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市場調查報告書

MediPoint:人工骨替代材料-南美市場分析與預測

MediPoint: Bone Grafts and Substitutes - South American Analysis and Market Forecasts

出版商 GlobalData 商品編碼 296029
出版日期 內容資訊 英文 174 Pages
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MediPoint:人工骨替代材料-南美市場分析與預測 MediPoint: Bone Grafts and Substitutes - South American Analysis and Market Forecasts
出版日期: 2014年01月31日 內容資訊: 英文 174 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。巴西是很大的潛在市場,不過ANVISA(巴西國家衛生監督局)對海外企業尋求的龐大的文件把市場的進入做為繁雜的東西。

本報告提供南美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: GDME1079CFR

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.

All manufacturers outside of Brazil will need to work with a third-party organization to obtain registration and renewals. Requirements include sales certifications, Good Manufacturing Process (GMP) documents, and letters authorizing a Brazilian firm to conduct distribution, clinical trials and details of the device. Due to the extensive paperwork ANVISA requires from foreign manufacturers, market entry is cumbersome for medical devices to enter Brazil, even though there is a huge market potential for orthopedic devices in this country.

Scope

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

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 South America, 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: Brazil 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 Brazil, 2011-2020
  • Figure 4: Traditional Allograft Bone Sales Volume in Brazil, 2011-2020
  • Figure 5: Machined Allograft Bone Sales Volume in Brazil, 2011-2020
  • Figure 6: Bone Grafts Substitutes Sales Volumes in Brazil, 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: Brazil BGS Market Sales Forecast ($m), 2011-2020
  • Figure 10: Brazil BGS Market Revenue Distribution, By Segment, 2011-2020
  • Figure 11: Other Primary Research Participants Breakdown, by Country (n=236)
  • Figure 12: Other Primary Research Participants Breakdown, by Institution (n=236)
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