United States Spinal Surgery Market Outlook to 2020 · United States Spinal Surgery Market Outlook to 2020 GDMECC0009DB / Published March 2014 © GlobalData. This report is a licensed

United States Spinal Surgery Market Outlook to 2020 GDMECC0009DB / Published March 2014

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

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United States Spinal Surgery Market

Outlook to 2020

Reference Code: GDMECC0009DB

Publication Date: March 2014



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1 Table of Contents

1 Table of Contents .................................................................................................................................................... 2

1.1 List of Tables .................................................................................................................................................. 10

1.2 List of Figures ................................................................................................................................................. 12

2 Introduction ............................................................................................................................................................ 13

2.1 What Is This Report About? ........................................................................................................................... 13

2.2 Spinal Surgery Market Segmentation ............................................................................................................ 13

2.3 Definitions of Markets Covered in the Report ................................................................................................ 14

3 Spinal Surgery Market, United States.................................................................................................................. 16

3.1 Spinal Surgery Market, United States, Revenue ($m), 2005-2012 ................................................................ 16

3.2 Spinal Surgery Market, United States, Revenue ($m), 2012-2020 ................................................................ 18

3.2.1 Spinal Fusion Market, United States, Revenue ($m), by Segment, 2005-2012 ........................................ 20

3.2.2 Spinal Non-Fusion Market, United States, Revenue ($m), by Segment, 2005-2012 ................................ 22

3.2.3 Vertebral Compression Fracture Repair Devices Market, United States, Revenue ($m), by Segment, 2005-2012 ................................................................................................................................................................ 24

3.2.4 Spinal Fusion Market, United States, Revenue ($m), by Segment, 2012-2020 ........................................ 26

3.2.5 Spinal Non-Fusion Market, United States, Revenue ($m), by Segment, 2012-2020 ................................ 28

3.2.6 Vertebral Compression Fracture Repair Devices Market, United States, Revenue ($m), by Segment, 2012-2020 ................................................................................................................................................................ 30

3.2.7 Pedicle Screw Systems Market, United States, Revenue ($m), by Sub Segment, 2005-2012 ................. 32

3.2.8 Spinal Plating Systems Market, United States, Revenue ($m), by Sub Segment, 2005-2012 .................. 34

3.2.9 Pedicle Screw Systems Market, United States, Revenue ($m), by Sub Segment, 2012-2020 ................. 36

3.2.10 Spinal Plating Systems Market, United States, Revenue ($m), by Sub Segment, 2012-2020 .............. 38

3.3 Spinal Surgery Market, United States, Volume (Units), 2005-2012 ............................................................... 40

3.4 Spinal Surgery Market, United States, Volume (Units), 2012-2020 ............................................................... 42

3.4.1 Spinal Fusion Market, United States, Volume (Units), by Segment, 2005-2012 ....................................... 44

3.4.2 Spinal Non-Fusion Market, United States, Volume (Units), by Segment, 2005-2012 ............................... 46

3.4.3 Vertebral Compression Fracture Repair Devices Market, United States, Volume (Units), by Segment, 2005-2012 ................................................................................................................................................................ 48

3.4.4 Spinal Fusion Market, United States, Volume (Units), by Segment, 2012-2020 ....................................... 50

3.4.5 Spinal Non-Fusion Market, United States, Volume (Units), by Segment, 2012-2020 ............................... 52

3.4.6 Vertebral Compression Fracture Repair Devices Market, United States, Volume (Units), by Segment, 2012-2020 ................................................................................................................................................................ 54

3.4.7 Pedicle Screw Systems Market, United States, Volume (Units), by Sub Segment, 2005-2012 ................ 56

3.4.8 Spinal Plating Systems Market, United States, Volume (Units), by Sub Segment, 2005-2012 ................. 58

3.4.9 Pedicle Screw Systems Market, United States, Volume (Units), by Sub Segment, 2012-2020 ................ 60

3.4.10 Spinal Plating Systems Market, United States, Volume (Units), by Sub Segment, 2012-2020 ............. 62

3.5 Spinal Surgery Market, United States, Average Price ($), 2005-2020 .......................................................... 64

3.6 Spinal Surgery Market, United States, Distribution Share by Revenue ($m), 2011-2012 ............................. 67

3.7 Spinal Surgery Market, United States, Company Share by Revenue ($m), 2011-2012 ................................ 68

4 Overview of Key Companies in United States Spinal Surgery Market ............................................................. 70



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4.1 Medtronic, Inc. ................................................................................................................................................ 70

4.1.1 Company Overview .................................................................................................................................... 70

4.2 DePuy Companies ......................................................................................................................................... 70


4.3 Stryker Corporation ........................................................................................................................................ 70


4.4 NuVasive, Inc. ................................................................................................................................................ 71


4.5 Globus Medical, Inc. ....................................................................................................................................... 71


4.6 Orthofix International N.V. .............................................................................................................................. 72


4.7 Zimmer Holdings, Inc. .................................................................................................................................... 72


4.8 Biomet, Inc. .................................................................................................................................................... 72


4.9 Alphatec Holdings, Inc. .................................................................................................................................. 73


4.10 K2M, Inc. ........................................................................................................................................................ 73

4.10.1 Company Overview ................................................................................................................................ 73

5 Spinal Surgery Market Pipeline Products ........................................................................................................... 74

6 Financial Deals Landscape ................................................................................................................................... 75

6.1 Acquisition ...................................................................................................................................................... 75

6.1.1 RTI Biologics Completes Acquisition Of Pioneer Surgical Technology For US$130 Million ..................... 75

6.1.2 NuVasive Acquires ANC, Maker Of Spine Implant, For US$4.5 Million .................................................... 78

6.1.3 TranS1 Completes Acquisition Of Baxano, Spine Surgical Tool Maker, For US$23 Million ..................... 79

6.1.4 Globus Medical Acquires Soteira, Orthopedic Device Developer .............................................................. 82

6.1.5 Precision Spine Acquires Spinal USA And Precision Medical of Mississippi For US$72 Million............... 84

6.1.6 Spine Pain Management Acquires Gleric Holdings, Healthcare IT Company ........................................... 85

6.2 Asset Transactions ......................................................................................................................................... 86

6.2.1 Stryker Acquires Spinal Implant Technologies From VertiFlex .................................................................. 86

6.2.2 Alphatec Completes Acquisition Of Spine Implant Business Of Phygen For US$15.2 Million .................. 88

6.3 Debt Offerings ................................................................................................................................................ 90

6.3.1 Stryker Completes Public Offering Of Notes Due 2018 For US$600 Million ............................................. 90

6.3.2 Stryker Completes Public Offering Of Notes Due 2043 For US$400 Million ............................................. 92

6.3.3 Medtronic Completes Public Offering Of Notes Due 2018 For US$1 Billion ............................................. 94

6.3.4 Medtronic Completes Public Offering Of Notes Due 2043 For US$750 Million ......................................... 96

6.3.5 Medtronic Completes Public Offering Of Notes Due 2023 For US$1.25 Billion ........................................ 98

6.4 Equity Offerings ............................................................................................................................................ 100

6.4.1 K2M Files Registration Statement For IPO .............................................................................................. 100

6.4.2 Baxano Surgical Announces Private Placement Of Shares For Up To US$7 Million .............................. 101



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6.4.3 LDR Holding Completes IPO For US$86.25 Million ................................................................................. 103

6.4.4 RTI Biologics Completes Private Placement Of Shares For US$50 Million ............................................ 105

6.4.5 InVivo Therapeutics Completes Private Placement Of Shares For US$16 Million Upon Exercise Of Warrants ................................................................................................................................................................ 107

6.4.6 InVivo Therapeutics Files Registration Statement For Public Offering Of Securities For Up To US$100 Million 108

6.4.7 InVivo Therapeutics Completes Private Placement Of Shares For US$6 Million Upon Exercise Of Warrants ................................................................................................................................................................ 109

6.4.8 TranS1 Completes Private Placement Of Shares For US$17 Million ...................................................... 110

6.4.9 CryoLife Files Registration Statement For Public Offering Of Securities For US$100 Million ................. 111

6.5 Partnerships ................................................................................................................................................. 112

6.5.1 DePuy Synthes Expands Co-Marketing Agreement With Brainlab ......................................................... 112

6.5.2 DePuy Spine Enters Into Integration Agreement With Brainlab For Surgical And Imaging Solutions ..... 114

6.5.3 Royal DSM Extends Licensing Agreement With AxioMed Spine For CarboSil TSPCU .......................... 115

6.5.4 K2M Enters Into Technology Integration Agreement With Cadwell Labs ................................................ 117

6.5.5 SurgiTech Enters Into Licensing Agreement With Amendia For SurgiFile Spinal Decompression System 118

6.6 Venture Financing ........................................................................................................................................ 119

6.6.1 Spinal Ventures Raises US$0.4 Million In Venture Financing ................................................................. 119

6.6.2 Innovative Surgical Designs Raises US$1 Million In Venture Financing ................................................. 120

6.6.3 VertiFlex Raises US$4 Million In Venture Financing ............................................................................... 121

6.6.4 Vertos Medical Raises US$23 Million In Series E Financing ................................................................... 122

6.6.5 Discgenics To Raise US$3 Million In Venture Financing ......................................................................... 124

6.6.6 OrthoData Raises US$1.1 Million In Venture Financing .......................................................................... 125

6.6.7 Eden Spine Holding To Raise US$2.5 Million In Venture Financing ....................................................... 126

6.6.8 Vertos Medical Raises US$2.1 Million In Venture Financing ................................................................... 127

6.6.9 Spinal Restoration Raises US$3 Mllion In Venture Financing ................................................................. 128

6.6.10 Intrinsic Therapeutics Raises US$11.7 Million In Venture Financing .................................................. 129

6.6.11 Spinal Restoration Raises US$3 Million In Venture Financing ............................................................ 130

6.6.12 Interventional Spine Raises US$3.4 Million In Venture Financing ....................................................... 132

6.6.13 Ascendx Spine Raises US$0.05 Million In Venture Financing ............................................................ 133

6.6.14 Benvenue Medical Raises US$25 Million Series D Financing ............................................................. 134

6.6.15 AxioMed Spine Raises US$5 Million In Series D Financing ................................................................ 136

6.6.16 Soteira Raises US$0.38 Million In Venture Financing ......................................................................... 137

6.6.17 LDR Holding, Developer Of Implantable Spine Systems, Raises US$9.7 Million In Venture Financing 138

6.6.18 OrthoData Raises US$0.03 Million In Venture Financing .................................................................... 139

6.6.19 Spinal Kinetics Raises US$2.5 Million In Venture Financing ............................................................... 140

6.6.20 Vertos Medical Raises US$5 Million In Venture Financing .................................................................. 142

6.6.21 Ascendx Spine Raises US$0.68 Million In Venture Financing ............................................................ 143

7 Recent Developments ......................................................................................................................................... 144

7.1 Corporate Communications ......................................................................................................................... 144



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7.1.1 Feb 13, 2014: Aurora Spine Appoints Executive Vice President of Sales ............................................... 144

7.1.2 Feb 05, 2014: NuVasive Announces Strategic Executive Leadership Changes ..................................... 144

7.1.3 Jan 23, 2014: Amedica Appoints Distinguished Surgical Device And Biomaterials Executive Jeff White To Board Of Directors ................................................................................................................................................. 145

7.1.4 Dec 19, 2013: NuVasive Further Strengthens Leadership Team in Europe ............................................ 145

7.1.5 Dec 04, 2013: NuVasive Announces Appointment of Gregory T. Lucier to the NuVasive Board of Directors ................................................................................................................................................................ 146

7.1.6 Nov 21, 2013: Aurora Spine Announces New Chief Financial Officer ..................................................... 146

7.1.7 Nov 19, 2013: Aurora Spine comments on trading halt ........................................................................... 147

7.1.8 Sep 25, 2013: Accellent Announces the Promotion of Jeremy Friedman to President and Chief Operating Officer for the Cardio & Vascular Business and the Appointment of Richard Johnson as Interim CFO ............... 147

7.1.9 Sep 09, 2013: DFINE Hires Greg Barrett As New President and CEO ................................................... 148

7.1.10 Aug 19, 2013: Orthofix Receives Expected NASDAQ Notice Related to Late Filing of Form 10-Q .... 148

7.1.11 Jul 23, 2013: Dean Schauer, Executive Vice President, Cardio & Vascular Group, Announces Resignation ............................................................................................................................................................ 149

7.1.12 Jul 09, 2013: SpineVision Inc. Appoints Former Wright Medical Exec Ken Yamada as Chief Operating Officer 149

7.1.13 Jul 09, 2013: CryoLife Enhances International Presence with Appointment of Andres Sarmiento as Latin America Sales Manager ............................................................................................................................... 150

7.1.14 May 08, 2013: Gianluca Iasci to Assume Role of Executive Vice President, Global Sales ................. 150

7.1.15 Apr 08, 2013: Stryker Names William Jellison As CFO ....................................................................... 151

7.1.16 Mar 11, 2013: Amedica Appoints Karl Farnsworth As CFO................................................................. 151

7.1.17 Feb 25, 2013: Zimmer Spine Launches Zimmer DTO 5.5 System ...................................................... 152

7.2 Financial Announcements ............................................................................................................................ 152

7.2.1 Feb 19, 2014: Trimedyne Reports Its Financial Results for the Quarter Ended December 31, 2013 ..... 152

7.2.2 Feb 18, 2014: Medtronic Reports Third Quarter Earnings ....................................................................... 153

7.2.3 Jan 15, 2014: NuVasive Announces Selected Preliminary Unaudited Full Year 2013 Financial Results154

7.2.4 Jan 15, 2014: Trimedyne Reports Financial Results for the Quarter and Fiscal Year Ended September 30, 2013 ................................................................................................................................................................. 155

7.2.5 Jan 13, 2014: Baxano Surgical Announces Preliminary Fourth Quarter and Full Year 2013 Unaudited Revenue ................................................................................................................................................................ 156

7.2.6 Nov 25, 2013: Cancer Genetics Will Showcase a Novel Diagnostic and Prognostic Test for Diffuse, Large B-Cell Lymphoma (DLBCL) at the American Society of Hematology Annual Meeting in New Orleans ............... 156

7.2.7 Nov 19, 2013: Medtronic Reports Second Quarter Earnings .................................................................. 158

7.2.8 Nov 11, 2013: Medtronic to Announce Financial Results for Its Second Quarter of Fiscal Year 2014 ... 159

7.2.9 Nov 07, 2013: Alphatec Spine Reports Third Quarter 2013 Financial Results ........................................ 160

7.2.10 Nov 07, 2013: Accellent Announces Third Quarter 2013 Results ....................................................... 162

7.2.11 Nov 06, 2013: Baxano Surgical, Inc. Reports Operating Results for the Third Quarter of 2013, Issues Fourth Quarter 2013 Guidance .............................................................................................................................. 163

7.2.12 Oct 29, 2013: CryoLife Third Quarter 2013 Revenues Increase 8 Percent to a Record $36.3 Million 163

7.2.13 Oct 29, 2013: NuVasive Announces Third Quarter 2013 Financial Results ........................................ 165

7.2.14 Oct 22, 2013: Alphatec Spine to Release Third Quarter 2013 Financial Results ................................ 166

7.2.15 Oct 17, 2013: Stryker Reports Third Quarter 2013 Results ................................................................. 166



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7.2.16 Oct 14, 2013: CryoLife Announces Release Date and Teleconference Call Details for 2013 Third Quarter Financial Results ...................................................................................................................................... 168

7.2.17 Oct 08, 2013: NuVasive Announces Conference Call and Webcast of Third Quarter 2013 Results .. 168

7.2.18 Oct 08, 2013: Preliminary Third Quarter 2013 Revenue Results in Advance of Attendance at the 28th Annual North American Spine Society Meeting in New Orleans, Louisiana ......................................................... 168

7.2.19 Sep 09, 2013: ICU Medical's New ChemoLock Needlefree Closed System Transfer Device Receives First-Ever FDA 510(k) Clearances for Both Pharmacy and Patient Administration Applications.......................... 169

7.2.20 Aug 22, 2013: Trimedyne Reports Its Financial Results for the Quarter and Nine Months Ended June 30, 2013 170

7.2.21 Aug 20, 2013: Medtronic Reports First Quarter Earnings .................................................................... 170

7.2.22 Aug 13, 2013: Accellent Announces Second Quarter 2013 Results ................................................... 172

7.2.23 Aug 12, 2013: Medtronic to Announce Financial Results for Its First Quarter of Fiscal Year 2014 .... 173

7.2.24 Aug 06, 2013: Accellent Announces Timing of Second Quarter 2013 Earnings Release and Conference Call ..................................................................................................................................................... 173

7.2.25 Aug 06, 2013: Alphatec Spine Announces Second Quarter 2013 Revenue and Financial Results .... 174

7.2.26 Jul 30, 2013: NuVasive Announces Second Quarter 2013 Financial Results ..................................... 175

7.2.27 Jul 25, 2013: CryoLife Reports Record Second Quarter Revenues .................................................... 176

7.2.28 Jul 25, 2013: Alphatec Spine Announces Date for Release of Second Quarter 2013 Financial Results 178

7.2.29 Jul 25, 2013: Baxano Surgical Schedules Second Quarter 2013 Results Conference Call for Thursday, August 8, 2013 ....................................................................................................................................................... 178

7.2.30 Jul 16, 2013: NuVasive Announces Conference Call and Webcast of Second Quarter 2013 Results 178

7.2.31 Jul 11, 2013: CryoLife Announces Release Date and Teleconference Call Details for 2013 Second Quarter Financial Results ...................................................................................................................................... 179

7.2.32 Jul 11, 2013: CryoLife Announces Release Date and Teleconference Call Details for 2013 Second Quarter Financial Results ...................................................................................................................................... 179

7.2.33 Jun 20, 2013: Trimedyne Reports Its Financial Results for the Quarter and Six Months Ended March 31, 2013 179

7.2.34 May 21, 2013: Medtronic Reports Revenue Of $16.6 Billion In Fiscal 2013 ....................................... 180

7.2.35 May 14, 2013: Accellent Reports Revenue Of $120.8m In Q1 2013 ................................................... 181

7.2.36 May 09, 2013: TranS1 Inc. Reports Operating Results for the First Quarter of 2013, Issues Second Quarter 2013 Guidance ......................................................................................................................................... 182

7.2.37 Apr 30, 2013: CryoLife Reports Revenue Of $35.5m In Q1 2013 ....................................................... 183

7.2.38 Apr 30, 2013: NuVasive Reports Revenue Of $159.5m In Q1 2013 ................................................... 185

7.2.39 Apr 30, 2013: Alphatec Spine Announces First Quarter 2013 Revenue and Financial Results .......... 186

7.2.40 Apr 24, 2013: Stryker Reports Revenue Of $2.2 Billion In Q1 2013 .................................................... 187

7.2.41 Apr 15, 2013: Alphatec Spine Announces Date for Release of First Quarter 2013 Financial Results 189

7.2.42 Apr 04, 2013: Medtronic Receives CE Mark For Sentrant Introducer Sheath ..................................... 189

7.2.43 Mar 27, 2013: Accellent Reports Revenue Of $498.6m In 2012 ......................................................... 190

7.2.44 Mar 04, 2013: TranS1 Reports Revenue Of $14.6m In 2012 .............................................................. 190

7.2.45 Feb 28, 2013: Alphatec Reports Revenue Of $196.3m In 2012 .......................................................... 191

7.2.46 Feb 26, 2013: NuVasive Reports Revenue Of $620.3m In 2012 ........................................................ 193

7.2.47 Feb 20, 2013: Trimedyne Reports Revenue Of $1.5m In Q1 Fiscal 2013 ........................................... 194

7.3 Government and Public Interest ................................................................................................................... 194



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7.3.1 Jan 06, 2014: Medtronic CEO Omar Ishrak to Speak at J.P. Morgan Healthcare Conference ............... 194

7.3.2 Dec 30, 2013: NuVasive to Present at J.P. Morgan Healthcare Conference .......................................... 194

7.3.3 Dec 04, 2013: Medtronic CFO Gary Ellis to Speak at Oppenheimer Healthcare Conference ................ 195

7.3.4 Nov 26, 2013: Medtronic EVP & President Mike Coyle to Speak at Piper Jaffray Healthcare Conference 195

7.3.5 Nov 25, 2013: CryoLife to Present at 25th Annual Piper Jaffray Healthcare Conference ....................... 195

7.3.6 Nov 25, 2013: Alphatec Spine to Present at 24th Annual Oppenheimer Healthcare Conference........... 195

7.3.7 Nov 19, 2013: Alphatec Spine to Present at 25th Annual Piper Jaffray Healthcare Conference ............ 195

7.3.8 Nov 18, 2013: Baxano Surgical Announces Participation in Two Healthcare Conferences .................... 196

7.3.9 Nov 12, 2013: Mazor Robotics to Report Third Quarter Financial Results on November 18, 2013 ........ 196

7.3.10 Nov 04, 2013: NuVasive to Host Investor Morning on November 14, 2013 ........................................ 196

7.3.11 Oct 31, 2013: NuVasive Management to Participate in Investor Events in November and December 2013 196

7.3.12 Sep 06, 2013: Medtronic CFO Gary Ellis to Speak at Morgan Stanley Healthcare Conference ......... 197

7.3.13 Aug 30, 2013: Stryker to Present at Investor Conference ................................................................... 197

7.3.14 Aug 28, 2013: Alphatec Spine to Present at the Stifel Healthcare Conference, 2013 ......................... 197

7.3.15 Aug 01, 2013: NuVasive Management to Participate in Investor Events in August and September 2013 197

7.3.16 May 21, 2013: Alphatec Spine to Present at the Jefferies Global Healthcare Conference ................. 198

7.3.17 May 07, 2013: Alphatec Spine to Present at the Bank of America Merrill Lynch 2013 Health Care Conference ............................................................................................................................................................ 198

7.3.18 Mar 13, 2013: Alphatec Spine to Present at the 2013 Canaccord/Genuity Musculoskeletal Conference in Chicago, IL on March 19, 2013 .......................................................................................................................... 198

7.3.19 Mar 11, 2013: Mazor Robotics to Present at Barclays Global Healthcare Conference ....................... 198

7.4 Legal And Regulatory ................................................................................................................................... 198

7.4.1 Feb 11, 2014: Alphatec Spine Announces Jury Verdict in the OrthoTec Litigation ................................. 198

7.4.2 Jan 22, 2014: Medtronic Statement on U.S. Supreme Court Ruling in Medtronic, Inc. v. Mirowski Family Ventures ................................................................................................................................................................ 199

7.4.3 Oct 19, 2013: Medtronic Statement on Medical Device Security ............................................................. 199

7.4.4 Oct 18, 2013: Glancy Binkow & Goldberg Announces Lead Plaintiff Deadline In The Class Action Lawsuit Against NuVasive .................................................................................................................................................. 200

7.4.5 Aug 28, 2013: Pomerantz Law Firm has filed a Class Action Against NuVasive and Certain Officers - NUVA 201

7.4.6 Aug 16, 2013: Glancy Binkow & Goldberg Announces Class Action Lawsuit Against Orthofix International 201

7.4.7 Aug 01, 2013: Medtronic Notifies More Than 2,700 Patients Of Lost Records ....................................... 202

7.4.8 Jul 02, 2013: Fifty-Five Hospitals to Pay U.S. More Than $34 Million to Resolve False Claims Act Allegations Related to Kyphoplasty ....................................................................................................................... 202

7.4.9 Jul 01, 2013: Bronstein, Gewirtz & Grossman, LLC Announces that a Securities Class Action has been Filed Against Medtronic, Inc. ................................................................................................................................. 204

7.4.10 Jun 17, 2013: DePuy Synthes Wins $16m From Globus Medical Over Patent Dispute ..................... 204

7.4.11 Jun 12, 2013: NuVasive Ordered To Pay Medtronic Royalties In Spinal Implant Suit ........................ 204

7.4.12 Mar 26, 2013: Excite Medical Does Not Own 510(k) Clearances For Any DRX System, FDA Inspection Reveals 205



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7.4.13 Mar 18, 2013: NuVasive Receives Warning Letter From FDA ............................................................ 206

7.5 Other Significant Developments ................................................................................................................... 206

7.5.1 Feb 13, 2014: Medtronic Announces Cash Dividend for Fourth Quarter of Fiscal Year 2014 ................ 206

7.5.2 Jan 28, 2014: Medtronic Relocates Its Regional Headquarters to Dubai ................................................ 206

7.5.3 Dec 04, 2013: Medtronic Issues $500,000 in Health Access Grants to Support Diabetes Services for the Underserved of Greater Los Angeles .................................................................................................................... 207

7.5.4 Nov 27, 2013: NuVasive to Commemorate Official Relocation and Expansion of UK Office .................. 209

7.5.5 Nov 21, 2013: CryoLife Announces Quarterly Cash Dividend for the Fourth Quarter 2013 .................... 209

7.5.6 Oct 25, 2013: Ortho Kinematics Launches New Physician Web Portal ................................................... 209

7.5.7 Oct 24, 2013: Ortho Kinematics Launches New Physician Web Portal ................................................... 210

7.5.8 Sep 16, 2013: Alphatec Spine Announces Intent to Restructure Scient'x Business Operations ............. 210

7.5.9 Aug 22, 2013: Medtronic Announces Cash Dividend for Second Quarter of Fiscal Year 2014 .............. 211

7.5.10 Aug 21, 2013: CryoLife Announces Quarterly Cash Dividend for the Third Quarter 2013 .................. 211

7.5.11 Aug 13, 2013: Precision Spine Announces Long-Term Exclusive Distribution Agreement with Mizuho for Japan 211

7.6 Product News ............................................................................................................................................... 212

7.6.1 Feb 18, 2014: NuVasive Solutions Named on Becker's ASC Review List of "100 Minimally Invasive Orthopedic & Spine Devices to Know" .................................................................................................................. 212

7.6.2 Jan 13, 2014: Providence Medical Technology Awarded Five More Patents for Facet Joint Implants and Methods of Placement ........................................................................................................................................... 213

7.6.3 Jan 03, 2014: InVivo Sends Amended Protocol to FDA and Six Clinical Sites ....................................... 213

7.6.4 Jan 02, 2014: Mazor Robotics Announces Two Renaissance Systems orders in the U.S. and International Markets ............................................................................................................................................. 214

7.6.5 Nov 15, 2013: FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall 214

7.6.6 Oct 31, 2013: Zimmer Announces Launch of Viewline Retractor System, Tube Retraction System and Posterior Instrument Set for Minimally Invasive Spinal Surgery ........................................................................... 215

7.6.7 Oct 21, 2013: Medtronic First to Offer Lateral Access Procedures to All Levels of the Lower Lumbar Spine 215

7.6.8 Oct 08, 2013: X-spine Announces Market Launch of Three New Spinal Implant Systems ..................... 216

7.6.9 Oct 07, 2013: Precision Spine Plans to Introduce New Products at North American Spine Society Meeting in New Orleans ........................................................................................................................................ 217

7.6.10 Aug 28, 2013: SpineGuard Receives FDA 510(k) Clearance for Miniaturized and Directional Versions of Its Pediguard Platform ....................................................................................................................................... 217

7.6.11 Apr 29, 2013: Medtronic Expands Top Cervical-Upper Thoracic System ........................................... 217

7.6.12 Mar 20, 2013: Integra Announces Addition Of ESS+ rod To Its Daytona And Malibu Spinal Systems 218

7.6.13 Mar 19, 2013: Ranier Technology Gets US Patent For Graduated Modulus Technology ................... 219

7.6.14 Feb 28, 2013: Amedica Receives New Patent For Silicon Nitride Total Disc Implant ......................... 219

7.7 Strategy And Business Planning .................................................................................................................. 219

7.7.1 Oct 07, 2013: EIZO and Stryker Announce Partnership in Integrated Large Monitor Management Systems for Operating Rooms .............................................................................................................................. 219

7.7.2 Sep 26, 2013: Baxano Surgical Announces International Expansion ...................................................... 220

7.7.3 Sep 17, 2013: Medtronic Opens New Customer Innovation Centre in Galway, Ireland .......................... 221



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7.7.4 Sep 02, 2013: Medtronic announces formation of hospital solutions business aimed at driving efficiencies 221

7.7.5 Aug 29, 2013: Medtronic To Set Up Global Center Of Excellence In Singapore For Business Model Innovation .............................................................................................................................................................. 222

7.7.6 Aug 15, 2013: NuVasive Announces Expansion and Relocation of UK Office ........................................ 223

7.7.7 Apr 24, 2013: NuVasive Opens New Office In Tokyo, Japan .................................................................. 223

7.7.8 Apr 15, 2013: Medtronic To Restructure Spine Division .......................................................................... 224

7.7.9 Mar 12, 2013: NLT Spine Opens New US Subsidiary To Support Commercialization Of New Technology Platform Applicable To MISS Procedures ............................................................................................................. 224

8 Appendix .............................................................................................................................................................. 226

8.1 Research Methodology ................................................................................................................................ 227

8.1.1 Coverage .................................................................................................................................................. 227

8.1.2 Secondary Research ................................................................................................................................ 227

8.1.3 Primary Research ..................................................................................................................................... 228

8.1.4 Market Modeling and Forecasting ............................................................................................................ 229

8.1.5 Company Share Analysis ......................................................................................................................... 232

8.1.6 Distribution Share Analysis ...................................................................................................................... 233

8.2 Expert Panel ................................................................................................................................................. 234

8.3 GlobalData Consulting ................................................................................................................................. 234

8.5 Disclaimer ..................................................................................................................................................... 234



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1.1 List of Tables

Table 1: Spinal Surgery Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ............................................ 17

Table 2: Spinal Surgery Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 .......................................... 19

Table 3: Spinal Fusion Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 .............................................. 21

Table 4: Spinal Non-Fusion Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ...................................... 23

Table 5: Vertebral Compression Fracture Repair Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-

2012 ................................................................................................................................................................................................. 25

Table 6: Spinal Fusion Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ............................................ 27

Table 7: Spinal Non-Fusion Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 .................................... 29

Table 8: Vertebral Compression Fracture Repair Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-

2020 ................................................................................................................................................................................................. 31

Table 9: Pedicle Screw Systems Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 .. 33

Table 10: Spinal Plating Systems Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 . 35

Table 11: Pedicle Screw Systems Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020

......................................................................................................................................................................................................... 37

Table 12: Spinal Plating Systems Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-202039

Table 13: Spinal Surgery Market, United States, Volume (Units), Historic, 2005-2012 .................................................................. 41

Table 14: Spinal Surgery Market, United States, Volume (Units), Forecast, 2012-2020 ................................................................ 43

Table 15: Spinal Fusion Market, United States, Volume (Units), Historic, 2005-2012 .................................................................... 45

Table 16: Spinal Non-Fusion Market, United States, Volume (Units), Historic, 2005-2012 ............................................................ 47

Table 17: Vertebral Compression Fracture Repair Devices Market, United States, Volume (Units), Historic, 2005-2012 ............. 49

Table 18: Spinal Fusion Market, United States, Volume (Units), Forecast, 2012-2020 .................................................................. 51

Table 19: Spinal Non-Fusion Market, United States, Volume (Units), Forecast, 2012-2020 .......................................................... 53

Table 20: Vertebral Compression Fracture Repair Devices Market, United States, Volume (Units), Forecast, 2012-2020............ 55

Table 21: Pedicle Screw Systems Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ........................ 57

Table 22: Spinal Plating Systems Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ......................... 59

Table 23: Pedicle Screw Systems Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ...................... 61

Table 24: Spinal Plating Systems Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ....................... 63

Table 25: Spinal Surgery Market, United States, Average Price ($), Historic, 2005-2012 .............................................................. 64

Table 26: Spinal Surgery Market, United States, Average Price ($), Forecast, 2012-2020 ............................................................ 65

Table 27: Spinal Surgery Market, United States, Distribution Share by Revenue ($m), USD Constant, 2011-2012 ...................... 67

Table 28: Spinal Surgery Market, United States, Company Share by Revenue ($m), USD Constant, 2011-2012 ......................... 69

Table 29: Spinal Surgery Market Pipeline Products ....................................................................................................................... 74

Table 30: RTI Biologics Completes Acquisition Of Pioneer Surgical Technology For US$130 Million ........................................... 75

Table 31: NuVasive Acquires ANC, Maker Of Spine Implant, For US$4.5 Million .......................................................................... 78

Table 32: TranS1 Completes Acquisition Of Baxano, Spine Surgical Tool Maker, For US$23 Million ........................................... 79

Table 33: Globus Medical Acquires Soteira, Orthopedic Device Developer ................................................................................... 82

Table 34: Precision Spine Acquires Spinal USA And Precision Medical of Mississippi For US$72 Million ..................................... 84

Table 35: Spine Pain Management Acquires Gleric Holdings, Healthcare IT Company ................................................................ 85

Table 36: Stryker Acquires Spinal Implant Technologies From VertiFlex ....................................................................................... 86

Table 37: Alphatec Completes Acquisition Of Spine Implant Business Of Phygen For US$15.2 Million ........................................ 88

Table 38: Stryker Completes Public Offering Of Notes Due 2018 For US$600 Million ................................................................... 90

Table 39: Stryker Completes Public Offering Of Notes Due 2043 For US$400 Million ................................................................... 92



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Table 40: Medtronic Completes Public Offering Of Notes Due 2018 For US$1 Billion ................................................................... 94

Table 41: Medtronic Completes Public Offering Of Notes Due 2043 For US$750 Million .............................................................. 96

Table 42: Medtronic Completes Public Offering Of Notes Due 2023 For US$1.25 Billion .............................................................. 98

Table 43: K2M Files Registration Statement For IPO ................................................................................................................... 100

Table 44: Baxano Surgical Announces Private Placement Of Shares For Up To US$7 Million ................................................... 101

Table 45: LDR Holding Completes IPO For US$86.25 Million ...................................................................................................... 103

Table 46: RTI Biologics Completes Private Placement Of Shares For US$50 Million .................................................................. 105

Table 47: InVivo Therapeutics Completes Private Placement Of Shares For US$16 Million Upon Exercise Of Warrants ........... 107

Table 48: InVivo Therapeutics Files Registration Statement For Public Offering Of Securities For Up To US$100 Million .......... 108

Table 49: InVivo Therapeutics Completes Private Placement Of Shares For US$6 Million Upon Exercise Of Warrants ............. 109

Table 50: TranS1 Completes Private Placement Of Shares For US$17 Million ........................................................................... 110

Table 51: CryoLife Files Registration Statement For Public Offering Of Securities For US$100 Million ....................................... 111

Table 52: DePuy Synthes Expands Co-Marketing Agreement With Brainlab ............................................................................... 112

Table 53: DePuy Spine Enters Into Integration Agreement With Brainlab For Surgical And Imaging Solutions ........................... 114

Table 54: Royal DSM Extends Licensing Agreement With AxioMed Spine For CarboSil TSPCU ................................................ 115

Table 55: K2M Enters Into Technology Integration Agreement With Cadwell Labs ..................................................................... 117

Table 56: SurgiTech Enters Into Licensing Agreement With Amendia For SurgiFile Spinal Decompression System .................. 118

Table 57: Spinal Ventures Raises US$0.4 Million In Venture Financing ...................................................................................... 119

Table 58: Innovative Surgical Designs Raises US$1 Million In Venture Financing ...................................................................... 120

Table 59: VertiFlex Raises US$4 Million In Venture Financing .................................................................................................... 121

Table 60: Vertos Medical Raises US$23 Million In Series E Financing ........................................................................................ 122

Table 61: Discgenics To Raise US$3 Million In Venture Financing .............................................................................................. 124

Table 62: OrthoData Raises US$1.1 Million In Venture Financing ............................................................................................... 125

Table 63: Eden Spine Holding To Raise US$2.5 Million In Venture Financing ............................................................................. 126

Table 64: Vertos Medical Raises US$2.1 Million In Venture Financing ........................................................................................ 127

Table 65: Spinal Restoration Raises US$3 Mllion In Venture Financing ...................................................................................... 128

Table 66: Intrinsic Therapeutics Raises US$11.7 Million In Venture Financing ............................................................................ 129

Table 67: Spinal Restoration Raises US$3 Million In Venture Financing ...................................................................................... 130

Table 68: Interventional Spine Raises US$3.4 Million In Venture Financing ................................................................................ 132

Table 69: Ascendx Spine Raises US$0.05 Million In Venture Financing ...................................................................................... 133

Table 70: Benvenue Medical Raises US$25 Million Series D Financing ...................................................................................... 134

Table 71: AxioMed Spine Raises US$5 Million In Series D Financing ......................................................................................... 136

Table 72: Soteira Raises US$0.38 Million In Venture Financing .................................................................................................. 137

Table 73: LDR Holding, Developer Of Implantable Spine Systems, Raises US$9.7 Million In Venture Financing ....................... 138

Table 74: OrthoData Raises US$0.03 Million In Venture Financing ............................................................................................. 139

Table 75: Spinal Kinetics Raises US$2.5 Million In Venture Financing ........................................................................................ 140

Table 76: Vertos Medical Raises US$5 Million In Venture Financing ........................................................................................... 142

Table 77: Ascendx Spine Raises US$0.68 Million In Venture Financing ...................................................................................... 143

Table 78: Total Number of Primary Research Participants, Orthopedic Devices Market, by Country .......................................... 229



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1.2 List of Figures

Figure 1: Spinal Surgery Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ........................................... 16

Figure 2: Spinal Surgery Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ......................................... 18

Figure 3: Spinal Fusion Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ............................................. 20

Figure 4: Spinal Non-Fusion Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ..................................... 22

Figure 5: Vertebral Compression Fracture Repair Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-

2012 ................................................................................................................................................................................................. 24

Figure 6: Spinal Fusion Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ........................................... 26

Figure 7: Spinal Non-Fusion Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ................................... 28

Figure 8: Vertebral Compression Fracture Repair Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-

2020 ................................................................................................................................................................................................. 30

Figure 9: Pedicle Screw Systems Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 . 32

Figure 10: Spinal Plating Systems Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 34

Figure 11: Pedicle Screw Systems Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020

......................................................................................................................................................................................................... 36

Figure 12: Spinal Plating Systems Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020

......................................................................................................................................................................................................... 38

Figure 13: Spinal Surgery Market, United States, Volume (Units), Historic, 2005-2012 ................................................................. 40

Figure 14: Spinal Surgery Market, United States, Volume (Units), Forecast, 2012-2020 ............................................................... 42

Figure 15: Spinal Fusion Market, United States, Volume (Units), Historic, 2005-2012 ................................................................... 44

Figure 16: Spinal Non-Fusion Market, United States, Volume (Units), Historic, 2005-2012 ........................................................... 46

Figure 17: Vertebral Compression Fracture Repair Devices Market, United States, Volume (Units), Historic, 2005-2012 ............ 48

Figure 18: Spinal Fusion Market, United States, Volume (Units), Forecast, 2012-2020 ................................................................. 50

Figure 19: Spinal Non-Fusion Market, United States, Volume (Units), Forecast, 2012-2020 ......................................................... 52

Figure 20: Vertebral Compression Fracture Repair Devices Market, United States, Volume (Units), Forecast, 2012-2020 .......... 54

Figure 21: Pedicle Screw Systems Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ....................... 56

Figure 22: Spinal Plating Systems Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ....................... 58

Figure 23: Pedicle Screw Systems Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ..................... 60

Figure 24: Spinal Plating Systems Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ..................... 62

Figure 25: Spinal Surgery Market, United States, Company Share (%) 2012 ................................................................................ 68

Figure 25: GlobalData Epidemiology-Based Forecasting Model .................................................................................................. 231

Figure 26: GlobalData Capital Equipment-Based Forecasting Model .......................................................................................... 232

Figure 27: Primary Interviews by Participant Type (%) ................................................................................................................. 233



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2 Introduction

Medical Equipment Market Reports are the ideal guide for anyone wishing to understand their market better in terms

of revenues, unit sales, distributors and competitors

2.1 What Is This Report About?

This report provides an overview and the following information related to the country, various categories, distribution

share and competitive landscape in the market:

1. Comprehensive data related to the market revenue, unit sale, average price, company share and

distribution share.

2. Corporate-level profiles of key companies operating in the Spinal Surgery market, which includes a brief

overview of the company. The selection of the companies is based on their operational presence.

3. A list of key products under development by different companies. The selection of this list is based on the

territory in which these products are being clinically investigated.

4. Key news and deals related to the Spinal Surgery market.

2.2 Spinal Surgery Market Segmentation

Spinal Surgery market is segmented as described below, in this report:

1. Spinal Fusion

• Spinal Fusion includes sub-segments such as Interbody Cages*Pedicle Screw Systems and Spinal

Plating Systems

2. Spinal Non-Fusion

• Spinal Non-Fusion includes sub-segments such as Artificial Disc Replacement (ADR)*Dynamic

Stabilization and Interspinous Process Decompression (IPD) Devices

3. Vertebral Compression Fracture Repair Devices

• Vertebral Compression Fracture Repair Devices includes sub-segments such as Vertebroplasty

devices and Kyphoplasty (also known as Balloon Kyphoplasty) devices



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2.3 Definitions of Markets Covered in the Report

Spinal Surgery

Spinal surgery includes devices used in the surgical treatment of degenerative disc diseases, intra-vertebral fractures, scoliosis

and so on. Spinal fusion and non fusion devices are included in this category.

Spinal Fusion

Spinal fusion is a surgical procedure that involves joining two vertebrae in the spine, with the help of certain devices, in order to

relieve pain. Interbody cages, pedicle screw systems and spinal plating systems are covered under this segment.

Interbody Cages

Interbody cage fusion uses a hollow threaded titanium or carbon fiber cylinder to fuse two vertebrae together to treat degenerative

disc disease. During the process the diseased disk is removed and two interbody cages are placed in the opening from where the

diseased disk has been removed. Bone allografts are not tracked under this segment. One unit consists of one cage.

Pedicle Screw Systems

Pedicle screws are used in a spinal fusion procedure to add extra support and strength to the fusion while it heals and are placed

above and below the vertebrae. Pedicle screw systems are made from a variety of materials such as various types of stainless

steel, titanium alloys, and unalloyed titanium. The device consists of a combination of anchors (such as bolts, hooks, and/or

screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (such as plates, rods,

and/or plate/rod combinations); and/or transverse connectors. One unit consists of four screws, two rods for one level surgery, six

screws and two rods for two level surgery and eight screws and two rods for three level surgery. Anchors such as bolts and hooks

are also tracked under Pedicle Screw Systems.

Spinal Plating Systems

Spinal plating system is an implant used to treat patients with degenerative disc disease affecting the spine. One unit consists of

one plate and four screws for one level surgery, one plate six screws for two level surgery, and one plate and eight screws for

three level surgery.

Spinal Non-Fusion

Spinal non-fusion surgery is a surgery that involves restoring the mobility of the spine by implanting an artificial disc in place of the

diseased or damaged disc. The devices covered are Artificial Disc Replacements (ADR), dynamic stabilization and Interspinous

Process Decompression (IPD) devices.

Cervical Disc Replacement

Cervical disc arthroplasty is a surgical procedure during which an artificial disc is used to replace degenerated intervertebral discs.

It is used for disc replacement in Cervical Region. One unit consists of one Cervical Disc.



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Lumbar Disc Replacement

Lumbar disc arthroplasty is a surgical procedure during which an artificial disc is used to replace degenerated intervertebral discs.

It is used for disc replacement in Lumbar Region. One unit consists of one Lumbar Disc.

Dynamic Stabilization

Dynamic stabilization systems include a superior component for attachment to a superior vertebra of a spinal motion segment and

an inferior component for attachment to an inferior vertebral of a spinal motion segment. One unit is one dynamic stabilization.

Interspinous Process Decompression (IPD) Devices

Interspinous process decompression is a surgical procedure in which an implant is placed between spinous processes in the back

of the spine. They are mostly used for spinal stenosis procedures. One unit refers to one IPD device.

Vertebral Compression Fracture Repair Devices

VCF Repair Devices are a set of surgical devices used to perform minimally invasive surgical procedures in patients suffering from

Vertebral Compression Fractures (VCF). These minimally invasive surgical procedures are known as Vertebroplasty and

Kyphoplasty procedures.

Vertebroplasty Devices

Vertebroplasty devices consist of a set of devices used to perform Percutaneous Vertebroplasty procedures in patients suffering

from Vertebral Compression Fractures. The devices are usually sold in the form of a single kit to be used in a procedure. The kit

consists of Vertebroplasty needle, coaxial bone & biopsy needle, stylet kit and cement injector along with bone cement as filler

material. The cost of bone cement is excluded while calculating the market size for Vertebroplasty Devices.

Kyphoplasty Devices

Kyphoplasty (also known as Balloon Kyphoplasty) devices are defined as a set of devices used for performing Balloon

Kyphoplasty procedures. The set of devices, usually sold as single kit, consists of a balloon tamp, vertebral augmentation needle,

coaxial bone and biopsy needle, stylet kit and cement injector. The cost of bone cement used in the procedure is not considered

when calculating the market size for Kyphoplasty Devices.



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3 Spinal Surgery Market, United States

3.1 Spinal Surgery Market, United States, Revenue ($m), 2005-2012

Figure 1: Spinal Surgery Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Source: GlobalData



Page 17

Table 1: Spinal Surgery Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Category 2005 2006 2007 2008 2009 2010 2011 2012 CAGR 05-12

Total

% Growth

Source: GlobalData



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3.2 Spinal Surgery Market, United States, Revenue ($m), 2012-2020

Figure 2: Spinal Surgery Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020

Source: GlobalData



Page 19

Table 2: Spinal Surgery Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020

Category 2012 2013 2014 2015 2016 2017 2018 2019 2020 CAGR 12-20

Total

% Growth

Source: GlobalData



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3.2.1 Spinal Fusion Market, United States, Revenue ($m), by Segment, 2005-2012

Figure 3: Spinal Fusion Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Source: GlobalData



Page 21

Table 3: Spinal Fusion Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Segment 2005 2006 2007 2008 2009 2010 2011 2012 CAGR 05-12

Total

% Growth

Source: GlobalData



Page 22

3.2.2 Spinal Non-Fusion Market, United States, Revenue ($m), by Segment, 2005-2012

Figure 4: Spinal Non-Fusion Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Source: GlobalData



Page 23

Table 4: Spinal Non-Fusion Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Segment 2005 2006 2007 2008 2009 2010 2011 2012 CAGR 05-12

Total

% Growth

Source: GlobalData



Page 226

8 Appendix

The data and analysis within this report are driven by Medical eTrack. Medical eTrack gives you the key

information required to drive sales, investment and deal-making activity in your business. It includes the following:

15,000+ data tables showing market size across more than 780 medical equipment segments and 15

countries, from 2005 and forecast to 2020

6,000+ primary expert interviews, conducted annually to ensure data and report quality

1,100+ medical equipment conference reports

1,000+ industry-leading reports per annum, covering growing sectors, market trends, investment

opportunities and competitive landscape

600+ analysis reports, covering market and pipeline product analysis, by indication; medical equipment

trends and issues, and investment and M&A trends worth over $3m

50,000+ medical equipment company profiles

2,000+ private, emerging and technology start-up company profiles

4,000+ company profiles of medical equipment manufacturers in China and India

2,000+ company profiles of medical equipment manufacturers in Japan

825+ companies‘ revenue splits and market shares

1,100+ quarterly and annual medical equipment company financials

700+ medical equipment company SWOTs

11,700+ pipeline product profiles

14,000+ marketed product profiles

16,900+ clinical trials

17,000+ trial investigators

18,000+ new product patents

3,700+ reports on companies with products in development

21,500+ reports on deals in the medical equipment industry

1,300+ surgical and diagnostic procedures by therapy area

50+ key healthcare indicators by country

For more information or to receive a free demonstration of the service, please visit:

http://www.medicaletrack.com/ContactUs.aspx?Id=RequestDemo



Page 227

8.1 Research Methodology

GlobalData‘s dedicated research and analysis teams consist of experienced professionals with advanced statistical

expertise and marketing, market research and consulting backgrounds in the medical devices industry.

GlobalData adheres to the codes of practice of the European Pharmaceutical Marketing Research Association

(http://www.ephmra.org/).

All GlobalData databases are continuously updated and revised.

8.1.1 Coverage

The objective of updating GlobalData‘s coverage is to ensure that it represents the most up-to-date vision of the

industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and

competitor sources.

Company coverage is based on three key factors: revenue; product and media attention; and innovation and market

potential.

The estimated revenue of all major companies, both private and public, are gathered and used to prioritize coverage.

GlobalData aims to cover all major news events and deals in the medical devices industry, updated on a daily basis.

The coverage is further streamlined and strengthened with additional input from GlobalData‘s expert panel.

8.1.2 Secondary Research

The research process begins with extensive secondary research using internal and external sources to gather all

relevant data and information pertaining to a particular market model for a particular country. The secondary research

sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings

Industry trade journals, scientific journals and other technical literature

Association and healthcare organization websites

PubMed, Medscape and other relevant services which compile extensive reviews of clinical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market



Page 228

8.1.3 Primary Research

GlobalData conducts interviews with industry participants and commentators in order to validate its data and analysis.

A typical research interview fulfills the following functions:

Provides first-hand information on market size, market trends, growth trends, competitive landscape and

future outlook

Helps to validate and strengthen secondary research findings

Further develops the analysis team‘s expertise and market understanding

Primary research involves email correspondence, telephone interviews and face-to-face interviews for each market,

category, segment and sub-segment across a range of geographies.

The participants who typically take part in such a process include, but are not limited to:

o Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and

national sales managers

o Distributors, paramedics and representatives from hospital stores, laboratories and pharmacies

o Outside experts: investment bankers, valuation experts and research analysts that specialize in specific

medical equipment markets

o Key opinion leaders: physicians and surgeons that specialize in the therapeutic areas in which the

medical device is used

The following table lists the total number of primary research participants by country, in this case for the orthopedic

devices market. Market data is validated using input from 1,200 primary research participants. These include

demand-side stakeholders such as orthopedic surgeons, and supply-side participants such as marketing managers,

sales managers and product managers of companies manufacturing/marketing orthopedic devices.



Page 229

Table 78: Total Number of Primary Research Participants, Orthopedic Devices Market, by Country

Country Total number of primary research participants

US 80

UK 104

Germany 83

France 86

Italy 85

Spain 75

Brazil 80

China 90

India 112

Russia 64

Japan 74

Australia 71

Canada 66

Mexico 64

South Korea 66

Total 1,200

Source: GlobalData

8.1.4 Market Modeling and Forecasting

GlobalData uses an epidemiology-based treatment flow model and capital equipment-based model to estimate and

forecast market size.

Epidemiology-Based Market Model and Forecasting

The epidemiology-based forecasting model uses epidemiology data gathered from research publications and primary

interviews with physicians to establish the target patient population and treatment flow pattern for individual diseases

and therapies. The data covers prevalence, incidence, diseased population, diagnosed population, and treatment

population.

The market forecast begins with the general population, the size of which varies depending on the indication.

Prevalence is the percentage of the total population that suffers from a particular disease or condition.

Incidence is the number of new cases of a condition, symptom, death or injury that develop during a specific

time period, such as one year.

The diseased population is the population suffering from a particular disease or condition.

The diagnosed population is the population that has been diagnosed with a particular disease or condition,

expressed as a percentage of the prevalence population.

The treatment population is the percentage of the population that has been diagnosed with a particular

disease or condition.



Page 230

Device uptake is the percentage of the treatment population using a particular device, determined based on

the primary responses and the information available in secondary sources.

The epidemiology-based forecasting model for a medical device is used to:

Determine the patient segment using a particular device or procedure

Determine the frequency of usage of a particular device depending on the patient type, which further helps to

determine the absolute unit sales of a device in a year

The market for any medical device is directly proportional to the volume of units sold and the price per unit.

Market size = volumes of units sold X ASP (Average Selling Price)

The volume of units sold is calculated from the number of patients using or that has been implanted with the device.

Data on treatment rate, diagnosis and surgical treatment rate, if unavailable from research publications, is gathered

from interviews with physicians and used to estimate the patient volume for the disease under consideration.

The ASP of a device is mostly gathered from primary and secondary sources. ASP is the price at which a device is

available in a target country to an end-user. For capital equipment, the end-user is typically considered to be the

healthcare setting. For implants and consumables purchased by patients, the end-user is the patient.

Factors such as company share, reimbursement, company type (local/domestic or multinational) are taken into

consideration during ASP analysis, which uses the following sources:

Company websites

Annual reports/industry reports

Press releases



Page 231

Epidemiology-Based Forecasting Model

Capital Equipment-Based Market Model and Forecasting

The capital equipment-based forecasting model is based on the installed base, replacements and new sales of a

specific type of capital equipment in healthcare facilities such as hospitals, clinics and diagnostic centers. The

installed base is calculated from the average number of units per facility. Sales for a particular year are arrived at by

calculating the number of replacement units and new units (additional and first-time purchases). Secondary sources

and interviews with supply-side participants and key opinion leaders from healthcare facilities are used to arrive at

installed base and unit sales for a particular year. The factors typically affecting the forecast growth rates are:

Growth in the number of healthcare facilities

Healthcare spending and government programs and initiatives

Migration from low-end equipment to high-end equipment

Growth in the diagnosed population and treatment population

Figure 25: GlobalData Epidemiology-Based Forecasting Model

Source: GlobalData



Page 232

Capital Equipment-Based Forecasting Model

8.1.5 Company Share Analysis

Company shares are calculated by analyzing a company‘s sales in a particular market. In the case of public

companies, annual reports and regulatory filings, investor presentations, earnings call transcripts and broker reports

are used to determine a company‘s revenue in a particular market and in a particular geography.

In the case of the private companies, company share data is gathered mostly from primary interviews and secondary

sources. Company share analysis is based on primary interviews with:

Supply side (manufacturers)

o Procurement side

o Distributors

Hospital purchasing groups

Figure 26: GlobalData Capital Equipment-Based Forecasting Model

Source: GlobalData



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Demand side (surgeons/specialists)

The benefits of this approach are:

High number of respondents to validate and from which to derive accurate company shares

Broad view from the supply, demand, and procurement side

Prevents biased opinions being reproduced

Demand-side interviews with key opinion leaders help to understand their preferences for the devices of

specific companies, strengthening company share estimates

Primary Interviews by Participant Type

Figure 27: Primary Interviews by Participant Type (%)

The final company share data is based on input from the supply side, the procurement side and the demand side, as

well as secondary sources.

8.1.6 Distribution Share Analysis

Distribution share information is gathered using a combination of secondary and primary research. It is supported by

primary interviews because the availability of secondary data is limited in most cases.

50

25

25

Procurement side Supply side Demand side



Page 234

8.2 Expert Panel

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData‘s expert panel comprises marketing managers, product specialists, international sales managers from

medical device companies, academics from research universities, key opinion leaders from hospitals, consultants

from venture capital funds and distributors/suppliers of medical equipment and supplies.

Historic data and forecasts are relayed to GlobalData‘s expert panel for feedback and adjusted accordingly.

8.3 GlobalData Consulting

We hope that the data and analysis in this brief will help you to make informed and imaginative business decisions. If

you have further requirements, GlobalData‘s consulting team may be able to help you. GlobalData offers tailor-made

analytical and advisory services to drive your key strategic decisions. For more information about GlobalData‘s

consulting capabilities

8.5 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.

Documents

United States Spinal Surgery Market Outlook to 2020 · United States Spinal Surgery Market Outlook to 2020 GDMECC0009DB / Published March 2014 © GlobalData. This report is a licensed