Breast Cancer Imaging
South America Analysis and Market Forecasts
GDME1036CFR / Published May 2013
Executive Summary
Breast Cancer Imaging: Key Metrics in South American*
markets
2011 Market Sales
Brazil
$42m
Key Features of the Report
Number of imaging techniques covered
17
Number of marketed products analyzed
51
Competitors profiled
17
Key Events (2011–2018)
Level of
Impact
Results of the Oslo Breast Cancer Screening Trial
↑↑↑↑
Results of the TOMMY trial
↑↑↑↑
Food and Drug Administration (FDA) approval of GE
Healthcare and Siemens Healthcare tomosynthesis
systems
↑↑
GlobalData calculated the South American (Brazil) breast
cancer imaging market to be worth $42m in 2011 and
estimates that it will be worth $71m in 2018, increasing at
a Compound Annual Growth Rate (CAGR) of 8% during
this time period.
The key drivers for the South American breast cancer
imaging market are:

Increase in the incidence of breast cancer

Increased awareness of the benefits of screening

Increased breast cancer incidence due to an aging
population
2018 Market Sales
Brazil
Source: GlobalData, 2013
$71m

FDA reclassification of mammography equipment

New technologies to drive growth in the market

Adoption of digital mammography units in South
South America = Brazil breast cancer imaging market
America
The key barriers for the South American breast cancer
imaging market are:

A shortage of dedicated breast radiologists

High
capital
Investment
for
full-field
digital
mammography (FFDM) and tomosynthesis in the
face of reduced hospital budgets
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
Refurbished equipment sales

Reimbursement issues
GDME1036CFR / Published MAY 2013
Executive Summary
Significant Unmet Needs and Challenges for the
In Brazil, FFDM systemswill continue to grow rapidly with
South American Breast Cancer Imaging Market
a
Even though the South American breast cancer imaging
market is a mature one, it has significant needs that still
have not been met. Some of these include exposure to
ionizing radiation during mammographic examinations,
patient discomfort due to compression of the breasts,
unreliable mammograms in breasts that have been
operated on and breasts with implants, a high number of
modest
uptake
in
tomosynthesis,
since
digital
mammography has yet to be widely adopted in these
regions and the breast cancer incidence is rising steadily.
What do Physicians Think?
Radiologists feel that mammography is not an ideal tool
for breast screening and there are significant unmet
needs.
of
‘’Mammography is a useful tool, but it’s a bad technique.’’
mammography sensitivity in dense breasts, and limited
Key Opinion Leader, January 2013
false-positives
training
and
provided
to
false-negatives,
technicians
by
loss
equipment
manufacturers. A few of these unmet needs are being
addressed to a certain extent by using modalities such as
ultrasound imaging and magnetic resonance imaging
‘’The
biggest
challenge
[is]
to
have…
patient
comfort…[during]…mammography, that’s number one, I
think’’
(MRI) in conjunction with mammography. However, there
Key Opinion Leader, January 2013
is a still a lot of room for improvement within the market,
Radiologists feel strongly that tomosynthesis is very
and new technologies currently in development that
promising
overcome these drawbacks show promise for the future.
mammography, the current paradigm.
Future Landscape
‘’Mammography is a useful tool, but it’s a bad technique.’’
and
will
The South American breast cancer imaging market is
primarily driven by the increasing incidence of breast
cancer. It is also fueled by the need to overcome the
drawbacks posed by film – screen mammography, which
is the most widely used technique for breast cancer
most
likely
replace
digital
Key Opinion Leader, January 2013
‘’I think there is space for everything...but the word is
digital, the word is 3D….[The] breast is a 3D organ. Why
should we look at [it] in 2D images?”
detection and diagnosis in this region. GlobalData
Key Opinion Leader, January 2013
anticipates that newer technologies, such as digital
‘’If it’s [tomosynthesis] going to find more cancers and
mammography and tomosynthesis, will drive the future
fewer recalls, then it should be a win-win.’’
growth of this market. Tomosynthesis is predicted to be
Key Opinion Leader, December 2012
the new gold standard in the near future, with high
adoption is western countries, including the US, due to its
‘’I’ll tell you today that I am 95% sure that tomosynthesis
promising increase in cancer detection and reduction of
is
false-positives,
mammography is gone.’’
which
are
key
mammography.
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concerns
with
mammography’s
future
and
conventional
Key Opinion Leader, January 2013
GDME1036CFR / Published MAY 2013
Executive Summary
‘’If I have to put money in something, I will put it in
Radiologists feel that there is not enough commitment
tomosynthesis and MRI [in the] short term [and in the]
from the manufacturers towards technician training.
long term, maybe….. molecular imaging techniques.’’
‘’A banker can buy a machine much faster than anyone
Key Opinion Leader, January 2013
Radiologists feel that the impact of tomosynthesis
out there, right? But I mean the banker cannot get a good
image.’’
compared with digital mammography is much greater in
Key Opinion Leader, January 2013
comparison to the change from analog to digital
‘’Training is needed because if the technician has not
mammography.
given good positioning, whatever good factors may be
‘’The change from analog to digital mammography [in the
there, good equipment may be there, you won’t be able
US], went so fast, so quickly.…amazing, now almost 90%
to see things.’’
[adoption]....If you look at the FDA site…90% [adoption], I
Key Opinion Leader, December 2012
mean it is incredible. So, what my way of thought is, I
say, look if from analog to digital , it was not such a big
Radiologists feel that in the future, they foresee more
deal, by that I mean it was the same technology, only
emphasis being placed on lowering radiation dose.
digital The difference was not so big [so only small
“[On future market trends] there is going to be more
improvement]…, like it is from mammography to
emphasis on low [radiation] dose, understanding breast
tomosynthesis. You are talking about [image] slices; you
density, and being efficient…doing more with less.’’
are talking about 3D [imaging] [so large improvement]….I
think,
the
gain
between
digital
[2D FFDM]
Key Opinion Leader, December 2012
and
tomo[synthesis] is much, much, much higher than it was
’If there is a good product which does good imaging and
from analog to digital.’
it has low [radiation] dose and it’s reliable, then it may be
of value.’’
Key Opinion Leader, January 2013
Key Opinion Leader, December 2012
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GDME1036CFR / Published MAY 2013
Table of Contents
1
Table of Contents
1 Table of Contents ............................................................................................................... 5
1.1
List of Tables .......................................................................................................... 13
1.2
List of Figures ......................................................................................................... 18
2 Introduction....................................................................................................................... 21
2.1
Catalyst .................................................................................................................. 21
3 Disease Overview ............................................................................................................. 22
3.1
Anatomy & Physiology of the Breast ....................................................................... 22
3.2
Pathophysiology of Breast Cancer .......................................................................... 23
3.3
Detection of Breast Cancer ..................................................................................... 23
3.4
Types of Breast Cancer .......................................................................................... 24
3.5
Clinical Presentation ............................................................................................... 26
3.6
Clinical Outcomes ................................................................................................... 27
3.6.1 Assessment Procedure ....................................................................................... 27
3.6.2 Screening Guidelines .......................................................................................... 30
3.7
Epidemiology of Breast Cancer ............................................................................... 31
3.8
Economic Impact of Breast Cancer Imaging ............................................................ 33
4 Imaging Techniques.......................................................................................................... 34
4.1
Mammography........................................................................................................ 34
4.1.1 Overview............................................................................................................. 34
4.1.2 Types of Mammography...................................................................................... 36
4.2
Non-Mammographic Techniques ............................................................................ 41
4.2.1 Breast Ultrasound Imaging .................................................................................. 41
4.2.2 Breast Magnetic Resonance Imaging .................................................................. 42
4.3
Comparison of Mammography, Ultrasound, and MRI .............................................. 43
4.4
Alternative Breast Imaging Techniques ................................................................... 44
4.4.1 Nuclear Imaging Techniques ............................................................................... 45
4.4.2 Computed Tomography....................................................................................... 46
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Table of Contents
4.4.3 Optical Breast Imaging ........................................................................................ 47
4.4.4 Electric Impedance-Based Techniques................................................................ 47
4.4.5 Thermography .................................................................................................... 48
4.4.6 Elastography ....................................................................................................... 48
4.4.7 Ductogram .......................................................................................................... 48
5 Competitive Assessment................................................................................................... 49
5.1
Overview ................................................................................................................ 49
5.2
Film Screen Mammography .................................................................................... 50
5.2.1 Performa (GE Healthcare)................................................................................... 50
5.2.2 Alpha RT/Alpha ST (GE Healthcare) ................................................................... 53
5.2.3 MAMMOMAT 1000 (Siemens Healthcare) ........................................................... 56
5.2.4 MAMMOMAT 3000 Nova (Siemens Healthcare).................................................. 58
5.2.5 M-IV/M-IV Platinum (Hologic) .............................................................................. 60
5.2.6 MammoDiagnost (Philips Healthcare).................................................................. 62
5.2.7 Planmed Nuance Classic (Planmed) ................................................................... 64
5.2.8 Planmed Sophie Classic (Planmed) .................................................................... 66
5.2.9 Analog Giotto Image (Internazionale Medico Scientifica) ..................................... 68
5.2.10 HAWK-2M (Hologic) ............................................................................................ 70
5.2.11 MGU-1000A (Toshiba Medical Systems) ............................................................. 72
5.3
CR Mammography.................................................................................................. 74
5.3.1 Fuji Computed Radiography Mammography Suite (FCRMS) (Fujifilm Medical
Systems) ........................................................................................................... 74
5.3.2 KODAK DirectView (Carestream Health) ............................................................. 77
5.3.3 Xpress CR System (Konica Minolta).................................................................... 79
5.3.4 REGIUS PureView (Konica Minolta) .................................................................... 81
5.3.5 Agfa CR Mammography Systems (DX-M, CR 30-Xm, and CR 85-X) (Agfa
Healthcare) ........................................................................................................ 83
5.4
Full-Field Digital Mammography .............................................................................. 85
5.4.1 Selenia Dimensions (Hologic).............................................................................. 86
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Table of Contents
5.4.2 Selenia (Hologic)................................................................................................. 89
5.4.3 Selenia S (Hologic) ............................................................................................. 91
5.4.4 Selenia Performance (Hologic) ............................................................................ 93
5.4.5 Senographe DS (GE Healthcare) ........................................................................ 95
5.4.6 Senographe Essential (GE Healthcare) ............................................................... 97
5.4.7 Senographe Care (GE Healthcare).................................................................... 100
5.4.8 SenoBright CESM (GE Healthcare) ................................................................... 102
5.4.9 MAMMOMAT Inspiration (Siemens Healthcare)................................................. 104
5.4.10 Aspire HD (US)/Amulet (Outside the US) (Fujifilm) ............................................ 106
5.4.11 MammoDiagnost DR (Philips Healthcare).......................................................... 108
5.4.12 MicroDose (Philips Healthcare) ......................................................................... 110
5.4.13 Giotto Image 3D/3DL (Internazionale Medico Scientifica) .................................. 112
5.4.14 Planmed Nuance/Nuance Excel (Planmed) ....................................................... 114
5.4.15 Fairy DR (Allengers Medical Systems) .............................................................. 116
5.4.16 Serenity ............................................................................................................ 118
5.5
3D Mammography ................................................................................................ 120
5.5.1 Selenia Dimensions 3D System (Hologic).......................................................... 120
5.5.2 GE Breast Tomosynthesis (GE Healthcare) ....................................................... 122
5.5.3 True 3D Breast Tomosynthesis (Siemens Healthcare)....................................... 124
5.5.4 Giotto Tomo (Internazionale Medico Scientifica) ................................................ 126
5.5.5 FUJIFILM 3Dimensional Mammography (Fujifilm) ............................................. 128
5.6
Breast Ultrasound Imaging.................................................................................... 130
5.6.1 somo.v Automated Breast Ultrasound (ABUS) (GE Healthcare)......................... 130
5.6.2 SonoCine AWBUS (SonoCine).......................................................................... 132
5.6.3 ACUSON S2000 ABVS (Siemens Healthcare) .................................................. 134
5.6.4 Terason t3200 Ultrasound System Breast Series (Terason Ultrasound) ............. 136
5.7
Breast MRI ........................................................................................................... 138
5.7.1 Aurora 1.5T Dedicated Breast MRI System (Aurora Imaging Technology) ......... 138
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Table of Contents
5.8
Other Breast Imaging Techniques ......................................................................... 140
5.8.1 PEM Flex Solo II (Naviscan).............................................................................. 140
5.8.2 Computerized Tomography Laser Mammography (CTLM) Model 1020 (Imaging
Diagnostic Systems) ........................................................................................ 142
5.8.3 Dilon 6800/Dilon 6800 Acella (Dilon Diagnostics) .............................................. 144
5.8.4 LumaGEM (Gamma Medica)............................................................................. 146
5.8.5 Discovery NM 750b (GE Healthcare)................................................................. 148
6 Unmet Needs.................................................................................................................. 150
6.1
Lower Radiation Dose........................................................................................... 150
6.2
Increase Patient Comfort ...................................................................................... 152
6.3
Reduce False-Positives and False-Negatives........................................................ 154
6.4
Loss of Sensitivity of Mammography in Dense Breasts.......................................... 156
6.5
Unreliable Mammograms in Surgically-Operated Breasts and Breasts with Implants
158
6.6
Commitment to Training ........................................................................................ 159
7 Pipeline Products ............................................................................................................ 162
7.1
Breast Cancer Imaging Pipeline Products Overview .............................................. 162
7.2
MAMMOMAT Inspiration PRIME Edition ............................................................... 163
7.2.1 Overview........................................................................................................... 163
7.2.2 SWOT Analysis................................................................................................. 163
7.3
MicroDose SI ........................................................................................................ 164
7.3.1 Overview........................................................................................................... 164
7.3.2 SWOT Analysis................................................................................................. 164
7.4
Selenia Dimensions 2D Contrast-Enhanced Digital Mammography (CEDM).......... 165
7.4.1 Overview........................................................................................................... 165
7.4.2 SWOT Analysis................................................................................................. 165
7.5
SenoCase............................................................................................................. 166
7.5.1 Overview........................................................................................................... 166
7.5.2 SWOT Analysis................................................................................................. 167
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Table of Contents
7.6
Electrical Mammogram ......................................................................................... 168
7.6.1 Overview........................................................................................................... 168
7.6.2 SWOT Analysis................................................................................................. 168
8 Industry Overview ........................................................................................................... 169
8.1
Purchasing Cycle .................................................................................................. 169
8.1.1 Product Life Cycle ............................................................................................. 169
8.1.2 Cost Effectiveness in Screening Settings........................................................... 171
8.1.3 Cost-Effectiveness in Diagnostic Settings .......................................................... 171
8.2
Market Access ...................................................................................................... 172
8.2.1 Purchasing Decisions........................................................................................ 172
8.2.2 Regulatory Process ........................................................................................... 172
8.3
Quality Assurance ................................................................................................. 173
8.4
Adoption of New Technologies.............................................................................. 174
8.4.1 Influence of Clinical Trials Results ..................................................................... 174
8.4.2 Reimbursement................................................................................................. 175
8.4.3 Economic Resources ........................................................................................ 175
8.4.4 Competitive Advantage ..................................................................................... 176
8.5
Current Reimbursement Trends ............................................................................ 176
8.6
Trends in Detector Technology for Digital Mammography...................................... 177
8.7
Evolving Scatter-Removal Mechanisms ................................................................ 181
8.8
Overdiagnosis....................................................................................................... 183
8.9
Malpractice Litigations .......................................................................................... 184
8.10 Mergers and Acquisitions/Key Partnerships .......................................................... 185
8.10.1 GE Healthcare Acquires U-Systems .................................................................. 185
8.10.2 Koninklijke Philips Electronics Acquires MicroDose Mammography from Sectra 185
8.10.3 Hologic Acquires Beijing Healthcome Technology ............................................. 185
8.10.4 Hologic Acquires Sentinelle Medical .................................................................. 185
8.10.5 Koninklijke Philips Electronics Acquires Shanghai Apex Electronics Technology186
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Table of Contents
8.10.6 Fujifilm Medical Systems acquired FUJIFILM-RU .............................................. 186
8.10.7 Other Key Events .............................................................................................. 186
9 Current and Future Players ............................................................................................. 187
9.1
Overview .............................................................................................................. 187
9.2
Trends in Corporate Strategy ................................................................................ 188
9.3
Company Profiles ................................................................................................. 189
9.3.1 GE Healthcare .................................................................................................. 189
9.3.2 Hologic ............................................................................................................. 191
9.3.3 Siemens............................................................................................................ 193
9.3.4 Koninklijke Philips Electronics ........................................................................... 194
9.3.5 Fujifilm Medical Systems ................................................................................... 196
9.3.6 Internazionale Medico Scientifica (IMS) ............................................................. 197
9.3.7 Planmed ........................................................................................................... 198
9.3.8 Konica Minolta Medical Imaging ........................................................................ 199
9.3.9 Agfa Healthcare ................................................................................................ 200
9.3.10 Carestream Health ............................................................................................ 201
9.3.11 SonoCine .......................................................................................................... 202
9.3.12 Aurora Imaging Technology .............................................................................. 203
9.3.13 Imaging Diagnostic Systems ............................................................................. 204
9.3.14 Naviscan ........................................................................................................... 206
9.3.15 Dilon Diagnostics .............................................................................................. 207
9.3.16 Gamma Medica................................................................................................. 208
9.3.17 Allengers Medical Systems ............................................................................... 209
10 Market Drivers & Opportunities ....................................................................................... 210
10.1 Market Drivers ...................................................................................................... 210
10.1.1 Increase in the Incidence of Breast Cancer ....................................................... 210
10.1.2 Increased Awareness of the Benefits of Screening ............................................ 210
10.1.3 Increased Breast Cancer Incidence Due to an Aging Population........................ 210
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Table of Contents
10.1.4 FDA Reclassification of Mammography Equipment ........................................... 211
10.1.5 New Technologies to Drive Market Growth ........................................................ 211
10.1.6 Adoption of Digital Mammography Units in South America ................................ 212
10.2 Opportunities ........................................................................................................ 215
10.2.1 Emerging Economies Promise Future Growth ................................................... 215
10.2.2 Invest in Emerging Technologies....................................................................... 216
10.2.3 Product Improvement ........................................................................................ 217
10.3 Market Barriers ..................................................................................................... 218
10.3.1 Shortage of Dedicated Mammography Professionals......................................... 218
10.3.2 Reduced Hospital Budgets ................................................................................ 218
10.3.3 Refurbished Equipment Sales ........................................................................... 219
10.3.4 Reimbursement................................................................................................. 220
10.3.5 Substitutes ........................................................................................................ 220
11 Country Outlooks & Forecasts ........................................................................................ 221
11.1 Brazil .................................................................................................................... 221
11.1.1 Brazil Market Analysis ....................................................................................... 221
12 Appendix ........................................................................................................................ 222
12.1 Bibliography.......................................................................................................... 222
12.2 Abbreviations ........................................................................................................ 248
12.3 Report Methodology.............................................................................................. 253
12.3.1 Overview........................................................................................................... 253
12.3.2 Coverage .......................................................................................................... 253
12.3.3 Secondary Research ......................................................................................... 253
12.3.4 Forecast Methodology....................................................................................... 254
12.4 Physicians and Specialists Included in this Study .................................................. 255
12.5 Primary Research ................................................................................................. 256
12.6 Physician Survey .................................................................................................. 256
12.7 About the Authors ................................................................................................. 257
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Table of Contents
12.7.1 Analysts ............................................................................................................ 257
12.7.2 Global Head of Healthcare ................................................................................ 258
12.8 Definitions............................................................................................................. 259
12.9 About MediPoint ................................................................................................... 260
12.10 About GlobalData ................................................................................................. 260
12.11 Contact Us............................................................................................................ 260
12.12 Disclaimer............................................................................................................. 261
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Table of Contents
1.1
List of Tables
Table 1:
Breast Cancer Types, Including Diagnostic Procedures....................................... 25
Table 2:
ACR Breast Imaging Reporting and Database System (BI-RADS) ....................... 27
Table 3:
Breast Cancer Incidence Rates in Brazil, 2002 .................................................... 31
Table 4:
Comparison of Mammography, Ultrasound, and MRI for Breast Imaging ............. 43
Table 5:
Performa Product Profile ..................................................................................... 51
Table 6:
Performa SWOT Analysis ................................................................................... 52
Table 7:
Alpha RT/Alpha ST Product Profile...................................................................... 54
Table 8:
Alpha RT/Alpha ST SWOT Analysis .................................................................... 55
Table 9:
MAMMOMAT 1000 Product Profile...................................................................... 56
Table 10:
MAMMOMAT 1000 SWOT Analysis .................................................................... 57
Table 11:
MAMMOMAT 3000 Nova Product Profile............................................................. 59
Table 12:
MAMMOMAT 3000 Nova SWOT Analysis ........................................................... 59
Table 13:
M-IV/M-IV Platinum Product Profile ..................................................................... 61
Table 14:
M-IV/M-IV Platinum SWOT Analysis.................................................................... 61
Table 15:
MammoDiagnost Product Profile ......................................................................... 63
Table 16:
MammoDiagnost SWOT Analysis........................................................................ 63
Table 17:
Planmed Nuance Classic Product Profile............................................................. 65
Table 18:
Planmed Nuance Classic SWOT Analysis ........................................................... 65
Table 19:
Planmed Sophie Classic Product Profile.............................................................. 66
Table 20:
Planmed Sophie Classic SWOT Analysis ............................................................ 67
Table 21:
Analog Giotto Image Product Profile.................................................................... 69
Table 22:
Analog Giotto Image SWOT Analysis .................................................................. 69
Table 23:
HAWK-2M Product Profile .................................................................................. 71
Table 24:
HAWK-2M SWOT Analysis ................................................................................. 71
Table 25:
MGU-1000A Product Profile ............................................................................... 72
Table 26:
MGU-1000A SWOT Analysis .............................................................................. 73
Table 27:
Fuji Computed Radiography Mammography Suite (FCRMS) Product Profile ....... 75
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Table of Contents
Table 28:
Fuji Computed Radiography Mammography Suite (FCRMS) SWOT Analysis ..... 76
Table 29:
KODAK DirectView CR System Product Profile ................................................... 78
Table 30:
KODAK DirectView CR System SWOT Analysis.................................................. 78
Table 31:
Xpress CR System Product Profile ...................................................................... 79
Table 32:
Xpress CR System SWOT Analysis .................................................................... 80
Table 33:
REGIUS PureView Product Profile ...................................................................... 82
Table 34:
REGIUS PureView SWOT Analysis..................................................................... 82
Table 35:
Agfa CR Mammography Systems (DX-M, CR 30-Xm, and CR 85-X) Product Profile
........................................................................................................................... 84
Table 36:
Agfa CR Mammography Systems (DX-M, CR 30-Xm, and CR 85-X) SWOT
Analysis .............................................................................................................. 84
Table 37:
FFDM SWOT Analysis ........................................................................................ 85
Table 38:
Selenia Dimensions Product Profile..................................................................... 87
Table 39:
Selenia Dimensions SWOT Analysis ................................................................... 88
Table 40:
Selenia Product Profile........................................................................................ 90
Table 41:
Selenia SWOT Analysis ...................................................................................... 90
Table 42:
Selenia S Product Profile .................................................................................... 92
Table 43:
Selenia S SWOT Analysis ................................................................................... 92
Table 44:
Selenia Performance Product Profile ................................................................... 94
Table 45:
Selenia Performance SWOT Analysis ................................................................. 94
Table 46:
Senographe DS Product Profile........................................................................... 96
Table 47:
Senographe DS SWOT Analysis ......................................................................... 96
Table 48:
Senographe Essential/Senographe Essential E Product Profile ........................... 98
Table 49:
Senographe Essential SWOT Analysis ................................................................ 99
Table 50:
Senographe Care Product Profile ...................................................................... 101
Table 51:
Senographe Care SWOT Analysis .................................................................... 101
Table 52:
SenoBright CESM Product Profile ..................................................................... 103
Table 53:
SenoBright CESM SWOT Analysis.................................................................... 103
Table 54:
MAMMOMAT Inspiration Product Profile ........................................................... 105
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Table of Contents
Table 55:
MAMMOMAT Inspiration SWOT Analysis .......................................................... 105
Table 56:
Aspire HD/Amulet Product Profile...................................................................... 107
Table 57:
Aspire HD/Amulet SWOT Analysis .................................................................... 107
Table 58:
MammoDiagnost DR Product Profile ................................................................. 108
Table 59:
MammoDiagnost DR SWOT Analysis................................................................ 109
Table 60:
MicroDose Product Profile................................................................................. 111
Table 61:
MicroDose SWOT Analysis ............................................................................... 111
Table 62:
Giotto Image 3D/3DL Product Profile................................................................. 113
Table 63:
Giotto Image 3D/3DL SWOT Analysis ............................................................... 113
Table 64:
Planmed Nuance/Nuance Excel Product Profile ................................................ 115
Table 65:
Planmed Nuance/Nuance Excel SWOT Analysis............................................... 115
Table 66:
Fairy DR Product Profile.................................................................................... 117
Table 67:
Fairy DR SWOT Analysis .................................................................................. 117
Table 68:
Serenity Product Profile..................................................................................... 119
Table 69:
Serenity SWOT Analysis ................................................................................... 119
Table 70:
Selenia Dimensions 3D System Product Profile................................................. 121
Table 71:
Selenia Dimensions SWOT Analysis ................................................................. 121
Table 72:
GE Breast Tomosynthesis Product Profile ......................................................... 123
Table 73:
GE Breast Tomosynthesis SWOT Analysis ....................................................... 123
Table 74:
True 3D Breast Tomosynthesis Product Profile ................................................. 125
Table 75:
True 3D Breast Tomosynthesis SWOT Analysis ................................................ 125
Table 76:
Giotto Tomo Product Profile .............................................................................. 127
Table 77:
Giotto Tomo SWOT Analysis............................................................................. 127
Table 78:
FUJIFILM 3Dimensional Mammography Product Profile .................................... 129
Table 79:
FUJIFILM 3Dimensional Mammography SWOT Analysis .................................. 129
Table 80:
somo.v ABUS Product Profile............................................................................ 131
Table 81:
somo.v ABUS SWOT Analysis .......................................................................... 131
Table 82:
SonoCine AWBUS Product Profile .................................................................... 133
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Table of Contents
Table 83:
SonoCine AWBUS SWOT Analysis ................................................................... 133
Table 84:
ACUSON S2000 ABVS Product Profile ............................................................. 135
Table 85:
Acuson S2000 ABVS SWOT Analysis ............................................................... 135
Table 86:
Terason t3200 Ultrasound System Breast Series Product Profile ....................... 137
Table 87:
Terason t3200 Ultrasound System Breast Series SWOT Analysis ..................... 137
Table 88:
Aurora 1.5T Dedicated Breast MRI System Product Profile................................ 139
Table 89:
Aurora 1.5T Dedicated Breast SWOT Analysis ................................................. 139
Table 90:
PEM Flex Solo II Product Profile ....................................................................... 141
Table 91:
PEM Flex Solo II SWOT Analysis ...................................................................... 141
Table 92:
Computerized Tomography Laser Mammography (CTLM) Model 1020 Product
Profile ............................................................................................................... 143
Table 93:
Computerized Tomography Laser Mammography (CTLM) Model 1020 SWOT
Analysis ............................................................................................................ 143
Table 94:
Dilon 6800/Dilon 6800 Acella Product Profile..................................................... 145
Table 95:
Dilon 6800/Dilon 6800 Acella SWOT Analysis ................................................... 145
Table 96:
LumaGEM Product Profile................................................................................. 147
Table 97:
LumaGEM SWOT Analysis ............................................................................... 147
Table 98:
Discovery NM 750b Product Profile ................................................................... 149
Table 99:
Discovery NM 750b SWOT Analysis ................................................................. 149
Table 100: Breast Cancer Imaging Pipeline Products.......................................................... 162
Table 101: MAMMOMAT Inspiration PRIME Edition SWOT Analysis .................................. 163
Table 102: Philips MicroDose SI SWOT Analysis ................................................................ 164
Table 103: Selenia Dimensions 2D Contrast Imaging SWOT Analysis ................................ 165
Table 104: SenoCase SWOT Analysis................................................................................ 167
Table 105: Electrical Mammogram SWOT Analysis ............................................................ 168
Table 106: Other Key Events in the Breast Cancer Imaging Market .................................... 186
Table 107: GE Healthcare SWOT Analysis, 2013 ............................................................... 190
Table 108: Hologic SWOT Analysis, 2013........................................................................... 192
Table 109: Siemens SWOT Analysis, 2013......................................................................... 193
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Table of Contents
Table 110: Koninklijke Philips Electronics SWOT Analysis, 2013 ........................................ 195
Table 111: Fujifilm Medical Systems, SWOT Analysis, 2013 ............................................... 196
Table 112: Internazionale Medico Scientifica SWOT Analysis, 2013 ................................... 197
Table 113: Planmed, SWOT Analysis, 2013 ....................................................................... 198
Table 114: Konica Minolta Medical Imaging, SWOT Analysis, 2013 .................................... 199
Table 115: Agfa Healthcare, SWOT Analysis, 2013 ............................................................ 200
Table 116: Carestream Health, SWOT Analysis, 2013 ........................................................ 201
Table 117: SonoCine, SWOT Analysis, 2013 ...................................................................... 202
Table 118: Aurora Imaging Technology, SWOT Analysis, 2013........................................... 203
Table 119: Imaging Diagnostic Systems, SWOT Analysis, 2013 ......................................... 205
Table 120: Naviscan, SWOT Analysis, 2013 ....................................................................... 206
Table 121: Dilon Diagnostics, SWOT Analysis, 2013 ......................................................... 207
Table 122: Gamma Medica, SWOT Analysis, 2013............................................................. 208
Table 123: Allengers Medical Systems, SWOT Analysis, 2013 ........................................... 209
Table 124: Sales Forecasts for Breast Cancer Imaging in Brazil, 2009–2018 ...................... 221
Table 125: Physicians Surveyed, By Country...................................................................... 256
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Table of Contents
1.2
List of Figures
Figure 1:
Anatomy of the Breast ......................................................................................... 22
Figure 2:
Breast Cancer Screening, Diagnostic Evaluation, and Follow-Up......................... 28
Figure 3:
Percentage Use of Ultrasound Imaging and MRI for Breast Cancer Screening and
Follow-Up, 2009–2016 ........................................................................................ 29
Figure 4:
Breast Cancer Risk Factors................................................................................. 31
Figure 5:
Projected Breast Cancer Incidence in Brazil, 2012–2018 ..................................... 32
Figure 6:
Comparison Between Digital (FFDM) and Analog (FSM) Mammography ............. 37
Figure 7:
Use of Alternative Breast Imaging Modalities, 2009–2016 ................................... 44
Figure 8:
Performa ............................................................................................................. 51
Figure 9:
Alpha RT............................................................................................................. 53
Figure 10: Alpha ST ............................................................................................................. 54
Figure 11: MAMMOMAT 1000 ............................................................................................. 56
Figure 12: MAMMOMAT 3000 Nova .................................................................................... 58
Figure 13: M-IV/M-IV Platinum ............................................................................................. 60
Figure 14: MammoDiagnost ................................................................................................. 62
Figure 15: Planmed Nuance Classic .................................................................................... 64
Figure 16: Planmed Sophie Classic ..................................................................................... 66
Figure 17: Analog Giotto Image ........................................................................................... 68
Figure 18: HAWK-2M........................................................................................................... 70
Figure 19: MGU-1000A ........................................................................................................ 72
Figure 20: Aspire CRm ........................................................................................................ 75
Figure 21: KODAK DirectView CR System ........................................................................... 77
Figure 22: Xpress CR System .............................................................................................. 79
Figure 23: REGIUS PureView Type M ................................................................................. 81
Figure 24: DX-M Digitizer..................................................................................................... 83
Figure 25: Selenia Dimensions ............................................................................................ 86
Figure 26: Selenia ............................................................................................................... 89
Figure 27: Selenia S ............................................................................................................ 91
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Figure 28: Selenia Performance........................................................................................... 93
Figure 29: Senographe DS .................................................................................................. 95
Figure 30: Senographe Essential ......................................................................................... 97
Figure 31: Senographe Care .............................................................................................. 100
Figure 32: SenoBright CESM*............................................................................................ 102
Figure 33: MAMMOMAT Inspiration ................................................................................... 104
Figure 34: Aspire HD ......................................................................................................... 106
Figure 35: MammoDiagnost DR ......................................................................................... 108
Figure 36: MicroDose ........................................................................................................ 110
Figure 37: Giotto Image 3D/3DL ........................................................................................ 112
Figure 38: Planmed Nuance/Nuance Excel ........................................................................ 114
Figure 39: Fairy DR ........................................................................................................... 116
Figure 40: Serenity ............................................................................................................ 118
Figure 41: Selenia Dimensions 2D System ........................................................................ 120
Figure 42: Senographe Essential ....................................................................................... 122
Figure 43: True 3D Breast Tomosynthesis* ........................................................................ 124
Figure 44: Giotto Tomo ...................................................................................................... 126
Figure 45: Fujifilm 3D Mammography Viewer ..................................................................... 128
Figure 46: somo.v ABUS ................................................................................................... 130
Figure 47: SonoCine AWBUS ............................................................................................ 132
Figure 48: ACUSON S2000 ABVS ..................................................................................... 134
Figure 49: Terason t3200 Ultrasound System Breast Series............................................... 136
Figure 50: Aurora 1.5T Dedicated Breast MRI System ....................................................... 138
Figure 51: PEM Flex Solo II ............................................................................................... 140
Figure 52: CTLM Model 1020 ............................................................................................ 142
Figure 53: Dilon 6800 Acella .............................................................................................. 144
Figure 54: Dilon 6800 ........................................................................................................ 145
Figure 55: LumaGEM ........................................................................................................ 146
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Table of Contents
Figure 56: Discovery NM 750b ........................................................................................... 148
Figure 57: Percentage of False-Positive, False-Negative and Accurate Breast Cancer
Diagnoses from 2011–2012 .............................................................................. 155
Figure 58: SenoCase ......................................................................................................... 166
Figure 59: Product Life Cycle ............................................................................................. 170
Figure 60: Detector Evolution............................................................................................. 177
Figure 61: Comparison Between a Typical Direct Conversion Detector and a Direct Optical
Switching Detector ............................................................................................ 178
Figure 62: Photon-Counting Detector Technology .............................................................. 180
Figure 63: Linear and High Transmission Cellular Grids ..................................................... 182
Figure 64: Increase in FFDM Systems in the US, 2004–2013 ............................................. 213
Figure 65: Trends in the Use of Mammographic Techniques, 2009–2016 ........................... 214
Figure 66: Sales Forecasts for Breast Cancer Imaging in Brazil, 2009–2018 ...................... 221
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Introduction
2
Introduction
Breast cancer is the most common form of cancer in women in both the developed and developing
world, but is a rare disease in men. The global incidence of breast cancer is increasing due to an
increased lifespan and increasing adoption of a westernized lifestyle, which is associated with an
increased risk of the disease.
Early diagnosis of breast cancer is the foundation for increasing survival rates, and diagnostic
imaging is the most widely used technique to achieve early detection, making it a cornerstone of
breast cancer control. Diagnostic imaging is used for the early detection of breast cancer in
asymptomatic patients in population-based screening programs in most developed countries, or for
opportunistic screening in developing nations. Regardless of these differences, imaging has proved
to be an indispensable tool in fighting breast cancer and has been proven to reduce mortality.
This report provides an analysis of the mammography market in relation to dedicated breast cancer
screening and diagnosis in South America (Brazil) and identifies the unmet needs in the market.
This report also discusses physician attitudes towards current breast cancer screening and
diagnostic techniques, and the future of breast cancer imaging modalities in the face of rapid
technological advancements.
2.1
Catalyst
The South American breast cancer imaging market is a mature industry with complex dynamics.
Therefore, it is essential to examine the market opportunities and barriers that are specific to this
region. This report provides an in-depth review of the evolving technologies and the regulatory
landscape in the South American breast cancer imaging market.
Another key issue, that is discussed, is that purchasing decisions concerning breast cancer
screening and diagnostic imaging equipment are complex. Firstly, breast cancer screening and
diagnosis involves the challenge of making major purchasing decisions concerning new capital
equipment in a technologically fast-evolving market. Secondly, diagnostic imaging modalities are
often multipurpose in nature, and so equipment purchasing decisions are not solely driven by the
needs of breast cancer screening and diagnosis. For example, a diagnostic mammogram is
accompanied by ultrasound imaging in over 50% of cases, but the ultrasound equipment also has
various other applications for imaging other parts of the human body.
Since the prevalence of breast cancer is higher in women than in men, this report is restricted to
the use of imaging techniques for breast cancer screening and diagnosis in women.
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Appendix
12.9
About MediPoint
MediPoint is the flagship product for GlobalData’s Medical team. Each MediPoint report is built
from the ground up by our team of healthcare analysts in the US and UK. Each report includes
input from experienced physicians and leading Key Opinion Leaders (KOLs). Running throughout
each report in the series, “What Physicians Think” quotes provide a unique insight into how
healthcare professionals are reacting to events within the industry, and what their responses could
mean for industry strategists.
12.10 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical R&D. Our integrated business intelligence solutions
include a range of interactive online databases, analytical tools, reports, and forecasts. Our
analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New
York, Boston, London, India, and Singapore.
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Appendix
12.12 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior
permission of the publisher, GlobalData.
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