2003 Cardiovascular Market Update
According to IMS MIDAS data, global sales of cardiovascular and antithrombotic drugs, i.e. anti-hypertensives, anti-dyslipidemics, antithrombotics and cardiac therapies, reached $72.6bn in 2002. However, competition within each of the four therapy areas is fierce, with many leading brands facing the threat of generic competition and other key patents due to expire over the next five years. The report provides a review of the cardiovascular market in 2003, with a focus on anti-hypertensives, anti-dyslipidemics and cardiac therapies.
Table of Contents
- EXECUTIVE SUMMARY - page 4
- Introduction - page 4
- Scope and coverage of the Brief - page 4
- Key findings about the cardiovascular market - page 5
- Growth in the anti-hypertensives market is principally driven by sales of the ARBs, which continue to benefit from patent protection - page 5
- Statins continue to lead the anti-dyslipidemic market, although generic competition is becoming more aggressive - page 6
- The antithrombotics market continues to show impressive growth, driven by the rapid uptake of Plavix (clopidogrel) - page 6
- Although generating the smallest revenue, cardiac therapy offers the greatest potential for new agents due to the substantial patient populations and high unmet need - page 7
- INTRODUCTION - page 8
- OVERVIEW OF THE CARDIOVASCULAR MARKET - page 8
- Key events of 2003 - page 11
- Overview of cardiovascular late-stage R&D - page 12
- ANTI-HYPERTENSIVES - page 14
- Top 10 anti-hypertensives - page 15
- Key events summary - page 17
- ACE inhibitors - page 19
- Overview - page 19
- Leading brand dynamics - page 19
- Key events in 2003 - page 20
- Patent challenge for Altace - page 20
- Development of a modified-release formulation of Altace - page 20
- Ramipril reduces onset of heart failure in high-risk patients - page 21
- ACE inhibitors superior to diuretics - page 22
- XSOLVD: 12-year follow-up of SOLVD studies - page 22
- ACE inhibitors reduce AF in heart failure - page 23
- Calcium channel blockers - page 24
- Overview - page 24
- Leading brand dynamics - page 25
- Key events in 2003 - page 25
- Sankyo launches Calblock - page 25
- Angiotensin receptor blockers - page 26
- Overview - page 26
- Leading brands dynamics - page 26
- Key events in 2003 - page 29
- A new indication for Cozaar following LIFE - page 29
- FDA approves Benicar HCT - page 31
- Beta blockers - page 31
- Overview - page 31
- Leading brands dynamics - page 31
- Key events in 2003 - page 32
- New landmark trial demonstrates carvedilol saves significantly more lives than metoprolol - page 32
- Diuretics - page 33
- Overview - page 33
- ACE inhibitors - page 19
- Anti-hypertensives sales forecasts - page 34
- ANTI-DYSLIPIDEMICS - page 36
- Top 10 anti-dyslipidemics - page 37
- Key events summary - page 39
- Statins - page 43
- Overview - page 43
- Leading brands dynamics - page 43
- Key events for 2003 - page 44
- Crestor (rosuvastatin) - page 44
- Crestor 80mg is withdrawn from clinical trials - page 44
- Crestor receives its first EU approval - page 44
- Germany, Spain and Norway wihdraw from Crestor’s MRP - page 44
- Crestor launched in Canada - page 44
- Beneficial effects of rosuvastatin alone and in combination with niacin ER in patients with combined dyslipidemia and low HDL-cholesterol levels. - page 45
- Approval of Crestor recommended in the US by the FDA - page 46
- Pitavastatin - page 46
- Approval of pitavastatin recommended in Japan - page 46
- Lipitor (atorvastatin) - page 47
- Results of the lipid arm of the ASCOT trial presented at the ACC - page 47
- Zocor (simvastatin) - page 48
- Zocor in the treatment of multiple sclerosis - page 48
- Simvastatin therapy slows coronary disease progression in patients with and without cardiovascular risk factors - page 48
- FDA approves inclusion of the findings from HPS in Zocor’s labeling - page 49
- Zocor loses patent protection in the UK and Germany - page 50
- Pravachol (pravastatin) - page 50
- No CHD reduction with pravastatin in ALLHAT trial - page 50
- Lescol (fluvastatin) - page 51
- Fluvastatin reduces risk of serious cardiac events in high risk patients - page 51
- Lescol approved for the prevention of coronary events in patients with CHD - page 52
- Lescol reduced heart attack risk in renal transplant patients - page 52
- Fibrates - page 52
- Overview - page 52
- Leading brands dynamics - page 53
- Statins - page 43
- Other anti-dyslipidemics - page 53
- Overview - page 53
- Leading brands dynamics - page 54
- Key events - page 56
- Niaspan/Advicor (niacin ER/niacin ER + lovastatin) - page 56
- Advicor versus Lipitor and Zocor, the ADVOCATE study - page 56
- Barr Laboratories receives tentative approval for generic ER niacin - page 57
- Zetia (ezetimibe) - page 57
- Mutual Recognition Procedure completed for Zetia - page 57
- C-reactive protein reduction nearly doubled by Zetia co-administered with simvastatin in patients with high cholesterol compared to simvastatin alone - page 58
- Ezetimibe + 10mg atorvastatin versus 20mg atorvastatin - page 58
- Ezetimibe + statin versus higher dose statin monotherapy - page 58
- Side-effect warning added to Zetia’s labeling - page 59
- Statins and anti-dyslipidemics - page 59
- Anti-dyslipidemics less effective outside of trials - page 59
- Link between non-HDL cholesterol, type 2 diabetes and heart disease - page 60
- Cholesterol-lowering drugs cut stroke risk - page 61
- Little change in cholesterol among US adults in 1999–2000 - page 61
- Anti-dislipidemics sales forecasts - page 62
- CARDIAC THERAPIES - page 63
- Top 10 cardiac therapies - page 65
- Key events summary - page 66
- Other cardiac therapies - page 67
- Overview - page 67
- Leading-brand dynamics - page 67
- Nitrites and nitrates - page 68
- Overview - page 68
- Leading-brand dynamics - page 68
- Anti-arrhythmics - page 69
- Overview - page 69
- Leading-brand dynamics - page 69
- Key events - page 71
- No reason for rhythm: AFFIRM and RACE trials support rate control as equivalent strategy in AF - page 71
- Keeping in rhythm: SAFE-T shows amiodarone able to maintain sinus rhythm longer than sotalol - page 73
- Cardiac glycosides and combinations - page 74
- Overview - page 74
- Leading brands dynamics - page 75
- Key events - page 76
- Digoxin benefits questioned once more - page 76
- Other cardiac therapies - page 67
- APPENDIX - page 78
- Bibliography - page 78
- Disclaimer - page 82
- Bibliography - page 78
- List of Tables
- Table 1: Global sales of the four key cardiovascular therapy areas ($m), 2001–02 - page 8
- Table 2: Top 10 cardiovascular brands in 2002 - page 10
- Table 3: Key cardiovascular late-stage R&D, 2003 - page 13
- Table 4: Global sales in the anti-hypertensives market by drug class ($m), 2001–02 - page 14
- Table 5: Global sales of the ten highest selling anti-hypertensives in 2001 and 2002 - page 16
- Table 6: Summary of key events in the anti-hypertensives market in 2003 - page 17
- Table 7: Global sales of the leading ARBs in 2001 and 2002 - page 28
- Table 8: Global sales forecasts for the anti-hypertensives market ($m), 2003–10 - page 34
- Table 9: Global sales in the anti-dyslipidemic market by drug class ($m), 2001–02 - page 36
- Figure 3: Growth and class market share of anti-dyslipidemics by drug class , 2001–02 - page 37
- Table 10: Global sales of the 10 highest selling anti-dyslipidemics in 2001 and 2002 - page 38
- Table 11: Summary of key events in the anti-dyslipidemic market in 2003 - page 39
- Table 12: Global sales forecasts of anti-dyslipidemic therapies, by drug class ($m), 2003–10 - page 62
- Table 13: Global sales of cardiac therapies, 2001–02 - page 63
- Table 14: Global sales of the top 10 leading cardiac therapies in 2001 and 2002 - page 65
- Table 15: Summary of key events in the cardiac therapy market in 2002 to 2003 - page 66
- Table 16: AMIOVIRT trial results - page 70
- Table 17: Adverse outcomes in AFFIRM - page 72
- Table 18: Median time to AF recurrence (days) in the SAFE-T trial - page 74
- Table 19: Adjusted outcomes and hazard ratios by SDCs in the DIG trial - page 77
- List of Figures
Figure 1: Growth and sales of the four key cardiovascular therapy areas, 2001-2002 - page 9
- List of Figures
- Figure 2: Growth and sales of the anti-hypertensive drug classes 2001–2002 - page 15
- Figure 4: Growth and class market share of cardiac therapies by drug class , 2001–02 - page 64
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