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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.
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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.
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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.”
Key Opinion Leader, April 2013
“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.”
Key Opinion Leader, April 2013
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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.”
Key Opinion Leader, April 2013
“‘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.”
Key Opinion Leader, April 2013
“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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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].”
Key Opinion Leader, April 2013
“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.”
Key Opinion Leader, April 2013
“The number of shoulder replacements done is not
reflective of the actual potential cases available,
because of high cost and low patient awareness.”
Key Opinion Leader, April 2013
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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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
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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
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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
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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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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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
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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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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.
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TOTAL SHOULDER REPLACEMENT - US ANALYSIS AND MARKET FORECASTS
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.