BIOCOMPATIBLE MATERIALS

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

• Study Reliability and Reporting Limitations
• Disclaimers
• Data Interpretation & Reporting Level
• Quantitative Techniques & Analytics
• Product Definition and Scope of Study
• Polymeric Materials
• Metallic Materials
• Natural Materials
• Other Materials

II. EXECUTIVE SUMMARY

1. Industry Overview

• R&D Creating Brighter Avenues
• Current and Future Analysis
• Regional Perspective
• Segment Wise Perspective
• Factors Determining Market Growth
• Awareness of Basic Mechanisms of Cell-Material Interaction
• Birth of Cross-Disciplinary Field of Tissue Engineering
• Rise in Biomaterial Prices
• Stem-Cell Technology - A Threat

2. Product Overview

• Biocompatible Materials - An Introduction
• Definition of Biocompatible Materials
• Applications
• Orthopedic Applications
• Cardiovascular Applications
• Dental Applications
• Biomaterials as Skin Replacements
• Biomaterials as Scaffolds for Tissue Engineering
• Product Segments
• Polymeric Materials
• Hydrogels
• Biodegradable Polymers
• Metallic Materials
• Natural Materials
• Collagen
• Hyaluronic Acid
• Other Materials
• Ceramics
• Bioactive Ceramics
• Applications
• Bone Substitutes
• Articulating Surfaces in Joint Implants
• Composites
• Pyloritic Carbon
• Biomaterial Segments and Applications: An Outline

3. Product Trends

• Biomaterials Play Crucial Role in Implants Market
• Natural Substances find Increasing Application in Biomaterial Syntheses
• Plastic Companies Join the Fray as Manufacturers of Biodegradable Materials
• Ceramic Fillings as Substitute for Silver-Tin-Mercury Amalgam Fillings
• Ceramics Offer Significant Potential in Crown Syntheses
• Hafnium - A Promising Material for Biocompatible Coatings
• Chitin as a New Biomaterial
• Bioglass - A Potential Material for Bone Regeneration
• Collagen - An Efficient Biomaterial for Synthetic Vascular Grafts
• Biopolymers as Biomaterials
• Bioabsorbable Intelligent Materials
• Biocompatible Coatings - A Boon for Medical Implant Applications
• Nanotechnology - Revolutionizes Development of Biomaterial Implants

4. End-Use Market Analysis

• Biosensors
• Implants
• Common Orthopedic Implants: Merits and Demerits
• Biocompatibility of Material Implants with Blood
• Integrating Heparin to Polymeric Surface
• Dental Implants
• Crown and Bridge Consumption
• Table 1: Worldwide Dental Implant Market (2005): Percentage Share Breakdown for Nobel Biocare, Straumann, Biomet/3i, Zimmer Dental, Dentsply/ Friadent and Others (includes corresponding Graph/Chart)
• Joint Implant
• Artificial Organs
• Artificial Heart
• Totally Implantable Artificial Heart (TAH) System
• Pneumatic Total Artificial Heart (PTAH)
• Cardiopulmonary Bypass System for Long-term Use
• Ventricular Assist Device
• Artificial Blood Vessels
• Artificial Blood
• Artificial Skin
• Surface Coatings
• Materials for Drug Delivery Systems
• Polyethylene Glycol as a Drug Delivery System
• Hydrogels as Drug Delivery System
• Vinylic based Drug Delivery Systems
• Collagen Based Drug Delivery System
• Electrodes
• Tissue Replacement Materials
• Dialysis/Separation/Filtration Systems
• Dialysis
• Filtration and Separation
• Cosmetic and Dental Materials
• Biomaterials for Cosmetic Formulations

5. Research and Development

• Biocompatible Materials - Key Research Objectives
• R&D Activity
• French Inventors Develop Three-Dimensional Filet Stitch Fabric Wall Reinforcement
• California Inventor Develops Biocompatible Material
• Scientists Develop Process for Producing Biocompatible Fibers
• Penn State Researchers Develop New Niobium Molding Process
• Doxa Commences Clinical Trials for Novel Biomaterial
• FzioMed Concludes Preliminary Study for Oxiplex Gel
• MIV' s Biomaterial Stent Coating Clears Pyrogen Clinical Testing

6. Regulatory Environment

• FDA Regulations
• American Society for Testing and Materials (ASTM)
• Joint Research Center (JRC)
• Biocompatibility Testing of Materials
• Testing Levels
• General Biocompatibility Testing
• Individual Biocompatibility Testing
• Testing Methods

7. Product Introductions/Innovations

• Invibio(r) Launches ENDOLIGN(tm) Polymer Composite
• Zimmer Dental Launches the Puros(r) Dermis Allograft Tissue Matrix
• Integra Launches Nerve Injury Products
• DePuy Mitek Expands Orthopedics Product Portfolio
• DSM Dyneema Introduces Polyethylene Fiber

8. Recent Industry Activity

• Tyco International Acquires Confluent Surgical
• SurModics Acquires Intralytix' s Biodegradable Polymer Technology
• Orthovita Signs a Collaboration Agreement with Aastrom Biosciences for Orthopedic Products
• Kuhnil Pharma Acquires Rights from BioSyntech
• SurModics Licenses Hydrophilic Coating to Devax
• BioSyntech Receives Notice of Allowance from the US Patent and Trademark Office for BST-CarGel(r)
• Artimplant Signs License and Development Agreements with Small Bone Innovations
• SaluMedica Licenses Proprietary Biomaterial to Spine Medica
• SurModics Licenses Hydrophilic Technology to Medtronic
• SurModics Obtains Exclusive Rights from Rutgers University to Biodegradable Polymers for Ophthalmology
• MIV Therapeutics Inks Research Agreement with University of British Columbia
• Zimmer Acquires Implex
• Biomet Acquires Interpore
• Angiotech Acquires NeuColl
• Synthes-Stratec Inc. and Mathys Medizinaltechnik AG Merge
• Kyocera and Kobe Steel Forms a Joint Venture
• Angiotech Expands Biomaterial Licensing Agreement with Poly-Med
• Genzyme Corp Enters into Agreement with Wyeth Pharmaceuticals
• OctoPlus Grants License to SurModics to Acquire Two Novel Biodegradable Polymers
• GP Surgical Receives FDA Approval for TiMESH

9. Focus on Select Players

• A.P. Pharma, Inc. (USA)
• Angiotech Pharmaceuticals Inc. (Canada)
• Artimplant (Sweden)
• AST Products, Inc. (USA)
• Biocoat, Inc. (USA)
• BIOSYNTECH (Canada)
• DENTSPLY International Inc. (USA)
• Invibio (UK)
• Integra LifeSciences Holdings Corporation (USA)
• Orthovita (USA)
• SaluMedica, LLC (USA)
• SurModics (USA)
• Synthes Inc (USA)
• United States Surgical (USA)

10. Global Market Perspective

• Table 2: World Recent Past, Current and Future Analysis for Biocompatible Materials by Geographic Region - North America, Japan, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
• Table 3: World Long-term Projections for Biocompatible Materials by Geographic Region -North America, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
• Table 4: World 10-Year Perspective for Biocompatible Materials by Geographic Region - Percentage Breakdown of Dollar Sales for North America, Japan, Europe, and Rest of World Markets for Years 2003, 2008 and 2012 (includes corresponding Graph/Chart)
• Table 5: World Recent Past, Current and Future Analysis for Polymeric Materials by Geographic Region - North America, Japan, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
• Table 6: World Long-term Projections for Polymeric Materials by Geographic Region -North America, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
• Table 7: World 10-Year Perspective for Polymeric Materials by Geographic Region - Percentage Breakdown of Dollar Sales for North America, Japan, Europe, and Rest of World Markets for Years 2003, 2008 and 2012 (includes corresponding Graph/Chart)
• Table 8: World Recent Past, Current and Future Analysis for Metallic Materials by Geographic Region - North America, Japan, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
• Table 9: World Long-term Projections for Metallic Materials by Geographic Region -North America, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
• Table 10: World 10-Year Perspective for Metallic Materials by Geographic Region - Percentage Breakdown of Dollar Sales for North America, Japan, Europe, and Rest of World Markets for Years 2003, 2008 and 2012 (includes corresponding Graph/Chart)
• Table 11: World Recent Past, Current and Future Analysis for Natural Materials by Geographic Region - North America, Japan, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
• Table 12: World Long-term Projections for Natural Materials by Geographic Region -North America, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
• Table 13: World 10-Year Perspective for Natural Materials by Geographic Region - Percentage Breakdown of Dollar Sales for North America, Japan, Europe, and Rest of World Markets for Years 2003, 2008 and 2012 (includes corresponding Graph/Chart)
• Table 14: World Recent Past, Current and Future Analysis for Other Materials by Geographic Region - North America, Japan, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
• Table 15: World Long-term Projections for Other Materials by Geographic Region -North America, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
• Table 16: World 10-Year Perspective for Other Materials by Geographic Region - Percentage Breakdown of Dollar Sales for North America, Japan, Europe, and Rest of World Markets for Years 2003, 2008 and 2012(includes corresponding Graph/Chart)

III. MARKET

1. North America

• A. Market Analysis
  • Outlook
  • Regulatory Environment
  • FDA Regulations
  • American Society for Testing and Materials (ASTM)
  • R&D Activity
  • Potential Biomaterial Shortage
  • Effects of Potential Shortages
  • Product Introductions/ Innovations
  • Strategic Corporate Developments
  • Select Players
• B. Market Analytics
  • Table 17: North America Recent Past, Current and Future Analysis for Biocompatible Materials by Product Segment - Polymeric Materials, Metallic Materials, Natural Materials and Other Materials Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
  • Table 18: North America Long-term Projections for Biocompatible Materials by Product Segment - Polymeric Materials, Metallic Materials, Natural Materials & Other Materials Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
  • Table 19: North America 10-Year Perspective for Biocompatible Materials by Product Segment - Percentage Breakdown of Dollar Sales for Polymeric Materials, Metallic Materials, Natural Materials and Other Materials Markets for 2003, 2008 and 2012 (includes corresponding Graph/Chart)

2. Japan

• A. Market Analysis
  • Outlook
  • An Overview
  • Import Scenario: Implants
  • Table 20: Japanese Percentage Imports by Implant Type (includes corresponding Graph/Chart)
  • History
  • Major Biomaterial Research Groups
  • Institute of Biomedical Engineering (Tokyo Women' s Medical University)
  • Tissue Engineering Research Institute (Kyoto University)
  • Institute of Biomaterials and Bioengineering (Tokyo Medical and Dental University)
  • Principal Research Institutions
  • Regulatory Environment
  • Medical Affairs Law
  • Strategic Corporate Development
• B. Market Analytics
  • Table 21: Japanese Recent Past, Current and Future Analysis for Biocompatible Materials by Product Segment - Polymeric Materials, Metallic Materials, Natural Materials and Other Materials Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
  • Table 22: Japanese Long-term Projections for Biocompatible Materials by Product Segment - Polymeric Materials, Metallic Materials, Natural Materials & Other Materials Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
  • Table 23: Japanese 10-Year Perspective for Biocompatible Materials by Product Segment - Percentage Breakdown of Dollar Sales for Polymeric Materials, Metallic Materials, Natural Materials and Other Materials Markets for 2003, 2008 and 2012 (includes corresponding Graph/Chart)

3. Europe

• A. Market Analysis
  • Outlook
  • UK Bioceramic Market
  • Regulatory Environment
  • Government Regulations
  • Joint Research Center (JRC)
  • Product Introductions/Innovations
  • Strategic Corporate Developments
  • Review of Select Players
• B. Market Analytics
  • Table 24: European Recent Past, Current and Future Analysis for Biocompatible Materials by Product Segment - Polymeric Materials, Metallic Materials, Natural Materials and Other Materials Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
  • Table 25: European Long-term Projections for Biocompatible Materials by Product Segment - Polymeric Materials, Metallic Materials, Natural Materials & Other Materials Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
  • Table 26: European 10-Year Perspective for Biocompatible Materials by Product Segment - Percentage Breakdown of Dollar Sales for Polymeric Materials, Metallic Materials, Natural Materials and Other Materials Markets for Years 2003, 2008 and 2012 (includes corresponding Graph/Chart)

4. Rest of World

• A. Market Analysis
  • Outlook
  • Strategic Corporate Development
• B. Market Analytics
  • Table 27: Rest of World Recent Past, Current and Future Analysis for Biocompatible Materials by Product Segment - Polymeric Materials, Metallic Materials, Natural Materials and Other Materials Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)
  • Table 28: Rest of World Long-term Projections for Biocompatible Materials by Product Segment - Polymeric Materials, Metallic Materials, Natural Materials & Other Materials Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
  • Table 29: Rest of World 10-Year Perspective for Biocompatible Materials by Product Segment - Percentage Breakdown of Dollar Sales for Polymeric Materials, Metallic Materials, Natural Materials and Other Materials Markets for 2003, 2008 and 2012 (includes corresponding Graph/Chart)