全球骨生物活性材料市场研究报告??The Global Orthobiologics Market - Players, Products and Technologies Driving Change 2008

2007年美国整形外科用生物材料市场创造了将近22亿美元的收益。

本报告书内容包括：美国整形外科用生物材料市场整体概要、骨移植片、利用玻尿酸补给黏性、切削椎间盘机器、膝软骨修复、血小板浓缩系统等市场动向及竞争分析。内容纲要摘记如下：

实施概要

方法论

第1章 整形外科用生物材料背景

• 骨移植片
• 变异性关节炎及利用玻尿酸补充黏性
• 椎间盘机器
• 膝软骨修复
• 血小板浓缩系统

第2章 美国整形外科用生物材料市场

• 市场概要
• 市场分析
  • 处置
  • 市场预测
• 竞争分析

第3章 骨移植片代用品

• 市场概要
• 市场分析
  • 处置
  • 市场预测
  • 市场发展因素及阻碍发展因素
  • 新兴技术
  • 竞争分析
  • 外科医生的意见反馈
• 脊椎固定术市场
  • 胸腰椎固定术市场
  • 颈椎固定术市场
• 外伤外科市场
  • 新伤骨折手术市场
  • 不连骨折手术市场
• 关节修整及重建手术市场
• 颅颜面正颚重建手术市场

第4章 利用玻尿酸补充黏性市场

• 市场概要
• 市场分析
  • 处置
  • 市场预测
  • 市场发展因素及阻碍发展因素
• 竞争分析

第5章 椎间盘机器市场

• 市场概要
• 市场分析
  • 市场预测
  • 市场发展因素及阻碍发展因素・动向
• 竞争分析

第6章 膝盖软骨修复市场

• 市场概要
• 市场分析
  • 处置
  • 市场预测
  • 市场发展因素及阻碍发展因素
  • 新兴技术
• 竞争分析

第7章 血小板浓缩系统市场

• 市场概要
• 市场分析
  • 处置
  • 市场预测
  • 市场发展因素及阻碍发展因素
• 竞争分析

 西安唐都医院骨科李军

摘要

Countries covered: Global

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

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.

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Additional Information

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

目录及图表

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 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

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 Dbm

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)

Dbx: 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 Dbm 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

Tabe 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