GDME0163MAR Vertebral Augmentation and …GDME0163MAR / Published OCT 2012

GDME0163MAR / Published OCT 2012 Page 1 Vertebral Augmentation and Vertebroplasty Devices - Global Pipeline

Analysis, Competitive Landscape and Market Forecasts to 2018 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form

Vertebral Augmentation and Vertebroplasty Devices - Global Pipeline Analysis, Competitive Landscape and Market

Forecasts to 2018 Reference Code: GDME0163MAR Publication Date: October 2012

The Global Vertebral Augmentation and Vertebroplasty Devices Market is Expected to Grow at a CAGR of XX% during 2011–2018

Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2011–2018

2011 2018

Rev

enue

($m

)

CAGR (2011-2018) XX%

Source: GlobalData; Analysis based on primary research interviews with marketing and product development managers, surgeons and radiologists in the G7 markets

The global vertebral augmentation and vertebroplasty devices market was valued at $XXm in 2011 and is forecast to grow at Compound Annual Growth Rate (CAGR) of XX% in the 2011–2018 period. The market is likely to be driven by the aging global population and the growing number cases of Vertebral Compression Fractures (VCFs) in the major markets for vertebral augmentation and vertebroplasty devices such as the US, Europe and Japan. In selective markets, the availability of reimbursements for vertebral augmentation (or balloon kyphoplasty) procedures, a comparatively expensive procedure, is also likely to boost the market growth for vertebral augmentation devices. The vertebral augmentation and vertebroplasty market has also recovered from the adverse impact caused by the two studies published in the New England Journal of Medicine (NEJM) in 2009 and procedure numbers using both balloon kyphoplasty and vertebroplasty devices are again increasing. Global vertebroplasty market is also likely to show growth due to launch of new technologies based on more precise bone cement delivery systems and the availability of better alternatives compared to poly(methyl methaacrylate) (PMMA), which is commonly used as bone cement and results in higher incidences of cement leakage than the alternatives.

The US is the Largest Market Driven by Growing Market for Vertebral Augmentation Devices and Reimbursement Availability

Vertebral Augmentation and Vertebroplasty Devices Market, Revenue by Geographic Region (%), 2011

US Market

Rest of the world Market


The US is the largest market for VCF devices testing market. In 2011, the market for vertebral augmentation and vertebroplasty devices was valued at $XXm in the US and is expected to grow at a CAGR of XX% in the 2011–2018 period. The US market is followed by the Japanese market, which is greater than the European market. The reason for the smaller size of the European market is the lower adoption rate for balloon kyphoplasty devices due to limited availability of reimbursements for the procedure.



1 Table of Contents 1 Table of Contents ............................................................................................................................ 3

1.1 List of Tables............................................................................................................................. 5 1.2 List of Figures............................................................................................................................ 7

2 Introduction ..................................................................................................................................... 8 2.1 GlobalData Report Guidance ..................................................................................................... 8

3 Vertebral Compression Fractures - Overview.................................................................................... 9 3.1 Epidemiology ............................................................................................................................ 9 3.2 Acute and Chronic Symptoms.................................................................................................. 10 3.3 Treatment Options for VCF...................................................................................................... 11

3.3.1 Benefits of Vertebral Augmentation over Vertebroplasty................................................... 13 3.3.2 Potential Complications................................................................................................... 13

3.4 Treatment Flow Model for Vertebral Augmentation and Vertebroplasty Devices......................... 13 4 Vertebral Augmentation and Vertebroplasty Devices: Global Market Characterization...................... 15

4.1 Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), Historic, 2004–2011.............................................................................................................................. 15

4.2 Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), Forecast, 2011–2018.............................................................................................................................. 16

4.3 Vertebral Augmentation and Vertebroplasty Devices Market, Key Trends.................................. 18 4.3.1 Recovery of Kyphoplasty and Vertebroplasty Market from Negative Impact of New England

Journal of Medicine Studies ............................................................................................ 18 4.3.2 Niche Status of Vertebral Augmentation Market with High Growth and Low Competition

Provides a Great Opportunity for Orthopedic Device Manufacturers ................................. 22 4.3.3 Ongoing Studies Comparing the Effectiveness of Vertebral Augmentation and

Vertebroplasty Techniques might decide the Course of Future Industry Growth ................ 23 4.4 Global Vertebral Augmentation and Vertebroplasty Devices, Market Dynamics ......................... 29

4.4.1 Market Drivers................................................................................................................ 30 4.4.2 Market Restraints ........................................................................................................... 38

5 Vertebral Augmentation and Vertebroplasty Devices Market, Analysis by Country, Revenue ($m), 2004 – 2018 .................................................................................................................................. 42

5.1 Vertebral Augmentation and Vertebroplasty Devices Market, the US, Revenue ($m), Historic, 2004–2011.............................................................................................................................. 42

5.2 Vertebral Augmentation and Vertebroplasty Devices Market, the US, Revenue ($m), Forecast, 2011–2018.............................................................................................................................. 43

5.3 Vertebral Augmentation and Vertebroplasty Devices Market, the UK, Revenue ($m), Historic, 2004–2011.............................................................................................................................. 45

5.4 Vertebral Augmentation and Vertebroplasty Devices Market, the UK, Revenue ($m), Forecast, 2011–2018.............................................................................................................................. 46

5.5 Vertebral Augmentation and Vertebroplasty Devices Market, Germany, Revenue ($m), Historic, 2004–2011.............................................................................................................................. 47

5.6 Vertebral Augmentation and Vertebroplasty Devices Market, Germany, Revenue ($m), Forecast, 2011–2018.............................................................................................................................. 48

5.7 Vertebral Augmentation and Vertebroplasty Devices Market, France, Revenue ($m), Historic, 2004–2011.............................................................................................................................. 49

5.8 Vertebral Augmentation and Vertebroplasty Devices Market, France, Revenue ($m), Forecast, 2011–2018.............................................................................................................................. 51

5.9 Vertebral Augmentation and Vertebroplasty Devices Market, Italy, Revenue ($m), Historic, 2004–2011 52

5.10 Vertebral Augmentation and Vertebroplasty Devices Market, Italy, Revenue ($m), Forecast, 2011–2018 53

5.11 Vertebral Augmentation and Vertebroplasty Devices Market, Spain, Revenue ($m), Historic, 2004–2011.............................................................................................................................. 54

5.12 Vertebral Augmentation and Vertebroplasty Devices Market, Spain, Revenue ($m), Forecast, 2011–2018.............................................................................................................................. 55

5.13 Vertebral Augmentation and Vertebroplasty Devices Market, Japan, Revenue ($m), Historic, 2004–2011.............................................................................................................................. 56

5.14 Vertebral Augmentation and Vertebroplasty Devices Market, Japan, Revenue ($m), Forecast, 2011–2018.............................................................................................................................. 57

6 Vertebral Augmentation and Vertebroplasty Devices Market: Strategic Competitive Assessment...... 59 6.1 Vertebral Augmentation and Vertebroplasty Devices, Key Market Participants........................... 60



6.1.1 Medtronic Inc.................................................................................................................. 60 6.1.2 Stryker Corporation......................................................................................................... 65 6.1.3 CareFusion..................................................................................................................... 67

7 Vertebral Augmentation and Vertebroplasty Devices: Other Marketed Products............................... 70 7.1 Confidence Spinal Cement System, Johnson & Johnson (DePuy/Synthes)................................ 70

7.1.1 Product Description ........................................................................................................ 70 7.2 Shield Kyphoplasty System, Soteira......................................................................................... 71

7.2.1 Product Description ........................................................................................................ 71 7.3 Kyphoplasty System, BONESUPPORT.................................................................................... 71

7.3.1 Product Description ........................................................................................................ 71 7.4 Acu-Cut Vertebral Augmentation System, Ascendx Spine......................................................... 71

7.4.1 Product Description ........................................................................................................ 71 7.5 V-MAX Delivery System, Johnson & Johnson (DePuy/Synthes) ................................................ 72

7.5.1 Product Description ........................................................................................................ 72 7.6 Integrated System for Vertebroplasty, Skeltex .......................................................................... 72

7.6.1 Product Description ........................................................................................................ 72 7.7 OsseoFix Spinal Fracture Reduction System, Alphatec Spine................................................... 72

7.7.1 Product Description ........................................................................................................ 72 8 Vertebral Augmentation and Vertebroplasty Devices: Key Pipeline Products ................................... 73

8.1 Crosstrees Pod, Crosstrees Medical Inc................................................................................... 73 8.1.1 Product Description ........................................................................................................ 73 8.1.2 Product Status................................................................................................................ 73

8.2 Kiva VCF System, Benvenue Medical, Inc................................................................................ 74 8.2.1 Product Description ........................................................................................................ 74 8.2.2 Product Status................................................................................................................ 74

8.3 OsseoFix Spinal Fracture Reduction System, Alphatec Spine, Inc............................................. 74 8.3.1 Product Description ........................................................................................................ 74 8.3.2 Product Status................................................................................................................ 74

8.4 VerteLift Implant, SpineAlign Medical, Inc................................................................................. 74 8.4.1 Product Description ........................................................................................................ 74 8.4.2 Product Status................................................................................................................ 74

8.5 AVAMAX Vertebroplasty Kits, CareFusion................................................................................ 75 8.5.1 Product Description ........................................................................................................ 75 8.5.2 Product Status................................................................................................................ 75

9 Vertebral Augmentation and Vertebroplasty Devices Market: Strategic Deals Analysis..................... 76 9.1 List of Venture Financing Deals................................................................................................ 77 9.2 List of Debt Offerings............................................................................................................... 79 9.3 List of Partnership Deals.......................................................................................................... 80 9.4 List of Equity Offerings Deals ................................................................................................... 80 9.5 Key Deals ............................................................................................................................... 80

9.5.1 Ascendx Spine Entered into Co-Marketing Agreement with Anwerina............................... 80 9.5.2 Benvenue Medical Raised $25m Series D Financing ....................................................... 81 9.5.3 Shanghai Kinetic Medical Completed IPO for $60m ......................................................... 81

10 Appendix....................................................................................................................................... 82 10.1 Market Definitions.................................................................................................................... 82

10.1.1 Vertebral Augmentation and Vertebroplasty Devices........................................................ 82 10.2 Acronyms................................................................................................................................ 82 10.3 Sources .................................................................................................................................. 83 10.4 Research Methodology............................................................................................................ 87

10.4.1 Secondary Research ...................................................................................................... 88 10.4.2 Primary Research........................................................................................................... 88 10.4.3 Models ........................................................................................................................... 88 10.4.4 Forecasts ....................................................................................................................... 89 10.4.5 Expert Panels................................................................................................................. 89

10.5 GlobalData Consulting............................................................................................................. 89 10.6 Contact Us .............................................................................................................................. 89 10.7 Disclaimer ............................................................................................................................... 89



1.1 List of Tables Table 1: VCF Prevalence in Cancer Patients..................................................................................... 10 Table 2: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2004–

2011................................................................................................................................... 15 Table 3: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2011–

2018................................................................................................................................... 17 Table 4: Details of New England Journal of Medicine Studies on Vertebroplasty And Vertebral

Augmentation Procedures, August 2009.............................................................................. 18 Table 5: Global Procedure Volume for Vertebral Augmentation and Vertebroplasty, 2008–2010 ......... 19 Table 6: Global Kyphoplasty and Vertebroplasty Market Recovery Pattern, 2008–2011...................... 21 Table 7: FREE (Fracture Reduction Evaluation), 2009....................................................................... 23 Table 8: FREE (Fracture Reduction Evaluation), 2011....................................................................... 24 Table 9: Cancer Patient Fracture Evaluation or CAFÉ, 2011.............................................................. 24 Table 10: Mortality Risk for Operated and Non-operated Vertebral Fracture Patients in the Medicare

population or The SAVE study, 2011 ................................................................................... 25 Table 11: Three-year Outcomes after Kyphoplasty in Patients with Osteoporosis with Painful Vertebral

Fractures , 2010 ................................................................................................................. 25 Table 12: Comparison of 5,766 Vertebral Compression Fractures Treated With or Without Kyphoplasty,

2010................................................................................................................................... 26 Table 13: The Kiva System as a Vertebral Augmentation Treatment (KAST), Ongoing......................... 27 Table 14: Balloon Kyphoplasty Versus Vertebroplasty for Treatment of Osteoporotic Vertebral

Compression Fracture: a Prospective, Comparative and Randomized Clinical Study............. 27 Table 15: Adjacent Vertebral Fractures after Percutaneous Vertebral Augmentation of Osteoporotic

Vertebral Compression Fracture: A Comparison of Balloon Kyphoplasty and Vertebroplasty, 2010................................................................................................................................... 28

Table 16: Efficacy of Unipedicular Balloon Kyphoplasty for Treatment of Multiple Myeloma Vertebral Lesions, 2011 ..................................................................................................................... 28

Table 17: Snapshot of New Diagnostic Technologies for Osteoporosis, 2010–2012 ............................. 31 Table 18: Vertebral Augmentation Devices Market, Japan, Revenue ($m), Forecast, 2011–2018 ......... 35 Table 19: Procedure Cost Comparison, Vertebroplasty vs. Vertebral Augmentation, the US, 2007–2008

.......................................................................................................................................... 36 Table 20: Vertebral Augmentation and Vertebroplasty Devices Market, by Country, Europe, Revenue

($m), 2011.......................................................................................................................... 40 Table 21: Vertebral Augmentation and Vertebroplasty Devices Market, the US, Revenue ($m), 2004–

2011................................................................................................................................... 42 Table 22: Vertebral Augmentation and Vertebroplasty Devices Market, the US, Revenue ($m), 2011–

2018................................................................................................................................... 44 Table 23: Vertebral Augmentation and Vertebroplasty Devices Market, the UK, Revenue ($m), 2004–

2011................................................................................................................................... 45 Table 24: Vertebral Augmentation and Vertebroplasty Devices Market, the UK, Revenue ($m), 2011–

2018................................................................................................................................... 46 Table 25: Vertebral Augmentation and Vertebroplasty Devices Market, Germany, Revenue ($m), 2004–

2011................................................................................................................................... 47 Table 26: Vertebral Augmentation and Vertebroplasty Devices Market, Germany, Revenue ($m), 2011–

2018................................................................................................................................... 48 Table 27: Vertebral Augmentation and Vertebroplasty Devices Market, France, Revenue ($m), 2004–

2011................................................................................................................................... 50 Table 28: Vertebral Augmentation and Vertebroplasty Devices Market, France, Revenue ($m), 2011–

2018................................................................................................................................... 51 Table 29: Vertebral Augmentation and Vertebroplasty Devices Market, Italy, Revenue ($m), 2004–2011

.......................................................................................................................................... 52 Table 30: Vertebral Augmentation and Vertebroplasty Devices Market, Italy, Revenue ($m), 2011–2018

.......................................................................................................................................... 53 Table 31: Vertebral Augmentation and Vertebroplasty Devices Market, Spain, Revenue ($), 2004–2011

.......................................................................................................................................... 54 Table 32: Vertebral Augmentation and Vertebroplasty Devices Market, Spain, Revenue ($m), 2011–2018

.......................................................................................................................................... 55 Table 33: Vertebral Augmentation and Vertebroplasty Devices Market, Japan, Revenue ($m), 2004–2011

.......................................................................................................................................... 56 Table 34: Vertebral Augmentation and Vertebroplasty Devices Market, Japan, Revenue ($m), 2011–2018

.......................................................................................................................................... 58



Table 35: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Company Share (%), 2011................................................................................................................................... 59

Table 36: Medtronic, Key Marketed Products, 2012............................................................................. 60 Table 37: Kyphoplasty Settlements Between Hospitals and US Federal Government, 2009 ─ 2011...... 62 Table 38: Medtronic, Quarterly Revenue Decline from Core Spine, 2012 ............................................. 63 Table 39: Stryker, Key Marketed Products, 2012................................................................................. 65 Table 40: CareFusion, Key Marketed Products, 2012.......................................................................... 68 Table 41: Vertebral Augmentation and Vertebroplasty Devices: Other Marketed Products.................... 70 Table 42: Confidence Spinal Cement System, Description, 2011......................................................... 70 Table 43: Shield Kyphoplasty System, Description, 2011..................................................................... 71 Table 44: Kyphoplasty System, Description, 2011............................................................................... 71 Table 45: Acu-Cut Vertebral Augmentation System, Description, 2011 ................................................ 71 Table 46: V-MAX Delivery System, Description, 2011 ......................................................................... 72 Table 47: Integrated System for Vertebroplasty (ISV), Description, 2011.............................................. 72 Table 48: OsseoFix Spinal Fracture Reduction System, Description, 2010........................................... 72 Table 49: Vertebral Augmentation and Vertebroplasty Devices: Key Pipeline Products......................... 73 Table 50: Crosstrees Pod, Status ....................................................................................................... 73 Table 51: Kiva VCF System, Status.................................................................................................... 74 Table 52: OsseoFix Spinal Fracture Reduction System, Status............................................................ 74 Table 53: VerteLift Implant ................................................................................................................. 74 Table 54: AVAMAX Vertebroplasty Kits, Status................................................................................... 75 Table 55: Vertebral Augmentation and Vertebroplasty Devices Market, Key Strategic Deals Analysis,

2010–2012 ......................................................................................................................... 76 Table 56: Vertebral Augmentation and Vertebroplasty Devices Market, Venture Financing Deals, 2010–

2012................................................................................................................................... 77 Table 57: Vertebral Augmentation and Vertebroplasty Devices Market, Debt Offerings, 2010–2012...... 79 Table 58: Vertebral Augmentation and Vertebroplasty Devices Market, Partnership Deals, 2010–2012 80 Table 59: Vertebral Augmentation and Vertebroplasty Devices Market, Equity Offering Deals, 2012..... 80



1.2 List of Figures Figure 1: Vertebral Compression Fracture, Treatment Options............................................................ 11 Figure 2: Treatment Flow Model: Vertebral Augmentation and Vertebroplasty Devices, Global, 2010... 13 Figure 3: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2004–

2011................................................................................................................................... 15 Figure 4: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2011–

2018................................................................................................................................... 16 Figure 5: Global Procedure Volume for Vertebral Augmentation and Vertebroplasty, 2008–2010 ......... 19 Figure 6: Global Kyphoplasty and Vertebroplasty Market Recovery Pattern, 2008–2011...................... 21 Figure 7: Global Vertebral Augmentation and Vertebroplasty Devices, Market Dynamics..................... 29 Figure 8: Vertebral Augmentation Devices Market, Japan, Revenue ($m), Forecast, 2011–2018 ......... 35 Figure 9: Vertebral Augmentation and Vertebroplasty Devices Market, by Country, Europe, Revenue

($m), 2011.......................................................................................................................... 39 Figure 10: Vertebral Augmentation and Vertebroplasty Devices Market, the US, Revenue ($m), 2004–

2011................................................................................................................................... 42 Figure 11: Vertebral Augmentation and Vertebroplasty Devices Market, the US, Revenue ($m), 2011–

2018................................................................................................................................... 43 Figure 12: Vertebral Augmentation and Vertebroplasty Devices Market, the UK, Revenue ($m), 2004–

2011................................................................................................................................... 45 Figure 13: Vertebral Augmentation and Vertebroplasty Devices Market, the UK, Revenue ($m), 2011–

2018................................................................................................................................... 46 Figure 14: Vertebral Augmentation and Vertebroplasty Devices Market, Germany, Revenue ($m), 2004–

2011................................................................................................................................... 47 Figure 15: Vertebral Augmentation and Vertebroplasty Devices Market, Germany, Revenue ($m), 2011–

2018................................................................................................................................... 48 Figure 16: Vertebral Augmentation and Vertebroplasty Devices Market, France, Revenue ($m), 2004–

2011................................................................................................................................... 49 Figure 17: Vertebral Augmentation and Vertebroplasty Devices Market, France, Revenue ($m), 2011–

2018................................................................................................................................... 51 Figure 18: Vertebral Augmentation and Vertebroplasty Devices Market, Italy, Revenue ($m), 2004–2011

.......................................................................................................................................... 52 Figure 19: Vertebral Augmentation and Vertebroplasty Devices Market, Italy, Revenue ($m), 2011–2018

.......................................................................................................................................... 53 Figure 20: Vertebral Augmentation and Vertebroplasty Devices Market, Spain, Revenue ($m), 2004–2011

.......................................................................................................................................... 54 Figure 21: Vertebral Augmentation and Vertebroplasty Devices Market, Spain, Revenue ($m), 2011–2018

.......................................................................................................................................... 55 Figure 22: Vertebral Augmentation and Vertebroplasty Devices Market, Japan, Revenue ($m), 2004–2011

.......................................................................................................................................... 56 Figure 23: Vertebral Augmentation and Vertebroplasty Devices Market, Japan, Revenue ($m), 2011–2018

.......................................................................................................................................... 57 Figure 24: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Company Share (%),

2011................................................................................................................................... 59 Figure 25: Medtronic, SWOT Analysis.................................................................................................. 61 Figure 26: Medtronic, Quarterly Revenue Decline from Core Spine, 2012 ............................................. 63 Figure 27: Stryker, SWOT Analysis...................................................................................................... 65 Figure 28: CareFusion, SWOT Analysis............................................................................................... 68 Figure 29: Vertebral Augmentation and Vertebroplasty Devices Market, Key Strategic Deals Analysis,

2010–2012 ......................................................................................................................... 76



2 Introduction Vertebral augmentation and vertebroplasty devices are non-surgical treatment options used for the treatment of vertebral compression fractures. The two procedures are usually performed in outpatient settings. The procedures are used for patients suffering from vertebral compression fractures for which conventional therapies such as rest, back bracing or drug-based therapies have not been effective. For such patients, vertebral augmentation and vertebroplasty devices offer an alternative to invasive surgical options.

In this report, the minimally invasive options for the treatment of Vertebral Compression Fractures (VCFs) are divided into: vertebral augmentation devices (sometimes referred to as balloon kyphoplasty devices) and vertebroplasty devices. Vertebral augmentation devices are defined as a set of devices used for performing vertebral augmentation procedures. The set of devices is usually sold as a single kit, consist of a balloon tamp, vertebral augmentation needle, coaxial bone and biopsy needle, stylet kit and cement injector. Similarly, vertebroplasty devices are defined as a set of devices used for performing vertebroplasty procedures. The set of devices is usually sold as a single kit, which consists of a vertebroplasty needle, coaxial bone and biopsy needle, stylet kit and cement injector.

2.1 GlobalData Report Guidance The report begins with an executive summary, which captures the key points in the global vertebral

augmentation and vertebroplasty devices market.

The chapter, ‘Vertebral Compression Fractures: Overview’ provides information about vertebral augmentation and vertebroplasty devices market, various segments and types of vertebral augmentation and vertebroplasty devices used.

The chapter, ‘Vertebral Augmentation and Vertebroplasty Devices: Global Market Characterization’ provides information on the global market size from 2004 through to 2018. The chapter also details the market trends, drivers and restraints affecting the market.

The chapter, ‘Vertebral Augmentation and Vertebroplasty Devices Market, Analysis by Country, Revenue ($m), 2004 – 2018’ provides information on the global market for each of the four segments under vertebral augmentation and vertebroplasty devices. It mentions the market size for each of these segments from 2004 to 2011 and from 2011 to 2018. It also mentions the market growth drivers and restraints specific to these segments.

The chapter, ‘Vertebral Augmentation and Vertebroplasty Devices Market: Strategic Competitive Assessment’ includes market analysis and forecast information for seven countries, the US, the UK, Germany, France, Spain, Italy and Japan for 2004, through to 2018.

The chapter, ‘Vertebral Augmentation and Vertebroplasty Devices: Other Marketed Products’ discusses the competitive landscape of the vertebral augmentation and vertebroplasty devices market. It also includes profiles of the key players in the market. The section also provides information on the key approved products in the vertebral augmentation and vertebroplasty devices market.

The chapter, ‘Vertebral Augmentation and Vertebroplasty Devices: Key Pipeline Products’ provides information about other key marketed vertebral augmentation and vertebroplasty devices which are present in the market, in addition to the products profiled in chapter 8.

The chapter, ‘Vertebral Augmentation and Vertebroplasty Devices Market: Strategic Deals Analysis’ discusses some of the key deals in the global vertebral augmentation and vertebroplasty devices market in the 2011–2012 period.



4 Vertebral Augmentation and Vertebroplasty Devices: Global Market Characterization

4.1 Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), Historic, 2004–2011

The below figure represents the global vertebral augmentation and vertebroplasty devices market for the 2004–2011 period. During the period, the market grew at a high CAGR of nearly XX%.

Figure 3: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2004–2011

2004 2005 2006 2007 2008 2009 2010 2011

Rev

enue

($m

)

Total vertebral augmentation devices market Total vertebroplasty devices market


The table below represents the global vertebral augmentation and vertebroplasty devices market for the 2004–2011 period.

Table 2: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2004–2011

2004 2005 2006 2007 2008 2009 2010 2011 CAGR (2004–

2011)

Total vertebral augmentation devices market

Total vertebroplasty devices market

Total vertebral augmentation devices and vertebroplasty market




4.2 Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), Forecast, 2011–2018

The figure below represents the forecast global vertebral augmentation and vertebroplasty devices market for the 2011–2018 period. During this period, the market is expected to grow at a CAGR of XX%.

Figure 4: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2011–2018

2011 2012 2013 2014 2015 2016 2017 2018

Rev

enue

($m

)

Total vertebral augmentation devices market Total vertebroplasty devices market




The table below represents the forecast global vertebral augmentation and vertebroplasty devices market for the 2011–2018 period.

Table 3: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Revenue ($m), 2011–2018

2011 2012 2013 2014 2015 2016 2017 2018 CAGR (2011–

2018)

Total vertebral augmentation devices Market

Total vertebroplasty devices market

Total vertebral augmentation devices and vertebroplasty market


The global vertebral augmentation and vertebroplasty devices market is expected to reach a value of $XX billion by 2018. In the 2011–2018 period, the market is expected to grow at a CAGR of XX%. The market will be primarily driven by growth in the vertebral augmentation devices market, which is expected to grow at a CAGR of XX% in the 2011–2018 period. The vertebroplasty devices market is also expected to grow at a healthy CAGR of XX% after recovery from the adverse impact of NEJM studies and aided by the launch of devices based on precise delivery and PMMA alternatives.



6 Vertebral Augmentation and Vertebroplasty Devices Market: Strategic Competitive Assessment

The below chart represents the company shares of the different market competitors present in the vertebral augmentation and vertebroplasty device market for 2011.

Figure 24: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Company Share (%), 2011

Medtronic

Stryker

CareFusionOthers


Table 35: Vertebral Augmentation and Vertebroplasty Devices Market, Global, Company Share (%), 2011

Company Market Share (%)

Medtronic

Stryker

CareFusion

Others


Medtronic (Kyphon) is the leader in the global vertebral augmentation and vertebroplasty devices market. The company has a share of XX% and is the dominant player in the vertebral augmentation devices market. Stryker holds the second position in the market, with a share of XX%. Stryker offers products for both vertebroplasty and vertebral augmentation procedures. CareFusion, who in 2010 entered the vertebral augmentation device market, holds the third position with nearly XX% of the market share.



10 Appendix

10.1 Market Definitions 10.1.1 Vertebral Augmentation and Vertebroplasty Devices Vertebral augmentation and vertebroplasty devices consist of a set of devices used to perform percutaneous vertebroplasty or vertebral augmentation procedures in patients suffering from vertebral compression fractures. The devices are usually sold in the form of a single kit to be used in procedure salong with bone cement as filler material. The cost of bone cement is excluded while calculating the market size for vertebral augmentation and vertebroplasty devices.

10.1.1.1 Vertebral Augmentation Devices

Vertebral augmentation devices are defined as a set of devices used for performing vertebral augmentation 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 vertebral augmentation devices.

10.1.1.2 Vertebroplasty Devices

Vertebroplasty devices are defined as a set of devices used for performing vertebroplasty procedure. The set of devices, usually sold as single kit, consists of vertebroplasty needle, coaxial bone and biopsy needle, stylet kit and cement injector. The cost of bone cement used in the procedure is not considered while calculating the market size for vertebroplasty devices.

10.2 Acronyms AAOS American Association of Orthopedic Surgeons

ASU Arizona State University

BKP Balloon Kyphoplasty

BMD Bone Mineral Density

CAFE Cancer Patient Fracture Evaluation

CAGR Compound Annual Growth Rate

CRDM Cardiac Rhythm Disease Management

CT Computerized Tomography

DEXA Dual Energy X-Ray Absorptiometry

DOJ Department of Justice

FCA False Claims Act

FREE Fracture Reduction Evaluation

HEAT Health Care Fraud Prevention and Enforcement Action Team

IBT Inflatable Bone Tamp

IDS Immunodiagnostic Systems

IOF International Osteoporosis Foundation

ISCD International Society for Clinical Densitometry

MRI Magnetic Resonance Imaging

NEJM New England Journal of Medicine

OI Osteogenesis imperfecta



OSSDP Osteoporosis Scanning Services Development Project

PDU Precision Delivery Unit

PMDA Pharmaceuticals and Medical Devices Agency

PMMA Poly (methyl methaacrylate)

PMU Power Management Unit

RDQ Roland–Morris Disability Questionnaire

TUM Technische Universitaet Muenchen

VCF Vertebral Compression Fracture

10.3 Sources Afshin G. et al. (2009). Quality Assurance Guidelines for Percutaneous Vertebroplasty.

Cardiovascular and Interventional Radiological Society of Europe; Members Lounge>Standards of practice> Quality Improvement Guidelines. Available from: http://www.cirse.org/files/File/07_qig.pdf.

Alphatec Spine (2012). OsseoFix spinal fracture reduction system. Available from: http://www.alphatecspine.com/products/osseofix.asp [Access date: August 15, 2012].

Alphatec Spine, Inc., OsseoFix Spinal Fracture Reduction System in Treating Spinal Compression Fracture, NCT00961714. Available from: http://clinicaltrials.gov/ct2/show/NCT00961714 Accessed on [August 15, 2012].

American Association of Neurological Surgeons (2007). Vertebral Compression Fractures. Available from: http://www.aans.org/Patient%20Information/Conditions%20and%20Treatments/Vertebral%20Compression%20Fractures.aspx [Access Date: July 12, 2012].

American Medical Devices and Diagnostics Manufacturers' Association (AMDD) (2011a). Comparison of market environment for medical devices in Japan, China, and Korea. Available from: http://amdd.jp/en/pdf/technology/Policy110921.pdf.

American Medical Devices and Diagnostics Manufacturers' Association (AMDD) (2011b). Issues Regarding to Medical Device Market and Idea of Solutions. Available from: http://amdd.jp/en/pdf/technology/Policy110627.pdf.

America's Ageing Population [August 16, 2012], copyright US Population Reference Bureau (PRB): http://www.prb.org/Publications/PopulationBulletins/2011/americas-aging-population.aspx.

Arizona State University (2012). Article named ‘Earlier detection of bone loss may be in future’. Available from: https://asunews.asu.edu/20120528_isotopes [Access Date: August 1, 2012].

B. Häussler et al. (2007). Epidemiology, treatment and costs of osteoporosis in Germany—the BoneEVA Study. Osteoporosis International; Volume 18, Issue 1, pages 77-84. Available from: http://rd.springer.com/article/10.1007/s00198-006-0206-y.

Benvenue Medical, Inc., The Kiva System as a Vertebral Augmentation Treatment (KAST), NCT01123512. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01123512?term=Kiva+VCF+System&rank=1 Accessed on [August 15, 2012].

Bonesupport kyphoplasty system. 21. BONESUPPORT. Available from: http://www.bonesupport.com/our-products/bonesupport-kyphoplasty-system.html [Access date: August 15, 2012].

Buchbinder et al (2009). A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures. New England Journal of Medicine; 361: Pages 557-568. Available from: www.nejm.org/doi/full/10.1056/NEJMoa0900429.

Carefusion (2012). Kyphoplasty. Available from: http://www.carefusion.com/medical-products/interventional-procedures/vertebral-augmentation/patient-resources/avamax-kyphoplasty.aspx. [Access Date: July 18, 2012].



Community Research and Development Information Service (CORDIS), Europe [August 1, 2012], copyright European Commission. http://cordis.europa.eu/home_en.html.

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10.4 Research Methodology The data and analysis within this report is driven by the Medical eTrack

Medical eTrack gives you key information to drive the sales, investment and deal-making activity of your business. It includes the following information:

14,000+ Market size data tables across 400 medical equipment segments and 37 countries with historic data from 2000 forecast to 2016

3,000+ Primary expert interviews conducted to ensure data and report quality

1,000+ Conferences on the medical equipment covered

1,000+ Industry leading reports covering growing sectors, market trends, investment opportunities and the competitive landscape

450+ Analysis reports covering market and pipeline product analysis reports by indication, medical equipment trends and issue reports and investment and M&A trend reports worth over $3m

20,000+ Medical equipment companies profiled

1,500+ Private, emerging and technology start-up company profiles

1,000+ Medical equipment manufacturers in China and India

1,500+ Medical equipment companies in Japan

450+ Companies with revenue splits and market shares by category

500+ Quarterly and annual medical equipment company financials

400+ Medical equipment company SWOTs

7,000+ Pipeline product profiles

4,000+ Marketed product profiles

1,500+ Pipeline technologies

10,500+ Clinical trials

12,000+ Trial investigators

9,000+ New product patents

2,500+ Companies with products in development

12,000+ Deals in the medical equipment industry

1,100+ Surgical and diagnostic procedures by therapy area

40+ Key healthcare indicators by country

For more information or to receive a free demo of the service visit:

http://www.medicaletrack.com/contactus.aspx?RD=Demo

GlobalData’s dedicated research and analysis teams consists of qualified professionals with experience in marketing, market research, consulting background in the medical devices industry and advanced statistical expertise.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research methodology is followed for all databases and reports.



10.4.1 Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

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;

Internal and external proprietary databases;

Relevant patent and regulatory databases;

National government documents, statistical databases and market reports;

Procedure registries; and

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

10.4.2 Primary Research GlobalData conducts thousands of interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on market size, market trends, growth trends, competitive landscape and future outlook

Helps in validating and strengthening the secondary research findings

Further develops the analysis team’s expertise and market understanding

Primary research involves e-mail and telephone interviews for each market, category, segment and sub-segment across geographies

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

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

Hospital stores, laboratories, pharmacies, distributors and paramedics

Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets

Key opinion leaders: physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.

10.4.3 Models Where no hard data is available, GlobalData uses modeling and estimates in order to produce comprehensive data sets. The following rigorous methodology is adopted:

Available hard data is cross-referenced with the following data types to produce estimates

Demographic data on population segments

Macro-economic indicators such as GDP, inflation rate

Healthcare indicators such as health expenditure, physician base, healthcare infrastructure and facilities

Selected epidemiological and procedure statistics.

Data is then cross-checked by the expert panel. All data and assumptions related to modeling are stored and are made available to clients on request.



10.4.4 Forecasts GlobalData uses proprietary forecast models. The following four factors are utilized in the forecast models:

Historic growth rates

Macro-indicators such as population trends and healthcare spending

Forecast epidemiological data

Qualitative trend information and assumptions.

The data is then cross-checked by the expert panel.

10.4.5 Expert Panels 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, KOLs 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 in accordance with their feedback.

10.5 GlobalData Consulting We hope that the data and analysis in this brief will help you 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.

10.7 Disclaimer All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData.

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