Global Biocompatible Materials Industry

This report analyzes the worldwide markets for Biocompatible Materials in US$ Million by the following Product Segments: Polymeric Materials, Metallic Materials, Natural Materials, and Other Materials. The report provides separate comprehensive analytics for the North America, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 68 companies including many key and niche players such as A.P. Pharma, Inc., Angiotech Pharmaceuticals Inc., Artimplant AB, AST Products, Inc., Biocoat, Inc., DENTSPLY International Inc., Invibio, Integra LifeSciences Holdings Corporation, SaluMedica, LLC, SurModics Inc., Synthes Inc., and United States Surgical. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Global Biomaterial Industry

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definition and Scope of Study I-3
Polymeric Materials I-4
Metallic Materials I-4
Natural Materials I-4
Other Materials I-4


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Biocompatible Materials Market Continues to Surge, Despite
Recession II-1
Developing Regions to Propel Future Growth II-1
R&D Creates Brighter Avenues II-2
Competitive Scenario II-2
Factors Determining Market Growth II-2
Awareness of Basic Mechanisms of Cell-Material Interaction II-2
Birth of Cross-Disciplinary Field of Tissue Engineering II-2
Rise in Biomaterial Prices II-3
Stem-Cell Technology - A Threat II-3

2. PRODUCT TRENDS II-4
Biomaterials Play Crucial Role in Implants Market II-4
Natural Substances find Increasing Application in Biomaterial
Syntheses II-4
Plastics Being Nudged Out by Newer Substrates II-4
Plastic Companies Join the Fray as Manufacturers of
Biodegradable Materials II-5
Ceramic Fillings as Substitute for Silver-Tin-Mercury Amalgam
Fillings II-5
Ceramics Offer Significant Potential in Crown Syntheses II-5
Hafnium - A Promising Material for Biocompatible Coatings II-5
Chitin as a New Biomaterial II-5
Bioglass - A Potential Material for Bone Regeneration II-6
Collagen - An Efficient Biomaterial for Synthetic Vascular Grafts II-6
Biopolymers as Biomaterials II-6
Bioabsorbable Intelligent Materials II-6
Biocompatible Coatings - A Boon for Medical Implant Applications II-7
Nanotechnology - Revolutionizes Development of Biomaterial
Implants II-7

3. END-USE MARKET ANALYSIS II-8
Biosensors II-8
Implants II-8
Common Orthopedic Implants: Merits and Demerits II-8
Biocompatibility of Implants with Blood II-8
Integrating Heparin to Polymeric Surface II-9
Dental Implants II-9
Recession Decelerates Dental Implant Market, Outlook Remains
Positive II-10
Significant Market Opportunities Exist for Dental Implants II-10
Nanotechnology Permeates Dental Implant Market II-11
Competitive Scenario II-11
Table 1: Global Dental Implant Market by Leading Players
(2009): Market Share Breakdown of Revenue for Nobel
Biocare, Straumann, Biomet/3i, Zimmer Dental, Dentsply and
Others (includes corresponding Graph/Chart) II-11
Joint Implant II-11
Artificial Organs II-12
Artificial Heart II-12
Totally Implantable Artificial Heart (TAH) System II-12
Pneumatic Total Artificial Heart (PTAH) II-12
Cardiopulmonary Bypass System for Long-term Use II-12
Ventricular Assist Device II-12
Artificial Blood Vessels II-12
Artificial Blood II-13
Artificial Skin II-13
Surface Coatings II-13
Materials for Drug Delivery Systems II-13
Polyethylene Glycol as a Drug Delivery System II-14
Hydrogels as Drug Delivery System II-14
Vinylic based Drug Delivery Systems II-14
Collagen Based Drug Delivery System II-14
Electrodes II-14
Tissue Replacement Materials II-15
Dialysis/Separation/Filtration Systems II-15
Dialysis II-15
Filtration and Separation II-16
Cosmetic and Dental Materials II-16
Biomaterials for Cosmetic Formulations II-16

4. RESEARCH AND DEVELOPMENT II-17
Biocompatible Materials - Key Research Objectives II-17
R&D Activity In the Recent Past II-18
French Inventors Develop Three-Dimensional Filet Stitch
Fabric Wall Reinforcement II-18
California Inventor Develops Biocompatible Material II-18
Scientists Develop Process for Producing Biocompatible Fibers II-18
Penn State Researchers Develop New Niobium Molding Process II-18
Doxa Commences Clinical Trials for Novel Biomaterial II-18
FzioMed Concludes Preliminary Study for Oxiplex Gel II-19
MIV’s Biomaterial Stent Coating Clears Pyrogen Clinical Testing II-19

5. REGULATORY ENVIRONMENT II-20
FDA Regulations II-20
American Society for Testing and Materials (ASTM) II-20
Joint Research Center (JRC) II-20
Biocompatibility Testing of Materials II-20
Testing Levels II-20
General Biocompatibility Testing II-20
Individual Biocompatibility Testing II-21
Testing Methods II-21

6. PRODUCT OVERVIEW II-22
Biocompatible Materials - An Introduction II-22
Definition of Biocompatible Materials II-22
Applications II-22
Orthopedic Applications II-22
Cardiovascular Applications II-22
Dental Applications II-23
Biomaterials as Skin Replacements II-23
Biomaterials as Scaffolds for Tissue Engineering II-23
Product Segments II-23
Polymeric Materials II-23
Hydrogels II-24
Biodegradable Polymers II-24
Metallic Materials II-25
Natural Materials II-26
Collagen II-26
Hyaluronic Acid II-26
Other Materials II-26
Ceramics II-26
Bioactive Ceramics II-27
Applications II-27
Bone Substitutes II-27
Articulating Surfaces in Joint Implants II-27
Composites II-27
Pyrolitic Carbon II-28
Biomaterial Segments and Applications: An Outline II-28

7. PRODUCT INTRODUCTIONS/INNOVATIONS II-29
Bayer MaterialScience Launches Baymedix Brand II-29
Exotech Bio Solutions Develops Super-Absorbent Polymers II-29
Wacker Launches Silpuran 6600 II-29
Thermo Fisher Scientific Launches HyperSep Retain Polymers II-29
Aesculap to Launch MonoMax Monofilament Absorbable Suture II-30
Lifecore Biomedical Launches Corgel BioHydrogel Research Hydrogel II-30
Incisive Surgical to Unveil Advanced INSORB® Absorbable Staple II-30
AGY Launches HPB Glass Fiber II-30
DSM Biomedical Unveils Modern Application for ComfortCoat II-31

8. PRODUCT INTRODUCTIONS/INNOVATIONS - A HISTORIC PERSPECTIVE BUILDER II-32
Medtronic Launches X-STOP PEEK IPD System II-32
K2M Enters into Biomaterials Sector II-32
Orthovita to Launch Vitoss Bioactive Foam Pack II-32
Cook Medical Unveils Umbilical Hernia Graft II-32
Stratasys Launches ABS-M30i Biocompatible Material II-33
K2M Launches Aleutian AN and Aleutian Anterior II-33
Invibio® Launches ENDOLIGN™ Polymer Composite II-33
Zimmer Dental Launches the Puros® Dermis Allograft Tissue Matrix II-34
Integra Launches Nerve Injury Products II-34
DePuy Mitek Expands Orthopedics Product Portfolio II-35

9. RECENT INDUSTRY ACTIVITY II-36
Stryker Acquires Orthovita II-36
Piramal Healthcare to Acquire Assets of BioSyntech II-36
DSM Biomedical and CID Enter into Partnership II-36
Angiotech Acquires Haemacure's Technology Assets and Product
Candidates II-37
Sigma-Aldrich and Boehringer Ingelheim Pharma Ink Distribution
Agreement II-37
ETEX Corporation's CarriGen Receives FDA Approval II-37
FDA Approves Custom Spine's PATHWAY ACIF II-38
Bayer Material Science Acquires PolyBioMed II-38
Allergan Snaps Up Serica Technologies II-38
ETEX and Orthopediatrics Enter Distribution Agreement II-38
Anika Therapeutics Takes Over Fidia Advanced Biopolymers II-39
TiGenix Acquires Orthomimetics II-39
ETEX Corporation and Alphatec Spine Sign Distribution Agreement II-39
NeuroVasx's cPAX Receives Canadian Approval II-40
PolyMedix Receives Grant for Developing Anti-Bacterial Materials II-40
Synovis Life Technologies Acquires Assets of Pegasus Biologics II-40
Immuno-Biological laboratories to Purchase NEOSILK II-40
NMT Medical Obtains Pre-Market Approval II-41
Xiros Launches Research Laboratory II-41
SyntheMed Receives Pre-Market approval for REPEL-CV Adhesion
Barrier II-41
Neovasc Enters into Agreement with LeMaitre Vascular II-41

10. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER II-42
Healionics Inks Agreement with TR BioSurgical II-42
Xceed Capital Raises Stake in PolyNovo Biomaterials II-42
CorMatrix Cardiovascular Receives Clearance for ECM™ Technology II-42
OPKO Health Takes Over Vidus Ocular II-42
Royal DSM NV to Acquire DSM PTG II-43
ETEX Signs Supply Agreement with AllloSource II-43
Orthovita and Medafor Enter into Distribution Agreement II-43
Bio-Bridge Signs Memorandum of Understanding with JR Scientific II-44
Etex Inks Supply Agreement with LifeNet Health II-44
Heparinex and Choncept Sign Option/License Agreement with
Biological E. II-44
LeMaitre Acquires Biomateriali II-45
Angiotech Pharmaceuticals inks Licensing Agreement with
Symphony Medical II-45
Vertellus Biomaterials Signs License and Supply Agreement II-45
Tyco International Acquires Confluent Surgical II-45
SurModics Acquires Intralytix’s Biodegradable Polymer Technology II-46
Orthovita Signs a Collaboration Agreement with Aastrom
Biosciences for Orthopedic Products II-46
Kuhnil Pharma Acquires Rights from BioSyntech II-46
SurModics Licenses Hydrophilic Coating to Devax II-46
BioSyntech Receives Notice of Allowance from the US Patent and
Trademark Office for BST-CarGel® II-46

11. FOCUS ON SELECT PLAYERS II-47
A.P. Pharma, Inc. (USA) II-47
Angiotech Pharmaceuticals Inc. (Canada) II-47
Artimplant AB (Sweden) II-47
AST Products, Inc. (USA) II-48
Biocoat, Inc. (USA) II-48
DENTSPLY International Inc. (USA) II-48
Invibio (UK) II-49
Integra LifeSciences Holdings Corporation (USA) II-49
SaluMedica, LLC (USA) II-50
SurModics Inc. (USA) II-50
Synthes Inc. (USA) II-50
United States Surgical (USA) II-51

12. GLOBAL MARKET PERSPECTIVE II-52

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
2009 through 2017 (includes corresponding Graph/Chart) II-52

Table 3: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) II-53

Table 4: World 15-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, 2011 and 2017 (includes corresponding
Graph/Chart) II-54

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
2009 through 2017 (includes corresponding Graph/Chart) II-55

Table 6: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) II-56

Table 7: World 15-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, 2011 and 2017 (includes corresponding Graph/
Chart) II-57

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
2009 through 2017 (includes corresponding Graph/Chart) II-58

Table 9: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) II-59

Table 10: World 15-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, 2011 and 2017 (includes corresponding Graph/
Chart) II-60

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 2009 through
2017 (includes corresponding Graph/Chart) II-61

Table 12: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) II-62

Table 13: World 15-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, 2011 and 2017 (includes corresponding Graph/
Chart) II-63

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 2009 through
2017 (includes corresponding Graph/Chart) II-64

Table 15: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) II-65

Table 16: World 15-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, 2011 and 2017 (includes corresponding Graph/
Chart) II-66


III. MARKET

1. NORTH AMERICA III-1
A.Market Analysis III-1
Outlook III-1
Demand for Orthopedic Biomaterials Surges III-1
Orthopedic Biomaterials Emerge Recession Proof III-2
Developments in the United States Dental Biomaterial Market III-2
Regulatory Environment III-2
FDA Regulations III-2
Potential Biomaterial Shortage III-3
Effects of Potential Shortages III-3
B.Market Analytics III-4
Table 17: North American Recent Past, Current & Future
Analysis for Biocompatible Materials by Type - Polymeric
Materials, Metallic Materials, Natural Materials and Other
Materials Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-4

Table 18: North American Historic Review for Biocompatible
Materials by Type - Polymeric Materials, Metallic Materials,
Natural Materials & Other Materials Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-5

Table 19: North American 15-Year Perspective for
Biocompatible Materials by Type - Percentage Breakdown of
Dollar Sales for Polymeric Materials, Metallic Materials,
Natural Materials and Other Materials Markets for Years
2003, 2011 and 2017 (includes corresponding Graph/Chart) III-6

2. JAPAN III-7
A.Market Analysis III-7
An Overview III-7
Import Scenario: Implants III-7
Table 20: Japanese Percentage Imports by Implant Type
(includes corresponding Graph/Chart) III-7
History III-8
Major Biomaterial Research Groups III-8
Institute of Biomedical Engineering (Tokyo Women’s Medical
University) III-8
Tissue Engineering Research Institute (Kyoto University) III-8
Institute of Biomaterials and Bioengineering (Tokyo Medical
and Dental University) III-8
Principal Research Institutions III-8
Regulatory Environment III-9
Medical Affairs Law III-9
B.Market Analytics III-10
Table 21: Japanese Recent Past, Current and Future Analysis
for Biocompatible Materials by Type - Polymeric Materials,
Metallic Materials, Natural Materials and Other Materials
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-10

Table 22: Japanese Historic Review for Biocompatible
Materials by Type - Polymeric Materials, Metallic Materials,
Natural Materials & Other Materials Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-11

Table 23: Japanese 15-Year Perspective for Biocompatible
Materials by Type - Percentage Breakdown of Dollar Sales
for Polymeric Materials, Metallic Materials, Natural
Materials and Other Materials Markets for Years 2003,
2011 and 2017 (includes corresponding Graph/Chart) III-12

3. EUROPE III-13
A.Market Analysis III-13
Key Growth Factors III-13
UK Bioceramic Market III-13
Regulatory Environment III-13
Government Regulations III-13
B.Market Analytics III-14
Table 24: European Recent Past, Current and Future Analysis
for Biocompatible Materials by Type - Polymeric Materials,
Metallic Materials, Natural Materials and Other Materials
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-14

Table 25: European Historic Review for Biocompatible
Materials by Type - Polymeric Materials, Metallic Materials,
Natural Materials & Other Materials Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-15

Table 26: European 15-Year Perspective for Biocompatible
Materials by Type - Percentage Breakdown of Dollar Sales
for Polymeric Materials, Metallic Materials, Natural
Materials and Other Materials Markets for Years 2003,
2011 and 2017 (includes corresponding Graph/Chart) III-16

4. REST OF WORLD III-17
Market Analytics III-17
Table 27: Rest of World Recent Past, Current and Future
Analysis for Biocompatible Materials by Type - Polymeric
Materials, Metallic Materials, Natural Materials and Other
Materials Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) III-17

Table 28: Rest of World Historic Review for Biocompatible
Materials by Type - Polymeric Materials, Metallic Materials,
Natural Materials & Other Materials Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-18

Table 29: Rest of World 15-Year Perspective for
Biocompatible Materials by Type - Percentage Breakdown of
Dollar Sales for Polymeric Materials, Metallic Materials,
Natural Materials and Other Materials Markets for Years
2003, 2011 and 2017 (includes corresponding Graph/Chart) III-19


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 68 (including Divisions/Subsidiaries - 78)

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Region/Country Players
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The United States 51
Canada 5
Japan 2
Europe 19
France 1
Germany 3
The United Kingdom 4
Rest of Europe 11
Middle East 1
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