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Disposable Medical Supplies Markets

Dallas 2/23/2012 4:30:00 PM

The purpose of this TriMark Publications report is to give an insight into the specific market segment called disposable medical supplies. Disposable medical supplies represent the largest segment within the global healthcare equipment and supplies sector. The disposable medical supplies include: conventional syringes with needles, prefilled syringes, disposable medical catheters, wound care products, isolation gowns, surgical drapes, facemasks, medical gloves, adult incontinence products, blood glucose test strips, lancets, lancing devices, procedure kits and trays, and disposable contact lenses. The global disposable medical supplies industry is primed to experience significant growth through the next decade, and this study provides in-depth analysis into the global and regional markets for these products. The report has made a survey of selected companies known to be marketing, manufacturing or developing various disposable medical supplies throughout the world. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included.

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Table Of Contents

1. Introduction 21

1.1 Advantages of Disposable Medical Supplies 21

1.2 The Shift from Reusable to Disposable Medical Supplies 21

1.3 Objectives of this Report 22

1.4 Scope of this Report 22

1.5 Methodology 22

1.6 Executive Summary 23


2. Disposable Medical Supplies: An Overview 26

2.1 Disposable Syringes and Needles 26

2.1.1 Prefilled Syringes 26

2.2 Disposable Medical Catheters 27

2.2.1 Urinary Catheters 27

2.2.2 Cardiac Catheter 27

2.2.3 Intravenous Catheter 28

2.2.5 Wound Care Products 28

2.3 Non-woven Medical Disposables 29

2.3.1 Non-woven Surgical and Patient Gowns 30

2.3.2 Isolation Gowns 30

2.3.3 Surgical Drapes 30

2.3.4 Facemask 31

2.4 Medical Gloves 31

2.4.1 Vinyl Synthetic Examination Gloves 31

2.4.2 Rubber Latex Examination Gloves 32

2.4.3 Nitrile Examination Gloves 32

2.4.4 Surgical Gloves 32

2.5 Adult Incontinence Products 33

2.6 Blood Glucose Test Strips 33

2.6.1 Lancet 34

2.6.2 Lancing Devices 34

2.7 Procedure Kits and Trays 35

2.7.1 Some Examples of Common Medical Kits 35

2.8 Disposable Surgical Instruments 35

2.9 Disposable Contact Lenses 36

2.9.1 Hard Contact Lenses 36

2.9.2 Gas Permeable Contact Lenses 36

2.9.3 Soft Contact Lenses 37

2.9.4 Disposable Contact Lenses 37

2.9.5 Bifocal Contact Lenses and Other Types 37


3. Medical Design Excellence Award Winning Disposable Medical Supplies, 2010-2011 38

3.1 Conveen Active Urine Collecting Bag 38

3.2 Encircle Compression Therapy Device 38

3.3 Pegasus Safety Closed IV Catheter System 38

3.4 Veinviewer Vision Vascular Imaging Device 39

3.5 JuggerKnot Soft Suture Anchor 39

3.6 MalleoLoc Ankle Orthosis 39

3.7 SpeediCath Compact Male Intermittent Catheter 40

3.8 Vitala Continence Control Device 40

3.9 Adjustable Single Incision Sling 40

3.10 Quill SRS Knottless Surgical Wound Closure Device 41


4. Market Analysis: Medical Devices and Supplies 42

4.1 Optimism toward Renewed Growth of Medical Devices and Supplies 42

4.2 Medical Devices and Supplies Companies by Region 43

4.3 Global Market Share of Medical Devices and Supplies by Segment 43

4.4 Global Market for Medical Devices and Supplies 44

4.4.1 U.S. Market for Medical Devices and Supplies 45

4.4.2 Canadian Market for Medical Devices and Supplies 46

4.4.3 Medical Devices and Supplies Market in Germany 48

4.4.4 U.K. Medical Device and Supplies Market 49

4.4.5 Medical Devices and Supplies Market in France 50

4.4.6 Medical Device and Supplies Market in Denmark 51

4.4.7 Market for Medical Devices and Supplies in Czech Republic 52

4.4.8 Medical Devices and Supplies and Supplies Market in Belgium 53

4.4.9 Market for Medical Devices and Supplies in Portugal 54

4.4.10 Medical Devices and Supplies Market in Austria 54

4.4.11 Medical Devices and Supplies Market in Russia 55

4.4.12 Market for Medical Device and Supplies in Lithuania 57

4.4.13 Market for Medical Devices and Supplies in Norway 58

4.4.14 Indian Market for Medical Devices and Supplies 59

4.4.15 Medical Devices and Supplies in Malaysia 61

4.4.16 Market for Medical Devices and Supplies in China 62


5. Market Analysis for Disposable Medical Supplies 64

5.1 Global Economic Climate and Trends in Medical Products Market 64

5.2 Positive Trends in Medical Products Market 64

5.3 Percent Growth of Disposable Medical Supplies Market 64

5.4 Global Market for Disposable Medical Supplies 65

5.4.1 Surgical Procedures that Consume Most of the Disposable Medical Supplies 66

5.5 U.S. Market for Disposable Medical Supplies 67

5.6 European Market for Disposable Medical Supplies 68

5.7 Market for Disposable Medical Supplies in the Rest of World 69


6. Wound Care 70

6.1 Types of Wounds 70

6.1.1 Surgical Wounds 70

6.1.2 Traumatic Wounds 70

6.1.3 Burn Wounds 71

6.1.4 Chronic Wounds 71

6.2 Wound Care Products 72

6.2.1 Wound Dressings 72

6.2.2 Types of Wound Dressings 73

6.2.2.1 Amorphous Hydrogel Dressings 73

6.2.2.2 Hydrogel Dressings 73

6.2.2.3 Hydrocolloid Dressings 73

6.2.2.4 Alginate Dressings 74

6.2.2.5 Composite Dressings 74

6.2.2.6 Transparent Film Dressings 74

6.3 Global Wound Care Market 75

6.3.1 Global Market for Advanced Wound Management 76

6.3.2 Global Market for Film Dressings 76

6.3.3 Global Market for Foam Dressings 77

6.3.4 Global Market for Hydrocolloids 78

6.3.5 Global Market for Alginate Dressings 79

6.3.6 Market for Hydrogel Wound Dressing Products 81

6.3.7 Market for Antimicrobial Dressings 81

6.3.8 Global Market for Wound Healing Tissue Engineered Products 83

6.4 U.S. Market for Tissue Engineered Wound Healing Products 83

6.5 Market for Growth Factor Therapies in Wound Management 84

6.6 Global Market Share of Advanced Wound Care Products by Company 85

6.6.1 Leading Players in Wound Healing Market 86

6.6.2 Global Wound Management Market by Country 86

6.6.3 Global Demand for Overall Wound Management Products by Region 86

6.6.4 Market leaders in Advanced Wound Management in Europe 87

6.6.5 Market Share of Leading Players in Wound Management in the U.S. and Europe 88

6.7 Global Market for Wound Closure Products 88

6.7.1 Market Leaders in Wound Closure Products 89

6.7.2 Global Market for Wound Closure Products by Type 89

6.7.3 Market for Tissue Sealants 90

6.7.4 Market Share of Surgical Adhesives by Company 91

6.7.5 Global Market for Non-Adherent Dressings 92

6.7.6 U.S. Market for Wound Closure Products 93

6.7.7 Surgical Securement Market in Latin America 93

6.7.8 Opportunity in High-Strength Medical Surgical Glue 94

6.7.9 Pressure Ulcers and Wound Management 94

6.7.10 Hemostasis Market 95


7. Disposable Syringes and Needles 97

7.1 Needles 97

7.2 Types of Syringes 97

7.2.1 Hypodermic syringes 97

7.2.2 Insulin Syringes 97

7.2.3 Prefilled Syringes 98

7.2.4 Safety Syringes 98

7.3 Global Market for Disposable Syringes 98

7.4 Prefill Market Trends 99

7.4.1 Components of a Pre-filled Syringe 99

7.4.2 The Shift from Vial to Pre-filled Syringes 100

7.5 Global Market for Prefilled Syringes 101

7.5.1 Global Market for Prefilled Pain Management Drugs 102

7.5.2 Global Sales of Enbrel in Prefilled Syringes 103

7.5.3 Global Market for Prefilled Psoriasis Drugs 104

7.5.4 Global Market for Prefilled Anemia Drugs 104

7.6 Disposable Insulin Pens 105

7.6.1 Insulin Pens in New Shapes 106

7.6.2 Insulin Pen with Memory 106

7.6.3 Global Market for Insulin Infusion Pumps 106

7.6.4 Global Market for Prefilled and Disposable Insulin Devices 107

7.6.5 Global Market for Oncology Drugs in Prfilled Syringes 109

7.6.6 Global Market for Prefilled Drugs for Multiple Sclerosis (MS) 109

7.6.7 Global Market for Prefilled Drugs for Arthritis 110

7.6.8 Global Market for Prefilled Vaccines 111

7.7 Auto-Injectors/Auto-Infusors 112


8. Catheters 114

8.1 Global Market for Catheters 114

8.2 Global Catheter Market by Segment 115

8.3 Market for Cardiovascular Catheters 116

8.4 Market for Balloon Catheters 117

8.5 U.S. Market for Drug-Coated Balloon Catheters in Coronary Applications 118

8.6 U.S. Market for Drug Coated Ballon Catheters 118

8.7 Peripheral Vascular Devices Market in BRIC Countries 119

8.8 Market for Elecrophysiology (EP) Ablation Catheters 120

8.8.1 North American Market for Electrophysiology Catheters 120

8.8.2 European Market for Electrophysiology Catheters 121

8.8.3 Asia/Pacific Market for EP Catheters 122

8.9 Leading Competitors in Radiofrequency Ablation Devices 122

8.10 Market for Urological catheters 123

8.11 China’s Exports and Imports of Catheters 124


9. Disposable Infusion Pumps 125

9.1 Global Market for Disposable Infusion Pumps 125

9.2 Ambulatory Infusion Pumps 126

9.2.1 Global Market for Ambulatory Infusion Pumps 126

9.3 Insulin Infusion Pumps 127

9.3.1 Global Market for Insulin Infusion Pumps 127

9.4 Enteral Feeding Pumps 128

9.4.1 Global Market for Enteral Feeding Pumps 128


10. Custom Kits and Trays 130

10.1 Advantages of Custom Kits and Trays 130

10.2 Global Market for Custom Kits and Trays 131

10.2.1 Challenges in Custom Kits and Trays Market 132

10.3 U.S. Market for Custom Kits and Trays 132

10.4 European Market for Custom Procedure Kits and Trays (CPT) 133

10.4.1 European Market for Procedure Kits and Trays by Country 134

10.4.2 European Market for Procedure Kits and Trays by Type 134

10.4.3 Market for Agiography CPT in Europe 135

10.4.4 Ophthalmic CPT Market in Europe 136

10.4.5 Operating Room CPT Market in Europe 137


11. Disposable Medical Gloves 139

11.1 Types of Disposable Medical Gloves 139

11.1.1 Latex Gloves 139

11.1.2 Disposable Nitrile Gloves 140

11.1.3 Disposable Vinyl Gloves 141

11.2 Choosing and Using the Right Surgical Glove 141

11.3 Disposable Medical Gloves: Market Analysis 142

11.3.1 Market Share of Medical Gloves by Geography 143

11.3.2 Global Market for Rubber Gloves 144

11.4 U.S. Market for Medical Gloves 145

11.5 European Market for Medical Gloves 145

11.5.1 Market Leaders of Gloves in Europe 146

11.5.2 Market for Medical Gloves in Germany 147

11.5.3 Market for Medical Gloves in France 147

11.5.4 U.K. Market for Medical Gloves 148

11.5.5 Disposable Medical Gloves Market in Italy 149

11.5.6 Market for Medical Gloves in Spain 149

11.6 Global Annual Demand of Medical Gloves 150

11.6.1 Major Rubber Glove Producing Countries 150

11.6.2 Malaysian Market Leaders in Rubber Medical Gloves 151

11.6.3 Three Sectors of Malaysian Medical Rubber Glove Manufacturing Industry 152

11.6.4 Preference for Powder-Free Natural Rubber Gloves 152

11.6.5 Export Destinations of Malaysian Medical Gloves 152

11.6.6 Powdered and Powder-Free Medical Glove Exports from Malaysia 153

11.6.7 Product Composition in Top Three Malaysian Vendors 154

11.6.8 Top Five Malaysian Medical Glove Exporters by Rank 154

11.6.9 Top Five Rubber Medical Glove Exporters in Malaysia by Rank 155

11.7 Emergence of Nitrile Gloves 156

11.7.1 Growth of Nitile Gloves 157

11.7.2 The Nitrile Advantage 157

11.7.3 Demand for Nitrile Gloves 157

11.7.4 Rush for Nitrile 158

11.8 Geographic Sales Breakdown of Medical Gloves by Prominent Vendors 158

11.8.1 Adventa’s Geographic Sales Breakdown 158

11.8.2 Latexx’s Geographic Sales Breakdown 159

11.8.3 Hartalega’s Geographic Sales Breakdown of Medical Gloves 160

11.8.4 Supermax’s Geographic Sales Breakdown of Medical Gloves 160

11.8.5 Kossan’s Geographic Sales Breakdown 161

11.8.6 Top Glove’s Geographic Sales Breakdown 161

11.8.7 Adventa’s Product Mix in Medical Gloves 162

11.8.8 Hartalega’s Product Mix in Medical Gloves 162

11.8.9 Kossan’s Product Mix in Medical Gloves 163

11.8.10 Latexx’s Product Mix in Medical Gloves 163

11.8.11 Supermax’s Product Mix in Medical Gloves 164

11.8.12 Top Glove’s Product Mix in Medical Gloves 164


12. Medical Non-wovens 165

12.1 Non-Implantable Medical Textiles 165

12.2 Implantable Medical Textiles 166

12.3 Extracorporeal Devices from Medical Textiles 166

12.4 Healthcare/Hygiene Products from Medical Textiles 167

12.5 Global Growth Potential for Medical Non-wovens by Geography 167

12.6 Growth Potential for Medical Non-wovens by Region 168

12.7 Global Growth Potential for Medical Non-wovens by Product Segment 169

12.8 Hospital-Acquired Infection and the Importance of Non-woven Disposables 169

12.8.1 Hospital Acquired Infection by Type 170

12.9 Medical Non-woven Textiles 170

12.9.1 Global Consumption of Medical Non-woven Textiles by Product Segment 171

12.9.2 Acceptance Levels of Non-wovens in Healthcare by Region/Country 171

12.9.3 Global Medical Non-wovens Consumption by Geography 172

12.10 Global Market for Medical Non-wovens 173

12.10.1 Medical Non-wovens Market in North America 173

12.11 Global Market for Disposable Non-woven Surgical Drapes 174

12.11.1 U.S. Market for Disposable Non-wovens Surgical Drapes 175

12.11.2 European Surgical Drapes Market 176

12.11.2.1 European Surgical Drapes Market Share by Company 176

12.11.3 Surgical Drapes Market in Germany 177

12.11.4 U.K. Market for Surgical Drapes 178

12.11.5 Italian Market for Disposable Surgical Drapes 178

12.11.6 Spanish Market for Surgical Drapes 179

12.12 Global Market for Medical Gowns 179

12.12.1 U.S. Market for Surgical Gowns 180

12.12.2 European Market for Surgical Gowns 181

12.12.2.1 German Market for Surgical Gowns 181

12.12.2.2 Surgical Gowns Market in France 182

12.12.2.3 U.K. Market for Surgical Gowns 182

12.12.2.4 Italian Market for Surgical Gowns 183

12.12.2.5 Spanish Market for Surgical Gowns 183

12.12.2.6 Market Leaders in European Surgical Gowns 184

12.13 Staff Apparels 184

12.13.1 Global Market for Staff Apparel 185

12.14 Global Market for Surgical Masks 185

12.15 Global Market Value for Surgical Caps 186

12.16 Global Market Value for Surgical Room Shoe Covers 187


13. Contact Lenses 188

13.1 Distribution of Gas-Permeable Contact Lenses 188

13.2 Distribution of Silicone Contact Lenses 188

13.3 Distribution of Extended Wear Lenses 188

13.4 Distribution of Daily Disposables 189

13.5 General Market Trends in Contact Lens 189

13.6 Market Leaders in Contact Lenses 190

13.7 Global Contact Lens Prescription by Material 191

13.8 Global Market for Contact Lenses 191

13.9 Global Trends in Contact Lens Prescribing 192

13.10 Global Trends in Rigid Lenses 192

13.11 Global Trends in Silicone Hydrogel Lenses 193

13.12 Global Trends in Daily Disposable Lenses 194

13.13 Global Trends in Toric Lenses 195

13.14 Popular Contact Lens Fits and Refits Modalities 196

13.15 Global Demand for Contact Lens by Type 198

13.16 Global Share of Contact Lens Wearables by Type 199

13.17 Global Market for Spheres 200

13.18 Global Market for Multi-focal Contact Lenses 200

13.19 Global Market for Toric Lenses 201

13.20 Market for Contact Lenses in Americas 202

13.20.1 Differences in Contact Lens Care Methods in the U.S. and Canada 203

13.20.2 Types of Contact Lenses Used in the U.S. and Canada 203

13.20.3 U.S. Contact Lens Market 203

13.20.4 Contact Lens Wearing in Americas by Type 204

13.20.5 Daily Disposable Contact Lenses in the U.S: Prescribing Trends and Pipeline Lenses 205

13.21 Contact Lens Market in EMEA Region 205

13.21.1 Contact Lens Wearing in EMEA by Type 206

13.22 Optics at a Glance in U.K., 2010 207

13.22.1 Sight Tests in U.K. 207

13.22.2 U.K. Market for Contact Lens 209

13.22.3 Number of Contact Lens Wearers in the U.K. 209

13.22.4 Key Trends in the U.K. Contact Lens Market 210

13.22.5 Contact Lens Prescribing in U.K., 2011 212

13.22.6 Future Contact Lens Prescribing in U.K. 213

13.22.7 Performance of Contact Lens Sector in the U.K. in 2011 214

13.22.8 Growth of SiH Daily Disposables in U.K 215

13.22.9 Growth of SiH Monthly/Weekly Disposables in U.K. 215

13.22.10 Growth of Silicone Hydrogels in the U.K by Segment 216

13.22.11 Growth of Traditional Hydrogels in U.K 217

13.22.12 Evolution of Contact Lens Market in the U.K 218

13.22.12.1 Evolutions in Lens Designs 218

13.22.12.2 Lens Replacement Frequencies in U.K 219

13.22.12.3 Lens Wearing Modalities in U.K 220

13.22.12.4 U.K. Contact Lens Market 221

13.22.12.5 Silicone Hydrogel vs. Traditional Hydrogels in U.K 222

13.23 Asia/Pacific Market for Contact Lenses 222

13.23.1 Contact Lens Wearing in Asia/Pacific by Type 223

13.23.2 Market Share of Contact Lenses by Type in Asia 224


14. Ostomy Care 226

14.1 Colostomy 226

14.2 Ileostomy 226

14.3 Urostomy 226

14.4 Global Market for Ostomy Products 227

14.4.1 Ostomy Market by Region 227


15. Adult Incontinence 229

15.1 Growth for Incontinence Products 229

15.2 Market Share for Incontinence Products by Company 230

15.3 Global Incontinence Market by Segment 230

15.4 Global Market Share of Incontinence Products by Vendor 231

15.5 Global Market Share for Enlarged Prostrate Products by Vendor 231

15.6 Market Leaders in Pelvic Prolapse Products 232

15.7 North American Market for Incontinence Products 232

15.7.1 The U.S. Urology Device Market 233

15.7.2 U.S. Urinary Incontinence Market by Segment 234

15.8 European Market for Incontinence Products 234


16. Global Market for Medical Device and Pharmaceutical Packaging 235

17. Global Market Value for Diabetes Test Strips 236

18. Company Profiles 237

18.1 3M Healthcare 237

18.2 Abbott 240

18.2.1 Abbott’s Immunology Products 240

18.2.2 Abbotts Oncology Products 240

18.2.3 Abbott’s Medical Products 241

18.3 Ahlstrom Corporation 241

18.3.1 Selected Medical Non-woven Products from Ahlstrom 241

18.4 Alcon Laboratories, Inc. 243

18.4.1 Alcon’s Business Performance 243

18.4.1.1 Alcon’s Glaucoma Business 243

18.4.1.2 Alcon’s Ophthalmic Surgery Business 244

18.4.1.3 Alcon’s Eye Care Business 245

18.5 Ansell Healthcare Products LLC 245

18.5.1 Ansell’s Powder-Free Surgical Gloves 245

18.5.2 Ansell’s Powder-Free Latex Gloves 245

18.5.3 Ansell’s Powdered Latex Gloves 245

18.6 Alpha Pro Tech, Ltd. 246

18.7 Baxter International Inc. 246

18.7.1 Baxter’s Anesthesia 246

18.7.2 Baxter’s BioSurgery 247

18.7.3 Baxter’s Clinical Nutrition Business 247

18.7.4 Baxter’s Critical Care Therapies 247

18.7.5 Baxter’s Hemophilia Therapies 247

18.7.6 Baxter’s Infusion Systems 247

18.7.7 Baxter’s Pharmaceuticals and IV Solutions 247

18.7.8 Baxter’s Renal Products 248

18.7.9 Baxter’s Business Performance 248

18.8 B. Braun 249

18.8.1 B. Braun’s Hospital Care Division 249

18.8.2 B. Braun’s Aesculap Division 250

18.8.3 B. Braun’s Out-Patient Market (OPM) Division 250

18.8.4 B. Braun’s Avitum Division 250

18.8.5 B. Braun’s Overall Business Performance 250

18.8.5.1 Baxter’s Hospital Care Division’s Business 250

18.8.5.2 Aesculap Division’s Business 251

18.8.5.3 OPM Division’s Business 251

18.8.5.4 Avitum Division’s Business 251

18.9 Becton, Dickinson & Co. 252

18.9.1 BD Medical 252

18.9.2 BD Diagnostics 252

18.9.3 BD Biosciences 252

18.10 Boston Scientific Corporation 253

18.10.1 Boston’s Product Portfolio 253

18.10.2 Boston’s Cardiac Rhythm Management 253

18.10.3 Boston’s Interventional Cardiology 254

18.10.3.1 Coronary Stent Systems 254

18.10.3.2 Coronary Revascularization 254

18.10.3.3 Intraluminal Ultrasound Imaging 254

18.10.3.4 Structural Heart Therapy 254

18.10.4 Boston’s Electrophysiology 255

18.10.5 Boston’s Peripheral Interventions 255

18.10.5.1 Embolic Protection 255

18.10.6 Endoscopy 255

18.10.6.1 Gastroenterology 255

18.10.6.2 Interventional Bronchoscopy 256

18.10.7 Boston’s Urology/Women’s Health 256

18.10.8 Boston’s Neuromodulation 256

18.11 Cardinal Health, Inc. 257

18.11.1 Cardinal’s Pharmaceuticals Segment Business 257

18.11.2 Cardinal’s Medical Segment Business 257

18.12 C.R. Bard, Inc. 257

18.12.1 Bard’s Vascular Products 258

18.12.2 Bard’s Urology Business 258

18.12.3 Bard’s Oncology Business 258

18.12.4 Bard’s Surgical Specialties Business 259

18.13 Coloplast Ltd. 259

18.13.1 Coloplast’s Ostomy Care 260

18.13.2 Coloplast’s Continence Care 260

18.13.3 Coloplast’s Urology Care 260

18.13.4 Coloplast’s Wound and Skin Care 260

18.13.5 Coloplast’s Business Performance by Geography 260

18.14 Contec, Inc. 261

18.15 Covidien Ltd. 262

18.15.1 Covidien’s Medical Devices Segment 262

18.15.2 Covidien’s Pharmaceuticals Segment 263

18.15.3 Covidien’s Medical Supplies Segment 263

18.16 DeRoyal Industries 263

18.17 Dynarex Corporation 266

8.18 Johnson & Johnson 267

8.18.1 Johnson & Johnson’s Medical Devices and Diagnostics 267

8.18.2 Johnson & Johnson’s Medical Devices and Diagnostics Business 268

8.19 Kimberly-Clark Corporation 268

8.19.1 Kimberly’s Personal Care Segment Business 269

8.19.2 Kimberly’s Consumer Tissue Segment Business 269

8.19.3 K-C Professional & Other Segment Business 269

8.20 Medline Industries, Inc. 269

18.21 Medtronic, Inc. 270

18.21.1 Medtronic’s Business in Cardiac Rhythm Management Products 271

18.21.2 Medtronic’s Business in Spinal Products 271

18.21.3 Medtronic’s Business in Cardiovascular Products 271

18.21.4 Medtronic’s Neuromodulation Products 271

18.21.5 Medtronic’s Business in Diabetes Products 271

18.21.6 Medtronic’s Business in Surgical Technologies Products 271

18.21.7 Medtronic’s Business in Physio-Control Products 271

18.22 Merit Medical Systems, Inc. 272

18.22.1 Merit’s Inflation Devices 272

18.22.2 Merit’s Hemostasis Valves 272

18.22.3 Merit’s Vascular Access Products 272

18.22.4 Merit’s Diagnostic Catheters, Guide Wires and Torque Devices 272

18.22.5 Merit’s Angiography and Accessories 273

18.22.6 Merit’s Safety and Waste Management Systems 273

18.22.7 Merit’s Obesity-Related Products 273

18.22.8 Merit’s Drainage Catheters and Accessories 273

18.22.9 Merit’s Paracentesis and Pericardiocentesis Catheters 274

18.22.10 Merit’s Therapeutic Infusion Catheters 274

18.22.11 Merit’s Dialysis and Interventional Nephrology Products 274

18.23 Paul Hartmann AG 274

18.23.1 Hartmann’s Medical Business 275

18.23.2 Growth in Wound Management Segment 275

18.23.3 Growth of Incontinence Management Segment 275

18.23.4 Few Selected Wound Care Products from Hartmann 277

18.24 Rochester Medical Corporation 282

18.24.1 Rochester’s Male External Catheters 282

18.24.2 Rochester’s Intermittent Catheters 282

18.24.3 Rochester’s Foley Catheters 283

18.25 Medline Industries, Inc. 283

18.25.1 Rochester’s Male External Catheters 284

18.25.2 Rochester’s Intermittent Catheters 284

18.25.3 Rochester’s Foley Catheters 285

18.26 Semperit AG Holding 285

18.26.1 Sempermed 285

18.26.2 Business Performance in Sempermed 286

18.27 Smith & Nephew 286

18.27.1 Smith & Nephew’s Orthopedics Products 286

18.27.2 Smith & Nephew’s Endoscopy Business 287

18.27.3 Smith & Nephew’s Endoscopy Products 287

18.27.4 Smith & Nephew’s Advanced Wound Management Products 287

18.28 St. Jude Medical, Inc. 287

18.28.1 St. Jude’s Business in Cardiac Rhythm Management Products 288

18.28.2 St. Judes Business in Cardiovascular Products 288

18.28.3 St. Jude’s Business in Atrial Fibrillation Products 288

18.29 Teleflex Medical 288

18.29.1 Teleflex Medical’s Venous Access Products 288

18.29.2 Teleflex Medical’s Urology Products 289

18.29.3 Teleflex Medical’s Anesthesia and Airway Management Products 289

18.29.4 Teleflex Medical’s Respiratory Products 289

18.29.5 Teleflex Medical’s Surgical Devices 289

18.29.6 Teleflex Medical’s OEM Products 289

18.29.7 Teleflex Medical’s Cardiac Care Products 289

18.30 Terumo Medical Corporation 290

18.30.1 Terumo’s General Hospital Business 290

18.30.2 Terumo’s Blood Transfusion Business 290

18.30.3 Terumo’s Cardiac and Vascular Business 290

18.30.4 Terumo’s Consumer Healthcare Business 290


Appendix 1: Summaries of Top 28 Medical Device and Disposables Companies 291

Appendix 1.1: Johnson & Johnson 291

Appendix 1.2: GE Healthcare 291

Appendix 1.3: Siemens 291

Appendix 1.4: Fresenius Medical 292

Appendix 1.5: Medtronic 292

Appendix 1.6: Abbott Laboratories 293

Appendix 1.7: Boston Scientific 293

Appendix 1.8: Cardinal Health 294

Appendix 1.9: Becton, Dickinson & Co. 294

Appendix 1.10: Baxter International 294

Appendix 1.11: Stryker Corporation 295

Appendix 1.12: Olympus Corporation 295

Appendix 1.13: Covidien 296

Appendix 1.14: B. Braun 296

Appendix 1.15: St. Jude Medical 297

Appendix 1.16: 3M Healthcare 297

Appendix 1.17: Zimmer Holdings 298

Appendix 1.18: Terumo Corporation 298

Appendix 1.19: Synthes (J & J) 299

Appendix 1.20: Beckman Coultrt 299

Appendix 1.21: Danaher Corporation 300

Appendix 1.22: Alcon 300

Appendix 1.23: C.R. Bard 300

Appendix 1.24: Biomet 301

Appendix 1.25: Dentsply International 301

Appendix 1.26: Agfa Healthcare 302

Appendix 1.27: Toshiba Corporation 302

Appendix 1.28: Hospira 303

Appendix 2: A Guide for the U.S. Exporters of Medical Devices and Supplies to the World Market 304

Appendix 2.1: European Union (E.U) 304

Appendix 2.1.1: CE Marking 304

Appendix 2.1.2: Exception to CE Marking 305

Appendix 2.1.3: Classification 305

Appendix 2.1.4: Borderline Products 305

Appendix 2.1.5: Compliance with “Essential Requirements” 305

Appendix 2.1.6: Use of E.U-wide Harmonized Standards 306

Appendix 2.1.7: Modules of Coformity Assessment 306

Appendix 2.1.8: Roles of a Notifyied Body 306

Appendix 2.1.9: Technical File 306

Appendix 2.1.10: Declaration of Conformity 306

Appendix 2.1.11: Authorized Representative 307

Appendix 2.1.12: Post-Market Surveillance 307

Appendix 2.1.13: New Regulatory Framework for Medical Devices 307

Appendix 2.1.14: Medical Devices and Machines 307

Appendix 2.1.15: MRI Equipment 308

Appendix 2.1.16: Packaging/Labelling 308

Appendix 2.1.17: Chemical Substances and Mixtures in Medical Devices 308

Appendix 2.2: Opportunities in Austria 308

Appendix 2.2.1: Market Entry 309

Appendix 2.2.2: Current Market Trends 309

Appendix 2.2.3: Main Competitors 309

Appendix 2.2.4: Current Demand 310

Appendix 2.3: Opportunities in Belgium 310

Appendix 2.3.1: Market Entry 310

Appendix 2.3.2: Current Market Trends 310

Appendix 2.3.3: Main Competitors 311

Appendix 2.4: Opportunities in Bulgaria 311

Appendix 2.4.1: Market Entry 311

Appendix 2.4.2: Current Market Trends 312

Appendix 2.4.3: Main Competitors 312

Appendix 2.4.4: Opportunities in Czech Republic 312

Appendix 2.4.5: Market Entry 312

Appendix 2.4.6: Current Market Trends and Demand 312

Appendix 2.5: Opportunities in Denmark 313

Appendix 2.5.1: Market Entry 313

Appendix 2.5.2: Current Market Trends 313

Appendix 2.5.3: Main Competitors 314

Appendix 2.5.4: Current Demand 314

Appendix 2.6: Opportunities in Finland 314

Appendix 2.6.1: Market Entry 314

Appendix 2.6.2: Current Market Trends and Demands 314

Appendix 2.6.3: Main Competitors 315

Appendix 2.7: Opportunities in France 315

Appendix 2.7.1: Market Entry 315

Appendix 2.7.2: Current Market Trends and Main Competitors 316

Appendix 2.7.3: Current Demand 316

Appendix 2.8: Opportunities in Germany 316

Appendix 2.8.1: Market Entry 317

Appendix 2.8.1.1: Distribution Practices 317

Appendix 2.8.1.2: Product Standards 318

Appendix 2.8.1.3: CE Mark 318

Appendix 2.8.1.4: Packaging and Labelling 318

Appendix 2.8.1.5: Payments and Financing Practices 319

Appendix 2.8.1.6: Tariffs and Import Regulation 319

Appendix 2.8.2: Current Market Trends 319

Appendix 2.8.3: Maintain Competitors 319

Appendix 2.8.4: Current Demand and Barriers 320

Appendix 2.8.5: Opportunities in Greece 320

Appendix 2.8.6: Market Entry 320

Appendix 2.8.7: Current Market Trends 321

Appendix 2.8.8: Main Competitors 322

Appendix 2.8.9: Current Demand 322

Appendix 2.9: Opportunities in Hungary 323

Appendix 2.9.1: Market Entry 323

Appendix 2.9.2: Current Market Trends 323

Appendix 2.9.3: Main Competitors 324

Appendix 2.9.4: Current Demand 324

Appendix 2.10: Opportunities in Ireland 324

Appendix 2.10.1: Market Entry 325

Appendix 2.10.2: Current Market Trends 325

Appendix 2.10.3: Main Competitors 325

Appendix 2.10.4: Current Demand 325

Appendix 2.11: Opportunities in Italy 326

Appendix 2.11.1: Market Entry 326

Appendix 2.11.2: Current Market Trends 326

Appendix 2.11.3: Main Competitors 326

Appendix 2.11.4: Current Demand 327

Appendix 2.12: Opportunities in Netherlands 327

Appendix 2.12.1: Market Entry 327

Appendix 2.12.2: Current Market Trends and Demands 328

Appendix 2.12.3: Main Competitors 328

Appendix 2.13: Opportunities in Norway 328

Appendix 2.13.1: Market Entry 328

Appendix 2.13.2: Current Market Trends 328

Appendix 2.13.3: Main Competitors 329

Appendix 2.13.4: Current Demand 329

Appendix 2.14: Opportunities in Poland 329

Appendix 2.14.1: Market Entry 329

Appendix 2.14.2: Current Market Trends 329

Appendix 2.14.3: Main Competitors 330

Appendix 2.14.4: Current Demand 330

Appendix 2.15: Opportunities in Romania 330

Appendix 2.15.1: Market Entry 331

Appendix 2.15.2: Current Market Trends 331

Appendix 2.15.3: Main Competitors 331

Appendix 2.15.4: Current Demand 331

Appendix 2.16: Slovak Republic 332

Appendix 2.16.1: Market Entry 332

Appendix 2.16.2: Current Market Trends 332

Appendix 2.16.3: Main Competitors 333

Appendix 2.16.4: Current Demand 333

Appendix 2.17: Opportunities in Spain 333

Appendix 2.17.1: Market Entry 334

Appendix 2.17.2: Current Market Trends 334

Appendix 2.17.3: Main Competitors 334

Appendix 2.17.4: Current Demand 334

Appendix 2.18: Opportunities in Sweden 334

Appendix 2.18.1: Market Entry 335

Appendix 2.18.2: Current Market Trends 335

Appendix 2.18.3: Main Competitors 335

Appendix 2.18.4: Current Demand 335

Appendix 2.19: Opportunities in Switzerland 336

Appendix 2.19.1: Market Entry 336

Appendix 2.19.2: Current Market Trends 336

Appendix 2.19.3: Main Competitors 336

Appendix 2.19.4: Current Demand 336

Appendix 2.20: Opportunities in Ukraine 336

Appendix 2.20.1: Market Entry 337

Appendix 2.20.2: Current Market Trends 337

Appendix 2.20.3: Main Competitors 337

Appendix 2.20.4: Current Demand 337

Appendix 2.21: Opportunities in the U.K. 338

Appendix 2.21.1: Market Entry 338

Appendix 2.21.2: Current Market Trends 338

Appendix 2.21.3: Main Competitors 338

Appendix 2.21.4: Current Demand 338

Appendix 2.22: Opportunities in Argentina 339

Appendix 2.22.1: Market Entry 339

Appendix 2.22.2: Current Market Trends 339

Appendix 2.22.2: Main Competitors 339

Appendix 2.22.3: Current Demand 339

Appendix 2.23: Opportunities in Brazil 340

Appendix 2.23.1: Market Entry 340

Appendix 2.23.2: Current Market Trends 340

Appendix 2.23.3: Main Competitors 340

Appendix 2.23.4: Current Demand 340

Appendix 2.24: Opportunities in Dominican Republic 341

Appendix 2.24.1: Market Entry 341

Appendix 2.24.2: Current Market Trends 341

Appendix 2.24.3: Main Competitors 341

Appendix 2.24.4: Current Demand 341

Appendix 2.25: Opportunities in Ecuador 342

Appendix 2.25.1: Market Entry 342

Appendix 2.25.2: Current Market Trends 343

Appendix 2.25.3: Main Competitors 343

Appendix 2.25.4: Current Demand 343

Appendix 2.26: Opportunities in El Salvador 343

Appendix 2.26.1: Market Entry 343

Appendix 2.26.2: Current Market Trends 343

Appendix 2.26.3: Main Competitors 344

Appendix 2.27: Opportunities in Mexico 344

Appendix 2.27.1: Market Entry 344

Appendix 2.27.2: Current Market Trends 344

Appendix 2.27.3: Main Competitors and Current Demand 344

Appendix 2.28: Opportunities in Panama 345

Appendix 2.28.1: Market Entry 345

Appendix 2.28.2: Current Market Trends 345

Appendix 2.28.3: Main Competitors 345

Appendix 2.28.4: Current Demand 345

Appendix 2.29: Opportunities in Israel 346

Appendix 2.29.1: Market Entry 346

Appendix 2.29.2: Current Market Trends 346

Appendix 2.29.3: Main Competitors 346

Appendix 2.29.4: Current Demand 346

Appendix 2.30: Opportunities in Saudi Arabia 347

Appendix 2.30.1: Market Entry 347

Appendix 2.30.2: Current Market Trends 347

Appendix 2.30.3: Main Competitors 348

Appendix 2.30.4: Current Demand 348

Appendix 2.31: Opportunities in Turkey 348

Appendix 2.31.1: Market Entry 349

Appendix 2.31.2: Current Market Trends 349

Appendix 2.31.3: Main Competitors 350

Appendix 2.31.4: Current Demand 350

Appendix 2.32: Opportunities in Australia 350

Appendix 2.32.1: Market Entry 350

Appendix 2.32.2: Current Market Trends 350

Appendix 2.32.3: Main Competitors 350

Appendix 2.32.4: Current Demand 351

Appendix 2.33: Opportunities in China 351

Appendix 2.33.1: Current Market Trends 352

Appendix 2.33.2: Market Entry 352

Appendix 2.33.3: Current Market Trends 352

Appendix 2.33.4: Main Competitors 352

Appendix 2.33.5: Current Demand 352

Appendix 2.34: Opportunities in India 353

Appendix 2.34.1: Market Entry 353

Appendix 2.34.2: Current Market Trends 353

Appendix 2.34.3: Main Competitors 354

Appendix 2.34.4: Current Demand 354

Appendix 2.35: Opportunities in Indonesia 354

Appendix 2.35.1: Market Entry 354

Appendix 2.35.2: Current Market Trends 354

Appendix 2.35.3: Main Competitors 354

Appendix 2.35.4: Current Demand 355

Appendix 2.36: Opportunities in Japan 355

Appendix 2.36.1: Market Entry 355

Appendix 2.36.2: Current Market Trends 356

Appendix 2.36.3: Main Competitors 356

Appendix 2.36.4: Current Demand 356

Appendix 2.37: Opportunities in Philippines 356

Appendix 2.37.1: Market Entry 357

Appendix 2.37.2: Current Market Trends 357

Appendix 2.37.3: Main Competitors and Current Demands 357

Appendix 2.38: Opportunities in Republic of Korea 357

Appendix 2.38.1: Market Entry 357

Appendix 2.38.2: Current Market Trends 358

Appendix 2.38.3: Main Competitors 359

Appendix 2.38.4: Current Demand 359

Appendix 2.39: Opportunities in Singapore 359

Appendix 2.39.1: Market Entry 359

Appendix 2.39.2: Current Market Trends 359

Appendix 2.39.3: Main Competitors 359

Appendix 2.39.4: Current Demand 360

Appendix 2.40: Opportunities in Taiwan 360

Appendix 2.40.1: Market Entry 360

Appendix 2.40.2: Current Market Trends 360

Appendix 2.40.3: Main Competitors 360

Appendix 2.40.4: Current Demand 360

Appendix 3: FDA Impact on U.S. Medical Technology Innovation 361

Appendix 3.1: FDA’s Regulatory Pathways 362

Appendix 3.2: Survey Results 363

Appendix 3.3: Perceptions of FDA Performance Relative to European Regulatory Authorities 365

Appendix 3.4: The Cost to Medtech Companies 367

Appendix 3.5: Implications to Patients 370

Appendix 3.6: Implications to U.S. Medtech Companies, Investors and Employees 370

Appendix 3.7: Implications to the U.S. Economy 371


List Of Tables


Table 2.1: The Top Five Lancing Devices in 2011 34

Table 6.1: Prevalence of Different Wound Types 72

Table 6.2: Classification of Wound Care Therapeutics 72

Table 6.3: Selected Commercially Available Alginate-Based Wound Dressings 80

Table 6.4: Antiseptic Agents Incorporated into Wound Dressings 82

Table 6.5: High-Strength Surgical Glues and Adhesives 91

Table 6.6: Selected Tropical Hemostasis Products 96

Table 7.1: Components of a Pre-filled Syringe 100

Table 7.2: Selected Injectable Therapeutics and Vaccines Available in the U.S. 101

Table 11.1: Characteristics of Natural Rubber Latex and Synthetic Rubber Latex 141

Table 12.1: Non-Implantable Materials Used in Medical Applications 165

Table 12.2: Implantable Medical Textiles 166

Table 12.3: Extracorporeal Devices Made from Medical Textiles 166

Table 12.4: Healthcare/Hygiene Products from Medical Textiles 167

Table 12.5: Major Uses of Non-woven Fabrics in Medical Industry 170

Table 13.1: Market Value and Number of Wearers of Contact Lens in U.K., 2009-2010 209

Table 13.2: Contact Lens Wearers in the U.K., 1992-2010 210

Table 13.3: Number of Contact Lens Wearers by Lens Type, 2000-2010 211

Table 18.1: Mops and Wipes from Contec 261

Table 18.2: FDA Approved Products from Dynarex 266

Table 18.3: Surgical Masks from Medline 270

Table 18.4: Surgical Gloves from Medline 270

Table 18.5: Surgical Drapes, Gowns and Gloves from Hartmann 275

Table 18.6: Surgical Masks from Medline 283

Table 18.7: Surgical Gloves from Medline 284

Table App. 1.1: Summary of Johnson & Johnson’s Business, 2008-2010 291

Table App. 1.2: Summary of GE Healthcare’s Business, 2008-2010 291

Table App. 1.3: Summary of Siemens’ Business, 2008-2010 292

Table App. 1.4: Summary of Fresenius’ Business, 2008-2010 292

Table App. 1.5: Summary of Medtronic’s Business, 2008-2010 292

Table App. 1.6: Summary of Abbott’s Business, 2008-2010 293

Table App. 1.7: Summary of Boston Scientific’s Business, 2008-2010 293

Table App. 1.8: Summary of Cardinal Health’s Business, 2008-2010 294

Table App. 1.9: Summary of Becton Dickinson’s Business, 2008-2010 294

Table App. 1.10: Summary of Baxter International’s Business, 2008-2010 295

Table App. 1.11: Summary of Stryker Corporation’s Business, 2008-2010 295

Table App. 1.12: Summary of Olympus Corporation’s Business, 2008-2010 296

Table App. 1.13: Summary of Covidien’s Business, 2008-2010 296

Table App. 1.14: Summary of B. Braun’s Business, 2008-2010 297

Table App. 1.15: Summary of St. Jude Medical’s Business, 2008-2010 297

Table App. 1.16: Summary of 3M Healthcare’s Business, 2008-2010 298

Table App. 1.17: Summary of Zimmer Holding’s Business, 2008-2010 298

Table App. 1.18: Summary of Terumo Corporation’s Business, 2008-2010 299

Table App. 1.19: Summary of Synthes’ Business, 2008-2010 299

Table App. 1.20: Summary of Beckman Coulter’s Business, 2008-2010 299

Table App. 1.21: Summary of Danaher Corporation’s Business, 2008-2010 300

Table App. 1.22: Summary of Alcon’s Business, 2008-2010 300

Table App. 1.23: Summary of C.R. Bard’s Business, 2008-2010 301

Table App. 1.24: Summary of Biomet’s Business, 2008-2010 301

Table App. 1.25: Summary of Dentsply’s Business, 2008-2010 302

Table App. 1.26: Summary of Agfa’s Business, 2008-2010 302

Table App. 1.27: Summary of Toshiba Corporation’s Business, 2008-2010 303

Table App. 1.28: Summary of Hospira’s Business, 2008-2010 303

Table App. 2.1: Imports of Medical Devices and Supplies by Slovak Republic from the U.S., 2009-2010 333

Table App. 3.1: Comparison of Industry vs. Participant Demographics 363


List Of Figures


Figure 4.1: The Top Five International Markets that Allure Foreign Investment 42

Figure 4.2: Medical Device and Supplies Companies by Region 43

Figure 4.3: Global Market Share of Medical Devices and Supplies by Segment 44

Figure 4.4: Global Market for Medical Devices and Supplies, 2011-2018 45

Figure 4.5: U.S. Market for Medical Devices and Supplies, 2011-2018 46

Figure 4.6: Canadian Market for Medical Devices and Supplies, 2011-2018 47

Figure 4.7: Canadian Medical Devices and Supplies Market by Segment 47

Figure 4.8: Medical Devices and Supplies Market in Germany, 2011-2018 48

Figure 4.9: U.K Market for Medical Devices and Supplies, 2011-2018 49

Figure 4.10: Medical Devices and Supplies Market in France, 2011-2018 50

Figure 4.11: Medical Device and Supplies Market in Denmark, 2011-2018 51

Figure 4.12: Market for Medical Devices and Supplies in Czech Republic, 2011-2018 52

Figure 4.13: Market for Medical Devices and Supplies in Belgium, 2011-2018 53

Figure 4.14: Medical Devices and Supplies Market in Portugal, 2011-2018 54

Figure 4.15: Medical Devices and Supplies Market in Austria, 2011-2018 55

Figure 4.16: Medical Devices and Supplies Market in Russia, 2011-2018 56

Figure 4.17: Market for Medical Device and Supplies in Lithuania, 2011-2018 58

Figure 4.18: Market for Medical Devices and Supplies in Norway, 2011-2018 59

Figure 4.19: Indian Market for Medical Devices and Supplies, 2011-2018 60

Figure 4.20: Indian Medical Devices and Supplies Industry by Segment 61

Figure 4.21: Malaysian Market for Medical Devices and Supplies, 2011-2018 62

Figure 4.22: Market for Medical Devices and Supplies in China, 2011-2018 63

Figure 5.1: Global Market for Disposable Medical Supplies, 2011-2018 65

Figure 5.2: Disposable Medical Supplies: The Largest Segment in Healthcare Industry 66

Figure 5.3: Surgical Interventions Consuming Disposables by Type 66

Figure 5.4: U.S. Market for Disposable Medical Supplies, 2011-2018 67

Figure 5.5: European Market for Disposable Medical Supplies, 2011-2018 68

Figure 5.6: Rest of the World Market for Disposable Medical Supplies, 2011-2018 69

Figure 6.1: Global Wound Care Market, 2011-2018 75

Figure 6.2: Global Market for Advanced Wound Management, 2011-2018 76

Figure 6.3: Global Market for Wound Healing Films, 2011-2018 77

Figure 6.4: Global Market for Wound Healing Foams, 2011-2018 78

Figure 6.5: Global Market for Wound Healing Hydrocolloids, 2011-2018 79

Figure 6.6: Global Market for Wound Healing Alginates, 2011-2018 80

Figure 6.7: Global Market for Wound Healing Hydrogel Products, 2011-2018 81

Figure 6.8: Global Market for Wound Healing Antimicrobial Products, 2011-2018 82

Figure 6.9: Global Market for Wound Healing Tissue Engineering Products, 2011-2018 83

Figure 6.10: The U.S. Market for Tissue Engineered Wound Healing Products, 2011-2018 84

Figure 6.11: Global Market for Growth-Factor Therapies, 2011-2018 85

Figure 6.12: Global Market Share for Advanced Wound Care Products by Company, 2011 85

Figure 6.13: Global Wound Management Market by Country 86

Figure 6.14: Global Wound Management Products Demand by Region, 2013 87

Figure 6.15: Market Share of Advanced Wound Management Vendors in Europe, 2010 87

Figure 6.16: Share of Moist Wound Healing Market in the U.S. and Europe by Company, 2010 88

Figure 6.18: Global Market Share for Wound Closure Products by Type, 2011 90

Figure 6.19: Global Market for Wound Closure Products by Type, 2011-2015 90

Figure 6.20: Global Market Share of Surgical Adhesives by Company, 2010 92

Figure 6.21: Global Market for Wound Healing Non-Adherent Products, 2011-2018 92

Figure 6.22: U.S. Market for Wound Closure Products, 2011-2018 93

Figure 6.23: Surgical Securement Market in Brazil, 2009 94

Figure 6.24: Number of Active Manufacturers of Wound Closures by Type 95

Figure 7.1: Global Market for Disposable Syringes and Needles, 2011-2018 99

Figure 7.2: Global Market for Pre-Filled Syringes, 2011-2018 102

Figure 7.3: Global Market for Prefilled Pain Management Medicines, 2011-2018 102

Figure 7.4: Worldwide Sales of Enbrel in Pre-Filled Syringes, 2005-2011 103

Figure 7.5: Global Market for Prefilled Psoriasis Drugs, 2011-2018 104

Figure 7.6: Global Market for Pre-Filled Anemia Drugs, 2011-2018 105

Figure 7.7: Global Market for Pre-Filled Insulin, 2011-2018 107

Figure 7.8: Growth of Prefilled Devices and Decline in Vial & Syringe, 1994-2010 108

Figure 7.9: Global Market for Oncology Drugs in Pre-Filled Syringes, 2011-2018 109

Figure 7.10: Global Market for Pre-Filled Drugs for Multiple Sclerosis, 2011-2018 110

Figure 7.11: Global Market for Rheumatoid Arthritis in Pre-Filled Syringes, 2011-2018 111

Figure 7.12: Percent Vaccines in Pre-Filled Syringe, 2011-2018 112

Figure 7.13: Global Market for Auto-Injectors/Auto-Infusors, 2011-2018 113

Figure 8.1: Global Catheter Market, 2011-2018 115

Figure 8.2: Global Market for Catheters by Percent Segmentation in 2014 116

Figure 8.3: Global Market for Cardiovascular Catheters, 2011-2018 117

Figure 8.4: Global Market for Balloon Catheters, 2011-2018 117

Figure 8.5: U.S. Market for Drug-Coated Balloon Catheters in Coronary Applications in 2012 118

Figure 8.6: U.S. Market for Drug Coated Balloon Catheters in Peripheral Applications in 2012 119

Figure 8.7: Market for Peripheral Vascular Devices in BRIC Countries, 2011-2018 119

Figure 8.8: Global Elecrophysiology (EP) Ablation Catheters Market, 2011-2018 120

Figure 8.9: North American Market for Electrophysiology (EP) Catheters, 2011-2018 121

Figure 8.10: European Market for Electrophysiology (EP) Ablation Catheters, 2011-2018 121

Figure 8.11: Asia/Pacific Market for Electrophysiology (EP) Catheters, 2011-2018 122

Figure 8.12: Market Shares of Leading Competitors in Radiofrequency Ablation Devices, 2010 123

Figure 8.13: Global Market for Urological Catheters, 2011-2018 123

Figure 8.14: The Top Five Exporters of Catheters to China by Percentage, 2010 124

Figure 9.1: Global Market for Disposable Infusion Pumps, 2011-2018 125

Figure 9.2: Global Market for Ambulatory Infusion Pumps, 2011-2018 126

Figure 9.3: Global Market for Diabetes Insulin Pumps, 2011-2018 127

Figure 9.4: Global Market for Enteral Feeding Pumps, 2011-2018 129

Figure 10.1: Reasons for Adopting Custom Kits 131

Figure 10.2: Global Market for Procedure Kits and Trays, 2011-2018 132

Figure 10.3: U.S. Market for Procedure Kits and Trays, 2011-2018 133

Figure 10.4: Custom Procedure Trays Market in Europe, 2011-2018 133

Figure 10.5: Percent (%) Revenue for Custom Procedure Trays in Europe by Region, 2011 134

Figure 10.6: Percent (%) Revenue for Custom Procedure Trays in Europe by Product Type, 2011 135

Figure 10.7: Market for Angiography CPT in Europe, 2011 136

Figure 10.8: Ophthalmic CPT Market in Europe, 2011 137

Figure 10.9: European Market for Operating Room CPT, 2011 138

Figure 11.1: Global Market for Rubber Gloves, 2011-2018 143

Figure 11.2: Market Share of Natural Rubber and Nitrile Gloves by Region, 2011 143

Figure 11.3: Increasing Global Demand for Medical Rubber Gloves, 2011-2018 144

Figure 11.4: U.S. Market for Medical Gloves, 2011-2018 145

Figure 11.5: European Medical Gloves Market, 2011-2018 146

Figure 11.6: European Medical Gloves Market Share by Company, 2011 146

Figure 11.7: German Market for Surgical Gloves, 2011-2018 147

Figure 11.8: French Market for Medical Gloves, 2011-2018 148

Figure 11.9: U.K. Market for Medical Gloves, 2011-2018 148

Figure 11.10: Italian Market for Surgical Gloves, 2011-2018 149

Figure 11.11: Spanish Market for Surgical Gloves, 2011-2018 149

Figure 11.12: Global Annual Demand of Medical Rubber Gloves, 2001-2011 150

Figure 11.13: Major Rubber Glove Producing Countries 151

Figure 11.14: Global Market Share of Rubber Glove Manufacturers 151

Figure 11.15: Dominance of Natural Rubber Gloves over Synthetic Nitrile Gloves 152

Figure 11.16: Malaysian Exports of Rubber Gloves by Region 153

Figure 11.17: Powder vs. Powder-Free Rubber Glove Exports from Malaysia by Percent 153

Figure 11.18: Comparison of Top Three Malaysian Vendors by Product Composition, 2011 154

Figure 11.19: Top Five Malaysian Exporters of All Types of Rubber by Ranking 155

Figure 11.20: Top Five Malaysian Exporters of Rubber Gloves by Ranking 155

Figure 11.21: Tilting of the Medical Gloves Market in Favor of Nitrile Gloves 158

Figure 11.22: Adventa’s Geographic Sales Breakdown of Medical Gloves, 2010 159

Figure 11.23: Latexx’s Geographic Sales Breakdown, 2010 159

Figure 11.24: Hartalega’s Geographic Sales Breakdown of Medical Gloves, 2010 160

Figure 11.25: Supermax’s Geographic Sales Breakdown of Medical Gloves, 2010 160

Figure 11.26: Kossan’s Geographic Sales Breakdown for Medical Gloves, 2010 161

Figure 11.27: Top Glove’s Geographic Sales Breakdown of Medical Gloves, 2010 161

Figure 11.28: Adventa’s Product Mix in Medical Gloves, 2010 162

Figure 11.29: Hartalega’s Product Mix in Medical Gloves, 2010 162

Figure 11.30: Kossan’s Product Mix in Medical Gloves, 2010 163

Figure 11.31: Latexx’s Product Mix in Medical Gloves, 2010 163

Figure 11.32: Supermax’s Product Mix in Medical Gloves, 2010 164

Figure 11.33: Top Glove’s Product Mix in Medical Gloves, 2010 164

Figure 12.1: Global Growth Potential for Medical Non-wovens by Geography in 2012 168

Figure 12.2: Growth Potential for Disposable Medical Non-wovens by Region, 2012-2018 168

Figure 12.3: Global Growth Potential for Medical Non-wovens by Product Segment in 2012 169

Figure 12.4: Hospital-Acquired Infection by Type 170

Figure 12.5: Global Medical Non-wovens Market Split by Product Segment 171

Figure 12.6: Percent (%) Penetration of Disposable Non-woven Textiles in Hospital Settings 172

Figure 12.7: Global Medical Non-wovens Market Share by Geography 172

Figure 12.8: Global Market for Medical Non-woven, 2011-2018 173

Figure 12.9: Medical Non-woven Market in North America, 2011-2018 174

Figure 12.10: Global Surgical Drapes Market, 2011-2018 175

Figure 12.11: U.S. Market for Surgical Drapes, 2011-2018 175

Figure 12.12: European Surgical Drapes Market, 2011-2018 176

Figure 12.13: European Surgical Drapes Market Share by Company, 2011 177

Figure 12.14: Surgical Drapes Market in Germany, 2011-2018 177

Figure 12.15: U.K. Market for Surgical Drapes, 2011-2018 178

Figure 12.16: Italian Market for Surgical Drapes, 2011-2018 178

Figure 12.17: Spanish Market for Surgical Drapes, 2011-2018 179

Figure 12.18: Global Surgical and Isolation Gowns Market, 2011-2018 180

Figure 12.19: U.S. Market for Surgical Gowns, 2011-2018 180

Figure 12.20: European Surgical Gowns Market, 2011-2018 181

Figure 12.21: German Market for Surgical Gowns, 2011-2018 181

Figure 12.22: Surgical Gowns Market in France, 2011-2018 182

Figure 12.23: U.K. Market for Surgical Gowns, 2011-2018 182

Figure 12.24: Italian Market for Surgical Gowns, 2011-2018 183

Figure 12.25: Spanish Market for Surgical Gowns, 2011-2018 183

Figure 12.26: European Surgical Gown Market Share by Company, 2011 184

Figure 12.27: Global Market for Staff Apparel, 2011-2018 185

Figure 12.28: Global Market for Surgical Masks, 2011-2018 186

Figure 12.29: Global Market for Surgical Caps, 2011-2018 186

Figure 12.30: Global Market for Surgical Room ShoeCovers, 2011-2018 187

Figure 13.1: Contact Lens Fits and Refit Material Classes, 2010 189

Figure 13.2: Company Market Share in Contact Lenses, 2011 190

Figure 13.3: Global Contact Lens Percent Market by Material, 2011 191

Figure 13.4: Global Market for Contact Lenses, 2011-2018 192

Figure 13.5: Proportion of Rigid Lenses Prescription Shown as New Fits and Refits in Selected Countries 193

Figure 13.6: New Soft Daily Fits with SiH (%) 194

Figure 13.7: Proportion of All Soft Lens Fits for Daily Disposability 195

Figure 13.8: Proportion of Soft Lenses Fitted in Toric Form 196

Figure 13.9: The Most Popular Contact Lens Fits and Refits Modalities, 2009-2010 197

Figure 13.10: Contact Lens Fits and Refits Replacement Shedules, 2010 197

Figure 13.11: Patient Replacement Schedule Compliance, 2009-2010 198

Figure 13.12: Global Soft Contact Lens Sales by Type, 2011-2018 199

Figure 13.13: Global Contact lens Wearables by Type, 2011 199

Figure 13.14: Global Market for Spheres, 2011-2018 200

Figure 13.15: Global Market for Multi-focal, 2011-2018 201

Figure 13.16: Global Market for Toric, 2011-2018 201

Figure 13.17: Contact Lens Market in Americas, 2011-2018 202

Figure 13.18: Contact Lens Wearers in the U.S. and Canada by Type, 2010 203

Figure 13.19: U.S. Market for Contact Lenses, 2011-2018 204

Figure 13.20: Contact Lens Wearing in Americas by Type, 2011 204

Figure 13.21: Contact Lens Market in EMEA Region, 2011-2018 206

Figure 13.22: Contact Lens Wearing in EMEA by Type in EMEA, 2011 206

Figure 13.23: Volume of NHS Sight Tests in U.K., 2010 207

Figure 13.24: NHS vs. Private: Total Number of Sight Tests (20.8 Million) Performed in U.K., 2010 208

Figure 13.25: Number of Sight Tests in U.K., 2004-2010 208

Figure 13.26: Growth in the Number of Contact Lens Wearers in U.K., 1992-2010 211

Figure 13.27: Proportion of Silicone Hydrogels Prescribed for Frequest Replacement in U.K, 1996-2011 212

Figure 13.28: Lens Design Types Prescribed to Presbyopic Lens Wearers, 2003-2011 213

Figure 13.29: Proportion of the Number of Silicone Hydrogel Lens Wearers, 1996-2012 214

Figure 13.30: Optical Market (%) in the U.K. by Segment (%), 2007-2011 214

Figure 13.31: The Growth (%) of SiH Daily Disposables in the U.K., 2007-2011 215

Figure 13.32: Growth (%) of Market for SiH Monthly/Weekly Disposables in the U.K., 2007-2011 216

Figure 13.33: Growth (%) of Silicone Hydrogels by Segment in the U.K., 2007-2011 217

Figure 13.34: Growth (%) of Traditional Hydrogels in the U.K., 2007-2011 218

Figure 13.35: Prescribing Contact Lenses in the U.K., 1996-2010 219

Figure 13.36: Designs of Soft Lenses Prescribed (%) in the U.K., 1996-2010 219

Figure 13.37: Soft Lens Replacement Frequencies Prescribed in the U.K., 10096-2010 220

Figure 13.38: Modalities of Soft Lenses Prescribed in the U.K., 1996-2010 221

Figure 13.39: Contact Lens Market in U.K., 2006-2010 221

Figure 13.40: Silicone Hydrogel vs. Traditional Hydrogel in U.K., 2006-2010 222

Figure 13.41: Contact Lens Market in Asia/Pacific, 2011-2018 223

Figure 13.42: Contact Lens Wearing in Asia/Pacific by Type, 2011 224

Figure 13.43: Market Share of Contact Lens by Type, 2010 224

Figure 13.44: Contact Lens Market by Country and Type in Asia, 2010 225

Figure 14.1: Global Ostomy Care Products Market, 2011-2018 227

Figure 14.2: Percent Market Value of Ostomy Devices by Region, 2010 228

Figure 15.1: Market for Absorbent Incontinence Products by Geography, 2010 229

Figure 15.2: Global Market Share for Incontinence Products by Company, 2010 230

Figure 15.3: Global Incontinence Market by Segment, 2010 230

Figure 15.4: Global Market Share for Male Incontinence Products by Vendor, 2010 231

Figure 15.5: Global Market Share for Enlarged Prostrate Products by Vendor, 2010 231

Figure 15.6: Global Market Share for Pelvic Prolapse by Vendor, 2010 232

Figure 15.7: North American Market for Incontinence Products by Number of Units, 2010-2016 233

Figure 15.8: The U.S. Urology Device Market by Segment 233

Figure 15.9: U.S. Urinary Incontinence Market by Segment 234

Figure 15.10: European Market for Incontinence Products by Number of Unit, 2010-2016 234

Figure 16.1: Global Medical Device and Pharmaceutical Packaging by Type 235

Figure 16.2: Global Medical Device and Pharmacutical Packaging Market, 2011-2018 235

Figure 17.1: Global Market for Diabetes Test Strips, 2011-2018 236

Figure App. 2.1: French Production, Export and Import of Medical Products, 2009-2011 315

Figure App. 2.2: German Production, Exports and Imports of Medical Products, 2009-2011 317

Figure App. 2.3: Turkey’s Production, Exports and Imports of Medical Devices and Supplies, 2009-2012 349

Figure App. 2.4: Chinese Exports and Imports of Medical Devices by Country 351

Figure App. 2.5: Korean Production, Exports and Imports of Medical Devices and Supplies, 2008-2010 358

Figure App. 3.1: 510 (k) Approvals and PMA Approvals, 1999-2009 361

Figure App. 3.2: 510 (k) and CE Mark Regulatory Timelines 364

Figure App. 3.3: PMA and CE Mark Regulatory Timeline 365

Figure App. 3.4: Ratings of FDA and E.U. Regulatory Performance 366

Figure App. 3.5: FDA vs. CE Reasonableness 366

Figure App. 3.6: FDA and CE Transparency 367

Figure App. 3.7: Average Time by Stage for 510 (k) Product 368

Figure App. 3.8: Average per Month Expenditure by Stage for 510 (k) Product 368

Figure App. 3.9: Average per Month Expenditure by Stage for PMA Product 369

Figure App. 3.10: Average Time by Stage for PMA Product 369

Figure App. 3.11: Average Total Expenditure by Stage for PMA Product 370

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