Portable Inhaler Devices - Current Market and Life Cycle Opportunities

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Publication Date: 2008-04-02

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An overview of the 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.

Scope

Summary of the advantages and disadvantages of the main types of portable inhaler devices

Market overview highlighting CFC-free and CFC-containing devices and devices delivering branded and generic molecules, based on 2007 IMS Sales Data

Overview of portable inhaler devices in non-pulmonary diseases, including inhaled insulin for the treatment of diabetes

Assessment of opportunities to use portable inhaler devices as key factors in a product's commercial success throughout its lifecycle

Report 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.

Reasons to Purchase

Understand key advantages and disadvantages of different types of portable inhaler devices

Identify future challenges for portable inhaler devices and best method of meeting these

Assess the respiratory market's segmentation and dynamics by device type and brand/generic split

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious disease and Respiratory (ID&R) pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Market definition for this report - page 3
- Objective of the analysis - page 4
- Strategic scoping and focus - page 5
- Data definitions, limitations and assumptions - page 5
  - Standard units - page 5
  - Derivation of Pricing Trends - page 5
- Datamonitor insight into the portable inhaler devices market - page 5
- Contributing experts - page 7
- Related reports - page 7
- Upcoming related reports - page 8
CHAPTER 2 PORTABLE INHALER DEVICES OVERVIEW - page 10
- Metered dose inhalers - page 12
  - Pressurized metered dose inhalers - page 12
    - Advantages - page 13
    - Disadvantages - page 15
  - Breath-activated metered dose inhalers - page 18
    - Advantages - page 19
    - Disadvantages - page 26
- Dry powder inhalers - page 27
  - Single-unit dose DPIs - page 28
  - Multi-dose reservoir DPIs - page 29
  - Multi-unit dose DPIs - page 30
  - Advantages - page 30
    - DPIs do not require actuation-inhalation co-ordination like pMDIs - page 30
  - Disadvantages - page 31
    - The wide variety of DPI types requires thorough patient-training - page 31
    - DPI performance relies on the strength of inhalation - page 32
    - Environmental factors have an impact on DPI performance - page 34
- Soft mist inhaler (the Respimat) - page 34
CHAPTER 3 CURRENT MARKET SITUATION - page 36
- Value and volume of the different inhaler devices - page 37
  - Sales of pMDIs versus DPIs versus BAIs - page 41
    - The pressurized metered dose inhalers - page 43
    - The dry powder inhalers - page 45
    - The breath-activated metered dose inhalers - page 47
  - Sales of branded versus generic products - page 49
  - Sales of CFC-containing versus CFC-free devices - page 51
  - Value and volume per country - page 53
- Pricing of the different inhaler devices - page 57
  - Pricing of pMDIs versus DPIs versus BAIs - page 57
  - Pricing of branded versus generic products - page 59
  - Pricing of CFC-containing versus CFC-free devices - page 60
- The availability of devices per molecule - page 61
  - Inhaled corticosteroids/long-acting beta2-agonist combinations - page 62
  - Inhaled corticosteroids - page 62
  - Long-acting beta2-agonists - page 63
  - Long-acting anticholinergics - page 64
  - Short-acting beta2-agonists - page 64
CHAPTER 4 THE LINK BETWEEN INHALER DEVICES AND DISEASE CONTROL - page 66
- The importance of disease control - page 66
- The relation between inhaler devices and disease control - page 68
  - Poor inhaler technique - page 69
- The relation between inhaler devices and molecules - page 71
- Does the ideal inhaler device exist? - page 74
CHAPTER 5 GAINING MARKET SHARE THROUGH INHALER DEVICES - page 77
- Spiriva (tiotropium bromide) - page 77
  - Spiriva differentiated with the help of the Respimat - page 78
- The CFC-HFA switch in the US - page 80
  - HFA as an alternative to CFC - page 80
  - 3M's patents will prevent entry of other HFA SABAs - page 82
  - Impact on individual brands - page 82
- Generic ICS/LABA combination products - page 83
CHAPTER 6 PORTABLE INHALER DEVICES IN NON-PULMONARY DISEASES - page 87
- Inhaled insulin for the treatment of diabetes - page 89
  - Where does Exubera's failure leave the other inhaled insulins in development? - page 91
- Inhaled drugs for the treatment of migraine - page 93
- Inhaled apomorphine for the treatment of Parkinson's disease and erectile dysfunction - page 94
- Inhaled fentanyl for the treatment of breakthrough pain - page 96
- Inhaled drugs for the treatment of other non-pulmonary diseases - page 96
CHAPTER 7 THE FUTURE OF PORTABLE INHALER DEVICES - page 97
- A differentiating device has biggest impact in medium-mature markets - page 97
- The availability of a high number of molecules in the same device may lead to product uptake - page 100
- The role of cost-effectiveness studies will become more important - page 102
- The interaction among Big Pharma, generics companies and drug delivery companies will continue to develop - page 104
  - The growing importance of generics companies and drug delivery companies - page 106
BIBLIOGRAPHY - page 108
- Papers - page 108
- Websites - page 120
- Press releases - page 120
- Datamonitor reports - page 121
APPENDIX A INDEXED HISTORICAL SALES - page 122
- Six major markets - page 122
- United States - page 123
- France - page 124
- Germany - page 125
- Italy - page 126
- Spain - page 127
- United Kingdom - page 128
APPENDIX B INDEXED HISTORICAL VOLUME - page 129
- Six major markets - page 129
- United States - page 130
- France - page 131
- Germany - page 132
- Italy - page 133
- Spain - page 134
- United Kingdom - page 135
APPENDIX C PRICING - page 136
- Six major markets - page 136
- United States - page 137
- France - page 138
- Germany - page 139
- Italy - page 140
- Spain - page 141
- UK - page 142
APPENDIX D OVERVIEW OF DEVICES AVAILABLE PER MOLECULE AND COUNTRY - page 143
- Inhaled corticosteroid/long-acting beta2-agonist combinations - page 143
- Inhaled corticosteroids - page 144
- Long-acting beta2-agonists - page 146
- Long-acting anticholinergics - page 147
- Short-acting beta2-agonists - page 148
- Short-acting anticholinergics - page 149
- Short-acting anticholinergic/beta2-agonist combinations - page 150
APPENDIX E - page 151
- Contributing experts - page 151
- Report methodology - page 151
- About Datamonitor - page 151
  - About Datamonitor Healthcare - page 152
  - About the Infectious Disease & Respiratory analysis team - page 153
  - Disclaimer - page 154

List of Tables
Table 1: Overview of New Form Codes included in this report - page 4
Table 2: Inhaler assessment grades - page 20
Table 3: Mean scores for pMDI + Volumatic, Turbuhaler and Easi-Breathe groups for each aspect of technique - page 22
Table 4: Patient inhaler preference - page 23
Table 5: Indexed total value sales by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 - page 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 - page 40
Table 7: Indexed total value sales by device type, in the six major markets, 2003-07 - page 42
Table 8: Indexed total value sales of pMDIs by molecule status and the presence of CFC, in the six major markets, 2003-07 - page 44
Table 9: Indexed total value sales of DPIs by molecule status and the presence of CFC, in the six major markets, 2003-07 - page 46
Table 10: Indexed total value sales of BAIs by molecule status and the presence of CFC, in the six major markets, 2003-07 - page 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 - page 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 - page 52
Table 13: Pricing of portable inhaler devices per standard unit in the six major markets, 2003-07 - page 57
Table 14: Prices of HFA (levo)salbutamol products in 2007 - page 83
Table 15: Inhaled insulin products - page 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 - page 100
Table 17: Indexed total sales by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 - page 122
Table 18: Indexed total sales by device type, molecule status and the presence of CFC, in the US, 2003-07 - page 123
Table 19: Indexed total sales by device type, molecule status and the presence of CFC, in France, 2003-07 - page 124
Table 20: Indexed total sales by device type, molecule status and the presence of CFC, in Germany, 2003-07 - page 125
Table 21: Indexed total sales by device type, molecule status and the presence of CFC, in Italy, 2003-07 - page 126
Table 22: Indexed total sales by device type, molecule status and the presence of CFC, in Spain, 2003-07 - page 127
Table 23: Indexed total sales by device type, molecule status and the presence of CFC, in the UK, 2003-07 - page 128
Table 24: Indexed total volume by device type, molecule status and the presence of CFC, in the six major markets, 2003-07 - page 129
Table 25: Indexed total volume by device type, molecule status and the presence of CFC, in the US, 2003-07 - page 130
Table 26: Indexed total volume by device type, molecule status and the presence of CFC, in France, 2003-07 - page 131
Table 27: Indexed total volume by device type, molecule status and the presence of CFC, in Germany, 2003-07 - page 132
Table 28: Indexed total volume by device type, molecule status and the presence of CFC, in Italy, 2003-07 - page 133
Table 29: Indexed total volume by device type, molecule status and the presence of CFC, in Spain, 2003-07 - page 134
Table 30: Indexed total volume by device type, molecule status and the presence of CFC, in the UK, 2003-07 - page 135
Table 31: Pricing of portable inhaler devices per standard unit in the six major markets, 2003-07 - page 136
Table 32: Pricing of portable inhaler devices per standard unit in the US, 2003-07 - page 137
Table 33: Pricing of portable inhaler devices per standard unit in France, 2003-07 - page 138
Table 34: Pricing of portable inhaler devices per standard unit in Germany, 2003-07 - page 139
Table 35: Pricing of portable inhaler devices per standard unit in Italy, 2003-07 - page 140
Table 36: Pricing of portable inhaler devices per standard unit in Spain, 2003-07 - page 141
Table 37: Pricing of portable inhaler devices per standard unit in the UK, 2003-07 - page 142
Table 38: Overview of devices per country delivering inhaled corticosteroid/long-acting beta2-agonist combinations, 2007 - page 143
Table 39: Overview of devices per country delivering inhaled corticosteroids, 2007 - page 144
Table 40: Overview of devices per country delivering long-acting beta2-agonists, 2007 - page 146
Table 41: Overview of devices per country delivering long-acting anticholinergics, 2007 - page 147
Table 42: Overview of devices per country delivering short-acting beta2-agonists, 2007 - page 148
Table 43: Overview of devices per country delivering short-acting anticholinergics, 2007 - page 149
Table 44: Overview of devices per country delivering short-acting anticholinergic/beta2-agonist combinations, 2007 - page 150

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

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Portable Inhaler Devices - Current Market and Life Cycle Opportunities

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