US Market Report for Breast Imaging 2016 - MedCore

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Date: 01-Sep-2016
No. of pages: 128
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Description

Market growth will be driven by the development of new imaging technologies as well as the aging population, which typically requires an above-average number of imaging procedures. In 2015, the largest segment in the breast imaging market was DBT. Most analog devices have already been converted to DR mammography units; thus, the significant growth in DR mammography that was seen is previous years has begun to slow. Furthermore, with the disappearance of analog and takeover of DR mammography the incentive to switch to CR mammography has become greatly reduced. With two out of four segments in decline and another undergoing the process of becoming a replacement market, the only segment remaining to drive market growth is the DBT market.

Abstract

In this report, the breast imaging market is segmented into mammography, breast ultrasound, breast MRI coils and Molecular Breast Imaging (MBI). Within the mammography market, segmentation consisting of analog mammography, computed radiography (CR) mammography, digital radiography (DR) mammography and digital breast tomosynthesis (DBT) further breaks down the market. Furthermore, the breast ultrasound market comprises manual breast ultrasound and automated breast ultrasound and the MBI market is composed of gamma imaging and positron emission mammography (PEM).

Companies


  • GE Healthcare

  • Siemens Healthcare

  • Philips Healthcare

  • Bayer

  • Hologic

  • Toshiba Medical Systems


Others include: Accutome, Agfa Healthcare, Amrad Medical, Analogic, Arcoma-IMIX, Assured Imaging Mobile Mammography, BK Medical, Bracco, C.R. Bard, Canon, Carestream Health, CMR-Naviscan, Cuattro, Del Medical, Digirad, Dilon Technologies, Ellex/Innovative Imaging, Esaote, eZono, Fischer-Giotto, FONAR, Fujifilm, Gamma Medica Inc., Guerbet, Hitachi Medical Systems, iCRco, Imaging Dynamics Company, IMRIS, Konica Minolta, Lakeshore Technologies Inc., Lantheus Medical Imaging, Machnet B.V., Mallinckrodt, MILabs, Mindray, Neusoft Medical Systems, Paradigm, Planmed OY, Quantel Medical, Rayence, Samsung Medison, Shimadzu, SonoCiné, Sonogage, Sonomed Escalon, SonoSite, Spectrum Dynamics Medical, SuperSonic Imagine, SuperSonic Imagine, Swissray, Teleflex, Terason, Tomey, TXR, ViewRay, Zonare, etc.

US Market Report for Breast Imaging 2016 - MedCore

Table of Contents

Table Of Contents I
List Of Figures Xxi
List Of Charts Xxvii

Executive Summary 1
U.S. Medical Imaging Device Market Overview 1
Competitive Analysis 3
Market Trends 6
Market Developments 8
Procedure Codes Investigated 9
Procedures Included 12
Markets Included 16
Key Report Updates 19
Version History 19

Research Methodology 20
1.1 Research Scope 20
1.2 Idata's 9-Step Methodology 20
Step 1: Project Initiation & Team Selection 20
Step 2: Prepare Data Systems and Perform Secondary Research 22
Step 3: Preparation for Interviews & Questionnaire Design 23
Step 4: Performing Primary Research 24
Step 5: Research Analysis: Establishing Baseline Estimates 26
Step 6: Market Forecast and Analysis 27
Step 7: Identify Strategic Opportunities 29
Step 8: Final Review and Market Release 30
Step 9: Customer Feedback and Market Monitoring 31

Product Assessment 32
2.1 Product Portfolios 32
2.1.1 Breast Imaging 32
2.1.1.1 Mammography 32
2.1.1.1.1 Analog Mammography Devices 33
2.1.1.1.2 Computed Radiography Mammography Devices 33
2.1.1.1.3 Digital Radiography Mammography Devices 33
2.1.1.1.4 Digital Breast Tomosynthesis Devices 33
2.1.1.2 Molecular Breast Imaging 35
2.1.1.2.1 Positron Emission Mammography Devices 35
2.1.1.2.2 Gamma Imaging Devices 35
2.1.1.3 Breast Ultrasound 36
2.1.1.3.1 Automated Breast Ultrasound Devices 36
2.1.1.3.2 Manual Breast Ultrasound Devices 37
2.1.1.4 Breast Magnetic Resonance Imaging 37
2.2 Regulatory Issues And Recalls 39
2.2.1 Breast Imaging Devices 39
2.3 Clinical Trials 42
2.3.1 Bayer 43
2.3.2 Bracco 43
2.3.3 Carestream Health 46
2.3.4 Fujifilm 49
2.3.5 GE Healthcare 52
2.3.6 Guerbet 69
2.3.7 Hologic 73
2.3.8 Lantheus Medical Imaging 74
2.3.9 Philips Healthcare 74
2.3.10 Siemens Healthcare 81
2.3.11 Toshiba Medical Systems 83

Breast Imaging Market 85
3.1 Market Overview 85
3.2 Market Analysis And Forecast 90
3.2.1 Total Mammography Market 90
3.2.1.1 Analog Mammography Market 93
3.2.1.2 Computed Radiography Mammography Market 95
3.2.1.3 Digital Radiography Mammography Market 97
3.2.1.4 Digital Tomosynthesis Market 99
3.2.2 Total Molecular Breast Imaging Market 101
3.2.2.1 Positron Emission Mammography Market 103
3.2.2.2 Gamma Imaging Market 105
3.2.3 Total Breast Ultrasound Market 107
3.2.3.1 Manual Breast Ultrasound Market 109
3.2.3.2 Automated Breast Ultrasound Market 111
3.2.4 MRI Coil Market 113
3.3 Drivers And Limiters 115
3.3.1 Market Drivers 115
3.3.2 Market Limiters 116
3.4 Competitive Market Share Analysis 117

Abbreviations 126

Appendix: Company Press Releases 128

List of Charts

Chart 1 1: Medical Imaging Device Market by Segment, U.S., 2012 - 2022 2
Chart 1 2: Medical Imaging Device Market Overview, U.S., 2012 & 2022 2
Chart 3 1: Breast Imaging Market by Segment, U.S., 2012 - 2022 88
Chart 3 2: Breast Imaging Market Breakdown, U.S., 2015 89
Chart 3 3: Breast Imaging Market Breakdown, U.S., 2022 89
Chart 3 4: Total Mammography Market by Segment, U.S., 2012 - 2022 92
Chart 3 5: Analog Mammography Market, U.S., 2012 - 2022 94
Chart 3 6: Computed Radiography Mammography Market, U.S., 2012 - 2022 96
Chart 3 7: Digital Radiography Mammography Market, U.S., 2012 - 2022 98
Chart 3 8: Digital Tomosynthesis Market, U.S., 2012 - 2022 100
Chart 3 9: Total Molecular Breast Imaging Market, U.S., 2012 - 2022 102
Chart 3 10: Positron Emission Mammography Market, U.S., 2012 - 2022 104
Chart 3 11: Gamma Imaging Market, U.S., 2012 - 2022 106
Chart 3 12: Total Breast Ultrasound Market by Segment, U.S., 2012 - 2022 108
Chart 3 13: Manual Breast Ultrasound Market, U.S., 2012 - 2022 110
Chart 3 14: Automated Breast Ultrasound Market, U.S., 2012 - 2022 112
Chart 3 15: MRI Coil Market, U.S., 2012 - 2022 114
Chart 3 16: Leading Competitors, Breast Imaging Market, U.S., 2015 125

List of Figures

Figure 1 1: Medical Imaging Device Competitor Market Share Ranking by Segment, U.S., 2015 (1 of 2) 3
Figure 1 2: Medical Imaging Device Competitor Market Share Ranking by Segment, U.S., 2015 (2 of 2) 3
Figure 1 3: Companies Researched in this Report, U.S., 2015 (1 of 2) 4
Figure 1 4: Companies Researched in this Report, U.S., 2015 (2 of 2) 5
Figure 1 5: Factors Impacting the Medical Imaging Device Market by Segment, U.S. (1 of 2) 6
Figure 1 6: Factors Impacting the Medical Imaging Device Market by Segment, U.S. (2 of 2) 7
Figure 1 7: Recent Events in the Medical Imaging Device Market, U.S., 2012 - 2015 8
Figure 1 8: Procedure Codes Investigated, U.S., 2015 (1 of 3) 9
Figure 1 9: Procedure Codes Investigated, U.S., 2015 (2 of 3) 10
Figure 1 10: Procedure Codes Investigated, U.S., 2015 (3 of 3) 11
Figure 1 11: Medical Imaging Procedures Covered, U.S., 2015 (1 of 4) 12
Figure 1 12: Medical Imaging Device Markets Covered, U.S., 2015 (1 of 3) 16
Figure 1 13: Medical Imaging Device Markets Covered, U.S., 2015 (2 of 3) 17
Figure 1 14: Medical Imaging Device Markets Covered, U.S., 2015 (3 of 3) 18
Figure 1 15: Key Report Updates 19
Figure 1 16: Version History 19
Figure 2 1: Mammography Devices by Company 34
Figure 2 2: Positron Emission Mammography Devices by Company 35
Figure 2 3: Gamma Imaging Devices by Company 36
Figure 2 4: Breast Ultrasound Devices by Company 37
Figure 2 5: Class 2 Device Recall Fujifilm Aspire HD, Full Field Digital, System 39
Figure 2 6: Class 2 Device Recall Mammomat Inspiration system 39
Figure 2 7: Class 2 Device Recall Siemens Mammomat Inspiration mammography systems 39
Figure 2 8: Class 2 Device Recall Hologic Selenia Full Field Digital Mammography System 39
Figure 2 9: Class 2 Device Recall Siemens MAMMOMAT Inspiration 40
Figure 2 10: Class 2 Device Recall Merge (Cedara) Mammo 40
Figure 2 11: Class 2 Device Recall Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x 40
Figure 2 12: Class 2 Device Recall Siemens Mammomat Inspiration 40
Figure 2 13: Class 2 Device Recall GE Healthcare Senographe Essential System 41
Figure 2 14: Class 2 Device Recall Soma v Automated Breast Ultrasound System 41
Figure 2 15: Class 2 Device Recall GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM 41
Figure 2 16: Class 2 Device Recall Siemens MAMMOMAT Inspiration 41
Figure 2 17: Perfusion CT as a Predictor for Response to Antiangiogenic Therapy 43
Figure 2 18: A Multicenter Study of Iomeron®-400 43
Figure 2 19: Retrospective Study of MRI in Pediatric Patients 44
Figure 2 20: A Pilot Trial Using BR55 Ultrasound Contrast Agent 44
Figure 2 21: Crossover Comparison of MultiHance and Dotarem (BENEFIT) 44
Figure 2 22: Multidetector Computed Tomography (MDCT) Tailored Protocol 45
Figure 2 23: Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body 45
Figure 2 24: Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body 46
Figure 2 25: CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol (CTP) 46
Figure 2 26: Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis 47
Figure 2 27: Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors 47
Figure 2 28: Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors 48
Figure 2 29: Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol (LLI-MSE) 48
Figure 2 30: A Multi-Reader Multi-Case Pivotal Trial 49
Figure 2 31: Pilot Mammography Reader Study 49
Figure 2 32: Acquisition of Breast Mammography Images 50
Figure 2 33: Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI) 50
Figure 2 34: Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection 50
Figure 2 35: Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury (TOMO) 51
Figure 2 36: Collection of FUJIFILM's 3Dimensional Mammograms (3DM) 51
Figure 2 37: International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients 52
Figure 2 38: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2) 52
Figure 2 39: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis 53
Figure 2 40: Non-invasive Quantification of Liver Iron With MRI 53
Figure 2 41: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis 54
Figure 2 42: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis 54
Figure 2 43: Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly) 55
Figure 2 44: Phase 4 Study to Demonstrate Prognostic Usefulness of AdreView™ Scintigraphy 55
Figure 2 45: Clinical Evaluation of an Integrated PET/MRI System (PET/MR_ZURICH) 56
Figure 2 46: Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening 56
Figure 2 47: Development of an Integrated PET/MR System, Accessories and Components 57
Figure 2 48: Comparison of 18F FDG PET/CT TO PET MRI (PET/MR US) 57
Figure 2 49: Compare Rates of Agreement Between Clinical Diagnosis and Visual Assessment of DaTscan™ Images 58
Figure 2 50: Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView 58
Figure 2 51: Clinical Evaluation for GE CT System 59
Figure 2 52: A Case Collection Study for Digital Breast Tomosynthesis (DBT) 59
Figure 2 53: Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection 60
Figure 2 54: Magnetic Resonance Imaging Using Innovative Pulse Sequences 60
Figure 2 55: MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal (MRI) 60
Figure 2 56: Contrast Ultrasound Detection of Sentinel Lymph Nodes 61
Figure 2 57: Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer 61
Figure 2 58: PET/CT for Staging Rectal Cancer Patients With and Without EMVI-MR 62
Figure 2 59: Contrast Enhanced Spectral Mammography (CESM) Study (CONTEND) 62
Figure 2 60: Assessment of Automated Breast Ultrasound 63
Figure 2 61: Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging 63
Figure 2 62: How Beta-amyloid Imagining Influences Clinician Diagnosis and Management 64
Figure 2 63: Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas 64
Figure 2 64: Use of MIBG Scan Images in PVC Ablations (PVC-MIBG) 64
Figure 2 65: Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI 65
Figure 2 66: Fluoro-L-Thymidine Positron Emission Tomography (FLT PET) vs. Adv. Magnetic Resonance (MR) Techniques 65
Figure 2 67: A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide 66
Figure 2 68: 123I-mIBG SPECT Imaging 66
Figure 2 69: Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma With PET and MRI (Flucipro) 67
Figure 2 70: FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients 67
Figure 2 71: The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease 68
Figure 2 72: Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury 68
Figure 2 73: Safety and Efficacy of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization (In-Live) 69
Figure 2 74: P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) 69
Figure 2 75: Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI 70
Figure 2 76: Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI 70
Figure 2 77: Evaluation of Gadoterate in Patients With Decreased Kidney Function 71
Figure 2 78: Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer 71
Figure 2 79: Hepatic Xenetix-CT Perfusion 72
Figure 2 80: Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis 72
Figure 2 81: Pancreatic Duct Evaluation in Autoimmune Pancreatitis: MR Pancreatography 73
Figure 2 82: Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis 73
Figure 2 83: Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI 74
Figure 2 84: Virtual Path Planning for Image-guided Needle Interventions 74
Figure 2 85: Applications of Dual-Energy Computed Tomography 75
Figure 2 86: X-ray Dose Reduction Study for Cardiac Angiography and Intervention 75
Figure 2 87: X-ray Dose Reduction Study for Endovascular Interventional Radiology 75
Figure 2 88: X-ray Dose Reduction in Electrophysiology 76
Figure 2 89: Multicenter Study of Magnetic Resonance-guided High Intensity Focused Ultrasound 76
Figure 2 90: MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer 76
Figure 2 91: Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids (SOFIA) 77
Figure 2 92: Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter 77
Figure 2 93: Percutaneous Closure of Atrial Septal Defects in Children 78
Figure 2 94: Assessment of 3D Transperineal Ultrasound Imaging w/ Matrix Array Transducers in Prostate Radiotherapy 78
Figure 2 95: Radio Frequency Ablation for Atrial Flutter With Magnetic Resonance Guidance and Tracking 79
Figure 2 96: Chest Ultrasound of ER Patients With Cough or SOB 79
Figure 2 97: The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer 80
Figure 2 98: Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation 80
Figure 2 99: MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases 81
Figure 2 100: Evaluation of Diagnostic Accuracy of Contrast Enhanced Dual Energy Mammography Imaging 81
Figure 2 101: Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions (VIPS) 82
Figure 2 102: PET/MRI in Patients With Suspected Prostate Cancer 82
Figure 2 103: Perfusion CT as a Predictor for Response to Antiangiogenic Therapy 83
Figure 2 104: Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain 83
Figure 2 105: General Investigative MRI Protocol 84
Figure 3 1: Breast Imaging Market by Segment, U.S., 2012 - 2022 (US$M) 87
Figure 3 2: Total Mammography Market by Segment, U.S., 2012 - 2022 (US$M) 91
Figure 3 3: Analog Mammography Market, U.S., 2012 - 2022 93
Figure 3 4: Computed Radiography Mammography Market, U.S., 2012 - 2022 95
Figure 3 5: Digital Radiography Mammography Market, U.S., 2012 - 2022 97
Figure 3 6: Digital Tomosynthesis Market, U.S., 2012 - 2022 100
Figure 3 7: Total Molecular Breast Imaging Market, U.S., 2012 - 2022 101
Figure 3 8: Positron Emission Mammography Market, U.S., 2012 - 2022 104
Figure 3 9: Gamma Imaging Market, U.S., 2012 - 2022 105
Figure 3 10: Total Breast Ultrasound Market by Segment, U.S., 2012 - 2022 (US$M) 108
Figure 3 11: Manual Breast Ultrasound Market, U.S., 2012 - 2022 109
Figure 3 12: Automated Breast Ultrasound Market, U.S., 2012 - 2022 111
Figure 3 13: MRI Coil Market, U.S., 2012 - 2022 114
Figure 3 14: Drivers and Limiters, Breast Imaging Market, U.S., 2015 116
Figure 3 15: Leading Competitors, Breast Imaging Market, U.S., 2015 (1 of 2) 123
Figure 3 16: Leading Competitors, Breast Imaging Market, U.S., 2015 (2 of 2) 124
Figure 5 1: Press Release Summary 129

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