Bone Grafts - A US Market Analysis

Jan 29, 2010, 07:51 ET from Reportlinker

NEW YORK, Jan. 29 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Bone Grafts - A US Market Analysis

http://www.reportlinker.com/p0164259/Bone-Grafts---A-US-Market-Analysis.html

Globally, approximately one million bone-grafting procedures are performed every year on the pelvis, spine, and other body extremities. Higher incidence of bone and joint related disorders such as osteoporosis, arthritis, and other diseases such as obesity, diabetes, and cancer, cause injury to orthopedic tissues and affect the health and capability of the human skeleton. Bone and joint disorders account for almost half of debilitating conditions in individuals over 50 years of age. With this cohort of the population expected to continue to increase, demographics alone will represent a key growth driver. In addition, market for bone grafts will continue to be driven by the risks associated with the use of autograft bone, the need to achieve superior and optimum bone fusion, speedy patient recovery, need to eliminate multiple surgeries (in case of bone harvesting from the patient), rising number of spinal fusion procedures, growing use of tissue-engineered bone in joint replacements, commercialization of new, next generation bone growth factors, and launch of innovative new bone products, among others.

These and other market data and trends are presented in "Bone Grafts: A US Market Analysis" by BizAcumen, Inc. Our reports are designed to be most comprehensive in geographic coverage and vertical market analyses.

BONE GRAFTS BMR-1059

CONTENTS

1. METHODOLOGY 1

Study Reliability and Reporting Limitations 1

Disclaimers 2

Quantitative Techniques & Reporting Level 3

2. MARKET OVERVIEW AND OUTLOOK 3

Bone Grafts: A Prelude 3

Orthobiologics Gain Traction in the Bone Grafts Market 4

Statistical Insights Into the World Orthopaedic Implants Market 5

Hospital Pricing, Not GDP is the Key Driver of Growth 6

Orthopedic Implant Pricing Grows Independent of Medicare

Reimbursement: Why? 7

Medicare Reimbursement Higher for Spinal Fusion With

Growth Factors 7

Is Consolidation Blowing in the Wind? 8

Patient Safety Emerges to Become a Top Priority 8

Bone Grafts Termed as Tissues Suffer From Inconsistent Patient

Outcomes 8

What Drives Physicians' Choice of Bone Grafts? 9

Key Market Trends & Issues: A Review 9

Aging Population: A Strong Demographic Driver 9

Rising Incidences of Degenerative Intervertebral Disc Diseases 10

Rise in Revision Orthopaedic Surgeries 11

Rise in Spinal Fusions in Private Healthcare 11

Increasing Visibility of Orthobiological Products to Spur

Grafting Options 11

Precision Machined Allograft Gain Surgeon Preference 11

Strong Prices Will Continue to Characterize Bone Graft

Technologies 12

Unmet Clinical Needs to Foster R&D Engine 12

Synthetic Bone Grafts To Fan Growth 12

Dental Bone Grafts On the Rise 13

Alliances with Organ Procurement Organizations: A Shot in the

Arm 13

Advanced Allografts Encroaching into the Use of Autografts

in Surgical Procedures 14

DBM: Strong Growth But Tough Competition 14

Adequate Reimbursement: An Impetus for Growth & Profitability 14

Aging Baby Boomers Render a Decreased Donor Pool 15

Limited Availability of Donor Tissues 15

Intense Competition from Alternative Tissue Repair Therapies 16

Substitute Technologies Threaten to Replace Spinal Fusions 16

Growing Off-Label Use of Infuse Bone Graft Raises Eyebrows 17

Technology Innovations in Orthopedic Biomaterials: The Way to Go! 17

MPCs: Offer Promising Breakthroughs in Bone-Graft Substitute 17

Peptide Signaling Molecules to the Rescue 18

Prostaglandin Agonists: Emerging From their Drawbacks 18

Platelet Concentrate Systems 18

Synthetic Bone Grafts 19

Combination of Bone Marrow and Bone Graft Substitute 19

Stem Cell Therapy 20

Bone Morphogenetic Proteins 20

GEM OS®1 Shows Promise 21

geneX® Synthetic Bone Graft Substitute 21

ACCELL Total Bone Matrix 21

Tissue Recovery & Processing: A Structural Review 21

Tissue Banks 21

Tissue Processing 23

Tissue Distribution 24

An Illustration of the Tissue Recovering, Processing, &

Distribution Network 25

3. COMPETITION 25

Competitive Scenario: A Primer 25

The New Batting Order in Key Product Markets in the US 26

Standard Bone Allografts 26

Machined Bone Allografts 27

Demineralized Bone Matrix (DBM) 27

Synthetic Bone Graft Substitutes 28

Platelet Concentration Systems 29

Allograft Tendon/Ligament 29

Spinal Fusion 29

The New Batting Order in Key Product Markets in Europe 30

Acceptance of Synthetic Bone Grafts in Europe: An Uphill Task 30

EU directive 2003/32/EC 30

DBM-based Products in Europe & Rest of World 30

Standard Bone Allografts 31

Machined Bone Allografts 31

Demineralised Bone Matrix Market 32

Bone Graft Substitutes Market: 32

4. REGULATORY ENVIRONMENT & REIMBURSEMENTS 33

Regulatory Issues 33

FDA Classification of Bone Products 33

Human Cells, Tissues and Cellular and Tissue-Based Products

(HCT/Ps) 33

National Organ Transplant Act (NOTA) 34

Good Tissue Practices 34

Tissue Banking Regulation 35

FDA Regulations on Xenograft 35

DBM-based Products in US 35

Synthetic Bone Graft Substitutes 35

Reimbursement Issues 35

CMS Implements 2008 Hospital IPPS 35

CMS Proposal for 2007 Hospital IPPS 36

(i) Fracture Treatment 36

(ii) C-codes for Spine Devices 36

(iii) Revised Payment Rates for DRG 497, 498 37

5. PRODUCT FACTS 37

A. Standard Allografts 37

B. Machined Bone Allografts 37

C. Demineralized Bone Matrix (DBM) 38

D. Bone Morphogenetic Protein (BMP) 38

E. Platelet Concentrators 38

F. Synthetic Bone Grafts 38

6. CORPORATE DEVELOPMENTS 39

Regeneration Technologies Merges with Tutogen Medical 39

Wright Medical Takes Over INBONE Technologies 39

NuVasive Acquires Osteocel Biologics 39

Integra LifeSciences Takes Over Theken 39

Osteotech Inks Distribution Contract with BioHorizons 39

Pioneer Surgical Secures FDA Approval for FortrOss 40

Inion Secures FDA Approval for Biodegradable Spine Products 40

Biocomposites Bags FDA Approval for geneX® Putty 40

IFGL Establishes Dental BioGraft Plant 40

Osteotech Receives FDA Approval for Plexur M™ Biocomposite 40

RTI Biologics Introduces CopiOs Implant for Dental Procedures 40

ETEX Unveils 'EquivaBone' Bone Graft Substitute 41

NovaBone Introduces New Type of Synthetic Bone Graft 41

Pioneer® Surgical Unleashes FortrOss™ 41

Alphatec Launches ProFUSE 41

Medtronic Releases Nanostim Synthetic Bone Paste 41

NovaBone Unveils 'NovaBone Putty' 42

RTI Introduces Fresh-Stored OC Allograft Range 42

Integra LifeSciences Unveils Smaller Size 'Accell TBM® 42

Orthovita Launches VITOSS® Bioactive Foam Pack 42

NovaBone Launches 'NovaBone Porous Morsels' 42

Wright Medical Group Introduces BIOFOAM 43

Integra LifeSciences Releases Accell Evo3 43

Millenium Signs an Asset Sale Agreement with Two Companies 43

INBONE Technologies Merges with Reiley Orthopedic 43

AlloSource Signs a License Agreement with IsoTis 43

Osteotech Inks Single Source Agreement for Allograft Products 44

Bonesupport Enters Into Distribution Agreement with Signus

Medical 44

Tornier Takes Over DVO 44

Zimmer Holdings Acquires Endius Inc. 44

Wright Medical Group Takes Over Darco International 44

Integra LifeSciences Completes Acquisition of IsoTis 45

Synthes Gets FDA Clearance for Bone Graft Substitute 45

Collagen Receives 510(k) Clearance from FDA for SynOss™ 45

ISTO Technologies Obtains 510(k) Clearance for InQu™ 45

RTI Signs Supply Contract with Stryker 45

RTI Signs a 10-Year Supply Agreement with Zimmer Holdings 46

Medtronic Sofamor Danek Receives FDA Approval for INFUSE 46

Smith and Nephew Acquires Plus Orthopedics 46

Medtronic Signs Development Agreement with OsteoGenix 46

NuVasive Buys Technology from Radius Medical 46

AlloSource Join Hands with Osiris 46

DePuy Spine Launches New Bone Graft Product 47

Medtronic Offers Progenix™ DBM Putty 47

Global Medical Launches Bone Graft Portfolio 47

Integra LifeSciences Introduces Mozaik™ 47

Collagen Unveils 'OssiMend™ Bone Graft Matrix 47

Wright Medical Launches PRO-DENSE Injectable Regenerative Graft 48

ApaTech Introduces Actifuse ABX Easyfill Putty 48

ApaTech Releases Actifuse E-Z-Prep 48

7. MAJOR PLAYERS 49

AlloSource (USA) 49

Biomet Inc (USA) 49

Interpore Cross International (USA) 49

BioMimetic Therapeutics Inc (USA) 49

DePuy Spine Inc (USA) 49

Exactech Inc (USA) 49

Integra LifeSciences Holdings Corporation (USA) 50

Integra OrthoBiologics (USA) 50

Lifelink Tissue Bank (USA) 50

LifeNet Health (USA) 50

Medtronic Inc (USA) 50

Medtronic Sofamor Danek Inc (USA) 50

Musculoskeletal Transplant Foundation (USA) 51

NovaBone Products LLC (USA) 51

NuVasive Inc (USA) 51

Orthovita Inc (USA) 51

Osiris Therapeutics Inc (USA) 51

Osteotech Inc (USA) 51

RTI Biologics, Inc. (USA) 52

Smith & Nephew Plc (UK) 52

Stryker Corporation (USA) 52

Synthes Inc (USA) 52

Wright Medical Technology, Inc (USA) 52

Zimmer Holdings, Inc (USA) 52

8. GLOBAL MARKET ANALYTICS 53

EXHIBITS

Table 1: Percentage Breakdown of Orthobiologics Manufacturer

Value Sales in the World - 2007

Table 2: Percentage Breakdown of Orthopaedic Manufacturer

Value Sales in the World - 2007

Table 3: Market Shares of Leading Companies in the Global

Market for Orthopaedic Implants in Spinal Procedures - 2007

Table 4: Market Shares of Leading Companies in the Global

Market for Orthopaedic Implants in Reconstructive Procedures -

2007

Table 5: Market Shares of Leading Companies in the Global

Market for Orthopaedic Implants in Trauma &

Craniomaxillofacial Procedures - 2007

Table 6: Breakdown of Osteoporotic Fractures by Site in the

US

Table 7: Payer Mix for Spinal (Cervical) Fusion Procedures in

the US

Table 8: Payer Mix for Spinal (Lumbar) Fusion Procedures in

the US

Table 9: Breakdown of Number of Tissue Processing Donors by

Select Processing Organization/Company in the US - 2006

Table 10: Leading Organizations/Companies in the US Tissue

Processing Market by Market Share- 2006

Table 11: Market Shares of Leading Tissue Processors in the US

Standard Bone Allografts Market - 2006

Table 12: Market Shares of Leading Tissue Processors in the US

Machined Bone Allografts Market - 2006

Table 13: Market Shares of Demineralized Bone Matrix

Manufacturer Value Sales in the US - 2006

Table 14: Market Shares of Synthetic Bone Graft Substitutes

Manufacturer Value Sales in the US - 2006

Table 15: Market Shares of Leading Platelet Concentration

Systems Manufacturer Value Sales in the US - 2006

Table 16: Market Shares of Leading Allograft Tendon/Ligament

Companies/Organizations in the US - 2006

Table 17: Market Shares of Spinal Fusion Manufacturers in the

US - 2006

Table 18: Market Shares of Leading Companies/Organizations in

the European Standard Bone Allografts Market - 2007

Table 19: Market Shares of Leading Companies/Organizations in

the European Machined Bone Allografts Market - 2007

Table 20: Market Shares of Leading Companies/Organizations in

the European Demineralized Bone Matrix Market - 2007

Table 21: Market Shares of Leading Players in the European

Bone Graft Substitutes Market - 2007

Table 22: Bone Grafts Market by Product Segment in the US:

2007-2015 (Sales in US$ Million)

Table 23: Percentage Breakdown of Bone Grafts Market by

Product Segment in the US for the Years 2009 & 2012

Table 24: Bone Grafts Market by End-Use Application in the US:

2007-2015 (Sales in US$ Million)

Table 25: Percentage Breakdown of Bone Grafts Market by

End-Use Application in the US for the Years 2009 & 2012

COMPANIES PROFILED

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Medical Equipment and Supply Industry: Bone Grafts - A US Market Analysis

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