FUTURE OF MOLECULAR IMAGING - MarketResearch · surrounding personalized medicine, where physicians...

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REFERENCE CODE GDME002MFR | PUBLICATION DATE AUG UST 2013 FUTURE OF MOLECULAR IMAGING

Transcript of FUTURE OF MOLECULAR IMAGING - MarketResearch · surrounding personalized medicine, where physicians...

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REFERENCE CODE GDME002MFR | PUBLICATION DATE AUGUST 2013

FUTURE OF MOLECULAR IMAGING

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FUTURE OF MOLECULAR IMAGING

Executive Summary

Future of Molecular Imaging: Key Events and Pipeline Assessment

Key Event Level of Impact

2016: Approval of [18F]flurpiridaz (Lantheus Medical Imaging) by Food and Drug Administration (FDA) and European Medicines Agency (EMA)

↑↑

2015: Approval of [18F]flutemetamol (GE Healthcare) by FDA and EMA ↑

2015: Approval of [18F]florbetaben (Piramal Imaging) by FDA and EMA ↑

2013: Centers for Medicare & Medicaid Services (CMS) issue draft guidance on Amyvid reimbursement

↑↑

2013: CMS agrees to reimburse multiple FDG-PET scans for most tumor indications. ↑↑↑

2013: Eli Lilly acquires two tau-imaging probes from Siemens. ↑

2013 : Progenics Pharmaceuticals acquires Molecular Insight Pharmaceuticals ↑

Pipeline and Competitive Landscape Assessment

Total pipeline products profiled 5

Total imaging probes profiled 14

Total companies profiled 20

Source: GlobalData, 2013

Innovation is Key to Enter the Molecular Imaging Market

Although the molecular imaging (MI) market is

relatively new from a commercial standpoint, there

is a lot of research being conducted in this field,

and Key Opinion Leaders (KOLs) interviewed by

GlobalData agreed that there have been rapid

changes in the field, and that many more products

in early development are showing promise. The MI

market offers immense opportunities for

companies that innovate and develop either

imaging probes or techniques that will fulfill an

unmet critical need.

The KOLs highlighted one example of how

innovation can change the landscape by illustrating

the hybrid imaging concept and the introduction of

the positron emission tomography/computed

tomography (PET/CT) systems.

“I think hybrid imaging is here to stay....Nuclear

medicine physicians did not understand the need

for anatomical registration when it first became

available, and now I don’t think any of them would

try to read a scan without it.’’

Key Opinion Leader, June 2013

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FUTURE OF MOLECULAR IMAGING

Executive Summary

Significant Unmet Needs Within the Molecular Imaging Market

There are several significant unmet needs within

the MI market that have yet to be fulfilled, including

minimization of radiation exposure, instrumentation

improvement, the lack of cross-trained

professionals, and standardization in data

interpretation and reporting methods across the

field.

The KOLs interviewed for this report showed

concern regarding the need for professionals with

multidisciplinary knowledge, since the mechanism

of all imaging probes is complex and variable.

Thus, training, or lack of it, affects the

interpretation of data and the reporting of results.

“I think one of the critical issues [that] is going to

happen is that as we get more [radiotracers],

assuming we can get more radiotracers into the

clinic, I think one of the potential issues [will be] the

training of the physicians reading the scan.’’

Key Opinion Leader, June 2013

In addition, the KOLs highlighted the need for

standardization protocols, since MI imaging is a

high-precision technique, making it essential that

studies be performed and reported in a particular

manner without significant variation from one

imaging center to another.

“I think standardization is a really big issue

because of the sort of quantitative and precise

information that is possible. It actually puts a higher

demand on doing the studies [in] a proper way,

because if you can tell things quantitatively,

spatially and in time, you need to do sort of extra

effort to make sure [that] your data should be of

great quality.’’

Key Opinion Leader, June 2013

Experts Express Measured Optimism for The Market’s Growth Due to Market Barriers

The KOLs interviewed for this report were in

agreement and indicated that the euphoria

surrounding MI is much greater than the actual rate

of growth of the field. Although there is both

immense investment for developing new imaging

probes and continuous innovation in imaging

modalities, which together are fueling interest in

personalized medicine, due to significant market

barriers, growth is impeded and these factors are

dragging down the market.

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FUTURE OF MOLECULAR IMAGING

Executive Summary

“I [expect] very slow growth....I think the euphoria

is that it will be exponential,...but I think that is

euphoria, because the costs are so prohibitive.’’

Key Opinion Leader, June 2013

Some of the market barriers include:

Costs affecting various levels of the MI market,

such as capital investment required for

scanning equipment

Regulatory burden in terms of setting up

research facilities

Expensive, tedious, and time-consuming

imaging probe development

Lack of reimbursement, as MI techniques are

comparatively more expensive than other more

widely used techniques

Insufficient imaging probe distribution network

Reduced hospital budgets

Increased consciousness towards radiation

dose exposure

Predicted medical isotope shortages

Most of these market barriers are long-term issues

that the KOLs underscored will not be resolved in

the near future. Hence, the MI market is expected

to experience modest, slow-paced growth around

the globe.

“We are also in the situation where people have

not fully appreciated if a whole bunch of these

radiotracers under development for PET, if they

were to all get approved, it is not clear that we

have a distribution network that can supply a

variety of PET radiotracers.’’

Key Opinion Leader, June 2013

“I think it’s there is no doubt that the regulatory

processes are too cumbersome. There is a lot of

impediments at sort of the early stage,…and given

that radiotracers are given in such small quantities,

it doesn’t really matter what it is, it’s such a small

trace amount.’’

Key Opinion Leader, June 2013

“Several million dollars were spent in setting up

this facility here when you look at what it took to

create the facility....That is the barrier.’’

Key Opinion Leader, June 2013

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FUTURE OF MOLECULAR IMAGING

Executive Summary

Future Landscape

The MI market is driven primarily by enthusiasm

surrounding personalized medicine, where

physicians can choose the most appropriate

treatment regimen for an individual by performing

MI tests.

“Well, I think a big part of the reason for the

interest in molecular imaging is that it fits so well

within the concept of personalized medicine, or I

guess more recently, people have started calling it

precision medicine….Because of its ability to really

provide very specific information about an

individual patient, it can provide, you know,

relevant information that is not only….You make

sure that you get the right treatment to the patient,

but also at the right sort of dosage levels.’’

Key Opinion Leader, July 2013

In addition, the increasing prevalence of disease

will lead to increased use of these techniques, as

early MI enables early diagnosis, when the

treatments are cost-efficient. The MI market is also

fueled by the need to innovate and develop new

techniques, such as hyperpolarized MRS, which

GlobalData anticipates will drive the growth within

this market. Furthermore, the increased use of MI

techniques as companion diagnostics to streamline

the drug discovery and development process will

also drive the growth of this market.

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FUTURE OF MOLECULAR IMAGING

Table of Contents

1 Table of Contents

1 Table of Contents .......................................................................................................................... 6

1.1 List of Tables ........................................................................................................................ 14

1.2 List of Figures ....................................................................................................................... 17

2 Introduction ................................................................................................................................. 19

2.1 Catalyst ................................................................................................................................ 19

2.2 Related Reports ................................................................................................................... 20

3 Overview ..................................................................................................................................... 21

3.1 What is Molecular Imaging? ................................................................................................. 21

3.2 What are Molecular Imaging Probes? ................................................................................... 22

3.3 Growth of Molecular Imaging ................................................................................................ 23

3.4 Imaging Techniques ............................................................................................................. 24

3.4.1 Overview ........................................................................................................................ 24

3.4.2 Positron Emission Tomography (PET) ............................................................................ 26

3.4.3 Single Photon Emission Computed Tomography (SPECT) ............................................. 32

3.4.4 Computed Tomography .................................................................................................. 34

3.4.5 Magnetic Resonance Imaging......................................................................................... 35

3.4.6 Ultrasound Imaging ......................................................................................................... 37

3.4.7 Other Emerging Techniques ........................................................................................... 39

3.5 Applications of MI ................................................................................................................. 41

3.5.1 Overview ........................................................................................................................ 41

3.5.2 Oncology ........................................................................................................................ 41

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Table of Contents

3.5.3 Cardiology ...................................................................................................................... 43

3.5.4 Neurology ....................................................................................................................... 44

4 Unmet Needs Analysis ................................................................................................................ 45

4.1 Overview .............................................................................................................................. 45

4.2 Radiation Exposure .............................................................................................................. 45

4.3 Instrumentation Improvement ............................................................................................... 46

4.4 Lack of Multidisciplinary-Trained Professionals .................................................................... 47

4.5 Standardization .................................................................................................................... 48

5 Market Opportunity Analysis ........................................................................................................ 50

5.1 Probes for Image-Guided Surgery ........................................................................................ 50

5.2 Gallium-68 ............................................................................................................................ 51

5.3 Low-Cost PET Systems ........................................................................................................ 52

5.4 Molecular Imaging in Infectious Disease ............................................................................... 54

5.5 Hybrid Imaging ..................................................................................................................... 55

5.6 Longer-Lived Isotopes .......................................................................................................... 57

5.7 Role of Imaging Probes in Drug Development ...................................................................... 58

6 Market Drivers and Barriers ......................................................................................................... 60

6.1 Overview .............................................................................................................................. 60

6.2 Driver: Increased Prevalence of Diseases ............................................................................ 60

6.3 Driver: Enthusiasm Surrounding Personalized Medicine ...................................................... 61

6.4 Driver: Hyperpolarized MRS with 13C Holds Promise ............................................................ 61

6.5 Driver: MI Applied to Drug Discovery and Development ....................................................... 62

6.6 Barrier: Regulatory Burden ................................................................................................... 63

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Table of Contents

6.7 Barrier: Cost ......................................................................................................................... 65

6.8 Barrier: Reimbursement........................................................................................................ 66

6.9 Barrier: Imaging Probe Production and Distribution Network ................................................ 67

6.10 Barrier: Predicted 99mTc Shortage ......................................................................................... 69

6.11 Barrier: Reduced Hospital Budgets ....................................................................................... 70

6.12 Barrier: Limited Practical Value of Diagnostics in the Absence of Therapeutics .................... 70

6.13 Barrier: Increased Consciousness Regarding Radiation Dose .............................................. 73

7 Imaging Probes Assessment ....................................................................................................... 75

7.1 Overview .............................................................................................................................. 75

7.2 Small Molecules ................................................................................................................... 76

7.2.1 Overview ........................................................................................................................ 76

7.2.2 SWOT Analysis .............................................................................................................. 77

7.2.3 [18F]Fluoro-2-deoxy-2-D-glucose ([18F]FDG) .................................................................. 77

7.2.4 3'-Deoxy-3'-[18F]fluorothymidine ([18F]FLT) ...................................................................... 81

7.2.5 [18F]Fluoromisonidazole ([18F]FMISO) ............................................................................. 84

7.2.6 1-(5-[18F]Fluoro-5-deoxy-α-D-arabinofuranosyl)-2-nitroimidazole ([18F]FAZA) ................ 87

7.2.7 L-3,4-Dihydroxy-6-[18F]fluorophenylalanine ([18F]FDOPA) ............................................. 90

7.2.8 [18F]Sodium flouride ([18F]NaF) ...................................................................................... 92

7.2.9 [11C]Acetate .................................................................................................................... 95

7.2.10 N-Methyl-[11C]-2-(4'-methylaminophenyl)-6-hydroxybenzothiasole ([11C]PiB) ................ 98

7.3 Peptides ............................................................................................................................. 101

7.3.1 Overview ...................................................................................................................... 101

7.3.2 SWOT Analysis ............................................................................................................ 102

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7.4 Nanoparticles ..................................................................................................................... 102

7.4.1 Overview ...................................................................................................................... 102

7.4.2 Types of Nanoparticles for Molecular Imaging .............................................................. 103

7.4.3 SWOT Analysis ............................................................................................................ 104

7.5 Engineered Proteins ........................................................................................................... 105

7.5.1 Overview ...................................................................................................................... 105

7.5.2 SWOT Analysis ............................................................................................................ 106

7.6 Aptamers ............................................................................................................................ 106

7.6.1 Overview ...................................................................................................................... 106

7.6.2 SWOT Analysis ............................................................................................................ 107

8 Probes Pipeline Assessment ..................................................................................................... 108

8.1 Overview ............................................................................................................................ 108

8.2 [18F]flurpiridaz (Lantheus Medical Imaging)......................................................................... 108

8.2.1 Overview ...................................................................................................................... 108

8.2.2 SWOT Analysis ............................................................................................................ 109

8.3 NAV4694 (Navidea Biopharmaceuticals) ............................................................................ 110

8.3.1 Overview ...................................................................................................................... 110

8.3.2 SWOT Analysis ............................................................................................................ 111

8.4 [18F]flutemetamol (GE Healthcare) .................................................................................... 111

8.4.1 Overview ...................................................................................................................... 111

8.4.2 SWOT Analysis ............................................................................................................ 112

8.5 [18F]florbetaben (Piramal Imaging) ...................................................................................... 113

8.5.1 Overview ...................................................................................................................... 113

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8.5.2 SWOT Analysis ............................................................................................................ 113

8.6 REDECTANE (Wilex) ......................................................................................................... 114

8.6.1 Overview ...................................................................................................................... 114

8.6.2 SWOT Analysis ............................................................................................................ 115

9 Current and Future Players ....................................................................................................... 116

9.1 Overview ............................................................................................................................ 116

9.2 Navidea Biopharmaceuticals .............................................................................................. 117

9.2.1 Overview ...................................................................................................................... 117

9.2.2 Portfolio Assessment .................................................................................................... 117

9.2.3 SWOT Analysis ............................................................................................................ 120

9.3 Lantheus Medical Imaging .................................................................................................. 121

9.3.1 Overview ...................................................................................................................... 121

9.3.2 Portfolio Assessment .................................................................................................... 121

9.3.3 SWOT Analysis ............................................................................................................ 124

9.4 Mallinckrodt Pharmaceuticals ............................................................................................. 125

9.4.1 Overview ...................................................................................................................... 125

9.4.2 Portfolio Assessment .................................................................................................... 125

9.4.3 SWOT Analysis ............................................................................................................ 127

9.5 Avid Radiopharmaceuticals (Eli Lilly) .................................................................................. 127

9.5.1 Overview ...................................................................................................................... 127

9.5.2 Portfolio Assessment .................................................................................................... 128

9.5.3 SWOT Analysis ............................................................................................................ 130

9.6 Bracco Imaging .................................................................................................................. 131

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Table of Contents

9.6.1 Overview ...................................................................................................................... 131

9.6.2 Portfolio Assessment .................................................................................................... 131

9.6.3 Product Recalls ............................................................................................................ 132

9.6.4 SWOT Analysis ............................................................................................................ 133

9.7 GE Healthcare .................................................................................................................... 133

9.7.1 Overview ...................................................................................................................... 133

9.7.2 Portfolio Assessment .................................................................................................... 134

9.7.3 SWOT Analysis ............................................................................................................ 136

9.8 Piramal Imaging ................................................................................................................. 137

9.8.1 Overview ...................................................................................................................... 137

9.8.2 Portfolio Assessment .................................................................................................... 137

9.8.3 SWOT Analysis ............................................................................................................ 138

9.9 Siemens ............................................................................................................................. 138

9.9.1 Overview ...................................................................................................................... 138

9.9.2 Portfolio Assessment .................................................................................................... 138

9.9.3 SWOT Analysis ............................................................................................................ 140

9.10 Novelos Therapeutics ......................................................................................................... 140

9.10.1 Overview ...................................................................................................................... 140

9.10.2 Portfolio Assessment .................................................................................................... 141

9.10.3 SWOT Analysis ............................................................................................................ 142

9.11 Affibody .............................................................................................................................. 142

9.11.1 Overview ...................................................................................................................... 142

9.11.2 Portfolio Assessment .................................................................................................... 142

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9.11.3 SWOT Analysis ............................................................................................................ 143

9.12 Atreus Pharmaceuticals ...................................................................................................... 144

9.12.1 Overview ...................................................................................................................... 144

9.12.2 Portfolio Assessment .................................................................................................... 144

9.12.3 SWOT Analysis ............................................................................................................ 145

9.13 Kereos ................................................................................................................................ 145

9.13.1 Overview ...................................................................................................................... 145

9.13.2 Portfolio Assessment .................................................................................................... 145

9.13.3 SWOT Analysis ............................................................................................................ 146

9.14 Progenics Pharmaceuticals ................................................................................................ 146

9.14.1 Overview ...................................................................................................................... 146

9.14.2 Portfolio Assessment .................................................................................................... 146

9.14.3 SWOT Analysis ............................................................................................................ 148

9.15 FluoroPharma Medical ....................................................................................................... 148

9.15.1 Overview ...................................................................................................................... 148

9.15.2 Portfolio Assessment .................................................................................................... 148

9.15.3 SWOT analysis ............................................................................................................. 150

9.16 Wilex .................................................................................................................................. 150

9.16.1 Overview ...................................................................................................................... 150

9.16.2 Portfolio Assessment .................................................................................................... 151

9.16.3 SWOT analysis ............................................................................................................. 152

9.17 Radiopharmaceutical Suppliers and Distributors ................................................................ 153

9.17.1 Supply-Chain Overview ................................................................................................ 153

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9.17.2 Nordion ......................................................................................................................... 154

9.17.3 Positron ........................................................................................................................ 155

9.17.4 Cardinal Health ............................................................................................................. 156

9.17.5 Advanced Accelerator Applications (AAA) .................................................................... 157

9.18 Other Companies ............................................................................................................... 159

9.19 Key Deals, Partnerships, and Agreements ......................................................................... 160

10 Appendix ................................................................................................................................... 161

10.1 Bibliography........................................................................................................................ 161

10.2 Definitions .......................................................................................................................... 177

10.3 Abbreviations...................................................................................................................... 178

10.4 Research Methodology ....................................................................................................... 181

10.4.1 Overview ...................................................................................................................... 181

10.4.2 Coverage ...................................................................................................................... 181

10.4.3 Secondary Research .................................................................................................... 182

10.5 Physicians and Specialists Included in this Study ............................................................... 183

10.6 Primary Research ............................................................................................................... 184

10.7 About the Authors ............................................................................................................... 185

10.7.1 Analysts ........................................................................................................................ 185

10.7.2 Global Head of Healthcare ............................................................................................ 186

10.8 Disclaimer .......................................................................................................................... 187

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Table of Contents

1.1 List of Tables

Table 1: Desired Characteristics of an MI Probe ............................................................................................ 23

Table 2: PET SWOT Analysis, 2013 .............................................................................................................. 31

Table 3: SPECT SWOT Analysis, 2013.......................................................................................................... 33

Table 4: CT SWOT Analysis, 2013 ................................................................................................................ 35

Table 5: MRI SWOT Analysis, 2013 ............................................................................................................... 37

Table 6: Ultrasound Imaging SWOT Analysis, 2013 ....................................................................................... 39

Table 7: Applications of MI ............................................................................................................................. 41

Table 8: Role of Biomarkers in Drug Development ......................................................................................... 58

Table 9: Molecular Imaging – Drivers and Barriers, 2013 ............................................................................... 60

Table 10: Small Molecules SWOT Analysis, 2013 .......................................................................................... 77

Table 11: Agent Profile of [18F]FDG................................................................................................................ 80

Table 12: [18F]FDG SWOT Analysis, 2013 ..................................................................................................... 80

Table 13: Agent Profile of [18F]FLT ................................................................................................................. 83

Table 14: [18F]FLT SWOT Analysis, 2013 ...................................................................................................... 83

Table 15: Agent Profile of [18F]FMISO ............................................................................................................ 86

Table 16: [18F]FMISO SWOT Analysis, 2013 .................................................................................................. 86

Table 17: Agent Profile of [18F]FAZA .............................................................................................................. 89

Table 18: [18F]FAZA SWOT Analysis, 2013 .................................................................................................... 89

Table 19: Agent Profile of [18F]FDOPA ........................................................................................................... 91

Table 20: [18F]FDOPA SWOT Analysis, 2013 ................................................................................................. 92

Table 21: Agent Profile of [18F]NaF ................................................................................................................ 94

Table 22: [18F]NaF SWOT Analysis, 2013 ...................................................................................................... 95

Table 23: Agent Profile of [11C]Acetate ........................................................................................................... 97

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Table 24: [11C]Acetate SWOT Analysis, 2013 ................................................................................................ 98

Table 25: Agent Profile of [11C]PiB ............................................................................................................... 100

Table 26: [11C]PiB SWOT Analysis, 2013 ..................................................................................................... 101

Table 27: Peptides SWOT Analysis, 2013 .................................................................................................... 102

Table 28: Nanoparticles SWOT Analysis, 2013 ............................................................................................ 104

Table 29: Engineered Proteins SWOT Analysis, 2013 .................................................................................. 106

Table 30: Aptamers SWOT Analysis, 2013 .................................................................................................. 107

Table 31: [18F]flurpiridaz SWOT Analysis, 2013............................................................................................ 109

Table 32: NAV4694 SWOT Analysis, 2013 .................................................................................................. 111

Table 33: [18F]flutemetamol SWOT Analysis, 2013 ....................................................................................... 112

Table 34: [18F]florbetaben SWOT Analysis, 2013 ......................................................................................... 113

Table 35: REDECTANE SWOT Analysis, 2013 ............................................................................................ 115

Table 36: Navidea Biopharmaceuticals’ Portfolio Assessment, 2013 ............................................................ 119

Table 37: Navidea Biopharmaceuticals SWOT Analysis, 2013 ..................................................................... 120

Table 38: Lantheus Medical Imaging Portfolio Assessment, 2013 ................................................................ 123

Table 39: Lantheus Medical Imaging SWOT Analysis, 2013 ......................................................................... 124

Table 40: Mallinckrodt Pharmaceuticals Portfolio Assessment, 2013 ............................................................ 126

Table 41: Mallinckrodt Pharmaceuticals SWOT Analysis, 2013 .................................................................... 127

Table 42: Avid Radiopharmaceuticals Portfolio Assessment, 2013 ............................................................... 129

Table 43: Avid Radiopharmaceuticals SWOT Analysis, 2013 ....................................................................... 130

Table 44: Bracco Imaging Portfolio Assessment, 2013 ................................................................................. 132

Table 45: Bracco Imaging SWOT Analysis, 2013 ......................................................................................... 133

Table 46: GE Healthcare Portfolio Assessment, 2013 .................................................................................. 135

Table 47: GE Healthcare SWOT Analysis, 2013 .......................................................................................... 136

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Table 48: Piramal Imaging Portfolio Assessment, 2013 ................................................................................ 137

Table 49: Piramal Imaging SWOT Analysis, 2013 ........................................................................................ 138

Table 50: Siemens Portfolio Assessment, 2013 ........................................................................................... 139

Table 51: Siemens SWOT Analysis, 2013 .................................................................................................... 140

Table 52: Novelos Therapeutics Portfolio Assessment, 2013 ....................................................................... 141

Table 53: Novelos Therapeutics SWOT Analysis, 2013 ................................................................................ 142

Table 54: Affibody Portfolio Assessment, 2013 ............................................................................................ 143

Table 55: Affibody SWOT Analysis, 2013 ..................................................................................................... 143

Table 56: Atreus Pharmaceuticals Portfolio Assessment, 2013 .................................................................... 144

Table 57: Atreus Pharmaceuticals SWOT Analysis, 2013............................................................................. 145

Table 58: Kereos Portfolio Assessment, 2013 .............................................................................................. 145

Table 59: Kereos SWOT Analysis, 2013 ...................................................................................................... 146

Table 60: Progenics Portfolio Assessment, 2013 ......................................................................................... 147

Table 61: Progenics Pharmaceuticals SWOT Analysis, 2013 ....................................................................... 148

Table 62: FluoroPharma Medical Portfolio Assessment, 2013 ...................................................................... 149

Table 63: FlouroPharma Medical SWOT Analysis, 2013 .............................................................................. 150

Table 64: Wilex Portfolio Assessment, 2013 ................................................................................................ 151

Table 65: Wilex SWOT Analysis, 2013 ......................................................................................................... 152

Table 66: Nordion SWOT Analysis, 2013 ..................................................................................................... 154

Table 67: Positron SWOT Analysis, 2013 .................................................................................................... 155

Table 68: Cardinal Health SWOT Analysis, 2013 ......................................................................................... 157

Table 69: AAA SWOT Analysis, 2013 .......................................................................................................... 158

Table 70: Other Companies in the MI Market, 2013 ..................................................................................... 159

Table 71: Other Key Events in the Molecular Imaging Market....................................................................... 160

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Table of Contents

1.2 List of Figures

Figure 1: Components of an MI Probe ........................................................................................................... 22

Figure 2: Imaging Modalities .......................................................................................................................... 25

Figure 3: Siemens Biograph TruePoint PET/CT Scanner ............................................................................... 28

Figure 4: GE Healthcare’s Discovery NM/CT 670 SPECT/CT Scanner ........................................................... 33

Figure 5: Philips’ Brilliance iCT CT Scanner ................................................................................................... 34

Figure 6: Toshiba Medical Systems’ Vantage Titan 3T MRI Scanner ............................................................. 36

Figure 7: Hitachi Preirus Ultrasound Scanner ................................................................................................. 38

Figure 8: Imaging Applications in Drug Discovery and Development .............................................................. 59

Figure 9: Categories of Imaging Probes ......................................................................................................... 75

Figure 10: Molecular Structure of [18F]FDG ..................................................................................................... 78

Figure 11: Whole-Body PET Scan Using [18F]FDG ......................................................................................... 79

Figure 12: Molecular Structure of [18F]FLT ..................................................................................................... 81

Figure 13: PET Scan Using [18F]FLT .............................................................................................................. 82

Figure 14: Molecular Structure of [18F]FMISO ................................................................................................ 84

Figure 15: CT Scan (A), PET/CT Using [18F]FDG (B), and PET/CT Scan Using [18F]FMISO (C) .................... 85

Figure 16: Molecular Structure of [18F]FAZA ................................................................................................... 87

Figure 17: [18F]FAZA-PET Scan ..................................................................................................................... 88

Figure 18: Molecular Structure of [18F]FDOPA................................................................................................ 90

Figure 19: MRI Scan (Left) and [18F]FDOPA-PET Scan (Right) ...................................................................... 91

Figure 20: Molecular structure of NaF ............................................................................................................ 93

Figure 21: [18F]NaF-PET Bone Scan .............................................................................................................. 94

Figure 22: Molecular Structure of [11C]Acetate ............................................................................................... 96

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Table of Contents

Figure 23: Comparison of Enhanced CT (A) with [18F]FDG-PET (B) and [11C]Acetate PET (C) ....................... 97

Figure 24: Molecular Structure of [11C]PiB ...................................................................................................... 99

Figure 25: Comparison of [11C]PiB-PET Scans in Subjects with AD and Control Group ................................ 100

Figure 26: Supply Chain for Medical Isotopes .............................................................................................. 153

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Introduction

2 Introduction

Molecular imaging (MI) is at the frontier of diagnostic imaging. It is a vast and multidisciplinary field

that consists of a range of techniques, allowing imaging of various organs and sites within the body

with specific targeted probes. According to the Society of Nuclear Medicine and Molecular Imaging

(SNMMI), MI can be defined as “the visualization, characterization and measurement of biological

processes at the molecular and cellular levels in human and other living systems.’’ However, no

single modality may be entirely sufficient to provide the information required for the diagnosis of

disease.

Although MI probes offer a great deal of information, the development of new probes is far from a

trivial matter. This report identifies the clinical and scientific rationale behind various imaging

modalities and probes, and critical analyses regarding where the future of the MI segment lies.

2.1 Catalyst

Although sluggish economic growth has hindered the growth of the MI market right from its

inception in the leading economies of the world, such as the United States and Europe, the market

has attracted attention from both academia and manufacturers in recent years. This report focuses

on the current and future industry trends within the MI market, discusses promising pipeline

products, and assesses the competitive landscape.

This report also highlights the current and future applications of MI, and evaluates which ones are

promising and may have some clinical applications. GlobalData has also identified the unmet

needs in the MI market and discusses them in detail in this report.

MI can be defined as “the visualization, characterization and measurement of biological processes at the molecular and cellular levels in human and other living systems.’’

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Appendix

10.8 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.