REFERENCE CODE GDME1117CFR PUBLICAT ION DATE OCTOBER 2014 AORTIC STENT GRAFTS
Executive Summary Table below provides the key metrics for aortic stent grafts in the 5EU (France, Germany, Italy, Spain, and UK,). Aortic Stent Grafts, Key Metrics in Major Markets (2013) Procedure Volume of Abdominal Aortic Aneurysms (2013) Procedure Volume of Thoracic Aortic Aneurysms 24,773 5,981 5EU $288m Key Events (2012 2019) (2014) Cordis Corporation of Johnson & Johnson; the INCRAFT endograft is currently undergoing clinical trials in Europe, Japan, and the US; it is expected to be approved in 2014, 2018, and 2017 in each of the territories, respectively. (2014) Strong expectation from Endologix to continue to acquire more market share, thereby slicing into the top three players shares. (2014) Medtronic to acquire Covidien for $42.9bn, which can result in cuts in their endovascular business. (2014) Strong pipeline of stent grafts with good pipeline products from Asian and Western players. Competitive Assessment Impact Number of Devices in Marketing Phase 56 5EU $445m Source: GlobalData; primary research interviews with leading vascular surgeons in 5EU 5EU = France, Germany, Italy, Spain, and UK Sales for Aortic Stent Grafts The total aortic stent graft sales market in 2013 was estimated to be $288m across the 5EU. By the end of the forecast, the stent graft sales market will grow to over $445m, with a Compound Annual Growth Rate (CAGR) of 6.4%. The key drivers for the market in the forecast are: The growing prevalence of aortic aneurysms along with the aging population across the globe with hypertension and obesity. The growing technological advancement in minimally invasive procedures and the desire to eliminate the need for open surgical procedures for aneurysms. The major underserved population for minimally invasive aneurysm treatment in the emerging markets that is driving the procedural numbers up. The unmet need for better clinical outcomes and long-term studies to reduce the risk of endoleaks and other complications. 2
Executive Summary Figure below depicts the projected growth revenue for aortic stent grafts in the 5EU from 2013 to 2020. Aortic Stent Graft Revenue by Major Market (2013 2020) 8% 27% 8% 28% 12% 11% 2013 $288m 2020 $445m 18% 18% 35% 35% France Germany Italy Spain UK Source: GlobalData; primary research interviews and surveys with leading vascular surgeons in the 5EU The European Union (EU) forms about 24% of the global share in 2013. The EU is technologically the most advanced market, with the best availability of fenestrated and custom stent grafts on the market. The emerging markets see the most open surgical procedures, but stent use is restricted due to the cost of the products and procedures. As training programs for surgeons increase and product prices decrease, the emerging markets will present a strong opportunity for additional revenue for manufacturers. The overall CAGR across all EU markets is 6.4%, with XYZ representing the biggest growth opportunities. The growing concerns for multinational companies reside with the need to better target the fast-growing markets and the need to continue to be the leader in development to combat the threat of rising local manufacturers. Technological Trends Within the last twenty years, endovascular products have dramatically changed with development relating to improved navigation, trackability, and flexibility, as well as with the stability of access, especially through tortuous anatomy. Imaging technology has had an immense impact on the treatment rates and detection of aneurysms as well. The advances in ultrasound technology have greatly reduced the incidence of aneurysm rupture. As a result of better detection, there can be earlier intervention and fewer open surgeries, thereby resulting in more stent graft placement. 3
Executive Summary The technological developments in endovascular repair will essentially continue to result in positive growth. The primary technological drivers include the development of ultra-low profile systems to access difficult anatomies and arteries that are smaller in diameter. The customized fenestrated products have provided a major opportunity for physicians to treat a new patient pool that was only subject to open repair. Thoracic endovascular aneurysm repair (TEVAR) is also an area that is still in its infancy, thus yielding low procedure numbers. As there is more development in those product lines and as the abdominal aortic stent graft product matures, there can be a strong platform for development in the abdominal market as well. Generally, there is still much room for development in endovascular aortic repair (EVAR) and TEVAR, and as the products evolve, there will be continued growth in this market. Unmet Needs Remain a Challenge The complications in endovascular repair usually occur during or immediately after the procedure, which must be treated immediately through either interventional or open surgery methods. Endoleaks are the most common complication and area of focus; the remaining complications, such as paraplegia, infection, and limb thrombosis, amongst others, occur from time to time and knowledge of them can help enhance future product design. Technological challenges also pose an opportunity for the development of better products with better clinical outcomes. The availability of lower profile systems will continue to improve accessibility. Customized fenestrated stent grafts will allow more complicated aneurysms to be treated, thereby enhancing the potential patient pool. Multibranched systems will also allow for more tortuous anatomy to be treated. Finally, addressing the need for more long-term clinical data will allow more surgeons to be comfortable implanting stent grafts, with the assurance of durability in younger patients. Key Players in the Aortic Stent Graft Market At present, the aortic stent grafts market is still dominated by the top three players: Cook Medical, Gore Medical, and Medtronic. The products that are currently approved and on the market are all of high quality and each have their strengths with fixation types. The products in development by those outside of the top three players are all innovative in their own way, but a product that will show superior benefits with a lower or at least equal cost will be the one to grow the most. The most talked about emerging player in the market, based on GlobalData s key opinion leaders (KOLs), is Endologix. Endologix has one of the strongest product pipelines with significantly new product features and a new approach to treatment that has the potential to grab a piece of market share. The next one to three years will determine the quality of the potential products for Endologix, 4
Executive Summary based on approval and clinical trials. In the EU, the top 82% of the EVAR market and top 92% in TEVAR market belongs to the three companies mentioned earlier. The ongoing trend in the aortic stent grafts market is that the leading players will continue to maintain market share, unless a disruptive technology in this segment dramatically changes clinical outcomes. Aortic Stent Graft Market Future Outlook The economic downturn has been a source of continued concern for high priced medical devices across the global market. The aortic stent grafts market is not one that is excluded from this trend. Despite the high product price, physicians still see a significant benefit in providing endovascular options versus performing open surgery. As physician education improves and they have access to more clinical trial data, the outlook for the aortic stent grafts looks strong with there being much room for product improvement. The market outlook looks strong in the Western markets, as there is still much room for product adoption and growth. Regionally, one can expect slightly different drivers for growth.. In some countries, the EU market is still restricted by cost, thereby making physicians choose their patients carefully before implantation of the device. The aortic stent grafts market is a moderately growing market at a CAGR of 6.7% in EU, with some individual markets boasting a stronger CAGR over others. Within the 5EU, it is the cardiovascular sector that is expected to continue to grow the most in response to the continual technological developments and physicians acceptance of the products successful clinical performance. The EU market is based on, and will be driven by, the rising prevalence of aortic aneurysms and the aging population. GlobalData expects continued growth in this niche market with the major deterrent, globally, to be product price once a product is accepted by a surgeon. What Do Physicians Think? Physicians expect the cost of implants to be a growing concern for practices and hospitals. Cost is a major issue all across the board, specifically here. We try to do everything with the least cost possible. So, if the grafts are exactly the same and treat the same problem, then we try to use the graft that's cheaper. Key Opinion Leader In an economic downturn, we need to be able to show that what we do is cost-effective. Many hospitals, for example, have capped down the number of procedures that can be done in a year. Key Opinion Leader 5
Executive Summary With regard to the technological trends and product enhancement expectations, KOLs speak on what is needed the most today. Smaller sheath size, introduction diameter. And the reason being, is that a major limitation is the size of the external iliac arteries, disease there, not allowing you to pass the stent graft up. Lowerprofile delivery devices, which are also in trial. Actually, they're not on trial. For many companies, they're brand-new. Key Opinion Leader Physicians discuss government regulations where reimbursement plays a big part in choosing to do endovascular repair procedures. We use the product we think we need. The expensive price is limiting our activity, of course. So, we have to choose the product by indication. So, we cannot use these products. More patients; [we] have to select the best patients to use on this because of the price, sure. Key Opinion Leader Physicians are interested in solid clinical studies to prove outcomes in products. In all honesty, the specific product features don't matter as much as the trials that show whether a device is durable or not. Everyone has their little, We have a hook here, and other people have the supra-aortic stents. We have ones with hooks, ones without hooks. We have screws that go into the aortic wall. The reality is, unless there's some sort of published data, everything else is just theoretical. And to me, that doesn't matter. Key Opinion Leader Physicians talk about the shift from open surgery to endovascular repair. In the smaller hospitals where you have older surgeons who didn't have endovascular training, those are the ones who need more experience with the devices than people like myself, who've been out about four or five years. Key Opinion Leader [The] endovascular device, we would use that almost exclusively, except in super young patients. Patients less than 60, we offer an open operation just because it's durable. Technically speaking, you're fixing the problem both ways. It's just that we know that open will last 30, 40 years. We still don't know that about endovascular. Key Opinion Leader 6
1 1... 7 1.1 List of Tables... 15 1.2 List of Figures... 20 2 Introduction... 21 2.1 Catalyst... 22 2.2 Related Reports... 23 2.3 Upcoming Related Reports... 23 3 Industry Overview... 24 3.1 Overview... 24 3.2 Indications... 25 3.2.1 Aortic Abdominal Aneurysm... 25 3.2.2 Thoracic Aortic Aneurysm... 26 3.2.3 Aortic Dissection... 27 3.3 Clinical Outcomes... 28 3.3.1 Lifestyle Changes... 29 3.3.2 Medication... 30 3.3.3 Open Surgery... 30 3.3.4 Endovascular Repair... 31 3.4 Procedure Trends... 33 3.4.1 EU... 33 3.5 Market Access... 35 7
3.5.1 Adoption... 36 3.5.2 Regulation... 41 3.5.3 Reimbursement... 42 3.6 Regulatory Issues/Recalls... 48 3.6.1 Anaconda Back on the Market in March 2014 after a Voluntary Recall of Anaconda by Vascutek... 48 3.6.2 Terminated FDA s Class II Recall of TriVascular s Ovation Prime in April 2014... 48 3.7 Mergers, Deals, and Acquisitions... 48 3.7.1 Medtronic Acquires Covidien... 48 3.7.2 TriVascular Launches $100m Initial Public Offering... 49 3.7.3 Lombard Medical Pursues US Initial Public Offering... 49 3.7.4 TriVascular Raises $40m in Series E Financing... 49 3.7.5 LifeTech Scientific Creates Partnership with Medtronic... 49 3.7.6 LeMaitre Vascular Terminates Distribution Agreement with Endologix... 49 3.7.7 Jotec Enters Licensing Agreement with Hydromer... 50 3.7.8 Endologix Public Offering of Notes... 50 3.7.9 Aptus Endosystems Secures Financing... 50 3.7.10 Altura Medical Secures Financing... 50 3.7.11 Endologix Acquires Nellix Endovascular... 50 3.8 Economic Impact... 51 3.8.1 Economic Impact of Aneurysms... 51 3.8.2 Treatment Costs of Aortic Aneurysms... 52 4 Unmet Needs... 54 8
4.1 Addressing the Complications... 54 4.1.1 Endoleaks... 54 4.1.2 Ischemic Complications... 55 4.1.3 Limb Thrombosis... 56 4.1.4 Infection... 56 4.1.5 Paraplegia in Thoracic Aortic Aneurysm... 56 4.2 The Seal and Landing Zone... 57 4.3 Short Neck... 58 4.4 Cost Containment... 59 4.5 More Low Profile Systems... 60 4.6 Customized Fenestrated Stent Grafts... 60 4.7 Multi-Branch Stent Grafts... 61 4.8 Thoracic Endovascular Aneurysm Repair Unmet Needs... 62 4.9 Long-Term Clinical Data... 63 5 Market Opportunity Analysis... 64 5.1 Emerging Markets... 64 5.2 Thoracic Aortic Disease Market... 65 5.3 Addition of Physician Training Programs... 66 5.4 Disruptive Technologies... 67 5.5 Minimally Invasive Trend... 68 6 Market Drivers, Barriers, and Substitutes... 69 6.1 Driver: Rising Disease Prevalence... 69 6.1.1 Diabetes Mellitus... 69 9
6.1.2 Hypertension... 69 6.1.3 Obesity... 69 6.1.4 Tobacco Use... 70 6.2 Driver: Aging... 70 6.3 Driver: Imaging... 71 6.4 Driver: Improved Clinical Outcomes with Endovascular Therapy... 72 6.5 Driver: Time Savings... 72 6.6 Driver: Patient Demand and Awareness... 73 6.7 Driver: Technological Developments... 74 6.7.1 Custom Branched and Fenestrated Stent Grafts... 74 6.7.2 Low Profile Delivery Systems... 74 6.8 Driver: Rising Competition and Innovation... 76 6.9 Barrier: Availability of Venture Capital... 76 6.10 Barrier: Burden of Rising Regulation... 77 6.11 Barrier: High Treatment Cost... 78 6.12 Barrier: Proving Long-Term Efficacy... 79 6.13 Barrier: High Radiation Dosages with Excessive Imaging... 80 6.14 Surgical Limitations... 80 6.15 Barrier: Medical Device Excise Tax... 81 6.16 Substitute: Open Surgery... 81 6.17 Substitute: Chimney Technique versus Fenestrated Grafts... 82 7 Competitive Assessment... 84 7.1 Overview... 84 10
7.2 Key Marketed Products... 84 7.2.1 Endovascular Aneurysm Repair and Thoracic Endovascular Aneurysm Repair Products... 84 8 Pipeline Assessment... 95 8.1 Overview... 95 8.2 Product Profiles... 95 8.2.1 Altura Medical Endograft... 95 8.2.2 Cordis INCRAFT... 96 8.2.3 EndoSpan Horizon... 97 8.2.4 EndoSpan Nexus... 98 8.2.5 MicroPort Scientific Castor Branched Stent Graft System... 99 8.2.6 BiFlow Medical Novel Side-Branch Stent... 100 8.2.7 Endoluminal Sciences Endograft Mechanism... 101 8.2.8 Medtronic Valiant Mona LSA Stent Graft System... 102 8.2.9 Endologix Ventana Fenestrated Stent Graft... 102 9 Clinical Trials to Watch... 104 9.1 Overview... 104 9.2 Altura Medical... 104 9.3 Cook Medical... 105 9.4 Gore Medical... 107 9.5 Terumo Corporation... 108 9.6 Endologix... 109 9.7 TriVascular... 110 11
9.8 Bolton Medical... 111 9.9 Medtronic... 112 9.10 Cordis Corporation... 114 10 Current and Future Players... 115 10.1 Overview... 115 10.2 Trends in Corporate Strategy... 115 10.3 Company Profiles... 116 10.3.1 Cook Medical... 116 10.3.2 Endologix... 119 10.3.3 Gore Medical... 122 10.3.4 Medtronic... 124 10.3.5 Terumo Corporation... 127 10.3.6 Altura Medical... 129 10.3.7 Aptus Endosystems... 130 10.3.8 Bolton Medical... 132 10.3.9 Braile Biomédica... 134 10.3.10 B. Braun... 137 10.3.11 Cardiatis... 138 10.3.12 LeMaitre Vascular... 140 10.3.13 Lifetech Scientific... 142 10.3.14 Getinge Group... 144 10.3.15 Grikin Advanced Materials... 147 10.3.16 Johnson & Johnson s Cordis Corporation... 148 12
10.3.17 Jotec... 150 10.3.18 Lombard Medical... 152 10.3.19 MicroPort Scientific Corporation... 153 10.3.20 Nano Endoluminal... 156 10.3.21 TriVascular... 158 10.3.22 Weike Medical Apparatus and Instrument... 161 10.3.23 YTH Biological Material Scitech... 161 11 Market Outlook... 162 11.1 Company Market Share... 162 11.2 By Market Segment... 163 11.2.1 Overview... 163 11.2.2 Endovascular Aneurysm Repair... 165 11.2.3 Thoracic Endovascular Aneurysm Repair... 166 11.3 By Geography... 167 11.3.1 EU Overview... 167 11.3.2 EU... 170 12 Appendix... 182 12.1 Bibliography... 182 12.2 Abbreviations... 196 12.3 Research Methodology... 199 12.3.1 Overview... 199 12.3.2 Coverage... 199 12.3.3 Secondary Research... 199 13
12.4 Physicians and Specialists Included in this Study... 201 12.4.1 Christopher Abularrage, MD, FACS... 201 12.4.2 Gaspar Mestres Alomar, MD... 201 12.4.3 Enio Buffolo, MD, PhD... 201 12.4.4 Ludovic Canaud, MD, PhD... 201 12.4.5 Holger Eggebrecht, MD... 201 12.4.6 Daisuke Fukui, MD, PhD... 201 12.4.7 Germano Melissano, MD... 201 12.4.8 Dr. Raghuram Sekhar MS, FRCS (Edinburgh), FRCS (Glasgow)... 201 12.4.9 Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS (Gen Surg), DIC... 202 12.4.10 Jiang Xiong, MD, PhD... 202 12.5 Primary Research... 203 12.5.1 Primary Research Key Opinion Leader Interviews... 203 12.5.2 Primary Research Physician and Industry Interviews... 203 12.5.3 Expert Panel Validation... 204 12.6 Forecasting Methodology... 205 12.7 About the Authors... 206 12.7.1 Analysts... 206 12.7.2 Global Head of Healthcare... 207 12.8 About MediPoint... 208 12.9 About GlobalData... 208 12.10 Disclaimer... 208 14
1.1 List of Tables Table 1: Summary of Indications, Symptoms, and Treatments... 25 Table 2: Thoracic Aortic Aneurysm Types... 27 Table 3: Medications for Reducing Risk of Aneurysm Growth and Rupture... 30 Table 4: Advantages and Disadvantages of Open Repair versus Endovascular Repair... 32 Table 5: Group Purchasing Organizations in the EU... 40 Table 6: Regulatory Differences between the US and EU... 42 Table 7: Direct and Indirect Costs of Open Surgery and Endovascular Repair... 52 Table 8: Comparison Costs and Other Variables for Treating AAA By Open Repair and Stent Grafts in 2012 ($US)... 53 Table 9: Endoleak Types... 54 Table 10: Zenith Family Marketed Products... 86 Table 11: Zenith AAA SWOT... 86 Table 12: Zenith TAA SWOT... 87 Table 13: Endologix s Marketed Products... 88 Table 14: AFX Endovascular SWOT... 88 Table 15: IntuiTrak Powerlink System SWOT... 88 Table 16: Gore Medical s Marketed Products... 90 Table 17: Gore AAA Product SWOT... 90 Table 18: Gore TAA Product SWOT... 91 Table 19: Medtronic s Marketed Products... 92 Table 20: Medtronic AAA Product SWOT... 93 Table 21: Medtronic TAA Product SWOT... 93 Table 22: Terumo Corporation Marketed Products... 94 15
able 23: Terumo Corporation AAA Product SWOT... 94 Table 24: SWOT Analysis Altura Medical Endograft... 96 Table 25: SWOT Analysis Cordis INCRAFT... 97 Table 26: SWOT Analysis EndoSpan Horizon... 98 Table 27: SWOT Analysis EndoSpan Nexus... 99 Table 28: SWOT Analysis MicroPort Scientific Castor Branched Stent Graft System... 100 Table 29: SWOT Analysis BiFlow Medical Novel Side-Branch Stent... 101 Table 30: SWOT Analysis Endoluminal Sciences Endograft Mechanism... 101 Table 31: SWOT Analysis Medtronic Valiant Mona LSA Stent Graft... 102 Table 32: SWOT Analysis Endologix Ventana Fenestrated Stent Graft... 103 Table 33: Major Clinical Trials of Altura Medical s Aortic Stent Grafts... 105 Table 34: Major Clinical Trials of Cook Medical s Aortic Stent Grafts... 106 Table 35: Major Clinical Trials of Gore Medical s Aortic Stent Grafts... 107 Table 36: Major Clinical Trials of Terumo s Aortic Stent Grafts... 108 Table 37: Major Clinical Trials of Endologix s Aortic Stent Grafts... 109 Table 38: Major Clinical Trials of TriVascular s Aortic Stent Grafts... 110 Table 39: Major Clinical Trials of Bolton Medical s Aortic Stent Grafts... 111 Table 40: Major Clinical Trials of Medtronic s Aortic Stent Grafts... 112 Table 41: Major Clinical Trials of Cordis Aortic Stent Grafts... 114 Table 42: Company Profile Cook Medical... 117 Table 43: Cook Medical Marketed Products... 118 Table 44: SWOT Analysis Cook Medical... 119 Table 45: Company Profile Endologix Inc.... 120 Table 46: Endologix Marketed Products... 121 16
Table 47: Endologix Pipeline Products... 121 Table 48: SWOT Analysis Endologix Inc.... 121 Table 49: Company Profile Gore Medical... 122 Table 50: Gore Medical Marketed Products... 123 Table 51: SWOT Analysis Gore Medical... 124 Table 52: Company Profile Medtronic... 125 Table 53: Medtronic Marketed Products... 126 Table 54: SWOT Analysis Medtronic... 126 Table 55: Company Profile Terumo Corporation... 127 Table 56:Terumo Corporation Marketed Products... 128 Table 57: SWOT Analysis Terumo Corporation... 129 Table 58: Company Profile Altura Medical Inc.... 129 Table 59: Altura Medical Inc. Marketed Products... 130 Table 60: SWOT Analysis Altura Medical Inc.... 130 Table 61: Company Profile Aptus Endosystems, Inc.... 131 Table 62: Aptus Endosystems Inc. Marketed Products... 132 Table 63: SWOT Analysis Aptus Endosystems Inc.... 132 Table 64: Company Profile Bolton Medical... 133 Table 65: Bolton Medical Marketed Products... 134 Table 66: SWOT Analysis Bolton Medical... 134 Table 67: Company Profile Braile Biomédica... 135 Table 68: Braile Biomédica Marketed Products... 136 Table 69: SWOT Analysis Braile Biomédica... 136 Table 70: Company Profile B. Braun... 137 17
Table 71: B. Braun Marketed Products... 138 Table 72: SWOT Analysis B. Braun... 138 Table 73: Company Profile Cardiatis... 139 Table 74: Cardiatis Marketed Products... 139 Table 75: SWOT Analysis Cardiatis... 140 Table 76: Company Profile LeMaitre Vascular... 141 Table 77: LeMaitre Vascular Medical Marketed Products... 141 Table 78: SWOT Analysis LeMaitre Vascular... 142 Table 79: Company Profile Lifetech Scientific... 143 Table 80: Lifetech Scientific Marketed Products... 143 Table 81: SWOT Analysis Lifetech Scientific... 144 Table 82: Company Profile Getinge Group... 145 Table 83: Getinge Group Marketed Products... 146 Table 84: SWOT Analysis Getinge Group... 146 Table 85: Company Profile Grikin Advanced Materials... 147 Table 86: Grikin Advanced Materials Marketed Products... 147 Table 87: SWOT Analysis Grikin Advanced Materials... 148 Table 88: Company Profile Johnson & Johnson Cordis Corporation... 148 Table 89: Cordis Corporation s Pipeline Product... 149 Table 90: SWOT Analysis Cordis Corporation... 149 Table 91: Company Profile Jotec... 150 Table 92: Jotec s Marketed Products... 151 Table 93: SWOT Analysis Jotec... 151 Table 94: Company Profile Lombard Medical... 152 18
Table 95: Lombard Medical Marketed Products... 153 Table 96: SWOT Analysis Lombard Medical... 153 Table 97: Company Profile Microport Scientific Corporation... 154 Table 98: MicroPort Scientific Marketed Products... 155 Table 99: SWOT Analysis MicroPort Scientific... 156 Table 100: Company Profile Nano Endoluminal... 157 Table 101: Nano Endoluminal Medical Marketed Products... 157 Table 102: SWOT Analysis Nano Endoluminal... 158 Table 103: Company Profile TriVascular... 159 Table 104: TriVascular Marketed Products... 160 Table 105: SWOT Analysis TriVascular... 160 Table 106: 5EU Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011 2020... 164 Table 107: 5EU Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011 2020... 165 Table 108: 5EU Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011 2020... 166 Table 109: Aortic Stent Grafts Sales ($m) for the 5EU, 2011 2020... 167 Table 110: Aortic Stent Grafts Sales ($m) Forecast for the 5EU, 2011 2020... 170 Table 111: Aortic Stent Grafts Sales ($m) Forecast for France, 2011 2020... 172 Table 112: Aortic Stent Grafts Sales ($m) Forecast for Germany, 2011 2020... 174 Table 113: Aortic Stent Grafts Sales ($m) Forecast for Italy, 2011 2020... 177 Table 114: Aortic Stent Grafts ($m) Forecast for Spain, 2011 2020... 179 Table 115: Aortic Stent Grafts Sales ($m) Forecast for the UK, 2011 2020... 181 19
1.2 List of Figures Figure 1: Treatment Methodology Markov Model... 29 Figure 2: Aortic Stent Graft Product Image... 32 Figure 3: EU Abdominal Aortic Stent Grafts Procedure Volume, 2011 2020... 34 Figure 4: EU Thoracic Aortic Stent Grafts Procedure Volume, 2011 2020... 35 Figure 5: EU Market Share for EVAR, 2013... 162 Figure 6: EU Market Share for TEVAR, 2013... 163 Figure 7: 5EU Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011 2020... 164 Figure 8: 5EU Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011 2020... 165 Figure 9: 5EU Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011 2020... 166 Figure 10: Aortic Stent Grafts Sales ($m) for 5EU, 2011 2020... 168 Figure 11: Aortic Stent Grafts by Major Market, 2013 and 2020... 169 Figure 12: 5EU Sales ($m) Forecast for Aortic Stent Grafts, 2011 2020... 171 Figure 13: France Sales ($m) Forecast for Aortic Stent Grafts, 2011 2020... 173 Figure 14: Germany Sales ($m) Forecast for Aortic Stent Grafts, 2011 2020... 175 Figure 15: Italy Sales ($m) Forecast for Aortic Stent Grafts, 2011 2020... 177 Figure 16: Spain Sales ($m) Forecast for Aortic Stent Grafts, 2011 2020... 179 Figure 17: UK Sales ($m) Forecast for Aortic Stent Grafts, 2011 2020... 181 Figure 18: Aortic Stent Graft Primary Research, Supply and Demand-Side Interviews... 204 20
Introduction 2 Introduction Aortic stent grafts are most commonly used to reinforce a weak spot in an artery, which is known as an aneurysm. The stent grafts are designed to seal tightly with the patient s native artery above and below the aneurysm, and are used to treat abdominal aortic aneurysms (AAAs) as well as thoracic aortic aneurysms (TAAs). Aortic aneurysms, as opposed to aneurysms found elsewhere in the body, are potentially very serious, as a burst aorta results in massive internal bleeding that can be fatal unless treated rapidly by an experienced emergency medical team. Since their introduction in patients in 1991, aortic stent graft devices have gained wide acceptance and availability, with their adoption fueled in great part by advances in stent-graft design and by a variety of devices for various anatomic features. Over time, these devices have gained traction for use in patients with ruptured aneurysms because they are minimally invasive and have shorter recovery times. Based on GlobalData s key opinion leader (KOL) research, in the more mature Western markets, about 80% of surgical treatments for aneurysms are treated through endovascular therapy. The remaining market is treated by open surgical options. This surgical rate is reduced further in the emerging nations, due to the high product cost. While endovascular therapy has its clear benefits, there are strong arguments still being made both clinically, and from a cost perspective, to continue doing open surgery. Overall, this minimally invasive endovascular technique saves hospitalization costs in the short run while it continues to bring in revenue for hospitals and practices, as several more of these cases can be scheduled in a day, with shorter surgical times. From a clinical standpoint, there are a multitude of clinical trials in progress as the stent grafts and their delivery systems are trending towards lower and lower profile systems, thereby allowing the products to be used on a wider patient population that previously, was treatable only through open techniques. Overall, GlobalData expects the procedural data to continue to grow across the European major markets (5EU) (France, Germany, Italy, Spain and UK,), with the greatest opportunity being in the emerging nations. This report focuses on the aortic stent graft implant market for abdominal and TAAs. The abdominal aortic market comprises about 80 90% of the market, with the niche market being the thoracic one. The thoracic aneurysm repair market is still a young market where there is a strong pipeline of products from both the large manufacturers and small emerging players. For most manufacturers, following the successful launch of an AAA product, the thoracic stent graft segment presents the opportunity with the most unmet needs for pursuit. 21
Introduction The 5EU are covered and forecast in this report, which provides the unmet needs, future adoption, and Compound Annual Growth Rates (CAGRs) in both the abdominal stent graft and thoracic stent graft markets. GlobalData s analysis demonstrates this market to be a young and growing market, subject to rapid technological development and with much room for product adoption. 2.1 Catalyst Increasing the applicability of aortic stent grafts to patients with difficult anatomic features will likewise require improvements as well as innovation in device design. Currently, the three most common anatomic reasons for exclusion from the endovascular repair of AAAs are inappropriate aortic (proximal) neck access, iliac artery aneurysms, and inadequate iliac access. Researchers have noted that the next frontier for aortic stent grafts will be the continued adoption and development of endografts that are capable of treating various types of aortic aneurysms for a number of different patient anatomies. Further, in order to avoid follow-up on patients with implanted devices, future aortic stent graft products will have increased durability, refined designs to allow for treatment in the most difficult anatomies, and advanced abilities to treat aneurysms involving the renal and visceral segments of the aorta. There are significant opportunities remaining for companies that can develop slimmer devices with reduced sheath diameter, improve the fixation of grafts, or add additional features including branches or fenestrated necks. Currently, some of the most frequently encountered barriers for aortic stent graft use consist of an inadequate or inappropriate proximal neck anatomy and an inadequate caliber of iliofemoral access vessels. As such, the ability of devices to accommodate patients with difficult necks or treacherous access vessels is important. That said, novel bifurcated endografts along with the development of widely available branched and fenestrated grafts are expected to address these barriers, thereby improving upon the already remarkable clinical Currently, some of the most frequently encountered barriers for aortic stent graft use consist of an inadequate or inappropriate proximal neck anatomy and an inadequate caliber of iliofemoral access vessels. success of this procedure. This report looks at the current aortic stent grafts market for cardiovascular disease and evaluates the adoption and opportunities for this technology in the 5EU. In the 5EU region, this market is expected to rise from $288 million in 2014 to $445 million in 2020, at a CAGR of 6.4%. 22
Introduction 2.2 Related Reports GlobalData (2012). Bioabsorbable Stents Global Market Analysis and Forecasts, December 2012, GDME0164MAR GlobalData (2012). Peripheral Vascular Stents Global Market Analysis and Forecasts, April 2012, GDME0168MAR GlobalData (2013). Drug Eluting Balloons Global Market Analysis and Forecasts, September 2013, GDME0179MAR GlobalData (2014). Neurovascular Interventions Global Market Analysis and Forecasts April 2014, GDME0194MAR 2.3 Upcoming Related Reports GlobalData (2014). Coronary Stents Global Market Analysis and Forecast, to be published 23
Appendix 12.8 About MediPoint MediPoint is the flagship product for GlobalData s Medical team. Each MediPoint report is built from the ground up by our team of healthcare analysts in the US and UK. Each report includes input from experienced physicians and leading Key Opinion Leaders (KOLs). Running throughout each report in the series are, What Do Physicians Think quotes, which provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. 12.9 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. 12.10 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. 208