![]() |
市場調查報告書
商品編碼
1842169
全球乳癌診斷市場:市場規模、佔有率、趨勢分析(按產品、類型、應用、最終用途和地區分類)、細分市場預測(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 |
||||||
全球乳癌診斷市場預計在 2024 年達到 54.8 億美元,預計到 2033 年將達到 113.6 億美元,2025 年至 2033 年的複合年成長率為 8.6%。
這一成長歸因於癌症發病率的上升以及政府為提高篩檢和診斷率而採取的措施不斷增加。
乳癌發生率的上升預計將推動乳癌診斷市場的發展。根據美國癌症協會發布的《2024年乳癌事實與數據》,乳癌仍是美國女性最常見的癌症。預計2024年將新增310,720例侵襲性乳癌病例,以及55,720例乳管原位癌(DCIS)病例。
多種因素導致乳癌發生率上升,包括人口老化、生活方式改變、遺傳易感性和環境影響。隨著預期壽命的延長,越來越多的女性步入乳癌高發生率。此外,肥胖、久坐不動的生活方式、荷爾蒙療法和延遲生育等風險因素也與更高的乳癌發生率有關。公眾意識的提高和篩檢計畫的改進使得更多癌症得以早期發現,從而增加了報告病例數。乳癌病例的增加凸顯了對高效能精準診斷技術的需求。雖然乳房X光攝影仍然是乳癌篩檢的黃金標準,但數位乳房斷層合成(DBT)、造影乳房X光乳房X光攝影、超音波、磁振造影(MRI)和分子診斷檢測等技術的進步推動了市場成長。人工智慧在影像解讀的應用進一步提高了早期檢測能力,提高了準確性,同時減少了假陽性和假陰性。此外,液態切片和基於生物標記的診斷方法已成為檢測乳癌和監測治療效果的非侵入性工具。
為了應對日益嚴重的乳癌負擔,全球醫療衛生系統加大了對乳癌篩檢計畫的投入。各國政府和私人醫療機構擴大了診斷服務的覆蓋範圍,尤其是在篩檢率歷來較低的發展中地區。對早期檢測和個人化醫療的重視加速了次世代定序儀(NGS)、基因檢測和伴隨診斷技術的應用。隨著乳癌發病率的持續上升,乳癌診斷市場也經歷了持續成長。技術的不斷進步,以及篩檢意識的提高和可及性的增強,推動了對能夠實現更早期、更精準癌症檢測的創新診斷解決方案的需求。
乳癌篩檢報銷和保險覆蓋範圍的擴大預計將推動市場成長。包括德國聯邦聯合委員會在內的多個國家政府機構已核准此項檢測納入全國報銷範圍。在美國,醫療補助計劃(Medicaid)、醫療保險計劃(Medicare)和第三方支付機構均涵蓋乳癌基因檢測(包括BRCA1和BRCA2基因檢測)的費用,且全球範圍內的檢測數量正在增加。此外,醫療保險B部分(Medicare Part B)為40歲及以上女性每年一次的乳房X光攝影和數位乳房X光攝影檢查提供80%的費用報銷。
2025年2月,Agendia宣布,布魯塞爾國家疾病與意外保險研究所(INAMI-RIZIV)已擴大MammaPrint的報銷範圍,將其用於新輔助治療。自2025年1月1日起,該決定將使HR+/HER2陰性早期乳癌患者獲得全額報銷,從而使粗針穿刺切片的基因組檢測能夠指南新輔助治療方案的製定。此次報銷範圍的擴大標誌著在為患者提供更個人化的醫療服務方面邁出了重要一步。布魯塞爾自由大學腫瘤學榮譽教授馬丁·皮卡特教授強調了這項進展的影響,她表示:“在比利時,MammaPrint技術應用於粗針穿刺切片檢體是乳癌個性化治療領域的一個重要里程碑。它在新輔助治療方面具有顯著優勢,使醫生能夠更精準地制定治療方案,尤其是在MammaPrint指導下。如果選擇合適的治療次數,這將有可能減少手術次數。
MammaPrint 在新輔助治療中展現出卓越的性能,尤其是在 FLEX (NCT03053193) 等研究中。 FLEX 是一項前瞻性、真實世界觀察性研究,以全轉錄組分析法研究乳癌。此檢測方法在匹配的手術切除標本和穿刺活體組織切片標本之間顯示出高度一致性,進一步增強了其臨床效用。此適應症的擴大凸顯了基因組檢測在乳癌管理中的重要作用,有助於制定更精準的治療策略。 Agendia執行長強調了此次醫保覆蓋範圍擴大的重要意義,他表示:「MammaPrint 醫保覆蓋範圍的擴大是抗擊乳癌的重要一步。這一決定將使更多比利時女性能夠獲得 Agendia 的先進診斷解決方案,這些方案是製定個性化治療方案的基礎。我們感謝 INAMI-RIZIV 認可精準醫療效果的重要性,並期待繼續致力於改善比利時乳癌的患者的效果。」
總體而言,技術的進步以及報銷和保險覆蓋範圍的擴大,顯著提高了乳癌的診斷水平,從而實現了早期發現、標靶治療和患者預後改善。隨著技術的不斷發展,持續的研究和開發對於進一步提高乳癌的診斷水平至關重要。
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: