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MediPoint:代用骨移植片−米国市場の分析と予測

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

発行 GlobalData 商品コード 295035
出版日 ページ情報 英文 183 Pages
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MediPoint:代用骨移植片−米国市場の分析と予測 MediPoint: Bone Grafts and Substitutes - US 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)導入が徐々に増加しています。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。この状況とは対照的に、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、米国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

  • 処置の動向
  • 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: GDME1076CFR

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 majority of the market revenue for BGS is contributed by the US. Medtronic is considered the top player in the US market due to its strength in multiple segments. In the allograft bone space (including both traditional and machined allograft bone segments), Medtronic and MTF were two of the tier one players in 2013. In the BMP/growth factor segment, Medtronic's dominance is widely considered not replicable despite surgeons' dampened enthusiasm about its INFUSE Bone Graft.

Scope

  • An overview of BGS, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized the US 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 the US BGS Market.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in the US 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 the US 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. US
  • 4.2. Market Access
    • 4.2.1. US
  • 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
  • 10.2. By Geography
    • 10.2.1. US

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: Medicare National Average Reimbursement Rates for Major Orthopedic Procedures that Involve the Usage of BGS, 2013-2014
  • Table 12: Currently Marketed Cell-Based Matrices in the US Market
  • Table 13: Differences between the US and EU Regulations for BGS
  • Table 14: Types of Autologous Grafting Commonly Used to Treat Non-Union
  • Table 15: Advanced Biologics' BGS Products
  • Table 16: SWOT Analysis - Advanced Biologics' BGS Portfolio
  • Table 17: AlloSource's BGS Products
  • Table 18: SWOT Analysis - AlloSource's BGS Portfolio
  • Table 19: Bacterin's BGS Products
  • Table 20: SWOT Analysis - Bacterin's BGS Portfolio
  • Table 21: Baxter's BGS Products
  • Table 22: SWOT Analysis - Baxter's BGS Portfolio
  • Table 23: Biomet's BGS Products
  • Table 24: SWOT Analysis - Biomet's BGS Portfolio
  • Table 25: DePuy Synthes' BGS Products
  • Table 26: SWOT Analysis - DePuy Synthes' BGS Portfolio
  • Table 27: Exactech's BGS Products
  • Table 28: SWOT Analysis - Exactech's BGS Portfolio
  • Table 29: Integra LifeSciences' BGS Products
  • Table 30: SWOT Analysis - Integra LifeSciences' BGS Portfolio
  • Table 31: Medtronic's BGS Products
  • Table 32: SWOT Analysis - Medtronic's BGS Portfolio
  • Table 33: MTF's BGS Products
  • Table 34: SWOT Analysis - MTF's BGS Portfolio
  • Table 35: NuVasive's BGS Products
  • Table 36: SWOT Analysis - NuVasive's BGS Portfolio
  • Table 37: Olympus Biotech's BGS Products
  • Table 38: SWOT Analysis - Olympus Biotech's BGS Portfolio
  • Table 39: Orthofix's BGS Products
  • Table 40: SWOT Analysis - Orthofix's BGS Portfolio
  • Table 41: RTI Surgical's BGS Products
  • Table 42: SWOT Analysis - RTI Surgical's BGS Portfolio
  • Table 43: Stryker's BGS Products
  • Table 44: SWOT Analysis - Stryker's BGS Portfolio
  • Table 45: Wright Medical's BGS Products
  • Table 46: SWOT Analysis - Wright Medical's BGS Portfolio
  • Table 47: Zimmer's BGS Products
  • Table 48: SWOT Analysis - Zimmer's BGS Portfolio
  • Table 49: Compelling Questions Regarding the Cell-Based Matrices
  • Table 50: Pipeline Products in the Global BGS Market
  • Table 51: Major Clinical Findings of the YODA Project
  • Table 52: Major Clinical Studies of Augment Bone Graft
  • Table 53: Major Clinical Studies of Trinity Evolution
  • Table 54: Major Clinical Study of AlloStem
  • Table 55: Major Clinical Study of AttraX
  • Table 56: Major Clinical Study of i-FACTOR
  • Table 57: Major Clinical Studies of AMPLEX
  • Table 58: Company Profile - Alphatec Spine
  • Table 59: SWOT Analysis - Alphatec Spine
  • Table 60: Company Profile - AlloSource
  • Table 61: SWOT Analysis - AlloSource
  • Table 62: Company Profile - Bacterin
  • Table 63: SWOT Analysis - Bacterin
  • Table 64: Company Profile - Biomet
  • Table 65: SWOT Analysis - Biomet
  • Table 66: Company Profile - DePuy Synthes
  • Table 67: SWOT Analysis - DePuy Synthes
  • Table 68: Company Profile - Exactech
  • Table 69: SWOT Analysis - Exactech
  • Table 70: Company Profile - Globus Medical
  • Table 71: SWOT Analysis - Globus Medical
  • Table 72: Company Profile - Integra LifeSciences
  • Table 73: SWOT Analysis - Integra LifeSciences
  • Table 74: Company Profile - Medtronic
  • Table 75: SWOT Analysis - Medtronic
  • Table 76: Company Profile - NuVasive
  • Table 77: SWOT Analysis - NuVasive
  • Table 78: Company Profile - Olympus Biotech
  • Table 79: SWOT Analysis - Olympus Biotech
  • Table 80: Company Profile - Orthofix
  • Table 81: SWOT Analysis - Orthofix
  • Table 82: Company Profile - RTI Surgical
  • Table 83: SWOT Analysis - RTI Surgical
  • Table 84: Company Profile - Stryker
  • Table 85:SWOT Analysis - Stryker
  • Table 86: Company Profile - Wright Medical
  • Table 87: SWOT Analysis - Wright Medical
  • Table 88: Company Profile - Zimmer Holdings
  • Table 89: SWOT Analysis - Zimmer Holdings
  • Table 90: Other Players in the US BGS Market
  • Table 91: US 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: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013
  • Figure 8: Global BGS Competitive Landscape, by Estimated Revenue, 2013
  • Figure 9: US BGS Competitive Landscape, 2013
  • Figure 10: US BGS Competitive Landscape, by Segment, 2013
  • Figure 11: US BGS Market Sales Forecast ($m), 2011-2020
  • Figure 12: US BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 13: Other Primary Research Participants Breakdown, by Country (n=236)
  • Figure 14: Other Primary Research Participants Breakdown, by Institution (n=236)
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