The U.S. breast cancer detection and diagnostic technologies market (defined in this report as including the 3 core imaging modalities of mammography, magnetic resonance imaging [MRI], and breast ultrasound, as well as minimally invasive breast biopsy and genetic testing) totaled more than $2.1 billion in the U.S. in 2008. This market is expected to grow at a healthy compound annual rate of 5.4% to more than $2.8 billion in 2013, despite the present economic uncertainty, impending healthcare reform, and cost/reimbursement issues.
As the population continues to age and the number of new breast cancer cases increases, the renewed importance on lowering healthcare costs will result in increased utilization of cost-effective, accurate, early cancer detection and prevention technologies. Next-generation imaging technologies that help lower the number of unnecessary biopsies while allowing for earlier detection with increased sensitivity and specificity over conventional mammography will be willingly adopted, and minimally invasive biopsy and genetic testing will continue to flourish. Minimally invasive biopsy systems will be increasingly preferred over open biopsy due to the ability to lessen patient disfigurement and pain. At the same time, the genetic testing products market will benefit from several factors including the ability to assist clinicians in recommending preventive care for women at high risk of contracting breast cancer, while sparing existing breast cancer patients unnecessary painful or ineffective chemotherapy by aiding in the selection of the most appropriate treatment plan.
This dynamic, new report from Medtech Insight includes analyses of products, markets, competitors, and opportunities in the U.S. breast cancer detection and diagnostic technologies market. Product areas include: analog and full-field digital mammography (FFDM) systems; computer-aided detection (CAD); computed radiography detectors; MRI systems and ultrasound systems used in breast imaging; minimally invasive biopsy; BRACAnalysis and other genetic testing (recurrence risk assays); and emerging technologies such as digital tomosynthesis, next-generation breast MRI and ultrasound, and technologies developed by several start-up companies entering the breast cancer detection and diagnostic products field.
EXECUTIVE SUMMARY i. Common Types of Breast Cancer ii. Symptoms iii. Risk Factors iv. Early Detection v. Treatment vi. Risk Reduction vii. Future Directions in Breast Cancer Detection viii. Breast Cancer Detection and Diagnostic Technologies Market Exhibit ES-1: Cancer Cases and Deaths, by Anatomic Site, 2007, 2008, and 2009 Exhibit ES-2: 2008, 5-Year Breast Cancer Survival Rates, by Stage Exhibit ES-3: 2008, Breast Cancer Survival Rates, 5-, 10-, and 15-Years Post-Diagnosis Exhibit ES-4: Age-Specific Risk of Developing Invasive Breast Cancer Exhibit ES-5: 2007, Breast Cancer Cases and Deaths, by Age Exhibit ES-6: Selected Limitations of Mammography Exhibit ES-7: Selected Breast Cancer Imaging Technologies Exhibit ES-8: Breast Cancer Detection and Diagnostic Technologies, Combined Market Forecast, 2008-2013 Exhibit ES-9: 2008, Breast Cancer Detection and Diagnostic Technologies Market, Share by Segment Exhibit ES-10: 2013, Breast Cancer Detection and Diagnostic Technologies Market, Share by Segment Exhibit ES-11: 2008, Combined Breast Cancer Detection and Diagnostic Technologies Market, Share by Supplier 1. CLINICAL OVERVIEW 1.1 Common Types of Breast Cancer 1.2 Symptoms 1.3 Risk Factors 1.3.1 Benign Breast Conditions 1.3.2 Family/Personal History 1.3.3 Genetic Risks 1.4 Early Detection 1.5 Treatment 1.5.1 Biologic Therapy, Chemotherapy, and Hormone Therapy 1.6 Risk Reduction 1.7 Future Trends in Breast Cancer Detection Exhibit 1-1: Cancer Cases and Deaths, by Anatomic Site, 2007, 2008, and 2009 Exhibit 1-2: 2008, 5-Year Breast Cancer Survival Rates, by Stage Exhibit 1-3: 2008, Breast Cancer Survival Rates, 5-, 10-, and 15-Years Post-Diagnosis Exhibit 1-4: Age-Specific Risk of Developing Invasive Breast Cancer Exhibit 1-5: 2007, Breast Cancer Cases and Deaths, by Age Exhibit 1-6: Benign Breast Disease, by Category Exhibit 1-7: Selected Benign Breast Diseases Exhibit 1-8: Selected Limitations of Mammography Exhibit 1-9: Selected Breast Cancer Imaging Technologies 2. MAMMOGRAPHY 2.1 Analog Mammography Systems 2.1.1 GE Healthcare/General Electric 2.1.2 Hologic 2.1.3 Planmed/Planmeca Group 2.1.4 Siemens Healthcare/Siemens 2.1.5 Others 2.2 Digital Mammography Systems 2.2.1 GE Healthcare/General Electric 2.2.2 Hologic 2.2.3 Siemens Healthcare/Siemens 2.2.4 Others 2.3 Computer-Aided Detection 2.3.1 Carestream Health/Onex 2.3.2 Hologic 2.3.3 iCAD 2.3.4 Scanis 2.4 Emerging Mammography Technology 2.4.1 BBN Technologies 2.4.2 Dexela 2.4.3 GE Healthcare/General Electric 2.4.4 Konica Minolta Medical Imaging/Konica Minolta Holdings 2.4.5 Hologic 2.4.6 Imaging Diagnostic Systems 2.4.7 Philips Healthcare/Royal Philips Electronics 2.4.8 Sectra 2.4.9 Siemens Healthcare/Siemens 2.4.10 XCounter 2.4.11 Others Exhibit 2-1: Diagram of a Mammography Examination Exhibit 2-2: BI-RADS Assessment Categories Exhibit 2-3: 2009, Selected Analog Mammography Systems Exhibit 2-4: Technologies Used in GE Healthcare's Diamond and Performa Analog Mammography Systems Exhibit 2-5: Hologic's M-IV Screen-Film Mammography System Exhibit 2-6: Hologic's MammoPad Breast Cushion Exhibit 2-7: The Planmed Sophie Classic with MaxView Breast Positioning System Exhibit 2-8: Siemens Healthcare's Mammomat 1000 and 3000 Nova Mammography Systems Exhibit 2-9: 2009, Selected Digital Mammography Systems Exhibit 2-10: GE Healthcare's Senographe Digital Mammography Systems Exhibit 2-11: Hologic's Selenia Digital Mammography System Exhibit 2-12: Siemens Healthcare's Mammomat Novation and Novation S Digital Mammography Systems Exhibit 2-13: Mammomat Digital Mammography Workflow Exhibit 2-14: Carestream Health's Picture Archiving and Communications System with Mammography Upgrade Exhibit 2-15: Fujifilm Medical Systems' ClearView-1m and ClearView-CSm Reader Systems Exhibit 2-16: Mammography Scan with Computer-Aided Detection Exhibit 2-17: 2009, Selected Computer-Aided Detection Systems Exhibit 2-18: Carestream Health's Mammography Computer-Aided Detection System Exhibit 2-19: Hologic's R2 ImageChecker Computer-Aided Detection System Exhibit 2-20: iCAD's SecondLook 300 Computer-Aided Detection Software Exhibit 2-21: Scanis' MAMMEX MammoCAD Mammography System Exhibit 2-22: 2009, Selected Emerging Mammography Systems Exhibit 2-23: BBN Technologies' Stereoscopic Digital Mammography System Exhibit 2-24: Dexela's Patented Digital Tomosynthesis Technology Exhibit 2-25: Hologic's Selenia Dimensions Breast Tomosynthesis System Exhibit 2-26: Imaging Diagnostic's Computed Tomography Laser Mammography System Exhibit 2-27: Philips Healthcare's MammoDiagnost Mammography System Exhibit 2-28: The Sectra MicroDose Mammography Detector with X-Ray Photon Counting Technology Exhibit 2-29: XCounter's XC Mammo-3T Tomosynthesis Imaging System Exhibit 2-30: ART Advanced Research Technologies' SoftScan Optical Imaging System 3. MAGNETIC RESONANCE IMAGING 3.1 Products 3.1.1 Aurora Imaging Technology 3.1.2 GE Healthcare/General Electric 3.1.3 Philips Healthcare/Royal Philips Electronics 3.1.4 Siemens Healthcare/Siemens 3.1.5 Others Exhibit 3-1: Magnetic Resonance Imaging Scan of a Breast with Ductal Carcinoma Exhibit 3-2: 2009, Selected Magnetic Resonance Imaging Systems Utilized in Breast Imaging Exhibit 3-3: The Aurora 1.5T Dedicated Breast Magnetic Resonance Imaging System Exhibit 3-4: GE Healthcare's Signa VIBRANT 1.5T Breast Imaging System Exhibit 3-5: Selected Components and Technologies of GE Healthcare's Breast Imaging System Module Exhibit 3-6: Selected Components and Technologies of Philips Healthcare's Elite Breast Clinical Solutions Exhibit 3-7: Siemens Healthcare's MAGNETOM Espree Pink 1.5T System Exhibit 3-8: Siemens Healthcare's MAGNETOM ESSENZA 1.5T System Exhibit 3-9: The Fonar 360° Scanner, Open Sky Room, and Upright Multi-Position Magnetic Resonance Imaging System 4. ULTRASOUND 4.1 Products 4.1.1 Advanced Imaging Technologies 4.1.2 GE Healthcare/General Electric 4.1.3 Hologic 4.1.4 Philips Healthcare/Royal Philips Electronics 4.1.5 Siemens Healthcare/Siemens 4.1.6 SonoCiné 4.1.7 SonoSite 4.1.8 TechniScan Medical Systems 4.1.9 Terason/Teratech 4.1.10 U-Systems 4.1.11 Others Exhibit 4-1: Sonogram of a Female Breast Showing Potential Cancer Exhibit 4-2: 2009, Selected Ultrasound Breast Imaging Systems Exhibit 4-3: Advanced Imaging Technologies' ARIA Breast Imaging System Exhibit 4-4: GE Healthcare's LOGIQ P5 Ultrasound System Exhibit 4-5: Hologic's DP-6600 Digital Ultrasonic Diagnostic Imaging System Exhibit 4-6: Philips Healthcare's iU22 Ultrasound System Exhibit 4-7: Selected Siemens Healthcare ACUSON Ultrasound Systems Exhibit 4-8: The SonoCiné Automated Whole Breast Ultrasound System Exhibit 4-9: SonoSite's S-Women's Health Ultrasound System Exhibit 4-10: TechniScan Medical Systems' UltraSound CT Imaging System Exhibit 4-11: The Terason t3000 Ultrasound System Exhibit 4-12: U-Systems' somo•v Automated Breast Ultrasound System 5. MINIMALLY INVASIVE BREAST BIOPSY 5.1 Fine Needle Aspiration 5.2 Core Needle Biopsy 5.3 Vacuum-Assisted Breast Biopsy 5.4 Products 5.4.1 Bard Biopsy Systems/Bard Peripheral Vascular/C.R. Bard 5.4.2 Ethicon Endo-Surgery/Johnson & Johnson 5.4.3 Hologic 5.4.4 SenoRx 5.4.5 Siemens Healthcare/Siemens 5.4.6 Others 220.127.116.11 Intact Medical 18.104.22.168 Rubicor Medical 22.214.171.124 Sanarus Exhibit 5-1: Selected Breast Biopsy Methods Exhibit 5-2: 2009, Selected Minimally Invasive Biopsy Systems Exhibit 5-3: Ethicon Endo-Surgery's MAMMOTOME Breast Biopsy Device Exhibit 5-4: Ethicon Endo-Surgery's MAMMOTOME EX Vacuum-Assisted Breast Biopsy System Exhibit 5-5: Hologic's MultiCare Platinum Prone Stereotactic Breast Biopsy Table Exhibit 5-6: Hologic's ATEC and Eviva Breast Biopsy Handpieces Exhibit 5-7: Hologic's ATEC Breast Biopsy Consoles Exhibit 5-8: Hologic's Celero Spring-Loaded Breast Biopsy Device Exhibit 5-9: Hologic's SecurMark and TriMark Biopsy Site Identifiers Exhibit 5-10: SenoRx's EnCor Vacuum-Assisted Breast Biopsy System Exhibit 5-11: SenoRx's SenoSonix II-t with EnCor Breast Biopsy System Exhibit 5-12: SenoRx's GelMark UltraCor Biopsy Site Identifier Exhibit 5-13: SenoRx's StarchMark Biopsy Site Identifiers Exhibit 5-14: Siemens Healthcare's MammoTest Breast Biopsy System Exhibit 5-15: Biopsy Procedure Using Intact Medical's Breast Lesion Excision System Exhibit 5-16: Rubicor Medical's FLASH, HALO, and PHANTOM Breast Biopsy Devices Exhibit 5-17: Sanarus' Cassi II Rotational Core Biopsy System 6. GENETIC TESTING 6.1 Breast Cancer Genes 1 and 2 Test 6.1.1 Myriad Genetics 6.2 Other Breast Cancer Genetic Assays 6.2.1 Abbott Laboratories 6.2.2 Abviva, Inc. 6.2.3 Agendia 6.2.4 Clarient 6.2.5 Dako Denmark and Genentech/Roche Group 6.2.6 deCODE genetics 6.2.7 Genomic Health 6.2.8 Siemens Healthcare/Siemens 6.2.9 Veridex/Johnson & Johnson Exhibit 6-1: 2009, Selected Genetic Tests for Breast Cancer Exhibit 6-2: Risks for Breast and Ovarian Cancer Due to Breast Cancer Gene Mutations Exhibit 6-3: Risk-Reducing Measures for Breast and Ovarian Cancer Exhibit 6-4: Agendia's MammaPrint Sampling Procedure Exhibit 6-5: Benefits of the deCODE BreastCancer Test 7. EMERGING TECHNOLOGIES 7.1 Dune Medical Devices 7.2 MacKay Life Sciences/MacKay Group 7.3 Medical Tactile 7.4 Menssana Research 7.5 NeoMatrix 7.6 Z-Tech Medical 7.7 Discontinued Products 7.8 Other Technologies 7.8.1 Positron Emission Tomography 126.96.36.199 GE Healthcare/General Electric 188.8.131.52 Naviscan 7.8.2 Single Photon Emission Computed Tomography/Scintimammography 7.8.3 Molecular Breast Imaging 184.108.40.206 Dilon Diagnostics/Dilon Technologies Exhibit 7-1: 2009, Selected Emerging Breast Cancer Screening Products Exhibit 7-2: Dune Medical Devices' MarginProbe Real-Time Tissue Characterization System Exhibit 7-3: MacKay Life Sciences' Breast Diagnostic System, Sensitivity and Specificity Rates Compared to Other Diagnostic Technologies Exhibit 7-4: Medical Tactile's SureTouch Visual Mapping System Exhibit 7-5: Menssana Research's Breath Collecting Apparatus Exhibit 7-6: NeoMatrix's HALO Breast Pap Test Risk Assessment System Exhibit 7-7: Positron Emission Tomography Scan of a Female with Metastasized Breast Cancer Exhibit 7-8: Naviscan's Positron Emission Mammography Scanner Exhibit 7-9: Dilon Diagnostics' Dilon 6800 Breast-Specific Gamma Imaging System 8. BREAST CANCER DETECTION AND DIAGNOSTIC TECHNOLOGIES MARKET 8.1 Mammography 8.1.1 Market Analysis 8.1.2 Competitive Analysis 8.2 Magnetic Resonance Imaging 8.2.1 Market Analysis 8.2.2 Competitive Analysis 8.3 Ultrasound 8.3.1 Market Analysis 8.3.2 Competitive Analysis 8.4 Minimally Invasive Breast Biopsy 8.4.1 Market Analysis 8.4.2 Competitive Analysis 8.5 Genetic Testing 8.5.1 Market Analysis 8.5.2 Competitive Analysis 8.6 Combined Market Analysis Exhibit 8-1: Mammography Systems, Market Forecast, 2008-2013 Exhibit 8-2: Mammography, Procedure Volumes Forecast, 2008-2013 Exhibit 8-3: Mammography, Selected Statistics Exhibit 8-4: Mammography, Medicare Reimbursement Rates, 2008-2009 Exhibit 8-5: Digital Mammography, Installed Base, 2005-2009 Exhibit 8-6: 2008, Mammography Systems Market, Share by Supplier Exhibit 8-7: Breast Magnetic Resonance Imaging Systems, Market Forecast, 2008-2013 Exhibit 8-8: 2008, Breast Magnetic Resonance Imaging Systems Market, Share by Supplier Exhibit 8-9: Breast Ultrasound Systems, Market Forecast, 2008-2013 Exhibit 8-10: 2008, Breast Ultrasound Systems Market, Share by Supplier Exhibit 8-11: Minimally Invasive Breast Biopsy Systems, Market Forecast, 2008-2013 Exhibit 8-12: 2008, Minimally Invasive Breast Biopsy Systems Market, Share by Supplier Exhibit 8-13: Breast Cancer Genetic Testing, Market Forecast, 2008-2013 Exhibit 8-14: 2008, Breast Cancer Genetic Testing Market, Share by Supplier Exhibit 8-15: Breast Cancer Detection and Diagnostic Technologies, Combined Market Forecast, 2008-2013 Exhibit 8-16: 2008, Breast Cancer Detection and Diagnostic Technologies Market, Share by Segment Exhibit 8-17: 2013, Breast Cancer Detection and Diagnostic Technologies Market, Share by Segment Exhibit 8-18: 2008, Combined Breast Cancer Detection and Diagnostic Technologies Market, Share by Supplier 9. COMPANY PROFILES 9.1 Abbott Laboratories 9.2 Aurora Imaging Technology, Inc. 9.3 Ethicon Endo-Surgery, Inc./Johnson & Johnson 9.4 GE Healthcare/General Electric Company 9.5 Genomic Health, Inc. 9.6 Hologic, Inc. 9.7 iCAD, Inc. 9.8 Myriad Genetics, Inc. 9.9 Philips Healthcare/Royal Philips Electronics NV 9.10 Sectra AB 9.11 SenoRx, Inc. 9.12 Siemens Healthcare/Siemens AG 9.13 U-Systems, Inc. APPENDIX: COMPANY LISTING