The Breast Lesion Localization Market in terms of revenue was estimated to be worth $244 million in 2021 and is poised to reach $305 million by 2026, growing at a CAGR of 4.6% from 2021 to 2026. The market is primarily driven by the increasing number of breast cancer screening programmes and an improved reimbursement scenario. The localization of breast lesions is a common procedure that has evolved as a surgical, imaging, and biomedical technology. The wire-guided localization method was introduced years ago and was the first technique introduced to help localise non-palpable image-guided breast lesions.

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Driver: Increasing incidence of breast cancer

Breast cancer is among the most common diseases affecting women in developed and developing countries. According to the American Cancer Society, breast cancer is the second-leading cause of cancer-related deaths in women across the globe. Globally, there has been significant growth in the number of breast cancer cases. This can majorly be attributed to changing lifestyles, the increasing use of oral contraceptives, and the growing number of women undergoing cosmetic surgeries, such as breast enhancement.

Growing rate of the aging population

With age, the risk of developing breast cancer increases. Aging increases multipotent progenitors (a type of adult stem cell at the root of many breast cancers) and decreases the number of myoepithelial cells, which line the breast’s milk-producing luminal cells and serve as tumor suppressors. According to the American Cancer Society, approximately 1 out of 8 invasive breast cancers develop in women less than 45 years. In contrast, approximately 2 out of 3 invasive breast cancers develop in women aged 55 and above.

The reasons such as growing incidence of breast cancer, growing ageing population and the rising awareness on the early detection of breast cancer contributes to the growth of breast lesion localization market. However, uncertainty in regulatory approval procedures can restrain the growth of the market during the forecast period.

Restraint: Uncertainty in regulatory approval procedures

Regulatory agencies such as the US FDA require comprehensive clinical data supporting the clinical safety and efficacy of a product under approval. With the presence of stringent regulatory requirements for product approval, players operating in the breast lesion localization methods (specially radioisotope localization) market need to obtain nuclear regulatory clearance from the Nuclear Regulatory Commission to ensure the safe use of radioactive seeds. This approval process is very lengthy and capital-intensive, which makes it difficult for small manufacturers and companies with limited budgets to sustain themselves in this market.

Opportunity: Emerging economies offer high growth potential

Developing economies, such as India, China, Brazil, South Korea, Turkey, Russia, and South Africa, offer high growth opportunities for the major players operating in the global market. A large population base—especially in India and China—offers a sustainable market for entire medical and surgical devices. As per GLOBOCAN 2020, the incidence of breast cancer in China is estimated to be 416,000 in 2020; this number is estimated to increase by 446,000 cases by 2025. Likewise, the number of women diagnosed with breast cancer is estimated to reach 272,000 in 2040 from 178,000 in 2020 in India. Breast cancer incidence among women aged more than 65 is expected to increase by ~61% and ~65% in India and China, respectively, by 2025.

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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Breast Lesion Localization Market Dynamics

In terms of value, the wire localization segment accounted for the largest share of the breast lesion localization market in 2020.

Based on type, the breast lesion localization market is segmented into wire localization, radioisotope localization, magnetic localization, electromagnetic localization, and other localization methods. The wire localization segment accounted for the largest share of the breast lesion localization market in 2020. The appropriate localization of abnormal tissues, the minimum removal of normal tissues, minimum scarring, and the availability of reimbursement for breast lesion localization devices are the major factors driving the growth of the wire localization segment.

Radio-guided occult lesion localization (ROLL) segment accounted for alargest share of the radioisotope localization market in 2020

Radioisotope localization is used for preoperative nonpalpable lesion localization during breast cancer surgeries as well as for sentinel lymph node mapping in cancer staging. By type, the radioisotope localization methods market is segmented into radio-guided occult lesion localization (ROLL) and radioactive seed localization (RSL). Radio-guided occult lesion localization (ROLL)segment accounted for a largest share of the breast lesion localization market in 2020.

In 2020, the Breast Biopsy segment accounted for a largest share of the breast lesion localization market.

Based on usage, the breast lesion localization methods market is segmented into Breast Biopsy and Breast Conservation (Lumpectomy). In 2020, the Breast Biopsy segment accounted for a largest share of the breast lesion localization market. The factors driving the growth of the market are the growing incidence of breast cancer, the rising number of breast cancer screening programs, improved reimbursement scenarios, increased awareness of early detection of breast cancer, and greater demand for minimally invasive and non-invasive procedures.

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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).

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Recent Developments:

• In January 2021, Hologic Inc. has completed the acquisition of Somatex Medical Technologies, which will enable Hologic Inc to strengthen their breast marker portfolio.
• In October 2020, Endomagnetics Ltd. launched a product named Magseed, which is implanted in the affected breast prior to the surgery, and through the use of a probe, can point out to the surgeon where exactly the cancerous tissue is located.
• In January 2019, IZI acquired Cook’s product portfolio of soft-tissue biopsy and breast localization needles. This will enable IZI to capture newer markets.

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