[Report] Antidyslipidemics Commercial Insight Market Research, Trends, Analysis TOC

ABOUT DATAMONITOR HEALTHCARE
ADDENDUM
- Pfizer provides update on plans for torcetrapib
CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the antidyslipidemics market
- Summary of key milestones in the antidyslipidemics market
CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Sales figures definition for this report
- Market definition for this report
- Current market situation
- Strategic scoping and focus
CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- Global: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- Patient numbers set to remain flat over the forecast period, but sheer numbers provide a sufficient patient pool
- Decreased rates of diagnosis should provide the catalyst for better physician and patient education ...
- ... While increasing treatment rates across 7MM could drive sales
- Big pharma cannot ignore the emerging markets of India and China
- New products should drive growth, but innovation comes at a price
- Growing awareness of the metabolic syndrome
- Threats
- Patent expiry and generic erosion
- Parallel trade
- The growing problem of counterfeited drugs
- The impact of poor public perception of the pharmaceutical industry
- US: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- 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
- Obesity becomes a super-sized epidemic in the US
- Threats
- High profile generic entrants into the statin class could slow growth
- Medicare and Medicaid
- Drug importation
- Pricing and reimbursement issues
- Japan: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- Ageing population
- An underdeveloped generics market slows brand erosion
- Threats
- Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future
- Biannual price cuts still threaten market growth
- Complex regulatory process
- New healthcare reforms under debate
- France: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- Innovation encouraged in the pharmaceutical industry
- Threats
- Continuation of cost-control measures
- Formulary access
- Take off of generic sector
- Germany: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- Pricing freedom which supports innovation
- Threats
- Cost-containment measures in Germany have led to a healthy generics market
- Italy: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- Single agency holds regulatory authority
- Negligible impact of generics is set to continue
- 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
- 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
- Increasing privatization has the potential to fuel use of higher-priced pharmaceuticals
- 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 the antidyslipidemics market size
CHAPTER 4 FORECAST ANALYSIS
- Key events
- Increased patient potential increases market size
- New product launches
- Atorvastatin plus torcetrapib
- JTT-705
- MK-0524A and MK-0524B
- Simcor (KS-01-019; simvastatin plus extended release niacin)
- FM-VP4 (disodium ascorbyl phytosanyl phosphate)
- Major clinical trials
- AIM-HIGH (Atherothrombosis intervention in metabolic syndrome with low HDL-C/high triglyceride and impact on global health outcomes)
- COMPELL (comparative effects on lipid levels of Niaspan and statins versus other lipid therapies)
- EXPLORER (examination of potential lipid modifying effects of rosuvastatin in combination with ezetimibe versus rosuvastatin alone)
- VYVeR (Vytorin versus rosuvastatin)
- GALAXY - AstraZeneca's landmark program for Crestor (rosuvastatin)
- HPS-2 THRIVE (treatment of HDL to reduce the incidence of vascular events)
- IMPROVE IT (Improved reduction of outcomes: Vytorin efficacy international trial)
- Additional indications
- AstraZeneca will seek a plaque reversal indication for Crestor, but only when METEOR is completed in 2007
- Pfizer obtains stroke prevention indication for Lipitor via SPARCL, but little impact on Lipitor sales is expected as a result of other, more effective, stroke prevention therapies being available
- Schering-Plough/Merck & Co. receive FDA approval to promote Zetia use in combination with fenofibrate, but little impact on Zetia sales expected
- Patent expiries
- Effect of Medicare Modernization Act in the US
- Biennial price cuts in Japan
- Generic erosion assumptions
- 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
- Torcetrapib: an assessment of Pfizer's position and key questions that will need to be answered before approval and launch
- Introduction
- HDL as a therapeutic target
- Raising HDL the torcetrapib way
- Pfizer's Phase III program for torcetrapib/atorvastatin - $800 million and counting
- All eyes will be on plaque regression data
- Will plaque regression have an impact on mortality?
- Is torcetrapib's pro-hypertensive side effect anything to worry about?
- What is the competition and how much will they affect torcetrapib's commercial success?
- In an era of increased sensitivity to price, what will the combination's price be?
- What is the patient potential for torcetrapib?
- Summary
- The patent expiries of Pravachol and Zocor in the US market: potential impacts, likely scenarios, desperate measures?
- Overview
- The antidyslipidemic patent landscape in the US
- The impact of Zocor's patent expiry - branded share is expected to erode considerably, and quickly
- The impact on Lipitor - will brand loyalty and marketing muscle be enough to maintain market share for Pfizer?
- The impact on the statins market - dynamics will swing in favor of generics
- Could the statins be a case study for future therapeutic substitution?
APPENDIX A - MARKET DATA AND MAJOR BRAND 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
- Tricor
- Other antidyslipidemics market data
- Zetia
APPENDIX B - MARKET FORECAST DATA
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- M5EU
- Global
APPENDIX C
- Bibliography
- References
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the Cardiovascular analysis team
- Key therapy team members
- Dr Allison Fleetwood, Director, Cardiovascular, Diabetes and Women's Health
- Disclaimer
- List of Tables
  - Table 1: 7MM sales of the antidyslipidemic drug classes, 2005
  - Table 2: Seven major market sales and market share of the 10 top-selling antidyslipidemics, 2005
  - Table 3: Prevalence of dyslipidemia (000s) in the seven major pharmaceutical markets, 2005-15 (totals are rounded to nearest thousand)
  - Table 4: US antidyslipidemic sales, 2005
  - Table 5: Prevalence of obesity in the seven major markets by age (000s), 2003 (all totals have been rounded where applicable)
  - Table 6: Japan antidyslipidemic sales, 2005
  - Table 7: An example of the savings to be realized by using generic drugs
  - Table 8: France antidyslipidemic sales, 2005
  - Table 9: Germany antidyslipidemic sales, 2005
  - Table 10: Italy antidyslipidemic sales, 2005
  - Table 11: Spain antidyslipidemic sales, 2005
  - Table 12: UK antidyslipidemic sales, 2005
  - Table 13: The ten clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005
  - Table 14: Summary of macro-environmental issues affecting the antidyslipidemics market, 2006
  - Table 15: Prevalence of dyslipidemia (000s) in the seven major pharmaceutical markets, 2005-15 (totals are rounded to nearest thousand)
  - Table 16: Efficacy of torcetrapib vs. JTT-705; HDL-C and LDL-C measure
  - Table 17: COMPELL study results: mean percent change from baseline at study end (week 12)
  - Table 18: Efficacy of Crestor plus Zetia; HDL-C and LDL-C measure
  - Table 19: Key efficacy results from Vytorin versus simvastatin
  - Table 20: Key efficacy results from Vytorin versus atorvastatin (VYVA)
  - Table 21: Key efficacy results from Vytorin versus rosuvastatin (VYVeR)
  - Table 22: Patent expiry information for key antidyslipidemic brands, 2006
  - Table 23: Selected statin outcome trials and the risk reduction
  - Table 24: Meta-analysis of standard versus intensive lipid lowering therapy in four large statin outcome trials (n=27,548); LDL-C reduction data
  - Table 25: Meta-analysis of standard versus intensive lipid lowering therapy in four large statin outcome trials (n=27,548); odds reduction and event data
  - Table 26: Phase II trial results for the atorvastatin + torcetrapib combination
  - Table 27: Mean percent increase in HDL-C
  - Table 28: Mean percentage decrease in LDL-C
  - Table 29: Patient discontinuation results
  - Table 30: Summary of torcetrapib's late-stage clinical development, 2006
  - Table 31: Examples of HDL-elevating strategies, both marketed and in development, that have the potential to compete with torcetrapib, 2006
  - Table 32: The US statin monotherapy* market, 2005
  - Table 33: Patent position for each of the statins in the US
  - Table 34: Lipitor: key facts
  - Table 35: Zocor: key facts
  - Table 36: Pravachol: key facts
  - Table 37: Crestor: key facts
  - Table 38: Vytorin: key facts
  - Table 39: Tricor: key facts
  - Table 40: Zetia: key facts
  - Table 41: US antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
  - Table 42: Japan antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
  - Table 43: France antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
  - Table 44: Germany antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
  - Table 45: France antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
  - Table 46: Spain antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
  - Table 47: UK antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
  - Table 48: M5EU antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
  - Table 49: Global antidyslpidemic sales forecasts ($m; 2005 figures are actuals)
- List of Figures
  - Figure 1: Key milestones expected to have an impact on the 7MM antidyslipidemics market, 2006 to 2015
  - Figure 2: 7MM pharmaceutical sales, 2004-05
  - Figure 3: Comparative antidyslipidemic market share information for 7MM in terms of sales value and sales volume, split by country, 2005
  - Figure 4: The prevalence of obesity is set to continue to rise in the US in the coming decade
  - Figure 5: Datamonitor research has shown that dyslipidemia diagnosis rates have fallen between 2003 and 2005
  - Figure 6: Datamonitor research has shown that dyslipidemia treatment rates have risen between 2003 and 2005
  - Figure 7: Age trends for mean TSC, LDL-C, and HDL-C in Chinese females (dashed lines) and Chinese males (solid lines).
  - Figure 8: Summary of potential licensing revenues due to Atherogenics in respect of out-licensing of AGI-1067 to AstraZeneca
  - Figure 9: Generalized distribution chain for parallel traded pharmaceutical products
  - Figure 10: AstraZeneca's Crestor (rosuvastatin) and Abbott's Tricor (fenofibrate) features on Public Citizen's www.worstpills.org website
  - Figure 11: The growing prevalence of obesity in the US
  - Figure 12: Pravachol only accounts for 11% of US statin monotherapy sales value ($m) and 8.6% of sales volume (SUm)
  - Figure 13: Key pressures facing drug developers
  - Figure 14: The Japanese generic market is underdeveloped because of a number of factors
  - Figure 15: The various elements of the GALAXY program
  - Figure 16: HDL-C metabolism and the role of CETP
  - Figure 17: HDL-C levels in male and female residents of the USA
  - Figure 18: Likely scenarios for switching from Zocor to generic simvastatin, and the effect of generic atorvastatin from 2011 on generic simvastatin sales
  - Figure 19: Between 2006 and 2011, the value of the branded US statin monotherapy market is expected to fall by $8 billion (50%) due to generic incursion on branded statin revenues
  - Figure 20: Segmentation of the antidyslipidemics market by country
  - Figure 21: Segmentation of the antidyslipidemics market by drug class

Commercial Insight: Antidyslipidemics - Branded statins beware, generics are amongst you

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