Molecular Imaging

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1.0 EXECUTIVE SUMMARY ............................................................................. 1

1.1 Molecular Basis of Cell Function........................................................................... 1
1.1.1 Personalized Medicine ....................................................................................... 2
1.2 Driving Health Care ............................................................................................... 2
1.3 Multicapabilities...................................................................................................... 3
1.4 The Power of Imaging ............................................................................................ 4
1.4.1 Key Modalities ................................................................................................... 5
1.5 World Market Summary........................................................................................ 7
1.5.1 Market Drivers and Challenges ......................................................................... 7
1.5.2 Growth Analysis ................................................................................................ 8
1.6 Methodology .......................................................................................................... 12

2.0 INTRODUCTION ....................................................................................... 13

2.1 Definition ............................................................................................................... 13
2.1.1 Visualizing Biological Events.......................................................................... 14
2.1.2 For Diagnosis and More................................................................................... 15
2.1.3 Molecular Agents ............................................................................................. 17
2.2 New Direction for Medicine ................................................................................. 19
2.3 Modalities and Applications................................................................................. 20
2.3.1 Nuclear Medicine ............................................................................................. 20
2.3.1.1 PET ........................................................................................................... 24
2.3.1.1.1 Understanding Disease Mechanisms ..................................................... 25
2.3.1.2 SPECT and Gamma Cameras ................................................................... 26
2.3.3 MRI .................................................................................................................. 31
2.3.4 Ultrasound ........................................................................................................ 33
2.3.5 Fusion Imaging ................................................................................................ 34
2.3.5.1 Dual-Modality Advantages ....................................................................... 34
2.3.5.2 PET/CT ..................................................................................................... 37
2.3.5.3 SPECT/CT ................................................................................................. 39
2.3.5.4 PET/MRI ................................................................................................... 41
2.3.5.4.1 Therapeutic Successes ........................................................................... 42
2.3.6 Optical Imaging ............................................................................................... 43
2.4 Drivers .................................................................................................................... 44
2.4.1 Complementary Opportunities ......................................................................... 44
2.4.2 Preventive Medicine ........................................................................................ 46
2.5 Issues and Challenges ........................................................................................... 47
2.5.1 Dual modality Issues ........................................................................................ 47
2.5.2 Standardization Needed ................................................................................... 48
2.5.3 Addressing Radiopharmaceutical Shortages.................................................... 49
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2.5.4 Signaling Improvements, Equipment Configurations Needed ........................ 50

2.5.5 Advances in Devices and Software.................................................................. 51
2.6 Health Care Reform ............................................................................................. 53
2.6.1 Utilization Rate ................................................................................................ 53
2.6.2 Tax Concerns ................................................................................................... 55

3.0 RESEARCH IMPACTING THE MARKET ................................................... 57

3.1 Diagnosing Fever of Unknown Origin ................................................................ 57
3.2 Determine Malignancy in Potential Ovarian Cancer ........................................ 58
3.3 PET/CT Impacts Brain Tumor Management .................................................... 59
3.4 Improving Care for Neuroendocrine Cancer .................................................... 60
3.5 PET Optimizes Virtual Colonoscopy .................................................................. 61
3.6 Staging Prostate Cancer ....................................................................................... 63
3.7 Cyclotron Expansion ............................................................................................ 63
3.8 Breast Cancer Screening ...................................................................................... 64
3.9 PET Indicates Therapy Effectiveness ................................................................. 65
3.10 Lower Dosage in Hybrid Imaging ..................................................................... 66
3.11 Analyze Differences in Biochemical Status of Tissues ..................................... 67
3.12 Myocardial Flow Reserve Analysis ................................................................... 67

4.0 MARKETS ................................................................................................ 69

4.1 Overview ................................................................................................................ 69
4.1.1 Growth In Cardiology ...................................................................................... 70
4.1.2 Merging Diagnosis and Treatment................................................................... 71
4.2 Procedures ............................................................................................................. 72
4.3 Forecasts ................................................................................................................ 77
4.3.1 PET .................................................................................................................. 77
4.3.1.1 PET/CT ......................................................................................................... 78
4.3.1.1.1 Time of Flight Impact............................................................................. 79
4.3.2 SPECT-Gamma Camera Systems .................................................................... 83
4.3.2.1 SPECT/CT ................................................................................................. 84
4.3.2.1.1 Driven by Cardiology ............................................................................ 85
4.3.3 MRI .................................................................................................................. 92
4.3.4 CT .................................................................................................................... 96
4.3.5 Ultrasound ...................................................................................................... 100

5.0 CORPORATE PROFILES ......................................................................... 105

5.1 ABT Molecular Imaging Inc. ............................................................................. 105
5.2 Advanced Cyclotron Systems Inc. ..................................................................... 106
5.3 Aspect Imaging .................................................................................................... 107

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5.4 Avid Radiopharmaceuticals Inc. ....................................................................... 108

5.5 Bioscan ................................................................................................................. 109
5.6 Cardinal Health................................................................................................... 110
5.7 Digirad Corp. ...................................................................................................... 112
5.8 Dilon Diagnostics................................................................................................. 114
5.9 Gamma Medica Inc. ........................................................................................... 115
5.10 GE Healthcare ................................................................................................... 117
5.11 Imaging Diagnostic Systems Inc. ..................................................................... 120
5.12 MIR Preclinical Services .................................................................................. 121
5.13 OptoSonics Inc. ................................................................................................. 123
5.14 Philips Healthcare ............................................................................................. 124
5.15 Photo Diagnostic Systems ................................................................................. 126
5.16 Positron Corp. ................................................................................................... 127
5.17 Shimadzu Corp. ................................................................................................ 129
5.18 Siemens Healthcare........................................................................................... 130
5.19 Spectrum Dynamics Ltd. .................................................................................. 132
5.20 Toshiba America Medical Systems ................................................................. 133
5.21 UltraSPECT Ltd. .............................................................................................. 134
5.22 VisEn Medical ................................................................................................... 136
5.23 Zecotek Photonics Inc. Unit 1120 .................................................................... 138

L I S T

O F

E X H I B I T S

1.0 EXECUTIVE SUMMARY

Exhibit 1: World Market for PET, 2011-2015 .........................................................................9
Exhibit 2: World Market for SPECT, 2011-2015 ...................................................................9
Exhibit 3: World Market for Molecular CT, 2011-2015 ......................................................10
Exhibit 4: World Market for Molecular MRI, 2011-2015 ...................................................10
Exhibit 5: World Market for Molecular Ultrasound, 2011-2015 ........................................11
Exhibit 6: World Market for PET/CT, 2011-2015................................................................11
Exhibit 7: World Market for SPECT/CT, 2011-2015...........................................................12

2.0 INTRODUCTION
Exhibit 8: Key Radionuclides ..................................................................................................23

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4.0 MARKETS
Exhibit 9: Worldwide SPECT Procedures, 2012 (Cardio., Cancer, Neuro.) ......................74
Exhibit 10: US SPECT Procedures, 2012 (Cardio., Cancer, Neuro.) ..................................74
Exhibit 11: Worldwide PET Procedures, 2012 (Cardio., Cancer, Neuro.)..........................75
Exhibit 12: US PET Procedures, 2012 (Cardio., Cancer, Neuro.)........................................75
Exhibit 13: Worldwide Molecular CT Procedures, 2012 (US, EU, ROW) ..........................76
Exhibit 14: Worldwide Molecular MRI Procedures, 2012 (US, EU, ROW) .......................76
Exhibit 15: World Medical Market for PET Systems, 2011-2015 ........................................80
Exhibit 16: World Medical Market for PET Systems by Geographic
Segment, 2011-2015 (U.S., Europe, BRIC, Japan, ROW) ..................................................80
Exhibit 17: World Medical Market for PET/CT Systems, 2011-2015 .................................81
Exhibit 18: World Medical Market for PET/CT Systems by Geographic
Segment, 2011-2015 (U.S., Europe, BRIC, Japan, ROW) ...................................................81
Exhibit 19: World Medical Market for PET Systems by Geographic
Segment, 2012 ..........................................................................................................................82
Exhibit 20: Worldwide Medical PET Installed Base, 2012 (U.S., World) ..........................83
Exhibit 21: World Medical Market for SPECT Systems, 2011-2015 ...................................87
Exhibit 22: World Medical Market for SPECT Systems by Geographic
Segment, 2011-2015 (U.S., Europe, BRIC, Japan, ROW) ..................................................88
Exhibit 23: World Medical Market for SPECT/CT Systems, 2011-2015 ............................89
Exhibit 24: World Medical Market for SPECT/CT Systems by Geographic
Segment, 2011-2015 (U.S., Europe, BRIC, Japan, ROW) ..................................................90
Exhibit 25: World Medical Market for SPECT Systems by Geographic
Segment, 2012 .........................................................................................................................91
Exhibit 26: Worldwide Medical SPECT Installed Base, 2012 ..............................................92
Exhibit 27: World Medical Market for MRI Molecular Imaging Systems, 2011-2015......94
Exhibit 28: World Medical Market for MRI Molecular Imaging Systems by
Geographic Segment, 2011-2015 (U.S., Europe, BRIC, Japan, ROW) ..............................95
Exhibit 29: World Medical Market for MRI Molecular Imaging Systems by
Geographic Segment 2012 ....................................................................................................96
Exhibit 30: World Medical Market for CT Molecular Imaging Systems............................98
2011-2015 ...................................................................................................................................98
Exhibit 31: World Medical Market for CT Molecular Imaging Systems by
Geographic Segment, 2011-2015 (U.S., Europe, BRIC, Japan, ROW) ..............................99

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Exhibit 32: World Medical Market for CT Molecular Imaging Systems by

Geographic Segment, 2012 ...................................................................................................100
Exhibit 33: World Medical Market for Ultrasound Molecular Imaging Systems, 20112015 .........................................................................................................................................102
Exhibit 34: World Medical Market for Ultrasound Molecular Imaging Systems
by Geographic Segment, 2011-2015 ....................................................................................103
Exhibit 35: World Medical Market for Ultrasound Molecular Imaging Systems
by Geographic Segment, 2012 .............................................................................................104

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Two: Introduction
18

agent FDG -- Fluorodeoxyglucose (18F) -- have made a significant contribution to the role
that nuclear medicine plays in the diagnosis of cancer. The emphasis placed on the
development of new contrast agents and radiopharmaceuticals is reflective of the vast
market potential for medical imaging technologies. Some of these new contrast agents
and radiopharmaceuticals will foster diagnostic applications in conjunction with existing
imaging technologies.
The expectation of innumerable new applications to come is expected to drive
imaging procedure volumes in the near future. For instance, in June 2012, GE Healthcare
signed an agreement with Affibody AB to collaborate on the development of a Her2targeted PET imaging agent, which eventually begin clinical trials. Future clinical trials
will investigate the confirmation of Her2 status in patients with breast cancer recurrence,
to determine if Her2 status changes over time, monitor therapy of patients with metastatic
breast cancer receiving anti-Her2 treatments, and help resolve indeterminate Her2 tests.
These studies, if positive, could ultimately pave the way for better targeting of anti-Her2
therapies to those patients most likely to benefit.
In general, molecular imaging agents can be grouped into three categories. Type
A agents bind directly to a target molecule. Type B agents are accumulated by the
molecular or cellular activity of the target. Type C agents are undetectable when injected
but can be imaged after they are activated by the target. Type A agents involve the use of
the fluorinated glucose derivative [fluorine-18]-fluorodeoxyglucose ([18F]-FDG). This
molecule is an analog of glucose. It is taken up into cells by glucose transporters and is
phosphorylated intracellularly by the enzyme hexokinase.
Once phosphorylated, [18F]-FDG is not metabolized further. It accumulates
within cells. As a result, an [18F]-FDG scan depicts the spatial distribution of high rates
of glucose metabolism, which in turn is closely linked to many important diseases and
conditions. For example, many tumors are characterized by increased glucose utilization,
and [18F]-FDG imaging is widely used for cancer imaging.
The first wave of molecular imaging appeared with SPECT and PET imaging
targeted to specific cellular surface receptors, the expression of glycolysis in cells, and
the metabolic and pathophysiological features of Alzheimer's disease. In addition,
molecular imaging has prompted new methods for testing drug safety and efficacy.
Preclinical small-animal imaging with microPET/CT, high-field MRI, and near-infrared
fluorescence optical imaging helps pharmaceutical companies decide if they should
invest in preclinical trials for investigational agents. Molecular imaging could reduce

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Three: Trends
61

molecular imaging to assess neuroendocrine tumors." Many neuroendocrine tumors are

asymptomatic and metastatic, which means they can develop unnoticed and spread from
their original location to other tissues and organs. Clinical decision making can be a
challenge when determining the most appropriate treatment for patients with these
cancers.
PET/CT was performed in conjunction with injection of an imaging probe that
works by combining the radionuclide Gallium-68 (Ga-68) with a molecular compound
that mimics hormones called somatostatins that regulate the neuroendocrine system.
Upon injection, the probe begins interacting with neuroendocrine cells, especially those
within cancerous tumors, because they are more active than healthy cells. These
biological processes show up as hot-spots on PET scans, letting clinicians know where
neuroendocrine cancer is proliferating.
Results indicated that PET/CT and Ga-68 Dotatate was highly sensitive and
specific for assessing neuroendocrine tumors and changed the course of treatment for a
large number of patients. Prior to imaging, more than half of the 61 patients who were
picked for the study were considered eligible for surgery to remove their cancer. The
remaining 29 were determined to be inoperable.11
3.5 PET OPTIMIZES VIRTUAL COLONOSCOPY
PET combined with CT colonography (CTC) may provide a suitable alternative to
the traditional colonoscopy for detecting polyps and cancer in the colon. "One of the first
indications of colorectal cancer is often the presence of polyps, which are abnormal tissue
growths on the inner lining of the colon or large intestine," says Stuart A. Taylor, M.D.,
University College London. "If these polyps are detected non-invasively and without the
use of bowel preparation and sedatives, the investigation can be much easier on patients
who would otherwise undergo colonoscopies."
Until now, the standard diagnostic test for colorectal cancer and polyps has been
colonoscopy. Although this technique is very effective, it is also invasive and can be
uncomfortable for patients. CTC offers a promising, less invasive alternative to

11

Schaefer, N. et al. Impact on management of Gallium-68 Dotatate PET/CT in patients with

neuroendocrine tumors. Society of Nuclear Medicine and Molecular Imaging. 59th Annual Meeting. June
9, 2012, San Antonio, TX.

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Four: Markets
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Exhibit 13
Worldwide Molecular CT Procedures, 2012 (US, EU, ROW)

Field
US
EU
ROW
Total

Procedures
(millions)

Source: Kalorama Information

Exhibit 14
Worldwide Molecular MRI Procedures, 2012 (US, EU, ROW)

Field
US
EU
ROW
Total

Procedures

Source: Kalorama Information

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