Breast Lesion Localization Methods Market Size, Share, Growth And Trends

The overall market for breast lesion localization methods market is expected to grow rapidly owing to the increasing number of breast cancer surgeries and increasing awareness on early detection of breast cancer. Furthermore, the demand for improved quality of care and growing awareness among patients about breast cancer screening also contributes to market growth. However, uncertainty in regulatory approval procedures may negatively affect the market.

The breast lesion localization methods market is divided into wire localization, isotope localization, magnetic localization, electromagnetic localization, and others. The wire localization segment accounted for the largest share of the breast lesion localization methods market in 2019. The large share of this segment is attributed to the increasing use of third-party independent quality controls due to their benefits such as longer shelf-lives and flexibility across different reagent lots, which help reduce the cost of operations.

Globally, there has been significant growth in the number of breast cancer cases. This can majorly be attributed to changing lifestyles, increasing use of oral contraceptives, and the growing number of women undergoing cosmetic surgeries, such as breast enhancement. Following are some major statistics in this regard: In the US, one in eight women develop invasive breast cancer over the course of their lifetime.

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According to the American Cancer Society and the National Cancer Institute, in 2018, over 265,000 new cases of invasive breast cancer were diagnosed among women in the US. The growing incidence of breast cancer is resulting in a growth in the number of breast cancer surgeries. This, in turn, is driving the demand for the pre-operative localization of non-palpable breast cancer.

Breast localization devices are Class II and III medical devices and have to undergo a stringent regulatory procedure in order to be approved by the FDA. In the US, it takes around 3 to 7 years to prove the medical safety of any new device. As per law, even a new size of a previously approved device needs to go through the entire process before commercialization.

With increasing technological advancements and a growing focus on patient care, regulatory requirements are becoming more stringent and rigorous, requiring extensive data and documentation for the validation and approval of new technologies. The 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.

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The sentinel lymph node identification segment is further divided by types of surgery into lumpectomy and mastectomy. The sentinel lymph node identification segment dominated the breast lesion localization methods market in 2019.

This segment is expected to grow at the highest rate during the forecast period, mainly due to the increasing acceptance of SLNB as a first-line diagnostic approach for breast cancer staging, as it is more sensitive and causes less morbidity than traditional techniques for the early staging of breast cancer. In addition, the increasing use of combined localization for non-palpable tumors and sentinel lymph nodes such as ROLL and magnetic localization will drive the growth of this segment.

The rapidly increasing patient population and healthcare expenditure, improving healthcare infrastructure, high government spending on breast cancer research, and increasing awareness about the importance of the early detection of breast cancer in several APAC countries are supporting the growth of the Asia Pacific breast lesion localization methods market.

Key Market Players

The key players operating in the breast lesion localization methods market include Becton, Dickinson and Company (US), Endomagnetics Limited (UK), SOMATEX Medical Technologies GmbH (Germany), Cianna Medical (US), Leica Biosystems (US) and IZI Medical Products (US).

Geographically, the breast lesion localization methods market is segmented into North America, Europe, the Asia Pacific and Rest of the World. The large share of the Asia Pacific region is due to improving healthcare infrastructure, high government spending on breast cancer research, and rising awareness about the importance of the early detection of breast cancer in several APAC countries.

Moreover, increasing focus of prominent players on emerging Asian countries will further support the growth of the market in this region.

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