Studie - Commercial Insight: Asthma/COPD in Australia

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.

*Understand critical success factors in growing and defending asthma/COPD brand franchises from new entrants and generics.

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

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

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 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

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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