MediPoint: Cervical Total Disc Replacement - Global Analysis and Market Forecasts

Summary

Symptomatic cervical disc disease (SCDD) is a degenerative condition of the spine that, in certain instances, can cause debilitating pain and neurological dysfunction. For the past fifty years, anterior cervical discectomy and fusion (ACDF) was the hallmark surgical intervention for this condition that provided excellent pain relief and outcomes in patients where more conservative therapies failed. However, as follow-up of patients who had undergone the procedure grew, surgeons discovered that similar symptomatic degeneration present at the treated level pre-operatively became evident, in the long term, at adjacent levels post-operatively. It was believed that the procedure’s fusion of adjacent vertebrae prompted the emergence of this adjacent-level disease. Cervical total disc replacements (C-TDR) were invented to replace the intervertebral disc as well as restore the lost motion.



Since the early 2000s, several devices have entered the international markets with a variety of design configurations, compositions, and indications. This report provides comprehensive analysis on the current and future performances of these competitors in nine major markets including the United States (US), the five major European markets, India, China, and Brazil. Additionally, the report provides actionable insights for existing or future competitors by identifying those unmet needs and opportunities that could transform them into a market leader.

Highlights

Key Questions Answered

- The US Food and Drug Administration (FDA) approved two C-TDR devices in 2012 and is expected to approve two more in 2013. (Q).How will the adoption of C-TDR devices in the US market change with the influx on new competition into the market? (Q).How will this adoption be affected by the impending FDA approval of the double level disc replacement indication?
- C-TDR devices have been approved and sold in major international markets since the early 2000s. (Q).Which countries are expected to see a rapid adoption of these devices through 2018 and why?
- The results of certain landmark clinical investigations were released in 2012 and more are expected to be published in 2013. (Q).What are the most important C-TDR clinical trials to follow in 2013 and how will their results impact the future adoption of these devices?
- Device manufacturers differentiate their products through variations in composition and design. (Q).Which features of C-TDR devices are most desirable by surgeons?
- The non-inferiority of C-TDR technology to ACDF procedures has been sufficiently explored and validated. However there are several key investigations left, that if positive results were produced, could lead to a significant competitive advantage for particular companies and the industry overall. (Q).How can device manufacturers address these opportunities in the C-TDR market to differentiate themselves from the competition?

Scope

- Overview of symptomatic cervical disc disease, including epidemiology, etiology, diagnosis, pathology, conservative treatment techniques and surgical interventions.
- Annualized Cervical Total Disc Replacement market revenue, annual cost of the device, and procedure volume data from 2009-2011 and forecast for seven years to 2018.
- Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement considerations, and implications for the cervical total disc replacement market.
- Pipeline analysis: Coverage of cervical total disc replacements that are currently under research and development or under investigation.
- Analysis of the current and future market competition in the global cervical total disc replacement market. Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

Reasons to buy

- "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. In this report you will understand the perceptions of leading Spinal Surgeons, Orthopedic Surgeons, and Neurosurgeons from around the world. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table Of Contents

Table of Contents

1 Table of Contents 5
1.1 List of Tables 11
1.2 List of Figures 14
2 Introduction 16
2.1 Catalyst 16
3 Disease Overview 18
3.1 Anatomy and Physiology 18
3.1.1 Vertebral Column 18
3.1.2 Intervertebral Discs and Vertebrae 19
3.2 Pathophysiology 21
3.2.1 Degenerative Disc Disease 21
3.3 Clinical Presentation 24
3.3.1 Symptoms 24
3.3.2 Radiculopathy 24
3.3.3 Myelopathy 25
3.3.4 Diagnosis 26
3.4 Clinical Outcomes 27
3.4.1 Non-Surgical Techniques 28
3.4.2 Surgical Techniques 31
3.5 Epidemiology 32
3.6 Economic Impact 34
3.6.1 Economic Impact of the Treating SCDD 34
3.6.2 Cost Effectiveness 35
3.6.3 Return to Work 36
4 Competitive Assessment 37
4.1 Overview 37
4.1.1 Current Devices 40
4.1.2 Competitive Assessment 42
4.2 US Marketed Products 44
4.2.1 Prestige ST Cervical Disc System 45
4.2.2 Bryan Cervical Disc 50
4.2.3 ProDisc-C Total Disc Replacement 53
4.2.4 SECURE-C Cervical Artificial Disc 56
4.2.5 Porous Coated Motion Cervical Disc 59
4.3 CE Marked Products 61
4.3.1 Kineflex|C Spinal System 61
4.3.2 Mobi-C 64
4.3.3 DISCOVER Artificial Cervical Disc 67
4.3.4 M6-C Artificial Disc Replacement 70
4.3.5 Prestige LP Cervical Disc System 73
4.3.6 NuNec Cervical Arthroplasty System 76
4.3.7 FREEDOM Cervical Disc 78
4.3.8 Additional Cervical Total Disc Replacements 79
5 Unmet Needs 80
5.1 Overview 80
5.2 Durability and Longevity of C-TDR Devices 82
5.3 Reduce Heterotopic Ossification 84
5.4 Over 65-year-old Patient Population 86
5.5 Economic and Financial Impact of C-TDR 89
5.6 Radiolucent Materials in Device Composition 91
5.7 Achieve Indication for Double-Disc Replacement in the US 92
6 Pipeline Products 94
6.1 Overview 94
6.1.1 United States 94
6.1.2 Outside the United States 96
6.2 Clinical Trial Analysis 97
6.2.1 Overview 97
6.2.2 Trials to Watch 97
7 Industry Overview 100
7.1 Procedure Trends 100
7.1.1 United States 100
7.1.2 Europe 101
7.1.3 Developing Economies 103
7.2 Market Access 105
7.3 Reimbursement Trends 105
7.3.1 United States 105
7.3.2 Europe 107
7.3.3 APAC 107
7.3.4 South America 108
7.4 Regulatory Issues/Recalls 108
7.5 Added Indications 109
7.6 Mergers and Acquisitions/Key Partnerships 109
8 Current and Future Players 111
8.1 Overview 111
8.2 Trends in Corporate Strategy 111
8.3 Company Profiles 112
8.3.1 AxioMed Corporation 112
8.3.2 DePuy Synthes Spine 114
8.3.3 FH Orthopedics 116
8.3.4 Globus Medical 117
8.3.5 LDR Holdings 119
8.3.6 Medicrea 121
8.3.7 Medtronic Sofamor Danek 123
8.3.8 Nuvasive 125
8.3.9 Osimplant 127
8.3.10 Pioneer Surgical 128
8.3.11 Ranier Technology 130
8.3.12 Spinal Kinetics 132
8.3.13 Spinal Motion 134
8.3.14 Stryker 136
9 Market Drivers, Opportunities and Barriers 138
9.1 Market Drivers 138
9.1.1 High Prevalence of Adjacent Segment Disease Following ACDF Operations 138
9.1.2 Comparable and Superior Clinical Trial Results for C-TDR Compared with ACDF in the Short Term and Long Term 139
9.1.3 Expanded US Private Insurance Coverage for Single Level and Double Level Replacement Procedures 139
9.1.4 Prevalence of Pseudoarthrosis Following ACDF Operations 140
9.2 Opportunities 140
9.2.1 Investigate C-TDR in Patients Over 65 Years Old 140
9.2.2 Develop an Intervention to Reduce Heterotopic Ossification 141
9.2.3 Investigate the Economic Benefits of Utilizing C-TDR 142
9.2.4 Obtain Double-Disc Replacement Indication in the US 143
9.2.5 Develop Next-Generation Device with Radiolucent Materials 144
9.3 Barriers 145
9.3.1 Adjacent Segment Disease 145
9.3.2 Reimbursement 146
9.3.3 Cost 147
9.3.4 Scant Clinical Trial Data 147
9.3.5 Nucleus Replacement Devices 147
10 Country Outlooks and Forecasts 149
10.1 Major Markets Overview 149
10.2 United States 151
10.2.1 Overview 151
10.2.2 United States Market Analysis 151
10.3 France 154
10.3.1 Overview 154
10.3.2 France Market Analysis 154
10.4 Germany 156
10.4.1 Overview 156
10.4.2 Germany Market Analysis 156
10.5 Italy 158
10.5.1 Overview 158
10.5.2 Italy Market Analysis 158
10.6 Spain 160
10.6.1 Overview 160
10.6.2 Spain Analysis 160
10.7 United Kingdom 162
10.7.1 Overview 162
10.7.2 United Kingdom Market Analysis 162
10.8 Brazil 164
10.8.1 Overview 164
10.8.2 Brazil Market Analysis 164
10.9 India 166
10.9.1 Overview 166
10.9.2 India Market Analysis 166
10.10 China 168
10.10.1 Overview 168
10.10.2 China Market Analysis 168
11 Appendix 169
11.1 Bibliography 169
11.2 Abbreviations 178
11.3 Report Methodology 179
11.3.1 Overview 179
11.3.2 Coverage 179
11.3.3 Primary Research 180
11.3.4 Secondary Research 181
11.3.5 Forecasting Methodology 182
11.4 Physicians and Specialists Included in this Study 184
11.5 Physician Survey 185
11.6 About the Authors 186
11.6.1 Joseph A. Gregory, Analyst, Surgical Devices 186
11.6.2 Derek Archila, MBA, Lead Analyst, Medical Devices 186
11.7 Global Head of Healthcare 187
11.7.1 Bonnie Bain, Ph.D., Global Head of Healthcare 187
11.8 About MediPoint 187
11.9 About GlobalData 187
11.10 Contact Us 188
11.11 Disclaimer 188



List of Tables

Table 1: Distribution of Age in Major Markets, 2012 33
Table 2: Direct Costs in the US for SCDD Treatment, 2006/2007 34
Table 3: Results from Cost Effectiveness Study Between ACDF and C-TDR over 10 Years 35
Table 4: C-TDR US Product Approvals by Date 40
Table 5: C-TDR OUS Product Approvals by Date 41
Table 6: Assessment of C-TDR Device Attributes 43
Table 7: Product Profile - Prestige ST 46
Table 8: Prestige ST SWOT Analysis, 2012 49
Table 9: Product Profile - Bryan Cervical Disc 51
Table 10: Bryan Cervical Disc SWOT Analysis, 2012 52
Table 11: Product Profile - ProDisc-C Cervical Disc 54
Table 12: ProDisc-C Total Disc Replacement SWOT Analysis, 2012 55
Table 13: Product Profile - Secure-C Cervical Disc 57
Table 14: Secure-C Total Disc Replacement SWOT Analysis, 2012 58
Table 15: Product Profile - PCM Cervical Disc 59
Table 16: PCM Cervical Disc SWOT Analysis, 2012 60
Table 17: Product Profile - Kineflex|C Cervical Disc 62
Table 18: Kineflex|C Cervical Disc SWOT Analysis, 2012 63
Table 19: Product Profile - Mobi-C Cervical Disc 65
Table 20: Mobi-C Cervical Disc SWOT Analysis, 2012 66
Table 21: Product Profile - Discover Cervical Disc 68
Table 22: Discover Cervical Disc SWOT Analysis, 2012 69
Table 23: Product Profile - M6-C Cervical Disc 71
Table 24: M6-C Cervical Disc SWOT Analysis, 2012 72
Table 25: Product Profile - Prestige LP Cervical Disc 74
Table 26: Prestige-LP Cervical Disc SWOT Analysis, 2012 75
Table 27: Product Profile - NuNec Cervical Disc 76
Table 28: NuNec Cervical Arthroplasty System SWOT Analysis, 2012 77
Table 29: Product Profile - Freedom Cervical Disc 78
Table 30: NuNec Cervical Arthroplasty System SWOT Analysis, 2012 79
Table 31: Overall Unmet Needs - Current Level of Attainment and Importance (n=75) 81
Table 32: Most Imperative Aspects of Heterotopic Ossification To Be Investigated 85
Table 33: Most Imperative Economic Analysis Topics To Be Investigated (n=75) 90
Table 34: Marketed Radiographic Friendly C-TDR Devices 91
Table 35: Pipeline Products in the United States 94
Table 36: US Health Insurance Coverage, 2012 105
Table 37: Decisions from Blue Cross Blue Shield Advisory Panel Meeting 106
Table 38: Company Portfolio - AxioMed Corporation 112
Table 39: AxioMed Corporation SWOT Analysis, 2012 113
Table 40: Company Portfolio - DePuy Synthes Spine 114
Table 41: DePuy Synthes Spine SWOT Analysis, 2012 115
Table 42: Company Portfolio - FH Orthopedics 116
Table 43: FH Orthopedics Corporation SWOT Analysis, 2012 116
Table 44: Company Portfolio - Globus Medical 117
Table 45: Globus Medical SWOT Analysis, 2012 118
Table 46: Company Portfolio - LDR Holdings 119
Table 47: LDR Holdings SWOT Analysis, 2012 120
Table 48: Company Portfolio - Medicrea 121
Table 49: Medicrea SWOT Analysis, 2012 122
Table 50: Company Portfolio - Medtronic Sofamor Danek 123
Table 51: Medtronic Sofamor Danek SWOT Analysis, 2012 124
Table 52: Company Portfolio - Nuvasive 125
Table 53: Nuvasive SWOT Analysis, 2012 126
Table 54: Company Portfolio - Osimplant 127
Table 55: Osimplant SWOT Analysis, 2012 127
Table 56: Company Portfolio - Pioneer Surgical 128
Table 57: Pioneer Surgical SWOT Analysis, 2012 129
Table 58: Company Portfolio - Ranier Technology 130
Table 59: Ranier Technology SWOT Analysis, 2012 131
Table 60: Company Portfolio - Spinal Kinetics 132
Table 61: Spinal Kinetics SWOT Analysis, 2012 133
Table 62: Company Portfolio - Spinal Motion 134
Table 63: Spinal Motion SWOT Analysis, 2012 135
Table 64: Company Portfolio - Stryker 136
Table 65: Stryker SWOT Analysis, 2012 137
Table 66: Global Sales ($m) Forecast for C-TDR, 2009-2018 149
Table 67: US Sales ($m) Forecast for C-TDR, 2009-2018 152
Table 68: France Sales ($m) Forecast for C-TDR, 2009-2018 154
Table 69: Germany Sales ($m) Forecast for C-TDR, 2009-2018 156
Table 70: Factors Affecting C-TDR Adoption in Italy, 2012 158
Table 71: Italy Sales ($m) Forecast for C-TDR, 2009-2018 158
Table 72: Factors Affecting C-TDR Adoption in Spain, 2012 160
Table 73: Spain Sales ($m) Forecast for C-TDR, 2009-2018 160
Table 74: UK Sales ($m) Forecast for C-TDR, 2009-2018 163
Table 75: Brazil Sales ($m) Forecast for C-TDR, 2009-2018 164
Table 76: India Sales ($m) Forecast for C-TDR, 2009-2018 167
Table 77: China Sales ($m) Forecast for C-TDR, 2009-2018 168
Table 78: Physicians Surveyed, By Country 185

1.2 List of Figures
Figure 1: Regions of the Vertebral Column 18
Figure 2: Anatomy of an Intervertebral Disc 19
Figure 3: Anatomy of a Vertebrae 20
Figure 4: Treatment Paradigm for SCDD 27
Figure 5: Prevalence of SCDD in 45-64-year-olds in Major Markets, 2009-2018 32
Figure 6: Companies in the US C-TDR Market with Approved Devices 38
Figure 7: Companies in C-TDR Market with Approved Devices Outside the United States 39
Figure 8: Global Market Share for C-TDR Devices, 2012 (n=75) 43
Figure 9: Structure of the Prestige ST Device 45
Figure 10: Structure of the Bryan Cervical Device 50
Figure 11: Structure of the ProDisc-C Cervical Device 53
Figure 12: Structure of the Secure-C Cervical Device 56
Figure 13: Structure of the PCM Device 59
Figure 14: Structure of the Kineflex|C 61
Figure 15: Structure of the Mobi-C 64
Figure 16: Structure of the Discover Artificial Disc 67
Figure 17: Structure of the M6-C Artificial Disc 70
Figure 18: Structure of the Prestige-LP Artificial Disc 73
Figure 19: Structure of the NuNec Cervical Arthroplasty System 76
Figure 20: Structure of the Freedom Cervical Disc 78
Figure 21: Necessity for Further Investigation: Durability and Longevity of C-TDR Devices 83
Figure 22: Level of Necessity for Further Investigation: Interventions to Reduce HO 85
Figure 23: US Market for SCDD by Age Group, 2012 87
Figure 24: Level of Necessity for Further Investigation: Patients Over 65 Years Old 88
Figure 25: Level of necessity for further investigation: Economic and Financial Impact 90
Figure 26: Level of Influence of Insurance on Double-Disc Replacements with C-TDR Devices 93
Figure 27: Pipeline Products in the United States 94
Figure 28: US C-TDR Procedure Volumes, 2009 to 2018 (n=75) 100
Figure 29: European C-TDR Procedure Volumes, 2009 to 2018 (n=75) 102
Figure 30: C-TDR Procedure Volumes in India, China, and Brazil, 2009 through 2018 104
Figure 31: Global Sales ($m) Forecast for C-TDR, 2009-2018 149
Figure 32: C-TDR Revenue by Major Market, 2011 and 2018 150
Figure 33: US C-TDR Market, 2009 through 2018 153
Figure 34: France C-TDR Market, 2009 and 2018 155
Figure 35: Germany C-TDR Market, 2009 through 2018 157
Figure 36: Italy C-TDR Market, 2009 through 2018 159
Figure 37: Spain C-TDR Market, 2009 through 2018 161
Figure 38: UK C-TDR Market, 2009 through 2018 163
Figure 39: Brazil C-TDR Market, 2009 through 2018 165
Figure 40: India C-TDR Market, 2009 and 2018 167
Figure 41: China C-TDR Market, 2009 and 2018 168



Companies Mentioned

AxioMed Corporation
DePuy Synthes Spine
FH Orthopedics
Globus Medical
LDR Holdings
Medicrea
Medtronic Sofamor Danek
Nuvasive
Osimplant
Pioneer Surgical
Ranier Technology
Spinal Kinetics
Spinal Motion
Stryker

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