Antithrombotics - Pipeline products to dampen the impact of patent expiries and cost containment initiatives
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 antithrombotics market - page 4
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 12
- Market definition for this report - page 12
- Current market situation - page 13
- Antithrombotics market: overview - page 13
- Anticoagulants market - page 15
- Heparins - page 17
- Low molecular weight heparin (LMWH) - page 19
- Parenteral non-heparinoid anticoagulants - page 30
- Oral anticoagulants - page 43
- Antiplatelets market - page 45
- ADP receptor antagonists - page 47
- cAMP enhancing platelet aggregation inhibitors - page 50
- GP 2b/3a inhibitors - page 54
- Other antiplatelets - page 61
- Thrombolytics market - page 65
- National markets - page 74
- Anticoagulants - page 76
- Antiplatelets - page 79
- Thrombolytics - page 81
- Key clinical trials - page 83
- Key clinical trials in the anticoagulant category - page 83
- Lovenox (enoxaparin) - page 83
- Angiomax (bivalirudin) - page 89
- Arixtra (fondaparinux) - page 96
- Key clinical trials in the antiplatelet category - page 99
- Plavix (clopidogrel) - page 99
- Key clinical trials in the thrombolytics category - page 113
- TNK (tenecteplase) - page 113
- Actilyse (tPA, alteplase) - page 117
- Key clinical trials in the anticoagulant category - page 83
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 120
- Current and future opportunities and threats in the antithrombotics market - page 120
- Global opportunities and threats - page 121
- Opportunity: increasing patient pool due to changes in demography and lifestyle - page 121
- Threat: cost-conscious pricing and reimbursement environment - page 128
- US - page 132
- US opportunities - page 132
- US threats - page 134
- Japan - page 138
- Japan opportunities - page 138
- Japan threats - page 141
- EU5: opportunities and threats - page 145
- EU5 Opportunities - page 145
- EU5 Threats - page 146
- France: opportunities and threats - page 149
- France opportunities - page 149
- France threats - page 151
- Germany: opportunities and threats - page 154
- Germany opportunities - page 154
- Germany threats - page 154
- Italy: opportunities and threats - page 161
- Italy opportunities - page 161
- Italy threats - page 162
- Spain: opportunities and threats - page 165
- Spain opportunities - page 165
- Spain threats - page 167
- UK: opportunities and threats - page 169
- UK opportunities - page 169
- UK threats - page 171
- Global opportunities and threats - page 121
- Summary of environmental issues affecting the antithrombotic market size - page 174
- Current and future opportunities and threats in the antithrombotics market - page 120
- CHAPTER 4 FORECAST ANALYSIS - page 177
- Key assumptions and events - page 177
- New products - page 177
- Future outlook on key marketed products - page 177
- Lovenox (enoxaparin) - page 177
- Angiomax (bivalirudin) - page 181
- Arixtra (fondaparinux) - page 183
- Plavix (clopidogrel) - page 185
- GP 2b/3a inhibitors and thrombolytics - page 190
- Generic incursion: patent expiries and marketing exclusivity - page 194
- Limitations of data - page 195
- Forecasts - page 195
- Key assumptions and events - page 177
- CHAPTER 5 CASE STUDIES: KEY PIPELINE AGENTS - page 196
- Case study A - What commercial potential does the oral anticoagulant market segment harbor? - page 196
- The market opportunity - page 196
- Warfarin's monitoring requirement and dosing complexity generates an opening in the market for novel oral anticoagulants - page 196
- Oral antiplatelets are unlikely to threaten commercial potential of emerging oral anticoagulants - page 199
- The key competitors in development - page 201
- The commercial potential of oral anticoagulants - page 205
- Patient potential of oral anticoagulants - page 205
- Sales forecast of the two most advanced oral anticoagulants - page 206
- Conclusions - page 212
- The market opportunity - page 196
- Case study B - Will prasugrel capture the antiplatelet market? - page 214
- The market opportunity - page 214
- The unmet need profile of the antiplatelet market indicates opportunities for novel antiplatelets. - page 214
- Commercial potential of prasugrel - page 221
- Drug overview: prasugrel (CS-747) - page 221
- Sales forecast of prasugrel - page 235
- The market opportunity - page 214
- Case study A - What commercial potential does the oral anticoagulant market segment harbor? - page 196
- APPENDIX A - page 238
- Bibliography - page 238
- Report methodology - page 245
- Standard units - page 245
- Japanese market data - page 246
- APPENDIX B - MARKET FORECAST DATA - page 247
- US forecasts - page 247
- Japan forecasts - page 251
- France forecasts - page 254
- Germany forecasts - page 258
- Italy forecasts - page 262
- Spain forecasts - page 266
- UK forecasts - page 270
- M5EU forecasts - page 274
- Global forecasts - page 279
- About Datamonitor - page 286
- About Datamonitor Healthcare - page 286
- About the Cardiovascular Disease analysis team - page 287
- Disclaimer - page 288
- List of Tables
- Table 1: Sales of antithrombotics in the seven major markets by drug category, 2004-05 - page 13
- Table 2: Sales of anticoagulants in the seven major markets by drug class, 2005 - page 15
- Table 3: The heparin market is dominated by LMWHs, 2005 - page 18
- Table 4: Growth and market share of the LMWHs in the seven major markets, 2005 - page 24
- Table 5: Growth and market share of the "other LMWHs" in the seven major markets, 2005 - page 26
- Table 6: Growth and market share of parenteral non-heparinoid anticoagulants in the seven major markets, 2005 - page 31
- Table 7: Growth and market share within the DTI subsegment of the parenteral non-heparinoid segment, 2005 - page 33
- Table 8: Warfarin sales in the seven major markets, 2005 - page 43
- Table 9: Sales of antiplatelets in the seven major markets by drug class, 2005 - page 46
- Table 10: Sales of thienopyridines in the seven major markets by drug class, 2005 - page 48
- Table 11: Platelet cAMP enhancers are heavily prescribed in Japan, 2005 - page 50
- Table 12: Sales of platelet cAMP enhancers in the seven major markets by value, 2005 - page 51
- Table 13: GP 2b/3a receptor properties: overview - page 54
- Table 14: Sales of GP 2b/3a inhibitors in the seven major markets by value, 2005 - page 56
- Table 15: Sales of "COX inhibitors and other antiplatelets" in the seven major markets by value, 2005 - page 61
- Table 16: Sales of thrombolytics in the seven major markets by drug class, 2005 - page 65
- Table 17: Comparison of tPA-based thrombolytics - page 67
- Table 18: Antithrombotics market in the seven major markets by country, 2005 - page 75
- Table 19: Anticoagulant market in the seven major markets by country, 2005 - page 77
- Table 20: Antiplatelet market in the seven major markets by country, 2005 - page 79
- Table 21: Thrombolytics market in the seven major markets by country, 2005 - page 81
- Table 22: Key results of CURE substudy - page 99
- Table 23: COMMIT/CCS-2 trial: efficacy endpoints - page 101
- Table 24: COMMIT/CCS-2 trial: safety endpoints - page 102
- Table 25: COMMIT/CCS-2 trial: time to treatment - page 102
- Table 26: COMMIT/CCS-2 trial: thrombolytic background therapy - page 103
- Table 27: ARMYDA-2: number of events at 30 days - page 105
- Table 28: ARMYDA-2: postprocedural peak biomarker levels - page 105
- Table 29: ARMYDA-2: percentage of patients with an elevation of CKMB/troponin I - page 105
- Table 30: ARMYDA-2: number of bleeding events at 30 days - page 106
- Table 31: The ageing population in the seven major markets, 2006-2015 - page 121
- Table 32: Prevalence of obesity in six major markets by age (000s), 2005 - page 125
- Table 33: Prevalence of overweight in the six of the seven major markets by age (000s), 2005 - page 126
- Table 34: Patient dynamics in cardiovascular conditions in the seven major markets, 2005-2015 (000s) - page 128
- Table 35: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005 - page 171
- Table 36: Generic incursion in the sales of key products within the forecasting period, 2006-2015 - page 194
- Table 37: Phase III anticoagulants (long-term indications), 2006 - page 201
- Table 38: Comparison of antiplatelet, antithrombotic, and antihemostatic effects of prasugrel, clopidogrel and ticlopidine - page 224
- Table 39: Number of adverse events in Phase IIa prasugrel dose-ranging study - page 229
- Table 40: JUMBO-TIMI 26: patient characteristics - page 231
- Table 41: JUMBO-TIMI 26: primary endpoint (significant bleeding) - page 231
- Table 42: JUMBO-TIMI 26: TIMI major bleeding - page 232
- Table 43: JUMBO-TIMI 26: total bleeding episodes (TIMI major/minor and minimal) - page 232
- Table 44: JUMBO-TIMI 26: secondary endpoint (MACE) - page 233
- Table 45: JUMBO-TIMI 26: MACE components - page 233
- Table 46: US antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 247
- Table 47: Japan antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 251
- Table 48: France antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 254
- Table 49: Germany antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 258
- Table 50: Italy antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 262
- Table 51: Spain antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 266
- Table 52: UK antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 270
- Table 53: 5MEU antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 274
- Table 54: Global antithrombotic sales forecasts ($m; 2005 figures are actuals) - page 279
- List of Figures
- Figure 1: Sales of antithrombotics in the seven major markets, 2005 - page 14
- Figure 2: Sales of anticoagulants in the seven major markets by drug class, 2005 - page 17
- Figure 3: The heparin market is dominated by LMWHs, 2005 - page 19
- Figure 4: Growth and market share of the LMWHs in the seven major markets, 2005 - page 25
- Figure 5: The broad indication roll-out of Lovenox (enoxaparin) is a barrier to market entry and penetration of novel anticoagulants - page 28
- Figure 6: Growth and market share of parenteral non-heparinoid anticoagulants in the seven major markets, 2005 - page 32
- Figure 7: Risk of stroke increases with age - page 44
- Figure 8: Sales of antiplatelets in the seven major markets by drug class, 2005 - page 47
- Figure 9: Sales of platelet cAMP enhancers in the seven major markets by value, 2005 - page 52
- Figure 10: Majority of the sales in "Other platelet cAMP enhancers" segment are confined to Japan, 2005 - page 53
- Figure 11: Sales of GP 2b/3a inhibitors in the seven major markets by value, 2005 - page 58
- Figure 12: Sales of "COX inhibitors and other antiplatelets" in the seven major markets by value, 2005 - page 62
- Figure 13: Sales of thrombolytics in the seven major markets by drug class, 2005 - page 66
- Figure 14: Antithrombotics market in the seven major markets by country, 2005 - page 76
- Figure 15: Anticoagulant market in the seven major markets by country, 2005 - page 78
- Figure 16: Antiplatelet market in the seven major markets by country, 2005 - page 80
- Figure 17: Thrombolytics market in the seven major markets by country, 2005 - page 82
- Figure 18: COMMIT/CCS-2 trial: dual antiplatelet therapy in AMI - page 101
- Figure 19: ARMYDA-2: trial design - page 104
- Figure 20: Increase in obese and overweight adults in the US, 1976-2000 - page 124
- Figure 21: A fall in reference prices is likely to lead to greater use of generics - page 158
- Figure 22: Although generic sales and volume use have increased over the last 10 years, the generics market only accounts for a small proportion of the Spanish pharmaceutical market - page 165
- Figure 23: Summary of global and EU specific opportunities and threats affecting the antithrombotics market, 2006 - page 174
- Figure 24: Summary of country-specific opportunities and threats affecting the US and Japanese antithrombotics markets, 2006 - page 175
- Figure 25: Summary of country-specific opportunities and threats affecting the EU5 antithrombotics markets, 2006 - page 176
- Figure 26: Sales forecasts for Rendix in the seven major markets, 2008-2015 - page 209
- Figure 27: Sales forecasts for rivaroxaban in the seven major markets, 2008-2015 - page 211
- Figure 28: Randomized two-way cross-over study in healthy subjects - page 227
- Figure 29: Randomized, partially blind, parallel group dose-ranging study - page 228
- Figure 30: JUMBO-TIMI 26: prasugrel in the setting of PCI - page 230
- Figure 31: TRITON-TIMI-38: trial design - page 234
- Figure 32: Sales forecasts for prasugrel in the seven major markets, 2008-2015 - page 235
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