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
- 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
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