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市場調查報告書
商品編碼
1744604
2032 年乳房病變定位市場預測:按類型、定位技術、應用、最終用戶和地區進行的全球分析Breast Lesion Localization Market Forecasts to 2032 - Global Analysis By Type, Localization Technique, Application, End User, and By Geography |
根據 Stratistics MRC 的數據,全球乳房病變定位市場預計在 2025 年將達到 3.053 億美元,預計到 2032 年將達到 4.682 億美元,預測期內的複合年成長率為 6.3%。
乳房病變定位是一種醫療程序,用於在手術切除前精確識別和標記乳房內的異常組織或腫瘤。導絲定位、放射性粒子定位和磁性標記等技術可引導外科醫師找到病灶的精確位置,確保精準切除,同時保留健康組織。這個過程在乳癌的診斷和治療中至關重要,可以改善手術效果,並最大限度地減少不必要的乳房組織切除。
根據美國癌症協會 (ACS) 統計,預計 2023 年美國將新增超過 28 萬例浸潤性乳癌病例,凸顯了精確定位病變以指導手術介入的迫切需求。
乳癌發生率上升
乳癌仍然是女性最常見的癌症之一,對早期發現和準確定位病變的需求正在快速成長。病例激增提高了人們對乳癌的認知,並擴大了篩檢計畫的覆蓋範圍,促使人們採用先進的定位技術來提高診斷準確性和治療效果。此外,影像和切片檢查方法的技術進步確保了及時有效的干涉,從而支持了這個市場的擴張。
有限的報銷政策
嚴格的支付法規和先進在地化流程的有限覆蓋範圍阻礙了創新技術的廣泛應用。這項挑戰在開發中國家和資源受限的醫療保健環境中尤其嚴峻,因為現代設備的高昂前期成本進一步限制了其普及。此外,複雜的監管核准流程和缺乏統一的報銷框架也阻礙了市場准入,並阻礙了對新本地化解決方案的投資,最終影響了患者獲得尖端醫療服務的管道。
人工智慧與數位健康的融合
人工智慧影像和數據分析技術能夠改善病變檢測、分類和手術規劃,從而改善患者預後並提高工作流程效率。此外,數位健康平台還能促進遠距會診和多專業團隊之間的即時協作。隨著醫療服務提供者擴大採用這些先進技術,技術創新、診斷準確性的提高以及更加個人化、以患者為中心的醫療服務潛力,市場有望加速成長。
對輻射暴露的擔憂
許多定位技術,尤其是乳房X光攝影和基於放射性同位素的方法,會使患者暴露於電離輻射,這引發了患者和醫療保健提供者的安全疑慮。這種擔憂可能導致患者在採用某些技術時猶豫不決,尤其是在重複手術和對輻射風險敏感的人群中。此外,監管監督和不斷發展的安全指南可能會進一步限制基於輻射的定位技術的應用,並促使人們轉向不使用輻射的替代技術。
新冠疫情嚴重擾亂了乳房病變定位市場,主要原因是擇期手術延後,篩檢量減少。許多乳房攝影影像機構的患者數量下降了80%至100%,大多數診所推遲了乳房X光攝影篩檢檢查。這導致診斷延遲、就診時腫瘤體積增大,以及放寬管制後病例暫時積壓。此外,患者不願前往醫療機構就診,以及恢復常規護理的後勤挑戰,也導致乳房攝影影像和定位服務恢復緩慢。
電線本地化細分市場預計將成為預測期內最大的細分市場
預計導絲定位技術將在預測期內佔據最大的市場佔有率。這項優勢歸功於其長期的臨床認可度、經驗證的有效性和成本效益。導絲定位技術被廣泛用於引導外科醫生找到難以觸及的乳房病變,為大多數外科團隊提供了一種可靠、簡單且易於操作的方法。儘管新技術層出不窮,導絲定位技術憑藉其簡便易行、易於操作且報銷範圍廣等特點,仍受到全球醫療保健提供者的青睞。
預計門診手術中心部分在預測期內將實現最高的複合年成長率。
預計門診手術中心細分市場將在預測期內實現最高成長率,這得益於微創乳房手術擴大轉向門診,因為門診手術可縮短患者恢復時間並降低費用。為了滿足日益成長的高效、患者友善治療需求,門診手術中心擴大配備了先進的定位技術。此外,有限的醫院預算和對最佳化手術室利用率的重視,進一步推動了這些中心乳房病變局部手術的採用。
預計北美將在預測期內佔據最大市場佔有率,這得益於其強大的醫療基礎設施、先進影像處理和定位技術的廣泛採用以及主要行業參與者的參與。美國尤其受益於廣泛的篩檢項目、優惠的報銷政策以及在研發方面的大量投資。此外,乳癌意識的提高和發病率的上升,持續推動對精準定位技術的需求,從而鞏固了北美市場的主導地位。
預計亞太地區在預測期內將呈現最高的複合年成長率。該地區的快速成長可歸因於醫療基礎設施的擴張、可支配收入的提高以及對乳癌早期發現意識的不斷增強。中國、印度和日本等國家乳癌發生率的急劇上升,促使人們採用了先進的在地化技術。此外,政府措施、醫療旅遊業的蓬勃發展以及對醫療可近性的重視,也推動市場的強勁擴張。
According to Stratistics MRC, the Global Breast Lesion Localization Market is accounted for $305.3 million in 2025 and is expected to reach $468.2 million by 2032 growing at a CAGR of 6.3% during the forecast period. Breast lesion localization is a medical procedure used to precisely identify and mark abnormal tissue or tumors within the breast before surgical removal. Techniques such as wire localization, radioactive seed localization, or magnetic markers guide surgeons to the exact lesion site, ensuring accurate excision while preserving healthy tissue. This process is crucial in breast cancer diagnosis and treatment, improving surgical outcomes and minimizing the removal of unnecessary breast tissue.
According to the American Cancer Society (ACS), over 280,000 new cases of invasive breast cancer were expected in the US in 2023, highlighting the critical need for accurate lesion localization to guide surgical interventions.
Rising incidence of breast cancer
Breast cancer remains one of the most commonly diagnosed cancers among women, and the demand for early detection and precise localization of lesions is growing rapidly. This surge in cases has led to heightened awareness and expanded screening programs, encouraging the adoption of advanced localization techniques to improve diagnostic accuracy and treatment outcomes. Furthermore, technological advancements in imaging and biopsy methods are supporting this market expansion, ensuring timely and effective interventions.
Limited reimbursement policies
Stringent payment regulations and restricted coverage for advanced localization procedures hinder the widespread adoption of innovative technologies. This challenge is particularly acute in developing countries and resource-constrained healthcare settings, where the high initial cost of modern devices further limits access. Additionally, complex regulatory approval processes and the lack of uniform reimbursement frameworks can delay market entry and discourage investment in new localization solutions, ultimately impacting patient access to cutting-edge care.
Integration of AI and digital health
AI-driven imaging and data analytics are enhancing the precision of lesion detection, classification, and surgical planning, leading to improved patient outcomes and workflow efficiency. Moreover, digital health platforms facilitate remote consultations and real-time collaboration among multidisciplinary teams. As healthcare providers increasingly adopt these advanced technologies, the market is poised for accelerated growth, driven by innovation, improved diagnostic accuracy, and the potential for more personalized, patient-centric care.
Concerns about radiation exposure
Many localization techniques, especially those relying on mammography or radioisotope-based methods, expose patients to ionizing radiation, raising safety concerns among both patients and healthcare providers. This apprehension can lead to hesitancy in adopting certain technologies, particularly for repeated procedures or in populations sensitive to radiation risks. Moreover, regulatory scrutiny and evolving safety guidelines may further restrict the use of radiation-based localization, prompting a shift toward alternative, non-radiative techniques.
The Covid-19 pandemic significantly disrupted the breast lesion localization market, primarily due to the postponement of elective procedures and reduced screening volumes. Many breast imaging facilities experienced an 80%-100% decline in patient volume, with screening mammography delayed in most practices. This led to delayed diagnoses, increased tumor sizes at presentation, and a temporary backlog of cases once restrictions eased. Furthermore, patient hesitancy to visit healthcare facilities and logistical challenges in resuming routine care contributed to a prolonged recovery in breast imaging and localization services.
The wire localization segment is expected to be the largest during the forecast period
The wire localization segment is expected to account for the largest market share during the forecast period. This dominance is attributed to its longstanding clinical acceptance, proven efficacy, and cost-effectiveness. Wire localization is widely used for guiding surgeons to non-palpable breast lesions, offering a reliable and straightforward approach that is familiar to most surgical teams. Despite the emergence of newer technologies, the simplicity, accessibility, and established reimbursement for wire localization procedures ensure its continued preference among healthcare providers globally.
The ambulatory surgical centers segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the ambulatory surgical centers segment is predicted to witness the highest growth rate driven by the increasing shift of minimally invasive breast procedures to outpatient settings, where patients benefit from shorter recovery times and reduced costs. Ambulatory surgical centers are increasingly equipped with advanced localization technologies, catering to the growing demand for efficient, patient-friendly care. Additionally, limited hospital budgets and a focus on optimizing operating room utilization further propel the adoption of breast lesion localization procedures in these centers.
During the forecast period, the North America region is expected to hold the largest market share, driven by robust healthcare infrastructure, high adoption of advanced imaging and localization technologies, and the presence of major industry players. The United States, in particular, benefits from extensive screening programs, favorable reimbursement policies, and significant investments in research and development. Moreover, heightened awareness and the rising incidence of breast cancer ensure sustained demand for precise localization methods, reinforcing North America's dominant market position.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR. The region's rapid growth is fueled by expanding healthcare infrastructure, rising disposable incomes, and increasing awareness of early breast cancer detection. Countries such as China, India, and Japan are experiencing a surge in breast cancer incidence, prompting greater adoption of advanced localization technologies. Additionally, government initiatives, growing medical tourism and a focus on improving healthcare accessibility are driving robust market expansion.
Key players in the market
Some of the key players in Breast Lesion Localization Market include Hologic, Inc., Becton, Dickinson and Company, Merit Medical Systems, Inc., Cianna Medical, Inc., Cook Medical, Endomagnetics Ltd, Somatex Medical Technologies GmbH, Argon Medical Devices, Inc., STERILAB S.r.l., Leica Biosystems Nussloch GmbH, GE Healthcare, Koninklijke Philips N.V., Ambu A/S, Medline Industries Inc., SurgicEye GmbH, Intra-Medical Imaging LLC, IsoAid, LLC and Mammotome.
In April 2024, the Radiological Society of North America (RSNA) and GE HealthCare announced their collaboration to provide mammography technology, training and educational tools to radiologists at Muhimbili National Hospital (MNH), part of the Muhimbili University of Health and Sciences (MUHAS), in Tanzania to improve access to screening and help clinicians lower the country's breast cancer mortality rate.
In November 2023, GE HealthCare announced the release of a new, all-in-one platform of artificial intelligence (AI) apps to support clinicians with breast cancer detection and improved workflow productivity called MyBreastAI Suite*. With this initial release, MyBreastAI Suite integrates three AI applications from iCAD including ProFound AI for DBT, SecondLook for 2D Mammography and PowerLook Density Assessment to help support early detection and improve patient outcomes, as well as help radiology departments improve operational productivity.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.