Forecast Insight: Antihypertensives New fixed dose combinations unable to stem the tide of patent expiries

Introduction

Following the patent expiries of ARBs Datamonitor expects antihypertensives sales in the seven major markets to record sales of $29.5 billion in 2018, a drop of over $6 billion compared to 2008. With no promising novel pipeline agents, pharmaceutical companies have little choice but to adopt line extension life cycle management strategies introducing a number of new fixed dose combinations.

Scope

*Description of the competitive landscape in antihypertensives across seven major markets with market definition and overview.

*Definition of the unmet need in the antihypertensives market.

*Event-driven updated sales forecasts for 2009-18 across the seven major markets: US, France, Germany, Italy, Spain, UK and Japan.

*Analysis of major events and brand dynamics affecting the hypertension market.

Highlights

The antihypertensive market is declining. The market is mature and does not present an attractive opportunity for R&D expenditure; consequently Big Pharma are shying away from the pursuit of novel mechanisms of action in favor of developing more efficacious combination therapies.

Cozaar's and Diovan's patent expiries in the US are expected to alter the structure of the antihypertensive market dramatically. Threats of generic substitution and money-saving healthcare strategies which have plagued other markets, are now approaching the successful ARB class, and will have an impact on the whole antihypertensive market.

Novartis have failed to strengthen its position in the antihypertensives arena with its new renin inhibitor Tekturna and Exforge is expected to face a number of competitive alternatives. More fixed dose combinations from all major players are soon expected to enter. Those agents however will be restricted to a niche population with limited growth.

Reasons to Purchase

*Quantify the future size of the antihypertensives market and identify opportunities for new products.

*Learn how recent changes related to product expiries will shape the antihypertensives market.

*Understand the barriers to uptake for novel antihypertensive agents, and the need for paradigm shift in clinical trial design.

Report Highlights
Highlights

The antihypertensive market is declining. The market is mature and does not present an attractive opportunity for R&D expenditure; consequently Big Pharma are shying away from the pursuit of novel mechanisms of action in favor of developing more efficacious combination therapies.

Cozaar's and Diovan's patent expiries in the US are expected to alter the structure of the antihypertensive market dramatically. Threats of generic substitution and money-saving healthcare strategies which have plagued other markets, are now approaching the successful ARB class, and will have an impact on the whole antihypertensive market.

Novartis have failed to strengthen its position in the antihypertensives arena with its new renin inhibitor Tekturna and Exforge is expected to face a number of competitive alternatives. More fixed dose combinations from all major players are soon expected to enter. Those agents however will be restricted to a niche population with limited growth.
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DATAMONITOR HEALTHCARE 2
About the cardiovascular analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5
Upcoming related reports 5
CHAPTER 2 MARKET DEFINITION 7
Market definition for this report 7
CHAPTER 3 MARKET OVERVIEW 8
Seven major markets 9
Current and future market overview 9
Class level analysis 9
Country level analysis 16
Key events 21
Opportunities and threats 26
Opportunities 26
Threats 33
US 41
Current and future market assessment 41
Opportunities and threats 46
Opportunities 46
Threats 53
Japan 66
Current and future market assessment 66
Opportunities and threats 69
Opportunities 69
Threats 72
Five major European markets (5EU) 75
Current and future market assessment 75
Opportunities and threats 81
Opportunities 81
Threats 82
France 84
Current and future market assessment 84
Germany 87
Current and future market assessment 87
Italy 90
Current and future market assessment 90
Spain 93
Current and future market assessment 93
UK 96
Current and future market assessment 96
Rest of the world snapshot 99
Current market assessment 100
CHAPTER 4 BRAND DYNAMICS 103
Overview of competitive landscape 103
Drivers of brand choice 106
Efficacy and side-effect profile 106
Use in niche populations 109
Marketing and pricing 109
US formulary tier status for leading brands 111
Trends in marketing strategies 112
Marketing strategy for leading brands 112
Promotional spend 113
Angiotensin receptor blockers 114
Diovan/Co-Diovan (valsartan/valsartan + HCT) 117
Cozaar (losartan)/Hyzaar (losartan + HTCZ) 122
Blopress/Atacand (candesartan) 125
Benicar (olmesartan) 128
Micardis (telmisartan) 133
Renin inhibitors (Tekturna/Rasilez (aliskiren)) 138
ARBs, ACE, Aliskiren, combinations and dual RAAS inhibition 143
CHAPTER 5 KEY DEVELOPERS 147
Strategic overview 147
Trends in corporate strategy 150
Recent strategic partnerships/deals 152
Novartis 153
Diversification into generics via Sandoz; Novartis breaks trend to enter generics market 153
Daiichi Sankyo 154
Olmesartan franchise central to Daiichi Sankyo's future growth 154
Two possible scenarios for olmesartan 154
Ranbaxy acquisition 155
Takeda 155
Over 80% of current ethical sales will soon be exposed to generic competition 156
Cash reserves utilized to steer strategy towards other therapy areas 156
CHAPTER 6 CASE STUDY: EFFECT OF THE KEY PATENT EXPIRIES ON MARKET DYNAMICS 157
Introduction 157
Patent expiries timeline 157
The impact of generic penetration 158
US 161
Japan 162
Five major European markets 162
France 164
Germany 165
Italy 166
Spain 167
UK 167
BIBLIOGRAPHY 169
Journal papers 169
Websites 172
Datamonitor reports 174
APPENDIX A - MARKET ASSUMPTIONS 175
New product launches 175
Patent expiries 176
APPENDIX B 177
Contributing experts 177
Report methodology 177
About Datamonitor 178
About Datamonitor Healthcare 178
About the Cardiovascular Disease analysis team 179
Disclaimer 181
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List of Tables
Table 1: Sales and growth of drug classes for antihypertensives in the seven major markets, 2008-18 10
Table 2: Sales and growth of antihypertensives market by country in the seven major markets, 2005-18 16
Table 3: Key events impacting the antihypertensives market, 2008-18 23
Table 4: Forecast sales of antihypertensives in the seven major markets, 2008-18 24
Table 5: Projected and forecast adult obesity prevalence (million) in the seven major markets, 2008-18 30
Table 6: Summary of opportunities and threats in the antihypertensives market across the seven major markets, 2008-18 40
Table 7: Sales and growth of drug classes for antihypertensives in the US, 2008-18 41
Table 8: Top 10 brands sales forecasts in hypertension in the US ($m), 2008-18 45
Table 9: Three generics companies are among the top 10 companies in terms of prescriptions filled under Medicare Part D, 2006 53
Table 10: Sales and growth of drug classes for antihypertensives in Japan, 2008-18 67
Table 11: Sales and growth of drug classes for antihypertensives in 5EU, 2008-18 76
Table 12: Top 10 brands sales forecasts in hypertension in five major European countries ($m), 2008-18 80
Table 13: Sales and growth of drug classes for antihypertensives in France, 2008-18 85
Table 14: Sales and growth of drug classes for antihypertensives in Germany, 2008-18 88
Table 15: Sales and growth of drug classes for antihypertensives in Italy, 2008-18 91
Table 16: Sales and growth of drug classes for antihypertensives in Spain, 2008-18 94
Table 17: Sales and growth of drug classes for antihypertensives in the UK, 2008-18 97
Table 18: Ranking of the leading branded drugs by revenue in 2007 and 2008 104
Table 19: Leading branded drug sales for antihypertensives in the seven major markets ($m), 2008-18 105
Table 20: Representative formulary tier status in the US for leading brands in inflammatory bowel disease, 2009 112
Table 21: Marketing strategies employed by US product websites of key antihypertensive brands, 2008 113
Table 22: Leading angiotensin receptor blockers sales ($m) for hypertension in the seven major markets, 2008-18 116
Table 23: Diovan: key facts 117
Table 24: Secondary market events affecting Diovan/Co-Diovan, 2008-09 119
Table 25: Sales forecast ($m) for the valsartan franchise in the seven major markets, 2008-18 119
Table 26: Key facts: Cozaar 122
Table 27: Sales forecast ($m) for the losartan franchise in the seven major markets, 2008-18 123
Table 28: Blopress/Atacand: key facts 125
Table 29: Sales forecast ($m) for the entire candesartan franchise for hypertension in the seven major markets, 2008-18 126
Table 30: Secondary market events affecting Blopress/Atacand, 2008-09 127
Table 31: Benicar: key facts 128
Table 32: Sales forecast ($m) for the olmesartan franchise in the seven major markets, 2008-18 130
Table 33: Secondary market events affecting Benicar, 2008-09 132
Table 34: Micardis: key facts 133
Table 35: Sales forecast ($m) for the telmisartan franchise in the seven major markets, 2008-18 135
Table 36: Secondary market events affecting Micardis, 2008-09 137
Table 37: Tekturna: key facts 139
Table 38: Sales forecast ($m) for the aliskiren franchise in the seven major markets, 2008-18 140
Table 39: Secondary market events affecting Tekturna, 2008-09 142
Table 40: Leading companies in the antihypertensives market, seven major markets, 2008-18 149
Table 41: Recent strategic partnerships/deals, 2006-08, in antihypertensives 152
Table 42: New product launches for the antihypertensives in the seven major markets, 2009-2012 175
Table 43: Patent expiry dates for the approved antihypertensives in the seven major markets, 2008-2018 176
List of Figures
Figure 1: Antihypertensives sales ($m) by class, 2005-18 12
Figure 2: Historical antihypertensives sales ($m), growth (% CAGR) and market share at class level, 2005-08 14
Figure 3: Forecasted antihypertensives sales ($m), growth (% CAGR) and market share at class level, 2008-18 15
Figure 4: Antihypertensives sales ($m) and year-on-year growth in units (volume) and revenue (value), 2007-08 18
Figure 5: Antihypertensives sales ($m) by region, 2005-18 20
Figure 6: Antihypertensives sales and volume growth (% CAGR) by region, 2005-18 21
Figure 7: Impact of key events on the antihypertensives market, 2008-18 22
Figure 8: Proportion of population aged 20-39 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004 27
Figure 9: Proportion of population aged 40-59 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004 28
Figure 10: Proportion of population aged 60-79 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004 29
Figure 11: Generalized distribution chain for parallel traded pharmaceutical products 35
Figure 12: Effect of recent major patent expiries of antihypertensives in the US sales ($m), 2005-18 42
Figure 13: US antihypertensives sales ($m) by class, 2005-18 43
Figure 14: Performance of main classes for antihypertensives in the US, 2008 vs. 2018 44
Figure 15: JNC6 and JNC7 compared: classification of blood pressure levels 48
Figure 16: Compelling indications for individual drug classes 50
Figure 17: Generic use in the US is promoted through a number of channels 55
Figure 18: Key pressures facing drug developers, 1990-2004 64
Figure 19: Japan antihypertensives sales ($m) by class, 2005-18 68
Figure 20: Performance of main classes for antihypertensives in Japan, 2008 vs. 2018 69
Figure 21: 5EU antihypertensives sales ($m) by class, 2005-18 77
Figure 22: Antihypertensives sales ($m) and growth (% CAGR) in 5EU by country, 2005-18 78
Figure 23: France antihypertensives sales ($m) by class, 2005-18 86
Figure 24: Performance of main classes for antihypertensives in France, 2008 vs. 2018 87
Figure 25: Germany antihypertensives sales ($m) by class, 2005-18 89
Figure 26: Performance of main classes for antihypertensives in Germany, 2008 vs. 2018 90
Figure 27: Italy antihypertensives sales ($m) by class, 2005-18 92
Figure 28: Performance of main classes for antihypertensives in Italy, 2008 vs. 2018 93
Figure 29: Spain antihypertensives sales ($m) by class, 2005-18 95
Figure 30: Performance of main classes for antihypertensives in Spain, 2008 vs. 2018 96
Figure 31: UK antihypertensives sales ($m) by class, 2005-18 98
Figure 32: Performance of main classes for antihypertensives in the UK, 2008 vs. 2018 99
Figure 33: Rest of the world versus seven major market sales split in the antihypertensives market ($m), 2008 100
Figure 34: Indexed annual sales of the antihypertensives market in the 'total rest of the world' group, 2005-08 101
Figure 35: Indexed annual sales of the antihypertensives market in the 'total rest of the world' group, segmented by class, 2005-08 102
Figure 36: Drivers of brand choice for antihypertensives 111
Figure 37: Total promotional spend (proportional) in the seven major markets for the key angiotensin II receptor blockers, 2005-08 114
Figure 38: Forecast sales of angiotensin receptor blockers, 2008-18 115
Figure 39: Sales ($m) forecast for Diovan in the seven major markets, 2008-18 121
Figure 40: Sales ($m) forecast for Cozaar in the seven major markets, 2008-18 124
Figure 41: Sales ($m) forecast for candesartan in the seven major markets, 2008-18 128
Figure 42: Sales ($m) forecast for Benicar in the seven major markets, 2008-19 131
Figure 43: Sales ($m) forecast for Micardis in the seven major markets, 2007-2017 136
Figure 44: Sales ($m) forecast for Tekturna in the seven major markets, 2008-18 141
Figure 45: Key antihypertensives patent expiries timeline 2007-2018 158
Figure 46: The impact of the key patent expiries with historical and forecasted revenue trends 2005-18 159
Figure 47: Comparison of branded vs. generic antihypertensive sales ($billion) in the seven major markets, 2005-18 160
Figure 48: Comparison of branded vs. generic antihypertensive sales ($billion) in the US, 2005-18 161
Figure 49: Comparison of branded vs. generic antihypertensive sales ($billion) in Japan, 2005-18 162
Figure 50: Comparison of branded vs. generic antihypertensive sales ($billion) in 5EU, 2005-18 163
Figure 51: Comparison of branded vs. generic antihypertensive sales ($billion) in France, 2005-18 164
Figure 52: Comparison of branded vs. generic antihypertensive sales ($billion) in Germany, 2005-18 165
Figure 53: Comparison of branded vs. generic antihypertensive sales ($billion) in Italy, 2005-18 166
Figure 54: Comparison of branded vs. generic antihypertensive sales ($billion) in Spain, 2005-18 167
Figure 55: Comparison of branded vs. generic antihypertensive sales ($billion) in the UK, 2005-18 168
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