OpportunityAnalyzer: Late-Stage Chronic Kidney Disease (CKD) - Opportunity Analysis and Forecasts to 2017 - San Diego, California News Station - KFMB Channel 8 - cbs8.com

OpportunityAnalyzer: Late-Stage Chronic Kidney Disease (CKD) - Opportunity Analysis and Forecasts to 2017

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LONDON, Feb. 19, 2014 /PRNewswire/ -- Reportbuyer.com just published a new market research report:

OpportunityAnalyzer: Late-Stage Chronic Kidney Disease (CKD) - Opportunity Analysis and Forecasts to 2017

OpportunityAnalyzer: Late-Stage Chronic Kidney Disease (CKD) - Opportunity Analysis and Forecasts to 2017

Summary

Late-stage chronic kidney disease (CKD), encompassing stage 4 and 5 CKD, is a disease that manifests in a host of co-morbidities. Of these, bone and mineral metabolism disorders are some of the most commonly treated and have significant impact on morbidity and mortality of patients. This report focuses on the current treatment landscape, unmet needs, pipeline and remaining opportunity in the late-stage CKD market with a focus on the treatment of hyperphosphatemia and secondary hyperparathyroidism (SHPT). GlobalData expects the late-stage CKD market to undergo significant flux over the next five years in the US and 5EU. This changeable landscape is a consequence of a number of contributory factors, including the patent expiries of market leading hyperphosphatemia brands, and the expected launch of three new entrants to the market. GlobalData expects US and European healthcare reimbursement reforms to have a drastic impact on the dialysis-dependent CKD market. This is particularly the case in the US, where the treatment landscape for dialysis care has changed significantly due to the 2011 inclusion of IV drugs to the Medicare dialysis reimbursement bundle. This bundle is likely to be expanded to include oral treatments during the study period of the report (2012-2017) and will thus have a major constraining impact on sales for oral drugs in this market.

Highlights

Key Questions Answered

- Based on interviewed KOL expert GlobalData has identified the major unmet needs in the late-stage CKD markets. What are the unmet needs for late-stage CKD patients with hyperphosphatemia and SHPT? Will the drugs under development fulfil the unmet needs of the late-stage CKD market?
- GlobalData anticipates the launch of new agents for the treatment of hyperphosphatemia and SHPT. Will these treatments address the key unmet needs identified by KOLs? What opportunities will remain for developers of novel treatments for these co-morbidities?
- How will the changing reimbursement environment in the US dialysis-dependent market impact the sales of marketed and pipeline products? What strategies are companies developing in order to gain traction in this increasingly constrained market?

Key Findings

- The late-stage CKD therapeutics market (hyperphosphatemia and SHPT), in the 6MM is forecasted to decline from $1.88bn in 2012 to $1.66bn in 2017, at a CAGR of -2.5%. This decline is attributed to the loss of patent protection for major brands and tightening reimbursement environment for oral treatments in dialysis patients.
- With the expected launch of three novel pipeline agents, the dialysis CKD market segment is due to become increasingly competitive over the forecast period as these agents enter a heavily genericized market.
- Interviewed experts report pipeline agents to have clinical advantages and expect them to partially address some key unmet needs. Remaining opportunities will be seized by future players who invest in considerable innovations through agents with novel mechanism of actions.
- GlobalData expects late-stage clinical trials to remain focused on biochemical endpoints in reduction of serum phosphorus or iPTH. GlobalData expects novel biomarkers, such as fibroblast growth factor 23 (FGF-23), to allow the detection of phosphorus imbalance in patients with earlier stage 3 or 4 disease, therefore broadening the potential patient population eligible for treatment with phosphate binders.

Scope

- Overview of late-stage CKD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Topline late-stage CKD therapeutics market revenue from 2012-2017. Annual cost of therapy, and major marketed and pipeline drug sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the late-stage CKD therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline drugs. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global late-stage CKD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global late-stage CKD therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global late-stage CKD therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Table of Contents 10
1.1 List of Tables 14
1.2 List of Figures 16
2 Introduction 18
2.1 Catalyst 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 21
3.2 Symptoms 24
3.3 Disease Management 25
3.3.1 Diagnosis 25
3.3.2 Drug Treatment for Underlying Causes of CKD 26
4 Epidemiology 40
4.1 Disease Overview 40
4.2 Risk Factors and Comorbidities 41
4.2.1 Diabetic CKD patients are more likely to have complications of CKD 43
4.2.2 Hypertensive patients are three times more likely to develop ESRD 45
4.2.3 Obesity at a younger age significantly increases the risk for CKD later in life 46
4.2.4 Women are twice as likely to develop CKD as men 47
4.2.5 Family history increases the risk of developing CKD by up to 10 times 48
4.2.6 CVD is prevalent in almost 40% of CKD patients in stages 4 and 5 49
4.3 Global Trends 50
4.3.1 US 51
4.3.2 5EU 55
4.4 Forecast Methodology 71
4.4.1 Sources Used 73
4.4.2 Forecast Assumptions and Methods 77
4.4.3 Sources Not Used 82
4.5 Epidemiology Forecast for CKD (2012-2022) 84
4.5.1 Prevalent Cases of CKD 84
4.5.2 Age-Specific Prevalent Cases of CKD 86
4.5.3 Sex-Specific Prevalent Cases of CKD 87
4.5.4 Age-Standardized Prevalence of CKD 89
4.5.5 Prevalent Cases of CKD by Stage 90
4.6 Discussion 92
4.6.1 Conclusions on Epidemiological Trends 92
4.6.2 Limitations of the Analysis 93
4.6.3 Strengths of the Analysis 94
5 Current Treatment Options 96
5.1 Overview 96
5.2 Product Profiles - Major Brands 99
5.2.1 Renvela (sevelamer carbonate) 99
5.2.2 Renagel (sevelamer hydrochloride) 103
5.2.3 Fosrenol (lanthanum carbonate) 107
5.2.4 BindRen (colestilan) 112
5.2.5 Zemplar (paricalcitol) 116
5.2.6 Sensipar/Mimpara (cinacalcet hydrochloride) 120
6 Unmet Needs Assessment and Opportunity Analysis 125
6.1 Overview 125
6.2 Unmet Needs Analysis 127
6.2.1 Unmet Need: Therapies that Provide Improved Efficacy 127
6.2.2 Unmet Need: Therapies that Provide Improved Compliance 128
6.2.3 Unmet Need: Safety and Tolerability 130
6.2.4 Unmet Need: Earlier Identification and Treatment of Patients Requiring Phosphate Control 131
6.2.5 Unmet Need: Lower Cost of Therapy 132
6.2.6 Unmet Need: Guidelines 134
6.3 Opportunity Analysis 135
6.3.1 Opportunity: Novel Treatments Targeting Phosphate Absorption 135
6.3.2 Opportunity: Flexibility in Formulation 137
6.3.3 Opportunity: Efficacious Treatments for iPTH Control in Pre-Dialysis Late-Stage CKD Patients 138
6.3.4 Opportunity: Phosphate Binders Targeted at Pre-Dialysis Late-Stage CKD Patients 139
7 R&D Strategies 141
7.1 Overview 141
7.1.1 Targeting Patients on Hemodialysis 141
7.1.2 Licensing and Alliances 142
7.1.3 Iron-Based Phosphate Binders 144
7.2 Clinical Trial Design 146
7.2.1 Hyperphosphatemia 146
7.2.2 Secondary Hyperparathyroidism 150
8 Pipeline Assessment 153
8.1 Overview 153
8.2 Promising Drugs in Clinical Development 154
8.2.1 PA-21 155
8.2.2 Zerenex (ferric citrate) 160
8.2.3 Velcalcetide (AMG-416) 165
8.3 Innovative Early-Stage Approaches 171
8.3.1 Hyperphosphatemia 172
8.3.2 Secondary Hyperparathyroidism 175
9 Pipeline Valuation Analysis 178
9.1 Clinical Benchmark of Key Pipeline Drugs 178
9.2 Commercial Benchmark of Key Pipeline Drugs 181
9.3 Competitive Assessment 182
9.4 Top-Line Five-Year Forecast 184
9.4.1 US 187
9.4.2 5EU 189
10 Appendix 191
10.1 Bibliography 191
10.2 Abbreviations 212
10.3 Methodology 214
10.4 Forecasting Methodology 214
10.4.1 Diagnosed Late-Stage CKD Patients 214
10.4.2 Percent Drug-Treated Patients 215
10.4.3 Drugs Included in Each Therapeutic Class 215
10.4.4 Launch and Patent Expiry Dates 215
10.4.5 General Pricing Assumptions 216
10.4.6 Individual Drug Assumptions 217
10.4.7 Generic Erosion 220
10.5 Physicians and Specialists Included in this Study 221
10.6 About the Authors 222
10.6.1 Authors 222
10.6.2 Epidemiologist 223
10.6.3 Global Head of Healthcare 224
10.7 About GlobalData 225
10.8 Disclaimer 225

List of Tables

Table 1: Diseases Associated with the Development of CKD 20
Table 2: Stages of Chronic Kidney Disease 21
Table 3: Common Comorbidities of CKD and ESRD 23
Table 4: Symptoms of Chronic Kidney Disease 24
Table 5: Common Diagnostic Tests for CKD and Associated Comorbidities 25
Table 6: Phosphate Binder Drug Classes 28
Table 7: Drug Treatments for SHPT 33
Table 8: KDOQI Classification of CKD 41
Table 9: Risk Factors and Comorbidities for CKD 42
Table 10: Trends in the Prevalence (%) of CKD by Stage in the US 51
Table 11: Trends in the Incidence and Prevalence of ESRD in the US (Cases per Million) 52
Table 12: Trends in the Incidence and Prevalence of RRT for ESRD in the US (Cases per Million) 53
Table 13: Trends in the Incidence and Prevalence of RRT for ESRD in Europe (Cases per Million) 55
Table 14: Trends in the Incidence and Prevalence of ESRD in France (Cases per Million) 57
Table 15: Trends in the Incidence and Prevalence of RRT for ESRD in France (Cases per Million) 59
Table 16: Trends in the Incidence and Prevalence of ESRD in Germany (Cases per Million) 61
Table 17: Trends in the Incidence and Prevalence of RRT for ESRD in Germany (Cases per Million) 62
Table 18: Trends in the Incidence and Prevalence of ESRD in Italy (Cases per Million) 63
Table 19: Trends in the Incidence* and Prevalence of RRT for ESRD in Italy (Cases per Million) 65
Table 20: Trends in the Incidence and Prevalence of ESRD in Spain (Cases per Million) 66
Table 21: Trends in the Incidence and Prevalence of RRT for ESRD in Spain (Cases per Million) 67
Table 22: Trends in the Incidence and Prevalence of ESRD in the UK (Cases per Million) 69
Table 23: Trends in the Incidence and Prevalence of RRT for ESRD in the UK (Cases per Million) 70
Table 24: Protocol For CKD Case Ascertainment Across All Studies Used in This Analysis 71
Table 25: 6MM, Sources of CKD Prevalence and Stage Data 72
Table 26: 6MM, Prevalent Cases of CKD, Ages ?20 Years, Men and Women, (N=Millions), 2012-2022 85
Table 27: 6MM, Prevalent Cases of CKD, by Age, Men and Women, (N=Millions), (Row %), 2012 86
Table 28: 6MM, Prevalent Cases of CKD, by Sex, Ages ?20 Years, N (Row %), 2012 88
Table 29: 6MM, Prevalent Cases of CKD by Stage, Ages ?20 Years, Men and Women, N (Row %), 2012 91
Table 30: Leading Treatments for Late-Stage CKD (Hyperphosphatemia and SHPT) 98
Table 31: Product Profile - Renvela 101
Table 32: Renvela SWOT Analysis 103
Table 33: Product Profile - Renagel 105
Table 34: Renagel SWOT Analysis 107
Table 35: Product Profile - Fosrenol 110
Table 36: Fosrenol SWOT Analysis 112
Table 37: Product Profile - BindRen 114
Table 38: BindRen SWOT Analysis 115
Table 39: Product Profile - Zemplar 117
Table 40: Zemplar SWOT Analysis 119
Table 41: Product Profile - Sensipar/Mimpara 122
Table 42: Sensipar/Mimpara SWOT Analysis 124
Table 43: Overall Unmet Needs - Current Level of Attainment 126
Table 44: Design of Pipeline Phase III Trials in Hyperphosphatemia 149
Table 45: Design of Pipeline Phase III Trials in SHPT 152
Table 46: Late-Stage CKD - Late-Stage Pipeline, 2013 154
Table 47: Product Profile - PA-21 157
Table 48: PA-21 SWOT Analysis 159
Table 49: Product Profile - Zerenex 162
Table 50: Zerenex SWOT Analysis 164
Table 51: Product Profile - Velcalcetide 167
Table 52: Velcalcetide SWOT Analysis 170
Table 53: Early-Stage Pipeline Products in Late-Stage CKD 171
Table 54: Clinical Benchmark of Key Pipeline Drugs - Hyperphosphatemia 178
Table 55: Clinical Benchmark of Key Pipeline Drugs - SHPT 179
Table 56: Commercial Benchmark of Key Pipeline Drugs for Late-Stage CKD 181
Table 57: Top-Line Sales Forecasts ($m) for Hyperphosphatemia, 2012-2017 185
Table 58: Top-Line Sales Forecasts ($m) for SHPT, 2012-2017 185
Table 59: Top-Line Sales Forecasts ($m) for Late-Stage CKD, 2012-2017 186
Table 60: Key Events Impacting Sales for Late-Stage CKD, 2013 188
Table 61: Late-Stage CKD Market - Drivers and Barriers, 2012-2017 188
Table 62: Key Launch Dates 2012-2017 215
Table 63: Key Patent Expiries 2012-2017 216

List of Figures

Figure 1: Conditions Responsible for End-Stage Renal Disease 20
Figure 2: US Treatment Algorithm for Stage 5 Dialysis-Dependent Patients with Hyperphosphatemia 31
Figure 3: Hemodialysis 37
Figure 4: Peritoneal Dialysis 38
Figure 5: Trends in the Prevalence (%) of CKD by Stage in the US 52
Figure 6: Trends in the Incidence and Prevalence of ESRD in the US (Cases per Million) 53
Figure 7: Trends in the Incidence and Prevalence (%) of RRT for ESRD in the US (Cases per Million) 54
Figure 8: Trends in the Incidence and Prevalence of RRT for ESRD in Europe (Cases per Million) 56
Figure 9: Trends in the Incidence and Prevalence of ESRD in France (Cases per Million) 58
Figure 10: Trends in the Incidence and Prevalence of RRT for ESRD in France (Cases per Million) 59
Figure 11: Trends in the Incidence and Prevalence of ESRD in Germany (Cases per Million) 61
Figure 12: Trends in the Incidence and Prevalence of RRT for ESRD in Germany (Cases per Million) 62
Figure 13: Trends in the Incidence and Prevalence of ESRD in Italy (Cases per Million) 64
Figure 14: Trends in the Incidence* and Prevalence of RRT for ESRD in Italy (Cases per Million) 65
Figure 15: Trends in the Incidence and Prevalence of ESRD in Spain (Cases per Million) 66
Figure 16: Trends in the Incidence and Prevalence of RRT for ESRD in Spain (Cases per Million) 67
Figure 17: Trends in the Incidence and Prevalence of ESRD in the UK (Cases per Million) 69
Figure 18: Trends in the Incidence and Prevalence of RRT for ESRD in the UK (Cases per Million) 70
Figure 19: 6MM, Prevalent Cases of CKD, Ages ?20 Years, Men and Women, 2012-2022 85
Figure 20: 6MM, Prevalent Cases of CKD, by Age, Men and Women, 2012 87
Figure 21: 6MM, Prevalent Cases of CKD, by Sex, Ages ?20 Years, 2012 88
Figure 22: 6MM, Age-Standardized Prevalence of CKD (%), Ages ?20 Years, Men and Women, 2012 90
Figure 23: 6MM, Prevalent Cases of CKD by Stage, Ages ?20 Years, Men and Women, 2012 91
Figure 24: Competitive Assessment of Marketed and Late-Stage Pipeline Agents in Late-Stage CKD, 2012-2017 183
Figure 25: Global Sales for Late-Stage CKD by Region, 2012-2017 186

Read the full report:
OpportunityAnalyzer: Late-Stage Chronic Kidney Disease (CKD) - Opportunity Analysis and Forecasts to 2017
http://www.reportbuyer.com/pharma_healthcare/diseases/opportunityanalyzer_late_stage_chronic_kidney_disease_ckd_opportunity_analysis_forecasts_2017.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

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