Global Breast Lesion Localization Market is Segmented By Type (Radioisotope Localization, Other), By Biopsy Technique(Fine Needle Aspiration Biopsy, Core Needle Biopsy, Surgical Biopsy, Other), By End User()Hospitals and Clinics, Diagnostic Centres, Ambulatory Surgical Centres, Other), By End-User (Automotive, Aerospace, Safety, Medical, Energy, Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030
Breast Lesion Localization Market Overview
The Global "Breast Lesion Localization Market" is Expected to reach at a CAGR of 12.8% during the forecast period (2023-2030). Breast lesion localization is a common procedure that has evolved as surgical, imaging, and biomedical technology have advanced.
Wire localization was the first technique introduced years ago to assist in the localization of nonpalpable, image-detected breast lesions.
Breast Lesion Localization Market Dynamics and Trends
The factors driving the global breast lesion localization market are technological advancements and increased public awareness of breast cancer diagnosis.
The technological advancements are expected to drive the market growth in the forecast period
Technological advancements can make localization easier, safer, and more accurate while improving care coordination and collaboration between radiologists and surgeons. Furthermore, they promise to spur further breast cancer detection and surgery innovation, such as streamlining sentinel lymph node procedures and allowing surgeons to improve cosmetic outcomes.
Instead of wires, some health care organizations are using newer implantable devices, such as radioactive seeds or other nonradioactive tags, to mark breast lesions. The most recent generation of fully implantable nonradioactive markers incorporates wireless radiofrequency identification (RFID) technology that can be detected by a handheld reader, which the FDA recently approved. These devices can establish a new standard of care for localization.
Furthermore, wire-guided localization (WL) is currently the most widely used method for locating non-palpable breast lesions. Preoperative image-guided localization of breast lesions is a common procedure that has evolved rapidly over the last few decades. Continuous technological advancements and the results of new clinical trials have provided increasing insight and new opportunities for breast specialists to choose from a variety of effective techniques.
The problems associated with breast lesion localization is expected to hamper the market growth
Patient discomfort, the potential need to perform localization on the day of surgery, creating logistical challenges that limit OR efficiency, wire migration and transection, the lack of a point source for reorientation during surgery, and a suboptimal cosmetic outcome are all limitations of WL (wire-guided localization). Wire-guided localization has a number of drawbacks. Because a portion of the wire is exposed, it has the potential to dislodge, migrate, kink, fracture, or be transected prior to or during surgery. Vasovagal reactions have been reported in 10–20% of patients. Furthermore, the radiologist's wire entry site may not correspond to the surgeon's preferred skin incision site. This jeopardises incision positioning, limiting the extent of surgical dissection and affecting cosmesis. Wire placement is typically performed on the day of surgery in the United States, limiting scheduling flexibility and OR efficiency.
COVID-19 Impact on Breast Lesion Localization Market
The COVID-19 pandemic posed a unique set of challenges for clinicians in managing women who required periodic screening mammography, imaging, and/or needle biopsy for suspected breast cancer. Because of the combination of lockdown, the need for social distancing, and limited hospital resources, routine outpatient breast imaging activity has been drastically reduced in many cases. As a result, it is critical to determine which women require immediate or non-reschedulable care can wait for a reasonable amount of time or can wait until the pandemic is over. Because of the change in service delivery caused by the pandemic, the logistics of breast surgery theatre list planning became more complex, especially because of the need for radiologists and the assistance of radiographers to wire localize breast lesions. With staffing uncertainty due to redeployment and the possibility of staff being absent due to illness or self-isolation, lists with wire localizations could not be planned with any certainty. Furthermore, many National Health Service (NHS) trusts relocated their cancer surgery to a 'cold site,' remote from their main radiology departments, where localizations would take place.
Breast Lesion Localization Market Segment Analysis
Based on type, the wire localization segment is expected to dominate the market growth
Wire localization is a procedure performed prior to breast cancer surgery to determine the location of the abnormality (the wire marks the spot) so that the surgeon knows exactly what tissue to remove. This procedure is performed under the supervision of a mammogram or an ultrasound. Many impalpable breast lesions are being detected as mammography screening for breast cancer increases. These lesions should be definitively diagnosed using image-guided needle biopsy first. Breast biopsy with needle localization is thus used to diagnose impalpable breast lesions. Some of these lesions may require diagnostic or therapeutic surgical biopsy after needle biopsy. Surgical excision is recommended if a malignant or indefinite diagnosis is obtained. In turn, this necessitates precise localization of the lesion to ensure correct and adequate removal of the lesions while minimizing the degree of cosmetic disfigurement.
For non-palpable lesions, wire localization is performed prior to surgery. A wire is inserted, usually with the aid of ultrasound, with the needle's tip-in or near the lesion. If the lesion cannot be seen on ultrasound, the wire can be inserted using a stereotactic or off-hand technique. Following excision, the specimen is X-rayed to ensure that the lesion has been removed. There is little discomfort associated with this procedure, aside from a small puncture in the skin caused by the needle.
Breast Lesion Localization Market Geographical Share
North America region is expected to hold the largest market share in the global breast lesion localization market
The increasing prevalence of breast cancer is expected to drive market growth. Approximately more than 2.8 million women in the United States undergo breast procedures that necessitate precisely locating a tumor for a lumpectomy or biopsy each year. One in every eight women in the United States (13%) will develop invasive breast cancer throughout their lifetime. An estimated 287,850 new cases of invasive breast cancer will be diagnosed in women in the United States in 2022, along with 51,400 new non-invasive breast cancer cases. Preoperative wire needle localization (WL) and non–wire localization (NL) are accepted standard methods in the United States for guiding intraoperative surgical excision of nonpalpable breast lesions.
Hence, with the increasing incidence of breast cancer procedures, the breast lesion localization market is expected to grow in this region.
Breast Lesion Localization Companies and Competitive Landscape
The global breast lesion localization market is highly competitive with acquisitions, product launches, and collaborations. Some of the key players in the market are SOMATEX Medical Technologies GmbH, Becton, Dickinson and Company, Merit Medical Systems., Endomagnetics Ltd, Ranfac Corp., Kubtec X-Ray, Miltenyi Biotec GMBH, Meditech Devices Pvt Ltd, Argon Medical, Vigeo srl, Mammotome
Somatex Medical Technologies GmbH
Overview: SOMATEX manufactures high-quality single-use medical devices to aid in diagnosis and therapy. The company manufactures products in breast care, soft tissue and bone marrow biopsy, pulmonary interventions, foetal therapy, assisted reproduction, and radiation protection. The company was founded in 1992 and had headquarters in Berlin.
Product Portfolio: The company's Somatex localization wires are 20-gauge thin, sharp puncture cannulas, which ensures that treatment is as minimally invasive as possible. Localization wires are made of the biocompatible implant material Nitinol and come in various cannula lengths.
