末期腎臟病變之藥物療法動向

Abstract

Overview

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

Report 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

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the cardiovascular pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Objective of the analysis
  • Datamonitor insight into the ESRD market
• CHAPTER 2 ESRD DEFINITIONS & SCOPE
  • Strategic scoping and focus
• CHAPTER 3 ESRD MARKET ASSESSMENT
  • ESRD: a clearly defined disease
  • Treatment of ESRD
    • Renal replacement therapy (RRT)
    • Hemodialysis (HD)
    • Peritoneal dialysis (PD)
  • Key factors influencing the ESRD market
    • The increasing prevalence of ESRD
    • ESRD occurrence is increasing in an aging population
    • Increasing causal risk factors - diabetes and hypertension
    • Comparative use of RRT
    • Increasing costs of treating ESRD
    • Healthcare payors concerns in reimbursing dialysis treatment
  • Drug treatment of dialysis patients
    • Prevention is better than cure
    • Comorbidities, symptoms and side effects drive drug treatment costs
• CHAPTER 4 COMORBIDITIES WITH ESRD
  • Introduction
  • Hypertension
    • Congestive heart failure
    • Hypertension-related drug usage in ESRD comorbidities
      • ACE inhibitors and ARBS are used to treat hypertension
      • Calcium channel blockers
      • Diuretics
  • Dyslipidemia
    • Drugs for dyslipidemia (lipid-lowering drugs)
      • Coronary artery disease (linked to dyslipidemia)
      • Statins
      • Fibrates
      • Niacin (nicotinic acid, vitamin B3)
      • Ion-exchange resins/bile-acid sequestrants
      • Cholesterol uptake inhibitors
      • Sevelamer
  • Diabetes
  • Myocardial damage
  • Respiratory diseases (e.g. COPD)
• CHAPTER 5 DRUGS TREATING ESRD SYMPTOMS
  • Introduction
  • The ESRD anemia market
    • An overview of anemia
      • The role of erythropoietin in ESRD-induced anemia
      • Importance of managing serum levels of iron prior to EPO treatment
      • Patient treatment patterns
    • The erythropoietin market
      • Epogen/Procrit (epoietin alpha)
      • Aranesp (darbepoietin alpha)
      • NeoRecormon (epoietin beta)
      • CERA
      • Dynepo (epoietin delta)
      • Epomax (epoietin omega)
      • Competitive environment in the EPO market
      • Patent expiries and new entrants
      • Future dynamics in the ESRD erythropoietin market
    • The intravenous (IV) iron market
      • INFeD (iron dextran)
      • Ferrlecit (iron gluconate)
      • Venofer (iron sucrose)
      • Competitive environment in the IV iron market
      • Patent expiries and new entrants
      • Opportunities in the IV iron market
  • The ESRD secondary hyperparathyroidism market
    • An overview of secondary hyperparathyroidism
      • ESRD's impact
    • Vitamin D and the secondary hyperparathyroidism market
      • Patient treatment patterns
      • Competitive environment in the vitamin D market
      • Patent expiries and new entrants
      • Future dynamics in the ESRD vitamin D market
    • Hyperphosphatemia in ESRD patients
      • Patient treatment patterns
      • Competition in the ESRD phosphate binder market
      • Patent expiries
      • Future dynamics in the phosphate binders market
• APPENDIX A
  • Usual doses of antihypertensive medication
• APPENDIX B
  • Bibliography
  • Report methodology
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the Cardiovascular Disease analysis team
  • Disclaimer
  • List of Tables
    • Table 1: The growth and distribution of the risk causal factors in ESRD in the seven major nations
    • Table 2: Biogeneric epoietin products
    • Table 3: Percent of the usual recommended dose of antihypertensive medication
  • List of Figures
    • Figure 1: The causes of ESRD in the US
    • Figure 2: The ESRD patient treatment pathway
    • Figure 3: Peritoneal dialysis
    • Figure 4: Increasing prevalence of ESRD in the developed world
    • Figure 5: Age distribution and growth of prevalent ESRD patients
    • Figure 6: The increasing prevalence of diabetes and hypertension in the major seven nations
    • Figure 7: Hemodialysis is preferred over peritoneal dialysis in all markets
    • Figure 8: The cost of treating dialysis patients in the US is increasing and now is estimated at over $60,000 per patient per year
    • Figure 9: Four key elements of drug treatment in dialysis patients
    • Figure 10: ESRD cardiovascular comorbidities in the US
    • Figure 11: Contributors to congestive heart failure in ESRD
    • Figure 12: The kidneys and the cardiovascular system
    • Figure 13: US ACE inhibitor market
    • Figure 14: Estimated ACE inhibitor usage within the US ESRD population (54,540 patients)
    • Figure 15: EU ACE inhibitor market
    • Figure 16: US ARB market
    • Figure 17: Estimated ARB usage within the US ESRD population (21,210 patients)
    • Figure 18: EU ARB market
    • Figure 19: US beta-blocker market
    • Figure 20: Estimated beta-blocker usage within the US ESRD population (112,780 patients)
    • Figure 21: EU beta-blocker market
    • Figure 22: US calcium channel blocker market
    • Figure 23: Estimated calcium channel blocker usage within the US ESRD population (85,017 patients)
    • Figure 24: EU calcium channel blocker market
    • Figure 25: Estimated loop diuretics usage within the US ESRD population
    • Figure 26: Distribution of US lipid-control drugs by usage
    • Figure 27: US statin market
    • Figure 28: Distribution of EU lipid-control drugs by usage
    • Figure 29: EU statin market
    • Figure 30: EU fibrates market
    • Figure 31: Diabetes comorbid patients use more insulin and less drugs
    • Figure 32: Contributors to myocardial damage in ESRD
    • Figure 33: Erythropoietin action
    • Figure 34: ESRD anemia EPO market drivers
    • Figure 35: The US EPO market
    • Figure 36: Pricing in the US EPO market
    • Figure 37: The EU EPO market
    • Figure 38: Pricing in the EU EPO market
    • Figure 39: Major EPO patent expiries
    • Figure 40: ESRD anemia IV iron market drivers
    • Figure 41: Differentiation of IV iron treatments by side effects
    • Figure 42: The US IV iron market
    • Figure 43: Pricing in the US IV iron market
    • Figure 44: The German IV iron market
    • Figure 45: The Italian IV iron market
    • Figure 46: The UK, Spanish and French IV iron markets
    • Figure 47: The pricing of IV iron in the EU
    • Figure 48: The mechanism of action of vitamin D
    • Figure 49: ESRD impact on control mechanisms of vitamin D, phosphate, and calcium
    • Figure 50: Patient treatment pattern
    • Figure 51: Mechanism of calcitriol treatment
    • Figure 52: Hectorol market positioning has changed from reducing hypercalcemia to a focus on the flexibility in formulations
    • Figure 53: Zemplar's mechanism of action
    • Figure 54: Why Zemplar is better than calcitriol
    • Figure 55: Sensipar's mechanism of action
    • Figure 56: Vitamin D ESRD SHPT market drivers
    • Figure 57: The US vitamin D ESRD market
    • Figure 58: Pricing in the US ESRD market
    • Figure 59: The German, French, and UK vitamin D markets
    • Figure 60: The Spanish vitamin D market
    • Figure 61: The Italian Vitamin D market
    • Figure 62: Major patent expiries
    • Figure 63: Hyperphosphatemia
    • Figure 64: ESRD phosphate control
    • Figure 65: Elevated Ca x P increases mortality risk
    • Figure 66: US phosphate binder market
    • Figure 67: US phosphate binder prices
    • Figure 68: EU phosphate binder markets
    • Figure 69: EU phosphate binder prices
    • Figure 70: Phosphate binders patent expiries