MediPoint: Trauma Fixation - US Analysis and Market Forecasts

Summary

Traumatic injury patients that come into the Emergency Room (ER) experience orthopedic injury in the form of fractures 60% to 65% of the time, based on GlobalData’s conversations with key opinion leaders. Of this population, 45%–50% are operable and require fracture repair techniques in the form of external or internal fixation. As the global population continues to grow in the emerging markets, with overcrowding and economic growth, some of the drivers for trauma fixation include motor vehicle accidents and aging. GlobalData’s analysis shows that while the orthopedics implant market is mature, where products have become commodities, trauma fixation is one that has room for more technological development and adoption.

GlobalData estimates the United States to be the largest market for trauma fixation implants. There are multiple drivers that contribute to the current state of the trauma fixation market. While factors such as reimbursement are currently not a challenge in the US for procedures and implants based on the proper indications, lowering physician reimbursement has driven orthopedic surgeons to seek other revenue streams and hold back some of the procedural numbers in joint replacement, stunting growth. This has in turn created more positive growth in plating and nail technology.

Scope

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

Reasons to buy

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

Table Of Contents

1 Table of Contents
1 Table of Contents 8


2 Introduction 19
2.1 Catalyst 20
3 Disease Overview 22
3.1 Anatomy and Physiology 22
3.1.1 Bone Biology 22
3.1.2 Skeletal Structure 22
3.2 Pathophysiology 25
3.2.1 Overview 25
3.2.2 Post-Traumatic Arthritis 25
3.2.3 Fracture 25
3.3 Clinical Presentation 26
3.3.1 Symptoms 26
3.3.2 Fracture Types 27
3.3.3 Fractures by Location 29
3.3.4 Hip Injury 31
3.4 Clinical Outcomes 32
3.4.1 Immobilization 32
3.4.2 Plates and Screws 33
3.4.3 Intramedullary Nails 35
3.4.4 Hip Fixation Device Options 35
3.4.5 External Fixation 38
4 Industry Overview 39
4.1 Overview 39
4.2 Procedure Trends 41
4.2.1 US 41
4.3 Market Access 42
4.3.1 US 42
4.4 Regulatory Issues / Recalls 47
4.4.1 Rigid FX FDA Warning Letter 47
4.4.2 DePuy Orthopedics LBS Lower Extremity Dovetail Intercalary Component Recall 47
4.5 Mergers, Acquisitions and Partnerships 47
4.5.1 Zimmer Acquires NORMED Medizin-Technik 47
4.5.2 Smith and Nephew Acquires Adler Mediequip Private Limited 47
4.5.3 Smith and Nephew plc Announces Acquisition of Brazil Distribution Business 48
4.5.4 Biomet Inc. Acquires DePuy Trauma 48
4.5.5 Zimmer Acquires ExtraOrtho XtraFix External Fixation Product Line 48
4.5.6 DePuy Orthopaedics (Johnson and Johnson) and Synthes Inc. Merge 48
4.5.7 Synthes Inc. and AO Foundation Partnership 49
4.6 Economic Impact 49
4.6.1 Developed Countries 49
4.6.2 Emerging Markets 50
4.7 Market Drivers 51
4.7.1 Rising Prevalence 51
4.7.2 Development Due to War 54
4.7.3 Bone Regeneration 55
4.7.4 Commoditization of Orthopedic Market 56
4.7.5 Patient Demand and Awareness 57
4.7.6 Technological Developments 58
4.7.7 Rising Competition and Innovation through Small Players 59
4.7.8 Materials Development 60
4.8 Market Opportunities 62
4.8.1 Mergers and Acquisitions 62
4.8.2 Emerging Markets 62
4.8.3 Extremities Growth 63
4.8.4 Capitalizing on Market Fragmentation 64
4.9 Market Barriers 65
4.9.1 Burden of Rising Regulation 65
4.9.2 Proving Efficacy 66
4.9.3 Pricing Pressures and Reimbursement 67
4.9.4 Medical Device Excise Tax 68
4.10 Substitutes 69
4.10.1 Joint Replacement 69
4.10.2 Generic Implants 70
4.10.3 External Fixation 71
5 Competitive Assessment 72
5.1 Overview 72
5.2 Global Market Share 72
5.2.1 Global Market Share 72
5.2.2 US Market Share 76
5.3 Marketed Products 80
5.3.1 Key Internal Fixation Products 81
5.3.2 Key External Fixation Devices 112
6 Unmet Needs 116
6.1 Addressing the Complications 116
6.2 Advanced Materials Research 116
6.3 Improving Borderline Patient Treatment Outcomes 118
6.4 Bioabsorbable Technology Development 118
6.5 Centralization 119
6.6 Cost Containment 119
6.7 Drug-Eluting Implants 120
6.8 Long-Term Clinical Data 121
6.9 Trauma Registry 123
7 Pipeline Products 125
7.1 Overview 125
7.2 Product Profiles 125
7.2.1 Drug-Releasing Screws by Bioretec 125
7.2.2 Small Bone Innovations Arthrodesis Plates 125
7.2.3 Semprus Biosciences Trauma Fixation Devices 125
7.2.4 Nanova Inc. Bioabsorbable Bone Screws 125
7.2.5 CAMBfix Ltd. Pipeline 126
7.2.6 Nutek Orthopaedics LLC External Fixation Pipeline 126
7.2.7 Innovia LLC Develops IM Nail 126
8 Clinical Trials to Watch 127
8.1 Overview 127
8.2 Orthopedic Trauma Patient Quality of Life Trial 127
8.3 Non-Operative vs. Operative Management of Olecranon Fractures 128
8.4 Smith and Nephew INTUIT Hip Fracture Study 128
8.5 Distal Radius Fracture Fixation Comparison 129
8.6 Nails versus Plates for Femur Fractures in Dar es Salaam, Tanzania 129
9 Current and Future Players 130
9.1 Trends in Corporate Strategy 130
9.2 Company Profiles 131
9.2.1 Acumed 131
9.2.2 Biomet 133
9.2.3 DePuy Synthes International 135
9.2.4 Integra LifeSciences 137
9.2.5 Orthofix 139
9.2.6 OsteoMed 141
9.2.7 Small Bone Innovations, Inc. 142
9.2.8 Smith and Nephew 144
9.2.9 Stryker 146
9.2.10 Tornier 148
9.2.11 Trimed Inc. 151
9.2.12 Wright Medical 152
9.2.13 Zimmer 155
9.2.14 Companies in Trauma 158
10 Market Outlook 162
10.1 US 162
11 Appendix 164
11.1 Abbreviations 164
11.2 Bibliography 166
11.3 Research Methodology 173
11.3.1 Overview 173
11.3.2 Coverage 173
11.3.3 Secondary Research 174
11.3.4 Forecasting Methodology 174
11.3.5 Primary Research - Key Opinion Leader Interviews 176
11.3.6 Primary Research - Physician Survey 176
11.3.7 Expert Panel Validation 178
11.4 Physicians and Specialists Included in this Study 178
11.4.1 Dr. Philippe Bellemere 178
11.4.2 Julio Duarte Clemente, MD, PhD. 178
11.4.3 Dr. Moussa Hamadouche 178
11.4.4 Dr. Vidhya Ravi 178
11.4.5 Robert M. Szabo, MD, MPH 179
11.4.6 Dr. Marcello Zaia Oliveira 179
11.4.7 Robert Zura, MD 179
11.5 About the Authors 180
11.5.1 Analysts 180
11.5.2 Global Head of Healthcare 181
11.6 About MediPoint 182
11.7 About GlobalData 182
11.8 Disclaimer 182

1.1 List of Tables
Table 1: Clinical Symptoms and Descriptions 26
Table 2: Fracture Locations in the Body 30
Table 3: Locking Plates vs. Non-Locking Plates Features 33
Table 4: IM Nail Technical Specifications 35
Table 5: Fixation Types for Hip Fractures 36
Table 6: Medicare Coding Guide for Trauma Fixation, 2013 46
Table 7: Medicare National Payment Average for Trauma in the Hand, 2013 46
Table 8: Direct and Indirect Costs of Orthopedics 50
Table 9: Acumed Lower Extremity Internal Fixation Products and Screws 81
Table 10: Acumed Upper Extremity Internal Fixation Products 82
Table 11: Acumed Plate and Screw Systems SWOT 83
Table 12: Acumed IM Nail Systems SWOT 83
Table 13: Biomet Internal Fixation Plates and Screws 84
Table 14: Biomet Internal Fixation IM Nails 85
Table 15: Biomet Plate and Screw Systems SWOT 85
Table 16: Biomet IM Nail Systems SWOT 86
Table 17: Bioretec Internal Fixation Implants 87
Table 18: Bioretec Bioabsorbable Screws SWOT 87
Table 19: DePuy Synthes Plates and Screws 88
Table 20: DePuy Synthes Intramedullary Nails 89
Table 21: DePuy Synthes Plate and Screw Systems SWOT 90
Table 22: DePuy Synthes IM Nail Systems SWOT 90
Table 23: Extremity Medical Plates, Screws and Nails 91
Table 24: Extremity Medical Internal Fixation Systems SWOT 91
Table 25: Integra Life Sciences Lower Extremity Internal Fixation Products 92
Table 26: Integra Life Sciences Upper Extremity Internal Fixation Products 93
Table 27: Integra Life Sciences Internal Fixation Systems SWOT 94
Table 28: Orthofix Internal Fixation Plates and Screws 95
Table 29: Orthofix Internal Fixation IM Nails 95
Table 30: Orthofix Plate and Screw Systems SWOT 95
Table 31: Orthofix IM Nails SWOT 96
Table 32: Osteomed Internal Fixation Lower Extremity 96
Table 33: Osteomed Internal Fixation Upper Extremity 97
Table 34: Osteomed Upper Extremity Systems SWOT 97
Table 35: Osteomed Lower Extremity Systems SWOT 97
Table 36: Small Bone Innovations Internal Fixation Lower Extremity 98
Table 37: Small Bone Innovations Internal Fixation Upper Extremity 98
Table 38: SBi Upper Extremity Systems SWOT 99
Table 39: SBi Lower Extremity Systems SWOT 99
Table 40: Smith and Nephew Internal Fixation 100
Table 41: Smith and Nephew Plate and Screw Systems SWOT 101
Table 42: Stryker Internal Fixation Upper Extremity 101
Table 43: Stryker Internal Fixation Lower Extremity 102
Table 44: Stryker Internal Fixation Foot and Ankle 103
Table 45: Stryker Upper Extremity Systems SWOT 104
Table 46: Stryker Lower Extremity Systems SWOT 104
Table 47: Tornier Internal Fixation Upper Extremity 105
Table 48: Tornier Plate and Screw Systems SWOT 106
Table 49: Trimed Internal Fixation Lower Extremity 106
Table 50: Trimed Internal Fixation Upper Extremity 107
Table 51: Trimed Plate and Screw Systems SWOT 107
Table 52: Wright Medical Internal Fixation Lower Extremity Plates and Screws 108
Table 53: Wright Medical Internal Fixation Upper Extremity Plates and Screws 109
Table 54: Wright Medical Lower Extremity Plate and Screw Systems SWOT 110
Table 55: Wright Medical Upper Extremity Plate and Screw Systems SWOT 110
Table 56: Zimmer Internal Fixation Plates and Screws 111
Table 57: Zimmer Internal Fixation IM Nails 111
Table 58: Zimmer Plate and Screw Systems SWOT 111
Table 59: Zimmer IM Nail System SWOT 112
Table 60: Biomet External Fixation 112
Table 61: DePuy Synthes External Fixation 112
Table 62: Orthofix External Fixation 113
Table 63: Smith and Nephew External Fixation 114
Table 64: Stryker External Fixation 114
Table 65: Wright Medical External Fixation 115
Table 66: Zimmer External Fixation 115
Table 67: Orthopedic Trauma Patient Quality of Life Trial 127
Table 68: Non-Operative vs. Operative Management of Olecranon Fractures 128
Table 69: INTUIT Hip Fracture Outcome Study 128
Table 70: Distal Radius Fracture Fixation Comparison 129
Table 71: Nails versus Plates for Femur Fractures in Dar es Salaam, Tanzania 129
Table 72: Company Profile - Acumed LLC 131
Table 73: SWOT Analysis - Acumed LLC 132
Table 74: Company Profile - Biomet Orthopedics 133
Table 75: SWOT Analysis - Biomet Orthopedics 134
Table 76: Company Profile - DePuy Synthes International 136
Table 77: SWOT Analysis - DePuy Synthes International 137
Table 78: Company Profile - Integra LifeSciences Inc. 138
Table 79: SWOT Analysis - Integra LifeSciences Inc. 139
Table 80: Company Profile - Orthofix Inc. 140
Table 81: SWOT Analysis - Orthofix Inc. 140
Table 82: Company Profile - OsteoMed 141
Table 83: SWOT Analysis - OsteoMed 142
Table 84: Company Profile - Small Bone Innovations Inc. 143
Table 85: SWOT Analysis - Small Bone Innovations Inc. 143
Table 86: Company Profile - Smith and Nephew 144
Table 87: SWOT Analysis - Smith and Nephew 145
Table 88: Company Profile - Stryker 147
Table 89: SWOT Analysis - Stryker 148
Table 90: Company Profile - Tornier N.V. 149
Table 91: SWOT Analysis - Tornier N.V. 150
Table 92: Company Profile - Trimed, Inc. 151
Table 93: SWOT Analysis - Trimed 152
Table 94: Company Profile - Wright Medical 153
Table 95: SWOT Analysis - Wright Medical 154
Table 96: Company Profile - Zimmer Holdings Inc. 156
Table 97: SWOT Analysis - Zimmer Holdings, Inc. 157
Table 98: Trauma Companies in the Global Market 158
Table 99: Trauma Companies in APAC Market 160
Table 100: Trauma Fixation Sales ($m) Forecast for the US, 2010-2019 163

1.2 List of Figures
Figure 1: Skeletal Structure 23
Figure 2: Joint Structure 24
Figure 3: Fracture Types 27
Figure 4: Hip Fracture Types 31
Figure 5: Hip Fracture Distribution 36
Figure 6: Fracture by Bones, 2008 39
Figure 7: Global Product Sales Volume for Trauma Fixation, 2010-2019 40
Figure 8: US Product Sales Volume for Trauma Fixation, 2010-2019 41
Figure 9: US Adoption of Nails vs. Plate Systems vs. External Fixation, 2010-2015 44
Figure 10: US Adoption of Locking vs. Non-Locking Plates, 2010-2015 45
Figure 11: Sources of Orthopedic Trauma (%) 52
Figure 12: Global Market Share for Plates and Screw Systems, 2012 73
Figure 13: Global Market Share for IM Nails, 2012 74
Figure 14: Global IM Nails Breakdown, 2012 74
Figure 15: Global Market Share for External Fixation, 2012 75
Figure 16: US Market Share for Trauma Fixation, 2012 76
Figure 17: US Market Share for Plates and Screw Systems, 2012 77
Figure 18: US Market Share for IM Nails, 2012 78
Figure 19: US Market Share for External Fixation, 2012 79
Figure 20: Influencing Factors for Plate and Screw Products 80
Figure 21: Challenging Aspects in Trauma Surgery 122
Figure 22: US Sales ($m) Forecast for Trauma Fixation, 2010-2019 163
Figure 23: Surgeon Location Breakdown Trauma Survey (n=103) 177
Figure 24: Surgeon Practice Setting Trauma Survey (n=103) 177

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