椎間板代替の市場規模と有識者の見解

INTRODUCTION

Spinal disc replacement represents an emerging technology that many consider to be one of the greatest advances in orthopaedics in many years, with the potential to revolutionize spinal surgery by decreasing the use of spinal fusion, which has many known disadvantages. Datamonitor interviewed nine opinion leaders to evaluate current opinion on this topic.

SCOPE OF THE REPORT

• Focus on total disc replacement, with secondary coverage of nucleus disc replacement, including product and company coverage
• Interviews with seven European spinal surgeons from six different countries, one US spinal surgeon, and one US surgeon with ties to the FDA
• Datamonitor estimates of sales potential for artificial discs, based on surgeon opinion
• Transcripts of eight surgeon interviews

REPORT HIGHLIGHTS

Opinion leading surgeons interviewed by Datamonitor are not confident that the use of artificial discs will reach the level of penetration suggested by many in the hype leading up to product approval. On average, surgeons expect that in ten years, only 30% of spinal fusion procedures will be replaced by total disc replacement.

In order to increase the level of penetration, companies will need to provide robust clinical data, clearly define indications, and make improvements to the existing devices and procedures. This effort will likely define the competitive structure of the spinal implant market in the future.

KEY REASONS TO BUY TH S REPORT

• Identify steps required to increase surgeon uptake
• Understand surgeon expectations for penetration of this technology
• Achieve competitive advantage based on surgeon suggested product improvements

Overview

Introduction

Scope

Report Highlights

Reasons to Purchase

Drivers and trends

Analysis of surgeon opinion over total disc replacement, and nucleus disc replacement, which are being touted as the future of spinal surgery by many, with the potential to become a billion dollar segment of the market.

• How steps do companies need to take to maximize surgeon uptake?
• Is there any way to ease the road to US market approval?
• How large will this market really be?

MARKET OVERVIEW

Provides the background of the spinal surgery market, and the place for total disc replacement and nucleus disc replacement within this market. Key marketed products and products in development are evaluated, along with a competitive overview.

Analysis of products in various stages of development

Which companies have the portfolios with the highest patient potential?

Which smaller companies with products in the development represent possible acquisition targets for companies that have not entered the market yet?

OPINION LEADER ANALYSIS

Provides analysis and key quotes from nine interviews of opinion leading spinal surgeons and contacts with knowledge of the FDA.

• Surgeon opinion of the "ideal candidate"
• Expected penetration of spinal surgery market
• Can FDA approval be more efficient?
• What product changes will lead to increased use?
• Surgeons discuss potential marketing strategies

OPINION LEADER INTERVIEWS

Provides transcripts of eight surgeon interviews, with insight on surgeon opinion of total disc and nucleus disc replacement, pricing and marketing strategies, and potential product improvements.

• What are the most difficult aspects of the total disc replacement procedure?
• Should companies actually limit the penetration of the product within the next few years?
• What is the early opinion of nucleus disc replacement?

ACTION POINTS

Four key action points for orthopaedic companies

• Action point 1 – Supplement prospective studies with as much retrospective data as possible
• Action point 2 – In markets where a premium pricing strategy is not possible, do not sacrifice the high profit margins gained from other spinal implants
• Action point 3 – Do not risk poor results through overly aggressive marketing in the next few years
• Action point 4 – Consider a PDP for gaining FDA approval of artificial discs in the US market

APPENDIX

List of contributing experts

DATASETS

Table 1: Surgeon opinion: predicted impact of total disc replacement on common related spinal surgeries, 2005

Table 2: Surgeon opinion: predicted impact of total disc replacement on common related spinal surgeries, 2013

Table 3: Selected total disc and nucleus disc replacement products, 2003

Table 4: Surgeon opinion: predicted impact of total disc replacement on common related spinal surgeries, 2005

Table 5: Surgeon opinion: predicted impact of total disc replacement on common related spinal surgeries, 2013

Table 6: Artificial disc potential impact on common spinal surgeries, Dr Federico Girardi, 2003

Table 7: Artificial disc potential impact on common spinal surgeries, Prof. Dr Dieter Grob, 2003

Table 8: Artificial disc potential impact on common spinal surgeries, Dr Robert Gunzburg, 2003

Table 9: Artificial disc potential impact on common spinal surgeries, Dr Marcus Jager, 2003

Table 10: Artificial disc potential impact on common spinal surgeries, French spinal surgeon, 2003

Table 11: Artificial disc potential impact on common spinal surgeries, Prof. Jean-Paul Steib, 2003

Table 12: Artificial disc potential impact on common spinal surgeries, European spinal surgeon, 2003

Table 13: Artificial disc potential impact on common spinal surgeries, Prof. Douglas Wardlaw, 2003

Figure 1: Total disc replacement procedures based on surgeon opinion, US and Europe, 2005e–2013

Figure 2: Leading spinal implant manufacturer potential total disc replacement vs. 2002 spinal implant sales

Figure 3: Predicted impact of total disc replacement on common related spinal surgeries, 2005

Figure 4: Predicted impact of total disc replacement on common related spinal surgeries, 2013

Figure 5: Total disc replacement procedures based on surgeon opinion, US and Europe, 2005e–2013