Global Breast Biopsy Devices Market Outlook
Revenue, 2024
$2.4B
Forecast, 2034
$4.7B
CAGR, 2025 - 2034
6.8%
The Breast Biopsy Devices industry revenue is expected to be around $2.6 billion in 2025 and expected to showcase growth with 6.8% CAGR between 2025 and 2034. The breast biopsy devices market expansion demonstrates its essential position for breast lesion detection and characterization because of increasing breast cancer screening programs and better diagnostic imaging access and minimally invasive biopsy techniques that reduce complications and recovery duration. The market demand focuses on Hospitals & Surgical Centers and dedicated Breast Care Centers because these facilities use 87.0% of their end user resources for image guided biopsy procedures that enable fast treatment planning and minimize patient complications. The product segment of biopsy needles leads all revenue streams because it generated $1.05 billion in sales during 2024 while demonstrating its essential role in medical diagnosis and interventional radiology device portfolios.
The breast biopsy market features multiple technologies which include reusable and disposable biopsy needles and vacuum assisted biopsy systems and localization and marking devices and automated biopsy guns for stereotactic and ultrasound and MRI guided breast biopsy procedures. The solutions function to extract tissue samples from breast lesions which appear on mammography images and other imaging tests for histopathological evaluation that supports precision oncology and personalized treatment choices and ongoing patient surveillance. The breast biopsy market experiences growing demand because healthcare providers now perform more procedures outside hospitals and because new image guided biopsy systems with digital pathology tools and single use devices that improve patient comfort and diagnostic accuracy have entered the market.
Market Key Insights
The Breast Biopsy Devices market is projected to grow from $2.4 billion in 2024 to $4.7 billion in 2034. This represents a CAGR of 6.8%, reflecting rising demand across Early Cancer Screening, Therapy Selection, and Treatment Monitoring.
Hologic, Danaher, and Becton Dickinson are among the leading players in this market, shaping its competitive landscape.
The Breast Biopsy Devices market shows the United States and China as its leading markets which will experience growth at rates of 4.4% to 6.5% CAGR from 2024 to 2030.
The market research predicts India, Brazil and Mexico will experience the highest growth rates at 7.8% to 9.4% CAGR.
Transition like Shift to Minimally Invasive Precision has greater influence in U.S. and China market's value chain; and is expected to add $127 million of additional value to Breast Biopsy Devices industry revenue by 2030.
.The Breast Biopsy Devices market will experience $2.2 billion growth during 2024-2034 while Therapy Selection & Treatment Monitoring Application will dominate market expansion.
The Breast Biopsy Devices market will experience a 93% expansion from 2024 to 2034 because of increasing breast cancer screening numbers and growing adoption of minimally invasive vacuum-assisted procedures and enhanced multimodality imaging systems for better precision and workflow optimization.
Opportunities in the Breast Biopsy Devices
United States integrated oncology networks focus on developing image guided breast biopsy devices which operate as part of AI powered mammography and MRI systems. Healthcare facilities require biopsy devices and guidance systems that operate together to create standardized procedures for remote planning and quality metric tracking for insurance reimbursement purposes. The global market for guidance systems will also expand from 0.59 billion in 2024 to reach 0.96 billion by 2030 which makes software enhanced stereotactic and ultrasound guided breast biopsy platforms the leading device segment in this market.
Growth Opportunities in North America and Asia Pacific
The North American market for breast biopsy devices depends most heavily on breast care centers because these facilities perform extensive breast screenings and complex breast lesion evaluations which drives their need for premium breast biopsy systems with digital breast tomosynthesis and advanced workflow capabilities; the market demands two main opportunities which involve upgrading current systems to advanced vacuum assisted biopsy technology and providing dedicated disposable tools and IT platform integration solutions for oncology and radiology systems; vendors must differentiate their products through superior image quality and shorter procedure times and enhanced patient comfort during minimally invasive breast procedures because hardware alone no longer serves as the main differentiator in this competitive market; vendors who offer complete training programs and clinical proof and extended service agreements to specialized centers and their affiliated imaging clinics will succeed in this market because of North America's strong screening protocols and positive medical insurance coverage for breast image guided procedures and its fast transition to outpatient facilities and its expanding team of breast care specialists.
The Asia Pacific region sees hospitals and surgical centers lead breast biopsy device adoption because they follow established care protocols and need significant financial resources for equipment acquisition thus becoming the main distribution channel for basic and advanced ultrasound guided biopsy and stereotactic breast biopsy solutions; The market demands adaptable product lines which start with affordable core needle systems and progress to mid to high end image guided platforms for interventional radiology suites and educational programs to develop procedural skills in new markets and smaller cities; The market competition consists of multinational companies and powerful regional businesses which compete through price based tenders and public procurement that benefits suppliers who can produce products locally and provide financing options and maintenance services; The main factors driving growth in this market include increasing breast cancer cases and new diagnostic facilities and government backed screening programs and fast growing private healthcare facilities which benefit companies that develop versatile breast biopsy systems which operate well in limited infrastructure settings and multiple clinical environments throughout the region.
Market Dynamics and Supply Chain
01
Driver: Rising breast cancer screening volumes and rapid shift toward minimally invasive vacuum assisted techniques boosting device demand
The rising number of people joining organized breast cancer screening programs leads to more early stage suspicious lesions which results in higher procedure numbers and requires advanced breast biopsy equipment. The combination of mammography and digital breast tomosynthesis and risk based screening protocols enables healthcare providers to detect nonpalpable abnormalities which need dedicated core needle biopsy and stereotactic biopsy systems for accurate tissue sampling. The medical field now favors vacuum assisted breast biopsy procedures for minimally invasive breast tissue removal because guidelines support outpatient care and lower patient risks and reduced healthcare expenses. The market requires new breast biopsy systems which combine compact design with ergonomic features and automated functionality and single insertion capability and enhanced tissue collection abilities and MRI and ultrasound guidance support for hospitals and imaging centers and ambulatory surgical facilities.
The development of new image guided biopsy systems through ultrasound MRI fusion and digital breast tomosynthesis integration enables better targeting of difficult to reach breast lesions which leads to higher expectations for breast biopsy equipment. The development of biopsy systems with built in navigation software and real time needle tracking and customizable targeting templates enables better management of difficult cases that involve architectural distortions and small calcifications. The improved imaging technology also creates a need for biopsy consoles that work together and specialized biopsy tables and smart needles which follow radiology procedures to shorten procedures and boost diagnostic accuracy.
02
Restraint: High procedure costs and inconsistent reimbursement structures suppress adoption of advanced breast biopsy devices worldwide
Premium breast biopsy products with image guidance and vacuum assistance require substantial initial expenses and individual procedure fees but healthcare providers face ongoing payment uncertainty in various markets. The financial performance of breast biopsy device manufacturers faces restrictions because hospitals and diagnostic centers and small clinics choose to delay equipment upgrades while selecting less expensive core needle biopsy systems. The market penetration of minimally invasive biopsy solutions remains slow in emerging economies because these regions have restricted breast cancer screening programs and hospitals operate with limited budgets and payers who demand affordable medical services.
03
Opportunity: Rising adoption of minimally invasive breast biopsy devices in urban outpatient imaging centers in India and Expanding access to portable breast biopsy devices for population based screening programs across Latin American public hospitals
The growing breast cancer awareness in India together with expanding day care diagnostic imaging centers create an unfulfilled need for sophisticated breast biopsy equipment. The medical field now favors outpatient facilities located in urban and tier 2 areas because these facilities perform minimally invasive procedures which shorten hospital stays and reduce pathology examination time. The global biopsy needles market will expand from 1.05 billion in 2024 to 1.50 billion by 2030 which makes disposable vacuum assisted breast biopsy solutions the best choice for Indian markets that need cost effective high volume solutions.
Multiple Latin American governments have initiated population based breast cancer screening programs but their public hospitals do not only have specific biopsy facilities. The need for portable breast biopsy equipment and battery operated guidance systems and compact biopsy tables has become apparent because they can accompany mobile mammography units to serve distant communities. The global biopsy table market will expand from 0.19 billion in 2024 to 0.25 billion by 2030 which creates the most promising opportunity for developing transportable ergonomic solutions that adapt to limited facilities and personnel resources.
04
Challenge: Growing preference for noninvasive diagnostics and imaging alternatives reduces procedure volumes for breast biopsy devices
The advancement of imaging technologies and noninvasive diagnostic methods leads some medical professionals to use advanced mammography and MRI and ultrasound surveillance instead of performing breast biopsy device confirmation for suspicious lesions. The growing practice of using noninvasive diagnostic methods leads to fewer vacuum assisted breast biopsy and core needle biopsy procedures which decreases the need for disposable needles and markers and accessories and shortens the duration of recurring revenue streams. Manufacturers need to spend more on clinical evidence development and workflow integration to protect procedure numbers because payers and providers keep adopting noninvasive strategies which create intense market competition for breast biopsy devices.
Supply Chain Landscape
1
Minimally Invasive Components
Becton DickinsonArgon Medical DevicesMerit Medical Systems
2
Device Manufacturers
HologicDanaherBecton Dickinson
3
Image-Guided Distribution
Merit Medical SystemsHologicArgon Medical Devices
4
Clinical End Users
HospitalsDiagnostic Imaging CentersAmbulatory Surgical Centers
1
Minimally Invasive Components
Becton DickinsonArgon Medical DevicesMerit Medical Systems
2
Device Manufacturers
HologicDanaherBecton Dickinson
3
Image-Guided Distribution
Merit Medical SystemsHologicArgon Medical Devices
4
Clinical End Users
HospitalsDiagnostic Imaging CentersAmbulatory Surgical Centers
Applications of Breast Biopsy Devices in Early Cancer Screening, Therapy Selection & Treatment Monitoring
Early Cancer Screening : The first stage of cancer screening requires breast biopsy devices to analyze mammography and ultrasound results which depend on core needle biopsy devices and vacuum assisted breast biopsy systems that use precise biopsy needles to get diagnostic tissue through small incisions. The imaging clinics and diagnostic centers which brought in 0.31 billion dollars in 2024 revenue expect a 9.27% annual growth rate to reach 2030 will use image guided breast biopsy systems and advanced guidance technology to achieve better microcalcification targeting and improved workflow performance at 24.3% of total demand. The application of breast biopsy technology depends on Hologic because their mammography platforms and stereotactic biopsy tables and vacuum assisted breast biopsy devices achieve high diagnostic accuracy. Becton Dickinson and Argon Medical Devices and Merit Medical Systems maintain strong positions in disposable breast biopsy needles and accessories which help patients achieve better results. Danaher maintains its market leadership through its ability to connect biopsy sample collection with fast pathology results.
Therapy Selection : The selection of therapy depends on breast biopsy devices which extract big high quality tissue samples for biomarker and genomic testing through powered core needle biopsy systems and advanced biopsy equipment and guidance systems that make up 24.3% of market demand for accurate tumor sampling in hospitals and surgical centers that brought in 1.41 billion dollars in 2024 revenue and show 5.3% annual growth. The hospitals select integrated biopsy equipment because it supports personalized medicine through its ability to generate enough tissue for hormone receptor and HER2 analysis which leads to better systemic and surgical treatment decisions. The application benefits from Hologic and Becton Dickinson core needle biopsy devices which offer high tissue yield through their robust vacuum assisted platforms. The combination of tissue acquisition with laboratory and companion diagnostic solutions from Danaher enables the company to enhance its market presence. The operating room and hybrid suite procedures benefit from reliable interventional radiology tools which Merit Medical Systems and Argon Medical Devices provide for maintaining procedural efficiency.
Treatment Monitoring : The process of treatment monitoring depends on breast biopsy devices which help doctors study tumor biology and detect remaining cancer cells and check for signs of treatment failure or cancer return. The use of image guided breast biopsy and minimally invasive vacuum assisted systems enables healthcare providers to collect multiple tissue samples from particular tumor region's through non invasive procedures that avoid open surgery complications. The 0.69 billion revenue from 2024 breast care centers will expand at 8.5% CAGR through 2024 while stereotactic biopsy tables and guidance systems reach 7.8% of market demand for precise lesion and scar targeting during follow up assessments. Hologic leads treatment monitoring through its breast biopsy devices and tables which work with tomosynthesis and MRI systems and Becton Dickinson and Argon Medical Devices and Merit Medical Systems offer diverse needles and localization tools for breast care center and imaging clinic follow up procedures. The installed base of diagnostic analyzers from Danaher enables serial biomarker testing on biopsy specimens which strengthens its market position throughout the treatment process.
Recent Developments
The breast biopsy device industry has shifted its focus toward developing more precise instruments which perform minimally invasive procedures while providing better comfort to patients because of increasing breast cancer screening rates. The growing number of breast cancer screenings has led manufacturers to create better vacuum assisted biopsy systems and image guided biopsy solutions that use ultrasound and MRI and stereotactic technologies for improved lesion detection. The market shows increasing interest in digital technology and AI based breast imaging solutions which improve diagnostic processes and help doctors detect breast cancer at earlier stages.
January 2025 : The acquisition of Gynesonics Inc by Hologic Inc has been finalized for $350 million according-to Hologic Inc which operates as a worldwide womens health market leader. The acquisition of Gynesonics Inc by Hologic Inc enables the company to expand its breast biopsy and GYN surgical product range through minimally invasive breast diagnostic and therapeutic solutions. The acquisition supports Hologics mission to develop womens health solutions through innovative medical technologies.
February 2025 : The global breast care leader Mammotome entered into an exclusive distribution deal with Sirius Medical to distribute Surgical Marker Navigation technology across the United States and Germany. The agreement enables Mammotome to distribute its breast biopsy solutions through Sirius Medicals advanced technology which delivers exact breast biopsy procedures with reduced invasiveness to additional healthcare facilities.
Impact of Industry Transitions on the Breast Biopsy Devices Market
As a core segment of the Medical Device industry,
the Breast Biopsy Devices market develops in line with broader industry shifts.
Over recent years, transitions such as Shift to Minimally Invasive Precision and Digital Integrated Biopsy Ecosystems have redefined priorities
across the Medical Device sector,
influencing how the Breast Biopsy Devices market evolves in terms of demand, applications and competitive dynamics.
These transitions highlight the structural changes shaping long-term growth opportunities.
01
Shift to Minimally Invasive Precision
The medical field now uses breast biopsy devices to perform minimally invasive image guided precision procedures instead of traditional open surgical methods which has transformed diagnostic delivery locations. The U.S. and China value chains experience the most significant disruption because their healthcare systems will adopt vacuum assisted and core needle biopsy systems at radiology suites and ambulatory centers which will create $126 million additional industry revenue by 2030. The transition to outpatient image guided procedures creates increased requirements for advanced ultrasound and MRI systems which simultaneously boosts the need for anesthesia services and sterilization products and digital pathology solutions. The adoption of value based care models by healthcare providers creates standardized minimally invasive treatment protocols which reduce procedure duration and hospital length of stay while establishing ongoing device sales and maintenance income in these expanding markets. This industry transition is expected to add $127 million in the industry revenue between 2024 and 2030.
02
Digital Integrated Biopsy Ecosystems
The development of breast biopsy devices now includes software based systems which unite imaging technology with guidance functions and post procedure data analysis to enhance oncology diagnosis and medical care coordination. The integration of AI decision support and automated needle placement and image guided biopsy data capture now occurs within medical systems which maintain direct connections to hospital information platforms. The evolution of medical technology creates expanding markets for health IT solutions and cloud based imaging storage and advanced data analysis systems which also support device PACS integration and remote quality monitoring and standardized protocol implementation between radiology networks and breast care centers.