INTRAVENOUS (IV) THERAPY AND VEIN ACCESS: GLOBAL MARKETS HLC046C November 2014 Mary C. Patton Project Analyst ISBN: 1-56965-982-6 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215 (toll-free within the USA), or (+1) 781-489-7301 www.bccresearch.com information@bccresearch.com
TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY OBJECTIVES 2 REASONS FOR DOING THIS STUDY 2 INTENDED AUDIENCE 2 SCOPE OF THE STUDY 3 METHODOLOGY 3 INFORMATION SOURCES 3 ANALYST'S CREDENTIALS 3 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH WEBSITE 4 DISCLAIMER 4 CHAPTER 2 SUMMARY OF IV THERAPY MARKET ESTIMATES 6 SUMMARY TABLE GLOBAL MARKET FORECAST FOR IV THERAPY AND VEIN ACCESS PRODUCTS, SUMMARY FIGURE GLOBAL MARKET FORECAST FOR IV THERAPY AND VEIN ACCESS PRODUCTS, 2013-2019 ($ MILLIONS) 6 7 CHAPTER 3 INTRAVENOUS THERAPY OVERVIEW 9 BACKGROUND ON THE HUMAN CIRCULATORY SYSTEM 9 DEFINITION OF INFUSION THERAPY 9 HISTORICAL DEVELOPMENT OF TRANSFUSION THERAPY 10 HISTORICAL DEVELOPMENT OF INTRAVENOUS INFUSION THERAPY 10 TABLE 1 GLOBAL MARKET FORECAST FOR INTRAVENOUS INFUSION PUMPS, GENERAL PRINCIPLES OF IV THERAPY 13 USE OF INTRAVENOUS INFUSION PUMPS 15 POSSIBLE MECHANICAL ISSUES WITH INFUSION PUMPS 17 12 CHAPTER 4 GLOBAL MARKETS FOR GENERAL IV SOLUTIONS AND ADMINISTRATION SETS BACKGROUND ON IV SOLUTION CONTAINER SYSTEMS 20 TABLE 2 GLOBAL MARKET FORECAST FOR INTRAVENOUS SOLUTIONS AND ADMINISTRATION SETS, TABLE 3 ESTIMATED PERCENTAGE OF IV CONTAINERS MANUFACTURED BY CONTAINER TYPE, U.S. ONLY, 2009 TO 2019 SMALL VOLUME PARENTERAL SOLUTION CONTAINERS 22 COMMON TYPES OF GENERAL IV SOLUTIONS 22 TABLE 4 COMMON EXAMPLES OF GENERAL OF IV SOLUTIONS 23 Leading Brands of General IV Solution Products 24 TABLE 5 BAXTER GENERAL IV SOLUTION PRODUCTS 25 TABLE 6 B. BRAUN GENERAL IV SOLUTION PRODUCTS 26 GLOBAL MARKET FOR GENERAL IV SOLUTIONS AND SETS 27 TABLE 7 GLOBAL MARKET FOR GENERAL IV SOLUTIONS AND SETS BY REGION, TABLE 8 GLOBAL MARKET FOR GENERAL IV SOLUTIONS AND SETS BY MANUFACTURER, 2013 20 20 21 27 28
CHAPTER 5 GLOBAL MARKETS FOR PRE-MIXED AND SPECIALTY IV SOLUTIONS 30 DEFINITION OF PRE-MIXED AND SPECIALTY IV SOLUTIONS 30 BENEFITS OF PRE-MIXED SPECIALTY IV SOLUTIONS 30 PRE-MIXED DRUG IV SOLUTIONS AND CONTAINER SYSTEMS 31 TABLE 9 BAXTER PRE-MIXED LIQUID IV SOLUTIONS 31 GLOBAL MARKET FOR PRE-MIXED DRUG IV SOLUTIONS 33 TABLE 10 GLOBAL MARKET FOR PRE-MIXED DRUG IV SOLUTION PRODUCTS BY REGION, TABLE 11 GLOBAL REVENUE OF PRE-MIXED DRUG IV SOLUTIONS BY MANUFACTURER, 2013 FIGURE 1 GLOBAL REVENUE OF PRE-MIXED DRUG IV SOLUTIONS BY MANUFACTURER, 2013 PARENTERAL NUTRITION SOLUTIONS AND CONTAINER SYSTEMS 35 LEADING BRANDS OF PARENTERAL NUTRITION SOLUTIONS 36 TABLE 12 HOSPIRA PARENTERAL NUTRITION SOLUTION PRODUCTS 38 GLOBAL MARKET FOR PARENTERAL NUTRITION SOLUTIONS 39 TABLE 13 GLOBAL MARKET FOR PARENTERAL NUTRITION SOLUTIONS BY REGION, TABLE 14 GLOBAL MARKET FOR PARENTERAL NUTRITION SOLUTIONS BY MANUFACTURER, 2013 FIGURE 2 GLOBAL MARKET FOR PARENTERAL NUTRITION SOLUTIONS BY MANUFACTURER, 2013 39 40 40 CHAPTER 6 GLOBAL MARKETS FOR GENERAL IV INFUSION PUMPS AND RELATED PRODUCTS OVERVIEW OF GENERAL IV INFUSION PUMPS 42 TABLE 15 ADVANTAGES AND DISADVANTAGES OF INFUSION DEVICES 43 TYPES OF GENERAL IV INFUSION PUMPS 43 LARGE VOLUME INFUSION PUMPS 43 LEADING BRANDS OF LARGE VOLUME INFUSION PUMPS 44 TABLE 16 SELECTED LARGE VOLUME IV PUMPS AND MANUFACTURERS 44 GLOBAL MARKET: LARGE VOLUME INFUSION PUMPS 47 TABLE 17 GLOBAL MARKET FORECAST FOR LARGE VOLUME INFUSION PUMPS BY CARE SETTING, TABLE 18 GLOBAL MARKET FORECAST FOR LARGE VOLUME INFUSION PUMPS BY REGION, TABLE 19 MANUFACTURERS' MARKET SHARE OF LARGE-VOLUME INFUSION PUMPS, 2013 FIGURE 3 MANUFACTURERS' MARKET SHARE OF LARGE-VOLUME INFUSION PUMPS, 2013 SYRINGE INFUSION PUMPS 49 LEADING BRANDS OF SYRINGE INFUSION PUMPS 50 TABLE 20 SYRINGE INFUSION PUMPS AND MANUFACTURERS 50 GLOBAL MARKET: SYRINGE INFUSION PUMPS 51 TABLE 21 GLOBAL MARKET FORECAST FOR SYRINGE INFUSION PUMPS BY CARE SETTING, TABLE 22 GLOBAL MARKET FORECAST FOR SYRINGE INFUSION PUMPS BY REGION, 42 48 48 49 49 52 52
TABLE 23 MANUFACTURERS' MARKET SHARE OF SYRINGE INFUSION PUMPS, 2013 FIGURE 4 MANUFACTURERS' MARKET SHARE OF SYRINGE INFUSION PUMPS, 2013 53 53 CHAPTER 7 GLOBAL MARKETS FOR SPECIALTY IV INFUSION PUMPS AND RELATED PRODUCTS OVERVIEW OF SPECIALTY INFUSION PUMPS 55 PCA INFUSION PUMPS 55 LEADING BRANDS OF PCA INFUSION PUMPS 56 TABLE 24 PCA INFUSION PUMPS AND MANUFACTURERS 56 GLOBAL MARKET: PCA INFUSION PUMPS 57 TABLE 25 GLOBAL MARKET FORECAST FOR PCA INFUSION PUMPS BY CARE SETTING, TABLE 26 GLOBAL REVENUE FOR PCA INFUSION PUMPS BY REGION, THROUGH 2019 ($ MILLIONS) TABLE 27 MANUFACTURERS' MARKET SHARE OF PCA INFUSION PUMPS, 2013 58 FIGURE 5 MANUFACTURERS' MARKET SHARE OF PCA INFUSION PUMPS, 2013 59 INSULIN INFUSION PUMPS 59 LEADING BRANDS OF INSULIN INFUSION PUMPS 60 TABLE 28 INSULIN INFUSION PUMPS AND MANUFACTURERS 60 GLOBAL MARKET: INSULIN INFUSION PUMPS 62 TABLE 29 GLOBAL MARKET FORECAST FOR INSULIN INFUSION PUMPS BY CARE SETTING, TABLE 30 GLOBAL MARKET FORECAST FOR INSULIN INFUSION PUMPS BY CARE SETTING, TABLE 31 MANUFACTURERS' MARKET SHARE OF INSULIN INFUSION PUMPS, 2013 FIGURE 6 MANUFACTURERS' MARKET SHARE OF INSULIN INFUSION PUMPS, 2013 ENTERAL FEEDING PUMPS 64 LEADING BRANDS OF ENTERAL INFUSION PUMPS 65 TABLE 32 ENTERAL FEEDING PUMP PRODUCTS AND MANUFACTURERS 65 GLOBAL MARKET: ENTERAL FEEDING PUMPS 66 TABLE 33 GLOBAL MARKET FORECAST FOR ENTERAL FEEDING PUMPS BY CARE SETTING, TABLE GLOBAL MARKET FORECAST FOR ENTERAL FEEDING PUMPS BY REGION, TABLE 35 MANUFACTURERS' MARKET SHARE OF ENTERAL FEEDING PUMPS, 2013 FIGURE 7 MANUFACTURERS' MARKET SHARE OF ENTERAL FEEDING PUMPS, 2013 AMBULATORY AND DISPOSABLE INFUSION PUMPS 68 LEADING BRANDS OF AMBULATORY AND DISPOSABLE INFUSION PUMPS 68 TABLE 36 AMBULATORY AND DISPOSABLE INFUSION PUMP PRODUCTS AND MANUFACTURERS GLOBAL MARKET: AMBULATORY AND DISPOSABLE PUMPS 69 TABLE 37 GLOBAL MARKET FORECAST FOR AMBULATORY AND DISPOSABLE PUMPS BY REGION, 55 57 58 62 63 63 63 66 67 67 68 69
TABLE 38 MANUFACTURERS' MARKET SHARE OF AMBULATORY AND DISPOSABLE PUMPS, 2013 FIGURE 8 MANUFACTURERS' MARKET SHARE OF AMBULATORY AND DISPOSABLE PUMPS, 2013 IMPLANTABLE INFUSION PUMPS 71 LEADING BRANDS OF IMPLANTABLE INFUSION PUMPS 72 TABLE 39 IMPLANTABLE INFUSION PUMPS AND MANUFACTURERS 72 GLOBAL MARKET: IMPLANTABLE INFUSION PUMPS 73 TABLE 40 GLOBAL REVENUE OF IMPLANTABLE INFUSION PUMPS AND RELATED DEVICES BY REGION, 73 CHAPTER 8 GLOBAL MARKETS FOR PERIPHERAL VENOUS ACCESS DEVICES 75 OVERVIEW 75 TABLE 41 GLOBAL MARKET FORECAST FOR VEIN ACCESS DEVICES, THROUGH 2019 ($ MILLIONS) LEADING BRANDS OF PERIPHERAL IV ACCESS CATHETERS 76 TABLE 42 PERIPHERAL IV ACCESS CATHETERS AND MANUFACTURERS 76 GLOBAL MARKET: PERIPHERAL IV ACCESS CATHETERS 78 TABLE 43 GLOBAL MARKET FORECAST FOR PERIPHERAL IV CATHETERS BY CARE SETTING, TABLE 44 GLOBAL MARKET FORECAST FOR PERIPHERAL IV CATHETERS BY REGION, TABLE 45 MANUFACTURERS' MARKET SHARE OF PERIPHERAL IV CATHETERS, 2013 FIGURE 9 MANUFACTURERS' MARKET SHARE OF PERIPHERAL IV CATHETERS, 2013 75 78 CHAPTER 9 GLOBAL MARKETS FOR CENTRAL VENOUS ACCESS CATHETERS 82 BACKGROUND ON CENTRAL VENOUS ACCESS CATHETERS 82 COMPLICATION RISKS OF CENTRAL VENOUS ACCESS CATHETERS 83 LEADING BRANDS OF CENTRAL VENOUS ACCESS CATHETERS 84 TABLE 46 CENTRAL VENOUS ACCESS CATHETERS AND MANUFACTURERS 85 GLOBAL MARKET: CENTRAL VENOUS ACCESS CATHETERS 88 TABLE 47 GLOBAL MARKET FORECAST FOR CENTRAL VENOUS ACCESS CATHETERS BY CARE SETTING, TABLE 48 GLOBAL MARKET FORECAST FOR CENTRAL VENOUS ACCESS CATHETERS BY REGION, TABLE 49 MANUFACTURERS' MARKET SHARE OF CENTRAL VENOUS CATHETERS, 2013 FIGURE 10 MANUFACTURERS' MARKET SHARE OF CENTRAL VENOUS CATHETERS, 2013 88 88 89 89 CHAPTER 10 REGULATION OF IV THERAPY SOLUTIONS AND DEVICES 91 INTRODUCTION 91 OVERVIEW OF THE U.S. HEALTHCARE SYSTEM 91 REGULATION OF HEALTHCARE PRODUCTS IN THE U.S. 92 FDA IV SOLUTION RECALLS AND SAFETY ALERTS 92 TABLE 50 FDA RECALLS OF IV SOLUTION PRODUCTS, 2011 TO SEPTEMBER 2014 92 FDA MEDICAL DEVICE RECALLS AND SAFETY ALERTS 93 TABLE 51 FDA RECALLS OF IV THERAPY MEDICAL DEVICES, 2012 TO JUNE 2014 93
EUROPEAN HEALTHCARE SYSTEM AND MEDICAL PRODUCTS REGULATION 97 MEDICAL PRODUCTS REGULATION IN THE ASIA-PACIFIC REGION 98 JAPAN S HEALTHCARE SYSTEM AND MEDICAL PRODUCTS REGULATION 98 INDIA'S HEALTHCARE SYSTEM AND MEDICAL PRODUCTS REGULATION 100 CHINA'S HEALTHCARE SYSTEM AND MEDICAL PRODUCTS REGULATION 101 CHAPTER 11 RECENTLY AWARDED PATENTS 105 TABLE 52 INTRAVENOUS SOLUTION-RELATED U.S. PATENTS 105 CHAPTER 12 THE FUTURE OF IV THERAPY 108 CHAPTER 13 INTRAVENOUS THERAPY COMPANY PROFILES 112 ANGEL ELECTRONIC EQUIPMENT CO. LTD. 112 ANGIODYNAMICS INC. 112 ANIMAS CORP. 113 ASANTE SOLUTIONS INC. 114 B. BRAUN MELSUNGEN AG 114 BARD ACCESS SYSTEMS INC. 115 BAXTER INTERNATIONAL INC. 117 BECTON, DICKINSON AND COMPANY 118 CAESAREA MEDICAL ELECTRONICS LTD. 119 CAREFUSION 119 CEQUR SA 120 CODMAN & SHURTLEFF INC. 121 COOK MEDICAL INC. 121 COVIDIEN PLC 122 DEBIOTECH 122 EDWARDS LIFESCIENCES CORP. 122 EXCELSIOR MEDICAL CORP. 123 FRESENIUS KABI AG 123 HOSPIRA INC. 124 ICU MEDICAL INC. 126 I-FLOW CORP. 126 INSULET CORP. 127 IRADIMED CORP. 127 MEDICAL COMPONENTS INC. (MEDCOMP) 127 MEDTRONIC CORP. 128 MICREL MEDICAL DEVICES SA 129 MOOG INC. 129 OTSUKA PHARMACEUTICAL CO. LTD. 130 ROCHE DIAGNOSTICS 130 SMITHS MEDICAL 131 SOOIL DEVELOPMENT LLC 132 TANDEM DIABETES CARE INC. 132 TELEFLEX INC. 133 TERUMO MEDICAL CORP. 1 VALERITAS INC. 1
VYGON SA 135 ZYNO MEDICAL LLC 135
LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FORECAST FOR IV THERAPY AND VEIN ACCESS PRODUCTS, TABLE 1 GLOBAL MARKET FORECAST FOR INTRAVENOUS INFUSION PUMPS, TABLE 2 GLOBAL MARKET FORECAST FOR INTRAVENOUS SOLUTIONS AND ADMINISTRATION SETS, TABLE 3 ESTIMATED PERCENTAGE OF IV CONTAINERS MANUFACTURED BY CONTAINER TYPE, U.S. ONLY, 2009 TO 2019 TABLE 4 COMMON EXAMPLES OF GENERAL OF IV SOLUTIONS 23 TABLE 5 BAXTER GENERAL IV SOLUTION PRODUCTS 25 TABLE 6 B. BRAUN GENERAL IV SOLUTION PRODUCTS 26 TABLE 7 GLOBAL MARKET FOR GENERAL IV SOLUTIONS AND SETS BY REGION, TABLE 8 GLOBAL MARKET FOR GENERAL IV SOLUTIONS AND SETS BY MANUFACTURER, 2013 TABLE 9 BAXTER PRE-MIXED LIQUID IV SOLUTIONS 31 TABLE 10 GLOBAL MARKET FOR PRE-MIXED DRUG IV SOLUTION PRODUCTS BY REGION, TABLE 11 GLOBAL REVENUE OF PRE-MIXED DRUG IV SOLUTIONS BY MANUFACTURER, 2013 TABLE 12 HOSPIRA PARENTERAL NUTRITION SOLUTION PRODUCTS 38 TABLE 13 GLOBAL MARKET FOR PARENTERAL NUTRITION SOLUTIONS BY REGION, TABLE 14 GLOBAL MARKET FOR PARENTERAL NUTRITION SOLUTIONS BY MANUFACTURER, 2013 TABLE 15 ADVANTAGES AND DISADVANTAGES OF INFUSION DEVICES 43 TABLE 16 SELECTED LARGE VOLUME IV PUMPS AND MANUFACTURERS 44 TABLE 17 GLOBAL MARKET FORECAST FOR LARGE VOLUME INFUSION PUMPS BY CARE SETTING, TABLE 18 GLOBAL MARKET FORECAST FOR LARGE VOLUME INFUSION PUMPS BY REGION, TABLE 19 MANUFACTURERS' MARKET SHARE OF LARGE-VOLUME INFUSION PUMPS, 2013 TABLE 20 SYRINGE INFUSION PUMPS AND MANUFACTURERS 50 TABLE 21 GLOBAL MARKET FORECAST FOR SYRINGE INFUSION PUMPS BY CARE SETTING, TABLE 22 GLOBAL MARKET FORECAST FOR SYRINGE INFUSION PUMPS BY REGION, TABLE 23 MANUFACTURERS' MARKET SHARE OF SYRINGE INFUSION PUMPS, 2013 TABLE 24 PCA INFUSION PUMPS AND MANUFACTURERS 56 TABLE 25 GLOBAL MARKET FORECAST FOR PCA INFUSION PUMPS BY CARE SETTING, TABLE 26 GLOBAL REVENUE FOR PCA INFUSION PUMPS BY REGION, THROUGH 2019 ($ MILLIONS) TABLE 27 MANUFACTURERS' MARKET SHARE OF PCA INFUSION PUMPS, 2013 58 TABLE 28 INSULIN INFUSION PUMPS AND MANUFACTURERS 60 TABLE 29 GLOBAL MARKET FORECAST FOR INSULIN INFUSION PUMPS BY CARE SETTING, 6 12 20 21 27 28 39 40 48 48 49 52 52 53 57 58 62
TABLE HEADING TABLE 30 GLOBAL MARKET FORECAST FOR INSULIN INFUSION PUMPS BY CARE SETTING, TABLE 31 MANUFACTURERS' MARKET SHARE OF INSULIN INFUSION PUMPS, 2013 63 TABLE 32 ENTERAL FEEDING PUMP PRODUCTS AND MANUFACTURERS 65 TABLE 33 GLOBAL MARKET FORECAST FOR ENTERAL FEEDING PUMPS BY CARE SETTING, TABLE GLOBAL MARKET FORECAST FOR ENTERAL FEEDING PUMPS BY REGION, TABLE 35 MANUFACTURERS' MARKET SHARE OF ENTERAL FEEDING PUMPS, 2013 67 TABLE 36 AMBULATORY AND DISPOSABLE INFUSION PUMP PRODUCTS AND MANUFACTURERS TABLE 37 GLOBAL MARKET FORECAST FOR AMBULATORY AND DISPOSABLE PUMPS BY REGION, TABLE 38 MANUFACTURERS' MARKET SHARE OF AMBULATORY AND DISPOSABLE PUMPS, 2013 TABLE 39 IMPLANTABLE INFUSION PUMPS AND MANUFACTURERS 72 TABLE 40 GLOBAL REVENUE OF IMPLANTABLE INFUSION PUMPS AND RELATED DEVICES BY REGION, TABLE 41 GLOBAL MARKET FORECAST FOR VEIN ACCESS DEVICES, THROUGH 2019 ($ MILLIONS) TABLE 42 PERIPHERAL IV ACCESS CATHETERS AND MANUFACTURERS 76 TABLE 43 GLOBAL MARKET FORECAST FOR PERIPHERAL IV CATHETERS BY CARE SETTING, TABLE 44 GLOBAL MARKET FORECAST FOR PERIPHERAL IV CATHETERS BY REGION, TABLE 45 MANUFACTURERS' MARKET SHARE OF PERIPHERAL IV CATHETERS, 2013 TABLE 46 CENTRAL VENOUS ACCESS CATHETERS AND MANUFACTURERS 85 TABLE 47 GLOBAL MARKET FORECAST FOR CENTRAL VENOUS ACCESS CATHETERS BY CARE SETTING, TABLE 48 GLOBAL MARKET FORECAST FOR CENTRAL VENOUS ACCESS CATHETERS BY REGION, TABLE 49 MANUFACTURERS' MARKET SHARE OF CENTRAL VENOUS CATHETERS, 2013 TABLE 50 FDA RECALLS OF IV SOLUTION PRODUCTS, 2011 TO SEPTEMBER 2014 92 TABLE 51 FDA RECALLS OF IV THERAPY MEDICAL DEVICES, 2012 TO JUNE 2014 93 TABLE 52 INTRAVENOUS SOLUTION-RELATED U.S. PATENTS 105 63 66 67 69 73 75 78 88 88 89
LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FORECAST FOR IV THERAPY AND VEIN ACCESS PRODUCTS, 2013-2019 ($ MILLIONS) FIGURE 1 GLOBAL REVENUE OF PRE-MIXED DRUG IV SOLUTIONS BY MANUFACTURER, 2013 FIGURE 2 GLOBAL MARKET FOR PARENTERAL NUTRITION SOLUTIONS BY MANUFACTURER, 2013 FIGURE 3 MANUFACTURERS' MARKET SHARE OF LARGE-VOLUME INFUSION PUMPS, 2013 FIGURE 4 MANUFACTURERS' MARKET SHARE OF SYRINGE INFUSION PUMPS, 2013 FIGURE 5 MANUFACTURERS' MARKET SHARE OF PCA INFUSION PUMPS, 2013 59 FIGURE 6 MANUFACTURERS' MARKET SHARE OF INSULIN INFUSION PUMPS, 2013 63 FIGURE 7 MANUFACTURERS' MARKET SHARE OF ENTERAL FEEDING PUMPS, 2013 68 FIGURE 8 MANUFACTURERS' MARKET SHARE OF AMBULATORY AND DISPOSABLE PUMPS, 2013 FIGURE 9 MANUFACTURERS' MARKET SHARE OF PERIPHERAL IV CATHETERS, 2013 FIGURE 10 MANUFACTURERS' MARKET SHARE OF CENTRAL VENOUS CATHETERS, 2013 7 40 49 53 89