- Summary
- Table Of Content
- Methodology
Breast Biopsy Market Size:
Breast Biopsy Market size is growing with a CAGR of 7.2% during the forecast period (2025-2032), and the market is projected to be valued at USD 4,033.83 Million by 2032 from USD 2,327.08 Million in 2024. Additionally, the market value for the 2025 attributes to USD 2,485.52 Million.
Breast Biopsy Market Scope & Overview:
Breast biopsy is a medical procedure where a small sample from the breast is removed. The procedure is performed to check for cancer or other abnormal cells. The cells such as solid mass, cysts, and microcalcifications are studied. These abnormal cells are detected during ultrasounds, mammograms, and physical examinations. The type of biopsy for breast includes fine-needle aspiration biopsy, core-needle biopsy, vacuum assisted biopsy, and others. These biopsies are performed using image guidance technology. The technology consists of ultrasound guided biopsy, MRI (Magnetic Resonance Imaging)-guided biopsy, mammography guided biopsy, and others. The end users that perform and assist biopsies for breast include hospitals, diagnostic centers, ambulatory surgical centers, and others.
Breast Biopsy Market Dynamics - (DRO) :
Key Drivers:
High Prevalence of Breast Cancer is Propelling the Breast Biopsy Market Growth.
Breast cancer is a disease where there is abnormal growth in the cells present in the breast. This cancer most commonly affects women. The awareness about this cancer educates women on early detection and conformation. Risk factors associated with breast cancer include lifestyle changes and genetics among others. This contributes to the rise in the prevalence of this cancer.
For instance,
- The data published by Breast Cancer Organization states that in 2024, 310,720 women are diagnosed with breast cancer in the U.S.
Thus, the rise in prevalence of breast cancer is influencing market development.
Development of Novel Breast Biopsy Site Marker is Driving the Breast Biopsy Market Demand.
A breast biopsy site marker is an instrument that is used to identify the exact location where the tissue is to be removed. It is a small metallic chip that is positioned in the breast for biopsy. Traditional site markers hinder with the imaging performed during biopsy. To overcome the imaging, advanced site marker is introduced. They are generally small in size. The developed marker enhances the visibility for various imaging. This is important for detecting the exact location.
For instance,
- In August 2023, Mammotome introduced a novel HydroMARKTM Plus Breast Biopsy Site Marker. This marker is designed to enhance visibility and improve the detection of location.
Thus, the development of novel site markers is developing the market.
Key Restraints:
Stringent Regulatory Standards is Hampering the Breast Biopsy Market Growth.
Stringent regulatory standards imposed by government bodies worldwide. This causes constraints to the market. These regulations are designed to protect the environment and public health. It increases production costs and slow down product development. The biopsy devices require approval from regulatory authorities for the commercialization and development of the devices. Compliance with these regulations increases the cost of product development and testing. The biopsy devices require extensive approval time. This delays and prevents the introduction of new biopsy devices. Thus, as per the breast biopsy market analysis, the adherence to stringent regulatory standards hinders the growth of the market globally.
Future Opportunities :
Advancements in Core Biopsy Systems is Creating Lucrative Breast Biopsy Market Opportunity.
Core biopsy systems are special devices that collect tissue from the sample. The advanced systems consist of specialized needles. These needles are consisting of a well-developed mechanism for their working. They consist of a spring that help the needle in penetrating and leaving the body. These systems collect a large portion of tissue sample compared to the traditional system.
For instance,
- In November 2024, Mammotome developed a Mammotome AutoCore system. This system offers a single insertion system. It is the first automated spring-loaded core needle device introduced on the market. The system also has an automated alarming system that allows for one-hand operations.
Thus, the advancement in the core biopsy systems in creating lucrative breast biopsy market opportunities.
Breast Biopsy Market Segmental Analysis :
By Type:
Based on type, the market is categorized into fine-needle aspiration biopsy, core-needle biopsy, vacuum assisted biopsy, and others.
Trends in the Type:
- Development of flexible needles for better diagnosis.
- Rise in the trend for minimally invasive procedures.
The core-needle biopsy segment accounted for the largest breast biopsy market share in 2024.
- Core needle biopsy is a minimally invasive procedure to obtain a sample of the tissue.
- In this procedure there is a hollow needle that is inserted in the breast.
- The needle is guided by imaging methods. The methods consist of mammography, ultrasound and others.
- The core biopsy collects large tissue samples compared to other types.
- Manufacturers are developing advanced core-needle systems. These systems offer advanced and proper sampling of tissue.
- For instance, in August 2022, Mammotome introduced Mammotome DualCore biopsy system. The system consists of a core needle. The system consists of three settings that allow for one-hand controlling.
- Thus, the rise in the use of core needle biopsy systems influences the breast biopsy market trends.
The vacuum assisted biopsy segment is expected to grow at the fastest CAGR over the forecast period.
- Vacuum assisted biopsy is a minimally invasive procedure.
- This type of biopsy uses systems that are vacuum powered. These systems help to gain multiple samples in one insertion.
- The needle used is a hollow needle. It is generally large in size compared to the core needle.
- The system is supported by imaging technology such as ultrasound.
- The vacuum system is started once the needle reaches the desired site. A rotating mechanism removes the sample of the tissue.
- The process is done various times without removing the tissue. This allows for the collection of tissue in large amount.
- Thus, the aforementioned factors are driving the demand of the segment.
By Image Guidance Technology:
Based on image guidance technology, the market is categorized into ultrasound guided biopsy, MRI-guided biopsy, mammography guided biopsy, and others
Trends in Image Guidance Technology:
- The development of advanced imaging technology to obtain better image is influencing the segment.
The ultrasound guided biopsy segment accounted for the largest market share in the year 2024.
- The ultrasound guided biopsy segment dominates the breast biopsy market trends.
- This imaging technology uses sound waves. These waves create a real-time image of the tissue that is present in the breast.
- Doctors use the ultrasound image to guide the needle to the desired area.
- The types of biopsies that use this imaging solution include fine needle aspiration, core needle biopsy and others.
- This technology is used for target screening in women with high risk of breast cancer.
- Novel systems are introduced that are guided by ultrasound.
- For instance, in February 2023, TransMed7 launched ultrasound guided biopsy device. The device is mainly for diagnosis of breast cancer. The system is automated and is vacuum assisted.
- Thus, the use of ultrasound guided biopsy is influencing the segment growth.
The MRI-guided biopsy segment is expected to grow at the fastest CAGR over the forecast period.
- The MRI-guided biopsy segment is growing at the fastest CAGR in the coming years.
- The MRI guidance offers a detailed image of the breast. This allows doctors to see the abnormalities that are not clear in other scans.
- This technology is helpful for women that have fuller breast. It increases the precision of biopsy.
- This type of biopsy allows for more accurate targeting. It also causes less scarring.
- It is also used to detect the tumor before surgery. The systems are generally widely available, and they are cost effective compared to other technologies.
- Thus, the development of MRI-based breast biopsy system is influencing the segment.
By End-User:
Based on end user, the market is categorized into hospitals, diagnostic centers, ambulatory surgical centers, and others.
Trends in the End User:
- Development of advanced diagnostic centers is influencing the segment.
- The rise in the trend for same day procedure and discharge is influencing the segment.
The hospital segment accounted for the largest market share of 52.11% in the year 2024.
- Hospitals are a dominant end-user in the breast biopsy industry. They provide well-equipped centers that perform biopsy procedures.
- The hospitals have departments for radiology and oncology. They have well-trained staff and technicians.
- These departments consist of well-equipped imaging solutions. They include imaging solutions such as ultrasound, MRI-machines, and others.
- Many hospitals are introducing new programs for more accurate diagnosis of cancer.
- For instance, in November 2023, Apollo Cancer Center in India introduced India’s fastest and more precise cancer detection program for breast cancer. This program is developed for early detection of cancer. They include diagnostic techniques such as ultrasound, biopsy, and MRI among others.
- Thus, these factors are influencing the growth of the segment.
The ambulatory surgical centers segment is expected to grow at the fastest CAGR over the forecast period.
- Ambulatory surgical centers (ASCs) are the fastest growing segment of the market.
- This facility provides a cost-effective alternative to hospitals. They are beneficial for numerous minimally invasive procedures such as biopsies.
- The facilities consist of advanced technology. They have experienced staff such as doctors and nurses among others.
- This allows them to perform a range of procedures safely and efficiently.
- These settings allow patients to get discharged the same day as the procedure. This is beneficial for many patients as it saves time and money.
- Thus, as per the market analysis, these ambulatory surgical centers as end-user is developing the segment.
Regional Analysis:
The regional segment includes North America, Europe, Asia Pacific, the Middle East and Africa, and Latin America.
In 2024, North America accounted for the highest market share at 38.29% and was valued at USD 891.01 Million and is expected to reach USD 1,438.42 Million in 2032. In North America, U.S. accounted for the highest market share of 72.86% during the base year of 2024.
The North America region dominates the market growth. The region has a high prevalence of breast cancer cases. There is rise in awareness about the early detection and diagnosis of breast cancer. This encourages diagnosis through biopsy procedure. The diagnosis leads to a rise in the number of cases.
For instance,
- The data published by the S. Centers for Disease Control and Prevention, in June 2024 states that new breast cancer cases in U.S. were 272,454. This includes a high number of women than men.
Additionally, manufacturers present in the North America region are introducing novel biopsy systems. These systems offer more accuracy and increase the speed of diagnosis. Thus, as per the breast biopsy market analysis, these factors are influencing the market development in this region.
Asia Pacific is experiencing the fastest growth with a CAGR of 9.1% over the forecast period. The market trend across the region is attributed to factors. The region has a well-developing healthcare industry. The healthcare infrastructure in this region is developing because of the availability of effective diagnostic solutions. The healthcare industry consists of novel diagnostic tools and devices. They include advanced imaging devices that are used for biopsy of the breast. Countries present in this region are investing in the development of healthcare infrastructure. This leads to the development of medical services for patients. Thus, based on the market analysis, the development in the healthcare industry in the Asia Pacific region is influencing the breast biopsy market expansion.
Europe offers a prominent contribution to the market. The European region provides various stringent regulations for the development of biopsy devices and systems. The numerous safety concerns necessitate all the newly developed biopsy devices and needle to adhere to strict regulations. Government bodies present in Europe have started various initiatives. These initiatives are necessary for the screening of breast cancer. This supports early detection of breast cancer by various minimally invasive methods such as biopsy. Thus, these factors are influencing the breast biopsy market expansion.
The Middle East and Africa (MEA) regions are experiencing breast biopsy market demand. This is because of the rise in the demand for early detection of breast cancer. Primary manufacturers are introducing novel imaging solutions that are guiding the biopsy procedure. These advanced devices provide a well-developed image of the specific tissue present in the breast for biopsy. Additionally, some of the countries present in the MEA region face challenges because of the lack of availability of good healthcare infrastructure. Hence, as per the market analysis, these aforementioned factors are influencing the market demand in this region.
Latin America is an emerging region in the breast biopsy market share. The region provides with significant potential for innovation. The growing number of cases of breast cancer is influencing the use of advanced biopsy systems. Manufacturers are presenting various newly developed biopsy systems. The systems include minimally invasive techniques such as vacuum assisted biopsy and core assisted biopsy among others. Development in these systems offers a comfortable and more accurate biopsy approach. Thus, as per the market analysis, the use of well-developed biopsy systems in this region provides potential opportunity for healthcare demand in the coming years.
Top Key Players and Market Share Insights:
The global Breast Biopsy market is highly competitive with major players providing precise products to the national and international markets. Key players are adopting several strategies in research and development (R&D) and product innovation to hold a strong position in the global Breast Biopsy market. Key players in the Breast Biopsy industry include-
- Hologic, Inc (United States)
- Devicor Medical Products, Inc. (United States)
- TransMed7, LLC (United States)
- Siemens Healthcare Private Limited (India)
- Trivitron Healthcare (United States)
- BD (United States)
- Argon Medical Devices (United States)
- Cook (United States)
- Advin Health Care (India)
Recent Industry Developments :
Product Launch:
- In November 2024, Mammotome developed a Mammotome AutoCore system. This system offers a single insertion system. It is the first automated spring-loaded core needle device introduced on the market. The system also has an automated alarming system that allows for one-hand operations.
Breast Biopsy Market Report Insights :
| Report Attributes | Report Details |
| Study Timeline | 2019-2032 |
| Market Size in 2032 | USD 4,033.83 Million |
| CAGR (2025-2032) | 7.2% |
| By Type |
|
| By Image Guidance Technology |
|
| By End User |
|
| By Region |
|
| Key Players |
|
| North America | U.S. Canada Mexico |
| Europe | U.K. Germany France Spain Italy Russia Benelux Rest of Europe |
| APAC | China South Korea Japan India Australia ASEAN Rest of Asia-Pacific |
| Middle East and Africa | GCC Turkey South Africa Rest of MEA |
| LATAM | Brazil Argentina Chile Rest of LATAM |
| Report Coverage |
|
Key Questions Answered in the Report
How big is the Breast Biopsy market? +
In 2024, the Breast Biopsy market is USD 2,327.08 Million.
Which is the fastest-growing region in the Breast Biopsy market? +
North America is the fastest-growing region in the Breast Biopsy market.
What specific segmentation details are covered in the Breast Biopsy market? +
Type, Image Guidance Technology, and End User segmentation details are covered in the Breast Biopsy market.
Who are the major players in the Breast Biopsy market? +
Hologic, Inc (United States), Devicor Medical Products, Inc. (United States), BD (United States) are some of the major players in the market.
