生物相容性材料市場的動向

本報告已在2011年08月08日停止出版。

簡介

目錄

Abstract

INTRODUCTION

A biocompatible material or a biomaterial is any natural or synthetic substance that incorporates or integrates into a patient' s body. The role of the biomaterial may be to perform, supplement, or replace a biological function that is attenuated or lost.

The goal of this report is to assess the current market for biocompatible materials including medical devices, tissue replacements, and surface coatings.

This report provides a complete overview of recent developments in each major sector of the biomaterials market. It also outlines the significant medical applications of each technology; the major market players; recent patents; and emerging technologies in implantable medical devices, advanced tissue replacements, and biocompatible surface coatings.

SCOPE OF STUDY

This report contains:

• An examination of the supporting products that have enhanced imaging at the chemical level (reagents and contrast media) and at the analysis level (software tools and image management)
• The U.S. markets for medical devices, tissue replacements, and surface coating biomaterials for a variety of biomaterials categories including metals, ceramics, polymers, and natural materials
• Assessment of the market for specific medical applications including orthopedic surgery, cardiovascular surgery and care, wound management, dentistry, urology, gastrointestinal surgery, ophthalmic care as well as plastics and reconstructive surgery
• A review of important technology and a discussion of patents in the past few decades
• Profiles of all the major companies in the industry.

INFORMATION SOURCES

This report has been assembled following an in-depth analysis of primary and secondary data. Primary research was conducted via telephone interviews with industry professionals, research scientists, physician-researchers, and laboratory heads to discover the most recent developments in their fields of interest. Secondary data was collected via a comprehensive search of the scientific, peer-reviewed literature, clinical trial reports and databases, industry trade media, company websites, annual reports, and industry press releases.

The market assessments provided have been assembled based on publicly available information from January 2002 up to and including January 2007. The base year for this report is 2007 and forecast data are provided through 2012. In many cases, figures for 2006 were not yet released and in these cases figures were extrapolated from 2006 statistics, first quarter projections for 2007, and historical trends between 2002 and 2007. Market figures are based on current (2007) dollars and inflation is not computed into the projection figures.

ANALYST' S CREDENTIALS

Amy Brock, Ph.D. has over 10 years of research experience working at the interface of the biological sciences, bioengineering, and biophysics. Trained at the Massachusetts Institute of Technology and Harvard University, she holds a B.S. and Ph.D. in biomedical science. She is the author of Pharmacogenomics: New Technologies in the Development of Personalized Therapies, Kinase Inhibitors and Genetic Diseases and Medical Imaging.

Table of Contents

• INTRODUCTIONSTUDY GOAL AND OBJECTIVES
  • REASONS FOR DOING THE STUDY
  • INTENDED AUDIENCE
  • SCOPE OF REPORT
  • INFORMATION SOURCES
  • ANALYST' S CREDENTIALS
  • RELATED BCC REPORTS
  • BCC ONLINE SERVICES
  • DISCLAIMER
  • SUMMARY
• Summary Table:
  • U.S. MARKET FORECAST FOR BIOCOMPATIBLE MATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Summary Figure:
  • U.S. MARKET FOR BIOCOMPATIBLE MATERIALS, BY SEGMENT 2004-2012 ($ MILLIONS)
• OVERVIEW
  • INTRODUCTION TO BIOCOMPATIBLE MATERIALS
  • TYPES OF MATERIALS
    • CERAMICS
      • Ceramics (Continued)
  • Table 1 COMMON BIOCOMPATIBLE CERAMICS
    • METALS
      • Titanium
      • Gold
      • Platinum
  • Table 2 COMMON BIOCOMPATIBLE METALS
    • POLYMERS
      • PLA and PGA
      • PTFE
  • Table 3 COMMON BIOCOMPATIBLE POLYMERES
    • NATURAL MATERIALS
      • Collagen
      • Chitosan
      • Alginate
  • Table 4 COMMON BIOCOMPATIBLE NATURAL MATERIALS
• TECHNOLOGY
  • ADVANCES IN BIOACTIVE MATERIALS
    • GROWTH FACTORS
    • DRUG-ELUTING SURFACES
    • HYDROGELS
      • Hydrogels for Growth Factor Delivery
      • Mechanoresponsive Hydrogels
      • Poly(HEMA)
  • DEGRADABLE OR BIORESORBABLE MATERIALS
    • Chitosan
    • Polyethylene Oxide
    • Ethylene-vinyl Acetate
• THE CHALLENGES OF BIOCOMPATIBILITY
  • BLOOD COMPATIBILITY AND PROTEIN ADSORPTION
    • Albumin
    • Immunoglobulins
    • Fibrinogen
  • CALCIFICATION
  • INFECTION AND BIOFILMS
  • HOST IMMUNE RESPONSE
    • Wound Healing and Inflammation
    • Foreign Body Immune Reaction and Rejection
    • Complement Immune Response
  • RECENT ADVANCES IN ENABLING TECHNOLOGIES
    • BIOMIMETICS
    • NANOTECHNOLOGY
    • TISSUE ENGINEERING
    • STEM CELLS
    • BIOREACTOR TECHNOLOGY
• PATENT ANALYSIS
  • PATENTS BY TECHNOLOGY
    • Table 5 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY TECHNOLOGY, JANUARY 2006-JANUARY 2007
    • Figure 1 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY TECHNOLOGY, JANUARY 2006-JANUARY 2007 (%)
  • PATENTS BY MEDICAL APPLICATION
    • Table 6 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY MEDICAL APPLICATION, JANUARY 2006-JANUARY 2007
    • Figure 2 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY MEDICAL APPLICATION, JANUARY 2006-JANUARY 2007 (%)
  • PATENTS BY REGION/OR COUNTRY (DEPENDING ON DISTRIBUTION)
    • Table 7 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY REGION, JANUARY 2006-JANUARY 2007
    • Figure 3 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY COUNTRY, JANUARY 2006-JANUARY 2007 (%)
  • PATENTS BY ASSIGNEE
    • Table 8 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY ASSIGNEE AFFILIATION, JANUARY 2006-JANUARY 2007
    • Figure 4 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY ASSIGNEE AFFILIATION, JANUARY 2006-JANUARY 2007 (%)
    • Table 9 BIOCOMPATIBLE MATERIALS ISSUED PATENTS BY ASSIGNEE, JANUARY 2006-JANUARY 2007
    • Table 9 (CONTINUED)
    • Table 9 (CONTINUED)
    • Table 9 (CONTINUED)
    • Table 9 (CONTINUED)
      • PATENTS OF INTEREST
        • Patent Title: Triggered Release Hydrogel Drug Delivery System
        • Patent Title: Adaptive Memory Prioritization for Implanted Medical Devices
        • Patent Title: Coumarin Endcapped Absorbable Polymers
        • Bioabsorbable Polymeric Implants and a Method Of Using The Same to Create Occlusions
      • SPECIAL ISSUES IN CARDIAC STENT PATENTING
        • Special Issues in Cardiac ...(Continued)
• GOVERNMENT REGULATION
  • FDA REGULATION OF MEDICAL DEVICES
    • BIOMATERIALS ACCESS ASSURANCE ACT OF 1998
    • REGULATION OF TISSUE ENGINEERED PRODUCTS
    • FDA REGULATION OF GOOD TISSUE PRACTICES
    • GOVERNMENT REGULATION OF NANOMATERIALS
    • NEW FDA APPROVALS
      • Novel Hernia Repair Material
      • Low Pressure Perfusion Catheter
      • Real-Time Continuous Glucose Monitor
      • Omega-3 Fatty Acid Coated Mesh
      • Wireless Telemetry and Cardiac Rhythm Management Implants
        • Wireless Telemetry ... (Continued)
• MARKET FOR BIOCOMPATIBLE MATERIALS
  • Table 10 U.S. MARKET FORECAST FOR BIOCOMPATIBLE MATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
    • IMPLANTABLE MEDICAL DEVICES
  • Table 11 U.S. MARKET FORECAST FOR IMPLANTABLE MEDICAL DEVICES BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Figure 5 U.S. MARKET FOR IMPLANTABLE MEDICAL DEVICES, BY SEGMENT 2004-2012 ($ MILLIONS)
    • TISSUE REPLACEMENTS
  • Table 12 U.S. MARKET FORECAST FOR TISSUE REPLACEMENTS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 12 (CONTINUED)
  • Figure 6 U.S. MARKET FOR TISSUE REPLACEMENTS, BY SEGMENT 2004-2012 ($ MILLIONS)
    • SURFACE COATINGS
  • Table 13 U.S. MARKET FORECAST FOR BIOCOMPATIBLE SURFACE COATINGS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Figure 7 U.S. MARKET FOR BIOCOMPATIBLE SURFACE COATINGS BY SEGMENT, 2004-2012 ($ MILLIONS)
    • SURFACE COATINGS (CONTINUED)
• U.S. MARKET FOR BIOMATERIALS, BY APPLICATION
  • Table 14 U.S. MARKET FORECAST FOR BIOMATERIALS BY APPLICATION, THROUGH 2012 ($ MILLIONS)
  • Figure 8 U.S. MARKET FOR BIOMATERIALS, BY MEDICAL APPLICATION 2004-2012 ($ MILLIONS)
    • ORTHOPEDIC APPLICATIONS
  • Table 15 U.S. MARKET FOR ORTHOPEDIC BIOMATERIALS, BY SEGMENT THROUGH 2012 ($ MILLIONS)
  • Figure 9 U.S. MARKET FOR ORTHOPEDIC BIOMATERIALS, BY SEGMENT, 2004-2012 ($ MILLIONS)
    • BONE-PLATE MATERIALS
      • Bone-Plate Materials (Continued)
• HIP REPLACEMENTS
  • Hip Resurfacing
    • KNEE REPLACEMENTS
      • Non-constrained Implants
      • Semi-constrained Implants
      • Constraint or Hinged Implants
      • Unicondylar Knee Replacement
  • SPINAL IMPLANTS
    • Types of Spinal Implants
    • Disc Arthroplasty
  • THE MARKET FOR ORTHOPEDIC BIOMATERIALS
• CARDIOVASCULAR APPLICATIONS
  • Table 16 U.S. MARKET FORECAST FOR CARDIOVASCULAR BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • CARDIAC PACEMAKERS
• IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
  • Implantable Cardioverter ... (Continued)
• CARDIAC STENTS
  • Metal Stents
  • Drug-Eluting Stents (DES)
  • Rapamycin and Related Immunosuppressants
  • Paclitaxel
  • Drug-Eluting Stents And Complications
• HEART VALVES
  • Percutaneous Implant
• VASCULAR ACCESS DEVICES
  • Midline Catheter
• Peripherally Inserted Central Catheter (PICC)
  • Tunneled Catheter
  • Subcutaneous Port
• PERIPHERAL VASCULAR GRAFTS
  • Figure 10 U.S. MARKET FOR CARDIOVASCULAR BIOMATERIALS, BY SEGMENT 2004-2012 ($ MILLIONS)
    • WOUND MANAGEMENT APPLICATIONS
  • Table 17 U.S. MARKET FORECAST FOR WOUND MANAGEMENT BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Figure 11 U.S. MARKET FOR WOUND MANAGEMENT BIOMATERIALS BY SEGMENT, 2004-2012 ($ MILLIONS)
    • TISSUE SEALANTS AND HEMOSTATS
      • Bovine Serum/ Albumin/ Glutaraldehyde
      • Fibrin
      • Gelatin Matrix/ Thrombin Sealants
      • Polyethylene Glycol Hydrogels
  • ADHESION BARRIERS
• Table 18 TYPES OF ADHESION BARRIERS AND MANUFACTURERS
  • SKIN SUBSTITUTES
    • Skin Substitutes (Continued)
• Table 19 MAJOR SKIN SUBSTITUTE PRODUCTS
  • Skin Substitutes (Continued)
    • Genetically Modified Skin Cells
• GASTROINTESTINAL APPLICATIONS
  • Table 20 U.S. MARKET FORECAST FOR GASTROINTESTINAL BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Figure 12 U.S. MARKET FOR GASTROINTESTINAL BIOMATERIALS, BY SEGMENT, 2004-2012 ($ MILLIONS)
    • UROLOGICAL BIOMATERIALS
  • Table 21 U.S. MARKET FORECAST FOR UROLOGY BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
    • URETERAL STENTS
    • URETHRAL STENTS
    • URINARY CATHETERS
      • Removal
      • Resistance to Encrustation
      • Biofilms
• Figure 13 U.S. MARKET FOR UROLOGY BIOMATERIALS BY SEGMENT, 2004-2012 ($ MILLIONS)
  • THE MARKET FOR UROLOGY BIOMATERIALS
    • PLASTIC SURGERY
• Table 22 U.S. MARKET FORECAST FOR PLASTIC SURGERY BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • BREAST IMPLANTS
    • Saline-Filled Implants
    • Silicone Gel Implants
    • Safety Considerations
      • Breakage and Leakage
        • Breakage and Leakage (Continued)
  • Scarring
  • Platinum
  • INJECTABLE FILLERS
    • Zyderm and Zyplast Collagen
    • Fibrel
    • Artecoll
    • Hylan B Gel
    • Resoplast
    • Autologen
    • Isolagen
    • Dermalogen
    • AlloDerm
    • Fat Injections
• Table 23 COLLAGEN FILLERS
  • FACIAL IMPLANTS
    • Teflon
    • Polyethylene
    • Hydroxyapatite
• Figure 14 U.S. MARKET FOR PLASTIC SURGERY BIOMATERIALS, BY SEGMENT 2004-2012 ($ MILLIONS)
  • THE MARKET FOR PLASTIC SURGERY BIOMATERIALS
    • The Market for Plastic ... (Continued)
• ON THE HORIZON
  • BIOMATERIALS FOR GENE AND PROTEIN DELIVERY
  • ELECTROSPINNING SCAFFOLDS
• COMPANY PROFILES
  • ABIOMED, INC
  • ADVANCED BIONICS CORPORATION
  • ALLERGAN INC.
  • BAXTER INTERNATONAL INC.
  • BIOINTERACTIONS LTD.
  • BIOMET, INC
  • COCHLEAR CORPORATION
  • CONMED CORPORATION
  • DEPUY ORTHOPAEDICS, INC.
  • ENCORE ORTHOPEDICS
  • GUIDANT CORP.
  • INTERPORE CROSS INTERNATIONAL
  • JOHNSON & JOHNSON MEDICAL, INC
  • MEDICAL ELECTRONICS (MED-EL)
  • MEDTRONIC, INC.
  • MENTOR CORPORATION
  • MIV THERAPEUTICS
  • SOFAMOR DANEK GROUP
  • STAAR SURGICAL COMPANY
  • STRYKER CORPORATION
  • SULZER MEDICA
    • SULZER MEDICA (CONTINUED)
  • SYNTHES CORPORATION
  • THORATEC LABORATORIES
  • ZIMMER CORP.
• MARKET SHARE
  • MARKET SHARE OF MAJOR COMPANIES' IMPLANTABLE MEDICAL DEVICES
• Table 24 MARKET SHARE OF MAJOR COMPANIES' IMPLANTABLE MEDICAL DEVICES (%)
• Figure 15 MARKET SHARE OF MAJOR COMPANIES IN IMPLANTABLE MEDICAL DEVICES (%)
  • MARKET SHARE OF MAJOR COMPANIES IN TISSUE REPLACEMENTS BIOMATERIALS
• Table 25 MARKET SHARE OF MAJOR COMPANIES IN TISSUE REPLACEMENTS (%)
• Figure 16 MARKET SHARE OF MAJOR COMPANIES IN TISSUE REPLACEMENTS (%)
  • MARKET SHARE OF MAJOR COMPANIES IN SURFACE COATINGS
• Table 26 MARKET SHARE OF MAJOR COMPANIES IN SURFACE COATINGS (%)
• Figure 17 MARKET SHARE OF MAJOR COMPANIES IN SURFACE COATINGS (%)
• LIST OF TABLES
  • Summary Table:
  • U.S. MARKET FORECAST FOR BIOCOMPATIBLE MATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 1 COMMON BIOCOMPATIBLE CERAMICS
  • Table 2 COMMON BIOCOMPATIBLE METALS
  • Table 3 COMMON BIOCOMPATIBLE POLYMERES
  • Table 4 COMMON BIOCOMPATIBLE NATURAL MATERIALS
  • Table 5 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY TECHNOLOGY, JANUARY 2006-JANUARY 2007
  • Table 6 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY MEDICAL APPLICATION, JANUARY 2006-JANUARY 2007
  • Table 7 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY REGION, JANUARY 2006-JANUARY 2007
  • Table 8 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY ASSIGNEE AFFILIATION, JANUARY 2006-JANUARY 2007
  • Table 9 BIOCOMPATIBLE MATERIALS ISSUED PATENTS BY ASSIGNEE, JANUARY 2006-JANUARY 2007
  • Table 10 U.S. MARKET FORECAST FOR BIOCOMPATIBLE MATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 11 U.S. MARKET FORECAST FOR IMPLANTABLE MEDICAL DEVICES BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 12 U.S. MARKET FORECAST FOR TISSUE REPLACEMENTS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 13 U.S. MARKET FORECAST FOR BIOCOMPATIBLE SURFACE COATINGS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 14 U.S. MARKET FORECAST FOR BIOMATERIALS BY APPLICATION, THROUGH 2012 ($ MILLIONS)
  • Table 15 U.S. MARKET FOR ORTHOPEDIC BIOMATERIALS, BY SEGMENT THROUGH 2012 ($ MILLIONS)
  • Table 16 U.S. MARKET FORECAST FOR CARDIOVASCULAR BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 17 U.S. MARKET FORECAST FOR WOUND MANAGEMENT BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 18 TYPES OF ADHESION BARRIERS AND MANUFACTURERS
  • Table 19 MAJOR SKIN SUBSTITUTE PRODUCTS
  • Table 20 U.S. MARKET FORECAST FOR GASTROINTESTINAL BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 21 U.S. MARKET FORECAST FOR UROLOGY BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 22 U.S. MARKET FORECAST FOR PLASTIC SURGERY BIOMATERIALS BY SEGMENT, THROUGH 2012 ($ MILLIONS)
  • Table 23 COLLAGEN FILLERS
  • Table 24 MARKET SHARE OF MAJOR COMPANIES' IMPLANTABLE MEDICAL DEVICES (%)
  • Table 25 MARKET SHARE OF MAJOR COMPANIES IN TISSUE REPLACEMENTS (%)
  • Table 26 MARKET SHARE OF MAJOR COMPANIES IN SURFACE COATINGS (%)
• LIST OF FIGURES
  • Summary Figure:
  • U.S. MARKET FOR BIOCOMPATIBLE MATERIALS, BY SEGMENT 2004-2012 ($ MILLIONS)
  • Figure 1 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY TECHNOLOGY, JANUARY 2006-JANUARY 2007 (%)
  • Figure 2 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY MEDICAL APPLICATION, JANUARY 2006-JANUARY 2007 (%)
  • Figure 3 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY COUNTRY, JANUARY 2006-JANUARY 2007 (%)
  • Figure 4 BIOCOMPATIBLE MATERIALS, ISSUED PATENTS BY ASSIGNEE AFFILIATION, JANUARY 2006-JANUARY 2007 (%)
  • Figure 5 U.S. MARKET FOR IMPLANTABLE MEDICAL DEVICES, BY SEGMENT 2004-2012 ($ MILLIONS)
  • Figure 6 U.S. MARKET FOR TISSUE REPLACEMENTS, BY SEGMENT 2004-2012 ($ MILLIONS)
  • Figure 7 U.S. MARKET FOR BIOCOMPATIBLE SURFACE COATINGS BY SEGMENT, 2004-2012 ($ MILLIONS)
  • Figure 8 U.S. MARKET FOR BIOMATERIALS, BY MEDICAL APPLICATION 2004-2012 ($ MILLIONS)
  • Figure 9 U.S. MARKET FOR ORTHOPEDIC BIOMATERIALS, BY SEGMENT, 2004-2012 ($ MILLIONS)
  • Figure 10 U.S. MARKET FOR CARDIOVASCULAR BIOMATERIALS, BY SEGMENT 2004-2012 ($ MILLIONS)
  • Figure 11 U.S. MARKET FOR WOUND MANAGEMENT BIOMATERIALS BY SEGMENT, 2004-2012 ($ MILLIONS)
  • Figure 12 U.S. MARKET FOR GASTROINTESTINAL BIOMATERIALS, BY SEGMENT, 2004-2012 ($ MILLIONS)
  • Figure 13 U.S. MARKET FOR UROLOGY BIOMATERIALS BY SEGMENT, 2004-2012 ($ MILLIONS)
  • Figure 14 U.S. MARKET FOR PLASTIC SURGERY BIOMATERIALS, BY SEGMENT 2004-2012 ($ MILLIONS)
  • Figure 15 MARKET SHARE OF MAJOR COMPANIES IN IMPLANTABLE MEDICAL DEVICES (%)
  • Figure 16 MARKET SHARE OF MAJOR COMPANIES IN TISSUE REPLACEMENTS (%)
  • Figure 17 MARKET SHARE OF MAJOR COMPANIES IN SURFACE COATINGS (%)

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