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MediPoint: Spinal Fusion - Global Analysis and Market Forecasts

Summary

Spinal fusion surgery is a well-established procedure that has been performed since the early 1900s. The procedure has benefited immensely from its long history of use, investments in advancing technologies, and its clinical success in a growing variety of spinal conditions. These traits have led spinal fusion surgery to become one of the most frequently performed surgeries in the US, which is undoubtedly, the largest geographic market for this procedure. Given the global phenomenon of an aging society and the associated increasing incidences of degenerative spinal conditions, the spinal fusion market is expected to remain strong over the forecast period.

However, there are still several barriers that are dampening the intervention’s potential adoption levels. Most notably, in the US, public payers are beginning to implement strict measures on reimbursement documentation in an effort to eliminate medically unnecessary procedures. For example, Medicare will now require spine surgeons to document conservative efforts to alleviate the patient’s symptoms prior to undergoing surgery. Another market barrier is the emergence of a new class of medical device technologies that seek to capitalize on one of the persistent weaknesses of spinal fusions. Non-fusion technologies are designed to retain motion at the operated level and reduce stresses experienced by adjacent segments. This is meant to eliminate the progression of symptomatic adjacent segment disease, which still troubles spinal fusion’s effectiveness to this day.

The spinal fusion market encompasses a variety of implantable medical technologies, where multiple devices can be utilized in a single procedure. For this research report, the three leading device categories are covered: spinal plating systems, interbody cages, and pedicle screw systems. Additionally, the specific anatomical regions being operated on are covered, including the cervical and thoracolumbar regions. Furthermore, this report analyzes the adoption of these implantables in one level, two level, and three level surgeries, creating the most comprehensive and accurate market valuations and coverage. The report analyzes how these surgical trends vary globally in the 10 major markets (10MM) (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India).

Highlights

Key Questions Answered

- The reimbursement landscape for spinal fusion procedures in the US is dramatically changing by requiring spine surgeons to provide proof of medical necessity. (Q).How will this payer pressure affect the increasing number of spinal fusion procedures in the US?
- One of the drivers for the spinal fusion market is the vast number of indications in which the surgery can be used. (Q).Which indications for spinal fusion have seen the highest adoption rates in the past five years? (Q).Which indications will have high adoption rates in the next five years?
- Non-fusion medical devices were developed to eliminate the progression of symptomatic adjacent segment disease, a major problem still associated with spinal fusion surgeries. (Q).Which non-fusion technologies pose the largest threat to spinal fusion procedures?
- The research and development (R&D) efforts amongst orthopedic medical device manufacturers are intense. (Q).What are the trends in the pipeline products for spinal fusion procedures that will have the most impact on the competitive landscape? (Q).Which companies are expected to become key players?
- Similar to other medical device markets, emerging economies will be a source of immense growth for the spinal fusion market. However, certain established economies will have large Compound Annual Growth Rates (CAGRs) as well. (Q).Which emerging economies will experience the largest CAGRs over the forecast period? (Q).Which established economies will experience the largest CAGRs over the forecast period?

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 Fusion - Global Analysis and Market Forecasts
1 Table of Contents

2 Introduction 15
2.1 Overview 15
2.2 Catalyst 15
3 Industry Overview 17
3.1 Indications 17
3.2 Types of Devices 19
3.2.1 Spinal Plating Systems 19
3.2.2 Interbody Cages 20
3.2.3 Pedicle Screw Systems 21
3.3 Procedure Trends 22
3.3.1 US 22
3.3.2 5EU 24
3.3.3 South America 29
3.3.4 APAC 31
3.4 Market Access 36
3.4.1 Regulation 36
3.4.2 Adoption 42
3.4.3 Reimbursement Trends 48
4 Market Dynamics: Mergers, Acquisitions and Key Partnerships 52
4.1 Overview 52
4.1.1 Amedica Corporation Acquires US Spine 53
4.1.2 Alphatec Spine Acquires Scient'x Group 53
4.1.3 Biomet Acquires Lanx, Inc. 53
4.1.4 Globus Medical Acquires Facet Solutions 53
4.1.5 Integra LifeSciences Holdings Corporation Acquires SeaSpine, Inc. 54
4.1.6 Medtronic Acquires Advanced Medical Technologies and China's Kanghui 54
4.1.7 Nuvasive Acquires ANC 54
4.1.8 TranS1 Inc. Acquires Baxano Inc. 54
4.2 Economic Impact 55
5 Unmet Needs 58
5.1 Improved Reimbursement Coverage for Minimally Invasive Surgical Procedures 58
5.2 Lack of Definitive Methods to Determine Fusion Performance 59
5.3 Technological Developments in the Use of Long Fusions 59
5.4 Research and Development into Fusion Enhancers 61
5.5 Improve Osseointegration of Bone and Screw Interface 62
6 Market Opportunity Analysis 64
6.1 Develop Signature Minimally Invasive Technique 64
6.2 Market Minimally Invasive Training Opportunities to Fellowship Programs 65
6.3 Increased Collaboration of Medical Device Implants and Biologics 66
6.4 Develop a Device that Provides Real-Time Fusion Updates 67
6.5 Increased Customization of Spinal Implants to Patient Anatomy 67
7 Market Drivers 69
7.1 Aging Patient Populations 69
7.2 Growth in the Spinal Stenosis Indication 71
7.3 Gold Standard for Treating Spinal Instability and Degenerative Conditions 73
7.4 Treatment for a Variety of Indications 73
7.5 Preference for Minimally Invasive Techniques 74
7.6 Advances in Navigation Technology 76
8 Market Barriers 77
8.1 Incidence of Adjacent Segment Disease 77
8.2 Performance of Non-Fusion Technologies 77
8.3 Increased Scrutiny over Spinal Fusion's Necessity in the US 79
8.4 Restricted Reimbursement from Private Payers 80
8.5 Performance in Treating Axial Back Pain 81
9 Pipeline Assessment 82
10 Clinical Trial Analysis 85
11 Current and Future Players 87
11.1 Overview 87
11.2 Trends in Corporate Strategy 87
11.3 Company Profiles 87
11.3.1 Aesculap 87
11.3.2 Alphatec Spine 90
11.3.3 Amedica Corporation 93
11.3.4 Medtronic Spinal and Biologics 95
11.3.5 DePuy Spine 98
11.3.6 Globus Medical 100
11.3.7 K2M 103
11.3.8 Biomet 105
11.3.9 Stryker 108
11.3.10 Zimmer 111
11.3.11 Nuvasive 115
11.3.12 Orthofix 118
11.3.13 Integra LifeSciences 121
12 Market Outlook 125
12.1 Company Market Share 125
12.1.1 US 125
12.1.2 5EU 126
12.1.3 APAC 128
12.1.4 South America 129
12.2 By Segment 130
12.2.1 Spinal Plating Systems 130
12.2.2 Interbody Cages 132
12.2.3 Pedicle Screw Systems 133
12.3 By Geography 135
12.3.1 Global 135
12.3.2 US 136
12.3.3 France 138
12.3.4 Germany 139
12.3.5 Italy 141
12.3.6 Spain 142
12.3.7 UK 144
12.3.8 Japan 145
12.3.9 Brazil 147
12.3.10 China 148
12.3.11 India 150
13 Appendix 152
13.1 Bibliography 152
13.2 Abbreviations 162
13.3 Report Methodology 163
13.3.1 Overview 163
13.3.2 Coverage 163
13.3.3 Primary Research 163
13.3.4 Secondary Research 164
13.3.5 Forecasting Methodology 165
13.4 Key Opinion Leaders Included in this Study 166
13.5 About the Authors 167
13.5.1 Joseph A. Gregory, Analyst, Surgical Devices 167
13.5.2 Derek Archila, MBA, Director of Research and Analysis, Medical Devices 167
13.6 Global Head of Healthcare 168
13.6.1 Bonnie Bain, Ph.D., Global Head of Healthcare 168
13.7 About MediPoint 169
13.8 About GlobalData 169
13.9 Disclaimer 169

1.1 List of Tables

Table 1: Indications for Lumbar Spinal Fusion 18
Table 2: Adoption of Spinal Fusion and Spinal Non-Fusion, US, 2013 and 2020 23
Table 3: Adoption of Spinal Fusion and Spinal Non-Fusion, 5EU, 2013 and 2020 24
Table 4: Spinal Plating Systems CAGR, 5EU, Based on 2013 and 2020 Procedure Volumes 25
Table 5: Interbody Cages CAGR, 5EU, Based on 2013 and 2020 Procedure Volumes 26
Table 6: Pedicle Screw Systems CAGR, 5EU, Based on 2013 and 2020 Procedure Volumes 28
Table 7: Adoption of Spinal Fusion and Spinal Non-Fusion, Brazil, 2013 and 2020 30
Table 8: Adoption of Spinal Fusion and Spinal Non-Fusion, APAC, 2013 and 2020 32
Table 9: Spinal Plating Systems CAGR, APAC, Based on 2013 and 2020 Procedure Volumes 32
Table 10: Interbody Cages CAGR, APAC, Based on 2013 and 2020 Procedure Volumes 34
Table 11: Pedicle Screw Systems CAGR, APAC, Based on 2013 and 2020 Procedure Volumes 35
Table 12: Adoption of Spinal Implants for Cervical Fusion Procedures, 5EU, 2013 44
Table 13: Adoption of Spinal Implants for Thoracolumbar Fusion Procedures, 5EU, 2013 45
Table 14: Adoption of Spinal Implants for Cervical Fusion Procedures, APAC, 2013 47
Table 15: Adoption of Spinal Implants for Thoracolumbar Fusion Procedures, APAC, 2013 48
Table 16: Mergers and Acquisitions, 2010-2014 52
Table 17: Population Aged 60 Years Old or Over, 1950-2050 (in millions) (percentage in older ages) 69
Table 18: Overall Perceived Advantages of Minimally Invasive Surgery Techniques, 2007 75
Table 19: Overall Perceived Limitations of Minimally Invasive Surgery Techniques, 2007 75
Table 20: Company Portfolio - Aesculap 88
Table 21: Product Portfolio - Aesculap 89
Table 22: Company Portfolio - Alphatec Spine 91
Table 23: Product Portfolio - Alphatec Spine 92
Table 24: Company Portfolio - Amedica 94
Table 25: Product Portfolio - Amedica 95
Table 26: Company Portfolio - Medtronic Spinal and Biologics 96
Table 27: Product Portfolio - Medtronic Spinal and Biologics 97
Table 28: Company Portfolio - DePuy Spine 99
Table 29: Product Portfolio - DePuy Spine 99
Table 30: Company Portfolio - Globus Medical 101
Table 31: Product Portfolio - Globus Medical 102
Table 32: Company Portfolio - K2M 104
Table 33: Product Portfolio - K2M 104
Table 34: Company Portfolio - Biomet 106
Table 35: Product Portfolio - Biomet 107
Table 36: Company Portfolio - Stryker 109
Table 37: Product Portfolio - Stryker 110
Table 38: Company Portfolio - Zimmer 113
Table 39: Product Portfolio - Zimmer 114
Table 40: Company Portfolio - Nuvasive 116
Table 41: Product Portfolio - Nuvasive 117
Table 42: Company Portfolio - Orthofix 119
Table 43: Product Portfolio - Orthofix 120
Table 44: Company Portfolio - Integra LifeSciences 122
Table 45: Product Portfolio - Integra LifeSciences 123
Table 46: Spinal Surgery, US Company Market Share, 2012 125
Table 47: Spinal Surgery, 5EU Company Market Share, 2012 127
Table 48: Spinal Surgery, APAC Company Market Share, 2012 128
Table 49: Spinal Surgery, South American Company Market Share, 2012 130
Table 50: Global Spinal Plating Systems Sales ($m) Forecast, 2011-2020 131
Table 51: Global Interbody Cages Sales ($m) Forecast, 2011-2020 132
Table 52: Global Pedicle Screw Systems Sales ($m) Forecast, 2011-2020 134
Table 53: Global Spinal Fusion Sales ($m) Forecast, 2011-2020 135
Table 54: US Spinal Fusion Sales ($m) Forecast, 2011-2020 137
Table 55: France Spinal Fusion Sales ($m) Forecast, 2011-2020 138
Table 56: Germany Spinal Fusion Sales ($m) Forecast, 2011-2020 140
Table 57: Italy Spinal Fusion Sales ($m) Forecast, 2011-2020 141
Table 58: Spain Spinal Fusion Sales ($m) Forecast, 2011-2020 143
Table 59: UK Spinal Fusion Sales ($m) Forecast, 2011-2020 144
Table 60: Japan Spinal Fusion Sales ($m) Forecast, 2011-2020 146
Table 61: Brazil Spinal Fusion Sales ($m) Forecast, 2011-2020 147
Table 62: China Spinal Fusion Sales ($m) Forecast, 2011-2020 149
Table 63: India Spinal Fusion Sales ($m) Forecast, 2011-2020 150

1.2 List of Figures

Figure 1: Spinal Fusion Procedure Volumes, US, 2011-2020 23
Figure 2: Spinal Plating Procedure Volumes, 5EU, 2011-2020 25
Figure 3: Interbody Cages Procedure Volumes, 5EU, 2011-2020 27
Figure 4: Pedicle Screw Systems Procedure Volumes, 5EU, 2011-2020 29
Figure 5: Spinal Fusion Procedure Volumes, Brazil, 2011-2020 31
Figure 6: Spinal Plating Procedure Volumes, APAC, 2011-2020 33
Figure 7: Interbody Cages Procedure Volumes, APAC, 2011-2020 34
Figure 8: Pedicle Screw Systems Procedure Volumes, APAC, 2011-2020 36
Figure 9: Adoption of Spinal Implants for the Fusion Procedures, US, 2013 43
Figure 10: Adoption of Spinal Implants for the Fusion Procedures, South America, 2013 46
Figure 11: Spinal Fusion Procedure Volumes, US, 2002-2011 56
Figure 12: Spinal Surgery, US Company Market Share, 2012 126
Figure 13: Spinal Surgery, 5EU Company Market Share, 2012 127
Figure 14: Spinal Surgery, APAC Company Market Share, 2012 129
Figure 15: Spinal Surgery, South American Company Market Share, 2012 130
Figure 16: Global Spinal Plating Systems Sales ($m) Forecast, 2011-2020 131
Figure 17: Global Interbody Cages Sales ($m) Forecast, 2011-2020 133
Figure 18: Global Pedicle Screw Systems Sales ($m) Forecast, 2011-2020 134
Figure 19: Global Spinal Fusion Sales ($m) Forecast, 2011-2020 136
Figure 20: US Spinal Fusion Sales ($m) Forecast, 2011-2020 137
Figure 21: France Spinal Fusion Sales ($m) Forecast, 2011-2020 139
Figure 22: Germany Spinal Fusion Sales ($m) Forecast, 2011-2020 140
Figure 23: Italy Spinal Fusion Sales ($m) Forecast, 2011-2020 142
Figure 24: Spain Spinal Fusion Sales ($m) Forecast, 2011-2020 143
Figure 25: UK Spinal Fusion Sales ($m) Forecast, 2011-2020 145
Figure 26: Japan Spinal Fusion Sales ($m) Forecast, 2011-2020 146
Figure 27: Brazil Spinal Fusion Sales ($m) Forecast, 2011-2020 148
Figure 28: China Spinal Fusion Sales ($m) Forecast, 2011-2020 149
Figure 29: India Spinal Fusion Sales ($m) Forecast, 2011-2020 151

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