REFERENCE CODE GDME0208M AR PUBLICATION DATE DECEMBER 2014 NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

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1 REFERENCE CODE GDME0208M AR PUBLICATION DATE DECEMBER 2014 NUCLEAR IMAGING- PET AND SPECT EQUIPMENT -

2 Executive Summary Nuclear Imaging Market Overview GlobalData estimates the global nuclear imaging market to have been worth $1.77 billion in 2012 and $1.83 billion in GlobalData estimates that this market will be worth $2.2 billion in 2020, increasing at a Compound Annual Growth Rate (CAGR) of 3.3% during the period of 2014 to The key drivers for the global nuclear imaging market are: Aging population and increasing disease prevalence Increasing referring physician awareness Increasing defensive medicine The key barriers of the global nuclear imaging market are: Legislation affecting reimbursements The lobbying efforts of medical insurance companies and consequent reduction in the number of procedures performed Greater scrutiny of electronic medical records by healthcare payers, leading to a reduction in the number of procedures performed. Increased use of appropriateness criteria, resulting in reduced examinations Practice guidelines reducing unnecessary procedures Increasing patient awareness Loss of nuclear medicine skills Increasing self-referral behavior High cost of instruments and reagents Increasing implementation of comparative effectiveness research Supply difficulties and increasing cost of radiopharmaceuticals Improved accreditation of imaging facilities Availability of new imaging reagents Increasing demand for cancer diagnoses Increasing demand for imaging-based companion diagnostics Replacement of positron emission tomography (PET)/computed tomography (CT) by PET/magnetic resonance imaging (MRI) Replacement of single-photon emission computed tomography (SPECT)-only systems Medical Device Excise tax increasing development costs Hospital consolidation reducing the number of scanning facilities The nuclear imaging market is a moderately growing market with a CAGR of 3.3% globally. It is a mature sector of the diagnostic imaging market; continued growth is expected along with continued technological developments and the emerging markets acceptance of products. 2

3 Executive Summary Below mentioned Table presents the key metrics of the nuclear imaging industry during Nuclear Imaging Key Metrics: Key Events and Pipeline Assessment 2012 Market Sales ($m) US 5EU APAC Brazil Total Key Events ( ) Patient Protection and Affordable Care Act of 2010 Affordable Care Act of 2011 Approval by European Council on new EU Medical Device Regulations in 2015 Implementation of new EU Medical Device Regulations during 2018 to 2020 Reform of CFDA Medical Device Regulation in 2014 Conclusion of Philips PET Alpha Ring trials in 2014 GE Healthcare PET/CT & PET/MRI Comparison Trial 2014 Pipeline and Competitive Landscape Assessment $1,216.4m $212.6m $286.1m $55.4m $1,770.6m Level of Impact Total pipeline products profiled 11 Total companies profiled Market Sales ($m) US 5EU APAC Brazil Total $1,165.6m $308.2m $631.5m $91.2m $2,196.3m Source: GlobalData, primary research interviews with leading nuclear medicine specialist in 10 markets (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India). 5EU = France, Germany, Italy, Spain, and UK; APAC = Asia-Pacific (Japan, China, and India) US Dominates the Nuclear Imaging Market In 2012, the US dominated the global nuclear imaging market, accounting for 69% of sales globally. The market is dominated by three companies: the market leader is Philips Healthcare with around 35% of the market by revenue, followed closely by GE Healthcare with around 33% of the market, and Siemens Healthcare at just under 30%. Global Nuclear Imaging Market in 2012 APAC 16% 5EU 12% Source: GlobalData Brazil 3% United States 69% APAC = Asia Pacific; 5EU = France, Germany, Italy, Spain, and UK Demand for Nuclear Imaging in US to Become Static The US is the largest market for nuclear imaging, in terms of the number of systems sold and the number of procedures carried out. However, a period of a rapid increase in procedures in the US, particularly PET and PET/CT, has led to measures to reduce the number of procedures that can be reimbursed, and thus reduce the demand for 3

4 Executive Summary nuclear imaging systems. Prior to healthcare reform, the major threat to the US nuclear imaging market was the limited supply of radiopharmaceuticals. APAC to Foster Future Growth APAC economies, especially China and Japan, will continue to provide immense opportunities for increasing sales within the global nuclear imaging market. GlobalData projects that Japan will increase its market share by 75% and that China will almost double its market share. GlobalData expects that the growth of sales in China will be attributed in part to the sale of more PET/CT and SPECT/CT systems, whereas in Japan, growth will be due to increasing demand for SPECT/CT and PET/MRI systems. Future Outlook The economic downturn has been a continued concern within the whole of the diagnostic imaging market. Indeed, the high cost of nuclear imaging equipment and procedures has made the nuclear imaging market more susceptible to the downturn. The market growth for nuclear imaging in the US and EU is heavily dependent on the replacement of already existing systems because, as is the case in most of the developed countries, the capacity for new installations is limited. As the US and EU economies recover, it can be expected that the equipment will be replaced. However, at this point in time, the key opinion leaders (KOLs) that GlobalData interviewed for this report indicated that not all equipment is replaced at the end of the average product lifecycle, negatively affecting sales in the US and EU markets. The rising prevalence of disease, an aging population, and a growing global population will act as major drivers of the increased use of nuclear imaging. However, cost-containment measures implemented by healthcare authorities will affect which nuclear imaging technologies are favored. What do Physicians Think? GlobalData interviewed a number of KOLs in the nuclear imaging setting; they discussed a wide variety of points and concerns, providing insight into clinicians view of the technologies found in nuclear imaging, both existing and future. In addition, the KOLs provided viewpoints into the healthcare regimes related to nuclear imaging, and how these might affect access to imaging. Physicians provided insight into the major imaging modalities, PET/CT, SPECT/CT and PET/MRI. PET/CT will eventually replace many SPECT/CT procedures, but this is dependent upon progress in developing new radiotracer compounds. Whenever a tracer appears that can replace SPECT/CT by PET/CT, SPECT/CT will tend to disappear, but this will be a very slow [process]. In the next ten years probably the number of PET/CT examinations will [double] and those by SPECT/CT [will halve]. EU KOL 4

5 Executive Summary But there is still space for SPECT, provided that the major manufacturer promotes it as a technique. [It s] only very recently that manufacturers have started promoting SPECT as a competitive tool. I m surprised; I don t know why it took so long. Maybe it s because they were pretty overwhelmed in their expanding PET market. EU KOL While SPECT is well-established, SPECT/CT still struggles to be reimbursed. Reimbursements are down, and specifically talking about nuclear medicine, we have been doing SPECT but there isn t any reimbursement for SPECT/CT; for those hybrid modalities there isn t a separate reimbursement, and that is where people are providing a service when needed and doing SPECT/CTs, but not getting any additional remuneration for these services provided. US KOL Physicians remain to be convinced that PET/MRI will revolutionize nuclear imaging. The real question is whether, given the expense and the complexity, if [PET/MRI] ever gets out of the academic medical centers and into general clinical practice. There hasn t been an application that really justifies the complexity and the added cost. Stricter policies by insurance companies are affecting patient access to nuclear imaging. More and more insurance companies are using appropriateness criteria strictly, and regulating access to PET/CT procedures especially the cancer population. US KOL US healthcare reforms may eventually increase patient access to nuclear imaging, but may not necessarily benefit the physician. As the effects of the Affordable Care Act kick in It may balance out where the volumes are increasing, because more people have insurance, but the reimbursements are going down. US KOL Changes in reimbursement policies, leading to a reduction in the number of nuclear imaging procedures, are affecting hiring at hospitals and leading to a potential loss of skills. These days they are hiring people with skills in the rest of radiology, such as CT, MR, and not just nuclear medicine, so that s the reason why nuclear medicine jobs are shrinking. US KOL US KOL 5

6 Executive Summary Ultimately, changes in reimbursement affecting the career prospects of specialist physicians may also result in the dilution of nuclear imaging skills might affect the effectiveness of diagnosing disease. Radiologists who read PET/CT studies are also not certified.. only have four months of nuclear medicine, so imagine the life of a cancer patient or a management position dependent on a person who has had only four months of training in that specialty. US KOL 6

7 List of Tables List of Figures Introduction Catalyst Related Reports Industry Overview Nuclear Imaging Techniques Positron Emission Tomography Single-Photon Emission Computed Tomography Planar Scintigraphy Hybrid Imaging Clinical Applications of Nuclear Imaging Technology Cancer Cardiology Neurology Infection and Inflammation Advantages and Disadvantages of Nuclear Imaging Technologies Market Access Product Life Cycle Purchasing Decisions Equipment Leasing Replacement of PET/CT by PET/MRI Reimbursement Overview US

8 3.5.3 France Germany Italy Spain UK Japan Brazil China India Procedure Trends US France Germany Italy Spain UK Japan Brazil China India Regulatory Issues/Recalls M&As and Key Partnerships Economic Impact US Europe Unmet Needs Overview

9 4.2 Improved Reimbursement for New Techniques Lack of Binding Clinical Guidelines Patient Comfort and Convenience Reducing Radiation Exposure Improved Scanner Performance Image Processing Software Improvements Increased Risk of Artifacts in Hybrid Images Demand for New Radiotracers Improved Clinical Input into the Design Process Market Opportunity Analysis Cheaper, Simpler Nuclear Imaging Devices SPECT/CT in Developing Countries Increased Demand for Teleradiology Services Market Drivers and Barriers Driver: Aging Population and Increasing Disease Prevalence Driver: Referring Physician Awareness Driver: Defensive medicine Driver: Patient Awareness Driver: Self-Referral Driver: New Imaging Agents Driver: Increasing Demand for Cancer Diagnostic Tests Driver: Companion Diagnostic Testing Barrier: Comparative Effectiveness Research Barrier: Reimbursement Legislation Barrier: Increasing Demand for Nuclear Imaging in Developing Markets Barrier: Insurance Company Lobbying to Reduce Unnecessary Imaging Barrier: Greater Payer Scrutiny of EMRs

10 6.14 Barrier: Increased Use of Appropriateness Criteria Barrier: Practice Guidelines to Reduce Unnecessary Procedures Barrier: Imaging Facility Accreditation Barrier: Loss of Nuclear Medicine Skills Barrier: High Cost of Instruments and Reagents Barrier: Radiopharmaceutical Cost and Supply Difficulties Barrier: Medical Device Excise Tax Barrier: Hospital Consolidation Competitive Assessment Overview Dedicated PET Systems Overview Product Profile SWOT Analysis PET/CT Systems Overview Product Profiles SWOT Analysis PET/MRI Systems Overview Product Profile SWOT Analysis Dedicated SPECT Systems Overview Product Profile SWOT Analysis SPECT/CT Systems

11 7.6.1 Overview Product Profile SWOT Analysis PET/Ultrasound and SPECT/Ultrasound Systems Overview Product Profile SWOT Analysis Pipeline Assessment Overview Pipeline by Phases in Development Product Profiles Brain Biosciences CerePET ECORAD Dual Modality Imager FMI Technologies ScintiStar PET/CT IntraMedical Imaging Marginator Beta Camera INSERT SPECT/MRI Nucare/Zecotek Photonics New Generation PET Scanning Device Philips Healthcare PET Alpha Ring Detector Photo Diagnostic Systems NeuroPET/CT SynchroPET Breast PET/MRI SynchroPET Wrist Scanner SurgicEye SPECT Hybrid Clinical Trials to Watch Overview Clinical Trial Profiles Current and Future Players Overview

12 10.2 Trends in Corporate Strategy Company Profiles DDD-Diagnostic Digirad GE Healthcare GVI Medical Devices Mediso Medical Imaging Systems NeuroLogica Neusoft Medical Systems NuCare Medical Systems Oncovision Philips Healthcare Shimadzu Siemens Healthcare SurgicEye Toshiba Medical Other Companies Market Outlooks Company Market Share Analysis Global Overview US France Germany Italy Spain UK Japan

13 Brazil China India Market Segment Share SPECT & SPECT/CT PET, PET/CT & PET/MRI By Geography Global Overview US France Germany Italy Spain UK Japan Brazil China India Appendix Abbreviations Bibliography Methodology Overview Coverage Secondary Research Physicians and Specialists Included in This Study Primary Research

14 Primary Research Key Opinion Leader Interviews Expert Panel Validation Stakeholder Survey Forecasting Methodology About the Authors Andrew Thompson, PhD, Senior Analyst Priya Radhakrishnan, MBA, Director, Medical Devices Bonnie Bain, PhD, Global Head of Healthcare About GlobalData Disclaimer List of Tables Table 1: Applications of Nuclear Imaging Table 2: FDG-PET Diagnostic Accuracy for Specific Cancers Table 3: Potential Clinical Benefits of Hybrid Nuclear Imaging in Cardiology Table 4: Applications of PET Imaging in Non-Cancer Neurology Table 5: Applications of SPECT Imaging in Non-Cancer Neurology Table 6: Characteristics of SPECT, PET, Ultrasound, CT, and MRI Table 7: The Age of Canada s Hospital-Based Medical Technology Inventories, Relative to ECCREI Rules, Table 8: Nuclear Imaging Trends in US, Table 9: Nuclear Imaging Trends in France, Table 10: Nuclear Imaging Trends in Germany, Table 11: Nuclear Imaging Trends in Italy, Table 12: Nuclear Imaging Trends in Spain, Table 13: Nuclear Imaging Trends in UK,

15 Table 14: Nuclear Imaging Trends in Japan, Table 15: Nuclear Imaging Trends in Brazil, Table 16: Nuclear Imaging Trends in China Table 17: Nuclear Imaging Trends in India, Table 18: Recent Device Recalls in the Nuclear Imaging Market Table 19: Recent Key Events in the Nuclear Imaging Market Table 20: Nuclear Imaging Market Drivers and Barriers Table 21: Duplicate Diagnostic Test Incidence in France, Germany, UK, and US Table 22: Dedicated PET Scanners Table 23: Dedicated PET SWOT Analysis Table 24: PET/CT Scanners Table 25: PET/CT SWOT Analysis Table 26: PET/MRI Systems Table 27: PET/MRI SWOT Analysis Table 28: Dedicated SPECT Systems Table 29: Dedicated SPECT SWOT Analysis Table 30: SPECT/CT Systems Table 31: SPECT/CT SWOT Analysis Table 32: SPECT-Ultrasound Systems Table 33: SPECT/Ultrasound SWOT Analysis Table 34: Nuclear Imaging Pipeline, Table 35: CerePET SWOT Analysis Table 36: ECORAD Dual Modality Imager SWOT Analysis Table 37: ScintiStar PET/CT SWOT Analysis

16 Table 38: Marginator SWOT Analysis Table 39: INSERT SPECT-MRI SWOT Analysis Table 40: Nucare/Zecotek Photonics New Generation PET Scanning Device SWOT Analysis Table 41: PET Alpha Ring Detector Table 42: NeuroPET/CT Scanner SWOT Analysis Table 43: SynchroPET Breast PET/MRI SWOT Analysis Table 44: SynchroPET Wrist Scanner Table 45: SurgicEye SPECT/Ultrasound device SWOT Analysis Table 46: Key Clinical Trials Table 47: Company Profile DDD-Diagnostic Table 48: DDD-Diagnostic SWOT Analysis Table 49: Company Profile Digirad Table 50: Digirad SWOT Analysis Table 51: Company Profile GE Healthcare Table 52: GE Healthcare Product Portfolio Table 53: GE Healthcare SWOT Analysis Table 54: Company Profile GVI Medical Devices Table 55: GVI Medical Devices SWOT Analysis Table 56: Company Profile Mediso Medical Imaging Systems Table 57: Mediso Medical Imaging Systems SWOT Analysis Table 58: Company Profile Neurologica Table 59: Neurologica SWOT Analysis Table 60: Company Profile Neusoft Medical Systems Table 61: Neusoft Medical Systems SWOT Analysis

17 Table 62: Company Profile NuCare Medical Systems Table 63: Nucare Medical Systems SWOT Analysis Table 64: Company Profile Oncovision Table 65: Oncovision SWOT Analysis Table 66: Company Profile Philips Healthcare Table 67: Philips Healthcare SWOT Analysis Table 68: Company Profile Shimadzu Table 69: Shimadzu SWOT Analysis Table 70: Company Profile Siemens Healthcare Table 71: Siemens Healthcare SWOT Analysis Table 72: Company Profile SurgicEye Table 73: SurgicEye SWOT Analysis Table 74: Company Profile Toshiba Medical Table 75: Toshiba Medical SWOT Analysis Table 76: Other Companies in the Nuclear Imaging Market, Table 77: Global Market Value Forecast by Market Segment for SPECT & SPECT/CT ( ) Table 78: Global Market Value Forecast by Market Segment for PET, PET/CT & PET/MRI ( ) Table 79: Global Sales of PET and SPECT Imaging Systems, Table 80: United States Market Value Forecast by Market Sub-segment ( ) Table 81: France Market Value Forecast by Market Sub segment ( ) Table 82: Germany Market Value Forecast by Market Sub segment ( ) Table 83: Italy Market Value Forecast by Market Sub-segment ( ) Table 84: Spain Market Value Forecast by Market Sub-segment ( ) Table 85: UK Market Value Forecast by Market Sub-segment ( )

18 Table 86: Japan Market Value Forecast by Market Sub-segment ( ) Table 87: Brazil Market Value Forecast by Market Sub-segment ( ) Table 88: China Market Value Forecast by Market Sub-segment ( ) Table 89: India Market Value Forecast by Market Sub-segment ( ) Table 90: Primary Research Summary Table 91: Primary Research Participants Affiliation List of Figures Figure 1: Cyclotron Distribution in 10 Countries Figure 2: Localization of Tumor in Chest Cavity by PET, CT, and PET/CT Figure 3: Mutually Beneficial Effects of PET/MRI Imaging Figure 4: Nuclear Imaging Trends in US, Figure 5: Nuclear Imaging Trends in France, Figure 6: Nuclear Imaging Trends in Germany, Figure 7: Nuclear Imaging Trends in Italy, Figure 8: Nuclear Imaging Trends in Spain, Figure 9: Nuclear Imaging Trends in UK, Figure 10: Nuclear Imaging Trends in Japan, Figure 11: Nuclear Imaging Trends in Brazil, Figure 12: Nuclear Imaging Trends in China, Figure 13: SPECT and PET Imaging Trends in India, Figure 14: Total Medicare Expenditures for Imaging Services Paid Under the Physician Fee Schedule, Figure 15: Imaging Utilization Rates (Number of Outpatient Visits with MRI/CT per 1,000 Persons), by Year in the US

19 Figure 16: Global Company Market Shares for Nuclear Imaging Equipment (2012) Figure 17: US Company Market Shares for Nuclear Imaging Equipment (2012) Figure 18: France Company Market Shares for Nuclear Imaging Equipment (2012) Figure 19: Germany Company Market Shares for Nuclear Imaging Equipment (2012) Figure 20: Italy Company Market Shares for Nuclear Imaging Equipment (2012) Figure 21: Spain Company Market Shares for Nuclear Imaging Equipment (2012) Figure 22: UK Company Market Shares for Nuclear Imaging Equipment (2012) Figure 23: Japan Company Market Shares for Nuclear Imaging Equipment (2012) Figure 24: Brazil Company Market Shares for Nuclear Imaging Equipment (2012) Figure 25: China Company Market Shares for Nuclear Imaging Equipment (2012) Figure 26: India Company Market Shares for Nuclear Imaging Equipment (2012) Figure 27: Global Market Value Forecast by Market Segment for SPECT & SPECT/CT ( ) Figure 28: Global Market Value Forecast by Market Segment for PET, PET/CT, and PET/MRI ( ) Figure 29: Global Sales of PET and SPECT Imaging Systems, Figure 30: Global Market Share of Nuclear Imaging, 2012 and Figure 31: United States Market Value Forecast by Market Sub-segment ( ) Figure 32: France Market Value Forecast by Market Subsegment ( ) Figure 33: Germany Market Value Forecast by Market Sub segment ( ) Figure 34: Italy Market Value Forecast by Market Sub segment ( ) Figure 35: Spain Market Value Forecast by Market Sub-segment ( ) Figure 36: UK Market Value Forecast by Market Sub-segment ( ) Figure 37: Japan Market Value Forecast by Market Sub segment ( ) Figure 38: Brazil Market Value Forecast by Market Sub segment ( ) Figure 39: China Market Value Forecast by Market Sub-segment ( )

20 Figure 40: India Market Value Forecast by Market Sub segment ( ) Figure 41: Primary Research Summary Figure 42: Primary Research Participants Affiliation

21 Introduction 2 Introduction An early diagnosis of disease is the foundation of increasing survival rates. Single-photon emission computed tomography (SPECT) and positron emission tomography (PET) imaging are diagnostic imaging techniques that are widely used in a variety of disease areas including oncology, cardiovascular disease, bone disease, and infectious disease. This report provides an analysis of the nuclear imaging market, with a particular focus on SPECT and PET imaging and hybrid modalities within the US, the 5EU (France, Germany, Italy, Spain, and UK), Brazil, and the Asia- Pacific (APAC) region (Japan, China, and India). This report identifies the drivers and barriers to nuclear imaging, as well as unmet needs in this market. This report also discusses physician attitudes towards current diagnostic nuclear imaging modalities, and the future of nuclear imaging in the face of rapid technological advancement and an increasingly challenging reimbursement environment. 2.1 Catalyst PET and SPECT imaging are well-established techniques in the nuclear imaging market. The advent of hybrid imaging has enabled PET/CT imaging to undergo explosive growth, but this has increased demand on struggling healthcare budgets. New developments in hybrid nuclear imaging promise to further increase the utility of these technologies, while significantly improving patient cost savings and safety by reducing the repeated or examinations. However, these improvements come with a significant increase in the capital cost of equipment. This report examines how new technologies can emerge in the face of healthcare reform and other economic pressures that may affect the demand for nuclear imaging. Further, it focuses on the industry trends, promising pipeline products, and competitive landscape of nuclear imaging. 21

22 Introduction 2.2 Related Reports GlobalData (2013). MediFocus: Future of Molecular Imaging, August, 2013, GDME002MFR. GlobalData (2013). MediPoint: Breast Cancer Imaging Global Analysis and Market Forecasts, May, 2013, GDME0166MAR. GlobalData (2014). MediPoint: Diagnostic Ultrasound Imaging - Global Analysis and Market Forecasts, January 2014, GDME0182MAR. GlobalData (2014). MediPoint: Diagnostic X-ray Imaging - Global Analysis and Market Forecasts, July 2014, GDME0203MAR. 22

23 Appendix 12.8 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 research and development. 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, San Francisco, Boston, London, India, Korea, Japan, Singapore, and Australia 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. 319