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

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.

Key Highlights

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?

Table of Contents

1 Table of Contents 7

1 1 List of Tables 15

1 2 List of Figures 20

2 Introduction 23

2 1 Catalyst 24

2 2 Related Reports 24

3 Clinical Outcomes 26

3 1 Overview 26

3 2 Autograft Bone 27

3 3 Allograft Bone 28

3 4 Bone Graft Substitutes 30

3 4 1 BMPs/Growth Factors 30

3 4 2 DBMs 32

3 4 3 Synthetic Bone Substitutes 33

3 4 4 Cell-Based Matrices 35

4 Industry Overview 36

4 1 Procedural Trends 36

4 1 1 Overview 36

4 1 2 US 37

4 1 3 5EU 43

4 1 4 Asia-Pacific 48

4 1 5 South America 51

4 2 Market Access 55

4 2 1 US 55

4 2 2 5EU 61

4 2 3 Asia-Pacific 64

4 2 4 South America 68

4 3 Regulatory Issues/Recalls 71

4 3 1 FDA Convened a Dispute Resolution Panel to Discuss Wright Medical’s Augment Bone Graft (October 2013) 71

4 3 2 FDA Issued a Warning Letter over Globus Medical’s MicroFuse Bone Growth Putty (September 2013) 71

4 3 3 Medtronic and the Australia Therapeutic Goods Administration Recalled Unused Lots of INFUSE LT-Cage Bone Graft Kits (June 2013) 72

4 3 4 Alphatec Spine Voluntarily Stopped Shipping PureGen (February 2013) 72

4 3 5 FDA Rejected Approval of Medtronic’s AMPLIFY rhBMP-2 Matrix (March 2011) 72

4 4 Mergers & Acquisitions/Key Partnerships 73

4 4 1 Bacterin Developed Strategic Alliance with DMP Spine Biologics (November 2013) 73

4 4 2 RTI Surgical Entered into a New Distribution Deal with Medtronic Sofamor Danek (October 2013) 73

4 4 3 RTI Biologics Completed Acquisition of Pioneer Surgical Technology (July 2013) 74

4 4 4 Amedica Commenced Distribution of Dynamic Surgical’s Dynamic Bone Expandable Allograft (April 2012) 74

4 5 Economic Impacts 74

4 6 Market Drivers 75

4 6 1 Disadvantages of Autografts 75

4 6 2 Continued Increase in the Procedure Volumes of Spinal and Orthopedic Surgeries 76

4 6 3 New Generation of Biological or Synthetic Materials 76

4 6 4 Cross-Selling 77

4 6 5 Improved Patient Awareness 78

4 7 Market Opportunities 79

4 7 1 Stem Cell Therapies 79

4 7 2 Foot and Ankle Market 80

4 7 3 Comprehensive Orthobiologics Platform 81

4 7 4 Antibiotics-Eluting Bone Graft Substitutes 82

4 7 5 Emerging Countries 83

4 8 Market Barriers 84

4 8 1 Variations in Regulations 84

4 8 2 Lingering Questions on rhBMP-2 to Generate Negative Spillover Effects 85

4 8 3 Negative Publicity Concerning Screening and Processing Methods of Allograft 86

4 8 4 Reimbursement and Pricing Pressure 86

4 8 5 Proving Clinical Efficacy 87

4 8 6 Medical Device Excise Tax 88

4 8 7 Substitutes 89

5 Competitive Assessment 91

5 1 Overview 91

5 2 Marketed Products 91

5 2 1 Advanced Biologics 91

5 2 2 AlloSource 92

5 2 3 Bacterin 94

5 2 4 Baxter 96

5 2 5 Biomet 97

5 2 6 DePuy Synthes 100

5 2 7 Exactech 102

5 2 8 Integra LifeSciences 104

5 2 9 Medtronic 106

5 2 10 Musculoskeletal Transplant Foundation (MTF) 109

5 2 11 NuVasive 110

5 2 12 Olympus Biotech 112

5 2 13 Orthofix 114

5 2 14 RTI Surgical 116

5 2 15 Stryker 119

5 2 16 Wright Medical 121

5 2 17 Zimmer 123

6 Unmet Needs 125

6 1 Clinical Data Transparency 125

6 2 Lack of Human Clinical Studies 126

6 3 Optimization of rhBMPs’ Dosage and Carrier 128

6 4 Standardization of DBM Products’ DBM Concentration across the Bone Banking Industry 129

6 5 Need for Products with Improved Osteoinductivity 130

6 6 Continued Research on Cell-Based Matrices 131

6 7 Need for Improved Medical Education on Bone Substitutes Products 132

6 8 Need for Cost Containment 134

7 Pipeline Products 135

7 1 Overview 135

7 2 Advanced Biologics’ OsteoMEM 135

7 3 Aursos’ Synthetic Bone Substitute 136

7 4 BioSET’s AMPLEX 136

7 5 CeraPedics’ i-FACTOR 136

7 6 NuVasive’s AttraX 136

7 7 Osiris Therapeutics’ OvationOS 137

7 8 Wright Medical’ Augment Bone Graft 137

8 Clinical Trials to Watch 138

8 1 Yale’s Review of Medtronic’s INFUSE Bone Graft 138

8 2 Wright Medical’s Augment Bone Graft 139

8 3 Orthofix’s Trinity Evolution 140

8 4 AlloSource’s AlloStem 141

8 5 NuVasive’s AttraX 141

8 6 CeraPedics’ i-FACTOR 142

8 7 BioSET’s AMPLEX 142

9 Current and Future Players 144

9 1 Trends in Corporate Strategy 144

9 2 Company Profiles 145

9 2 1 Alphatec Spine 145

9 2 2 AlloSource 147

9 2 3 Bacterin 149

9 2 4 Biomet 151

9 2 5 DePuy Synthes 153

9 2 6 Exactech 155

9 2 7 Globus Medical 156

9 2 8 Integra LifeSciences 158

9 2 9 Medtronic 160

9 2 10 NuVasive 163

9 2 11 Olympus Biotech 165

9 2 12 Orthofix 166

9 2 13 RTI Surgical 168

9 2 14 Stryker 170

9 2 15 Wright Medical 172

9 2 16 Zimmer Holdings 174

9 3 Other Players 177

10 Market Outlooks 180

10 1 Market Share Analysis 180

10 1 1 Global 180

10 1 2 US 181

10 1 3 5EU 184

10 2 By Geography 186

10 2 1 Overview 186

10 2 2 US 190

10 2 3 France 193

10 2 4 Germany 196

10 2 5 Italy 198

10 2 6 Spain 200

10 2 7 UK 202

10 2 8 Japan 204

10 2 9 Brazil 206

10 2 10 China 208

10 2 11 India 210

11 Appendix 213

11 1 Abbreviations 213

11 2 Bibliography 216

11 3 Report Methodology 225

11 3 1 Overview 225

11 3 2 Coverage 225

11 3 3 Secondary Research 225

11 3 4 Forecasting Methodology 226

11 3 5 Primary Research – Key Opinion Leader Interviews 227

11 3 6 Expert Panel Validation 228

11 4 Physicians and Specialists Included in this Study 229

11 5 About the Authors 232

11 5 1 Analysts 232

11 5 2 Bonnie Bain, Ph D , Global Head of Healthcare 233

11 6 About MediPoint 234

11 7 About GlobalData 234

11 8 Disclaimer 234

List of Tables

Table 1: Definition of Bone Growth Mechanisms 26

Table 2: Advantages and Disadvantages of Autografts 28

Table 3: Advantages and Disadvantages of Allografts 29

Table 4: Differences Between INFUSE Bone Graft and OP-1 Products 31

Table 5: Advantages and Disadvantages of BMPs 31

Table 6: Advantages and Disadvantages of DBMs 32

Table 7: Major Types of Synthetic Bone Substitutes 33

Table 8: Advantages and Disadvantages of Synthetic Bone Substitutes 35

Table 9: Advantages and Disadvantages of Cell-Based Matrices 35

Table 10: Usage of BGS by Procedure Type in the US, 2013 38

Table 11: Usage of BGS by Procedure Type in 5EU, 2013 43

Table 12: Usage of BGS by Procedure Type in APAC, 2013 48

Table 13: Usage of BGS by Procedure Type in South America, 2013 51

Table 14: Medicare National Average Reimbursement Rates for Major Orthopedic Procedures that Involve the Usage of BGS, 2013–2014 60

Table 15: Currently Marketed Cell-Based Matrices in the US Market 79

Table 16: Differences between the US and EU Regulations for BGS 84

Table 17: Types of Autologous Grafting Commonly Used to Treat Non-Union 89

Table 18: Advanced Biologics’ BGS Products 92

Table 19: SWOT Analysis – Advanced Biologics’ BGS Portfolio 92

Table 20: AlloSource’s BGS Products 93

Table 21: SWOT Analysis – AlloSource’s BGS Portfolio 94

Table 22: Bacterin’s BGS Products 95

Table 23: SWOT Analysis – Bacterin’s BGS Portfolio 96

Table 24: Baxter’s BGS Products 97

Table 25: SWOT Analysis – Baxter’s BGS Portfolio 97

Table 26: Biomet’s BGS Products 98

Table 27: SWOT Analysis – Biomet’s BGS Portfolio 99

Table 28: DePuy Synthes’ BGS Products 101

Table 29: SWOT Analysis – DePuy Synthes’ BGS Portfolio 102

Table 30: Exactech’s BGS Products 103

Table 31: SWOT Analysis – Exactech’s BGS Portfolio 104

Table 32: Integra LifeSciences’ BGS Products 105

Table 33: SWOT Analysis – Integra LifeSciences’ BGS Portfolio 106

Table 34: Medtronic’s BGS Products 108

Table 35: SWOT Analysis – Medtronic’s BGS Portfolio 109

Table 36: MTF’s BGS Products 109

Table 37: SWOT Analysis – MTF’s BGS Portfolio 110

Table 38: NuVasive’s BGS Products 111

Table 39: SWOT Analysis – NuVasive’s BGS Portfolio 111

Table 40: Olympus Biotech’s BGS Products 113

Table 41: SWOT Analysis – Olympus Biotech’s BGS Portfolio 113

Table 42: Orthofix’s BGS Products 115

Table 43: SWOT Analysis – Orthofix’s BGS Portfolio 115

Table 44: RTI Surgical’s BGS Products 117

Table 45: SWOT Analysis – RTI Surgical’s BGS Portfolio 119

Table 46: Stryker’s BGS Products 120

Table 47: SWOT Analysis – Stryker’s BGS Portfolio 121

Table 48: Wright Medical’s BGS Products 122

Table 49: SWOT Analysis – Wright Medical’s BGS Portfolio 123

Table 50: Zimmer’s BGS Products 124

Table 51: SWOT Analysis – Zimmer’s BGS Portfolio 124

Table 52: Compelling Questions Regarding the Cell-Based Matrices 132

Table 53: Pipeline Products in the Global BGS Market 135

Table 54: Major Clinical Findings of the YODA Project 138

Table 55: Major Clinical Studies of Augment Bone Graft 139

Table 56: Major Clinical Studies of Trinity Evolution 140

Table 57: Major Clinical Study of AlloStem 141

Table 58: Major Clinical Study of AttraX 141

Table 59: Major Clinical Study of i-FACTOR 142

Table 60: Major Clinical Studies of AMPLEX 143

Table 61: Company Profile – Alphatec Spine 145

Table 62: SWOT Analysis – Alphatec Spine 146

Table 63: Company Profile – AlloSource 147

Table 64: SWOT Analysis – AlloSource 148

Table 65: Company Profile – Bacterin 149

Table 66: SWOT Analysis – Bacterin 150

Table 67: Company Profile – Biomet 151

Table 68: SWOT Analysis – Biomet 152

Table 69: Company Profile – DePuy Synthes 153

Table 70: SWOT Analysis – DePuy Synthes 154

Table 71: Company Profile – Exactech 155

Table 72: SWOT Analysis – Exactech 156

Table 73: Company Profile – Globus Medical 157

Table 74: SWOT Analysis – Globus Medical 158

Table 75: Company Profile – Integra LifeSciences 159

Table 76: SWOT Analysis – Integra LifeSciences 160

Table 77: Company Profile – Medtronic 161

Table 78: SWOT Analysis – Medtronic 162

Table 79: Company Profile – NuVasive 163

Table 80: SWOT Analysis – NuVasive 164

Table 81: Company Profile – Olympus Biotech 165

Table 82: SWOT Analysis – Olympus Biotech 166

Table 83: Company Profile – Orthofix 167

Table 84: SWOT Analysis – Orthofix 168

Table 85: Company Profile – RTI Surgical 169

Table 86: SWOT Analysis – RTI Surgical 169

Table 87: Company Profile – Stryker 170

Table 88:SWOT Analysis – Stryker 171

Table 89: Company Profile – Wright Medical 173

Table 90: SWOT Analysis – Wright Medical 174

Table 91: Company Profile – Zimmer Holdings 175

Table 92: SWOT Analysis – Zimmer Holdings 176

Table 93: Other Players in the Global BGS Market 177

Table 94: Global BGS Market Sales Forecast ($m), 2011–2020 187

Table 95: US BGS Market Sales Forecast ($m), 2011–2020 192

Table 96: France BGS Market Sales Forecast ($m), 2011–2020 194

Table 97: Germany BGS Market Sales Forecast ($m), 2011–2020 196

Table 98: Italy BGS Market Sales Forecast ($m), 2011–2020 198

Table 99: Spain BGS Market Sales Forecast ($m), 2011–2020 200

Table 100: UK BGS Market Sales Forecast ($m), 2011–2020 202

Table 101: Japan BGS Market Sales Forecast ($m), 2011–2020 205

Table 102: Brazil BGS Market Sales Forecast ($m), 2011–2020 207

Table 103: China BGS Market Sales Forecast ($m), 2011–2020 209

Table 104: India BGS Market Sales Forecast ($m), 2011–2020 211

List of Figures

Figure 1: An Overview of BGS Used in Orthopedic Surgeries 27

Figure 2: Usage of Autograft, Allograft, and Bone Graft Substitutes, by Country, 2013 37

Figure 3: Bone Grafting Procedure Volumes in the US, 2011–2020 39

Figure 4: Traditional Allograft Bone Sales Volume in the US, 2011–2020 40

Figure 5: Machined Allograft Bone Sales Volume in the US, 2011–2020

Figure 6: Bone Grafts Substitutes Sales Volumes in the US, 2011–2020

Figure 7: Bone Grafting Procedure Volumes in 5EU, 2011–2020 44

Figure 8: Traditional Allograft Bone Sales Volume in 5EU, 2011–2020

Figure 9: Machined Allograft Bone Sales Volume in 5EU, 2011–2020 46

Figure 10: Bone Grafts Substitutes Sales Volumes in 5EU, 2011–2020

Figure 11: Bone Grafting Procedure Volumes in APAC, 2011–2020 49

Figure 12: Traditional Allograft Bone Sales Volume in APAC, 2011–2020 50

Figure 13: Bone Grafts Substitutes Sales Volumes in APAC, 2011–2020 51

Figure 14: Bone Grafting Procedure Volumes in Brazil, 2011–2020 52

Figure 15: Traditional Allograft Bone Sales Volume in Brazil, 2011–2020 53

Figure 16: Machined Allograft Bone Sales Volume in Brazil, 2011–2020 53

Figure 17: Bone Grafts Substitutes Sales Volumes in Brazil, 2011–2020 54

Figure 18: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013 80

Figure 19: Global BGS Competitive Landscape, by Estimated Revenue, 2013 181

Figure 20: US BGS Competitive Landscape, 2013 182

Figure 21: US BGS Competitive Landscape, by Segment, 2013 183

Figure 22: France BGS Competitive Landscape, 2013 184

Figure 23: Germany BGS Competitive Landscape, 2013 184

Figure 24: Italy BGS Competitive Landscape, 2013 185

Figure 25: Spain BGS Competitive Landscape, 2013 185

Figure 26: UK BGS Competitive Landscape, 2013 186

Figure 27: Global BGS Market Sales Forecast in 10 Countries, 2011–2020 187

Figure 28: BGS Market by Major Market, 2013 and 2020 188

Figure 29: Global BGS Market Revenue Distribution, By Segment, 2013 and 2020 189

Figure 30: US BGS Market Sales Forecast ($m), 2011–2020 192

Figure 31: US BGS Market Revenue Distribution, By Segment, 2011–2020 193

Figure 32: France BGS Market Sales Forecast ($m), 2011–2020 195

Figure 33: France BGS Market Revenue Distribution, By Segment, 2011–2020 195

Figure 34: Germany BGS Market Sales Forecast ($m), 2011–2020 197

Figure 35: Germany BGS Market Revenue Distribution, By Segment, 2011–2020 197

Figure 36: Italy BGS Market Sales Forecast ($m), 2011–2020 199

Figure 37: Italy BGS Market Revenue Distribution, By Segment, 2011–2020 199

Figure 38: Spain BGS Market Sales Forecast ($m), 2011–2020 201

Figure 39: Spain BGS Market Revenue Distribution, By Segment, 2011–2020 201

Figure 40: UK BGS Market Sales Forecast ($m), 2011–2020 203

Figure 41: UK BGS Market Revenue Distribution, By Segment, 2011–2020 203

Figure 42: Japan BGS Market Sales Forecast ($m), 2011–2020 205

Figure 43: Japan BGS Market Revenue Distribution, By Segment, 2011–2020 206

Figure 44: Brazil BGS Market Sales Forecast ($m), 2011–2020 207

Figure 45: Brazil BGS Market Revenue Distribution, By Segment, 2011–2020 208

Figure 46: China BGS Market Sales Forecast ($m), 2011–2020 209

Figure 47: China BGS Market Revenue Distribution, By Segment, 2011–2020 210

Figure 48: India BGS Market Sales Forecast ($m), 2011–2020 212

Figure 49: India BGS Market Revenue Distribution, By Segment, 2011–2020 212

Figure 50: Other Primary Research Participants Breakdown, by Country (n=236) 231

Figure 51: Other Primary Research Participants Breakdown, by Institution (n=236) 231

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