Peripherally inserted central catheters (PICCs) are introduced through the basilic, cephalic or median cubital veins in the arm, and the tip of the catheter is then directed to the superior vena cava (SVC). PICCs have a wide range of applications and are commonly used for delivering chemotherapy and antibiotics, and for drawing blood. Generally, the devices are used for one week to three months but can range in use from a few days to over a year. This flexibility sets PICCs apart from other vascular access catheters and contributes to the increased use of PICCs in general. The most frequent indwelling time for a PICC is three weeks. Although the number of PICC procedures is relatively small compared with those involving central venous catheters (CVCs), PICCs are taking market share away from other catheter types. This is due to the fact that PICCs are associated with a lower infection rate in comparison to CVCs.
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TABLE OF CONTENTS I
LIST OF FIGURES XVII
LIST OF CHARTS XXII
EXECUTIVE SUMMARY 1
EUROPEAN MARKET FOR VASCULAR ACCESS DEVICES AND ACCESSORIES OVERVIEW 1
COMPETITIVE ANALYSIS 3
MARKET TRENDS 5
MARKET DEVELOPMENTS 6
PROCEDURE NUMBERS 7
MARKETS INCLUDED 8
KEY REPORT UPDATES 11
VERSION HISTORY 12
RESEARCH METHODOLOGY 13
1.1 RESEARCH SCOPE 13
1.2 IDATA’S 9-STEP METHODOLOGY 13
Step 1: Project Initiation & Team Selection 13
Step 2: Prepare Data Systems and Perform Secondary Research 15
Step 3: Preparation for Interviews & Questionnaire Design 16
Step 4: Performing Primary Research 17
Step 5: Research Analysis: Establishing Baseline Estimates 19
Step 6: Market Forecast and Analysis 20
Step 7: Identify Strategic Opportunities 22
Step 8: Final Review and Market Release 23
Step 9: Customer Feedback and Market Monitoring 24
DISEASE OVERVIEW 25
2.1 BASIC ANATOMY 25
2.1.1 Human Vascular System 25
2.2 VASCULAR PATHOLOGY AND DISORDERS 26
2.2.1 Cancer 26
2.2.2 End-Stage Renal Disease 27
2.2.3 Diabetes 29
PRODUCT ASSESSMENT 32
3.1 PRODUCT PORTFOLIOS 32
3.1.1 Peripherally Inserted Central Catheters 32
3.1.1.1 Introduction 32
3.1.1.1.1 PICC Placement 32
3.1.1.2 AngioDynamics 34
3.1.1.2.1 BioFlo® 34
3.1.1.3 Argon Medical 34
3.1.1.3.1 First PICC™ 34
3.1.1.3.2 L-Cath™ 34
3.1.1.4 B. Braun 34
3.1.1.4.1 V-5™ 34
3.1.1.4.2 Other PICC Offerings 34
3.1.1.5 Cook Medical 34
3.1.1.5.1 Spectrum® 34
3.1.1.5.2 Other PICC Offerings 35
3.1.1.6 C.R. Bard 35
3.1.1.6.1 PowerPICC® 35
3.1.1.6.2 Groshong® 35
3.1.1.6.3 Per-Q-Cath® 35
3.1.1.6.4 Other PICC Offerings 35
3.1.1.7 GaltNeedleTech 35
3.1.1.7.1 SYNERGY™ 35
3.1.1.8 Medcomp 36
3.1.1.8.1 Pro-PICC™ 36
3.1.1.8.2 Vascu-PICC™ 36
3.1.1.9 Neo Medical 36
3.1.1.9.1 Neo-Magic™ 36
3.1.1.9.2 V-Cath™ 36
3.1.1.10 PFM Medical 36
3.1.1.10.1 pfm CT PICC II 36
3.1.1.11 Teleflex Medical 36
3.1.1.11.1 ARROW® 36
3.1.1.12 Trinity Sterile 37
3.1.1.12.1 Trinity™ PICC II 37
3.1.1.13 Vygon 37
3.1.1.13.1 Premicath™ 37
3.1.1.13.2 Epicutaneo-Cava™ 37
3.1.1.13.3 Nutriline™ 37
3.1.1.13.4 Lifecath™ 37
3.2 REGULATORY ISSUES AND RECALLS 38
3.2.1 November 2015 38
3.2.2 October 2015 38
3.2.3 September 2015 39
3.2.4 August 2015 41
3.2.5 July 2015 42
3.2.6 April 2015 44
3.2.7 March 2015 45
3.2.8 February 2015 46
3.2.9 January 2015 46
3.2.10 December 2014 47
3.2.11 October 2014 48
3.2.12 September 2014 49
3.2.13 May 2014 50
3.2.14 April 2014 50
3.2.15 March 2014 51
3.2.16 January 2014 51
3.2.17 December 2013 52
3.2.18 September 2013 53
3.2.19 August 2013 54
3.2.20 June 2013 54
3.2.21 March 2013 55
3.2.22 February 2013 56
3.2.23 December 2012 56
3.2.24 August 2012 56
3.2.25 June 2012 57
3.2.26 May 2012 58
3.2.27 March 2012 59
3.2.28 February 2012 60
3.2.29 January 2012 60
3.3 CLINICAL TRIALS 64
3.3.1 Peripherally Inserted Central Catheters 65
3.4 PRODUCT PIPELINES 75
3.4.1 Alliance Vascular Devices, LLC 75
3.4.1.1 FreeHand Safety Huber Needle® 75
3.4.2 AngioDynamics 75
3.4.2.1 Celerity™ PICC Tip Confirmation System with Navigation 75
3.4.2.2 Firefly 75
3.4.2.3 BioFlo® PICC Line Extension 76
3.4.2.4 BioFlo® Port Line Extension 76
3.4.2.5 Next Generation BioFlo® PICC 76
3.4.2.6 Next Generation BioFlo® Port 76
3.4.3 Bluegrass Vascular Technologies, Inc. 76
3.4.3.1 Surfacer® Inside-Out™ Access System 76
3.4.4 C.R. Bard 76
3.4.4.1 Chemical-Resistant PICCs 76
3.4.4.2 Novel Advanced Material PICCs 77
3.4.4.3 PowerGlide® Pro Midline 77
3.4.4.4 AccuCath® 77
3.4.4.5 Xenesis™ Acute Hemodialysis Catheter 77
3.4.4.6 Site~Rite® 8 Ultrasound System 77
3.4.5 M. C. Johnson 77
3.4.5.1 PICC Securement Device 77
3.4.6 Nipro Medical 78
3.4.6.1 Shielding Safety Needle 78
3.4.6.2 Safety Syringe 78
3.4.6.3 Safety PIVC 78
3.4.7 Parasol Medical 78
3.4.7.1 Catheter Securement Device 78
3.4.8 PAVmed Inc. 78
3.4.8.1 NextCath™ 78
3.4.9 Phase One Medical 78
3.4.9.1 Goldilocks™ Long Term Hemodialysis Catheter 78
3.4.9.2 Triple-Lumen Symetrex™ Hemodialysis Catheter 79
3.4.10 Prodigy Diabetes Care, LLC. 79
3.4.10.1 Insulin Pen Needles 79
3.4.11 Sharklet Technologies, Inc. 79
3.4.11.1 Sharklet™ Central Venous Catheter 79
3.4.12 Starboard Medical 79
3.4.12.1 Catheter Securement Devices 79
3.4.13 Teleflex Medical 80
3.4.13.1 Arrow® Endurance™ Extended Dwell Peripheral Catheter System 80
3.4.13.2 Tip Confirmation for CVCs, Chronic Hemodialysis Catheters & Ports 80
3.4.14 Vascular Access Technologies, Inc. 80
3.4.14.1 SAFECVAD™ 80
COUNTRY PROFILES 81
4.1 INTRODUCTION 81
4.1.1 Population 81
4.1.2 GDP Per Capita 81
4.1.3 Price Index 81
4.2 GERMANY 82
4.3 FRANCE 83
4.4 UNITED KINGDOM 84
4.5 ITALY 85
4.6 SPAIN 86
4.7 BENELUX 87
4.8 SCANDINAVIA 88
4.9 AUSTRIA 89
4.10 SWITZERLAND 90
4.11 PORTUGAL 91
PERIPHERALLY INSERTED CENTRAL CATHETER MARKET 92
5.1 INTRODUCTION 92
5.1.1 PICC Placement 92
5.1.2 Catheter Material 93
5.1.3 Power-Injectable PICCs 94
5.2 UNIT ANALYSIS 95
5.2.1.1 Peripherally Inserted Central Catheter Units Sold by Lumen Number 95
5.3 MARKET OVERVIEW 96
5.4 MARKET ANALYSIS AND FORECAST 100
5.4.1 Total Peripherally Inserted Central Catheter Market 100
5.4.1.1 Conventional Peripherally Inserted Central Catheter Market 108
5.4.1.2 Power-Injectable Peripherally Inserted Central Catheter Market 116
5.5 DRIVERS AND LIMITERS 124
5.5.1 Market Drivers 124
5.5.2 Market Limiters 125
5.6 COMPETITIVE MARKET SHARE ANALYSIS 128
ABBREVIATIONS 133
APPENDIX: COMPANY PRESS RELEASES 135
Chart 1 1: Vascular Access Device and Accessories Market by Segment, Europe, 2013 – 2023 2
Chart 1 2: Vascular Access Device and Accessories Market Overview, Europe, 2016 & 2023 2
Chart 4 1: Country Profile, Germany, 2016 82
Chart 4 2: Country Profile, France, 2016 83
Chart 4 3: Country Profile, United Kingdom, 2016 84
Chart 4 4: Country Profile, Italy, 2016 85
Chart 4 5: Country Profile, Spain, 2016 86
Chart 4 6: Country Profile, Benelux, 2016 87
Chart 4 7: Country Profile, Scandinavia, 2016 88
Chart 4 8: Country Profile, Austria, 2016 89
Chart 4 9: Country Profile, Switzerland, 2016 90
Chart 4 10: Country Profile, Portugal, 2016 91
Chart 5 1: Peripherally Inserted Central Catheter Market by Segment, Europe, 2013 – 2023 98
Chart 5 2: Peripherally Inserted Central Catheter Market by Segment, Europe, 2016 99
Chart 5 3: Peripherally Inserted Central Catheter Market by Segment, Europe, 2023 99
Chart 5 4: Total Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 102
Chart 5 5: Conventional Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 110
Chart 5 6: Power-Injectable Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 118
Chart 5 7: Leading Competitors, Peripherally Inserted Central Catheter Market, Europe, 2016 132
Figure 1 1: Vascular Access Device and Accessories Competitor Market Share Ranking by Segment, Europe, 2016 (1 of 2) 3
Figure 1 2: Vascular Access Device and Accessories Competitor Market Share Ranking by Segment, Europe, 2016 (2 of 2) 3
Figure 1 3: Companies Researched in this Report, Europe, 2016 4
Figure 1 4: Factors Impacting the Vascular Access Device and Accessories Market by Segment, Europe, 2016 5
Figure 1 5: Recent Events in the Vascular Access Device and Accessories Market, Europe, 2013 – 2016 6
Figure 1 6: Vascular Access Procedures Covered, Europe, 2016 7
Figure 1 7: Vascular Access Device and Accessories Markets Covered, Europe, 2016 (1 of 3) 8
Figure 1 8: Vascular Access Device and Accessories Markets Covered, Europe, 2016 (2 of 3) 9
Figure 1 9: Vascular Access Device and Accessories Markets Covered, Europe, 2016 (3 of 3) 10
Figure 1 10: Key Report Updates 11
Figure 1 11: Version History 12
Figure 3 1: Class 2 Device Recall Medtronic 38
Figure 3 2: Class 2 Device Recall Smiths Medical 38
Figure 3 3: Class 2 Device Recall Arrow 39
Figure 3 4: Class 2 Device Recall Arrow 39
Figure 3 5: Class 2 Device Recall Covidien (Medtronic) 40
Figure 3 6: Class 2 Device Recall Arrow 41
Figure 3 7: Class 2 Device Recall Medline 41
Figure 3 8: Class 2 Device Recall Arrow 41
Figure 3 9: Class 2 Device Recall B. Braun 41
Figure 3 10: Class 3 Device Recall Bard Access 42
Figure 3 11: Class 2 Device Recall Covidien (Medtronic) 42
Figure 3 12: Class 2 Device Recall Bard Access 44
Figure 3 13: Class 2 Device Recall Bard Access 44
Figure 3 14: Class 2 Device Recall Medcomp & AngioDynamics 45
Figure 3 15: Class 2 Device Recall Bard Access 45
Figure 3 16: Class 2 Device Recall Arrow 46
Figure 3 17: Class 2 Device Recall Medcomp 46
Figure 3 18: Class 2 Device Recall Arrow 46
Figure 3 19: Class 2 Device Recall Arrow 47
Figure 3 20: Class 2 Device Recall Smiths Medical 47
Figure 3 21: Class 2 Device Recall PFM Medical 47
Figure 3 22: Class 2 Device Recall PFM Medical 47
Figure 3 23: Class 2 Device Recall Becton Dickinson 48
Figure 3 24: Class 2 Device Recall Arrow 48
Figure 3 25: Class 2 Device Recall Arrow 48
Figure 3 26: Class 2 Device Recall Navilyst Medical 48
Figure 3 27: Class 2 Device Recall Argon Medical 49
Figure 3 28: Class 2 Device Recall Arrow 50
Figure 3 29: Class 2 Device Recall Arrow 50
Figure 3 30: Class 2 Device Recall Arrow 51
Figure 3 31: Class 2 Device Recall Bard Access 51
Figure 3 32: Class 2 Device Recall Navilyst Medical 51
Figure 3 33: Class 2 Device Recall Bard Access 52
Figure 3 34: Class 2 Device Recall Smiths Medical 52
Figure 3 35: Class 2 Device Recall B. Braun 52
Figure 3 36: Class 2 Device Recall Smiths Medical 53
Figure 3 37: Class 2 Device Recall Access Scientific 53
Figure 3 38: Class 2 Device Recall Covidien (Medtronic) 53
Figure 3 39: Class 2 Device Recall Arrow 54
Figure 3 40: Class 2 Device Recall Bard Access 54
Figure 3 41: Class 2 Device Recall Becton Dickinson 54
Figure 3 42: Class 2 Device Recall Churchill Medical Systems, Inc. A Vygon Company 55
Figure 3 43: Class 2 Device Recall Bard Access 55
Figure 3 44: Class 2 Device Recall Churchill Medical Systems, Inc. A Vygon Company 55
Figure 3 45: Class 2 Device Recall Medcomp 56
Figure 3 46: Class 2 Device Recall Becton Dickinson 56
Figure 3 47: Class 3 Device Recall Bard Access 56
Figure 3 48: Class 2 Device Recall Medcomp 57
Figure 3 49: Class 1 Device Recall Arrow 57
Figure 3 50: Class 2 Device Recall Arrow 57
Figure 3 51: Class 2 Device Recall Vygon 57
Figure 3 52: Class 2 Device Recall Covidien (Medtronic) 58
Figure 3 53: Class 2 Device Recall Medcomp 59
Figure 3 54: Class 2 Device Recall Churchill Medical Systems, Inc. A Vygon Company 59
Figure 3 55: Class 2 Device Recall Christie Medical Holdings 59
Figure 3 56: Class 3 Recall Bard Access 59
Figure 3 57: Class 2 Device Recall AngioDynamics 60
Figure 3 58: Class 2 Device Recall Becton Dickinson 60
Figure 3 59: Class 2 Device Recall AngioDynamics 60
Figure 3 60: Class 2 Device Recall AngioDynamics 62
Figure 3 61: Class 3 Device Recall AngioDynamics 63
Figure 3 62: Class 2 Device Recall AngioDynamics 63
Figure 3 63: A Pragmatic Randomized Trial Standard of Care Vascular Access Strategies 65
Figure 3 64: PICC and Midline Related Complications: A Multicenter Observational Study 66
Figure 3 65: Complications Associated With Central Venous Access 66
Figure 3 66: Evaluation of Electrocardiographic Guidance 66
Figure 3 67: Phase II Randomised Study Comparing the Tolerance of PICC Line 67
Figure 3 68: Randomized, Prospective, Single-center Study 67
Figure 3 69: A Randomized Controlled Trial Comparing Ultrasound Guided PICC Line Insertion 68
Figure 3 70: Ultrasound-guided Peripheral Vascular Access 68
Figure 3 71: Vascular Access in Cancer Patients 69
Figure 3 72: A Monocenter Prospective Study 70
Figure 3 73: Vascular Access in Hematological Patients 70
Figure 3 74: ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip 70
Figure 3 75: Sequential Pneumatic Compression 71
Figure 3 76: Reliability of Central Venous Pressure Measurements 71
Figure 3 77: Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation 72
Figure 3 78: A Randomized Open-labeled Multicenter Study 72
Figure 3 79: A Phase III Study of Peripherally Inserted Versus Centrally Inserted Central Venous Catheters 73
Figure 3 80: A Randomized Prospective Multicenter Evaluation 73
Figure 3 81: Randomized Double Blind Comparison 74
Figure 3 82: An Observational, Prospective, Single-center Study of Placement and Confirmation 74
Figure 5 1: Peripherally Inserted Central Catheter Units Sold by Lumen Number, Europe, 2016 95
Figure 5 2: Peripherally Inserted Central Catheter Market by Segment, Europe, 2013 – 2023 (€M) 97
Figure 5 3: Peripherally Inserted Central Catheter Market by Segment, Europe, 2013 – 2023 (US$M) 97
Figure 5 4: Total Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€ and US$) 101
Figure 5 5: Units Sold by Country, Total Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 103
Figure 5 6: Average Selling Price by Country, Total Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€) 104
Figure 5 7: Average Selling Price by Country, Total Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (US$) 105
Figure 5 8: Market Value by Country, Total Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€M) 106
Figure 5 9: Market Value by Country, Total Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (US$M) 107
Figure 5 10: Conventional Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€ and US$) 109
Figure 5 11: Units Sold by Country, Conventional Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 111
Figure 5 12: Average Selling Price by Country, Conventional Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€) 112
Figure 5 13: Average Selling Price by Country, Conventional Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (US$) 113
Figure 5 14: Market Value by Country, Conventional Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€M) 114
Figure 5 15: Market Value by Country, Conventional Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (US$M) 115
Figure 5 16: Power-Injectable Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€ and US$) 117
Figure 5 17: Units Sold by Country, Power-Injectable Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 119
Figure 5 18: Average Selling Price by Country, Power-Injectable Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€) 120
Figure 5 19: Average Selling Price by Country, Power-Injectable Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (US$) 121
Figure 5 20: Market Value by Country, Power-Injectable Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (€M) 122
Figure 5 21: Market Value by Country, Power-Injectable Peripherally Inserted Central Catheter Market, Europe, 2013 – 2023 (US$M) 123
Figure 5 22: Drivers and Limiters, Peripherally Inserted Central Catheter Market, Europe, 2016 127
Figure 5 23: Leading Competitors by Country, Peripherally Inserted Central Catheter Market, Europe, 2016 131
Figure 7 1: Press Release Summary 135
3DT Holdings LLC
3M
Access Scientific
Ambu Inc.
AngioDynamics
Artsana
B. Braun
Baxter International
Becton Dickinson
Bionic
C. R. Bard
Cardinal Health
CareFusion
Codan
Cook Medical
Covidien
Deltamed
Districlass Medical
Edwards Lifesciences
Endeavor Capital
Fresenius
Grupo Sendal
Interrad Medical
Investindustrial
Ivera Medical Corporation
Joline
Kimal
LPI
Medcomp
Medikit
Medtronic
Navilyst Medical
Nipro Medical
Nostix, LLC
Novico
Pentaferte
Perouse Medical
PFM Medical
PFM Medical
PositiveID Corp.
Rays
Romedex
Roundtable Healthcare
Safety Syringes Inc.
Semprus BioSciences
Smiths Medical
SonoSite, Inc.
Teleflex Medical
Terumo
Troge
Vascular Pathways, Inc.
VeriTeQ Acquisition Corp.
VigMed
V-Tech
Vygon
