Global Mammography Equipment Industry

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Reportbuyer.com just published a new market research report: Global Mammography Equipment Industry.

This report analyzes the worldwide markets for Mammography Equipment in Units and US$ Million by the following Product Segments: Analog Mammography Equipment, and Digital Mammography Equipment.

The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World.

Annual estimates and forecasts are provided for the period 2010 through 2018. Also, a six-year historic analysis is provided for these markets. The report also analyses the total market for Mammography Equipment by installed base for US and Rest of World.

The report profiles 27 companies including many key and niche players such as Fujifilm Corporation, GE Healthcare, Hologic, Inc., I.M.S. (Internazional Medico Scientifica) srl, Metaltronica SpA, Philips Healthcare, Planmed Oy, Siemens Healthcare, and Toshiba Medical Systems Corporation.

Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Analog Mammography I-3
Digital Mammography I-3
3D Mammography I-4

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Mammography - An Introduction II-1
Table 1: World Breast Cancer Statistics: Top 20 Countries
with Highest Breast Cancer Rates (includes corresponding
Graph/Chart) II-2
Mammography - The Gold Standard Technique in Breast Cancer
Screening II-2
Table 2: A Comparison of Breast Cancer Screening Techniques
by Sensitivity and Specificity Rates (includes corresponding
Graph/Chart) II-3
Global Market Analysis II-3
Regional Analysis II-4
Emerging Markets - The Long-term Growth Avenue for Mammography II-4
Segmental Analysis II-4
Digital Mammography Equipment: The Faster Growing Segment II-4
Analog Mammography Market to Witness Decline II-5
Key Drivers of Digital Mammography II-5
Innovations Continue to Mark the Mammography Space II-5

2. TRENDS AND ISSUES II-7
Advantages of Digital Technology Boosts Mammography Market
Prospects II-7
The DMIST Study and Uptake of 2D Mammography Systems II-7
Increasing Awareness Drives Demand for Mammography Devices in
Developed Markets II-8
Demand for FFDM Devices to Surge II-8
DR and CR Remain Popular in Emerging Markets II-8
Breast Imaging Screening Programs Push Sales of Mammography
Equipment II-9
Screening Programs: The Savior during Recession II-9
Price Hinders Faster Penetration II-9
New Technologies to Drive Mammography Market II-10
Data Compression Area Requires Further Developments II-10
Developing Regions Offer Growth Potential for Analog Systems II-10
Non-US FFDM Markets - Set to Grow II-11
Shortage of Radiologists to Obstruct Growth II-11
Flat-Panel Monitors - Add-On to DR Systems II-11
CR Mammography - A New Dimension II-11
Breast Cushions Provide Improved Image Quality & Comfort II-12
Alternative Breast Imaging Technologies: Strong Contenders for
Mammography II-12
Computer Aided Detection (CAD) in Breast Cancer - An Insight II-13
Computer Aided Detection Stimulates Growth of Mammography
Systems II-13
CAD Use Rises despite Controversies II-13
Breast CAD to Hold its Fort in the CAD Market II-13
FDA’s FFDM Reclassification to Benefit CAD Market II-14
Physicians’ Reluctance to Follow USPSTF - A Shot in the Arm
for CAD Manufacturers II-14
CAD Simplifies Breast MRI Image Analysis; Tremendous Scope
for Adoption Ahead II-14
Breast MRI - Lagging behind Mammography in Cancer Detection II-15

3. 3D MAMMOGRAPHY MARKET - AN INSIGHT II-16
Breast Tomosynthesis - the Next Generation Technology in
Digital Mammography II-16
Major Benefits of Tomosynthesis II-16
Major Drawbacks/Issues II-16
Will Tomosynthesis Emulate the Penetration Rate Trends of 2D
Digital Mammography? II-17
Initial Delays Inevitable for 3D Mammography Adoption in the US II-17
Diagnosis or Screening - Where Does the Real Opportunity Lie
for Tomosynthesis? II-17
Hologic Sponsored Trials Show Promise for 3D Mammography II-18
The Oslo Study and its Impact on Tomosynthesis Market II-18
Where Do Clinicians Recover their Investments in 3D Mammography? II-19
Product Differentiation - A Critical Factor to Ward off
Competition II-19
Table 3: A Comparison of Three Major Tomosynthesis Systems by
Projection Views, Angle of Image Acquisition and Slice
Thicknesses II-19
Hologic - Riding the Wave of Early 3D Adoption II-20

4. COMPETITIVE LANDSCAPE II-21
Consolidation: A Major Trend II-21
Table 4: Leading Players in the Worldwide Mammography
Equipment Market (2012): Percentage Breakdown of Value Sales
for GE Healthcare, Hologic, Siemens and Others (includes
corresponding Graph/Chart) II-21
Competitive Overview of the FFDM Market II-21
Table 5: Leading Players in the Global FFDM Systems Market
(2012): Percentage Breakdown of Revenues for Hologic, GE,
Siemens and Others (includes corresponding Graph/Chart) II-22
Entry-Level Mammography System to Surge Hologic’s
International Sales II-22
Hologic’s Analog Systems - Targeting Price-Sensitive Markets II-22

5. MAMMOGRAPHY - AN OVERVIEW II-23
Mammography - Facts & Figures II-23
Uses of Mammography II-24
Risk Associated with Mammography II-24
Mammograms and HRT II-24
Uncertainty of Test Accuracy II-24
Types of Mammography II-24
Screening Mammogram II-24
Diagnostic Mammography II-25
Types of Mammography Equipment based on Technology II-25
Analog Mammography II-25
Screening Systems II-25
World Analog X-Ray Mammography Market: Select Screening
Products Offered by Major Players: GE Healthcare, Hologic,
GE/Instrumentarium Imaging, Planmed, Siemens Healthcare
and Toshiba Medical II-26
Analog Stereotactic-Interventional Add-Ons II-26
Digital Mammography II-26
Computer Aided Detection (CAD) II-27
Full-Field Digital Mammography II-27
Small-Field Digital Mammography II-27
Digital Diagnostic Systems II-27
Analog Vs. Digital Mammography II-27
Factors in Favor of and Against Digital Mammography II-28
Growth Boosters for Digital Mammography Equipment II-29
Systems in Use II-29
FFDM Systems of Major Manufacturers II-29
Mobile Mammography Systems II-30
Determination of Abnormalities Using Mammography II-30
Xeromammography II-30
Telemammography II-30
Ductography II-31

6. COMPLEMENTARY CANCER DIAGNOSTIC TECHNOLOGIES II-32
Computer Assisted Detection (CAD) Mammography II-32
How Does CAD Work? II-32
Microwave Radiometry II-32
Benefits of Microwave Radiometry II-32
Breastscan II-33
Digital Infrared Imaging/Breast Thermography II-33
Digital Infrared Imaging Vs. Mammography II-33
DII Not a Replacement for Mammography II-33
Diaphanography II-34
Magnetic Resonance Imaging (MRI) II-34
Breast MRI Gaining Popularity as a Diagnostic Tool II-34
Ultrasound II-35
Ultrasound Vs. Mammography II-35
Limitations of Ultrasound II-35
Computed Tomography Laser Mammography (CTLM) II-35
T-Scan Technology II-35
Nuclear Medicine Breast Imaging (Scintimammography) II-35
Cases where Nuclear Medicine is Useful II-36
Functional Imaging II-36
Biologic-based Technologies II-36
Bioelectric Imaging II-37
Contrast-Enhanced Mammography II-37
Tomosynthesis and 3D Imaging II-37
New Technology to Replace Mammography II-37
Thermal Imaging II-37

7. BREAST CANCER - A BACKDROP II-38
Stages in Breast Cancer II-38
Table 6: Breast Cancer Survival Rate by Stages (includes
corresponding Graph/Chart) II-38
Classification of Various Cancer Stages II-38
T: Tumor Size II-38
N: Palpable Nodes II-39
M: Metastasis II-39
Factors Affecting Breast Cancer II-39

8. CANCER STATISTICS - A REVIEW II-40
Rising Incidence of Cancer - A Major Market Driver II-40
Cancer Prone Sites based on Age II-40
World Cancer Statistics - Incidence and Mortality Data II-40
Table 7: World Cancer Incidence by Geographic Region and
Gender (2012): Number of New Cancer Cases Reported in
Thousands for Asia-Oceania, Europe, North America, Latin
America & the Caribbean, and Africa (includes corresponding
Graph/Chart) II-40

Table 8: World Cancer Mortality by Geographic Region and
Gender (2012): Number of Cancer-Related Deaths in Thousands
for Asia-Oceania, Europe, North America, Latin America & the
Caribbean, and Africa (includes corresponding Graph/Chart) II-41

Table 9: Global Incidence of Common Cancers in Men (2012):
Number of New Cases Reported in Thousands for Lung &
Bronchus, Prostate, Colorectal and Liver Cancers (includes
corresponding Graph/Chart) II-41

Table 10: Global Incidence of Common Cancers in Women (2012):
Number of New Cases Reported in Thousands for Breast,
Colorectal, Lung & Bronchus and Liver Cancers (includes
corresponding Graph/Chart) II-42

Table 11: Global Cancer Mortality in Men for Select Cancers
(2012): Number of Deaths in Thousands for Lung & Bronchus,
Liver, Colorectal and Prostate Cancers (includes
corresponding Graph/Chart) II-42

Table 12: Global Cancer Mortality in Women for Select Cancers
(2012): Number of Deaths in Thousands for Breast, Lung &
Bronchus, Colorectal and Liver (includes corresponding
Graph/Chart) II-42

9. PRODUCT INTRODUCTIONS/APPROVALS II-43
Philips Receives 510(k) Approval for MicroDose SI Mammography
System II-43
iCAD Obtains FDA Approval for PowerLook Advanced Mammography
Platform™ II-43
Hologic Secures FDA Approval for C-View 2D Imaging Software II-43
Giotto Secures 510(k) Approval for Giotto Digital Mammography
Systems II-43
Medi-Future Receives SFDA Approval for Bresitge Digital
Mammography System II-44
Fujifilm Introduces Aspire CRm Full Field Digital Mammography
System II-44
Philips and Smit Mobile to Launch MicroDose in Middle East II-44
Agfa HealthCare Receives US FDA Approval for DX-M Digitizer II-45
Vucomp Receives Premarket Approval for M-Vu Computer-Aided
Detection System II-45
Russia Approves Low-Dose Digital Mammography System from Sectra II-45
GE Receives US FDA Approval for SenoBright Spectral
Mammography Device II-45
Philips Launches MicroDose Mammography Device in North America II-45
Barco Unveils Mammo Tomosynthesis 5 MP, Display System for
Digital Breast Imaging II-46
Carestream Launches Advanced Version of MIN-R 2000 Mammography
Film II-46
Sectra Imtec Receives FDA Approval for MicroDose Mammography
L30 Unit II-46
Carestream Health Obtains FDA Approval for CR System for
Mammography II-46
iCAD Obtains FDA Approval for SecondLook Digital CAD Technology II-47
Naviscan Introduces its PEM Scanner in Europe II-47
Konica Minolta Launches Nano HQ for Single Bay CR II-47
Imaging Diagnostic Systems Secures Inclusion Approval for
Marketing of CT Laser Mammography System II-48
Hologic Obtains US FDA Approvable Letter for Selenia
Dimensions 3D Digital Mammography Tomosynthesis System II-48
Siemens Introduces Mammomat Inspiration Digital Mammography
System in US II-48
GE Launches SenoBright Contrast Enhanced Spectral Mammography
Technology II-49
Southern Medical Clinic Unveils ADM Equipment II-49

10. RECENT INDUSTRY ACTIVITY II-50
Fischer Secures Distribution Rights to Giotto Digital
Mammography Systems II-50
Hologic Unveils 3D Mammography Mobile Coach Tour II-50
Planmed Oy Passes EUREF Type Test for Planmed Nuance™ Excel II-50
GE Healthcare Takes Over U-Systems II-51
Imaging Diagnostic Systems Demonstrates Positive Clinical
Results of CTLM® II-51
ACR Receives FDA Approval to Accredit Siemens Mammomat
Inspiration II-51
Philips Takes Over Mammography-Modality Operation of Sectra II-51
Naviscan and Chindex Collaborate for Marketing PEM Tool in
China and Hong Kong II-52
Sectra Secures Order of Digital Mammography Systems from
Trillium Imaging II-52
Hologic Receives EUREF Certification for 2D Selenia
Mammography System II-52
Imaging Diagnostic Selects Ultra-X for CT Laser Mammography
System Distribution in Brazil II-53
South Shore Health Inaugurates Digital Mammography Facility II-53
Fairfield Medical Center Initiates Operations at New
Mammography Suite II-53
Myriad Genetics Inks Agreement with Mammography Reporting Systems II-53
Sectra and Xtron Imaging Ink Distribution Agreement II-54
Mikron Digital to Distribute Aspire Digital Mammography
Equipment of FUJIFILM II-54

11. FOCUS ON SELECT PLAYERS II-55
Fujifilm Corporation (Japan) II-55
GE Healthcare (US) II-55
Hologic, Inc. (US) II-56
I.M.S. (Internazional Medico Scientifica) srl (Italy) II-57
Metaltronica SpA (Italy) II-58
Philips Healthcare (The Netherlands) II-59
Planmed Oy (Finland) II-60
Siemens Healthcare (Germany) II-60
Toshiba Medical Systems Corp. (Japan) II-61

12. GLOBAL MARKET PERSPECTIVE II-62
Installed Base II-62

Table 13: World Recent Past, Current and Future Analysis for
Mammography Equipment by Geographic Region - US and Rest of
World Markets Independently Analyzed with Installed Base
Figures in Units for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-62

Table 14: World 9-Year Perspective for Mammography Equipment
by Geographic Region - Percentage Breakdown of Installed Base
Figures for US and Rest of World Markets for Years 2010, 2013
and 2018 (includes corresponding Graph/Chart) II-63

Table 15: World Recent Past, Current and Future Analysis for
Analog Mammography Equipment by Geographic Region - US and
Rest of World Markets Independently Analyzed with Installed
Base Figures in Units for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-64

Table 16: World 9-Year Perspective for Analog Mammography
Equipment by Geographic Region - Percentage Breakdown of
Installed Base Figures for US and Rest of World Markets for
Years 2010, 2013 and 2018 (includes corresponding
Graph/Chart) II-65

Table 17: World Recent Past, Current and Future Analysis for
Digital Mammography Equipment by Geographic Region - US and
Rest of World Markets Independently Analyzed with Installed
Base Figures in Units for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-66

Table 18: World 9-Year Perspective for Digital Mammography
Equipment by Geographic Region - Percentage Breakdown of
Installed Base Figures for US and Rest of World Markets for
Years 2010, 2013 and 2018 (includes corresponding
Graph/Chart) II-67
Volume Analytics II-68

Table 19: World Recent Past, Current & Future Analysis for
Mammography Equipment by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan) and Rest of
World Markets Independently Analyzed with Annual Sales
Figures in Units for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-68

Table 20: World Historic Review for Mammography Equipment by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan) and Rest of World Markets Independently
Analyzed with Annual Sales Figures in Units for Years 2004
through 2009 (includes corresponding Graph/Chart) II-69

Table 21: World 15-Year Perspective for Mammography Equipment
by Geographic Region - Percentage Breakdown of Unit Sales for
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
and Rest of World Markets for Years 2004, 2013 & 2018
(includes corresponding Graph/Chart) II-70
Volume Analytics by Segment II-71

Table 22: World Recent Past, Current & Future Analysis for
Analog Mammography Equipment by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific (excluding Japan) and
Rest of World Markets Independently Analyzed with Annual
Sales Figures in Units for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-71

Table 23: World Historic Review for Analog Mammography
Equipment by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan) and Rest of World Markets
Independently Analyzed with Annual Sales Figures in Units
for Years 2004 through 2009 (includes corresponding
Graph/Chart) II-72

Table 24: World 15-Year Perspective for Analog Mammography
Equipment by Geographic Region - Percentage Breakdown of
Unit Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Rest of World Markets for Years 2004,
2013 & 2018 (includes corresponding Graph/Chart) II-73

Table 25: World Recent Past, Current & Future Analysis for
Digital Mammography Equipment by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific (excluding Japan) and
Rest of World Markets Independently Analyzed with Annual
Sales Figures in Units for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-74

Table 26: World Historic Review for Digital Mammography
Equipment by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan) and Rest of World Markets
Independently Analyzed with Annual Sales Figures in Units
for Years 2004 through 2009 (includes corresponding
Graph/Chart) II-75

Table 27: World 15-Year Perspective for Digital Mammography
Equipment by Geographic Region - Percentage Breakdown of
Unit Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Rest of World Markets for Years 2004,
2013 & 2018 (includes corresponding Graph/Chart) II-76
Dollar Analytics II-77

Table 28: World Recent Past, Current & Future Analysis for
Mammography Equipment by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), and Rest of
World Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-77

Table 29: World Historic Review for Mammography Equipment by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Rest of World Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2004 through 2009 (includes corresponding Graph/Chart) II-78

Table 30: World 15-Year Perspective for Mammography Equipment
by Geographic Region - Percentage Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), and Rest of World Markets for Years 2004, 2013 & 2018
(includes corresponding Graph/Chart) II-79
Dollar Analytics by Segment II-80

Table 31: World Recent Past, Current & Future Analysis for
Analog Mammography Equipment by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific (excluding Japan), and
Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Thousand for Years 2010 through 2018
(includes corresponding Graph/Chart) II-80

Table 32: World Historic Review for Analog Mammography
Equipment by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Thousand for Years 2004 through 2009 (includes corresponding
Graph/Chart) II-81

Table 33: World 15-Year Perspective for Analog Mammography
Equipment by Geographic Region - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Rest of World Markets for Years 2004,
2013 & 2018 (includes corresponding Graph/Chart) II-82

Table 34: World Recent Past, Current & Future Analysis for
Digital Mammography Equipment by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific (excluding Japan), and
Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Thousand for Years 2010 through 2018
(includes corresponding Graph/Chart) II-83

Table 35: World Historic Review for Digital Mammography
Equipment by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Thousand for Years 2004 through 2009 (includes corresponding
Graph/Chart) II-84

Table 36: World 15-Year Perspective for Digital Mammography
Equipment by Geographic Region - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Rest of World Markets for Years 2004,
2013 & 2018 (includes corresponding Graph/Chart) II-85

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current & Future Analysis III-1
The Mammography Market Opportunity III-1
Analog Screening Mammography Market III-1
Digital Mammography Equipment Market III-2
New Laws Likely to Encourage Adoption of Alternative Imaging
Technologies III-2
Industry Eyes Replacement Demand as Penetration Reaches All
-time High for 2D Mammo III-3
The Case for Transition to Tomosynthesis III-3
Sensitivity Benefits to Drive Interest Among Physicians III-3
Hurdles Exist for Widespread Adoption of Tomosynthesis III-4
Investments on Capital Equipment Remains a Constraint III-4
Healthcare Providers Keen on Uptake of 3D Systems despite
Issues III-4
Reimbursement - A Hurdle for 3D Mammography III-5
Oslo Study Results - A Short in the Arm for 3D Tomo Mammography III-5
Decline in Breast Imaging Facilities - A Dent in Market
Prospects III-5
Rising Incidence of Cancer III-6
Breast Cancer - the Most Common Form of Cancer in Women III-6
Key Statistics III-7

Table 37: Cancer Incidence in US Women by Site (2013):
Breakdown of Number of New Cases for Breast, Lung &
Bronchus, Colorectal, Uterine Corpus, Thyroid and Others
(includes corresponding Graph/Chart) III-7

Table 38: Cancer Mortality in US Women by Site (2013):
Breakdown of Number of Deaths for Lung & Bronchus, Breast,
Colorectal, Pancreas, Ovary and Others (includes
corresponding Graph/Chart) III-7

Table 39: US Breast Cancer Incidence in Women by State
(2013): New Cases of Breast Cancer in Leading 15 States
(includes corresponding Graph/Chart) III-8

Table 40: Risk Assessment of Breast Cancer in US Women by
Age Group Analyzed in terms of Probability of Developing
Invasive Breast Cancer and Incidence Rate: 2013 (includes
corresponding Graph/Chart) III-8
Mammography Accreditations in the US III-9

Table 41: US Mammography Market: Total MQSA-Certified
Mammography Facilities and Certified Facilities with FFDM
Units in the US for Years 2009-2013 (includes corresponding
Graph/Chart) III-9
Regulations on Mammography Screening III-9
From Class III Devices to Class II Devices - the Journey
of Regulations Covering Digital Mammography Systems III-10
An Insight into Regulations on Mammography III-10
Will New FDA Guidance Open Up Digital Mammography Market
Place? III-11
Regulatory Requirements III-11
Reimbursement for Mammography III-12

Table 42: Medicare Reimbursement Codes and Allowable Rates
for Technical Component of Film

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For more information:
Sarah Smith
Research Advisor at Reportbuyer.com
Email: query@reporbuyer.com
Tel: +44 208 816 85 48
Website: http://www.reportbuyer.com

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