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MediPoint: Total Ankle Replacement - US Analysis and Market Forecasts

Published: Feb 2013 | No Of Pages: 105 | Published By: GlobalData


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.


  • 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 markets 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.
  • Whats the next big thing in the US TAR market landscape? Identify, understand and capitalize.

1. Table of Contents
1.1. List of Tables
1.2. List of Figures

2. Introduction
2.1. Catalyst

3. Disease Overview
3.1. Anatomy and Physiology
3.2. Pathophysiology
3.2.1. Overview
3.2.2. Post-Traumatic Arthritis
3.2.3. Inflammatory Arthritis
3.2.4. Primary Osteoarthritis
3.2.5. Others
3.3. Clinical Presentation
3.3.1. Symptoms
3.3.2. Diagnosis
3.4. Clinical Outcomes
3.4.1. Overview
3.4.2. Conservative Treatments
3.4.3. Joint-Preserving Surgeries
3.4.4. Definitive Procedures
3.5. Epidemiology
3.5.1. Prevalence
3.5.2. Treatments
3.6. Economic Impact
3.6.1. Economic Impact in the US

4. Competitive Assessment
4.1. Overview
4.2. Competitive Assessment
4.3. US Marketed Products
4.3.1. Scandinavian Total Ankle Replacement (STAR)
4.3.2. Agility LP
4.3.3. Salto Talaris
4.3.4. INBONE II
4.3.5. Zimmer Trabecular Metal Total Ankle

5. Unmet Needs
5.1. Long-Term Follow-Up
5.2. Commitment to Medical Education
5.3. Advanced Biological Fixation
5.4. Minimal Bone Resection
5.4.1. Tibial Component
5.4.2. Talar Component
5.5. Mobile-Bearing versus Fixed-Bearing
5.6. Bespoke Instrumentation
5.7. Custom Prostheses
5.8. Revision Components

6. Pipeline Products
6.1. Overview
6.2. INBONE II Total Ankle with Calcaneal Stem Fixation
6.2.1. Overview
6.2.2. SWOT Analysis

7. Industry Overview
7.1. Procedure Trends
7.2. Market Access
7.2.1. Regulatory Process
7.2.2. Adoption
7.3. Reimbursement Trends
7.4. Regulatory Issues/Recalls
7.4.1. No Custom Devices for DePuy\'s Agility Total Ankle Prosthesis in the US
7.5. Mergers & Acquisitions/Key Partnerships

8. Current and Future Players
8.1. Overview
8.2. Trends in Corporate Strategy
8.3. Company Profiles
8.3.1. Small Bone Innovation, Inc.
8.3.2. DePuy Synthes
8.3.3. Tornier
8.3.4. Wright Medical Group, Inc.
8.3.5. Zimmer Holdings, Inc.

9. Market Drivers, Opportunities, and Barriers
9.1. Market Drivers
9.1.1. Superiority to Ankle Fusion
9.1.2. Rising Prevalence
9.1.3. Expanded Insurance Coverage
9.1.4. Availability of Long-Term Data
9.1.5. Increased Patient Awareness
9.2. Opportunities
9.2.1. Expanded Indications
9.2.2. Advanced Biological Fixation Approaches
9.2.3. Revision TAR
9.2.4. Demand for Custom Prostheses
9.2.5. Demand for a Comprehensive Foot and Ankle Product Portfolio
9.3. Market Barriers
9.3.1. Preoperative Patient Selection
9.3.2. Long Learning Curve
9.3.3. Complications
9.3.4. Cost
9.3.5. Reimbursement
9.3.6. Substitutes

10. Country Outlooks and Forecasts
10.1. US Market Analysis

11. Appendix
11.1. Abbreviations
11.2. Bibliography
11.3. Methodology
11.3.1. Coverage
11.3.2. Secondary Research
11.3.3. Primary Research
11.3.4. Forecasting Methodology
11.4. Physicians and Specialists Included in this Study
11.5. Physician Survey
11.6. About the Authors
11.6.1. Analysts
11.6.2. Global Head of Healthcare
11.7. About MediPoint
11.8. About GlobalData
11.9. Contact Us
11.10. Disclaimer

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: SBis 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 Holdings 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 (20092018) 90
Table 37: Abbreviations 93


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 (20092018) 29
Figure 9: Treatment Modalities of Ankle Arthritis in Developed Countries 30
Figure 10: Estimated Costs of Ankle Arthritis, 20092018 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 (20092018) 60
Figure 17: Sales Forecasts for TAR in the US (20092018) 90

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