Global Breast Biopsy Devices Market - 2025 - 2033

The global breast biopsy devices market reached US$ 2.25 billion in 2024 and is expected to reach US$ 3.77 billion by 2033, growing at a CAGR of 6.1% during the forecast period 2025-2033.

A breast biopsy is a medical procedure that includes removing a tiny sample of breast tissue for diagnostic purposes. This treatment is necessary to determine whether a concern detected in the breast is malignant or benign. Pathologists, who specialize in using laboratory tests to diagnose diseases, analyze the tissue sample. Breast biopsies are considered the most definitive procedure for diagnosing breast cancer since they provide conclusive evidence of the existence of malignant cells.

Breast biopsy techniques vary, with each using a distinct imaging technology to guide the procedure. Core needle biopsy (CNB) and vacuum-assisted biopsy (VAB) are two common minimally invasive procedures. A hollow needle is used in a core needle biopsy to take a small cylinder of tissue from the breast, whereas a suction-assisted biopsy collects several tissue samples in a single insertion. Other procedures include fine needle aspiration (FNA), which removes fluid or cells using a very thin needle, and surgical biopsies, which require removing bigger pieces of tissue through an incision. The characteristics of the abnormality found during imaging examinations such as mammograms, ultrasounds, or MRIs frequently influence the type of biopsy method used.

Market Dynamics: Drivers & Restraints

Increasing demand for breast biopsy devices

The increasing demand for breast biopsy procedures is expected to be a significant factor in the growth of the global breast biopsy market. The demand for breast biopsy procedures is increasing owing to the rising prevalence of breast cancer, technological advancements, growing awareness regarding breast cancer, and recent launches and approvals.

As breast cancer continues to be one of the most prevalent cancers worldwide, the need for accurate and timely diagnostic procedures has never been more critical. For instance, according to the Union for International Cancer Control (UICC), Breast cancer is the most commonly diagnosed cancer in women worldwide and in 157 countries, accounting for one in every four cancer cases. It is the second most common malignancy in both sexes and the major cause of mortality from cancer in women. Breast cancer is expected to cause 2.3 million new cases in 2022, accounting for nearly one out of every nine malignancies diagnosed in both sexes worldwide. Breast cancer is expected to kill 669,418 people in 2022, with a disproportionate amount of these fatal incidents taking place in low-income communities. The rising prevalence of breast cancer is driving healthcare systems to prioritize early detection procedures like breast biopsies, which are critical for confirming diagnoses and deciding effective treatment strategies.

As breast cancer remains one of the most common malignancies worldwide, with millions of new cases diagnosed each year, the need for accurate diagnostic tools has never been greater. Breast biopsy equipment has become more accessible, efficient, and less intrusive due to technological advancements, promoting more women to receive essential tests and biopsies. There are many recent launches and approvals that use novel technology and the latest manufacturing techniques. For instance, in May 2024, BSC (Barcelona Supercomputing Center) launched clinical validation of an establishing radiation-free breast cancer diagnosis technology at Vall d'Hebron University Hospital. This novel strategy combines modern ultrasound technology with supercomputing to improve imaging quality for breast cancer detection, providing a substantial alternative to standard procedures such as mammograms, which rely on ionizing radiation. The new technology, part of the QUSTom initiative, aims to increase diagnostic accuracy while keeping patients comfortable during the test.

Risk of infections

Factors such as the risk of infections are expected to hamper the global breast biopsy market. Biopsy techniques, which include incisions or needle insertions to collect tissue samples, have the potential to introduce pathogens into the body. This danger is especially high in invasive methods like surgical and core needle biopsies when deeper penetration exposes patients to ambient germs and other infectious agents. Studies have indicated that post-procedure infections can lead to problems, including delayed recovery times and further medical treatments, which may prevent patients from undergoing these required diagnostic procedures.

The fear of post-biopsy infections can cause anxiety and reluctance among patients, potentially leading to delayed breast cancer diagnosis and treatment. This delay is especially concerning because early identification is crucial for boosting survival rates in breast cancer patients. Healthcare practitioners are increasingly aware of these concerns and are working to improve patient safety by introducing stricter sterilizing processes and developing novel biopsy techniques that minimize invasiveness.

Segment Analysis

The global breast biopsy market is segmented based on product, technique type, guidance technology, end-user, and region.

Core needle biopsy segment is expected to dominate the global breast biopsy market share

The core needle biopsy segment is anticipated to dominate the global breast biopsy market owing to its growing importance in the diagnosis of breast cancer, technological advancements, recent launches and approvals, and increase in the number of breast cancer. Core needle biopsies use a stronger, hollow needle to take a cylindrical tissue sample from the breast, providing for a more thorough examination than fine needle aspiration biopsies (FNA) and other traditional methods, which typically obtain smaller samples. This capability not only improves diagnosis accuracy but also provides more detailed architectural information about the tissue, which is critical for assessing the possibility and severity of cancer.

Core needle biopsies are now much more precise due to technological integration with imaging modalities including ultrasonography, mammography, and MRI. Recently launched technologies such as PrecisionCore combine modern imaging technology with real-time guidance, allowing clinicians to precisely target lesions during the biopsy procedure. This breakthrough not only improves diagnostic accuracy but also increases patient safety by decreasing unwanted tissue removal. Moreover, in May 2024, Hologic introduced a new disposable 7-gauge breast biopsy needle as part of its Brevera breast biopsy system in Europe.

This advancement is significant as it allows radiologists to capture larger tissue samples, which can enhance diagnostic accuracy while potentially reducing patient discomfort and the duration of compression during the procedure. The Brevera system is notable for being the world's first vacuum-assisted breast biopsy solution that integrates tissue acquisition, real-time imaging, and post-biopsy handling. The newly launched 7-gauge needle complements the existing 9-gauge options, providing healthcare professionals with more flexibility to choose the most appropriate needle size for specific procedures. This adaptability is crucial for accommodating varying patient needs and enhancing overall procedural efficiency.

Recent advancements in molecular analysis techniques have significantly reinforced the importance of core needle biopsy in customized therapy. Core needle biopsies allow for the analysis of proteins and genetic mutations within tumor tissues, facilitating individualized therapy methods for patients. This skill is essential for monitoring individual responses to medicines and optimizing treatment programs based on specific tumor features.

Geographical Analysis

North America is expected to hold a significant position in the global breast biopsy market share

North America will likely account for a significant share of the global breast biopsy market, owing to its advanced healthcare infrastructure, extensive research capabilities, proactive patient awareness initiatives a high prevalence of breast cancer, technological advancements, and recent launches and approvals. The increasing number of breast cancer cases is a primary driver of the breast biopsy market in North America.

For instance, according to breastcancer.org, approximately 13% (or one out of every eight) of women in the United States will develop invasive breast cancer over their lives. In recent years, incidence rates have grown somewhat, approximately 0.5% each year. Breast cancer is one of the leading causes of cancer-related deaths among women in the United States, trailing only lung cancer. Breast cancer is the most commonly diagnosed cancer in women in the United States, second only to skin cancer. Every year, breast cancer accounts for around 30% of all newly diagnosed cancers in women. In the United States, approximately four million women have been diagnosed with breast cancer. So, the increasing number of breast cancers increases the demand for cancer diagnostics which increases the demand for breast biopsy devices.

The region has established itself as a pioneer in the use of advanced medical technologies, particularly in oncology. The design and functionality of biopsy equipment have advanced significantly. The discovery of liquid biopsy techniques, which examine circulating tumor cells or cell-free DNA in blood samples, represents a significant advancement. For instance, in June 2023, Labcorp launched liquid biopsy to detect cancer biomarkers. This non-invasive method offers a viable alternative to standard tissue biopsies and is gaining popularity in the North American market due to its potential for early diagnosis and monitoring of breast cancer progression. Patients find these tests appealing because they can be performed with minimal discomfort.

Asia Pacific is growing at the fastest pace in the global breast biopsy market

The Asia Pacific region is emerging as the fastest-growing market for breast biopsy, owing to a combination of demographic trends, increased healthcare investment, recent launches, technological advancements, and a rising number of breast cancers. The Asia-Pacific (APAC) region is experiencing strong expansion in the breast biopsy market, owing mostly to the increased incidence of breast cancer. This concerning trend is highlighted by considerable increases in breast cancer cases in different countries, including China, India, and South Korea. According to the World Health Organization, breast cancer is currently the most frequent cancer in the world, affecting millions of women each year. In APAC, the expanding population and aging demographic exacerbate the situation, as older women are more likely to acquire breast cancer. For instance, according to the National Institute of Health, Female breast cancer (BC) is the major cause of cancer incidence and mortality in India, accounting for 13.5% of new cancer cases and 10% of all cancer-related deaths. So, the increasing number of breast cancers increases the demand for cancer diagnostics which increases the demand for breast biopsy devices.

Competitive Landscape

The major global players in the global breast biopsy market include STERYLAB S.r.l., Argon Medical Devices, Danaher Corporation, Cigna, Siemens Healthcare Private Limited, BD, Hologic, Inc., Devicor Medical Products, Inc., F. Hoffmann-La Roche Ltd, Cook among others.

Emerging Players

AOA DX, Kheiron Medical, and Hera-MI among others

Key Developments

• In November 2024, Mammotome launched the Mammotome AutoCore, the first-ever single-insertion, spring-loaded core biopsy technology. This novel technology intends to transform ultrasound-guided breast biopsy operations by greatly increasing efficiency and patient satisfaction. The AutoCore's unique design enables clinicians to perform biopsies with a single insertion, decreasing procedural complexity.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global breast biopsy market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.