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Commercial Perspectives: Drug Treatment in End-Stage Renal Disease - The Price of Failure

Published by: Datamonitor

Published: Jan. 18, 2006 - 118 Pages


Table of Contents


TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY 3

Objective of the analysis 3

Datamonitor insight into the ESRD market 3

CHAPTER 2 ESRD DEFINITIONS & SCOPE 9

Strategic scoping and focus 11

CHAPTER 3 ESRD MARKET ASSESSMENT 12

ESRD: a clearly defined disease 12

Treatment of ESRD 13

Renal replacement therapy (RRT) 15

Hemodialysis (HD) 15

Peritoneal dialysis (PD) 15

Key factors influencing the ESRD market 16

The increasing prevalence of ESRD 17

ESRD occurrence is increasing in an aging population 17

Increasing causal risk factors - diabetes and hypertension 18

Comparative use of RRT 20

Increasing costs of treating ESRD 21

Healthcare payors concerns in reimbursing dialysis treatment 22

Drug treatment of dialysis patients 23

Prevention is better than cure 24

Comorbidities, symptoms and side effects drive drug treatment costs 25

CHAPTER 4 COMORBIDITIES WITH ESRD 26

Introduction 26

Hypertension 26

Congestive heart failure 27

Hypertension-related drug usage in ESRD comorbidities 27

ACE inhibitors and ARBS are used to treat hypertension 27

Calcium channel blockers 41

Diuretics 44

Dyslipidemia 47

Drugs for dyslipidemia (lipid-lowering drugs) 47

Coronary artery disease (linked to dyslipidemia) 47

Statins 48

Fibrates 51

Niacin (nicotinic acid, vitamin B3) 53

Ion-exchange resins/bile-acid sequestrants 54

Cholesterol uptake inhibitors 54

Sevelamer 55

Diabetes 56

Myocardial damage 57

Respiratory diseases (e.g. COPD) 57

CHAPTER 5 DRUGS TREATING ESRD SYMPTOMS 59

Introduction 59

The ESRD anemia market 60

An overview of anemia 60

The role of erythropoietin in ESRD-induced anemia 60

Importance of managing serum levels of iron prior to EPO treatment 61

Patient treatment patterns 61

The erythropoietin market 62

Epogen/Procrit (epoietin alpha) 63

Aranesp (darbepoietin alpha) 63

NeoRecormon (epoietin beta) 64

CERA 64

Dynepo (epoietin delta) 64

Epomax (epoietin omega) 65

Competitive environment in the EPO market 66

Patent expiries and new entrants 70

Future dynamics in the ESRD erythropoietin market 74

The intravenous (IV) iron market 75

INFeD (iron dextran) 75

Ferrlecit (iron gluconate) 76

Venofer (iron sucrose) 77

Competitive environment in the IV iron market 77

Patent expiries and new entrants 83

Opportunities in the IV iron market 84

The ESRD secondary hyperparathyroidism market 84

An overview of secondary hyperparathyroidism 84

ESRD’s impact 85

Vitamin D and the secondary hyperparathyroidism market 86

Patient treatment patterns 86

Competitive environment in the vitamin D market 91

Patent expiries and new entrants 100

Future dynamics in the ESRD vitamin D market 101

Hyperphosphatemia in ESRD patients 101

Patient treatment patterns 103

Competition in the ESRD phosphate binder market 105

Patent expiries 109

Future dynamics in the phosphate binders market 110

APPENDIX A 111

Usual doses of antihypertensive medication 111

APPENDIX B 114

Bibliography 114

Report methodology 116

About Datamonitor 117

About Datamonitor Healthcare 117

About the Cardiovascular Disease analysis team 118

Disclaimer 119



Abstract

Introduction
Increased prevalence of diabetes, obesity, and cardiovascular disease, all causal factors of renal disease, drives growth of the end-stage renal disease (ESRD) sector. On average, an ESRD patient uses >$7,000 of drugs/year, representing a significant opportunity for pharmaceutical companies in treating the symptoms, comorbid conditions and treatment side effects of ESRD.

Scope
Analysis of the ESRD sector in the US, and in the 5 major European markets Germany, France, UK, Italy and Spain
Analysis of issues facing the ESRD market: rising prevalence, treatment costs and greater focus on prevention, and differences in treatment patterns
Insight into drugs in the treatment of comorbidities of ESRD including: hypertension, dyslipidemia and diabetes
Review of drugs in the treatment of dialysis side effects including: erythropoietins, IV iron, vitamin D and phosphate lowering drugs
Highlights
The ESRD market is growing at a rate of 6% in the US, 7% in Japan and 4% in Europe. It is a large cost burden on healthcare payors with treatment costs increasing by a CAGR of 5% to over $60,000 per patient per year.

Diabetes and hypertension are considered a causal factor in >72% of the cases of ESRD and cardiovascular disease is the cause of death for over 60% of ESRD patients. The ESRD market represents around 1% of the cardiovascular market, but the overall chronic kidney disease (CKD) market is a much larger target population.

Costs of drugs directly treating symptoms of ESRD represent over 14% of the treatment costs. Erythropoietin treatment of renal-disease-related anemia represents over 70% of these costs, followed by vitamin D treatment of secondary hyperparathyroidism. Costs are expected to reduce with the introduction of biosimilars or biogenerics in 2007 to 2010.

Reasons to Purchase
Gain insight into the dynamics and key issues in the ESRD market
Understand how to position drugs used to treat the comorbidities of ESRD patients
Look at the opportunities in treating dialysis patients


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