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Home > Market Research > Biotechnology > Biocompatible Materials for the Human Body
REPORT HIGHLIGHTS
The U.S. market for biocompatible materials is valued at $ 22.2 billion in 2007 and is expected to grow with a compound annual growth rate (CAGR) of 6.9% to reach $30.9 billion in 2012.
Tissue replacements constitute the largest segment with a value of nearly $11.7 billion in 2007. This represents 52% of the total biomaterials market value. The tissue replacements will grow at a CAGR of 6.6% to reach over $16 billion in 2012.
The smallest segment of the biomaterials market is biocompatible surface coatings with a value of $2.6 billion in 2007. This segment is expected to grow with a CAGR of 5.7% to $3.4 billion by 2012.
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.
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Table of Contents
INTRODUCTION
STUDY 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 (%)
For full details, please email keithw@cmsinfo.com
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