Breast Biopsy Market Outlook:
Breast Biopsy Market size was estimated at over USD 2.6 billion in 2024 and is projected to reach USD 5.2 billion by the end of 2037, exhibiting a CAGR of 6.9% during the forecast period 2025-2037. In 2025, the industry size of the breast biopsy is evaluated at USD 2.5 billion.
The breast biopsy market is evolving steadily with the rising number of breast cancer cases registered and corresponding patient volume necessitating the diagnostic procedure. As per the U.S. Centers for Disease Control and Prevention, over 264,010 cases are diagnosed annually for women in the U.S, and nearly 42,005 resulting in death. Hence, this provides a significant need for diagnostic intervention and biopsies. This is mainly seen in the high-income and middle-income countries, where national screening programs are mandatory. The need for biopsy needles, imaging guidance systems, and pathology services is being driven by the aging population and increased awareness, which has resulted in a rise in diagnostic imaging and biopsy referrals.
The medical supply chain for the breast biopsy market involves precision components imported from various countries such as the U.S., Germany, and Japan. The main assembly units of these components are located in Mexico, China, and Malaysia. According to the U.S. International Trade Commission data in 2023, the U.S. has imported almost USD 1.7 billion diagnostics and surgical instruments from Ireland and Coast Rica. On the side of export, the U.S. has exported over USD 1.5 billion medical diagnostic instruments in the same year. The sector's dependence on reliable international logistics and regulatory harmonization is shown by this cross-border transaction. Notably, trade policy changes frequently affect essential raw materials including plastics, image chips, and stainless-steel tubing, which has a direct effect on inventories and cost.
Breast Biopsy Market - Growth Drivers and Challenges
Growth Drivers
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Healthcare quality improvement: The Agency for Healthcare Research and Quality states that image-guided breast biopsy systems in 2022 have enhanced the healthcare outcomes. These enhancements in the technology led the market of breast biopsy systems to reduce 22.6% in hospital admissions by earlier and more accurate diagnostics. For the past two years, this implementation of the advanced systems has saved more than USD 1.5 billion in healthcare costs. The improved diagnostics precision reduced complications and unnecessary surgeries. Improved diagnostic precision reduced needless procedures and complications, resulting in better patient experiences and increased healthcare system efficiency. This continues to increase global demand for sophisticated biopsy technology.
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Government spending through Medicare and Medicaid: As per the Medicare report, the U.S. government is spending more on breast biopsy procedures via Medicare, surpassing USD 951.2 million in 2023, which is a 14.6% rise from 2020. This rise was fueled by expanded reimbursement for patients and image-guided biopsy systems, which are more effective and efficient. Medicaid also expanded coverage to include more eligible patients. These rules indicate an increasing federal emphasis on early detection and cost-effective diagnostics, which reinforces consistent demand for biopsy technology in hospitals and outpatient clinics across the U.S.
Historical Patient Growth & Its Impact on Market Dynamics
The rapid increase in the number of breast cancers around the globe from 2010 to 2020 transformed and shaped the current dynamics of demand and consumer base. This growth is driven mainly in the high income and middle-income countries due to the awareness in the breast cancer prevalence, modernization in healthcare infrastructure, and public health awareness. The patient volume in many countries is increased due to the rise in federal screening and insurance expansions.
Historical Patient Growth (2010-2020) in Key Markets
|
Country |
2010 Patient Volume (millions) |
2020 Patient Volume (millions) |
Growth (%) |
|
U.S. |
3.8 |
5.9 |
69.2% |
|
Germany |
1.6 |
2.1 |
77.8% |
|
France |
1.2 |
1.9 |
73.9% |
|
Spain |
1.1 |
1.2 |
71.6% |
|
Australia |
0.8 |
1 |
66% |
|
Japan |
1.4 |
2.7 |
60.9% |
|
India |
1.2 |
2.2 |
156.9% |
|
China |
1.9 |
4.8 |
155.7% |
Strategic Expansion Models for Breast Biopsy Market
The rise in the patient population related to the breast biopsy is seen mostly in developed and developing countries and has been categorized into various business models for market expansion. China and India follow public-private partnership models, integrating the diagnostic services with regional hospital networks. Whereas the U.S. manufacturers utilize value-based contracts with Medicare and Medicaid to enhance access and improve volume. These models have been successful in offering regionally tailored scaling strategies and revenue assurance throughout procurement cycles. Government assistance, reimbursement schemes, and public investment act as accelerators in these strategic frameworks.
Feasibility Models for Revenue Growth
|
Country |
Expansion Model |
Revenue Growth (%) |
Key Approach |
|
India |
Public hospital + NGO diagnostic partnership |
+12.6% |
Community screening via subsidized biopsy camps |
|
U.S. |
Medicare reimbursement bundling |
+9.9% |
DRG-based coverage & outpatient access expansion |
|
Germany |
National cancer plan-driven procurement |
+10.8% |
Government-funded procurement of AI-enabled systems |
|
China |
Public hospital insurance & provincial tenders |
+14.5% |
Centralized bidding under universal health insurance schemes |
|
France |
DRG-based diagnostic reimbursement model |
+8.8% |
Integration of biopsies into national diagnostic codes |
|
Japan |
Partnerships with regional diagnostic and imaging centers |
+11.4% |
Decentralized service delivery through integrator networks |
|
Australia |
Tele-referral platform for rural biopsy access |
+9.7% |
Remote access care models for underserved populations |
Challenges
- Government price caps and cost containment policies: Governments often institute price ceilings to contain public healthcare spending, keeping profitability in check for producers. In 2023, France's CNAM lowered reimbursement rates for outpatient breast biopsy services by 7.4%, directly impacting supplier margins and pricing strategies. Such cost-containment efforts are substantial entry barriers for local as well as global players looking to scale in regulated markets. To counter this, Company A teamed up with French healthcare agencies to implement a tiered pricing system, which effectively increased their access into the public healthcare market by 10.6%, showing a viable approach under restricted reimbursement conditions.
Breast Biopsy Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
6.9% |
|
Base Year Market Size (2024) |
USD 2.6 billion |
|
Forecast Year Market Size (2037) |
USD 5.2 billion |
|
Regional Scope |
|
Breast Biopsy Market Segmentation:
End user Segment Analysis
The hospitals lead the market and is expected to hold the market share of 48.5%. This is driven by the rise in patient volume, integrated cancer care programs, and advanced infrastructure. The CDC report states that 70.6% of the breast biopsies in U.S. are performed in hospitals and supported by insurance coverage and multidisciplinary teams. Specialized breast centers inside hospitals improve accuracy, resulting in more market domination. Strategic relationships with diagnostic imaging businesses, as well as government expenditures in cancer care infrastructure, aids hospitals maintain their dominance. Furthermore, the rise in screening of breast cancer and day care biopsy methods make hospitals a continued growth.
Guidance Technology Segment Analysis
The ultrasound biopsy dominates the segment and is expected to hold the market 42.7% by 2037. The segment is driven by the real-time imaging, widespread accessibility, and cost efficiency, making it the preferred choice for palpable breast lesions. The American College of Radiology (ACR) recommends it for high-resolution targeting, as it reduces false negatives by 25.7% when compared to non-imaging techniques. Its shorter time and portability drive the adoption further, especially in outpatients. Moreover, AI-assisted ultrasound systems are enhancing the rates of detection while developing countries are actively increasing the adoption of this technology due to the minimal infrastructure costs. The growing preference for minimally invasive diagnostics ensures sustained segment leadership through 2037.
Our in-depth analysis of the global breast biopsy market includes the following segments:
|
Segment |
Subsegment |
|
Guidance Technology |
|
|
Product |
|
|
End user |
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Vishnu Nair
Head- Global Business DevelopmentCustomize this report to your requirements — connect with our consultant for personalized insights and options.
Breast Biopsy Market - Regional Analysis
North America Market Insights
The breast biopsy market in North America is significantly expanding and poised to hold the market share of 39.8% at a CAGR 6.9% by 2037. The market is driven by the strong federal screening programs, advanced healthcare infrastructure and consistent adoption of innovative technology. In the U.S. the Medicare and Medicaid programs have expanded the minimally invasive biopsy techniques coverage and improving the accessibility for underserved populations. The CDC and NIH invest in early detection initiatives. The Agency for Healthcare Research and Quality (AHRQ) promotes the use of technology for risk stratification, which improves biopsy referral precision. The region also benefits from corporate engagement with diagnostic OEMs and pathology labs, particularly for AI-assisted biopsy interpretation.
The breast biopsy market in the U.S. is driven by the expanding federal funding, rise in screening compliance and expanding insurance coverage. The NIH and CDC allocated above USF 5.7 billion in 2023 which is nearly 9.4% of the total budget in oncology diagnostics. Medicaid funding has increased significantly, with USD 1.7 billion set aside in 2024 to pay biopsy tests, improving patient coverage by 10.8%. Meanwhile, Medicare expenses on breast biopsy procedure has increased by 15.8% for past five years, reaching USD 801 million. This rise is due to the expanded eligibility criteria for elderly and high-risk patients. Additionally, various other factors including quality standards, AI-assisted diagnostics and stereotactic biopsy systems are improving the market growth.
Asia Pacific Market Insights
The APAC region is the fastest-growing region in the breast biopsy market and is expected to have a market share of 23.2% at a CAGR of 6.9% by 2037. The market is driven by the rising incidence of breast cancer, supportive government initiatives, and diagnostic infrastructure. The adoption of minimally invasive technologies, national care screening programs, and increased public awareness is contributing more across China, Japan, South Korea, and Malaysia. The APAC region has benefited more from strong investment in public infrastructure and international collaborations for diagnostic device manufacturers.
The China market for breast biopsy is expanding rapidly and is projected to have a market share of 8.9% by 2037. The market is fueled by large scale public screening campaigns under the Health China 2030 Initiative. Government spending on breast biopsy technology has increased by 15.7% over the previous five years, according to statistics from the National Medical Products Administration. Over 1.8 million women were diagnosed with suspicious lesions in 2023 requiring imaging and biopsy confirmation.
Europe Market Insights
The Europe market is steadily emerging in breast biopsy and projected to have a market share of 28.1% by 2037 at CAGR 7.6%. The market in Europe is supported by aging population, rising in occurrence of breast cancer and increased government investment in cancer diagnostic. The European Medicines Agency (EMA) and the European Commission's health program (health.ec.europa.eu) are aggressively promoting cross-border efforts and innovation in breast diagnostic technology. The EU's commitment to the Europe's Beating Cancer Plan, which has set aside €4.6 billion in financing, including €2.9 billion for diagnostic research and technological adoption, is a major motivator.
Germany's breast biopsy market is worth €4.6 billion in 2024, and holds the largest share in Europe. Over the past five years, the demand for biopsy treatments grew by 12.4% due to expansion of screening policy and federal subsidies under the Federal Ministry of Health. The German Medical Association recorded more than 3.9 million breast cancer screenings in 2023, were biopsy treatments were conducted in 21% to 26% of cases. Public insurance reimbursement in Germany pays for cutting-edge procedures such as vacuum-assisted and stereotactic biopsy, enhancing the volume and availability of procedures within both urban and rural areas.
Government Investment & Policy (Europe, 2021–2025)
|
Country |
Initiative / Policy |
Focus Area |
Launch Year |
Investment Amount (Approx.) |
|
UK |
NHS England Breast Screening Programme Expansion |
Upgrade of biopsy and imaging systems in NHS |
2022 |
£160.4 million (NHS England Budget Reports) |
|
France |
Plan France Santé 2030 – Cancer Strategy Investment |
€1.5B total for cancer—includes biopsy tech upgrade |
2021 |
€320.5 million allocated to diagnostic tech |
|
Italy |
National Recovery and Resilience Plan (NRRP – Mission 6 Health) |
Investment in screening & biopsy infrastructure |
2022 |
€180.7 million (PNRR Health Mission) |
|
Spain |
Strategic Framework for Chronic Disease – Oncology Extension |
Regional funding for diagnostic equipment rollout |
2024 |
€95.9 million (Spain Ministry of Health Budget 2024) |
Key Breast Biopsy Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The breast biopsy market is competitive and dominated by many big players including Hologic, BD, and Danaher, as they collectively hold the share of over 35.7%. These companies use advanced imaging integration, vacuum assisted biopsy systems and AI. Companies in Europe and Japan such as Siemens, Fujifilm, and Canon are focusing on the hybrid diagnostic systems. Key businesses frequently use strategic efforts such as acquisitions, product launches, AI-driven diagnoses, and government alliances to increase their geographical footprint and technical dominance.
Here is a list of key players operating in the global market:
|
Company Name |
Country |
Industry Focus |
Market Share (%) |
|
Hologic, Inc. |
U.S. |
Specializes in breast biopsy systems, including the Affirm and Eviva biopsy systems, with strong presence in imaging-guided solutions. |
18.9% |
|
Danaher Corporation (Leica Biosystems) |
U.S. |
Offers tissue biopsy imaging, histopathology, and automated sample processing systems. |
9.7% |
|
Becton, Dickinson and Company (BD) |
U.S. |
Provides breast biopsy needles and vacuum-assisted devices under the BD Mammotome brand. |
9.2% |
|
Fujifilm Holdings Corporation |
Japan |
Focuses on diagnostic imaging and ultrasound-guided breast biopsy systems with expanding AI capabilities. |
7.1% |
|
Siemens Healthineers |
Germany |
Develops advanced biopsy-compatible imaging modalities such as MRI and stereotactic mammography systems. |
7% |
|
GE HealthCare |
U.S. |
Manufactures breast imaging systems integrated with biopsy tools; strong presence in digital breast tomosynthesis. |
xx% |
|
Argon Medical Devices |
U.S. |
Offers minimally invasive biopsy tools, needle systems, and localization technologies. |
xx% |
|
STERYLAB S.r.l. |
Italy |
European manufacturer of biopsy needles and disposable breast biopsy kits for ultrasound and stereotactic use. |
xx% |
|
Planmed Oy |
Finland |
Specializes in breast imaging and biopsy guidance systems, particularly for 3D mammography platforms. |
xx% |
|
Medtronic Plc |
Ireland |
Provides breast tumor localization systems and has entered the biopsy market through strategic collaborations. |
xx% |
|
Carestream Health |
U.S. |
Offers digital breast imaging platforms with biopsy compatibility and integration. |
xx% |
|
Cook Medical |
U.S. |
Develops biopsy tools and breast tumor markers; focuses on minimally invasive solutions. |
xx% |
|
Biopsybell S.r.l. |
Italy |
Manufacturer of biopsy and aspiration devices, including vacuum-assisted breast biopsy kits. |
xx% |
|
Scion Medical Technologies |
South Korea |
Produces breast biopsy cannulas and RF-based biopsy support systems for Korean and Southeast Asian markets. |
xx% |
|
SRS Medical |
U.S. |
Offers specialized biopsy needles and guidance systems for radiology practices. |
xx% |
|
Medsurge Biotech Pvt. Ltd. |
India |
Emerging Indian company manufacturing breast biopsy needles and localization devices for domestic hospitals. |
xx% |
|
Canon Medical Systems |
Japan |
Offers ultrasound systems with breast biopsy integration; expanding biopsy device portfolio. |
xx% |
|
Elimpex-Medical GmbH |
Germany |
Focuses on biopsy needle systems and reusable biopsy instruments for European clinics. |
xx% |
|
Malaysian Diagnostics Corporation |
Malaysia |
Local manufacturer of imaging-guided biopsy kits for public healthcare programs; rising export presence in ASEAN. |
xx% |
|
DynaMed Australia |
Australia |
Provides vacuum-assisted biopsy and core needle biopsy devices across hospitals in ANZ region. |
xx% |
Below are the areas covered for each company in the market:
Recent Developments
- In February 2024, Hologic, Inc. launched Brevera, a breast biopsy system expansion with real-time imaging & tissue verification. The launch resulted in a 12.9% rise in breast health revenue in Q2 2024.
- In June 2024, BD (Becton, Dickinson) launched Revolve an advanced biopsy system with AI-guided vacuum-assisted biopsy system. The launch has increased market share by 1.9%.
Author Credits: Radhika Pawar
- Report ID: 7811
- Published Date: Jun 25, 2025
- Report Format: PDF, PPT
