The Global Market for Orthobioligical Products

Product Code ESP00723
Publication Date August 2010
Publisher Espicom
Product Type Report
Pages 124
ISBN Number not applicable
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The Global Market for Orthobioligical Products

Growth is currently being driven by the increased awareness and adoption of orthobiologics, technological advancements and higher numbers of orthopaedic-related procedures being undertaken globally. Demographic factors such as the ageing population are the main driver of the higher number of orthopaedic procedures being undertaken. As well as leading to more orthopaedic procedures, the ageing population also means orthopaedic patients often have poor bone stock or osteoporosis. This in turn means more patients are requiring a bone graft substitute as they are unsuitable for autograft.

Other growth drivers include the rising numbers of obese patients with increasing levels of osteoarthritis and the resulting need for cartilage repair procedures. In addition, increasing numbers of patients have diabetes, which can lead to slower natural bone and soft tissue healing, and a greater number of people are participating in sports, leading to higher numbers of trauma and sport-related injuries.

Safety concerns about bone morphogenetic protein (BMP)...

BMP product sales have suffered from a July 2008 US Public Health Notification regarding complications associated with their use in the cervical spine. The off-label use of BMP products has also led to negative publicity regarding the products, as well as legal proceedings brought against the market leader, Medtronic. Stryker, the only other company with an FDA-approved growth factor, has also experienced setbacks with its products. In March 2009, the FDA's Orthopaedic and Rehabilitation Devices Advisory Panel voted not to recommend broad-based marketing approval for the use of Stryker's OP-1 for spinal fusion. In contrast, Medtronic is currently pursuing FDA approval for a new, higher-concentration BMP product, AMPLIFY. If approved, AMPLIFY could regenerate Medtronic's flagging BMP operations. In July 2010, the FDA's Orthopaedic and Rehabilitation Devices Advisory Panel gave a positive recommendation of AMPLIFY.

...has refocused interest on other technologies

Synthetic bone graft substitutes have benefited from increased demand as a result of their lower cost compared with competing products, ease-of-use, ready availability and ease of storage. This led to an 18% increase in sales volumes during 2009.

In addition, cell-based products, including autologous cartilage repair therapies, blood separation systems and bone marrow concentration systems, experienced 20% growth in 2009. However, this market is still in its infancy and was worth just US$180 million during the year. Growth for cell-based products is being driven by their clinical effectiveness, increased surgeon acceptance, and new product innovation in this sector.

Human-derived products such as allograft and DBM each saw around 5% growth in 2009, to US$790 and US$575 million, respectively. While there continues to be increased demand, growth is somewhat hampered by a lack of availability, particularly in the case of allograft products.

Medtronic acquires Osteotech - an ever changing competitive landscape

As this report went to press, Medtronic announced it had agreed to acquire Osteotech, a leading competitor. While consolidating Medtronic's domination of the market, this development marks the latest corporate move to secure market share. Increasing interest from multi-nationals can be seen. For example, Baxter International made its formal entry into the biologics market by acquiring ApaTech, a UK-based company that has developed and markets innovative synthetic bone substitutes.

Providing...

  • Sales forecasts for key orthobiologic sectors
  • Market share for leading companies
  • A review of the complex regulatory requirement in the US and EU
  • Evaluation of key orthobiologic applications areas
  • Detailed examination of product offerings by company for each sector

Covering all major areas including...

  • Allograft
  • Demineralised bone matrix
  • Synthetic bone grafts
  • Soft tissue implants
  • Growth factors
  • Autologous platelet separation products
  • Autologous bone marrow concentration products
  • Autologous chondrocyte transplantation
  • Stem cell therapy
  • At-a-glance competitive comparisons for major and emerging companies
  • aap Implantate AG
  • Aastrom Biosciences Inc.
  • Allograft Tissue systems
  • AlloSource
  • Alphatec Holdings Inc
  • Anika Therapeutics Inc
  • ApaTech Ltd
  • Arteriocyte Medical Systems Inc
  • Artimplant AB
  • B Braun Melsungen AG
  • Bacterin International
  • Baxter International Inc Berkeley Advanced Biomaterials Inc.
  • Biocomposites Ltd
  • Biocoral Inc
  • Biomatlante Sarl
  • Biomet Inc.
  • BioMimetic Therapeutics
  • Biosafe Group SA
  • Bone Biologics Inc
  • Bone Solutions Inc
  • BoneSupport AB
  • Cardium Therapeutics
  • Ceramisys Ltd Cerapedics Inc
  • co.don AG
  • Collagen Matrix Inc
  • Community Tissue Services
  • curasan AG
  • Cytomedix Inc
  • DePuy Inc.
  • EmCyte Corp
  • ETEX Corporation
  • Exactech Inc.
  • Fidia Advanced Biopolymers srl
  • Geistlich Pharma AG GenOsteo Inc.
  • Genzyme Biosurgery
  • Geron Corp
  • Graftys
  • Harvest Technologies Corp
  • Histogenics Corp
  • Integra LifeSciences
  • Interventional Spine Inc
  • ISTO Technologies Inc
  • Kasios
  • Kensey Nash Corp
  • Kinetic Concepts Inc
  • Kuros Biosurgery AG
  • Lanx Inc
  • LifeNet Health
  • Medtronic Inc.
  • Merck Serono SA
  • Mesoblast Ltd
  • MiMedx Group Inc.
  • Musculoskeletal Transplant Foundation
  • Nanotherapeutics Inc
  • NovaBone Products LLC
  • NuVasive Inc
  • Olympus Terumo Biomaterials Corp Orteq Bioengineering
  • Orthofix International NV
  • Orthox Ltd
  • Osiris Therapeutics Inc
  • Ossacur AG
  • Osteotech Inc
  • Pioneer Surgical Technology
  • Parcell Laboratories
  • PolyNovo Biomaterials Pty Ltd
  • ProChon Biotech Ltd
  • Progenteq Ltd
  • Progentix Orthobiology BV ReGen Biologics Inc
  • RepRegen Ltd.
  • RTI Biologics Inc
  • Scil Technology GmbH
  • SIGNUS Medizintechnik
  • Smith & Nephew plc
  • Spinal Restoration
  • SpineSmith Partners LP
  • Stryker Corp
  • Synovis Life Technologies
  • Synthes Inc
  • TEKNIMED SA ThermoGenesis Corp
  • TiGenix NV
  • Tissue Banks International
  • TissueGene Inc
  • Tissue Genesis Inc
  • Tissue Regenix Group PLC
  • Tornier SAS
  • US Spine
  • Wright Medical Group Inc

Contents

  • Executive Summary
  • Background
    • Comparison of Currently Available Orthobiologic Products
  • Addressable Markets
    • Fig.1: Global Musculoskeletal Market, 2009 US$32.5 billion
    • Fig.2: Global Orthobiologics Market by Product Application, 2009
    • Bone Grafting
    • Fracture Repair
    • Spinal Surgery
    • Revision Hip and Knee Replacement
    • Soft Tissue Repair
    • Cartilage Repair and Regeneration
    • Tendon and Ligament Repair
  • Competitive Environment
    • Selected Manufacturers' Orthobiologics Sales, 2005-2010 (US$ million)
    • Selected International Manufacturers' Orthobiologics Sales, 2004-2009 (million)
    • Fig.3: Global Orthobiologics Market Shares by Company, 2009
    • Industry Consolidation
  • Current Market Dynamics
    • Fig.4: Global Orthobiologics Market by Product Type, 2009
    • Regional Perspective
    • Fig.5: Global Orthobiologics Market by Geographic Region, 2009
    • Regulatory Environment
    • Orthobiologic Products: Regulatory Environment
  • Future Trends and Forecasts
    • Orthobiologics: Market Drivers, Restraints & Future Opportunities
    • Orthobiologics Market by Product Type, 2008-2015 (US$ million)
    • Global Orthobiologics Market Growth by Product, 2009-2015 (%)
    • Fig.6: Global Orthobiologics Market, 2008-2015(E) (US$ million)
    • Fig.7: Global Orthobiologics Market by Product Type, 2015 (E)
  • Products and Technologies
  • Allografts
    • Advantages of Allografts
    • Limitations of Allografts
    • Regulation and Safety Standards
    • The Musculoskeletal Allograft Market
    • Fig.8: Global Allograft Market, 2008-2015(E) (US$ million)
    • Key Providers of Allografts
    • AlloSource
    • Interventional Spine's RENEW Interspinous Allograft Technology
    • LifeNet Health
    • Musculoskeletal Transplant Foundation
    • Osteotech's Allografts
    • Fig.9: Osteotech: Allograft Sales, 2005-2009 (US$ thousands)
    • FacetLinx Spinal Allograft Implant
    • RTI Biologics' Allografts
    • Fig.10: RTI Biologics: Allograft Sales, 2005-2009 (US$ thousands)
    • Spinal Allograft
    • RTI Biologics: Spinal Allograft Portfolio and Distributors
    • Sports Medicine Allograft
    • General Orthopaedic Allografts
    • Advanced Technologies
    • NuVasive's Osteocel plus
    • Orthofix' Trinity Evolution Viable Cryopreserved Cellular Bone Matrix
  • Demineralised Bone Matrix Products
    • Fig.11: Global DBM Market, 2008-2015(E) (US$ million)
    • DBM Regulatory Requirements
    • DBM Product Highlights
    • Competitive Landscape: Demineralised Bone Matrix Products
    • Alphatec Holdings' DBM Products
    • B Braun/Aesculap's ProSpace DBM-D
    • ETEX' EquivaBone
    • Integra LifeSciences' Accell DBM Products
    • Integra LifeSciences' OsteoSparx and OsteoSurge
    • Integra LifeSciences' Trel-X and Trel-XC
    • Osteotech's Grafton DBM
    • Fig.12: Osteotech: DBM Sales, 2005-2009 (US$ thousands)
    • Osteotech's Synthetic and Hybrid Bone Grafts
    • Fig.13: Osteotech: Hybrid/Synthetic Bone Graft Sales, 2005-2009 (US$ thousands)
    • Osteotech's MagniFuse Bone Graft
    • Osteotech's Plexur Products
    • RTI Biologics' DBM-Based Bone Substitutes
    • RTI Biologics: Bone Substitute Allograft Paste Portfolio and Distributors
    • Fig.14: RTI Biologics: DBM Bone Substitute Sales, 2005-2009 (US$ thousands)
  • Synthetic Bone Graft Substitutes
    • Fig.15: Global Synthetic Bone Substitute Market, 2008-2015(E) (US$ million)
    • Competitive Landscape: Synthetic Bone Substitutes
    • Product Highlights
    • ApaTech/Baxter's Actifuse and ApaPore
    • Actifuse
    • ApaPore
    • Alphatec/Scient'x' Bone'X
    • Biocomposites' geneX Products
    • Biocomposites' Allogran-N
    • Bone Solutions' OsteoCrete Bone Void Filler
    • BoneSupport's Cerament Products
    • curasan's Osbone
    • curasan's Cerasorb
    • DePuy's Healos
    • ETEX' Nanocrystalline-Based Products
    • Stryker's Bio MatrX Structure and Bio MatrX Generate
    • Graftys' Synthetic Bone Substitutes
    • Integra LifeSciences' Integra Mozaik Bone Substitutes
    • Integra LifeSciences' OsteoStrux Osteoconductive Scaffold
    • Integra LifeSciences' Integra OS Osteoconductive Scaffold
    • ISTO Technologies' InQu Bone Graft Extender and Substitute
    • Medtronic/Kensey Nash's MasterGraft Products
    • Orthovita's Orthobiologic Products
    • Vitoss Bone Graft Substitutes
    • Cortoss Bone Augmentation Material
    • Wright Medical's Pro-Stim Injectable Osteoinductive Bone Graft Substitute
    • Products in Development
    • Kuros Biosurgery's Synthetic Bone Healing Products
    • GenOsteo's Bone-like Scaffolds
    • Orthox' Spidrex Bone
    • PolyNovo Biomaterials' Novosorb
    • RepRegen's StronBone
  • Soft Tissue Repair Implants
    • Competitive Landscape: Soft Tissue Repair Implants
    • DePuy's Restore Orthobiologic Soft Tissue Implant
    • Collagen-Based Products
    • Collagen Matrix' TenoMend Collagen Tendon Wrap
    • LifeCell's Conexa Reconstructive Tissue Matrix
    • Synovis Life Technologies' OrthADAPT Products
    • Wright Medical's GraftJacket Matrix
    • Wright Medical's Biotape XM Reinforcement Matrix
    • Dermal Matrix Products
    • Musculoskeletal Transplant Foundation's Allopatch HD Acellular Human Dermis
    • Synthetic and Combination Products
    • Artimplant's Artelon Implants
    • Resurfacing Concept
    • Reinforcement Concept
    • Kensey Nash's Cartilage Repair Device
    • Orteq's Actifit
    • Products in Development
    • Biomet's ChonDux
    • Kensey Nash/Arthrex Collaboration
    • MiMedx'CollaFix Products
    • Orthox' Spidrex Cartilage Technology
    • Osteotech's Human Collagen Technology
    • TiGenix' Chondromimetic
    • Tissue Regenix' dCELL Meniscus
  • Growth Factors
    • Fig.16: Global Market for Growth Factors, 2008-2015(E) (US$ million)
    • Bone Morphogenetic Proteins
    • Current Challenges for BMP Products
    • Medtronic's Infuse Bone Graft
    • Medtronic's InductOs
    • Stryker's OP-1
    • Products in Development
    • Medtronic's AMPLIFY rhBMP-2 Matrix
    • Scil Technology's ST01 rhBMP Growth Factor Product
    • Platelet-Derived Growth Factors
    • BioMimetic Therapeutics' Augment Bone Graft
    • Augment Clinical Trial and Safety Data
    • Augment Injectable Bone Graft
    • Augment for Sports Medicine
    • Cerapedics' i-FACTOR Peptide Enhanced Bone Grafts
    • Products in Development
    • Bone Biologics' NELL 1 Protein (UCB-1)
    • Cardium Therapeutics' Gene Activated Matrix Technology
    • Osteorate
    • Future Developments
    • Johnson & Johnson's Intradiscal rhGDF-5
    • Merck Serono's FGF-18
    • Scil Technology's rhCD-RAP-Based Products
    • TissueGene's TissueGene-C
  • Cell-Based Technologies
    • Fig.17: Global Cell-Based Orthobiologics Market, 2008-2015(E) (US$ million)
    • Regulatory Environment
    • EU Advanced Therapy Medicinal Products
    • Autologous Platelet Separation and Concentration Products
    • Arteriocyte Medical Systems' Magellan Autologous Platelet Separator System
    • FDA Warning Letter
    • Biomet's Platelet Separation Products
    • Cytomedix' Angel Whole Blood Separation System
    • Emcyte/Exactech's Accelerate Platelet Concentrate Products
    • Harvest Technologies' SmartPrep 2 Systems
    • Musculoskeletal Transplant Foundation's Cascade Autologous Platelet System
    • Smith & Nephew's Caption Disposable Platelet Concentration System
    • Autologous Chondrocyte Transplantation
    • Current Market Limitations
    • B Braun's Novocart 3D Autologous Chondrocyte Transplantation
    • co.don's Autologous Cell Therapies
    • Fig.18: co.don: Product Sales, 2005-2009
    • Fig.19: co.don: Cell Transplants by Region, 2009
    • Fig.20: co.don: Cell Transplants by Product, 2009
    • Fidia Advanced Biopolymers Hyaluronan-Based Tissue-Engineered Cartilage
    • Geistlich's Chondro-Gide
    • Genzyme's Carticel Cell Therapy and MACI
    • ProCon Biotech's BioCart System
    • TiGenix' ChondroCelect
    • Products in Development
    • Histogenics' NeoCart Implant
    • TiGenix' Cell-Based Technologies
    • Living Cartilage Implants
    • ISTO Technologies/Zimmer's DeNovo NT Natural Tissue Graft
    • ISTO Technologies/Zimmer's DeNovo ET Living Cartilage Implant
    • ISTO Technologies' NuQu Injectable Cell-Based Therapy
    • Stem Cell Technologies
    • Autologous Bone Marrow Concentration Products
    • Biomet's BioCUE Platelet Concentration System
    • Emcyte's GenesisCS and Sequire Systems
    • Emcyte/Exactech's Accelerate Bone Marrow Concentrate System
    • Harvest Technologies' SmartPReP 2 Bone Marrow Aspirate Concentrate System
    • ThermoGenesis' MXP MarrowXpress and Res-Q 60 BMC
    • Biosafe's Sepax Stem Cell Processing Products
    • Autologous Stem Cell Products - Mesoblast's Mesenchymal Precursor Cell Products
    • MPCs for Fracture Repair
    • Adipose Tissue Stem Cell Technology
    • Tissue Genesis
    • ThermoGenesis/GID
    • Allogeneic Stem Cell Therapies in Development
    • Alphatec Spine/Parcell Spine's ELA Stem Cell
    • Geron and University of Edinburgh - Human Embryonic Stem Cell Technologies
    • Mesoblast's NeoFuse for Spinal Fusion
    • Mesoblast's RepliCart for Knee Cartilage Repair
    • Mesoblast's MCSs for Degenerative Disc Disease
    • Osiris Therapeutics' Chondrogen
    • Osiris Therapeutics' Osteocel XC
    • TiGenix' Cell-Based Technologies
    • Progenteq's Progenitor Cell-Based Therapy
    • Fibrin-Based Products
    • Kuros Biosurgery/Baxter's Bone Healing Products
    • KUR-111
    • KUR-113
    • KUR-411
    • Spinal Restoration's Biostat System
  • Company Directory
  • Appendices
    • Appendix 1 - List of Abbreviations
    • Appendix 2 - Report Methodology