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MediPoint:代用骨移植片−アジア太平洋市場の分析と予測

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

発行 GlobalData 商品コード 296028
出版日 ページ情報 英文 183 Pages
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MediPoint:代用骨移植片−アジア太平洋市場の分析と予測 MediPoint: Bone Grafts and Substitutes - APAC Analysis and Market Forecasts
出版日: 2014年01月31日 ページ情報: 英文 183 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。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、アジア太平洋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: GDME1078CFR

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 global competitive landscape in each of the segments (including traditional allograft bone, machined allograft bone, BMPs, DBMs, synthetic bone substitutes, and cell-based matrices) is difficult to define as the regulatory conditions for BGS differ from country to country, and therefore the market leaders can vary significantly in each segment of the market.

Scope

  • An overview of BGS, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized APAC BGS market revenue and future forecasts from 2010 to 2012, forecast for 7 years to 2019.
  • Investigation of current and future market competition for BGS.
  • Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
  • Competitor assessment including device approval analysis and device sales forecasts.
  • Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
  • Analysis of unmet needs within the market and opportunities for future players.
  • Technology trends evaluation to assess strength of pipeline.
  • An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
  • Company profiles including business description, financial overview and SWOT analysis.
  • Coverage of key market players.
  • Strategic assessment of the BGS sector through market impact analysis, future market scenario and company analysis.
  • Direct quotes from Key Opinion Leaders (KOL).

Reasons to buy

  • Understand the trends shaping and driving APAC BGS Market.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in APAC BGS market through 2019.
  • Quantify candidate patient populations to better design product pricing & launch plans.
  • Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
  • Perform benchmarking analysis of growth opportunities against currently marketed products.
  • Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
  • Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.
  • Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
  • What's the next big thing in APAC BGS market landscape? Identify, understand and capitalize.

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. Asia-Pacific
  • 4.2. Market Access
    • 4.2.1. Asia-Pacific
  • 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
  • 10.2. By Geography
    • 10.2.1. Overview
    • 10.2.2. Japan
    • 10.2.3. China
    • 10.2.4. 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. Contact Us
  • 11.9. 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 APAC, 2013
  • Table 11: Currently Marketed Cell-Based Matrices in the US Market
  • Table 12: Differences between the US and EU Regulations for BGS
  • Table 13: Types of Autologous Grafting Commonly Used to Treat Non-Union
  • Table 14: Advanced Biologics' BGS Products
  • Table 15: SWOT Analysis - Advanced Biologics' BGS Portfolio
  • Table 16: AlloSource's BGS Products
  • Table 17: SWOT Analysis - AlloSource's BGS Portfolio
  • Table 18: Bacterin's BGS Products
  • Table 19: SWOT Analysis - Bacterin's BGS Portfolio
  • Table 20: Baxter's BGS Products
  • Table 21: SWOT Analysis - Baxter's BGS Portfolio
  • Table 22: Biomet's BGS Products
  • Table 23: SWOT Analysis - Biomet's BGS Portfolio
  • Table 24: DePuy Synthes' BGS Products
  • Table 25: SWOT Analysis - DePuy Synthes' BGS Portfolio
  • Table 26: Exactech's BGS Products
  • Table 27: SWOT Analysis - Exactech's BGS Portfolio
  • Table 28: Integra LifeSciences' BGS Products
  • Table 29: SWOT Analysis - Integra LifeSciences' BGS Portfolio
  • Table 30: Medtronic's BGS Products
  • Table 31: SWOT Analysis - Medtronic's BGS Portfolio
  • Table 32: MTF's BGS Products
  • Table 33: SWOT Analysis - MTF's BGS Portfolio
  • Table 34: NuVasive's BGS Products
  • Table 35: SWOT Analysis - NuVasive's BGS Portfolio
  • Table 36: Olympus Biotech's BGS Products
  • Table 37: SWOT Analysis - Olympus Biotech's BGS Portfolio
  • Table 38: Orthofix's BGS Products
  • Table 39: SWOT Analysis - Orthofix's BGS Portfolio
  • Table 40: RTI Surgical's BGS Products
  • Table 41: SWOT Analysis - RTI Surgical's BGS Portfolio
  • Table 42: Stryker's BGS Products
  • Table 43: SWOT Analysis - Stryker's BGS Portfolio
  • Table 44: Wright Medical's BGS Products
  • Table 45: SWOT Analysis - Wright Medical's BGS Portfolio
  • Table 46: Zimmer's BGS Products
  • Table 47: SWOT Analysis - Zimmer's BGS Portfolio
  • Table 48: Compelling Questions Regarding the Cell-Based Matrices
  • Table 49: Pipeline Products in the Global BGS Market
  • Table 50: Major Clinical Findings of the YODA Project
  • Table 51: Major Clinical Studies of Augment Bone Graft
  • Table 52: Major Clinical Studies of Trinity Evolution
  • Table 53: Major Clinical Study of AlloStem
  • Table 54: Major Clinical Study of AttraX
  • Table 55: Major Clinical Study of i-FACTOR
  • Table 56: Major Clinical Studies of AMPLEX
  • Table 57: Company Profile - Alphatec Spine
  • Table 58: SWOT Analysis - Alphatec Spine
  • Table 59: Company Profile - AlloSource
  • Table 60: SWOT Analysis - AlloSource
  • Table 61: Company Profile - Bacterin
  • Table 62: SWOT Analysis - Bacterin
  • Table 63: Company Profile - Biomet
  • Table 64: SWOT Analysis - Biomet
  • Table 65: Company Profile - DePuy Synthes
  • Table 66: SWOT Analysis - DePuy Synthes
  • Table 67: Company Profile - Exactech
  • Table 68: SWOT Analysis - Exactech
  • Table 69: Company Profile - Globus Medical
  • Table 70: SWOT Analysis - Globus Medical
  • Table 71: Company Profile - Integra LifeSciences
  • Table 72: SWOT Analysis - Integra LifeSciences
  • Table 73: Company Profile - Medtronic
  • Table 74: SWOT Analysis - Medtronic
  • Table 75: Company Profile - NuVasive
  • Table 76: SWOT Analysis - NuVasive
  • Table 77: Company Profile - Olympus Biotech
  • Table 78: SWOT Analysis - Olympus Biotech
  • Table 79: Company Profile - Orthofix
  • Table 80: SWOT Analysis - Orthofix
  • Table 81: Company Profile - RTI Surgical
  • Table 82: SWOT Analysis - RTI Surgical
  • Table 83: Company Profile - Stryker
  • Table 84:SWOT Analysis - Stryker
  • Table 85: Company Profile - Wright Medical
  • Table 86: SWOT Analysis - Wright Medical
  • Table 87: Company Profile - Zimmer Holdings
  • Table 88: SWOT Analysis - Zimmer Holdings
  • Table 89: Other Players in the Global BGS Market
  • Table 90: APAC BGS Market Sales Forecast ($m), 2011-2020
  • Table 91: Japan BGS Market Sales Forecast ($m), 2011-2020
  • Table 92: China BGS Market Sales Forecast ($m), 2011-2020
  • Table 93: India BGS Market Sales Forecast ($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 APAC, 2011-2020
  • Figure 4: Traditional Allograft Bone Sales Volume in APAC, 2011-2020
  • Figure 5: Bone Grafts Substitutes Sales Volumes in APAC, 2011-2020
  • Figure 6: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013
  • Figure 7: Global BGS Competitive Landscape, by Estimated Revenue, 2013
  • Figure 8: Global BGS Market Sales Forecast in 10 Countries, 2011-2020
  • Figure 9: APAC BGS Market by Major Market, 2013 and 2020
  • Figure 10: APAC BGS Market Revenue Distribution, By Segment, 2013 and 2020
  • Figure 11: Japan BGS Market Sales Forecast ($m), 2011-2020
  • Figure 12: Japan BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 13: China BGS Market Sales Forecast ($m), 2011-2020
  • Figure 14: China BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 15: India BGS Market Sales Forecast ($m), 2011-2020
  • Figure 16: India BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 17: Other Primary Research Participants Breakdown, by Country (n=236)
  • Figure 18: Other Primary Research Participants Breakdown, by Institution (n=236)
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