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市场调查报告书
商品编码
1662812
2030 年微量残存疾病市场预测:按产品、样本类型、临床效用、技术、最终用户和地区进行的全球分析Minimal Residual Disease Market Forecasts to 2030 - Global Analysis By Offering (Hematological Malignancies and Solid Tumors), Sample Type, Clinical Utility, Technology, End User and By Geography |
根据 Stratistics MRC 的数据,全球微量残存疾病市场预计在 2024 年将达到 19.6 亿美元,预计到 2030 年将达到 45.1 亿美元,预测期内的复合年增长率为 14.88%。
微量残存疾病(MRD)是白血病、淋巴瘤和多发性骨髓瘤等血癌的重要标誌。 MRD 可帮助医生了解治疗效果,并协助他们做出未来治疗的决策。流式细胞技术、聚合酵素链锁反应(PCR) 和次世代定序(NGS) 等先进技术能够灵敏地检测 MRD,从而实现个人化治疗调整、早期疗育并改善患者的长期预后。此外,MRD 是指治疗后仍残留在患者体内的少量癌细胞,无法透过传统的影像检查或实验室检测检测到,但可能导致疾病復发。
根据BD Biosciences介绍,MRD是急性淋巴性白血病和多发性骨髓瘤等血癌临床检测的重要生物标记物,敏感性和特异性值通常超过95%。
个性化医疗的传播
随着精准肿瘤学变得越来越普及,对 MRD 检测的需求也日益增加。 MRD 检测透过准确识别残留疾病,可以实现个人化治疗调整,例如,降低復发风险低患者的治疗强度,增加復发风险高患者的治疗剂量。这种方法可以改善患者的治疗效果,同时减少不必要治疗的副作用和经济负担。此外,由于 MRD 测试被纳入精准医疗框架,市场正在扩大。
昂贵的 MRD 检测
MRD 检测的高成本是阻碍其广泛应用的主要障碍之一。数位 PCR、多参数流式细胞技术和下一代定序 (NGS) 等先进方法成本高昂,因为它们需要专门的设备、化学品和熟练的劳动力。根据所使用的技术和测试的标记数量,每次 MRD 测试的费用从几百美元到数千美元不等。对于资源不足的卫生系统来说,负担能力仍然是一个问题,特别是在开发中国家。此外,对接受长期治疗的癌症患者进行 MRD 定期监测会进一步增加成本并限制治疗机会。
扩大固体癌的 MRD 检测
儘管微量残存疾病检测已广泛应用于骨髓恶性肿瘤,但在固体癌中的应用仍提供了巨大的成长机会。循环肿瘤DNA (ctDNA) 分析是识别前列腺癌、结肠癌、肺癌和乳腺癌等固体癌中的 MRD 的一种有前途的方法。与传统成像方法相比,透过 ctDNA 检测 MRD 可以在肿瘤出现在扫描中之前检测分子復发,从而实现早期干预。此外,Foundation Medicine、Natera 和 Guardant Health 等公司对固体癌MRD 检测的投资正在刺激新癌症类型的研究和商业性扩展。
严格的监管要求
MRD 测试受到严格的监管审查,因为其临床应用影响重要的癌症治疗决策。在核准MRD检测法之前,欧洲药品管理局 (EMA)、美国食品药物管理局(FDA) 等监管机构以及其他国际医疗机构都要求进行彻底的临床检验。监管核准过程漫长且成本高昂,这可能会延迟新产品的推出。此外,由于不同地区法律规范不同,寻求国际企业发展的公司面临合规挑战。不遵守不断变化的监管要求可能会导致产品召回、处罚和市场准入限制。
COVID-19 疫情以多种方式影响了微小残留疾病 (MRD) 市场。最初,封锁和医疗系统负担过重导致实验室测试、癌症筛检和诊断程序被暂停。许多非紧急的癌症监测测试,例如 MRD 评估,已被降低优先顺序或推迟,导致测试量减少。然而,这次疫情也激发了人们对非侵入性MRD检测技术的兴趣,例如循环肿瘤DNA (ctDNA) 分析,透过加速远端监控、液态切片的采用和分散实验室检测的发展。此外,疫情爆发后,人们对精准医疗和肿瘤学研究的关注度不断提高,这也再次证明了 MRD 检测的重要性,从而带来了新的投资、监管支持和技术发展,推动了市场扩张。
预测期内,检测试剂套件和试剂部分预计将达到最大幅度成长。
预计在预测期内,检测试剂套件和试剂部分将占据市场占有率。这些检测套件和试剂是 MRD 检测中经常采用的方法所必需的,包括流式细胞技术、聚合酵素链锁反应(PCR) 和下一代定序 (NGS)。它们的重复使用确保了它们在医院、研究机构和诊断实验室的持续使用,从而支持它们在市场上继续占据主导地位。此外,用于检测残留癌细胞痕迹的高灵敏度和特异性试剂的开发进一步推动了该细分市场的成长,成为 MRD 市场的重要收益驱动力。
治疗反应评估部分预计在预测期内以最高复合年增长率成长
预计治疗反应评估部分在预测期内将呈现最高的成长率。 MRD 检测在评估免疫疗法、标靶治疗和化疗方案的疗效方面的应用日益广泛,这推动了这个市场的发展。数位 PCR 和次世代定序(NGS) 的发展现在使临床医生能够根据 MRD 状态即时调整治疗方案,从而有可能改善患者的治疗效果并减少不必要的治疗毒性。此外,监管部门核准MRD 作为临床试验和市场开发的生物标记也推动了该市场的成长,加速了其纳入癌症治疗方案。
在预测期内,北美预计将占据最大的市场占有率,这得益于其先进的医疗基础设施、精准医疗的高度采用以及对癌症研究的强劲投资。该地区骨髓恶性肿瘤发生率高,诊断实验室声誉良好,并且可以轻鬆获得用于 MRD 检测的数位 PCR 和次世代定序 (NGS) 等最尖端科技。此外,美国FDA 的支持性法规、使用 MRD 作为生物标记的临床试验数量的增加以及製药和诊断公司之间日益增长的伙伴关係,都有助于北美市场在 MRD 中占据主导地位。
预计预测期内亚太地区将呈现最高的复合年增长率。这是由于癌症发生率的增加、医疗设施的改善以及尖端诊断工具的使用增加。随着中国、印度和日本等国家大力投资精准医疗和肿瘤学研究,对 MRD 检测的需求也随之增加。此外,政府改善癌症诊断的措施、增加医疗保健支出以及提高对早期癌症检测的认识也推动了市场的成长。该地区的外国诊断公司和当地医疗保健提供者之间的合作也在增加,预计将提高 MRD 技术的采用和可近性。
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%.
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.
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.
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.
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.
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.
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.
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.
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.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.