The Global Market for Orthobioligical Products

Date: August 22, 2010
Pages: 124
US$ 1,040.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)

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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.

  • 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…

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
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
Harvest Technologies Corp
Histogenics Corp
Integra LifeSciences
Interventional Spine Inc
ISTO Technologies Inc
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


Comparison of Currently Available Orthobiologic Products


  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


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


  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


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)



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
  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


  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)


  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
  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


  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


  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 Protein (UCB-1)
  Cardium Therapeutics’ Gene Activated Matrix Technology
    Future Developments
  Johnson & Johnson’s Intradiscal rhGDF-5
  Merck Serono’s FGF-18
  Scil Technology’s rhCD-RAP-Based Products
  TissueGene’s TissueGene-C


  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
  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
    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
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


Kuros Biosurgery/Baxter’s Bone Healing Products
Spinal Restoration’s Biostat System



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