Breast cancer is the most common cancer in women worldwide, with nearly 2.3 million new cases and nearly 685,000 deaths in 2020. In 2021, the global breast cancer diagnostic products market (including imaging, biopsy, and sample testing products) was valued at approximately $4.9bn.
Market drivers include the increasing global incidence of breast cancer due to a combination of behavioral factors and the aging of the population, increasing awareness regarding the importance of personalized breast cancer screening, the development of advanced imaging technologies, and increased use of advanced technologies such as gene expression and liquid biopsy. Limiters of the market include difficulties around reimbursement and cost containment, the lack of population-based screening programs in many countries, and the limitation of sales of traditional screening products as more advanced technologies gain market share.
This analysis includes a discussion of products, current/forecast markets, competitors, and opportunities in the global markets for breast cancer diagnostic products; these include mammography systems (film-screen, full-field digital mammography, and digital breast tomosynthesis systems as well as computer-aided detection software sold with mammography devices), automated breast ultrasound systems, magnetic resonance imaging coils, biopsy systems (biopsy guidance consoles and consumables, as well as minimally invasive biopsy systems), and sample testing systems (tumor marker tests, HER2 amplification status tests, gene expression profiling tests, and liquid biopsy tests for minimal residual disease).
Countries covered by this report include the US, five major European markets (France, Germany, Italy, Spain, and the UK), Japan, and the Rest of World. The forecast range for this report is 2021-26.
Table of Contents
Executive Summary
i. Breast cancer overview
ii. Global breast cancer market
- Exhibit ES-1: Breast cancer diagnostic products, global market forecast, by product segment ($m), 2021-26
a. Market drivers and limiters
b. Product overview
c. Technology trends
d. Market leaders
iii. Methodology
iv. Bibliography
1. Breast Cancer Overview
- Exhibit 1-1: Estimated incident cases of breast cancer by molecular subtype, US, 2021 and 2026
- Exhibit 1-2: Estimated incident cases of breast cancer by molecular subtype, 5 Euro, 2021 and 2026
- Exhibit 1-3: Estimated incident cases of breast cancer by molecular subtype, Japan, 2021 and 2026
- Exhibit 1-4: Estimated incident cases of breast cancer by stage, US, 2021 and 2026
- Exhibit 1-5: Estimated incident cases of breast cancer by stage, 5 Euro, 2021 and 2026
- Exhibit 1-6: Estimated incident cases of breast cancer by stage, Japan, 2021 and 2026
1.1 Risk factors
- Exhibit 1-7: Factors that increase the relative risk for breast cancer in women
1.2 Detection and diagnosis
1.2.1 Susceptibility testing
1.2.2 Clinical breast examination
1.2.3 Screening mammography
- Breast density and mammography
- Participation in national screening programs
- Overdiagnosis
- Exhibit 1-8: National screening guidelines for breast cancer and possible changes
- Personalized breast screening
- Types of mammography systems
- Exhibit 1-9: Developments in breast screening technology
- Installed base of mammography systems
- Exhibit 1-10: Installed base of mammography systems, by country
1.2.4 Other breast cancer imaging technologies
- Automated breast ultrasound
- Breast MRI
- Molecular breast imaging
- Positron emission tomography
- Radiofrequency imaging
- Tomographic optical breast imaging
1.2.5 Blood/liquid biopsy tests
1.2.6 Biopsy
1.2.7 Sample testing
- Hormone receptor status
- HER2/neu status
- Gene expression profiling
- Companion diagnostics
- Broad molecular profiling tests
- Tumor marker tests
1.3 Treatment pathways
1.3.1 Surgery
- Lumpectomy guidance systems
1.3.2 Breast irradiation
- Types of radiation therapy
- Whole breast irradiation
- Accelerated partial breast irradiation
- Intraoperative radiation therapy
- Stereotactic body radiotherapy
- Current recommendations for the use of APBI
- 3D tissue marker for breast irradiation
- Exhibit 1-11: Selected APBI systems
1.3.3 Breast ablation
- Cryoablation
- Laser interstitial thermal therapy
1.3.4 Chemotherapy
1.3.5 Hormone therapy
1.3.6 Targeted treatments
1.4 Bibliography
2. Breast Cancer Diagnostic Products
2.1 Mammography and other imaging products
2.1.1 Film-based mammography systems
2.1.2 Computed radiography systems
2.1.3 Full-field digital mammography systems
- Exhibit 2-1: Selected full field digital mammography systems, 2022
2.1.4 Digital breast tomosynthesis systems
- Exhibit 2-2: Selected clinical trials comparing digital breast tomosynthesis to full-field digital mammography
- Canon Medical Systems
- Fujifilm
- GE Healthcare
- Hologic
- IMS Giotto/GMM Group
- Planmed
- Siemens Healthineers
- Exhibit 2-3: Selected digital breast tomography systems, 2022
2.1.5 Computer-aided detection software
- iCAD
- ScreenPoint Medical
- Hologic
- Therapixel
- Lunit
- Nanox.AI
- Kheiron Medical Technologies
2.1.6 Breast density software
- Densitas
- CureMetrix
- iCAD
- Volpara Health
- Future development
- Exhibit 2-4: Selected clinical trials evaluating artificial intelligence in breast cancer screening
2.1.7 Automated breast ultrasound systems
- Delphinus Medical Technologies
- GE Healthcare
- iVu Imaging
- Siemens Healthineers
- SonoCiné
- Reimbursement
- Exhibit 2-5: Selected automated breast ultrasound systems, 2022
2.1.8 Breast-specific magnetic resonance imaging coils
2.1.9 Computed tomography
2.2 Stereotactic biopsy guidance systems
- GE Healthcare
- Hologic
- Other suppliers
- Exhibit 2-6: Selected stereotactic biopsy guidance systems and tables, 2022
2.3 Minimally invasive biopsy products
2.3.1 Core-needle biopsy systems
2.3.2 Vacuum-assisted biopsy systems
- BD
- Devicor Medical Products/Danaher
- Hologic
2.3.3 Specimen radiography systems
- Hologic
- Devicor Medical Products
- Cirdan
- Kubtec
2.4 Sample testing, therapy selection, and monitoring products
2.4.1 HER2 amplification status tests
- Siemens Healthineers
- Paige
- Foundation Medicine
- Exhibit 2-7: Selected HER2 tests, 2022
2.4.2 Gene expression profiling tests
- Agendia
- Biotheranostics/Hologic
- Exact Sciences
- Myriad Genetics
- Sysmex
- Veracyte
2.4.3 Companion diagnostics
- Exhibit 2-8: Selected companion diagnostics for breast cancer, 2022
2.4.4 Tumor marker tests
2.4.5 Liquid biopsy products for breast cancer
- Exhibit 2-9: Selected liquid biopsy tests for breast cancer management, 2022
2.5 Bibliography
3. Breast Cancer Diagnostic Products Market
3.1 Global market insights
3.2 Market value
- Exhibit 3-1: Breast cancer diagnostic products, global market forecast, by product segment ($m), 2021-26
3.3 Segment insights
3.3.1 Mammography
- Exhibit 3-2: Mammography systems, global market forecast, by product segment ($m), 2021-26
3.3.2 Automated breast ultrasound systems
- Exhibit 3-3: Automated breast ultrasound systems, global market forecast ($m), 2021-26
3.3.3 MRI coils
- Exhibit 3-4: Magnetic resonance imaging coils, global market forecast ($m), 2021-26
3.3.4 Biopsy systems
- Exhibit 3-5: Biopsy systems, global market forecast ($m), 2021-26
3.3.5 Sample testing, therapy selection, and disease monitoring products
- Gene expression/tumor profiling tests
- HER2 amplification status tests
- Tumor marker tests
- Liquid biopsy tests for MRD monitoring
- Exhibit 3-6: Breast cancer sample testing products, global market forecast ($m), 2021-26
3.4 Regional insights
3.4.1 US
- Market forecast
- Exhibit 3-7: Breast cancer diagnostic products, US market forecast ($m), 2021-26
3.4.2 Five major European markets
- Market forecast
- Exhibit 3-8: Breast cancer diagnostic products, 5 Euro market forecast ($m), 2021-26
3.4.3 Japan
- Market forecast
- Exhibit 3-9: Breast cancer diagnostic products, Japan market forecast ($m), 2021-26
3.4.4 Rest of world
- Market forecast
- Exhibit 3-10: Breast cancer diagnostic products, RoW market forecast ($m), 2021-26
3.5 Market trends
- Industry consolidation
- Collaboration across technology sectors
- Computer-aided detection maturing
- Personalized breast cancer screening is anticipated to boost the use of newer technologies
- One-stop clinics
3.6 Market drivers and limiters
3.7 Market leaders
3.7.1 Hologic
- Exhibit 3-11: Hologic, revenues by segment, FY2022
3.7.2 GE Healthcare
- Exhibit 3-12: General Electric, revenues by segment, FY2021
3.7.3 Fujifilm
- Exhibit 3-13: Fujifilm, revenues by segment, FY2021
3.7.4 Siemens Healthineers
- Exhibit 3-14: Siemens, revenues by segment, FY2022
3.7.5 Other suppliers
- Exhibit 3-15: Breast cancer diagnostic products market, share by supplier, 2021
3.8 Bibliography
- Company Listing
Companies Mentioned
- Agendia
- BD
- Biotheranostics/Hologic
- Canon Medical Systems
- Cirdan
- CureMetrix
- Delphinus Medical Technologies
- Densitas
- Devicor Medical Products/Danaher
- Exact Sciences
- Foundation Medicine
- Fujifilm
- Future development
- GE Healthcare
- Hologic
- iCAD
- IMS Giotto/GMM Group
- iVu Imaging
- Kheiron Medical Technologies
- Kubtec
- Lunit
- Myriad Genetics
- Nanox.AI
- Paige
- Planmed
- Reimbursement
- ScreenPoint Medical
- Siemens Healthineers
- SonoCiné
- Sysmex
- Therapixel
- Veracyte
- Volpara Health
