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Published by: Datamonitor
Published: Jul. 11, 2007 - 188 Pages
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
- Tricor / Lipanthyl
- Other antidyslipidemics market data
- Zetia
- 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
AbstractIntroduction
The restrictive, highly competitive antidyslipidemic market is going to become even further genericized, which will add to the challenges that drug makers are facing. Despite over 300m people being eligible for antidyslipidemic treatment, there is still a lot of under-diagnosis and under-treatment, but it will be a major issue capturing all the eligible population.
Scope
Assessment of each of the seven major markets, key drivers for growth and resistors to growth Overview of the main opportunities and threats in each of the seven major markets Forecast analysis including the key events, among them new product launches, major clinical trials and patent expiries. Overview of two case studies (on CETP inhibitors and on the second wave of patent expiries) including worst and best case scenarios.
Highlights
Despite over 300m people being eligible for treatment in seven major markets, as well as the recommended treatment goals capturing more patients and promoting more aggressive therapy, there is a lot of under-diagnosis and under-treatment. Cost-saving policies further limit the patient potential for branded agents. Lowering of LDL-C treatment goals cannot counteract the impact of cost-saving policies, and does not guarantee a revenue stream for branded agents. This is why there are currently several outcome trials that regard the potential of branded agents (Crestor, Vytorin) in new indications/patient groups, e.g. heart failure and renal disease. Branded statins' market share is diminishing. Due to the patent expiries of statins that have taken place in the past five years (especially that of Zocor) and those going to take place in the near future (especially that of Lipitor) the branded statins are losing their market share rapidly.
Reasons to Purchase
Understand key drivers and predict the future performance of key compounds Optimize sales and marketing strategy to counter market threats Develop commercial strategies across the seven major markets
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