Study # 2255: Implantable Medical Devices

Summary

This study examines the US market for implantable medical devices, covering cardiac, orthopedic and other products that are implanted inside the body for health care or cosmetic purposes. Cardiac implants include carotid, coronary and peripheral stents; heart valves and heart valve repair accessories; implantable cardioverter defibrillators (ICDs); internal heart monitors; pacemakers and accessories; vascular and other heart-related grafts; vena cava filters; and ventricular-assist devices. Orthopedic implants consist of bone cement; knee, hip, shoulder and other joint reconstructive systems; spinal fusion and repair products; tissue extenders and expanders; and trauma fixation devices and supplies. Other implantable medical devices encompass cochlear implants, dermal implants, internal drug delivery systems, neurological stimulators, saline and silicone breast implants, urological devices and various specialized products (such as airway and esophageal stents, gastric bands and hemostatic clips). The study does not cover dental implants. An analysis of the US market for dental implants is included in Freedonia Study #2044 Dental Products & Materials (4/06).

Unless otherwise indicated, all statistics and forecasts represent demand for implantable medical devices stated in current US dollars. The term ""demand"" is equivalent to ""value of consumption"" or ""manufacturers' sales"" and is defined as the value of domestic production plus the value of imports minus the value of exports. Historical data (1996, 2001, 2006) and forecasts to 2011 and 2016 are provided for implantable medical devices by product group and type. Consumption patterns and projections for implantable medical device components and materials (ceramics, elastomers, microelectronic assemblies, polymers, specialty metals and other) are also included in the study.

""Industry Structure,"" are based on estimates derived from published company reports and personal interviews with competitors, industry experts and sources within the companies themselves. Macroeconomic indicators were taken from The Freedonia Group Incorporated Consensus Forecasts dated August 2007. The sum of individual components appearing in the study tables may not always add to the apparent total due to independent rounding. All ratios were calculated on the basis of unrounded numbers.

Information and data related to the US market for implantable medical devices were obtained from a variety of primary and secondary sources, including government agencies, trade associations, industry participants, online databases and other Freedonia studies. Primary information was gathered through consultations with officers and marketing/technical personnel of participating companies and other industry specialists. Secondary and background information were obtained from several health care publications, including Biomedical Market Newsletter , Drug Delivery Systems , Medical Design Technology , Medical Device & Diagnostic Industry , Medical Plastics and Biomaterials , Medical Product Manufacturing News and Surgical Products . Corporate annual reports, SEC Form 10-K filings, product catalogs and other company information were also used extensively in framing the industry environment and as input for market size assessments.

Related Freedonia publications consulted during the preparation of this study included #2196 Disposable Medical Supplies(05/07), #2168 Nanotechnology in Health Care (2/07), #2111 Biocompatible Materials (9/06), #2099 Cosmetic Surgery Productsb (9/06) and #1878 Diabetes Monitoring Products & Therapies (2/05).

Contents

• Introduction
• I. Executive Summary
• Ii. Market Environment
  • General
  • Economic Factors
  • Demographic Patterns
  • Health Care Trends
  • Health Insurance
  • Acute Conditions
  • Chronic Conditions
  • Cardiovascular Conditions
  • Coronary Heart Disease
  • Heart Rhythm Disorders
  • Peripheral Artery Disease
  • Valvular Heart Disease
  • Congestive Heart Failure Stroke
  • Congenital Heart Disease
  • Orthopedic Conditions
  • Mobility Impairments
  • Arthritis
  • Osteopenia & Osteoporosist's Disease
  • Neurological Conditions
  • Other Chronic Conditions
  • National Health Expenditures
  • Medical Providers
  • Hospitals
  • Outpatient Facilities
  • Skilled Nursing Homes
  • Physicians
  • Patient Activity
  • Hospital Activity
  • Outpatient Episodes
  • Surgical Procedures
  • Implant Procedures
  • Heart-Related Implant Procedures
  • Orthopedic Implant Procedures
  • Other Implant Procedures
  • Medical Product Markets
  • Pharmaceuticals & Biologicals
  • Surgical Appliances & Supplies
  • Surgical & Medical Instruments
  • Electromedical Equipment
  • Other Medical Products
• Iii. Materials & Components
  • General
  • Microelectronic Components
  • Specialty Metals
  • Titanium
  • Stainless Steel
  • Other Metals
  • Polymers
  • Acrylics
  • Nylon
  • Polytetrafluoroethylene (Ptfe)
  • Silicone Polymers
  • Sulfone-Based Resins
  • Thermoset Polyurethane
  • Ultra High Molecular Weight Polyethylene (Uhmw-Pe)
  • Other Polymers
  • Elastomers
  • Other Materials
  • Biologicals & Pharmaceuticals
  • Ceramics
  • Alumina
  • Hydroxyapatite
  • Zirconia
  • Pyrolytic Carbon
  • Nanotechnology
  • Collagen
  • All Other Materials
• Iv. Product Overview
  • General
  • Market Outlook
  • Historical Demand Patterns
  • Regulatory Considerations
  • Pricing Trends
  • Us Trade
  • International Markets
• V. Cardiac Implants
  • General
  • Market Trends
  • Product Overview
  • Defibrillators & Related Devices
  • Cardiac Resynchronization Therapy Devices
  • Crt-D Types & Functions
  • Producers
  • Implantable Cardioverter Defibrillators (Icds)
  • Icd Technology
  • Producers
  • Icd/Crt-D Leads
  • Batteries
  • Cardiac Stents
  • Drug-Eluting Coronary Stents
  • Peripheral Stents
  • Bare-Metal Coronary Stents
  • Carotid Stents
  • Pacemakers & Accessories
  • Demand Patterns
  • Producers
  • Heart-Related Grafts
  • Vascular & Endovascular Grafts
  • Vascular Grafts
  • Endovascular Grafts
  • Peripheral Grafts
  • Arterial-To-Venous Grafts
  • Heart Valves
  • Types Of Heart Valves
  • Demand Patterns
  • Tissue Heart Valves
  • Mechanical Heart Valves
  • Heart Valve Repair Products & Accessories
  • Vena Cava Filters
  • Ventricular-Assist Devices
  • Implantable Heart Monitors
  • Insertable Loop Recorders (Ilrs)
  • Implantable Hemodynamic Monitors (Ihms)
• Vi. Orthopedic Implants
  • General
  • Product Overview
  • Reconstructive Implants
  • Knee Implants
  • Demand Patterns
  • Alternative Therapies
  • Producers
  • Hip Implants
  • Demand Patterns
  • Alternative Therapies
  • Producers
  • Shoulder Implants
  • Other Reconstructive Implants
  • Elbow Implants
  • Ankle Implants
  • All Other Joint Replacement Implants
  • Spinal Implants
  • Internal Spinal Fixation Devices
  • Bone Grafts & Substitutes
  • Natural Bone
  • Intravertebral Spacers
  • Bone Substitutes
  • Fusion Cages
  • Implantable Stimulators
  • Trauma Fixation Implants
  • Internal Fixation Devices
  • Bone Grafts & Substitutes
  • Craniomaxillofacial Implants
  • Bone Cement
  • Tissue Implants
• Vii. Other Implantable Medical Devices
  • General
  • Neurological Stimulators
  • Ophthalmic Implants
  • Intraocular Lenses
  • Phakic Lenses
  • Producers
  • Retinal & Other Ophthalmic Implants
  • Breast Implants
  • Types Of Breast Implants
  • Producers
  • Drug Implants
  • Drug Inserts
  • Brachytherapy
  • Implantable Drug Pumps
  • Urological Implants
  • Penile Implants
  • Biliary Stents
  • Other Urological Implants
  • Cochlear Implants
  • Dermal Implants
  • All Other Implantable Medical Devices
• Viii. Industry Structure
  • General
  • Market Share
  • Competitive Strategies
  • Medtronic
  • Johnson & Johnson
  • Boston Scientific
  • Stryker
  • Zimmer
  • St. Jude Medical
  • Synthes
  • Abbott Laboratories
  • Biomet
  • Smith & Nephew
  • Other Companies
  • Mergers & Acquisitions
  • Licensing & Related Agreements
  • Research & Development
  • Marketing & Distribution
  • Manufacturing
  • Company Profiles
  • Abbott Laboratories
  • Abiomed Incorporated
  • Advanced Medical Optics Incorporated
  • Advanced Neuromodulation Systems Incorporated,
  • See St. Jude Medical Incorporated
  • Akzo Nobel Nv
  • Allergan Incorporated
  • Alza Corporation, See Johnson & Johnson
  • American Medical Systems Holdings Incorporated
  • Bard (Cr) Incorporated
  • Bausch & Lomb Incorporated
  • Biomet Incorporated
  • Boston Scientific Corporation
  • Cochlear Limited
  • Codman & Shurtleff Incorporated, See Johnson & Johnson
  • Coloplast A/S
  • Conor Medsystems Incorporated, See Johnson & Johnson
  • Cook Group Incorporated
  • Cordis Corporation, See Johnson & Johnson
  • Cyberonics Incorporated
  • Davol Incorporated, See Cr Bard Incorporated
  • Depuy Incorporated, See Johnson & Johnson
  • Edwards Lifesciences Corporation
  • Endoard Sa, See Allergan Incorporated
  • Endotex Interventional Systems Incorporated, See Boston
  • Scientific Corporation
  • Ethicon Endo-Surgery Incorporated, See Johnson &Johnson
  • Ethicon Incorporated, See Johnson & Johnson
  • Gore (Wl) & Associates Incorporated
  • Groupe Corneal Laboratories, See Allergan Incorporated
  • Guidant Corporation, See Boston Scientific Corporation
  • Hand Innovations Llc, See Johnson & Johnson
  • Inamed Corporation, See Allergan Incorporated
  • Johnson & Johnson
  • Medtronic Incorporated
  • Mentor Corporation
  • Optobionics Corporation
  • Organon International Incorporated, See Akzo Nobel
  • Osteobiologics Incorporated, See Smith & Nephew
  • Savacor Incorporated, See St. Jude Medical Incorporated
  • Smith & Nephew Plc
  • St. Jude Medical Incorporated
  • Stryker Corporation
  • Synthes Incorporated
  • Theragenics Corporation
  • Zimmer Holdings Incorporated
• Section I -- Executive Summary
• Summary Table
• Section Ii -- Market Environment
  • 1 Macroeconomic Indicators
  • 2 Population By Age Group
  • 3 Acute Conditions
  • 4 Cardiovascular Conditions
  • 5 Orthopedic Conditions
  • 6 Neurological & Other Selected Chronic Conditions
  • 7 National Health Expenditures
  • 8 Medical Providers By Type
  • 9 Patient Activity By Type
  • 10 Implant Procedures By Type
  • 11 Medical Product Demand
• Section Iii -- Materials & Components
  • 1 Implantable Medical Device Material & Component Demand By Type
• Section Iv -- Product Overview
  • 1 Implantable Medical Device Demand By Product Group
  • 2 Implantable Medical Device Demand Patterns, 1996-2006
  • 3 Us Trade In Implantable Medical Devices
  • 4 World Implantable Medical Device Demand By Region
• Section V -- Cardiac Implants
  • 1 Cardiac Implant Demand By Product Group
  • 2 Defibrillator & Related Device Demand
  • 3 Cardiac Stent Demand By Type
  • 4 Pacemaker & Accessory Demand By Type
  • 5 Heart-Related Graft Demand By Type
  • 6 Heart Valve Implant Demand By Type
  • 7 Vena Cava Filter Demand
  • 8 Ventricular-Assist Device Demand
  • 9 Implantable Heart Monitor Demand
• Section Vi -- Orthopedic Implants
  • 1 Orthopedic Implant Demand By Product Group
  • 2 Reconstructive Implant Demand
  • 3 Knee Implant Demand
  • 4 Hip Implant Demand
  • 5 Shoulder Implant Demand
  • 6 Other Reconstructive Implant Demand
  • 7 Spinal Implant Demand By Type
  • 8 Trauma Fixation Implant Demand By Type
  • 9 Bone Cement Demand
  • 10 Tissue Implant Demand
• Section Vii -- Other Implantable Medical Devices
  • 1 Other Implantable Medical Device Demand By Product Group
  • 2 Implantable Neurological Stimulator Demand
  • 3 Ophthalmic Implant Demand
  • 4 Breast Implant Demand
  • 5 Drug Implant Demand
  • 6 Urological Implant Demand
  • 7 Cochlear Implant Demand
  • 8 Dermal Implant Demand
  • 9 All Other Implantable Medical Device Demand
• Section Viii -- Industry Structure
  • 1 Implantable Medical Device (Imd) Sales By Company, 2006
  • 2 Selected Acquisitions & Divestitures
  • 3 Selected Cooperative Agreements
• List Of Charts
• Section Iii -- Materials & Components
  • 1 Implantable Medical Device Material & Component Demand By Type, 2006
• Section Iv -- Product Overview
  • 1 Implantable Medical Device Demand By Product Group, 2006
• Section V -- Cardiac Implants
  • 1 Cardiac Implant Demand By Product Group, 2006
• Section Vi -- Orthopedic Implants
  • 1 Orthopedic Implant Demand By Product Group, 2006
• Section Vii -- Other Implantable Medical Devices
  • 1 Other Implantable Medical Device Demand By Product Group, 2006
• Section Viii -- Industry Structure
  • 1 Implantable Medical Device (Imd) Market Share By Company, 2006