Total Ankle Replacement - MarketResearch · The total ankle replacement ... interest within the...

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Total Ankle Replacement US Analysis and Market Forecasts

GDME1014CFR / Published February 2013

Executive Summary

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. GDME1014CFR / Published FEB 2013

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


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


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.”


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.”


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].”


“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.”


Executive Summary


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.”


Table of Contents


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


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


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


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


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


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


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


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

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 106 GDME1014CFR / Published FEB 2013

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

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 107 GDME1014CFR / Published FEB 2013

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.

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