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Total Ankle Replacement US Analysis and Market Forecasts
GDME1014CFR / Published February 2013
Executive Summary
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Total Ankle Replacement: Key Metrics in the US Markets Diseased population 1.1 million
2011 Market Sales ($m) $41.7m
Competitive Assessment
Number of devices in marketing phase 5
Two-component fixed-bearing devices 4
Three-component mobile-bearing devices 1
Key Events (2011–2018) Impact
Expected commercial launch of INBONE total ankle with calcaneal stem fixation in the US in 2015 ↑↑↑
2018 Market Sales ($m) $135.3m
Source: GlobalData.
The total ankle replacement (TAR) market is expected to
enjoy significant growth during the forecast period.
GlobalData estimates the US market in 2011 was
$41.7m. The market is expected to expand at a
Compound Annual Growth Rate (CAGR) of 18.3% to
reach $135.3m by 2018.
The key drivers for the market in the forecast period are:
Increase in the TAR population, primarily due to an
increase in the elderly population, a soaring demand
for trauma care, and an improved public awareness
of TAR
The need for a treatment that helps late-stage ankle
arthritis patients maintain the ankle’s range of motion
and regain some recreational activities
Expanded medical education and surgeon adoption
The launch of pipeline TAR products such as the
INBONE total ankle with calcaneal stem fixation
developed by Wright Medical Group
The TAR market has more than three decades of medical
history in managing late-stage ankle arthritis patients in
the US. The promising clinical outcomes associated with
the third-generation TAR prostheses are mainly due to
updated design philosophies and appropriate surgical
techniques accumulated by surgeons.
At present, the US is leading the way with almost 5,000
TARs performed every year (US Key Opinion Leaders,
December, 2012), and is expected to continue to
contribute the most to the global TAR market over the
forecast period. According to GlobalData’s TAR survey
with orthopedic surgeons in the US, approximately one-
fifth of the definitive procedures for late-stage ankle
arthritis patients are done through TAR in the US.
Expanded approval of TAR products will generate more
interest within the foot and ankle community, leading to
widespread surgeon adoption.
Executive Summary
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Multiple Unmet Needs in TAR Market
The application of TAR in treating selective late-stage
ankle arthritis patients has been proven effective by the
American Orthopaedic Foot and Ankle Society (AOFAS)
and the American College of Foot and Ankle Surgeons
(ACFAS); however, there is still room for improvement to
enhance TAR’s clinical efficacy. Extensive bone
resection has plagued previous generations of devices,
and current products aim to minimize resection of the
tibial and talar bone to promote implant stability.
Additionally, orthopedic surgeons have called for
enhanced biological fixation materials to further improve
the osseointegration rate and the strength of bone-
prosthetic bonding. Efforts from manufacturers on
advancing preoperative evaluation techniques to achieve
better alignment are also expected. Clinical longevity of
TAR can be highly dependent on the long-term efficacies
of TAR compared with ankle fusion; the availability of
more long-term clinical data is therefore also one of the
major unmet needs in the TAR market. Continuous
efforts from manufacturers on refining instrumentations
and delivering revision-specific components are also
anticipated in the following years.
Key Players in the TAR Market
The current TAR prostheses are either two-component
fixed-bearing or three-component mobile-bearing.
Several design adaptations have been adopted across
the TAR industry as companies look to differentiate their
product from the competition. Key players in the arena
involve Johnson & Johnson’s DePuy Synthes, Tornier,
Small Bone Innovations, Wright Medical Group and
Integra LifeSciences. While DePuy and Tornier have
been enjoying a significant market share in the European
TAR market for years, they are experiencing competition
in the US market, with Small Bone Innovations being the
strongest contestant. Currently the Food and Drug
Administration (FDA)’s regulation for three-component
mobile-bearing TAR implants has potentially set hurdles
for European companies with those implants to access
the US market, which resulted in completely different
competitive landscapes on either side of the Atlantic
Ocean. Zimmer jumped into the US TAR market in late
2012 with a fixed-bearing prosthesis, adopting its
proprietary trabecular metal technology. Wright Medical
has demonstrated its effort on expanding the indications
of TAR to include subtalar insufficiency by incorporating
calcaneal fixation stem into its INBONE total ankle
prosthesis. As more entrants enter the market in the
future, these points of difference between various TAR
prostheses are likely to drive sales. Yet new players may
need to combat initial challenges with surgeon adoption
as a result of retraining necessary for a new TAR
prosthesis.
Executive Summary
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TAR Market Future Outlook
Promising results of the second-generation prostheses
revived interest in TAR and fueled further innovations in
the prosthetic design. After decades of trial and error,
TAR is finally becoming a viable alternative to ankle
fusion for end-stage ankle arthritis patients. There is
cautious optimism that with meticulous attention to
surgical technique, refined instrumentation, and
continued scrutiny in the literature regarding long-term
follow-up, TAR will enjoy similar longevity to that seen
with hip and knee replacement. The procedure volume
for TAR has risen most notably in the US and will
continue to surge over the forecast period.
What Physicians Think?
The major benefit associated with TAR lies in its
capability to help restore an ankle’s range of motion.
“It restores, to some degree, or at least preserves the
range of motion. An experienced surgeon will tell you that
any motion is better than no motion. A patient’s functional
activity is greatly increased with a replacement.”
Key Opinion Leader, December 2012
Revived interest in TAR was seen in the
management of late-stage ankle arthritis patients in
the past decade.
“There is continued increase in TAR volume in parallel
with a certain decrease in ankle fusion.”
Key Opinion Leader, November 2012
Several factors are driving the increase in the
procedure volume of TAR over the past few years.
“There has been a huge increase in the number of ankle
replacements that we are able to do, because we have
better understandings of correcting deformities. Also
public awareness of ankle replacement has increased
dramatically, primarily due to the internet, and to a lesser
extent, to the marketing by companies.”
Key Opinion Leader, December 2012
Currently, it is still in debate within the US foot and
ankle community whether three-component mobile-
bearing TAR implants generate better clinical
outcomes than two-component fixed-bearing ones.
“Right now we’ve been unable to tell the differences
between mobile-bearing and fixed-bearing. Worldwide,
it’s accepted that the mobile-bearing is better. But there
is no proof of that, just based on intuition.”
Key Opinion Leader, November 2012
Despite the promising early clinical outcomes of the
present TAR implants, many are calling for further
improvements.
“I personally don’t believe any of the current (TAR)
implants available in the US market have very good rates
of biological fixation. We just don’t see the ingrowth that
we’ve seen in the hip and the knee [replacement
implants].”
Key Opinion Leader, December 2012
“None of the companies really make a reasonable set of
implants for the second-time operation. All of these
implants have distinct drawbacks when it’s time to revise
them.”
Key Opinion Leader, December 2012
Executive Summary
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At this point, the US TAR market contributes the
most to global revenue. Significant future market
growth is anticipated in the US as the previous non-
clinical barriers have been overcome.
“It used to be a struggle, over two years ago. Some
insurance firms simply refused to authorize TAR by
quoting it experimental. As more articles have come out,
particularly the STAR which included more than 600 TAR
surgeries and compared it to ankle arthrodesis, insurance
companies are no longer able to say it’s experimental.
Furthermore, TAR has the endorsement from the
AOFAS. So we don’t really have non-clinical barriers
anymore.”
Key Opinion Leader, November 2012
Table of Contents
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1 Table of Contents
1 Table of Contents ............................................................................................................... 6
1.1 List of Tables ............................................................................................................. 10
1.2 List of Figures ........................................................................................................... 12
2 Introduction ....................................................................................................................... 13
2.1 Catalyst ..................................................................................................................... 13
2.2 Related Reports ........................................................................................................ 13
3 Disease Overview ............................................................................................................. 14
3.1 Anatomy and Physiology ........................................................................................... 14
3.2 Pathophysiology ........................................................................................................ 15
3.2.1 Overview............................................................................................................. 15
3.2.2 Post-Traumatic Arthritis ....................................................................................... 16
3.2.3 Inflammatory Arthritis .......................................................................................... 17
3.2.4 Primary Osteoarthritis ......................................................................................... 18
3.2.5 Others ................................................................................................................. 18
3.3 Clinical Presentation .................................................................................................. 19
3.3.1 Symptoms ........................................................................................................... 19
3.3.2 Diagnosis ............................................................................................................ 20
3.4 Clinical Outcomes ..................................................................................................... 21
3.4.1 Overview............................................................................................................. 21
3.4.2 Conservative Treatments .................................................................................... 21
3.4.3 Joint-Preserving Surgeries .................................................................................. 22
3.4.4 Definitive Procedures .......................................................................................... 25
3.5 Epidemiology ............................................................................................................ 29
3.5.1 Prevalence .......................................................................................................... 29
3.5.2 Treatments ......................................................................................................... 30
3.6 Economic Impact ....................................................................................................... 31
3.6.1 Economic Impact in the US ................................................................................. 32
Table of Contents
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4 Competitive Assessment ................................................................................................... 33
4.1 Overview ................................................................................................................... 33
4.2 Competitive Assessment ........................................................................................... 34
4.3 US Marketed Products .............................................................................................. 35
4.3.1 Scandinavian Total Ankle Replacement (STAR) .................................................. 35
4.3.2 Agility LP............................................................................................................. 37
4.3.3 Salto Talaris ........................................................................................................ 40
4.3.4 INBONE II ........................................................................................................... 43
4.3.5 Zimmer Trabecular Metal Total Ankle .................................................................. 46
5 Unmet Needs.................................................................................................................... 48
5.1 Long-Term Follow-Up ................................................................................................ 49
5.2 Commitment to Medical Education ............................................................................ 50
5.3 Advanced Biological Fixation ..................................................................................... 51
5.4 Minimal Bone Resection ............................................................................................ 53
5.4.1 Tibial Component ................................................................................................ 53
5.4.2 Talar Component ................................................................................................ 53
5.5 Mobile-Bearing versus Fixed-Bearing ........................................................................ 54
5.6 Bespoke Instrumentation ........................................................................................... 56
5.7 Custom Prostheses ................................................................................................... 56
5.8 Revision Components ............................................................................................... 57
6 Pipeline Products .............................................................................................................. 58
6.1 Overview ................................................................................................................... 58
6.2 INBONE II Total Ankle with Calcaneal Stem Fixation ................................................. 58
6.2.1 Overview............................................................................................................. 58
6.2.2 SWOT Analysis ................................................................................................... 59
7 Industry Overview ............................................................................................................. 60
7.1 Procedure Trends...................................................................................................... 60
7.2 Market Access........................................................................................................... 61
Table of Contents
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7.2.1 Regulatory Process ............................................................................................. 61
7.2.2 Adoption ............................................................................................................. 62
7.3 Reimbursement Trends ............................................................................................. 63
7.4 Regulatory Issues/Recalls ......................................................................................... 65
7.4.1 No Custom Devices for DePuy’s Agility Total Ankle Prosthesis in the US ............ 65
7.5 Mergers & Acquisitions/Key Partnerships .................................................................. 66
8 Current and Future Players ............................................................................................... 67
8.1 Overview ................................................................................................................... 67
8.2 Trends in Corporate Strategy..................................................................................... 67
8.3 Company Profiles ...................................................................................................... 68
8.3.1 Small Bone Innovation, Inc. ................................................................................. 68
8.3.2 DePuy Synthes ................................................................................................... 70
8.3.3 Tornier ................................................................................................................ 72
8.3.4 Wright Medical Group, Inc. .................................................................................. 74
8.3.5 Zimmer Holdings, Inc. ......................................................................................... 76
9 Market Drivers, Opportunities, and Barriers ....................................................................... 78
9.1 Market Drivers ........................................................................................................... 78
9.1.1 Superiority to Ankle Fusion.................................................................................. 78
9.1.2 Rising Prevalence ............................................................................................... 80
9.1.3 Expanded Insurance Coverage ........................................................................... 81
9.1.4 Availability of Long-Term Data............................................................................. 81
9.1.5 Increased Patient Awareness .............................................................................. 82
9.2 Opportunities ............................................................................................................. 83
9.2.1 Expanded Indications .......................................................................................... 83
9.2.2 Advanced Biological Fixation Approaches ........................................................... 83
9.2.3 Revision TAR ...................................................................................................... 84
9.2.4 Demand for Custom Prostheses .......................................................................... 84
9.2.5 Demand for a Comprehensive Foot and Ankle Product Portfolio .......................... 85
Table of Contents
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9.3 Market Barriers.......................................................................................................... 86
9.3.1 Preoperative Patient Selection ............................................................................ 86
9.3.2 Long Learning Curve ........................................................................................... 87
9.3.3 Complications ..................................................................................................... 88
9.3.4 Cost .................................................................................................................... 88
9.3.5 Reimbursement................................................................................................... 88
9.3.6 Substitutes .......................................................................................................... 89
10 Country Outlooks and Forecasts ....................................................................................... 90
10.1 US Market Analysis ................................................................................................... 90
11 Appendix .......................................................................................................................... 93
11.1 Abbreviations ............................................................................................................ 93
11.2 Bibliography .............................................................................................................. 94
11.3 Methodology ............................................................................................................. 99
11.3.1 Coverage ............................................................................................................ 99
11.3.2 Secondary Research ........................................................................................... 99
11.3.3 Primary Research ............................................................................................. 100
11.3.4 Forecasting Methodology .................................................................................. 101
11.4 Physicians and Specialists Included in this Study .................................................... 102
11.5 Physician Survey ..................................................................................................... 102
11.6 About the Authors ................................................................................................... 104
11.6.1 Analysts ............................................................................................................ 104
11.6.2 Global Head of Healthcare ................................................................................ 105
11.7 About MediPoint ...................................................................................................... 106
11.8 About GlobalData .................................................................................................... 106
11.9 Contact Us .............................................................................................................. 106
11.10 Disclaimer ......................................................................................................... 107
Table of Contents
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1.1 List of Tables
Table 1: Common Clinical Symptoms of Ankle Arthritis ....................................................... 19
Table 2: Indications and Contraindications of TAR .............................................................. 28
Table 3: Direct and Indirect Costs of Arthritis ...................................................................... 31
Table 4: Currently Marketed Total Ankle Replacement Implants ......................................... 33
Table 5: Product Profile – STAR ......................................................................................... 36
Table 6: SWOT Analysis – STAR ....................................................................................... 36
Table 7: Product Profile – Agility LP.................................................................................... 38
Table 8: SWOT Analysis – Agility LP .................................................................................. 39
Table 9: Product Profile – Salto Talaris ............................................................................... 41
Table 10: SWOT Analysis – Salto Talaris ............................................................................. 42
Table 11: Product Profile – INBONE II .................................................................................. 44
Table 12: SWOT Analysis – INBONE II ................................................................................ 45
Table 13: Product Profile – Zimmer Trabecular Metal Total Ankle ......................................... 47
Table 14: SWOT Analysis - Zimmer Trabecular Metal Total Ankle ........................................ 47
Table 15: Overall Unmet Needs – Current Level of Attainment and Importance (n=30) ......... 48
Table 16: Coating Methods of Currently Marketed TAR Implants .......................................... 51
Table 17: Product Profile – INBONE II Total Ankle with Calcaneal Stem Fixation .................. 58
Table 18: SWOT Analysis of INBONE II Total Ankle with Calcaneal Stem Fixation ............... 59
Table 19: 2011 Medicare National Payment Average for Total Ankle Replacement ............... 63
Table 20: Company Profile – Small Bone Innovations ........................................................... 68
Table 21: Portfolio Assessment – Small Bone Innovations, 2013 .......................................... 68
Table 22: SBi’s Foot and Ankle Business SWOT Analysis, 2013 .......................................... 69
Table 23: Company Profile – DePuy Synthes Companies ..................................................... 70
Table 24: DePuy's Total Ankle Replacement Portfolio Assessment, 2013 ............................. 71
Table 25: DePuy's Foot and Ankle Business SWOT Analysis, 2013...................................... 71
Table 26: Company Profile – Tornier .................................................................................... 72
Table 27: Tornier's Total Ankle Replacement Portfolio Assessment, 2013 ............................ 72
Table of Contents
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Table 28: Tornier's Foot and Ankle Business SWOT Analysis, 2013 ..................................... 73
Table 29: Company Profile – Wright Medical Group.............................................................. 74
Table 30: Wright Medical's Total Ankle Replacement Portfolio Assessment, 2013 ................ 75
Table 31: Wright Medical's Foot and Ankle Business SWOT Analysis, 2013 ......................... 75
Table 32: Company Profile – Zimmer Holdings ..................................................................... 76
Table 33: Zimmer Holding’s Total Ankle Replacement Portfolio Assessment, 2013 ............... 76
Table 34: Zimmer's Foot and Ankle Business SWOT Analysis, 2013 .................................... 77
Table 35: Advantages and Disadvantages of Ankle Fusion and Total Ankle Replacement .... 79
Table 36: Sales Forecasts for TAR in the US (2009–2018) ................................................... 90
Table 37: Abbreviations ........................................................................................................ 93
Table of Contents
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1.2 List of Figures
Figure 1: Schematic Diagram of Ankle Anatomy................................................................. 14
Figure 2: Ankle Arthritis Subtypes ...................................................................................... 15
Figure 3: Causes of Post-Traumatic Ankle Arthritis............................................................. 16
Figure 4: Staged Treatment Approach of Ankle Arthritis ..................................................... 21
Figure 5: An Example of Ankle Distraction Arthroplasty ...................................................... 24
Figure 6: An Example of Ankle Fusion ............................................................................... 25
Figure 7: An Example of a Total Ankle Replacement Implant ............................................. 27
Figure 8: US Population with Ankle Arthritis (2009–2018) ................................................... 29
Figure 9: Treatment Modalities of Ankle Arthritis in Developed Countries ........................... 30
Figure 10: Estimated Costs of Ankle Arthritis, 2009–2018 .................................................... 32
Figure 11: Product Image – STAR ....................................................................................... 35
Figure 12: Product Image – Agility LP .................................................................................. 38
Figure 13: Product Image – Salto Talaris ............................................................................. 40
Figure 14: Product Image – INBONE II ................................................................................ 44
Figure 15: Product Image – Zimmer Trabecular Metal Total Ankle ....................................... 46
Figure 16: TAR Procedure Volume in the US (2009–2018) .................................................. 60
Figure 17: Sales Forecasts for TAR in the US (2009–2018) ................................................. 90
Introduction
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2 Introduction
With a much lower incidence of arthritis, the ankle joint enjoys a unique biological resilience to the
degenerative process that routinely plagues the hips and the knees. Nonetheless, the ankle joint is
still susceptible to arthritis, mostly in the form of post-traumatic arthritis. Total ankle replacement
(TAR) enables implantation of prosthesis within the diseased native ankle joint to help patients
maintain their ankles’ range of motion. Early experience with TAR in the US was met with
unacceptable failure and complication rates in the 1980s, such that the procedure was largely
abandoned. In the past decade, newer generations of TAR prostheses with a more anatomical
replication of the ankle joint demonstrated some encouraging early and medium-term clinical
results. Meanwhile, long-term results following successful early ankle fusion have brought to light
somewhat disappointing long-term satisfaction rates. TAR is becoming an increasingly popular
alternative to ankle fusion lately, as professional and commercial interest intensifies and long-term
effectiveness becomes available. As more competitors enter the market and the indications of TAR
have been suggested to expand to include younger patients and those with some hindfoot
deformities, surgeon adoption will further increase and this industry will enjoy steady growth in
coming years.
2.1 Catalyst
TAR represents a promising option for late-stage ankle arthritis patients as an alternative to ankle
fusion, which has historically been presumed to be the gold-standard procedure. Clinical longevity
of TAR hinges on the availability of its long-term clinical efficacy, improved patient awareness, and
updated insurance policies, as well as suppliers’ efforts on shortening the steep learning curve
presented to surgeons. This report focuses on the US TAR market. GlobalData identified currently
marketed TAR prostheses, evaluated the unmet needs in the market and provided an
understanding of surgeon perception of TAR within the US foot and ankle community. According to
our analysis, widespread adoption of TAR will be realized in the US in the next few years. To
successfully capitalize within the global TAR market, companies need to provide deliverables
adopting better design philosophies that address the current unmet needs, and to put more energy
into clinical education to drive surgeon adoption.
Appendix
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11.7 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 (KOL). Running throughout
each report in the series, “What Physicians Think” quotes provide a unique insight into how
healthcare professionals are reacting to events within the industry, and what their responses could
mean for industry strategists.
11.8 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports and
forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has
offices in New York, Boston, London, India and Singapore.
Appendix
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11.10 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.