Celero Hologic

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According to a new series of reports on the female and neonatal diagnostic device market by iData Research, unit sales will continue to increase, driven primarily by the increasing average age of patients. As a person ages, the incidence of cancer or suspicious lesions that may require a biopsy increases. While other factors such as exposure to carcinogens, diet and level of physical activity also affect the rates of cancer, a patient’s age is the most dominant driving force.

Breast biopsy needles are used in conjunction with vacuum-assisted breast biopsy (VABB) devices or used with spring-loaded core needles. VABB devices accounted for almost 90% of the revenues in the breast biopsy market in 2015. Spring-loaded core needles have been on the market much longer than VABB devices, and their use is widespread. However, because the average selling price of spring-loaded core needles is a fraction of that of VABB devices, their portion of the total market is somewhat limited.

Minimally invasive procedures account for the majority of breast biopsy procedures in the United States. Minimally invasive procedure numbers are growing faster because of their speedy procedure times, shorter recovery times and lower rates of complications. These procedures are also often able to be performed in the physician’s office, which makes them less costly. In addition, the implementation of the Affordable Care Act in 2011 required the full reimbursement of screening mammograms which has increased the number of mammogram procedures performed each year. This has led to an increase in the number of breast lesions found and therefore, biopsy procedures conducted.

“These new reimbursement rates caused the VABB device market to decrease in value”, explains Dr. Kamran Zamanian, CEO of iData. “However, the price drop was absorbed by the manufacturers, and as a result, with increased breast health awareness, and advancements in imaging capabilities, the market should increase to over $180 million by 2022.”

In addition, new legislation is currently being lobbied to restore reimbursement rates to previous or similar levels.

Hologic is the leader of the breast biopsy market with a market share of over 40%. It only competed in the VABB device market with their Celero®, Eviva® and ATEC® line of products, which are manufactured by its subsidiary company Suros Surgical Systems. The Celero® device is completely disposable and requires no investment in capital equipment for its use, which has helped increase its adoption rate in the marketplace.

Mammotome, a Devicor company, is the second leading competitor in the breast biopsy market. Despite the need for an initial investment in expensive capital equipment, the global adoption rate of the company’s Mammotome® Legacy biopsy system has been high, which is expected to continue over the forecast period.

C. R. Bard is the third leading competitor in the U.S. breast biopsy market. C. R. Bard expanded the use of its devices by offering reusable handles for free when disposable needles were purchased. They produce the Vacora® which is a self-contained VABB device, meaning it requires no additional capital equipment. This makes the Vacora® more likely to be adopted by spring core users and places it in direct competition with Hologic’s Celero® and Devicor’s Mammotome Elite®. Other competitors in the breast biopsy market include CareFusion, Intact Medical and Scion Medical Technologies among others.

For Further Information
More on the breast biopsy market in the US can be found in a report series published by iData Research entitled the US Market for Female and Neonatal Diagnostic Devices. The reports cover: bone densitometry, DXA markets, breast biopsy devices, core needle devices, vacuum-assisted breast biopsy devices, breast imaging equipment, mammography, obstetrics and gynecology ultrasound equipment, fetal and neonatal monitoring devices, infant warmer and incubators, NICU, and gynecological chairs.

Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about breast biopsy market data or procedure data, register online or email us at [email protected] for a US Market for Female and Neonatal Diagnostic Devices report series brochure and synopsis.

About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by State, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.

About Reimbursement Tracker
iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.


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