[英文調查報告書] 異常脂質血症

Introduction

At present despite the availability of numerous agents for the treatment of dyslipidemia there is a large scope for expanding the market by improving diagnosis and treatment of the dyslipidemic patients. However, for new agents, gaining a secure foothold on the market will be challenging, and can be improved through targeting niche patient populations and conducting outcome trials.

Scope

Assessment of the patient potential for developmental anti-dyslipidemia agents over the period 2007-16
Overview of the anti-dyslipidemia R&D pipeline, with detailed information on the classes in development and comparator drugs
Commercial analysis of key compounds in development regarding their ability to take away market share from the currently available drugs
Sales forecasts for key late-stage developmental anti-dyslipidemia agents in the seven major markets to 2016

Report Highlights

Single-pill combinations have their appeal, but not for every market. SPCs have had a rather low uptake, especially in Europe, due to lack of titration flexibility and cost issues. This development will halt the progress of SPCs onto the major markets and will limit their success, especially In Europe and Japan.

Increased efficacy in HDL-C raising is the most important unmet need, but the fiasco of torcetrapib will impede speedy launch of efficacious HDL-raising agents, as the CETP inhibitors will have to prove both their safety and efficacy in extensive trials that will delay their arrival to market.

The crowded antidyslipidemic market undergoing high genericization will make it challenging for the developmental compounds to secure a share of the market. In order to do so, the new developmental agent will need to offer a major improvement or a major cost benefit.

Reasons to Purchase

Understand the key factors that will contribute to the success of the next generation of anti-dyslipidemia drugs
View independent sales forecasts for products in late stage development for therapy of dyslipidemia
Analyze competitive environment at time of product launch

About the cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the dyslipidemia market
  - Single-pill combinations have their appeal, but not for every market
  - Increased efficacy in HDL-C raising is the most important unmet need, but the fiasco of torcetrapib will impede speedy launch of efficacious HDL-raising agents
  - Innovation is scarce among the pipeline agents
  - The crowded antidyslipidemic market undergoing high genericization will make it challenging for the developmental compounds to secure a share of the market
- Datamonitor Pipeline Assessment Summary
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- The antidyslipidemic pipeline is mechanistically diversified
- The antidyslipidemic pipeline is rich in Phase I and Phase II candidates
- Numerous companies have their stake in the R&D landscape
- Abbott holds most advanced developmental agents, but no innovation value
- Merck - unclear whether there is innovation in the pipeline
- GSK and Japan Tobacco hold more promise to satisfy the unmet needs
- Key R&D company strategies
CHAPTER 3 DYSLIPIDEMIA - MARKET POTENTIAL
- Definition of dyslipidemia
  - What is dyslipidemia?
- Segmentation of dyslipidemia
  - Markers for dyslipidemia
  - Main types of dyslipidemia
    - Hypercholesterolemia
    - Familial hypercholesterolemia
    - Hypertriglyceridemia
    - Familial hypertriglyceridemia
    - Mixed dyslipidemia
- Epidemiology of dyslipidemia
- Epidemiology methodology
  - US
  - Japan
  - France
  - Germany
  - Italy
  - Spain
  - UK
  - Unmet needs in dyslipidemia
  - Major obstacles between the drugs and the market
  - Increased efficacy in raising HDL-cholesterol
  - Drugs with novel mechanisms of actions
  - Ability to prevent or even reverse the progression of atherosclerosis
  - Increased efficacy in lowering LDL-C
  - Combination therapies to treat patients with complicated lipid profiles
  - Long-term data to support prevention of acute CVD events
  - Further statin safety data
CHAPTER 4 R&D APPROACH
- Classification of pipeline products
  - Statins and statin combinations
    - Statins dominate the antidyslipidemic market
    - Mechanism of action
  - Fibrates - PPAR-alpha agonists
  - Cholesteryl ester transfer protein (CETP) inhibitors: targeting HDL-C
  - Lipoprotein lipase activator
  - Microsomal triglyceride transfer (MTP) inhibitors
  - Squalene synthase inhibitor
  - Apolipoprotein B100 antagonist
  - Dual PPAR agonists
  - PPAR- delta agonists
  - Transcription factor inhibitor
  - Cholesterol transport/absorption Inhibitors
- Clinical trial design in dyslipidemia
  - Short-term endpoints: controlling cholesterol levels
  - Long-term endpoints: reduction in morbidity and mortality
CHAPTER 5 STATINS AND STATIN COMBINATIONS - LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for statins and statin combinations
  - Pipeline summary
  - Comparative forecasts
  - Definition of current comparator therapy
    - Pfizer' s Lipitor remains the current comparator therapy
- Pitavastatin
  - Drug overview
  - Clinical trial data
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- KS-01-019 (Simcor; Simvastatin + niacin ER)
  - Drug overview
  - Clinical trial data
    - OCEANS
    - SEACOAST
    - AIM-HIGH
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Zolip (simvastatin + fenofibrate)
  - Drug overview
  - Clinical trial data
    - Zolip 0501
    - Zolip 0502
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Other statins/statin combinations
  - Rosuvastatin + ABT-335
  - MK-0524B
CHAPTER 6 OTHER THERAPIES - LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for other therapies
  - Pipeline summary
  - Comparative forecasts
  - Definition of current comparator therapy
    - Niacin remains the HDL raising agent with highest efficacy
    - Ezetimibe remains the biggest revenue generating adjunct therapy
- Lapaquistat
  - Drug overview
  - Clinical trial data
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- JTT-705 (R1658)
  - Drug overview
  - Clinical trial data
    - 34% increase in HDL in Phase II clinical trials
    - Ongoing clinical trials
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- FM-VP4 (phytosterol analogue)
  - Drug overview
  - Clinical trial data
    - Phase I trials show excellent safety profile
    - Phase II trials bring forward disappointing efficacy
  - Patient potential
  - Marketing factors
    - FM VP4 will require a marketing partner
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- ISIS-301012, injectable
  - Drug overview
  - Clinical trial data
    - Phase II results
    - Phase I results
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Other agents
  - MK-0524A
    - Clinical Trials
    - Trial Results
  - ABT-335
  - MD-0727
  - CRD-5
  - KB-2115
  - CETi-1 (vaccine)
  - Implitapide (BAY-13-9952; AEGR-427)
  - MK-0859
  - AEGR-733 (BMS-201038)
  - QC-BT16
  - LY-674 (LY-518674)
  - KRP-101
  - 3,5-diiodothyropropionic acid (DITPA)
  - Ibrolipim (NO-1886)
  - AVE-0847
  - LBM-642
  - GW-501516
  - GW-590735
  - GFT-14
  - Fenofibrate and pravastatin
BIBLIOGRAPHY
- Bibliography
  - Epidemiology sources
    - US
    - Japan
    - France
    - Germany
    - Italy
    - Spain
    - UK
  - Clinical trial data
APPENDIX A
- Methodology
  - Product forecasts
  - Definition of a standard unit (only use if ForeSight model used to forecast)
APPENDIX B
- About the Disease analysis team
  - Disclaimer
- List of Tables
  - Table 1: R&D pipeline in Dyslipidemia, 2007
  - Table 2: The pipeline for antidyslipidemic agents by mechanism of action, 2007
  - Table 3: Pipeline of antidyslipidemic agents by company, 2007
  - Table 4: Key changes to lipid levels between the NCEP II and NCEP III
  - Table 5: Prevalence estimates of dyslipidemia (000s), 2007-16
  - Table 6: Currently available statins, 2007
  - Table 7: Key products in the late-stage R&D pipeline for statins and statin combinations, 2007
  - Table 8: Lipitor: key facts, 2007
  - Table 9: Ability of pitavastatin to satisfy the unmet needs
  - Table 10: Impacting factors on the revenues of pitavastatin, 2007-2016
  - Table 11: Ability of Simcor to satisfy the unmet needs
  - Table 12: Impacting factors on the revenues of Simcor, 2007-2016
  - Table 13: Ability of Zolip to satisfy the unmet needs
  - Table 14: Impacting factors on the revenues of Zolip, 2007-2016
  - Table 15: Key products in late-stage R&D pipeline for other therapies, 2007
  - Table 16: Niaspan: key facts, 2007
  - Table 17: Zetia: key facts, 2007
  - Table 18: Ability of Lapaquistat to satisfy the unmet needs
  - Table 19: Impacting factors on the revenues of Lapaquistat, 2007-2016
  - Table 20: Ability of JTT-705 to satisfy the unmet needs
  - Table 21: Impacting factors on the revenues of JTT-705, 2007-2016
  - Table 22: Ability of FM-VP4 to satisfy the unmet needs
  - Table 23: Impacting factors on the revenues of FM-VP4, 2007-2016
  - Table 24: Ability of ISIS-301012 (injectable) to satisfy the unmet needs
  - Table 25: Impacting factors on the revenues of ISIS-301012 (injectable), 2007-2016
  - Table 26: Datamonitor drug assessment parameters
- List of Figures
  - Figure 1: drug assessment summary of statins and statin combinations in development for dyslipidemia, 2007
  - Figure 2: drug assessment summary of other therapies in development for dyslipidemia, 2007
  - Figure 3: Pipeline of antidyslipidemic compounds, 2007
  - Figure 4: The pipeline for antidyslipidemic agents by mechanism of action, 2007
  - Figure 5: Pipeline maturity: percentage of R&D products in each Phase of development, 2007
  - Figure 6: Unmet needs in the dyslipidemia market, 2007
  - Figure 7: drug assessment summary of statins and statin combinations in development for dyslipidemia, 2007
  - Figure 8: Sales forecasts for statins and statin combinations, seven major markets, 2007-2016
  - Figure 9: Sales forecast for Pitavastatin in dyslipidemia to 2016, seven major markets
  - Figure 10 competitive positioning analysis of Pitavastatin, 2007
  - Figure 11: Clinical and commercial attractiveness of pitavastatin broken down by main parameters
  - Figure 12: Sales forecast for Simcor in dyslipidemia to 2016, seven major markets
  - Figure 13: competitive positioning analysis of KS-01-19 (Simcor), 2007
  - Figure 14: Clinical and commercial attractiveness of Simcor broken down by main parameters
  - Figure 15: Sales forecast for Zolip in dyslipidemia to 2016, seven major markets
  - Figure 16:competitive positioning analysis of Zolip, 2007
  - Figure 17: Clinical and commercial attractiveness of Zolip broken down by main parameters
  - Figure 18: Datamonitor drug assessment summary of other therapies in development for dyslipidemia, 2007
  - Figure 19: Sales forecasts for other therapies, seven major markets, 2007-2016
  - Figure 20: Sales forecast for Lapaquistat in dyslipidemia to 2016, seven major markets
  - Figure 21: competitive positioning analysis of Lapaquistat, 2007
  - Figure 22: Clinical and commercial attractiveness of Lapaquistat broken down by main parameters
  - Figure 23: Sales forecast for JTT-705 in dyslipidemia to 2016, seven major markets
  - Figure 24: competitive positioning analysis of JTT-705, 2007
  - Figure 25: Clinical and commercial attractiveness of JTT-705 broken down by main parameters
  - Figure 26: Sales forecast for FM-VP4 in dyslipidemia to 2016, seven major markets
  - Figure 27: competitive positioning analysis of FM-VP4, 2007
  - Figure 28: Clinical and commercial attractiveness of FM-VP4 broken down by main parameters
  - Figure 29: Sales forecast for ISIS-301012 (injectable) in dyslipidemia to 2016, seven major markets
  - Figure 30: competitive positioning analysis of ISIS-301012 (injectable), 2007
  - Figure 31: Clinical and commercial attractiveness of ISIS-301012 (injectable) broken down by main parameters
  - Figure 32: drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007

血脂異常：不被看好能活化市場的產品線藥

Pipeline Insight: Dyslipidemia - Pipeline agents unlikely to rejuvenate the market

Introduction

Scope

Report Highlights

Reasons to Purchase

Table of Contents