Antihypertensives - New challenges for a maturing market
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the hypertension market - page 3
- Summary of key milestones in the antihypertensives market - page 4
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 15
- Sales figures definition for this report - page 15
- Market definition and overview for this report - page 15
- Current pharmaceutical market situation - page 16
- Strategic scoping and focus - page 21
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 23
- Global market level assessment, opportunities and threats - page 23
- Market level assessment - page 23
- Opportunities - page 23
- Demographic and lifestyle trends continue to dominate the agenda, and have the potential to increase the hypertensive patient population - page 23
- Big pharma cannot ignore the emerging markets of India and China - page 28
- Novel products are expected, but innovation is lacking in antihypertensive R&D - page 29
- Growing awareness of the metabolic syndrome - page 30
- Threats - page 30
- Increased generic competition - page 30
- Parallel trade - page 30
- US: market level assessment, opportunities and threats - page 34
- Market level assessment - page 34
- Opportunities - page 34
- Direct-to-consumer (DTC) advertising is legal in the US and has been shown to influence patient prescription choice and increase diagnosis rates - page 34
- Leveraging the JNC7 guidelines to maximize pharmacotherapy - page 35
- Threats - page 41
- The changing healthcare environment in the US will drive future generic use - page 41
- Medicare Part D is expected to lead to greater generic use - page 54
- Patient power - page 58
- Pharmaceutical re-importation issues continue to dog big pharma - page 58
- Formularies promote quality, but restrict choice - page 59
- Pricing and reimbursement issues - page 60
- Japan: market level assessment, opportunities and threats - page 62
- Market level assessment - page 62
- Opportunities - page 63
- Ageing population - page 63
- An underdeveloped generics market slows brand erosion - page 63
- Possible introduction of direct-to-consumer advertising - page 64
- Threats - page 65
- Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future - page 65
- Flat sum reimbursement - page 66
- Complex regulatory process - page 67
- Biannual price cuts still threaten market growth - page 67
- New healthcare reforms under debate - page 68
- France: market level assessment, opportunities and threats - page 68
- Market level assessment - page 68
- Opportunities - page 69
- Innovation encouraged in the pharmaceutical industry - page 69
- Demographic changes provide opportunity for market expansion of chronic illnesses - page 70
- Threats - page 70
- Continuation of cost-control measures - page 70
- Formulary access - page 71
- Take off of generic sector - page 71
- Limitations on prescriptions dispensed from hospitals to patients in the community - page 72
- Germany: opportunities and threats - page 72
- Market level assessment - page 72
- Opportunities - page 73
- Pricing freedom which supports innovation - page 73
- Threats - page 74
- German healthcare reforms...again - page 74
- Cost containment measures - page 75
- Italy: market level assessment, opportunities and threats - page 75
- Market level assessment - page 75
- Opportunities - page 76
- Single agency holds regulatory authority - page 76
- Negligible impact of generics is set to continue - page 76
- Threats - page 77
- Ongoing cost-containment measures - page 77
- Stringent reference pricing system - page 78
- Spain: market level assessment, opportunities and threats - page 79
- Market level assessment - page 79
- Opportunities - page 80
- Underdeveloped generics market both an opportunity and a threat - page 80
- Threats - page 80
- R&D activity expected to decline - page 80
- Reference pricing systems (RPS) likely to have an impact on branded revenues - page 81
- UK: market level assessment, opportunities and threats - page 82
- Market level assessment - page 82
- Opportunities - page 82
- NICE guidance advises against the use of beta-blockers - page 82
- GMS contact improvements - page 84
- Threats - page 86
- Pharmaceutical Price Regulation Scheme (PPRS) implements periodic price cuts - page 86
- Cost containment measures encourage continued high use of generics - page 87
- Summary of environmental issues affecting antihypertensive market size - page 88
- Global market level assessment, opportunities and threats - page 23
- CHAPTER 4 FORECAST ANALYSIS - page 91
- Assumptions and events - page 91
- Increasing market size - page 91
- Increasing use of fixed-dose combinations - page 91
- Major clinical trials - page 91
- ONTARGET - page 91
- DREAM - page 92
- NAVIGATOR - page 92
- TROPHY - page 93
- Outcomes program for Rasilez: ALTITUDE, AVIATOR - page 94
- New Product Launches - page 96
- Rasilez (aliskiren) marketed by Novartis - page 96
- Exforge (valsartan+ amlodipine) marketed by Novartis - page 99
- Additional Indications - page 100
- Irbesartan gains congestive heart failure indication - page 101
- Valsartan gains additional diabetes indication - page 101
- Diovan gains indications for post-MI use - page 101
- Micardis (telmisartan) gains type 2 diabetic nephropathy indication - page 101
- Candesartan gains diabetic retinopathy indication - page 102
- Patent Expiries - page 103
- ARB patent expiries - page 104
- CCB patent expiries - page 105
- Beta blocker patent expiries - page 106
- ACE inhibitor patent expiries - page 106
- Other patent expiries - page 107
- Data definitions, limitations and assumptions - page 108
- Standard units - page 108
- Japanese market data - page 108
- Derivation of sales forecasts and pricing trends - page 108
- Forecasts - page 109
- Forecast methodology - page 109
- Assumptions and events - page 91
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 110
- Introduction - page 110
- Case studies - page 110
- Case Study 1: Novartis - future prospects - page 110
- Executive summary - page 110
- Cardio-metabolic franchise overview - page 111
- Pipeline dynamics of the company - page 112
- Overall pipeline - page 112
- Rasilez - page 115
- Exforge - page 118
- Life Cycle Management Issues for Novartis. - page 119
- Conclusion - page 121
- Case study 2: The loss of patent protection for Cozaar (losartan) in the US market; potential impacts, likely scenarios. - page 122
- Executive summary - page 122
- Angiotensin Receptor Blockers (ARBs) - page 122
- The US ARB market - page 123
- The US ARB market dynamics - page 123
- Patent expiries - page 126
- Conclusion - page 131
- Case Study 1: Novartis - future prospects - page 110
- CHAPTER 6 BIBLIOGRAPHY AND REFERENCES - page 132
- Bibliography - page 132
- References - page 134
- APPENDIX A - MARKET DATA AND MAJOR BRAND FACTS - page 135
- Global antihypertensive market data - page 135
- Segmentation by country - page 135
- Segmentation by class - page 136
- Major brand facts - page 136
- C7 BBs - page 137
- C8 CCBs - page 140
- C9 ACEs - page 142
- C9 ARBs - page 144
- Anatomical Therapeutic Chemical (ATC) classification - page 147
- Global antihypertensive market data - page 135
- APPENDIX B - MARKET FORECAST DATA - page 149
- US Forecasts - page 149
- Japan Forecasts - page 156
- France Forecasts - page 161
- Germany Forecasts - page 167
- Italy Forecasts - page 174
- Spain Forecasts - page 181
- UK Forecasts - page 187
- Five Major European Markets Forecasts - page 193
- Seven Major Markets Forecasts - page 200
- APPENDIX C - page 208
- Report methodology - page 208
- About Datamonitor - page 209
- About Datamonitor Healthcare - page 209
- About the cardiovascular disease analysis team - page 210
- Key therapy team members - page 210
- Dr Allison Fleetwood, Director, Cardiovascular, Diabetes and Women's Health - page 210
- Disclaimer - page 212
- List of Tables
- Table 1: 7MM sales of the antihypertensive drug classes, 2005 - page 17
- Table 2: Seven major market sales and market share of the 10 top-selling antihypertensives, 2005 - page 19
- Table 3: Prevalence of obesity in the seven major markets by age (000s), 2003 (all totals have been rounded where applicable) - page 27
- Table 4: US antihypertensive sales, 2005 - page 34
- Table 5: Five generics companies are among the top 10 companies in terms of prescriptions filled under Medicare Part D - page 44
- Table 6: The actual generic fill rate varies between therapeutic classes - page 50
- Table 7: Japan antihypertensive sales, 2005 - page 62
- Table 8: An example of the savings to be realized by using generic drugs - page 66
- Table 9: France antihypertensive sales, 2005 - page 69
- Table 10: Germany antihypertensive sales, 2005 - page 73
- Table 11: Italy antihypertensive market, 2005 - page 76
- Table 12: Spain antihypertensive market, 2005 - page 79
- Table 13: UK antihypertensive market, 2005 - page 82
- Table 14: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005 - page 85
- Table 15: Summary of macro-environmental issues affecting the anthypertensive, 2006 - page 89
- Table 16: Patent expiry dates used in forecasting the antihypertensive market across the seven major markets - page 103
- Table 17: Sales of selected Novartis marketed cardio-metabolic products, 2005 - page 111
- Table 18: Forecasts for Rasilez (aliskiren) - page 117
- Table 19: Sales forecasts for Exforge (valsartan plus amlodipine) - page 119
- Table 20: Kredex: key facts - page 137
- Table 21: Toprol-XL: key facts - page 138
- Table 22: Tenormin; key facts - page 138
- Table 23: Inderal: key facts - page 139
- Table 24: Norvasc: key facts - page 140
- Table 25: Plendil: key facts - page 140
- Table 26: Cardizem LA: key facts - page 141
- Table 27: Adalat: key facts - page 141
- Table 28: Altace: key facts - page 142
- Table 29: Aceon: key facts - page 142
- Table 30: Accupro: key facts - page 143
- Table 31: Atacand; key facts - page 144
- Table 32: Teveten: key facts - page 144
- Table 33: Avapro: key facts - page 145
- Table 34: Cozaar: key facts - page 145
- Table 35: Benicar: key facts - page 146
- Table 36: Micardis: key facts - page 146
- Table 37: Diovan: key facts - page 147
- Table 38: Antihypertensive classifications - page 148
- Table 39: US antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 149
- Table 40: Japan antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 156
- Table 41: France antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 161
- Table 42: Germany antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 167
- Table 43: Italy antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 174
- Table 44: Spain antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 181
- Table 45: UK antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 187
- Table 46: Five major markets antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 193
- Table 47: Seven major markets antihypertensive sales forecasts ($m; 2005 figures are actuals) - page 200
- List of Figures
- Figure 1: Key milestones expected to have an impact on the 7MM antihypertensives market, 2007 - 2015 - page 5
- Figure 2: 7MM pharmaceutical sales, 2004-05 - page 16
- Figure 3: Segmentation of the antihypertensive market by country - page 18
- Figure 4: Proportion of population aged 20-39 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004 - page 24
- Figure 5: Proportion of population aged 40-59 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004 - page 25
- Figure 6: Proportion of population aged 60-79 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004 - page 26
- Figure 7: The growing prevalence of obesity in the US - page 28
- Figure 8: Generalized distribution chain for parallel traded pharmaceutical products - page 31
- Figure 9: JNC6 and JNC7 compared: classification of blood pressure levels - page 37
- Figure 10: Compelling indications for individual drug classes - page 39
- Figure 11: More than half of all prescriptions dispensed in the US are generics - page 42
- Figure 12: Generic companies dominate the US pharmaceutical market in terms of prescriptions - page 43
- Figure 13: Generic use in the US is promoted through a number of channels - page 46
- Figure 14: The generic fill rates in the US for 2003 varied considerably by state - page 51
- Figure 15: The tiered co-payment system will lead to greater use of generics - page 55
- Figure 16: Key pressures facing drug developers - page 61
- Figure 17: The Japanese generic market is underdeveloped because of a number of factors - page 64
- Figure 18: The oncology therapy area accounts for the highest share of 1,377 projects in clinical development, from 178 companies. - page 113
- Figure 19: Novartis's investigational drugs by therapeutic category - page 115
- Figure 20: Effects of patent expiry on Cozaar (losartan) in the US market - page 124
- Figure 21: Datamonitor forecasts of the effects of Cozaar's patent expiry on Cozaar (losartan), Diovan (valsartan) and their respective generics, in the US market - page 129
- Figure 22: Segmentation of the antihypertensives market by country - page 135
- Figure 23: Segmentation of the antihypertensives market by class - page 136
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