This report examines how new technologies can emerge in the face of economic pressures that may affect the demand for nuclear imaging, and how healthcare reforms are impacting nuclear medicine. The advent of hybrid imaging has enabled PET/CT imaging to undergo explosive growth. However, this has been at the cost of an increased demand on struggling healthcare budgets. PET and SPECT imaging are well established techniques within nuclear imaging, and are the main focus of this report PET imaging uses Positron Emitting radioactive tracers with a short half life, to image metabolically active organs PET combined with CT allows precise anatomical imaging of the body, identifying diseased areas depending upon the tracer used PET/CT is most often used for cancer diagnosis PET/MRI is a new technique that was introduced to reduce patient exposure to radiation PET only systems are now generally considered obsolete, due to the superior imaging quality of PET/CT

PET/MRI is expected to remain a nascent segment in the US nuclear imaging market, far behind well-established and generally well regarded PET/CT scanners. No replacement sales are expected during the forecast period, and the volume of systems sold (only one per year) is expected to remain low, due to physician skepticism of the clinical validity of this hybrid modality.

Scope

• An overview of Nuclear Imaging, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
• Annualized the US Nuclear Imaging market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
• Investigation of current and future market competition for Nuclear Imaging.
• Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
• Competitor assessment including device approval analysis and device sales forecasts.
• Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
• Analysis of unmet needs within the market and opportunities for future players.
• Technology trends evaluation to assess strength of pipeline.
• An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
• Company profiles including business description, financial overview and SWOT analysis.
• Coverage of key market players.
• Strategic assessment of the Nuclear Imaging sector through market impact analysis, future market scenario and company analysis.
• Direct quotes from Key Opinion Leaders (KOL) as well as doctors

Reasons to buy

• Understand the trends shaping and driving the US Nuclear Imaging market.
• Realize device preferences of physicians who have performed the tests already.
• Access market sizing, forecasts and quantified growth opportunities in the US Nuclear Imaging market through 2018.
• Quantify candidate patient populations to better design product pricing & launch plans.
• Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
• Perform benchmarking analysis of growth opportunities against currently marketed products.
• Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
• Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
• Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
• Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
• What’s the next big thing in the US Nuclear Imaging market landscape? Identify, understand and capitalize.

Table of Contents

1 Table of Contents 6
1.1 List of Tables 12
1.2 List of Figures 15

2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 16

3 Industry Overview 17
3.1 Nuclear Imaging Techniques 17
3.1.1 Positron Emission Tomography 17
3.1.2 Single-Photon Emission Computed Tomography 19
3.1.3 Planar Scintigraphy 19
3.1.4 Hybrid Imaging 20
3.2 Clinical Applications of Nuclear Imaging Technology 25
3.2.1 Cancer 25
3.2.2 Cardiology 27
3.2.3 Neurology 29
3.2.4 Infection and Inflammation 31
3.3 Advantages and Disadvantages of Nuclear Imaging Technologies 34
3.4 Market Access 35
3.4.1 Product Life Cycle 35
3.4.2 Purchasing Decisions 37
3.4.3 Equipment Leasing 42
3.4.4 Replacement of PET/CT by PET/MRI 42
3.5 Reimbursement 47
3.6 Procedure Trends 48
3.7 Regulatory Issues/Recalls 52
3.8 M&As and Key Partnerships 52
3.9 Economic Impact 54

4 Unmet Needs 58
4.1 Overview 58
4.2 Improved Reimbursement for New Techniques 58
4.3 Lack of Binding Clinical Guidelines 59
4.4 Patient Comfort and Convenience 60
4.5 Reducing Radiation Exposure 60
4.6 Improved Scanner Performance 63
4.7 Image Processing Software Improvements 63
4.8 Increased Risk of Artifacts in Hybrid Images 66
4.9 Demand for New Radiotracers 67
4.10 Improved Clinical Input into the Design Process 68

5 Market Opportunity Analysis 70
5.1 Cheaper, Simpler Nuclear Imaging Devices 70
5.2 SPECT/CT in Developing Countries 70
5.3 Increased Demand for Teleradiology Services 72

6 Market Drivers and Barriers 74
6.1 Driver: Aging Population and Increasing Disease Prevalence 74
6.2 Driver: Referring Physician Awareness 75
6.3 Driver: Defensive medicine 76
6.4 Driver: Patient Awareness 78
6.5 Driver: Self-Referral 78
6.6 Driver: New Imaging Agents 79
6.7 Driver: Increasing Demand for Cancer Diagnostic Tests 79
6.8 Driver: Companion Diagnostic Testing 80
6.9 Barrier: Comparative Effectiveness Research 81
6.10 Barrier: Reimbursement Legislation 83
6.11 Barrier: Increasing Demand for Nuclear Imaging in Developing Markets 83
6.12 Barrier: Insurance Company Lobbying to Reduce Unnecessary Imaging 85
6.13 Barrier: Greater Payer Scrutiny of EMRs 85
6.14 Barrier: Increased Use of Appropriateness Criteria 86
6.15 Barrier: Practice Guidelines to Reduce Unnecessary Procedures 88
6.16 Barrier: Imaging Facility Accreditation 88
6.17 Barrier: Loss of Nuclear Medicine Skills 89
6.18 Barrier: High Cost of Instruments and Reagents 90
6.19 Barrier: Radiopharmaceutical Cost and Supply Difficulties 91
6.20 Barrier: Medical Device Excise Tax 94
6.21 Barrier: Hospital Consolidation 94

7 Competitive Assessment 96
7.1 Overview 96
7.2 Dedicated PET Systems 96
7.2.1 Overview 96
7.2.2 Product Profile 97
7.2.3 SWOT Analysis 98
7.3 PET/CT Systems 98
7.3.1 Overview 98
7.3.2 Product Profiles 99
7.3.3 SWOT Analysis 101
7.4 PET/MRI Systems 101
7.4.1 Overview 101
7.4.2 Product Profile 103
7.4.3 SWOT Analysis 104
7.5 Dedicated SPECT Systems 104
7.5.1 Overview 104
7.5.2 Product Profile 106
7.5.3 SWOT Analysis 107
7.6 SPECT/CT Systems 108
7.6.1 Overview 108
7.6.2 Product Profile 110
7.6.3 SWOT Analysis 111
7.7 PET/Ultrasound and SPECT/Ultrasound Systems 112
7.7.1 Overview 112
7.7.2 Product Profile 112
7.7.3 SWOT Analysis 113

8 Pipeline Assessment 114
8.1 Overview 114
8.2 Pipeline by Phases in Development 115
8.3 Product Profiles 115
8.3.1 Brain Biosciences CerePET 115
8.3.2 ECORAD Dual Modality Imager 117
8.3.3 FMI Technologies ScintiStar PET/CT 118
8.3.4 IntraMedical Imaging Marginator Beta Camera 120
8.3.5 INSERT SPECT/MRI 121
8.3.6 Nucare/Zecotek Photonics New Generation PET Scanning Device 124
8.3.7 Philips Healthcare PET Alpha Ring Detector 125
8.3.8 Photo Diagnostic Systems NeuroPET/CT 126
8.3.9 SynchroPET Breast PET/MRI 127
8.3.10 SynchroPET Wrist Scanner 128
8.3.11 SurgicEye SPECT Hybrid 129

9 Clinical Trials to Watch 131
9.1 Overview 131
9.2 Clinical Trial Profiles 131

10 Current and Future Players 134
10.1 Overview 134
10.2 Trends in Corporate Strategy 134
10.3 Company Profiles 135
10.3.1 DDD-Diagnostic 135
10.3.2 Digirad 137
10.3.3 GE Healthcare 141
10.3.4 GVI Medical Devices 146
10.3.5 Mediso Medical Imaging Systems 149
10.3.6 NeuroLogica 151
10.3.7 Neusoft Medical Systems 153
10.3.8 NuCare Medical Systems 156
10.3.9 Oncovision 158
10.3.10 Philips Healthcare 160
10.3.11 Shimadzu 167
10.3.12 Siemens Healthcare 172
10.3.13 SurgicEye 177
10.3.14 Toshiba Medical 180
10.3.15 Other Companies 185

11 Market Outlooks 188
11.1 Company Market Share Analysis 188
11.2 By Geography 188

12 Appendix 192
12.1 Abbreviations 192
12.2 Bibliography 196
12.3 Methodology 222
12.3.1 Overview 222
12.3.2 Coverage 222
12.3.3 Secondary Research 222
12.4 Physicians and Specialists Included in This Study 224
12.5 Primary Research 226
12.5.1 Primary Research - Key Opinion Leader Interviews 226
12.5.2 Expert Panel Validation 226
12.5.3 Stakeholder Survey 227
12.6 Forecasting Methodology 229
12.7 About the Authors 230
12.7.1 Andrew Thompson, PhD, Senior Analyst 230
12.7.2 Priya Radhakrishnan, MBA, Director, Medical Devices 230
12.7.3 Bonnie Bain, PhD, Global Head of Healthcare 231
12.8 About GlobalData 232
12.9 Disclaimer 232

List of Tables

Table 1: Applications of Nuclear Imaging 25
Table 2: FDG-PET Diagnostic Accuracy for Specific Cancers 26
Table 3: Potential Clinical Benefits of Hybrid Nuclear Imaging in Cardiology 29
Table 4: Applications of PET Imaging in Non-Cancer Neurology 30
Table 5: Applications of SPECT Imaging in Non-Cancer Neurology 30
Table 6: Characteristics of SPECT, PET, Ultrasound, CT, and MRI 35
Table 7: The Age of Canada's Hospital-Based Medical Technology Inventories, Relative to ECCREI Rules, 2009 36
Table 8: Nuclear Imaging Trends in US, 2012-2020 51
Table 9: Recent Device Recalls in the Nuclear Imaging Market 52
Table 10: Recent Key Events in the Nuclear Imaging Market 54
Table 11: Nuclear Imaging Market Drivers and Barriers 74
Table 12: Duplicate Diagnostic Test Incidence in France, Germany, UK, and US 86
Table 13: Dedicated PET Scanners 97
Table 14: Dedicated PET SWOT Analysis 98
Table 15: PET/CT Scanners 99
Table 16: PET/CT SWOT Analysis 101
Table 17: PET/MRI Systems 103
Table 18: PET/MRI SWOT Analysis 104
Table 19: Dedicated SPECT Systems 106
Table 20: Dedicated SPECT SWOT Analysis 107
Table 21: SPECT/CT Systems 110
Table 22: SPECT/CT SWOT Analysis 111
Table 23: SPECT-Ultrasound Systems 112
Table 24: SPECT/Ultrasound SWOT Analysis 113
Table 25: Nuclear Imaging Pipeline, 2014 115
Table 26: CerePET SWOT Analysis 117
Table 27: ECORAD Dual Modality Imager SWOT Analysis 118
Table 28: ScintiStar PET/CT SWOT Analysis 120
Table 29: Marginator SWOT Analysis 121
Table 30: INSERT SPECT-MRI SWOT Analysis 124
Table 31: Nucare/Zecotek Photonics New Generation PET Scanning Device SWOT Analysis 125
Table 32: PET Alpha Ring Detector 126
Table 33: NeuroPET/CT Scanner SWOT Analysis 127
Table 34: SynchroPET Breast PET/MRI SWOT Analysis 128
Table 35: SynchroPET Wrist Scanner 129
Table 36: SurgicEye SPECT/Ultrasound device SWOT Analysis 130
Table 37: Key Clinical Trials 132
Table 38: Company Profile - DDD-Diagnostic 135
Table 39: DDD-Diagnostic SWOT Analysis 137
Table 40: Company Profile - Digirad 138
Table 41: Digirad SWOT Analysis 141
Table 42: Company Profile - GE Healthcare 142
Table 43: GE Healthcare Product Portfolio 143
Table 44: GE Healthcare SWOT Analysis 146
Table 45: Company Profile - GVI Medical Devices 147
Table 46: GVI Medical Devices SWOT Analysis 148
Table 47: Company Profile - Mediso Medical Imaging Systems 149
Table 48: Mediso Medical Imaging Systems SWOT Analysis 150
Table 49: Company Profile - Neurologica 151
Table 50: Neurologica SWOT Analysis 153
Table 51: Company Profile - Neusoft Medical Systems 154
Table 52: Neusoft Medical Systems SWOT Analysis 156
Table 53: Company Profile - NuCare Medical Systems 157
Table 54: Nucare Medical Systems SWOT Analysis 158
Table 55: Company Profile - Oncovision 159
Table 56: Oncovision SWOT Analysis 160
Table 57: Company Profile - Philips Healthcare 161
Table 58: Philips Healthcare SWOT Analysis 167
Table 59: Company Profile - Shimadzu 168
Table 60: Shimadzu SWOT Analysis 171
Table 61: Company Profile - Siemens Healthcare 172
Table 62: Siemens Healthcare SWOT Analysis 177
Table 63: Company Profile - SurgicEye 178
Table 64: SurgicEye SWOT Analysis 180
Table 65: Company Profile - Toshiba Medical 181
Table 66: Toshiba Medical SWOT Analysis 184
Table 67: Other Companies in the Nuclear Imaging Market, 2014 185
Table 68: US Sales of PET and SPECT Imaging Systems, 2012-2020 189
Table 69: United States Market Value Forecast by Market Sub-segment (2012-2020) 190
Table 70: Primary Research Summary 227
Table 71: Primary Research Participants Affiliation 228

List of Figures

Figure 1: Cyclotron Distribution in 10 Countries 18
Figure 2: Localization of Tumor in Chest Cavity by PET, CT, and PET/CT 22
Figure 3: Mutually Beneficial Effects of PET/MRI Imaging 24
Figure 4: Nuclear Imaging Trends in US, 2012-2020 51
Figure 5: Total Medicare Expenditures for Imaging Services Paid Under the Physician Fee Schedule, 2000-2006 55
Figure 6: Imaging Utilization Rates (Number of Outpatient Visits with MRI/CT per 1,000 Persons), by Year in the US 75
Figure 7: US Company Market Shares for Nuclear Imaging Equipment (2012) 188
Figure 8: US Sales of PET and SPECT Imaging Systems, 2012-2020 189
Figure 9: United States Market Value Forecast by Market Sub-segment (2012-2020) 190
Figure 10: Primary Research Summary 227
Figure 11: Primary Research Participants Affiliation 228