Breast Lesion Localization Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global breast lesion localization market growth forecasted to transform from USD 0.3 billion in 2023 to USD 0.4 billion by 2028, driven by a CAGR of 6.9%. The increasing number of breast cancer screening programs and improved reimbursement scenarios are expected to drive market growth. Additionally, the rising number of breast cancer surgeries and increasing awareness of early detection are further supporting the growth of this market.

However, factors such as errors in screening alongside misdiagnosis and uncertainty in regulatory approval procedures are expected to hinder the growth of the breast lesion localization market during the forecast period.

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Breast Lesion Localization Market Dynamics

Driver: Growing rate of the aging population

Breast cancer is most common in women over the age of 50, and the number of people in this age group is increasing as the population ages. In the United States, the number of people over the age of 50 is projected to increase by 35% between 2010 and 2030. This means that there will be more women in danger of developing breast cancer, and the overall number of cases is projected to surge. In addition to age, other factors which are contributing to the risk of breast cancer cases are genetics, lifestyle changes and family history. However, among these, the age is the most significant risk factor. Thus, the aging population is the foremost reason for increase in breast cancer cases in years to come. The aging increases the multipotent progenitors, which are a type of adult stem cell at the root of many breast cancers and decreases the number of myoepithelial cells. The myoepithelial cells line the breast’s milk-producing luminal cells and assist as tumor suppressors.

According to the WHO, about 70% of breast cancer cases are diagnosed in women over the age of 50, in the United States. The risk of developing breast cancer intensifies by about 1% each year over the age of 50. Furthermore, according to the American Cancer Society, around 1 out of 8 invasive breast cancers can develop in women less than 45 years. In disparity, approximately 2 out of 3 of the invasive breast cancers occur in women aged 55 and above. In addition to this, as per GLOBOCAN 2020 estimates, the number of new breast cancer cases diagnosed in the women above 70 age was estimated to be 507,000 in 2020 and is expected to reach 975,000 by 2040, across the globe. Thus, the growing rate of the aging population is expected to increase the number of breast cancer cases and drive the demand for breast lesion localization devices and procedures market across the globe.

Restraint: Uncertainty in regulatory approval procedures

The regulatory process for approving medical devices is complex and can involve multiple agencies and departments. This can lead to delays and uncertainty, as different agencies may have different priorities or interpretations of the regulations. Organizations such as the US FDA need complete clinical analysis pertaining to the efficacy and safety of the medical product which is under approval process. Thus, under such strict guidelines and requirements, getting clearance becomes difficult for the market players operating in the breast lesion localization market.

Especially when it comes to the radioisotope localization, which requires mandatory nuclear regulatory clearance from the Nuclear Regulatory Commission. This clearance is necessary to certify the safe use of radioactive seeds during the lesion localization procedures. Hence, approval for the radioisotope localization products becomes very costly and time consuming, making it tough for small players with limited budget to sustain in the market.

The breast localization devices are grouped into Class II and III medical devices and thus must endure a stringent regulatory procedure for FDA approval. Approximately, 3 to 7 years are required in the US to prove the medical safety of any new product. Even a new size of any previously approved product needs to go through the entire stringent process of approval before getting commercially approved, as per the law. Moreover, the regulatory requirements are becoming more difficult with new technological advancements and increased focus on the patient care. Thus, these regulations demand extensive documentation and data for the approval and validation of new product and technologies.

Across the mature markets, mostly the US, the pipeline developments are delayed majorly by pricing pressure faced by key product manufacturers due to obstructive government reforms undertaken in the last few years.

Opportunity: Increasing adoption of technologically advanced localization procedures

Traditionally, wire localization was considered as a benchmark procedure for the preoperative localization of non-palpable breast lesions. Wire-guided localization (WL) is the most widely used method for the localization of non-palpable breast lesions. The limitations of WL include patient discomfort, potential need to perform localization the day of surgery, creating logistic challenges, which limit operating room (OR) efficiency, possible wire migration and transaction, the lack of a point source for reorientation during surgery, and suboptimal cosmetic outcome.

These disadvantages have led to the development of alternative approaches, such as radioactive seed localization (RSL), non-radioactive radar localization (SAVI SCOUT), magnetic seed (Magseed) localization (MSL), radiofrequency identification (RFID), and hematoma ultrasound-guided (HUG) localization.

Over the years, breast localization techniques have witnessed significant advancements and have evolved from wire and radio-guided localization to non-radio-guided localization, such as electromagnetic reflectors and magnetic tracers. These advancements have helped improve workflows, efficiency, and cost-effectiveness and eliminate the issues related to radioactive technologies. In May 2021, the US FDA approved MOLLI Surgical's new wire-free localization technology for breast cancer surgery. The device is a small, implantable marker that is placed in the breast lesion using a needle. The marker can be detected using a handheld wand during surgery, which helps the surgeon to precisely locate the lesion.

Furthermore, In April 2022, the FDA approved Merit Medical System's Scout Bx delivery system, a wire-free breast localization solution used during stereotactic and MRI-guided biopsy in breast cancer surgery. The system uses a small, radiopaque marker that is placed in the breast lesion using a needle. The marker can be detected using a handheld wand during surgery, which helps the surgeon to precisely locate the lesion.Further research and increasing investments by new players in this field will drive the breast localization methods market in the coming years.

Challenge: Shortage of oncologists

Breast surgical oncologists are surgeons who have completed extra training in the diagnosis and treatment of breast cancer. They are experts in performing a variety of breast surgeries, including, Lumpectomy, Mastectomy, Sentinel lymph node biopsy and Reconstruction surgery. Breast surgical oncologists work closely with other cancer specialists, such as medical oncologists, radiation oncologists, and plastic surgeons, to provide comprehensive care for patients with breast cancer. They are also involved in research on new treatments for breast cancer. However, there is a shortage of oncologists in breast surgeries.

The ASCO projects that there will be a shortage of 2,200 oncologists by 2025. Also, the Association of American Medical Colleges (AAMC) projects that there will be a shortage of 55,200 physicians by 2030, including 12,700 oncologists. According to the most recent “2021 ASCO Snapshot: State of the Oncology Workforce in America,” there are 13,146 oncologists engaged in active patient care in 1638 oncology practices. Of those oncologists, 21.1% are nearing retirement (age 64+), whereas only 14.5% are early-career oncologists (age <40); the overall median age was 53 years. Female oncologists in practice represent 35.2% of the total, while they represent approximately 45% in oncology fellowship programs. Only 11.2% of oncologists practice in areas defined as rural. The fewest oncologists practice in the West North Central and West South-Central regions.

Over the years, the incidence of breast cancer has increased significantly and is expected to increase further in the coming years. However, there has not been a subsequent growth in the number of oncologists, and this situation is more pronounced in developing countries. This dearth of trained professionals is thus expected to hamper the growth of the breast lesion localization market during the forecast period.

Breast Lesion Localization Market Ecosystem

Leading players in this market include well-established and financially stable manufacturers of breast lesion localization. These companies have been operating in the market for several years and possess a diversified product portfolio, advanced technologies, and strong global presence. Prominent companies in this market include Hologic, Inc. (US), Becton, Dickinson and Company (US), Merit Medical Systems (US), Leica Biosystems Nussloch GmbH (US), Argon Medical Devices (US).

The electromagnetic localization segment of the Breast Lesion Localization Industry is expected to register the highest CAGR during the forecast period.

Based on type, the breast lesion localization market is segmented into wire localization, radioisotope localization, magnetic localization, electromagnetic localization, and other localization types. The electromagnetic localization segment is projected to grow at the highest CAGR during 2023 to 2028. Factors such as reduction in surgical delays, improved patient satisfaction, optimal surgical planning, and no need for radioactive components are driving the segment growth. Electromagnetic localization make smaller incisions which are more precise and save more of the normal tissue during surgeries.

The breast conservation segment of breast lesion localization industry is estimated to grow at a higher CAGR during the forecast period.

Based on usage (application), the breast lesion localization market is segmented into breast biopsy and breast conservation (lumpectomy). The breast conservation segment is estimated to grow at a higher CAGR during the forecast period. Growth in this segment can be attributed to the increasing early-stage breast cancer diagnosis and the shift toward minimally invasive procedures.

The ambulatory surgical centers segment of the breast lesion localization industry is expected to grow at the highest CAGR during the forecast period.

Based on end user, the breast lesion localization market is segmented into hospitals and clinics, ambulatory surgical centers, diagnostic imaging centers, and other end users. The growth of the ambulatory surgical centers segment is attributed to the ongoing increase in the number of minimally invasive procedures and the increasing number of image-guided breast lesion localization procedures performed in ambulatory surgical centers.

APAC is estimated to be the fastest-growing regional market for breast lesion localization industry

The global breast lesion localization market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2022, APAC is estimated to be the fastest-growing regional market for breast lesion localization. The high growth in this market can majorly be attributed to the rising number of hospitals and increasing healthcare expenditure, the significant growth in patient volume, and the demand for healthcare services.

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The breast lesion localization market is dominated by a few globally established players such as GE Healthcare (US), Dragerwerk Ag & Co. KGAA (Germany), Koninklijke Philips N.V. (Netherlands), Ambu AS (Denmark), Medline Industries Inc. (US). Major players adopt growth strategies to expand their geographical presence and garner higher shares in the global market, such as product launches and approvals, expansions, collaborations, and acquisitions.

Scope of the Breast Lesion Localization Industry

The study categorizes the breast lesion localization market to forecast revenue and analyze trends in each of the following submarkets:

By Type

• Wire Localization
• Radioisotope Localization
  • Radioguided Occult Lesion Localization (ROLL)
  • Radioactive Seed Localization (RSL)
• Magnetic Localization
• Electromagnetic Localization
• Other Localization Methods

By Usage

• Breast Biopsy
• Breast Conservation (Lumpectomy)

By End User

• Hospitals & Clinics
• Diagnostic Imaging Centers
• Ambulatory Surgical Centers
• Others

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
• Middle East and Africa

Recent Developments of Breast Lesion Localization Industry

• In December 2022, Merit Medical Systems launched Scout Bx. Scout Bx is a wireless, radar-guided localization system used to assist breast surgeons in identifying biopsied tumors for removal.
• In August 2022, Leica Biosystems Nussloch GmbH launched DualCore Dual Stage Core Biopsy System. The Mammotome DualCore biopsy system is the first dual stage core biopsy instrument for needle biopsies.

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