World Market for Infusion Pumps

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EXECUTIVE SUMMARY .........................................................................................1

Overview and Scope of Study ............................................................................................. 1
Size and Growth of the Market .......................................................................................... 4
Key Issues and Trends Affecting Market .......................................................................... 7
Leading Competitors ........................................................................................................... 8

INDUSTRY OVERVIEW AND TRENDS ................................................................9

Overview............................................................................................................................... 9
Types of Infusion and Pumps ............................................................................................. 9
Applications ....................................................................................................................... 11
Military Applications ...................................................................................................... 20
Healthcare Industry .......................................................................................................... 21
The U.S. Market .............................................................................................................. 22
Consumer Spending ........................................................................................................ 23
European Healthcare Markets ......................................................................................... 25
Asia-Pacific Healthcare Markets ..................................................................................... 25
Infusion Pumps and Reducing Medication Errors ......................................................... 27
Opportunities in Infusion Pump Rentals and Leasing ................................................... 36
Health Risks Associated with Infusion Pump Use .......................................................... 37
Infection .......................................................................................................................... 37
Phlebitis ........................................................................................................................... 38
Infiltration/Extravasation ................................................................................................ 38
Occlusion......................................................................................................................... 39
Electrolyte Imbalance...................................................................................................... 39
Air Embolism .................................................................................................................. 40
Fluid Overload ................................................................................................................ 40
Infusion Pump Recalls ...................................................................................................... 40
Adverse Events and Specific Infusion Pump Issues ....................................................... 44
FDA Initiatives Concerning Infusion Pump Market Submissions .................................. 48
Increasing Life Expectancy and the Growing Demand for Innovative Products ........ 50
Growing and Aging World Population ........................................................................... 53
Incidence, Prevalence of Disease: United States ............................................................. 56
Reducing Hospital Inpatient Length of Stay Steady Increase for Home Health
Services ............................................................................................................................... 58
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TRADITIONAL INFUSION PUMPS......................................................................61

Overview of Products ....................................................................................................... 61
Large Volume Infusion Pumps ........................................................................................ 62
Key Products, Manufacturers and Recent Developments............................................... 62
Market Summary ............................................................................................................ 67
Competitive Summary .................................................................................................... 70
Ambulatory Infusion Pumps ............................................................................................ 72
Key Products, Manufacturers and Recent Developments............................................... 72
Market Summary ............................................................................................................ 78
Competitive Summary .................................................................................................... 83
Syringe Infusion Pumps ................................................................................................... 85
Key Products, Manufacturers and Recent Developments............................................... 85
Market Summary ............................................................................................................ 91

SPECIALTY INFUSION PUMPS ...........................................................................95

Overview ............................................................................................................................ 95
Enteral Feeding Pumps .................................................................................................... 96
Key Products, Manufacturers and Recent Developments............................................... 96
Market Summary .......................................................................................................... 101
Competitive Summary .................................................................................................. 104
Insulin Infusion Pumps................................................................................................... 106
Key Products, Manufacturers, and Recent Developments............................................ 106
Market Summary .......................................................................................................... 112
Competitive Summary .................................................................................................. 115
Implantable Infusion Pumps .......................................................................................... 118
Key Products, Manufacturers and Recent Developments............................................. 118
Market Summary .......................................................................................................... 120
Competitive Summary .................................................................................................. 123

TOTAL MARKET ANALYSIS .............................................................................125

Market Overview ............................................................................................................ 125
Traditional Infusion Pump Market Analysis ............................................................... 128
Specialty Infusion Pump Market Analysis ................................................................... 132
Geographical Market Analysis ...................................................................................... 136
U.S. Market................................................................................................................... 139
European Market .......................................................................................................... 142
Other Markets ............................................................................................................... 145

MANUFACTURER PROFILES ............................................................................149

Overview .......................................................................................................................... 149
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Abbott Laboratories ....................................................................................................... 151

Animas/Johnson & Johnson ........................................................................................... 153
Baxter ............................................................................................................................... 155
B. Braun ........................................................................................................................... 158
CareFusion ....................................................................................................................... 160
Covidien ............................................................................................................................ 163
Fresenius Kabi ................................................................................................................. 165
Hospira ............................................................................................................................. 167
I-Flow ................................................................................................................................ 170
Insulet ............................................................................................................................... 172
IRadimed .......................................................................................................................... 175
Medtronic ......................................................................................................................... 177
Moog ................................................................................................................................. 179
Smiths Group ................................................................................................................... 181
Tandem ............................................................................................................................. 183

LIST OF SIGNIFICANT INFUSION PUMP MARKET CONTRIBUTORS...184

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CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Worldwide Infusion Pump Market Analysis, 2007-2017 .......................................... 5

CHAPTER TWO: INDUSTRY OVERVIEW AND TRENDS

Table 2-1: Registered Hospitals and Acute Care Centers by Country .................................... 12
Figure 2-1: Number of Hospitals in the US, 1975-2005, Estimated 2015 ................................ 13
Table 2-2: U.S. Registered Hospitals by Type, 2010.................................................................. 14
Table 2-3: Leading For-Profit U.S. Hospital Chains, 2008 and 2010 ...................................... 15
Figure 2-2: Number of Nursing Homes, 2000-2010 ................................................................... 16
Table 2-4: U.S. Nursing Homes, Beds, Residents and Occupancy Rate, 2010 ........................ 17
Figure 2-3: Growth in Hospice Programs in the United States, 1998-2010 ............................ 18
Figure 2-4: Patients Served with Hospice Programs in the United States, 1998-2009 ........... 19
Table 2-5: Percentage of Hospice Admissions by Primary Diagnosis, 2005 -2009 ................. 20
(% of Hospice Admissions) .......................................................................................................... 20
Figure 2-5: U.S. Consumer Spending and a Comparison to the U.K. and Japan .................. 23
Figure 2-6: The U.S. Healthcare Spending (1960-2015)............................................................ 24
Table 2-6: Barcode Adoption in Hospitals by Year, United States .......................................... 33
Table 2-7: High-Alert Medication ListClasses/Categories of Medications ......................... 35
Table 2-8: Documented Safety Problems with Infusion Pumps ............................................... 46
Figure 2-7: Average Life Expectancy in Years by Country 1980 and 2011 ............................ 52
Table 2-10: World Population by Selected Geographical Region, 2010 - 2050 ...................... 53
Figure 2-8: World Population by Selected Geographical Region, 20102050 ........................ 54
Table 2-11: Percent Population Over 65 by Year and Region, 2010-2050 .............................. 55
Table 2-12: U.S. Prevalence of Selected Medical Conditions ................................................... 56

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Figure 2-9: U.S. Prevalence of Selected Medical Conditions ................................................... 57

Table 2-13: Average International Length of Stay, by Country 2010 ..................................... 59
Figure 2-10: Length of Service Days for Hospice Patients in the
United States, 2001-2010 ...................................................................................................... 60

CHAPTER THREE: TRADITIONAL INFUSION PUMPS

Table 3-1: Selected Large Volume Infusion Pumps .................................................................. 66
Table 3-2: Large Volume Infusion Pump Market Analysis, 2007-2017 .................................. 68
Figure 3-1: Large Volume Infusion Pump Market Analysis, 2007-2017 ................................ 69
Table 3-3: Large Volume Infusion Pump Market Estimated Revenues
and Market Share of Leading Suppliers 2012 .................................................................... 71
Figure 3-2: Large Volume Infusion Pump Market Estimated Market Share
by Leading Suppliers 2012................................................................................................... 71
Table 3-4: Selected Ambulatory Infusion Pumps ..................................................................... 77
Table 3-5: Ambulatory Infusion Pump Market Analysis, 2007-2017 ..................................... 79
Figure 3-3: Ambulatory Infusion Pump Market Analysis, 2007-2017 .................................... 80
Table 3-6: Ambulatory Infusion Pump Market by End-User, Estimated 2012 ..................... 81
Figure 3-4: Ambulatory Infusion Pump Market by End-User, Estimated 2012 .................... 82
Table 3-7: Ambulatory Infusion Pump Market Estimated Revenues and
Market Share of Leading Suppliers 2012 ............................................................................ 84
Figure 3-5: Ambulatory Infusion Pump Market Estimated Market Share
by Leading Suppliers 2012................................................................................................... 84
Table 3-8: Selected Syringe Infusion Pumps ............................................................................. 90
Table 3-9: Syringe Infusion Pump Market Analysis, 2007-2017 ............................................. 92
Figure 3-6: Syringe Infusion Pump Market Analysis, 2007-2017............................................ 93
Table 3-10: Syringe Infusion Pump Market Estimated Revenues and
Market Share of Leading Suppliers 2012 ............................................................................ 94

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Figure 3-7: Syringe Infusion Pump Market Estimated Market Share

by Leading Suppliers 2012 ................................................................................................... 94

CHAPTER FOUR: SPECIALTY INFUSION PUMPS

Table 4-1: Selected Enteral Feeding Pumps............................................................................. 100
Table 4-2: Enteral Feeding Pump Market Analysis, 2007-2017............................................. 102
Figure 4-1: Enteral Feeding Pump Market Analysis, 2007-2017 ........................................... 103
Table 4-3: Enteral Feeding Pump Market Estimated Revenues and
Market Share of Leading Suppliers 2012 ......................................................................... 104
Figure 4-2: Enteral Feeding Pump Market Estimated Market Share by Leading Suppliers
2012 ....................................................................................................................................... 105
Table 4-4: Selected Insulin Infusion Pumps ............................................................................. 111
Table 4-5: Insulin Infusion Pump Market Analysis, 2007-2017 ............................................. 113
Figure 4-3: Insulin Infusion Pump Market Analysis, 2007-2017 ........................................... 114
Table 4-6: Insulin Infusion Pump Market Estimated Revenues and
Market Share of Leading Suppliers 2012 ......................................................................... 116
Figure 4-4: Insulin Infusion Pump Market Estimated Market Share
by Leading Suppliers 2012 ................................................................................................. 117
Table 4-7: Implantable Infusion Pump Market Analysis, 2007-2017 .................................... 121
Figure 4-5: Implantable Infusion Pump Market Analysis, 2007-2017 .................................. 122
Table 4-8: Implantable Infusion Pump Market Estimated Revenues and
Market Share of Leading Suppliers 2012 ......................................................................... 123
Figure 4-6: Implantable Infusion Pump Market Estimated Market Share
by Leading Suppliers 2012 ................................................................................................. 124

CHAPTER FIVE: TOTAL MARKET ANALYSIS

Table 5-1: Worldwide Infusion Pump Market Analysis, 2007-2017 ...................................... 126

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Table 5-2: Worldwide Traditional Infusion Pump Market Analysis by

Product Type, 2007-2017 .................................................................................................... 129
Table 5-2: Worldwide Traditional Infusion Pump Market Analysis by
Product Type, 2007-2017 ................................................................................................... 131
Table 5-3: Worldwide Specialty Infusion Pump Market Analysis by
Product Type, 2007-2017 ................................................................................................... 133
Table 5-4: Worldwide Specialty Infusion Pump Market Analysis by
Product Type, 2007-2017 ................................................................................................... 134
Table 5-4: Worldwide Infusion Pump Market Analysis by
Geographical Region, 2007-2012 ....................................................................................... 137
Table 5-5: U.S. Infusion Pump Market, Estimated 2012........................................................ 140
Figure 5-7: U.S. Share: Infusion Pump Market, Estimated 2012 .......................................... 141
Table 5-6: Europe Infusion Pump Market, Estimated 2012 .................................................. 143
Figure 5-8: Europe Share: Infusion Pump Market, Estimated 2012 .................................... 144
Table 5-7: Rest of World (excl. U.S. and Europe) Infusion Pump Market,
Estimated 2012.................................................................................................................... 146
Figure 5-9: ROW Share: Infusion Pump Market, Estimated 2012 ....................................... 147
Table 5-8: Significant Trends and Impact ............................................................................... 148

CHAPTER SIX: MANUFACTURER PROFILES

Figure 6-1: Abbotts Net Revenues for 2008-2011 .................................................................. 152
Figure 6-2: Johnson & Johnsons Net Revenues for 2008-2011 ............................................ 154
Figure 6-3: Baxters Net Revenues for 2008-2011................................................................... 156
Figure 6-4: B. Brauns Net Revenues for 2008-2011............................................................... 159
Figure 6-5: CareFusions Net Revenues for 2009-2011 .......................................................... 161
Figure 6-6: Covidiens Net Revenues for 2008-2011 ............................................................... 164
Figure 6-7: Fresenius SEs Net Revenues for 2008-2011 ........................................................ 166
Figure 6-8: Hospiras Net Revenues for 2008-2011 ................................................................ 168
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Figure 6-9: Kimberly Clark's Health Care Division Net Revenues for 2008-2011 ............... 171
Figure 6-10: Insulets Net Revenues for 2008-2011 ................................................................. 173
Figure 6-11: Medtronics Net Revenues for 2008-2011 ........................................................... 178
Figure 6-12: Moogs Net Revenues for 2008-2011 ................................................................... 180
Figure 6-13: Smiths Groups Net Revenues for 2008-2011..................................................... 182

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Two: Introduction
39

Occlusion
The general medical definition of an occlusion is obstruction or a closure of a
passageway or vessel. The problem related to infusion pumps is that a blockage in the
IV line can result in patients not receiving the solution. In some cases the upstream
manual clamp is accidentally left in place. Other situations can create an occlusion
such as clogged filters or using a non-vented bottle with a non-vented IV set.
In the case of an upstream occlusion, some pumps will not alarm and
subsequently show an incorrect amount of infused solution. Complications from this
situation come from trying to resolve the situation without knowing drug
administration was started or how much medication has been delivered. Patients may
also be at risk from not receiving medications. Blood clots can form in the needle as
well creating issues with further IV infusion. There are, however, pumps that detect
and sound an alarm if an upstream occlusion is present.
When using a syringe pump, occlusion alarms may not sound soon enough to
prevent an adverse event. Health Canada alerted health professionals of international
incidents due to the nature of these specific pumps and the situations that could cause
a problem. Because syringe pumps typically deliver smaller amounts of more potent
medications, the correction measures if an occlusion happens must be done carefully
to not deliver too much or too little medication. One of the components of a situation
that would delay detecting an occlusion is the use of a large syringe with a low flow
rate. Length and conformity of tubing also affect a devices ability to trigger alarms
with accuracy.

Electrolyte Imbalance
An electrolyte imbalance can be caused if a patient receives too concentrated a
solution. Issues from this include a reduced amount of electrolytes in the blood such
as potassium, sodium, and magnesium. Electrolytes regulate hydration, blood pH, and
are important for nerve and muscle function. In order to correctly manage this
balance, blood tests are typically performed.

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Three: Traditional Infusion Pumps

79
Table 3-5

Ambulatory Infusion Pump Market Analysis, 2007-2017

(in millions of dollars at the manufacturers level)
Year

Revenues

Percent Change

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017

Compound Annual Growth Rate

2007-2012
2012-2017
2007-2017
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Four: Specialty Infusion Pumps

118

IMPLANTABLE INFUSION PUMPS

Implantable infusion pumps are the least utilized and most complex of
infusion pumps discussed in this study. These pumps are typically labeled for
specific drugs, dosages, and routes of administration and require a high level of
sophistication in the technology to run these pumps. For this reason, there are few
pumps approved by regulatory agencies around the world and unit costs for these
pumps remain high.
The most common applications for implantable infusion pumps include the
delivery of chemotherapy for liver and colorectal cancers, specifically the delivery of
5-FU. Medtronic has had success in delivering a pump to meet the needs of sufferers
with severe spasticity that requires muscle relaxants and anti-spasmodics.
Implantable pumps are used to deliver opioid drugs intrathecally or epidurally for
patients with severe chronic intractable pain.
Medtronic is the primary company discussed in the implantable infusion pump
segment.

Key Products, Manufacturers and Recent Developments

Medtronic
Medtronic is a leader in the implantable infusion pump segment with its
offering of SynchroMed II. This is a programmable drug infusion pump implanted in
the spine to deliver precise amounts of a muscle relaxant, Lioresal (offered by
Novartis) into the intrathecal space in the spine. This pump is designed to be used in
combination with medication to improve function, quality of life, and offer ease of
care to patients with severe spasticity of cerebral and spinal origin, including stroke,
cerebral palsy, brain injury, spinal cord injury, and multiple sclerosis.
Medtronic previously offered the IsoMed Constant Flow Infusion System,
however it has discontinued manufacturing for this product. However, some systems

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