Implantable Medical Devices Market

• Publication date: March 2012

US demand to increase 7.7% annually through 2015 US demand for implantable medical devices will increase 7.7 percent annually to $52 billion in 2015. These products have benefited from technological advances, and growth is expected to be strong over the forecast period. Next generation devices have increased confidence in orthopedic, cardiovascular and other implants. Demand will also benefit from the lack of alternative treatments...

US demand to increase 7.7% annually through 2015

US demand for implantable medical devices will increase 7.7 percent annually to $52 billion in 2015. These products have benefited from technological advances, and growth is expected to be strong over the forecast period. Next generation devices have increased confidence in orthopedic, cardiovascular and other implants. Demand will also benefit from the lack of alternative treatments for many chronic disorders and injuries. Over the long term, sales for medical implants will be challenged by tightening control by insurance providers over maximum payment for implantations. However, the ability of medical implants to reduce overall treatment cost for many conditions, including osteoarthritis and chronic heart failure, will work in favor of growth for these products.

Orthopedic products to dominate medical implants

Orthopedic implants will remain the largest implantable device segment, both in market value and growth opportunities. US demand for orthopedic implants is forecast to increase 8.8 percent annually to $29.4 billion in 2015, spurred by technological advances and safety enhancements. It will also reflect the growing prevalence of degenerative musculoskeletal disorders, and lifestyle changes that place people at risk for sports and exercise injuries. Improved orthopedic product designs allow less invasive surgeries. At the same time, as products become more durable and longlived, demand will come from an enlarged patient base for new surgeries rather than for replacements. Also challenging this segment over the long term will be advances in pharmaceutical alternatives to treat arthritic conditions. However, the segment will benefit from the high rate of insurance coverage for orthopedic implants, combined with a stable and well-funded medical delivery system.

CRT devices to benefit cardiovascular implants segment

Cardiovascular implants have strong potential to reduce the overall treatment cost for heart disease, and at the same time contribute significantly to improved quality of life. Demand for these devices is expected to expand 5.1 percent yearly to $14.6 billion in 2015. Pacing devices will realize greatest sales, largely due to growth in cardiac resynchronization therapy (CRT). A focus on developing products that reduce mortality and improve patient outcomes has resulted in greater pricing flexibility in an increasingly cost-conscious health care environment. Demand for cardiovascular stents and related devices will follow pacing devices. Fastest growth will be in structural implants, as technological advances in heart valves, ventricularassist devices and implantable monitors encourage greater use.

Wide range of other implants to spur growth

Neurostimulators will continue to represent substantial sales, favorably building on existing applications in neurodegenerative disorders and penetrating indications involving psychiatric disorders. Drug implants will experience greatest growth, with brachytherapy in particular demonstrating rapidly changing applications to treat a wider array of cancers. Ophthalmic implants, for which applications are also extending, will experience significant demand.

Study coverage

Details on these and other findings are contained in the upcoming industry study, Implantable Medical Devices, presents historical demand data (2000, 2005 and 2010) plus forecasts for 2015 and 2020 by type of implant. The study also considers key market environment factors, assesses the industry structure, evaluates company market share and profiles 26 competitors in the US industry.

Orthopedic Industry in the United States

TABLE OF CONTENTS

INTRODUCTION xi

I. EXECUTIVE SUMMARY 1

II. MARKET ENVIRONMENT 4

General 4
Macroeconomic Outlook 5
Demographic Patterns 9
Health Care Trends 11
Health Insurance 12
Medical Conditions 15
Acute Conditions 15
Chronic Conditions 16
Cardiovascular Conditions 18
Orthopedic Conditions 20
Other Chronic Conditions 20
National Health Expenditures 22
Medical Providers 24
Hospitals 25
Skilled Nursing Homes 26
Outpatient Facilities 26
Physicians 27
Patient Activity 27
Hospital Activity 28
Surgical Procedures 29
Outpatient Consultations 29
Implant Procedures 31
Orthopedic Procedures 33
Cardiovascular Procedures 34
Other Implant Procedures 36
Regulatory Considerations 36
Historical Market Trends 39
Pricing Trends 41
US Trade 43
International Markets 44
Product Overview 46

III. ORTHOPEDIC IMPLANTS 50

General 50
Reconstructive Joint Replacements 54
Knee Replacements 58
Types of Knee Replacements 59
Cemented & Cementless Knee Replacements 62
Producers 63
Hip Replacement Implants 64
Types of Hip Replacements 67
Producers 70
Other Reconstructive Joint Replacements 71
Shoulder Implants 72
Elbow Implants 75
Ankle Implants 76
All Other Reconstructive Joint Replacements 77
Spinal Implants 78
Thoracolumbar Implants 81
Intervertebral Spacers 83
Non-Bone Implants 84
Machined Allografts 86
Motion Preservation Devices 87
Cervical Implants 88
Implantable Spinal Stimulators 90
Orthobiologics 92
Hyaluronic Acid 94
Bone Substitutes 96
Bone Growth Factors 98
Bone Cement 100
Tissue Implants 102
Trauma Implants 104
Internal Fixation Devices 105
Craniomaxillofacial Implants 107
Implantable Trauma Stimulators 109
Dental & Other Implants 111

IV. CARDIOVASCULAR IMPLANTS 115

General 115
Pacing Devices 119
Cardiac Resynchronization Therapy Devices (CRTs) 121
Implantable Cardioverter Defibrillators (ICDs) 124
Implantable Cardiac Pacemakers (ICPs) 128
Pacing Accessories 134
Pacing Leads 135
Pacing Batteries 137
Cardiac Stents & Related Implants 138
Coronary Stents 141
Drug-Eluting Stents 143
Bare-Metal Coronary Stents 147
Peripheral Stents 148
Endovascular Stent-Grafts 151
Renal & Related Stents 153
Femoral & Related Stents 154
Carotid Stents 156
Stent-Related Implants 159
Synthetic Grafts 160
Vascular Grafts 161
Peripheral Grafts 162
Vena Cava Filters 163
Structural Cardiac Implants 166
Heart Valves & Accessories 168
Tissue Heart Valves 169
Mechanical Heart Valves 173
Heart Valve Repair Devices 176
Ventricular-Assist Devices 178
Implantable Heart Monitors 180
Insertable Loop Recorders (ILRs) 181
Implantable Hemodynamic Monitors (IHMs) 183

V. OTHER MEDICAL IMPLANTS 185

General 185
Neurological Stimulators 187
Ophthalmic Implants 194
Intraocular Lenses 195
Glaucoma & Other Lenses 197
Gynecological Devices 199
Soft Tissue Repair 200
Intrauterine Devices 202
Drug Implants 205
Hormonal Implants 206
Brachytherapy Products 207
Implantable Drug Pumps 210
Otolaryngeal Implants 211
Cochlear Implants 213
Airway & Esophageal Stents 215
Other Otolaryngeal Implants 217
Cosmetic Implants 218
Breast Implants 220
Other Cosmetic Implants 224
Gastroenterological Implants 226
Gastric Bands 227
Biliary Stents 229
Other Gastroenterological Implants 230
Urological Implants 231
Penile & Testicular Implants 232
Other Urological Devices 233
Other Implantable Medical Devices 235

VI. INDUSTRY STRUCTURE 237

General 237
Market Share 240
Competitive Strategies 241
Mergers & Acquisitions 247
Licensing & Related Agreements 251
Research & Development 257
Marketing & Distribution 259
Manufacturing 260
Company Profiles 261
Abbott Laboratories 262
Alcon, see Novartis
Allergan Incorporated 267
American Medical Systems Holdings, see Endo
Pharmaceuticals Holdings
Bard (CR) Incorporated 271
Bausch & Lomb Incorporated 276
Biomet Incorporated 279
Boston Scientific Corporation 288
Codman & Shurtleff, see Johnson & Johnson
Conor Medsystems, see Johnson & Johnson
Cordis, see Johnson & Johnson
Davol, see Bard
DePuy, see Johnson & Johnson
Edwards Lifesciences Corporation 295
Endo Pharmaceuticals Holdings Incorporated 298
Ethicon, see Johnson & Johnson
General Electric Company 302
Gore (WL) & Associates Incorporated 303
Intelect Medical, see Boston Scientific
Johnson & Johnson 306
Medtronic Incorporated 317
Mentor Worldwide, see Johnson & Johnson
Merck & Company Incorporated 330
Novartis AG 331
Oncura, see General Electric
Orthofix International NV 333
Orthovita, see Stryker
Osteotech, see Medtronic
Porex Surgical, see Stryker
Sadra Medical, see Boston Scientific
Smith & Nephew plc 337
Sorin SpA 342
St. Jude Medical Incorporated 346
Stryker Corporation 352
Synthes Incorporated 363
Thoratec Corporation 370
Tornier NV 372
Wright Medical Group Incorporated 376
Zimmer Holdings Incorporated 383
Other Companies Mentioned in Study 390

LIST OF TABLES

SECTION I -- EXECUTIVE SUMMARY

Summary Table 3

SECTION II -- MARKET ENVIRONMENT

1 Macroeconomic Indicators 8
2 Population by Age Group 11
3 Health Insurance Coverage of the US Population 14
4 Acute Conditions by Type 16
5 Chronic Conditions by Type 18
6 Cardiovascular Conditions by Type 19
7 Orthopedic Conditions by Type 20
8 National Health Expenditures by Type 24
9 Medical Providers by Type 25
10 Patient Activity by Type & Volume 28
11 Medical Implant Procedures by Type 32
12 Implantable Medical Devices -- Historical Market, 2000-2010 41
13 US Trade in Implantable Medical Devices 44
14 Implantable Medical Device Demand by Product Group 49

SECTION III -- ORTHOPEDIC IMPLANTS

1 Orthopedic Implants Demand by Product Group 53
2 Reconstructive Joint Replacements Demand by Type 57
3 Reconstructive Knee Replacements Demand by Type 59
4 Reconstructive Hip Replacements Demand by Type 67
5 Other Reconstructive Joint Replacements Demand by Product
Group 72
6 Spinal Implants Demand by Product Group 80
7 Thoracolumbular Implants Demand by Application 83
8 Intervertebral Spacers Demand by Type 84
9 Motion Preservation Device Demand 88
10 Cervical Implants Demand by Application 90
11 Implantable Spinal Stimulators Demand 92
12 Orthobiologics Demand by Product Group 93
13 Hyaluronic Acid Demand 96
14 Bone Substitutes Demand 98
15 Bone Growth Factors Demand 100
16 Bone Cement Demand 102
17 Tissue Implants Demand 104
18 Trauma Implant Device Demand by Product Group 105
19 Internal Fixation Device Demand by Application 107
20 Craniomaxillofacial Implants Demand 109
21 Implantable Trauma Stimulators Demand 111
22 Dental & Other Implants Demand 114

SECTION IV -- CARDIOVASCULAR IMPLANTS

1 Cardiovascular Implants Demand by Product Group 118
2 Pacing Devices by Product Group 120
3 Cardiac Resynchronization Therapy Devices (CRT) Demand 124
4 Implantable Cardioverter Defibrillators (ICD) Demand by Type 128
5 Implantable Cardiac Pacemakers (ICP) Demand by Type 133
6 Pacing Accessories Demand by Product Group 134
7 Cardiac Stents & Related Implants Demand by Product Group 140
8 Coronary Stents Demand by Type 143
9 Drug-Eluting Stent Demand 146
10 Bare-Metal Coronary Stents Demand 148
11 Peripheral Stents Demand by Product Group 150
12 Endovascular Stent Grafts Demand 152
13 Renal & Related Stents Demand 154
14 Femoral & Related Stents Demand 156
15 Carotid Stents Demand 159
16 Stent-Related Implants Demand by Product Group 160
17 Synthetic Grafts Demand 161
18 Vena Cava Filters Demand 166
19 Structural Cardiac Implants Demand by Product Group 168
20 Heart Valves & Related Accessories Demand by Type 169
21 Ventricular-Assist Devices (VAD) Demand 180
22 Implantable Heart Monitors Demand 181

SECTION V -- OTHER MEDICAL IMPLANTS

1 Other Implantable Medical Device Demand by Product Group 187
2 Implantable Neurological Stimulators Demand 194
3 Ophthalmic Implants Demand by Product Group 195
4 Gynecological Implants Demand by Product Group 200
5 Drug Implants Demand by Product Group 206
6 Otolaryngeal Implants Demand by Product Group 212
7 Cosmetic Implants Demand by Type 219
8 Gastroenterological Implants Demand by Product Group 227
9 Urological Implants Demand by Type 232
10 All Other Implantable Medical Devices 236

SECTION VI -- INDUSTRY STRUCTURE

1 US Implantable Medical Devices Sales by Company, 2010 238
2 Selected Acquisitions & Divestitures 250
3 Selected Cooperative Agreements 253

LIST OF CHARTS

SECTION VII -- EXECUTIVE SUMMARY
SECTION VIII -- MARKET ENVIRONMENT
1 Implantable Medical Device Demand by Product Group, 2010 49
SECTION IX -- ORTHOPEDIC IMPLANTS
1 Orthopedic Implants Demand by Product Group, 2010 54
2 Reconstructive Joint Replacements Demand by Type, 2010 58
3 Spinal Implants Demand by Product Group, 2010 81
4 Orthobiologics Demand by Product Group, 2010 94
SECTION X -- CARDIOVASCULAR IMPLANTS
1 Cardiovascular Implants Demand by Product Group, 2010 119
2 Pacing Device Demand by Product Group, 2010 121
3 Cardiac Stents & Related Implants Demand
by Product Group, 2010 141
SECTION XI -- OTHER MEDICAL IMPLANTS
SECTION XII -- INDUSTRY STRUCTURE
1 US Implantable Medical Devices -- Market Share
by Company, 2010 241

Orthopedic in United States

United States Other Artificial Body Parts Sales Per Capita, Us$, % Growth

• $ 250
• Industry data
• February 2013

Yearly, From 2007 To 2020
By Business Monitor International
Source: BMI Espicom

• Industries : Orthopedic
• Countries : United States

United States Other Artificial Body Parts Sales Per Capita, Us$

• $ 250
• Industry data
• February 2013

Yearly, From 2006 To 2020
By Business Monitor International
Source: BMI Espicom

• Industries : Orthopedic
• Countries : United States

United States Orthopaedic & Prosthetic Total Sales, Usdmn, % Growth

• $ 250
• Industry data
• February 2013

Yearly, From 2007 To 2020
By Business Monitor International
Source: BMI Espicom

• Industries : Orthopedic
• Countries : United States

United States Orthopaedic & Prosthetic Total Sales, 5 Year Historic Cagr

• $ 250
• Industry data
• February 2013

Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: BMI Espicom

• Industries : Orthopedic
• Countries : United States

United States Orthopaedic & Prosthetic Total Sales Per Capita, Us$, % Growth

• $ 250
• Industry data
• February 2013

Yearly, From 2007 To 2020
By Business Monitor International
Source: BMI Espicom

• Industries : Orthopedic
• Countries : United States