Spinal Non-fusion - US Analysis and Market Forecasts

Date: December 15, 2015
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Publisher: GlobalData
Report type: Strategic Report
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Spinal Non-fusion - US Analysis and Market Forecasts
Spinal Non-fusion - US 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.

The US spinal non-fusion market has been estimated in this report up to 2021. The report provides an investigation of unmet needs, future adoption trends and compound annual growth rates (CAGR) for each market segment. In addition, this report presents the current market drivers and barriers which will influence the future market growth of spinal non-fusion devices.

This is an on-demand report and will be delivered within 4 working days (excluding weekends) of the purchase.

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 the US?
  • 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 in the US?
  • 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 in the US?
  • 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 in the US?
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.
1 TABLE OF CONTENTS

1.1 LIST OF TABLES
1.2 LIST OF FIGURES

2 EXECUTIVE SUMMARY

2.1 Market Dynamics
2.2 Key Players in the Global Spinal Non-fusion Market
2.3 Global Market Future Outlook
2.4 What Do Physicians Think?

3 INTRODUCTION

3.1 Catalyst
3.2 Related Reports

4 TREATMENT MODALITIES OVERVIEW

4.1 Spinal Fusion
4.2 Spinal Non-fusion
  4.2.1 Pedicle Screw-Based Dynamic Stabilization
  4.2.2 Interspinous Process Decompression
  4.2.3 Artificial Disc Replacement
  4.2.4 Facet Arthroplasty
  4.2.5 Annulus Repair
  4.2.6 Nuclear Disc Replacement

5 COMPETITIVE ASSESSMENT

5.1 Pedicle Screw-Based Dynamic Stabilization
5.2 Interspinous Process Decompression
5.3 Artificial Disc Replacement
5.4 Annulus Repair
5.5 Facet Arthroplasty
5.6 Nuclear Disc Prostheses

6 PIPELINE PRODUCTS

6.1 Overview
6.2 DIAM Spinal Stabilization System (Medtronic)
6.3 Flexus Interspinous Spacer (Globus Medical)
6.4 M6-C (Spinal Kinetics)
6.5 Triadyme-C Disc System (Dymicron)
6.6 Simplify Disc (Simplify Medical)
6.7 Synergy Disc (Synergy Disc Replacement)
6.8 XL TDR Lumbar Disc (NuVasive)
6.9 Freedom Lumbar Disc System (AxioMed)
6.10 Triumph (Globus Medical)
6.11 ACADIA (Globus Medical)
6.12 Barricaid (Intrinsic Therapeutics)
6.13 NuBac (RTI Surgical)

7 INDUSTRY OVERVIEW

7.1 Procedural Trends
  7.1.1 US
7.2 Reimbursement Trends
  7.2.1 US
7.3 Mergers and Acquisitions/Key Partnerships
  7.3.1 RTI Biologics Acquires Pioneer Surgical Technology for $130m (July 2013)
  7.3.2 Stryker Buys “Non-Core” Spinal Implants from VertiFlex (March 2013)
  7.3.3 Johnson & Johnson Acquires Synthes for $19.7 Billion (June 2012)
  7.3.4 Globus Medical Acquires Facet Solutions (January 2011)

8 MARKET DRIVERS AND BARRIERS

8.1 Driver: Aging Patient Populations
8.2 Driver: Drawbacks of Spinal Fusion Surgeries
8.3 Driver: Cervical Total Disc Replacement
8.4 Driver: Direct-To-Consumer Marketing
8.5 Barrier: Spinal Fusion Remains the Gold Standard for Treating Spinal Degenerative Conditions
8.6 Barrier: Insufficient Evidence to Prove Clinical Efficacy
8.7 Barrier: Restricted Reimbursement
8.8 Barrier: Cost

9 UNMET NEEDS AND MARKET OPPORTUNITIES

9.1 Multi-Level Cervical Total Disc Replacement in the US
9.2 Lumbar Total Disc Replacement
9.3 Surgeon Training on Non-fusion Techniques
9.4 Emerging Markets

10 CURRENT AND FUTURE PLAYERS

10.1 Trends in Corporate Strategy
10.2 Major Manufacturers
  10.2.1 Aesculap
  10.2.2 Alphatec Spine
  10.2.3 DePuy Synthes
  10.2.4 Globus Medical
  10.2.5 Medtronic
  10.2.6 LDR
  10.2.7 NuVasive
  10.2.8 Paradigm Spine
  10.2.9 RTI Surgical
  10.2.10 Zimmer-Biomet

11 MARKET OUTLOOK

11.1 Market Share Analysis by Country
  11.1.1 US Market
11.2 By Geography
  11.2.1 US

12 APPENDIX

12.1 Bibliography
12.2 Abbreviations
12.3 Report Methodology
  12.3.1 Overview
  12.3.2 Coverage
  12.3.3 Secondary Research
  12.3.4 Forecasting Methodology
  12.3.5 Primary Research - Key Opinion Leader Interviews
  12.3.6 Expert Panel Validation
12.4 Physicians and Specialists Included in This Study
12.5 About the Authors
12.6 About MediPoint
12.7 About GlobalData
12.8 Contact Us
12.9 Disclaimer

LIST OF TABLES

Table 1: Spinal Non-fusion: Key Metrics in the 10MM, 2014-2021
Table 2: Major Pedicle Screw-Based Dynamic Stabilization Systems on the Market, 2015
Table 3: Major Interspinous Process Decompression Systems on the Market, 2015
Table 4: FDA-Approved C-TDR Devices with Number of Patients Enrolled in IDE Study
Table 5: Major Artificial Disc Replacement Systems on the Market, 2015
Table 6: Major Annulus Repair Systems on the Market, 2015
Table 7: Major Facet Arthroplasty Systems on the Market, 2015
Table 8: Major Pipeline Products in the Spinal Non-fusion Market, 2015
Table 9: US Procedure Trends for Spinal Non-fusion, 2012-2021
Table 10: Major US Health Insurance Carriers’ Coverage for Spinal Non-fusion Procedures, 2015
Table 11: Population Aged 60 Years Old or Over, 1950-2050, in millions (percentage)
Table 12: Company Profile - Aesculap
Table 13: Aesculap’s Spinal Non-fusion Portfolio Assessment, 2015
Table 14: SWOT Analysis - Aesculap
Table 15: Company Profile - Alphatec Spine
Table 16: Alphatec Spine’s Spinal Non-fusion Portfolio Assessment, 2015
Table 17: SWOT Analysis - Alphatec Spine
Table 18: Company Profile - DePuy Synthes
Table 19: DePuy Synthes’ Spinal Non-fusion Portfolio Assessment, 2015
Table 20: SWOT Analysis - DePuy Synthes
Table 21: Company Profile - Globus Medical
Table 22: Globus Medical’s Spinal Non-fusion Portfolio Assessment, 2015
Table 23: SWOT Analysis - Globus Medical
Table 24: Company Profile - Medtronic
Table 25: Medtronic’s Spinal Non-fusion Portfolio Assessment, 2015
Table 26: SWOT Analysis - Medtronic
Table 27: Company Profile - LDR Holding
Table 28: LDR Holding’s Spinal Non-fusion Portfolio Assessment, 2015
Table 29: SWOT Analysis - LDR Holding
Table 30: Company Profile - NuVasive
Table 31: LDR Holding’s Spinal Non-fusion Portfolio Assessment, 2015
Table 32: SWOT Analysis - NuVasive
Table 33: Company Profile - Paradigm Spine
Table 34: Paradigm Spine’s Spinal Non-fusion Portfolio Assessment, 2015
Table 35: SWOT Analysis - Paradigm Spine
Table 36: Company Profile - RTI Surgical
Table 37: RTI Surgical’s Spinal Non-fusion Portfolio Assessment, 2015
Table 38: SWOT Analysis - RTI Surgical
Table 39: Company Profile - Zimmer-Biomet
Table 40: Zimmer-Biomet’s Spinal Non-fusion Portfolio Assessment, 2015
Table 41: SWOT Analysis - Zimmer-Biomet
Table 42: US Spinal Non-fusion Market Revenue ($m), 2012-2021

LIST OF FIGURES

Figure 1: Spinal Non-fusion Market by Major Market, 2014 and 2021
Figure 2: US Procedure Trends for Spinal Non-fusion, 2012-2021
Figure 3: US Spinal Non-fusion Market Share, 2014
Figure 4: US Spinal Non-fusion Market Revenue ($m), 2012-2021
Figure 5: US Spinal Non-fusion Market Revenue Distribution, 2014 and 2021
Figure 6: Breakdown of Physician Survey Participants by Geography (N=67)
Figure 7: Breakdown of Other Primary Research Participants by Geography (N=80)
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