Cardiovascular market overview - Raft of patent expires threaten blockbusters

ABOUT DATAMONITOR HEALTHCARE 2
About the cardiovascular pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor 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 UK's 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
Pfizer's 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
About Datamonitor 249
About Datamonitor Healthcare 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