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Strategic Perspectives: Antidyslipidemics Current market is not conducive for growth

Datamonitor
October 22, 2008
223 Pages - SKU: DFMN1933600

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Introduction

The antidyslipidemic market is increasingly governed by cost concerns which appear to be more pressing than the safety and efficacy concerns. Cost-saving initiatives together with the continuing genericization are going to bring the antidyslipidemic revenues down by 25% from $26.6 billion in 2007 to $19.9 billion in 2017.

Scope

Description of the competitive landscape in antidyslipidemics market with detailed overview of main challenges for launched and novel agents.
Event-driven updated sales forecasts for 2008-17 across the seven major markets: US, France, Germany, Italy, Spain, UK and Japan.
Analysis of major events and brand dynamics affecting the antidyslipidemics market, including the overview of the pipeline drugs.

Highlights

The patent expiry of Zocor in 2006 in the US steepened the drastic revenue fall. With Lipitor losing its patent protection within the next five years, the market is expected to shrink further to $19.9bln by 2017 and become even harder to enter. In strong relation to this is Pfizer's decision to exit the CV development.

The US FDA has been becoming ever more conservative over the recent years. Its recent tightening of the approval process has resulted in the non-approval of Cordaptive (Tredaptive) in the US. This is the first time in the history of antidyslipidemic development that a drug approval may be delayed until the outcome data are available.

The current late-stage pipeline offers a number of SPCs, which is an eloquent marker of a certain degree of stagnation in the development of novel agents, as it is now associated with more risks than before, due to the torcetrapib's failure in 2006, as well as the non-approval of Cordaptive in the US this year.

Reasons to Purchase

Quantify the future size and understand the background of the antidyslipidemic market
Quantify the impact of the recent ENHANCE results on the dynamics of the market
Size up the potential for the market expansion and revenue increases that recent guidelines, initiatives and regulatory changes may bring.

ABOUT DATAMONITOR HEALTHCARE: About the cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Strategic scoping and focus; Datamonitor insight into the disease market; Related reports; Upcoming related reports
CHAPTER 2 MARKET DEFINITION: Market definition for this report
CHAPTER 3 MARKET OVERVIEW: US; Current market assessment; Future market 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; The FDA's increasing safety focus; Changes in the US patent law may weaken the position of Pharma; Japan; Current market assessment; Future market assessment; Opportunities; Aging 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, Labour 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; Current market assessment; Future market 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; Reference price system; Formulary access; Take-off of generic sector; Pharmacists are being mandated to drive generic dispensing; Germany; Current market assessment; Future market assessment; Opportunities; Pricing freedom which supports innovation; Reimbursement is granted to almost all drugs; 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; Current market assessment; Future market assessment; Opportunities; Single agency holds regulatory authority; Negligible impact of generics; Innovative drug development rewarded with premium price and 100% reimbursement; Threats; Ongoing cost-containment measures; Restructured reimbursement categories; Intellectual property to conform with rest of EU; Spain; Current market assessment; Future market assessment; Opportunities; New initiatives to improve prevention; Traditionally underdeveloped generics market; Threats; Complex pricing system; Increased scrutiny of new drugs; Compulsory patient co-payments; Government awareness campaign promotes generic use; UK; Current market assessment; Future market assessment; Opportunities; Attractiveness of market; Supplementary and expanded prescribing powers; Taking the GMS contract to the next level; Fast-track drug assessment process speeds up time between licensing and NICE recommendations; Threats; The National Institute for Health and Clinical Excellence (NICE); 2009 PPRS is expected to be more stringent than 2005 PPRS; Cost-containment measures encourage continued high use of generics; Rest of World snapshot; Current market assessment
CHAPTER 4 BRAND DYNAMICS: Overview of competitive landscape; Drivers of prescription choice; Cost becoming more important than efficacy and safety: generics; Cost playing a role in the brand choice: formulary status; Lipitor - the would-be gold standard; Drug profile; Product positioning; Brand forecast to 2017; Strategic recommendations; Vytorin - the success of an SPC; Drug profile; Product positioning; Vytorin's sales plateau; Brand forecast to 2017; Strategic recommendations; Crestor - the newest statin is on the rise; Drug profile; Product positioning; Brand forecast to 2017; Strategic recommendations; Pipeline - making it to the top 10?; TriLipix - joining the list; Development overview; Product positioning; Drug forecast to 2017; The rest of the pipeline - the reasons behind the lack of blockbuster; Livalo - not fitting into the overcrowded market; Dalcetrapib and anacetrapib - CETP inhibitors still under scrutiny; Mipomersen - the niche success?; Fenoglide - what does the new fenofibrate have to offer?; Cordaptive - more tolerable, but is it worth the risks?; Statin SPCs - waging the battle with generics unarmed?
CHAPTER 5 KEY PLAYERS: Strategic overview; Trends in corporate strategy; Pfizer; Corporate strategy; Antidyslipidemic portfolio assessment; Merck & Co.; Corporate strategy; Antidyslipidemic portfolio assessment; AstraZeneca; Corporate strategy; Antidyslipidemic portfolio assessment; Abbott; Corporate strategy; Antidyslipidemic portfolio assessment
CHAPTER 6 CASE STUDIES AND FORECAST SCENARIOS: TriLipix - will fenofibrate stay evergreen?; TriLipix - will Abbott's fenofibrate continue the domination?; Surrogate end points in dyslipidemia - a matter of the past?; ILLUMINATE puts HDL cholesterol into the spotlight; Torcetrapib's fiasco; The future of anacetrapib and dalcetrapib still in the dark; ENHANCE undermines trust in LDL cholesterol; Vytorin - is lower still better?; Potential impact of ENHANCE; Surrogate end points in dyslipidemia - an out of date concept?; Impact of ILLUMINATE and ENHANCE on drug development; SPCs - conquering the new horizons?; The first SPC - Vytorin; SPCs - aggressive marketing and significant advantages required; Development of the SPCs in the future; IMPROVE-IT - waiting for the new perspective on Zetia and Vytorin; Overview and importance of the study; IMPROVE-IT - worst and best case scenarios; Worst case scenario; Best case scenario; CETP Inhibitors; CETP inhibitors: the past 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 a side effect of torcetrapib; Failure of torcetrapib - potential reasons; Anacetrapib and dalcetrapib - same mechanism of action, same outcome?; CETP inhibitors - what can be done to ensure successful launch?; CETP Inhibitors - worst and best case scenarios; Cordaptive and the FDA; Cordaptive/Tredaptive: the improved niacin not good enough for the FDA; Reasons for the non-approval and what it says about the FDA; Potential consequences may make Europe a more attractive market for launch; THRIVE: the light at the end of the tunnel?; UK: NICE recent guidelines - a nice surprise?; NICE Lipid Modification Guidelines - the driver of market expansion; NICE-led expansion of the market - an opportunity for Pharma?; BIBLIOGRAPHY; Journal papers; Websites; Datamonitor reports
APPENDIX A - MARKET ASSUMPTIONS: New product launches; Patent expiries; Data definitions, limitations and assumptions; Standard units; Japanese market data; Derivation of sales forecasts and pricing trends; Forecast methodology
APPENDIX B: Contributing experts; Experts contributing to this report; Experts contributing to previous reports; Report methodology; About Datamonitor; About Datamonitor Healthcare; About the cardiovascular analysis team; Disclaimer
List of Tables: Table 1: US sales and growth of drug classes in the antidyslipidemic market, 2007; Table 2: Japan sales and growth of drug classes in the antidyslipidemic market, 2007; Table 3: An example of the savings to be realized by using generic drugs in Japan, 2006; Table 4: France sales and growth of drug classes in the antidyslipidemic market, 2007; Table 5: Germany sales and growth of drug classes in the antidyslipidemic market, 2007; Table 6: Italy sales and growth of drug classes in the antidyslipidemic market, 2007; Table 7: Spain sales and growth of drug classes in the antidyslipidemic market, 2007; Table 8: UK sales and growth of drug classes in the antidyslipidemic market, 2007; Table 9: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005; Table 10: Formulary status in the US for leading brands in dyslipidemia, 2007; Table 11: Lipitor: key facts, 2008; Table 12: Sales forecast ($m) for Lipitor in the seven major markets ($m), 2007-2017; Table 13: Impacting factors on Lipitor revenues, 2008-2017; Table 14: Vytorin: key facts, 2008; Table 15: Sales forecast for Vytorin in the seven major markets ($m), 2008-2017; Table 16: Impacting factors on Vytorin, revenues, 2007-2017; Table 17: Crestor: key facts, 2008; Table 18: Sales forecast for Crestor in the seven major markets ($m), 2007-2017; Table 19: Impacting factors on Crestor revenues, 2008-2017; Table 20: Summary of pipeline antidyslipidemic agents that are likely to launch with the forecast period, 2008-2017; Table 21: Sales forecast ($m) for TriLipix for dyslipidemia in the 7MM, 2007-2017; Table 22: Impacting factors on the revenues of TriLipix, 2007-2017; Table 23: Leading 10 companies in the seven major markets dyslipidemia market, 2007-2017; Table 24: Strategic importance of antidyslipidemic drugs to leading companies' portfolios, 2007; Table 25: Summary of statin-containing SPCs that are likely to launch within the forecast period, 2007-2017; Table 26: Phase II trial results for the atorvastatin + torcetrapib combination; Table 27: Mean percentage 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: Datamonitor's launch dates for antidyslipidemics in the 5EU and US, 2008-2017; Table 32: Patent expiry dates for the approved antidyslipidemics in the seven major markets, 2008-2017
List of Figures: Figure 1: Annual US sales ($m)of the antidyslipidemic drug classes, 2004-07; Figure 2: Performance of the key antidyslipidemic therapies in the US ($m), 2006-07; Figure 3: Market share of antidyslipidemic drugs in the US, 2007 versus 2017; Figure 4: New US Patent and Trademark Office (PTO) rules are unfavorable for Pharma and biotech; Figure 5: Annual Japan sales of the antidyslipidemic drug classes, 2004-07; Figure 6: Performance of the key antidyslipidemic therapies in Japan ($m), 2006-07; Figure 7: Market share of antidyslipidemic drugs in Japan, 2007 versus 2017; Figure 8: Annual France sales of the antidyslipidemic drug classes, 2004-07; Figure 9: Performance of the key antidyslipidemic therapies in France ($m), 2006-07; Figure 10: Market share of antidyslipidemic drugs in France, 2007 versus 2017; Figure 11: Annual Germany sales of the antidyslipidemic drug classes, 2004-07; Figure 12: Performance of the key antidyslipidemic therapies in Germany ($m), 2006-07; Figure 13: Market share of antidyslipidemic drugs in Germany, 2007 versus 2017; Figure 14: Annual Italy sales of the antidyslipidemic drug classes, 2004-07; Figure 15: Performance of the key antidyslipidemic therapies in Italy ($m), 2006-07; Figure 16: Market share of antidyslipidemic drugs in Italy, 2007 versus 2017; Figure 17: Annual Spain sales of the antidyslipidemic drug classes, 2004-07; Figure 18: Performance of the key antidyslipidemic therapies in Spain ($m), 2006-07; Figure 19: Market share of antidyslipidemic drugs in Spain, 2007 versus 2017; Figure 20: Annual UK sales of the antidyslipidemic drug classes, 2004-07; Figure 21: Performance of the key antidyslipidemic therapies in the UK ($m), 2006-07; Figure 22: Market share of antidyslipidemic drugs in the UK, 2007 vs. 2017; Figure 23: Rest of World versus seven major market sales in the antidyslipidemic market ($ billion and %), 2007; Figure 24: Global antidyslipidemic sales growth by region (%), 2004-07; Figure 25: Top 10 cardiovascular brands in the seven major markets by sales, 2004-2017; Figure 26: Sales of top 10 brands in the seven major markets, 2004-17; Figure 27: Sales forecast for Lipitor in the seven major markets ($ billion), 2007-2017; Figure 28: The relationship between the pricing advantage and the market share of Vytorin, 2007; Figure 29: Sales forecast for Vytorin in the seven major markets ($ billion), 2008-2017; Figure 30: Sales forecast for Crestor in the seven major markets ($ billion), 2008-2017; Figure 31: Leading 4 companies as proportion of the whole market, 2007 versus 2017; Figure 32: Forecasted sales of Zetia, three scenarios, $m; Figure 33: Forecasted sales of Vytorin, three scenarios, $m; Figure 34: HDL-C metabolism and the role of CETP; Figure 35: HDL-C levels in male and female residents of the USA; Figure 36: Forecast sales of dalcetrapib across the seven major markets - three scenarios ($m), 2008-2017; Figure 37: Forecast sales of anacetrapib across the seven major markets - three scenarios ($m), 2008-2017

Strategic Perspectives: Antidyslipidemics Current market is not conducive for growth

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