Breast Lesion Localization Methods Market Size, Share & Trends Analysis Report By Type (Wire Guided Localization, Radioisotope Localization, Magnetic Tracer, & Others), By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global breast lesion localization methods market size was estimated at USD 2.14 billion in 2023 and is projected to grow at a CAGR of 7.8% from 2024 to 2030. The increasing adoption of advanced imaging technologies for precise lesion localization, a growing focus on minimally invasive biopsy procedures, and the increasing prevalence of breast cancer is expected to drive the market growth over the forecast period. For instance, as per a report by Breastcancer.org, in 2023, it is estimated, that around 297,790 new cases of invasive breast cancer will be diagnosed in women in the U.S., along with 55,720 new cases of ductal carcinoma in situ (DCIS).

The rising number of government and non-government reimbursement policies for breast cancer diagnostics, biopsy, and other related medical procedures is estimated to boost the adoption of breast lesion localization methods. Moreover, rising demand for better healthcare infrastructure and facilities and increasing awareness level about breast cancer screening are also expected to boost the market growth. For instance, UICC's Breast Cancer program aims to speed up progress in breast cancer by strengthening and involving the global breast cancer community. The overall objective is to reduce premature deaths from breast cancer and enhance the quality of life for patients. In addition, national breast cancer screening program in Australia called the Breast Screen Australia, which provides free mammogram test services every two years for women aged between 50 and 74. Developing regions, such as India and China, are also spreading awareness about early diagnosis.

In addition, introduction of technologically advanced products on the grounds of accuracy, safety, and cost-effectiveness is considered as the high impact-rendering factor for the breast lesion localization methods market. For instance, In 2022, Merit Medical has received FDA clearance for its SCOUT Bx Delivery System. This innovative system represents the first wire-free solution for breast localization, designed to be deployed during stereotactic or MRI-guided biopsy procedures. Moreover, companies, such as Endomagnetics and Cianna Inc. have developed a new range of techniques respectively working on magnetic and electroradar guidance for localization of breast lesions.

Market Characteristics & Concentration

The degree of innovation in the market has been quite significant in recent years, reflecting the development of advanced technologies to improve the accuracy, safety, effectiveness, and efficiency of treatments for breast lesion localization. Moreover, innovations in imaging technologies such as ultrasound, MRI, and tomosynthesis improve the accuracy and precision of lesion localization.

The market is also characterized by a high level of merger and acquisition (M&A) activity by the leading players. The increasing demand for innovative and effective breast lesion localization management drives this trend. Major healthcare companies and medical device manufacturers are keen on expanding their product portfolios and enhancing their technological capabilities through strategic acquisitions.

Regulatory requirements in the breast lesion localization methods are crucial for maintaining patient safety and the effectiveness of products. However, compliance requirements, such as FDA approval in the US or CE marking in Europe, demand significant investment in research and development, clinical trials, and quality assurance processes. While ensuring patient safety, these regulations can slow down the introduction of new technologies and escalate costs, affecting market dynamics and the accessibility of advanced healthcare solutions.

Alternative methods to traditional wire localization for breast lesions include technologies such as magnetic seeds and radiofrequency identification (RFID) tags, each offering unique benefits such as non-radioactive options or real-time surgical guidance, catering to varying clinical needs and patient preferences in breast lesion localization procedures.

The market is significantly affected by the concentration of end users such as hospitals, clinics, and diagnostic imaging centers that perform breast imaging and surgical procedures. These entities require localization methods that are accurate, compatible with existing equipment, and integrate seamlessly into clinical workflows. Additionally, research institutions and academic centers contribute to market dynamics through innovation and clinical validation.

Type Insights

In terms of type, the wire-guided localization segment dominated the market in 2023 with the largest revenue share of 33.90%. This growth can be attributed to the early establishment and higher adoption of this technique among end-users. Furthermore, the cost-effectiveness of WGL is a key factor contributing to its dominance in the breast lesion localization method market. Unlike newer alternatives such as radioactive seed localization (RSL) or magnetic resonance imaging (MRI)-guided techniques, WGL is typically more economical and accessible. This affordability makes it particularly appealing in healthcare environments that emphasize financial efficiency and cost-containment strategies. Additionally, established reimbursement policies and regulatory approvals further bolster the widespread adoption of WGL among healthcare providers globally.

Because of its well-established reliability and widespread clinical acceptance, wire-guided localization (WGL) is preferred in the breast lesion localization method market. WGL entails inserting a thin wire directly into the breast tissue to precisely locate non-palpable lesions identified through imaging techniques like mammography or ultrasound. Its extensive use over many years has ingrained trust and familiarity among healthcare providers globally.

The magnetic tracer segment is anticipated to grow at the fastest CAGR over the forecast period. Magnetic tracer methods, including MRI-guided localization, are preferred for their enhanced precision and localization accuracy over conventional techniques such as wire-guided localization (WGL). This technological edge makes them appealing to healthcare providers who prioritize precise localization of non-palpable breast lesions.

MRI-guided localization and other magnetic tracer techniques are frequently preferred by patients due to their ability to offer a more comfortable experience compared to invasive methods like WGL. This reduction in patient discomfort can result in increased patient satisfaction and may incentivize healthcare providers to adopt these advanced technologies. These factors are driving the segment growth over the forecast period.

Regional Insights 

The breast lesion localization methods market in North America held the largest share and accounted for 35.98% of global revenue in 2023. The presence of well-established healthcare infrastructure and key manufacturers in the U.S. is projected to augment the regional growth. Technological advancements coupled with high economic development in this region are also likely to drive the market. Furthermore, various activities by government and private firms to increase awareness are expected to boost the region’s development.

U.S. Breast Lesion Localization Methods Market Trends

The U.S. breast lesion localization methods market held the largest share in North America market in 2023. Increasing incidences of breast cancer, advancements in medical imaging technologies, rising awareness about early detection, and initiatives promoting regular breast screenings are expected to fuel market growth. For instance, as per a report published by National Breast Cancer Foundation, Inc., in April 2024, it is projected that 310,720 new instances of invasive breast cancer and 56,500 additional cases of non-invasive (in situ) breast cancer will be detected in women in the U.S. in 2024. The market for breast lesion localization methods is anticipated to be driven by these factors.

Europe Breast Lesion Localization Methods Market Trends

The breast lesion localization methods market in Europe is experiencing a shift towards advanced imaging technologies for precise lesion localization, an increasing emphasis on minimally invasive biopsy procedures, and a growing focus on early detection and diagnosis of breast lesions. In addition, there is a trend towards value-based healthcare and the integration of artificial intelligence in breast lesion localization, reflecting notable developments in the region that are contributing to the growth of Europe breast lesion localization methods market.

UK breast lesion localization methods market is driven by factors such as government initiatives promoting regular breast screenings and the development of sophisticated localization methods also contribute to the market's growth in the UK.

The breast lesion localization methods market in France is anticipated to witness significant growth over the forecast period owing to technological advancements, the rising prevalence of breast cancer, and increasing healthcare expenditure are some of the factors fueling the market growth.

Germany breast lesion localization methods market is driven by the factors, such as an increase in the prevalence of breast cancer, and the high adoption of technologically advanced products are among the major factors driving the growth of Germany market over the forecast period.

Asia Pacific Breast Lesion Localization Methods Market Trends

The breast lesion localization methods market in Asia Pacific is anticipated to witness significant growth. This is due to rising disposable incomes, significant unmet clinical needs, and increasing patient awareness of early diagnosis. Additionally, the region's rapidly evolving healthcare infrastructure and growing demand for breast-conserving surgery are anticipated to create substantial growth opportunities. Factors such as the rise in medical tourism in emerging APAC countries further contribute to driving market expansion in this dynamic region.

China breast lesion localization methods market is experiencing a transition towards advanced technologies like MRI-guided localization and radioactive seed localization (RSL). This shift is spurred by rising healthcare expenditures and a growing emphasis on precise breast cancer diagnosis and treatment. Government initiatives aimed at early detection, the expansion of urban healthcare infrastructure, and the incorporation of digital health solutions are also key drivers contributing to the market's expansion.

The breast lesion localization methods market in Japan is moderately competitive, government efforts to promote early detection, coupled with improvements in healthcare infrastructure and increasing patient awareness, are driving growth in Japan's breast lesion localization methods market. These developments underscore a growing commitment to enhancing diagnostic accuracy and improving outcomes for breast cancer patients nationwide.

Latin America Breast Lesion Localization Methods Market Trends

Latin America breast lesion localization methods market is driven due to the region's rising prevalence of breast cancer and rising healthcare costs, which are expected to fuel demand for breast lesion localization methods in coming years. Moreover, increased awareness among healthcare providers and patients regarding the advantages of advanced localization methods is driving their adoption in the Latin America breast lesion localization methods market. These trends signify a collective regional initiative to improve breast cancer care by leveraging effective and modern localization techniques

MEA Breast Lesion Localization Methods Market Trends

The breast lesion localization methods market in the MEA region is expected to witness significant growth due to various factors, such as growing health insurance penetration, increasing privatization, and rising regional disease burden are factors expected to drive regional market growth. The Saudi Arabia market accounted for the largest share of the MEA market.

Key Breast Lesion Localization Methods Company Insights

Top manufacturers are adapting the shift towards user comfort through technological advancements, and innovative products. These innovative products are driving the market growth positively over the forecast period. Moreover, the market is experiencing significant growth, driven by advancements in minimally invasive surgical procedures and a rising incidence of breast cancer. Emerging players in this market are contributing to its dynamic landscape through innovation and strategic expansions.

Key emerging companies in the market include:

• Cianna Medical: Cianna Medical is recognized for its SAVI Brachy technology, offering advanced solutions in breast cancer treatment and localization, including seed localization methods.

• Endomagnetics: Endomagnetics specializes in magnetic localization technologies, such as Magseed, providing precise lesion localization without wires, thereby improving patient comfort and surgical accuracy.

• Lumicell: Lumicell is developing imaging technologies for real-time detection of cancerous tissue during surgery, potentially minimizing the necessity for additional surgical procedures.

• Soliton: Soliton is exploring acoustic shockwave technology for accurate and non-invasive tumor localization, serving as an alternative to conventional wire localization methods.

Recent Developments

• In August 2022, Mammotome launched the Mammotome Revolve EX Dual Vacuum-Assisted Breast Biopsy System, the first device of its kind tailored for excising benign breast lesions. It operates twice as quickly as traditional vacuum-assisted biopsy systems. This minimally invasive solution enhances patient care by eliminating the need for open surgical procedures, thereby reducing risks and trauma while minimizing scarring.

• In August 2022, MOLLI Surgical, in collaboration with Sunnybrook Health Sciences Centre, has introduced Molli into hospitals throughout Canada. This initiative aims to enhance the localization of tumors, facilitating more precise surgical procedures.

Breast Lesion Localization Methods Market Report Scope

Global Breast Lesion Localization Methods Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Grand View Research has segmented the global breast lesion localization methods market based on type and region:

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Wire Guided Localization

  • Radioisotope Localization

    • Radio guided occult-lesion localization (ROLL)

    • Radioactive-seed localization (RSL)

    • Others

  • Magnetic Tracer

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait