MediPoint: Spinal Fusion – Global Analysis and Market Forecasts

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).

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Table of Contents

1Table of Contents1

1.1List of Tables5

1.2List of Figures8

2Executive Summary10

2.1Overview10

2.2Global Outlook11

2.3Future Outlook13

2.4What Do Physicians Think?13

3Introduction15

3.1Overview15

3.2Catalyst16

4Industry Overview17

4.1Indications17

4.2Types of Devices19

4.2.1Spinal Plating Systems19

4.2.2Interbody Cages20

4.2.3Pedicle Screw Systems21

4.3Procedure Trends22

4.3.1US22

4.3.25EU24

4.3.3South America29

4.3.4APAC31

4.4Market Access36

4.4.1Regulation36

4.4.2Adoption42

4.4.3Reimbursement Trends48

5Market Dynamics: Mergers, Acquisitions and Key Partnerships51

5.1Overview51

5.1.1Amedica Corporation Acquires US Spine53

5.1.2Alphatec Spine Acquires Scient’x Group53

5.1.3Biomet Acquires Lanx, Inc.53

5.1.4Globus Medical Acquires Facet Solutions53

5.1.5Integra LifeSciences Holdings Corporation Acquires SeaSpine, Inc.54

5.1.6Medtronic Acquires Advanced Medical Technologies and China’s Kanghui54

5.1.7Nuvasive Acquires ANC54

5.1.8TranS1 Inc. Acquires Baxano Inc.54

5.2Economic Impact54

6Unmet Needs57

6.1Improved Reimbursement Coverage for Minimally Invasive Surgical Procedures57

6.2Lack of Definitive Methods to Determine Fusion Performance58

6.3Technological Developments in the Use of Long Fusions59

6.4Research and Development into Fusion Enhancers61

6.5Improve Osseointegration of Bone and Screw Interface62

7Market Opportunity Analysis63

7.1Develop Signature Minimally Invasive Technique63

7.2Market Minimally Invasive Training Opportunities to Fellowship Programs64

7.3Increased Collaboration of Medical Device Implants and Biologics65

7.4Develop a Device that Provides Real-Time Fusion Updates66

7.5Increased Customization of Spinal Implants to Patient Anatomy66

8Market Drivers67

8.1Aging Patient Populations67

8.2Growth in the Spinal Stenosis Indication69

8.3Gold Standard for Treating Spinal Instability and Degenerative Conditions71

8.4Treatment for a Variety of Indications71

8.5Preference for Minimally Invasive Techniques72

8.6Advances in Navigation Technology74

9Market Barriers74

9.1Incidence of Adjacent Segment Disease74

9.2Performance of Non-Fusion Technologies75

9.3Increased Scrutiny over Spinal Fusion’s Necessity in the US77

9.4Restricted Reimbursement from Private Payers78

9.5Performance in Treating Axial Back Pain78

10Pipeline Assessment79

11Clinical Trial Analysis81

12Current and Future Players82

12.1Overview82

12.2Trends in Corporate Strategy82

12.3Company Profiles83

12.3.1Aesculap83

12.3.2Alphatec Spine85

12.3.3Amedica Corporation88

12.3.4Medtronic Spinal and Biologics90

12.3.5DePuy Spine93

12.3.6Globus Medical95

12.3.7K2M98

12.3.8Biomet100

12.3.9Stryker103

12.3.10Zimmer106

12.3.11Nuvasive110

12.3.12Orthofix113

12.3.13Integra LifeSciences116

13Market Outlook119

13.1Company Market Share119

13.1.1US119

13.1.25EU120

13.1.3APAC122

13.1.4South America123

13.2By Segment124

13.2.1Spinal Plating Systems124

13.2.2Interbody Cages126

13.2.3Pedicle Screw Systems127

13.3By Geography129

13.3.1Global129

13.3.2US130

13.3.3France132

13.3.4Germany133

13.3.5Italy135

13.3.6Spain136

13.3.7UK138

13.3.8Japan139

13.3.9Brazil141

13.3.10China142

13.3.11India144

14Appendix146

14.1Bibliography146

14.2Abbreviations155

14.3Report Methodology156

14.3.1Overview156

14.3.2Coverage156

14.3.3Primary Research156

14.3.4Secondary Research157

14.3.5Forecasting Methodology158

14.4Key Opinion Leaders Included in this Study159

14.5About the Authors160

14.5.1Joseph A. Gregory, Analyst, Surgical Devices160

14.5.2Derek Archila, MBA, Director of Research and Analysis, Medical Devices160

14.6Global Head of Healthcare161

14.6.1Bonnie Bain, Ph.D., Global Head of Healthcare161

14.7About MediPoint161

14.8About GlobalData161

14.9Contact Us162

14.10Disclaimer162

List of Tables

Table 1: Overview of Global Spinal Fusion Market*10

Table 2: Indications for Lumbar Spinal Fusion17

Table 3: Adoption of Spinal Fusion and Spinal Non-Fusion, US, 2013 and 202022

Table 4: Adoption of Spinal Fusion and Spinal Non-Fusion, 5EU, 2013 and 202024

Table 5: Spinal Plating Systems CAGR, 5EU, Based on 2013 and 2020 Procedure Volumes24

Table 6: Interbody Cages CAGR, 5EU, Based on 2013 and 2020 Procedure Volumes26

Table 7: Pedicle Screw Systems CAGR, 5EU, Based on 2013 and 2020 Procedure Volumes28

Table 8: Adoption of Spinal Fusion and Spinal Non-Fusion, Brazil, 2013 and 202030

Table 9: Adoption of Spinal Fusion and Spinal Non-Fusion, APAC, 2013 and 202031

Table 10: Spinal Plating Systems CAGR, APAC, Based on 2013 and 2020 Procedure Volumes32

Table 11: Interbody Cages CAGR, APAC, Based on 2013 and 2020 Procedure Volumes33

Table 12: Pedicle Screw Systems CAGR, APAC, Based on 2013 and 2020 Procedure Volumes35

Table 13: Adoption of Spinal Implants for Cervical Fusion Procedures, 5EU, 201344

Table 14: Adoption of Spinal Implants for Thoracolumbar Fusion Procedures, 5EU, 201344

Table 15: Adoption of Spinal Implants for Cervical Fusion Procedures, APAC, 201347

Table 16: Adoption of Spinal Implants for Thoracolumbar Fusion Procedures, APAC, 201347

Table 17: Mergers & Acquisitions, 2010–201451

Table 18: Population Aged 60 Years Old or Over, 1950–2050 (in millions) (percentage in older ages)67

Table 19: Overall Perceived Advantages of Minimally Invasive Surgery Techniques, 200773

Table 20: Overall Perceived Limitations of Minimally Invasive Surgery Techniques, 200773

Table 21: Company Portfolio – Aesculap83

Table 22: Product Portfolio – Aesculap84

Table 23: Company Portfolio – Alphatec Spine86

Table 24: Product Portfolio – Alphatec Spine87

Table 25: Company Portfolio – Amedica89

Table 26: Product Portfolio – Amedica90

Table 27: Company Portfolio – Medtronic Spinal and Biologics91

Table 28: Product Portfolio – Medtronic Spinal and Biologics92

Table 29: Company Portfolio – DePuy Spine93

Table 30: Product Portfolio – DePuy Spine94

Table 31: Company Portfolio – Globus Medical96

Table 32: Product Portfolio – Globus Medical97

Table 33: Company Portfolio – K2M98

Table 34: Product Portfolio – K2M99

Table 35: Company Portfolio – Biomet101

Table 36: Product Portfolio – Biomet102

Table 37: Company Portfolio – Stryker104

Table 38: Product Portfolio – Stryker105

Table 39: Company Portfolio – Zimmer107

Table 40: Product Portfolio – Zimmer109

Table 41: Company Portfolio – Nuvasive111

Table 42: Product Portfolio – Nuvasive112

Table 43: Company Portfolio – Orthofix113

Table 44: Product Portfolio – Orthofix115

Table 45: Company Portfolio – Integra LifeSciences117

Table 46: Product Portfolio – Integra LifeSciences118

Table 47: Spinal Surgery, US Company Market Share, 2012119

Table 48: Spinal Surgery, 5EU Company Market Share, 2012121

Table 49: Spinal Surgery, APAC Company Market Share, 2012122

Table 50: Spinal Surgery, South American Company Market Share, 2012123

Table 51: Global Spinal Plating Systems Sales ($m) Forecast, 2011–2020124

Table 52: Global Interbody Cages Sales ($m) Forecast, 2011–2020126

Table 53: Global Pedicle Screw Systems Sales ($m) Forecast, 2011–2020127

Table 54: Global Spinal Fusion Sales ($m) Forecast, 2011–2020129

Table 55: US Spinal Fusion Sales ($m) Forecast, 2011–2020131

Table 56: France Spinal Fusion Sales ($m) Forecast, 2011–2020132

Table 57: Germany Spinal Fusion Sales ($m) Forecast, 2011–2020134

Table 58: Italy Spinal Fusion Sales ($m) Forecast, 2011–2020135

Table 59: Spain Spinal Fusion Sales ($m) Forecast, 2011–2020137

Table 60: UK Spinal Fusion Sales ($m) Forecast, 2011–2020138

Table 61: Japan Spinal Fusion Sales ($m) Forecast, 2011–2020140

Table 62: Brazil Spinal Fusion Sales ($m) Forecast, 2011–2020141

Table 63: China Spinal Fusion Sales ($m) Forecast, 2011–2020143

Table 64: India Spinal Fusion Sales ($m) Forecast, 2011–2020144

List of Figures

Figure 1: Composition of Global Spinal Fusion Market, 2013 and 202012

Figure 2: Spinal Fusion Procedure Volumes, US, 2011–202023

Figure 3: Spinal Plating Procedure Volumes, 5EU, 2011–202025

Figure 4: Interbody Cages Procedure Volumes, 5EU, 2011–202027

Figure 5: Pedicle Screw Systems Procedure Volumes, 5EU, 2011–202029

Figure 6: Spinal Fusion Procedure Volumes, Brazil, 2011–202030

Figure 7: Spinal Plating Procedure Volumes, APAC, 2011–202032

Figure 8: Interbody Cages Procedure Volumes, APAC, 2011–202034

Figure 9: Pedicle Screw Systems Procedure Volumes, APAC, 2011–202036

Figure 10: Adoption of Spinal Implants for the Fusion Procedures, US, 201343

Figure 11: Adoption of Spinal Implants for the Fusion Procedures, South America, 201346

Figure 12: Spinal Fusion Procedure Volumes, US, 2002–201156

Figure 13: Spinal Surgery, US Company Market Share, 2012120

Figure 14: Spinal Surgery, 5EU Company Market Share, 2012121

Figure 15: Spinal Surgery, APAC Company Market Share, 2012122

Figure 16: Spinal Surgery, South American Company Market Share, 2012124

Figure 17: Global Spinal Plating Systems Sales ($m) Forecast, 2011–2020125

Figure 18: Global Interbody Cages Sales ($m) Forecast, 2011–2020127

Figure 19: Global Pedicle Screw Systems Sales ($m) Forecast, 2011–2020128

Figure 20: Global Spinal Fusion Sales ($m) Forecast, 2011–2020130

Figure 21: US Spinal Fusion Sales ($m) Forecast, 2011–2020131

Figure 22: France Spinal Fusion Sales ($m) Forecast, 2011–2020133

Figure 23: Germany Spinal Fusion Sales ($m) Forecast, 2011–2020134

Figure 24: Italy Spinal Fusion Sales ($m) Forecast, 2011–2020136

Figure 25: Spain Spinal Fusion Sales ($m) Forecast, 2011–2020137

Figure 26: UK Spinal Fusion Sales ($m) Forecast, 2011–2020139

Figure 27: Japan Spinal Fusion Sales ($m) Forecast, 2011–2020140

Figure 28: Brazil Spinal Fusion Sales ($m) Forecast, 2011–2020142

Figure 29: China Spinal Fusion Sales ($m) Forecast, 2011–2020143

Figure 30: India Spinal Fusion Sales ($m) Forecast, 2011–2020145

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