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MediPoint: Bone Grafts and Substitutes - Global Analysis and Market Forecasts

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MediPoint: Bone Grafts and Substitutes - Global Analysis and Market Forecasts
http://www.reportlinker.com/p02013605/MediPoint-Bone-Grafts-and-Substitutes---Global-Analysis-and-Market-Forecasts.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Orthopedic

MediPoint: Bone Grafts and Substitutes - Global Analysis and Market Forecasts

Summary

Although autograft is still perceived as the gold-standard material in bone grafting, the wide array of alternatives available in the market has resulted in a gradual shift towards increased adoption of bone grafts and substitutes (BGS), especially in the US and European markets. In contrast to the general picture in developed countries, autograft bone still represents the most popular option during bone grafting in the Asia-Pacific (APAC) region and South America.

The market for BGS is characterized by rapid technological change, frequent new introductions, changes in customers' demands and evolving industry standards. An example is the industry's recent re-evaluation of the expanding utilization of BMPs. Moving forward, the shift to lower-dosed BMPs is expected to be accompanied with continued rise in the sales volume of synthetic bone substitutes in all markets, and increased adoption of cell-based matrices in the US market. Since BGS companies have uncovered new ways of using their technologies to find synergies with spine hardware products, and orthopedic implants to deliver better therapeutic outcomes, future access in the market will hinge on suppliers positioning their products as part of a broader therapy system for bone repair that includes multiple offerings. Meanwhile, companies will need to understand two basic driving forces in the global BGS arena – surgeons who continuously seek improved patient outcomes and healthcare systems who become increasingly concerned about the economics.

Highlights

Key Questions Answered

- Given the negative media literature surrounding Medtronic's INFUSE Bone Graft, surgeons now hold varied opinions regarding the BMP products. (Q).What are surgeons' attitudes about the cost-effectiveness of BMP/growth factor products? (Q).How will the overall BGS market evolve following the continuing revenue decline in the BMP/growth factor segment?
- As health executives are scrutinizing purchases and using multiple channels to procure biologics at highly competitive prices, surgeon's preference is no longer considered the top priority in many hospitals' decision-making process. (Q).How are governments' cost-containment measures affecting the utilization of different types of BGS products?
- Currently, in the BGS market, the lack of reliable studies to demonstrate products' efficacy in human clinical settings has led to many surgeons reluctant to adopt newly-launched biological products. (Q).What are the current adoption levels of different types of BGS products?
- Cell-based matrices have received increased enthusiasm in the US market. Yet ongoing scrutiny of the segment may have a negative impact on future growth of this segment. (Q).Will the cell-based matrices segment benefit from declining utilization of BMP/growth factor products? (Q).How are companies strategically responding to this attractive segment?
- In the years to come, launching and marketing a comprehensive orthobiologics portfolio with a clear value proposition will remain critical to companies' success. (Q).Will the BGS market maintain growth amid regulatory setbacks and austerity measures? (Q).Which materials are more favorably positioned for increasing adoption?

Reasons to buy

- "What Do Physicians Think" quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.
1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 13
1.2 List of Figures 17
2 Introduction 20
2.1 Catalyst 21
2.2 Related Reports 21
3 Clinical Outcomes 23
3.1 Overview 23
3.2 Autograft Bone 24
3.3 Allograft Bone 25
3.4 Bone Graft Substitutes 27
3.4.1 BMPs/Growth Factors 27
3.4.2 DBMs 29
3.4.3 Synthetic Bone Substitutes 30
3.4.4 Cell-Based Matrices 32
4 Industry Overview 33
4.1 Procedural Trends 33
4.1.1 Overview 33
4.1.2 US 34

4.1.3 5EU 40
4.1.4 Asia-Pacific 45
4.1.5 South America 48
4.2 Market Access 52
4.2.1 US 52
4.2.2 5EU 58
4.2.3 Asia-Pacific 61
4.2.4 South America 65
4.3 Regulatory Issues/Recalls 68
4.3.1 FDA Convened a Dispute Resolution Panel to Discuss Wright Medical's Augment Bone Graft (October 2013) 68
4.3.2 FDA Issued a Warning Letter over Globus Medical's MicroFuse Bone Growth Putty (September 2013) 68
4.3.3 Medtronic and the Australia Therapeutic Goods Administration Recalled Unused Lots of INFUSE LT-Cage Bone Graft Kits (June 2013) 69
4.3.4 Alphatec Spine Voluntarily Stopped Shipping PureGen (February 2013) 69
4.3.5 FDA Rejected Approval of Medtronic's AMPLIFY rhBMP-2 Matrix (March 2011) 69
4.4 Mergers & Acquisitions/Key Partnerships 70
4.4.1 Bacterin Developed Strategic Alliance with DMP Spine Biologics (November 2013) 70
4.4.2 RTI Surgical Entered into a New Distribution Deal with Medtronic Sofamor Danek (October 2013) 70
4.4.3 RTI Biologics Completed Acquisition of Pioneer Surgical Technology (July 2013) 71
4.4.4 Amedica Commenced Distribution of Dynamic Surgical's Dynamic Bone Expandable Allograft (April 2012) 71
4.5 Economic Impacts 71
4.6 Market Drivers 72
4.6.1 Disadvantages of Autografts 72
4.6.2 Continued Increase in the Procedure Volumes of Spinal and Orthopedic Surgeries 73
4.6.3 New Generation of Biological or Synthetic Materials 73
4.6.4 Cross-Selling 74
4.6.5 Improved Patient Awareness 75
4.7 Market Opportunities 76
4.7.1 Stem Cell Therapies 76
4.7.2 Foot and Ankle Market 77

4.7.3 Comprehensive Orthobiologics Platform 78
4.7.4 Antibiotics-Eluting Bone Graft Substitutes 79
4.7.5 Emerging Countries 80
4.8 Market Barriers 81
4.8.1 Variations in Regulations 81
4.8.2 Lingering Questions on rhBMP-2 to Generate Negative Spillover Effects 82
4.8.3 Negative Publicity Concerning Screening and Processing Methods of Allograft 83
4.8.4 Reimbursement and Pricing Pressure 83
4.8.5 Proving Clinical Efficacy 84
4.8.6 Medical Device Excise Tax 85
4.8.7 Substitutes 86
5 Competitive Assessment 88
5.1 Overview 88
5.2 Marketed Products 88
5.2.1 Advanced Biologics 88
5.2.2 AlloSource 89
5.2.3 Bacterin 91
5.2.4 Baxter 93
5.2.5 Biomet 94
5.2.6 DePuy Synthes 97

5.2.7 Exactech 99
5.2.8 Integra LifeSciences 101
5.2.9 Medtronic 103
5.2.10 Musculoskeletal Transplant Foundation (MTF) 106
5.2.11 NuVasive 107
5.2.12 Olympus Biotech 109
5.2.13 Orthofix 111
5.2.14 RTI Surgical 113
5.2.15 Stryker 116
5.2.16 Wright Medical 118
5.2.17 Zimmer 120
6 Unmet Needs 122
6.1 Clinical Data Transparency 122
6.2 Lack of Human Clinical Studies 123
6.3 Optimization of rhBMPs' Dosage and Carrier 125
6.4 Standardization of DBM Products' DBM Concentration across the Bone Banking Industry 126
6.5 Need for Products with Improved Osteoinductivity 127
6.6 Continued Research on Cell-Based Matrices 128
6.7 Need for Improved Medical Education on Bone Substitutes Products 129
6.8 Need for Cost Containment 131
7 Pipeline Products 132
7.1 Overview 132
7.2 Advanced Biologics' OsteoMEM 132
7.3 Aursos' Synthetic Bone Substitute 133
7.4 BioSET's AMPLEX 133

7.5 CeraPedics' i-FACTOR 133
7.6 NuVasive's AttraX 133
7.7 Osiris Therapeutics' OvationOS 134
7.8 Wright Medical' Augment Bone Graft 134
8 Clinical Trials to Watch 135
8.1 Yale's Review of Medtronic's INFUSE Bone Graft 135
8.2 Wright Medical's Augment Bone Graft 136
8.3 Orthofix's Trinity Evolution 137
8.4 AlloSource's AlloStem 138
8.5 NuVasive's AttraX 138
8.6 CeraPedics' i-FACTOR 139
8.7 BioSET's AMPLEX 139
9 Current and Future Players 141
9.1 Trends in Corporate Strategy 141
9.2 Company Profiles 142
9.2.1 Alphatec Spine 142
9.2.2 AlloSource 144
9.2.3 Bacterin 146
9.2.4 Biomet 148
9.2.5 DePuy Synthes 150
9.2.6 Exactech 152
9.2.7 Globus Medical 153
9.2.8 Integra LifeSciences 155
9.2.9 Medtronic 157
9.2.10 NuVasive 160
9.2.11 Olympus Biotech 162
9.2.12 Orthofix 163
9.2.13 RTI Surgical 165
9.2.14 Stryker 167
9.2.15 Wright Medical 169
9.2.16 Zimmer Holdings 171
9.3 Other Players 174

10 Market Outlooks 177
10.1 Market Share Analysis 177
10.1.1 Global 177
10.1.2 US 178
10.1.3 5EU 181
10.2 By Geography 183
10.2.1 Overview 183
10.2.2 US 187
10.2.3 France 190
10.2.4 Germany 193
10.2.5 Italy 195
10.2.6 Spain 197
10.2.7 UK 199
10.2.8 Japan 201
10.2.9 Brazil 203
10.2.10 China 205
10.2.11 India 207
11 Appendix 210
11.1 Abbreviations 210
11.2 Bibliography 213

11.3 Report Methodology 222
11.3.1 Overview 222
11.3.2 Coverage 222
11.3.3 Secondary Research 222
11.3.4 Forecasting Methodology 223
11.3.5 Primary Research - Key Opinion Leader Interviews 224
11.3.6 Expert Panel Validation 225
11.4 Physicians and Specialists Included in this Study 226
11.5 About the Authors 229
11.5.1 Analysts 229
11.5.2 Bonnie Bain, Ph.D., Global Head of Healthcare 230
11.6 About MediPoint 231
11.7 About GlobalData 231
11.8 Disclaimer 231

1.1 List of Tables

Table 1: Definition of Bone Growth Mechanisms 23
Table 2: Advantages and Disadvantages of Autografts 25
Table 3: Advantages and Disadvantages of Allografts 26
Table 4: Differences Between INFUSE Bone Graft and OP-1 Products 28
Table 5: Advantages and Disadvantages of BMPs 28
Table 6: Advantages and Disadvantages of DBMs 29
Table 7: Major Types of Synthetic Bone Substitutes 30
Table 8: Advantages and Disadvantages of Synthetic Bone Substitutes 32
Table 9: Advantages and Disadvantages of Cell-Based Matrices 32
Table 10: Usage of BGS by Procedure Type in the US, 2013 35
Table 11: Usage of BGS by Procedure Type in 5EU, 2013 40
Table 12: Usage of BGS by Procedure Type in APAC, 2013 45
Table 13: Usage of BGS by Procedure Type in South America, 2013 48
Table 14: Medicare National Average Reimbursement Rates for Major Orthopedic Procedures that Involve the Usage of BGS, 2013-2014 57
Table 15: Currently Marketed Cell-Based Matrices in the US Market 76
Table 16: Differences between the US and EU Regulations for BGS 81
Table 17: Types of Autologous Grafting Commonly Used to Treat Non-Union 86
Table 18: Advanced Biologics' BGS Products 89

Table 19: SWOT Analysis - Advanced Biologics' BGS Portfolio 89
Table 20: AlloSource's BGS Products 90
Table 21: SWOT Analysis - AlloSource's BGS Portfolio 91
Table 22: Bacterin's BGS Products 92
Table 23: SWOT Analysis - Bacterin's BGS Portfolio 93
Table 24: Baxter's BGS Products 94
Table 25: SWOT Analysis - Baxter's BGS Portfolio 94
Table 26: Biomet's BGS Products 95
Table 27: SWOT Analysis - Biomet's BGS Portfolio 96
Table 28: DePuy Synthes' BGS Products 98
Table 29: SWOT Analysis - DePuy Synthes' BGS Portfolio 99
Table 30: Exactech's BGS Products 100
Table 31: SWOT Analysis - Exactech's BGS Portfolio 101
Table 32: Integra LifeSciences' BGS Products 102
Table 33: SWOT Analysis - Integra LifeSciences' BGS Portfolio 103
Table 34: Medtronic's BGS Products 105
Table 35: SWOT Analysis - Medtronic's BGS Portfolio 106
Table 36: MTF's BGS Products 106
Table 37: SWOT Analysis - MTF's BGS Portfolio 107
Table 38: NuVasive's BGS Products 108
Table 39: SWOT Analysis - NuVasive's BGS Portfolio 108
Table 40: Olympus Biotech's BGS Products 110
Table 41: SWOT Analysis - Olympus Biotech's BGS Portfolio 110
Table 42: Orthofix's BGS Products 112
Table 43: SWOT Analysis - Orthofix's BGS Portfolio 112
Table 44: RTI Surgical's BGS Products 114
Table 45: SWOT Analysis - RTI Surgical's BGS Portfolio 116

Table 46: Stryker's BGS Products 117
Table 47: SWOT Analysis - Stryker's BGS Portfolio 118
Table 48: Wright Medical's BGS Products 119
Table 49: SWOT Analysis - Wright Medical's BGS Portfolio 120
Table 50: Zimmer's BGS Products 121
Table 51: SWOT Analysis - Zimmer's BGS Portfolio 121
Table 52: Compelling Questions Regarding the Cell-Based Matrices 129
Table 53: Pipeline Products in the Global BGS Market 132
Table 54: Major Clinical Findings of the YODA Project 135
Table 55: Major Clinical Studies of Augment Bone Graft 136
Table 56: Major Clinical Studies of Trinity Evolution 137
Table 57: Major Clinical Study of AlloStem 138
Table 58: Major Clinical Study of AttraX 138
Table 59: Major Clinical Study of i-FACTOR 139
Table 60: Major Clinical Studies of AMPLEX 140
Table 61: Company Profile - Alphatec Spine 142
Table 62: SWOT Analysis - Alphatec Spine 143
Table 63: Company Profile - AlloSource 144
Table 64: SWOT Analysis - AlloSource 145
Table 65: Company Profile - Bacterin 146
Table 66: SWOT Analysis - Bacterin 147
Table 67: Company Profile - Biomet 148
Table 68: SWOT Analysis - Biomet 149

Table 69: Company Profile - DePuy Synthes 150
Table 70: SWOT Analysis - DePuy Synthes 151
Table 71: Company Profile - Exactech 152
Table 72: SWOT Analysis - Exactech 153
Table 73: Company Profile - Globus Medical 154
Table 74: SWOT Analysis - Globus Medical 155
Table 75: Company Profile - Integra LifeSciences 156
Table 76: SWOT Analysis - Integra LifeSciences 157
Table 77: Company Profile - Medtronic 158
Table 78: SWOT Analysis - Medtronic 159
Table 79: Company Profile - NuVasive 160
Table 80: SWOT Analysis - NuVasive 161
Table 81: Company Profile - Olympus Biotech 162
Table 82: SWOT Analysis - Olympus Biotech 163
Table 83: Company Profile - Orthofix 164

Table 84: SWOT Analysis - Orthofix 165
Table 85: Company Profile - RTI Surgical 166
Table 86: SWOT Analysis - RTI Surgical 166
Table 87: Company Profile - Stryker 167
Table 88:SWOT Analysis - Stryker 168
Table 89: Company Profile - Wright Medical 170
Table 90: SWOT Analysis - Wright Medical 171
Table 91: Company Profile - Zimmer Holdings 172
Table 92: SWOT Analysis - Zimmer Holdings 173
Table 93: Other Players in the Global BGS Market 174
Table 94: Global BGS Market Sales Forecast ($m), 2011-2020 184
Table 95: US BGS Market Sales Forecast ($m), 2011-2020 189
Table 96: France BGS Market Sales Forecast ($m), 2011-2020 191
Table 97: Germany BGS Market Sales Forecast ($m), 2011-2020 193
Table 98: Italy BGS Market Sales Forecast ($m), 2011-2020 195
Table 99: Spain BGS Market Sales Forecast ($m), 2011-2020 197
Table 100: UK BGS Market Sales Forecast ($m), 2011-2020 199
Table 101: Japan BGS Market Sales Forecast ($m), 2011-2020 202
Table 102: Brazil BGS Market Sales Forecast ($m), 2011-2020 204
Table 103: China BGS Market Sales Forecast ($m), 2011-2020 206
Table 104: India BGS Market Sales Forecast ($m), 2011-2020 208

1.2 List of Figures
Figure 1: An Overview of BGS Used in Orthopedic Surgeries 24
Figure 2: Usage of Autograft, Allograft, and Bone Graft Substitutes, by Country, 2013 34
Figure 3: Bone Grafting Procedure Volumes in the US, 2011-2020 36
Figure 4: Traditional Allograft Bone Sales Volume in the US, 2011-2020 37
Figure 5: Machined Allograft Bone Sales Volume in the US, 2011-2020 38
Figure 6: Bone Grafts Substitutes Sales Volumes in the US, 2011-2020 39
Figure 7: Bone Grafting Procedure Volumes in 5EU, 2011-2020 41
Figure 8: Traditional Allograft Bone Sales Volume in 5EU, 2011-2020 42
Figure 9: Machined Allograft Bone Sales Volume in 5EU, 2011-2020 43
Figure 10: Bone Grafts Substitutes Sales Volumes in 5EU, 2011-2020 45
Figure 11: Bone Grafting Procedure Volumes in APAC, 2011-2020 46
Figure 12: Traditional Allograft Bone Sales Volume in APAC, 2011-2020 47
Figure 13: Bone Grafts Substitutes Sales Volumes in APAC, 2011-2020 48
Figure 14: Bone Grafting Procedure Volumes in Brazil, 2011-2020 49
Figure 15: Traditional Allograft Bone Sales Volume in Brazil, 2011-2020 50
Figure 16: Machined Allograft Bone Sales Volume in Brazil, 2011-2020 50
Figure 17: Bone Grafts Substitutes Sales Volumes in Brazil, 2011-2020 51
Figure 18: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013 77

Figure 19: Global BGS Competitive Landscape, by Estimated Revenue, 2013 178
Figure 20: US BGS Competitive Landscape, 2013 179
Figure 21: US BGS Competitive Landscape, by Segment, 2013 180
Figure 22: France BGS Competitive Landscape, 2013 181
Figure 23: Germany BGS Competitive Landscape, 2013 181
Figure 24: Italy BGS Competitive Landscape, 2013 182
Figure 25: Spain BGS Competitive Landscape, 2013 182
Figure 26: UK BGS Competitive Landscape, 2013 183
Figure 27: Global BGS Market Sales Forecast in 10 Countries, 2011-2020 184
Figure 28: BGS Market by Major Market, 2013 and 2020 185
Figure 29: Global BGS Market Revenue Distribution, By Segment, 2013 and 2020 186
Figure 30: US BGS Market Sales Forecast ($m), 2011-2020 189
Figure 31: US BGS Market Revenue Distribution, By Segment, 2011-2020 190
Figure 32: France BGS Market Sales Forecast ($m), 2011-2020 192

Figure 33: France BGS Market Revenue Distribution, By Segment, 2011-2020 192
Figure 34: Germany BGS Market Sales Forecast ($m), 2011-2020 194
Figure 35: Germany BGS Market Revenue Distribution, By Segment, 2011-2020 194
Figure 36: Italy BGS Market Sales Forecast ($m), 2011-2020 196
Figure 37: Italy BGS Market Revenue Distribution, By Segment, 2011-2020 196
Figure 38: Spain BGS Market Sales Forecast ($m), 2011-2020 198
Figure 39: Spain BGS Market Revenue Distribution, By Segment, 2011-2020 198
Figure 40: UK BGS Market Sales Forecast ($m), 2011-2020 200
Figure 41: UK BGS Market Revenue Distribution, By Segment, 2011-2020 200
Figure 42: Japan BGS Market Sales Forecast ($m), 2011-2020 202
Figure 43: Japan BGS Market Revenue Distribution, By Segment, 2011-2020 203
Figure 44: Brazil BGS Market Sales Forecast ($m), 2011-2020 204
Figure 45: Brazil BGS Market Revenue Distribution, By Segment, 2011-2020 205
Figure 46: China BGS Market Sales Forecast ($m), 2011-2020 206
Figure 47: China BGS Market Revenue Distribution, By Segment, 2011-2020 207
Figure 48: India BGS Market Sales Forecast ($m), 2011-2020 209
Figure 49: India BGS Market Revenue Distribution, By Segment, 2011-2020 209
Figure 50: Other Primary Research Participants Breakdown, by Country (n=236) 228
Figure 51: Other Primary Research Participants Breakdown, by Institution (n=236) 228

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