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Infusion Devices: Technologies and Global Markets

Price:
USD $4,850.00
ISBN/SKU #:
GB-HLC071A
Research Group:
BCC
Date of Publication:
February 2010
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Summary

This study was to determine the current status of the global market for infusion pumps and assess its growth potential over a 5-year period from 2009 to 2014. Of particular interest were changes to the regulatory environment and delivery infrastructure due to healthcare reform in the U.S. and other countries, and the rapid changes in product offerings following a series of high-profile product recalls over the past 2 years.

In addition, this report describes the transition to “smart pump” technology and giving an overview of the complex systems that complement and compete with infusion pumps as mode of treatment. The key objective was to present a comprehensive analysis of the current market for infusion pumps and its future growth prospects in providing safe and effective delivery of medications, nutrients, and analgesics.

Almost every aspect of the infusion pump sector is undergoing dramatic change at this time. In response to numerous product recalls, manufacturers have introduced new smart pump technology to reduce Adverse Drug Events (ADEs) and other serious problems associated with previous administrative methods.

Competition from other drug delivery systems, chiefly transdermal and inhaled medicines, may put boundaries on growth for infusion pumps. Demand is growing for continuous administration of medicines and analgesics due to demographic changes in the world’s population and the increasing incidence of diabetes. Ancillary devices such as meters and monitors are becoming a significant force in the market, and design changes have produced new pumps that are smaller, less obtrusive, and have a sense of style, rendering them much more acceptable as ambulatory infusion pumps.

This report provides the interplay between these various factors and how they will interact with other changes occurring in the broader landscape of healthcare delivery. This report covers infusion pumps used for continuous or intermittent administration of medications (including antibiotics), nutrients, and analgesics. This report analyzes current conditions in the global market and examines the current market condition and variable factors to forecast the future growth of the market. Medical, scientific, technological, social, and economic issues associated with this market are examined. An educated estimate and forecast of growth from 2009 to 2014 are presented by examining the current market and variable factors of each category of diagnostic or therapeutic product.
 
The global market for infusion pumps, with an examination of how they interact with other selected drug delivery systems. We examined current Food and Drug Administration (FDA)-approved medical devices by each category, industry pipelines, and technology innovation through patent protection in the U.S. Patent and Trademark Office (USPTO), the European Patent Office (EPO), and the World Intellectual Property Organization (WIPO), and market competition from transdermal drug-delivery systems and inhaled medications.

Forecasts of the infusion pump market are undertaken by examination of medical and scientific issues, the economic environment, technology innovation, industry pipeline development, market competition, and market growth potential from 2009 to 2014. Market leaders and smaller innovative companies are also introduced. This study will be of interest to the global pharmaceutical industry, drug and medical device manufacturers, drug and medical device distributors, healthcare maintenance organizations (HMOs) and hospitals, insurance underwriters, government agency regulators, government policy makers, institutional and private investors, and various patient educational communities.

THIS REPORT:

  • Focus on end-user markets, including hospitals, research facilities, freestanding clinics, and doctors’ offices that use the devices to administer therapeutics such as analgesics, antimicrobials, blood products, chemotherapy, and nutrients.
  • Provide data on the global market for the devices in 2008, and forecast the market from 2009 through 2014.
  • Discuss well-established technologies, such as electronic syringe infusion devices, injection pens, needleless jet injectors, as well as emerging technologies, such as transdermal drug delivery for illnesses such as cardiovascular disease.
  • Examine improvements in quality, effectiveness, and safety.

TABLE OF CONTENTS

Chapter- 1: INTRODUCTION

STUDY GOALS AND OBJECTIVES

1

REASONS FOR DOING THE STUDY

1

SCOPE OF REPORT

2

INTENDED AUDIENCE

2

INFORMATION SOURCES

2

DISCLAIMER

3

 

Chapter-2: SUMMARY

SUMMARY

4

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

6

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

6

 

Chapter-3: OVERVIEW

INDUSTRY DEFINITION

7

INFUSION PUMPS

7

Importance of Infusion Pumps

7

General

7

Drug-delivery Systems

8

Product and Technology Life Cycle

10

HISTORY OF INFUSION

10

INDUSTRY DEVELOPMENT

12

FORECAST

13

CURRENT ACTIVITY

14

CURRENT STATE OF INFUSION DEVICES AND THERAPIES

14

DEMAND AND COST

15

DEMOGRAPHIC FACTORS

16

2009 IN REVIEW

18

INDUSTRY DEVELOPMENTS

18

CAREFUSION/ALARIS

18

SMITHS MEDICAL

19

BAXTER, COLLEAGUE, SIGMA, AND SPECTRUM

19

KIMBERLY CLARK AND I-FLOW

19

MEDINGO

19

MOOG ROLL-UP STRATEGY

19

YEAR(S) OF THE RECALL

20

DEVELOPMENTS OUTSIDE THE INDUSTRY

20

PORTABLE DIALYSIS MACHINE

20

ISLET CELL INJECTION

20

U.S. HEALTHCARE REFORM

21

MEDICAL DEVICE MANUFACTURERS TAX

22

HOME INFUSION THERAPY

22

MEDICAL DEVICES REGISTRY

22

SUNSHINE PROVISION

23

COMPARATIVE EFFECTIVENESS RESEARCH

23

 

Chapter-4: MAJOR COMPANIES AND MARKET SHARE

MAJOR COMPANIES AND MARKET SHARE

24

TABLE 1 GLOBAL MEDICAL INFUSION PUMP EXPENDITURES BY TYPE OF PUMP, THROUGH 2014 ($ MILLIONS)

25

FIGURE 1 GLOBAL MEDICAL INFUSION PUMP EXPENDITURES, 2008-2014 ($ MILLIONS)

26

MAJOR MARKETS

27

FIGURE 2 HEALTHCARE EXPENDITURES AS PERCENTAGE OF GDP (%)

28

U.S.

29

JAPAN

29

CANADA

30

AUSTRALIA

31

 

Chapter-5: MARKETS BY PRODUCT

MARKETS BY PRODUCT

32

ELASTOMERIC AND MECHANICAL INFUSION PUMPS

33

ELASTOMERIC PUMPS

33

PERISTALTIC PUMPS

34

CASSETTE PUMPS

35

TABLE 2 GLOBAL MANUFACTURERS OF ELASTOMERIC AND MECHANICAL INFUSION PUMPS MARKET SHARE, 2008 (%)

35

FIGURE 3 GLOBAL MANUFACTURERS OF ELASTOMERIC AND MECHANICAL INFUSION PUMPS GLOBAL MARKET SHARE, 2008 (%)

36

TABLE 3 GLOBAL MEDICAL ELASTOMERIC AND MECHANICAL INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)

36

TABLE 4 U.S. MEDICAL ELASTOMERIC AND MECHANICAL INFUSION PUMP MARKET BY SECTOR, THROUGH 2014 ($ MILLIONS)

37

SYRINGE PUMPS

37

TABLE 5 GLOBAL SYRINGE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

38

FIGURE 4 GLOBAL SYRINGE INFUSION PUMP MANUFACTURERS’ MARKET 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 INFUSION PUMPS

40

TABLE 8 GLOBAL ELECTRONIC SYRINGE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

41

FIGURE 5 GLOBAL ELECTRONIC SYRINGE INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

42

TABLE 9 GLOBAL ELECTRONIC SYRINGE INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)

42

TABLE 10 GLOBAL ELECTRONIC SYRINGE PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)

43

TABLE 11 U.S. ELECTRONIC SYRINGE INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)

43

IIPS

44

TABLE 12 GLOBAL IMPLANTABLE INFUSION 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

TABLE 13 U.S. IMPLANTABLE INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)

47

TABLE 14 GLOBAL MEDICAL IMPLANTABLE INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)

47

 

Chapter-6: TYPES OF APPLICATIONS

VOLUMETRIC INFUSION PUMPS

48

TABLE 15 GLOBAL VOLUMETRIC INFUSION PUMP 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)

50

TABLE 17 U.S. VOLUMETRIC INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)

50

SMART PUMPS

51

TABLE 18 GLOBAL SMART PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

51

FIGURE 8 GLOBAL SMART INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

52

TABLE 19 GLOBAL SMART INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)

52

TABLE 20 U.S. SMART INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)

53

SMART PUMPS (CONTINUED)

54

AMBULATORY INFUSION PUMPS

55

TABLE 21 GLOBAL AMBULATORY INFUSION PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

56

FIGURE 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)

57

TABLE 23 U.S. AMBULATORY INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)

58

INSULIN PUMPS

58

TABLE 24 GLOBAL INSULIN PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

60

FIGURE 10 GLOBAL INSULIN PUMP MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

61

TABLE 25 GLOBAL INSULIN INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)

61

TABLE 26 U.S. INSULIN INFUSION PUMP EXPENDITURES BY MARKET SECTOR, THROUGH 2014 ($ MILLIONS)

62

 

Chapter-7: CONDITIONS

CONDITIONS PAIN MANAGEMENT

63

MEDICATION

66

DIABETES

67

ENTERAL NUTRITION

67

PN

68

ANTIBIOTICS

69

 

Chapter-8: COMPETING AND COMPLEMENTARY TECHNOLOGIES

NEEDLELESS INJECTORS

70

TABLE 27 GLOBAL NEEDLELESS INJECTOR MANUFACTURERS’ MARKET SHARE BASED ON DOLLAR SALES, 2008 (%)

70

INJECTION PENS

73

MINIBAGS

73

GLUCOSE MONITORING

74

SELF-MONITORING OF BLOOD GLUCOSE

74

CGMS

75

TRADITIONAL INSULIN DELIVERY

75

DISRUPTIVE TECHNOLOGY CHALLENGES

75

TRANSDERMAL DRUG DELIVERY

76

TRANSDERMAL PATCH PUMPS

80

INHALED MEDICATIONS AND DEVICES

80

TABLE 28 PROGRESS TOWARD NEEDLEFREE VACCINE DELIVERY

82

NANOTECHNOLOGY

87

BIOTECHNOLOGY

89

 

Chapter-9: GOVERNMENT REGULATIONS

U.S. FDA

91

FDA PRE-MARKET REVIEW

92

FDA PRE-MARKET REVIEW PROCESS UNDER SCRUTINY

93

FDA REPORTING AND VIGILANCE

93

FDA RECALLS

94

TABLE 29 KEY FDA PRODUCT RECALLS: INFUSION PUMPS, 2007–2009

95

FDA AND STATE AND LOCAL GOVERNMENTS

101

MEDICARE AND MEDICAID

102

MEDICARE

102

MEDICARE NATIONAL GUIDELINES: INFUSION DEVICE COVERAGE

102

TABLE 30 NATIONAL MEDICARE COVERAGE DETERMINATIONS PERTAINING TO INFUSION DEVICES

103

MEDICARE AND HOME INFUSION

105

Medicare Part A Covers Drugs and Equipment for Hospital and Hospice Stays

105

MEDICAID

105

 

Chapter-10: CLINICAL GUIDELINES BY PROFESSIONAL GROUPS

THE JOINT COMMISSION

107

ECRI INSTITUTE

107

THE INSTITUTE FOR SAFE MEDICATION PRACTICES (ISMP)

108

THE ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)

108

THE ISO

109

 

Chapter-11: PATIENT SAFETY

INTRODUCTION

110

INFUSION PUMPS

110

INSULIN PENS

111

NEEDLELESS JET INJECTORS

111

IIPS

112

ELASTOMERIC INFUSION PUMPS

112

 

Chapter-12: INDUSTRY STRUCTURE

FORCES DRIVING THE INDUSTRY

113

CURRENT PERFORMANCE

114

INDUSTRY CONTEXT

114

MANUFACTURERS

115

DISTRIBUTORS

115

GOVERNMENTS AND REGULATORY BODIES

115

INSURANCE COMPANIES

116

HOSPITALS

116

TABLE 31 U.S. HOSPITAL EXPENDITURES ON INFUSION PUMPS BY TECHNOLOGY TYPE, THROUGH 2014 ($ MILLIONS)

117

GROUP PURCHASING ORGANIZATIONS

117

THE HOME INFUSION SECTOR

118

TABLE 32 U.S. HOME INFUSION PROVIDERS’, INCLUDING PHARMACIES, EXPENDITURES ON INFUSION PUMPS BY TECHNOLOGY TYPE, THROUGH 2014 ($ MILLIONS)

119

FULL-SERVICE PROVIDERS

120

NURSING CARE PROVIDERS

121

DRUG PROVIDERS

121

PROVISION OF INFUSION THERAPY SERVICES

122

GOVERNMENT

122

INFUSION THERAPY DELIVERY MODELS

123

INFUSION THERAPY IN AN ALTERNATE SITE

123

TABLE 33 U.S. DOCTORS’ OFFICE EXPENDITURES ON INFUSION PUMPS BY TECHNOLOGY TYPE, THROUGH 2014 ($ MILLIONS)

124

TABLE 34 U.S. ALTERNATE SITE EXPENDITURES ON INFUSION PUMPS BY TECHNOLOGY TYPE, THROUGH 2014 ($ MILLIONS)

124

 

Chapter-13: INTERNATIONAL ASPECTS

TABLE 35 GLOBAL INFUSION PUMP EXPENDITURES BY GEOGRAPHIC REGION, THROUGH 2014 ($ MILLIONS)

125

TABLE 36 GEOGRAPHIC DISTRIBUTION OF MAJOR MANUFACTURERS’ SALES (%)

126

INTERNATIONAL REGULATIONS

127

TABLE 37 SIGNIFICANT INTERNATIONAL REGULATORY ACTION

128

AUSTRALIA

129

CANADA

129

EUROPEAN UNION

130

JAPAN

131

REST OF ASIA

131

 

Chapter-14: TRENDS IN PRICE AND PRICE/PERFORMANCE

GENERAL INFUSION PUMP

133

PV/LCC ANALYSIS ASSUMPTIONS

134

INSULIN PUMPS

134

TABLE 38 COMPARING COSTS OF INSULIN ADMINISTRATION METHODS ($)

134

OTHER FACTORS INFLUENCING DEMAND

135

COST

135

CLINICAL EFFECTIVENESS

135

ERRORS

135

SMART INFRASTRUCTURE

136

TRAINING

136

Training Time

136

DEMOGRAPHICS

137

General

137

TABLE 39 DEMOGRAPHIC PROJECTIONS THROUGH 2050 (POPULATION IN MILLIONS)

138

TABLE 40 AGING OF WORLD POPULATION, 2000 AND 2014

139

Diabetes

139

TABLE 41 GLOBAL INCIDENCE OF DIABETES, 2000 AND 2030

140

TABLE 42 LEADING COUNTRIES, DIABETES, 2000 AND 2030 (MILLIONS)

140

Cancer

141

U.S.

141

MARKET SATURATION

142

 

Chapter-15: TECHNOLOGY, INCLUDING PATENT EVALUATION

TECHNOLOGY, INCLUDING PATENT EVALUATION

144

TABLE 43 U.S. MEDICATORS AND RECEPTORS PATENTS, GENERAL ACTIVITY IN SELECTED COMPANIES, 2004–2008

146

TABLE 44 GLOBAL PATENT ACTIVITY IN INFUSION PUMP TECHNOLOGIES, 2005–2009

147

PATENT ACTIVITY 2009: ELASTOMERIC INFUSION PUMPS

148

TABLE 45 GLOBAL PATENT ACTIVITY 2009: ELASTOMERIC INFUSION PUMPS

149

PATENT ACTIVITY 2009: INJECTION PENS

150

TABLE 46 GLOBAL PATENT ACTIVITY 2009: INJECTION PENS

150

PATENT ACTIVITY 2009: NEEDLELESS INJECTOR JETS

150

TABLE 47 GLOBAL PATENT ACTIVITY 2009: NEEDLELESS INJECTOR JETS

151

PATENT ACTIVITY 2009: MECHANICAL INFUSION PUMPS

151

TABLE 48 GLOBAL PATENT ACTIVITY 2009: MECHANICAL INFUSION PUMPS

151

PATENT ACTIVITY 2009: SYRINGE PUMPS

152

 

Chapter-16: COMPANY PROFILES

INFUSION PUMPS

153

ALARIS MEDICAL SYSTEMS, INC.

153

BAXA

154

B. BRAUN MELSUNGEN AG

154

B. Braun Medical, Inc.

155

BAXTER INT’L, INC.

156

CAREFUSION

157

COVIDIEN, PLC/KENDALL

157

Kendall

158

KENDALL CO.

158

FRESENIUS KABI AG

159

HOSPIRA, INC.

160

KIMBERLY-CLARK CORP./I-FLOW

161

I-FLOW CORP.

162

LMA INT’L

163

LMA North America, Inc.

163

MOOG, INC.

164

SIGMA INT’L

165

SMITHS MEDICAL

165

STRYKER CORP.

166

TERUMO CORP.

167

Terumo Medical Corp.

167

ZHUKAI FORNIA

168

Ashlar Holdings, LLC

168

INSULIN PUMPS

169

ANIMAS CORP.

169

DEBIOTECH

170

INSULET CORP.

170

JOHNSON & JOHNSON CO.

171

Animas

171

Codman & Shurtleff, Inc.

171

MEDINGO MEDICAL SOLUTIONS

172

Medingo Medical Solutions U.S.

172

MEDTRONIC, INC.

173

MEDTRONIC DIABETES

173

NIPRO CORP.

174

Nipro Diabetes Systems

174

ROCHE DIAGNOSTICS CORP.

175

SOOIL DEVELOPMENT

176

SOOIL Development U.S.

177

NEEDLELESS INJECTORS

177

ANTARES PHARMA, INC.

177

BIOJECT MEDICAL TECHNOLOGIES, INC.

178

CROSSJECT

179

INJEX-EQUIDYNE SYSTEMS

179

NATIONAL MEDICAL PRODUCTS, INC.

180

PFIZERM, INC.

180

ZOGENIX

181

MINIBAGS

182

INHALED/TRANSDERMAL DRUG DELIVERY SYSTEMS

182

3M DRUG DELIVERY SYSTEMS

182

ALKERMES, INC.

183

ARADIGM CORP.

184

MANNKIND CORP.

184

VECTURA

185

INJECTION PENS

186

NOVO NORDISK A/S

186

Novo Nordisk U.S.

186

OWEN MUMFORD, LTD.

188

YPSOMED

188

 

Chapter-17: APPENDIX

APPENDIX

190

TABLE 49 GLOBAL PATENTS AND PATENT APPLICATIONS BY COMPANY, 2009

190

 

 

Warranty Information

Number of Pages: 194

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