Bone Grafts: Market Research Report

December 2013 | 187 pages | ID: B17DA75FE29EN
Global Industry Analysts, Inc

Abstracts

This report analyzes the worldwide markets for Bone Grafts in US$ Million. The US market for Bone Graft Substitutes is also analyzed by the following segments: Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Stem Cell Based Bone Grafts, and Synthetic Bone Grafts. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2012 through 2020. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 61 companies including many key and niche players such as -

• AlloSource
• Biomet, Inc.
• DePuy Synthes Companies
• Exactech, Inc.
• LifeNet Health, Inc.
• Medtronic, Inc.

Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
  A. Standard Allografts
  B. Machined Bone Allografts
  C. Demineralized Bone Matrix (DBM)
  D. Bone Morphogenetic Protein (BMP)
  E. Stem Cell Based Bone Grafts
  F. Synthetic Bone Grafts

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW

Bone Grafts: A Prelude
Bone Graft Substitute Market – Showcasing Promising Growth
Growing Clinical Use of Bone Graft Substitutes in Surgical Procedures
Synthetic Bone Graft – The Latest Trend
DBM: Strong Growth but Tough Competition
Bone Morphogenetic Protein – Safety Concerns Affect Growth Prospects
Stem Cell Based Bone Grafts – Fastest Growing Bone Graft Substitute Segment
Developing Markets Hold Lucrative Potential for Bone Graft Substitutes
Autograft: Gold Standard for Bone Grafting Procedures
Allografts: Leading the Race over Autografts
Advanced Allografts Encroaching into the Use of Autografts in Surgical Procedures
Review of Major Factors Affecting Growth
Aging Population: A Strong Demographic Driver

Table 1. Percentage of 65+ Population in Total Population for Select Countries (2012) (includes corresponding Graph/Chart)

Rising Incidences of Degenerative Intervertebral Disc Diseases

Table 2. % of Women Affected by Osteoporosis (includes corresponding Graph/Chart)

Rising Prevalence of Arthritis and Other Orthopedic Disorders
Rise in Revision Orthopedic Surgeries
Rise in Spinal Fusions in Private Healthcare
Applications of Bone Grafts
Spine Fusion – The Largest Bone Graft Indication
Dental Bone Grafting – A High Potential Market

Table 3. Global Dental Regeneration Market (2013E): Percentage Share Breakdown of Value Sales for Bone Allografts, Membranes, Tissue Regeneration (includes corresponding Graph/Chart)

What Drives Physicians’ Choice of Bone Grafts?
Challenges for Different Bone Grafts
Patient Safety Emerges as a Top Priority
Competitive Scenario

2. MARKET DYNAMICS

Orthopedic Industry: An Overview

Table 4. Fractures by Age Group (2012): Percentage Share Breakdown of Number of Fractures by Age Group (includes corresponding Graph/Chart)

Table 5. Global Orthopedic Market by Segment (2013E): Percentage Breakdown of Value Sales for Spine, Trauma, Knees, Hips, Orthobiologics, Extremities and Others (includes corresponding Graph/Chart)

Is Consolidation Blowing in the Wind?
Product Mix of Reconstructive Devices Companies
Key Statistics in Global Orthopedics Industry

Table 6. Worldwide Orthopedic Market (2013E): Percentage Share Breakdown of Value Sales by Company for DePuy Synthes, Stryker, Zimmer, Smith & Nephew, Medtronic, and Others (includes corresponding Graph/Chart)

Table 7. Worldwide Market for Orthopedic Implants in Spinal Procedures (2013E): Percentage Share Breakdown of Value Sales by Company for Medtronic, J&J and Others (includes corresponding Graph/Chart)

Table 8. Worldwide Market for Orthopedic Implants for Reconstructive Procedures (2013E): Percentage Share Breakdown of Value Sales by Company for Zimmer, J&J, Stryker, Biomet, Smith & Nephew, and Others (includes corresponding Graph/Chart)

Table 9. Worldwide Market for Orthopedic Implants for Trauma Procedures (2013E): Percentage Share Breakdown of Value Sales by Company for J&J, Stryker, Biomet Smith & Nephew, Zimmer, and Others (includes corresponding Graph/Chart)

Table 10. Global Joint Replacement Market (2013E): Percentage Share Breakdown of Sales for Zimmer, DePuy Synthes, Stryker, Biomet, Smith & Nephew, and Others (includes corresponding Graph/Chart)

Orthobiologics Gain Traction in the Bone Grafts Market

Table 11. Global Orthobiologics Market (2012): Percentage Share Breakdown of Value Sales for Viscosupplements, Allograft & DBM, Hemostasis, Synthetic Bone Graft Substitutes, Growth Factors, and Blood & Marrow-based Products (includes corresponding Graph/Chart)

Table 12. Leading Players in the Global Orthobiologics Market (2013): Percentage Share Breakdown of Value Sales for Medtronic, J&J/Synthes, Sanofi, Baxter, Stryker, and Others (includes corresponding Graph/Chart)

Increasing Visibility of Orthobiological Products to Spur Grafting Options
Technological Advancements Drive the Market for Bone Grafts
Synthetic Bone Grafts Set to Replace Conventional Autografts and Allografts
Foot and Extremity Reconstruction – Promising Market for Bone Grafts
Precision Machined Allograft Gain Surgeon Preference
Unmet Clinical Needs to Foster R&D Engine
Biological Solutions in Sports Medicine – Beyond Bone Grafting
Disease Transmission through Bone Grafts – A Major Safety Concern
Lack of Standards in Bone Graft Substitute Market
Reimbursement Issues Continue to Haunt Bone Grafts Market

Table 13. Payer Mix in Orthopedic-driven Surgeries Worldwide (2012) (includes corresponding Graph/Chart)

Regional Regulations & Religious Beliefs Hamper Bone Graft Substitutes Market
Synthetic Bone Grafts – Solution for Halal Bone Graft Implantation
Bone Glue – A Potential Threat to the Bone Graft Market
Alliances with Organ Procurement Organizations: A Shot in the Arm
Aging Baby Boomers Render a Decreased Donor Pool
Limited Availability of Donor Tissues
Intense Competition from Alternative Tissue Repair Therapies
Substitute Technologies Threaten to Replace Spinal Fusions
Bone Grafts Termed as Tissues Suffer From Inconsistent Patient Outcomes
Innovations in Orthopedic Biomaterials: A Glance at Developments over the Years
MPCs: Offer Promising Breakthroughs in Bone-Graft Substitute
Peptide Signaling Molecules to the Rescue
Prostaglandin Agonists: Emerging From their Drawbacks
Synthetic Bone Grafts
Combination of Bone Marrow and Bone Graft Substitute
Stem Cell Therapy
Bone Morphogenetic Proteins
GEM OS1 Shows Promise
geneX Synthetic Bone Graft Substitute
ACCELL Total Bone Matrix
New Ways of Fixing Broken Bones
BoneCure Sleeve – Heading Towards the Human Market
Bioactive Glass – Suitable for Weight Bearing Portion
Tissue Recovery & Processing: A Review
Tissue Banks
Tissue Processing
Tissue Distribution
An Illustration of the Tissue Recovering, Processing, & Distribution Network

3. PRODUCT OVERVIEW

Bone Grafts: A Definition
Bone Grafts: A Peek into their Mechanism of Action
Types of Bone Grafts
Scoring of Osteoconduction, Osteoinduction, and Osteogenesis Properties of Bone Grafts by Type
Autografts
Advantages
Disadvantages
Standard Allografts
Advantages
Disadvantages
Machined Bone Allografts
Commercially Available Allograft and Xenograft Bone Products
Demineralized Bone Matrix
Commercially Available Demineralized Bone Matrix Products
Bone Morphogenetic Proteins (BMPs)
Basic Functions of TGF-Beta
Commercially Available BMP-Products in the Marketplace
Infuse

OP

Synthetic Bone Grafts
Collagen-based Matrices
Advantages
Disadvantages
Ceramic: A Material of Choice
Hydroxyapatite: A Major Calcium Phosphate Based Ceramic
Calcium Sulfate
Polymer Based Bone Grafts
Coral: A Valuable Synthetic Graft Material
Commercially Available Bone Substitutes Products
Application of Bone Grafts
Spinal Fusion

Table 14. Worldwide Market for Orthopedic Implants in Spinal Procedures (2010): Percentage Share Breakdown of Value Sales by Application - Thoracolumbar, Interbody Devices, Vertebral Compression Fractures, Cervical, and Electrical Stimulation (includes corresponding Graph/Chart)

Trauma & Reconstructive Surgeries
Trauma
Reconstructive Surgeries
Joint Revision Arthroplasty

Table 15. Worldwide Orthopedic Large Joint Market by Segment (2013E): Percentage Share Breakdown of Value Sales for Spine, Knee and Hip (includes corresponding Graph/Chart)

Table 16. Worldwide Orthopedic Extremities Market by Segment (2013E): Percentage Share Breakdown of Value Sales for Foot/Ankle, Shoulder, Wrist/Finger and Elbow (includes corresponding Graph/Chart)

Oral, Periodontal, and Cranio-Maxillofacial

Table 17. Worldwide Market for Orthopedic Implants in Trauma & Craniomaxillofacial Procedures (2010): Percentage Share Breakdown of Value Sales by Application - Hip Fracture, Lower Extremity, Neuro & Craniomaxillofacial, Deformities, Pediatric & Foot and Upper Extremity (includes corresponding Graph/Chart)

4. REGULATORY ENVIRONMENT & REIMBURSEMENTS

Regulatory Issues
FDA Classification of Bone Products
Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
National Organ Transplant Act (NOTA)
Good Tissue Practices
Tissue Banking Regulation
FDA Regulations on Xenograft
DBM-based Products in US
Synthetic Bone Graft Substitutes

5. PRODUCT INNOVATIONS/INTRODUCTIONS

AlloSource Introduces AlloMend
Orthofix Launches Trinity ELITE
Synergy Biomedical to Introduce Biosphere Putty
K2M Launches VENADO Bone Graft Systems
Bonesupport Receives CE Mark Approval for Cerament|G resorbable
PlusLife Launches Innovative Allogeneic Bone Gel for Orthopedic Uses (Australia)
RTI Surgical Introduces BioReady DBM Putty
K2M Rolls Out VESUVIUS Osteobiologic Systems
BioHorizons Introduces MinerOss Cancellous
Amedica Introduces Dynamic Bone
Orthogen Introduces NanoGen
SIRAKOSS Introduces MaxS
BioMimetic to Introduce Augmatrix Biocomposite Bone Graft Line
Orthofix International Introduces Collage Osteoconductive Scaffold
BioMimetic Obtains Approval from TGA for Commercialization of Augment Bone Graft
Medtronic Launches ARTISAN Space Maintenance System
NovaBone Introduces MacroPor-Si+
RTI Surgical Announces First Application of map3TM Cellular Allogeneic Bone Graft in Ankle and Foot Fusion Procedures (US)
Integra Receives FDA Clearance for Accell Evo
RTI Surgical Introduces BioAdapt DBM Foam
Integra Unveils Trel-Xpress Demineralized Bone Matrix
Keystone Dental Introduces DynaMatrix Plus
Wright Introduces FUSIONFLEX Demineralized Moldable Scaffold
Micromedics Launches OsteoXpress 15cc Bone Graft Delivery Device
Bacterin Unveils OsteoSpongeSC
Integra Launches Allograft Cancellous Sponge
Orthos Receives CE Approval for βGel Synthetic Bone Graft Substitute

6. RECENT INDUSTRY ACTIVITY

RTI Biologics Acquires Pioneer Surgical Technology
Wright Medical Group Acquires BioMimetic Therapeutics
Titan Spine Enters into Distribution Agreement with Biomet
Bioventus and Pfizer Enter into Agreement
AlloSource Enters into Partnership with Humacyte
MicroPort Medical to Acquire OrthoRecon Business of Wright Medical Group
J&J Takes Over Synthes
Stryker Acquires Orthovita
Zimmer Dental and Curasan Enter into Distribution Agreement
Cayenne Medical Enters into Partnership with Parametrics Medical
NuVasive Signs Licensing Agreement with AlloSource
Stryker Divests OP-1 Product Range

7. FOCUS ON SELECT PLAYERS

AlloSource (USA)
Biomet, Inc. (USA)
DePuy Synthes Companies (USA)
Synthes Inc (USA)
DePuy Spine, Inc. (USA)
Exactech, Inc. (USA)
Integra LifeSciences Holdings Corporation (USA)
LifeNet Health, Inc. (USA)
Medtronic, Inc. (USA)
NovaBone Products LLC (USA)
NuVasive, Inc. (USA)
Olympus Biotech Corporation (USA)
RTI Surgical, Inc. (USA)
Smith & Nephew Plc (UK)
Stryker Corporation (USA)
Wright Medical Technology, Inc. (USA)
BioMimetic Therapeutics LLC (USA)
Zimmer Holdings, Inc. (USA)

8. MARKET PERSPECTIVE

Table 18. World Recent Past, Current and Future Analysis for Bone Graft Substitutes by Geographic Region/Country - US, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

Table 19. World Historic Review for Bone Graft Substitutes by Geographic Region/Country - US, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

Table 20. World 15-Year Perspective for Bone Graft Substitutes by Geographic Region/Country - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

A. Market Analysis
  Bone Graft Substitutes Market: Opportunities for Growth
  Bone Grafts Market – An Insight
  Aging Population: A Strong Demographic Driver

Table 21. North American Elderly Population by Age Group (1975-2050) (includes corresponding Graph/Chart)

Table 22. US Population Breakdown by Age Group (2012) (includes corresponding Graph/Chart)

  Rising Incidence of Degenerative Intervertebral Disc Diseases
  Back Pain
  Arthritis

Table 23. % of Population Diagnosed with Arthritis by Age Group (includes corresponding Graph/Chart)

  Osteoporosis

Table 24. Osteoporosis Population in the US: 2002, 2005, 2008 & 2012 (includes corresponding Graph/Chart)

Table 25. Breakdown of Osteoporotic Fractures by Site in the US (includes corresponding Graph/Chart)

  Rise in Revision Orthopedic Surgeries
  Increasing Visibility of Orthobiological Products to Spur Grafting Options
  Precision Machined Allograft Gain Surgeon Preference
  Unmet Clinical Needs to Foster R&D Engine
  Synthetic Bone Grafts to Fan Growth
  Spinal Surgery Market: Opportunity for Bone Grafts Market
  Dental Bone Graft Substitutes Market: An Overview
  Orthopedic Biomaterials Market – An Overview
  Regulatory Challenges Limit Growth in the US Orthopedic Biomaterials Market
  Orthobiologics Market – Overview
  Adequate Reimbursement: An Impetus for Growth & Profitability

Table 26. Payer Mix for Spinal (Cervical) Fusion Procedures in the US (includes corresponding Graph/Chart)

Table 27. Payer Mix for Spinal (Lumbar) Fusion Procedures in the US (includes corresponding Graph/Chart)

  Competitive Scenario
  Standard Bone Allografts

Table 28. US Market for Standard Bone Allografts (2012): Percentage Market Share Breakdown of Leading Tissue Processors (includes corresponding Graph/Chart)

  Machined Bone Allografts

Table 29. US Market for Machined Bone Allografts (2012): Percentage Market Share Breakdown of Leading Tissue Processors (includes corresponding Graph/Chart)

  Demineralized Bone Matrix (DBM)

Table 30. Leading Players in the US DBM Market (2012): Percentage Breakdown of Sales for Synthes/DePuy Spine, Medtronic, Integra, Bacterin, RTI Surgical, Wright Medical, Exactech, Stryker, and Others (includes corresponding Graph/Chart)

  Synthetic Bone Graft Substitutes

Table 31. US Market for Synthetic Bone Graft Substitutes (2012): Percentage Share Breakdown of Value Sales by Company - Stryker, Wright Medical, Biomet, J&J, and Others (includes corresponding Graph/Chart)

  Product Launches
  Strategic Corporate Developments
  Select Key Players
B. Market Analytics

Table 32. US Recent Past, Current and Future Analysis for Bone Graft Substitutes by Product Segment - Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Stem Cell Based and Synthetic Bone Grafts Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

Table 33. US Historic Review for Bone Graft Substitutes by Product Segment - Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Stem Cell Based and Synthetic Bone Grafts Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

Table 34. US 15-Year Perspective for Bone Graft Substitutes by Product Segment - Percentage Breakdown of Dollar Sales for Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Stem Cell Based and Synthetic Bone Grafts Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

2. EUROPE

A. Market Analysis
  Outlook
  Orthopedic Biomaterials Market – Overview

Table 35. European Bone Graft Substitutes Market (2012): Percentage Share Breakdown of Value Sales for Synthetic, Allograft, and DBM (includes corresponding Graph/Chart)

  Synthetic Bone Graft Market Drives the BGS Market
  Bone Morphogenetic Protein (BMP) Market
  Dental Biomaterials Market in Europe: An Insight
  Overview
  Medical Tourism Bodes Well for Dental Implants Market
  Turkey – Fastest Growing Dental Implant Market
  Competitive Scenario
  Key Statistical Data

Table 36. European Market for Standard Bone Allografts (2012): Percentage Share Breakdown of Revenues by Leading Companies/ Organizations (includes corresponding Graph/Chart)

Table 37. European Market for Machined Bone Allografts (2012): Percentage Share Breakdown of Revenues by Leading Companies/ Organizations (includes corresponding Graph/Chart)

Table 38. European Market for Demineralized Bone Matrix (2012): Percentage Market Share Breakdown of Revenues by Leading Companies/ Organizations (includes corresponding Graph/Chart)

Table 39. European Market for Bone Graft Substitutes (2012): Percentage Share Breakdown of Value Sales by Leading Players (includes corresponding Graph/Chart)

  Regulatory Overview
  EU Directive 2003/32/EC
  DBM-based Products in Europe & Rest of World
  Product Launches
  Strategic Corporate Developments
  Smith & Nephew Plc – A Key Player
B. Market Analytics

Table 40. European Recent Past, Current and Future Analysis of Bone Graft Substitutes Market Analyzed with Annual Sales Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

Table 41. European Historic Review of Bone Graft Substitutes Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

3. REST OF WORLD

A. Market Analysis
  Outlook
  Focus on Select Regional Markets
  Asia-Pacific
  Dental Bone Graft Substitutes and Biomaterials Market – An Overview

Table 42. Over 65 Years Individuals as % of Total Population in Select Asian Countries (includes corresponding Graph/Chart)

  India
  Orthopedic Biomaterials and Dental Bone Grafts Market – An Insight
  Rise in Medical Tourism Drives Bone Grafts Market
  China
  Orthopedic Biomaterials Market – A Review
  Malaysia
  Singapore
  A Major Hub for Spine, Knee and Hip Surgeries
  Latin America
  Dental Bone Graft Substitutes Market – Overview
  Overview of Brazilian Orthopedic Devices Market
  Japan
  Orthopedic Devices Market – Overview
  Canada
  Favorable Growth Prospects in Bone Graft Substitutes Market
  Product Launches
B. Market Analytics

Table 43. Rest of World Recent Past, Current and Future Analysis of Bone Graft Substitutes Market Analyzed with Annual Sales Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

Table 44. Rest of World Historic Review of Bone Graft Substitutes Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 61 (including Divisions/Subsidiaries - 72)
The United States (53)
Europe (15)
  France (3)
  Germany (2)
  The United Kingdom (4)
  Rest of Europe (6)
Asia-Pacific (Excluding Japan) (3)
Africa (1)