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