Breast biopsy refers to tissue or fluid surgical removal for analysis and determination of any potential infection. The extracted tissue is studied under a microscope to check the occurrence of breast cancer. These samples are typically sent to the research labs and are tested by professionals using different instruments and equipment such as needles, tables, wires, and guidance systems to analyze the sample.
The global breast biopsy market size was estimated at USD 1.1 billion in 2019 and is expected to grow at a 10.8% CAGR during the forecast period.
|Market Size||USD 1100 million in 2019|
|Fastest Growing Market||Asia Pacific|
|Largest Market||North America|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
The incidence of breast cancer has mounted dramatically during the last 4 decades. Moreover, escalating international acceptance of western-style sexual and reproductive practices has been allied with a surge in global breast cancer rates. Breast cancer is the 2nd-leading cause of cancer-related deaths amongst women across the globe, according to the American Cancer Society. In the U.S., 1 in 8 women develops invasive breast cancer for their lifetime. As per the American Cancer Society and the National Cancer Institute, more than 265,000 new cases of invasive breast cancer were detected amongst women in the U.S. in 2018, with 63,960 new cases of non-invasive (in situ) breast cancer. As per the data published by the Canadian Cancer Society, in Canada, about 26,300 women were diagnosed with breast cancer in 2017, signifying 25% new cancer cases. More than 70,000 newly diagnosed cases of breast cancer are reported in Germany each year.
A biopsy is a confirmatory procedure that helps cancer/tumor to be diagnosed early, resulting in rapid healing, improved survival, and decreased morbidity and mortality. For early breast cancer diagnosis, health experts prescribe breast biopsy. Novel projects are being pursued by numerous government and private agencies, market-based businesses, and hospitals to increase public awareness of breast cancer and the health effects of its early diagnosis through screening services. In India, the Pink Chain Campaign is a nationwide campaign that started with encouraging awareness of breast cancer. Moreover, growing funding for R&D is likely to support breast biopsy market growth. For instance, as per the National Cancer Research Institute (NCRI), cancer research funding by NCRI partners was around USD 750 million in 2018/19. Consequently, these efforts to increase awareness of early breast cancer detection and diagnosis are expected to fuel breast biopsy systems, furthering market development.
North America accounted for the majority share due to cancer diagnostics firms' ongoing growth and rising demand for new therapies and treatment. Government organizations, voluntary healthcare associations, pharma and biotech firms, and research institutions are investing heavily in several medical and health-related research and development activities, further contributing to the breast biopsy market growth. Recent advances in 3D scanning technologies produce waves adding to the revolution in the breast biopsy industry. For instance, CareMountMedical (New York) provides a 3D image-guided breast biopsy with a prone system. The 360° view helps lesions to be accessed by radiologists without repositioning the patient. The firm has also installed a software enhancement that brings with color mapping technologies the best detection of unusual regions on a breast MRI.
In the U.S., Lima Memorial Health Systems received a 3-year endorsement for stereotactic biopsy from the American College of Radiology. This authorization has abetted reserve the center's status as a 'Breast Imaging Center of Excellence' being wholly recognized in mammography, breast MRI, breast ultrasound, and stereotactic biopsy.
In Asian countries, conventional biopsy technologies, such as core-needle biopsies and surgical biopsies, currently dominate the disease diagnosis market. According to GLOBOCAN estimates, breast cancer has been the most prevalent cancer among women worldwide in recent years, with significantly more cases in developing countries. The Breast International Group (BIG) states that in Asia, many breast cancer cases in women have been diagnosed, accounting for about 40%. Enormous studies have revealed that breast cancer occurs in many parts of Asia at a younger age, with a median diagnostic age in South Korea, Singapore, Malaysia, Hong Kong, China, and India of 49-50 years compared to Japan's 57 years.
Moreover, increasing awareness of breast biopsy procedures tends to tap into the diagnostic domain in developing economies, allowing players to invest in these emerging economies for breast biopsy devices. In countries such as China, India, and South Korea, health technology is evolving rapidly, leading to substantial investments by hospitals and breast care centers in innovative systems (comprising liquid breast biopsy and vacuum-assisted biopsy devices, amongst others). For instance, in India, Cytecare Hospital was declared in Bengaluru as the 1st hospital to incorporate 3D mammography (Digital Breast Tomosynthesis) in women. 3D Mammography has the upper hand over 2D scans as it uses low concentrations of x-rays at varying angles to create several sequential slides through the tissues. The scans take 10 seconds, and the inferences are passed on to the computer.
The risk of breast cancer rises with aging and is thus primarily found in people over 50 years. At the age of 50, about 77% of women were diagnosed with breast cancer, and there are 2.8 million breast cancer survivors living in the U.S. It is observed that different diagnostic firms are investing in the study and development of novel breast imaging methods and needle biopsies, further leading to segmental growth.
Rising acceptance of image-guided processes and the launch of technologically advanced and innovative designs such as the tri-axial needle are key factors leading to segment growth. This needle consists of an outermost pincer needle, an outer cutting needle, and a sharp stylet on the inner side. Without compressing it, the needle shape helps healthcare practitioners to slice into the tissue. The needle displays good visibility under ultrasound and C.T., widely used for biopsy guidance because of its unique shape. A few years back, the US-based Cook Medical launched the EchoTipProCore 20 Gauge Needle, a biopsy needle. It was intended for a fine needle biopsy (FNB) guided by ultrasound. In January 2019, IZI Medical Products acquired Cook Medical's soft tissue biopsy and breast localization needle product line.
Liquid biopsy has evolved as a groundbreaking procedure that is offering new dimensions in oncology diagnostics. The segment's substantial growth is due to the increasing acceptance in most developed countries of novel NGS-based assays and droplet automated PCR technologies to perform liquid biopsies. To introduce new products to the consumer, firms operating in the sector rely more on research and development activities. According to the recent studies, the pre-analytical and analytical phases, the two well-developed biomarkers identified by liquid biopsy, circulating tumor cells (CTCs) and circulating cell-free tumor DNA (ctDNA), are subject to technological variance. The sales growth might also be further driven by ongoing clinical trials and a compelling product pipeline.
In April 2019, Hologic Inc. launched Trident H.D. specimen radiography system in the U.S. It might deliver the superior image quality and the workflow for sample verification during breast-conserving surgeries and stereotactic breast biopsies. It also aids the physicians to get superior breast surgical specimens and a range of surgical and biopsy samples. This launch had extended the firm's product portfolio.
In June 2019, a legal agreement to purchase US-based MRS Systems Inc. (MRS) was signed by Volpara Health Technologies. According to the company, Volparamight then broadens its product range and follow its tremendous enjoyment of synthetic intelligence (A.I.) and system acquisition (ML) expertise to revolutionize custom breast care by creating a new age.
In August 2018, SOMATEX Medical Technologies GmbH launched Tumark Eye, a sophisticated tag marking scheme for breast cancer with excellent ultrasound usability. It is an excellent instrument for the detection and naming of breast biopsy sites. This launch might grow the business's biopsy clip range to include more precise options for breast treatment.