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MediPoint:人工骨替代材料-歐盟市場分析與預測

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

出版商 GlobalData 商品編碼 296027
出版日期 內容資訊 英文 186 Pages
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MediPoint:人工骨替代材料-歐盟市場分析與預測 MediPoint: Bone Grafts and Substitutes - EU Analysis and Market Forecasts
出版日期: 2014年01月31日 內容資訊: 英文 186 Pages
簡介

在骨移植中,已知自體骨為代表性移植材料,不過市場中可利用的人工骨骼替代物很多,尤其在美國和歐洲市場上人工骨替代材料(BGS)引進慢慢擴大。在人工骨替代材料市場中最大的收益市場是美國。相對的,亞太地區和南非,骨移植片最常見的選項為自體骨。由於根據歐洲各地的不穩定經濟形勢,及緊縮財政,EU主要5個國家多採取限制關節重建這種進階的手術以抑制醫療費的虧損的對策,不過隨著今後經濟形勢恢復,骨移植的治療數將以患者數的增加和整形外科用設備穩定供給為背景,預計穩定成長。

本報告提供EU的人工骨替代材料市場相關資料、骨移植概要、產業分析、競爭情形、開發中產品、當下的未滿足需求和今後的市場機會、技術開發趨勢等分析,並將結果概述為以下內容。

第1章 目錄

第2章 簡介

第3章 臨床結果

  • 概要
  • 自體骨
  • 異體骨
  • 人工骨替代材料

第3章 產業概要

  • 治療的趨勢
  • 市場進入
  • 法規上的課題/產品回收
  • 企業合併、收購(M&A)主要的夥伴關係
  • 經濟上的影響
  • 推動市場要素
  • 市場機會
  • 進入障礙

第5章 競爭評估

  • 概要
  • 上市產品

第6章 未滿足需求

  • 臨床資料的透明度
  • 以人為實驗對象的臨床研究不足
  • rhBMP的劑量及載體
  • 骨銀行產業的DBM產品中的DBM濃度的標準化
  • 具更高的骨誘導性的產品需求
  • 細胞矩陣的持續研究
  • 對人工骨骼替代物產品更高的醫療教育需求
  • 成本控制的需求

第7章 開發中產品

  • 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 值得注意的臨床試驗

  • Yale大學對Medtronic的INFUSE Bone Graft的檢討
  • Wright Medical(Augment Bone Graft)
  • Orthofix (Trinity Evolution)
  • AlloSource (AlloStem)
  • NuVasive (AttraX)
  • CeraPedics (i-FACTOR)
  • BioSET (AMPLEX)

第9章 現在及未來加入廠商

  • 企業策略趨勢
  • 企業簡介
  • 其他的企業

第10章 市場預測

  • 市場佔有率分析
  • 各地區

第11章 附錄

圖表一覽

目錄
Product Code: GDME1077CFR

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.

Due to the economic uncertainty and severe budgetary restrictions in the Eurozone, most 5EU countries have put in place measures to prevent excessive healthcare budget deficits and ration high-volume surgeries, such as joint reconstruction. As the market continues to recover from the economic turmoil, expanding patient population for orthopedic surgical treatments and the steady domestic supply of orthopedic devices in the European countries will all contribute to a steady increase in the bone grafting procedure volume in the next decade.

Scope

  • An overview of BGS, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized EU 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 EU BGS Market.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in EU 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 EU 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. 5EU
  • 4.2. Market Access
    • 4.2.1. 5EU
  • 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. Bacterin
    • 5.2.2. Baxter
    • 5.2.3. Biocomposites
    • 5.2.4. Biomet
    • 5.2.5. DePuy Synthes
    • 5.2.6. Exactech
    • 5.2.7. Integra LifeSciences
    • 5.2.8. Medtronic
    • 5.2.9. NuVasive
    • 5.2.10. Olympus Biotech
    • 5.2.11. Orthofix
    • 5.2.12. RTI Surgical
    • 5.2.13. Stryker
    • 5.2.14. Wright Medical
    • 5.2.15. 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. Osiris Therapeutics' OvationOS
  • 7.7. 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. Bacterin
    • 9.2.3. Biomet
    • 9.2.4. DePuy Synthes
    • 9.2.5. Exactech
    • 9.2.6. Globus Medical
    • 9.2.7. Integra LifeSciences
    • 9.2.8. Medtronic
    • 9.2.9. NuVasive
    • 9.2.10. Olympus Biotech
    • 9.2.11. Orthofix
    • 9.2.12. RTI Surgical
    • 9.2.13. Stryker
    • 9.2.14. Wright Medical
    • 9.2.15. Zimmer Holdings
  • 9.3. Other Players

10. Market Outlooks

  • 10.1. Market Share Analysis
    • 10.1.1. Global
    • 10.1.2. 5EU
  • 10.2. By Geography
    • 10.2.1. Overview
    • 10.2.2. France
    • 10.2.3. Germany
    • 10.2.4. Italy
    • 10.2.5. Spain
    • 10.2.6. UK

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 5EU, 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: Bacterin's BGS Products
  • Table 15: SWOT Analysis - Bacterin's BGS Portfolio
  • Table 16: Baxter's BGS Products
  • Table 17: SWOT Analysis - Baxter's BGS Portfolio
  • Table 18: Biocomposites' BGS Products
  • Table 19: Biomet's BGS Products
  • Table 20: SWOT Analysis - Biomet's BGS Portfolio
  • Table 21: DePuy Synthes' BGS Products
  • Table 22: SWOT Analysis - DePuy Synthes' BGS Portfolio
  • Table 23: Exactech's BGS Products
  • Table 24: SWOT Analysis - Exactech's BGS Portfolio
  • Table 25: Integra LifeSciences' BGS Products
  • Table 26: SWOT Analysis - Integra LifeSciences' BGS Portfolio
  • Table 27: Medtronic's BGS Products
  • Table 28: SWOT Analysis - Medtronic's BGS Portfolio
  • Table 29: NuVasive's BGS Products
  • Table 30: SWOT Analysis - NuVasive's BGS Portfolio
  • Table 31: Olympus Biotech's BGS Products
  • Table 32: SWOT Analysis - Olympus Biotech's BGS Portfolio
  • Table 33: Orthofix's BGS Products
  • Table 34: SWOT Analysis - Orthofix's BGS Portfolio
  • Table 35: RTI Surgical's BGS Products
  • Table 36: SWOT Analysis - RTI Surgical's BGS Portfolio
  • Table 37: Stryker's BGS Products
  • Table 38: SWOT Analysis - Stryker's BGS Portfolio
  • Table 39: Wright Medical's BGS Products
  • Table 40: SWOT Analysis - Wright Medical's BGS Portfolio
  • Table 41: Zimmer's BGS Products
  • Table 42: SWOT Analysis - Zimmer's BGS Portfolio
  • Table 43: Compelling Questions Regarding the Cell-Based Matrices
  • Table 44: Pipeline Products in the Global BGS Market
  • Table 45: Major Clinical Findings of the YODA Project
  • Table 46: Major Clinical Studies of Augment Bone Graft
  • Table 47: Major Clinical Studies of Trinity Evolution
  • Table 48: Major Clinical Study of AlloStem
  • Table 49: Major Clinical Study of AttraX
  • Table 50: Major Clinical Study of i-FACTOR
  • Table 51: Major Clinical Studies of AMPLEX
  • Table 52: Company Profile - Alphatec Spine
  • Table 53: SWOT Analysis - Alphatec Spine
  • Table 54: Company Profile - Bacterin
  • Table 55: SWOT Analysis - Bacterin
  • Table 56: Company Profile - Biomet
  • Table 57: SWOT Analysis - Biomet
  • Table 58: Company Profile - DePuy Synthes
  • Table 59: SWOT Analysis - DePuy Synthes
  • Table 60: Company Profile - Exactech
  • Table 61: SWOT Analysis - Exactech
  • Table 62: Company Profile - Globus Medical
  • Table 63: SWOT Analysis - Globus Medical
  • Table 64: Company Profile - Integra LifeSciences
  • Table 65: SWOT Analysis - Integra LifeSciences
  • Table 66: Company Profile - Medtronic
  • Table 67: SWOT Analysis - Medtronic
  • Table 68: Company Profile - NuVasive
  • Table 69: SWOT Analysis - NuVasive
  • Table 70: Company Profile - Olympus Biotech
  • Table 71: SWOT Analysis - Olympus Biotech
  • Table 72: Company Profile - Orthofix
  • Table 73: SWOT Analysis - Orthofix
  • Table 74: Company Profile - RTI Surgical
  • Table 75: SWOT Analysis - RTI Surgical
  • Table 76: Company Profile - Stryker
  • Table 77:SWOT Analysis - Stryker
  • Table 78: Company Profile - Wright Medical
  • Table 79: SWOT Analysis - Wright Medical
  • Table 80: Company Profile - Zimmer Holdings
  • Table 81: SWOT Analysis - Zimmer Holdings
  • Table 82: Other Players in the Global BGS Market
  • Table 83: 5EU BGS Market Sales Forecast ($m), 2011-2020
  • Table 84: France BGS Market Sales Forecast ($m), 2011-2020
  • Table 85: Germany BGS Market Sales Forecast ($m), 2011-2020
  • Table 86: Italy BGS Market Sales Forecast ($m), 2011-2020
  • Table 87: Spain BGS Market Sales Forecast ($m), 2011-2020
  • Table 88: UK BGS Market Sales Forecast ($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 5EU, 2011-2020
  • Figure 4: Traditional Allograft Bone Sales Volume in 5EU, 2011-2020
  • Figure 5: Machined Allograft Bone Sales Volume in 5EU, 2011-2020
  • Figure 6: Bone Grafts Substitutes Sales Volumes in 5EU, 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: France BGS Competitive Landscape, 2013
  • Figure 10: Germany BGS Competitive Landscape, 2013
  • Figure 11: Italy BGS Competitive Landscape, 2013
  • Figure 12: Spain BGS Competitive Landscape, 2013
  • Figure 13: UK BGS Competitive Landscape, 2013
  • Figure 14: 5EU BGS Market Sales Forecast, 2011-2020
  • Figure 15: BGS Market by Major Market, 2013 and 2020
  • Figure 16: 5EU BGS Market Revenue Distribution, By Segment, 2013 and 2020
  • Figure 17: France BGS Market Sales Forecast ($m), 2011-2020
  • Figure 18: France BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 19: Germany BGS Market Sales Forecast ($m), 2011-2020
  • Figure 20: Germany BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 21: Italy BGS Market Sales Forecast ($m), 2011-2020
  • Figure 22: Italy BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 23: Spain BGS Market Sales Forecast ($m), 2011-2020
  • Figure 24: Spain BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 25: UK BGS Market Sales Forecast ($m), 2011-2020
  • Figure 26: UK BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 27: Other Primary Research Participants Breakdown, by Country (n=236)
  • Figure 28: Other Primary Research Participants Breakdown, by Institution (n=236)
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