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Chapter- 1: INTRODUCTION

STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
INFORMATION SOURCES
ANALYST CREDENTIALS
RELATED BCC REPORTS
BCC ONLINE SERVICES
DISCLAIMER

Chapter-2: SUMMARY

SUMMARY
SUMMARY TABLE GLOBAL INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
SUMMARY FIGURE GLOBAL INFUSION PUMP SPENDING BY GEOGRAPHIC REGION, 2008-2014 ($ MILLIONS)

Chapter-3: OVERVIEW

INDUSTRY DEFINITION
INFUSION PUMPS
Importance of Infusion Pumps
General
Drug-delivery Systems
Product and Technology Life Cycle
HISTORY OF INFUSION
INDUSTRY DEVELOPMENT
FORECAST
CURRENT ACTIVITY
CURRENT STATE OF INFUSION DEVICES AND THERAPIES
DEMAND AND COST
DEMOGRAPHIC FACTORS
2009 IN REVIEW
INDUSTRY DEVELOPMENTS
CAREFUSION/ALARIS
SMITHS MEDICAL
BAXTER, COLLEAGUE, SIGMA, AND SPECTRUM
KIMBERLY CLARK AND I-FLOW
MEDINGO
MOOG ROLL-UP STRATEGY
YEAR(S) OF THE RECALL
DEVELOPMENTS OUTSIDE THE INDUSTRY
PORTABLE DIALYSIS MACHINE
ISLET CELL INJECTION
U.S. HEALTHCARE REFORM
MEDICAL DEVICE MANUFACTURERS TAX
HOME INFUSION THERAPY
MEDICAL DEVICES REGISTRY
SUNSHINE PROVISION
COMPARATIVE EFFECTIVENESS RESEARCH

Chapter-4: MAJOR COMPANIES AND MARKET SHARE

MAJOR COMPANIES AND MARKET SHARE
TABLE 1 GLOBAL MEDICAL INFUSION PUMP EXPENDITURES BY TYPE OF PUMP, THROUGH 2014 ($ MILLIONS)
FIGURE 1 GLOBAL MEDICAL INFUSION PUMP EXPENDITURES, 2008-2014 ($ MILLIONS)
MAJOR MARKETS
FIGURE 2 HEALTHCARE EXPENDITURES AS PERCENTAGE OF GDP (%)
U.S.
JAPAN
CANADA
AUSTRALIA

Chapter-5: MARKETS BY PRODUCT

MARKETS BY PRODUCT
ELASTOMERIC AND MECHANICAL INFUSION PUMPS
ELASTOMERIC PUMPS
PERISTALTIC PUMPS
CASSETTE PUMPS
TABLE 2 GLOBAL MANUFACTURERS OF ELASTOMERIC AND MECHANICAL INFUSION PUMPS MARKET SHARE, 2008 (%)
FIGURE 3 GLOBAL MANUFACTURERS OF ELASTOMERIC AND MECHANICAL INFUSION PUMPS GLOBAL MARKET SHARE, 2008 (%)
TABLE 3 GLOBAL MEDICAL ELASTOMERIC AND MECHANICAL INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 4 U.S. MEDICAL ELASTOMERIC AND MECHANICAL INFUSION PUMP MARKET BY SECTOR, THROUGH 2014 ($ MILLIONS)
SYRINGE PUMPS
TABLE 5 GLOBAL SYRINGE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
FIGURE 4 GLOBAL SYRINGE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
TABLE 6 GLOBAL MEDICAL SYRINGE INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 7 U.S. MEDICAL SYRINGE INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)
ELECTRONIC SYRINGE INFUSION PUMPS
TABLE 8 GLOBAL ELECTRONIC SYRINGE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
FIGURE 5 GLOBAL ELECTRONIC SYRINGE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
TABLE 9 GLOBAL ELECTRONIC SYRINGE INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 10 GLOBAL ELECTRONIC SYRINGE PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 11 U.S. ELECTRONIC SYRINGE INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)
IIPS
TABLE 12 GLOBAL IMPLANTABLE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
FIGURE 6 GLOBAL IMPLANTABLE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
TABLE 13 U.S. IMPLANTABLE INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)
TABLE 14 GLOBAL MEDICAL IMPLANTABLE INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)

Chapter-6: TYPES OF APPLICATIONS

VOLUMETRIC INFUSION PUMPS
TABLE 15 GLOBAL VOLUMETRIC INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
FIGURE 7 GLOBAL VOLUMETRIC INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
TABLE 16 GLOBAL VOLUMETRIC INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 17 U.S. VOLUMETRIC INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)
SMART PUMPS
TABLE 18 GLOBAL SMART PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
FIGURE 8 GLOBAL SMART INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
TABLE 19 GLOBAL SMART INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 20 U.S. SMART INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)
AMBULATORY INFUSION PUMPS
TABLE 21 GLOBAL AMBULATORY INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
FIGURE 9 GLOBAL AMBULATORY INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
TABLE 22 GLOBAL AMBULATORY INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 23 U.S. AMBULATORY INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)
INSULIN PUMPS
TABLE 24 GLOBAL INSULIN PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
FIGURE 10 GLOBAL INSULIN PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
TABLE 25 GLOBAL INSULIN INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 26 U.S. INSULIN INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)

Chapter-7: CONDITIONS

CONDITIONS
PAIN MANAGEMENT
MEDICATION
DIABETES
ENTERAL NUTRITION
PN
ANTIBIOTICS

Chapter-8: COMPETING AND COMPLEMENTARY TECHNOLOGIES

NEEDLELESS INJECTORS
TABLE 27 GLOBAL NEEDLELESS INJECTOR MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)
INJECTION PENS
MINIBAGS
GLUCOSE MONITORING
SELF-MONITORING OF BLOOD GLUCOSE
CGMS
TRADITIONAL INSULIN DELIVERY
DISRUPTIVE TECHNOLOGY CHALLENGES
TRANSDERMAL DRUG DELIVERY
TRANSDERMAL PATCH PUMPS
INHALED MEDICATIONS AND DEVICES
TABLE 28 PROGRESS TOWARD NEEDLEFREE VACCINE DELIVERY
NANOTECHNOLOGY
BIOTECHNOLOGY

Chapter-9: GOVERNMENT REGULATIONS

U.S. FDA
FDA PRE-MARKET REVIEW
FDA PRE-MARKET REVIEW PROCESS UNDER SCRUTINY
FDA REPORTING AND VIGILANCE
FDA RECALLS
TABLE 29 KEY FDA PRODUCT RECALLS: INFUSION PUMPS, 2007--2009
FDA AND STATE AND LOCAL GOVERNMENTS
MEDICARE AND MEDICAID
MEDICARE
MEDICARE NATIONAL GUIDELINES: INFUSION DEVICE COVERAGE
TABLE 30 NATIONAL MEDICARE COVERAGE DETERMINATIONS PERTAINING TO INFUSION DEVICES
MEDICARE AND HOME INFUSION
Medicare Part A Covers Drugs and Equipment for Hospital and Hospice Stays
MEDICAID

Chapter-10: CLINICAL GUIDELINES BY PROFESSIONAL GROUPS

THE JOINT COMMISSION
ECRI INSTITUTE
THE INSTITUTE FOR SAFE MEDICATION PRACTICES (ISMP)
THE ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)
THE ISO

Chapter-11: PATIENT SAFETY

INTRODUCTION
INFUSION PUMPS
INSULIN PENS
NEEDLELESS JET INJECTORS
IIPS
ELASTOMERIC INFUSION PUMPS

Chapter-12: INDUSTRY STRUCTURE

FORCES DRIVING THE INDUSTRY
CURRENT PERFORMANCE
INDUSTRY CONTEXT
MANUFACTURERS
DISTRIBUTORS
GOVERNMENTS AND REGULATORY BODIES
INSURANCE COMPANIES
HOSPITALS
TABLE 31 U.S. HOSPITAL EXPENDITURES ON INFUSION PUMPS BY TECHNOLOGY TYPE, THROUGH 2014 ($ MILLIONS)
GROUP PURCHASING ORGANIZATIONS
THE HOME INFUSION SECTOR
TABLE 32 U.S. HOME INFUSION PROVIDERS’, INCLUDING PHARMACIES, EXPENDITURES ON INFUSION PUMPS BY TECHNOLOGY TYPE, THROUGH 2014 ($ MILLIONS)
FULL-SERVICE PROVIDERS
NURSING CARE PROVIDERS
DRUG PROVIDERS
PROVISION OF INFUSION THERAPY SERVICES
GOVERNMENT
INFUSION THERAPY DELIVERY MODELS
INFUSION THERAPY IN AN ALTERNATE SITE
TABLE 33 U.S. DOCTORS’ OFFICE EXPENDITURES ON INFUSION PUMPS BY TECHNOLOGY TYPE, THROUGH 2014 ($ MILLIONS)
TABLE 34 U.S. ALTERNATE SITE EXPENDITURES ON INFUSION PUMPS BY TECHNOLOGY TYPE, THROUGH 2014 ($ MILLIONS)

Chapter-13: INTERNATIONAL ASPECTS

TABLE 35 GLOBAL INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)
TABLE 36 GEOGRAPHIC DISTRIBUTION OF MAJOR MANUFACTURERS’ SALES (%)
INTERNATIONAL REGULATIONS
TABLE 37 SIGNIFICANT INTERNATIONAL REGULATORY ACTION
AUSTRALIA
CANADA
EUROPEAN UNION
JAPAN
REST OF ASIA

Chapter-14: TRENDS IN PRICE AND PRICE/PERFORMANCE

GENERAL INFUSION PUMP
PV/LCC ANALYSIS ASSUMPTIONS
INSULIN PUMPS
TABLE 38 COMPARING COSTS OF INSULIN ADMINISTRATION METHODS ($)
OTHER FACTORS INFLUENCING DEMAND
COST
CLINICAL EFFECTIVENESS
ERRORS
SMART INFRASTRUCTURE
TRAINING
Training Time
DEMOGRAPHICS
General
TABLE 39 DEMOGRAPHIC PROJECTIONS THROUGH 2050 (POPULATION IN MILLIONS)
TABLE 40 AGING OF WORLD POPULATION, 2000 AND 2014
Diabetes
TABLE 41 GLOBAL INCIDENCE OF DIABETES, 2000 AND 2030
TABLE 42 LEADING COUNTRIES, DIABETES, 2000 AND 2030 (MILLIONS)
Cancer
U.S.
MARKET SATURATION

Chapter-15: TECHNOLOGY, INCLUDING PATENT EVALUATION

TECHNOLOGY, INCLUDING PATENT EVALUATION
TABLE 43 U.S. MEDICATORS AND RECEPTORS PATENTS, GENERAL ACTIVITY IN SELECTED COMPANIES, 2004--2008
TABLE 44 GLOBAL PATENT ACTIVITY IN INFUSION PUMP TECHNOLOGIES, 2005--2009
PATENT ACTIVITY 2009: ELASTOMERIC INFUSION PUMPS
TABLE 45 GLOBAL PATENT ACTIVITY 2009: ELASTOMERIC INFUSION PUMPS
PATENT ACTIVITY 2009: INJECTION PENS
TABLE 46 GLOBAL PATENT ACTIVITY 2009: INJECTION PENS
PATENT ACTIVITY 2009: NEEDLELESS INJECTOR JETS
TABLE 47 GLOBAL PATENT ACTIVITY 2009: NEEDLELESS INJECTOR JETS
PATENT ACTIVITY 2009: MECHANICAL INFUSION PUMPS
TABLE 48 GLOBAL PATENT ACTIVITY 2009: MECHANICAL INFUSION PUMPS
PATENT ACTIVITY 2009: SYRINGE PUMPS

Chapter-16: COMPANY PROFILES

INFUSION PUMPS
ALARIS MEDICAL SYSTEMS, INC.
BAXA
B. BRAUN MELSUNGEN AG
B. Braun Medical, Inc.
BAXTER INT’L, INC.
CAREFUSION
COVIDIEN, PLC/KENDALL
Kendall
KENDALL CO.
FRESENIUS KABI AG
HOSPIRA, INC.
KIMBERLY-CLARK CORP./I-FLOW
I-FLOW CORP.
LMA INT’L
LMA North America, Inc.
MOOG, INC.
SIGMA INT’L
SMITHS MEDICAL
STRYKER CORP.
TERUMO CORP.
Terumo Medical Corp.
ZHUKAI FORNIA
Ashlar Holdings, LLC
INSULIN PUMPS
ANIMAS CORP.
DEBIOTECH
INSULET CORP.
JOHNSON & JOHNSON CO.
Animas
Codman & Shurtleff, Inc.
MEDINGO MEDICAL SOLUTIONS
Medingo Medical Solutions U.S.
MEDTRONIC, INC.
MEDTRONIC DIABETES
NIPRO CORP.
Nipro Diabetes Systems
ROCHE DIAGNOSTICS CORP.
SOOIL DEVELOPMENT
SOOIL Development U.S.
NEEDLELESS INJECTORS
ANTARES PHARMA, INC.
BIOJECT MEDICAL TECHNOLOGIES, INC.
CROSSJECT
INJEX-EQUIDYNE SYSTEMS
NATIONAL MEDICAL PRODUCTS, INC.
PFIZERM, INC.
ZOGENIX
MINIBAGS
INHALED/TRANSDERMAL DRUG DELIVERY SYSTEMS
3M DRUG DELIVERY SYSTEMS
ALKERMES, INC.
ARADIGM CORP.
MANNKIND CORP.
VECTURA
INJECTION PENS
NOVO NORDISK A/S
Novo Nordisk U.S.
OWEN MUMFORD, LTD.
YPSOMED

Chapter-17: APPENDIX

APPENDIX
TABLE 49 GLOBAL PATENTS AND PATENT APPLICATIONS BY COMPANY, 2009