異常脂質血症治療薬動向

Abstract

Overview

Introduction

Commercial Insight: Antidyslipidemics explores current trends and key future issues in the management of dyslipidemia and the effects of generic competition and healthcare reforms on the main drug classes in this market. The growth potential of the leading classes is discussed, and case studies are used to highlight possible strategies to maximize future growth for lipid management franchises.

Scope

• Event-driven sales forecasts, for the period 2006-15, for the US, Japan, France, Germany, Italy, Spain and the UK, along with a global overview
• Discussion of individual products in five main classes, focusing mainly on the statins, fibrates and other antidyslipidemics (e.g. Zetia, Niaspan)
• Profiles of the country and market specific issues which will impact future sales in the market including generic erosion and new product launches
• Commercial impact case studies on R&D innovation and the impact of generic erosion

Highlights

2006 is likely to mark an inflexion point in the sales value of the statin class across the seven major markets (7MM). Key drivers of this include patent expiries to Zocor and Pravachol in the US, with a predicted $8 billion expected to be wiped off the value of the branded statin monotherapy market between 2006-11 as a result.

Strategies designed to blunt the impact of generic erosion on lipid management franchises include the development and commercialization of novel products. With further advances in LDL-C lowering efficacy unlikely, current research is focused on developing better tolerated and more effective HDL-C targeted therapies.

A growing in-licensing and acquisition trend has surfaced in lipid management and antiatherosclerotic R&D. As in-house productivity falls, big pharma has spent billions on shoring up product pipelines, focusing particular on novel HDL-C targeted therapies, which Datamonitor believes is evolving into the new battleground in lipid management.

Reasons to Purchase

• Gain insight into the antidyslipidemics market via up-to-date thought-leader opinions and gold-standard IMS Health sales data
• Assess the potential impact of clinical trial results, generic erosion and new product launches on the antidyslipidemics market
• Access independent, event-driven forecasts for key antidyslipidemic products and classes across the seven major markets

Table of Contents

• 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