Pipeline/Commercial Insight: Antihypertensives New class opportunity offset by key patent expiries
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the cardiovascular pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the hypertension market - page 3
- Contributing experts - page 5
- Related reports - page 5
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 7
- Definition of drug classes included - page 7
- Current market situation - page 7
- The antihypertensives market segmented by class - page 7
- The antihypertensives market segmented by country - page 9
- Antihypertensive market landscape - page 10
- Market growth and market restraint - page 11
- Factors driving growth of the antihypertensives market - page 12
- Factors restraining growth of the antihypertensives market - page 12
- Strategic scope and report focus - page 13
- US antihypertensives market dynamics - page 13
- Consideration of market unmet needs - page 13
- Conflicting evidence from clinical trials and guideline alterations - page 13
- Paradigm shift in antihypertensive R&D - page 13
- Defining the unmet need in the antihypertensives market - page 14
- Need beyond cosmetic blood pressure reduction - page 14
- Improved diagnosis - page 15
- Improved blood pressure management - page 15
- Increased uptake of fixed-dose combination therapies - page 16
- Targeting global cardiovascular risk and target organ damage - page 18
- Patient and primary care physician education - page 19
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 21
- Seven major market level assessment, opportunities and threats - page 21
- Market level assessment - page 21
- Opportunities - page 21
- Demographic and lifestyle trends continue to dominate the agenda, and have the potential to increase the hypertensive patient population - page 21
- Big Pharma cannot ignore the emerging markets of India and China - page 26
- Novel products are expected, but innovation is lacking in antihypertensive R&D - page 27
- Growing awareness of the metabolic syndrome - page 28
- Increasing co-operation between regulatory bodies - page 28
- Threats - page 29
- Increased generic competition - page 29
- Parallel trade - page 30
- Ongoing cost-containment measures - page 33
- Increasingly conservative regulatory environments - page 33
- Restrictive pricing and reimbursement policies - page 34
- Reduced periods of market exclusivity - page 35
- Mandatory registration of all clinical trial results - page 35
- US: market level assessment, opportunities and threats - page 36
- Market level assessment - page 36
- Opportunities - page 36
- Direct-to-consumer (DTC) advertising is legal in the US and has been shown to influence patient prescription choice and increase diagnosis rates - page 36
- Leveraging the JNC7 guidelines to maximize pharmacotherapy - page 37
- Price of drugs - page 43
- Threats - page 44
- The changing healthcare environment in the US will drive future generic use - page 44
- Medicare Part D is expected to lead to greater generic use - page 56
- Patient power - page 59
- Pharmaceutical re-importation issues continue to dog Big Pharma - page 60
- Formularies promote quality, but restrict choice - page 60
- Pricing and reimbursement issues - page 61
- Curbing of DTC advertising will lead to greater emphasis on risk of products - page 63
- Wal-Mart $4 a day generic program introduces further cost competition - page 64
- Japan: market level assessment, opportunities and threats - page 66
- Market level assessment - page 66
- Opportunities - page 67
- Ageing population - page 67
- An underdeveloped generics market slows brand erosion - page 67
- Possible introduction of direct-to-consumer advertising - page 68
- Multiple patent extensions and labeling regulations - page 69
- Opening up the Japanese market - page 69
- Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare - page 71
- Reduced product approval time - page 71
- Harmonization of approval process - page 72
- The Internet is an effective means to reach out to patients - page 72
- Threats - page 73
- Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future - page 73
- Flat sum reimbursement - page 74
- Complex regulatory process - page 75
- Biannual price cuts still threaten market growth - page 75
- New healthcare reforms under debate - page 76
- France: market level assessment, opportunities and threats - page 77
- Market level assessment - page 77
- Opportunities - page 77
- Innovation encouraged in the pharmaceutical industry - page 77
- Demographic changes provide opportunity for market expansion of chronic illnesses - page 78
- Consumers in France readily recognize the Internet as a source of high-quality medical information - page 79
- Generic consumption in France is particularly low - page 79
- Threats - page 80
- Continuation of cost-control measures - page 80
- Formulary access - page 80
- Take-off of generic sector - page 80
- Limitations on prescriptions dispensed from hospitals to patients in the community - page 81
- Pharmacists are being mandated to drive generic dispensing - page 82
- Germany: opportunities and threats - page 83
- Market level assessment - page 83
- Opportunities - page 83
- Pricing freedom which supports innovation - page 83
- ePharmacy and mail-order drugs legalized - page 84
- Threats - page 84
- Cost-containment measures in Germany have led to a healthy generics market - page 84
- German doctors set to receive bonuses for prescribing generics - page 86
- Italy: market level assessment, opportunities and threats - page 86
- Market level assessment - page 86
- Opportunities - page 87
- Single agency holds regulatory authority - page 87
- Negligible impact of generics is set to continue - page 87
- Threats - page 88
- Stringent reference pricing system - page 89
- Restructured reimbursement categories - page 90
- Intellectual property to conform with rest of EU - page 90
- Spain: market level assessment, opportunities and threats - page 91
- Market level assessment - page 91
- Opportunities - page 91
- Underdeveloped generics market both an opportunity and a threat - page 91
- Threats - page 92
- R&D activity expected to decline - page 92
- Reference pricing systems (RPS) likely to have an impact on branded revenues - page 93
- UK: market level assessment, opportunities and threats - page 93
- Market level assessment - page 93
- Opportunities - page 94
- NICE guidance advises against the use of beta-blockers - page 94
- GMS contact improvements - page 96
- Threats - page 98
- Pharmaceutical Price Regulation Scheme (PPRS) implements periodic price cuts - page 98
- Cost containment measures encourage continued high use of generics - page 98
- Summary of environmental issues affecting antihypertensive market size - page 99
- Seven major market level assessment, opportunities and threats - page 21
- CHAPTER 4 PIPELINE DYNAMICS ANALYSIS - page 103
- Outlook for developmental antihypertensives - page 103
- Pipeline overview - page 103
- Pipeline agents by phase of development - page 106
- Pipeline antihypertensives segmented by mechanism of action - page 108
- Pipeline activity segmented by company - page 111
- Companies developing key novel antihypertensive agents - page 113
- Novartis - page 113
- Daiichi Sankyo - page 114
- Gilead - page 114
- Takeda - page 115
- Companies developing key novel antihypertensive agents - page 113
- CHAPTER 5 COMPARATIVE ASSESSMENT OF KEY PIPELINE PRODUCTS - page 116
- Overview - page 116
- Key pipeline product positioning - page 117
- Darusentan - page 118
- Mechanism of action - page 118
- Clinical assessment - page 119
- Commercial assessment - page 119
- Exforge (valsartan/amlodipine) - page 120
- Mechanism of action - page 120
- Clinical assessment - page 120
- Commercial Assessment - page 121
- Olmesartan/amlodipine - page 122
- Mechanism of action - page 122
- Clinical assessment - page 122
- Commercial Assessment - page 122
- Zanipress (enalapril/lercanidipine) - page 123
- Mechanism of action - page 123
- Clinical assessment - page 123
- Commercial assessment - page 123
- CYT006-AngQb - page 124
- Mechanism of action - page 124
- Clinical assessment - page 124
- Commercial assessment - page 125
- Darusentan - page 118
- CHAPTER 6 FORECAST ANALYSIS - page 126
- Overview - page 126
- Changes in medical practice - page 126
- Increased use of ambulatory BP monitoring and home BP monitoring - page 126
- Assessment of overall cardiovascular risk - page 127
- Physician incentives to control blood pressure - page 128
- Pressure to increase compliance through the use of single-pill combination products - page 129
- Major clinical trials - page 129
- ONTARGET - page 129
- DREAM - page 132
- TROPHY - page 133
- Outcomes program for Rasilez: ALTITUDE, AVIATOR - page 134
- New product launches - page 136
- Tekturna/Rasilez (aliskiren) marketed by Novartis - page 136
- Exforge (valsartan+ amlodipine) marketed by Novartis - page 138
- Additional indications - page 140
- Irbesartan gains congestive heart failure indication - page 140
- Valsartan gains additional diabetes indication - page 141
- Micardis (telmisartan) gains type 2 diabetic nephropathy indication - page 141
- Patent expiries - page 142
- ARB patent expiries - page 143
- CCB patent expiries - page 143
- Betablocker patent expiries - page 144
- ACE inhibitor patent expiries - page 144
- Other patent expiries - page 145
- Data definitions, limitations and assumptions - page 146
- Standard units - page 146
- Japanese market data - page 146
- Derivation of sales forecasts and pricing trends - page 146
- Forecasts - page 147
- Forecast methodology - page 147
- CHAPTER 7 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 148
- Introduction - page 148
- Case Study 1: Aliskiren - up to the hype? - page 148
- Introduction - page 148
- Mechanism of action - page 148
- Aliskiren - page 149
- Clinical development of aliskiren - page 149
- Key Phase III Trials with aliskiren - page 150
- Aliskiren in combination with a diuretic - page 151
- Aliskiren versus CCB and their combination - page 152
- Aliskiren versus ACEI and their combination - page 152
- Efficacy - As good, but no better - page 153
- Benign side-effect profile - Not good enough - page 153
- Long duration of action - The saving grace? - page 154
- The negative-feedback conundrum - page 154
- End organ protection - page 155
- Prevention of organ damage with ACEIs and ARBs - page 155
- Additional benefit from renin inhibition? - page 156
- Summary of key advantages: - page 159
- Can Novartis justify price premium? - page 159
- Datamonitor assessment - page 159
- Case study 2: ESC/ESH GUIDELINES - page 161
- Emphasis on the assessment of total cardiovascular risk - page 161
- Consideration of absolute risk versus relative cardiovascular risk - page 162
- Targeting end-organ damage - page 162
- Recommendation for lifestyle modification - page 164
- First-line treatment strategy - page 164
- Managing hypertension and comorbidities - page 165
- Treatment of specific patient groups - page 165
- Opinion leader SWOT analysis - page 165
- Strengths: - page 166
- Weaknesses: - page 166
- Potential barriers to uptake: - page 166
- Commercial implications and further work - page 167
- Implication for clinical trial design - page 168
- CHAPTER 8 BIBLIOGRAPHY AND REFERENCES - page 169
- Bibliography - page 169
- References - page 171
- APPENDIX A - MARKET DATA AND MAJOR BRAND FACTS - page 174
- Mechanisms of action - page 174
- Beta blockers - page 174
- Calcium channel blockers - page 174
- Diuretics - page 174
- Angiotensin converting enzyme inhibitors - page 175
- Angiotensin-II receptor blockers (ARBs) - page 175
- Seven major market antihypertensive market data - page 175
- Segmentation by country - page 175
- Segmentation by class - page 176
- Major brand facts - page 176
- C7 Betablockers - page 177
- C8 Calcium channel blockers - page 180
- C9 Angiotensin converting enzyme inhibitors - page 182
- C9 Angiotensin II receptor blockers - page 184
- Anatomical Therapeutic Chemical (ATC) classification - page 187
- Mechanisms of action - page 174
- APPENDIX B - MARKET FORECAST DATA - page 189
- US Forecasts - page 189
- Japan Forecasts - page 198
- France Forecasts - page 208
- Germany Forecasts - page 216
- Italy Forecasts - page 225
- Spain Forecasts - page 233
- UK Forecasts - page 241
- Report methodology - page 247
- About Datamonitor - page 248
- About Datamonitor Healthcare - page 248
- About the cardiovascular disease analysis team - page 249
- Disclaimer - page 250
- List of Tables
- Table 1: Seven major market antihypertensive sales ($m), 2006. - page 8
- Table 2: Sales of antihypertensives across the seven major markets by country Sales of Antihypertensives by Country($m), 2006. - page 9
- Table 3: Seven major market sales and market share of the 10 top-selling antihypertensives, 2006 - page 11
- Table 4: Prevalence of obesity in the seven major markets by age (000s), 2003 (all totals have been rounded where applicable) - page 25
- Table 5: US antihypertensive sales, 2006 - page 36
- Table 6: Five generics companies are among the top 10 companies in terms of prescriptions filled under Medicare Part D, 2006 - page 46
- Table 7: The actual generic fill rate varies between therapeutic classes, 2006 - page 52
- Table 8: Wal-Mart is selling many generic antihypertensives for less than the mean price per standard unit in the US in 2006 - page 64
- Table 9: Japan antihypertensive sales, 2006 - page 66
- Table 10: An example of the savings to be realized by using generic drugs in the Japanese market, 2006 - page 74
- Table 11: France antihypertensive sales, 2005 - page 77
- Table 12: Germany antihypertensive sales, 2005 - page 83
- Table 13: Italy antihypertensive market, 2006 - page 87
- Table 14: Spain antihypertensive market, 2006 - page 91
- Table 15: UK antihypertensive market, 2006 - page 94
- Table 16: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005 - page 97
- Table 17: Summary of macro-environmental issues affecting the antihypertensive market, 2007 - page 100
- Table 18: The antihypertensive R&D pipeline, 2007 - page 104
- Table 19: Patent expiry dates used in forecasting the antihypertensive market across the seven major markets, 2007-2016 - page 142
- Table 20: Effects of Circulating RAS and Tissue RASe - page 156
- Table 21: Kredex: key facts - page 177
- Table 22: Toprol-XL: key facts - page 178
- Table 23: Tenormin; key facts - page 178
- Table 24: Inderal: key facts - page 179
- Table 25: Norvasc: key facts - page 180
- Table 26: Plendil: key facts - page 180
- Table 27: Cardizem LA: key facts - page 181
- Table 28: Adalat: key facts - page 181
- Table 29: Altace: key facts - page 182
- Table 30: Aceon: key facts - page 182
- Table 31: Accupro: key facts - page 183
- Table 32: Atacand; key facts - page 184
- Table 33: Teveten: key facts - page 184
- Table 34: Avapro: key facts - page 185
- Table 35: Cozaar: key facts - page 185
- Table 36: Benicar: key facts - page 186
- Table 37: Micardis: key facts - page 186
- Table 38: Diovan: key facts - page 187
- Table 39: Antihypertensive classifications - page 188
- Table 40: US Antihypertensives $ (000s)Sales Forecast 2006-2016 - page 189
- Table 41: Japan Antihypertensives $ (000s)Sales Forecast 2006-2016 - page 198
- Table 42: France Antihypertensives $ (000s)Sales Forecast 2006-2016 - page 208
- Table 43: Germany Antihypertensives $ (000s)Sales Forecast 2006-2016 - page 216
- Table 44: Italy Antihypertensives $ (000s)Sales Forecast 2006-2016 - page 225
- Table 45: Spain Antihypertensives $ (000s)Sales Forecast 2006-2016 - page 233
- Table 46: US Antihypertensives $ (000s)Sales Forecast 2006-2016 - page 241
- List of Figures
- Figure 1: Growth in the antihypertensives market by country, 2003-06 - page 10
- Figure 2: 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 22
- Figure 3: 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 23
- Figure 4: 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 24
- Figure 5: The growing prevalence of obesity in the US, 2005-2015 - page 26
- Figure 6: Generalized distribution chain for parallel traded pharmaceutical products - page 30
- Figure 7: JNC6 and JNC7 compared: classification of blood pressure levels - page 39
- Figure 8: Compelling indications for individual drug classes - page 41
- Figure 9: More than half of all prescriptions dispensed in the US are generics, 1994-2005 - page 44
- Figure 10: Generic companies dominate the US pharmaceutical market in terms of prescriptions - page 45
- Figure 11: Generic use in the US is promoted through a number of channels - page 48
- Figure 12: The generic fill rates in the US for 2003 varied considerably by state - page 53
- Figure 13: The tiered co-payment system will lead to greater use of generics - page 56
- Figure 14: Key pressures facing drug developers, 1990-2004 - page 62
- Figure 15: Wal-Mart's $4 generic drug program web-page - page 65
- Figure 16: The Japanese generic market is underdeveloped because of a number of factors - page 68
- Figure 17: Pipeline antihypertensive agents segmented by phase of development, 2007 - page 107
- Figure 18: Pipeline antihypertensive agents segmented by mechanism of action, 2007 - page 108
- Figure 19: The nature of the compounds in the antihypertensives pipeline, 2006 - page 110
- Figure 20: Nature of antihypertensive developmental compounds according to company type, 2007 - page 111
- Figure 21: Pipeline maturity index for antihypertensive agents, 2007 - page 112
- Figure 22: Comparative assessment of pipeline antihypertensive agents - page 117
- Figure 23: Segmentation of the antihypertensives market by country, 2007 - page 175
- Figure 24: Segmentation of the antihypertensives market by class, 2007 - page 176
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