IntroductionThe Australian asthma/COPD market grew from $278m in 2006 to $333m in 2009. Its growth will slow considerably with the market projected to reach revenues of $354m in 2019. As new drugs launched will be me-too products or combinations of existing classes, Datamonitor assumes that these will be priced similarly to current brands in order to receive reimbursement, leading to a stabilizing market.Scope*Forecast for marketed and late-stage pipeline asthma/COPD products in Australia.*Assessment of Australia-specific drivers and resistors likely to impact the market.*Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates.*Case study focusing on the impact of the lack of reimbursement of Xolair (omalizumab; Novartis) on its position in the Australian market.HighlightsThe ICS/LABA class was the highest-selling class in 2009 with sales of $182m. Growth has been driven by continued patient switching from ICS and LABA monotherapies, but will continue at a much slower rate during 20092019 as competition fragments the market and generic entry forces prices down.Current brand leaders Advair/Seretide and Spiriva (tiotropium; Boehringer Ingelheim) will be succeeded by their follow-on products once-daily ICS/LABA Relovair (fluticasone furoate/vilanterol; GlaxoSmithKline) and LABA/LAMA combination BI1744/Spiriva (olodaterol/tiotropium; Boehringer Ingelheim).While sales of Xolair (omalizumab; Novartis) were over $400m in the US in 2009, sales in Australia reached only $0.5m in the same year. Xolair's lack of Pharmaceutical Benefits Scheme (PBS) listing is expected to remain a significant barrier to further uptake in Australia in the short term.Reasons to Purchase*Identify opportunities and threats that will impact the Australian asthma/COPD market as a whole and key brands and pipeline products in particular.*Quantify the future size and Scope of the Australian asthma/COPD market and predict the performance of its key compounds.*Understand critical success factors in growing and defending asthma/COPD brand franchises from new entrants and generics.

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Commercial Insight: Asthma/COPD in Australia
Published on May 2010
Report Summary
Introduction
The Australian asthma/COPD market grew from $278m in 2006 to $333m in 2009. Its growth will slow considerably with the market
projected to reach revenues of $354m in 2019. As new drugs launched will be me-too products or combinations of existing classes,
Datamonitor assumes that these will be priced similarly to current brands in order to receive reimbursement, leading to a stabilizing
market.
Scope
*Forecast for marketed and late-stage pipeline asthma/COPD products in Australia.
*Assessment of Australia-specific drivers and resistors likely to impact the market.
*Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch
dates.
*Case study focusing on the impact of the lack of reimbursement of Xolair (omalizumab; Novartis) on its position in the Australian
market.
Highlights
The ICS/LABA class was the highest-selling class in 2009 with sales of $182m. Growth has been driven by continued patient
switching from ICS and LABA monotherapies, but will continue at a much slower rate during 20092019 as competition fragments the
market and generic entry forces prices down.
Current brand leaders Advair/Seretide and Spiriva (tiotropium; Boehringer Ingelheim) will be succeeded by their follow-on products
once-daily ICS/LABA Relovair (fluticasone furoate/vilanterol; GlaxoSmithKline) and LABA/LAMA combination BI1744/Spiriva
(olodaterol/tiotropium; Boehringer Ingelheim).
While sales of Xolair (omalizumab; Novartis) were over $400m in the US in 2009, sales in Australia reached only $0.5m in the same
year. Xolair's lack of Pharmaceutical Benefits Scheme (PBS) listing is expected to remain a significant barrier to further uptake in
Australia in the short term.
Reasons to Purchase
*Identify opportunities and threats that will impact the Australian asthma/COPD market as a whole and key brands and pipeline
products in particular.
*Quantify the future size and Scope of the Australian asthma/COPD market and predict the performance of its key compounds.
Commercial Insight: Asthma/COPD in Australia Page 1/8

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*Understand critical success factors in growing and defending asthma/COPD brand franchises from new entrants and generics.
Table of Content
OVERVIEW 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Asia-Pacific pharmaceutical analysis team 2
About the Immunology and Inflammation pharmaceutical analysis team 2
EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the asthma/COPD market 3
Related reports 4
Upcoming related reports 4
Table of Contents 5
1. MARKET DEFINITION 6
Asthma/COPD market definition for this report 6
Asthma/COPD indication split 6
2. MARKET OVERVIEW 8
Prevalence of asthma and COPD in Australia 8
Asthmatic population high but steady 8
COPD burden significant and growing 9
Indigenous Australians at greater risk 11
Current and future market overview 12
Opportunities and threats 14
Opportunities 14
COPD prevalence is increasing 14
Unmet treatment needs remain for refractory patients 15
Potential for new delivery mechanisms and regimens 15
Non-government programs aim to raise awareness of COPD 16
Threats 17
Asthma prevalence likely to have reached plateau 17
Lucrative ICS/LABA market will soon break down into many pieces, leaving relatively low sales for new entries 17
Cost-containment measures drive lower pricing and greater use of generics 18
Reimbursement a key to success, but can be difficult to obtain 20
3. BRAND DYNAMICS 22
Overview of competitive landscape 22
Patient acquisition process 23
Introduction 23
Patient care path 24
Points of influence in the patient care path 25
Trigger point 1: increase disease awareness among the general public 25
Trigger point 2: increase disease awareness among physicians 25
Trigger point 3: influence initial brand choice 25
Trigger point 4: influence switching decisions 26
Drivers of brand choice 26
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Total cost to patient 26
Patient preference 27
The inhaler device 28
Dosing frequency 28
Trends in marketing strategies 30
Marketing strategy for leading brands 30
Physician events and promotion 30
Disease awareness campaigns 30
Sponsorship 31
Advair/Seretide (fluticasone propionate/salmeterol; GlaxoSmithKline) 31
Drug profile 32
Product positioning 33
SWOT analysis 34
Brand forecast to 2019 36
Launch of me-too ICS/LABA combination products 37
Once-daily product is GlaxoSmithKline's hope to continue successful franchise 37
First generics will enter the market in 2015 38
Spiriva (tiotropium; Boehringer Ingelheim) 39
Drug profile 40
Product positioning 41
SWOT analysis 41
Brand forecast to 2019 42
Launch of Respimat expected to protect Spiriva's sales 44
Launch of at least two competitor once-daily LAMAs is imminent 44
LABA/LAMA combinations to threaten sales 45
Symbicort (budesonide/formoterol; AstraZeneca) 46
Drug profile 46
Product positioning 48
SWOT analysis 48
Brand forecast to 2019 49
Use of Symbicort in COPD is uncertain 50
Combination products to halt positive growth 51
Generics not to enter market until 2017 51
Singulair (montelukast; Merck Sharp & Dohme) 51
Drug profile 52
Product positioning 54
SWOT analysis 54
Brand forecast to 2019 55
First generics will enter Australian market in 2013 56
Additional studies are unlikely to have a significant impact on Singulair sales 57
OTC approval sought for seasonal allergic rhinitis 57
Other marketed drug classes 57
Inhaled corticosteroids 57
Long-acting bronchodilators 59
Short-acting bronchodilators 59
Relovair (fluticasone furoate/vilanterol trifenatate; GlaxoSmithKline) 60
Drug profile 61
Development overview 61
Product positioning 65
SWOT analysis 66
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Drug forecast to 2019 67
Other ICS/LABA combinations 69
QMF149 (mometasone/indacaterol; Novartis/Merck & Co.) 69
Dulera (mometasone/formoterol; Novartis/Merck & Co.) 69
Flutiform (fluticasone propionate/formoterol; SkyePharma/Mundipharma/Abbott) 70
BI1744/Spiriva (olodaterol/tiotropium; Boehringer Ingelheim) 70
Drug profile 71
Development overview 71
Product positioning 73
SWOT analysis 74
Drug forecast to 2019 74
Other LABA/LAMA combinations 76
QVA149 (mometasone/indacaterol; Novartis/Merck & Co.) 76
GSK573719/GSK642444 (GSK573719/vilanterol trifenatate; GlaxoSmithKline) 76
Other drugs in development 77
Long-acting anticholinergics (LAMAs) 77
Long-acting beta2-agonists (LABAs) 77
Phosphodiesterase-4 (PDE-4) inhibitors 78
4. CASE STUDY 80
Xolair's future in the Australian asthma/COPD market is uncertain 80
Introduction 80
Characteristics of biologics 81
Regulatory approvals for Xolair 82
Reimbursement for Xolair 82
Xolair's future in Australia 84
5. BIBLIOGRAPHY 86
Journal papers and articles 86
Websites 90
Datamonitor reports 90
APPENDIX A - MARKET ASSUMPTIONS 92
Forecasting assumptions 92
New product launches 92
Patent expiries 92
Pricing assumptions 93
Data definitions, limitations and assumptions 93
Standard units 93
Derivation of sales forecasts and pricing trends 94
Exchange rates 94
Forecast methodology 94
APPENDIX B 95
Contributing experts 95
Report methodology 95
About Datamonitor 95
About Datamonitor Healthcare 96
About the Immunology and Inflammation analysis team 96
Disclaimer 98
List of Tables
Table 1: Asthma prevalence in Australia, 2000, 2005 and 2010 9
Table 2: Australia: sales and growth of asthma/chronic obstructive pulmonary disease (COPD) drug classes ($000 and %), 2009-2019
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12
Table 3: Australia: summary of opportunities and threats in the asthma/chronic obstructive pulmonary disease (COPD) market, 2010
21
Table 4: Australia: leading branded drug sales for asthma/chronic obstructive pulmonary disease (COPD) ($m), 2009-2019 22
Table 5: Key products in late-stage R&D pipeline for asthma/chronic obstructive pulmonary disease (COPD), 2010 23
Table 6: Advair/Seretide (fluticasone/salmeterol) - drug profile in Australia, 2010 32
Table 7: Advair/Seretide (fluticasone/salmeterol) - TGA approval and PBS listing, 2010 33
Table 8: Impacting factors on the revenues of Advair/Seretide in Australia, 2009-2019 37
Table 9: Spiriva (tiotropium) - drug profile in Australia, 2010 40
Table 10: Spiriva (tiotropium) - TGA approval and PBS listing, 2010 41
Table 11: Impacting factors on the revenues of Spiriva in Australia, 2009-2019 44
Table 12: Symbicort (budesonide/formoterol) - drug profile in Australia, 2010 46
Table 13: Symbicort (budesonide/formoterol) - TGA approval and PBS listing, 2010 47
Table 14: Impacting factors on the revenues of Symbicort in Australia, 2009-2019 50
Table 15: Singulair (montelukast) - drug profile in Australia, 2010 52
Table 16: Singulair (montelukast) - TGA approval and PBS listing, 2010 53
Table 17: Impacting factors on the revenues of Singulair in Australia, 2009-2019 56
Table 18: Relovair (fluticasone furoate/vilanterol trifenatate) - drug profile in Australia, 2010 61
Table 19: Phase III clinical trials of Relovair for chronic obstructive pulmonary disease (COPD) 62
Table 20: Phase III clinical trials of Relovair for asthma 64
Table 21: Impacting factors on the revenues of Relovair in Australia, 2009-2019 68
Table 22: BI1744/Spiriva (olodaterol/tiotropium) - drug profile in Australia, 2010 71
Table 23: Current clinical trials of BI1744/Spiriva for chronic obstructive pulmonary disease (COPD) 72
Table 24: Impacting factors on the revenues of BI1744/Spiriva in Australia, 2009-2019 75
Table 25: Xolair (omalizumab) - drug profile in Australia, 2010 81
Table 26: Estimated potential market for severe persistent allergic asthma treatments in Australia, 2010 84
Table 27: New product launches in the asthma/chronic obstructive pulmonary disease (COPD) market in Australia, 2009-2019 92
Table 28: Patent expiry dates for key asthma/chronic obstructive pulmonary disease (COPD) brands in Australia, 2009-2019 92
Table 29: Pricing assumptions for key asthma/chronic obstructive pulmonary disease (COPD) pipeline products in Australia,
2009-2019 93
Table 30: Exchange rates from US dollars, 2010 94
List of Figures
Figure 1: Australia: prevalence of smoking by gender (%) and total population affected (millions), 1995, 2001, 2005 and 2008 11
Figure 2: Australia: top 5 asthma/chronic obstructive pulmonary disease (COPD) brands ($m), 2009 and 2019 13
Figure 3: Australia: population demographics by grouped (%) and median (years) age, 2001-2021 14
Figure 4: Australia: total sales of inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA)combination products ($m), 2009-2019
18
Figure 5: Australia: relative expenditure on asthma pharmaceuticals (%), 2004-05 19
Figure 6: Australia: asthma/chronic obstructive pulmonary disease (COPD) patient care path, 2010 24
Figure 7: Australia: drivers of brand choice in the asthma/chronic obstructive pulmonary disease (COPD) market, 2010 29
Figure 8: Advair/Seretide (fluticasone/salmeterol; GlaxoSmithKline) - SWOT analysis in Australia, 2010 35
Figure 9: Advair/Seretide (fluticasone/salmeterol; GlaxoSmtihKline) sales in Australia ($000), 2009-2019 36
Figure 10: Spiriva (tiotropium bromide; Boehringer Ingelheim) - SWOT analysis in Australia, 2010 42
Figure 11: Spiriva (tiotropium bromide; Boehringer Ingelheim) sales in Australia ($m), 2009-2019 43
Figure 12: Symbicort (budesonide/formoterol; AstraZeneca) - SWOT analysis in Australia, 2010 49
Figure 13: Symbicort (budesonide/formoterol; AstraZeneca) sales in Australia ($m), 2009-2019 50
Figure 14: Singulair (montelukast; Merck Sharp & Dohme) - SWOT analysis in Australia, 2010 55
Figure 15: Singulair (montelukast; Merck Sharp & Dohme) sales in Australia ($m), 2009-2019 56
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Figure 16: Relovair (fluticasone furoate/vilanterol trifenatate; GlaxoSmtihKline) - SWOT analysis in Australia, 2010 67
Figure 17: Relovair (fluticasone furoate/vilanterol trifenatate; GlaxoSmithKline) sales in Australia ($m), 2009-2019 68
Figure 18: BI1744/Spiriva (olodaterol/tiotropium; Boehringer Ingelheim) - SWOT analysis in Australia, 2010 74
Figure 19: BI1744/Spiriva (olodaterol/tiotropium; Boehringer Ingelheim) sales in Australia ($m), 2009-2019 75
Figure 20: Timeline of significant approvals for Xolair, 2002-09 83
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