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Commercial Insight: Cardiovascular Market Overview - Raft of Patent Expires Threaten Blockbusters
Datamonitor, Oct 2007, Pages: 262
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Insight into the cardiovascular market 3
Related reports 6
Upcoming reports 6
CHAPTER 2 MARKET OVERVIEW AND DYNAMICS 8
Cardiovascular market 8
Seven major markets 9
Cardiovascular market by disease area 12
US 14
Japan 15
France 16
Germany 17
Italy 18
Spain 19
UK 20
The Top 25 cardiovascular active agents 21
The Top 25 cardiovascular brands 26
Geographical variations 29
Top 25 active agents 29
Top 25 brands 31
Disease areas 33
Hypertension 33
Dyslipidemia 37
Diabetes 41
Thrombosis 45
CHAPTER 3 MARKET ANALYSIS 50
Intellectual property risk assessment 50
Seven major markets 53
US 54
Japan 55
France 56
Germany 57
Italy 58
Spain 59
UK 60
Key patent expiries 60
Patent challenges 62
Company portfolio assessment 64
The Top 25 cardiovascular companies 64
The Top 10 cardiovascular companies profiles 66
Pfizer 66
Sanofi-Aventis 67
Merck & Co 68
Amgen 69
Novartis 69
Takeda 70
GlaxoSmithKline 70
Bristol-Myers Squibb 70
AstraZeneca 71
Novo Nordisk 71
Company vulnerability 72
Sales - winners and losers 75
SUs sold - winners and losers 79
Drug pricing 83
The generic threat 85
Major brands facing generic erosion during forecast period 85
Reformulations and evergreening 86
Biosimilars 87
CHAPTER 4 COUNTRY MARKET ASSESSMENTS 89
Global opportunities and threats 89
Opportunities 89
Demographic and lifestyle trends continue to dominate the agenda, and have the potential to increase the hypertensive patient population 89
Large patient population and low treatment goals in dyslipidemia 91
Development of novel compounds 93
Growing awareness of the metabolic syndrome 95
Increasing co-operation between regulatory bodies 96
The emerging markets of India and China cannot be ignored 97
Threats 98
Increased generic competition 98
Parallel trade 98
New EU states may lead to a flood of cheap drug exports 101
Ongoing cost-containment measures 102
Increasingly conservative regulatory environments 102
Restrictive pricing and reimbursement policies 103
Reduced periods of market exclusivity 103
Mandatory registration of all clinical trial results 104
US: opportunities and threats 105
Opportunities 105
Direct-to-consumer (DTC) advertising is legal in the US and has been shown to influence patient prescription choice and increase diagnosis rates 105
Leveraging the JNC7 guidelines to maximize pharmacotherapy 105
Leveraging the NCEP ATP III guidelines 108
Lower targets will intensify the treatment of diabetes 109
Price of drugs 109
Threats 110
The changing healthcare environment in the US will drive future generic use 110
Generics 115
Medicare Part D is expected to lead to greater generic use 125
Patient power 129
Pharmaceutical re-importation issues continue to dog Big Pharma 130
Further genericization encouraged by new legislation and public programs 130
Formularies promote quality, but restrict choice 132
Pricing and reimbursement issues 133
$10 billion cut planned in Medicaid between 2005 and 2010 135
Curbing of DTC advertising will lead to greater emphasis on risk of products 135
Wal-Mart $4 a day generic program introduces further cost competition 136
The obesity epidemic 138
Japan: opportunities and threats 139
Opportunities 139
Ageing population 139
Separation of manufacturing and marketing entities benefits both Japanese and foreign companies 139
Fewer outsourcing restrictions enhances manufacturing efficiency 140
An underdeveloped generics market slows brand erosion 140
Possible introduction of direct-to-consumer advertising 141
Multiple patent extensions and labeling regulations 142
Opening up the Japanese market 142
Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare 144
Reduced product approval time 145
Harmonization of approval process 145
Threats 145
Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future 145
Generic drug use is expected to increase 147
Flat-sum reimbursement 147
Complex regulatory process 148
Biannual price cuts still threaten market growth 149
New healthcare reforms under debate 149
5EU: opportunities and threats 150
5EU opportunities 150
Revisions to EU pharmaceutical laws 150
Extra year of marketing protection 150
5EU threats 151
Single European pricing 151
Facilitated entry of generics 151
Generic substitution 152
Finalization of biosimilar legislation 152
Parallel trade 152
Formulary changes 154
France: opportunities and threats 154
Opportunities 154
Innovation encouraged in the pharmaceutical industry 154
Demographic changes provide opportunity for market expansion of chronic illnesses 154
Consumers in France readily recognize the Internet as a source of high-quality medical information 155
Generic consumption in France is particularly low 156
Threats 157
Attractiveness of French market hit by higher taxes, lower prices and a shorter reimbursement list 157
Continuation of cost-control measures 158
Formulary access 158
Take-off of generic sector 158
Limitations on prescriptions dispensed from hospitals to patients in the community 159
Pharmacists are being mandated to drive generic dispensing 159
Germany: opportunities and threats 160
Opportunities 160
Pricing freedom supports innovation 160
ePharmacy and mail-order drugs legalized 161
Threats 161
Cost-containment measures in Germany have led to a healthy generics market 161
German doctors set to receive bonuses for prescribing generics 163
Italy: opportunities and threats 165
Opportunities 165
Single agency holds regulatory authority 165
Negligible impact of generics is set to continue 165
Innovative drug development rewarded with premium price and 100% reimbursement 166
Threats 167
Single agency holds regulatory authority 167
Ongoing cost-containment measures 167
Stringent reference pricing system 168
Restructured reimbursement categories 168
Further pharmaceutical price cuts planned 169
Intellectual property to conform with rest of EU 169
Spain: opportunities and threats 170
Opportunities 170
Underdeveloped generics market both an opportunity and a threat 170
Electronic prescribing will improve access to treatments and promote the rational use of drugs 170
Threats 170
Increased scrutiny of new drugs 170
R&D activity expected to decline 171
Reference pricing systems (RPS) likely to have an impact on branded revenues 172
Compulsory patient co-payments 172
Government awareness campaign promotes generic use 173
New medicines bill pushes more price cuts and increases pharmaceutical tax 173
UK: opportunities and threats 174
Opportunities 174
Attractiveness of market 174
Supplementary and expanded prescribing powers 174
New fast-track drug assessment process speeds up time between licensing and NICE recommendations 175
NICE guidance advises against the use of betablockers 175
GMS contract improvements 176
Threats 178
The National Institute of Clinical Excellence (NICE) 178
Pricing controls dominate budgetary cost containment strategies 179
The NHS is unreceptive to new treatments compared to the rest of Europe 180
Falling foul of the ABPI, the UKs Pharma watchdog 180
Pharmaceutical Price Regulation Scheme (PPRS) implements periodic price cuts 182
Cost containment measures encourage continued high use of generics 182
Public space smoking ban 183
Summary of environmental issues affecting the cardiovascular market size 184
CHAPTER 5 FORECAST ANALYSIS 186
New product launches 186
Tekturna/Rasilez (Aliskiren) marketed by Novartis 186
Exforge (amlodipine + valsartan) marketed by Novartis 186
Byetta LAR 186
Januvia 187
Zetia (ezetimibe) in Japan 187
Sales forecast 2006-2016 187
Case studies 192
Avandia - FDA negligence or political grandstanding? 192
Pfizers sales cliff 193
Where to next? 195
Exit the franchise 195
Cost control 195
R&D productivity 196
Licensing and M&A 196
Blockbuster to nichebuster 197
The rise of Japan 197
Emerging markets 198
Data definitions, limitations and assumptions 198
Standard units 198
Japanese market data 198
Derivation of sales forecasts and pricing trends 198
Forecasts 199
Forecast methodology 199
APPENDIX A - BIBLIOGRAPHY 200
Journals 200
Press releases 201
Web articles 201
Databases 204
Datamonitor reports 205
APPENDIX B - MARKET FORECAST DATA 207
US forecasts 207
Japan forecasts 211
France forecasts 214
Germany forecasts 218
Italy forecasts 223
Spain forecasts 227
UK forecasts 231
5EU forecasts 235
Seven major market forecasts 242
APPENDIX C 249
Report methodology 249
Disclaimer 251
List of Tables
Table 1: Top 25 cardiovascular active agents in the seven major markets, 2003-2016 23
Table 2: Top 25 cardiovascular brands in the seven major markets, 2003-2016 28
Table 3: Key patent expiries during the forecast period, 2006-2016 61
Table 4: Significant Paragraph IV challenges to Top 25 brands in US, September 2007 63
Table 5: Top 25 cardiovascular companies in the seven major markets by sales, 2003-06 65
Table 6: Top 25 cardiovascular companies in the seven major markets by SUs sold, 2003-06 66
Table 7: Prevalence of obesity in six major markets by age (000s), 2005 91
Table 8: Five generics companies are among the Top 10 companies in terms of prescriptions filled under Medicare Part D, 2006 113
Table 9: The actual generic fill rate varies between therapeutic classes, 2006 122
Table 10: Wal-Mart is selling many generic antihypertensives for less than the mean price per standard unit in the US in 2006 137
Table 11: An example of the savings to be realized by using generic drugs in the Japanese market, 2006 146
Table 12: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005 177
Table 13: Sales forecast for the major brands and active agents in the US ($ million), 2006-16 207
Table 14: Sales forecast for the major brands and active agents in the Japan ($ million), 2006-16 211
Table 15: Sales forecast for the major brands and active agents in the France ($ million), 2006-16 214
Table 16: Sales forecast for the major brands and active agents in the Germany ($ million), 2006-16 218
Table 17: Sales forecast for the major brands and active agents in the Italy ($ million), 2006-16 223
Table 18: Sales forecast for the major brands and active agents in the Spain ($ million), 2006-16 227
Table 19: Sales forecast for the major brands and active agents in the UK ($ million), 2006-16 231
Table 20: Sales forecast for the major brands and active agents in the 5 EU ($ million), 2006-16 235
Table 21: Sales forecast for the major brands and active agents in the seven major markets ($ million), 2006-16 242
List of Figures
Figure 1: Cardiovascular sales and Standard Units sold in the seven major markets, 2003-06 8
Figure 2: Geographical distribution of cardiovascular sales in the seven major markets by value, 2003 and 2006 9
Figure 3: Geographical distribution of cardiovascular sales in the seven major markets by volume, 2003 and 2006 10
Figure 4: Cardiovascular sales in the seven major markets by value ($ billion), 2003-06 11
Figure 5: Cardiovascular sales in the seven major markets by volume (SUs), 2003-06 12
Figure 6: Cardiovascular sales in the seven major markets by disease area, 2006 13
Figure 7: Cardiovascular sales in the seven major markets by disease area, 2016 14
Figure 8: US cardiovascular sales by disease area, 2003-06 15
Figure 9: Japanese cardiovascular sales by disease area, 2003-06 16
Figure 10: French cardiovascular sales by disease area 2003-06 17
Figure 11: German cardiovascular sales by disease area, 2003-06 18
Figure 12: Italian cardiovascular sales by disease area, 2003-06 19
Figure 13: Spanish cardiovascular sales by disease area, 2003-06 20
Figure 14: UK cardiovascular sales by disease area, 2003-06 21
Figure 15: Top 10 cardiovascular active agents in the seven major markets by sales, 2003-2016 22
Figure 16: Total sales of the top 10 and top 25 active agents in the seven major markets, 2003-2016 24
Figure 17: Top 10 cardiovascular branded/licensed/generic active agents in the seven major markets, 2006 25
Figure 18: Top 10 cardiovascular brands in the seven major markets by sales, 2003-2016 27
Figure 19: Growth of top 10 and top 25 brands by sales in the seven major markets, 2003-16 29
Figure 20: Geographical variations in sales and launch of the Top 25 active agents in the seven major markets, 2006 31
Figure 21: Geographical variations in sales and launch of the Top 25 brands in the seven major markets, 2006 33
Figure 22: Leading mechanisms of action in the hypertension market by SUs sold in the seven major markets, 2003-06 34
Figure 23: National hypertension markets split by main mechanism of action and SUs sold in the seven major markets, 2006 35
Figure 24: Leading mechanisms of action in the hypertension market by sales value in the seven major markets, 2003-06 36
Figure 25: National hypertension markets split by main mechanism of action and sales in the seven major markets, 2006 37
Figure 26: Dyslipidemia market split by main mechanism of action and SUs sold in the seven major markets, 2003-06 38
Figure 27: National dyslipidemia markets split by main mechanism of action and SUs sold in the seven major markets, 2006 39
Figure 28: Dyslipidemia market split by sales of statins and other mechanisms in the seven major markets, 2003-06 40
Figure 29: National dyslipidemia market sales split by main mechanism of action and sales in the seven major markets, 2006 41
Figure 30: Diabetes market split by main mechanisms of action and SUs sold in the seven major markets, 2003-06 42
Figure 31: National diabetes markets split by main mechanisms of action and SUs sold in the seven major markets, 2006 43
Figure 32: Leading mechanisms of action in the diabetes market by sales in the seven major markets, 2003-06 44
Figure 33: National diabetes markets split by main mechanisms of action and sales in the seven major markets, 2006 45
Figure 34: Leading mechanisms of action in the thrombosis market by sales in the seven major markets, 2003--06 46
Figure 35: National thrombosis markets split by main mechanisms of action and SUs sold in the seven major markets, 2006 47
Figure 36: Leading mechanisms of action in the thrombosis market by sales in the seven major markets, 2003-06 48
Figure 37: National thrombolytic markets split by main mechanism of action and sales in the seven major markets, 2006 49
Figure 38: Intellectual property risk assessment - division of risk field 52
Figure 39: Intellectual property risk assessment of Top 10 brands in the seven major markets, weighted by 2006 sales 53
Figure 40: Intellectual property risk assessment of Top 10 US brands, weighted by 2006 sales 54
Figure 41: Intellectual property risk assessment of Top 10 Japanese brands, weighted by 2006 sales 55
Figure 42: Intellectual property risk assessment of Top 10 French brands, weighted by 2006 sales 56
Figure 43: Intellectual property risk assessment of Top 10 German brands, weighted by 2006 sales 57
Figure 44: Intellectual property risk assessment of Top 10 Italian brands, weighted by 2006 sales 58
Figure 45: Intellectual property risk assessment of Top 10 Spanish brands, weighted by 2006 sales 59
Figure 46: Intellectual property risk assessment of Top 10 UK brands, weighted by 2006 sales 60
Figure 47: Vulnerability of Top 10 cardiovascular companies by sales, 2003-06 73
Figure 48: Vulnerability of Top 10 cardiovascular companies by SUs sold, 2003-06 74
Figure 49: IP assessment of Top 10 brands in the seven major markets and their importance to the marketing companies, weighted by 2006 sales 75
Figure 50: Overall sales growth of the 10 best-performing companies out of the Top 25 cardiovascular players in the seven major markets, 2003-06 76
Figure 51: Overall sales performance of the 10 worst-performing companies out of the top 25 cardiovascular players in the seven major markets, 2003-06 77
Figure 52: Cardiovascular sales growth of the 10 best-performing companies out of the Top 25 pharmaceutical companies in the seven major markets, 2003-06 78
Figure 53: Cardiovascular sales growth of the 10 worst-performing of the Top 25 pharmaceutical companies in the seven major markets, 2003-06 79
Figure 54: Overall SUs sold growth of the 10 best-performing of the Top 25 cardiovascular companies in the seven major markets, 2003-06 80
Figure 55: Overall SUs sold growth of the 10 worst-performing of the Top 25 cardiovascular companies in the seven major markets, 2003-06 81
Figure 56: Cardiovascular SUs sold growth of the 10 best-performing of the Top 25 pharmaceutical companies in the seven major markets, 2003-06 82
Figure 57: Cardiovascular SUs sold growth of the 10 worst-performing of the top 25 pharmaceutical companies in the seven major markets, 2003-06 83
Figure 58: National price variations from the mean for the seven major markets, 2006 84
Figure 59: Branded drugs as a proportion of the Top 25 cardiovascular active agents, 2003-06 85
Figure 60: US patent expiries of the Top 10 brands, 2006-2016 86
Figure 61: Proportion of population aged 60-79 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004 90
Figure 62: Generalized distribution chain for parallel traded pharmaceutical products 99
Figure 63: JNC6 and JNC7 compared: classification of blood pressure levels 107
Figure 64: More than half of all prescriptions dispensed in the US are generics, 1984-2005 111
Figure 65: Generic companies dominate the US pharmaceutical market in terms of prescriptions, 2006 112
Figure 66: Generic use in the US is promoted through a number of channels 117
Figure 67: The generic fill rates in the US for 2003 varied considerably by state 123
Figure 68: The tiered co-payment system will lead to greater use of generics 126
Figure 69: Key pressures facing drug developers, 1990-2004 134
Figure 70: Wal-Marts $4 generic drug program web-page 138
Figure 71: The Japanese generic market is underdeveloped because of a number of factors 141
Figure 72: Summary of global opportunities and threats affecting the cardiovascular market, 2007 184
Figure 73: Summary of regional opportunities and threats affecting the cardiovascular market, 2007 185
Figure 74: Impact of cardiovascular pipeline on total sales, 2006-2016 188
Figure 75: Sales growth in the main geographical regions, 2003-2016) 189
Figure 76: Growth in cardiovascular sales by disease area, 2006-2016 190
Figure 77: The future is generics - cardiovascular sales, 2006-2016 191
Figure 78: Avandia and Actos sales, 2006-16 193
Figure 79: Pfizers cardiovascular sales cliff 194
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