The Global Orthobiologics Market

SUMMARY

This report provides extensive competitive comparison and evaluation of major and emerging companies in the orthobiologics market covering key sectors: alllograft tissue, demineralised bone matrix, growth factors, synthetic bone graft, stem cell therapy, joint fluid therapy and cartilage repair.

The emergence and establishment of orthobiologic products and solutions is expanding treatment options in orthopaedics from traditional metal implants, plates and screws to biologically-based products for hard and soft tissue regeneration. This new generation of products is fast gaining acceptance and offers the potential to improve patient quality of life and reduce health costs.

An intensely competitive market

The orthobiologics market is intensely competitive and is the fastest growing segment of the global orthopaedics market. There is a constant need for bone graft material to provide support, fill voids and enhance biologic repair of skeletal defects. Of the more than three million musculoskeletal procedures performed annually in the US, about half involve bone grafting with either an autograft or an allograft. Worldwide, autografts and allografts are used in approximately 2.2 million orthopaedic procedures annually.

Autograft bone has historically been the standard of care. This procedure is well established among surgeons, has extensive long-term data and has remained relatively unchanged for many years. However, its use is limited by donor-site morbidity and supply. Allografts are suitable replacements for autografts, but also have their limitations.

Owing to the limitations and associated problems inherent with these grafts, alternative bone substitute materials have been sought. So far, many of these have employed a variety of materials, including natural and synthetic polymers, ceramics, and composites, whereas others have incorporated factor- and cell-based strategies that are used either alone or in combination with other materials. However, despite the many advances in bone graft substitutes, to date, no ideal bone substitute has been found and there remains a real need for an alternative with optimal bone regeneration properties.

The race is on...

Who will lead the race for market dominance in the future? What are the emerging technologies that need to be watched? Who's working with whom in this high growth sector? The answers to these and thousands of other questions can be found in this new, comprehensive and up-to-date report on the global orthobiologics market, the companies involved and their products.

Highly competitive

In the highly competitive orthobiologics sector there appears to be a growing preference towards the use of synthetic materials rather than traditional autografts and allografts. Growth factors, in particular, bone morphogenic proteins (BMPs) are also becoming increasingly popular, although their higher cost is an ongoing issue.

Providing…

• Extensive competitive comparison and evaluation of major and emerging companies
• Orthobiologics market valuation and markets in context
• Appraisal of products, research and innovation

Covering key sectors

• Allograft Tissue
• Demineralised Bone Matrix
• Growth Factors
• Synthetic Bone Graft
• Stem Cell Therapy
• Joint Fluid Therapy
• Cartilage Repair

TABLE OF CONTENTS

Volume 1

GLOBAL ORTHOBIOLOGICS MARKET

• Orthobiologic Market Segments
  • Table 1: Global Orthobiologics Market by Product, 2007-2012 (US$ million)
  • Table 2: Global Orthobiologics Market by Geographic Region 2007-2012
  • Figure 1: Bone Graft Substitute Materials Market, 2007 US$2.4 Billion
• Orthobiologics Sector - Market Players
• Recent Industry Highlights
• Orthobiologics Market - Market Drivers
  • Figure 2: Population Aged 65 and Over, US and Europe (Millions)
  • Figure 3: Percentage of Population Aged 65 and Over, US and Europe
  • Figure 4: US Population Aged 65 and Over, 2000-2050
  • Table 3: Obesity (most recent) by Country
• Growth in Number of Orthopaedic Procedures
  • Table 4: United States, Diagnoses by CCS Category, 2005
  • Table 5: United States - Clinical Procedures by CCS Code, 2000-05 (All Listed)
  • Table 6: Most Common Musculoskeletal Procedures in US hospitals, 2004
  • Table 7: Number of Hospitalisations for Hip and Knee Replacement Procedures in Canada, 1994/1995-2004/2005
• Western Europe
  • Table 8: Germany; Inpatients by Diagnosis, 2000-2004
  • Table 9: Ambulatory Surgery Rates for Arthroscopies Performed in Public and Private Hospitals in France, 2001
  • Table 10: Inpatient Activity in Public Short-Stay Units in France, 2003
  • Table 11: Inpatient Activity in Private Short-Stay Units in France, 2003
  • Table 12: Hip & Knee Joint Replacements in England & Wales, 2005/2006
  • Table 13: Primary Diagnosis in England by ICD10 Diagnostic Group, Diseases of the Musculoskeletal System 2004/05 and 2005/06
  • Table 14: Orthopaedic Operations performed in English Hospitals, 2005/06
  • Table 15: Operations performed in English Hospitals, 2004/05
  • Table 16: Hospital Activity, Diseases of the Musculoskeletal System in Italy, 2004
  • Table 17: Orthopaedic & Traumatology Procedures in Italy, 2005
• Musculoskeletal Conditions
• The Need for Bone Substitute Materials
  • Table 18: Bone Graft Procedures/Indications
• Autograft
• Alternative Bone Substitute Materials
• ORTHOBIOLOGICALS - FDA REGULATORY ENVIRONMENT

ALLOGRAFT TISSUE MARKET

• Advantages of Allografts
• Disadvantages of Allografts
• Market Drivers
• Market Players
• Traditional Allografts
• Precision Machined Spinal Allografts
• Allograft Tissue Matrix
• Fresh Osteochondral Allografts

DEMINERALISED BONE MATRIX MARKET SEGMENT

• Advantages and Disadvantages of DBM
• DBM Market Size
• DBM Market Players

GROWTH FACTORS MARKET

• BONE MORPHOGENIC PROTEINS market
• Medtronic
• Stryker Biotech
• DePuy
• BioMimetic Therapeutics
• CeraPedics
• Tornier and BioSET
• Cost of BMPs
• InFUSE Bone Graft LT Cage - Economic Impact
  • Table 19: InFUSE Bone Graft - Economic Impact; Payor Model - Two-Year Time Period Results
  • Table 20: Cost of Lumbar Spinal Fusion without InFUSE Bone Graft (Anterior Approach)
  • Table 21: Cost of Lumbar Spinal Fusion with InFUSE Bone Graft (Anterior Approach)
• PLATELET-DERIVED GROWTH FACTORS
  • Platelet-Rich Plasma
  • Advantages of PRP
  • Disadvantages of PRP
• AUTOLOGOUS PLATELET GEL PREPARATION SYSTEMS
  • Harvest Technologies/DePuy
    • Table 22: Performance Summary of Platelet Gel Technology Platforms
  • Biomet
  • Medtronic
  • Smith & Nephew
  • Exactech/EmCyte
  • Erythrosave Ltd
  • Platelet-Rich Fibrin

SYNTHETIC BONE GRAFT MARKET

• CERAMIC-BASED BONE GRAFT SUBSTITUTES
• Calcium Phosphate Products
• Market Players
• Calcium-Sulphate based products
• Bioactive Glass
• Composite Grafts
• Collagen-based Materials

JOINT FLUID THERAPY MARKET

• HYALURONIC ACID VISCOSUPPLEMENTATION
  • Table 23: NSAID-related deaths and admissions to hospital, UK, USA and Canada
• Leading Market Players
  • Table 24: Level of Hyaluronate in Healthy and Osteoarthritic Synovial Fluid
  • Table 25: Comparison of Synvisc with Other Selected Viscosupplements
• HA Viscosupplementation Treatments
• Is Viscosupplementation Clinically Effective?

SOFT TISSUE REPAIR

• ARTICULAR CARTILAGE REPAIR MARKET
• Market Drivers
• Market Size and Potential
  • Figure 5: Global Cartilage Repair Market Potential, US$3 Billion*
• Cell-Based Cartilage Repair Therapies: ACI , MACI , AMIC , CACI
• Synthetic Cartilage Repair
• Combination Synthetic/ACI Cartilage Repair
• Future Cartilage Repair Technologies
• Acellular Cartilage Repair

STEM CELL THERAPIES

• Market Size
• Mesenchymal STEM CELLS - alternative to autograft
  • Bone Marrow Harvesting
• MESENCHYMAL STEM CELL products
  • Osiris / Blackstone Medical
  • Aastrom Biosciences
  • Osteotech
  • Smith & Nephew and RE MEDI
  • TiGenix
  • Mesoblast
  • BioE - Phillips Plastics
  • Massachusetts General Hospital and the Harvard Stem Cell Institute
• Amniotic Fluid-Derived Stem (AFS) Cells
  • Research at Wake Forest and Harvard Universities
• FAT-DERIVED STEM CELLS
  • Fat-derived stem cells could aid percutaneous spine therapies

GENE THERAPY

• Light Activated Gene Therapy
• Freeze-Dried Tendon Implants Loaded with Gene Therapy
• New Procedure for Creating Bone
• summing up
• FUTURE MARKET TRENDS

MERGERS & ACQUISITIONS IN THE ORTHOBIOLOGICS SECTOR

AGREEMENTS IN THE ORTHOBIOLOGICS SECTOR

REFERENCES

Volume 2

MANUFACTURERS OF ORTHOBIOLOGIC PRODUCTS

• 3DM
  • PuraMatrix Hydrogels
• AAP IMPLANTATE
  • Orthobiologics
  • Mergers and Acquisitions
  • Agreements
  • Financial Results
    • Table 1: aap Implantate 2006-2007 Sales
• AASTROM BIOSCIENCES
  • Financial Results
• ABBOTT SPINE
  • Biologics
  • Agreements
• ALLOGRAFT TISSUE SYSTEMS INC (ATSI)
  • Allograft Products
  • Agreements
• ALLOSOURCE
• ALPHATEC SPINE
  • Allograft Systems
  • Bone Grafting Materials
  • Acquisitions
  • Agreements
  • Financial Results
• APATECH
• ARTHRO KINETICS
  • Development Projects
  • Business Rationale
  • Agreements
• BERKELEY ADVANCED BIOMATERIALS
  • Ostetic Hydroxyapatite Products
  • GenerOs
  • Demineralised Bone Matrix
  • Agreements
• BIOMET
  • Biomaterials and Biologics
  • Agreements
  • Financial Results
    • Table 2: Biomet Revenue by Product Type, 2005-2007 (US$ million)*
• BIOMIMETIC THERAPEUTICS
  • Recombinant Protein Therapeutics with Tissue Specific Scaffolds
• BIONICHE PHARMA
• BIOSYNTECH
  • BST -Gel
  • Financial Results
• CO.DON AG
  • Orthopaedic Products
  • Agreements
  • Financial Results
• COLLAGEN MATRIX
  • Orthopaedic/Spine Applications
• CSIRO
  • Articular Cartilage Repair
• CURASAN AG
  • Synthetic Bone Graft Substitute
  • Joint Fluid Therapy
  • Agreements
  • Financial Results
    • Table 3: Curasan, Key Financial Results, 2004-2006
• DEPUY
  • Orthobiologic Products
  • Acquisitions
  • Agreements
  • Financial Results
    • Figure 1: DePuy Sales, 2004-2006 (US$ million)
• ETEX CORPORATION
  • Bone Substitute Materials
  • Carrier for Cells and Therapeutic Agents
  • Resorbable Orthopaedic Devices
  • Implant Surface Angstrom Coatings
  • Agreements
• EXACTECH
  • Biologics
  • Optecure DB M
  • Opteform and Optefil
  • OpteMx
  • Accelerate Platelet Concentrate System
  • Altiva Products
  • Acquisitions
  • Direct Distribution Operation in Japan
  • Licence Agreement - Cartilage Repair
  • Financial Results
• FERRING PHARMACEUTICALS
  • Non-Avian Sourced HA Viscosupplement
  • Mergers and Acquisitions
  • Financials
• FIDIA ADVANCED BIOPOLYMERS
  • Hyaluronan-Based Tissue-Engineered Cartilage
• GEISTLICH BIOMATERIALS
  • Regenerative Orthopaedic Products
  • Financial Results
  • Company Aims
• GENZYME
  • Biosurgery Products
  • Articular Cartilage Repair
  • New R&D Facility - China
  • Financial Results
• GRAFTYS
  • Graftys BCP Synthetic Bone Substitute
  • Resorbable Bioactive Cement
  • Combination Technologies
• HISTOGENICS
  • Cartilage Repair Products
  • Intellectual Property
  • Funding
• INTEGRA LIFESCIENCES
  • Orthobiologic Products
  • Agreements
  • Financial Results
    • Table 4: Integra LifeSciences Fiscal 2007 Revenue (US$ thousands)
    • Table 5: Integra LifeSciences 2008 Outlook
    • Table 6: Integra LifeSciences: Financial Indicators, 2002-2006
• ISTO TECHNOLOGIES
  • InQu Synthetic Bone Graft Substitute
  • Cartilage Regeneration Products
  • Agreements
• KASIOS
  • Kasios TCP Synthetic Bone Substitute
  • JectOS Injectable Bone Substitute
  • JectOS + Radiopaque Injectable Synthetic Bone Substitute
  • KAGE and KG Bone Cervical Cage with Synthetic Bone Substitute
  • TCH Synthetic Bone Substitute
• KINAMED
  • Allograft Tissue Products
• LIFECELL
  • KCI to Acquire LifeCell
  • LifeCell's Orthopaedic Tissue Products
    • Table 7: Estimated Market Data for LifeCell's Major Product Applications in the US
  • Financial Results
• LIFENET HEALTH
  • Allograft Tissue Products
• MAGNECELL
  • Magnetic Nanoparticles Cartilage Repair Technology
• MEDTRONIC
  • Biologics
  • Agreements
  • Mergers and Acquisitions
  • Financials
    • Table 8: Medtronic - Key Financial Data 2005-2007 (US$ million)
    • Table 9: Medtronic - Revenue by Operating Segment, 2005-2007 (US$ million)
    • Table 10: Medtronic - Spinal & Navigation Revenues, 2005-2007 (US$ million)
• MESOBLAST
  • Orthopaedic Applications
• MUSCULOSKELETAL TRANSPLANT FOUNDATION (MTF)
  • DB X: Demineralised Bone Matrix
  • Bone Void Fillers: Orthopaedic Allografts
  • Osteochondral Grafts for Cartilage Repair
  • Meniscal Transplantation
  • Large Grafts: Structural Repair Allografts
  • Synthes Spine: Precision Spinal Allografts
  • NovaBone
• NANOCOATINGS PTY LTD
  • BioAlmog Synthetic Bone Graft Material
• NANOTHERAPEUTICS
  • Origen DB M with Bioactive Glass
• OLYMPUS TERUMO BIOMATERIALS CORP
  • Company Background
  • Products
• ORTHOFIX
  • Biologics
  • Blackstone Medical Products
  • Financial Results
    • Table 11: Orthofix' Net Sales by Business Segment, 2005-2007
    • Table 12: Orthofix' Net sales by Market Sector, 2005-2007 (US$ million)
    • Table 13: Orthofix Sales by Market Sector for the Three Month Period Ended 31st March 2008
    • Table 14: Orthofix Sales by Market Sector for the Three Month Period Ended 31st March 2007
• ORTHOMIMETICS
  • Tissue Regeneration Scaffolds
  • TSB Award
• ORTHOVITA
  • Synthetic Bone Graft Materials
  • Agreements
  • Financial Results
    • Table 15: Orthovita's Product Sales 2006-2007
• OSIRIS
  • Orthobiologic Products
  • Agreements
  • Financial Results
• OSSACUR
  • Synthetic Bone Graft Material
  • Biological Bone Void Fillers
• OSTEOTECH
  • Grafton DBM
  • Spinal Allografts
  • Plexur Biocomposites
  • Traditional Allograft Tissue
  • Xenograft Bone Tissue Products
  • Agreements
  • Purchasing Contract
  • Research and Development
  • Financial Results
    • Table 16: Osteotech Consolidated Segment Revenue Fiscal 2006-7 (in US$ thousand)
• PEGASUS BIOLOGICS
  • Collagen Scaffolds
  • Product Pipeline
  • Financing
• PIONEER SURGICAL TECHNOLOGY
  • E-Matrix
  • NanOss
• Q-MED AB
  • Durolane HA Viscosupplement
• REGEN BIOLOGICS
  • Menaflex Collagen Meniscus Implant
• RTI BIOLOGICS
  • Fresh-stored Osteochondral OC Allografts
  • Agreements
  • Tutogen Medical Agreements
  • Financial Results
    • Table 17: RTI Biologics, Amount and Percentage of Revenue 2005-2007
• SMITH & NEPHEW
  • Joint Fluid Therapy
  • Platelet Concentration System
  • Articular Cartilage Repair
  • Synthetic Bone Graft Substitutes
  • Development Agreements
  • Distribution Agreements
  • Mergers and Acquisitions
  • OsteoBiologics
  • Financial Results
• SPINAL RESTORATION
  • Biostat Disc Augmentation System
  • Agreements
• SPINEOVATIONS
  • DiscSeal
  • Acquisitions
• STELLAR PHARMACEUTICALS
  • Joint Fluid therapy
  • Synthetic Bone Graft
  • Financial Results
    • Table 18: Stellar Pharmaceuticals - Key Financial Data 2004-2006 (Canadian dollars)
• STRYKER
  • OP -1 (Osteogenic Protein-1, BMP-7)
  • Spinal Allografts
  • Synthetics
  • Financial Results
    • Table 19: Stryker's Net sales 2005-2007 (US$ millions)
• SYNTHES
  • chronOS Synthetic Bone Grafts
  • Demineralised Bone Matrix
  • Allograft Chips and Blocks
  • Norian Craniofacial Repair System
  • Norian SRS (Skeletal Repair System)
  • Porous Polyethylene Implants
  • Agreements
  • Financial Results
    • Table 20: Synthes' Consolidated Net Sales (First Quarter 2008, January to March)
• TIGENIX
  • ChondroCelect
  • Partnership with Fidia Advanced Biopolymers
  • Research and Development - Product Pipeline
• TRB CHEMEDICA
  • Joint Fluid Therapy
  • Synovial Fluid Replacement after Arthroscopy
• WRIGHT MEDICAL
  • Biologics Products
  • Financial Results
    • Table 21: Wright Medical's Net Sales by Product Line, 2005-2007
• ZIMMER
  • Puros Allograft Products
  • Bone Graft Substitutes
  • Cartilage Repair
  • Agreements