The breast lesion localization methods market is not expected to be impacted greatly by the Covid-19 pandemic in 2020-2021. However, routine breast cancer screening at hospitals and annual screening programs have been suspended in many countries in order to maintain social distancing protocols and minimize patient flow in health care centers.
Moreover, non-essential procedures and surgeries have been postponed for the post lockdown period which could have a slight impact on the market only for Q1 and Q2 of 2020 in most regions. breast lesion localization methods market.
Globally, there has been a 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.
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.
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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.
With increasing technological advancements and 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 in this market.
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.