Inhalable Drug Delivery

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Publication Date: 2005-12-21

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Currently driven by the needs of the expanding respiratory market, the inhalable drug delivery sector has also been invigorated by the promise of growth through the systemic delivery of drugs via the lungs as the first inhalable insulin nears the market. But whether the technology can deliver on its promise has yet to be proven.

Scope

Presents historical and forecast sales (2001-2010) of the inhalable products that will drive demand for future inhalable drug delivery technology

Profiles the seven leading inhalable technology providers, benchmarking their strategic outlook, financial position, technology platform and pipeline

Evaluates the growth potential of this sector of the drug delivery market and the expected impact of systemic inhalable drugs reaching the market

Examines the pulmonary and systemic markets, detailing the key issues impacting the present and future, for each of these contrasting markets

Report Highlights
Although currently driven by the respiratory market, demand for inhalable drug delivery technology looks set to increase rapidly in the longer term if systemic inhalable therapies can achieve their full potential

Generic drug manufacturers, such as Ivax, are increasingly developing or acquiring the expertise to enhance generic pulmonary treatments by applying proprietary technology. This represents a real threat to the current pulmonary market value as the result would increase competition from cheaper branded super-generic products

Inhalable devices provide a more patient-acceptable delivery for protein therapeutics. However, the late stage inhalable insulin devices are bulky with usability issues which may confuse and discourage the patient population and act as a barrier to uptake. It is crucial that technological improvements are made in order to ensure long term growth

Reasons to Purchase

Understand the key drivers and resistors of growth within this area of drug delivery

Benchmark your position within the inhalable drug delivery market and identify the optimum strategy for future growth

Evaluate the comparative opportunities offered by the different indications being targeted by inhalable therapies

CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope - page 3
- Key findings - page 3
  - Demand for inhalable drug delivery technology is currently driven almost entirely by the respiratory market, which is forecast to continue to experience steady growth over the next five years generating increasing demand for technology. The delivery of drugs systemically through the lungs looks set to become reality in 2006 with the expected launch of the first inhaled insulin, Pfizer/Sanofi-Aventis's Exubera, presenting this sector with an opportunity for additional growth - page 4
  - Traditional technology licensing agreements provide inhalable drug delivery companies with a limited stream of licensing revenues. However, many of the key players in this market have identified the improved opportunities offered by in-house development of proprietary products, either to take them directly to market or to out-license at a later stage for higher returns. However, this strategy represents higher costs and ultimately higher risk. - page 6
  - As well as improving patient acceptance and compliance by introducing inhalable alternatives to current needle-injected treatments, such as inhalable insulin, improved onset of action is another key growth driver as well as technological innovation for the future evolution of certain therapy areas. However, the technology is currently not at a stage which will enable the new systemic therapies to make serious in-roads. - page 7
CHAPTER 2 MARKET SIZING - page 19
- Introduction - page 19
- Sizing the market for inhalable drugs - page 19
  - Total inhalable product market size 2001-2010 - page 19
  - Current market dominated by pulmonary inhalables - page 23
  - Future market dynamics reliant on systemic inhalables - page 28
CHAPTER 3 THE INHALABLE PULMONARY DRUG MARKET - page 34
- Introduction - page 34
- Different inhaler technologies - page 34
- Key Issues facing the pulmonary drug delivery market - page 38
  - Generics and supergenerics; an emerging market, case study - IVAX - page 38
  - The CFC - HFA propellant switch has driven recent technology development - page 44
  - The emergence of oral and biologics as therapies for asthma could threaten the market for inhalable drug delivery - page 47
CHAPTER 4 SYSTEMIC INHALABLE DRUG DELIVERY: AN OPPORTUNITY FOR GROWTH - page 51
- Introduction - page 51
- Systemic delivery of drugs through the lungs: why is it a good idea? - page 51
  - The lungs as a logical target - page 51
  - To deliver the drug effectively however inhalation devices must insure deep penetration - page 52
  - Therapeutic aerosol particle design is key to achieving consistent delivery - page 54
- Key technology providers - page 55
  - Will technology differentiation be the key to success? - page 58
    - Aradigm's "value-added approach" offers the potential for improved patient compliance and monitoring - page 58
    - Vectura is aiming to compete by offering a smaller device - page 59
- The main therapeutic targets for systemic inhalable delivery - page 60
- The likely success of inhaled systemic therapies for a variety of indications will ultimately be determined by the advantages and disadvantages of this delivery method - page 62
  - The key advantages driving the development of inhalable systemic treatments are the potential improvements in patient compliance and the rapid onset of action - page 63
    - Patient compliance drives development of inhalable insulin, but significant obstacles must be overcome - page 63
    - Short term safety benefits - page 64
    - Onset of action drives the development of inhalable treatments for erectile dysfunction and pain - page 65
  - Offsetting the advantages of inhalable systemic therapies are a number of unanswered questions - page 66
CHAPTER 5 COMPANY PROFILES - page 70
- Introduction - page 70
- Pharmaceutical companies use a variety of different strategies to gain access to inhalable drug delivery technology - page 70
- 3M - page 72
  - Key findings - page 72
  - Strategy - page 72
  - Strategic outlook - page 73
  - Alliance network - page 74
  - Financial outlook - page 75
  - Technology platform - page 77
  - Portfolio and pipeline - page 78
- Alkermes - page 79
  - Key findings - page 79
  - Strategy - page 79
  - Strategic outlook - page 80
  - Alliance network - page 81
  - Financial outlook - page 82
  - Technology platform - page 84
  - Portfolio and pipeline - page 84
- Aradigm - page 86
  - Key findings - page 86
  - Strategy - page 87
  - Strategic outlook - page 87
  - Alliance network - page 88
  - Financial outlook - page 89
  - Technology platform - page 91
  - Portfolio and pipeline - page 92
- Inyx - page 93
  - Key findings - page 94
  - Strategy - page 94
  - Strategic outlook - page 95
  - Alliance network - page 96
  - Financial outlook - page 97
  - Technology platform - page 99
  - Portfolio and pipeline - page 99
- Nektar - page 100
  - Key findings - page 101
  - Strategy - page 102
  - Strategic outlook - page 103
  - Alliance network - page 103
  - Financial outlook - page 104
  - Technology platform - page 106
  - Portfolio and pipeline - page 107
- SkyePharma - page 108
  - Key findings - page 108
  - Strategy - page 109
  - SWOT analysis - page 109
  - Strategic outlook - page 109
  - Alliance network - page 110
  - Financial outlook - page 111
  - Technology platform - page 113
  - Portfolio and pipeline - page 114
- Vectura - page 115
  - Key findings - page 115
  - Strategy - page 116
  - Alliance network - page 117
  - Technology platform - page 119
  - Financial outlook - page 119
  - Portfolio and pipeline - page 121
CHAPTER 6 APPENDIX - page 123
- Exchange rates - page 123
- PharmaVitae Company Tracking - page 123

List of Tables
Table 1: The key players in asthma and COPD - page 25
Table 2: Key product launches within the forecast period, 2005-2010 - page 28
Table 3: Future focus of systemic inhalables under development by leading 55 pharmaceutical companies - page 31
Table 4: Key players within the systemic drug delivery - page 56
Table 5: Leading providers of inhalable drug delivery technology - page 70
Table 6: 3M's alliance network for inhalable delivery systems - page 74
Table 7: Key financial figures for 3M - page 76
Table 8: 3M's pipeline 2005 - page 78
Table 9: Alkermes's alliance network for inhalable delivery systems - page 82
Table 10: Key financial figures for Alkermes - page 83
Table 11: Alkermes's pipeline, 2005 - page 85
Table 12: Aradigm's alliance network for inhalable delivery systems - page 89
Table 13: Key financial figures for Aradigm - page 90
Table 14: Aradigm's pipeline, 2005 - page 92
Table 15: Inyx's alliance network for inhalable delivery systems - page 97
Table 16: Key financial figures for Inyx - page 98
Table 17: Nektar's alliance network for inhalable delivery systems - page 104
Table 18: Key financial figures for Nektar - page 105
Table 19: Nektar's pipeline, 2005 - page 107
Table 20: SkyePharma's alliance network for inhalable delivery systems - page 111
Table 21: Key financial figures for SkyePharma - page 112
Table 22: SkyePharma's pipeline, 2005 - page 114
Table 23: Vectura's alliance network for inhalable delivery systems - page 118
Table 24: Key financial figures for Vectura - page 120
Table 25: Vectura's pipeline, 2005 - page 121
Table 29: Exchange rates, 2004 - page 123
Table 27: Companies included in the PharmaVitae Company Tracking Service - page 123

List of Figures
Figure 1: Key growth drivers and resistors - page 5
Figure 2: Assessment of revenue potential for the key development areas of systemic inhalable therapies - page 8
Figure 3: Total global market of inhalable drug delivery 2001-2010 - page 20
Figure 4: Key growth drivers and resistors - page 21
Figure 5: The emergence of inhalable systemic treatments - page 22
Figure 6: The current inhalable pulmonary drug delivery market - page 23
Figure 7: The evolution of the pulmonary inhalable market - page 26
Figure 8: The key players in asthma and COPD - page 27
Figure 9: Key players in the global systemic inhalable market, 2005-2010 - page 30
Figure 10: Evolution of market shares of systemic inhalable products of key players 2008-2010 - page 31
Figure 11: Development focus of the inhalable market players: Pulmonary vs Systemic - page 32
Figure 12: An example of an MDI: 3M's MDI anatomy - page 35
Figure 13: The advantages and disadvantages of the MDI - page 36
Figure 14: The advantages and disadvantages of the DPI - page 37
Figure 15: Global spread of inhalable generics manufacturers - page 39
Figure 16: Global inhalable market impact of GSK's "Super-Advair" - page 44
Figure 17: Comparison of injectable, inhalable and oral growth rates for asthma and COPD treatments for the top 55 pharmaceutical companies. - page 49
Figure 18: Pathway of an inhaled drug - page 53
Figure 19: Drug delivery company's interests - page 57
Figure 20: Assessment of revenue potential for the key development areas of systemic inhalable therapies - page 60
Figure 21: Key growth drivers and resistors - page 63
Figure 22: The drug delivery sector - page 71
Figure 23: Assessment of 3M's strategic position - page 73
Figure 24: Assessment of Alkermes's strategic position - page 80
Figure 25: Assessment of Aradigm strategic position - page 87
Figure 26: Assessment of Inyx's strategic position - page 95
Figure 27: Assessment of Nektar's strategic position - page 102
Figure 28: Assessment of SkyePharma's strategic position - page 109
Figure 29: Assessment of Vectura's strategic position - page 116

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Inhalable Drug Delivery

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