Table of Contents

Executive Summary

1 Markets

• 1.1 Product Definition
• 1.2 Inclusion and Exclusion Criteria
• 1.3 Market Scope
  • 1.3.1 Scope of the Study
  • 1.3.2 Key Questions Answered in the Report
• 1.4 Research Methodology
  • 1.4.1 Global MRD Testing Market: Research Methodology
  • 1.4.2 Data Sources
    • 1.4.2.1 Primary Data Sources
    • 1.4.2.2 Secondary Data Sources
• 1.5 Market Estimation Model
  • 1.5.1 Criteria for Company Profiling

2 Market Overview

• 2.1 MRD Testing Workflow Analysis
• 2.2 MRD Testing: Solid Tumor vs. Hematological Malignancy
• 2.3 Evolution of MRD Testing
• 2.4 Market Footprint
• 2.5 Market Size and Future Growth Potential

3 Industry Insights

• 3.1 Legal and Regulatory Framework of MRD Tests
  • 3.1.1 U.S.
  • 3.1.2 Europe
  • 3.1.3 Asia-Pacific
    • 3.1.3.1 Japan
    • 3.1.3.2 China
    • 3.1.3.3 India
• 3.2 Reimbursement Scenario
  • 3.2.1 North America
  • 3.2.2 European Union
  • 3.2.3 Asia-Pacific
• 3.3 Supply Chain Analysis
  • 3.3.1 For Laboratory Developed Tests (LDTs)
  • 3.3.2 For In-Vitro Diagnostics (IVDs)

4 Market Dynamics

• 4.1 Overview
• 4.2 Market Drivers
  • 4.2.1 Advent of MRD Testing and its Awareness among Consumers
  • 4.2.2 Increasing Incidence of Cancer Cases Demanding MRD Testing
  • 4.2.3 Rise in Administration of Solid Tumor Diagnosis in MRD Testing Ecosystem
  • 4.2.4 Expanding Medicare Coverage for MRD Testing
• 4.3 Market Challenges
  • 4.3.1 Early-Risk of Progression and Relapse due to MRD Negative Results
  • 4.3.2 Substantially High Cost of MRD Testing
• 4.4 Market Opportunities
  • 4.4.1 Advancements in the Development of Companion Diagnostics
  • 4.4.2 Rising Number of Clinical Trials in Prolonged MRD-Negative Treatment Decisions

5 Competitive Insights

• 5.1 Overview
• 5.2 Key Strategies and Developments
  • 5.2.1 Synergistic Activities
  • 5.2.2 Product Launches, Upgradations, and Approvals
  • 5.2.3 Business Expansion
  • 5.2.4 Mergers and Acquisitions
  • 5.2.5 Funding and Other Activities
• 5.3 Company Share Analysis
• 5.4 Growth Share Analysis

6 Global Minimal Residual Testing Market (by Technology), 2022-2033

• 6.1 Overview
• 6.2 Flow Cytometry
• 6.3 Polymerase Chain Reaction (PCR)
• 6.4 Next-Generation Sequencing (NGS)
• 6.5 Other Technologies

7 Global Minimal Residual Testing Market (by Target Detection), 2022-2033

• 7.1 Overview
• 7.2 Leukemia
  • 7.2.1 Multiple Myeloma
  • 7.2.2 Acute Lymphoblastic Leukemia
  • 7.2.3 Chronic Lymphocytic Leukemia
  • 7.2.4 Acute Myeloid Leukemia
  • 7.2.5 Chronic Myeloid Leukemia
  • 7.2.6 Other Leukemia
• 7.3 Lymphoma
  • 7.3.1 Non-Hodgkin's Lymphoma
  • 7.3.2 Hodgkin's Lymphoma
• 7.4 Solid Tumor
  • 7.4.1 Colorectal Cancer
  • 7.4.2 Breast Cancer
  • 7.4.3 Lung Cancer
  • 7.4.4 Other Cancer

8 Global Minimal Residual Disease Testing Market (by End User), 2022-2033

• 8.1 Overview
• 8.2 Hospitals and Specialty Clinics
• 8.3 Diagnostic Laboratories
• 8.4 Research Institutions
• 8.5 Others

9 Global Minimal Residual Disease Testing Market (by Region), 2022-2033

• 9.1 Overview
• 9.2 North America
  • 9.2.1 North America MRD Testing Market, by End User
  • 9.2.2 North America MRD Testing Market, by Country
    • 9.2.2.1 U.S.
    • 9.2.2.2 Canada
• 9.3 Europe
  • 9.3.1 Europe MRD Testing Market, by End User
  • 9.3.2 Europe MRD Testing Market, by Country
    • 9.3.2.1 Germany
    • 9.3.2.2 France
    • 9.3.2.3 U.K.
    • 9.3.2.4 Italy
    • 9.3.2.5 Spain
    • 9.3.2.6 Rest-of-Europe
• 9.4 Asia-Pacific
  • 9.4.1 Asia-Pacific MRD Testing Market, by End User
  • 9.4.2 Asia-Pacific MRD Testing Market, by Country
    • 9.4.2.1 China
    • 9.4.2.2 India
    • 9.4.2.3 Japan
    • 9.4.2.4 South Korea
    • 9.4.2.5 Australia
    • 9.4.2.6 Singapore
    • 9.4.2.7 Rest-of-Asia-Pacific
• 9.5 Latin America and Middle East
  • 9.5.1 Latin America and Middle East MRD Testing Market, by End User
  • 9.5.2 Latin America and Middle East MRD Testing Market, by Country
    • 9.5.2.1 Brazil
    • 9.5.2.2 Mexico
    • 9.5.2.3 Saudi Arabia
    • 9.5.2.4 Rest-of-Latin America (RoLATAM) and Middle East
• 9.6 Rest-of-the-World (RoW)
  • 9.6.1 Rest-of-the-World MRD Testing Market, by End User

10 Company Profiles

• 10.1 Overview
• 10.2 MRD Testing Ecosystem Active Players
• 10.3 Adaptive Biotechnologies
  • 10.3.1 Company Overview
  • 10.3.2 Role of Adaptive Biotechnologies in the Global MRD Testing Market
  • 10.3.3 Financials
  • 10.3.4 Recent Developments
  • 10.3.5 Analyst Perspective
• 10.4 ARUP Laboratories
  • 10.4.1 Company Overview
  • 10.4.2 Role of ARUP Laboratories in the Global MRD Testing Market
  • 10.4.3 Recent Developments
  • 10.4.4 Analyst Perspective
• 10.5 Bio-Rad Laboratories, Inc.
  • 10.5.1 Company Overview
  • 10.5.2 Role of Bio-Rad Laboratories, Inc. in the Global MRD Testing Market
  • 10.5.3 Financials
  • 10.5.4 Recent Developments
  • 10.5.5 Analyst Perspective
• 10.6 Cergentis B.V.
  • 10.6.1 Company Overview
  • 10.6.2 Role of Cergentis B.V. in the Global MRD Testing Market
  • 10.6.3 Analyst Perspective
• 10.7 F. Hoffmann-La Roche Ltd
  • 10.7.1 Company Overview
  • 10.7.2 Role of F. Hoffmann-La Roche Ltd in the Global MRD Testing Market
  • 10.7.3 Financials
  • 10.7.4 Recent Developments
  • 10.7.5 Analyst Perspective
• 10.8 Guardant Health, Inc.
  • 10.8.1 Company Overview
  • 10.8.2 Role of Guardant Health, Inc. in the Global MRD Testing Market
  • 10.8.3 Financials
  • 10.8.4 Recent Developments
  • 10.8.5 Analyst Perspective
• 10.9 Invivoscribe, Inc.
  • 10.9.1 Company Overview
  • 10.9.2 Role of Invivoscribe, Inc. in the Global MRD Testing Market
  • 10.9.3 Analyst Perspective
• 10.10 Laboratory Corporation of America Holdings
  • 10.10.1 Company Overview
  • 10.10.2 Role of Laboratory Corporation of America Holdings in the Global MRD Testing Market
  • 10.10.3 Financials
  • 10.10.4 Recent Developments
  • 10.10.5 Analyst Perspective
• 10.11 Mission Bio, Inc.
  • 10.11.1 Company Overview
  • 10.11.2 Role of Mission Bio, Inc. in the Global Minimal Residual Disease Testing Market
  • 10.11.3 Recent Developments
  • 10.11.4 Analyst Perspective
• 10.12 ICON plc
  • 10.12.1 Company Overview
  • 10.12.2 Role of ICON plc in the Global MRD Testing Market
  • 10.12.3 Financials
  • 10.12.4 Analyst Perspective
• 10.13 Natera, Inc.
  • 10.13.1 Company Overview
  • 10.13.2 Role of Natera, Inc. in the Global MRD Testing Market
  • 10.13.3 Financials
  • 10.13.4 Recent Developments
  • 10.13.5 Analyst Perspective
• 10.14 NeoGenomics Laboratories, Inc.
  • 10.14.1 Company Overview
  • 10.14.2 Role of NeoGenomics Laboratories, Inc. in the Global MRD Testing Market
  • 10.14.3 Financials
  • 10.14.4 Recent Developments
  • 10.14.5 Analyst Perspective
• 10.15 OPKO Health, Inc.
  • 10.15.1 Company Overview
  • 10.15.2 Role of OPKO Health, Inc. in the Global MRD Testing Market
  • 10.15.3 Financials
  • 10.15.4 Recent Developments
  • 10.15.5 Analyst Perspective
• 10.16 Quest Diagnostics Incorporated
  • 10.16.1 Company Overview
  • 10.16.2 Role of Quest Diagnostics Incorporated in the Global MRD Testing Market
  • 10.16.3 Financials
  • 10.16.4 Recent Developments
  • 10.16.5 Analyst Perspective
• 10.17 Sysmex Corporation
  • 10.17.1 Company Overview
  • 10.17.2 Role of Sysmex Corporation in the Global MRD Testing Market
  • 10.17.3 Financials
  • 10.17.4 Analyst Perspective