With more than 200,000 diagnoses and 40,000 deaths each year, breast cancer is the most frequently diagnosed malignancy in the U.S. and is the second-leading cause of cancer mortality in women.  More than 2 million women in the U.S. have been treated for breast cancer; as with other cancers, early detection and treatment of breast cancer dramatically improves survival rates. 

In 2004, sales of breast-specific screening and diagnostic products (e.g., biological tumor markers, breast biopsy products, computer-aided detection systems, conventional and digital mammography systems, emerging breast cancer detection products, pharmacogenetic and prognostic testing products, and susceptibility testing products) totaled approximately $690 million.  In addition, sales of non-breast-specific diagnostic technologies (e.g., nuclear imaging products, magnetic resonance imaging products, and ultrasound products) totaled approximately $4 billion.  Over the forecast period covered by this report, sales of these products are expected to increase significantly. 

This 423-page report from Medtech Insight includes analyses of products, technologies, current and forecast markets, competitors, and opportunities in the U.S. breast disease detection and diagnostic technologies market.  Topics discussed in this report include breast cancer statistics and trends, computer-aided detection, conventional and digital mammography, emerging technologies for breast cancer diagnosis, magnetic resonance imaging, nuclear imaging, an overview of benign and malignant breast diseases, surgical and minimally invasive breast biopsy, tumor markers, and ultrasound. 

TABLE OF CONTENTS AND LIST OF EXHIBITS

EXECUTIVE SUMMARY

i.   Susceptibility Testing

ii.   Mammography

a.  Conventional Mammography

b.  Digital Mammography

c.  Computer-Aided Detection Mammography

iii.  Breast Biopsy

iv.  Ultrasound

v.  Magnetic Resonance Imaging

vi.  Nuclear Medicine Imaging

vii. Biological Tumor Markers

viii. Emerging Breast Cancer Diagnostic Technologies

ix.  Combined Market Forecast

Exhibit ES-1:    2006, Comparison of Selected Breast Disease Detection and Diagnosis Technologies

Exhibit ES-2:    Breast Cancer Gene Testing Systems, Market Forecast, 2004-2009

Exhibit ES-3:    Conventional, Digital, and Computer-Aided Mammography Systems, Market Forecast, 2004-2009

Exhibit ES-4:    Breast Biopsy Products, Market Forecast, 2004-2009

Exhibit ES-5:    Ultrasound Products, Market Forecast, 2004-2009

Exhibit ES-6:    Magnetic Resonance Imaging Systems, Market Forecast, 2004-2009

Exhibit ES-7:    Nuclear Medicine Imaging Systems, Market Forecast, 2004-2009

Exhibit ES-8:    Breast Cancer Marker Assays, Market Forecast, 2004-2009

Exhibit ES-9:    Emerging Breast Cancer Diagnostic Products, Market Forecast, 2004-2009

Exhibit ES-10:   Breast-Specific Screening and Diagnostic Technologies, Market Forecast, 2004-2009

Exhibit ES-11:   Non-Breast-Specific Diagnostic Technologies, Market Forecast, 2004-2009

1. CLINICAL AND STATISTICAL OVERVIEW OF BREAST DISEASE

1.1 Breast Anatomy and Disease Processes

1.1.1 Typical Breast Development and Physiology

1.1.2 Benign Breast Diseases

1.1.2.1 Atypical Ductal Hyperplasia

1.1.2.2 Fibroadenoma

1.1.2.3 Fibrocystic Disease

1.1.2.4 Other Benign Breast Conditions

1.1.3 Malignant Breast Diseases

1.1.3.1 Etiology and Epidemiology

1.1.3.2 Ductal Carcinoma In Situ

1.1.3.3 Invasive Breast Cancer

1.1.3.4 Other Malignant Breast Diseases

1.2 Breast Cancer Statistics and Trends

1.2.1 Signs and Symptoms

1.2.2 Incidence, Prevalence, and Mortality

1.2.3 Causes and Risk Factors

1.2.4 Methods of Prevention

1.3 Breast Cancer Detection and Diagnosis

1.3.1 Breast Self-Examination

1.3.2 Susceptibility Testing

1.3.2.1 Genetic Factors

1.3.2.1.1 Androgen Receptor Gene

1.3.2.1.2 Ataxia Telangiectasia Mutated Gene

1.3.2.1.3 Breast Cancer Gene One (BRCA1) and Breast Cancer Gene Two (BRCA2)

1.3.2.1.4 Checkpoint Homolog Gene

1.3.2.1.5 DIRAS3 Gene

1.3.2.1.6 HER-2/neu Gene

1.3.2.1.7 RecA Homolog Escherichia Coli Gene

1.3.2.2 Breast Cancer Gene Analysis

1.3.2.3 Commercial Susceptibility Testing

1.3.2.4 Market Analysis

1.3.3 Breast Cancer Screening

Exhibit 1-1:    Relative Risk of Developing Invasive Breast Cancer, by Benign Breast Condition

Exhibit 1-2:    Types of Benign Breast Disease

Exhibit 1-3:    Breast Cancer Risk, by Age

Exhibit 1-4:    Types of Breast Cancer

Exhibit 1-5:    Distant Recurrence of Breast Cancer, by Tumor Grade

Exhibit 1-6:    Five-Year Survival Rates for Breast Cancer, by Stage at Diagnosis

Exhibit 1-7:    Breast Cancer Survival Rates, by Number of Years after Diagnosis

Exhibit 1-8:    2006, Selected Screening Methods for Breast Disease

Exhibit 1-9:    Breast Cancer Risk for Women with Breast Cancer Gene Mutation, by Age

Exhibit 1-10:  Breast Cancer Gene Testing Systems, Market Forecast, 2004-2009

2. MAMMOGRAPHY PRODUCTS MARKET

2.1 Conventional Mammography

2.1.1 Technologies

2.1.2 Mammography Combined With Other Modalities

2.1.3 Breast Imaging Reporting and Database System

2.1.4 Products and Competitors

2.1.4.1 Eastman Kodak

2.1.4.2 FUJIFILM Medical Systems USA/Fuji Photo Film

2.1.4.3 GE Healthcare/General Electric

2.1.4.4 Lorad/Hologic

2.1.4.5 Philips Medical Systems North America/Royal Philips Electronics

2.1.4.6 Planmed Oy/Planmeca Group

2.1.4.7 Siemens Medical Solutions/Siemens

2.2 Digital Mammography

2.2.1 Technologies

2.2.2 Products and Competitors

2.2.2.1 DALSA Life Sciences/DALSA

2.2.2.2 Fischer Imaging

2.2.2.3 FUJIFILM Medical Systems USA/Fuji Photo Film

2.2.2.4 GE Healthcare/General Electric

2.2.2.5 Lorad/Hologic

2.2.2.6 Sectra

2.2.2.7 Siemens Medical Solutions/Siemens

2.2.3 Computer-Aided Detection

2.2.3.1 Technologies

2.2.3.2 Products and Competitors

2.2.3.2.1 CTI Mirada Solutions/Siemens

2.2.3.2.2 Eastman Kodak

2.2.3.2.3 iCAD

2.2.3.2.4 R2 Technology

2.2.3.2.5 Riverain Medical

2.2.3.2.6 SCANIS

2.2.4 Patient Comfort Devices for Mammography

2.3 Market Analysis

2.4 Technological Advances

2.5 Competitive Analysis

Exhibit 2-1: 2005, Screening Mammography Rate, by Ethnicity and Socioeconomic Status

Exhibit 2-2: Breast Imaging Reporting and Database System Assessment Scores

Exhibit 2-3: 2006, Selected Conventional Mammography Systems

Exhibit 2-4: 2005, Centers for Medicare & Medicaid Services Mammography Reimbursement Rates

Exhibit 2-5: 2006, Selected Digital Mammography Systems

Exhibit 2-6: 2006, Selected Computer-Aided Detection Mammography Systems

Exhibit 2-7: Conventional and Digital Mammography Systems, Unit Volumes Forecast, 2004-2009

Exhibit 2-8: Conventional, Digital, and Computer-Aided Mammography Systems, Market Forecast, 2004-2009

Exhibit 2-9: 2004, Conventional and Digital Mammography Systems Market, Share by Supplier

3. BREAST BIOPSY PRODUCTS MARKET

3.1 Surgical Biopsy

3.2 Large-Core Stereotactic Biopsy

3.3 Minimally Invasive Biopsy

3.3.1 Core-Needle Biopsy

3.3.2 Fine-Needle Aspiration

3.3.3 Vacuum-Assisted Biopsy

3.3.4 Percutaneous Intact Specimen Retrieval

3.4 Products and Competitors

3.4.1 Bard Biopsy Systems/C.R. Bard

3.4.2 Boston Scientific

3.4.3 Cardinal Health

3.4.4 Ethicon Endo-Surgery/Johnson & Johnson

3.4.5 Fischer Imaging

3.4.6 InterV

3.4.7 Lorad/Hologic

3.4.8 Intact Medical

3.4.9 Rubicor Medical

3.4.10 Sanarus Medical

3.4.11 SenoRx

3.4.12 Suros Surgical Systems

3.5 Market Analysis

3.6 Competitive Analysis

Exhibit 3-1: 2004, Breast Biopsies, by Type

Exhibit 3-2: Selected Breast Biopsy Methods

Exhibit 3-3: Comparison of Fine-Needle Aspiration and Core-Needle Biopsy for Nonpalpable Breast Lesions

Exhibit 3-4: Comparison of MAMMOTOME Procedure with Core-Needle and Open Surgical Biopsy

Exhibit 3-5: 2006, Selected Breast Biopsy Products

Exhibit 3-6: Breast Biopsy Products, Market Forecast, 2004-2009

Exhibit 3-7: 2004, Breast Biopsy Products Market, Share by Supplier

4. ULTRASOUND PRODUCTS MARKET

4.1 Technologies

4.1.1 Doppler Ultrasound

4.1.2 Tissue Harmonic Imaging

4.2 Technological Advances

4.2.1 Three-Dimensional Imaging

4.2.2 Compound Imaging

4.2.3 Elastography

4.2.4 Holographic Ultrasound

4.3 Products and Competitors

4.3.1 Advanced Imaging Technologies

4.3.2 ALOKA/Japan Radio

4.3.3 Esaote

4.3.4 GE Healthcare/General Electric

4.3.5 Hitachi Medical Systems America/Hitachi

4.3.6 Lorad/Hologic

4.3.7 Medison America/Medison

4.3.8 Philips Medical Systems North America/Royal Philips Electronics

4.3.9 Shimadzu Medical Systems/Shimadzu

4.3.10 Siemens Medical Solutions/Siemens

4.3.11 SonoSite

4.3.12 TechniScan Medical Systems

4.3.13 Terason/Teratech

4.3.14 Toshiba America Medical Systems/Toshiba

4.3.15 U-Systems

4.3.16 ZONARE Medical Systems

4.4 Market Analysis

4.5 Competitive Analysis

Exhibit 4-1: 2006, Selected Ultrasound Products

Exhibit 4-2: Ultrasound Products, Market Forecast, 2004-2009

Exhibit 4-3: 2004, Ultrasound Products Market, Share by Supplier

5. MAGNETIC RESONANCE IMAGING PRODUCTS MARKET

5.1 Technology

5.2 Products and Competitors

5.2.1 Analogic

5.2.2 Aurora Imaging Technology

5.2.3 Esaote

5.2.4 FONAR

5.2.5 GE Healthcare/General Electric

5.2.6 Hitachi Medical Systems America/Hitachi

5.2.7 Philips Medical Systems North America/Royal Philips Electronics

5.2.8 Siemens Medical Solutions/Siemens

5.2.9 Toshiba America Medical Systems/Toshiba

5.3 Technological Advances

5.3.1 Confirma

5.4 Market Analysis

5.5 Competitive Analysis

Exhibit 5-1: 2006, Selected Magnetic Resonance Imaging Systems

Exhibit 5-2: Magnetic Resonance Imaging Systems, Market Forecast, 2004-2009

Exhibit 5-3: 2004, Magnetic Resonance Imaging Equipment Market, Share by Supplier

6. NUCLEAR MEDICINE IMAGING PRODUCTS MARKET

6.1 Positron Emission Tomography

6.1.1 Positron Emission Mammography

6.2 Single-Photon Emission Computed Tomography

6.2.1 Scintimammography

6.3 Positron Emission Tomography, Products and Competitors

6.3.1 GE Healthcare/General Electric

6.3.2 Hitachi Medical Systems America/Hitachi

6.3.3 Naviscan PET Systems

6.3.4 Philips Medical Systems North America/Royal Philips Electronics

6.3.5 Positron

6.3.6 Siemens Medical Solutions/Siemens

6.4 Single-Photon Emission Computed Tomography, Products and Competitors

6.4.1 Digirad

6.4.2 Dilon Technologies

6.4.3 Gamma Medica Ideas

6.4.4 GE Healthcare/General Electric

6.4.5 IntraMedical Imaging

6.4.6 IS2 Medical Systems

6.4.7 Philips Medical Systems North America/Royal Philips Electronics

6.4.8 Siemens Medical Solutions/Siemens

6.4.9 Toshiba America Medical Systems/Toshiba

6.5 Market Analysis

6.6 Competitive Analysis

Exhibit 6-1: 2006, Selected Positron Emission Tomography Products

Exhibit 6-2: 2006, Selected Single-Photon Emission Computed Tomography Products

Exhibit 6-3: Nuclear Medicine Imaging Systems, Market Forecast, 2004-2009

Exhibit 6-4: 2004, Nuclear Medicine Imaging Systems Market, Share by Supplier

7. BREAST TUMOR MARKERS MARKET

7.1 Technology

7.1.1 Carcinoembryonic Antigen

7.1.2 CA15.3 Antigen

7.1.3 CA 27.29 Antigen

7.1.4 Tissue Polypeptide Antigen

7.1.5 Ki-67 Antigen

7.1.6 TA-90 Antigen

7.2 Products and Competitors

7.2.1 Abbott Laboratories

7.2.2 Bayer HealthCare Diagnostics/Bayer

7.2.3 BioGenex Laboratories

7.2.4 Cell Sciences

7.2.5 CLINIQA

7.2.6 DiaSorin

7.2.7 Fujirebio Diagnostics/Fujirebio

7.2.8 MP Biomedicals

7.3 Technological Advances

7.3.1 Biomedical Diagnostics/Genesis Bioventures

7.3.2 CeMines

7.3.3 Ciphergen Biosystems

7.3.4 Matritech

7.4 Market Analysis

Exhibit 7-1: Advantages and Disadvantages of Selected Biological Tumor Markers

Exhibit 7-2: Breast Cancer Marker Assays, Market Forecast, 2004-2009

8. EMERGING BREAST CANCER DIAGNOSTIC PRODUCTS MARKET

8.1 Smart Probe

8.1.1 Technology

8.1.2 Market Analysis

8.2 Tuned-Aperture Computed Tomography

8.2.1 Technology and Competitors

8.3 Electrical Impedance

8.3.1 Technology and Competitors

8.3.2 Market Analysis

8.4 Electrical Potential and Palpation

8.4.1 Electrical Potential, Technology and Competitors

8.4.2 Electronic Palpation, Technology and Competitors

8.5 Thermal Imaging Technologies

8.5.1 Technology and Competitors

8.5.1.1 Advanced BioPhotonics

8.5.1.2 Computerized Thermal Imaging

8.5.1.3 Infrared Sciences

8.5.1.4 Lifeline Biotechnologies

8.5.2 Market Analysis

8.6 Microwave Imaging Spectroscopy

8.6.1 Technology and Competitors

8.7 Optical Imaging and Spectroscopy

8.7.1 Technology

8.7.2 Competitors

8.7.2.1 ART Advanced Research Technologies

8.7.2.2 DOBI Medical International

8.7.2.3 Imaging Diagnostic Systems

8.7.3 Market Analysis

8.8 Ductal Lavage/Ductoscopy

8.8.1 Technology

8.8.2 Competitors

8.8.2.1 Acueity

8.8.2.2 Cytyc

8.8.2.3 Lifeline Biotechnologies

8.8.3 Market Analysis

8.9 Thermoacoustic Computed Tomography

8.9.1 Technology and Competitors

8.9.1.1 OptoSonics

8.9.1.2 Imasonic
8.10 Sentinel Node Biopsy

8.10.1 Technology

8.10.2 Competitors

8.10.2.1 Capintec

8.10.2.2 Gamma Medica-Ideas

8.10.2.3 IntraMedical Imaging

8.10.2.4 United States Surgical/Tyco International

8.11 Pharmacogenetic and Prognostic Testing

8.11.1 Technology

8.11.1.1 Human Epidermal Growth Factor Receptor 2

8.11.1.2 Estrogen/Progesterone Receptors

8.11.1.3 p53

8.11.1.4 pS2

8.11.1.5 Cathepsin-D

8.11.1.6 Phosphatase and Tensin Homolog Deleted on Chromosome Ten

8.11.1.7 Mammaglobin

8.11.1.8 Circulating Tumor Cells

8.11.2 Competitors

8.11.2.1 Applied Imaging

8.11.2.2 Bayer HealthCare Diagnostics/Bayer

8.11.2.3 Biomedical Diagnostics/Genesis Bioventures

8.11.2.4 Clarient/Safeguard Scientifics

8.11.2.5 Dako

8.11.2.6 Ventana Medical Systems

8.11.2.7 Vysis/Abbott Laboratories

8.11.3 Technological Advances

8.11.4 Market Analysis

8.12 Early-Stage Experimental Technologies

8.12.1 Hall Effect Imaging

8.12.2 Magnetomammography

8.12.3 Immune Cell Testing

Exhibit 8-1:    Electrical Impedance Breast Imaging Systems, Market Forecast, 2004-2009

Exhibit 8-2:    2006, Selected Thermal Breast Imaging Systems

Exhibit 8-3:    Thermal Breast Imaging Systems, Market Forecast, 2004-2009

Exhibit 8-4:    2006, Selected Optical Breast Imaging Systems

Exhibit 8-5:    Optical Breast Imaging Systems, Market Forecast, 2004-2009

Exhibit 8-6:    2006, Selected Ductal Lavage/Ductoscopy Systems

Exhibit 8-7:    Ductal Lavage/Ductoscopy Systems, Market Forecast, 2004-2009

Exhibit 8-8:    Comparison of Chromogenic In Situ Hybridization, Fluorescence In Situ Hybridization, and Immunohistochemical Testing

Exhibit 8-9:    Prognosis for Response to Hormone Therapy, by Estrogen and Progesterone Receptors Test Response

Exhibit 8-10:  2006, Selected Genetic Testing and Marker Products

Exhibit 8-11:  Breast Cancer Pharmacogenetic and Prognostic Testing Systems, Market Forecast, 2004-2009

9. COMPANY PROFILES

9.1   Acueity, Inc.

9.2   Applied Imaging Corporation

9.3   Bard Biopsy Systems, Inc./C.R. Bard, Inc.

9.4   BioLuminate, Inc.

9.5   Cytyc Corporation

9.6   DALSA Life Sciences, Inc./DALSA, Inc.

9.7   DOBI Medical International, Inc.

9.8   Ethicon Endo-Surgery, Inc./Johnson & Johnson

9.9   Fischer Imaging Corporation

9.10 GE Healthcare, Inc./General Electric Company

9.11 Imaging Diagnostic Systems, Inc.

9.12 Lifeline Biotechnologies, Inc.

9.13 Lorad Corporation/Hologic, Inc.

9.14 Matritech, Inc.

9.15 Medical Tactile, Inc.

9.16 Myriad Genetics, Inc.

9.17 OptoSonics, Inc.

9.18 Philips Medical Systems North America/Royal Philips Electronics NV

9.19 Planmed Oy/Planmeca Group

9.20 R2 Technology, Inc.

9.21 SenoRx, Inc.

9.22 Siemens Medical Solutions, Inc./Siemens AG

9.23 Toshiba America Medical Systems, Inc./Toshiba Group

APPENDIX:  COMPANY LISTING

Copyright 2006, Medtech Insight, LLC