The Global Orthobiologics Market - Players, products and technologies driving change 2008

Date: May 22, 2008
Pages: 294
Price:
US$ 1,215.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: G877B3379CBEN
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The Global Orthobiologics Market - Players, products and technologies driving change 2008
The primary advantage of synthetic bone graft substitutes and growth factors compared with allograft bone tissue is that they do not depend on the availability of donated human tissue. In addition, owing to the potential risk of disease transmission, synthetic materials and growth factors may be perceived as safer than allograft-based bone tissue. Many new composite products are also becoming available which seek to harness the combined characteristics of synthetic and natural materials in one single product optimised for rapid bone repair and regeneration.

Stem cell therapy is also showing huge potential as an alternative to autograft. Mesenchymal stem cells (MSCs) found in bone marrow, can form a variety of cells in the laboratory, including fat cells, cartilage, bone, tendon and ligaments, muscles cells, skin cells and even nerve cells. Unlike most other human adult stem cells, MSCs can be obtained in quantities appropriate for clinical applications, making them good candidates for use in tissue repair. They also offer the advantage of low morbidity and cost.

The last twelve months has seen consolidation in the orthobiologic sector, although most of the acquisitions have been relatively small in terms of money. The largest acquisition, and of particular interest, is the rather surprising entry into the segment of negative-pressure woundcare company, Kinetic Concepts, with its proposed acquisition of LifeCell, a leading provider of biological products for soft tissue repair, for US$1.7 billion.

The emergence of gene therapy?

Gene therapy has the potential to provide the ideal solution for treating a variety of musculoskeletal disorders. The promise of gene therapy is the ability to efficiently transfer new genetic material into patient cells to either replace defective genes or introduce therapeutic genes in order to treat disease.

To date, much of the research in gene therapy for the enhancement of spine fusion has centred on the transfer of genes-encoding BMPs and related proteins. Recombinant, osteogenic growth factors are now available to enhance bone repair, particularly in those applications related to the treatment of fracture non-unions and the enhancement of fusion of the spine. However, there is concern that a single dose of an exogenous protein will not induce an adequate osteogenic signal in many patients, particularly in those cases where there is a compromise of host bone and the surrounding soft tissue.

Questions answered
  • What will the value of stem cell therapies be in 2012?
  • What are the market growth drivers for the allograft tissue market?
  • What are the advantages and disadvantages of platelet-derived growth factors?
  • The synthetic bone graft market was estimated to be worth US$250 million in 2007. By what annual rate is it expected to grow over the next 5 years?
  • Who are the companies with novel technology in the soft tissue repair area?
  • What is DePuy’s product line-up in the orthobiologics sector?
  • What is Genzyme’s interest in China?
  • With which Australian company did Smith & Nephew sign a distribution deal in March 2008?


To understand the market and the leading companies that are driving growth and innovation you need this report

The Global Market for Orthobiologics:

Players, products and technologies driving change

Volume I:
Market Sectors


Volume I of the report looks more closely at the issues and markets as a whole and focuses on current and novel development in the following key sectors:
  • Allograft Tissue
  • Demineralised Bone Matrix
  • Growth Factors
  • Synthetic Bone Graft
  • Stem Cell Therapy
  • Joint Fluid Therapy
  • Cartilage Repair

Market estimates for orthobiologics materials vary greatly because the orthobiologics market is not clearly defined. Some estimates include only bone substitute materials, whereas this report also includes hyaluronic acid injections for joint fluid therapy and articular cartilage repair products.

The global orthobiologics market was estimated by Espicom to be worth US$4.2 billion in 2007 and accounted for 13% of the US$33 billion total orthopaedic market. With an annual growth rate of 17%, orthobiologics is the fastest growing orthopaedic segment.

The global orthobiologics market is projected to almost double by 2012, driven by technological advances and an ageing, increasingly active population giving rise to more people aged over 60 diagnosed with musculoskeletal conditions. Stem-cell therapies are forecast to be the fastest-growing category, with a CAGR of 53.9% over the next five years.


Volume II:
Company Analysis


Volume II of the report provides extensive company information on over 50 leading companies focusing on:
  • Product Portfolio
  • Research Programmes
  • Who’s Working with Whom?

While the large multinationals have a significant presence, the orthobiologics segment is very fragmented and is mainly inhabited by much smaller companies, many of which have products that are only in the early stages of development. The orthobiologics market is currently led by Medtronic which has an expanding orthobiologics portfolio, the lead product of which is the company’s InFUSE Bone Graft, which dominates the bone morphogenic protein market with an over 90% market share.

To illustrate the corporate rationalisation of the market, in November 2007 Regeneration Technologies, Inc. (RTI), a leading processor of orthopaedic and other biologic implants, and Tutogen Medical, a leading manufacturer of sterile biological implants made from human (allograft) and animal (xenograft) tissue, announced a definitive agreement to combine the two companies in a tax-free, stock-for-stock exchange valued at US$205 million.

Among the companies covered in the report

3DM
AAP Implantate
Aastrom Biosciences
Abbott Spine
Allograft Tissue Systems Inc (ATSI)
Allosource
Alphatec Spine
Apatech
Arthro Kinetics
Berkeley Advanced Biomaterials
Biomet
Biomimetic Therapeutics
Bioniche Pharma
Biosyntech
co.don AG
Collagen Matrix
CSIRO
Curasan AG
DePuy
ETEX Corporation
Exactech
Ferring Pharmaceuticals
Fidia Advanced Biopolymers
Geistlich Biomaterials
Genzyme
Graftys
Integra Lifesciences
ISTO Technologies
Kasios
Kinamed
Lifecell
Lifenet Health
Magnecell
Mica
Medtronic
Mesoblast
Nanocoatings Pty Ltd
Nanotherapeutics
Orthofix
Orthomimetics
Orthovita
Osiris
Ossacur
Osteotech
Pegasus Biologics
Regen Biologics
RTI Biologics
Smith & Nephew
Spinal Restoration
Stellar Pharmaceuticals
Stryker
Synthes
Tigenix
TRB Chemedica
Wright Medical
Zimmer
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 BONEGRAFT 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

STEMM 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 REMEDI
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

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