MediPoint: Knee Replacement - US Analysis and Market Forecasts

Summary

The current knee replacement market is a crowded space, with an increasing number of companies offering a myriad of partial, primary/total, and revision prostheses to meet orthopedic surgeons’ demands in the management of knee diseases, primarily osteoarthritis. Worldwide, the primary/total knee segment represents about 80–90% of the entire knee market, with the remainder being partial knee and revision knee. Overall, clinical data show that short- to medium-term survivorship is excellent after almost all common types of knee replacement, regardless of fixation, constraint, and bearing type. Future competition among vendors will be more likely to center on the instrumentation and the ancillary equipment, such as patient-specific instruments, navigation systems, and robotic systems.

The primary factor for growth in the US knee market has been the rise in the aging population and the desire of these patients to maintain a productive lifestyle. This, coupled with constant innovations in implant design and a favorable reimbursement scenario in the US, has led to a continued increase in the procedure volume, despite it being slow and gradual. However, given the current economic situation, patients may choose to postpone their primary joint replacements.

Scope

- An overview of hypertension, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized the US Knee replacement market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for Knee replacement
- 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 Knee replacement sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as cardiologists

Reasons to buy

- Understand the trends shaping and driving the US Knee replacement market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the US Knee replacement 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 Knee replacement market landscape? Identify, understand and capitalize.

Table Of Contents

1 Table of Contents
1 Table of Contents 6


2 Introduction 19
2.1 Catalyst 20
3 Disease Overview 21
3.1 Anatomy and Physiology 21
3.2 Pathophysiology 23
3.2.1 Overview 23
3.2.2 Primary Osteoarthritis 23
3.2.3 Rheumatoid Arthritis 24
3.2.4 Post-Traumatic Arthritis 25
3.2.5 Avascular Necrosis 25
3.3 Clinical Presentation 26
3.3.1 Diagnosis 26
3.4 Clinical Outcomes 27
3.4.1 Overview 27
3.4.2 Conservative Treatments 27
3.4.3 Joint-Preserving Treatments 29
3.4.4 Joint Replacement 31
3.5 Economic Impact 42
3.5.1 United States 43
4 Industry Overview 44
4.1 Procedural Trends 44
4.1.1 United States 44
4.2 Market Access 48
4.2.1 United States 48
4.3 Regulatory Issues/Recalls 64
4.3.1 DePuy Orthopaedic’s Diaphyseal Sleeve Components of the Limb Preservation System (LPS) 64
4.3.2 Stryker’s ShapeMatch Cutting Guides 64
4.3.3 Smith and Nephew’s Journey Uni Tibial Insert, Right Medial/Left Lateral 65
4.4 Mergers and Acquisitions/Key Partnerships 65
4.4.1 Stryker’s Acquisition of MAKO Surgical 65
4.4.2 MicroPort Medical B.V.’s Acquisition of Wright Medical’s OrthoRecon Business 65
4.4.3 Stryker’s Extension of Co-Marketing Agreement with OrthoSensor 66
4.4.4 Blue Belt Technologies’ Co-Marketing Agreement with DJO Surgical 66
4.4.5 Biomet and OrthoSensor Enter Into Co-Promotion Partnership 66
4.4.6 Italian Consortium 2IL Orthopaedics Acquires Corin Group 67
4.4.7 Smith and Nephew Acquires LifeModeler, Inc. (LMI) 67
4.5 Market Drivers, Opportunities, and Barriers 68
4.5.1 Market Drivers 68
4.5.2 Market Opportunities 73
4.5.3 Market Barriers 79
5 Competitive Assessment 84
5.1 Overview 84
5.2 Global Market Share 86
5.3 B. Braun 87
5.3.1 Primary Knee Replacement 87
5.3.2 Partial Knee Replacement 89
5.3.3 Revision Knee Replacement 90
5.3.4 SWOT Analysis 90
5.4 Biomet 91
5.4.1 Primary Knee Replacement 91
5.4.2 Partial Knee Replacement 94
5.4.3 Revision Knee Replacement 95
5.4.4 SWOT Analysis 96
5.5 DePuy Synthes 97
5.5.1 Primary Knee Replacement 97
5.5.2 Partial Knee Replacement 102
5.5.3 Revision Knee Replacement 103
5.5.4 SWOT Analysis 104
5.6 DJO Surgical 105
5.6.1 Primary Knee Replacement 105
5.6.2 Partial Knee Replacement 108
5.6.3 Revision Knee Replacement 108
5.6.4 SWOT Analysis 109
5.7 Exactech 110
5.7.1 Primary Knee Replacement 110
5.7.2 Partial Knee Replacement 111
5.7.3 Revision Knee Replacement 112
5.7.4 SWOT Analysis 112
5.8 Smith and Nephew 113
5.8.1 Primary Knee Replacement 113
5.8.2 Partial Knee Replacement 117
5.8.3 Revision Knee Replacement 118
5.8.4 SWOT Analysis 119
5.9 Stryker 120
5.9.1 Primary Knee Replacement 120
5.9.2 Partial Knee Replacement 123
5.9.3 Revision Knee Replacement 124
5.9.4 SWOT Analysis 125
5.10 Wright Medical (MicroPort) 126
5.10.1 Primary Knee Replacement 126
5.10.2 Revision Knee Replacement 128
5.10.3 SWOT Analysis 129
5.11 Zimmer 130
5.11.1 Primary Knee Replacement 130
5.11.2 Partial Knee Replacement 136
5.11.3 Revision Knee Replacement 136
5.11.4 SWOT Analysis 138
6 Unmet Needs 139
6.1 Availability of Long-Term Clinical Data 139
6.2 Complete Knee Platform 141
6.3 Need for Cost-Containment 143
6.4 Training for Computer Navigation Technologies 144
6.5 Continued Innovations in Instrumentation 146
6.6 Advanced Materials 147
6.7 Implants for Metal-Sensitive Patients 148
6.8 National Joint Registry 149
7 Pipeline Products 151
7.1 Overview 151
7.2 Biomet’s Vanguard XP Total Knee System 151
7.3 Corentec’s Lospa Total Knee System 152
7.4 NovoSource’s NovoKnee 152
7.5 Pipeline Orthopedics’ NEO PS Knee System 152
7.6 Bonovo Orthopedics’ JMM Total Knee System 152
7.7 Corin Group’s Unity Knee Systems 153
7.8 Kinamed’s GEM Total Knee System 153
7.9 Emerge Medical 153
8 Current and Future Players 154
8.1 Trends in Corporate Strategy 154
8.2 Established Players 155
8.2.1 B. Braun 155
8.2.2 Biomet 159
8.2.3 Corin Group 163
8.2.4 DePuy Synthes 166
8.2.5 DJO Global 170
8.2.6 Exactech 173
8.2.7 Medacta 176
8.2.8 Smith and Nephew 178
8.2.9 Stryker 182
8.2.10 Waldemar LINK 186
8.2.11 Wright Medical Group (MicroPort) 189
8.2.12 Zimmer Holdings 193
8.3 Emerging Players 197
8.3.1 Blue Belt Technologies 197
8.3.2 ConforMIS 199
8.3.3 MAKO Surgical 202
8.3.4 OmniLife science 205
8.3.5 Other Emerging Players 208
9 Market Outlooks 209
9.1 US 209
10 Appendix 212
10.1 Abbreviations 212
10.2 Bibliography 215
10.3 Report Methodology 233
10.3.1 Overview 233
10.3.2 Coverage 233
10.3.3 Secondary Research 234
10.3.4 Forecasting Methodology 235
10.3.5 Primary Research - Key Opinion Leader Interviews 236
10.3.6 Expert Panel Validation 236
10.4 Physicians and Specialists Included in This Study 237
10.5 About the Authors 239
10.5.1 Analysts 239
10.5.2 Bonnie Bain, Ph.D., Global Head of Healthcare 241
10.6 About MediPoint 242
10.7 About GlobalData 242
10.8 Disclaimer 242

1.1 List of Tables
Table 1: Risk Factors for Primary OA of the Knee 24
Table 2: Common Clinical Symptoms of Knee Arthritis 26
Table 3: Common Reasons for Failed Knee Implants 38
Table 4: Advantages of CAS 40
Table 5: Direct, Indirect, and Intangible Costs of Arthritis 42
Table 6: Medicare Reimbursement Coding Guide for Knee Arthroplasty, 2013 60
Table 7: Medicare National Average Reimbursement Rates for Knee Arthroplasty, 2012-2013 61
Table 8: Common Reasons for Revision After Total and Partial Knee Replacement 80
Table 9: Product Profile - Columbus Total Knee System 88
Table 10: Product Profile - e.motion Total Knee System 89
Table 11: Product Profile - univation Unicondylar Knee System 89
Table 12: Product Profile - B. Braun’s Revision Knee Replacement Systems 90
Table 13: SWOT Analysis - B. Braun’s Knee Portfolio 90
Table 14: Product Profile - Vanguard Complete Knee System 92
Table 15: List of Select Clinical Studies - Vanguard Complete Knee System 92
Table 16: Product Profile - AGC Total Knee System 93
Table 17: List of Select Clinical Studies - AGC Total Knee System 94
Table 18: Product Profile - Biomet’s Partial Knee Replacement Systems 95
Table 19: Product Profile - Biomet’s Revision Knee Replacement Systems 95
Table 20: Select Clinical Study - Biomet’s Revision Knee Replacement Systems 96
Table 21: SWOT Analysis - Biomet’s Knee Portfolio 96
Table 22: Product Profile - LCS Complete Knee Systems 98
Table 23: List of Select Clinical Studies - LCS Complete Knee System 98
Table 24: Product Profile - Sigma Knee System 100
Table 25: List of Select Clinical Studies - Sigma Knee System 100
Table 26: Product Profile - Attune Knee System 101
Table 27: List of Select Clinical Studies - Attune Knee System 102
Table 28: Product Profile - Sigma HP Partial Knee System 102
Table 29: Product Profile - DePuy’s Revision Knee Replacement Systems 103
Table 30: List of Select Clinical Studies - DePuy’s Revision Knee Replacement Systems 104
Table 31: SWOT Analysis - DePuy’s Knee Portfolio 104
Table 32: Product Profile - Movation Knee System 105
Table 33: Product Profile - 3D Knee System 106
Table 34: Product Profile - Foundation Knee System 107
Table 35: Product Profile - EPIK Knee System 108
Table 36: Product Profile - Foundation Revision Knee System 108
Table 37: SWOT Analysis - DJO’s Knee Portfolio 109
Table 38: Product Profile - Optetrak Knee System 111
Table 39: Product Profile - Optetrak Unicondylar Knee System 111
Table 40: Product Profile - Optetrack Constrained Condylar (CC) Knee System 112
Table 41: SWOT Analysis - Exactech’s Knee Portfolio 112
Table 42: Product Profile - LEGION Knee System 114
Table 43: List of Select Clinical Studies - GENESIS II Total Knee System 114
Table 44: Product Profile - JOURNEY Knee System 116
Table 45: List of Select Clinical Studies - JOURNEY Knee System 116
Table 46: Product Profile - Smith and Nephew’s Partial Knee Replacement Systems 117
Table 47: Product Profile - Smith and Nephew’s Revision Knee Systems 118
Table 48: SWOT Analysis - Smith and Nephew’s Knee Portfolio 119
Table 49: Product Profile - Triathlon Total Knee System 121
Table 50: List of Select Clinical Studies - Triathlon Total Knee System 121
Table 51: Product Profile - Scorpio Knee System 122
Table 52: Product Profile - Stryker’s Partial Knee Replacement Systems 123
Table 53: Product Profile - Stryker’s Revision Knee Replacement Systems 124
Table 54: Select Clinical Study - Stryker’s Revision Knee Replacement System 124
Table 55: SWOT Analysis - Stryker’s Knee Portfolio 125
Table 56: Product Profile - Advance Knee System 127
Table 57: Product Profile - Evolution Medial-Pivot Knee System 128
Table 58: Product Profile - Wright Medical’s Revision Knee Replacement Systems 128
Table 59: SWOT Analysis - Wright Medical’s Knee Portfolio 129
Table 60: Product Profile - NexGen Knee System 131
Table 61: List of Select Clinical Studies - NexGen Knee System 132
Table 62: Product Profile - Gender Solutions Knee Systems 133
Table 63: List of Select Clinical Studies - Gender Solutions Knee System 134
Table 64: Product Profile - Persona Knee System 135
Table 65: List of Select Clinical Studies - Persona Knee System 135
Table 66: Product Profile - Zimmer’s Partial Knee Replacement Systems 136
Table 67: Product Profile - Zimmer’s Revision Knee Replacement Systems 137
Table 68: SWOT Analysis - Zimmer’s Knee Portfolio 138
Table 69: Pipeline Products in the Global Knee Replacement Market, 2013 151
Table 70: Company Profile - B. Braun 156
Table 71: Portfolio Assessment - B. Braun 157
Table 72: SWOT Analysis - B. Braun 158
Table 73: Company Profile - Biomet 160
Table 74: Portfolio Assessment - Biomet 161
Table 75: SWOT Analysis - Biomet 162
Table 76: Company Profile - Corin Group 163
Table 77: Portfolio Assessment - Corin Group 164
Table 78: SWOT Analysis - Corin Group 165
Table 79: Company Profile - DePuy Synthes 166
Table 80: Portfolio Assessment - DePuy Synthes 168
Table 81: SWOT Analysis - DePuy Synthes 169
Table 82: Company Profile - DJO Global 170
Table 83: Portfolio Assessment - DJO Global 171
Table 84: SWOT Analysis - DJO Global 172
Table 85: Company Profile - Exactech 173
Table 86: Portfolio Assessment - Exactech 174
Table 87: SWOT Analysis - Exactech 175
Table 88: Company Profile - Medacta 176
Table 89: Portfolio Assessment - Medacta 177
Table 90: SWOT Analysis - Medacta 177
Table 91: Company Profile - Smith and Nephew 179
Table 92: Portfolio Assessment - Smith and Nephew 180
Table 93: SWOT Analysis - Smith and Nephew 181
Table 94: Company Profile - Stryker 183
Table 95: Portfolio Assessment - Stryker 184
Table 96: SWOT Analysis - Stryker 185
Table 97: Company Profile - Waldemar LINK 186
Table 98: Portfolio Assessment - Waldemar LINK 187
Table 99: SWOT Analysis - Waldemar LINK 188
Table 100: Company Profile - Wright Medical Group 190
Table 101: Portfolio Assessment - Wright Medical Group 191
Table 102: SWOT Analysis - Wright Medical Group 192
Table 103: Company Profile - Zimmer Holdings 194
Table 104: Portfolio Assessment - Zimmer Holdings 195
Table 105: SWOT Analysis - Zimmer Holdings 196
Table 106: Company Profile - Blue Belt Technologies 197
Table 107: Portfolio Assessment - Blue Belt Technologies 198
Table 108: SWOT Analysis - Blue Belt Technologies 198
Table 109: Company Profile - ConforMIS 199
Table 110: Portfolio Assessment - ConforMIS 200
Table 111: SWOT Analysis - ConforMIS 201
Table 112: Company Profile - MAKO Surgical 202
Table 113: Portfolio Assessment - MAKO Surgical 203
Table 114: SWOT Analysis - MAKO Surgical 204
Table 115: Company Profile - OMNIlife science 205
Table 116: Portfolio Assessment - OMNIlife science 206
Table 117: SWOT Analysis - OMNIlife science 207
Table 118: Other Emerging Players in the Global Knee Replacement Market, 2013 208
Table 119: US Knee Replacement Market Sales Forecast ($m), 2010-2019 210
Table 120: Abbreviations 212

1.2 List of Figures
Figure 1: Schematic Diagram of Knee Anatomy 21
Figure 2: Unicompartmental Knee Replacement 32
Figure 3: Patellofemoral Knee Replacement 34
Figure 4: Bicompartmental Knee Replacement 35
Figure 5: CR and PS Designs 36
Figure 6: Knee Replacement Procedure Volume, US, 2010-2019 44
Figure 7: Partial Knee Replacement Procedure Volume, US, 2010-2019 45
Figure 8: Primary Knee Replacement Procedure Volume, US, 2010-2019 46
Figure 9: Revision Knee Replacement Procedure Volume, US, 2010-2019 47
Figure 10: Adoption Trend for Total Knee Implants in the US, Fixed-Bearing vs. Mobile-Bearing, 2011-2015 52
Figure 11: Adoption Trend for Total Knee Implants in the US, Cruciate-Retaining vs. Cruciate-Sacrificing, 2011-2015 53
Figure 12: Adoption Trend for Revision Knee Implants in the US, 2011-2015 54
Figure 13: Adoption Trend for Computer-Assisted Technologies in the US, 2012 55
Figure 14: Medicare Payment Trend for Hip and Knee Replacements, 1985-2009 63
Figure 15: Global Knee Replacement Market, Competitive Landscape by Sales Revenue, 2012 86
Figure 16: Columbus Total Knee System 87
Figure 17: e.motion Total Knee System 88
Figure 18: Vanguard Complete Knee System 91
Figure 19: AGC Total Knee System 93
Figure 20: LCS Complete Knee System 97
Figure 21: Sigma Knee System 99
Figure 22: Attune Knee System 101
Figure 23: Movation Knee System 105
Figure 24: 3D Knee System 106
Figure 25: Foundation Knee System 107
Figure 26: Optetrak Logic Knee System 110
Figure 27: GENESIS II Total Knee System 113
Figure 28: Journey Knee System 115
Figure 29: Triathlon Total Knee System 120
Figure 30: Scorpio Knee System 122
Figure 31: Advance Knee System 126
Figure 32: Evolution Medial-Pivot Knee System 127
Figure 33: NexGen Knee System 130
Figure 34: Gender Solutions’ NexGen High-Flex Knee 133
Figure 35: Persona Knee System 135
Figure 36: Level of Impact of the Availability of Long-Term Clinical Data Upon Decision-Making (n=103) 140
Figure 37: Level of Impact of a Complete Knee System Upon Decision-Making (n=103) 141
Figure 38: US Knee Replacement Market Sales Forecast ($m), 2010-2019 210
Figure 39: US Primary Knee Replacement Market Segmentation by Type, 2012 and 2019 211

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