The World Market for Stents

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CHAPTER ONE: EXECUTIVE SUMMARY .................................................................. 1

Disease Overview .......................................................................................................................... 1
Cardiovascular Disease............................................................................................................... 1
Market Overview .......................................................................................................................... 3
Revenue Forecast ........................................................................................................................ 3

CHAPTER TWO: CARDIOVASCULAR DISEASE OVERVIEW ............................... 7

Disease Overview .......................................................................................................................... 7
Top Ten Causes of Death ........................................................................................................... 8
World Cardiovascular Disease Statistics .................................................................................. 12
Mortality Rates for IHD ........................................................................................................... 15
Economic Burden of Cardiovascular Disease .......................................................................... 16
Expenditure on Cardiovascular Disease, Worldwide ............................................................... 16
Prevalence of Ischemic Heart Disease ...................................................................................... 18

CHAPTER THREE: CORONARY STENTS OVERVIEW.......................................... 19

Overview ...................................................................................................................................... 19
Restenosis ................................................................................................................................. 20
Types of Stents ............................................................................................................................ 20
Bare Metal Stents...................................................................................................................... 21
First Generation of Bare Metal Stents ................................................................................. 23
Second Generation of Bare Metal Stents ............................................................................. 24
Third Generation of Bare Metal Stents ................................................................................ 25
Omega Platinum-Chromium Stent ....................................................................................... 25
Nuloy Molybdenum-Rhenium Stent ...................................................................................... 26
Safety Issues of Bare Metal Stents ........................................................................................... 27
Drug-Eluting Stents .................................................................................................................... 29
Types of Drugs Used on Drug-Eluting Stents .......................................................................... 31
Paclitaxel.............................................................................................................................. 32
Sirolimus .............................................................................................................................. 32
Everolimus............................................................................................................................ 33
Tacrolimus............................................................................................................................ 33
Biolimus A9 .......................................................................................................................... 34
Novolimus ............................................................................................................................. 34
Other Drug Classes .............................................................................................................. 34
Types of Polymers .................................................................................................................... 35
Safety Concerns of Drug-Eluting Stents .............................................................................. 39
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Late Stent Thrombosis ..........................................................................................................39

Mechanical Problems of Polymers .......................................................................................41

CHAPTER FOUR: RECENT ADVANCES IN CORONARY

STENTS TECHNOLOGIES ............................................................................................. 43
Reduced Polymer Coatings.........................................................................................................44
Biodegradable Polymers ...........................................................................................................45
Advantages and Disadvantages of Biodegradable Polymers ...............................................45
Current Biodegradable Polymers Stents ..............................................................................46
BioMatrix ..............................................................................................................................47
Nobori ...................................................................................................................................48
Supralimus ............................................................................................................................49
Infinnium ...............................................................................................................................49
DESyne BD stent...................................................................................................................50
Synergy .................................................................................................................................50
MiStent ..................................................................................................................................50
BioMime................................................................................................................................51
Abrax ....................................................................................................................................51
Polymer-Free and Novel Coatings Drug-eluting Stents ............................................................52
Optima Jet .............................................................................................................................53
Cre8 ......................................................................................................................................54
Orsiro Hybrid DES ...............................................................................................................54
EPC Capturing Technology ..................................................................................................54
Direct Application of Drug on Stent Surface ............................................................................55
Amazonia Pax .......................................................................................................................56
Yukon DES ............................................................................................................................57
BioFreedom ..........................................................................................................................58
Mitsu .....................................................................................................................................58
Medtronic S10 platform ........................................................................................................59
Catania stent .........................................................................................................................60
MGuard Prime ......................................................................................................................61
Titan-2 ..................................................................................................................................61
Bioresorbable Stents .................................................................................................................62
Drawbacks of Bioresorbable Polymeric Stents .........................................................................65
Selected Bioresorbable Coronary Stents ...................................................................................66
The Absorb stent ...................................................................................................................67
Biotroniks Dreams stent ......................................................................................................69
DESolve stent ........................................................................................................................70
ReZolve Stent ........................................................................................................................70
IDEAL stent ..........................................................................................................................71
Other bioresorbable stents....................................................................................................72
Lesion Specific Stents ..................................................................................................................73
Dedicated Bifurcated Stents ......................................................................................................73
Axxess ...................................................................................................................................75
Nile Pax ................................................................................................................................76
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Stentys Self-Apposing stent................................................................................................... 77

Taxus Petal ........................................................................................................................... 78
Xience Side Branch Access .................................................................................................. 78
Sparrow ................................................................................................................................ 80
Taxus Liberte Atom .............................................................................................................. 81
Xience nano .......................................................................................................................... 81

CHAPTER FIVE: INDUSTRY STRUCTURE & TRENDS ......................................... 85

Sales and Marketing Capabilities ........................................................................................ 90
Differentiation Strategies .......................................................................................................... 91
Improved Stent Materials ..................................................................................................... 91
Reduced DAPT Duration ..................................................................................................... 91
Lesion-Specific Stents .............................................................................................................. 92
Extended Indications ............................................................................................................ 92
Significant Trends In The Coronary Stents Market .................................................................. 93
Market Drivers ............................................................................................................................ 94
New devices Expanded Indications ........................................................................................ 96
Acute Myocardial Infarction and Diabetes .......................................................................... 96
Emerging Markets Are Expected To Spur The Overall Market Growth. ................................. 97
Market Restraints ....................................................................................................................... 98
Price decline hampers growth in the overall market................................................................. 98
Cost Constraints ........................................................................................................................ 98
Difficult Economic Conditions ................................................................................................. 99
Notable Recent Industry Events .............................................................................................. 100
Recent Mergers and Acquisitions ........................................................................................... 100
Biosensors International acquired CardioMind and Devax .............................................. 100
Medtronic Acquired Invatec ............................................................................................... 101
Xenogenics Corporation Acquired Bioabsorbable Therapeutics....................................... 101
Market Exits ........................................................................................................................... 101

CHAPTER SIX: MARKET REVENUES AND FORECAST ..................................... 103

Market by Type of Stent........................................................................................................... 108
Drug Eluting Stents Market .................................................................................................... 108
Market Snapshot................................................................................................................. 108
Products Analysis ................................................................................................................... 109
Xience V ............................................................................................................................. 109
Promus Element/Plus ......................................................................................................... 111
Resolute Integrity ............................................................................................................... 112
Market Dynamics in the Drug-Eluting Stents Segment ...................................................... 113
Revenue Forecast ...................................................................................................................... 117
Bare Metal Stents Market ....................................................................................................... 119
Market Snapshot................................................................................................................. 119
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Market Dynamics ................................................................................................................120

Revenue Forecast................................................................................................................122
United States ..............................................................................................................................124
Market Snapshot .....................................................................................................................125
Revenue Forecast ....................................................................................................................127
Europe ........................................................................................................................................128
Market snapshot ......................................................................................................................129
Revenue Forecast ....................................................................................................................131
Japan ..........................................................................................................................................132
Market snapshot ......................................................................................................................132
Revenue forecast .....................................................................................................................134
China ..........................................................................................................................................136
Market Snapshot .....................................................................................................................136
Revenue forecast .................................................................................................................138
India ............................................................................................................................................140
Market snapshot ......................................................................................................................140
Revenue Forecast...............................................................................................................142
Rest of the World.......................................................................................................................144
Revenue Forecast ....................................................................................................................145

CHAPTER SEVEN: COMPANY PROFILES .............................................................. 149

Abbott Laboratories ..................................................................................................................149
Biosensors International ...........................................................................................................151
Boston Scientific ........................................................................................................................153
Biotronik SE & Co.KG .............................................................................................................155
CID Vascular .............................................................................................................................156
Elixir Medical Corporation ......................................................................................................158
Medtronic ...................................................................................................................................159
Meril Life Sciences Pvt. Ltd. ....................................................................................................161
MicroPort Medical (Shanghai) Co., Ltd..................................................................................162
Minvasys .....................................................................................................................................163
OrbusNeich ................................................................................................................................164
REVA Medical ...........................................................................................................................165
Stentys S.A. ................................................................................................................................166
Terumo Corporation .................................................................................................................167

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CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Top Ten Causes of Death in the World by Development Level, 2008 ..................... 2
Figure 1-1: Global Market Revenues Forecast 2010-2017
(Bare Metal Stents, Drug Eluding Stents, Total) ...................................................................... 4

CHAPTER TWO: CARDIOVASCULAR DISEASE OVERVIEW ............................ 7

Table 2-1: Top Ten Causes of Death in the World by Geographical Region, 2008 .................. 8
Table 2-2: Top Ten Causes of Death in the World by Development Level, 2008 ..................... 9
Table 2-3: Top Ten Causes of Death in the World in High Income Countries, 2008............. 10
Table 2-4: Top Ten Causes of Death in the World in Middle Income Countries, 2008 ......... 11
Table 2-5: Top Ten Causes of Death in the World in Low Income Countries, 2008.............. 12
Figure 2-1: Percentage of Deaths Related to Cardiovascular Disease in
the Seven Major World Markets, 2008 .................................................................................... 13
Table 2-6: Projected Deaths from Ischemic Heart Disease (IHD) and Acute
Myocardial Infarction (AMI) in the Seven Major World Markets, 2012............................. 14
Table 2-7: Age-Standardized Mortality Rates for Ischemic Heart Disease (IHD)
and Acute Myocardial Infarction (AMI) by Gender in the Seven Major
World Markets, 2009 .................................................................................................................. 16
Table 2-8: Estimated Total Cost of Cardiovascular Disease in Europe, 2006 ........................ 17
Table 2-9: Estimated Total Cost of Cardiovascular Disease in Major Markets, 2012........... 17

CHAPTER THREE: CORONARY STENTS OVERVIEW....................................... 19

Table 3-1: Selected Marketed Bare Metal Stents, 2012 ............................................................ 22
Table 3-2: Selected Bare Metal Coronary Stents, 2012 ............................................................ 27
Table 3-3: Selected Marketed Drug-Eluting Stents, 2012 ........................................................ 30
Table 3-4: Selected Features of Different Generations of Commercially
Available Drug-eluting Stents ................................................................................................... 38

CHAPTER FOUR: RECENT ADVANCES IN CORONARY STENTS

TECHNOLOGIES ......................................................................................................... 43
Table 4-1: Selected Coronary Stents using Biodegradable Polymers, 2012 ............................ 47
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Table 4-2: Selected Coronary Polymer-free and Novel Coating Stents, 2012 ........................ 53
Table 4-3: Selected Direct Drug Application Coronary Stents, 2012...................................... 56
Table 4-4: Selected Coronary Polymer and Drug-free Coating Stents, 2012 ......................... 60
Table 4-5: Advantages and Disadvantages of Bioresorbable Stents ....................................... 63
Table 4-6: Selected Bioresorbable Coronary Stents, 2012 ....................................................... 67
Table 4-7: Selected Dedicated Bifurcation Coronary Drug-Eluting Stents, 2012 .................. 75
Table 4-8: Selected Dedicated Small Vessels Coronary Drug-Eluting Stents, 2012 .............. 80
Table 4-9: Drug Release Parameters of Selected Drug-Eluting Stents ................................... 83

CHAPTER FIVE: INDUSTRY STRUCTURE ............................................................ 85

Table 5-1: Industry Structure Major Competitors and Selected
Marketed Products, 2012.......................................................................................................... 86
Table 5-2: Significant Trends in the Coronary Stents Market, 2012 ...................................... 94

CHAPTER SIX: MARKET REVENUES AND FORECAST .................................. 103

Table 6-1: Coronary Stents Estimated Global Market Shares, 2011 .................................... 105
Figure 6-1: Stents Market Share, 2011 .................................................................................... 106
Table 6-2: Global Market Revenues for Coronary Stents ($ Millions) ................................. 107
Figure 6-2: Global Stents Market Forecast ............................................................................. 107
Figure 6-3: Market Breakdown by Type of Stent (BMS, DES) ............................................. 114
Figure 6-4: Drug Eluting Stents Market Shre, 2011 ............................................................... 115
Table 6-3: Global Market Revenues for Coronary Stents ($ Millions) ................................. 118
Figure 6-5: Global Market Revenues Forecast ($ Billions)
Drug-Eluting Stents, 2010-2017 ................................................................................................ 118
Figure 6-6: Market Breakdown by Type of Stent (BMS, DES) ............................................. 121
Figure 6-7: Market Share Bare Metal Stents .......................................................................... 122
Table 6-4: Global Market Revenues for Coronary Bare Metal Stents, 2010-2017 (Bare Metal
Stent, Drug Eluding Stent, Total) ........................................................................................... 123
Figure 6-8: Bare Metal Stents Market 2010-2017 ................................................................... 123
Figure 6-9: United States Share of World Market ................................................................. 125
Table 6-5: U.S. Market Revenues for Coronary Stents (Bare Metal Stent, Drug Eluding Stent,
Total) ......................................................................................................................................... 127
Figure 6-10: U.S. Market Revenues for Coronary Stents
(Bare Metal Stent, Drug Eluding Stent, Total) ..................................................................... 128
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Figure 6-11: Europe Share of World Stents Market ............................................................... 129

Table 6-6: European Market Revenues for Coronary Stents
(Bare Metal Stent, Drug Eluding Stent, Total) ...................................................................... 131
Figure 6-12: European Market Revenues for Coronary Stents
(Bare Metal Stent, Drug Eluding Stent, Total) ..................................................................... 132
Figure 6-13: Japan Share of World Stents Market ................................................................. 133
Table 6-7: Japanese Market Revenues for Coronary Stents
(Bare Metal Stent, Drug Eluding Stent, Total) .................................................................. 135
Figure 6-14: Japanese Market Revenues for Coronary Stents
(Bare Metal Stent, Drug Eluding Stent, Total) ................................................................. 135
Figure 6-15: China Share of World Stents Market ................................................................. 136
Table 6-8: Market Revenues for Coronary Stents in China
(Bare Metal Stent, Drug Eluding Stent, Total) ................................................................. 139
Figure 6-15: Market Revenues for Coronary Stents in China
(Bare Metal Stent, Drug Eluding Stent, Total) ................................................................. 139
Figure 6-16: India Share of World Market.............................................................................. 140
Table 6-9: Market Revenues for Coronary Stents in India
(Bare Metal Stent, Drug Eluding Stent, Total) .................................................................. 143
Figure 6-17: Market Revenues for Coronary Stents in India
(Bare Metal Stent, Drug Eluding Stent, Total) .................................................................. 143
Figure 6-18: Rest of World Share of World Stents Market ................................................... 144
Table 6-10: Market Revenues for Coronary Stents in the Rest of the World
(Bare Metal Stent, Drug Eluding Stent, Total) .................................................................. 146
Figure 6-19: Market Revenues for Coronary Stents in the Rest of the World
(Bare Metal Stent, Drug Eluding Stent, Total) ................................................................. 147

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Three: Coronary Stents Overview

20

stents were developed to prevent the risk of restenosis following percutaneous

coronary interventions, as well as that of abrupt artery closure.
Restenosis
The process of restenosis at the site of treatment occurs via two mechanisms:
thrombosis, or blood clotting, and endothelial tissue proliferation, or scar formation.
The risk of thrombosis is greatest after the procedure was performed, as the tissue
trauma triggers the process of blood clotting, but it can be significantly reduced by
the administration of anti-coagulation drugs during and after the procedure. The risk
of restenosis resulting via the endothelial tissue proliferation mechanism is more
difficult to address, as it is not reduced by the anti-coagulation drugs, tends to occur
during the first three to six months after the procedure, and may require a new
surgical intervention. Prior to the introduction of stents, restenosis occurred in XX% to
XX% of patients undergoing percutaneous coronary interventions.
Coronary stents are small, expandable wire mesh tubes that are similar in
appearance to the spring in a ballpoint pen. Stents are delivered in the artery during
the PTCA procedure via the catheter, and are subsequently deployed in the artery by
the expansion of a balloon or by a self-expanding delivery design. Stents are placed at
the site of blockage in the coronary artery, and are kept in it permanently, with the
scope of maintaining the artery open, increasing the blood flow to the heart muscle,
and preventing restenosis. The introduction of stents resulted in a considerable
reduction approximately one third - in the occurrence of overall restenosis in
patients undergoing percutaneous coronary interventions. While coronary stents do
not cure heart disease, they provide an effective therapeutic approach to improve the
lives of people suffering from heart disease, and reduce the need for additional costly
and invasive percutaneous coronary interventions or by-pass surgery.

TYPES OF STENTS
Coronary stents are primarily constructed of inert materials such as metals,
alloys and, more recently, biodegradable polymers. There are two major types of
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Four: Recent Technology Trends

55

reduce the risk of late stent thrombosis even in patients undergoing short-term
durations of dual anti-platelet therapy. The company obtained CE marking for two
anti-CD34 antibodies-coated stents, Genous Stainless Steel and Genous CobaltChromium. Despite the attractive properties of the EPC technology, the stents
clinical efficacy did not improve in comparison to newer generations of drug-eluting
stents; the late lumen loss observed with this stent in several clinical trials was above
0.6 mm in many cases, which is actually considerably higher than that achieved with
newer stents. Besides the high late loss, the Trias HR study also reported a higher
target vessel failure than that observed in patients treated with Taxus. As the CD34
markers are not specific to endothelial progenitor cells exclusively, but are shared by
other hematopoietic cells, a better understanding of the cellular processes would
benefit the development of this EPC capturing technology for applications on stents.
Despite these disappointing results, the EPC technology appears to perform
better when used as dual therapy in combination with an anti-proliferative drug. The
Combo Stent, also developed by OrbusNeich, has an abluminal coating composed of
sirolimus and a biodegradable polymer, in addition to anti-CD34 antibodies. Due to
this combination, the Combo Stent is expected to simultaneously reduce the risk of
re-stenosis and enhance the vessel healing process. The Combo Stent is currently
evaluated in comparison with Taxus Liberte in the randomized clinical trial Remedee
in Australia.

Direct Application of Drug on Stent Surface

Various commercially available or in-development stents incorporate the antiproliferative drug onto the stent surface without the use of a polymer. In these stents,
the risk of adverse polymer-related effects is eliminated, and the integrity of the stent
surface is not compromised by possible polymer damage. However, the rate of drug
elution is more difficult to control in polymer-free stents, and they have a potentially

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Four: Recent Technology Trends

75

Novel Dedicated Bifurcation Stents

Table 4-7 presents selected novel dedicated bifurcation coronary drug-eluting
stents.

Table 4-7
Selected Dedicated Bifurcation Coronary Drug-Eluting Stents, 2012

Company

Brand

Platform/ Type

Coating/ Drug/ Dose

Status

Source: Kalorama Information, Company Information

Axxess
Developed by Devax and acquired by Biosensors International in October
2010, the Axxess stent received CE marking in April 2011. The device is a selfexpanding nitinol stent coated with a resorbable PLA polymer and XX g/mm
biolimus A9 on the abluminal side. The stent releases XX% of the drug within XX
days. Axxess has a conical design
intended to conform to the flared bifurcation
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