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MediPoint:代用骨移植片−世界市場の分析と予測

MediPoint: Bone Grafts and Substitutes - Global Analysis and Market Forecasts

発行 GlobalData 商品コード 295034
出版日 ページ情報 英文 232 Pages
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MediPoint:代用骨移植片−世界市場の分析と予測 MediPoint: Bone Grafts and Substitutes - Global Analysis and Market Forecasts
出版日: 2014年01月31日 ページ情報: 英文 232 Pages
概要

骨移植において、未だ自家骨は代表的な移植材と認識されていますが、市場において利用可能な代用骨は多岐にわたっており、特に米国や欧州市場では代用骨移植片(BGS)導入が徐々に広まっています。急速な技術変化や頻繁な新技術の導入、顧客ニーズや業界標準の変化などが同市場の特徴として挙げられますが、企業はより良い治療結果を得るために、脊椎用ハードウェア製品や骨インプラントとの相乗効果を模索し技術を公開しており、将来の市場における参入度はサプライヤーが骨疾患治療という広範な体系の中で製品をいかに位置づけるかにかかっています。代用骨移植片市場において最大の収益をあげている市場は米国です。対照的に、アジア太平洋地域や南アフリカでは、骨移植片の最も一般的な選択肢は自家骨となっています。

当レポートでは、世界における代用骨移植片市場について、骨移植の概要、業界の分析、競合情勢、パイプライン製品、目下のアンメットニーズと今後の市場機会、技術開発動向などを分析し、その結果を概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 臨床転帰

  • 概要
  • 自家骨
  • 他家骨
  • 代用骨移植片

第3章 産業概要

  • 処置の傾向
  • 市場アクセス
  • 規制上の課題/製品リコール
  • 企業合併・買収(M&A)と主なパートナーシップ
  • 経済的な影響
  • 市場促進要因
  • 市場機会
  • 参入障壁

第5章 競合評価

  • 概要
  • 上市製品

第6章 アンメットニーズ

  • 臨床データの透明性
  • 人間を被験者とした臨床研究の不足
  • rhBMPの投与およびキャリアー
  • 骨バンク産業のDBM製品におけるDBM濃度の標準化
  • より高い骨誘導性をもつ製品に対するニーズ
  • 細胞マトリックスの継続研究
  • 代用骨製品に対するより高い医療教育へのニーズ
  • 費用抑制へのニーズ

第7章 パイプライン製品

  • 概要
  • Advanced Biologics'(OsteoMEM)
  • Aursos (Synthetic Bone Substitute)
  • BioSET (AMPLEX)
  • CeraPedics(i-FACTOR)
  • NuVasive(AttraX)
  • Osiris Therapeutics(OvationOS)
  • Wright Medical (Augment Bone Graft)

第8章 注目すべき臨床試験

  • MedtronicのINFUSE Bone Graftに対するYale大学のレビュー
  • Wright Medical(Augment Bone Graft)
  • Orthofix (Trinity Evolution)
  • AlloSource (AlloStem)
  • NuVasive (AttraX)
  • CeraPedics (i-FACTOR)
  • BioSET (AMPLEX)

第9章 現在および将来の参入企業

  • 企業戦略の動向
  • 企業プロファイル
  • その他の企業

第10章 市場の見通し

  • 市場シェア分析
  • 地域別

第11章 付録

図表一覧

目次
Product Code: GDME0192MAR

Although autograft is still perceived as the gold-standard material in bone grafting, the wide array of alternatives available in the market has resulted in a gradual shift towards increased adoption of bone grafts and substitutes (BGS), especially in the US and European markets. In contrast to the general picture in developed countries, autograft bone still represents the most popular option during bone grafting in the Asia-Pacific (APAC) region and South America.

The market for BGS is characterized by rapid technological change, frequent new introductions, changes in customers' demands and evolving industry standards. An example is the industry's recent re-evaluation of the expanding utilization of BMPs. Moving forward, the shift to lower-dosed BMPs is expected to be accompanied with continued rise in the sales volume of synthetic bone substitutes in all markets, and increased adoption of cell-based matrices in the US market. Since BGS companies have uncovered new ways of using their technologies to find synergies with spine hardware products, and orthopedic implants to deliver better therapeutic outcomes, future access in the market will hinge on suppliers positioning their products as part of a broader therapy system for bone repair that includes multiple offerings. Meanwhile, companies will need to understand two basic driving forces in the global BGS arena - surgeons who continuously seek improved patient outcomes and healthcare systems who become increasingly concerned about the economics.

Highlights

Key Questions Answered

  • Given the negative media literature surrounding Medtronic's INFUSE Bone Graft, surgeons now hold varied opinions regarding the BMP products. (Q).What are surgeons' attitudes about the cost-effectiveness of BMP/growth factor products? (Q).How will the overall BGS market evolve following the continuing revenue decline in the BMP/growth factor segment?
  • As health executives are scrutinizing purchases and using multiple channels to procure biologics at highly competitive prices, surgeon's preference is no longer considered the top priority in many hospitals' decision-making process. (Q).How are governments' cost-containment measures affecting the utilization of different types of BGS products?
  • Currently, in the BGS market, the lack of reliable studies to demonstrate products' efficacy in human clinical settings has led to many surgeons reluctant to adopt newly-launched biological products. (Q).What are the current adoption levels of different types of BGS products?
  • Cell-based matrices have received increased enthusiasm in the US market. Yet ongoing scrutiny of the segment may have a negative impact on future growth of this segment. (Q).Will the cell-based matrices segment benefit from declining utilization of BMP/growth factor products? (Q).How are companies strategically responding to this attractive segment?
  • In the years to come, launching and marketing a comprehensive orthobiologics portfolio with a clear value proposition will remain critical to companies' success. (Q).Will the BGS market maintain growth amid regulatory setbacks and austerity measures? (Q).Which materials are more favorably positioned for increasing adoption?

Reasons to buy

  • "What Do Physicians Think" quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports

3. Clinical Outcomes

  • 3.1. Overview
  • 3.2. Autograft Bone
  • 3.3. Allograft Bone
  • 3.4. Bone Graft Substitutes
    • 3.4.1. BMPs/Growth Factors
    • 3.4.2. DBMs
    • 3.4.3. Synthetic Bone Substitutes
    • 3.4.4. Cell-Based Matrices

4. Industry Overview

  • 4.1. Procedural Trends
    • 4.1.1. Overview
    • 4.1.2. US
    • 4.1.3. 5EU
    • 4.1.4. Asia-Pacific
    • 4.1.5. South America
  • 4.2. Market Access
    • 4.2.1. US
    • 4.2.2. 5EU
    • 4.2.3. Asia-Pacific
    • 4.2.4. South America
  • 4.3. Regulatory Issues/Recalls
    • 4.3.1. FDA Convened a Dispute Resolution Panel to Discuss Wright Medical's Augment Bone Graft (October 2013)
    • 4.3.2. FDA Issued a Warning Letter over Globus Medical's MicroFuse Bone Growth Putty (September 2013)
    • 4.3.3. Medtronic and the Australia Therapeutic Goods Administration Recalled Unused Lots of INFUSE LT-Cage Bone Graft Kits (June 2013)
    • 4.3.4. Alphatec Spine Voluntarily Stopped Shipping PureGen (February 2013)
    • 4.3.5. FDA Rejected Approval of Medtronic's AMPLIFY rhBMP-2 Matrix (March 2011)
  • 4.4. Mergers & Acquisitions/Key Partnerships
    • 4.4.1. Bacterin Developed Strategic Alliance with DMP Spine Biologics (November 2013)
    • 4.4.2. RTI Surgical Entered into a New Distribution Deal with Medtronic Sofamor Danek (October 2013)
    • 4.4.3. RTI Biologics Completed Acquisition of Pioneer Surgical Technology (July 2013)
    • 4.4.4. Amedica Commenced Distribution of Dynamic Surgical's Dynamic Bone Expandable Allograft (April 2012)
  • 4.5. Economic Impacts
  • 4.6. Market Drivers
    • 4.6.1. Disadvantages of Autografts
    • 4.6.2. Continued Increase in the Procedure Volumes of Spinal and Orthopedic Surgeries
    • 4.6.3. New Generation of Biological or Synthetic Materials
    • 4.6.4. Cross-Selling
    • 4.6.5. Improved Patient Awareness
  • 4.7. Market Opportunities
    • 4.7.1. Stem Cell Therapies
    • 4.7.2. Foot and Ankle Market
    • 4.7.3. Comprehensive Orthobiologics Platform
    • 4.7.4. Antibiotics-Eluting Bone Graft Substitutes
    • 4.7.5. Emerging Countries
  • 4.8. Market Barriers
    • 4.8.1. Variations in Regulations
    • 4.8.2. Lingering Questions on rhBMP-2 to Generate Negative Spillover Effects
    • 4.8.3. Negative Publicity Concerning Screening and Processing Methods of Allograft
    • 4.8.4. Reimbursement and Pricing Pressure
    • 4.8.5. Proving Clinical Efficacy
    • 4.8.6. Medical Device Excise Tax
    • 4.8.7. Substitutes

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Marketed Products
    • 5.2.1. Advanced Biologics
    • 5.2.2. AlloSource
    • 5.2.3. Bacterin
    • 5.2.4. Baxter
    • 5.2.5. Biomet
    • 5.2.6. DePuy Synthes
    • 5.2.7. Exactech
    • 5.2.8. Integra LifeSciences
    • 5.2.9. Medtronic
    • 5.2.10. Musculoskeletal Transplant Foundation (MTF)
    • 5.2.11. NuVasive
    • 5.2.12. Olympus Biotech
    • 5.2.13. Orthofix
    • 5.2.14. RTI Surgical
    • 5.2.15. Stryker
    • 5.2.16. Wright Medical
    • 5.2.17. Zimmer

6. Unmet Needs

  • 6.1. Clinical Data Transparency
  • 6.2. Lack of Human Clinical Studies
  • 6.3. Optimization of rhBMPs' Dosage and Carrier
  • 6.4. Standardization of DBM Products' DBM Concentration across the Bone Banking Industry
  • 6.5. Need for Products with Improved Osteoinductivity
  • 6.6. Continued Research on Cell-Based Matrices
  • 6.7. Need for Improved Medical Education on Bone Substitutes Products
  • 6.8. Need for Cost Containment

7. Pipeline Products

  • 7.1. Overview
  • 7.2. Advanced Biologics' OsteoMEM
  • 7.3. Aursos' Synthetic Bone Substitute
  • 7.4. BioSET's AMPLEX
  • 7.5. CeraPedics' i-FACTOR
  • 7.6. NuVasive's AttraX
  • 7.7. Osiris Therapeutics' OvationOS
  • 7.8. Wright Medical' Augment Bone Graft

8. Clinical Trials to Watch

  • 8.1. Yale's Review of Medtronic's INFUSE Bone Graft
  • 8.2. Wright Medical's Augment Bone Graft
  • 8.3. Orthofix's Trinity Evolution
  • 8.4. AlloSource's AlloStem
  • 8.5. NuVasive's AttraX
  • 8.6. CeraPedics' i-FACTOR
  • 8.7. BioSET's AMPLEX

9. Current and Future Players

  • 9.1. Trends in Corporate Strategy
  • 9.2. Company Profiles
    • 9.2.1. Alphatec Spine
    • 9.2.2. AlloSource
    • 9.2.3. Bacterin
    • 9.2.4. Biomet
    • 9.2.5. DePuy Synthes
    • 9.2.6. Exactech
    • 9.2.7. Globus Medical
    • 9.2.8. Integra LifeSciences
    • 9.2.9. Medtronic
    • 9.2.10. NuVasive
    • 9.2.11. Olympus Biotech
    • 9.2.12. Orthofix
    • 9.2.13. RTI Surgical
    • 9.2.14. Stryker
    • 9.2.15. Wright Medical
    • 9.2.16. Zimmer Holdings
  • 9.3. Other Players

10. Market Outlooks

  • 10.1. Market Share Analysis
    • 10.1.1. Global
    • 10.1.2. US
    • 10.1.3. 5EU
  • 10.2. By Geography
    • 10.2.1. Overview
    • 10.2.2. US
    • 10.2.3. France
    • 10.2.4. Germany
    • 10.2.5. Italy
    • 10.2.6. Spain
    • 10.2.7. UK
    • 10.2.8. Japan
    • 10.2.9. Brazil
    • 10.2.10. China
    • 10.2.11. India

11. Appendix

  • 11.1. Abbreviations
  • 11.2. Bibliography
  • 11.3. Report Methodology
    • 11.3.1. Overview
    • 11.3.2. Coverage
    • 11.3.3. Secondary Research
    • 11.3.4. Forecasting Methodology
    • 11.3.5. Primary Research - Key Opinion Leader Interviews
    • 11.3.6. Expert Panel Validation
  • 11.4. Physicians and Specialists Included in this Study
  • 11.5. About the Authors
    • 11.5.1. Analysts
    • 11.5.2. Bonnie Bain, Ph.D., Global Head of Healthcare
  • 11.6. About MediPoint
  • 11.7. About GlobalData
  • 11.8. Disclaimer

List of Tables

  • Table 1: Definition of Bone Growth Mechanisms
  • Table 2: Advantages and Disadvantages of Autografts
  • Table 3: Advantages and Disadvantages of Allografts
  • Table 4: Differences Between INFUSE Bone Graft and OP-1 Products
  • Table 5: Advantages and Disadvantages of BMPs
  • Table 6: Advantages and Disadvantages of DBMs
  • Table 7: Major Types of Synthetic Bone Substitutes
  • Table 8: Advantages and Disadvantages of Synthetic Bone Substitutes
  • Table 9: Advantages and Disadvantages of Cell-Based Matrices
  • Table 10: Usage of BGS by Procedure Type in the US, 2013
  • Table 11: Usage of BGS by Procedure Type in 5EU, 2013
  • Table 12: Usage of BGS by Procedure Type in APAC, 2013
  • Table 13: Usage of BGS by Procedure Type in South America, 2013
  • Table 14: Medicare National Average Reimbursement Rates for Major Orthopedic Procedures that Involve the Usage of BGS, 2013-2014
  • Table 15: Currently Marketed Cell-Based Matrices in the US Market
  • Table 16: Differences between the US and EU Regulations for BGS
  • Table 17: Types of Autologous Grafting Commonly Used to Treat Non-Union
  • Table 18: Advanced Biologics' BGS Products
  • Table 19: SWOT Analysis - Advanced Biologics' BGS Portfolio
  • Table 20: AlloSource's BGS Products
  • Table 21: SWOT Analysis - AlloSource's BGS Portfolio
  • Table 22: Bacterin's BGS Products
  • Table 23: SWOT Analysis - Bacterin's BGS Portfolio
  • Table 24: Baxter's BGS Products
  • Table 25: SWOT Analysis - Baxter's BGS Portfolio
  • Table 26: Biomet's BGS Products
  • Table 27: SWOT Analysis - Biomet's BGS Portfolio
  • Table 28: DePuy Synthes' BGS Products
  • Table 29: SWOT Analysis - DePuy Synthes' BGS Portfolio
  • Table 30: Exactech's BGS Products
  • Table 31: SWOT Analysis - Exactech's BGS Portfolio
  • Table 32: Integra LifeSciences' BGS Products
  • Table 33: SWOT Analysis - Integra LifeSciences' BGS Portfolio
  • Table 34: Medtronic's BGS Products
  • Table 35: SWOT Analysis - Medtronic's BGS Portfolio
  • Table 36: MTF's BGS Products
  • Table 37: SWOT Analysis - MTF's BGS Portfolio
  • Table 38: NuVasive's BGS Products
  • Table 39: SWOT Analysis - NuVasive's BGS Portfolio
  • Table 40: Olympus Biotech's BGS Products
  • Table 41: SWOT Analysis - Olympus Biotech's BGS Portfolio
  • Table 42: Orthofix's BGS Products
  • Table 43: SWOT Analysis - Orthofix's BGS Portfolio
  • Table 44: RTI Surgical's BGS Products
  • Table 45: SWOT Analysis - RTI Surgical's BGS Portfolio
  • Table 46: Stryker's BGS Products
  • Table 47: SWOT Analysis - Stryker's BGS Portfolio
  • Table 48: Wright Medical's BGS Products
  • Table 49: SWOT Analysis - Wright Medical's BGS Portfolio
  • Table 50: Zimmer's BGS Products
  • Table 51: SWOT Analysis - Zimmer's BGS Portfolio
  • Table 52: Compelling Questions Regarding the Cell-Based Matrices
  • Table 53: Pipeline Products in the Global BGS Market
  • Table 54: Major Clinical Findings of the YODA Project
  • Table 55: Major Clinical Studies of Augment Bone Graft
  • Table 56: Major Clinical Studies of Trinity Evolution
  • Table 57: Major Clinical Study of AlloStem
  • Table 58: Major Clinical Study of AttraX
  • Table 59: Major Clinical Study of i-FACTOR
  • Table 60: Major Clinical Studies of AMPLEX
  • Table 61: Company Profile - Alphatec Spine
  • Table 62: SWOT Analysis - Alphatec Spine
  • Table 63: Company Profile - AlloSource
  • Table 64: SWOT Analysis - AlloSource
  • Table 65: Company Profile - Bacterin
  • Table 66: SWOT Analysis - Bacterin
  • Table 67: Company Profile - Biomet
  • Table 68: SWOT Analysis - Biomet
  • Table 69: Company Profile - DePuy Synthes
  • Table 70: SWOT Analysis - DePuy Synthes
  • Table 71: Company Profile - Exactech
  • Table 72: SWOT Analysis - Exactech
  • Table 73: Company Profile - Globus Medical
  • Table 74: SWOT Analysis - Globus Medical
  • Table 75: Company Profile - Integra LifeSciences
  • Table 76: SWOT Analysis - Integra LifeSciences
  • Table 77: Company Profile - Medtronic
  • Table 78: SWOT Analysis - Medtronic
  • Table 79: Company Profile - NuVasive
  • Table 80: SWOT Analysis - NuVasive
  • Table 81: Company Profile - Olympus Biotech
  • Table 82: SWOT Analysis - Olympus Biotech
  • Table 83: Company Profile - Orthofix
  • Table 84: SWOT Analysis - Orthofix
  • Table 85: Company Profile - RTI Surgical
  • Table 86: SWOT Analysis - RTI Surgical
  • Table 87: Company Profile - Stryker
  • Table 88:SWOT Analysis - Stryker
  • Table 89: Company Profile - Wright Medical
  • Table 90: SWOT Analysis - Wright Medical
  • Table 91: Company Profile - Zimmer Holdings
  • Table 92: SWOT Analysis - Zimmer Holdings
  • Table 93: Other Players in the Global BGS Market
  • Table 94: Global BGS Market Sales Forecast ($m), 2011-2020
  • Table 95: US BGS Market Sales Forecast ($m), 2011-2020
  • Table 96: France BGS Market Sales Forecast ($m), 2011-2020
  • Table 97: Germany BGS Market Sales Forecast ($m), 2011-2020
  • Table 98: Italy BGS Market Sales Forecast ($m), 2011-2020
  • Table 99: Spain BGS Market Sales Forecast ($m), 2011-2020
  • Table 100: UK BGS Market Sales Forecast ($m), 2011-2020
  • Table 101: Japan BGS Market Sales Forecast ($m), 2011-2020
  • Table 102: Brazil BGS Market Sales Forecast ($m), 2011-2020
  • Table 103: China BGS Market Sales Forecast ($m), 2011-2020
  • Table 104: India BGS Market Sales Forecast ($m), 2011-2020

List of Figures

  • Figure 1: An Overview of BGS Used in Orthopedic Surgeries
  • Figure 2: Usage of Autograft, Allograft, and Bone Graft Substitutes, by Country, 2013
  • Figure 3: Bone Grafting Procedure Volumes in the US, 2011-2020
  • Figure 4: Traditional Allograft Bone Sales Volume in the US, 2011-2020
  • Figure 5: Machined Allograft Bone Sales Volume in the US, 2011-2020
  • Figure 6: Bone Grafts Substitutes Sales Volumes in the US, 2011-2020
  • Figure 7: Bone Grafting Procedure Volumes in 5EU, 2011-2020
  • Figure 8: Traditional Allograft Bone Sales Volume in 5EU, 2011-2020
  • Figure 9: Machined Allograft Bone Sales Volume in 5EU, 2011-2020
  • Figure 10: Bone Grafts Substitutes Sales Volumes in 5EU, 2011-2020
  • Figure 11: Bone Grafting Procedure Volumes in APAC, 2011-2020
  • Figure 12: Traditional Allograft Bone Sales Volume in APAC, 2011-2020
  • Figure 13: Bone Grafts Substitutes Sales Volumes in APAC, 2011-2020
  • Figure 14: Bone Grafting Procedure Volumes in Brazil, 2011-2020
  • Figure 15: Traditional Allograft Bone Sales Volume in Brazil, 2011-2020
  • Figure 16: Machined Allograft Bone Sales Volume in Brazil, 2011-2020
  • Figure 17: Bone Grafts Substitutes Sales Volumes in Brazil, 2011-2020
  • Figure 18: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013
  • Figure 19: Global BGS Competitive Landscape, by Estimated Revenue, 2013
  • Figure 20: US BGS Competitive Landscape, 2013
  • Figure 21: US BGS Competitive Landscape, by Segment, 2013
  • Figure 22: France BGS Competitive Landscape, 2013
  • Figure 23: Germany BGS Competitive Landscape, 2013
  • Figure 24: Italy BGS Competitive Landscape, 2013
  • Figure 25: Spain BGS Competitive Landscape, 2013
  • Figure 26: UK BGS Competitive Landscape, 2013
  • Figure 27: Global BGS Market Sales Forecast in 10 Countries, 2011-2020
  • Figure 28: BGS Market by Major Market, 2013 and 2020
  • Figure 29: Global BGS Market Revenue Distribution, By Segment, 2013 and 2020
  • Figure 30: US BGS Market Sales Forecast ($m), 2011-2020
  • Figure 31: US BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 32: France BGS Market Sales Forecast ($m), 2011-2020
  • Figure 33: France BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 34: Germany BGS Market Sales Forecast ($m), 2011-2020
  • Figure 35: Germany BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 36: Italy BGS Market Sales Forecast ($m), 2011-2020
  • Figure 37: Italy BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 38: Spain BGS Market Sales Forecast ($m), 2011-2020
  • Figure 39: Spain BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 40: UK BGS Market Sales Forecast ($m), 2011-2020
  • Figure 41: UK BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 42: Japan BGS Market Sales Forecast ($m), 2011-2020
  • Figure 43: Japan BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 44: Brazil BGS Market Sales Forecast ($m), 2011-2020
  • Figure 45: Brazil BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 46: China BGS Market Sales Forecast ($m), 2011-2020
  • Figure 47: China BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 48: India BGS Market Sales Forecast ($m), 2011-2020
  • Figure 49: India BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 50: Other Primary Research Participants Breakdown, by Country (n=236)
  • Figure 51: Other Primary Research Participants Breakdown, by Institution (n=236)
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