Hypertension - Multiple Layers of Therapy Cover all Eventualities

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Publication Date: 2005-12-19

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Hypertension is a deadly disease and an important global public health challenge. Datamonitor estimates that there are currently 192m people with hypertension in the seven major markets, and this number is set to rise to 212m by 2015. Yet, a significant fraction of this sizeable patient pool remains undiagnosed or aborts treatment, considerably limiting the size of the market.

Scope

Analysis of diagnosis, treatment and blood pressure control rates for the hypertensive population

Assessment of the extent to which physicians treat sub-populations differently

Examination of the use of combination therapy, drug classes and brands across the hypertensive sub-populations

Evaluation of future prescribing trends and the potential of novel antihypertensive therapies

Report Highlights
There is a significant proportion of patients who drop out of antihypertensive therapy prematurely. These therapy drop-outs substantially limit market size. To reduce concomitant loss of potential revenue, drug manufacturers must sustain aggressive awareness campaigns designed to help patients understand that hypertension is a deadly disease.

There is space for novel antihypertensive therapies in the hypertension market. The overwhelming majority of patients are receiving multiple layers of therapy to control their hypertension, but combination therapy does not sit well with many patients, as the drugs are costly and often have side effects.

Physicians are generally aware of developmental antihypertensive therapies but appear reluctant to administer them to their own consulting population.

Reasons to Purchase

Identify the most lucrative target niche populations for developmental products

Understand how to position new antihypertensive therapies

Gain insight into prescribing patterns and physician opinions on current treatment paradigms

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the cardiovascular pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the hypertension market - page 4
  - Greater awareness and education of hypertension is required - page 5
  - Inhibitors of the renin-angiotensin system (RAS) are the number one choice for the treatment of hypertension at any line of therapy - page 6
  - There is space for novel antihypertensive therapies in the hypertension market - page 8
  - Datamonitor conclusions - page 9
CHAPTER 2 INTRODUCTION AND SCOPE - page 17
- Coverage of the Stakeholder Insight Survey - page 18
CHAPTER 3 COUNTRY TREATMENT TREES - page 21
- Introduction to the treatment trees - page 21
- US - page 23
- Japan - page 27
- France - page 31
- Germany - page 35
- Italy - page 39
- Spain - page 43
- UK - page 47
CHAPTER 4 EPIDEMIOLOGY OF HYPERTENSION - page 51
- Definition of hypertension - page 51
  - Prevalence of hypertension in the US - page 51
  - Prevalence of hypertension in Japan - page 53
  - Prevalence of hypertension in France - page 54
  - Prevalence of hypertension in Germany - page 55
  - Prevalence of hypertension in Italy - page 56
  - Prevalence of hypertension in Spain - page 57
  - Prevalence of hypertension in the UK - page 58
  - Prevalence of hypertension across the seven major markets - page 59
CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS - page 62
- Diagnosis rates - page 65
- Segmentation of hypertensive patients - page 68
  - Diabetic hypertensive patients - page 68
  - Hypertensives with renal disease - page 69
  - Isolated systolic hypertension - page 71
- Breakdown of disease severity - page 75
- Prevalence of conditions comorbid to hypertension - page 77
- Target SBP for diabetic hypertensives - page 79
- Treatment rates - page 85
CHAPTER 6 OVERALL PRESCRIBING TRENDS - page 87
- Overall prescribing trend not dominated by any one class - page 87
  - Angiotensin converting enzyme inhibitors - page 91
  - Angiotensin II receptor blockers - page 93
  - Beta blockers - page 95
  - Calcium channel blockers - page 98
  - Diuretics - page 100
- Combination therapy - page 103
  - Proportion of patients receiving combination drug therapy - page 103
    - Total hypertensive patients - page 105
    - Diabetic hypertensives - page 110
    - Non-diabetic hypertensive patients with renal disease - page 113
    - Patients with isolated systolic hypertension - page 115
    - Hypertensives of African descent - page 117
  - Use of single-pill combination therapy - page 119
- Resistant hypertension - page 122
CHAPTER 7 FIRST- TO SECOND-LINE THERAPY - page 125
- First-line therapy - page 125
  - Breakdown of antihypertensive first-line therapy by drug class - page 125
    - ACE inhibitors - page 129
    - Beta blockers - page 129
    - Angiotensin II receptor blockers - page 130
    - Calcium channel blockers - page 130
    - Diuretics - page 130
- Second-line therapy - page 133
  - Breakdown of antihypertensive second-line therapy by drug class - page 134
    - ACE inhibitors: first versus second line - page 136
    - Beta blockers - page 138
    - Angiotensin II receptor blockers - page 139
    - Calcium channel blockers - page 140
    - Diuretics - page 141
  - Breakdown of antihypertensive third-line therapy by drug class - page 142
- Changes in antihypertensive therapy - page 143
  - Continuation and discontinuation of therapy - page 143
  - Type of change in antihypertensive therapy - page 147
  - Reasons for changes in antihypertensive therapy - page 148
CHAPTER 8 INDIVIDUAL PRODUCT ASSESSMENT - page 150
- ACE inhibitors - page 150
  - Breakdown of ACE inhibitor use - page 151
    - Overall hypertensive population - page 152
    - Subpopulation differences - page 154
  - Branded versus generic ACE inhibitors - page 157
    - US - page 158
    - Japan - page 159
    - France - page 161
    - Germany - page 162
    - Italy - page 164
    - Spain - page 166
    - UK - page 168
  - Plain ACE inhibitor versus ACE inhibitor combinations - page 172
- Angiotensin II receptor blockers - page 173
  - Breakdown of ARB use - page 174
    - Overall hypertensive population - page 174
    - Sub-population differences - page 177
  - Plain ARB versus ARB diuretic single-pill combinations - page 179
  - Key factors influencing ARB use in the future - page 182
- Beta blockers - page 187
  - Breakdown of beta blocker use - page 187
    - Overall hypertensive population - page 187
    - Branded versus generic beta blockers - page 189
- Calcium channel blockers - page 190
  - Breakdown of CCB use - page 190
    - Overall hypertensive population - page 190
    - Branded versus generic CCBs - page 194
- Diuretics - page 195
  - Breakdown of diuretics inhibitor use - page 195
    - Overall hypertensive population - page 195
    - Branded versus generic diuretics - page 198
CHAPTER 9 FUTURE DEVELOPMENTS - page 200
- Pipeline products - page 200
  - Olmesartan-HCTZ single-pill combination: Benicar HCT - page 200
  - Atorvastatin-amlodipine single-pill combination: Caduet - page 204
  - Enalapril-lercanidipine single-pill combination: Zanipress - page 208
  - Eplerenone: Inspra - page 211
  - S-amlodipine - page 214
  - Aliskiren (SPP-100) - page 217
- Prescription drivers of the antihypertensive market - page 222
  - Efficacy and side-effect profile - page 224
  - Quality of life improvement - page 224
  - Use in niche populations - page 225
  - Number of additional indications upon launch - page 226
  - Marketing and pricing - page 226
  - Single-pill combinations: with diuretic, cross-risk factor and multi-modal drugs - page 228
APPENDIX A BIBLIOGRAPHY - page 230
- References - page 230
- Hypertension management guidelines - page 236
  - JNC 7 - page 236
  - ESH/ESC - page 236
  - WHO/ISH - page 236
  - BHS-IV - page 236
APPENDIX B PRIMARY RESEARCH - page 237
- Physician research methodology - page 237
  - Physician sample breakdown - page 237
  - US - page 237
  - Japan - page 238
  - France - page 238
  - Germany - page 239
  - Italy - page 239
  - Spain - page 240
  - UK - page 240
- Questionnaire - page 241
  - Diagnosis - page 242
  - Treatment - page 246
    - ACE inhibitors - page 253
    - Angiotensin II receptor blockers (ARBs) - page 255
    - Diuretics - page 258
    - Calcium channel blockers - page 259
    - Beta blockers - page 260
  - Treatment outcomes - page 262
  - Future developments - page 263
- Disclaimer - page 265

List of Tables
Table 1: Prevalence of hypertension in the US (000s), 2005-15 - page 53
Table 2: Prevalence of hypertension in Japan (000s), 2005-15 - page 54
Table 3: Prevalence of hypertension in France (000s), 2005-15 - page 55
Table 4: Prevalence of hypertension in Germany (000s), 2005-15 - page 56
Table 5: Prevalence of hypertension in Italy (000s), 2005-15 - page 57
Table 6: Prevalence of hypertension in Spain (000s), 2005-15 - page 58
Table 7: Prevalence of hypertension in the UK (000s), 2005-15 - page 59
Table 8: Prevalence of hypertension in the seven major markets (000s), 2005-15 - page 59
Table 9: The statistical base of physician survey data relating to patients of African descent per country, 2005 - page 63
Table 10: Proportion of hypertensives patients among consulting population, 2005 - page 66
Table 11: Breakdown of hypertensive populations by disease severity in the seven major markets, 2005 - page 75
Table 12: Estimated proportion of hypertensive patients with comorbid conditions and risk factors in the seven major markets, 2005 - page 77
Table 13: Evolution of treatment guidelines with respect to target blood pressure and therapy options: reducing the risk of nephropathy in patients with diabetes or kidney disease - page 80
Table 14: Distribution of physicians' SBP goals for diabetic hypertensives with and without proteinuria across the seven major markets, 2005 - page 82
Table 15: Proportion of hypertensive patients receiving antihypertensive drug therapy, 2005 - page 85
Table 16: Drug classes prescribed at any line of antihypertensive therapy, 2005 - page 87
Table 17: Prescription of ACE inhibitors by patient type, 2005 - page 91
Table 18: Prescription of ARBs by patient type, 2005 - page 95
Table 19: Prescription of beta blockers by patient type, 2005 - page 96
Table 20: Physician opinion: CCBs are highly effective at lowering blood pressure and are, therefore, beneficial as early lines of therapy, 2005 - page 99
Table 21: Prescription of CCBs by patient type, 2005 - page 100
Table 22: Prescription of diuretics by patient type, 2005 - page 102
Table 23: Proportion of hypertensive patients receiving monotherapy and combination therapy in the seven major markets, 2005 - page 104
Table 24: Proportion of hypertensive patients remaining resistance once all treatment options have been exhausted, 2005 - page 122
Table 25: Proportion of hypertensive patients receiving each class of antihypertensive at first line in the seven major markets, 2005 - page 125
Table 26: Proportion of hypertensive patients receiving each class of anti-hypertensive at second line in the seven major markets, 2005 - page 134
Table 27: Breakdown of ACE inhibitor prescribing in the overall hypertensive population in the seven major markets, 2005 - page 152
Table 28: Breakdown of ACE inhibitor prescribing in hypertensive patients with ISH in the seven major markets, 2005 - page 155
Table 29: Breakdown of ACE inhibitor prescribing in hypertensive patients of African descent in the seven major markets, 2005 - page 156
Table 30: Drivers and resistors for genericization in the Italian pharmaceutical market - page 165
Table 31: Summary of current generic substitution policies in the EU5 - page 168
Table 32: BP goals defined in the new GMS contract - page 170
Table 33: Prescription of plain ACE inhibitor vs. ACE inhibitor-diuretic single-pill combination, 2005 - page 172
Table 34: Breakdown of ARB prescribing in the hypertensive population in the seven major markets, 2005 - page 174
Table 35: Current indications for ARBs in addition to hypertension - page 177
Table 36: Prescription of plain ARB vs. ARB-diuretic single-pill combination, 2005 - page 179
Table 37: Proportion of physicians estimating their prescribing of ARBs will increase or decrease over the next three years in the seven major markets, 2005 - page 181
Table 38: Physicians' ratings of the importance of clinical or regulatory influences on their ARB prescribing, 2005 - page 182
Table 39: Physician rating: key drivers and resistors of ARB prescribing, 2005 - page 184
Table 40: Physician rating: ARBs should only be reserved for patients that are unable to tolerate ACE inhibitors, 2005 - page 186
Table 41: Breakdown of beta blocker prescribing in the hypertensive population in the seven major markets, 2005 - page 187
Table 42: Breakdown of CCB prescribing in the hypertensive population in the seven major markets, 2005 - page 191
Table 43: Breakdown of diuretics prescribing in the hypertensive population in the seven major markets, 2005 - page 195
Table 44: Physician awareness: Sankyo's olmesartan-HCTZ single-pill combination (Benicar-HCT), 2005 - page 200
Table 45: Proportion of patients to whom interviewed physicians would prescribe Benicar HCT in its first year on the market, 2005 - page 202
Table 46: Physician awareness of Pfizer's amlodipine-atorvastatin single-pill combination (Caduet), 2005 - page 204
Table 47: Proportion of patients to whom interviewed physicians would prescribe Caduet in its first year on the market, 2005 - page 205
Table 48: Physician awareness of Recordati's enalapril-lercanidipine single-pill combination (Zanipress), 2005 - page 208
Table 49: Proportion of patients to whom interviewed physicians would prescribe Zanipress in its first year on the market, 2005 - page 210
Table 50: Physician awareness of Pfizer's Inspra, 2005 - page 211
Table 51: Proportion of patients to whom interviewed physicians would prescribe Inspra in its first year on the market as an antihypertensive, 2005 - page 213
Table 52: Physician awareness of Sepracor's S-amlodipine, 2005 - page 214
Table 53: Proportion of patients to whom interviewed physicians would prescribe S-amlodipine in its first year on the market, 2005 - page 216
Table 54: Physician awareness of Novartis's aliskiren, 2005 - page 218
Table 55: Proportion of patients to whom interviewed physicians would prescribe aliskiren in its first year on the market, 2005 - page 219
Table 56: Proportion of physicians estimating the impact of factors on the uptake of new antihypertensives in the seven major markets, 2005 - page 222
Table 57: US physician sample breakdown, 2005 - page 237
Table 58: Japan physician sample breakdown, 2005 - page 238
Table 59: France physician sample breakdown, 2005 - page 238
Table 60: Germany physician sample breakdown, 2005 - page 239
Table 61: Italy physician sample breakdown, 2005 - page 239
Table 62: Spain physician sample breakdown, 2005 - page 240
Table 63: UK physician sample breakdown, 2005 - page 240

List of Figures
Figure 1: Breakdown of the overall hypertensive population in the US by diagnosis, subpopulations, disease severity and prevalence of comorbidities, 2005 - page 23
Figure 2: Breakdown of the drug treated hypertensive population and sub-populations by combination therapy and drug classes prescribed in the US, 2005 - page 24
Figure 3: Breakdown of drug classes prescribed at first- and second-line for the drug-treated hypertensive population and sub-populations in the US, 2005 - page 25
Figure 4: Segmentation of the overall drug-treated hypertensive population by drug class and individual compounds prescribed in the US, 2005 - page 26
Figure 5: Breakdown of the overall hypertensive and sub-populations by diagnosis, disease severity and drug treatment in Japan, 2005 - page 27
Figure 6: Breakdown of the drug-treated hypertensive population and sub-populations by combination therapy and drug classes prescribed in Japan, 2005 - page 28
Figure 7: Breakdown of drug classes prescribed at first- and second-line for the drug-treated hypertensive population and sub-populations in Japan, 2005 - page 29
Figure 8: Segmentation of the overall drug-treated hypertensive population by drug class and individual compounds prescribed in Japan, 2005 - page 30
Figure 9: Breakdown of the overall hypertensive and sub-populations by diagnosis, disease severity and drug treatment in France, 2005 - page 31
Figure 10: Breakdown of the drug-treated hypertensive population and sub-populations by combination therapy and drug classes prescribed in France, 2005 - page 32
Figure 11: Breakdown of drug classes prescribed at first- and second-line for the drug-treated hypertensive population and sub-populations in France, 2005 - page 33
Figure 12: Segmentation of the overall drug-treated hypertensive population by drug class and individual compounds prescribed in France, 2005 - page 34
Figure 13: Breakdown of the overall hypertensive and sub-populations by diagnosis, disease severity and drug treatment in Germany, 2005 - page 35
Figure 14: Breakdown of the drug-treated hypertensive population and sub-populations by combination therapy and drug classes prescribed in Germany, 2005 - page 36
Figure 15: Breakdown of drug classes prescribed at first- and second-line for the drug-treated hypertensive population and sub-populations in Germany, 2005 - page 37
Figure 16: Segmentation of the overall drug-treated hypertensive population by drug class and individual compounds prescribed in Germany, 2005 - page 38
Figure 17: Breakdown of the overall hypertensive and sub-populations by diagnosis, disease severity and drug treatment in Italy, 2005 - page 39
Figure 18: Breakdown of the drug-treated hypertensive population and sub-populations by combination therapy and drug classes prescribed in Italy, 2005 - page 40
Figure 19: Breakdown of drug classes prescribed at first- and second-line for the drug-treated hypertensive population and sub-populations in Italy, 2005 - page 41
Figure 20: Segmentation of the overall drug-treated hypertensive population by drug class and individual compounds prescribed in Italy, 2005 - page 42
Figure 21: Breakdown of the overall hypertensive and sub-populations by diagnosis, disease severity and drug treatment in Spain, 2005 - page 43
Figure 22: Breakdown of the drug-treated hypertensive population and sub-populations by combination therapy and drug classes prescribed in Spain, 2005 - page 44
Figure 23: Breakdown of drug classes prescribed at first- and second-line for the drug-treated hypertensive population and sub-populations in Spain, 2005 - page 45
Figure 24: Segmentation of the overall drug-treated hypertensive population by drug class and individual compounds prescribed in Spain, 2005 - page 46
Figure 25: Breakdown of the overall hypertensive and sub-populations by diagnosis, disease severity and drug treatment in the UK, 2005 - page 47
Figure 26: Breakdown of the drug-treated hypertensive population and sub-populations by combination therapy and drug classes prescribed in the UK, 2005 - page 48
Figure 27: Breakdown of drug classes prescribed at first- and second-line for the drug-treated hypertensive population and sub-populations in the UK, 2005 - page 49
Figure 28: Segmentation of the overall drug-treated hypertensive population by drug class and individual compounds prescribed in the UK, 2005 - page 50
Figure 29: Prevalence of hypertension in the seven major markets (000s), 2005-15 - page 60
Figure 30: Proportion of interviewed physicians with hypertensive patients of African descent, 2005 - page 64
Figure 31: Proportion of hypertensives patients among consulting population, 2005 - page 66
Figure 32: Proportion of diagnosed hypertensive population that is diabetic, 2005 - page 69
Figure 33: Proportion of the diagnosed hypertensive population that has non-diabetic renal disease, 2005 - page 70
Figure 34: Proportion of the diagnosed hypertensive population that has ISH, 2005 - page 72
Figure 35: Breakdown of overall hypertensive population by disease severity in the seven major markets, 2005 - page 76
Figure 36: Country-average distribution of physicians' SBP goals for diabetic hypertensives with and without proteinuria, 2005 - page 83
Figure 37: Pharmacological strategies for the inhibition of the renin-angiotensin system - page 90
Figure 38: The majority of patients need at least a combination of two antihypertensive drugs to reach target BP - page 103
Figure 39: Proportion of overall hypertensive patients receiving different layers of therapy to varying extent in the seven major markets, 2005 - page 105
Figure 40: Proportion of diagnosed and drug treated hypertensive patients reaching target blood pressure in the seven major markets, 2005 - page 108
Figure 41: Proportion of diabetic hypertensive patients receiving different layers of therapy to varying extent in the seven major markets, 2005 - page 110
Figure 42: Proportion of diagnosed and drug-treated diabetic hypertensive patients reaching target blood pressure in the seven major markets, 2005 - page 111
Figure 43: Proportion of non-diabetic hypertensive patients with renal disease receiving different layers of therapy to varying extent in the seven major markets, 2005 - page 113
Figure 44: Proportion of diagnosed and drug treated non-diabetic hypertensive patients with renal disease who are reaching target blood pressure in the seven major markets, 2005 - page 114
Figure 45: Proportion of hypertensive patients with ISH receiving different layers of therapy to varying extent in the seven major markets, 2005 - page 115
Figure 46: Proportion of diagnosed and drug treated hypertensive patients with ISH who are reaching target blood pressure in the seven major markets, 2005 - page 116
Figure 47: Proportion of hypertensive patients of African descent receiving different layers of therapy to varying extent in the seven major markets, 2005 - page 117
Figure 48: Proportion of diagnosed and drug-treated hypertensive patients of African descent who are reaching target blood pressure in the seven major markets, 2005 - page 118
Figure 49: Proportion of hypertensive patients receiving single-pill combinations, 2005 - page 119
Figure 50: Use of diuretics-based single-pill combinations versus diuretics-free single-pill combinations, 2005 - page 121
Figure 51: First line therapy: relative popularity of antihypertensive drug classes used in the overall hypertensive population in the seven major markets, 2005 - page 127
Figure 52: Proportion of hypertensive patients progressing to second-line therapy in the seven major markets, 2005 - page 133
Figure 53: Second-line therapy: relative popularity of antihypertensive drug classes used in the overall hypertensive population in the seven major markets, 2005 - page 136
Figure 54: Proportion of overall hypertensive patients receiving ACE inhibitors at first and second line in the seven major markets, 2005 - page 137
Figure 55: Proportion of overall hypertensive patients receiving beta blockers at first- and second-line in the seven major markets, 2005 - page 138
Figure 56: Proportion of overall hypertensive patients receiving ARBs at first and second line in the seven major markets, 2005 - page 139
Figure 57: Proportion of overall hypertensive patients receiving CCBs at first and second line in the seven major markets, 2005 - page 140
Figure 58: Proportion of overall hypertensive patients receiving diuretics at first and second line in the seven major markets, 2005 - page 141
Figure 59: Proportion of hypertensive patients progressing to third-line therapy and beyond, 2005 - page 142
Figure 60: Proportion of patients discontinuing therapy in the course of one year versus proportion of patients continuing therapy in the course of one year, 2005 - page 143
Figure 61: Proportion of patients newly diagnosed with hypertension in the course of one year, 2005 - page 145
Figure 62: Proportion of overall hypertensive patients undergoing various changes in antihypertensive therapy in the seven major markets, 2005 - page 147
Figure 63: Reason for change in antihypertensive therapy in the seven major markets, 2005 - page 148
Figure 64: Breakdown of ACE inhibitor prescribing in the overall hypertensive population in the seven major markets, 2005 - page 153
Figure 65: Breakdown of ACE inhibitor use by branded and generic compounds in the hypertensive population in the seven major markets, 2005 - page 157
Figure 66: Breakdown of ARB prescribing in the hypertensive population in the seven major markets, 2005 - page 175
Figure 67: Proportion of physicians intending to change their prescription of ARBs, 2005 - page 180
Figure 68: Breakdown of beta blocker prescribing in the hypertensive population in the seven major markets, 2005 - page 188
Figure 69: Breakdown of beta blocker use by branded and generic compounds in the hypertensive population in the seven major markets, 2005 - page 189
Figure 70: Breakdown of CCB prescribing in the hypertensive population in the seven major markets, 2005 - page 192
Figure 71: Breakdown of calcium channel blocker use by branded and generic compounds in the hypertensive population in the seven major markets, 2005 - page 194
Figure 72: Breakdown of diuretics prescribing in the hypertensive population in the seven major markets, 2005 - page 196
Figure 73: Breakdown of diuretics use by branded and generic compounds in the hypertensive population in the seven major markets, 2005 - page 198
Figure 74: Physician awareness: Sankyo's olmesartan-HCTZ single-pill combination (Benicar-HCT), 2005 - page 201
Figure 75: Physician awareness of Pfizer's amlodipine-atorvastatin single pill combination (Caduet), 2005 - page 205
Figure 76: Physician awareness of Recordati's enalapril-lercanidipine single-pill combination (Zanipress), 2005 - page 209
Figure 77: Physician awareness of Pfizer's Inspra, 2005 - page 212
Figure 78: Physician awareness of Sepracor's S-amlodipine, 2005 - page 215
Figure 79: Physician awareness of Novartis's aliskiren, 2005 - page 218

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Hypertension - Multiple Layers of Therapy Cover all Eventualities

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