transcatheter aortic valve replacementmarket is forecast to have significant growth during the...
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Transcatheter Aortic Valve Replacement Analysis and Market Forecast - US Market GDME1001CFR / Published November 2012
Executive Summary
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 2 GDME1001CFR / Published NOV 2012
Transcatheter Aortic Valve Replacement: Key Metrics in US Device Markets
Diseased population 1.45 million
Severe, Symptomatic Population 0.20 million
High Risk or Inoperable Population 0.13 million
2011 Market Sales
US $28.0m
Pipeline Assessment
Number of preclinical devices 7
Number of early clinical devices 4
Number of late clinical devices 3
Pericardium Tissue Valves 87%
Synthetic Polymer Valves 13%
Key events (2011-2018) Level of Impact
US FDA approval of Sapien valve for inoperable
patients via transfemoral access in 2011 ↑↑↑
US FDA expanded approval for high-risk patients
via transapical access in 2012 ↑↑
US FDA approval of CoreValve in 2014 ↑↑
US FDA approval of Acurate TA valve in 2014 ↑
US FDA of Sapien XT in 2014 ↑
2018 Market Sales
US $1,086m
Source: GlobalData
Transcatheter Aortic Valve Market is Forecast to Witness Significant Growth Through 2018
The Transcatheter Aortic Valve Replacement (TAVR)
market is forecast to have significant growth during the
forecast period. GlobalData estimates the US market in
2011 was $28.0 million, and it is expected to grow to
reach $1,086.1 million by 2018.
The key drivers for the market in the forecast period are:
Increase in the TAVR patient population, primarily
due to an increase in the elderly population and
expanded approval of TAVR
US FDA approval of TAVR using Sapien valve in
inoperable candidates via transfemoral access in
2011
FDA expanded approval of TAVR for high-risk
patients and transapical access in 2012
FDA approval of CoreValve in 2014
FDA approval of Acurate TA valve in 2014
FDA approval of Sapien XT valve in 2014
The major barriers for the TAVR market are:
Lacking and incomplete reimbursement for TAVR
procedures
Slow adoption of TAVR as heart centers are trained
in the procedure
High cost of current devices compared to surgically
implanted valve prosthetics
Executive Summary
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Companies Working to Get Their Devices Approved in the TAVR Market
The TAVR market has been developing quickly as a
result of US rapid adoption of the procedure. Ever since
the Sapien valve was approved by the FDA in the US in
2011, additional companies have been working to enter
the market as well. TAVR device technology has already
entered the next stage of development, with many
second-generation prosthetics due to launch in the US in
the near future. In parallel development with device
designs, companies are looking to further improve their
delivery systems as well.
Expanded approval of TAVR in the US has generated
considerable interest within the healthcare community.
GlobalData expects that most major heart centers will
offer the procedure in coming years.
Significant Unmet Needs in TAVR Market
Use of TAVR in high-risk and inoperable patients has
proven effective in treating aortic valve disease; however,
there is still much room for improvement. Paravalvular
regurgitation and a high incidence of stroke have plagued
first-generation devices, and emerging products aim to
reduce these side effects while also reducing the cost of
the device. Additionally, physicians have called for other
device improvements, most notably repositionability and
reduced delivery sheath sizes. Improvements to the
device design will help TAVR be approved for moderate
and low surgical risk patients by improving patient
outcomes, reducing device cost, and making TAVR
superior to surgical valve replacement.
Remaining Opportunities for New Entrants
Significant market opportunities still exist for novel TAVR
devices in terms of superior efficacy, improved ease of
use, lower adverse effects, and cost. There have been
numerous design adaptations across the TAVR industry
as companies look to differentiate their product from the
competition. Compared to the first TAVR products
approved, many second-generation devices are smaller
in profile size as well as repositionable. Looking ahead,
others including Direct Flow Medical and AorTech
International are working to develop devices with
prosthetic valve leaflets made of synthetic polymers in an
attempt to improve durability and reduce the device cost.
Also working towards improved durability, ValveXchange
has developed a TAVR system with exchangeable
leaflets that can be replaced as they wear out. In an
attempt to reduce regurgitation, Boston Scientific and
Symetis are both developing valves that utilize sealing
membrane skirts to increase prosthetic conformance to
the native valve annulus and reduce paravalvular
regurgitation.
Most device improvements have been related to accurate
positioning of the prosthetic, secure anchoring, improved
durability, ease of deployment and cost. As more
companies enter the market, these points of difference
between various TAVR products are likely to drive sales.
Leading TAVR Companies and Future Landscape
Edwards is the only company with a device currently
approved in the US. As the US market opens up to other
competitors, GlobalData believes the TAVR market will
continue to grow rapidly in the near term. Additionally,
several medical device giants have still not developed
their own TAVR technologies, and so GlobalData expects
significant merger and acquisition activity within the
TAVR market.
New players entering the market will combat initial
challenges with physician adoption as a result of the
retraining necessary for new TAVR devices; each
prosthetic behaves differently. The market is still very
young, though, and there is great potential for new
entrants with superior efficacy, lower costs, or both.
Executive Summary
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Assessment of TAVR Device Features Repositionability
High durability and long device lifetime
Most Desirable Features of
TAVR Devices
Proven safety of device
Non-thrombogenic
Dynamic responsivenessFeatures Most Satisfied With
(Met Needs) Valve-tissue interaction
Cost of device
Retrievability of deviceFeatures Least Satisfied With
(Unmet Needs) Self-repairing ability of device
Source: GlobalData
What do Physicians Think?
Physicians feel strongly that TAVR adoption will be
strong in coming years.
“I think that most patients are probably going to go for
transcatheter valves once the newer technology is
available…TAVR is going to explode. It’s going to be
THE valve platform in ten years, I mean, nobody’s
going to be doing open valve anymore.”
Key Opinion Leader, October 2012
While adoption of TAVR in the US has been slower
than in Europe, many believe the approval of second
generation devices will boost sales.
“Once the FDA approves the smaller devices, you
will see a big increase in the number of implants in
the US and also the number of approaches.”
Key Opinion Leader, October 2012
From a patient standpoint, the procedure and
recovery time for TAVR is much less compared with
conventional surgical valve replacement.
“Transcatheter procedures take two hours instead of
the usual four or five hours [with surgical
implantation]…we’re shifting, and more patients that
were otherwise operated on will in the future be
treated with transcatheter heart valves.”
Key Opinion Leader, October 2012
While TAVR is currently only approved for high-risk
and inoperable patients, it is likely that moderate and
low-risk patients will be candidates for TAVR in the
future.
“We already, more or less, are convinced that lower
risk patients may benefit from a transcatheter heart
valve. So, we’re already shifting to these lower risk
patients.”
Key Opinion Leader, October 2012
But before TAVR is approved for lower risk patients,
many are calling for further improvement.
“Limitations have to be addressed before offering
TAVR to lower risk patients...so maybe in a short
time, maybe five years, the surgical-risk requirement
for TAVR will go down.”
Key Opinion Leader, November 2012
While physicians are calling for numerous device
improvements, two attributes are of particular
importance.
“The two most important things will be the
development of more predictable devices with fewer
complications, and the price of the valves going
down. If these two things happen, the numbers will
further increase.”
Key Opinion Leader, November 2012
Table of Contents
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1 Table of Contents 1 Table of Contents ...............................................................................................................5
1.1 List of Tables ..............................................................................................................11
1.2 List of Figures .............................................................................................................14
2 Introduction.......................................................................................................................15
2.1 Catalyst.......................................................................................................................15
3 Disease Overview.............................................................................................................16
3.1 Anatomy & Physiology ................................................................................................16
3.1.1 Heart Valves .......................................................................................................16
3.2 Pathophysiology..........................................................................................................18
3.2.1 Heart Valve Disorders .........................................................................................18
3.2.2 Etiology of AVD...................................................................................................19
3.2.3 Acquired Disorders..............................................................................................19
3.2.4 Congenital Defects..............................................................................................21
3.2.5 Other Disorders...................................................................................................22
3.3 Clinical Presentation ...................................................................................................22
3.3.1 Symptoms...........................................................................................................22
3.3.2 Diagnosis............................................................................................................22
3.4 Clinical Outcomes.......................................................................................................26
3.4.1 Treatment Modalities...........................................................................................27
3.4.2 Medication ..........................................................................................................30
3.4.3 Heart Valve Repair..............................................................................................31
3.4.4 Surgical/Intervention Strategies...........................................................................32
3.4.5 Surgical Heart Valve Replacement......................................................................32
3.4.6 Transcatheter Heart Valve Replacement .............................................................34
3.4.7 Associated Mortality............................................................................................37
3.5 Epidemiology ..............................................................................................................37
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3.5.1 Prevalence..........................................................................................................37
3.5.2 Treatment and Mortality ......................................................................................39
3.6 Economic Impact ........................................................................................................41
3.6.1 Individual Costs...................................................................................................42
3.6.2 Industry Costs.....................................................................................................43
4 Competitive Assessment...................................................................................................44
4.1 Overview.....................................................................................................................44
4.1.1 Initial Devices......................................................................................................45
4.1.2 Current Devices ..................................................................................................45
4.1.3 Competitive Assessment.....................................................................................46
4.2 US Marketed Product Profile .......................................................................................47
4.2.1 Sapien valve (Edwards Lifesciences) ..................................................................47
5 Unmet Needs....................................................................................................................50
5.1 Delivery & Implantation ...............................................................................................51
5.1.1 Repositionable ....................................................................................................51
5.1.2 Low Profile..........................................................................................................51
5.1.3 Accurate Anatomic Positioning............................................................................52
5.1.4 Expansion Mechanism ........................................................................................53
5.1.5 Rapid Pacing ......................................................................................................53
5.1.6 Motorized Delivery Systems................................................................................53
5.1.7 Coronary Ostia Impairment .................................................................................54
5.2 Conformance ..............................................................................................................54
5.2.1 Regurgitation ......................................................................................................54
5.2.2 Sizing..................................................................................................................55
5.2.3 Effective Orifice Area ..........................................................................................55
5.2.4 Removal of Native Valve Leaflets........................................................................55
5.3 Lifetime.......................................................................................................................56
5.3.1 Durability.............................................................................................................56
5.3.2 Retrievability .......................................................................................................57
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5.3.3 Pacemaker Placement (heart block)....................................................................57
5.3.4 Replaceable Leaflets...........................................................................................57
5.4 Materials.....................................................................................................................58
5.4.1 Alternative Surfaces............................................................................................58
5.4.2 Endothelialization................................................................................................58
5.4.3 Regenerative Medicine........................................................................................59
5.4.4 Tailored Treatment..............................................................................................59
5.5 Pre-Crimped Packaging ..............................................................................................59
5.6 Embolic Protection ......................................................................................................59
5.7 Robotic Assistance......................................................................................................60
5.8 Hemodynamic Performance........................................................................................60
6 Pipeline Products..............................................................................................................61
6.1 Overview.....................................................................................................................61
6.2 Pipeline by Phases in Development ............................................................................62
6.3 Pipeline Products Profiles ...........................................................................................64
6.3.1 Acurate TA Valve (Symetis) ................................................................................64
6.3.2 Acurate TF valve (Symetis) .................................................................................65
6.3.3 AorTech valve (AorTech International) ................................................................67
6.3.4 AorTx valve (Hansen Medical).............................................................................68
6.3.5 Centera valve (Edwards Lifesciences).................................................................70
6.3.6 Colibri valve (Colibri Heart Valve)........................................................................71
6.3.7 Cormove (Perouse Medical)................................................................................72
6.3.8 CoreValve (Medtronic, Inc.).................................................................................73
6.3.9 Direct Flow valve (Direct Flow Medical) ...............................................................76
6.3.10 Engager valve (Medtronic, Inc.)...........................................................................79
6.3.11 Heart Leaflet Technology (Bracco SpA)...............................................................80
6.3.12 Innovare valve (Braile Biomedica) .......................................................................81
6.3.13 JenaValve (JenaValve) .......................................................................................83
6.3.14 Portico valve (St. Jude Medical, Inc.)...................................................................84
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6.3.15 Sadra Lotus valve (Boston Scientific) ..................................................................85
6.3.16 Sapien XT valve (Edwards Lifesciences) .............................................................87
6.3.17 Sapien 3 (Edwards Lifesciences) ........................................................................89
6.3.18 Trinity valve (Transcatheter Technologies GmbH) ...............................................90
6.3.19 Vanguard Exchangeable Heart Valve System (ValveXchange)............................91
6.4 Clinical Trial Analysis ..................................................................................................94
6.4.1 Overview.............................................................................................................94
6.4.2 Trials to Watch....................................................................................................94
6.4.3 Summary ............................................................................................................96
7 Industry Overview.............................................................................................................97
7.1 Procedure Trends .......................................................................................................97
7.1.1 Reimbursement Hinders Adoption.......................................................................97
7.2 Market Access ............................................................................................................98
7.2.1 Adoption of TAVR ...............................................................................................98
7.2.2 Heart Teams for Specialized Care.....................................................................100
7.2.3 Facilities Enabling TAVR...................................................................................102
7.2.4 Training and Protocols for Care.........................................................................102
7.3 Reimbursement Trends............................................................................................. 103
7.4 Regulatory Issues/Recalls......................................................................................... 104
7.5 Mergers & Acquisitions/Key Partnerships ..................................................................105
8 Current and Future Players............................................................................................. 107
8.1 Overview...................................................................................................................107
8.2 Trends in Corporate Strategy ....................................................................................107
8.3 Company Profiles......................................................................................................108
8.3.1 AorTech International plc ..................................................................................108
8.3.2 Boston Scientific ............................................................................................... 109
8.3.3 Bracco SpA.......................................................................................................110
8.3.4 Braile Biomedica............................................................................................... 112
8.3.5 Colibri Heart Valve, LLC....................................................................................113
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8.3.6 Direct Flow Medical........................................................................................... 114
8.3.7 Edwards Lifesciences, Inc. ................................................................................115
8.3.8 Hansen Medical ................................................................................................ 117
8.3.9 JenaValve Technology...................................................................................... 118
8.3.10 Medtronic, Inc. ..................................................................................................119
8.3.11 Perouse Medical ............................................................................................... 120
8.3.12 St. Jude Medical ............................................................................................... 121
8.3.13 Symetis.............................................................................................................123
8.3.14 Transcatheter Technologies GmbH...................................................................124
8.3.15 ValveXchange...................................................................................................125
9 Market Drivers, Opportunities and Barriers......................................................................127
9.1 Market Drivers ..........................................................................................................127
9.1.1 Superior to Conventional Treatment ..................................................................127
9.1.2 New Alternative for Patients with No Options.....................................................128
9.1.3 Expected Launch of CoreValve, Acurate TA, and Sapien XT in US....................128
9.1.4 Expanded Approval in US .................................................................................128
9.1.5 Supportive Imaging ........................................................................................... 128
9.2 Opportunities ............................................................................................................129
9.2.1 Repositionability................................................................................................ 130
9.2.2 Miniaturization of Valve Systems.......................................................................130
9.2.3 Single Operator Devices ...................................................................................131
9.2.4 Lower Cost .......................................................................................................131
9.2.5 Dilation Scoring Balloon ....................................................................................131
9.2.6 Removal of Native Valve Leaflets......................................................................132
9.2.7 Temporary Aortic Valves ...................................................................................132
9.3 Market Barriers .........................................................................................................133
9.3.1 Reimbursement.................................................................................................133
9.3.2 Slow Adoption...................................................................................................133
9.3.3 Cost ..................................................................................................................133
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9.3.4 Substitutes........................................................................................................133
10 Country Outlooks & Forecasts ........................................................................................ 135
10.1 US Markets Overview ............................................................................................... 135
10.2 United States ............................................................................................................137
10.2.1 United States Market Analysis...........................................................................137
11 Appendix ........................................................................................................................ 140
11.1 Abbreviations ..........................................................................................................140
11.2 Bibliography............................................................................................................142
11.3 Methodology ...........................................................................................................146
11.4 Coverage ................................................................................................................146
11.5 Secondary Research............................................................................................... 147
11.6 Forecasting Methodology ........................................................................................ 147
11.6.1 Diagnosed Aortic Valve Disease (AVD) Patients................................................148
11.6.2 Percent Transcatheter Aortic Valve Replacement Patients ................................ 148
11.6.3 Pricing Assumptions.......................................................................................... 148
11.6.4 Prevalence in Surgical Risk Segments .............................................................. 148
11.6.5 Cost of Aortic Valve Disease .............................................................................148
11.7 Physicians and Specialists Included in this Study ....................................................149
11.8 Primary Research ...................................................................................................149
11.9 Physician Survey ....................................................................................................150
11.10 About the Authors ...................................................................................................151
11.10.1 Analysts............................................................................................................151
11.10.2 Global Head of Healthcare ................................................................................152
11.11 Definitions.............................................................................................................153
11.12 About GlobalData..................................................................................................154
11.13 Contact Us............................................................................................................154
11.14 Disclaimer.............................................................................................................154
Table of Contents
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1.1 List of Tables
Table 1: Etiology of Single Left-Side Valve Disease ..............................................................19
Table 2: Initial Presenting Symptoms of Aortic Valve Disease...............................................22
Table 3: Basic Frequency of Examination.............................................................................24
Table 4: Modifiers of Examination Frequency .......................................................................24
Table 5: Cardiovascular Risk Factors and Comorbidities ......................................................25
Table 6: Investigations Performed to Diagnose AVD.............................................................26
Table 7: Basic Principles for Management of AVD Patients...................................................27
Table 8: Aortic Valve Disease National Indirect and Direct Costs ($bn), 2009-2018...............43
Table 9: TAVR Product Approvals by Date ...........................................................................45
Table 10: Assessment of TAVR Device Features....................................................................46
Table 11: Product Profile - Sapien ..........................................................................................47
Table 12: Sapien SWOT Analysis, 2012 .................................................................................49
Table 13: TAVR Global Product Pipeline, 2012.......................................................................63
Table 14: Product Profile - Acurate TA....................................................................................64
Table 15: Acurate TA SWOT Analysis, 2012...........................................................................65
Table 16: Product Profile - Acurate TF....................................................................................66
Table 17: Acurate TF SWOT Analysis, 2012...........................................................................67
Table 18: Product Profile - AorTech........................................................................................67
Table 19: AorTech SWOT Analysis, 2012...............................................................................68
Table 20: Product Profile - AorTx............................................................................................69
Table 21: AorTx SWOT Analysis, 2012...................................................................................70
Table 22: Product Profile - Centera.........................................................................................70
Table 23: Centera SWOT Analysis, 2012................................................................................71
Table 24: Product Profile - Colibri ...........................................................................................71
Table 25: Colibri SWOT Analysis, 2012 ..................................................................................72
Table 26: Product Profile - Cormove.......................................................................................73
Table 27: Cormove SWOT Analysis, 2012..............................................................................73
Table 28: Product Profile - CoreValve.....................................................................................74
Table of Contents
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Table 29: CoreValve SWOT Analysis, 2012............................................................................76
Table 30: Product Profile - Direct Flow....................................................................................77
Table 31: Direct Flow SWOT Analysis, 2012...........................................................................78
Table 32: Product Profile - Engager........................................................................................79
Table 33: Engager SWOT Analysis, 2012...............................................................................80
Table 34: Product Profile - Heart Leaflet Technology ..............................................................80
Table 35: Heart Leaflet Technology SWOT Analysis, 2012 .....................................................81
Table 36: Product Profile - Innovare .......................................................................................81
Table 37: Innovare SWOT Analysis, 2012 ..............................................................................82
Table 38: Product Profile - JenaValve.....................................................................................83
Table 39: JenaValve SWOT Analysis, 2012............................................................................84
Table 40: Product Profile - Portico ..........................................................................................84
Table 41: Portico SWOT Analysis, 2012 .................................................................................85
Table 42: Product Profile - Sadra Lotus ..................................................................................86
Table 43: Sadra Lotus SWOT Analysis, 2012 .........................................................................87
Table 44: Product Profile - Sapien XT.....................................................................................87
Table 45: Sapien XT SWOT Analysis, 2012............................................................................89
Table 46: Product Profile - Sapien 3 .......................................................................................89
Table 47: Sapien 3 SWOT Analysis, 2012 ..............................................................................90
Table 48: Product Profile - Trinity ...........................................................................................91
Table 49: Trinity SWOT Analysis, 2012 ..................................................................................91
Table 50: Product Profile - Vanguard......................................................................................92
Table 51: Vanguard SWOT Analysis, 2012.............................................................................93
Table 52: Company Profile - AorTech International plc ......................................................... 108
Table 53: AorTech International SWOT Analysis, 2012......................................................... 109
Table 54: Company Profile - Boston Scientific ......................................................................109
Table 55: Boston Scientific SWOT Analysis, 2012 ................................................................ 110
Table 56: Company Profile - Bracco SpA..............................................................................111
Table 57: Bracco SpA SWOT Analysis, 2012........................................................................112
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Table 58: Company Profile - Braile Biomedica......................................................................112
Table 59: Braile Biomedica SWOT Analysis, 2012................................................................ 113
Table 60: Company Profile - Colibri Heart Valve ...................................................................113
Table 61: Colibri Heart Valve SWOT Analysis.......................................................................114
Table 62: Company Profile - Direct Flow Medical..................................................................115
Table 63: Direct Flow Medical SWOT Analysis, 2012............................................................ 115
Table 64: Company Profile - Edwards Lifesciences .............................................................. 116
Table 65: Edwards Lifesciences SWOT Analysis, 2012 ........................................................ 117
Table 66: Company Profile - Hansen Medical .......................................................................117
Table 67: Hansen Medical SWOT Analysis, 2012.................................................................118
Table 68: Company Profile - JenaValve Technology............................................................. 118
Table 69: JenaValve Technology SWOT Analysis, 2012....................................................... 119
Table 70: Company Profile - Medtronic.................................................................................119
Table 71: Medtronic SWOT Analysis, 2012...........................................................................120
Table 72: Company Profile - Perouse Medical ......................................................................120
Table 73: Perouse Medical SWOT Analysis, 2012................................................................ 121
Table 74: Company Profile - St. Jude Medical ......................................................................121
Table 75: St. Jude Medical SWOT Analysis, 2012 ................................................................ 122
Table 76: Company Profile - Symetis....................................................................................123
Table 77: Symetis SWOT Analysis, 2012..............................................................................123
Table 78: Company Profile - Transcatheter Technologies .....................................................124
Table 79: Transcatheter Technologies SWOT Analysis, 2012...............................................124
Table 80: Company Profile - ValveXchange..........................................................................125
Table 81: ValveXchange SWOT Analysis, 2012 ...................................................................126
Table 82: Major Events Affecting the Global TAVR Market ...................................................136
Table 83: Sales Forecasts for TAVR in the US, 2011-2018...................................................137
Table 84: Physicians Surveyed, By Country .........................................................................150
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1.2 List of Figures
Figure 1: Diagram of Human Heart ........................................................................................17
Figure 2: Strategy for Evaluating Heart Murmurs....................................................................23
Figure 3: General Treatment Modalities for Aortic Valve Disease ...........................................28
Figure 4: Aortic Valve Replacement Treatment Modalities in the US ......................................29
Figure 5: Surgical Risk of Symptomatic, Severe AVD Patients, 2011 .....................................38
Figure 6: Prevalence of Moderate or Severe Valve Disease in US Population 2011 ...............39
Figure 7: Prevalence of AVD in Patients 65+ .........................................................................39
Figure 8: Breakdown of Severe AVD Patients Receiving Surgical Valve Replacement &
Transcatheter Valve Replacement ..........................................................................41
Figure 9: Total Costs at One Year for TAVR and SAVR as Calculated in 2011 in Europe.......42
Figure 10:Companies in TAVR Market with Approved Devices...............................................44
Figure 11:TAVR Device Attributes by Current Satisfaction and Importance, 2011...................62
Figure 12:TAVR Pipeline by Stage in Clinical Development, 2012 ..........................................63
Figure 13:TAVR Procedures Per Year..................................................................................135
Figure 14:Sales Forecasts for TAVR in the US, 2011-2018 ..................................................138
Introduction
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2 Introduction For patients suffering from severe aortic valve disease or valve dysfunction, percutaneous
Transcatheter Aortic Valve Replacement (TAVR) enables implantation of a prosthetic heart valve
within the diseased native aortic valve without the need for open heart surgery or cardiopulmonary
bypass; TAVR provides a new therapeutic option for elderly patients who are considered to have
high surgical risk or contraindications to open heart surgery, in addition to an alternative option for
all other aortic valve disease patients. TAVR is becoming an increasingly popular alternative to
open heart surgery as professional and commercial interest intensifies and effectiveness becomes
proven; the percutaneous approach is less invasive and has a shorter recovery time compared with
open-heart access. As approved indications for use of TAVR expand as well as more competitors
enter the market, this industry will grow substantially in coming years.
2.1 Catalyst
Transcatheter Aortic Valve Replacement offers a novel and groundbreaking technology for
accessing the heart valves in patients who are extremely high-risk or inoperable candidates for
conventional surgical valve replacement, with the expectation that this technology may be utilized
in lower risk surgical candidates in the future. An estimated 55,000 patients worldwide have already
undergone TAVR (Holmes et al., 2012). TAVR has been adopted in many centers in the US. As
centers around the world improve their catheterization facilities as well as introduce training to their
staff for TAVR procedures, it is expected that TAVR could be used on upwards of 10%-20% of the
Aortic Valve Disease (AVD) population in coming years, and has an estimated 2018 market value
of over $2 billion. This report examines procedural volumes in the US, as well as adoption trends
for the quickly spreading TAVR procedure.
With improvements in cardiac imaging and robotics, it’s expected that TAVR procedures will be
easier to perform in the future and have fewer associated side effects as training improves.
Additionally, as TAVR is reliant on so many different types of technology, there is much room for
improvement across the board in how these procedures are carried out. This report examines
current unmet needs, opportunities for development and market penetration, expectations for an
expanding target market, and associated complications with TAVR. This report looks at market
breakdown by company, new entrants to the TAVR industry, and drivers for future growth.
Appendix
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11.12 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 medical device 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, Boston, London, India and Singapore.
11.14 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.