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Cervical Total Disc Replacement Global Analysis and Market Forecasts

GDME0169MAR / Published January

Executive Summary

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. GDME0169MAR / Published JAN 2013

Cervical Total Disc Replacements, Key Metrics in Major Markets

(2011) Prevalence of Symptomatic Cervical Disc Disease 11 million

2011 Market Sales ($m) $231 million

Key Events (2011-2018)

(2013) Expected US Food and Drug Administration approval of LDR Medical's Mobi-C® Cervical Disc for double disc replacement indication

↑↑↑

(2013) Expected US Food and Drug Administration approval of SpinalMotion's Kineflex®|C Cervical Disc

↑↑

(2014) Estimated expanded US private insurance coverage for single level C-TDR procedures

↑↑↑

(2016) Expected US Food and Drug Administration approval of Medtronic's Prestige-LP® Cervical Disc fo double level dis replacement indication

↑↑↑

(2016) Estimated expanded US private insurance coverage for double level C-TDR procedures

↑↑↑

(2018) Expected US Food and Drug Administration approval of Spinal Kinectics' M6-C Artificial Cervical Disc

↑↑

(2018) Expected release of ten year results from subjects on FDA IDE trial of ProDisc-C ↑↑↑

2018 Market Sales ($m) $756 million

US $601 million

5EU $66 million

Developing Economies $89 million

Source: GlobalData, Primary Research Interviews with Leading Spine Surgeons and Neurosurgeons, 2012 Note: 5 EU = France, Germany, Italy, Spain, and UK.

Sales for Cervical Total Disc Replacements (C-TDR) by Region

We estimate the 2011 C-TDR sales to be $231m across

the nine regions covered in this report, which are the

United States (US), France, Germany, Italy, Spain, the

United Kingdom (UK), Brazil, India, and China.

By the end of the forecast, sales will grow to over $756m

with a Compound Annual Growth Rate (CAGR) of 21.7%.

The key drivers for the market in the forecast are:

The high prevalence of symptomatic adjacent

segment disease following Anterior Cervical

Discectomy and Fusion (ACDF) procedures in the

long run.

Clinical trials for C-TDR devices achieving non-

inferior and superior efficacy and safety profiles

compared to ACDF procedures.

Expanded US Private Insurance Coverage for Single

Level and Double Level Replacement Procedures

The high prevalence of psuedoarthrosis following

ACDF procedures in the long run.

C-TDR Revenue by Major Market, 2011 and 2018

63%

27%

9% 1%

US EU APAC South America

2011$231m

79.5%

8.7%

11.7%0.1%

US EU APAC South America

2018$756m

Source: GlobalData, Primary Research Interviews and Surveys with Leading Spine Surgeons and Neurosurgeons, 2012.

Executive Summary


As of 2011, the US and the European Union (EU)

comprised a majority of the global market share with 63%

and 27%, respectively. GlobalData estimates that the

market share for the EU will shift over the forecast as

both the United States and the Asia Pacific region

(APAC) take larger shares. In the US, an overall 40%–

50% increase in procedural volume for both single-level

and double-level disc replacements are expected to

increase during the forecast. In India, a minimum of a

40% increase in procedure volumes is expected each

year subsequent to 2012. Adoption rates in the other

major markets are projected to remain fairly steady over

the forecast, given their current states of reimbursement

and the general consensus concerning the questioned

superiority of the devices over ACDF procedures.

Unmet Needs Remain a Challenge

C-TDR technology has evolved over the years to address

the challenges in treating patients and to create a device

that could outperform ACDF procedures in both safety

and efficacy. Although the marketplace has grown with

the entrance of quality implants, gaps still remain that

offer an opportunity for competitors to gain an advantage.

The majority of C-TDR clinical trials to date have focused

exclusively on the safety and efficacy profiles of a

company’s device compared to ACDF procedures. These

investigations have repeatedly validated their non-

inferiority in several key clinical outcomes. However,

there are several other avenues for clinical investigations

for which successful results could be lead to competitive

advantages for a specific company and the industry

overall. Heterotopic ossification has become a growing

concern as longer-term follow up has documented its

increasing prevalence. The durability and longevity of

these devices has been questioned given that these

devices are intended for permanent implantation.

Another void in clinical investigations has been the

performance of these devices in the over 65 year old

patient population. It has remained unexplored due to

certain stigmas that arose from lumbar disc replacement

investigations. Finally, there is a surprising lack of large-

scale trials assessing the performance of C-TDR against

ACDF in double level procedures.

Key Players in the C-TDR Market

Two large medical device manufacturers have dominated

the market since its inception in the early 2000s. Both

Medtronic Sofamor Danek and Johnson and Johnson’s

DePuy Synthes Spine entered the C-TDR market through

acquisitions and were able to get their products approved

in the major markets. These companies have used their

international presence and clinical trial results to remain

market leaders all the way through 2012. However,

GlobalData believes that their market shares will

decrease with the entrance of new, competitive devices

in the US market in 2012 and 2013 and the subsequent

release of their two-year, randomized clinical trial data.

Such entrants include Nuvasive, LDR Holdings, and

SpinalMotion.

C-TDR Market Future Outlook

C-TDR devices are expected to thrive in both the US and

India over the forecast. Improved reimbursement

coverage and the FDA’s approval of a double level disc

replacement indication will drive the growth in the US. In

India, leading C-TDR device manufacturers, like

Medtronic Sofamor Danek, are beginning to enter the

market with positive adoption from the region’s surgeons.

In the covered European countries and the remaining

developing economies, growth for these devices will

remain stagnant. European surgeons currently see these

devices as expensive alternatives to ACDF procedures

that provide only comparable patient outcomes.

Executive Summary


The geography of developing economies makes it difficult

for smaller device companies to comprehensively

penetrate their markets.

What Do Physicians Think?

Physicians are optimistic about the future adoption of

C-TDR devices.

“I don’t know what is going to happen in the next

calendar year but in the next three to five years cervical

total disc replacement is going to be 70% of the

procedures done for one- or two-level cervical disc

disease. I can almost guarantee it.”

Key Opinion Leader, October 2012

“You will see an exponential increase. I think it will go

from 2% to 50% right away because most of the surgery

we do right now is single level and double level. And I do

know that some companies are very close to getting

double level. I think there will be a dramatic increase.”


Physicians are interested in understanding the

device’s performance in the long term.

“If you are treating a 60–70-year-old patient then you

don’t want them to be coming back for another surgery

when they are 73.”


“A lot of the patients that undergo these surgeries go on

to live 30–40 years. So the question is whether they will

last that long. [This is] something that could impact the

future of artificial disc. There are some that just fail

decades later. Just like hip issues that come up.”


Physicians are interested in devices that are

radiographic friendly and are not keel based.

“And with metal on poly, if you can eliminate the imaging

artifact of stainless steel or cobalt chromium and replace

it with titanium or titanium ceramic then you get the best

of all worlds.”


“One of the disadvantages of a keel base is the incidence

of vertebral body fractures. The keel just makes a big cut

in the vertebral body and especially if you have some

osteoporotic bone or heavy smokers.”


Physicians are concerned over the current state of

the clinical trial data.

“Clinically it is not relevant that you have a statistical

[significant] result. And that is major problem with all

those studies. […] The way the results are interpreted in

the US it is common believed that C-TDR is better but if

you look carefully at the studies nothing is showing in

favor of the C-TDR.”

Key Opinion Leader, November 2012

Physicians are interested in exploring the

performance of C-TDR devices in the over 65 y/o

patient population.

“If somebody is brave enough to undertake that they will

definitely reap the harvest big time.”


Table of Contents


1 Table of Contents

1 Table of Contents ............................................................................................................... 5

1.1 List of Tables ............................................................................................................. 11

1.2 List of Figures ........................................................................................................... 14

2 Introduction ....................................................................................................................... 16

2.1 Catalyst ..................................................................................................................... 16

3 Disease Overview ............................................................................................................. 18

3.1 Anatomy and Physiology ........................................................................................... 18

3.1.1 Vertebral Column ................................................................................................ 18

3.1.2 Intervertebral Discs and Vertebrae ...................................................................... 19

3.2 Pathophysiology ........................................................................................................ 21

3.2.1 Degenerative Disc Disease ................................................................................. 21

3.3 Clinical Presentation .................................................................................................. 24

3.3.1 Symptoms ........................................................................................................... 24

3.3.2 Radiculopathy ..................................................................................................... 24

3.3.3 Myelopathy ......................................................................................................... 25

3.3.4 Diagnosis ............................................................................................................ 26

3.4 Clinical Outcomes ..................................................................................................... 27

3.4.1 Non-Surgical Techniques .................................................................................... 28

3.4.2 Surgical Techniques ............................................................................................ 31

3.5 Epidemiology ............................................................................................................ 32

3.6 Economic Impact ....................................................................................................... 34

3.6.1 Economic Impact of the Treating SCDD .............................................................. 34

3.6.2 Cost Effectiveness .............................................................................................. 35

3.6.3 Return to Work .................................................................................................... 36

4 Competitive Assessment ................................................................................................... 37

4.1 Overview ................................................................................................................... 37

4.1.1 Current Devices .................................................................................................. 40

Table of Contents


4.1.2 Competitive Assessment ..................................................................................... 42

4.2 US Marketed Products .............................................................................................. 44

4.2.1 Prestige ST Cervical Disc System ....................................................................... 45

4.2.2 Bryan Cervical Disc ............................................................................................. 50

4.2.3 ProDisc-C Total Disc Replacement ..................................................................... 53

4.2.4 SECURE-C Cervical Artificial Disc....................................................................... 56

4.2.5 Porous Coated Motion Cervical Disc ................................................................... 59

4.3 CE Marked Products ................................................................................................. 61

4.3.1 Kineflex|C Spinal System .................................................................................... 61

4.3.2 Mobi-C ................................................................................................................ 64

4.3.3 DISCOVER Artificial Cervical Disc....................................................................... 67

4.3.4 M6-C Artificial Disc Replacement ........................................................................ 70

4.3.5 Prestige LP Cervical Disc System ....................................................................... 73

4.3.6 NuNec Cervical Arthroplasty System ................................................................... 76

4.3.7 FREEDOM Cervical Disc .................................................................................... 78

4.3.8 Additional Cervical Total Disc Replacements ....................................................... 79

5 Unmet Needs.................................................................................................................... 80

5.1 Overview ................................................................................................................... 80

5.2 Durability and Longevity of C-TDR Devices ............................................................... 82

5.3 Reduce Heterotopic Ossification ................................................................................ 84

5.4 Over 65-year-old Patient Population .......................................................................... 86

5.5 Economic and Financial Impact of C-TDR ................................................................. 89

5.6 Radiolucent Materials in Device Composition ............................................................ 91

5.7 Achieve Indication for Double-Disc Replacement in the US........................................ 92

6 Pipeline Products .............................................................................................................. 94

6.1 Overview ................................................................................................................... 94

6.1.1 United States ...................................................................................................... 94

6.1.2 Outside the United States ................................................................................... 96

Table of Contents


6.2 Clinical Trial Analysis ................................................................................................ 97

6.2.1 Overview............................................................................................................. 97

6.2.2 Trials to Watch .................................................................................................... 97

7 Industry Overview ........................................................................................................... 100

7.1 Procedure Trends.................................................................................................... 100

7.1.1 United States .................................................................................................... 100

7.1.2 Europe .............................................................................................................. 101

7.1.3 Developing Economies...................................................................................... 103

7.2 Market Access......................................................................................................... 105

7.3 Reimbursement Trends ........................................................................................... 105

7.3.1 United States .................................................................................................... 105

7.3.2 Europe .............................................................................................................. 107

7.3.3 APAC ................................................................................................................ 107

7.3.4 South America .................................................................................................. 108

7.4 Regulatory Issues/Recalls ....................................................................................... 108

7.5 Added Indications .................................................................................................... 109

7.6 Mergers and Acquisitions/Key Partnerships ............................................................. 109

8 Current and Future Players ............................................................................................. 111

8.1 Overview ................................................................................................................. 111

8.2 Trends in Corporate Strategy................................................................................... 111

8.3 Company Profiles .................................................................................................... 112

8.3.1 AxioMed Corporation ........................................................................................ 112

8.3.2 DePuy Synthes Spine ....................................................................................... 114

8.3.3 FH Orthopedics ................................................................................................. 116

8.3.4 Globus Medical ................................................................................................. 117

8.3.5 LDR Holdings .................................................................................................... 119

8.3.6 Medicrea ........................................................................................................... 121

8.3.7 Medtronic Sofamor Danek ................................................................................. 123

Table of Contents


8.3.8 Nuvasive ........................................................................................................... 125

8.3.9 Osimplant ......................................................................................................... 127

8.3.10 Pioneer Surgical................................................................................................ 128

8.3.11 Ranier Technology ............................................................................................ 130

8.3.12 Spinal Kinetics .................................................................................................. 132

8.3.13 Spinal Motion .................................................................................................... 134

8.3.14 Stryker .............................................................................................................. 136

9 Market Drivers, Opportunities and Barriers ...................................................................... 138

9.1 Market Drivers ......................................................................................................... 138

9.1.1 High Prevalence of Adjacent Segment Disease Following ACDF Operations ..... 138

9.1.2 Comparable and Superior Clinical Trial Results for C-TDR Compared with

ACDF in the Short Term and Long Term .......................................................... 139

9.1.3 Expanded US Private Insurance Coverage for Single Level and Double Level

Replacement Procedures ................................................................................. 139

9.1.4 Prevalence of Pseudoarthrosis Following ACDF Operations .............................. 140

9.2 Opportunities ........................................................................................................... 140

9.2.1 Investigate C-TDR in Patients Over 65 Years Old .............................................. 140

9.2.2 Develop an Intervention to Reduce Heterotopic Ossification .............................. 141

9.2.3 Investigate the Economic Benefits of Utilizing C-TDR ........................................ 142

9.2.4 Obtain Double-Disc Replacement Indication in the US ...................................... 143

9.2.5 Develop Next-Generation Device with Radiolucent Materials ............................. 144

9.3 Barriers ................................................................................................................... 145

9.3.1 Adjacent Segment Disease ............................................................................... 145

9.3.2 Reimbursement................................................................................................. 146

9.3.3 Cost .................................................................................................................. 147

9.3.4 Scant Clinical Trial Data .................................................................................... 147

9.3.5 Nucleus Replacement Devices .......................................................................... 148

10 Country Outlooks and Forecasts ..................................................................................... 150

10.1 Major Markets Overview .......................................................................................... 150

Table of Contents


10.2 United States .......................................................................................................... 152

10.2.1 Overview........................................................................................................... 152

10.2.2 United States Market Analysis ........................................................................... 152

10.3 France .................................................................................................................... 155

10.3.1 Overview........................................................................................................... 155

10.3.2 France Market Analysis ..................................................................................... 155

10.4 Germany ................................................................................................................. 157

10.4.1 Overview........................................................................................................... 157

10.4.2 Germany Market Analysis ................................................................................. 157

10.5 Italy ......................................................................................................................... 159

10.5.1 Overview........................................................................................................... 159

10.5.2 Italy Market Analysis ......................................................................................... 159

10.6 Spain ...................................................................................................................... 161

10.6.1 Overview........................................................................................................... 161

10.6.2 Spain Analysis .................................................................................................. 161

10.7 United Kingdom ....................................................................................................... 163

10.7.1 Overview........................................................................................................... 163

10.7.2 United Kingdom Market Analysis ....................................................................... 163

10.8 Brazil ....................................................................................................................... 165

10.8.1 Overview........................................................................................................... 165

10.8.2 Brazil Market Analysis ....................................................................................... 165

10.9 India ........................................................................................................................ 167

10.9.1 Overview........................................................................................................... 167

10.9.2 India Market Analysis ........................................................................................ 167

10.10 China ................................................................................................................ 169

10.10.1 Overview ......................................................................................................... 169

10.10.2 China Market Analysis ..................................................................................... 169

11 Appendix ........................................................................................................................ 170

Table of Contents


11.1 Bibliography ............................................................................................................ 170

11.2 Abbreviations .......................................................................................................... 179

11.3 Report Methodology ................................................................................................ 180

11.3.1 Overview........................................................................................................... 180

11.3.2 Coverage .......................................................................................................... 180

11.3.3 Primary Research ............................................................................................. 181

11.3.4 Secondary Research ......................................................................................... 182

11.3.5 Forecasting Methodology .................................................................................. 183

11.4 Physicians and Specialists Included in this Study .................................................... 185

11.5 Physician Survey ..................................................................................................... 186

11.6 About the Authors ................................................................................................... 187

11.6.1 Joseph A. Gregory, Analyst, Surgical Devices ................................................... 187

11.6.2 Derek Archila, MBA, Lead Analyst, Medical Devices.......................................... 187

11.7 Global Head of Healthcare ...................................................................................... 188

11.7.1 Bonnie Bain, Ph.D., Global Head of Healthcare ................................................. 188

11.8 About MediPoint .................................................................................................... 189

11.9 About GlobalData .................................................................................................. 189

11.10 Contact Us ............................................................................................................ 189

11.11 Disclaimer ............................................................................................................. 190

Table of Contents


1.1 List of Tables

Table 1: Distribution of Age in Major Markets, 2012 ................................................................ 33

Table 2: Direct Costs in the US for SCDD Treatment, 2006/2007 ........................................... 34

Table 3: Results from Cost Effectiveness Study Between ACDF and C-TDR over 10 Years ... 35

Table 4: C-TDR US Product Approvals by Date ..................................................................... 40

Table 5: C-TDR OUS Product Approvals by Date ................................................................... 41

Table 6: Assessment of C-TDR Device Attributes................................................................... 43

Table 7: Product Profile – Prestige ST.................................................................................... 46

Table 8: Prestige ST SWOT Analysis, 2012 ........................................................................... 49

Table 9: Product Profile – Bryan Cervical Disc ....................................................................... 51

Table 10: Bryan Cervical Disc SWOT Analysis, 2012 ............................................................. 52

Table 11: Product Profile – ProDisc-C Cervical Disc ............................................................... 54

Table 12: ProDisc-C Total Disc Replacement SWOT Analysis, 2012 ...................................... 55

Table 13: Product Profile – Secure-C Cervical Disc ................................................................ 57

Table 14: Secure-C Total Disc Replacement SWOT Analysis, 2012 ....................................... 58

Table 15: Product Profile – PCM Cervical Disc ....................................................................... 59

Table 16: PCM Cervical Disc SWOT Analysis, 2012 .............................................................. 60

Table 17: Product Profile – Kineflex|C Cervical Disc ............................................................... 62

Table 18: Kineflex|C Cervical Disc SWOT Analysis, 2012 ...................................................... 63

Table 19: Product Profile – Mobi-C Cervical Disc ................................................................... 65

Table 20: Mobi-C Cervical Disc SWOT Analysis, 2012 ........................................................... 66

Table 21: Product Profile – Discover Cervical Disc ................................................................. 68

Table 22: Discover Cervical Disc SWOT Analysis, 2012 ......................................................... 69

Table 23: Product Profile – M6-C Cervical Disc ...................................................................... 71

Table 24: M6-C Cervical Disc SWOT Analysis, 2012 .............................................................. 72

Table 25: Product Profile – Prestige LP Cervical Disc............................................................. 74

Table 26: Prestige-LP Cervical Disc SWOT Analysis, 2012 .................................................... 75

Table 27: Product Profile – NuNec Cervical Disc .................................................................... 76

Table of Contents


Table 28: NuNec Cervical Arthroplasty System SWOT Analysis, 2012 ................................... 77

Table 29: Product Profile – Freedom Cervical Disc ................................................................. 78

Table 30: NuNec Cervical Arthroplasty System SWOT Analysis, 2012 ................................... 79

Table 31: Overall Unmet Needs – Current Level of Attainment and Importance (n=75) ........... 81

Table 32: Most Imperative Aspects of Heterotopic Ossification To Be Investigated ................. 85

Table 33: Most Imperative Economic Analysis Topics To Be Investigated (n=75) ................... 90

Table 34: Marketed Radiographic Friendly C-TDR Devices .................................................... 91

Table 35: Pipeline Products in the United States .................................................................... 94

Table 36: US Health Insurance Coverage, 2012 ................................................................... 105

Table 37: Decisions from Blue Cross Blue Shield Advisory Panel Meeting ........................... 106

Table 38: Company Portfolio – AxioMed Corporation ........................................................... 112

Table 39: AxioMed Corporation SWOT Analysis, 2012 ......................................................... 113

Table 40: Company Portfolio – DePuy Synthes Spine .......................................................... 114

Table 41: DePuy Synthes Spine SWOT Analysis, 2012 ........................................................ 115

Table 42: Company Portfolio – FH Orthopedics .................................................................... 116

Table 43: FH Orthopedics Corporation SWOT Analysis, 2012 .............................................. 116

Table 44: Company Portfolio – Globus Medical .................................................................... 117

Table 45: Globus Medical SWOT Analysis, 2012.................................................................. 118

Table 46: Company Portfolio – LDR Holdings....................................................................... 119

Table 47: LDR Holdings SWOT Analysis, 2012 .................................................................... 120

Table 48: Company Portfolio – Medicrea .............................................................................. 121

Table 49: Medicrea SWOT Analysis, 2012 ........................................................................... 122

Table 50: Company Portfolio – Medtronic Sofamor Danek .................................................... 123

Table 51: Medtronic Sofamor Danek SWOT Analysis, 2012 ................................................. 124

Table 52: Company Portfolio – Nuvasive .............................................................................. 125

Table 53: Nuvasive SWOT Analysis, 2012 ........................................................................... 126

Table 54: Company Portfolio – Osimplant ............................................................................ 127

Table 55: Osimplant SWOT Analysis, 2012 .......................................................................... 127

Table of Contents


Table 56: Company Portfolio – Pioneer Surgical .................................................................. 128

Table 57: Pioneer Surgical SWOT Analysis, 2012 ................................................................ 129

Table 58: Company Portfolio – Ranier Technology ............................................................... 130

Table 59: Ranier Technology SWOT Analysis, 2012 ............................................................ 131

Table 60: Company Portfolio – Spinal Kinetics ..................................................................... 132

Table 61: Spinal Kinetics SWOT Analysis, 2012 ................................................................... 133

Table 62: Company Portfolio – Spinal Motion ....................................................................... 134

Table 63: Spinal Motion SWOT Analysis, 2012 .................................................................... 135

Table 64: Company Portfolio – Stryker ................................................................................. 136

Table 65: Stryker SWOT Analysis, 2012 .............................................................................. 137

Table 66: Global Sales ($m) Forecast for C-TDR, 2009–2018 .............................................. 150

Table 67: US Sales ($m) Forecast for C-TDR, 2009–2018 ................................................... 153

Table 68: France Sales ($m) Forecast for C-TDR, 2009–2018 ............................................. 155

Table 69: Germany Sales ($m) Forecast for C-TDR, 2009–2018 .......................................... 157

Table 70: Factors Affecting C-TDR Adoption in Italy, 2012 ................................................... 159

Table 71: Italy Sales ($m) Forecast for C-TDR, 2009–2018 .................................................. 159

Table 72: Factors Affecting C-TDR Adoption in Spain, 2012 ................................................. 161

Table 73: Spain Sales ($m) Forecast for C-TDR, 2009–2018 ............................................... 161

Table 74: UK Sales ($m) Forecast for C-TDR, 2009–2018 ................................................... 164

Table 75: Brazil Sales ($m) Forecast for C-TDR, 2009–2018 ............................................... 165

Table 76: India Sales ($m) Forecast for C-TDR, 2009–2018 ................................................ 168

Table 77: China Sales ($m) Forecast for C-TDR, 2009–2018 ............................................... 169

Table 78: Physicians Surveyed, By Country ......................................................................... 186

Table of Contents


1.2 List of Figures

Figure 1: Regions of the Vertebral Column ............................................................................. 18

Figure 2: Anatomy of an Intervertebral Disc ............................................................................ 19

Figure 3: Anatomy of a Vertebrae .......................................................................................... 20

Figure 4: Treatment Paradigm for SCDD ................................................................................ 27

Figure 5: Prevalence of SCDD in 45–64-year-olds in Major Markets, 2009–2018 ................... 32

Figure 6: Companies in the US C-TDR Market with Approved Devices ................................... 38

Figure 7: Companies in C-TDR Market with Approved Devices Outside the United States ...... 39

Figure 8: Global Market Share for C-TDR Devices, 2012 (n=75) ............................................ 43

Figure 9: Structure of the Prestige ST Device ......................................................................... 45

Figure 10: Structure of the Bryan Cervical Device .................................................................. 50

Figure 11: Structure of the ProDisc-C Cervical Device ............................................................ 53

Figure 12: Structure of the Secure-C Cervical Device ............................................................. 56

Figure 13: Structure of the PCM Device ................................................................................. 59

Figure 14: Structure of the Kineflex|C ..................................................................................... 61

Figure 15: Structure of the Mobi-C ......................................................................................... 64

Figure 16: Structure of the Discover Artificial Disc .................................................................. 67

Figure 17: Structure of the M6-C Artificial Disc ....................................................................... 70

Figure 18: Structure of the Prestige-LP Artificial Disc.............................................................. 73

Figure 19: Structure of the NuNec Cervical Arthroplasty System ............................................ 76

Figure 20: Structure of the Freedom Cervical Disc ................................................................. 78

Figure 21: Necessity for Further Investigation: Durability & Longevity of C-TDR Devices ........ 83

Figure 22: Level of Necessity for Further Investigation: Interventions to Reduce HO ............... 85

Figure 23: US Market for SCDD by Age Group, 2012 ............................................................. 87

Figure 24: Level of Necessity for Further Investigation: Patients Over 65 Years Old ............... 88

Figure 25: Level of necessity for further investigation: Economic and Financial Impact ........... 90

Figure 26: Level of Influence of Insurance on Double-Disc Replacements with C-TDR Devices

............................................................................................................................... 93

Figure 27: Pipeline Products in the United States ................................................................... 94

Table of Contents


Figure 28: US C-TDR Procedure Volumes, 2009 to 2018 (n=75) .......................................... 100

Figure 29: European C-TDR Procedure Volumes, 2009 to 2018 (n=75) ................................ 102

Figure 30: C-TDR Procedure Volumes in India, China, and Brazil, 2009 through 2018 ......... 104

Figure 31: Global Sales ($m) Forecast for C-TDR, 2009–2018 ............................................. 150

Figure 32: C-TDR Revenue by Major Market, 2011 and 2018 ............................................... 151

Figure 33: US C-TDR Market, 2009 through 2018 ................................................................ 154

Figure 34: France C-TDR Market, 2009 and 2018 ................................................................ 156

Figure 35: Germany C-TDR Market, 2009 through 2018....................................................... 158

Figure 36: Italy C-TDR Market, 2009 through 2018 .............................................................. 160

Figure 37: Spain C-TDR Market, 2009 through 2018 ............................................................ 162

Figure 38: UK C-TDR Market, 2009 through 2018 ................................................................ 164

Figure 39: Brazil C-TDR Market, 2009 through 2018 ............................................................ 166

Figure 40: India C-TDR Market, 2009 and 2018 ................................................................... 168

Figure 41: China C-TDR Market, 2009 and 2018 .................................................................. 169

Introduction


2 Introduction

Symptomatic cervical disc disease (SCDD) is a degenerative condition of the spine that in certain

instances can cause debilitating pain and neurological dysfunction. For the past fifty years, anterior

cervical discectomy and fusion (ACDF) was the hallmark surgical intervention that provided

excellent pain relief and outcomes for patients where more conservative therapies failed. However,

as post-operative follow-up of patients who had undergone the procedure grew, surgeons

discovered that the signs and symptoms that had been produced by the treated level pre-

operatively had actually progressed to adjacent intervertebral disc levels. It was believed that the

fusing of adjacent vertebrae was prompting the emergence of this adjacent-level disease. Cervical

total disc replacements (C-TDR) were invented to replace the intervertebral disc as well as restore

the lost motion.

This report focuses on the C-TDR market in nine major global markets (the United States, the

United Kingdom, Germany, Spain, Italy, France, China, India, and Brazil). It identifies the unmet

needs in each market and isolates those factors that will most effectively lead to increase in C-TDR

adoption.

2.1 Catalyst

This report is being published at a pivotal time in the development of this device market. If this

report had been published in early 2012, the market would have looked the same as it did in 2007.

Devices manufactured by large corporations would be dominating the international markets, clinical

trial data would be restricted to short-term, two-year follow-up, and the reimbursement landscape

would only provide coverage from selected providers.

However, significant events have transpired in this market. First, the emergence of results from

several pivotal clinical trials is going to have a drastic effect on how these devices are perceived

and adopted by the spinal surgery community. The first study details a device’s performance over

the course of five to seven years. Another study explores how well C-TDR devices reduce the

development of adjacent segment disease with intermediate follow-up. Additionally, the first

randomized clinical trial results comparing double-level ACDF and C-TDR are expected to be

released.

In addition to clinical trial data, the market is being introduced to companies with devices that

harness newer technologies and designs. The traditional ball and socket configuration of the first

market entrants is going to be tested by newer devices that seek to more accurately mimic the

anatomy and physiology of the intervertebral disc. Additionally, some devices are being released

that incorporate more radiolucent materials that provide enhancements to post-operative imaging.

Introduction


All of these factors surfaced towards the end of 2012 and will have their effect on the market in

2013 and beyond. This report provides complete coverage of the impending market dynamics and

incorporates recommendations on how companies in the market or companies interested in

entering can best navigate it.

Appendix

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11.8 About MediPoint

MediPoint is the flagship product for GlobalData’s Medical team. Each MediPoint report is built

from the ground up by our team of healthcare analysts in the US and UK. Each report includes

input from experienced physicians and leading Key Opinion Leaders (KOL). Running throughout

each report in the series, “What 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.

11.9 About GlobalData

GlobalData is a leading global provider of business intelligence in the Healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug research, disease analysis, and clinical research and development. Our integrated business

intelligence solutions include a range of interactive online databases, analytical tools, reports and

forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has

offices in New York, Boston, London, India and Singapore.

11.10 Contact Us

If you have any queries about this report or would like further information, please contact us at the

below given telephone numbers or email address.

Appendix

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. 0 GDME0169MAR / Published JAN 2013

11.11 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.

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