U.S. MARKETS FOR ORTHOPEDIC BIOMATERIALS FOR BONE REPAIR AND REGENERATION

180 Pages | 49 Exhibits | 2013 Analysis | Forecasts Through 2017 Product Family: Market Reports




OVERVIEW:
In the United States (U.S.), more than 430,000 spinal fusions are performed each year, and approximately 20% of the more than 5 million fractures that occur are associated with healing difficulties.

This dynamic new report from Medtech Insight includes analyses of products, competitors, and opportunities in the U.S. market for biomaterial products for bone healing/regeneration and spinal fusion indications. This market, as covered by the scope of this report, includes bioresorbable fixation devices (pins, screws, tacks, suture anchors, and meniscal repair devices); allografts and bone replacement materials (base tissue, demineralized bone matrix, machined bone allografts, and synthetic bone grafts), and osteobiologics (autologous therapy/platelet concentrate systems, gene therapy, platelet-derived growth factors, recombinant human bone morphogenetic proteins, small molecule therapies, and stem cells). During the forecast period covered by this report, the combined U.S. market for orthopedic biomaterials for bone repair and regeneration is projected to reach an estimated value of $3.5 billion in the year 2017.

This is the first of two reports covering the U.S. market for orthopedic biomaterials. Report #A322, "U.S. Markets for Orthopedic Biomaterials for Viscosupplementation and Cartilage, Ligament/Tendon, and Meniscal Repair and Regeneration" has also published.

TABLE OF CONTENTS:
EXECUTIVE SUMMARY

i. Bioresorbable Fixation Devices 
ii. Bone Allograft and Synthetic Bone Graft Products 
iii. Osteobiologics 
iv. Combined Market Forecast 
v. Methodology 

Exhibit ES-1: Types of Bioresorbable Fixation Devices 
Exhibit ES-2: Bioresorbable Fixation Devices, Market Forecast, 2012-2017 
Exhibit ES-3: Bone Allografts and Synthetic Bone Graft Substitutes, Market Forecast, 2012-2017 
Exhibit ES-4: 2012, Bone Allografts and Synthetic Bone Graft Substitutes Market, Share by Tissue Type 
Exhibit ES-5: Recombinant Human Bone Morphogenetic Protein Products, Market Forecast, 2012-2017 
Exhibit ES-6: Osteobiologics, Market Forecast, 2012-2017 
Exhibit ES-7: 2012, Market Shares of Stem Cell Applications for Bone Healing and Spinal Fusion 
Exhibit ES-8: Orthopedic Biomaterials for Bone Repair and Regeneration, Combined Market Forecast, 2012-2017 

1. MUSCULOSKELETAL SYSTEM OVERVIEW

1.1 Bone Structure and Function 
	1.1.1 Cellular Framework 
		1.1.1.1 Osteoblasts 
		1.1.1.2 Osteocytes 
		1.1.1.3 Osteoclasts 
		1.1.1.4 Osteogenesis 
	1.1.2 Bone Tissue 
		1.1.2.1 Cancellous and Cortical Bone Tissue 
		1.1.2.2 Bone Marrow 
	1.1.3 Bone Anatomy 
		1.1.3.1 Diaphysis and Epiphysis 
		1.1.3.2 Endosteum 
		1.1.3.3 Periosteum 
	1.1.4 Joint Components 
		1.1.4.1 Cartilage 
			1.1.4.1.1 Elastic Cartilage 
			1.1.4.1.2 Fibrocartilage 
			1.1.4.1.3 Hyaline Cartilage 
		1.1.4.2 Bursae 
		1.1.4.3 Joint Cavity 
		1.1.4.4 Menisci 
		1.1.4.5 Synovial Membrane and Fluid 
		1.1.4.6 Ligaments and Tendons 
		1.1.4.7 Muscles 
	1.1.5 Joint Structures 
		1.1.5.1 Ankle 
		1.1.5.2 Digits 
		1.1.5.3 Elbow 
		1.1.5.4 Hip 
		1.1.5.5 Knee 
		1.1.5.6 Shoulder 
		1.1.5.7 Wrist 
	1.1.6 Bone Formation and Remodeling 
		1.1.6.1 In the Fetus 
		1.1.6.2 In Childhood 
		1.1.6.3 In Adulthood 
		1.1.6.4 In Old Age 
		1.1.6.5 Mechanical Stress and Wolff's Law 
	1.1.7 Factors Affecting Bone Physiology 
		1.1.7.1 Age 
		1.1.7.2 Gender 
		1.1.7.3 Genetic Disposition 
		1.1.7.4 Hormonal Activity 
		1.1.7.5 Physical Activity 
		1.1.7.6 Cigarette Smoking 
		1.1.7.7 Alcohol and Caffeine Intake 
		1.1.7.8 Nutritional Deficiencies 
1.2 Joint Structure and Function 
	1.2.1 Types of Joints 
		1.2.1.1 Synarthroses 
		1.2.1.2 Amphiarthroses 
		1.2.1.3 Diarthroses 
			1.2.1.3.1 Ball-and-Socket 
			1.2.1.3.2 Condyloid 
			1.2.1.3.3 Hinge 
			1.2.1.3.4 Gliding 
			1.2.1.3.5 Pivot 
	1.2.2 Arthritis 
		1.2.2.1 Osteoarthritis 
		1.2.2.2 Rheumatoid Arthritis 
1.3 Management of Joint Disorders 
	1.3.1 Joint Replacement 
		1.3.1.1 Dislocation 
		1.3.1.2 Ligament and Tendon Injuries 
		1.3.1.3 Meniscal Injuries 

Exhibit 1-1: Illustration of Bone Tissue 
Exhibit 1-2: Types of Cartilage 
Exhibit 1-3: Stages of Bone Remodeling 

2. BIORESORBABLE FIXATION DEVICES

2.1 Materials 
2.2 Products 
	2.2.1 Bioresorbable Pins 
	2.2.2 Bioresorbable Screws, Nails, and Tacks 
	2.2.3 Bioresorbable Interference Screws 
	2.2.4 Bioresorbable Suture Anchors 
	2.2.5 Bioresorbable Meniscal Repair Devices 
2.3 Market Analysis 
	2.3.1 Potential Market for Bioresorbable Fixation Devices 
		2.3.1.1 Meniscal Repair 
		2.3.1.2 Cruciate Ligament Fixation 
		2.3.1.3 Shoulder Reconstruction 
		2.3.1.4 Small Joint/Bone Fragment Fixation 
2.4 Competitive Analysis 

Exhibit 2-1: Advantages of Bioresorbable Fixation Devices 
Exhibit 2-2: Factors Affecting the Properties of Bioresorbable Polymers 
Exhibit 2-3: Types of Bioresorbable Fixation Devices 
Exhibit 2-4: 2013, Selected Bioresorbable Pins 
Exhibit 2-5: 2013, Selected Bioresorbable Nails, Screws, and Tacks 
Exhibit 2-6: 2013, Selected Bioresorbable Interference Screws 
Exhibit 2-7: 2013, Selected Bioresorbable Suture Anchors 
Exhibit 2-8: 2013, Selected Bioresorbable Meniscal Repair Devices 
Exhibit 2-9: 2012, Bioresorbable Fixation Devices Market, By Procedure Type 
Exhibit 2-10: Bioresorbable Fixation Devices,  Market Forecast, 2012-2017 
Exhibit 2-11: 2012, Bioresorbable Fixation Devices Market, Share by Supplier 

3. BONE ALLOGRAFT AND SYNTHETIC BONE GRAFT PRODUCTS

3.1 Bone Graft Materials 
	3.1.1 Autograft 
	3.1.2 Allograft 
		3.1.2.1 Regulations Governing Allograft Providers 
			3.1.2.1.1 National Organ Transplant Act 
			3.1.2.1.2 United States Food and Drug Administration Requirements 
		3.1.2.2 Donor Screening 
		3.1.2.3 Recovering Tissue 
		3.1.2.4 Processing Tissue 
		3.1.2.5 Tissue Banking Industry 
		3.1.2.6 Base Tissue 
		3.1.2.7 Demineralized Bone Matrix Products 
		3.1.2.8 Machined Bone 
3.2 Synthetic Bone Grafts 
	3.2.1 Products 
3.3 Bone Graft Applications 
	3.3.1 Fracture Repair 
	3.3.2 Revision Total Joint Surgery 
	3.3.3 Tumors 
	3.3.4 Spine 
3.4 Market Analysis 
3.5 Competitive Analysis 
	3.5.1 Demineralized Bone Matrix 
	3.5.2 Machined Bone Allografts 
	3.5.3 Synthetic Bone Graft Substitutes 

Exhibit 3-1: Selected Categories of Bone Grafts 
Exhibit 3-2: Base Tissue Bone Allograft Applications in Orthopedic Surgery 
Exhibit 3-3: Base Tissue Bone Allograft Applications in Spine Surgery 
Exhibit 3-4: 2013, Description and Representative Pricing of Base Allografts Used in Spine Surgery 
Exhibit 3-5: 2013, Selected Demineralized Bone Matrix Products 
Exhibit 3-6: 2013, Selected Machined Bone Allografts 
Exhibit 3-7: Materials Used in Bone Graft Substitutes 
Exhibit 3-8: 2013, Selected Synthetic Bone Grafts 
Exhibit 3-9: Applications for Bone Grafts 
Exhibit 3-10: Bone Allografts and Synthetic Bone Graft Substitutes, Market Forecast, 2012-2017 
Exhibit 3-11: 2012, Bone Allografts and Synthetic Bone Graft Substitutes Market, Share by Tissue Type 
Exhibit 3-12: 2012, Demineralized Bone Matrix Products Market, Share by Supplier 
Exhibit 3-13: 2012, Machined Bone Allografts Market, Share by Supplier 
Exhibit 3-14: 2012, Synthetic Bone Grafts Market, Share by Supplier 

4. OSTEOBIOLOGICS

4.1 Bone Growth Factors 
	4.1.1 Bone Morphogenetic Proteins 
		4.1.1.1 Products 
			4.1.1.1.1 Infuse Bone Graft 
			4.1.1.1.2 Osteogenic Protein-1 
		4.1.1.2 Emerging Products 
		4.1.1.3 Clinical Trials 
	4.1.2 Fibroblast Growth Factors 
	4.1.3 Recombinant Platelet-Derived Growth Factor 
		4.1.3.1 Products 
	4.1.4 Autologous (Blood-Derived) Growth Factors 
		4.1.4.1 Products 
4.2 Small Molecules 
4.3 Stem Cell Therapy 
	4.3.1 Products 
	4.3.2 Emerging Products 
4.4 Gene Therapy 
	4.4.1 Gene Therapy versus Growth Factors 
	4.4.2 Systemic Gene Therapy 
	4.4.3 Regional Gene Therapy 
4.5 Other Osteobiologics 
4.6 Market Analysis 
	4.6.1 Bone Morphogenetic Proteins 
	4.6.2 Other Osteobiologics 
4.7 Competitive Analysis 

Exhibit 4-1: Selected Bone Morphogenetic Proteins 
Exhibit 4-2: Selected Recombinant Human Bone Morphogenetic Protein Products 
Exhibit 4-3: Selected Recombinant Human Bone Morphogenetic Proteins Under Development 
Exhibit 4-4: 2013, Selected Autologous Therapy/Platelet Concentrate Systems 
Exhibit 4-5: 2013, Selected Growth Factor and Small Molecule Therapies Under Development for Bone Healing and Spinal Fusion Applications 
Exhibit 4-6: 2013, Selected Stem Cell Products for Bone Healing and Enhancement of Spinal Fusion 
Exhibit 4-7: 2013, Selected Stem Cell Products Under Development for Orthopedic and Spinal Fusion Applications 
Exhibit 4-8: Comparison of Growth Factors with Gene Therapyfor Bone Repair 
Exhibit 4-9: Gene Therapy Delivery Methods for Bone Repair 
Exhibit 4-10: Recombinant Human Bone Morphogenetic Protein Products, Market Forecast, 2012-2017 
Exhibit 4-11: Stem Cells and Other Osteobiologic Agents for Bone Healing and Enhancement of Spinal Fusion, Market Forecast, 2012-2017 
Exhibit 4-12: 2012, Market Shares of Stem Cell Applications for Bone Healing and Spinal Fusion 
Exhibit 4-13: 2012, Stem Cell Products Market for Bone Healing and Spinal Fusion, Share by Supplier 

5. COMPANY PROFILES

5.1 Arthrex, Inc. 
5.2 Baxter International, Inc. 
5.3 DiFusion Technologies 
5.4 Johnson & Johnson 
5.5 LifeNet Health, Inc. 
5.6 Medtronic, Inc. 
5.7 Musculoskeletal Transplant Foundation, Inc. 
5.8 NuVasive, Inc. 
5.9 Orthofix International NV 
5.10 RTI Biologics, Inc. 
5.11 Smith & Nephew PLC 
5.12 Stryker Corporation 

APPENDIX:  COMPANY LISTING


COMPANIES COVERED:

  1. aap Implantate AG
  2. Accelalox, Inc.
  3. Acumed LLC
  4. Aesculap, Inc./B. Braun Melsungen
  5. AlloSource, Inc.
  6. Alphatec Spine, Inc.
  7. Arthrex, Inc.
  8. ArthroCare Corporation
  9. Astellas Pharma, Inc.
  10. Baxter BioSurgery/Baxter International, Inc.
  11. Biocomposites LTD
  12. Biomet, Inc.
  13. Biomimetic Therapeutics, Inc./Wright Medical Group, Inc.
  14. BioSet, Inc.
  15. BioTime, Inc.
  16. Bioventus LLC
  17. Collagen Matrix, Inc.
  18. ConMed Linvatec/ConMed Corporation
  19. Cytori Therapeutics, Inc.
  20. DePuy Synthes/Johnson & Johnson
  21. DiFusion Technologies
  22. Etex Corporation
  23. Exactech, Inc.
  24. GE Capital/General Electric Company
  25. Geron Corporation
  26. Globus Medical, Inc.
  27. Harvest Technologies Corporation/Terumo Corporation
  28. Inion LTD
  29. Integra LifeSciences Corporation
  30. ISTO Technologies, Inc.
  31. K2M, Inc.
  32. Kensey Nash Corporation/Royal DSM NV
  33. LifeLink Tissue Bank/LifeLink Foundation
  34. LifeNet Health, Inc.
  35. Medtronic, Inc.
  36. Mesoblast LTD
  37. Musculoskeletal Transplant Foundation, Inc.
  38. NeuroPro Technologies, Inc.
  39. NovaBone Products LLC
  40. Novartis AG
  41. NuVasive, Inc.
  42. Olympus America, Inc./Olympus Corporation
  43. Orthofix International NV
  44. Osiris Therapeutics, Inc.
  45. Parcell Laboratories LLC
  46. Pfizer, Inc.
  47. Pioneer Surgical Technology, Inc.
  48. RTI Biologics, Inc.
  49. Smith & Nephew PLC
  50. Spineology, Inc.
  51. Stryker Corporation
  52. Tissue Bank International, Inc.
  53. TissueGene, Inc.
  54. Tornier NV
  55. Wright Medical Technology, Inc./Wright Medical Group, Inc.
  56. Zimmer Holdings, Inc.
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