Breast Biopsy Device Market By Type (Breast Biopsy Guidance Systems, Needle-Based Breast Biopsy Guns, Breast Biopsy Needles, Breast Biopsy Forceps), Application (Surgical Biopsy, Diagnostic Biopsy, Surveillance), End-User (Hospitals and Clinics, Ambulatory Surgery Centers (ASCs), Specialty Clinics, Diagnostic Imaging Centers), & Region for 2024-2031

Breast Biopsy Device Market Valuation – 2024-2031

Growing preference for minimally invasive diagnostic techniques, which offer high accuracy while minimizing patient discomfort and recovery time. This shift is prompting more healthcare providers to adopt advanced biopsy technologies. Thus, the increasing demand for minimally invasive diagnostic techniques surged the growth of market size surpassing USD 2.12 Billion in 2023 to reach a valuation of USD 3.02 Billion by 2031.

Government and non-governmental initiatives aimed at promoting regular breast cancer screening are significantly supporting market growth by increasing awareness and encouraging early diagnosis. Thus, the government initiatives enable the market to grow at a CAGR of 4.50% from 2024 to 2031.

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Breast Biopsy Device Market: Definition/ Overview

Breast biopsy devices are essential tools for diagnosing breast abnormalities, particularly in detecting and confirming breast cancer. A breast biopsy involves extracting tissue or cells for analysis, providing critical information that aids in accurate diagnosis and effective disease management. Among the various biopsy techniques, needle biopsy, and surgical biopsy are the primary types. Needle biopsy, commonly performed with a hollow needle, is a quick, minimally invasive method used to sample breast tissue, with core needle biopsy as the standard for diagnosing breast cancer. For lumps that can be felt, fine needle aspiration (FNA) may be performed as an initial, less invasive approach.

Recent advancements in breast biopsy devices have focused on enhancing diagnostic accuracy and patient comfort. Devices like the Advanced Breast Biopsy Instrumentation (ABBI) System, which leverages stereotactic imaging technology, enable precise targeting of lesions, improving biopsy effectiveness and aiding in early cancer detection. These innovations reflect a growing market focus on developing more accurate, efficient biopsy tools to support optimal patient care and disease management.

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How Does the Growing Prevalence of Breast Cancer and the Increasing Aging Female Population Surge the Growth of the Breast Biopsy Devices Market?

The increasing prevalence of breast cancer globally and the growing female geriatric population accelerate the growth of the breast cancer devices market. According to the WHO, breast cancer has become the most common cancer globally, with 2.3 million new cases reported annually. The American Cancer Society estimates that about 297,790 new cases of invasive breast cancer will be diagnosed in women in 2023. Approximately 1 in 8 women (13%) will develop invasive breast cancer in their lifetime. The UN Population Division reports that women aged 50+ (highest risk group) will increase to 1.3 billion globally by 2030. Women over 50 account for approximately 80% of all breast cancer diagnoses. The median age of breast cancer diagnosis is 62 years in the US

The growing awareness and screening programs and rising insurance coverage also contribute to the adoption of breast biopsy devices. Breast cancer screening rates increased by 12% globally between 2018-2022. The NHS Breast Screening Programme in England reported screening 2.1 million women in 2021-22. Mammography screening rates in developed countries reach up to 80% of eligible women. The Affordable Care Act requires all health insurance plans to cover breast cancer screening and diagnostic tests. European insurance companies have expanded coverage for minimally invasive breast biopsies by 35% since 2020. Out-of-pocket costs for breast biopsies decreased by 25% in developed countries between 2019-2023.

How Does the High Cost of Biopsy Devices and Procedures Impede the Growth of the Breast Biopsy Device Market?

The high cost of the biopsy devices and the stringent procedure hamper the growth of the market. The average cost of a breast biopsy in the US ranges from $1,000 to $7,000. Vacuum-assisted breast biopsy devices cost between $25,000 to $45,000 per unit. Out-of-pocket expenses for breast biopsies can reach up to $2,500 even with insurance coverage. According to WHO, approximately 50% of women in developing countries cannot afford basic diagnostic procedures. Also, the limited healthcare infrastructure in developing regions hinders the adoption of breast biopsy devices. Only 30% of low-income countries have the necessary equipment for breast cancer diagnostics. 80% of women in developing countries present breast cancer at advanced stages due to limited access to early diagnostic facilities. Less than 25% of African countries have pathology services available in public facilities. WHO reports that radiotherapy is available in only 4 out of 54 African countries

In addition, the shortage of skilled healthcare professionals and the risk of complications and technical failures create challenges for market growth. The American Society of Clinical Oncology projects a shortage of 2,200 oncologists by 2025. Only 45% of radiologists are specifically trained in breast imaging procedures. Developing countries face a critical shortage with less than 1 specialist per 100,000 population. Training for specialized breast biopsy procedures takes an additional 12-18 months. Studies show a 2-10% rate of sampling errors in breast biopsies. Post-biopsy complications occur in approximately 1-2% of cases. Equipment malfunction rates are reported at 3-5% during procedures. False-negative results occur in about 1-2% of image-guided breast biopsies

Category-Wise Acumens

How the Easy Use of Surgeons and Radiologists Surge the Growth of Breast Biopsy Needles Segment?

The breast biopsy needle segment dominates the breast biopsy devices market, owing to its cost-effectiveness and ease of use for surgeons and radiologists. Designed to facilitate precise sample collection, biopsy needles are thin, hollow instruments used alongside syringes to gather cells, fluids, or tissue from a suspicious mass or abnormal region within the body. This technique allows healthcare providers to determine whether a lump or mass is benign, such as a cyst or infection, or malignant. Needle biopsies offer surgeons a straightforward and efficient approach, particularly when guided by imaging technologies for accurate lesion targeting. The segment’s widespread adoption is driven by the reliability and compatibility of these needles with imaging modalities, allowing for minimally invasive procedures that yield precise diagnostic samples.

Additionally, continuous advancements in needle design and technology have enhanced diagnostic accuracy, a factor that reassures healthcare professionals about their ability to make informed diagnoses. Such innovations support improved targeting and sample collection, making biopsy needles a preferred choice within the broader breast biopsy devices market. With these advantages, the Breast Biopsy Needles segment is well-positioned to maintain its leading market share as demand for effective, minimally invasive diagnostic tools continues to grow.

How the Advanced Infrastructure and Skilled Medical Professionals Foster the Growth of Hospital Segment?

The hospital segment leads the breast biopsy devices market, owing to its advanced infrastructure, skilled medical professionals, and integration of sophisticated biopsy techniques. Hospitals are equipped with cutting-edge imaging technologies, which enable accurate, minimally invasive breast biopsy procedures, encouraging widespread adoption of these services. The trust patients place in hospital-based diagnostics further strengthens this segment, as hospitals are often viewed as more reliable and comprehensive settings for breast cancer diagnosis and treatment.

Additionally, the high volume of patients seeking diagnostic and surgical procedures for breast cancer positions hospitals as central hubs for breast biopsy procedures. Recognizing this, companies in the breast biopsy devices market are increasingly implementing strategies that involve training surgeons and radiologists within hospitals to enhance the reach and quality of these services. By providing specialized training on advanced biopsy techniques, companies aim to improve procedural accuracy and patient outcomes, reinforcing hospitals as preferred providers in breast cancer diagnostics. This focus on professional development and skill-building is gaining significant traction, as it enhances patient access to high-quality diagnostic care within trusted healthcare institutions.

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Country/Region-wise Acumens

How Does the High Prevalence of Breast Cancer and Strong Screening Programs Accelerate the Growth of the Breast Biopsy Devices Market in North America?

North America substantially dominates the breast biopsy devices market owing to the robust screening programs and growing cases of breast cancer. According to the American Cancer Society (2023), about 297,790 new cases of invasive breast cancer were diagnosed in U.S. women. CDC reports that 70.3% of women aged 50-74 years had a mammogram within the past 2 years. In Canada, breast cancer represents 25% of all new cancer cases in women (2022). The National Cancer Institute reported that early-stage breast cancer detection increased by 48% between 2020-2023 due to improved screening methods

Also, the advanced healthcare infrastructure and insurance coverage increase the high investment in healthcare devices in the region.  U.S. healthcare spending reached $4.3 trillion in 2022, representing 18.3% of GDP. Medicare spending on breast cancer diagnostics increased by 35% from 2020 to 2023. The Affordable Care Act ensures 100% coverage for breast cancer screening in the U.S. About 92% of U.S. women have access to at least one accredited breast imaging center within 20 miles (American College of Radiology, 2022)

How Does the Rising Breast Cancer Incidence in Key Asian Markets Escalate the Growth of Breast Biopsy Devices Market in Asia Pacific?

Asia Pacific is anticipated to witness the fastest growth in the breast biopsy devices market during the forecast period driven by the increasing prevalence of breast cancer cases. China reported over 416,000 new breast cancer cases in 2022, representing a 15% increase from 2020. In India, breast cancer incidence grew by 13.5% annually between 2020-2023, with 178,361 new cases reported in 2022. Japan witnessed approximately 92,000 new breast cancer cases in 2022, with an annual growth rate of 4.5%. South Korea reported a 22% increase in breast cancer cases among women aged 40-50 between 2020-2023.

Also, the growing medical tourism and private healthcare sector increase the adoption of breast biopsy devices in the region. Thailand’s medical tourism for cancer diagnostics grew by 35% from 2020 to 2023. Private hospital chains in India increased their breast cancer diagnostic centers by 45% between 2020-2023. South Korea reported a 28% increase in international patients seeking cancer diagnostics from 2021 to 2023. Singapore’s private healthcare sector invested USD 2.8 Billion in advanced diagnostic equipment between 2020-2023. The number of accredited breast cancer centers in China increased by 60% from 2020 to 2023.

Competitive Landscape

The Breast Biopsy Device Market is dynamic and competitive, driven by technological advancements, the increasing incidence of breast cancer, and the growing emphasis on early detection. Key players in this market are focused on developing innovative products that offer improved accuracy, reduced procedure time, and enhanced patient comfort.

The organizations focus on innovating their product line to serve the vast population in diverse regions. Some of the prominent players operating in the Breast Biopsy Device Market include:

• Hologic, Inc.
• Becton
• Dickinson and Company
• Leica Biosystems
• Argon Medical Devices, Inc.
• Cook Medical
• Scion Medical Technologies
• R. Bard, Inc.
• Devicor Medical Products, Inc.
• Intact Medical Corporation
• Planmed Oy

Latest Developments:

• In August 2023, Mammotome announced the launch of the HydroMARK Plus Breast Biopsy Site Marker, which improves ultrasound visibility, and ease of location, and reduces displacement during surgical procedures.
• In August 2022, TransMed7, LLC announced the first clinical cases of the ultimate commercial production. A version of the Sparrow device (a member of the new SpeedBird family of vacuum-assisted, single-insertion.

Report Scope

Breast Biopsy Device Market, By Category

Type:

• Breast Biopsy Guidance Systems
• Needle-Based Breast Biopsy Guns
• Breast Biopsy Needles
• Breast Biopsy Forceps

Application:

• Surgical Biopsy
• Diagnostic Biopsy
• Surveillance

End-User:

• Hospitals and Clinics
• Ambulatory Surgery Centers (ASCs)
• Specialty Clinics
• Diagnostic Imaging Centers

Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

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