Commercial Insight: Hormonal Contraceptives - Look beyond oral contraception for a competitive edge

ABOUT DATAMONITOR HEALTHCARE 2
About the Genitourinary pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 6
Upcoming related reports 6
CHAPTER 2 MARKET DEFINITION 8
Introduction 8
Market definition for this report 8
CHAPTER 3 MARKET OVERVIEW 12
Seven major markets 15
Current and future market overview 15
Regional market dynamics - The US was the largest hormonal contraceptive market in 2008 15
Drug class dynamics - monophase preparations <50mcg estrogen will remain clear market leader 20
Indication analysis - hormonal contraceptives are mostly used for contraception 23
Drug analysis - Mirena will become market leader by 2018 despite generic erosion in the US 25
Opportunities and threats 30
Opportunity 1 - there is the need to develop new administration propositions that will increase real world drug efficacy 30
Opportunity 2 - switch to over-the-counter sales 38
Opportunity 3 - emergency contraceptives is a growth market 44
Opportunity 4 - education and public relations increase awareness of hormonal contraceptives 48
Opportunity 5 - development of male hormonal contraceptives 48
Threat 1 - safety concerns over hormonal treatments can hamper hormonal contraceptive sales 50
Threat 2 - sales force and marketing budget cuts 51
US 52
Current and future market assessment 52
The US market will continue to grow up to 2018 52
G3A1 (Monophase preparation <50mcg estrogen) will continue to dominate the market 54
Use of natural estrogen likely to be perceived as safer by women in the US and will drive market growth 55
Opportunities and threats 60
Opportunity 1 - new government administration will support better access to hormonal contraceptives 60
Opportunity 2 - increase in contraceptive coverage from insurers 61
Threat 1 - poor patent protection for oral contraceptives poses a threat to marketed brands 62
Threat 2 - the US market is dominated by high incursion of generic hormonal contraceptives 63
Threat 3 - continuous litigation in the hormonal contraceptive market will limit innovation and cause players to exit the market 64
Threat 4 - the US healthcare reform poses a threat to Pharma 65
Threat 5 - direct-to-consumer advertising may be restricted 66
Japan 67
Current and future market assessment 67
Hormonal contraceptive market in Japan remains highly underdeveloped 67
Japanese market is set to grow 68
Triphasic hormonal contraceptives are by far the most popular choice of hormonal contraceptive in Japan 69
Bayer-Schering is one of the leading companies in Japan too 70
Triquilar (levonorgestrel + ethinylestradiol, Bayer- Schering) will remain the market leading brand in 2018 71
Opportunities and threats 74
Opportunities 74
Threats 76
Five major EU markets (5EU) 77
Current and future market assessment 77
The five major EU markets are expected to plateau starting from 2015 77
Germany will remain the largest EU market but Spain will be the fastest growing 77
G3A1 is by far the largest selling class of contraceptives 80
Opportunities and threats 88
Opportunity 1 - the EU is expected to continue to experience few generic launches and low penetration rate 88
Opportunity 2 - UK - National Institute for Health and Clinical Excellence (NICE) recommends the use of long-acting hormonal contraceptives 89
Opportunity 3 - UK - betterpatient education needed to overcome contraceptive myths 91
Threat 1 - physicians will continue to prescribe according to personal preference 92
Threat 2 - European Union threats to tighten information provision 93
Threat 3 - Italy - new hormonal contraceptives are not reimbursed 93
France 94
Current and future market assessment 94
Mirena (levonorgestrel, Bayer-Schering) and Cerazette (desogestrel, Schering-Plough) will be the market leaders by 2018 96
Germany 99
Current and future market assessment 99
Italy 105
Current and future market assessment 105
Spain 111
Current and future market assessment 111
UK 118
Current and future market assessment 118
Rest of the world snapshot 126
Current market assessment 126
The global hormonal contraceptive market displays strong growth 126
The rest of the world accounted for 31.4% of the hormonal contraceptive global market in 2008 126
The rest of the world outstrips the seven major markets in terms of volume 128
BRIC countries are the fastest growing group out of the rest of the world markets 130
Low estrogen monophasic hormonal contraceptives are the most prescribed in the rest of the world 132
Yasmin brand franchise (drospirenone + ethinylestradiol, Bayer-Schering) is the largest brand in the rest of the world group 134
Opportunities and threats 136
Opportunities 137
Threats 139
CHAPTER 4 BRAND DYNAMICS 140
Overview of competitive landscape 141
Drivers of brand choice 142
US formulary tier status for leading brands 143
Trends in marketing strategies 144
Marketing strategy for leading brands 144
In the future companies will have to concentrate also on the secondary benefits of hormonal contraceptives 146
Promotional spend 147
Physician detailing is key to success in marketing hormonal contraceptives 148
Direct-to-consumer advertising 148
Yasmin franchise (drospirenone + ethinylestradiol; Bayer-Schering) 149
Drug profile 149
Product positioning 151
Brand franchise offsets generic incursion in 2008 153
SWOT analysis 153
Brand forecast to 2018 154
Yasmin brand franchise will continue to remain a key market player despite generic launches 154
NuvaRing (etonogestrel and ethinylestradiol, Schering-Plough) 157
Drug profile 157
NuvaRing threatened by litigation proceedings 158
Product positioning 159
SWOT analysis 160
Brand forecast to 2018 161
Mirena (levonorgestrel; Bayer-Schering) 163
Drug profile 163
The effectiveness of Mirena is just as good if not better than tubal sterilization 163
Product positioning 164
Mirena has become a common treatment for the treatment of menorrhagia 164
Mirena displayed strong growth in all seven major markets 166
SWOT analysis 167
Brand forecast to 2018 168
Mirena will be the leading brand in 2015 prior to patent expiry in the US 168
Ortho Evra (norelgestromin + ethinylestradiol; Johnson & Johnson) 170
Drug profile 170
Product positioning 172
SWOT analysis 173
Brand forecast to 2018 174
Implanon (etonogestrel; Schering-Plough) 176
Drug profile 176
Product positioning 177
SWOT analysis 178
Brand forecast to 2018 179
Plan B (levonorgestrel; Teva) 180
Drug profile 180
Effectiveness of emergency contraceptives decreases linearly with time 181
Product positioning 182
SWOT analysis 182
Brand forecast to 2018 183
Other marketed hormonal contraceptive drugs 184
Ortho Tri-Cyclen Lo (norgestimate + ethinylestradiol; Johnson & Johnson) 185
Qlaira (estradiol valerate/dienogest; Bayer-Schering) 187
Emergency contraceptives - Levonelle (levonorgestrel; Bayer-Schering) and NorLevo (levonorgestrel; HRA Pharma) 188
ellaOne/PGL4001/CDB-2914 (ulipristal; HRA Pharma) 189
Drug profile 189
Development overview 190
Product positioning 193
Drug forecast to 2018 193
Nomac/E2 (nomegestrol acetate + natural estrogen, Schering-Plough) 195
Drug profile 195
Development overview 196
Product positioning 198
Drug forecast to 2018 198
CHAPTER 5 KEY DEVELOPERS 200
Trends in corporate strategy 201
A diverse portfolio remains key to success in the hormonal contraceptive market 201
Branded generics are common in the hormonal contraceptive market 201
Recent strategic partnerships/deals 202
Large M&A deals could threaten genitourinary therapy area in the short term 204
Bayer-Schering 206
Corporate strategy 206
Hormonal contraceptive portfolio assessment 206
Bayer-Schering remains committed to the hormonal contraceptive market and is set to maintain its market share 208
Schering-Plough 209
Corporate strategy 209
Hormonal contraceptive portfolio assessment 209
Alternative delivery methods drive Schering-Plough's market growth 209
Schering-Plough hormonal contraceptive market share threatened by a limited pipeline 210
CHAPTER 6 CASE STUDIES 212
Case study - Yasmin brand franchise (drospirenone + ethinylestradiol; Bayer-Schering) success factors 213
New proposition 213
Lifecycle management 214
Franchise expansion 214
Indication expansion 216
The importance of marketing in the hormonal contraceptive market 217
Patent expiry management strategies in the US 221
Authorized generics are increasingly used as a quick-fix for tackling generic erosion 221
BIBLIOGRAPHY 223
Journal papers 223
Websites 225
Datamonitor reports 231
Conferences attended 232
APPENDIX A - MARKET ASSUMPTIONS 233
Forecasting assumptions 233
Data definitions, limitations and assumptions 237
Standard units 237
Country group definitions 237
Rest of European Union 237
Middle East and North Africa (MENA) 237
Rest of World 237
Derivation of sales forecasts and pricing trends 238
APPENDIX B 239
Contributing experts 239
Conferences attended 239
Report methodology 239
About Datamonitor 240
About Datamonitor Healthcare 240
About the Genitourinary analysis team 241
Disclaimer 243
List of Tables
Table 1: Summary of hormonal contraceptive therapeutic classes by ATC code, 2009 9
Table 2: Summary of the ICD-10 codes used to derive indication-specific sales for hormonal contraceptive brands 9
Table 3: Hormonal contraceptive sales across the seven major markets, 2004-2018 19
Table 4: Hormonal contraceptive sales ($m) across the seven major markets by ATC class, 2004-2018 21
Table 5: Key marketed hormonal contraceptive brand sales ($m) across the seven major markets, 2004-2018 25
Table 6: Hormonal contraceptives sales forecasts in the seven major markets ($m), 2008-2018 26
Table 7: Key events impacting the hormonal contraceptive market by region, 2009-2018 29
Table 8: Summary of opportunities and threats in the hormonal contraceptive market across the seven major markets, 2009-2018 30
Table 9: Sales ($m) of hormonal contraceptives across the seven major markets by delivery method, 2004-08 36
Table 10: Male hormonal contraceptive clinical pipeline, 2009 49
Table 11: Hormonal contraceptive sales ($m) by ATC class in the US, 2004-2018 55
Table 12: Hormonal contraceptives sales forecasts in the US ($m), 2008-2018 57
Table 13: Summary of opportunities and threats in the hormonal contraceptive market in the US, 2009-2018 60
Table 14: Price ($) of leading hormonal contraceptive brands per treatment cycle, 2008 66
Table 15: Hormonal contraceptive sales ($m) by ATC class in Japan, 2004-2018 70
Table 16: Hormonal contraceptives sales forecasts in Japan($m), 2008-2018 73
Table 17: Summary of opportunities and threats in the hormonal contraceptive market in Japan, 2009-2018 74
Table 18: Hormonal contraceptive sales ($m) in the five major EU markets, 2004-2018 80
Table 19: Hormonal contraceptive sales ($m) by ATC class in the five major EU markets, 2004-2018 84
Table 20: Hormonal contraceptive sales forecasts in the five major EU markets ($m), 2008-2018 85
Table 21: Summary of opportunities and threats for hormonal contraceptives in the five major EU markets, 2009 88
Table 22: Hormonal contraceptive sales ($m) by ATC class in France, 2004-2018 96
Table 23: Hormonal contraceptives sales forecasts in France ($m), 2008-2018 97
Table 24: Hormonal contraceptive sales ($m) by ATC class in Germany, 2004-2018 101
Table 25: Hormonal contraceptives sales forecasts in Germany ($m), 2008-2018 102
Table 26: Hormonal contraceptive sales ($m) by ATC class in Italy, 2004-2018 107
Table 27: Hormonal contraceptives sales forecasts in Italy ($m), 2008-2018 109
Table 28: Hormonal contraceptive sales ($m) by ATC class in Spain, 2004-2018 113
Table 29: Hormonal contraceptives sales forecasts in Spain ($m), 2008-2018 115
Table 30: Hormonal contraceptive sales ($m) by ATC class in the UK, 2004-2018 121
Table 31: Hormonal contraceptives sales forecasts in the UK ($m), 2008-2018 123
Table 32: Global sales ($m) dynamics of the hormonal contraceptive market, 2004-08 127
Table 33: Global hormonal contraceptive market sales ($m) split by region, 2004-08 130
Table 34: Rest of the world sales ($m) of hormonal contraceptive sales by ATC class, 2008 134
Table 35: Comparison of leading hormonal contraceptive branded drug sales ($m) in the seven major markets and the Rest of the world, 2004-08 135
Table 36: Summary of opportunities and threats in the hormonal contraceptive market across the rest of the world, 2009-2018 136
Table 37: Leading branded drug sales for hormonal contraceptives in the seven major markets ($m), 2008-2018 141
Table 38: Key products in late-stage R&D pipeline for hormonal contraceptives, 2009 142
Table 39: Representative formulary tier status in the US for leading hormonal contraceptive brands, 2009 144
Table 40: Marketing strategies employed by the companies behind the key hormonal contraceptive market brands, 2008 145
Table 41: Yasmin (drospirenone + ethinylestradiol; Bayer-Schering) - Drug profile, 2009 150
Table 42: Yaz (drospirenone + ethinylestradiol; Bayer-Schering - Drug profile, 2009 151
Table 43: Impacting factors on the revenues of Yasmin brand franchise* (drospirenone + ethinylestradiol; Bayer-Schering), 2009-2018 156
Table 44: NuvaRing (etonogestrel and ethinylestradiol, Schering-Plough) - Drug profile, 2009 158
Table 45: Impacting factors on the revenues of NuvaRing (etonogestrel and ethinylestradiol, Schering-Plough), 2009-2018 162
Table 46: Mirena (levonorgestrel; Bayer-Schering) - Drug profile, 2009 164
Table 47: Impacting factors on the revenues of Mirena (levonorgestrel; Bayer-Schering), 2009-2018 170
Table 48: Ortho Evra (norelgestromin + ethinylestradiol; Johnson & Johnson) - Drug profile, 2009 171
Table 49: Impacting factors on the revenues of Ortho Evra (norelgestromin + ethinylestradiol; Johnson & Johnson), 2009-2018 175
Table 50: Implanon (etonogestrel; Schering-Plough) - Drug profile, 2009 176
Table 51: Plan B (levonorgestrel; Teva) - Drug profile, 2009 181
Table 52: Impacting factors on the revenues of Plan B (levonorgestrel; Teva), 2009-2018 184
Table 53: Summary of other marketed hormonal contraceptive drugs in the seven major markets, 2008-2018 184
Table 54: ellaOne - Drug profile, 2009 190
Table 55: Clinical trial summary for ulipristal, 2009 192
Table 56: Impacting factors on the revenues of ellaOne (ulipristal; HRA Pharma), 2009-2018 195
Table 57: Nomac/E2 - Drug profile, 2009 196
Table 58: Clinical trial summary for Nomac/E2, 2009 197
Table 59: Impacting factors on the revenues Nomac/E2 (nomegestrol acetate + natural estrogen, Schering-Plough), 2009-2018 199
Table 60: Key strategic deals and events in the hormonal contraceptive market, 2009 203
Table 61: Key mergers and acquisitions in the hormonal contraceptive market, 2009 204
Table 62: Bayer-Schering hormonal contraceptive marketed portfolio across the seven major markets, 2009 207
Table 63: Bayer-Schering hormonal contraceptive lifecycle management product pipeline, 2009 208
Table 64: Schering-Plough hormonal contraceptive marketed portfolio across the seven major markets, 2009 210
Table 65: Schering-Plough hormonal contraceptive product pipeline, 2009 211
Table 66: Key leading hormonal contraceptive brands indications, 2009 217
Table 67: Patent expiries and generic incursions in the hormonal contraceptive marketing the US and Japan, 2009-2018 233
Table 68: Patent expiries and generic incursions in the hormonal contraceptive marketing the five major EU countries, 2009-2018 234
Table 69: New product launches in the hormonal contraceptive market, 2009-2018 235
Table 70: Indications extensions in the hormonal contraceptive market, 2009-2018 236
List of Figures
Figure 1: Indexed change in seven major market hormonal contraceptive sales value by region, 2004-08 15
Figure 2: Seven major market hormonal contraceptive sales ($m) dynamics, 2004-08 16
Figure 3: Indexed change in seven major market hormonal contraceptive sales volume (IMS standard units sold) by region, 2004-08 17
Figure 4: Hormonal contraceptive market forecast across the seven major markets, 2008-2018 18
Figure 5: Seven major market hormonal contraceptive sales ($m) dynamics, 2008-2018 19
Figure 6: Hormonal contraceptives ATC class sales ($m) across the seven major markets, 2004-08 22
Figure 7: Hormonal contraceptives ATC class sales ($m) across the seven major markets, 2008-2018 23
Figure 8: Hormonal contraceptive use by indication across the seven major markets, 2008 24
Figure 9: Hormonal contraceptive market across the seven major markets by delivery method, 2004-08 35
Figure 10: Historical seven major market hormonal and emergency hormonal contraceptive market sales ($m) dynamics, 2004-08 45
Figure 11: Forecast seven major market hormonal and emergency hormonal contraceptive market sales ($m) dynamics, 2008-2018 46
Figure 12: Indexed US hormonal contraceptives sales by ATC class, 2004-08 52
Figure 13: Hormonal contraceptive market forecast ($m) by ATC class in the US, 2008-2018 54
Figure 14: US state mandates for contraceptive coverage, 2008 62
Figure 15: Yasmin (drospirenone + ethinylestradiol, Bayer-Schering) generic erosion in the US, Q1-Q4 2008 64
Figure 16: Indexed Japan hormonal contraceptives sales by ATC class, 2004-08 68
Figure 17: Hormonal contraceptive market forecast ($m) by ATC class in Japan, 2008-2018 69
Figure 18: Performance of hormonal contraceptive brands in Japan, 2004-08 71
Figure 19: Contraceptive methods among Japanese women in Japan, 1950-2004 75
Figure 20: Five major EU market hormonal contraceptive sales ($m) dynamics, 2004-08 78
Figure 21: Five major EU market hormonal contraceptive forecast sales ($m) dynamics, 2008-2018 79
Figure 22: Indexed five major EU market hormonal contraceptive sales by ATC class, 2004-08 82
Figure 23: Hormonal contraceptive market forecast ($m) by ATC class in the five major EU markets, 2008-2018 83
Figure 24: Indexed sales of Depo-Provera (medroxyprogesterone, Pfizer), Mirena (levonorgestrel, Bayer-Schering) and Implanon (etonogestrel, Schering-Plough) in the UK, 2004-08 90
Figure 25: Hormonal contraceptive delivery methods in the UK, 2004-08 91
Figure 26: Indexed hormonal contraceptives sales by ATC class in France, 2004-08 94
Figure 27: Hormonal contraceptive market forecast ($m) by ATC class in France, 2008-2018 95
Figure 28: Indexed hormonal contraceptives sales by ATC class in Germany, 2004-08 99
Figure 29: Hormonal contraceptive market forecast ($m) by ATC class in Germany, 2008-2018 100
Figure 30: Indexed hormonal contraceptives sales by ATC class in Italy, 2004-08 105
Figure 31: Hormonal contraceptive market forecast ($m) by ATC class in Italy, 2008-2018 106
Figure 32: Indexed hormonal contraceptives sales by ATC class in Spain, 2004-08 111
Figure 33: Hormonal contraceptive market forecast ($m) by ATC class in Spain, 2008-2018 112
Figure 34: Indexed hormonal contraceptives sales by ATC class in the UK, 2004-08 119
Figure 35: Hormonal contraceptive market forecast ($m) by ATC class in the UK, 2008-2018 120
Figure 36: Global hormonal contraceptive market sales value by region, 2004-08 126
Figure 37: Global hormonal contraceptive market sales ($m) dynamics, 2004-08 128
Figure 38: Global hormonal contraceptive market volume (IMS standard units sold) and value ($) sales, 2008 129
Figure 39: Indexed rest of the world hormonal contraceptive market sales value, 2004-08 131
Figure 40: Rest of the world hormonal contraceptives regional market dynamics, 2004-08 132
Figure 41: Rest of the world hormonal contraceptive market by ATC class, 2004-08 133
Figure 42: Indexed sales of leading hormonal contraceptive brands across rest of the world, 2004-08 136
Figure 43: Sales dynamics of hormonal contraceptives by delivery method in the rest of world, 2004-08 139
Figure 44: Driver of brand choice in hormonal contraceptive use, 2009 143
Figure 45: Estimated US and five major EU market promotional spend for the key hormonal contraceptive brands, 2008 147
Figure 46: Yasmin (drospirenone + ethinylestradiol; Bayer-Schering) use by indication across the US and five major EU markets, 2008 152
Figure 47: Yasmin brand franchise (drospirenone + ethinylestradiol; Bayer-Schering) indexed sales performance in the seven major markets, 2004-08 153
Figure 48: Yasmin brand franchise (drospirenone + ethinylestradiol; Bayer-Schering) SWOT analysis, 2009 154
Figure 49: Forecast sales of the Yasmin (drospirenone + ethinylestradiol; Bayer-Schering), Yaz and Yasminelle brand franchise across the seven major markets, 2008-2018 155
Figure 50: Forecast sales of the Yasmin brand franchise (drospirenone + ethinylestradiol; Bayer-Schering) in the seven major markets split by country, 2008-2018 156
Figure 51: NuvaRing (etonogestrel and ethinylestradiol, Schering-Plough) use by indication across the US and five major EU markets, 2008 159
Figure 52: NuvaRing (etonogestrel and ethinylestradiol, Schering-Plough) indexed sales performance in the seven major markets, 2004-08 160
Figure 53: NuvaRing (etonogestrel and ethinylestradiol, Schering-Plough) SWOT analysis, 2009 161
Figure 54: Forecast sales of the NuvaRing (etonogestrel and ethinylestradiol, Schering-Plough) across the seven major markets, 2008-2018 162
Figure 55: Mirena (levonorgestrel; Bayer-Schering) use by indication across the US and five major EU markets, 2008 165
Figure 56: Mirena (levonorgestrel; Bayer-Schering) indexed sales performance in the seven major markets, 2004-08 167
Figure 57: Mirena (levonorgestrel; Bayer-Schering) - SWOT analysis, 2009 168
Figure 58: Forecast sales of the Mirena (levonorgestrel; Bayer-Schering), across the seven major markets, 2008-2018 169
Figure 59: Ortho Evra (norelgestromin + ethinylestradiol; Johnson & Johnson) use by indication across the US and five major EU markets, 2008 172
Figure 60: Ortho Evra (norelgestromin + ethinylestradiol; Johnson & Johnson) indexed sales performance in the seven major markets, 2004-08 173
Figure 61: Ortho Evra (norelgestromin + ethinylestradiol; Johnson & Johnson) SWOT analysis, 2009 174
Figure 62: Forecast sales of the Ortho Evra (norelgestromin + ethinylestradiol; Johnson & Johnson), across the seven major markets, 2008-2018 175
Figure 63: Implanon (etonogestrel; Schering-Plough) use by indication across the US and five major EU markets, 2008 177
Figure 64: Implanon (etonogestrel; Schering-Plough) indexed sales performance in the seven major markets, 2004-08 178
Figure 65: Implanon (etonogestrel; Schering-Plough) SWOT analysis, 2009 179
Figure 66: Forecast sales of the Implanon (etonogestrel; Schering-Plough), across the seven major markets, 2008-2018 180
Figure 67: Plan B (levonorgestrel; Teva) indexed sales performance in the seven major markets, 2004-08 182
Figure 68: Plan B (levonorgestrel; Teva) SWOT analysis, 2009 183
Figure 69: Forecast sales of the Plan B (levonorgestrel; Teva) across the seven major markets, 2008-2018 183
Figure 70: Forecast sales ($m) of other hormonal contraceptive drugs, 2008-2018 185
Figure 71: Ortho Tri-Cyclen Lo (norgestimate + ethinylestradiol) use by indication across the US and five major EU markets, 2008 186
Figure 72: Forecast sales of ellaOne (ulipristal; HRA Pharma), across the seven major markets, 2010-18 194
Figure 73: Forecast sales of Nomac/E2 (nomegestrol acetate + natural estrogen, Schering-Plough) across the seven major markets, 2010-18 199
Figure 74: Schering-Plough and Merck & Co global revenue by therapy area, 2001-2014 205
Figure 75: Yasmin brand franchise performance in the seven major markets, 2004-08 215
Figure 76: Examples of Bayer-Schering advertising campaigns, 2009 218
Figure 77: Leading brands' promotional spend ($000s) in the hormonal contraceptive market in the seven major markets, 2008 220