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1、,MARKET RESEARCH REPORT,INFUSION DEVICES:TECHNOLOGIES,AND GLOBAL MARKETS,HLC071A,Thomas FullerProject Analyst,BCC Research,35 Walnut Street,Wellesley,MA 02481,Phone:866-285-7215(sales),Web Address:,E-mail:,ISBN:1-59623-565-9,ii,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTEN
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10、CC Research Wellesley,MA 02481,Reproduction of any material in this report is strictly forbidden without express permission of thePublisher.,To receive a complete catalog of BCC studies,please visit our Web site at,FEBRUARY 2010,Copyright BCC Research,Wellesley,MA USA,Web:,iii,HLC071A Infusion Devic
11、es:Technologies and Global Markets,TABLE OF CONTENTS,CHAPTER ONE:INTRODUCTION.1STUDY GOALS AND OBJECTIVES.1REASONS FOR DOING THE STUDY.1SCOPE OF REPORT.2INTENDED AUDIENCE.2INFORMATION SOURCES.2ANALYST CREDENTIALS.3RELATED BCC REPORTS.3BCC ONLINE SERVICES.3DISCLAIMER.3CHAPTER TWO:SUMMARY.4SUMMARY.4SU
12、MMARY(CONTINUED).5SUMMARY TABLE GLOBAL INFUSION PUMP EXPENDITURES BYGEOGRAPHIC REGION,THROUGH 2014($MILLIONS).6,SUMMARY FIGURE GLOBAL INFUSION PUMP SPENDING BY,GEOGRAPHIC REGION,2008-2014($MILLIONS).6CHAPTER THREE:OVERVIEW.7INDUSTRY DEFINITION.7INFUSION PUMPS.7,Importance of Infusion Pumps.7,General
13、.7Drug-delivery Systems.8,Drug-(Continued).9Product and Technology Life Cycle.10HISTORY OF INFUSION.10HISTORY OF INFUSION(CONTINUED).11INDUSTRY DEVELOPMENT.12FORECAST.13CURRENT ACTIVITY.14CURRENT STATE OF INFUSION DEVICES AND,THERAPIES.14DEMAND AND COST.15DEMOGRAPHIC FACTORS.16,Demographic Factors(C
14、ontinued).172009 IN REVIEW.18INDUSTRY DEVELOPMENTS.18CAREFUSION/ALARIS.18SMITHS MEDICAL.19,Copyright BCC Research,Wellesley,MA USA,Web:,iv,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,BAXTER,COLLEAGUE,SIGMA,AND SPECTRUM.19KIMBERLY CLARK AND I-FLOW.19MEDINGO.19MOOG ROLL-
15、UP STRATEGY.19YEAR(S)OF THE RECALL.20DEVELOPMENTS OUTSIDE THE INDUSTRY.20PORTABLE DIALYSIS MACHINE.20ISLET CELL INJECTION.20U.S.HEALTHCARE REFORM.21MEDICAL DEVICE MANUFACTURERS TAX.22HOME INFUSION THERAPY.22MEDICAL DEVICES REGISTRY.22SUNSHINE PROVISION.23COMPARATIVE EFFECTIVENESS RESEARCH.23CHAPTER
16、FOUR:MAJOR COMPANIES AND MARKET SHARE.24MAJOR COMPANIES AND MARKET SHARE.24TABLE 1 GLOBAL MEDICAL INFUSION PUMP EXPENDITURES BYTYPE OF PUMP,THROUGH 2014($MILLIONS).25FIGURE 1 GLOBAL MEDICAL INFUSION PUMP EXPENDITURES,2008-2014($MILLIONS).26MAJOR MARKETS.27,FIGURE 2 HEALTHCARE EXPENDITURES AS PERCENT
17、AGE OF,GDP(%).28U.S.29JAPAN.29CANADA.30AUSTRALIA.31CHAPTER FIVE:MARKETS BY PRODUCT.32MARKETS BY PRODUCT.32ELASTOMERIC AND MECHANICAL INFUSION PUMPS.33ELASTOMERIC PUMPS.33PERISTALTIC PUMPS.34CASSETTE PUMPS.35TABLE 2 GLOBAL MANUFACTURERS OF ELASTOMERIC AND,MECHANICAL INFUSION PUMPS MARKET SHARE,2008(%
18、).35,FIGURE 3 GLOBAL MANUFACTURERS OF ELASTOMERIC ANDMECHANICAL INFUSION PUMPS GLOBAL MARKET SHARE,2008(%).36,Copyright BCC Research,Wellesley,MA USA,Web:,v,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,TABLE 3 GLOBAL MEDICAL ELASTOMERIC AND MECHANICALINFUSION PUMP EXPEN
19、DITURES BY GEOGRAPHIC REGION,THROUGH 2014($MILLIONS).36,TABLE 4 U.S.MEDICAL ELASTOMERIC AND MECHANICALINFUSION PUMP MARKET BY SECTOR,THROUGH 2014($,MILLIONS).37,SYRINGE PUMPS.37TABLE 5 GLOBAL SYRINGE INFUSION PUMP MANUFACTURERSMARKET SHARE BASED ON DOLLAR SALES,2008(%).38FIGURE 4 GLOBAL SYRINGE INFU
20、SION PUMP MANUFACTURERSMARKET SHARE BASED ON DOLLAR SALES,2008(%).38,TABLE 6 GLOBAL MEDICAL SYRINGE INFUSION PUMP,EXPENDITURES BY GEOGRAPHIC REGION,THROUGH 2014($,MILLIONS).39,TABLE 7 U.S.MEDICAL SYRINGE INFUSION PUMP,EXPENDITURES BY MARKET SECTOR,THROUGH 2014($,MILLIONS).39,ELECTRONIC SYRINGE INFUS
21、ION PUMPS.40TABLE 8 GLOBAL ELECTRONIC SYRINGE INFUSION PUMPMANUFACTURERS MARKET SHARE BASED ON DOLLAR SALES,2008(%).41,FIGURE 5 GLOBAL ELECTRONIC SYRINGE INFUSION PUMPMANUFACTURERS MARKET SHARE BASED ON DOLLAR SALES,2008(%).42,TABLE 9 GLOBAL ELECTRONIC SYRINGE INFUSION PUMPEXPENDITURES BY GEOGRAPHIC
22、 REGION,THROUGH 2014($,MILLIONS).42TABLE 10 GLOBAL ELECTRONIC SYRINGE PUMP EXPENDITURESBY GEOGRAPHIC REGION,THROUGH 2014($MILLIONS).43,TABLE 11 U.S.ELECTRONIC SYRINGE INFUSION PUMPEXPENDITURES BY MARKET SECTOR,THROUGH 2014($,MILLIONS).43,IIPS.44,IIPs(Continued).45,TABLE 12 GLOBAL IMPLANTABLE INFUSIO
23、N PUMP,MANUFACTURERS MARKET SHARE BASED ON DOLLAR SALES,2008(%).46,FIGURE 6 GLOBAL IMPLANTABLE INFUSION PUMP,MANUFACTURERS MARKET SHARE BASED ON DOLLAR SALES,2008(%).46,Copyright BCC Research,Wellesley,MA USA,Web:,vi,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,TABLE 13
24、 U.S.IMPLANTABLE INFUSION PUMP EXPENDITURESBY MARKET SECTOR,THROUGH 2014($MILLIONS).47,TABLE 14 GLOBAL MEDICAL IMPLANTABLE INFUSION PUMPEXPENDITURES BY GEOGRAPHIC REGION,THROUGH 2014($,MILLIONS).47CHAPTER SIX:TYPES OF APPLICATIONS.48VOLUMETRIC INFUSION PUMPS.48,TABLE 15 GLOBAL VOLUMETRIC INFUSION PU
25、MP,MANUFACTURERS MARKET SHARE BASED ON DOLLAR SALES,2008(%).48,FIGURE 7 GLOBAL VOLUMETRIC INFUSION PUMP,MANUFACTURERS MARKET SHARE BASED ON DOLLAR SALES,2008(%).49,TABLE 16 GLOBAL VOLUMETRIC INFUSION PUMP,EXPENDITURES BY GEOGRAPHIC REGION,THROUGH 2014($,MILLIONS).50TABLE 17 U.S.VOLUMETRIC INFUSION P
26、UMP EXPENDITURES BYMARKET SECTOR,THROUGH 2014($MILLIONS).50SMART PUMPS.51,TABLE 18 GLOBAL SMART PUMP MANUFACTURERS MARKET,SHARE BASED ON DOLLAR SALES,2008(%).51FIGURE 8 GLOBAL SMART INFUSION PUMP MANUFACTURERSMARKET SHARE BASED ON DOLLAR SALES,2008(%).52TABLE 19 GLOBAL SMART INFUSION PUMP EXPENDITUR
27、ES BYGEOGRAPHIC REGION,THROUGH 2014($MILLIONS).52,TABLE 20 U.S.SMART INFUSION PUMP EXPENDITURES BY,MARKET SECTOR,THROUGH 2014($MILLIONS).53,SMART PUMPS(CONTINUED).54AMBULATORY INFUSION PUMPS.55,TABLE 21 GLOBAL AMBULATORY INFUSION PUMP,MANUFACTURERS MARKET SHARE BASED ON DOLLAR SALES,2008(%).56,FIGUR
28、E 9 GLOBAL AMBULATORY INFUSION PUMP,MANUFACTURERS MARKET SHARE BASED ON DOLLAR SALES,2008(%).57,TABLE 22 GLOBAL AMBULATORY INFUSION PUMP,EXPENDITURES BY GEOGRAPHIC REGION,THROUGH 2014($,MILLIONS).57TABLE 23 U.S.AMBULATORY INFUSION PUMP EXPENDITURES BYMARKET SECTOR,THROUGH 2014($MILLIONS).58,Copyrigh
29、t BCC Research,Wellesley,MA USA,Web:,vii,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,INSULIN PUMPS.58INSULIN PUMPS(CONTINUED).59TABLE 24 GLOBAL INSULIN PUMP MANUFACTURERS MARKETSHARE BASED ON DOLLAR SALES,2008(%).60FIGURE 10 GLOBAL INSULIN PUMP MANUFACTURERS MARKETSHAR
30、E BASED ON DOLLAR SALES,2008(%).61TABLE 25 GLOBAL INSULIN INFUSION PUMP EXPENDITURES BYGEOGRAPHIC REGION,THROUGH 2014($MILLIONS).61,TABLE 26 U.S.INSULIN INFUSION PUMP EXPENDITURES BY,MARKET SECTOR,THROUGH 2014($MILLIONS).62CHAPTER SEVEN:CONDITIONS.63PAIN MANAGEMENT.64PAIN MANAGEMENT(CONTINUED).65MED
31、ICATION.66DIABETES.67ENTERAL NUTRITION.67PN68,ANTIBIOTICS.69,CHAPTER EIGHT:COMPETING AND COMPLEMENTARY,TECHNOLOGIES.70NEEDLELESS INJECTORS.70TABLE 27 GLOBAL NEEDLELESS INJECTOR MANUFACTURERSMARKET SHARE BASED ON DOLLAR SALES,2008(%).70TABLE 27(CONTINUED).71,NEEDLELESS INJECTORS(CONTINUED).72INJECTIO
32、N PENS.73MINIBAGS.73GLUCOSE MONITORING.74SELF-MONITORING OF BLOOD GLUCOSE.74CGMS.75TRADITIONAL INSULIN DELIVERY.75DISRUPTIVE TECHNOLOGY CHALLENGES.75TRANSDERMAL DRUG DELIVERY.76TRANSDERMAL DRUG DELIVERY(CONTINUED).77TRANSDERMAL DRUG DELIVERY(CONTINUED).78TRANSDERMAL DRUG DELIVERY(CONTINUED).78TRANSD
33、ERMAL DRUG DELIVERY(CONTINUED).79TRANSDERMAL PATCH PUMPS.80INHALED MEDICATIONS AND DEVICES.80,Copyright BCC Research,Wellesley,MA USA,Web:,viii,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,Inhaled Medications(Continued).81TABLE 28 PROGRESS TOWARD NEEDLEFREE VACCINE DELI
34、VERY.82TABLE 28(CONTINUED).83TABLE 28(CONTINUED).84TABLE 28(CONTINUED).85TABLE 28(CONTINUED).86TABLE 28(CONTINUED).87NANOTECHNOLOGY.87NANOTECHNOLOGY(CONTINUED.88BIOTECHNOLOGY.89BIOTECHNOLOGY(CONTINUED).90CHAPTER NINE:GOVERNMENT REGULATIONS.91U.S.FDA.91FDA PRE-MARKET REVIEW.92FDA PRE-MARKET REVIEW PR
35、OCESS UNDER SCRUTINY.93FDA REPORTING AND VIGILANCE.93FDA RECALLS.94TABLE 29 KEY FDA PRODUCT RECALLS:INFUSION PUMPS,20072009.95TABLE 29(CONTINUED).96TABLE 29(CONTINUED).97TABLE 29(CONTINUED).98TABLE 29(CONTINUED).99TABLE 29(CONTINUED).100,FDA AND STATE AND LOCAL GOVERNMENTS.101MEDICARE AND MEDICAID.1
36、02MEDICARE.102MEDICARE NATIONAL GUIDELINES:INFUSION DEVICECOVERAGE.102TABLE 30 NATIONAL MEDICARE COVERAGE DETERMINATIONSPERTAINING TO INFUSION DEVICES.103TABLE 30(CONTINUED).104,MEDICARE AND HOME INFUSION.105,Medicare Part A Covers Drugs and Equipment for,Hospital and Hospice Stays.105MEDICAID.105,M
37、edicaid(Continued).106CHAPTER TEN:CLINICAL GUIDELINES BY PROFESSIONAL GROUPS.107THE JOINT COMMISSION.107,Copyright BCC Research,Wellesley,MA USA,Web:,ix,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,ECRI INSTITUTE.107THE INSTITUTE FOR SAFE MEDICATION PRACTICES(ISMP).108T
38、HE ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL,INSTRUMENTATION(AAMI).108THE ISO.109CHAPTER ELEVEN:PATIENT SAFETY.110INTRODUCTION.110INFUSION PUMPS.110INSULIN PENS.111NEEDLELESS JET INJECTORS.111IIPS.112ELASTOMERIC INFUSION PUMPS.112CHAPTER TWELVE:INDUSTRY STRUCTURE.113FORCES DRIVING THE INDUSTRY.113C
39、URRENT PERFORMANCE.114INDUSTRY CONTEXT.114MANUFACTURERS.115DISTRIBUTORS.115GOVERNMENTS AND REGULATORY BODIES.115INSURANCE COMPANIES.116HOSPITALS.116TABLE 31 U.S.HOSPITAL EXPENDITURES ON INFUSION PUMPSBY TECHNOLOGY TYPE,THROUGH 2014($MILLIONS).117GROUP PURCHASING ORGANIZATIONS.117THE HOME INFUSION SE
40、CTOR.118,TABLE 32 U.S.HOME INFUSION PROVIDERS,INCLUDINGPHARMACIES,EXPENDITURES ON INFUSION PUMPS BY,TECHNOLOGY TYPE,THROUGH 2014($MILLIONS).119,FULL-SERVICE PROVIDERS.120NURSING CARE PROVIDERS.121DRUG PROVIDERS.121PROVISION OF INFUSION THERAPY SERVICES.122GOVERNMENT.122INFUSION THERAPY DELIVERY MODE
41、LS.123INFUSION THERAPY IN AN ALTERNATE SITE.123TABLE 33 U.S.DOCTORS OFFICE EXPENDITURES ON INFUSIONPUMPS BY TECHNOLOGY TYPE,THROUGH 2014($MILLIONS).124TABLE 34 U.S.ALTERNATE SITE EXPENDITURES ON INFUSIONPUMPS BY TECHNOLOGY TYPE,THROUGH 2014($MILLIONS).124,Copyright BCC Research,Wellesley,MA USA,Web:
42、,x,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,CHAPTER THIRTEEN:INTERNATIONAL ASPECTS.125,TABLE 35 GLOBAL INFUSION PUMP EXPENDITURES BY,GEOGRAPHIC REGION,THROUGH 2014($MILLIONS).125,TABLE 36 GEOGRAPHIC DISTRIBUTION OF MAJOR,MANUFACTURERS SALES(%).126INTERNATIONAL REGUL
43、ATIONS.127TABLE 37 SIGNIFICANT INTERNATIONAL REGULATORY ACTION.128,AUSTRALIA.129CANADA.129EUROPEAN UNION.130JAPAN.131REST OF ASIA.131,Rest of Asia(Continued).132,CHAPTER FOURTEEN:TRENDS IN PRICE AND,PRICE/PERFORMANCE.133GENERAL INFUSION PUMP.133PV/LCC ANALYSIS ASSUMPTIONS.134INSULIN PUMPS.134,TABLE
44、38 COMPARING COSTS OF INSULIN ADMINISTRATION,METHODS($).134OTHER FACTORS INFLUENCING DEMAND.135COST.135CLINICAL EFFECTIVENESS.135ERRORS.135SMART INFRASTRUCTURE.136TRAINING.136,Training Time.136DEMOGRAPHICS.137General.137TABLE 39 DEMOGRAPHIC PROJECTIONS THROUGH 2050,(POPULATION IN MILLIONS).138TABLE
45、40 AGING OF WORLD POPULATION,2000 AND 2014.139,Diabetes.139TABLE 41 GLOBAL INCIDENCE OF DIABETES,2000 AND 2030.140TABLE 42 LEADING COUNTRIES,DIABETES,2000 AND 2030,(MILLIONS).140,Cancer.141U.S.141MARKET SATURATION.142,Market Saturation/Continued).143,Copyright BCC Research,Wellesley,MA USA,Web:,xi,H
46、LC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,CHAPTER FIFTEEN:TECHNOLOGY,INCLUDING PATENT,EVALUATION.144TECHNOLOGY,INCLUDING PATENT EVALUATION.144TECHNOLOGY,INCLUDING PATENT(CONTINUED).145,TABLE 43 U.S.MEDICATORS AND RECEPTORS PATENTS,GENERAL ACTIVITY IN SELECTED COMPANIE
47、S,20042008.146TABLE 43(CONTINUED).147TABLE 44 GLOBAL PATENT ACTIVITY IN INFUSION PUMP,TECHNOLOGIES,20052009.147TABLE 44(CONTINUED).148PATENT ACTIVITY 2009:ELASTOMERIC INFUSION PUMPS.148,TABLE 45 GLOBAL PATENT ACTIVITY 2009:ELASTOMERIC,INFUSION PUMPS.149PATENT ACTIVITY 2009:INJECTION PENS.150TABLE 46
48、 GLOBAL PATENT ACTIVITY 2009:INJECTION PENS.150PATENT ACTIVITY 2009:NEEDLELESS INJECTOR JETS.150,TABLE 47 GLOBAL PATENT ACTIVITY 2009:NEEDLELESS,INJECTOR JETS.151PATENT ACTIVITY 2009:MECHANICAL INFUSION PUMPS.151,TABLE 48 GLOBAL PATENT ACTIVITY 2009:MECHANICAL,INFUSION PUMPS.151TABLE 48(CONTINUED).1
49、52PATENT ACTIVITY 2009:SYRINGE PUMPS.152CHAPTER SIXTEEN:COMPANY PROFILES.153INFUSION PUMPS.153ALARIS MEDICAL SYSTEMS,INC.153BAXA.154B.BRAUN MELSUNGEN AG.154,B.Braun Medical,Inc.155BAXTER INTL,INC.156CAREFUSION.157COVIDIEN,PLC/KENDALL.157Kendall.158KENDALL CO.158FRESENIUS KABI AG.159HOSPIRA,INC.160KI
50、MBERLY-CLARK CORP./I-FLOW.161I-FLOW CORP.162LMA INTL.163,LMA North America,Inc.163,Copyright BCC Research,Wellesley,MA USA,Web:,xii,HLC071A Infusion Devices:Technologies and Global Markets,TABLE OF CONTENTS,MOOG,INC.164SIGMA INTL.165SMITHS MEDICAL.165STRYKER CORP.166TERUMO CORP.167,Terumo Medical Co
