Stakeholder Opinions: Portable Inhaler Devices - Key tools to differentiate brands and survive generic pressure

Introduction

An overview ofthe market for portable inhalers, looking at market shares,usefulness as tools for franchise protection and -expansion. Patient- and physician preferences are being analyzed as well as suitablility of molecules and inhaler types.,

Report Highlights
Highlights

Although a direct link between the type of device and level of disease control has never been proven, the latter is possibly indirectly influenced by the respective device's ease of use, its airflow resistance and the patient's device preferences. There are still opportunities in the asthma/COPD market to gain market share by differentiating with an improved inhaler device. One of such strategies would be to introduce a product line of different molecules in the same device model in order to give physicians the opportunity to minimize the scope for error on the patient side. Inhaled drugs are increasingly being developed for systemic use in non-pulmonary diseases. Reasons for this include improved patient acceptance and compliance and a faster onset of action. However, the commercial failure of Pfizer's inhaled insulin illustrates the difficulties in striking the right balance.
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TABLE OF CONTENTS
ABOUT DATAMONITOR HEALTHCARE 2
About the Infectious disease and Respiratory (ID&R) pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Market definition for this report 3
Objective of the analysis 4
Strategic scoping and focus 5
Data definitions, limitations and assumptions 5
Standard units 5
Derivation of Pricing Trends 5
Datamonitor insight into the portable inhaler devices market 5
Contributing experts 7
Related reports 7
Upcoming related reports 8
CHAPTER 2 PORTABLE INHALER DEVICES OVERVIEW 10
Metered dose inhalers 12
Pressurized metered dose inhalers 12
Advantages 13
Disadvantages 15
Breath-activated metered dose inhalers 18
Advantages 19
Disadvantages 26
Dry powder inhalers 27
Single-unit dose DPIs 28
Multi-dose reservoir DPIs 29
Multi-unit dose DPIs 30
Advantages 30
DPIs do not require actuation-inhalation co-ordination like pMDIs 30
Disadvantages 31
The wide variety of DPI types requires thorough patient-training 31
DPI performance relies on the strength of inhalation 32
Environmental factors have an impact on DPI performance 34
Soft mist inhaler (the Respimat) 34
CHAPTER 3 CURRENT MARKET SITUATION 36
Value and volume of the different inhaler devices 37
Sales of pMDIs versus DPIs versus BAIs 41
The pressurized metered dose inhalers 43
The dry powder inhalers 45
The breath-activated metered dose inhalers 47
Sales of branded versus generic products 49
Sales of CFC-containing versus CFC-free devices 51
Value and volume per country 53
Pricing of the different inhaler devices 57
Pricing of pMDIs versus DPIs versus BAIs 57
Pricing of branded versus generic products 59
Pricing of CFC-containing versus CFC-free devices 60
The availability of devices per molecule 61
Inhaled corticosteroids/long-acting beta2-agonist combinations 62
Inhaled corticosteroids 62
Long-acting beta2-agonists 63
Long-acting anticholinergics 64
Short-acting beta2-agonists 64
CHAPTER 4 THE LINK BETWEEN INHALER DEVICES AND DISEASE CONTROL 66
The importance of disease control 66
The relation between inhaler devices and disease control 68
Poor inhaler technique 69
The relation between inhaler devices and molecules 71
Does the ideal inhaler device exist? 74
CHAPTER 5 GAINING MARKET SHARE THROUGH INHALER DEVICES 77
Spiriva (tiotropium bromide) 77
Spiriva differentiated with the help of the Respimat 78
The CFC-HFA switch in the US 80
HFA as an alternative to CFC 80
3M's patents will prevent entry of other HFA SABAs 82
Impact on individual brands 82
Generic ICS/LABA combination products 83
CHAPTER 6 PORTABLE INHALER DEVICES IN NON-PULMONARY DISEASES 87
Inhaled insulin for the treatment of diabetes 89
Where does Exubera's failure leave the other inhaled insulins in development? 91
Inhaled drugs for the treatment of migraine 93
Inhaled apomorphine for the treatment of Parkinson's disease and erectile dysfunction 94
Inhaled fentanyl for the treatment of breakthrough pain 96
Inhaled drugs for the treatment of other non-pulmonary diseases 96
CHAPTER 7 THE FUTURE OF PORTABLE INHALER DEVICES 97
A differentiating device has biggest impact in medium-mature markets 97
The availability of a high number of molecules in the same device may lead to product uptake 100
The role of cost-effectiveness studies will become more important 102
The interaction among Big Pharma, generics companies and drug delivery companies will continue to develop 104
The growing importance of generics companies and drug delivery companies 106
BIBLIOGRAPHY 108
Papers 108
Websites 120
Press releases 120
Datamonitor reports 121
APPENDIX A INDEXED HISTORICAL SALES 122
Six major markets 122
United States 123
France 124
Germany 125
Italy 126
Spain 127
United Kingdom 128
APPENDIX B INDEXED HISTORICAL VOLUME 129
Six major markets 129
United States 130
France 131
Germany 132
Italy 133
Spain 134
United Kingdom 135
APPENDIX C PRICING 136
Six major markets 136
United States 137
France 138
Germany 139
Italy 140
Spain 141
UK 142
APPENDIX D OVERVIEW OF DEVICES AVAILABLE PER MOLECULE AND COUNTRY 143
Inhaled corticosteroid/long-acting beta2-agonist combinations 143
Inhaled corticosteroids 144
Long-acting beta2-agonists 146
Long-acting anticholinergics 147
Short-acting beta2-agonists 148
Short-acting anticholinergics 149
Short-acting anticholinergic/beta2-agonist combinations 150
APPENDIX E 151
Contributing experts 151
Report methodology 151
About Datamonitor 151
About Datamonitor Healthcare 152
About the Infectious Disease & Respiratory analysis team 153
Disclaimer 154
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Table 1: Overview of New Form Codes included in this report 4
Table 2: Inhaler assessment grades 20
Table 3: Mean scores for pMDI + Volumatic, Turbuhaler and Easi-Breathe groups for each aspect of technique 22
Table 4: Patient inhaler preference 23
Table 5: Indexed total value sales by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 38
Table 6: Indexed total volume (standard units) by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 40
Table 7: Indexed total value sales by device type, in the six major markets, 2003-07 42
Table 8: Indexed total value sales of pMDIs by molecule status and the presence of CFC, in the six major markets, 2003-07 44
Table 9: Indexed total value sales of DPIs by molecule status and the presence of CFC, in the six major markets, 2003-07 46
Table 10: Indexed total value sales of BAIs by molecule status and the presence of CFC, in the six major markets, 2003-07 48
Table 11: Indexed total value sales of devices delivering branded versus generic molecules, across all device types, in the six major markets, 2003-07 50
Table 12: Indexed total value sales of CFC-containing and CFC-free devices, irrespective of the molecules status, in the six major markets, 2003-07 52
Table 13: Pricing of portable inhaler devices per standard unit in the six major markets, 2003-07 57
Table 14: Prices of HFA (levo)salbutamol products in 2007 83
Table 15: Inhaled insulin products 90
Table 16: Number of asthma patients using single or multiple inhaler devices and proportion of those patients with inadequate technique, over two time periods 100
Table 17: Indexed total sales by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 122
Table 18: Indexed total sales by device type, molecule status and the presence of CFC, in the US, 2003-07 123
Table 19: Indexed total sales by device type, molecule status and the presence of CFC, in France, 2003-07 124
Table 20: Indexed total sales by device type, molecule status and the presence of CFC, in Germany, 2003-07 125
Table 21: Indexed total sales by device type, molecule status and the presence of CFC, in Italy, 2003-07 126
Table 22: Indexed total sales by device type, molecule status and the presence of CFC, in Spain, 2003-07 127
Table 23: Indexed total sales by device type, molecule status and the presence of CFC, in the UK, 2003-07 128
Table 24: Indexed total volume by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 129
Table 25: Indexed total volume by device type, molecule status and the presence of CFC, in the US, 2003-07 130
Table 26: Indexed total volume by device type, molecule status and the presence of CFC, in France, 2003-07 131
Table 27: Indexed total volume by device type, molecule status and the presence of CFC, in Germany, 2003-07 132
Table 28: Indexed total volume by device type, molecule status and the presence of CFC, in Italy, 2003-07 133
Table 29: Indexed total volume by device type, molecule status and the presence of CFC, in Spain, 2003-07 134
Table 30: Indexed total volume by device type, molecule status and the presence of CFC, in the UK, 2003-07 135
Table 31: Pricing of portable inhaler devices per standard unit in the six major markets, 2003-07 136
Table 32: Pricing of portable inhaler devices per standard unit in the US, 2003-07 137
Table 33: Pricing of portable inhaler devices per standard unit in France, 2003-07 138
Table 34: Pricing of portable inhaler devices per standard unit in Germany, 2003-07 139
Table 35: Pricing of portable inhaler devices per standard unit in Italy, 2003-07 140
Table 36: Pricing of portable inhaler devices per standard unit in Spain, 2003-07 141
Table 37: Pricing of portable inhaler devices per standard unit in the UK, 2003-07 142
Table 38: Overview of devices per country delivering inhaled corticosteroid/long-acting beta2-agonist combinations, 2007 143
Table 39: Overview of devices per country delivering inhaled corticosteroids, 2007 144
Table 40: Overview of devices per country delivering long-acting beta2-agonists, 2007 146
Table 41: Overview of devices per country delivering long-acting anticholinergics, 2007 147
Table 42: Overview of devices per country delivering short-acting beta2-agonists, 2007 148
Table 43: Overview of devices per country delivering short-acting anticholinergics, 2007 149
Table 44: Overview of devices per country delivering short-acting anticholinergic/beta2-agonist combinations, 2007 150

Figure 1: Timeline of the development of inhaler devices for pulmonary diseases 10
Figure 2: Advantages and disadvantages of the main three types of portable inhaler devices 11
Figure 3: A pressurized metered dose inhaler 12
Figure 4: Market share of pMDIs in the total portable inhaler market in Europe, 2007 14
Figure 5: pMDI-dependent errors made by patients when using their usual inhaler 16
Figure 6: A breath-activated metered dose inhaler 19
Figure 7: Patients' perception of the ease of use of a pMDI and a BAI 24
Figure 8: Distribution of NHS costs for BAI and standard pMDI patients 25
Figure 9: Several types of dry powder inhalers 28
Figure 10: Instructions for DPI use from patient information leaflets 32
Figure 11: The Respimat Soft Mist Inhaler (SMI) 35
Figure 12: Sales of inhaled drugs in the six major markets, 2006-16 36
Figure 13: The asthma/COPD market by method of drug delivery, 2007 37
Figure 14: Indexed total value sales by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 39
Figure 15: Indexed total volume (standard units) by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 41
Figure 16: Indexed total value sales by device type, in the six major markets, 2003-07 43
Figure 17: Indexed total value sales of pMDIs by molecule status and the presence of CFC, in the six major markets, 2003-07 45
Figure 18: Indexed total value sales of DPIs by molecule status and the presence of CFC, in the six major markets, 2003-07 47
Figure 19: Indexed total value sales of BAIs by molecule status and the presence of CFC, in the six major markets, 2003-07 49
Figure 20: Indexed total value sales of devices delivering branded versus generic molecules, across all device types, in the six major markets, 2003-07 51
Figure 21: Indexed total value sales of CFC-containing and CFC-free devices, irrespective of the molecules status, in the six major markets, 2003-07 53
Figure 22: Value and volume shares of the different types of devices in the US, 2007 54
Figure 23: Value and volume shares of the different types of devices in France, 2007 54
Figure 24: Value and volume shares of the different types of devices in Germany, 2007 55
Figure 25: Value and volume shares of the different types of devices in Italy, 2007 55
Figure 26: Value and volume shares of the different types of devices in Spain, 2007 56
Figure 27: Value and volume shares of the different types of devices in the UK, 2007 56
Figure 28: The average price per SU for the four main device types in the six major markets, 2003-07 59
Figure 29: The average price per SU for branded and generic molecules across all device types in the six major markets, 2003-07 60
Figure 30: The average price per SU for CFC and CFC-free devices across all types in the six major markets, 2003-07 61
Figure 31: Overview of the links between the device and disease control 66
Figure 32: Levels of asthma control according to the GINA guidelines 67
Figure 33: Characteristics of an ideal inhaler device 74
Figure 34: Factors influencing inhaler choice 75
Figure 35: Key drivers and resistors for the success of inhaled drug delivery in non-pulmonary diseases 87
Figure 36: Reasons why Exubera (inhaled insulin) failed 92
Figure 37: Overview of the characteristics of three types of asthma/COPD markets per drug class, 2007 98
Figure 38: Overview of the inhaled drug delivery sector 105
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