| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 1.29 Billion |
| Market Size (2030) | USD 1.66 Billion |
| CAGR (2025 - 2030) | 5.12 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Breast Biopsy Devices Market Analysis
The Breast Biopsy Devices Market size is estimated at USD 1.29 billion in 2025, and is expected to reach USD 1.66 billion by 2030, at a CAGR of 5.12% during the forecast period (2025-2030).
The emergence of the COVID-19 pandemic restrained the breast biopsy devices market. It had a detrimental effect on the market due to the reduction in screening rates for breast cancer, and postponing mammograms, which help doctors determine whether the patient needs a breast biopsy or not, contributed to a delayed diagnosis. These changes in screening rate led to a high number of advanced-stage patients, an increasing mortality rate, and a low supply of diagnostic services. According to the Journal of the American College of Radiology (JACR) report 2023, COVID-19 significantly impacted the breast cancer diagnostic rate. The breast biopsy rate was reduced to 47.3% during the first wave of the pandemic in the United States. The breast biopsies and diagnostic mammography rate was reduced to 47.3% and 57%, respectively, during the first wave of the pandemic in the United States, which hasn’t returned to normal stage like pre-pandemic. Hence, COVID-19 had a negative impact on screening mammography volumes and biopsies rates. However, the breast biopsy devices market is likely to witness growth momentum in coming years owing to the rising burden of breast cancer and growing awareness about early disease diagnosis.
The major factors driving the market are the rising prevalence and awareness of breast cancer and the rising demand for minimally invasive breast biopsy procedures. According to the World Health Organization 2023 report, there are more than 2.3 million cases of breast cancer that occur every year, which makes it the most common cancer among adults. However, nearly 80% of deaths from breast cancer occur in low- and middle-income countries. Breast cancer survival rate has increased to five years after diagnosis and now increased to 80% in most high-income countries, compared with 66% in developing countries like India and just 40% in South Africa. In 95% of countries of the world, breast cancer is the first or second leading cause of female cancer deaths. To control such high incidences and mortality rates due to breast cancer, WHO has launched the Global Breast Cancer Initiative Framework, which gives a road map for all countries to control the prevalence and mortality rate. The main objective of this initiative is to promote early detection and effective management to deliver the full treatment course to at least 80% of diagnosed patients. This initiative will increase the diagnostic rate and treatment rate of breast cancer, which will directly accelerate the breast biopsy devices market. Along with the global initiatives taken by the WHO, there are regional initiatives taken by the European Commission to create awareness about the screening of breast cancer will also have further additional effects on the breast biopsy devices market in that region.
Moreover, the rising demand for minimally invasive breast biopsy procedures will accelerate the market. Minimally invasive biopsy (MIB) has replaced open surgical biopsy in patients with imaging-detected suspicious or indeterminate breast lesions. Compared to surgical excision, MIB has the same or even better precision, decreases the psychological burden affecting the patients, and reduces the costs of treatment. MIB reduces the number of surgical procedures required in patients with impalpable breast cancer compared to diagnostic open surgery. Additionally, the new product launch of MIB accelerates the market. For instance, in February 2022, the FDA approved TeesuVac Breast Biopsy Device Mark 1, a minimally invasive device indicated to obtain percutaneous core biopsy specimens from soft tissue and tumors of the breast, which is developed by TeesuVac ApS, which has expertise in developing biopsy medical devices for more than a decade. Hence, cost-effectiveness and new product launches of minimally invasive breast biopsies will accelerate the breast biopsy devices market.
However, the risk of infections due to the wound formed after biopsy will likely restrain the growth of the breast biopsy devices market's growth rate.
Breast Biopsy Devices Market Trends
The Breast Biopsy Needles Under Product Segment is Expected to Hold a Significant Share in the Market
The breast biopsy needle occupies a significant market share due to its application in different kinds of procedures like fine needle aspiration biopsy, vacuum-assisted biopsy, and core needle biopsy. These procedures, where needles are used to collect the breast tissue sample rather than the surgical procedure, make breast cancer treatment more affordable. According to the NIH Report 2021, the average mortality rates among breast cancer women were significantly greater in South Asia and Sub-Saharan Africa. Countries in South Asia are spending from 0.05% to 0.08% of GDP to fight breast cancer every year. This economic burden can be reduced by using cost-effective diagnostic procedures where needles are used. For instance, according to an NIH report study in 2021, the most common diagnostic practice for breast biopsy in pathology centers of Saharan African countries is fine needle aspiration and core needle aspiration.
Therefore, due to the higher utilization of needles in different procedures and cost-effectiveness, new product launches led to new product launches. For instance, in February 2022, TeesuVac ApS, a Denmark company, launched a new needle biopsy device known as TeesuVac Breast Biopsy Device Mark 1, which is indicated to obtain percutaneous core biopsy specimens from soft tissue and tumors of the breast. Hence, new product launches are expected to boost the breast biopsy needles segment, which is estimated to witness significant growth over the forecast period.
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North America is Expected to Dominate the Breast Biopsy Devices Market
North America is expected to dominate the market owing to factors such as high awareness and prevalence rate of breast cancers among people in the region, new technological advancements, favorable reimbursement scenarios by the government, and new breast density notification laws in the United States. According to the American Society of Cancer (ASC) Report 2023, breast cancer is the most common cancer in women in the United States, except for skin cancers. Breast cancer accounts for 30% of all female cancers affected each year. To reduce the prevalence rate and mortality rate of breast cancer, the government has introduced certain laws to support patients with diagnosis and treatment costs. For instance, the Breast and Cervical Cancer Mortality Prevention Act of the United States provides economic support to low-income families for the treatment of breast cancer. Such awareness and reimbursement initiatives by the government in the region will accelerate the breast biopsy device market in the region.
Furthermore, the new technological advancements for the diagnosis of breast cancer and FDA approvals will accelerate the market in the region. For instance, in August 2022, the FDA approved the Guardant360 CDx (Guardant Health, Inc.), which is a liquid biopsy test device used to identify advanced or metastatic breast cancer patients with ESR1 mutations. In addition, in April 2022, the FDA approved HydroMARK Breast Biopsy Site Marker (Devicor Medical Products, Inc.), which is used to mark tissue during percutaneous breast biopsy procedures.
Therefore, owing to the high awareness and prevalence rate of breast cancer, new technological advancements, and reimbursement scenarios are expected to drive the market in the North American region.
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Breast Biopsy Devices Industry Overview
The breast biopsy devices market is moderately consolidated and competitive due to the presence of many players. The market's major players are concentrating on joint ventures, strategic alliances, the introduction of new products, and geographic growth into developing and economically advantageous areas. Some of the major players include F. Hoffmann-La Roche Ltd, Ferring B.V., Hologic Inc., Danaher Corporation, Argon Medical Devices, Merit Medical Systems, Menarini-Silicon Biosystems, NeoGenomics, Sterylab S.R.L., Bio-Rad Laboratories, Inc., Qiagen, Exact Sciences Corporation, Sysmex Inostics, Becton Dickinson and Company, Guardant Health, Inc.
Breast Biopsy Devices Market Leaders
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F. Hoffmann-La Roche Ltd
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Becton Dickinson and Company
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Danaher Corporation
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Merit Medical Systems
- *Disclaimer: Major Players sorted in no particular order
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Breast Biopsy Devices Market News
- June 2023: Quest Diagnostics, a leading provider of diagnostic information services, acquired Haystack Oncology. With this acquisition, global Quest Diagnostics added a Sensitive MRD Liquid Biopsy Technology to its Diagnostics Portfolio.
- August 2022: Mammotome, a global player in breast care and the pioneer of vacuum-assisted breast biopsy, launched the Mammotome RevolveTM EX Dual Vacuum-Assisted Breast Biopsy System. This device is a vacuum-assisted biopsy device designed specifically for cutting out benign breast lesions.
Breast Biopsy Devices Industry Segmentation
As per the scope of the report, breast biopsy refers to a procedure that is used for the removal of tissue from the breast. The procedure is done to identify breast cancer and other kinds of diseases. Different devices, like spring-loaded needles, thin guide wires, and vacuum-assisted devices, are used to perform this procedure effectively. The breast biopsy device market is segmented by product (breast biopsy needles, breast biopsy tables, localization wires, and others), procedure (vacuum-assisted biopsy, core needle biopsy, fine needle aspiration biopsy, liquid biopsy, and surgical biopsy), technique (image-guided biopsy, liquid biopsy), indication (fibroadenoma, suspicious micro-calcifications, complex cyst, recurrent breast cancer, invasive lobular carcinoma, and other indications), end user (breast care centers, hospitals and clinics, and diagnostic centers), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD) for the above segments. The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally.
The report offers the value (in USD) for the above segments.
| By Product | Breast Biopsy Needles | ||
| Breast Biopsy Tables | |||
| Assay Kits | |||
| Localization Wires | |||
| Others | |||
| By Procedure | Vacuum Assisted Biopsy | ||
| Core Needle Biopsy | |||
| Fine Needle Aspiration Biopsy | |||
| Liquid Biopsy | |||
| Surgical Biopsy | |||
| By Technique | Image Guided Biopsy | Stereotactic Guided Breast Biopsy | |
| Ultrasound Guided Breast Biopsy | |||
| CT Guided Breast Biopsy | |||
| MRI Guided Breast Biopsy | |||
| Liquid Biopsy | Next-generation Sequencing Based Biopsy | ||
| Polymerase Chain Reaction Based Biopsy | |||
| Microarray-based Biopsy | |||
| By Indication | Fibroadenoma | ||
| Suspicious Micro-calcifications | |||
| Complex Cyst | |||
| Recurrent Breast Cancer | |||
| Invasive Lobular Carcinoma | |||
| Other Indications | |||
| By End User | Breast Care Centers | ||
| Hospitals and Clinics | |||
| Diagnostic Centers | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Breast Biopsy Devices Market Research FAQs
How big is the Breast Biopsy Devices Market?
The Breast Biopsy Devices Market size is expected to reach USD 1.29 billion in 2025 and grow at a CAGR of 5.12% to reach USD 1.66 billion by 2030.
What is the current Breast Biopsy Devices Market size?
In 2025, the Breast Biopsy Devices Market size is expected to reach USD 1.29 billion.
Who are the key players in Breast Biopsy Devices Market?
F. Hoffmann-La Roche Ltd, Becton Dickinson and Company, Danaher Corporation and Merit Medical Systems are the major companies operating in the Breast Biopsy Devices Market.
Which is the fastest growing region in Breast Biopsy Devices Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Breast Biopsy Devices Market?
In 2025, the North America accounts for the largest market share in Breast Biopsy Devices Market.
What years does this Breast Biopsy Devices Market cover, and what was the market size in 2024?
In 2024, the Breast Biopsy Devices Market size was estimated at USD 1.22 billion. The report covers the Breast Biopsy Devices Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Breast Biopsy Devices Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Breast Biopsy Devices Industry Report
Statistics for the 2025 Breast Biopsy Devices market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Breast Biopsy Devices analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
