According to Research Report Breast Lesion Localization Market in terms of revenue was estimated to be worth $0.3 billion in 2023 and is poised to reach $0.4 billion by 2028, growing at a CAGR of 6.9% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. The new research study consists of industry trends, pricing analysis, patent analysis key stakeholder and buying criteria in the market. The increasing number of breast cancer screening programs, and improved reimbursement scenarios are expected to drive the market growth. In addition, the increasing number of breast cancer surgeries and rising awareness on the early detection of breast cancer is supporting the growth of this market.

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Browse in-depth TOC on " Breast Lesion Localization Market”

249– Tables

59– Figures

281– Pages

Key Market Players:

Key players in the breast lesion localization market Hologic, Inc. (US), Becton, Dickinson and Company (US), Merit Medical Systems (US), Leica Biosystems Nussloch GmbH (US), Argon Medical Devices (US), Laurane Medical LLC (France), Endomagnetics Ltd. (UK), Intramedical Imaging, LLC (US), Isoaid (US), Surgiceye GmbH (Germany), Ranfac Corp. (US), Mermaid Medical Group (Denmark), Izi Medical Products, LLC (US), MatekMedikal (Turkey), Tsunami Medical Srl (Italy), BPB Medica (Italy), Sirius Medical Systems B.V. (Netherlands), Molli Surgical Inc. (Canada). Other players in the breast lesion localization market are Sterylab S.R.L. (Italy), CP Medical (Georgia), MDL SRL (Italy), Biomedical Srl (Italy), Elucent Medical (US), Vigeosrl (Italy), and Medax Medical Devices (Italy).

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.

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.

Challenge: Shortage of oncologists

To achieve better outcomes, breast cancer surgeries and lesion localization procedures are performed by skilled professionals. These surgeries are considered to involve more risks when compared to other surgeries because of various challenges, such as the localization of tumors, risk of healthy tissue excision, lymphedema and seroma. Similarly, the use of radioactive materials may increase a patient’s risk of developing radiation-induced cancer. Exposure to radiation has several short-term and long-term side effects, which usually occur within six months or even after a year of exposure. Some of the common side-effects after radiation exposure are mild pain or discomfort around the breast, skin damage, swelling or inflammation of the breast or surrounding tissues, loss of hair in the armpit or chest, and fatigue. Moreover, radiation exposure can also lead to the damage of nerves in the arm, hand, or chest. To reduce such risks, localization procedures require trained operators and radiologists, who are required to go through a certification process to perform breast lesion localization.

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Wire localization accounted for the largest share of the breast lesion localization market.

Based on type, the breast lesion localization market is segmented into wire localization, radioisotope localization, magnetic localization, electromagnetic localization, and other localization types. In 2022, the wire localization segment commanded the largest share of the breast lesion localization market due to widespread availability, moderate pricing, the simple storing requirements of wires, multiple ways of usage that can be used with a wide variety of image guidance techniques, the appropriate localization of abnormal tissues, minimum removal of normal tissues, minimum scarring, and the availability of reimbursement.

The hospitals & clinics segment accounted for the largest share of the breast lesion localization market.

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. Hospitals and clinics are the major end users of breast lesion localization market. The large share of this end-user segment can be attributed to the growing healthcare sector in emerging economies, the increasing out-of-pocket healthcare expenditure across the world, and the rising number of breast biopsy procedures.

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Recent Developments:

  • 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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