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U.S. Markets for Breast Cancer Detection and Diagnostic Technologies
Report #A409 - October 2009
351 Pages – 103 Exhibits - 13 Company Profiles


According to the American Cancer Society (ACS), breast cancer is the most common cancer among women (excluding non-melanoma skin cancers), accounting for more than 1 in 4 cancers diagnosed in United States (U.S.) women. In 2009, approximately 192,370 women will be diagnosed with breast cancer and approximately 40,170 will die of the disease. However, due to the increased awarenesss, availability, and adoption of highly effective breast cancer screening technologies, the average 5-year relative survival rate for early stage, localized breast cancer now approaches 100%, emphasizing the importance of early breast cancer detection and diagnosis.

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.

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 Report# Publication
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U.S. Markets for Breast Cancer Detection and Diagnostic Technologies

A409

October 2009

$4,750
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Methodology

Reports are produced exclusively by Medtech Insight, through extensive primary and secondary research among the clinicians, researchers, and competitors in the marketplace, and draw upon the industry expertise of a network of industry insiders. Medtech Insight exhaustively corroborates the data as a baseline for completing forward-looking analysis and providing insight into product, technology and market evolution.

 

TABLE OF CONTENTS

 

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

5.4.6.1 Intact Medical

5.4.6.2 Rubicor Medical

5.4.6.3 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

7.8.1.1 GE Healthcare/General Electric

7.8.1.2 Naviscan

7.8.2 Single Photon Emission Computed Tomography/Scintimammography

7.8.3 Molecular Breast Imaging

7.8.3.1 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

 

 

 

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