INDUSTRY MARKET RESEARCH FOR BUSINESS LEADERS, STRATEGISTS, DECISION MAKERS

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Biocompatible Materials
US Industry Study with Forecasts to 2010 & 2015
Study #2111 | September 2006 | $4400 | 264 pages

The Freedonia Group

767 Beta Drive

www.freedoniagroup.com

Cleveland, OH 44143-2326 USA Toll Free US Tel: 800.927.5900 or +1 440.684.9600 Fax: +1 440.646.0484 E-mail: info@freedoniagroup.com

Study #2111 September 2006 $4400 264 Pages

Biocompatible Materials
US Industry Study with Forecasts to 2010 & 2015

Table of Contents
IntroductIon ExEcutIvE Summary markEt EnvIronmEnt
General ...................................................4 Economic Factors ......................................5 Demographic Patterns ................................8 Health Care Trends .................................. 10 Medical Conditions ............................... 11 Chronic Conditions ............................ 12 Acute Conditions .............................. 14 Health Insurance & Reimbursement ........ 15 National Health Expenditures ................. 18 Medical Providers ................................. 21 Hospitals......................................... 24 Physicians ....................................... 24 Dentists .......................................... 25 Outpatient Facilities ......................... 26 Skilled Nursing Homes ....................... 27 Patient Activity ................................... 27 Surgical Procedures ........................... 29 Outpatient Episodes .......................... 29 Medical Product Shipments .................... 31 Pharmaceuticals & Biologicals ............ 32 Surgical & Medical Instruments ........... 33 Surgical Appliances & Supplies............ 34 Electromedical Equipment .................. 34 In Vitro Diagnostic Products ............... 35 Dental Products ................................ 35 Ophthalmic Goods............................. 36 Other Medical Products ...................... 36 Regulatory Considerations ........................ 37 Medical Devices ................................... 37 Drug Delivery Systems .......................... 39 Historical Demand Patterns....................... 40 Pricing Trends......................................... 42 US Trade ................................................ 42 International Markets .............................. 44 Polyvinyl Chloride ................................ 57 Environmental & Safety Concerns ........ 58 Production....................................... 60 Resin Properties ............................... 60 Producers & Compounds..................... 61 Fluoropolymers .................................... 63 PTFE ............................................... 64 Modified PTFE .................................. 65 FEP ................................................ 66 ETFE ............................................... 67 PFA ................................................ 67 MFA................................................ 67 Polyurethane ....................................... 68 Production & Properties ..................... 69 Applications .................................... 69 Producers & Compounds..................... 70 Polycarbonate ..................................... 71 Production....................................... 72 Applications .................................... 73 Producers & Compounds..................... 73 Silicone .............................................. 74 Production....................................... 75 Applications .................................... 76 Producers & Compounds..................... 79 Acrylic Compounds ............................... 79 Applications .................................... 81 Producers & Compounds..................... 83 Thermoplastic Polyesters ....................... 84 Types of Compounds.......................... 85 Properties ....................................... 86 Applications .................................... 87 Producers & Compounds..................... 88 Polypropylene ..................................... 89 Production & Types ........................... 90 Applications .................................... 91 Producers & Compounds..................... 91 Low Density Polyethylenes .................... 92 Production & Types ........................... 93 Properties ....................................... 95 Applications .................................... 96 Producers & Compounds..................... 96 Nylon................................................. 97 Production & Types ........................... 97 Applications .................................... 98 Producers & Compounds..................... 99 Sulfone Resins ..................................... 99 High Density Polyethylenes ................. 101 Other Synthetic Biocompatible Polymers 103 Natural Polymers ................................... 111 Cellulose Polymers ............................. 113 Drug Delivery ................................. 114 Surgical Appliances & Supplies.......... 116 Collagen ........................................... 117 Surgical Appliances & Supplies.......... 118 Dental Products .............................. 119 Producers ...................................... 119 Starch Blends .................................... 121 Other Natural Polymers .................... 123 Hyaluronic Acid ........................... 124 Alginates ................................... 126 Carrageenan ............................... 127 Other Natural Polymers ................. 128 Biocompatible Metals ............................ 130 Precious Metals ................................. 132 Gold ............................................. 133 Silver............................................ 133 Other Precious Metals ...................... 135 Stainless Steel................................... 136 Titanium .......................................... 139 Other Biocompatible Metals ................. 143 Biocompatible Ceramics ......................... 144 Porcelain .......................................... 146 Alumina ........................................... 146 Hydroxyapatite .................................. 147 Zirconia............................................ 147 Other Ceramics & Related Materials ....... 147 Surgical Appliances & Supplies ............. 148 Dental Products ................................. 150 Electromedical Equipment ................... 152

aPPLIcatIonS

General ............................................... 153 Surgical Appliances & Supplies ................ 155 Surgical & Medical Instruments ............... 162 Dental Products .................................... 164 Drug Delivery ....................................... 167 Electromedical Equipment ...................... 172 In Vitro Diagnostic Products ................... 174 Ophthalmic Goods ................................. 176

InduStry StructurE

BIocomPatIBLE matErIaLS

General ................................................. 46 Synthetic Polymers .................................. 48 Thermoplastic Elastomers ...................... 51 Silicone Elastomers ........................... 53 Styrene Block Copolymers .................. 54 Thermoplastic Copolyesters ................ 55 Thermoplastic Polyamides .................. 55 Thermoplastic Polyolefins ................... 56 Thermoplastic Polyurethanes .............. 56 Thermoplastic Vulcanizates ................ 56

General ............................................... 178 Market Share ........................................ 180 Competitive Strategies ........................... 181 Mergers & Acquisitions........................... 186 Licensing & Related Agreements .............. 189 Research & Development ........................ 193 Channels of Distribution......................... 194 Marketing ............................................ 196 Manufacturing ...................................... 197

comPany ProfILES
(listed on next page)

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Study #2111 September 2006 $4400 264 Pages

Biocompatible Materials
US Industry Study with Forecasts to 2010 & 2015

comPany ProfILES

Allegheny Technologies ......................... 200 Angiotech Pharmaceuticals ..................... 205 Arkema SA ........................................... 207 Artimplant AB ...................................... 209 BASF AG .............................................. 211 Bayer AG ............................................. 213 BioSyntech Incorporated ........................ 215 Celanese Corporation ............................. 216 Chevron Phillips Chemical ....................... 218 Dow Chemical ....................................... 219 Dow Corning ........................................ 221 DuPont (EI) de Nemours ......................... 223 Eastman Chemical ................................ 225 Exxon Mobil ......................................... 227 FMC Corporation.................................... 228 General Electric .................................... 230 Genzyme Corporation ............................. 232 Georgia Gulf ......................................... 233 Gore (WL) & Associates .......................... 234 Imperial Chemical Industries................... 237 Ineos Group ......................................... 239 Integra LifeSciences ............................. 240 International Specialty Products .............. 242 Johnson & Johnson ............................... 243 Johnson Matthey plc ............................. 244 Lyondell Chemical ................................ 245 Memry Corporation ................................ 246 Morgan Crucible .................................... 249 Orthovita Incorporated .......................... 251 OxyVinyls LP ........................................ 253 PolyOne Corporation .............................. 254 Saint-Gobain ........................................ 255 Solvay SA ............................................ 257 Total SA............................................... 260 Westlake Plastics .................................. 261 Additional Companies ............................ 262

National Health Expenditures ............. 21 Selected Medical Providers by Type ...... 23 Selected Patient Activity by Type ........ 28 Medical Product Shipments by Type ..... 32 Biocompatible Material Demand, 1995-2005 ................................. 41 10 US Trade in Biocompatible Materials .... 43 11 World Biocompatible Material Demand by Region ......................... 45

5 6 7 8 9

matErIaLS

List of Tables/Charts
ExEcutIvE Summary
1 Summary Table ...................................3

markEt EnvIronmEnt

1 Macroeconomic Indicators ....................7 2 Resident Population by Age Group .........9 3 Medical Conditions by Duration & Type ........................ 12 4 Health Insurance Coverage ................. 18

1 Biocompatible Material Demand by Type ............................ 47 Cht Biocompatible Material Demand by Type, 2005 ................... 47 2 Synthetic Biocompatible Polymer Demand by Type ................ 50 Cht Synthetic Biocompatible Polymer Demand by Type, 2005 ................... 51 3 Biocompatible Thermoplastic Elastomer Demand by Application .... 53 4 Biocompatible Polyvinyl Chloride Demand by Application ...... 58 5 Biocompatible Fluoropolymer Demand by Application .................. 64 6 Biocompatible Polyurethane Demand by Application .................. 68 7 Biocompatible Polycarbonate Demand by Application .................. 72 8 Biocompatible Silicone Demand by Application .................. 75 9 Biocompatible Acrylic Demand by Application .................. 81 10 Biocompatible Thermoplastic Polyester Demand by Application ..... 85 11 Biocompatible Polypropylene Demand by Application .................. 89 12 Biocompatible Low Density Polyethylenes Demand by Application .............................. 93 13 Biocompatible Nylon Demand by Application .................. 97 14 Biocompatible Sulfone Resin Demand by Application ........ 101 15 Biocompatible High Density Polyethylenes Demand by Application ............................ 103 16 Other Synthetic Biocompatible Polymer Demand by Application ..... 105 17 Natural Biocompatible Polymer Demand by Type .......................... 112 Cht Natural Biocompatible Polymer Demand by Type, 2005 ................. 112

18 Biocompatible Cellulose Polymer Demand by Application ................ 113 19 Biocompatible Collagen Demand by Application ................ 118 20 Biocompatible Starch Blend Demand by Application ................ 123 21 Other Natural Biocompatible Polymer Demand by Type & Application .................. 124 22 Biocompatible Metal Demand by Type .......................... 131 Cht Biocompatible Metal Demand by Type, 2005 ............................. 131 23 Biocompatible Precious Metal Demand by Application ........ 132 24 Biocompatible Stainless Steel Demand by Application ......... 139 25 Biocompatible Titanium Demand by Application ................ 143 26 Other Biocompatible Metal Demand by Application ................ 144 27 Biocompatible Ceramic Demand by Type & Application .................. 145

aPPLIcatIonS

1 Biocompatible Material Demand by Application ................ 154 Cht Biocompatible Material Demand by Application, 2005 ........ 154 2 Biocompatible Material Demand in Surgical Appliances & Supplies ...... 156 3 Biocompatible Material Demand in Surgical & Medical Instruments...... 164 4 Biocompatible Material Demand in Dental Products .......... 165 5 Biocompatible Material Demand in Drug Delivery .............. 168 6 Biocompatible Material Demand in Electromedical Equipment ......... 173 7 Biocompatible Material Demand in In Vitro Diagnostic Products.......... 175 8 Biocompatible Material Demand in Ophthalmic Goods .................... 177

InduStry StructurE

1 US Biocompatible Material Sales by Company, 2005 ............... 179 Cht Biocompatible Material Market Share, 2005 ...................... 181 2 Selected Acquisitions & Divestitures ................................ 188 3 Selected Cooperative Agreements ...... 190

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Biocompatible Materials
US Industry Study with Forecasts to 2010 & 2015

Spurred by expanding applications in cosmetic surgery and wound management, hyaluronic acid and collagen will generate the fastest gains in US demand among biocompatible natural polymers.

US demand to grow 6.6% per year through 2010

Demand for biocompatible materials in the US will increase 6.6 percent annually to $3.7 billion in 2010. Synthetic polymers will continue to record more than half of revenues and post slightly better than average gains in demand. Based on quality and safety advantages in catheters, IV administration sets, IV and blood containers, and orthopedic implants, engineered resins -- especially polycarbonate, thermoplastic elastomers, silicone and sulfone compounds -- will provide the best growth opportunities. By contrast, demand for polyvinyl chloride in biocompatible products will expand at a below average pace due to ongoing concerns about DEHP plasticizer migration.

Synthetic Polymers 52%

US Biocompatible Materials Demand, 2005

($2.7 billion)
photo courtesy of USDA

Natural Polymers 22%

Metals 16% Ceramics 10%

Hyaluronic acid, collagen to pace natural polymers

Increasing use in pharmaceutical excipients, drug delivery systems, cosmetic implants, tissue engineering and wound dressings will boost demand for natural polymers. Hyaluronic acid and collagen will post the strongest gains as new improved bioengineered formulations broaden applications in cosmetic and orthopedic surgery as well as in wound management. Based on well-established performance results, cellulose polymers and starch blends will continue to record substantial gains in pharmaceutical excipients and controlled-release drug delivery systems.

Titanium to provide best prospects among metals

Precious metals will sustain the largest demand value among biocompatible metals based on high price and widespread use in dental repair and restoration products. However, reflecting advantages of high strength, low modulus and strong body fluid resistance, titanium and titanium alloys will provide the best growth opportunities. These metals will extend applications in joint replacement systems; dental implants; fusion cages; trauma fixation devices; pacemaker and defibrillator cases; cochlear implant houses; stents; and mechanical heart valves. The penetration of titanium and titanium alloys into new and existing

uses will weaken the growth potential of stainless steel and other biocompatible metals, such as cobalt chromium alloys.

Ceramics to be fastest growing biocompatibles

Ceramics will realize the strongest growth among all biocompatible materials as advances in the properties and processing ease of these compounds broaden their uses. New generations of alumina-zirconia nanocomposites are expected to see the strongest gains. These high density structures incorporate greater resistance to cracking, an important advantage in orthopedic implants, fixation devices, and dental repair and restoration products.
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Study #2111 September 2006 $4400 264 Pages

Biocompatible Materials
US Industry Study with Forecasts to 2010 & 2015

Sample Text, Table & Forecast

table iii-2 sYNtHetic biocompatible polYmer DemaND bY tYpe (million dollars) Item Medical Product Shipments (bil $) $ biocomp polymers/000$ shpts 1995 2000 2005 2010 2015 152 3.98 245 3.61 379 3.75 530 3.72 735 3.58

biocompatible materials

Synthetic Biocompatible Polymers 605 885 1420 1970 2630 Thermoplastic Elastomers (TPEs) 72 109 191 285 400 synthetic polymers Polyvinyl Chloride (PVC) 90 119 179 223 265 Synthetic polymers will remain the dominant materials employed Fluoropolymers 70 103 161 219 290 in biocompatible products. Total synthetic polymer demand in biocomPolyurethane (PUR) 45 88 149 210 283 patible applications is projected to increase 4.2 percent annually to 695 Polycarbonate (PC) 59 83 134 205 287 million pounds, valued at nearly $2 billion, in 2010. These amounts Silicone will 50 72 101 150 220 correspond to nearly 72 percent of the volume and almost 53 percentAcrylic of 52 71 100 130 166 the value of biocompatible materials consumed in the US. Thermoplastic Polyesters (TPs) 30 45 77 106 140 Polypropylene (PP) 26 36 66 92 125 The leading position of synthetic polymers in various medical, Low Density Polyethylene (LDPE) 27 34 55 71 91 dental pharmaceutical segments reflects ongoing innovations and im-Nylon 19 26 41 52 64 provements in compounds. Technological advances have made available Sulfone Resins 12 18 31 46 65 resins that meet the needs of end-use products as to biocompatibility,High Density Polyethylene (HDPE) 9 12 21 28 36 chemical resistance, infection resistance, clarity, sterilization compatOther 44 69 114 153 198 ibility, processing ease, and overall quality and cost efficiency. All or virtually all medical tubing devices, IV containers and components, $/lb 1.69 1.92 2.51 2.83 3.09 syringe cartridges, specimen tubes, and intraocular and contact lenses, Synthetic Biocomp Polymers (mil lbs) 358 460 565 695 850 as well as a large percentage of dental materials and devices, orthopedic Demand for low density implants, drug delivery systems and wound management supplies, are polyethylenes (including composed of synthetic polymers. Further improvements and refinements conventional low density, in materials will extend the range of biocompatible products adaptable to commodity and engineered plastic resins. linear low density, ultra low

SaMPLE TExT

SaMPLE TaBLE

Growth opportunities for synthetic biocompatible polymers will extend into most classes of commodity and engineered resins. Based on cost effectiveness and the availability of improving grades, commodity resins, especially polyvinyl chloride, will continue to dominate low- and medium-value applications in less invasive supplies and devices, such as IV containers and components. Conversely, demand for products with high biocompatibility requirements, including dental and orthopedic implants, and injectable drug delivery systems, will be met mostly through engineered plastics. Thermoplastic elastomers, fluoropolymers, thermoset polyurethanes, silicone, acrylics and thermoplastic polyesters 48
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density and metallocene grades) in the production of biocompatible products is projected to increase 3.6 percent annually to 69.8 million pounds, valued at $71 million, in 2010. Fiber applications in bandages, wound dressings and incontinence garments will lead gains. In other biocompatible products adaptable to LDPEs, such as ... --Section III, pg. 92

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Biocompatible Materials
US Industry Study with Forecasts to 2010 & 2015

Sample Profile, Table & Chart

Item

table iV-6 biocompatible material DemaND iN electromeDical eQUipmeNt (million dollars) 1995 2000 2005 2010 2015 24.0 18.0 5.3 5.5 0.2 0.1 6.9 2.0 1.2 0.2 0.6 4.0 37.0 27.0 9.1 7.4 0.3 0.2 10.0 3.0 1.8 0.3 0.9 7.0 61.0 43.0 14.4 12.2 0.5 0.4 15.5 5.0 2.3 1.2 1.5 13.0 87.0 120.0 58.0 76.0 20.3 28.3 15.7 19.0 0.8 1.2 0.5 0.6 20.7 26.9 7.0 9.0 2.9 3.6 1.6 2.2 2.5 3.2 22.0 35.0

COMPANY PROFILES
Orthovita Incorporated 45 Great Valley Parkway Malvern, PA 19355 610-640-1775 http://www.orthovita.com Sales: $35 million (2005) US Sales: $32 million (2005) Employment: 140 (2005)

Electromedical Equipment Demand Synthetic Polymers: Thermoplastic Elastomers Nylon Acrylic High Density Polyethylene Other Metals: Stainless Steel Titanium Other Ceramics

SaMPLE TaBLE

SaMPLE PrOFILE
table V-1 biocompatible material marKet sHare, 2005 ($2.7 billion)
5.2% 4.1% GE

Key Products:synthetic, biologically active, tissue engineering products Orthovita is a biomaterials firm. The Company develops, manufactures and commercializes synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications, including bone regeneration. Orthovitas synthetic, biologically active, tissue engineering products include VITOSS bone graft substitutes, VITOMATRIX particulate synthetic scaffold biomaterials, IMBIBE bone marrow aspirate and delivery devices, VITAGEL composite liquid surgical hemostat, CELLPACKER plasma collection systems, CORTOSS synthetic cortical bone, ALIQUOT micro delivery systems and ENDOSKELETON Others TA vertebral body replacement structural devices. VITOSS bone graft 68.5% substitute is an ultra-porous resorbable beta-tricalcium phosphate bone void filler material adaptable to a wide range of spinal, dental and orthopedic procedures. VITOMATRIX particulate synthetic scaffold biomaterials, which are based on proprietary beta-tricalcium phosphate biomaterials, are used to make VITOSS bone graft substitutes. IMBIBE bone marrow aspirate and delivery devices from Orthovita extract and harvest bone marrow from patients for use in bone 166
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Allegheny Bayer PolyOne DuPont BASF

Market Leaders 31.5%

SaMPLE 3.5% CHarT 3.1% 3.0%

2.6% 2.4% 2.0% 1.7%

3.9%

OxyVinyls Exxon Mob Georgia G Dow Chem

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INDUSTRY MARKET RESEARCH FOR BUSINESS LEADERS, STRATEGISTS, DECISION MAKERS

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About The Freedonia Group

The Freedonia Group, Inc., is a leading international industry market research company that provides its clients with information and analysis needed to make informed strategic decisions for their businesses. Studies help clients identify business opportunities, develop strategies, make investment decisions and evaluate opportunities and threats. Freedonia research is designed to deliver unibiased views and reliable outlooks to assist clients in making the right decisions. Freedonia capitalizes on the resources of its proprietary in-house research team of experienced economists, professional analysts, industry researchers and editorial groups. Freedonia covers a diverse group of industries throughout the United States, the emerging China market, and other world markets. Industries analyzed by Freedonia include: Chemicals Plastics Life Sciences Packaging Building Materials Security & Electronics Industrial Components & Equipment Automotive & Transportation Equipment Household Goods Energy/Power Equipment

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US natural polymer demand will grow 5.9% annually through 2010 based on increased food production and opportunities in packaging and medical uses. Starch and fermentation products will grow the fastest and surpass cellulose ethers as the dominant type by 2015. The food and beverage market will remain dominant while medical uses will lead gains. The study analyzes the $2.7 billion US natural polymer industry for 2010 and 2015 by product and market. It also details market share and profiles major players.

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