[英文調查報告書] 心臟衰竭治療藥

Abstract

Overview

Introduction

Datamonitor expects few new products to emerge from a week pipeline for both acute and chronic heart failure. Sales in the seven major markets will be modest with all the new drugs being add-on therapies to current standard regimes. Significant unmet patients needs will remain in both acute and chronic heart failure.

Scope

Comprehensive analysis of the current acute and chronic heart failure pipeline detailing the broad of developmental classes.
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.

Highlights

The heart failure market is relatively stable, with few drugs being launched in the past five years and many of those launched having significant safety or commercial viability issues.

It is also a market with high unmet need waiting to be addressed. Patients with heart failure have a poor prognosis with half of all patients diagnosed with severe heart failure dying within four years.

The R&D pipeline for heart failure is a Phase II-heavy, diverse range of novel agents, with 50% all of candidates being in Phase II trials.

Reasons to Purchase

Quantify the future drugs in the acute and chronic heart failure market.
Identify licensing opportunities based on company portfolio and market needs.
Assess the remaining market opportunity, where established therapies and other developmental compounds fail to address key unmet clinical needs.

ABOUT HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the heart failure disease market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Related reports
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- Heart failure: a diverse pipeline
  - Greatest number of candidates in Phase II of development
  - High attrition rate within the pipeline
  - Market not dominated by one company
- Key R&D company strategies
  - Expanded indications for approved drugs
  - Niche patient subgroups
CHAPTER 3 HEART FAILURE OVERVIEW - MARKET POTENTIAL
- Definition of Heart Failure
  - Acute heart failure
  - Chronic heart failure
- Etiology of heart failure
  - Segmentation of heart failure
    - Disease severity
    - Low versus high output failure
    - Systolic versus diastolic heart failure
    - Age group
- Co-morbidities, complications and risk factors
  - Anemia: an emerging risk factor in chronic heart failure
    - Erythropoietin in the treatment of anemia in chronic heart failure
- Devices and surgery: treatments for end-point heart failure
  - Cardiac devices
    - Cardiac resynchronization therapy (CRT)
    - Implantable cardioverter defibrillators (ICD)
    - Ventricular Assist Devices (VAD)
    - Total artificial heart
    - Novel devices under development
  - Surgery
    - Heart transplantation
- Telemedicine (Disease management)
- Epidemiology of heart failure
  - Future incidence of acute heart failure
  - Future prevalence of chronic heart failure
- Future trends in the incidence and prevalence of heart failure
- Unmet need in heart failure
  - Acute heart failure
    - Unmet need 1: increased efficacy
    - Unmet need 2: drugs with novel mechanisms of action
    - Unmet need 3: reduced length of hospital stay/ re-hospitalization
    - Unmet need 4: improved safety profile
    - Unmet need 5: increased mortality benefit
  - Chronic heart failure
    - Unmet need 1: targeting niche markets
    - Unmet need 2: increased efficacy
    - Unmet need 3: increased compliance
    - Unmet need 4: increased safety profile
    - Unmet need 5: ability to halt or reverse the progression of the disease
    - Unmet need 6: drugs with novel mechanisms of action
CHAPTER 4 R&D APPROACH
- Classification of pipeline products
- Acute heart failure
  - Potassium channel activator/nitric oxide donor
  - Vasopressin V2 antagonists
    - Preclinical and clinical progress
  - Adenosine A1 antagonists
    - Preclinical and clinical progress
  - Atrial natriuretic peptide (ANP) agonists
    - Preclinical and clinical progress
  - Endothelin ET-A antagonists
    - Preclinical and clinical progress
  - Cardiac myosin activators
    - Preclinical and clinical progress
  - CRF-R2 agonists
    - Preclinical and clinical progress
  - Na+/K+ ATPase inhibitors
    - Preclinical and clinical progress
  - ORL-1 agonists
    - Preclinical and clinical progress
  - Soluble guanylate cyclase modulators
    - Preclinical and clinical progress
- Chronic heart failure
  - Angiotensin II antagonists
    - Clinical progress
  - Adenosine A1 antagonists
    - Preclinical and clinical progress
  - Renin inhibitors
    - Preclinical and clinical progress
  - HMG CoA reductase inhibitors (statins)
    - Preclinical and clinical progress
  - Immunotherapy
    - Preclinical and clinical progress
  - Chelating agents
    - Preclinical and clinical progress
  - Brain natriuretic protein (BNP) agonists
    - Preclinical and clinical progress
  - Dual NEP/ECE inhibitors
    - Preclinical and clinical progress
  - Sino-atrial node inhibitors
    - Preclinical and clinical progress
  - Endothelial nitric oxide synthase (eNOS) transcription enhancer
    - Preclinical and clinical progress
  - Chymase inhibitors
    - Preclinical and clinical progress
  - AGE crosslink breakers
    - Preclinical and clinical progress
- Undefined heart failure
  - Myoblast cell therapy
    - Preclinical and clinical progress
  - PPARa agonists
    - Preclinical and clinical progress
  - Relaxin agonists
    - Preclinical and clinical progress
  - SERCA 2a gene therapy
    - Preclinical and clinical progress
  - CGRP agonists
    - Preclinical and clinical progress
- Clinical trial design in heart failure
  - Comparators: add-on versus replacement therapy
- Clinical trials endpoints in heart failure
  - Use of surrogate endpoints
  - Trials in acute heart failure
    - True endpoints
    - Surrogate endpoints
  - Trials in chronic heart failure
    - True endpoints
    - Surrogate endpoints
CHAPTER 5 ACUTE HEART FAILURE LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for acute heart failure
  - Pipeline summary
  - Comparative forecasts
  - Definition of current comparator therapy
    - Oral diuretics
    - Nitrates
    - Inotropic agents
    - Vasodilators
- Tolvaptan
  - Drug overview
  - Clinical data
    - Ongoing clinical trials
  - Completed trials
    - EVEREST
    - SALT-1 and SALT-2
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - SWOT analysis
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Ularitide (urodilatin)
  - Drug overview
  - Clinical trial data
    - SIRIUS II
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - SWOT analysis
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- KW-3902
  - Drug overview
  - Ongoing clinical trials
    - REACH UP
    - PROTECT-1 and PROTECT-2
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - SWOT analysis
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Other drugs in acute heart failure
  - CK-1827452 (CK-452)
    - Drug profile
    - Clinical data
  - Sitaxentan (Thelin)
    - Restarting of clinical trials
  - Urocortin II
    - Drug profile
    - Clinical data
  - Istaroxime (PST-2744)
    - Drug profile
    - Clinical data
  - ZP-120
    - Drug profile
- Innovative early-stage projects
  - TBC-3711
    - Drug overview
    - Preclinical data
  - BAY-58-2667
    - Drug overview
    - Preclinical development
- Late-stage development compounds recently discontinued
  - Levosimendan (Simdax)
  - Carperitide (HANP)
CHAPTER 6 CHRONIC HEART FAILURE LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for chronic heart failure
  - Pipeline summary
  - Comparative forecasts
  - Definition of comparator therapy
    - Chronic heart failure ' gold standard'
- Irbesartan (Aprovel)
  - Drug overview
  - Clinical trial data
    - Ongoing clinical trials
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - SWOT analysis
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Aliskiren (Tekturna)
  - Drug overview
  - Ongoing clinical trials
    - ALOFT
    - ASPIRE
    - NCT00409578
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - SWOT analysis
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Rosuvastatin (Crestor)
  - Drug overview
  - Ongoing clinical trials
    - CORONA
    - NCT00176332
    - GISSI-HF
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - SWOT analysis
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Celacade (VAS-991)
  - Drug overview
  - Clinical data
    - ACCLAIM
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - SWOT analysis
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Other drugs in chronic heart failure
  - Trientine
    - Drug overview
    - Clinical data
  - CG-77X56 (Cardeva)
    - Drug overview
  - Daglutril
    - Drug overview
    - Clinical data
  - BG-9928
    - Drug overview
    - Clinical data
  - SLV-320
    - Clinical data
  - Ivabradine
    - Drug overview
  - Alagebrium chloride (ALT-711)
    - Drug overview
    - Clinical trials restart
- Innovative early-stage projects
  - AVE-3085 and AVE-9488
    - Drug overview
    - Preclinical data
  - TPC-806
    - Drug overview
    - Preclinical data
  - Renin inhibitors
    - Drug overview
- Late-stage development compounds recently discontinued
  - Oxypurinol
  - rGLP-1
  - DITPA
  - SSR-180575
CHAPTER 7 UNDEFINED HEART FAILURE LATE-STAGE DRUG ANALYSIS
- Nicorandil
  - Drug overview
  - Clinical data
- Myocell
  - Drug overview
  - Clinical data
- Other drugs in undefined heart failure
  - AVE-8134
  - Relaxin
- Innovative early-stage projects
  - Mydicar
    - Drug overview
  - Vasonex CR
CHAPTER 8 BIBLIOGRAPHY
- Epidemiology sources
- General and clinical trial data
APPENDIX A
- Methodology
  - Epidemiology
    - Incidence of acute heart failure
    - Prevalence of chronic heart failure
  - Datamonitor drug assessment summary
- Appendix B
- About Datamonitor
  - About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
  - About the Disease analysis team
  - Disclaimer
- List of Tables
  - Table 1: Incidence and prevalance of Heart Failure for the seven major markets
  - Table 2: Forecast key pipeline products in Acute Heart Failure in 2016 ($m)
  - Table 3: Forecast key pipeline products in Chronic Heart Failure in 2016 ($m)
  - Table 4: R&D pipeline in the acute heart failure market, 2007
  - Table 5: R&D pipeline in the chronic heart failure market, 2007
  - Table 6: R&D pipeline in the undefined heart failure market, 2007
  - Table 7: Heart failure pipeline by mechanism of action, 2007
  - Table 8: Heart failure pipeline by company, 2007
  - Table 9: Causes of heart failure in the seven major markets (%), 2004
  - Table 10: Prevalence of chronic heart failure by age group in the seven major markets (000s), 2005
  - Table 11: Estimated proportion of chronic heart failure patients with co-morbid conditions and risk factors in the seven major markets (%), 2004
  - Table 12: Future estimated incidence of acute heart failure in the seven major markets (000s), 2007-2016
  - Table 13: Future estimated incidence of chronic heart failure in the seven major markets (000s), 2007-2016
  - Figure 11: Unmet needs in acute heart failure, 2007
  - Table 14: Key products in late-stage R&D pipeline for acute heart failure, 2007
  - Table 15: Sales forecasts for late-stage acute heart failure pipeline drugsacross the seven major markets, 2007-2016
  - Table 16: Discontinued R&D projects in acute heart failure, 2005-07
  - Table 17: Key agents in late-stage R&D pipeline for chronic heart failure, 2007
  - Table 18: Datamonitor forecasts for late-stage chronic heart failure pipeline drugs across the seven major markets, 2007-2016
  - Table 19: Datamonitor drug assessment parameters
- List of Figures
  - Figure 1: Datamonitor drug assessment summary of pipeline therapies in development for acute heart failure, 2007
  - Figure 2: Datamonitor drug assessment summary of pipeline therapies in development for chronic heart failure, 2007
  - Figure 3: Candidates in development for heart failure by indication
  - Figure 4: Overview of heart failure pipeline, 2007
  - Figure 5: Percentage of heart failure R&D products in development, 2007
  - Figure 6: Heart failure pipeline development by company type, 2007
  - Figure 7: Geographical location of companies with agents in development for heart failure pipeline, 2007
  - Figure 8: Segmentation of diagnosed chronic heart failure patients by disease severity, 2004
  - Figure 9: ACC/AHA practice guidelines for the evaluation and management of chronic heart failure, 2005
  - Figure 10: Breakdown of heart failure patients according to whether failure is systolic, diastolic or both systolic and diastolic in the seven major markets, 2004
  - Figure 12: Unmet needs in chronic heart failure, 2007
  - Figure 13: Key mechanisms of disease progression in Heart Failure
  - Figure 14: Datamonitor drug assessment summary of pipeline therapies in development for acute heart failure, 2007
  - Figure 15: Datamonitor forecasts for late-stage acute heart failure pipeline drugs across the seven major markets, 2007-2016
  - Figure 16: SWOT analysis: tolvaptan
  - Figure 17: Datamonitor forecast for tolvaptan in acute heart failure across the seven major markets, 2007-2016
  - Figure 18: Datamonitor' s competitive positioning analysis of Tolvaptan, 2007
  - Figure 19: SWOT analysis: ularitide
  - Figure 20: Datamonitor' s forecast for ularitide in acute heart failure across the seven major markets, 2007-2016
  - Figure 21: Datamonitor' s competitive positioning analysis of ularitide, 2007
  - Figure 22: SWOT analysis: KW-3902
  - Figure 23: Datamonitor' s forecast for KW-3902 in acute heart failure across the seven major markets, 2007-2016
  - Figure 24: Datamonitor' s competitive positioning analysis of KW-3902, 2007
  - Figure 25: Datamonitor drug assessment summary of pipeline therapies in development for chronic heart failure, 2007
  - Figure 26: Datamonitor' s forecasts for late-stage chronic heart failure pipeline drugs across the seven major markets , 2007-2016
  - Figure 27: SWOT analysis: irbesartan
  - Figure 28: Datamonitor' s forecast for irbesartan in chronic heart failure across the seven major markets, 2007-2016
  - Figure 29: Datamonitor' s competitive positioning analysis of Irbesartan, 2007
  - Figure 30: SWOT analysis: aliskiren
  - Figure 31: Datamonitor' s forecast for aliskiren in chronic heart failure across the seven major markets, 2007-2016
  - Figure 32: Datamonitor' s competitive positioning analysis of Aliskiren, 2007
  - Figure 33: SWOT analysis: rosuvastatin
  - Figure 34: Datamonitor' s forecast for rosuvastatin in chronic heart failure across the seven major markets, 2007-2016
  - Figure 35: Datamonitor' s competitive positioning analysis of Rosuvastatin, 2007
  - Figure 36: SWOT analysis: Celacade
  - Figure 37: Datamonitor' s forecast for VAS-991 in chronic heart failure across the seven major markets, 2007-2016
  - Figure 38: Datamonitor' s competitive positioning analysis of VAS-991, 2007-2016
  - Figure 39: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007

心臟衰竭治療藥市場動向

Pipeline Insight: Heart failure - Weak pipeline dominated by new indications and add-on diuretics

Abstract

Overview

Introduction

Scope

Highlights

Reasons to Purchase

Table of Contents