Commercial Insight: Antidyslipidemics - The competitive cost-conscious antidyslipidemics market presents challenges
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 4
- Objective of the analysis - page 4
- Datamonitor insight into the Antidyslipidemics market - page 4
- Contributing experts - page 6
- Experts interviewed for this report (interviewed in May 2007) - page 6
- Experts interviewed for Pipeline Insight 2006: Dyslipidemia, DMHC2285 (interviewed in March 2007) - page 6
- Related reports - page 6
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 8
- Market definition for this report - page 8
- Current market situation - page 9
- Overview of the market by drug classes and countries - page 9
- Key drivers to market growth - page 12
- Key resistors of market growth - page 12
- Ten top selling brands - page 13
- Gold-standard therapy - page 16
- Strategic scoping and focus - page 18
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 20
- Seven major markets: opportunities and threats - page 20
- Opportunities - page 20
- Large patient population and low treatment goals - page 20
- Development of novel compounds - page 23
- Growing awareness of metabolic syndrome - page 24
- Increasing co-operation between regulatory bodies - page 24
- The emerging markets of India and China cannot be ignored - page 26
- Threats - page 27
- Restrictive pricing and reimbursement policies - page 27
- Reduced periods of market exclusivity - page 27
- Mandatory registration of all clinical trial results - page 27
- Increasingly conservative regulatory environments - page 28
- Ongoing cost-containment measures - page 29
- New EU states may lead to a flood of cheap drug exports - page 30
- Increasing generic competition - page 31
- Opportunities - page 20
- US: market level assessment, opportunities and threats - page 32
- Market level assessment - page 32
- Opportunities - page 34
- Price of drugs - page 34
- Leveraging the NCEP ATP III guidelines - page 34
- Direct-to-consumer (DTC) advertising is legal in the US and has been shown to influence patient prescription choice and increase diagnosis rates - page 35
- Threats - page 36
- High profile generic entrants into the statin class could slow growth - page 36
- Medicare and Medicaid - page 38
- Drug importation - page 38
- Pricing and reimbursement issues - page 39
- Curbing of DTC advertising will lead to greater emphasis on risk of products - page 41
- Wal-Mart $4 a day generic program introduces further cost competition - page 42
- Japan: market level assessment, opportunities and threats - page 44
- Market level assessment - page 44
- Opportunities - page 46
- Ageing population - page 46
- An underdeveloped generics market slows brand erosion - page 46
- Multiple Patent Extensions and Labeling Regulations - page 47
- Harmonization of approval process and opening up the Japanese market - page 48
- Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare - page 50
- Reduced product approval time - page 50
- The Internet is an effective means to reach out to patients - page 51
- Threats - page 51
- Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future - page 51
- Biennial price cuts still threaten market growth - page 54
- Complex regulatory process - page 54
- New healthcare reforms under debate - page 55
- Flat-sum reimbursement discourages physicians from prescribing highly priced medicines - page 55
- France: market level assessment, opportunities and threats - page 56
- Market level assessment - page 56
- Opportunities - page 58
- Innovation encouraged in the pharmaceutical industry - page 58
- Consumers in France readily recognize the Internet as a source of high-quality medical information - page 58
- Generic consumption in France is particularly low - page 58
- Threats - page 59
- Continuation of cost-control measures - page 59
- Formulary access - page 60
- Take- off of generic sector - page 60
- Pharmacists are being mandated to drive generic dispensing - page 61
- Germany: market level assessment, opportunities and threats - page 62
- Market level assessment - page 62
- Opportunities - page 63
- Pricing freedom which supports innovation - page 63
- ePharmacy and mail-order drugs legalized - page 64
- Threats - page 64
- Cost-containment measures in Germany have led to a healthy generics market - page 64
- German doctors set to receive bonuses for prescribing generics - page 66
- Italy: market level assessment, opportunities and threats - page 67
- Market level assessment - page 67
- Opportunities - page 68
- Single agency holds regulatory authority - page 68
- Negligible impact of generics is set to continue - page 69
- Innovative drug development rewarded with premium price and 100% reimbursement - page 69
- Threats - page 70
- Ongoing cost-containment measures - page 70
- Stringent reference pricing system - page 70
- Restructured reimbursement categories - page 71
- Intellectual property to conform with rest of EU - page 71
- Spain: market level assessment, opportunities and threats - page 72
- Market level assessment - page 72
- Opportunities - page 73
- Underdeveloped generics market - page 73
- Threats - page 74
- Complex pricing system - page 74
- Increased scrutiny of new drugs - page 74
- Compulsory patient co-payments - page 74
- Government awareness campaign promotes generic use - page 75
- UK: market level assessment, opportunities and threats - page 75
- Market level assessment - page 75
- Opportunities - page 76
- Attractiveness of market - page 76
- Supplementary and expanded prescribing powers - page 77
- Taking the GMS contract to the next level - page 77
- New fast track drug assessment process speeds up time between licensing and NICE recommendations - page 79
- Threats - page 79
- Falling foul of the ABPI, the UK's Pharma watchdog - page 79
- The National Institute of Clinical Excellence (NICE) - page 81
- PPRS implements periodic price cuts - page 82
- Cost-containment measures encourage continued high use of generics - page 83
- Summary of environmental issues affecting antidyslipidemics market size - page 83
- Seven major markets: opportunities and threats - page 20
- CHAPTER 4 FORECAST ANALYSIS - page 86
- Key events - page 86
- Increased patient potential could increase market size - page 88
- New product launches - page 88
- Zetia (ezetimibe) in Japan - page 89
- Simcor (KS-01-019) - page 89
- Pitavastatin - page 90
- Lapaquistat (TAK-475) - page 92
- FM-VP4 - page 92
- Atorvastatin plus ezetimibe - page 94
- Pravafen (pravastatin + fenofibrate) - page 94
- JTT-705 - page 95
- Zolip (simvastatin + fenofibrate) - page 97
- ISIS-301012 - page 98
- Major clinical trials - page 99
- ENHANCE - page 100
- CORONA - page 100
- JUPITER - page 101
- SEARCH - page 101
- GISSI-HF - page 102
- AURORA - page 102
- SEAS - page 103
- IMPROVE-IT - page 103
- SHARP - page 104
- Patent expiries - page 105
- Pravachol - page 105
- Lescol (fluvastatin) - page 105
- Lipanthyl (micronized fenofibrate) - page 105
- Lipitor (atorvastatin) - page 105
- Crestor (rosuvastatin) - page 105
- Livalo (pitavastatin) - page 106
- Advicor (lovastatin + niacin, modified release) - page 106
- Zetia (ezetimibe) - page 106
- Data definitions, limitations and assumptions - page 107
- Standard units - page 107
- Japanese market data - page 107
- Derivation of sales forecasts and pricing trends - page 107
- Forecasts - page 108
- Forecast methodology - page 108
- Key events - page 86
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 109
- Introduction - page 109
- Case studies - page 109
- Case study 1 - CETP inhibitors: the history and the future; what will be needed for successful launch? - page 109
- Overview of the mechanism of action - page 109
- HDL raising is one of the most important unmet needs - page 110
- Torcetrapib - the most promising agent in development in 2006 - page 112
- CETP inhibition in general - page 120
- Hypertension as side effect of torcetrapib - page 120
- Failure of torcetrapib - potential reasons - page 122
- JTT-705 -same mechanism of action, same outcome? - page 124
- JTT-705 - what can be done in order to successfully launch the agent? - page 124
- JTT-705 - worst and best case scenarios - page 125
- Case study 2 - the second wave of patent expiries - page 128
- Major statin patent expiries to come - page 128
- Patent expiries - worst case scenario - page 131
- Patent expiries - best case scenario - page 132
- Case study 1 - CETP inhibitors: the history and the future; what will be needed for successful launch? - page 109
- BIBLIOGRAPHY - page 134
- Epidemiology sources - page 134
- US - page 134
- Japan - page 134
- France - page 134
- Germany - page 135
- Italy - page 135
- Spain - page 135
- UK - page 135
- Journal papers - page 136
- Websites - page 139
- Datamonitor reports - page 142
- Epidemiology sources - page 134
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 144
- Summary of market data - page 144
- Segmentation by country - page 144
- Segmentation by drug class - page 145
- Major brand facts - page 146
- Statin market data - page 146
- Lipitor - page 146
- Zocor - page 147
- Pravachol - page 148
- Crestor - page 149
- Vytorin - page 150
- Fibrate market data - page 151
- Tricor / Lipanthyl - page 151
- Other antidyslipidemics market data - page 152
- Zetia - page 152
- Statin market data - page 146
- Summary of market data - page 144
- APPENDIX B - MARKET FORECAST DATA - page 153
- US - page 153
- Japan - page 157
- France - page 161
- Germany - page 164
- Italy - page 167
- Spain - page 170
- UK - page 173
- APPENDIX C - page 176
- Contributing experts - page 176
- Experts interviewed for this report (interviewed in May 2007) - page 176
- Experts interviewed for Pipeline Insight 2006: Dyslipidemia, DMHC2285 (interviewed in March 2007) - page 176
- Report methodology - page 176
- About Datamonitor - page 177
- About Datamonitor Healthcare - page 177
- About the Cardiovascular analysis team - page 178
- Disclaimer - page 179
- Contributing experts - page 176
- List of Tables
- Table 1: Seven major market sales of the antidyslipidemic drug classes, 2006 - page 10
- Table 2: Seven major market sales and market share of the 10 top selling antidyslipidemics, 2006 - page 14
- Table 3: Prevalence estimates of dyslipidemia (000s), 2007-16 - page 21
- Table 4: US antidyslipidemic sales, 2006 - page 32
- Table 5: Japan antidyslipidemic sales, 2006 - page 44
- Table 6: An example of the savings to be realized by using generic drugs - page 52
- Table 7: France antidyslipidemic sales, 2006 - page 56
- Table 8: Germany antidyslipidemic sales, 2006 - page 62
- Table 9: Italy antidyslipidemic sales, 2006 - page 67
- Table 10: Spain antidyslipidemic sales, 2006 - page 72
- Table 11: UK antidyslipidemic sales, 2006 - page 75
- Table 12: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005 - page 78
- Table 13: Phase II trial results for the atorvastatin + torcetrapib combination - page 114
- Table 14: Mean percent increase in HDL-C - page 115
- Table 15: Mean percentage decrease in LDL-C - page 115
- Table 16: Patient discontinuation results - page 116
- Table 17: Summary of torcetrapib's late-stage clinical development, 2006 - page 117
- Table 18: Lipitor: key facts - page 146
- Table 19: Zocor: key facts - page 147
- Table 20: Pravachol: key facts - page 148
- Table 21: Crestor: key facts - page 149
- Table 22: Vytorin: key facts - page 150
- Table 23: Tricor / Lipanthyl: key facts - page 151
- Table 24: Zetia: key facts - page 152
- Table 25: US dyslipidemia drug sales ($m) forecasts, 2007-16 - page 153
- Table 26: Japan dyslipidemia drug sales ($m) forecasts, 2007-16 - page 157
- Table 27: France dyslipidemia drug sales ($m) forecasts, 2007-16 - page 161
- Table 28: Germany dyslipidemia drug sales ($m) forecasts, 2007-16 - page 164
- Table 29: Italy dyslipidemia drug sales ($m) forecasts, 2007-16 - page 167
- Table 30: Spain dyslipidemia drug sales ($m) forecasts, 2007-16 - page 170
- Table 31: UK dyslipidemia drug sales ($m) forecasts, 2007-16 - page 173
- List of Figures
- Figure 1: Performance of the antidyslipidemic drug classes across the seven major markets, 2005-06 - page 11
- Figure 2: Breakdown of antidyslipidemic market share for seven major markets by sales value and sales volume, split by country, 2006 - page 12
- Figure 3: Annual US sales of antidyslipidemic drug classes, 2003-2006 - page 33
- Figure 4: US Sales of Pravastatin and Simvastatin, 2006 ($m) - page 37
- Figure 5: Key pressures facing drug developers - page 40
- Figure 6: Wal-Mart's $4 generic drug program web-page - page 43
- Figure 7: Annual Japan sales of antidyslipidemic drug classes, 2003-2006 - page 45
- Figure 8: The Japanese generic market is underdeveloped because of a number of factors - page 47
- Figure 9: Annual France sales of antidyslipidemic drug classes, 2003-2006 - page 57
- Figure 10: Annual Germany sales of antidyslipidemic drug classes, 2003-2006 - page 63
- Figure 11: Annual Italy sales of antidyslipidemic drug classes, 2003-2006 - page 68
- Figure 12: Annual Spain sales of antidyslipidemic drug classes, 2003-2006 - page 73
- Figure 13: Annual UK sales of antidyslipidemic drug classes, 2003-2006 - page 76
- Figure 14: Key environmental issues affecting the growth of the antidyslipidemic market across the seven major markets, 2007 - page 84
- Figure 15: Key environmental issues affecting the growth of the antidyslipidemic market, US and Japan, 2007 - page 84
- Figure 16: Key environmental issues affecting the growth of the antidyslipidemic market, France and Germany, 2007 - page 85
- Figure 17: Key environmental issues affecting the growth of the antidyslipidemic market, Italy, Spain and the UK, 2007 - page 85
- Figure 18: Impact of each key event on the antidyslipidemic market across the seven major markets, 2007-2016 - page 87
- Figure 19: HDL-C metabolism and the role of CETP - page 110
- Figure 20: HDL-C levels in male and female residents of the USA - page 111
- Figure 21: Forecasted sales of JTT-705, three scenarios, $m - page 127
- Figure 22: Statin patent expiries, 2004-2017 - page 128
- Figure 23: Ratio of branded versus generic statins (revenue), 2003 and 2006 - page 129
- Figure 24: Ratio of branded versus generic statins (revenue), 2016 - page 130
- Figure 25: Forecasted sales of atorvastatin, three scenarios, $m - page 131
- Figure 26: Forecasted Sales of statins in the seven major markets, worst case scenario, 2016($m) - page 132
- Figure 27: Forecasted Sales of statins in the seven major markets, best case scenario, 2016($m) - page 133
- Figure 28: Breakdown of antidyslipidemic market share for seven major markets by sales value and sales volume, split by country, 2006 - page 144
- Figure 29: Performance of the antidyslipidemic drug classes across the seven major markets , 2005-06 - page 145
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