ReportsandReports - Forecast Insight: Antidyslipidemics - Crestor drives growth before the Lipitor patent cliff hits
Forecast Insight: Antidyslipidemics - Crestor drives growth before the Lipitor patent cliff hits
Browse All Datamoniter Reports at Datamonitor
http://www.reportsandreports.com/reports/33219-forecast-insight-antidyslipidemics-crestor-drives-growth-befo.html
The antidyslipidemic market is approaching further genericization when in 2011, leading statin brand Lipitor will lose patent exclusivity and trigger decline of the entire market value. Clinical trials continue to produce an evidence base that justifies the dominant position held by statins and extends their reach into further indications.
Scope
- Analysis of revenue and volume sales of antidyslipidemic drug classes in the seven major markets
- Assess the impact of key patent expiries, such as Pfizer's Lipitor
- Forecast antidyslipidemic revenue and volume sales including performance of developmental agents and understand barriers to their uptake
- Understand the impact of clinical trials such as JUPITER on market dynamics and consider the epidemiologic trends in dyslipidemia
A rise in value of the antidyslipidemic market from 2008 to 2009 has been driven by acceleration in Crestor sales following the positive results from the JUPITER trial which led to the approval of Crestor in a new preventative indication.
Although past peak sales, Lipitor, the gold standard therapy and highest selling brand commanded 40% of antidyslipidemic revenues in 2009. This will change dramatically after the loss of its patent protection reducing Lipitor's market share to 9% by 2019, taking a large amount of the market's value with it.
Vytorin sales are down 29% from their 2007 peak after being sent into decline following the results of the ENHANCE and SEAS trials. Whilst sales growth of Zetia has been curbed by the same results, significant challenges remain for dyslipidemia therapies outside the statin class.
Reasons to Purchase
- Quantify and qualify antidyslipidemic sales in each of the seven major markets for 20062019
- Examine the future performance of leading antidyslipidemic brands and the growth of generics
- Understand the commercial landscape and challenges faced by pipeline agents
Overview 1
Catalyst 1
Summary 1
Executive Summary 2
Strategic scoping and focus 2
Datamonitor insight into the disease market 2
Related reports 3
Table of Contents 4
Table of figures 5
Table of tables 6
Market definition and overview 7
Market definition for this report 7
Countries and regions included in this report 7
Seven major market assessment 8
Current and future market overview 8
US revenues will grow before patent cliff 13
Generics promote steady growth of volume sales but reduce the market value 15
Japanese sales help major brands maintain strong revenues to 2019 19
Rest of world snapshot 20
BRIC and RoW growth eclipsed by that of the seven major markets 21
EPIDEMIOLOGICAL CONTEXT 24
Introduction 24
Key points 24
Disease definition, classification and diagnosis criteria 25
Risk factors 26
Gender 26
Age 27
Lifestyle factors 27
Genetic predisposition 27
Co-morbidities 27
Global variation and temporal trends 27
Epidemiologic forecasting of dyslipidemia 28
Sources of epidemiologic data 28
Description of methods 28
Japan 29
US 29
Five major EU markets 29
France 29
Germany 30
Italy 30
Spain 30
UK 30
Results 31
Current prevalent cases and future trends 31
Annual growth rate of disease population 33
Japan 33
US 33
Discussion 34
Strengths and limitations of Datamonitor's epidemiologic projections 35
Conclusions 35
Brand Dynamics 36
Overview of competitive landscape 36
Statins 39
Lipitor (atorvastatin; Pfizer) 41
Lipitor gains approval for pediatric use in the EU 45
Actavis launch first generic atorvastatin in Spain 45
Generic atorvastatin launched in Canada and South Africa 45
Lipitor beats Crestor in two small renal disease trials 45
Lipitor's revenues to crash after patent expiry 46
Crestor (rosuvastatin; AstraZeneca) 46
US FDA gives approval for Crestor indication expansion 49
Crestor patient population expanded in the EU 49
JUPITER review causes a stir 49
AstraZeneca victory in Crestor patient challenge 50
Crestor to become the last of the blockbuster statins 50
Statin combinations 51
Vytorin (ezetimibe and simvastatin, Merck) 52
FDA deems Vytorin and Zetia safe 53
United Health doubles co-pay for Vytorin and Zetia 54
Mylan claims first-to-file status 54
Vytorin's sales continue to decline 54
Other 56
Zetia (ezetimibe, Merck) 57
Glenmark to launch first generic ezetimibe 58
Zetia loses to Niaspan in final results from ARBITER 6-HALTS 59
Zetia's growth reaches plateau 60
Fibrates 61
Tricor (fenofibrate, Solvay, Abbott) 62
Fenofibrates fail to show benefit for type 2 diabetics in ACCORD LIPID trial 64
Abbott settles antitrust case surrounding Tricor 65
Tricor succeeded by Trilipix 65
Trilipix (choline fenofibrate, Solvay, Abbott) 66
Trilipix plus Crestor combination, Certriad receives complete response letter 67
Tricor succeeded by Trilipix 67
Noteworthy pipeline agents 67
Livalo gets US launch but might be too late to have an impact 68
Dalcetrapib and anacetrapib - CETP inhibitors still under scrutiny 68
Certriad launch delayed by FDA complete response letter 69
Mipomersen - the novel injectable will be a niche drug 69
Atorvastatin plus ezetimibe combination 70
Bibliography 71
Journal papers 71
Websites 71
Datamonitor reports 74
Epidemiology references 74
APPENDIX A - MARKET ASSUMPTIONS 78
New product launches 78
Patent expiries 79
Data definitions, limitations and assumptions 79
Standard units 79
Derivation of sales forecasts and pricing trends 79
Exchange rates 80
Forecast methodology 80
Appendix B 81
Report methodology 81
About Datamonitor 81
About Datamonitor Healthcare 81
About the Cardiovascular analysis team 82
Disclaimer 82
List of Tables
Table 1: National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) classification of low-density lipoprotein (LDL), Total, and high-density lipoprotein (HDL) cholesterol (mg/dL) 26
Table 2: ICD-10 Codes for dyslipidemia, 2010 26
Table 3: Population-based studies of total prevalent cases of dyslipidemia in adults based on the National Cholesterol Education Program (NCEP) classification criteria used in Datamonitor's analysis 31
Table 4: Total prevalent cases of dyslipidemia (million) in the seven major markets, 2010-2020 32
Table 5: Leading branded antidyslipidemic drug sales ($m) in the seven major markets, 2009 and 2019 37
Table 6: Lipitor - drug profile, 2010 43
Table 7: Sales forecast for Lipitor in the seven major markets ($m), 2009-2019 46
Table 8: Crestor - drug profile, 2010 47
Table 9: Sales forecast for Crestor in the seven major markets ($m), 2009-2019 50
Table 10: Vytorin - drug profile, 2010 53
Table 11: Sales forecast for Vytorin in the seven major markets ($m), 2009-2019 56
Table 12: Zetia - drug profile, 2010 58
Table 13: Sales forecast for Zetia for dyslipidemia in the seven major markets ($m), 2009-2019 61
Table 14: Tricor - drug profile, 2010 63
Table 15: Sales forecast for Tricor in the seven major markets ($m), 2009-2019 66
Table 16: Trilipix - drug profile, 2010 66
Table 17: Sales forecast for Trilipix (choline fenofibrate) in the seven major markets ($m), 2009-2019 67
Table 18: Datamonitor's estimated launch dates for antidyslipidemic products in the seven major markets, 2010-19 78
Table 19: Patent expiry dates for the antidyslipidemic brands in the seven major markets, 2010-19 79
About Us
ReportsandReports comprises an online library of 10,000 reports, in-depth market research studies of over 5000 micro markets, and 25 industry specific websites. Our client list boasts almost all well-known publishers of such reports across the globe. We as a third-party reseller of market research reports employ a number of marketing tools, such as press releases, email-marketing and effective search-engine optimization techniques to drive revenues for our clients. We also provide 24/7 online and offline support service to our customers.
Contact:
Ms. Sunita
7557 Rambler road,
Suite 727, Dallas,
TX 75231
Tel: +1-888-989-8004
http://reportsandreports.blogspot.com/
http://reportsandreports.proarticles.co.uk/
http://reportsnreports.wordpress.com/
