Breast Biopsy Market

Market Overview

The global breast biopsy market size was valued at USD 2.3 billion in 2023 and is projected to reach USD 5.8 billion by 2032, registering a CAGR of 10.8% during the forecast period (2024-2032). The rising technical advancements in breast biopsy and molecular imaging are market drivers propelling the growth of the breast biopsy market.

A breast biopsy is a medical procedure that involves collecting a sample of breast tissue for examination and analysis. This procedure is typically used when breast imaging reveals suspicious findings, such as a lump, changes in breast tissue, or an abnormal result on a mammogram, ultrasound, or magnetic resonance imaging (MRI). The primary goal of a breast biopsy is to determine whether the detected abnormality is cancerous (malignant) or benign.

The market is being pushed for a variety of reasons, including an increase in the global incidence of breast cancer, increased awareness of early detection and diagnosis, technical developments in imaging modalities and biopsy techniques, and a rising desire for minimally invasive procedures. The market provides a wide range of biopsy methods, including core needle biopsy, vacuum-assisted biopsy, fine needle aspiration, and surgery. Furthermore, there is a growing tendency toward using image-guided biopsy methods, such as ultrasound-guided, mammography-guided, and magnetic resonance imaging (MRI)-guided biopsies, which provide greater accuracy and precision.

Furthermore, the market is seeing the introduction of novel biopsy devices and systems, such as automated biopsy guns, handheld biopsy devices, and stereotactic biopsy systems, which improve procedural efficiency and patient comfort. 

Highlights

• Biopsy Needles generates the highest revenue share in the market by product.
• Fine-needle aspiration Biopsy (FNAB) holds a significant market share by biopsy type.
• Liquid Biopsy accounts for the largest share by guidance.
• Early Cancer Screening contributes significantly to the market by application.
• Hospitals & Surgical Center dominates the market by end-user.

Market Dynamics

Global Breast Biopsy Market Drivers

Increasing Prevalence of Breast Cancer

The global increase in breast cancer incidence primarily drives the breast biopsy market. As breast cancer rates rise, there is a greater need for accurate diagnostic procedures, such as biopsies, to detect and confirm the presence of malignancies. In 2023, an estimated 297,790 women and 2,800 men in the United States will be diagnosed with invasive breast carcinoma. Breast cancer is the most common cancer among American women, with one woman being diagnosed every two minutes.

In addition, according to the American Cancer Society, one in every eight women (13%) will be diagnosed with breast cancer by 2023. For men, the lifetime risk of developing breast cancer is one in 833 (0.12%). Breast cancer accounts for one-third of all new female cancers each year. In 95% of countries, breast cancer is the first or second leading cause of death among women. The ongoing rise in breast cancer incidence highlights the critical need for practical diagnostic tools, such as breast biopsies, to confirm and characterize suspected lesions.

Moreover, the increasing prevalence of breast cancer emphasizes the importance of early detection and accurate diagnosis. As healthcare systems around the world seek to address the growing burden of breast cancer, there is a corresponding increase in demand for breast biopsy procedures that provide definitive information about the nature of detected abnormalities. With aging populations, changing lifestyles, and increased awareness all contributing to higher breast cancer detection rates, demand for breast biopsy services is expected to remain high. Advances in biopsy technologies will be critical in meeting the diagnostic needs of an expanding patient population. The rising incidence of breast cancer is a significant driver of the breast biopsy market trend, emphasizing the importance of biopsy procedures in the overall management of breast cancer cases. 

Global Breast Biopsy Market Restraints

Patient Anxiety and Discomfort

The prospect of having a breast biopsy can cause patients anxiety and discomfort. The fear of pain or the unknown may cause some people to avoid or postpone the procedure, reducing the overall number of breast biopsies. A study published in the "Journal of Breast Imaging" found that a significant number of women express anxiety and fear about breast biopsies. The study found that psychological factors such as fear of pain and the unknown influence a patient's decision-making process, resulting in delayed or avoided biopsy procedures.

Furthermore, according to an American Cancer Society survey, the most common concerns among people undergoing breast biopsies were fear of pain and anxiety about the procedure itself. The survey found that nearly 40% of respondents were anxious or stressed about their biopsy experience. Patient anxiety and discomfort can lead to delays in diagnosis and missed opportunities for early intervention. In cases where a biopsy is required, effective communication, clear information, and supportive care can help reduce anxiety and increase patient compliance.

Global Breast Biopsy Market Opportunity

Rising Demand for Minimally Invasive Techniques

The growing demand for breast biopsies, combined with a preference for less invasive techniques, represents a significant opportunity for market expansion. Minimally invasive biopsy methods have several advantages, including reduced patient discomfort, faster recovery times, and better cosmetic results. Vacuum-assisted biopsy (VAB) is a prime example of a minimally invasive technique gaining popularity. VAB uses a vacuum-powered device to collect multiple tissue samples from a single skin incision. This method is known for its precision and ability to obtain larger tissue samples, resulting in more accurate diagnoses.

In addition, according to research published in the Journal of the American College of Radiology, vacuum-assisted biopsy has more than 97% diagnostic accuracy for nonpalpable breast lesions. The study demonstrated the efficacy of VAB in obtaining adequate tissue for diagnosis while minimizing invasiveness. The opportunity lies in further developing and adopting minimally invasive biopsy technologies. Companies that invest in R&D to improve the precision and efficiency of such techniques are well-positioned to meet the increasing demand for breast biopsies while prioritizing patient comfort.

As technology advances, there is a push for even less invasive biopsy methods, including those guided by advanced imaging technologies like ultrasound and MRI. Continued advancements in minimally invasive techniques are expected to shape the future of breast biopsy procedures.

Regional Analysis

The global breast biopsy market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global breast biopsy market shareholder, estimated to grow at a CAGR of 10.7% over the forecast period. North America accounted for most of the share due to the continued growth of cancer diagnostics companies and the rising demand for new therapies and treatments. Government organizations, voluntary healthcare associations, pharmaceutical and biotechnology companies, and research institutions are investing heavily in medical and health-related research and development, helping drive the growth of breast biopsy. Recent advances in 3D scanning technologies have created waves, adding to the revolution in the breast biopsy industry.

For example, CareMountMedical (New York) offers a prone system for 3D image-guided breast biopsy. The 360° view allows radiologists to access lesions without repositioning the patient. The company has also installed a software update incorporating color mapping technologies to detect unusual regions on a breast MRI. Lima Memorial Health Systems in the United States has received a three-year endorsement for stereotactic biopsy from the American College of Radiology. This authorization has helped preserve the center's status as a 'Breast Imaging Center of Excellence,' fully recognized in mammography, breast MRI, breast ultrasound, and stereotactic biopsy. 

Asia-Pacific is anticipated to exhibit a CAGR of 11.2% over the forecast period. In Asian countries, traditional biopsy technologies like core needles and surgical biopsies dominate the disease diagnosis market. According to GLOBOCAN estimates, breast cancer has become the most common cancer among women worldwide in recent years, with significantly more cases occurring in developing countries. Breast, colorectum, and lung cancer are among the most common cancers in Asian women. Asia accounts for 45% of global breast cancer cases. Pakistan has the highest breast cancer incidence rate in Asia (50.1 per 100,000), followed by Singapore (48.7 per 100,000) and the Philippines (46.6 per 100,000). 

Furthermore, raising awareness of breast biopsy procedures tends to open up the diagnostic domain in developing economies, allowing players to invest in breast biopsy devices in these emerging markets. Health technology rapidly evolves in countries such as China, India, and South Korea, prompting hospitals and breast care centers to invest heavily in innovative systems (including liquid breast biopsy and vacuum-assisted biopsy devices). For example, in India, Cytecare Hospital in Bengaluru was designated as the first hospital to offer women 3D mammography (Digital Breast Tomosynthesis). 3D mammography has an advantage over 2D scans because it uses low doses of X-rays at varying angles to create several sequential slides through the tissues. The scans take 10 seconds, and the inferences are sent to the computer.

Europe holds a significant market share. The United Kingdom is expected to have a significant CAGR in the European breast biopsy devices market over the forecast period. Because the population in the United Kingdom is more health-conscious, and cancer screening and diagnosis rates are high, the demand for breast biopsy equipment is expected to grow faster. Furthermore, the large population and adult population of the United Kingdom are more vulnerable to breast cancer due to weakened immune systems and changing lifestyles. 

Additionally, the market for breast biopsy devices is being driven in developed economies such as France, Germany, and Spain by the same factors, resulting in increased sales of breast biopsy devices in Europe. The region's rapidly developing countries have invested in infrastructure development for healthcare research, accelerating the growth of the breast biopsy device market.

Segmental Analysis

The global breast biopsy market is segmented based on product, biopsy type, guidance, application, and end-user,

The market is further segmented by product into Biopsy Needles, Biopsy Forceps, Guidance Systems, Needle Based Biopsy Guns, Localization Wires, and Other Guidance Techniques.

Biopsy needles are essential to various breast biopsy procedures that extract tissue samples for diagnostic purposes. These needles come in multiple sizes and types, such as core biopsy needles and vacuum-assisted biopsy needles. Core biopsy needles are commonly used in procedures such as core needle biopsy, whereas vacuum-assisted biopsy needles allow for the collection of larger tissue samples, increasing diagnostic accuracy. These devices are critical in collecting representative tissue specimens for pathology analysis, which aids in diagnosing breast abnormalities.

Biopsy forceps are specialized tools for extracting tissue samples during specific endoscopic procedures. In breast biopsy, they may be used in minimally invasive procedures such as endoscopic ultrasound-guided biopsy. The forceps are guided to the target tissue, allowing for precise sample collection. Biopsy forceps improve the efficiency of specific biopsy methods, particularly when endoscopic guidance is used, by providing healthcare professionals with a tool for targeted tissue retrieval.

Based on biopsy type, the market is fragmented into Fine-Needle Aspiration Biopsy (FNAB), Core Needle Biopsy (CNB), Vacuum-assisted Breast Biopsy (VABB), Excisional and Incisional Breast Biopsy, Open Surgical Breast Biopsy, Liquid Breast Biopsy.

FNAB is a minimally invasive biopsy technique that uses a thin, hollow needle to extract a small sample of cells or fluid from a breast lump or mass. This method is frequently used to evaluate palpable or visible lesions. FNAB is quick, well-tolerated, and suitable for sampling fluid-filled cysts or solid masses, yielding fast results.

CNB is a popular biopsy technique that employs a more extensive, hollow-core needle to extract small, cylindrical samples (cores) of breast tissue for examination. CNB is especially useful for obtaining tissue from suspicious lesions detected through imaging, as it provides larger samples than FNAB. This method is effective for diagnosing a wide range of breast conditions, including tumors and non-malignant abnormalities.

Based on guidance, the market is classified into Image-Guided Biopsy, Liquid Biopsy.

Liquid biopsy is a non-invasive diagnostic technique that examines components such as circulating tumor DNA (ctDNA), RNA, or proteins in bodily fluids, usually blood. In the context of breast biopsy, liquid biopsy provides information about genetic changes and molecular characteristics of breast tumors. This method is frequently used to monitor treatment response, detect minimal residual disease, and evaluate tumor genetic profiles. Liquid biopsy is a less invasive alternative to traditional tissue biopsies, providing valuable information about the genomic landscape of breast cancer. The segment's significant growth is attributed to the growing acceptance of novel NGS-based assays and droplet-automated PCR technologies for liquid biopsies in most developed countries.

Image-guided biopsy uses a variety of imaging modalities to visualize and precisely target the suspected area for biopsy. Mammography, ultrasound, and magnetic resonance imaging (MRI) are the most common imaging techniques. Image guidance ensures accurate targeting of abnormal tissue, increasing the chances of obtaining representative samples for diagnosis. This method is beneficial when abnormalities are not palpable or readily visible, improving the precision of the biopsy procedure.

The market can be bifurcated by application into Early Cancer Screening, Therapy Selection, Treatment Monitoring, and Recurrence Monitoring.

Early cancer screening is the use of breast biopsy procedures to detect abnormalities at an early stage, often before symptoms appear. This application uses biopsies in routine screening programs or response to suspicious imaging results. Early screening seeks to detect and diagnose breast cancer in its early stages, when it is more treatable, thereby improving overall patient outcomes.

Biopsies for therapy selection are performed to obtain tissue samples that aid in the determination of the specific characteristics of breast cancer, including molecular profile. This information is critical for developing personalized treatment plans, such as selecting targeted therapies or determining the suitability of hormone therapy. Therapy selection biopsies assist oncologists in choosing the most effective and targeted treatment options for each patient.

The market is divided into hospitals and surgical centers, breast care centers, and imaging and diagnostic centers by end-users.

Hospitals and surgical centers are major end users of breast biopsy services. Biopsies and other medical procedures are performed in these settings to diagnose and treat a variety of medical conditions, including breast abnormalities. Hospitals, which have extensive medical facilities and surgical capabilities, frequently provide a central location for performing breast biopsies, particularly those that require surgical intervention. This end-user segment is critical to providing comprehensive healthcare services, including diagnostic and therapeutic aspects of breast care.

Breast care centers are specialized facilities that provide comprehensive management of breast health, including screening, diagnosis, and treatment. These centers specialize in breast-related conditions and play an essential role in early detection and breast cancer management. Breast care centers may provide various services, such as imaging, biopsies, and consultations with breast health specialists. These centers help streamline specialized care for people seeking breast health services as separate entities.

Recent Developments

• February 2024- Hologic launched Genius™ Digital Diagnostics System, the first and only FDA-cleared digital cytometry system.
• November 2023- Hologic, Inc. showcased several recent developments in next-generation AI solutions at the 109th Scientific Assembly and Annual Meeting of the Radiological Society of North America, RSNA 2023, which took place from November 26 to 30 in Chicago, Illinois. The global leader in breast imaging unveiled advances on the show floor and in multiple workshops that use AI to improve cancer detection, workflow, and patient satisfaction. 
• January 2024- BD promoted health equity for Kenyan women through critical cancer screening.