The growth of this market is primarily driven by factors such as the rising incidence of breast cancer, an increasing number of breast cancer surgeries, and growing awareness on the early detection of breast cancer.
However, the uncertain regulatory approval process faced by prominent players is hampering the growth of the breast lesion localization methods market.
Covid-19 Impact on the Breast Lesion Localization Methods Market
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 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.
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. 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.
The sentinel lymph node identification segment is expected to grow at the fastest rate in the forecast period, growth in this segment can be attributed to the increase in 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.
1. In 2019, Hologic Inc. (US) launched LOCalizer wire-free guidance system.
2. In 2019, Argon Medical Devices (US) acquired Mana-Tech, Ltd. (UK) enabling Argon to distribute its products across UK and Ireland.
3. In 2019, IZI Medical Products, LLC acquired Cook’s acquired product portfolio of soft tissue biopsy and breast localization needle assets to enable it to capture newer markets.