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MediPoint: Spinal Non-fusion - Global Analysis and Market Forecasts

Summary

The promise of spinal non-fusion technologies, while initially large during its infancy, has tapered somewhat with challenges developing in specific non-fusion device segments due to insufficient evidence of clinical efficacy. Currently, total disc replacement (TDR) represents the most frequently performed spinal non-fusion surgery. In particular, the safety and efficacy of cervical total disc replacement (C-TDR) has been established with a growing body of level-1 evidence that is compelling enough to no longer consider this surgery investigational. This evidence is bolstered by experience with multiple devices, at multiple sites, in and out of the investigational setting and with short-, intermediate-, and long-term follow-up. At this point, C-TDR is widely seen as a viable alternative to anterior cervical discectomy and fusion surgeries in select indications. The increasing availability of clinical efficacy data, together with the rising prevalence of degenerative spine diseases and the industry’s aggressive efforts on physician training and DTC marketing, is propelling the market forward. In fact, the C-TDR market has already started to cannibalize a small portion of the spinal fusion market.

Highlights

Key Questions Answered

- Future growth in the spinal non-fusion market lies in the C-TDR segment. How will the C-TDR segment drive the market revenue growth in the upcoming years? What are the current utilization patterns of one-level and double-level C-TDR procedures in different geographies?
- Most of the spine surgeons GlobalData interviewed indicated that the actual clinical effectiveness of lumbar TDR (L-TDR) is still unclear. Has this impacted the procedure volume growth of L-TDR procedures? How will this market evolve in the next five years?
- Moving forward, while IPD devices are expected to continue to generate traction in the spine community, the growth in the procedure number of IPD surgeries is likely to slow down. What are the current adoption trends of IPD devices?
- Market leading companies, such as DePuy Synthes and Medtronic, entered the non-fusion market initially through acquisitions. Since then, a league of small- to medium-sized companies have internally developed and marketed their artificial discs or other non-fusion technologies.Who are the major players in the spinal non-fusion market in different regions?

Reasons to buy

- “What Do 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. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table Of Contents

MediPoint: Spinal Non-fusion - Global Analysis and Market Forecasts
1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 11
1.2 List of Figures 14
2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 16
3 Treatment Modalities Overview 18
3.1 Spinal Fusion 18
3.2 Spinal Non-fusion 19
3.2.1 Pedicle Screw-Based Dynamic Stabilization 19
3.2.2 Interspinous Process Decompression 20
3.2.3 Artificial Disc Replacement 21
3.2.4 Facet Arthroplasty 21
3.2.5 Annulus Repair 22
3.2.6 Nuclear Disc Replacement 22
4 Competitive Assessment 23
4.1 Pedicle Screw-Based Dynamic Stabilization 23
4.2 Interspinous Process Decompression 25
4.3 Artificial Disc Replacement 28
4.4 Annulus Repair 31
4.5 Facet Arthroplasty 33
4.6 Nuclear Disc Prostheses 34
5 Pipeline Products 35
5.1 Overview 35
5.2 DIAM Spinal Stabilization System (Medtronic) 35
5.3 Flexus Interspinous Spacer (Globus Medical) 36
5.4 M6-C (Spinal Kinetics) 36
5.5 Triadyme-C Disc System (Dymicron) 36
5.6 Simplify Disc (Simplify Medical) 37
5.7 Synergy Disc (Synergy Disc Replacement) 37
5.8 XL TDR Lumbar Disc (NuVasive) 37
5.9 Freedom Lumbar Disc System (AxioMed) 38
5.10 Triumph (Globus Medical) 38
5.11 ACADIA (Globus Medical) 38
5.12 Barricaid (Intrinsic Therapeutics) 38
5.13 NuBac (RTI Surgical) 39
6 Industry Overview 40
6.1 Procedural Trends 40
6.1.1 US 40
6.1.2 5EU 48
6.1.3 Asia-Pacific 52
6.1.4 South America 54
6.2 Reimbursement Trends 57
6.2.1 US 57
6.2.2 Outside the US 59
6.3 Mergers and Acquisitions/Key Partnerships 60
6.3.1 RTI Biologics Acquires Pioneer Surgical Technology for $130m (July 2013) 60
6.3.2 Stryker Buys “Non-Core” Spinal Implants from VertiFlex (March 2013) 60
6.3.3 Johnson and Johnson Acquires Synthes for $19.7 Billion (June 2012) 60
6.3.4 Globus Medical Acquires Facet Solutions (January 2011) 61
7 Market Drivers and Barriers 62
7.1 Driver: Aging Patient Populations 62
7.2 Driver: Drawbacks of Spinal Fusion Surgeries 63
7.3 Driver: Cervical Total Disc Replacement 63
7.4 Driver: Direct-To-Consumer Marketing 65
7.5 Barrier: Spinal Fusion Remains the Gold Standard for Treating Spinal Degenerative Conditions 65
7.6 Barrier: Insufficient Evidence to Prove Clinical Efficacy 66
7.7 Barrier: Restricted Reimbursement 67
7.8 Barrier: Cost 68
8 Unmet Needs and Market Opportunities 70
8.1 Multi-Level Cervical Total Disc Replacement in the US 70
8.2 Lumbar Total Disc Replacement 71
8.3 Surgeon Training on Non-fusion Techniques 73
8.4 Emerging Markets 74
9 Current and Future Players 75
9.1 Trends in Corporate Strategy 75
9.2 Major Manufacturers 75
9.2.1 Aesculap 75
9.2.2 Alphatec Spine 77
9.2.3 DePuy Synthes 79
9.2.4 Globus Medical 81
9.2.5 Medtronic 83
9.2.6 LDR 86
9.2.7 NuVasive 88
9.2.8 Paradigm Spine 90
9.2.9 RTI Surgical 92
9.2.10 Zimmer-Biomet 93
10 Market Outlook 96
10.1 Market Share Analysis 96
10.1.1 US Market 96
10.1.2 5EU Market 97
10.1.3 Asia-Pacific Market 97
10.1.4 Brazil Market 98
10.2 By Market Segment 99
10.2.1 Pedicle Screw-Based Dynamic Stabilization 99
10.2.2 Interspinous Process Decompression Devices 100
10.2.3 Artificial Disc Replacement 101
10.2.4 Annulus Repair, Facet Arthroplasty, and Nuclear Disc Replacement Prostheses 103
10.3 By Geography 104
10.3.1 Overview 104
10.3.2 US 108
10.3.3 France 111
10.3.4 Germany 113
10.3.5 Italy 115
10.3.6 Spain 117
10.3.7 UK 119
10.3.8 Japan 121
10.3.9 Brazil 123
10.3.10 China 126
10.3.11 India 129
11 Appendix 133
11.1 Bibliography 133
11.2 Abbreviations 137
11.3 Report Methodology 139
11.3.1 Overview 139
11.3.2 Coverage 139
11.3.3 Secondary Research 139
11.3.4 Forecasting Methodology 140
11.3.5 Primary Research - Key Opinion Leader Interviews 141
11.3.6 Expert Panel Validation 141
11.4 Physicians and Specialists Included in This Study 142
11.5 About the Authors 145
11.5.1 Analysts 145
11.5.2 Tyler Fletcher, Global Head of Medical Devices 146
11.6 About MediPoint 147
11.7 About GlobalData 147
11.8 Disclaimer 147

1.1 List of Tables
Table 1: Major Pedicle Screw-Based Dynamic Stabilization Systems on the Market, 2015 23
Table 2: Major Interspinous Process Decompression Systems on the Market, 2015 27
Table 3: FDA-Approved C-TDR Devices with Number of Patients Enrolled in IDE Study 29
Table 4: Major Artificial Disc Replacement Systems on the Market, 2015 30
Table 5: Major Annulus Repair Systems on the Market, 2015 33
Table 6: Major Facet Arthroplasty Systems on the Market, 2015 34
Table 7: Major Pipeline Products in the Spinal Non-fusion Market, 2015 35
Table 8: US Procedure Trends for Spinal Non-fusion, 2012-2021 40
Table 9: 5EU Procedure Trends for Spinal Non-fusion, 2012-2021 50
Table 10: APAC Procedure Trends for Spinal Non-fusion, 2012-2021 53
Table 11: Brazil Procedure Trends for Spinal Non-fusion, 2012-2021 56
Table 12: Major US Health Insurance Carriers' Coverage for Spinal Non-fusion Procedures, 2015 58
Table 13: Population Aged 60 Years Old or Over, 1950-2050, in millions (percentage) 62
Table 14: Company Profile - Aesculap 76
Table 15: Aesculap's Spinal Non-fusion Portfolio Assessment, 2015 77
Table 16: SWOT Analysis - Aesculap 77
Table 17: Company Profile - Alphatec Spine 78
Table 18: Alphatec Spine's Spinal Non-fusion Portfolio Assessment, 2015 78
Table 19: SWOT Analysis - Alphatec Spine 79
Table 20: Company Profile - DePuy Synthes 80
Table 21: DePuy Synthes' Spinal Non-fusion Portfolio Assessment, 2015 80
Table 22: SWOT Analysis - DePuy Synthes 81
Table 23: Company Profile - Globus Medical 82
Table 24: Globus Medical's Spinal Non-fusion Portfolio Assessment, 2015 83
Table 25: SWOT Analysis - Globus Medical 83
Table 26: Company Profile - Medtronic 84
Table 27: Medtronic's Spinal Non-fusion Portfolio Assessment, 2015 85
Table 28: SWOT Analysis - Medtronic 86
Table 29: Company Profile - LDR Holding 87
Table 30: LDR Holding's Spinal Non-fusion Portfolio Assessment, 2015 87
Table 31: SWOT Analysis - LDR Holding 88
Table 32: Company Profile - NuVasive 89
Table 33: LDR Holding's Spinal Non-fusion Portfolio Assessment, 2015 89
Table 34: SWOT Analysis - NuVasive 90
Table 35: Company Profile - Paradigm Spine 90
Table 36: Paradigm Spine's Spinal Non-fusion Portfolio Assessment, 2015 91
Table 37: SWOT Analysis - Paradigm Spine 91
Table 38: Company Profile - RTI Surgical 92
Table 39: RTI Surgical's Spinal Non-fusion Portfolio Assessment, 2015 93
Table 40: SWOT Analysis - RTI Surgical 93
Table 41: Company Profile - Zimmer-Biomet 94
Table 42: Zimmer-Biomet's Spinal Non-fusion Portfolio Assessment, 2015 95
Table 43: SWOT Analysis - Zimmer-Biomet 95
Table 44: Global Pedicle Screw-Based Dynamic Stabilization Market Revenue ($m), by Region, 2012-2021 99
Table 45: Global Interspinous Process Decompression Market Revenue ($m), by Region, 2012-2021 100
Table 46: Global Artificial Disc Replacement Market Revenue ($m), by Region, 2012-2021 102
Table 47: Global Annulus Repair, Facet Arthroplasty, and Nuclear Disc Prostheses Market Revenue ($m), by Region, 2012-2021 103
Table 48: Global Spinal Non-fusion Market Revenue ($m), by Segment, 2012-2021 105
Table 49: Global Spinal Non-fusion Market Revenue ($m), by Geography, 2012-2021 107
Table 50: US Spinal Non-fusion Market Revenue ($m), 2012-2021 109
Table 51: France Spinal Non-fusion Market Revenue ($m), 2012-2021 112
Table 52: Germany Spinal Non-fusion Market Revenue ($m), 2012-2021 114
Table 53: Italy Spinal Non-fusion Market Revenue ($m), 2012-2021 116
Table 54: Spain Spinal Non-fusion Market Revenue ($m), 2012-2021 118
Table 55: UK Spinal Non-fusion Market Revenue ($m), 2012-2021 120
Table 56: Japan Spinal Non-fusion Market Revenue ($m), 2012-2021 122
Table 57: Brazil Spinal Non-fusion Market Revenue ($m), 2012-2021 124
Table 58: China Spinal Non-fusion Market Revenue ($m), 2012-2021 127
Table 59: India Spinal Non-fusion Market Revenue ($m), 2012-2021 130

1.2 List of Figures
Figure 1: US Procedure Trends for Spinal Non-fusion, 2012-2021 41
Figure 2: US Adoption Trend for Cervical Total Disc Replacement, by Level, 2014 46
Figure 3: 5EU Procedure Trends for Spinal Non-fusion, 2012-2021 51
Figure 4: 5EU Adoption Trends for Cervical Total Disc Replacement, by Level, 2014 52
Figure 5: APAC Procedure Trends for Spinal Non-fusion, 2014-2021 54
Figure 6: APAC Adoption Trends for Cervical Total Disc Replacement, by Level, 2014 54
Figure 7: Brazil Procedure Trends for Spinal Non-fusion, 2012-2021 56
Figure 8: Brazil Adoption Trends for Cervical Total Disc Replacement, by Level, 2014 57
Figure 9: US Spinal Non-fusion Market Share, 2014 96
Figure 10: 5EU Spinal Non-fusion Market Share, 2014 97
Figure 11: APAC Spinal Non-fusion Market Share, 2014 98
Figure 12: Brazil Non-fusion Market Share, 2014 98
Figure 13: Global Pedicle Screw-Based Dynamic Stabilization Market Revenue ($m), by Region, 2012-2021 100
Figure 14: Global Interspinous Process Decompression Market Revenue ($m), by Region, 2012-2021 101
Figure 15: Global Artificial Disc Replacement Market Revenue ($m), by Region, 2012-2021 102
Figure 16: Global Annulus Repair, Facet Arthroplasty, and Nuclear Disc Prostheses Market Revenue ($m), by Region, 2012-2021 103
Figure 17: Global Spinal Non-fusion Market Revenue ($m), by Segment, 2012-2021 105
Figure 18: Global Spinal Non-fusion Market Revenue ($m), by Segment, 2014 and 2021 106
Figure 19: Global Spinal Non-fusion Market Revenue ($m), by Geography, 2014 and 2021 108
Figure 20: US Spinal Non-fusion Market Revenue ($m), 2012-2021 110
Figure 21: US Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 111
Figure 22: France Spinal Non-fusion Market Revenue ($m), 2012-2021 112
Figure 23: France Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 113
Figure 24: Germany Spinal Non-fusion Market Revenue ($m), 2012-2021 114
Figure 25: Germany Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 115
Figure 26: Italy Spinal Non-fusion Market Revenue ($m), 2012-2021 116
Figure 27: Italy Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 117
Figure 28: Spain Spinal Non-fusion Market Revenue ($m), 2012-2021 118
Figure 29: Spain Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 119
Figure 30: UK Spinal Non-fusion Market Revenue ($m), 2012-2021 120
Figure 31: UK Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 121
Figure 32: Japan Spinal Non-fusion Market Revenue ($m), 2012-2021 122
Figure 33: Japan Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 123
Figure 34: Brazil Spinal Non-fusion Market Revenue ($m), 2012-2021 125
Figure 35: Brazil Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 126
Figure 36: China Spinal Non-fusion Market Revenue ($m), 2012-2021 128
Figure 37: China Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 129
Figure 38: India Spinal Non-fusion Market Revenue ($m), 2012-2021 131
Figure 39: India Spinal Non-fusion Market Revenue Distribution, 2014 and 2021 132
Figure 40: Breakdown of Physician Survey Participants by Geography (N=67) 143
Figure 41: Breakdown of Other Primary Research Participants by Geography (N=80) 144

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