OpportunityAnalyzer: Hyperparathyroidism-Opportunity Analysis and Forecasts to 2025

OpportunityAnalyzer: Hyperparathyroidism-Opportunity Analysis and Forecasts to 2025


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Executive Summary

OpportunityAnalyzer: Hyperparathyroidism-Opportunity Analysis and Forecasts to 2025

Summary

Hyperparathyroidism (HPT) is a common endocrinal disorder characterised by excessive plasma levels of parathyroid hormone (PTH) stemming from overactivity of the parathyroid glands. The parathyroid glands, of which there are four, regulate physiological calcium homeostasis through a negative feedback mechanism involving PTH secretion. HPT is classified into either primary, secondary, or tertiary, and it is important to differentiate between the three as their underlying aetiology, pathology, and treatment differ. Primary HPT (PHPT), which is characterised by hypercalcemia, results from the overproduction of PTH from one or more parathyroid glands due to the formation of sporadic and/or hereditary adenomas or carcinomas on the parathyroid gland(s). Secondary HPT (SHPT) develops, in particular, due to declining kidney function and/or vitamin D deficiencies, which result in the hypersecretion of PTH in response to induced hypocalcaemia and hyperphosphatemia in this manner. Tertiary HPT is rare and occurs most commonly in patients with long-standing SHPT who develop parathyroid hyperplasia that leads to autonomous PTH production in conjunction with hypercalcemia.

Highlights

Key Questions Answered

The newly launched iron-based phosphate binders, Velphoro and Auryxia, will see an increase in patient shares for the treatment secondary HPT against the cornerstone binder, sevelamer. Will these newly marketed make a significant impact on the HPT market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

The most notable candidate in the current late-stage HPT pipeline is new generation IV calcimimetic, Parsabiv (etelcalcetide), which is predicted to have a notable impact in the HPT space over this forecast period. However, there are still considerably high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the HPT market?

We have seen a notable increase in the HPT population in terms of diagnosed prevalent HPT cases for primary, secondary, and tertiary HPT. How will epidemiological changes impact the growth of the future market?

Key Findings

The main driver for the HPT market will be the launch of Amgen's first IV calcimimetic, Parsabiv (etelcalcetide), in all 7MM throughout 2017. Increased use of new iron-based phosphate binders, Velphoro and Auryxia, as well as newly launched vitamin D sterol, Rayaldee, will also contribute growth to the HPT market.

The major global barrier for the HPT market will be the generic erosion of key players in HPT space: phosphate binders Fosrenol, Renvela/Renagel, and Velphoro, as well as first-in-class calcimimetic blockbuster, Sensipar, over this forecast period.

In the future, the dynamics of the lucrative secondary HPT market will shift greatly from the historical strategy of developing phosphate binding therapies, towards optimising phosphate control with inhibitors of phosphate transport and/or absorption.

The key market opportunities lie in addressing unmet needs through the development of optimal agents for controlling phosphate levels to prevent the progression of secondary HPT, as well as optimised pharmacological therapies for the treatment of primary HPT.

Scope

Overview of HPT, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized HPT therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HPT therapeutics market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

Analysis of the current and future market competition in the global HPT 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

The report will enable you to

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. Additionally a list of acquisition targets included in the pipeline product company list.

Develop business strategies by understanding the trends shaping and driving the global HPT therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HPT therapeutics market in 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.

Track drug sales in the global HPT therapeutics market from 2015-2025.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.



Read More



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Ken Research
Ankur Gupta, Head Marketing & Communications

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1 Table of Contents

1 Table of Contents 9

1.1 List of Tables 15

1.2 List of Figures 18

2 Introduction 19

2.1 Catalyst 19

2.2 Related Reports 20

3 Disease Overview 21

3.1 Etiology and Pathophysiology 21

3.1.1 Etiology 21

3.1.2 Pathophysiology 23

3.2 Symptoms 26

3.3 Prognosis 27

3.3.1 Primary Hyperparathyroidism 27

3.3.2 Secondary Hyperparathyroidism 27

3.3.3 Tertiary Hyperparathyroidism 27

3.4 Quality of Life 28

4 Epidemiology 29

4.1 Disease Background 29

4.2 Risk Factors and Comorbidities 30

4.2.1 Global Trends 31

4.2.2 Forecast Methodology 33

4.2.3 Sources Not Used 45

4.3 Epidemiological Forecast of HPT (2015-2025) 46

4.3.1 Diagnosed Prevalent Cases 46

4.3.2 Total Prevalent Cases of SHPT 53

4.3.3 Diagnosed Prevalent Cases of THPT 64

4.4 Discussion 67

4.4.1 Epidemiological Forecast Insight 67

4.4.2 Limitations of the Analysis 68

4.4.3 Strengths of the Analysis 69

5 Current Treatment Options 70

5.1 Overview 70

5.1.1 Diagnosis and Monitoring 71

5.1.2 Treatment Guidelines and Leading Prescribed Drugs 72

5.2 Clinical Practice 77

5.2.1 Primary HPT 77

5.2.2 Secondary HPT 79

5.2.3 Tertiary HPT 81

5.3 Calcimimetics 82

5.3.1 Sensipar (cinacalcet hydrochloride) 82

5.4 Vitamin D Sterols 87

5.4.1 Nutritional/Native Vitamin D 87

5.4.2 Vitamin D Receptor Agonists (VDRA) 91

5.5 Phosphate Binding Therapies 96

5.5.1 Calcium-Based Phosphate Binders 97

5.5.2 Aluminum-Containing Phosphate Binders 98

5.5.3 Magnesium-Containing Phosphate Binders 98

5.5.4 Renvela/Renagel (sevelamer carbonate/hydrochloride) 99

5.5.5 Fosrenol (Lanthanum carbonate) 103

5.5.6 Velphoro (Sucroferric oxyhydroxide) 107

5.5.7 Auryxia (ferric citrate) 112

5.6 Bisphosphonates 116

5.6.1 Overview 116

5.6.2 Efficacy 118

5.6.3 Safety 118

5.6.4 SWOT analysis 119

5.7 Surgical Management 119

6 Unmet Needs Assessment and Opportunity Analysis 122

6.1 Overview 122

6.2 Optimal Management of Phosphate in SHPT 123

6.2.1 Unmet Need 123

6.2.2 Gap Analysis 124

6.2.3 Opportunity 126

6.3 Optimal Treatments for PHPT 126

6.3.1 Unmet Need 126

6.3.2 Gap Analysis 127

6.3.3 Opportunity 128

6.4 Cost of Drugs and Market Access 128

6.4.1 Unmet Need 128

6.4.2 Gap Analysis 129

6.4.3 Opportunity 130

6.5 Improved Compliance of HPT Therapies 130

6.5.1 Unmet Need 130

6.5.2 Gap Analysis 131

6.5.3 Opportunity 132

7 Research and Development Strategies 133

7.1 Overview 133

7.1.1 Licensing and Alliances 133

7.1.2 Optimizing Safety and Compliance 134

7.1.3 Iron-based Phosphate Binders 135

7.2 Clinical Trial Design 137

7.2.1 Hyperphosphatemia 137

7.2.2 Secondary Hyperparathyroidism 139

8 Pipeline Assessment 141

8.1 Overview 141

8.2 Promising Drugs in Clinical Development 142

8.2.1 Parsabiv (etelcalcetide hydrochloride) 142

8.2.2 DP-001 147

8.2.3 PT20 151

8.3 Innovative Early-Stage Approaches 154

8.3.1 CTAP-201 156

8.3.2 Lunacalcipol 157

8.3.3 Renazorb (SPI-014) 157

8.3.4 Tenapanor hydrochloride 158

8.3.5 Alpharen (fermagate) 159

9 Pipeline Valuation Analysis 160

9.1 Clinical Benchmark of Key Pipeline Drugs 160

9.2 Commercial Benchmark of Key Pipeline Drugs 164

9.3 Competitive Assessment 167

9.4 Top-Line 10-Year Forecast 171

9.4.1 US 176

9.4.2 5EU 177

9.4.3 Japan 178

10 Appendix 180

10.1 Bibliography 180

10.2 Abbreviations 196

10.3 Methodology 198

10.4 Forecasting Methodology 198

10.4.1 Diagnosed HPT Patients 198

10.4.2 Percent Drug-Treated Patients 199

10.4.3 Drugs Included in Each Therapeutic Class 199

10.4.4 Launch and Patent Expiration Dates 199

10.4.5 General Pricing Assumptions 200

10.4.6 Individual Drug Assumptions 201

10.4.7 Generic Erosion 204

10.4.8 Pricing of Pipeline Agents 204

10.5 Primary Research-KOLs Interviewed for this Report 205

10.6 Primary Research-Prescriber Survey 207

10.7 About the Authors 208

10.7.1 Analyst 208

10.7.2 Therapy Area Director 208

10.7.3 Epidemiologist 209

10.7.4 Managing Epidemiologist 210

10.7.5 Global Director of Therapy Analysis and Epidemiology 211

10.8 About GlobalData 212

10.9 Disclaimer 212

1.2 List of Figures

Figure 1: Key Pathways Controlling PTH Secretion 24

Figure 2: The Pathogenesis of SHPT. 25

Figure 3: 7MM, Diagnosed Prevalent Cases of PHPT, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 47

Figure 4: 7MM, Age-Specific Diagnosed Prevalent Cases of PHPT, Ages ?20 Years, Both Sexes, N, 2015 50

Figure 5: 7MM, Sex-Specific Diagnosed Prevalent Cases of PHPT, Ages ?20 Years, 2015 52

Figure 6: 7MM, Age-Standardized Diagnosed Prevalent Cases of PHPT, Ages ?20 Years, N, 2015 53

Figure 7: 7MM, Total Prevalent Cases of SHPT, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 55

Figure 8: 7MM, Age-Specific Total Prevalence of SHPT, Ages ?20 Years, Both Sexes, N, 2015 57

Figure 9: 7MM, Sex-Specific Total Prevalent Cases of SHPT, Ages ?20 Years, N, 2015 59

Figure 10: 7MM, Age-Standardized Total Prevalent Cases of SHPT, Ages ?20 Years, N, 2015 60

Figure 11: 7MM, SHPT in Pre-Dialysis CKD Total Prevalent Population (Stages 3-5), Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 62

Figure 12: 7MM, SHPT in Dialysis CKD Total Prevalent Population (Stages 5D), Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 63

Figure 13: 7MM, Diagnosed Prevalent Cases of THPT, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 65

Figure 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of THPT, Ages ?20 Years, N, 2015 67

Figure 15: Competitive Assessment of Marketed and Pipeline Phosphate Binder Agents in HPT, 2015-2025 168

Figure 16: Competitive Assessment of Marketed and Pipeline Calcimimetic Agents in HPT, 2015-2025 169

Figure 17: Competitive Assessment of Marketed and Pipeline Vitamin D Agents in HPT, 2015-2025 170

Figure 18: Top-Line Sales for HPT by Region, 2015-2025 173

Figure 19: Global Sales for HPT by Drug Class, 2015 and 2025 174

1.1 List of Tables

Table 1: Genetic Abnormalities Associated with Hereditary PHPT 22

Table 2: Main Conditions Associated with HPT 26

Table 3: Risk Factors and Comorbidities of HPT 31

Table 4: Diagnositc Criteria for PHPT, SHPT, and THPT 34

Table 5: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of PHPT 34

Table 6: 7MM, Sources Used to Forecast the Total Prevalent Cases of SHPT 35

Table 7: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of THPT 36

Table 8: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD 36

Table 9: 7MM, Diagnosed Prevalent Cases of PHPT, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 47

Table 10: 7MM, Age-Specific Diagnosed Prevalent Cases of PHPT, Ages ?20 Years, Both Sexes, N (Row %), 2015 49

Table 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of PHPT, Ages ?20 Years N (Row %), 2015 51

Table 12: 7MM Total Prevalent Cases of SHPT, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 54

Table 13: 7MM, Age-Specific Total Prevalent Cases of SHPT, Both Sexes, N (Row %), 2015 56

Table 14: 7MM, Sex-Specific Total Prevalent Cases of SHPT, Ages ?20 Years, N (Row %), 2015 58

Table 15: 7MM, SHPT in Pre-Dialysis CKD Total Prevalent Population (Stages 3-5), Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 61

Table 16: 7MM, SHPT in Dialysis CKD Total Prevalent Population (Stage 5D), Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 63

Table 17: 7MM, Diagnosed Prevalent Cases of THPT, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 64

Table 18: 7MM, Sex-Specific Diagnosed Prevalent Cases of THPT, Ages ?20 Years, N (Row %), 2015 66

Table 19: Common Monitoring Procedures for PHPT and SHPT patients. 72

Table 20: Treatment Guidelines for HPT 74

Table 21: Leading Treatments for HPT, 2015 75

Table 22: Product Profile-Sensipar/Mimpara 85

Table 23: Sensipar SWOT Analysis 2015 87

Table 24: Nutritional Vitamin D Sterols 89

Table 25: Product Profile-Rayaldee 90

Table 26: Rayaldee SWOT Analysis 91

Table 27: Common Vitamin D Receptor Agonists 93

Table 28: Product Profile-VDRAs 94

Table 29: Paricalcitol SWOT Analysis 96

Table 30: Product Profile-Sevelamer 101

Table 31: Sevelamer SWOT Analysis 103

Table 32: Product Profile-Fosrenol 105

Table 33: Fosrenol SWOT Analysis 107

Table 34: Product Profile-Velphoro 109

Table 35: Velphoro SWOT Analysis 111

Table 36: Product Profile-Auryxia 113

Table 37: Auryxia SWOT Analysis 115

Table 38: Product Profile-Bisphosphonates 117

Table 39: Bisphosphonate SWOT Analysis 119

Table 40: Guidelines for surgery in asymptomatic PHPT 121

Table 41: Unmet Need and Opportunity in HPT, 2015 123

Table 42: Key Late-Stage Pipeline Agents for HPT 142

Table 43: Product Profile-Etelcalcetide 145

Table 44: Etelcalcetide SWOT Analysis 147

Table 45: Product Profile-DP-001 149

Table 46: DP-001 SWOT Analysis 151

Table 47: Product Profile-PT20 153

Table 48: PT20 SWOT Analysis 154

Table 49: Early-Stage Pipeline Products for HPT 156

Table 50: Clinical Benchmarking of Key Marketed & Pipeline Products (Phosphate Binders) 161

Table 51: Clinical Benchmarking of Key Marketed and Pipeline Products (calcimimetics) 162

Table 52: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D Sterols) 164

Table 53: Commercial Benchmarking of Key Marketed & Pipeline Products (Phosphate Binders) 165

Table 54: Commercial Benchmarking of Key Marketed & Pipeline Products (calcimimetics) 166

Table 55: Commercial Benchmarking of Key Marketed & Pipeline Products (Vitamin D Sterols) 167

Table 56: Top-Line Sales Forecasts ($m) for HPT, 2015-2025 172

Table 57: Key Events Impacting Sales for HPT, 2015-2025 175

Table 58: HPT Market-Global Drivers and Barriers, 2015?2025 175

Table 59: Key Launch Dates for HPT 199

Table 60: Key Patent Expirations for HPT 200

Table 61: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 207

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