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市场调查报告书
商品编码
1842169
全球乳癌诊断市场:市场规模、份额、趋势分析(按产品、类型、应用、最终用途和地区划分)、细分市场预测(2025-2033 年)Breast Cancer Diagnostics Market Size, Share & Trends Analysis Report By Product (Platform-based, Instrument-based), By Type (Imaging, Biopsy, Genomic Tests, Blood Tests), By Application, By End-use, By Region, And Segment Forecasts, 2025 - 2033 |
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全球乳癌诊断市场预计在 2024 年达到 54.8 亿美元,预计到 2033 年将达到 113.6 亿美元,2025 年至 2033 年的复合年增长率为 8.6%。
这一增长归因于癌症发病率的上升以及政府为提高筛检和诊断率而采取的措施不断增加。
乳癌发生率的上升预计将推动乳癌诊断市场的发展。根据美国癌症协会发布的《2024年乳癌事实与数据》,乳癌仍是美国女性最常见的癌症。预计2024年将新增310,720例侵袭性乳癌病例,以及55,720例乳管原位癌(DCIS)病例。
多种因素导致乳癌发生率上升,包括人口老化、生活方式改变、遗传易感性和环境影响。随着预期寿命的延长,越来越多的女性步入乳癌高发生率。此外,肥胖、久坐不动的生活方式、荷尔蒙疗法和延迟生育等风险因素也与更高的乳癌发生率有关。公众意识的提高和筛检计画的改进使得更多癌症得以早期发现,从而增加了报告病例数。乳癌病例的增加凸显了对高效能精准诊断技术的需求。虽然乳房X光摄影仍然是乳癌筛检的黄金标准,但数位乳房断层合成(DBT)、造影乳房X光乳房X光摄影、超音波、磁振造影(MRI)和分子诊断检测等技术的进步推动了市场成长。人工智慧在影像解读的应用进一步提高了早期检测能力,提高了准确性,同时减少了假阳性和假阴性。此外,液态切片和基于生物标记的诊断方法已成为检测乳癌和监测治疗效果的非侵入性工具。
为了应对日益严重的乳癌负担,全球医疗卫生系统加大了对乳癌筛检计画的投入。各国政府和私人医疗机构扩大了诊断服务的覆盖范围,尤其是在筛检率历来较低的发展中地区。对早期检测和个人化医疗的重视加速了次世代定序仪(NGS)、基因检测和伴随诊断技术的应用。随着乳癌发病率的持续上升,乳癌诊断市场也经历了持续成长。技术的不断进步,以及筛检意识的提高和可及性的增强,推动了对能够实现更早期、更精准癌症检测的创新诊断解决方案的需求。
乳癌筛检报销和保险覆盖范围的扩大预计将推动市场成长。包括德国联邦联合委员会在内的多个国家政府机构已核准此项检测纳入全国报销范围。在美国,医疗补助计划(Medicaid)、医疗保险计划(Medicare)和第三方支付机构均涵盖乳癌基因检测(包括BRCA1和BRCA2基因检测)的费用,且全球范围内的检测数量正在增加。此外,医疗保险B部分(Medicare Part B)为40岁及以上女性每年一次的乳房X光摄影和数位乳房X光摄影检查提供80%的费用报销。
2025年2月,Agendia宣布,布鲁塞尔国家疾病与意外保险研究所(INAMI-RIZIV)已扩大MammaPrint的报销范围,将其用于新辅助治疗。自2025年1月1日起,该决定将使HR+/HER2阴性早期乳癌患者获得全额报销,从而使粗针穿刺切片的基因组检测能够指南新辅助治疗方案的製定。此次报销范围的扩大标誌着在为患者提供更个人化的医疗服务方面迈出了重要一步。布鲁塞尔自由大学肿瘤学荣誉教授马丁·皮卡特教授强调了这项进展的影响,她表示:“在比利时,MammaPrint技术应用于粗针穿刺切片检体是乳癌个性化治疗领域的一个重要里程碑。它在新辅助治疗方面具有显着优势,使医生能够更精准地制定治疗方案,尤其是在MammaPrint指导下。如果选择合适的治疗次数,这将有可能减少手术次数。
MammaPrint 在新辅助治疗中展现出卓越的性能,尤其是在 FLEX (NCT03053193) 等研究中。 FLEX 是一项前瞻性、真实世界观察性研究,以全转录组分析法研究乳癌。此检测方法在匹配的手术切除标本和穿刺活检标本之间显示出高度一致性,进一步增强了其临床效用。此适应症的扩大凸显了基因组检测在乳癌管理中的重要作用,有助于制定更精准的治疗策略。 Agendia执行长强调了此次医保覆盖范围扩大的重要意义,他表示:「MammaPrint 医保覆盖范围的扩大是抗击乳癌的重要一步。这一决定将使更多比利时女性能够获得 Agendia 的先进诊断解决方案,这些方案是製定个性化治疗方案的基础。我们感谢 INAMI-RIZIV 认可精准医疗效果的重要性,并期待继续致力于改善比利时乳癌的患者的效果。」
总体而言,技术的进步以及报销和保险覆盖范围的扩大,显着提高了乳癌的诊断水平,从而实现了早期发现、标靶治疗和患者预后改善。随着技术的不断发展,持续的研究和开发对于进一步提高乳癌的诊断水平至关重要。
The global breast cancer diagnostics market size was estimated at USD 5.48 billion in 2024 and is projected to reach USD 11.36 billion by 2033, growing at a CAGR of 8.6% from 2025 to 2033. The growth can be attributed to the increasing prevalence of cancer and rising government initiatives to increase the screening and diagnostic rate.
The increasing incidence of breast cancer is expected to drive the breast cancer diagnostics market. According to the American Cancer Society's Breast Cancer Facts & Figures 2024, breast cancer remained the most commonly diagnosed cancer among women in the United States. In 2024, an estimated 310,720 new cases of invasive breast cancer were expected to be diagnosed, along with 55,720 cases of ductal carcinoma in situ (DCIS).
Several factors contributed to the increasing incidence of breast cancer, including aging populations, lifestyle changes, genetic predisposition, and environmental influences. As life expectancy increased, more women reached ages where breast cancer risk was higher. Moreover, risk factors such as obesity, sedentary lifestyles, hormonal therapies, and delayed childbearing were linked to a greater likelihood of developing breast cancer. Increased awareness and improved screening programs also led to a rise in reported cases, as more cancers were detected at earlier stages. With the growing number of breast cancer cases, the need for effective and accurate diagnostic technologies expanded. Mammography remained the gold standard for breast cancer screening, but advancements in digital breast tomosynthesis (DBT), contrast-enhanced mammography, ultrasound, MRI, and molecular diagnostic tests drove market growth. The integration of AI in imaging interpretation further improved early detection capabilities, enhancing accuracy while reducing false positives and negatives. In addition, liquid biopsy and biomarker-based diagnostics emerged as non-invasive tools for detecting breast cancer and monitoring treatment response.
Healthcare systems worldwide increased investments in breast cancer screening programs to address the rising burden. Governments and private healthcare providers expanded access to diagnostic services, particularly in developing regions where screening rates had historically been lower. The focus on early detection and personalized medicine accelerated the adoption of next-generation sequencing (NGS), genetic testing, and companion diagnostics. As breast cancer incidence continued to rise, the breast cancer diagnostics market experienced sustained growth. Ongoing technological advancements, combined with greater awareness and improved accessibility to screening, drove demand for innovative diagnostic solutions that enabled earlier and more accurate cancer detection.
The increasing reimbursement and insurance coverage for breast cancer testing is anticipated to drive market growth. Government agencies in various countries, such as the German Federal Joint Committee, have approved tests for nationwide reimbursement. In the U.S., Medicaid, Medicare, and third-party payer benefit plans cover the cost of breast cancer genetic testing, including BRCA1 and BRCA2 tests, increasing the number of procedures conducted globally. Furthermore, Medicare Part B covers 80% of the cost of one mammogram and digital mammogram screening per year for women aged 40 and older.
In February 2025, Agendia, Inc. announced that the National Institute for Sickness and Invalidity Insurance (INAMI-RIZIV) in Brussels expanded the reimbursement criteria for MammaPrint, now covering its use in the neoadjuvant setting. Effective January 1, 2025, this decision allows full reimbursement for patients with HR+/HER2-negative early-stage breast cancer, enabling genomic testing on core needle biopsies to guide neoadjuvant treatment decisions. This expansion marks a significant step forward in providing patients with more personalized care. Professor Martine Piccart, Honorary Professor of Oncology at the Universite Libre de Bruxelles, highlighted the impact of this advancement, stating, "The ability to use MammaPrint on core needle biopsy specimens in Belgium represents a major milestone for personalized breast cancer treatment. The benefits of neoadjuvant therapy are substantial, especially when guided by MammaPrint, as it enables physicians to tailor treatment plans more precisely. This can lead to less extensive surgical procedures when the appropriate treatment is selected."
MammaPrint has demonstrated strong performance in the neoadjuvant setting, particularly through studies like FLEX (NCT03053193), a prospective, real-world observational breast cancer study utilizing whole transcriptome analysis. The assay has shown high concordance between matched surgical resection samples and core needle biopsy specimens, reinforcing its clinical utility. This expanded indication underscores the critical role of genomic testing in breast cancer management, supporting more precise treatment strategies. Chief Executive Officer at Agendia, emphasized the significance of this reimbursement expansion, stating, "The broader reimbursement of MammaPrint represents a major step forward in the fight against breast cancer. This decision ensures that more women in Belgium likely to access to Agendia's advanced diagnostic solutions, which serve as the foundation for personalized treatment decisions. We are grateful for INAMI-RIZIV's recognition of the importance of precision medicine and look forward to continuing our commitment to improving outcomes for breast cancer patients in Belgium.
Overall technological advancements, along with increasing reimbursement and insurance coverage, have significantly improved breast cancer diagnostics, leading to earlier detection, targeted treatments, and improved patient outcomes. Ongoing research and development efforts are essential to enhance breast cancer diagnostics further as technology continues to evolve.
Global Breast Cancer Diagnostics Market Report Segmentation
This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the global breast cancer diagnostics market report based on type, product, application, end use, and region: