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Stakeholder Opinions: Cardiovascular and Metabolic Generics - Generics continue to gain prominence
Introduction
Looming patent cliffs threaten the cardiovascular and metabolic disease branded market and present growth opportunities to the generic market. Dyslipidemia is the next major disease area to become heavily genericized as the blockbuster statin patents expire. Usage of generics is rising but varies wildly across the seven major markets, Datamonitor reports France is approaching the mature markets.
Scope
*Analysis of generic sales in each geography of the seven major markets
*Examination of historical and forecast growth of generics in hypertension, diabetes, dyslipidemia, thrombosis and obesity
*Forecast of the future performance of leading generic agents
*Explanation of generic erosion of cardiovascular and metabolic brands
Highlights
Cardiovascular and metabolic generic sales are predicted to be 127 billion standard units across the seven major markets in 2018 - double the size of the branded market by volume. By 2018 the generics market will be worth $21.4 billion and account for 20% of total cardiovascular and metabolic market revenues
Dyslipidemia generics usage is expected to triple by 2018 when it will account for 23% of total cardiovascular and metabolic generic volume sales. Its forecast compound annual growth rate for 20082018 is the highest of the major cardiovascular and metabolic disease areas
Data for cardiovascular and metabolic generic entrants from 200508 suggest that the healthcare market in France is adjusting to more frequent, speedy adoption of generics than in the past and implies the country's generics market is maturing.
Reasons to Purchase
*Quantify and qualify generic sales in each of the seven major markets
*Understand the key drivers and predict the future performance of leading generic agents
*Identify the impact of major patent expiries on branded products
Overview 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the cardiovascular and metabolic analysis team 2
Executive Summary 3
Scope of the analysis 3
Datamonitor insight into the generics market 3
Related reports 4
TABLE OF CONTENTS 5
1. Market overview and dynamics 6
Market overview 6
The generic market outstripped the branded market in 2008 by volume but generated significantly smaller revenues 6
Seven major markets 8
US accounts for half of the seven major market generic revenues 8
Volume 9
Revenue 9
Disease area analysis 11
Hypertension - the largest generic disease area and growing 12
Hypertension 12
Dyslipidemia 13
Diabetes 13
Thrombosis 13
Obesity 14
Branded and generic distribution 15
Leading generic agents 16
Simvastatin leads by revenues, metformin by volume 16
Degree of generic penetration and pricing of generics 19
US 22
Japan 23
Five major EU markets 24
France 24
Germany 25
Italy 25
Spain 25
UK 26
Branded price 27
Recent generic entrants 29
Seven major markets 29
Recent patent expiries show the French market is maturing 30
Price-induced migration of patients 34
Simvastatin patent expiry drew sales from atorvastatin in the US 34
Patent expiry sends statin class revenues into decline 36
2. Forecast overview and dynamics 39
Seven major markets 39
Future patent cliffs will lower the revenue gap between branded and generic markets 40
Rapid expansion of the generics market set to continue 41
All seven major markets are expected to grow, the less mature markets at the highest rate 42
Disease area analysis 46
Dyslipidemia generics will show the highest revenue and volume growth 46
Leading generic agents 49
Atorvastatin is due to become the top generic by 2014 49
By volume the best molecules retain their positions 51
In 2018 the statins will be the most valuable generic agents 53
3. Issues and discussion 55
Big Pharma strategy 55
A history in generics 55
Recent generic expansions 55
Marketing generics in emerging markets 56
Patent defense 56
Quality control suffers in push for low costs 56
Pressure for low cost 56
Quality control failures 57
Possible repercussions 59
Biosimilars 59
Challenges of biosimilars 59
Approval pathway 60
Antitrust and pay-for-delay 60
Stance of trade authorities 60
Examples of deals 61
Paragraph IV and first-mover advantage 61
Bibliography 63
Journals 63
Websites 63
Datamonitor reports 64
Appendix A 65
Data definitions, limitations and assumptions 65
Standard units 65
Appendix B 66
Report methodology 66
About Datamonitor 67
About Datamonitor Healthcare 67
About the cardiovascular and metabolic analysis team 68
Disclaimer 70
LIST OF TABLES
Table 1: Cardiovascular and metabolic generic growth rates and market size in the seven major markets, 2008 9
LIST OF FIGURES
Figure 1: Cardiovascular and metabolic branded and generic market size by revenue across the seven major markets, 2005-08 6
Figure 2: Cardiovascular and metabolic branded and generic market size by volume across the seven major markets, 2005-08 7
Figure 3: Cardiovascular and metabolic generic market revenues in the seven major markets, 2005-08 8
Figure 4: US dyslipidemia and thrombosis generic market revenues, 2005-08 10
Figure 5: Cardiovascular and metabolic generic drug market volume in the seven major markets, 2005-08 11
Figure 6: Cardiovascular and metabolic generic market revenues split by disease area in the seven major markets, 2005-08 12
Figure 7: Cardiovascular and metabolic generic market volumes by disease area in the seven major markets, for 2005-08 14
Figure 8: Distribution between major disease areas for cardiovascular and metabolic branded and generic markets by volume, in the seven major markets (billion standard units), 2008 15
Figure 9: Top 10 cardiovascular and metabolic generic agents by revenue in the seven major markets, 2008 16
Figure 10: Top 10 cardiovascular and metabolic generic agents by revenue and their share of volume sales in the seven major markets, 2008 17
Figure 11: Top 10 cardiovascular and metabolic generic agents' share of revenue in comparison to all other generic agents in the seven major markets, 2005-08 18
Figure 12: Top 10 cardiovascular and metabolic generic agents' (by revenue) share of volume sales in comparison to all other generic agents in the seven major markets, 2005-08 19
Figure 13: Average cardiovascular and metabolic generic penetration for the seven major markets, 2008 20
Figure 14: Average price per cardiovascular or metabolic generic drug as a percentage of the average branded price, 2008 21
Figure 15: Generic penetration and generic price as a percentage of the branded price in the seven major markets, 2008 22
Figure 16: Illustration of the direct relationship between generic penetration and generic price in the seven major markets, 2008 23
Figure 17: Average price for cardiovascular and metabolic branded drugs post patent expiry in the seven major markets, 2008 27
Figure 18: Comparison of the seven major markets by generic penetration and branded price, 2010 28
Figure 19: Rate of generic uptake following patent expiry for key cardiovascular and metabolic molecules in the seven major markets, excluding Germany, 2005-08 30
Figure 20: Rate of generic uptake following patent expiry for key cardiovascular and metabolic molecules in Japan, Italy and Spain, 2005-08 31
Figure 21: Change in the price of branded drugs 1 year after patent expiry for key cardiovascular and metabolic molecules in the seven major markets, excluding Germany, 2005-08 32
Figure 22: Cardiovascular and metabolic branded drug quarterly revenues 1 year after generic entry in the seven major markets, excluding Germany, patent expiries between 2005-08 33
Figure 23: Quarterly US volumes of atorvastatin, Zocor and generic simvastatin, Q2 2005-Q4 2008 34
Figure 24: Quarterly US revenues of atorvastatin, Zocor and generic simvastatin, Q2 2005-Q4 2008 36
Figure 25: Quarterly US volumes of atorvastatin, simvastatin and pravastatin, Q2 2005-Q4 2008 37
Figure 26: Quarterly US revenues of atorvastatin, simvastatin and pravastatin, Q2 2005-Q4 2008 38
Figure 27: Cardiovascular and metabolic branded and generic drug market forecast by revenue across the seven major markets, 2008-2018 39
Figure 28: Cardiovascular and metabolic branded and generic forecast sales by volume across the seven major markets, 2008-2018 41
Figure 29: Cardiovascular and metabolic generic market volume forecast in the seven major markets, 2008-2018 42
Figure 30: Cardiovascular and metabolic generic market volume forecast split by seven major markets, 2008 and 2018 43
Figure 31: Cardiovascular and metabolic generic market revenue forecast in the seven major markets, 2008-2018 44
Figure 32: Cardiovascular and generic market revenue forecasts split by seven major markets, 2008 and 2018 45
Figure 33: Cardiovascular and metabolic generic market volume forecast split by disease area in the seven major markets, 2008-2018 46
Figure 34: Cardiovascular and metabolic generic market volume forecast split by disease area in the seven major markets, 2008 and 2018 47
Figure 35: Cardiovascular and metabolic generic market revenue forecast split by disease area in the seven major markets, 2008-2018 48
Figure 36: Cardiovascular and metabolic generic market revenue forecast split by disease area in the seven major markets, 2008 and 2018 49
Figure 37: Leading cardiovascular and metabolic generic agents by revenue forecast in the seven major markets, 2008-2018 50
Figure 38: Leading cardiovascular and metabolic generic agents by volume forecast in the seven major markets, 2008-2018 51
Figure 39: Top 10 cardiovascular and metabolic generic agents by revenue forecast in the seven major markets, 2018 53
Figure 40: Patent cliff for the two beta-blockers Coreg and Toprol-XL, Q1 2006-Q4 2009 58
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Generic Drug Industry: Stakeholder Opinions: Cardiovascular and Metabolic Generics - Generics continue to gain prominence
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