Bayer Schering Pharma AG: PharmaVitae Profile

This analysis examines the historical and forecast performance for Bayer Schering Pharma in the ethical pharma sector. The profile encompasses global company strategy, portfolio and pipeline analysis and assessment of financial performance, with 1-6 year sales forecasts for key drugs. An interactive forecasting and analysis tool provides continually updated quantitative and qualitative information

Report Highlights

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About the Infectious Disease and Respiratory (ID&R) pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the asthma market 5
Contributing experts 6
Related reports 7
Upcoming related reports 7
CHAPTER 2 COUNTRY TREATMENT TREES 9
Introduction to treatment trees 9
US 10
5EU 12
Japan 14
France 16
Germany 18
Italy 20
Spain 22
UK 24
CHAPTER 3 PATIENT SEGMENTATION AND EPIDEMIOLOGY 26
Disease definition: the importance of inflammation 27
Asthma is caused by a combination of exogenous and genetic factors 27
Exogenous factors 28
Genetic factors 30
The role of airway inflammation, airway hyper-responsiveness and airway remodeling 31
Co-morbidities 35
Allergic rhinitis is the most common co-morbidity of asthma 35
Asthma and COPD can co-exist but true interaction between these diseases is unclear 36
Obesity may become even more important in the future of asthma 38
Disease classification - asthma control 39
Disease classification - asthma phenotypes 43
Allergic asthma is by far the most common phenotype 46
Asthma can be irreversible with chronic airflow obstruction 47
Awareness of nocturnal asthma as a phenotype may be low 48
Is exercise-induced asthma a separate phenotype? 49
Patients with steroid-resistant asthma have highest unmet needs 50
Why are phenotypes (not) used? 51
Asthma prevalence 53
Difference between physician's impression and publicized data is related to asthma definition 56
Asthma prevalence seems to be stabilizing 56
US 58
Japan 61
Europe 63
France 64
Germany 65
Italy 66
Spain 68
UK 69
CHAPTER 4 DIAGNOSIS AND DIAGNOSTIC TESTS 71
Presentation of asthma - symptoms 72
Diagnosis of asthma 72
Spirometry and PEF measurements are still underused 73
Allergen skin tests mostly used for initial diagnosis 75
Airway responsiveness challenges are mainly useful for difficult-to-diagnose patients 76
Upcoming diagnostic tests: sputum eosinophil count and fraction exhaled nitric oxide (FENO) 77
CHAPTER 5 TREATMENT OPTIONS AND TRENDS 79
Treatment options 80
Bronchodilators (relievers) 80
Beta2-agonists 80
Anticholinergics 81
Combination beta2-agonist/anticholinergic 82
Methyl xanthines 82
Anti-inflammatories (controllers) 83
Inhaled corticosteroids 83
Systemic corticosteroids 84
Non-steroidal anti-inflammatory drugs (NSAIDs) 84
ICS/LABA combinations 85
Biologicals 86
Inhaler device options 87
The ideal inhaler device 89
Treatment guidelines 91
The Global Initiative for Asthma (GINA) guidelines are most important international guidelines 92
The National Heart, Lung, and Blood Institute (NHLBI) guidelines follow GINA's focus on control 95
American Thoracic Society (ATS) and the European Respiratory Society (ERS) do not have specific asthma guidelines 97
National guidelines can supersede international guidelines 98
Most guidelines are now evidence-based 98
Treatment trends 101
Almost all patients receive some type of controller medication 102
Mild asthma is over-treated with long-term reliever medication 102
ICS/LABA combinations even used in mildest forms of asthma 103
Inhaled corticosteroids are less used as severity progresses 105
Long-acting bronchodilators mainly used in conjunction with an ICS 106
Antileukotriene drugs are especially popular in Japan 108
Short-acting bronchodilators is the most often used drug class in most severities 109
Theophylline is still prominent in Japanese treatment regimen 110
Omalizumab is reserved for the most severe asthma patients 111
CHAPTER 6 KEY PRESCRIBING INFLUENCES AND BRAND ASSESSMENT 114
Factors influencing physician decision making 115
Symptomatic improvement 116
Duration of action 119
Side-effect profile 121
Speed of onset 122
Recommended in treatment guidelines 124
Cost 125
Once-daily dosing 126
Flexible dosing 126
Device/mode of administration 127
Patient age 128
Physician perception of key products 129
Total scores per drug per country 131
Interpreting a brand map 133
The ICS/LABA combination class 135
The ICS/LABA combination products 136
The inhaled corticosteroid class 141
The inhaled corticosteroid products 142
The long-acting bronchodilator class 147
The long-acting bronchodilator products 148
The antileukotriene class 151
The antileukotriene products 152
Short-acting bronchodilators 153
Biologics - Xolair (omalizumab) 154
CHAPTER 7 TREATMENT OUTCOMES AND NEW PRODUCT DEVELOPMENT 157
Treatment outcomes 158
Unmet needs 160
Increase access to safe and effective immunotherapy 161
Improve therapeutic response by phenotyping 162
Reduce cost of medication 163
Reduce over-treatment of asthma 164
Develop ICS without side effects 165
Other unmet needs 166
New product development 167
Awareness of pipeline products 167
Combination products 167
LABAs and LAMAs 168
Novel mechanisms of action 169
Future use of pipeline products 170
Novel ICS/LABA combinations 171
Novel LABA/LAMA combinations 176
Novel LAMAs 177
Novel LABAs 179
Novel mechanisms of action 181
BIBLIOGRAPHY 185
Journal papers 185
Websites 204
Datamonitor reports 205
APPENDIX A 206
Physician research methodology 206
Physician sample breakdown 206
US 206
Japan 207
France 207
Germany 208
Italy 208
Spain 209
UK 209
Contributing experts 210
APPENDIX B 211
The survey questionnaire 211
Section 1 - Patient Segmentation 211
Section 2 - Diagnosis 215
Section 3 - Treatment 215
Section 4 - Treatment Outcomes 217
Section 5 - Product Profiles 218
Section 6 - Products in Development 223
APPENDIX C 226
About Datamonitor 226
About Datamonitor Healthcare 226
About the Infectious Disease and Respiratory (ID&R) analysis team 227
Disclaimer 228
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Table 1: Bayer AG- PharmaVitae forecasts at a glance 8
Table 2: Bayer Schering Pharma AG key product developments, Q1 2008 25
Table 3: Bayer Schering Pharma AG product deals and alliances, Q1 2008 26
Table 4: Bayer Schering Pharma AG technology deals and alliances, Q1 2008 26
Table 5: Bayer HealthCare M&A activity, Q1 2008 27
Table 6: Bayer AG company announcements, Q1 2008 28
Table 7: Bayer Schering Pharma future product milestones, Q2 2008-Q1 2010 29
Table 8: Bayer Schering Pharma product portfolio overview, sales ($m), 2001-07 43
Table 9: Bayer Schering Pharma product portfolio overview, global sales ($m), 2007-13 46
Table 10: Bayer Schering Pharma therapy portfolio overview, sales ($m), 2001-07 51
Table 11: Bayer Schering Pharma therapy portfolio overview, sales ($m), 2007-13 54
Table 12: Bayer Schering Pharma portfolio overview by geographic region, sales ($m), 2001-07 60
Table 13: Bayer Schering Pharma portfolio overview by geographic region, sales ($m), 2007-13 62
Table 14: Bayer Schering Pharma launch portfolio overview ($m), 2007-13 67
Table 15: Bayer Schering Pharma core portfolio overview ($m), 2007-13 69
Table 16: Bayer Schering Pharma expiry portfolio overview ($m), 2007-13 71
Table 17: Bayer Schering Pharma portfolio overview by molecule type ($m), 2001-07 77
Table 18: Bayer Schering Pharma product portfolio overview by molecule type ($m), 2007-13 79
Table 19: Bayer Schering Pharma product portfolio overview by source ($m), 2001-07 83
Table 20: Bayer Schering Pharma AG product portfolio overview by source ($m), 2007-13 85
Table 21: Total Bayer AG revenue by business unit ($m), 2001-07 89
Table 22: Bayer AG profit and loss account ($m), 2001-07 91
Table 23: Bayer AG balance sheet ($m), 2001-07 94
Table 24: Bayer AG operating revenue/cost analysis ($m), 2001-07 97
Table 25: Bayer AG operating cost ratio analysis (% of total revenue), 2001-07 100
Table 26: Bayer AG operating cost ratio analysis (% of total revenue), 2007-13 102
Table 27: Bayer AG operating revenue/cost analysis ($m), 2007-13 106
Table 28: Bayer AG capital employed ($m), 2001-07 109
Table 29: Bayer AG EBIT return on capital employed ($m), 2001-07 111
Table 30: Bayer AG EBIT pre-tax return/Capital employed driver analysis ($m), 2001-07 112
Table 31: Bayer AG market capitalization ($ billion), 2001-07 115
Table 32: Bayer AG total shareholder returns, 2001-07 (annual %) 117
Table 33: Bayer Schering Pharma: Key products overview 120
Table 34: Kogenate: overview 121
Table 35: Kogenate: sales forecast ($m), 2007-13 122
Table 36: Xarelto: overview 125
Table 37: Xarelto: sales forecast ($m), 2007-13 126
Table 38: Mirena: overview 128
Table 39: Mirena: sales forecast ($m), 2007-13 129
Table 40: Key players in the oral contraceptives market, 2001-13 130
Table 41: Levitra: overview 132
Table 42: Levitra: sales forecast ($m), 2007-13 133
Table 43: Yasmin: overview 135
Table 44: Yasmin: sales forecast ($m), 2007-13 136
Table 45: Key players in the oral contraceptives market, 2007-13 138
Table 46: Yaz: overview 140
Table 47: Yaz: sales forecast ($m), 2007-13 141
Table 48: Nexavar: overview 144
Table 49: Nexavar: sales forecast ($m), 2007-13 145
Table 50: Leukine: overview 148
Table 51: Leukine: sales forecast ($m), 2007-13 149
Table 52: Betaferon: overview 151
Table 53: Betaferon: sales forecast ($m), 2007-13 152
Table 54: Avelox: overview 156
Table 55: Avelox: sales forecast ($m), 2007-13 157
Table 56: Key players in the antibiotics market, 2007 158
Table 57: Ciprobay: overview 160
Table 58: Ciprobay: sales forecast ($m), 2007-13 161
Table 59: Adalat: overview 163
Table 60: Adalat: sales forecast ($m), 2007-13 164
Table 61: Glucobay: overview 167
Table 62: Glucobay: sales forecast ($m), 2007-13 168
Table 63: Bayer Schering Pharma AG's NME pipeline (Phase I-registration) 171
Table 64: Bayer Schering Pharma AG's indication broadening pipeline (Phase I-registration) 172
Table 65: Exchange rates, 2007 174
Figure 1: Bayer AG prescription pharmaceutical performance, sales ($m) and growth rate (%), 2001-13 5
Figure 2: Bayer AG financial performance ($m), 2001-13 7
Figure 3: Bayer AG corporate development, 2001-13 9
Figure 4: Bayer Schering Pharma prescription pharmaceutical sales by source ($m), 2007-13 13
Figure 5: Bayer Schering Pharma prescription pharmaceutical sales by therapy area ($m), 2001-13 14
Figure 6: Bayer Schering Pharma SWOT analysis 16
Figure 7: Current corporate structure 32
Figure 8: M&A/divestment history Bayer AG 34
Figure 9: Bayer Schering Pharma prescription pharmaceutical performance, sales ($m) and growth rate (%), 2001-13 40
Figure 10: Bayer Schering Pharma key sales growth drivers and resistors ($m), 2001-07 44
Figure 11: Bayer Schering Pharma key sales growth drivers and resistors ($m), 2007-13 47
Figure 12: Bayer Schering Pharma prescription pharmaceutical sales by therapy area ($m), 2001-13 50
Figure 13: Bayer Schering Pharma prescription pharma sales by therapy area, (% of total), 2001-13 57
Figure 14: Bayer Schering Pharma prescription pharmaceutical sales by geographic region ($m), 2001-13 59
Figure 15: Bayer Schering Pharma drivers and resistors by geographic region, sales ($m), 2001-07 60
Figure 16: Bayer Schering Pharma drivers and resistors by geographic region, sales ($m), 2007-13 62
Figure 17: Bayer Schering Pharma prescription pharmaceutical sales by geographic region (% of total), 2001-13 64
Figure 18: Bayer Schering Pharma launch/core/expiry configuration ($m), 2007-13 74
Figure 19: Bayer Schering Pharma prescription pharmaceutical sales by molecule type ($m), 2001-13 76
Figure 20: Bayer Schering Pharma growth drivers & resistors by molecule type ($m), 2007-13 80
Figure 21: Bayer Schering Pharma prescription pharmaceutical sales by source ($m), 2001-13 82
Figure 22: Bayer Schering Pharma growth drivers & resistors by source ($m), 2001-07 83
Figure 23: Bayer Schering Pharma growth drivers & resistors by source ($m), 2007-13 86
Figure 24: Bayer AG operating revenue/cost analysis ($m), 2001-13 96
Figure 25: Bayer AG operating cost ratio analysis (% of total revenue), 2001-13 104
Figure 26: Bayer AG return on capital employed, EBIT margin and capital turnover, 2001-07 108
Figure 27: Return on capital employed formula 113
Figure 28: Bayer AG market capitalization ($ billion), 2001-07 116
Figure 29: Bayer AG total shareholder returns (annual %), 2001-07 117
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