The global sales of breast biopsy devices are estimated to be worth USD 2.47 billion in 2025 and anticipated to reach a value of USD 4.21 billion by 2035. Sales are projected to rise at a CAGR of 5.5% over the forecast period between 2025 and 2035. The revenue generated by breast biopsy devices in 2024 was USD 2.34 billion.
There has been a constant rise in the number of breast cancer patients worldwide, which forms a major driver for the market of breast biopsy devices. The diagnosis of breast cancer is the most common form when it comes to women, and there remain several health challenges in control of this kind.
According to the World Health Organization, breast cancer is one of the leading cancers that account for a substantial portion of new cases annually with billions of women affected worldwide. Similarly, statistics from the American Cancer Society illustrate a consistent rise in the incidence rates of breast cancer, primarily in developed and some developing nations, due to changes in lifestyle, hormonal influences, and genetic predispositions.
Global Breast Biopsy Devices Industry Analysis
| Attributes | Key Insights |
|---|---|
| Historical Size, 2024 | USD 2.34 billion |
| Estimated Size, 2025 | USD 2.47 billion |
| Projected Size, 2035 | USD 4.21 billion |
| Value-based CAGR (2025 to 2035) | 5.5% |
This increase in occurrence intensifies the demand for effective diagnostic equipment. Thus, these various breast biopsy devices have become indispensable in modern healthcare.
Early diagnosis is paramount in improving one's chances of survival against breast cancer since early-stage cancers are generally less dangerous than when their progresses are much more extensive. The types of biopsy used for the exact diagnosis of all the different breast abnormalities include core needle biopsy (CNB), fine-needle aspiration biopsy (FNAB), and vacuum-assisted biopsy (VAB).
Running in parallel with most of these forms of diagnosing will be better performed by the integration of biopsy devices and advanced imaging technologies, like mammography, ultrasound, and Magnetic Resonance Imaging (MRI).
Mass screening exercises around the globe have often been given some priority by the government and health organizations-this is sometimes done for early detection of any suspicious breast lesion as it entails a biopsy for pathologic evaluation.
In conclusion, the growing incidence of breast cancer reiterates the pressing need for improved and reliable biopsy devices, boosting market growth to meet the worldwide healthcare challenge of early-stage diagnosis of this ailment.
Exclusive Offer: 30% Off on Regional Reports
Get a free sample report and customize your regions for a 30% discount on your regional report!
The below table presents the expected CAGR for the global breast biopsy devices market over several semi-annual periods spanning from 2025 to 2035. In the first half (H1) of the decade from 2024 to 2034, the business is predicted to surge at a CAGR of 6.2%, followed by a slightly lower growth rate of 5.9% in the second half (H2) of the same decade.
| Particular | Value CAGR |
|---|---|
| H1 | 6.2% (2024 to 2034) |
| H2 | 5.9% (2024 to 2034) |
| H1 | 5.5% (2025 to 2035) |
| H2 | 5.0% (2025 to 2035) |
Moving into the subsequent period, from H1 2025 to H2 2035, the CAGR is projected to decrease slightly to 5.5% in the first half and decrease moderately at 5.0% in the second half. In the first half (H1) the market witnessed a decrease of 70.00 BPS while in the second half (H2), the market witnessed an increase of 90.00 BPS.
The Expansion of Screening Programs and Awareness Campaigns Is Driving the Growth for Breast biopsy devices market.
Government and non-governmental associations across the world have focused on creating breast cancer awareness and early detection through comprehensive initiatives. These programs will help the public understand the importance of regular checkups, why they are risky, and possibly help the patient survive earlier.
For example, activities like Breast Cancer Awareness Month spearheaded by any organization like the American Cancer Society (ACS) and World Health Organization (WHO) have been crucial in fostering awareness across the globe.
Mass screening programs, especially mammography, form the core of these efforts. With such programs being initiated, thousands of women become a part of routine screening processes, which mostly reveal suspicious lesions or abnormalities in the breast tissue.
The discovery of these anomalies calls for further diagnostic evaluation, and the gold standard for the final diagnosis is breast biopsy. This direct correlation of increased screening efforts with the need for biopsy procedures has driven the advancement of breast biopsy devices.
Advancements in image-guided biopsy techniques have now made follow-up evaluations more efficient as well as highly accurate, well in line with the objectives behind such awareness measures that would ultimately allow for time- and evidence-based diagnosis. This increases the cumulative pool of the patient population getting biopsy procedures thus becoming an overarching factor in the acceleration of the demand for breast biopsy devices.
Advancements in Vacuum-Assisted Biopsy (VAB) Systems Are a Key Driver of Growth in The Market for breast biopsy devices
These systems have revolutionized the way breast tissue samples are collected, offering significant advantages over traditional biopsy techniques. Unlike conventional methods, VAB systems use a vacuum mechanism to extract tissue samples, enabling the collection of larger and more intact specimens.
This ability to obtain high-quality samples improves diagnostic precision, particularly in detecting subtle or early-stage abnormalities, which are crucial for effective breast cancer diagnosis and treatment planning.
The minimally invasive nature of VAB systems has pushed forward their application further. Such instruments can accurately reach small or located lesions which other techniques might have difficulty reaching.
The technique can be guided through advanced imaging techniques such as ultrasound, mammography, or MRI, to provide accuracy in collecting samples and limiting damage to other tissues. This makes VAB a patient-friendly option, reducing recovery time, procedure-related discomfort, and the need for repeat biopsies.
In addition, improvements in VAB systems, such as automation and ergonomic designs, have streamlined the process for clinicians to be faster and more efficient. These advancements are in line with the increased need for cost-effective, accurate, and patient-centered diagnostic solutions in modern healthcare settings.
Therefore, the constant improvement and adoption of VAB systems have become a significant driver of the expansion of the market for breast biopsy devices.
The Increasing Preference for Outpatient Settings Like Ambulatory Surgical Centers (ASCs) For Performing Biopsy Procedures Presents a Significant Opportunity
Ambulatory surgical centers have become the preference for patients and healthcare providers as they are less expensive, require shorter waiting periods, and the whole process runs much more efficiently than in hospitals. The growth of outpatient care has been further encouraged by a rising demand for minimally invasive procedures that take much less time and can be accomplished with minimal recovery time, so breast biopsies are most suitable for such ASCs.
This has opened up an area for manufacturers to develop compact, portable, and easy-to-use biopsy devices suitable for the ASCs' requirements. The devices have to be manufactured keeping in mind the need for high precision and efficiency while being user-friendly to clinicians who function in a high-pace environment.
In addition, the cost-sensitive nature of the ASC will require diagnostic tools to be affordable yet with advanced technology, an area for innovative biopsy technologies.
In addition, the increasing number of ASCs worldwide, especially in developed and emerging markets, increases the potential customer base for breast biopsy device manufacturers. Devices designed for ASCs not only make procedures more efficient but also increase patient satisfaction due to faster procedures and quicker recovery times. This trend represents untapped growth potential in this market segment.
The Dependence of Breast Biopsy Devices on Advanced Imaging Modalities as Significant Growth Barrier for Market for breast biopsy devices Growth
Advanced imaging modalities such as MRI, mammography, and ultrasound pose a significant restraint on the market for breast biopsy devices, mainly because of resource-limited settings. These imaging systems are an essential part of many biopsy procedures that are performed with precision and effectiveness, because they allow accurate localization and targeting of suspicious lesions.
However, the high cost and need for specialized infrastructure make these unavailable, especially in smaller healthcare facilities and rural areas.
In developing areas or low-income countries, accessibility to advanced imaging technology is confined because of various economic constraints along with low-budget healthcare and inadequacy of infrastructure. Smaller clinics or outpatient centers also refrain from the investment of advanced imaging equipment in the developed regions also, thereby declining their ability for performing advanced biopsies through them.
These restrictions limit the usage of devices that are primarily based on the aforementioned modalities and act as a constraint toward the growth in the market.
In addition, the imaging-guided biopsy systems are operated by trained personnel who have knowledge in both imaging and biopsy techniques. The lack of such trained professionals in many areas aggravates the challenge, leaving some populations underserved.
For manufacturers, this reliance on imaging systems adds complexity, as devices must be designed to integrate seamlessly with a range of imaging technologies, further increasing costs. In summery, the availability of advanced imaging technologies can significantly limit access and widespread acceptance of breast biopsy instruments, limiting growth in low resource regions.
The global breast biopsy devices industry recorded a CAGR of 4.9% during the historical period between 2020 and 2024. The growth of breast biopsy devices industry was positive as it reached a value of USD 2.34 billion in 2024 from USD 1.90 billion in 2020.
The advances in technology and breast cancer detection awareness have steered the market for breast biopsy devices in an upward growth trajectory. From being led by the manual biopsy techniques and other methods, the interest shifted towards minimally invasive and image-guided approaches, such as vacuum-assisted and core needle biopsies. These advances have increased the accuracy of diagnosis, reduced patient discomfort, and shortened recovery time, making these devices intrinsic to modern cancer diagnostics.
Upcoming trends would be automation and AI integration into biopsy systems that will allow for real-time feedback, increased accuracy, and minimal human error. Robot-assisted biopsy technologies are becoming increasingly adopted, especially when targeting complex or small lesions. Portable and wireless devices are also surfacing, aiming to address point-of-care diagnostics and improve access in resource-poor settings.
The market is also moving towards the concept of personalized medicine, where tissue sampling is to be done accurately for molecular and genetic profiling. In addition, disposable biopsy products are gaining momentum due to sterility and infection control advantages that match the strict healthcare regulations.
The market is placed to grow through early cancer detection by healthcare systems, expansion in screening programs and innovative biopsy technology. Emerging markets and hybrid biopsy devices are further opportunities for expanding in the coming years.
Tier 1 companies comprise market leaders with a significant market share of 58.9% in global market. These companies engage in strategic partnerships and acquisitions to expand their product portfolios and access cutting-edge technologies. Additionally, they emphasize extensive clinical trials to validate the efficacy and safety of their products. Prominent companies in tier 1 include F. Hoffmann-La Roche Ltd., GE Healthcare, Cook Medical Inc., Becton Dickinson and Company.
Tier 2 companies include mid-size players having presence in specific regions and highly influencing the local market and holds around 21.9% market share. They typically pursue partnerships with multispecialty hospitals and research organizations to leverage emerging technologies and expedite product development.
These companies often emphasize agility and adaptability, allowing them to quickly bring new products to market, additionally targeting specific types medical needs. Additionally, they focus on cost-effective production methods to offer competitive pricing. Prominent companies in tier 2 include Hologic, Inc., Siemens Healthier, ARGON MEDICAL, C.R. Bard, Inc. and Devicor Medical Products, Inc.
Finally, Tier 3 companies, such as Leica Biosystems, Medax Srl Unipersonale, Planmed Oy, and Scion Medical Technologies, LLC. They specialize in specific products and cater to niche markets, adding diversity to the industry.
Overall, while Tier 1 companies are the primary drivers of the market, Tier 2 and 3 companies also make significant contributions, ensuring the breast biopsy devices sales remains dynamic and competitive.
Check Free Sample Report & Save 40%!
Select your niche segments and personalize your insights for smart savings. Cut costs now!
The section below covers the industry analysis for the market for breast biopsy devices for different countries. Market demand analysis on key countries in several regions of the globe, including North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe and Middle Ease & Africa, is provided. The United States is anticipated to remain at the forefront in North America, with higher market share through 2035. In South Asia & Pacific, India is projected to witness a CAGR of 5.5% by 2035.
| Countries | Value CAGR (2025 to 2035) |
|---|---|
| United States | 2.9% |
| Germany | 3.9% |
| France | 3.5% |
| Spain | 4.1% |
| China | 5.1% |
| India | 5.5% |
| Australia & New Zealand | 4.8% |
| Japan | 5.0% |
United States. market for breast biopsy devices is poised to exhibit a CAGR of 2.9% between 2025 and 2035. Currently, it holds the highest share in the North American market.
According to the American Cancer Society (ACS), breast cancer is the most frequently diagnosed cancer among women in the country, with over 300,000 new cases of invasive and non-invasive breast cancer reported annually. This alarming incidence rate has heightened the need for early detection and accurate diagnosis, making advanced diagnostic tools, including breast biopsy devices, essential in healthcare.
Early diagnosis is very important for the effective treatment, and breast biopsy devices play a crucial role in confirming malignancies and guiding therapeutic decisions. This increasing prevalence has also led the government and nongovernmental initiatives to encourage widespread breast cancer screening, often finding suspicious lesions that require biopsy. This steady demand for accurate and reliable diagnostic solutions continues to propel the adoption and development of new and innovative breast biopsy technologies in the USA market.
Germany’s market for breast biopsy devices is poised to exhibit a CAGR of 3.9% between 2025 and 2035. Currently, it holds the highest share in the Western Europe market, and the trend is expected to continue during the forecast period.
The initiatives and healthcare campaigns carried out in Germany have equipped the public with information on breast cancer risks, signs, and early diagnosis benefits. National Mammography Screening Program emphasizes the need for women aged 50-69 years to be screened regularly, allowing for early detection of abnormal lesions in the breast.
This awareness helps to generate proactive healthcare behavior in that among other things, a larger segment of the female population has accepted regular check-ups and these tests. The additional tests are usually followed by biopsy procedures when evidence of abnormality is found.
The seemingly growing demand for such modern and accurate breast biopsy devices can be linked towards the rising awareness on breast cancer found among the various segments of the German population. Along with this is a well-educated and equally health-conscious German populace that promotes an immense call for timely medical intervention, maintaining a steady demand for diagnostic solutions. This focus on awareness and a preventive approach to healthcare also supports powerfully the growth of the market for breast biopsy devices in the country.
Japan market for breast biopsy devices is poised to exhibit a CAGR of 5.0% between 2025 and 2035. Currently, it holds the highest share in the East Asia market, and the trend is expected to continue during the forecast period.
Japan's rapidly aging population significantly impacts the market for breast biopsy devices. As of 2022, over 29% of Japan's population was aged 65 and above, reflecting a substantial increase over the past decade. This demographic shift correlates with a rise in breast cancer cases, particularly among older women. In 2020, approximately 92,150 new breast cancer cases were diagnosed among Japanese women, a significant increase from over 44,000 cases in 2003.
Elderly populations also suffer from hence, putting them at an increased risk of having comorbidities and hence making early diagnosis and the delivery of treatment all the more urgent. Biopsy devices, more so even minimally invasive ones, are now increasingly being embraced in giving appropriate diagnoses with low discomfort to the patient. The health care system in Japan, powered by universal coverage, endorses the systems toward the older generation accessing those tools. The government health initiatives also boost regular screening to assist in early detection of breast lesions that require biopsy.
The section contains information about the leading segments in the industry. By product, the vacuum-assisted device (VAD) segment holds the highest market share of 55.6% in 2025.
| By Product | Vacuum-Assisted Device (VAD) |
|---|---|
| Value Share (2025) | 55.6% |
The VAD has grasped the market for breast biopsy devices on account of its evidence-based better performance coupled with its patient-friendly features. The VAD is capable of excising comparatively bigger intact tissue samples than traditional biopsy methods, thus ensuring more accuracy in detecting and diagnosing breast lesions. Such precision is quite beneficial in identifying small or difficult-to-access lesions.
Because they are highly targeted, minimally invasive VAD procedures diminish levels of patient discomfort, operative risk, and time or recovery, thus mirroring the growing trend toward advanced patient-centric diagnostic tools. VADs can also be used in conjunction with certain imaging technologies, including ultrasound, mammography, and MRI, thereby increasing their efficiency with targeted biopsies.
Its versatility and efficiency make vacuum-assisted devices suitable for outpatient and ambulatory =surgical centers, which are increasingly favored for diagnostic procedures. Also, the high rates of reimbursement for vacuum-assisted biopsies in developed areas have led to their broad uptake.
| By End User | Hospitals |
|---|---|
| Value Share (2025) | 62.1% |
Hospitals are the largest end users of breast biopsy devices owing to their advanced infrastructure, specialized diagnostics, and comprehensive patient care services. Hospitals are the primary points for diagnosis and treatment for cancer, with a build-up of high-tech imaging technologies, such as mammography, ultrasound, and MRI; all of which are part of the breast biopsy procedures and support the effective utilization of advanced biopsy devices such as vacuum-assisted and image-guided systems.
Within the ambit of this procedure, there are also concentrated and skillful professionals congregated in hospitals, e.g., radiologists and oncologists, precisely trained to help perform the diagnostic procedures. This is done in context to their capacity for patient traffic being able to diagnose and intervene within a very large spectrum; hence, hospitals would naturally constitute the first choice for breast biopsies.
Besides, hospitals are engaged in government/private screening programs which provide more patients with intervals for diagnostic follow-ups. Hospitals are recognized as being in a position to provide reimbursements for biopsy procedures; hence, they are the principal players in this market segment.
The market players are using strategies to stay competitive, such as product differentiation through innovative formulations, strategic partnerships with healthcare providers for distribution. Another key strategic focus of these companies is to actively look for strategic partners to bolster their product portfolios and expand their global market presence.
Recent Industry Developments in Market for breast biopsy devices
In terms of product, the industry is divided into- biopsy needle, MRI-guide biopsy systems, ultrasound guided breast biopsy systems, vacuum-assisted device (VAD), guide wire (localization wire) and breast biopsy marker.
In terms of indication, the industry is segregated into- complex cyst, solid mass, suspicious solid mass (fibroadenoma) and suspicious micro-calcifications.
In terms of end user, the industry is segregated into- hospitals, specialty clinics, ambulatory surgical centers and cancer research institutes.
Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia and Pacific, East Asia and Middle East and Africa (MEA) have been covered in the report.
The global breast biopsy devices market is projected to witness CAGR of 5.5% between 2025 and 2035.
The global breast biopsy devices industry stood at USD 2.34 billion in 2024.
The global breast biopsy devices market is anticipated to reach USD 4.21 billion by 2035 end.
India is set to record the highest CAGR of 6.4% in the assessment period.
The key players operating in the global breast biopsy devices market include F. Hoffmann-La Roche Ltd., GE Healthcare, Cook Medical Inc., Becton Dickinson and Company, Hologic, Inc., Siemens Healthier, ARGON MEDICAL, C.R. Bard, Inc., Devicor Medical Products, Inc., Leica Biosystems, Medax Srl Unipersonale, Planmed Oy, and Scion Medical Technologies, LLC.
| Estimated Size, 2024 | USD 60.4 billion |
|---|---|
| Projected Size, 2034 | USD 136.7 billion |
| Value-based CAGR (2024 to 2034) | 8.5% |
| Market Estimated Size in 2023 | USD 1,827.00 million |
|---|---|
| Projected Market Value in 2033 | USD 2,672.30 million |
| Value-based CAGR from 2023 to 2033 | 3.90% |
| Market Value 2023 | USD 95.6 Million |
|---|---|
| Market Value 2033 | USD 244.3 Million |
| CAGR (2023 to 2033) | 9.8% |
Explore Therapeutic Device Insights
View Reports
Breast Biopsy Devices Market
Thank you!
You will receive an email from our Business Development Manager. Please be sure to check your SPAM/JUNK folder too.
