유방 생검 시장 평가 : 제품 유형, 용도, 최종사용자 및 지역별 기회와 예측(2017-2031년)

Global breast biopsy market is projected to witness a CAGR of 6.58% during the forecast period, between 2024-2031, growing from USD 2.11 billion in 2023 to USD 3.51 billion in 2031F. The market is anticipated to be influenced by factors such as the growing prevalence of breast cancer among females, rising preference for minimally invasive procedures, growing awareness about breast cancer and its screening methods along with technical advancements in biopsy techniques and devices such as vacuum-assisted biopsy, core needle biopsy, and stereotactic-guided biopsy techniques.

Additionally, various programs run by governments and other organizations are expected to spread awareness about early detection of breast cancer, positively impacting the demand for its diagnostics. A significant rise in investments has been made in recent years to develop breast cancer therapeutics and diagnostics solutions, further expanding the market offerings. WHO confirms that most common type of cancer being diagnosed globally is breast cancer and it is also the leading cause of cancer related deaths among women. The increasing geriatric female population is adding more numbers to the prevalence, as women above the age of 50 years are highly prone to breast cancer.

However, the high cost associated with advanced biopsy procedures, and equipment poses a significant challenge for the market in low and middle-income countries. Despite being a minimally invasive procedure, breast biopsy procedures have the risk of infections and tissue damage. Alongside, patient discomfort is another factor posing limitations for the adoption of breast biopsies. Stringent regulatory guidelines for manufacturing biopsy instruments are another major challenge for market expansion.

In August 2023, Mammotome released a new breast biopsy site marker called HydroMARK Plus, which is designed to improve ultrasound visibility, ease of locating, and prevent displacement during surgical procedures. The HydroMARK Plus Breast Biopsy Site Marker is anticipated to be be available to healthcare professionals in the United States by the end of 2023, and company haveplans to expand the market to Canada and some other selected countries worldwide.

High Prevalence of Breast Cancer

Breast cancer is the most commonly diagnosed cancer type in women and the most common cancer type among all types of cancers globally. With changing lifestyles and increasing exposure to radiation and carcinogenic chemicals in day-to-day life, the prevalence of breast cancer is anticipated to increase further. Genetics and family history of breast cancer is a dominating factor while increasing use of hormone-based contraceptives in females to avoid unwanted pregnancies is another major factor contributing to the rising prevalence of breast cancer.

Although breast cancer mainly occurs in females, around 0.5-1% of breast cancer cases are diagnosed in men, which may occur due to hormonal imbalance or other reasons. Physical examination of breasts is a preliminary diagnostic method, but confirmation is done by biopsy method with high precision. The high prevalence is anticipated to significantly increase the demand for breast biopsy equipment and procedures in the assessment period.

As per the American Cancer Society, incidence rates of breast cancer in the United States have increased by 0.6% per year. The rise in incidence rates is steeper in women younger than 50 years (1.0%). WHO estimates around 685,000 annual death cases due to breast cancer globally.

Advancements in Breast Biopsy Methods

Previously, surgical excisional biopsy was the single alternative, but presently there are minimally invasive procedures available for diagnosis of breast cancer. The paradigm shift towards image-guided breast biopsy methods, such as ultrasound-guided biopsy mammographic stereotactic biopsy, magnetic resonance imaging-guided biopsy, tomosynthesis-guided biopsy, and vacuum-assisted biopsy have opened further opportunities for precision diagnostics. Liquid biopsy is a newer technique that involves analyzing blood samples to detect circulating tumor cells or cell-free DNA, which may help personalize breast cancer diagnosis and prognosis. Vacuum-assisted biopsy is becoming a popular choice due to lesser trauma to patients. Manufacturers are encashing market opportunities by producing innovative solutions.

For instance, in December 2023, Exai Bio announced new data that its AI-driven liquid biopsy test can detect breast cancer at early stages and small tumor sizes, including DCIS, using a standard blood sample. In a recent study, the test showed 87% sensitivity for stage I breast cancer and 81% for tumors =10mm at 90% specificity. Overall sensitivity was 88% for invasive breast cancer stages, outperforming any DNA-based liquid biopsy. The sensitivity for DCIS was 78%. These findings are being presented at the San Antonio Breast Cancer Symposium (SABCS), 2023.

Dominance of Biopsy Needle Segment

The biopsy needle segment is anticipated to dominate the breast biopsy market with the highest share. The dominance of biopsy needles in breast biopsy procedures can be attributed to their cost efficiency and research-based efficacy. A study comparing image-guided and palpation-guided core needle biopsies of palpable breast masses. It found that image-guided biopsies were considered more accurate than palpation-guided biopsies, with image-guided biopsies being preferred for sampling breast masses, even if they are palpable. The research suggests that core needle biopsy, especially when guided by imaging, is preferred for its accuracy and safety in diagnosing breast lesions. Biopsy needles are hollow needle instruments used to collect tissues from the breast and analyze them. These instruments are easy to handle and are thus preferred by professionals.

For instance, in February 2024, NeoDynamics received clearance (US plate_number_1(k)) for their innovative breast biopsy system, NeoNavia. This groundbreaking technology utilizes a patented pulse system to provide accurate and controlled needle insertion, based on research carried out at Karolinska Institutet. The system comprises of a base unit, a handheld driver, and three distinct biopsy needles. The pulse technology delivers precise needle placement within the tumor, allowing for high-quality tissue samples from both breasts and lymph nodes.

Invasive Breast Cancer to Dominate the Market

Invasive breast cancer spreads into the surrounding breast tissues, it can be of two types, invasive ductal carcinoma and invasive lobular carcinoma. Due to the high prevalence of these types of breast cancer, the related segment is anticipated to dominate the breast biopsy market. Another reason can be the widespread application of biopsy in deeper tissue extraction in case of invasive types of cancer. As per the American Cancer Society, invasive (or infiltrating) breast cancer is the most common type and within it, Invasive ductal carcinoma makes up about 70-80% of all breast cancers.

The American Cancer Society estimates that about 310,720 new cases of invasive breast cancer will be diagnosed in women in 2024 in the United States and about 56,500 new cases of ductal carcinoma in situ (DCIS) are expected to be diagnosed. Another estimate states that approximately 13% (about one in eight) of women in the United States are going to develop invasive breast cancer during their lives.

North America to be the Dominating Region

North America, particularly the United States and Canada, exhibits a notable prevalence of breast cancer, which can be attributed to several factors. The region has well-established screening programs that detect breast cancer at early stages, leading to higher diagnosis rates. Also, changes in risk factors, such as increased obesity and physical inactivity, have contributed to higher breast cancer rates. Socioeconomic factors, including access to healthcare and lifestyle choices, play a role in breast cancer prevalence. Additionally, genetic factors, like the presence of BRCA1 and BRCA2 mutations, are more common in North America, contributing to higher breast cancer rates. Despite these factors, breast cancer mortality rates have been declining in North America, which may be due to improved detection and treatment. With such factors, North America is expected to lead in the demand for breast biopsy methods.

For example, as per the statistics by the Centers for Disease Control and Prevention, about 240,000 cases of breast cancer per year are diagnosed in women and about 2,100 cases of breast cancer in men in the United States only. About 42,000 women and 500 men die from breast cancer in the United States every year. Within these statistics, the number of black women is higher as they are genetically more prone to breast cancer as compared to other races..

Future Market Scenario

Advancements in imaging techniques have led to enhanced tissue visualization and improved efficacy of biopsy methods, promising a bright future for the breast biopsy market. Novel techniques such as multiparametric MRI, photoacoustic imaging, and virtual biopsy provide advanced diagnostic insights. Imaging-guided therapies and theragnostic promise targeted precision treatment, revolutionizing the future of breast radiology. Similar to other domains, the integration of artificial intelligence in biopsy methods is another promising advancement that is anticipated to contribute to the market expansion.

For instance, in November 2023, Syantra, a company that specializes in liquid biopsy platforms and innovation, announced the expansion of its Intellectual Property (IP) portfolio and a strategic partnership with Limmi which is a US-based technology company. Limmi focuses on AI-driven insights to facilitate the development of next-generation techniques for disease detection and management. These achievements are major milestones for Syantra and represent significant advancements in the understanding of human diseases, starting with Syantra DX Breast Cancer.

Key Players Landscape and Outlook

The key players in the breast biopsy market include a variety of players ranging from multi-billion dollar companies to small startups. Some of the major players in global breast biopsy market are Becton, Dickinson and Company, Hologic Inc., Danaher Corporation, Argon Medical Devices, and Devicor Medical Products, Inc. (Mammotome). These players are constantly involved in innovation and R&D to cater to the demand for breast biopsy products. Market tactics like mergers and acquisitions, and collaborations have been significant contributors to the market expansion.

In April 2023, Quest Diagnostics announced a definitive agreement to acquire Haystack Oncology in an all-cash equity transaction. Quest Diagnostics is the United States' leading provider of diagnostic information services, and Haystack Oncology is an early-stage oncology company dedicated for testing of minimal residual cancer cells which helps in the early andaccurate detection of residual or recurring cancers, such as in the case of breast cancer, to provide better-informed therapy decisions.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Executive Summary

4. Global Breast Biopsy Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. By Product Type
  • 4.2.1. Biopsy Needle
    • 4.2.1.1. Core Needles
    • 4.2.1.2. Fine Aspiration Needles
  • 4.2.2. MRI-Guided Biopsy Systems
  • 4.2.3. Ultrasound Guided Breast Biopsy Systems
  • 4.2.4. Vacuum-Assisted Device (VAD)
  • 4.2.5. Guide Wire
  • 4.2.6. Breast Biopsy Marker
• 4.3. By Application
  • 4.3.1. Invasive Breast Cancers
  • 4.3.2. Ductal Carcinoma In Situ
• 4.4. By End-user
  • 4.4.1. Hospitals
  • 4.4.2. Specialty Clinics
  • 4.4.3. Ambulatory Surgical Centers
  • 4.4.4. Cancer Research Institutes
• 4.5. By Region
  • 4.5.1. North America
  • 4.5.2. Europe
  • 4.5.3. Asia-Pacific
  • 4.5.4. South America
  • 4.5.5. Middle East and Africa
• 4.6. By Company Market Share (%), 2023

5. Global Breast Biopsy Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
    • 5.1.1.2. By Volume
  • 5.1.2. By Product Type
    • 5.1.2.1. Biopsy Needle
    • 5.1.2.1.1. Core Needles
    • 5.1.2.1.2. Fine Aspiration Needles
    • 5.1.2.2. MRI-Guided Biopsy Systems
    • 5.1.2.3. Ultrasound Guided Breast Biopsy Systems
    • 5.1.2.4. Vacuum-Assisted Device (VAD)
    • 5.1.2.5. Guide Wire
    • 5.1.2.6. Breast Biopsy Marker
  • 5.1.3. By Application
    • 5.1.3.1. Invasive Breast Cancers
    • 5.1.3.2. Ductal Carcinoma In Situ
  • 5.1.4. By End-user
    • 5.1.4.1. Hospitals
    • 5.1.4.2. Specialty Clinics
    • 5.1.4.3. Ambulatory Surgical Centers
    • 5.1.4.4. Cancer Research Institutes
  • 5.1.5. United States*
    • 5.1.5.1. Market Size & Forecast
    • 5.1.5.1.1. By Value
    • 5.1.5.1.2. By Volume
    • 5.1.5.2. By Product Type
    • 5.1.5.2.1. Biopsy Needle
    • 5.1.5.2.1.1. Core Needles
    • 5.1.5.2.1.2. Fine Aspiration Needles
    • 5.1.5.2.2. MRI-Guided Biopsy Systems
    • 5.1.5.2.3. Ultrasound Guided Breast Biopsy Systems
    • 5.1.5.2.4. Vacuum-Assisted Device (VAD)
    • 5.1.5.2.5. Guide Wire
    • 5.1.5.2.6. Breast Biopsy Marker
    • 5.1.5.3. By Application
    • 5.1.5.3.1. Invasive Breast Cancers
    • 5.1.5.3.2. Ductal Carcinoma In Situ
    • 5.1.5.4. By End-user
    • 5.1.5.4.1. Hospitals
    • 5.1.5.4.2. Specialty Clinics
    • 5.1.5.4.3. Ambulatory Surgical Centers
    • 5.1.5.4.4. Cancer Research Institutes
  • 5.1.6. Canada
  • 5.1.7. Mexico

All segments will be provided for all regions and countries covered

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. India
  • 5.3.2. China
  • 5.3.3. Japan
  • 5.3.4. Australia
  • 5.3.5. Vietnam
  • 5.3.6. South Korea
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East & Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Product Type
• 6.2. By Application
• 6.3. By End-user
• 6.4. By Region

7. Macro Environment and Industry Structure

• 7.1. Demand Supply Analysis
• 7.2. Import Export Analysis
• 7.3. Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.4.7. Supplier Power
  • 7.4.8. Buyer Power
  • 7.4.9. Substitution Threat
  • 7.4.10. Threat from New Entrant
  • 7.4.11. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges and Restraints)

9. Regulatory Framework and Innovation

• 9.1. Clinical Trials
• 9.2. Patent Landscape
• 9.3. Regulatory Approvals
• 9.4. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)

11. Case Studies

12. Key Players Outlook

• 12.1. Becton, Dickinson and Company
  • 12.1.1. Company Details
  • 12.1.2. Key Management Personnel
  • 12.1.3. Products & Services
  • 12.1.4. Financials (As reported)
  • 12.1.5. Key Market Focus & Geographical Presence
  • 12.1.6. Recent Developments
• 12.2. Hologic Inc.
• 12.3. Danaher Corporation
• 12.4. Argon Medical Devices Inc.
• 12.5. Devicor Medical Products, Inc. (Mammotome)
• 12.6. Merit Medical Systems, Inc.
• 12.7. Qiagen NV
• 12.8. Cook Medical Inc.
• 12.9. OncoCyte Corporation
• 12.10. INRAD, Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

13. Strategic Recommendations

14. About Us & Disclaimer