The Breast Biopsy Device Market size was estimated to be USD 372.9 million in 2015. It is a diagnostic procedure that involves the removal of tissue or fluid from a suspicious area. The test requires working with a guiding system, the purpose of which is to locate a lump or abnormality in the breast region.
The different modalities employed as guiding systems in the detection of breast tumors include the ultrasound, mammography, and magnetic resonance imaging. The ultrasound segment is anticipated to witness the fastest growth owing to the rise in demand of non-radiation biopsies along with the increasing demand for minimally invasive procedures. The increase in the frequency of breast cancers in women globally, as well as the rise in cancer awareness screening programs is some of the factors that are estimated to contribute to the market growth over the forecast period.
Additionally, the varying types of product enhancements, continually launched in the market are further expected to have a positive impact on this industry during the forecast period. For instance, C.R Bard’s Mission Truguide disposable coaxial biopsy needles, made up of ultrathin walls, provide high efficiency and accuracy in the acquisition of tissue samples.
However, the risks involved in the procedures are likely to affect the Breast Biopsy Device Market negatively. The degree of risk reflects on the invasiveness of the procedure used. Surgical core procedures might be more accurate and effective but it involves major risks. Moreover, approximately 60%to 80% of the biopsies acquired are benign. Thus, women are encouraged to take a second opinion before undergoing any such surgical procedures, which in turn is expected to negatively affect the market growth.
U.S. Breast Biopsy Device Market, by guidance type, 2013 - 2024 (USD Million)
Test Type Insights
On the basis of type, this industry is classified into needle breast and open surgical biopsies. The former is further categorized into fine-needle aspiration, core-needle biopsy, and vacuum-assisted core biopsy. The fine-needle aspiration segment is estimated to account for the largest share in 2015 due mainly to a rise in the demand for minimally invasive procedures. On the other hand, the vacuum-assisted core biopsy is anticipated to grow at a high CAGR value during the forecast period owing to the less-invasive nature of this technique, which involves making a small incision through which the needle is inserted, followed by sample acquisition using a vacuum-powered device.
The key products in the industry include needles, tables, localization wires, and guidance systems, among others. The needles segment account for a major share in the year of 2015. This growth corresponds to its wide applicability in the needle breast biopsy market. Most of the enhancements and advancements are perceived in the products segment. For instance, the Stryker PreciseCore needle enables sample acquisition with greater precision and with far less tissue damage risks involved. Furthermore, the guidance systems product segment is anticipated to witness a high growth rate during the forecast period.
Guidance Type Insights
The biopsy procedures require guidance systems to locate the lump or abnormality in the breast region. The available guiding systems used for biopsies include the ultrasound-guided, mammography-guided stereotactic, and magnetic resonance guided biopsies, among others that aid with the procedure in detecting and locating the presence of abnormal cell growths. The mammography-guided segment contributes to the largest share in the sector. However, the probability of false positive results associated with the imaging of dense breast tissues is relatively high. The ultrasound-guided procedure yields more accurate results and is anticipated to witness the highest growth rate during the study period.
The key regions surveyed in the report are North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. In terms of growth rate, the Asia Pacific Breast Biopsy Device Market is estimated to witness the highest growth during the forecast period. This growth is attributable largely to the increased frequency of breast cancer in women. As of 2015, North America contributes to the largest share in the industry due to the rise in awareness achieved through cancer screening programs along with other supportive government initiatives.
Competitive Market Share Insights
Some key players operating in the Breast Biopsy Device Market are Becton, Dickinson and Company (BD), C.R Bard, Inc., Devicor Medicals Products, Inc., and Hologic, Inc., among others. These companies are majorly engaged in the development of new products and in undertaking strategic initiatives, such as joint ventures, FDA approvals, mergers, and acquisitions to maintain their position in the industry. For instance, in April 2016, Hologic, Inc. announced the FDA clearance for the commercially available Affirm Prone biopsy system. The new product is a guided system enabled with 2D/3D imaging features.
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