末梢動脈障害（PAD）

Abstract

Overview

Introduction

Peripheral artery disease, sometimes also referred to as peripheral vascular disease, is atherosclerosis in peripheral regions, which can lead to loss of blood flow to the limbs, and can result in loss of life, limb amputation and cardiovascular events. The current pharmacological treatment options are limited, and there are large unmet needs associated with the disease.

Scope

• Evaluate therapies under development for peripheral artery disease (PAD)
• A detailed clinical and commercial assessment of all key emerging therapies
• Epidemiological based sales forecasts for key late-stage developmental heart failure agents in the seven major markets to 2016

Report Highlights

PAD is severely undertreated and underdiagnosed. Despite the high prevalence (23.4 million subjects by 2016) and grave consequences, such as cardiovascular events, amputations and death, PAD is not considered as "fascinating" as coronary artery disease and the lack of PAD awareness even among physicians is staggering.

Drug therapy plays a limited role in the management of PAD, due to the restricted treatment options. For intermittent claudication (IC) patients the mainstay of pharmacological treatment is prevention of CV events with antiplatelets and statins. Cilostazol (Pletal), an antiplatelet, is recommended as first-line therapy for claudication

The new agents in development for PAD are primarily as secondary indications. This is due to the issues new agents will face reaching the underdiagnosed, undertreated patient population. Overall, there are very few clinical trials to develop PAD agents, and the trials are very much underpowered.

Reasons to Purchase

• Understand patient segmentation relevant to pipeline products and analyze competitive environment at time of product launch
• Justify go/no-go decisions on basis of potential return on investment
• Utilize product profiles to aid pricing and reimbursement decisions

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Disease pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Datamonitor insight into the PAD market
  • Key metrics
  • Datamonitor Pipeline Assessment Summary
• CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
  • Pipeline overview
  • The PAD pipeline shows diverse mechanisms of action
  • The PAD pipeline is rich in Phase II candidates
  • Numerous companies have their stake in the R&D landscape
  • Key companies involved in the PAD pipeline
  • Key R&D company strategies
    • PAD as a secondary indication
    • Identifying suitable patient groups
• CHAPTER 3 Peripheral artery disease - MARKET POTENTIAL
  • Definition of Peripheral Artery Disease
    • Intermittent claudication
    • Critical Limb Ischemia
    • Consequences of PAD
  • Segmentation of PAD
  • Epidemiology of PAD
  • Forecasts of PAD
  • Unmet needs in PAD
    • Major obstacles between the drugs and the market
      • Patient awareness of PAD
      • Physician awareness of PAD
    • Clinical unmet needs
      • More treatment options required
      • Drugs trialed in patients with concomitant disease
      • Drugs with no / lower resistance
      • Drugs with greater efficacy
      • Ability to prevent cardiovascular events and amputations
      • More cost-effective care
      • Drugs with fewer side-effects
• CHAPTER 4 R&D APPROACH
  • Classification of pipeline products
    • Gene therapy
    • Antiplatelets
    • Thrombolytics
    • Prostaglandins
    • Others
  • Clinical trial design in PAD
    • Absolute claudication distance/initial claudication distance
    • Ankle to brachial index
    • Imaging
      • Pulse volume recording waveform analysis
      • Duplex arterial imaging or ultrasound imaging
      • Angiography
    • Improvement in symptoms and quality of life
    • Long-term morbidity and mortality
    • Potential areas for improvement in the clinical trial design
      • Trialing of new agents in specific patient subsets
      • Size of clinical trials
      • Outcome trials
• CHAPTER 5 ANTIPLATELETS LATE-STAGE DRUG ANALYSIS & FORECASTS
  • Overview for antiplatelets
    • Pipeline summary
    • Definition of current comparator therapy
  • Parogrelil (INDI-702)
    • Drug overview
    • Clinical trial data
    • Patient potential
    • Marketing factors
      • Conduct more trials on efficacy and resistance
    • Satisfaction of unmet needs
    • Forecasts to 2016
    • Datamonitor drug assessment summary
• CHAPTER 6 PROSTAGLANDINS LATE-STAGE DRUG ANALYSIS & FORECASTS
  • Overview for prostaglandins
    • Pipeline summary
    • Definition of current comparator therapy - Prostavasin
  • Liprostin (liposomal prostaglandin E-1, Endovasc)
    • Drug overview
    • Clinical trial data
    • Patient potential
    • Marketing factors
    • Satisfaction of unmet needs
    • Forecasts to 2016
    • Datamonitor drug assessment summary
• BIBLIOGRAPHY
  • Epidemiology
  • Clinical trial data and other
• APPENDIX A
  • Methodology
    • Datamonitor forecast methodology
      • Epidemiology forecasts
      • Product forecasts
• APPENDIX B
  • About Datamonitor
    • About Datamonitor Healthcare
  • Datamonitor Healthcare' s therapy area capabilities
    • About the Disease analysis team
    • Disclaimer
  • List of Tables
    • Table 1: Forecast prevalence of PAD (excluding borderline PAD) in the seven major markets (000), 2007-2016
    • Table 2: R&D pipeline for the treatment of PAD, 2007
    • Table 3: PAD pipeline by company, 2007
    • Table 4: Fontaine classification system for PAD
    • Table 5: Rutherford' s classification of PAD
    • Table 6: Forecast prevalence of PAD (excluding borderline PAD) in the seven major markets (000), 2007-2016
    • Table 7: PAD pipeline agents by drug class
    • Table 8: Antiplatelets for the treatment of PAD
    • Table 9: Otsuka and Pfizer' s Pletal: key facts
    • Table 10: Ability of parogrelil to satisfy the unmet needs, 2007
    • Table 11: Prostaglandins for the treatment of PAD
    • Table 12: Prostavasin: key facts
    • Table 13: Ability of Liprostin to satisfy the unmet needs, 2007
    • Table 14: Forecast prevalence of PAD (including borderline PAD) in the seven major markets (000), 2007-2016
    • Table 15: Datamonitor drug assessment parameters
  • List of Figures
    • Figure 1: Sales forecasts for antiplatelets, 7 major markets, 2007-16
    • Figure 2: Sales forecasts for prostaglandins, 7 major markets, 2007-16
    • Figure 3: Datamonitor drug assessment summary of antiplatelets in development for PAD, 2007
    • Figure 4: Datamonitor drug assessment summary of prostaglandins in development for PAD, 2007
    • Figure 5: R&D Pipeline for PAD agents, 2007
    • Figure 6: Main classes of agents in development for PAD, 2007
    • Figure 7: Percentage of R&D products in each Phase of development for PAD, 2007
    • Figure 8: Breakdown of PAD population
    • Figure 9: The most important unmet needs in PAD, 2007
    • Figure 10: Datamonitor drug assessment summary of antiplatelets in development for PAD, 2007
    • Figure 11: The percent mean improvement in maximal walking distance in trials with cilostazol
    • Figure 12: Sales forecast for parogrelil in PAD to 2016, seven major markets
    • Figure 13: Datamonitor' s competitive positioning analysis of parogrelil, 2007
    • Figure 14: Datamonitor drug assessment summary of prostaglandins in development for PAD, 2007
    • Figure 15: Sales forecast for Liprostin in PAD to 2016, seven major markets
    • Figure 16: Datamonitor' s competitive positioning analysis of Liprostin, 2007
    • Figure 17: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007