MediPoint: Total Ankle Replacement - US Analysis and Market Forecasts

Summary

Ankle arthritis is a severe and debilitating problem with notable increasing prevalence in both the developed and developing world. In a society constantly seeking out a modern lifestyle, sports-related injuries, trauma, aging, and obesity are contributing to an increased incidence of ankle arthritis. Total ankle replacement (TAR) enables implantation of prosthesis within the diseased native ankle joint to help patients maintain their ankles’ range of motion. Promising results of newer generation prostheses revived interest in TAR and fueled further innovations in the prosthetic design. After decades of trial and error, TAR is now becoming 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. This report focuses on the TAR markets in the US. This report identifies unmet needs in the market, surgeon attitudes towards current TAR prostheses, and the future of TAR in the face of rapid technological advancement.

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.

Scope

- An overview of Ankle arthritis, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized US TAR market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for TAR
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the TAR device sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as oncologists

Reasons to buy

- Understand the trends shaping and driving the US TAR Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the US TAR Market through 2018.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What’s the next big thing in the US TAR market landscape? Identify, understand and capitalize.

Table Of Contents

1 Table of Contents
1 Table of Contents 6


2 Introduction 13
2.1 Catalyst 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
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
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 and 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
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 103
11.6 About the Authors 103
11.6.1 Analysts 103
11.6.2 Global Head of Healthcare 104
11.7 About MediPoint 104
11.8 About GlobalData 104
11.9 Contact Us 105
11.10 Disclaimer 105

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 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

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

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