Total Shoulder Replacement US sample - MarketResearch“Companies have done a great job going to...

REFERENCE CODE GDME1046CFR | PUBLICAT ION DATE JUNE 2013

TOTAL SHOULDER REPLACEMENT – US ANALYSIS AND MARKET FORECASTS

Total Shoulder Replacement - US Analysis and Market Forecasts 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS

Executive Summary

Total Shoulder Replacement: Key Metrics in the US Market

Prevalence of Symptomatic Shoulder Arthritis in 2013 2.8 million

Prevalence of Proximal Humerus Fracture in 2013 0.21 million

2012 Market Sales ($m)

US $366.1m

Competitive Assessment

Anatomic Total Shoulder Replacement Implants 23

Anatomic Stemless Total Shoulder Replacement Implants 6

Reverse Total Shoulder Replacement Implants 13

Key Events (2012–2019) Impact

Commercial launch of Global Steptech APG system from DePuy Synthes in 2012 ↑

US Food and Drug Administration (FDA) approval and commercial launch of Segmental Revision System (SRS) from Biomet in 2012

↑

Worldwide commercial launch of the Global Unite shoulder system from DePuy Synthes in Q1 2013

↑↑

Expected commercial launch of Ascend Flex Convertible shoulder system from Tornier in the US in Q3 2013

↑↑

Expected commercial launch of a patient-specific image-driven glenoid replacement device from Tornier in late 2013

↑

Expected commercial launch of a reverse shoulder replacement implant from Stryker in late 2013

↑↑

Expected commercial launch of a reverse shoulder replacement implant from Integra LifeSciences in late 2013

↑↑

Expected commercial launch of Promos Reverse shoulder replacement implants from Smith & Nephew in 2013–2014

↑↑

Expected US Food and Drug Administration (FDA) approval of Simpliciti stemless shoulder system from Tornier in 2015

↑↑↑

2019 Market Sales ($m)

US $701.6m

Source: GlobalData, secondary research and primary research interviews with leading shoulder orthopedic surgeons in the US.

The total shoulder replacement market (TSR),

including anatomic and reverse total shoulder

replacements, is expected to enjoy significant

growth during the forecast period. GlobalData

estimates the US market in 2012 was $366.1m. By

the end of the forecast, the TSR sales will surpass

$701.6m with a Compound Annual Growth Rate

(CAGR) of 9.7%.

Key Drivers during the Forecast Period:

Growing prevalence of symptomatic shoulder

arthritis and proximal humerus fracture due to

global aging

Increased patient awareness and the desire of

patients to be able to maintain full range of

motion and regain productivity

The launch of more reverse total shoulder

replacement devices in the US market

Expanded medical education and surgeon

adoption of TSR across the country

The total shoulder replacement market continues

to grow at a faster rate than either total hip or total

knee. It also represents the fastest growing of the

upper extremity joint replacements. Today, the

market consists of anatomic and reverse shoulder

replacement implants and offers a myriad of

prostheses to meet orthopedic surgeons’ demands

in the management of shoulder problems including

glenohumeral arthritis, rotator cuff tear arthropathy,

and proximal humerus fractures.



Executive Summary

The promising clinical outcomes associated with

both types of shoulder prostheses are mainly due

to updated design philosophies and appropriate

surgical techniques accumulated by physicians.

As of 2013, the US comprised a majority of the

market share, with 69.6%, and is expected to

continue to contribute a substantial amount to the

global TSR market over the forecast period.

Unmet Needs Remain a Challenge

Total shoulder replacement has been gaining

extensive interest among both surgeons and

medtech manufacturers. While the technology has

developed greatly, there is still much room for

technological advancement. As with other total

joint procedures, total shoulder replacement can

be associated with a multitude of complications. To

date, the most common mid-term and long-term

complication of anatomic total shoulder

replacement is glenoid component loosening.

Considerable attention has been devoted to

optimizing the design features and implantation

techniques that maximize the opportunity of

improved wear characteristics of the glenoid

component. Yet shoulder surgeons still

overwhelmingly see the glenoid component as an

area where advanced and innovative techniques

could be applied to further improve its wear

performance and biological fixation. As for reverse

total shoulder replacement, despite its clinical

success in cuff-deficient patients, its widespread

use is limited by a high reported complication rate.

There is clearly a need for emphasis on the

complications and better understanding of the

mechanisms, from both academia and the

companies.

Additionally, as the number of total shoulder

replacements has increased exponentially over the

last 10 years, GlobalData expects a more

prominent role for revision surgeries in the future.

Continuous efforts from the supply side on refining

instrumentations and delivering revision-specific

systems are anticipated.

Key Players in the TSR Market

The four primary players in the US TSR market are

DePuy Synthes, Tornier, Zimmer and Biomet.

While there are a range of other smaller players as

well, these four comprise more than 75% of the

market share. In particular, DePuy Synthes and

Tornier represent more than half of the total market

size. With the most diversified and innovated

shoulder portfolios in hand, DePuy and Tornier are

expected to be the leading players in the arena for

another five years. Following these two are Zimmer

and Biomet, who have each established platform

technologies and secured a strong foothold in the

past few years. The rest of the players, such as

Exactech, DJO Surgical and Smith & Nephew,

have been fiercely competing against each other.

GlobalData anticipates an evolving competitive

landscape in the US TSR market as more players

launch their reverse shoulder implants.



Executive Summary

Anatomic and Reverse TSR Market Future Outlook

The TSR market has experienced steady growth in

the past decade thanks to the constant innovations

in prosthesis design, the FDA approval of reverse

shoulder implants, and well-established

reimbursement in western society. Over the

forecast period, despite the dampening effect of

downward pricing pressure, the TSR market is

expected to enjoy healthy growth, primarily driven

by the surge of patient population with shoulder

arthritis and proximal humerus fractures, the trend

of active aging, continuous medical education

efforts from the supply side, the introduction of

additional reverse shoulder implants and the FDA’s

approval of modern stemless designs. In particular,

the market size of reverse TSR is expected to grow

at a much faster pace compared with anatomic

TSR.

What Do Physicians Think?

Aging pandemic is accelerating the increase in the

global procedure volume of total shoulder

replacement.

“The most important contributor is the changing

demographics and the demand for active aging.

We have more population over 75 today. Shoulder

patients above 75 years old would love to return to

daily activities and therefore they are willing to

receive these procedures.”

Key Opinion Leader, April 2013

Physicians expressed different attitudes about the

current wave of enthusiasm towards reverse total

shoulder replacement.

“We thought we might have more problems with

reverse shoulders, but this is not true. The patient

is satisfied because the pain is gone and the

mobility is not bad. Maybe a little higher infection

rate, mainly in revision situations.”


“Reverse shoulder replacement does not offer an

easy revision. When an anatomic total shoulder

replacement fails, you may be able to salvage

using a reverse shoulder. But if a reverse shoulder

fails, you may not have many choices then.”




Executive Summary

“Companies have done a great job going to

orthopedic surgeons and going to the public in

general, and marketing the concept of reverse

shoulder. It had been given the impression that it’s

an easier procedure than anatomic total shoulder

replacement. In the Medicare population in the

Unites States, the breakdown of reverse and

anatomic total is almost 50:50, and that’s

ridiculous. I think in our country, reverse is over-

utilized. Quite frankly, in Europe it’s even worse.”


“‘There’s no bail-out for reverse’ is a very valid

comment. That’s one of the reasons I think caution

needs to be exercised when using this in younger

patients, because the current revision systems are

very limited. There might be kind of a return to

some of the concepts that reverse [shoulder

replacement] should be performed in older patients

with less demand of manual labor.”

Key Opinion Leader, May 2013

Physicians are interested in more innovation on the

glenoid component.

“If you ask me what is the strongest holdback to

real growth in shoulder arthroplasty, it is the

durability of the glenoid component. All types of

polyethylene that have better wear characteristics

obviously are helpful. But to be honest, if you want

to make a glenoid component last for a lifetime in

most patients who will get it, it needs to last 50

years. We do not have a glenoid component that

even close to last 50 years.”


“Personally, I think it’s going to be a focus more on

the fixation [of glenoid] now, using a trabecular

metal for example.”

Key Opinion Leader, May 2013



Executive Summary

Physicians in emerging markets are calling for

improved medical education and heightened public

awareness of total shoulder replacement.

“Started 15 years ago in the late 90s, at that time,

many surgeons had a tendency to do

hemiarthroplasty because of the technical difficulty

and long-term prognosis of the glenoid. Even if it is

an arthritic shoulder, the general tendency in my

country is to do a hemi [arthroplasty].”


“Because there is a lack of sufficient knowledge

about shoulder arthroplasty, almost every shoulder

surgeon in my country tends to do arthroscopy.

When you have to do an arthroplasty, we only do

hemiarthroplasty, even if there is a very good

indication for total shoulder arthroplasty.”


“The number of shoulder replacements done is not

reflective of the actual potential cases available,

because of high cost and low patient awareness.”




Table of Contents

1 Table of Contents

1 Table of Contents ...................................................................................................................... 7

1.1 List of Tables ...................................................................................................................... 15

1.2 List of Figures ..................................................................................................................... 22

2 Introduction ............................................................................................................................. 26

2.1 Catalyst ............................................................................................................................... 27

2.2 Related Reports .................................................................................................................. 27

3 Disease Overview ................................................................................................................... 28

3.1 Anatomy and Physiology ..................................................................................................... 28

3.2 Pathophysiology .................................................................................................................. 30

3.2.1 Overview ........................................................................................................................ 30

3.2.2 Primary Osteoarthritis ..................................................................................................... 30

3.2.3 Rotator Cuff Tear Arthropathy ......................................................................................... 31

3.2.4 Post-Traumatic Arthritis .................................................................................................. 33

3.2.5 Proximal Humerus Fracture ............................................................................................ 33

3.2.6 Avascular Necrosis ......................................................................................................... 35

3.2.7 Rheumatoid Arthritis ....................................................................................................... 36

3.3 Clinical Presentation ........................................................................................................... 37

3.3.1 Diagnosis ........................................................................................................................ 37

3.4 Clinical Outcomes ............................................................................................................... 38

3.4.1 Overview ........................................................................................................................ 38

3.4.2 Conservative Treatments ................................................................................................ 38



Table of Contents

3.4.3 Joint-Preserving Treatments ........................................................................................... 39

3.4.4 Joint Replacement .......................................................................................................... 41

3.5 Epidemiology ...................................................................................................................... 52

3.5.1 Shoulder Arthritis ............................................................................................................ 52

3.5.2 Proximal Humerus Fractures .......................................................................................... 54

3.6 Economic Impact ................................................................................................................ 55

3.6.1 Shoulder Arthritis ............................................................................................................ 55

3.6.2 Rotator Cuff Diseases ..................................................................................................... 57

3.6.3 Proximal Humerus Fractures .......................................................................................... 57

3.6.4 Cost-Effectiveness of Total Shoulder Replacement ........................................................ 58

3.6.5 Cost-Effectiveness of Reverse Total Shoulder Replacement .......................................... 58

4 Competitive Assessment ......................................................................................................... 59

4.1 Overview ............................................................................................................................. 59

4.2 Anatomic Total Shoulder Replacement ............................................................................... 63

4.2.1 Univers II (Arthrex) .......................................................................................................... 63

4.2.2 Comprehensive (Biomet) ................................................................................................ 65

4.2.3 Comprehensive Fracture (Biomet) .................................................................................. 67

4.2.4 Global Advantage (DePuy Synthes)................................................................................ 70

4.2.5 Global Fx (DePuy Synthes) ............................................................................................ 74

4.2.6 Global AP (DePuy Synthes) ............................................................................................ 76

4.2.7 Global Unite (DePuy Synthes) ........................................................................................ 79

4.2.8 Turon (DJO Surgical) ...................................................................................................... 81

4.2.9 Equinoxe (Exactech) ....................................................................................................... 84



Table of Contents

4.2.10 TITAN (Integra LifeSciences) .......................................................................................... 86

4.2.11 SMR (Lima Corporate) .................................................................................................... 88

4.2.12 Cofield 2 (Smith & Nephew) ............................................................................................ 91

4.2.13 Neer 3 (Smith & Nephew) ............................................................................................... 94

4.2.14 Promos Standard (Smith & Nephew) .............................................................................. 97

4.2.15 Solar (Stryker) ................................................................................................................ 99

4.2.16 ReUnion (Stryker) ......................................................................................................... 101

4.2.17 Aequalis Primary (Tornier) ............................................................................................ 103

4.2.18 Aequalis Fracture (Tornier) ........................................................................................... 106

4.2.19 Affiniti (Tornier) ............................................................................................................. 108

4.2.20 Aequalis Ascend (Tornier) ............................................................................................ 111

4.2.21 Bigliani/Flatow (Zimmer) ............................................................................................... 113

4.2.22 Anatomical (Zimmer) .................................................................................................... 116

4.2.23 Trabecular Metal (Zimmer) ........................................................................................... 118

4.3 Anatomic Stemless Total Shoulder Replacement .............................................................. 122

4.3.1 Eclipse (Arthrex) ........................................................................................................... 122

4.3.2 T.E.S.S. (Total Evolutive Shoulder System) Anatomic (Biomet) .................................... 124

4.3.3 Comprehensive Nano (Biomet) ..................................................................................... 127

4.3.4 Simpliciti (Tornier) ......................................................................................................... 129

4.3.5 InSpyre (Tornier)........................................................................................................... 132

4.3.6 Sidus (Zimmer) ............................................................................................................. 134

4.4 Reverse Total Shoulder Replacement ............................................................................... 137

4.4.1 Univers Revers (Arthrex) .............................................................................................. 137



Table of Contents

4.4.2 T.E.S.S. (Total Evolutive Shoulder System) Reverse (Biomet) ..................................... 139

4.4.3 Comprehensive Reverse (Biomet) ................................................................................ 142

4.4.4 Delta Xtend (DePuy Synthes) ....................................................................................... 144

4.4.5 Reverse Shoulder Prosthesis (RSP) (DJO Surgical) ..................................................... 147

4.4.6 Equinoxe Reverse (Exactech)....................................................................................... 150

4.4.7 SMR Reverse (Lima Corporate) .................................................................................... 153

4.4.8 Promos Reverse (Smith & Nephew) ............................................................................. 156

4.4.9 Aequalis Reversed II (Tornier) ...................................................................................... 158

4.4.10 Aequalis Reversed Fracture (Tornier) ........................................................................... 161

4.4.11 Ascend Flex (Tornier) ................................................................................................... 163

4.4.12 Anatomical Reverse (Zimmer) ...................................................................................... 165

4.4.13 Trabecular Metal Reverse (Zimmer) ............................................................................. 167

5 Unmet Needs ........................................................................................................................ 170

5.1 Durable Glenoid Components ........................................................................................... 170

5.2 Augmented Glenoid Components ..................................................................................... 173

5.3 Grammont-Style versus Frankle-Style ............................................................................... 174

5.4 Addressing Complications of Reverse Shoulder Replacement .......................................... 176

5.5 Bone-Sparing Stemless Designs: Pros and Cons ............................................................. 178

5.6 Revision Systems ............................................................................................................. 181

5.7 Long-Term Follow-Up ....................................................................................................... 182

5.8 Patient Awareness in Emerging Markets ........................................................................... 183

6 Pipeline Products .................................................................................................................. 184

6.1 Overview ........................................................................................................................... 184



Table of Contents

6.2 aSpire Total Shoulder Replacement System (Shoulder Options) ...................................... 185

6.2.1 Overview ...................................................................................................................... 185

6.2.2 SWOT Analysis ............................................................................................................ 186

6.3 Luna Stemless Humeral Prosthesis (Shoulder Options) .................................................... 187

6.3.1 Overview ...................................................................................................................... 187

6.3.2 SWOT Analysis ............................................................................................................ 189

6.4 AFT Proximal Humerus Fracture Prosthesis (Shoulder Options) ....................................... 190

6.4.1 Overview ...................................................................................................................... 190

6.4.2 SWOT Analysis ............................................................................................................ 191

6.5 Others ............................................................................................................................... 192

6.5.1 Stryker’s Reverse Shoulder Implant .............................................................................. 192

6.5.2 Tornier’s Patient-Specific Image-Driven Glenoid Replacement Device ......................... 192

6.5.3 Integra’s Reverse Shoulder Implant .............................................................................. 192

6.5.4 Integra’s PYROHEMI .................................................................................................... 192

7 Industry Overview.................................................................................................................. 193

7.1 Procedure Trends ........................................................................................................... 193

7.2 Market Access .................................................................................................................. 197

7.2.1 Regulation .................................................................................................................... 197

7.2.2 Adoption ....................................................................................................................... 198

7.2.3 Procurement ................................................................................................................. 199

7.3 Reimbursement Trends ..................................................................................................... 201

7.4 Regulatory Issues/Recalls ................................................................................................. 205

7.4.1 Lima Corporate’s SMR Anatomic Polyethylene Liner .................................................... 205



Table of Contents

7.5 Mergers & Acquisitions/Key Partnerships .......................................................................... 206

7.5.1 Integra LifeSciences Acquires Ascension Orthopedics ................................................. 206

8 Current and Future Players ................................................................................................... 207

8.1 Trends in Corporate Strategy ............................................................................................ 207

8.2 Company Profiles .............................................................................................................. 208

8.2.1 DePuy Synthes ............................................................................................................. 208

8.2.2 Tornier N.V. .................................................................................................................. 212

8.2.3 Biomet .......................................................................................................................... 216

8.2.4 Zimmer Holdings........................................................................................................... 220

8.2.5 Exactech ....................................................................................................................... 224

8.2.6 Smith & Nephew ........................................................................................................... 227

8.2.7 Stryker .......................................................................................................................... 230

8.2.8 DJO Global ................................................................................................................... 233

8.2.9 Arthrex .......................................................................................................................... 236

8.2.10 Integra LifeSciences ..................................................................................................... 238

8.2.11 Wright Medical Group ................................................................................................... 241

8.2.12 Lima Corporate S.p.a. ................................................................................................... 244

8.2.13 Other Companies.......................................................................................................... 246

9 Market Drivers & Opportunities .............................................................................................. 247

9.1 Market Drivers................................................................................................................... 247

9.1.1 Rising Prevalence of Shoulder Diseases ...................................................................... 247

9.1.2 Expanded Indications of Reverse Shoulder Replacement ............................................. 248

9.1.3 Increased Patient Awareness ....................................................................................... 249



Table of Contents

9.1.4 Availability of Long-Term Clinical Data .......................................................................... 250

9.1.5 Corporate Promotions and Medical Education .............................................................. 251

9.1.6 Expected Launch of New Devices in the US ................................................................. 251

9.2 Opportunities .................................................................................................................... 252

9.2.1 Pyrocarbon ................................................................................................................... 252

9.2.2 Revision Instrumentation .............................................................................................. 253

9.2.3 Demand for a Comprehensive Shoulder Reconstruction Portfolio ................................. 253

9.2.4 Computer-Assisted Navigation...................................................................................... 254

9.2.5 Procedure-Specific Patient Education Platform ............................................................. 255

9.2.6 Emerging Markets......................................................................................................... 255

9.3 Market Barriers ................................................................................................................. 256

9.3.1 Postoperative Complications ........................................................................................ 256

9.3.2 Steep Learning Curve ................................................................................................... 257

9.3.3 Cost .............................................................................................................................. 258

9.3.4 Reimbursement ............................................................................................................ 259

9.3.5 Medical Device Excise Tax ........................................................................................... 260

9.3.6 Substitutes .................................................................................................................... 260

10 Country Outlooks & Forecasts ............................................................................................... 262

11 Appendix ............................................................................................................................... 265

11.1 Abbreviations .................................................................................................................... 265

11.2 Bibliography ...................................................................................................................... 266

11.3 Report Methodology .......................................................................................................... 284

11.3.1 Overview ...................................................................................................................... 284



Table of Contents

11.3.2 Coverage ...................................................................................................................... 284

11.3.3 Secondary Research .................................................................................................... 285

11.3.4 Forecasting Methodology.............................................................................................. 285

11.3.5 Primary Research – Key Opinion Leader Interviews ..................................................... 287

11.3.6 Expert Panel Validation................................................................................................. 287

11.4 Physicians and Specialists Included in this Study ............................................................. 288

11.5 About the Authors ............................................................................................................. 291

11.5.1 Analysts ........................................................................................................................ 291

11.5.2 Bonnie Bain, Ph.D., Global Head of Healthcare ............................................................ 292

11.6 About MediPoint ................................................................................................................ 293

11.7 About GlobalData .............................................................................................................. 293

11.8 Disclaimer ......................................................................................................................... 293



Table of Contents

1.1 List of Tables

Table 1: Walch Classification of Glenoid Wear Associated with Primary Osteoarthritis ................................... 31

Table 2: Clinical Symptoms and Descriptions ................................................................................................. 37

Table 3: Major Indications and Contraindications for Humeral Head Resurfacing ........................................... 42

Table 4: Major Indications and Contraindications for Stemmed Partial Shoulder Replacement ....................... 45

Table 5: Major Indications and Contraindications for Anatomic Total Shoulder Replacement .......................... 48

Table 6: Major Indications and Contraindications for Anatomic Total Shoulder Replacement .......................... 51

Table 7: Shoulder Arthritis Prevalence in the US (2013–2019) ....................................................................... 52

Table 8: Proximal Humerus Fracture Prevalence in the US (2013–2019) ....................................................... 54

Table 9: Direct and Indirect Costs of Arthritis ................................................................................................. 56

Table 10: Currently Marketed Anatomic Total Shoulder Replacement Implants .............................................. 61

Table 11: Currently Marketed Anatomic Stemless Shoulder Replacement Implants ....................................... 62

Table 12: Currently Marketed Reverse Total Shoulder Replacement Implants ................................................ 62

Table 13: Product Profile – Univers II ............................................................................................................. 64

Table 14: SWOT Analysis – Univers II ........................................................................................................... 65

Table 15: Product Profile – Comprehensive ................................................................................................... 66

Table 16: SWOT Analysis – Comprehensive .................................................................................................. 67

Table 17: Product Profile – Comprehensive Fracture ..................................................................................... 68

Table 18: List of Clinical Studies – Comprehensive Fracture .......................................................................... 69

Table 19: SWOT Analysis – Comprehensive Fracture .................................................................................... 69

Table 20: Product Profile – Global Advantage ................................................................................................ 72

Table 21: List of Clinical Studies – Global Anchor Peg Glenoid ...................................................................... 73

Table 22: SWOT Analysis – Global Advantage .............................................................................................. 73

Table 23: Product Profile – Global Fx ............................................................................................................. 75



Table of Contents

Table 24: SWOT Analysis – Global Fx ........................................................................................................... 76

Table 25: Product Profile – Global AP ............................................................................................................ 77

Table 26: List of Clinical Studies – Global AP ................................................................................................. 78

Table 27: SWOT Analysis – Global AP .......................................................................................................... 78

Table 28: Product Profile – Global Unite ........................................................................................................ 80

Table 29: SWOT Analysis – Global Unite ....................................................................................................... 81

Table 30: Product Profile – Turon .................................................................................................................. 83

Table 31: SWOT Analysis – Turon ................................................................................................................. 83

Table 32: Product Profile – Equinoxe ............................................................................................................. 85

Table 33: SWOT Analysis – Equinoxe ........................................................................................................... 86

Table 34: Product Profile – TITAN ................................................................................................................. 87

Table 35: SWOT Analysis – TITAN ................................................................................................................ 88

Table 36: Product Profile – SMR .................................................................................................................... 89

Table 37: List of Clinical Studies – SMR......................................................................................................... 90

Table 38: SWOT Analysis – SMR .................................................................................................................. 90

Table 39: Product Profile – Cofield 2 .............................................................................................................. 92

Table 40: List of Clinical Studies – Cofield 2................................................................................................... 92

Table 41: SWOT Analysis – Cofield 2 ............................................................................................................ 93

Table 42: Product Profile – Neer 3 ................................................................................................................. 95

Table 43: SWOT Analysis – Neer 3................................................................................................................ 96

Table 44: Product Profile – Promos Standard ................................................................................................ 98

Table 45: List of Clinical Studies – Promos Standard ..................................................................................... 98

Table 46: SWOT Analysis – Promos Standard ............................................................................................... 99

Table 47: Product Profile – Solar ................................................................................................................. 100



Table of Contents

Table 48: SWOT Analysis – Solar ................................................................................................................ 101

Table 49: Product Profile – ReUnion ............................................................................................................ 102

Table 50: SWOT Analysis – ReUnion .......................................................................................................... 102

Table 51: Product Profile – Aequalis Primary ............................................................................................... 104

Table 52: List of Clinical Studies – Aequalis Primary .................................................................................... 105

Table 53: SWOT Analysis – Aequalis Primary .............................................................................................. 105

Table 54: Product Profile – Aequalis Fracture .............................................................................................. 107

Table 55: List of Clinical Studies – Aequalis Fracture ................................................................................... 107

Table 56: SWOT Analysis – Aequalis Fracture ............................................................................................. 108

Table 57: Product Profile – Affiniti ................................................................................................................ 110

Table 58: List of Clinical Studies – Affiniti ..................................................................................................... 110

Table 59: SWOT Analysis – Affiniti .............................................................................................................. 111

Table 60: Product Profile – Aequalis Ascend ................................................................................................ 112

Table 61: SWOT Analysis – Aequalis Ascend .............................................................................................. 113

Table 62: Product Profile – Bigliani/Flatow ................................................................................................... 114

Table 63: List of Clinical Studies – Bigliani/Flatow ........................................................................................ 115

Table 64: SWOT Analysis – Bigliani/Flatow.................................................................................................. 115

Table 65: Product Profile – Anatomical ........................................................................................................ 117

Table 66: SWOT Analysis – Anatomical ....................................................................................................... 118

Table 67: Product Profile – Trabecular Metal ............................................................................................... 120

Table 68: List of Clinical Studies – Trabecular Metal .................................................................................... 120

Table 69: SWOT Analysis – Trabecular Metal .............................................................................................. 121

Table 70: Product Profile – Eclipse .............................................................................................................. 123

Table 71: List of Clinical Studies – Eclipse ................................................................................................... 123



Table of Contents

Table 72: SWOT Analysis – Eclipse ............................................................................................................. 124

Table 73: Product Profile – T.E.S.S. Anatomic ............................................................................................. 125

Table 74: List of Clinical Studies – T.E.S.S. Anatomic .................................................................................. 126

Table 75: SWOT Analysis – T.E.S.S. Anatomic............................................................................................ 127

Table 76: Product Profile – Comprehensive Nano ........................................................................................ 128

Table 77: SWOT Analysis – Compressive Nano .......................................................................................... 129

Table 78: Product Profile – Simpliciti ............................................................................................................ 130

Table 79: List of Clinical Studies – Simpliciti ................................................................................................. 131

Table 80: SWOT Analysis – Simpliciti .......................................................................................................... 131

Table 81: Product Profile – InSpyre.............................................................................................................. 133

Table 82: SWOT Analysis – InSpyre ............................................................................................................ 133

Table 83: Product Profile – Sidus ................................................................................................................. 135

Table 84: List of Clinical Studies – Sidus ...................................................................................................... 135

Table 85: SWOT Analysis – Sidus ............................................................................................................... 136

Table 86: Product Profile – Univers Revers .................................................................................................. 138

Table 87: List of Clinical Studies – Univers Revers....................................................................................... 138

Table 88: SWOT Analysis – Univers Reverse .............................................................................................. 139

Table 89: Product Profile – T.E.S.S. Reverse ............................................................................................... 140

Table 90: List of Clinical Studies – T.E.S.S. Reverse ................................................................................... 141

Table 91: SWOT Analysis – T.E.S.S. Reverse ............................................................................................. 141

Table 92: Product Profile – Comprehensive Reverse ................................................................................... 143

Table 93: SWOT Analysis – Comprehensive Reverse .................................................................................. 144

Table 94: Product Profile – Delta Xtend ....................................................................................................... 145

Table 95: List of Clinical Studies – Delta Xtend ............................................................................................ 146



Table of Contents

Table 96: SWOT Analysis – Delta Xtend ...................................................................................................... 146

Table 97: Product Profile – Reverse Shoulder Prosthesis (RSP) .................................................................. 148

Table 98: List of Clinical Studies – Reverse Shoulder Prosthesis (RSP) ....................................................... 149

Table 99: SWOT Analysis – Reverse Shoulder Prosthesis (RSP)................................................................. 150

Table 100: Product Profile – Equinoxe Reverse ........................................................................................... 151

Table 101: List of Clinical Studies – Equinoxe Reverse ................................................................................ 152

Table 102: SWOT Analysis – Equinoxe Reverse .......................................................................................... 152

Table 103: Product Profile – SMR Reverse .................................................................................................. 154

Table 104: List of Clinical Studies – SMR Reverse ....................................................................................... 155

Table 105: SWOT Analysis – SMR Reverse ................................................................................................ 155

Table 106: Product Profile – Promos Reverse .............................................................................................. 157

Table 107: List of Clinical Studies – Promos Reverse .................................................................................. 157

Table 108: SWOT Analysis – Promos Reverse ............................................................................................ 158

Table 109: Product Profile – Aequalis Reversed II........................................................................................ 159

Table 110: List of Clinical Studies – Aequalis Reversed II ............................................................................ 160

Table 111: SWOT Analysis – Aequalis Reversed II ...................................................................................... 160

Table 112: Product Profile – Aequalis Reversed Fracture............................................................................. 162

Table 113: List of Clinical Studies – Aequalis Reversed Fracture ................................................................. 162

Table 114: SWOT Analysis – Aequalis Reversed Fracture ........................................................................... 163

Table 115: Product Profile – Ascend Flex .................................................................................................... 164

Table 116: SWOT Analysis – Ascend Flex ................................................................................................... 165

Table 117: Product Profile – Anatomical Reverse ........................................................................................ 166

Table 118: SWOT Analysis – Anatomical Reverse ...................................................................................... 167

Table 119: Product Profile – Trabecular Metal Reverse ................................................................................ 168



Table of Contents

Table 120: List of Clinical Studies – Trabecular Metal Reverse .................................................................... 169

Table 121: SWOT Analysis – Trabecular Metal Reverse .............................................................................. 169

Table 122: Currently Marketed Grammont-Style and Frankle-Style Reverse Shoulder Implants .................. 175

Table 123: Major Pipeline Products in Total Shoulder Replacement Market, 2013 ........................................ 184

Table 124: Product Profile – aSpire.............................................................................................................. 185

Table 125: SWOT Analysis – aSpire ............................................................................................................ 186

Table 126: Product Profile – Luna ............................................................................................................... 188

Table 127: SWOT Analysis – Luna .............................................................................................................. 189

Table 128: Product Profile – AFT ................................................................................................................. 190

Table 129: SWOT Analysis – AFT ............................................................................................................... 191

Table 130: Medicare Coding Guide for Shoulder Arthroplasty – 2013 ........................................................... 201

Table 131: 2013 Medicare National Payment Average for Shoulder Arthroplasty .......................................... 203

Table 132: Company Profile – DePuy Synthes ............................................................................................ 208

Table 133: DePuy Synthes’ Shoulder Portfolio Assessment, 2013 ............................................................... 210

Table 134: DePuy Synthes’ SWOT Analysis, 2013....................................................................................... 211

Table 135: Company Profile – Tornier N.V. .................................................................................................. 212

Table 136: Tornier’s Shoulder Portfolio Assessment, 2013 ........................................................................... 214

Table 137: Tornier's SWOT Analysis, 2013 .................................................................................................. 215

Table 138: Company Profile – Biomet .......................................................................................................... 216

Table 139: Biomet’s Shoulder Portfolio Assessment, 2013 ........................................................................... 218

Table 140: Biomet’s SWOT Analysis, 2013 .................................................................................................. 219

Table 141: Company Profile – Zimmer Holdings .......................................................................................... 221

Table 142: Zimmer Holdings’ Shoulder Portfolio Assessment, 2013 ............................................................. 222

Table 143: Zimmer Holdings’ SWOT Analysis, 2013 .................................................................................... 223



Table of Contents

Table 144: Company Profile – Exactech ...................................................................................................... 224

Table 145: Exactech’s Shoulder Portfolio Assessment, 2013 ...................................................................... 225

Table 146: Exactech's SWOT Analysis, 2013............................................................................................... 226

Table 147: Company Profile – Smith & Nephew ........................................................................................... 228

Table 148: Smith & Nephew’s Shoulder Portfolio Assessment, 2013 ............................................................ 229

Table 149: Smith & Nephew’s SWOT Analysis, 2013 ................................................................................... 229

Table 150: Company Profile – Stryker .......................................................................................................... 230

Table 151: Stryker’s Shoulder Portfolio Assessment, 2013 ........................................................................... 231

Table 152: Stryker's SWOT Analysis, 2013 .................................................................................................. 232

Table 153: Company Profile – DJO Global ................................................................................................... 233

Table 154: DJO Global’s Shoulder Portfolio Assessment, 2013 .................................................................... 234

Table 155: DJO Global's SWOT Analysis, 2013 ........................................................................................... 235

Table 156: Company Profile – Arthrex ......................................................................................................... 236

Table 157: Arthrex’s Shoulder Portfolio Assessment, 2013 .......................................................................... 237

Table 158: Arthrex's SWOT Analysis, 2013 .................................................................................................. 237

Table 159: Company Profile – Integra LifeSciences ..................................................................................... 238

Table 160: Integra LifeSciences’ Shoulder Portfolio Assessment, 2013 ........................................................ 239

Table 161: Integra LifeSciences' SWOT Analysis, 2013 ............................................................................... 240

Table 162: Company Profile – Wright Medical Group ................................................................................... 242

Table 163: Wright Medical Group’s Shoulder Portfolio Assessment, 2013 .................................................... 242

Table 164: Wright Medical Group's SWOT Analysis, 2013 ........................................................................... 243

Table 165: Company Profile – Lima Corporate S.p.a. ................................................................................... 244

Table 166: Lima Corporate S.p.a.’s Shoulder Portfolio Assessment, 2013 .................................................... 245

Table 167: Lima Corporate S.p.a.'s SWOT Analysis, 2013 ........................................................................... 245



Table of Contents

Table 168: Other Companies in the Global Shoulder Replacement Market, 2013 ......................................... 246

Table 169: Sales Forecasts for TSR in the US (2012–2019) ........................................................................ 262

1.2 List of Figures

Figure 1: Schematic Diagram of Shoulder Anatomy ....................................................................................... 28

Figure 2: Schematic Diagram of Rotator Cuff ................................................................................................. 29

Figure 3: Wide Spectrum of Disease Seen in Rotator Cuff Tear Arthropathy .................................................. 32

Figure 4: Neer Classification of Proximal Humerus Fractures ......................................................................... 34

Figure 5: Four-Part and Three-Part Proximal Humerus Fractures ................................................................... 35

Figure 6: An Example of Humeral Head Resurfacing ..................................................................................... 42

Figure 7: An Example of Stemmed Partial Shoulder Replacement ................................................................. 45

Figure 8: An Example of Anatomic Total Shoulder Replacement .................................................................... 48

Figure 9: An Example of Reverse Total Shoulder Replacement ..................................................................... 49

Figure 10: Shoulder Arthritis Prevalence in the US ......................................................................................... 53

Figure 11: Proximal Humerus Fracture Prevalence in the US ......................................................................... 54

Figure 12: Product Image – Univers II ............................................................................................................ 63

Figure 13: Product Image – Univers Glenoid Components ............................................................................. 64

Figure 14: Product Image – Comprehensive .................................................................................................. 66

Figure 15: Product Image – Comprehensive Fracture .................................................................................... 68

Figure 16: Product Image – Global Advantage ............................................................................................... 71

Figure 17: Product Image – Global Steptech Anchor Peg Glenoid .................................................................. 71

Figure 18: Product Image – Global Fx ............................................................................................................ 74

Figure 19: Product Image – Global AP ........................................................................................................... 77

Figure 20: Product Image – Global Unite ....................................................................................................... 79



Table of Contents

Figure 21: Product Image – Turon ................................................................................................................. 82

Figure 22: Product Image – Equinoxe Primary ............................................................................................... 84

Figure 23: Product Image – Equinoxe Fracture .............................................................................................. 85

Figure 24: Product Image – TITAN ................................................................................................................ 87

Figure 25: Product Image – SMR (Anatomic and Fracture) ............................................................................ 89

Figure 26: Product Image – Cofield 2 ............................................................................................................. 91

Figure 27: Product Image – Neer 3 ................................................................................................................ 95

Figure 28: Product Image – Promos Standard ............................................................................................... 97

Figure 29: Product Image – Solar ................................................................................................................ 100

Figure 30: Product Image – ReUnion ........................................................................................................... 101

Figure 31: Product Image – Aequalis Primary .............................................................................................. 103

Figure 32: Product Image – Aequalis Fracture ............................................................................................. 106

Figure 33: Product Image – Affiniti ............................................................................................................... 109

Figure 34: Product Image – Cortiloc Glenoid ................................................................................................ 109

Figure 35: Product Image – Aequalis Ascend ............................................................................................... 112

Figure 36: Product Image – Bigliani/Flatow .................................................................................................. 114

Figure 37: Product Image – Anatomical Primary .......................................................................................... 116

Figure 38: Product Image – Anatomical Fracture ......................................................................................... 117

Figure 39: Product Image – Trabecular Metal .............................................................................................. 119

Figure 40: Product Image – Eclipse ............................................................................................................. 122

Figure 41: Product Image – T.E.S.S. Anatomic ............................................................................................ 125

Figure 42: Product Image – Comprehensive Nano ....................................................................................... 128

Figure 43: Product Image – Simpliciti ........................................................................................................... 130

Figure 44: Product Image – InSpyre............................................................................................................. 132



Table of Contents

Figure 45: Product Image – Sidus ................................................................................................................ 134

Figure 46: Product Image – Univers Revers ................................................................................................. 137

Figure 47: Product Image – T.E.S.S. Reverse .............................................................................................. 139

Figure 48: Product Image – Comprehensive Reverse .................................................................................. 143

Figure 49: Product Image – Delta Xtend ...................................................................................................... 145

Figure 50: Product Image – Reverse Shoulder Prosthesis (RSP) ................................................................. 147

Figure 51: Product Image – RSP Monoblock ................................................................................................ 148

Figure 52: Product Image – Equinoxe Reverse ............................................................................................ 151

Figure 53: Product Image – SMR Reverse and SMR Reverse HP ................................................................ 153

Figure 54: Product Image – Promos Reverse ............................................................................................... 156

Figure 55: Product Image – Aequalis Reversed II ........................................................................................ 159

Figure 56: Product Image – Aequalis Reversed Fracture ............................................................................. 161

Figure 57: Product Image – Ascend Flex ..................................................................................................... 164

Figure 58: Product Image – Anatomical Reverse ......................................................................................... 166

Figure 59: Product Image – Trabecular Metal Reverse................................................................................. 168

Figure 60: Product Image – aSpire .............................................................................................................. 185

Figure 61: Product Image – Luna ................................................................................................................. 187

Figure 62: Product Image – Luna Anchored ................................................................................................. 188

Figure 63: Product Image – AFT .................................................................................................................. 190

Figure 64: Shoulder Replacement Procedure Volume in the US (1993–2008) .............................................. 193

Figure 65: Shoulder Replacement Procedure Volume in the US (2010–2019) .............................................. 194

Figure 66: Anatomic and Reverse Total Shoulder Replacement Procedure Volumes in the US “ (2010–2019) ............................................................................................................................... 196

Figure 67: Adoption Trend of Shoulder Replacement in the US, 2013 and 2019 ........................................... 198



Table of Contents

Figure 68: Changes in Implant Cost, Surgeon and Hospital Reimbursement for Total Shoulder Replacement (2008–2013) ......................................................................................................... 202

Figure 69: Sales Forecasts for TSR Market in the US (2010–2019) .............................................................. 263

Figure 70: US TSR Market Competitive Landscape, 2013 ............................................................................ 264

Total Shoulder Replacement - US Analysis and Market Forecasts 26

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


Introduction

2 Introduction

Shoulder replacement surgery was first performed in the United States in the 1950s to treat severe

shoulder fractures. Over the years, shoulder replacement has come to be used for many other

painful conditions of the shoulder, such as different forms of arthritis. Compared with the more

mature reconstruction markets, such as hip and knee replacements, shoulder reconstruction is

developing as a specialty. Current market growth in shoulder reconstruction is mainly driven by

total shoulder replacement, which comprises anatomic total, anatomic stemless total and reverse

total shoulder replacements.

The anatomic total shoulder replacement market has seen an influx of modular systems over the

past decade. The introduction of the modularity gives surgeons the opportunity to closely

reconstruct the anatomy of the proximal humerus, and thus improve an implant’s survival rate.

Reverse total shoulder replacement is receiving a great deal of attention in the US since it is the

“newest” shoulder implant, despite the fact that it has been implanted in Europe for more than 20

years. Although the FDA recommends reverse shoulder arthroplasty to be performed in patients 70

years or older, the success of the procedure has led some surgeons to expand their indications,

particularly in younger, more active patients. In addition to the wave of enthusiasm towards reverse

shoulder replacement, orthopedic surgeons have also indicated a budding market for stemless

shoulder prostheses. Initially introduced in Europe in the mid-2000s, the stemless design offers a

new solution for the shoulder replacement continuum of care, bridging the gap between traditional

resurfacing and stemmed shoulder implants by eliminating violation of the humeral canal.

Total Shoulder Replacement - US Analysis and Market Forecasts 27

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


Introduction

2.1 Catalyst

Although sluggish economic growth has hindered the large-joint replacement market in the United

States, the total shoulder replacement market has seen a promising growth rate in the past few

years. This healthy growth can be attributed to an increasing patient population, an improved

surgeon adoption of reverse shoulder implants, as well as evolving insurance and reimbursement

landscape. This report focuses on TSR market in the US. GlobalData evaluated currently marketed

TSR prostheses, identified the unmet needs in the market, and provided an understanding of

surgeon perception of the latest advances within the shoulder community. With manufacturers’

continuous innovation in implant development and fueling interest in reverse shoulder in the

orthopedic community, the market revenue of total shoulder replacement is expected to experience

further increase across the globe. To successfully capitalize within the TSR space, companies

need to provide deliverables adopting better design philosophies that address the current unmet

needs, and to put more energy into clinical education to drive surgeon adoption.



Appendix

11.6 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 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. The MediPoint series also features Excel-based forecast models that

are robust, fully transparent, and easy to navigate. Moreover, our models support data presented in

the reports and the complete methodology is outlined in the report and the model.

11.7 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.

11.8 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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