OpportunityAnalyzer: Hyperparathyroidism – Opportunity Analysis and Forecasts to 2025

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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.

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.

Key Highlights

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?

Amgen
Shire
Shield Therapeutics
Keryx Biopharmaceuticals
Sanofi/Genzyme
Vifor Pharmaceuticals
OPKO Health, Inc.
Deltanoid Pharmaceuticals
Ardelyx
Spectrum Pharmaceuticals

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

3.3Prognosis

3.3.1Primary Hyperparathyroidism

3.3.2Secondary Hyperparathyroidism

3.3.3Tertiary Hyperparathyroidism

3.4Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.2.1Global Trends

4.2.2Forecast Methodology

4.2.3Sources Not Used

4.3Epidemiological Forecast of HPT (2015–2025)

4.3.1Diagnosed Prevalent Cases

4.3.2Total Prevalent Cases of SHPT

4.3.3Diagnosed Prevalent Cases of THPT

4.4Discussion

4.4.1Epidemiological Forecast Insight

4.4.2Limitations of the Analysis

4.4.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.1.1Diagnosis and Monitoring

5.1.2Treatment Guidelines and Leading Prescribed Drugs

5.2Clinical Practice

5.2.1Primary HPT

5.2.2Secondary HPT

5.2.3Tertiary HPT

5.3Calcimimetics

5.3.1Sensipar (cinacalcet hydrochloride)

5.4Vitamin D Sterols

5.4.1Nutritional/Native Vitamin D

5.4.2Vitamin D Receptor Agonists (VDRA)

5.5Phosphate Binding Therapies

5.5.1Calcium-Based Phosphate Binders

5.5.2Aluminum-Containing Phosphate Binders

5.5.3Magnesium-Containing Phosphate Binders

5.5.4Renvela/Renagel (sevelamer carbonate/hydrochloride)

5.5.5Fosrenol (Lanthanum carbonate)

5.5.6Velphoro (Sucroferric oxyhydroxide)

5.5.7Auryxia (ferric citrate)

5.6Bisphosphonates

5.6.1Overview

5.6.2Efficacy

5.6.3Safety

5.6.4SWOT analysis

5.7Surgical Management

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Optimal Management of Phosphate in SHPT

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Optimal Treatments for PHPT

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Cost of Drugs and Market Access

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Improved Compliance of HPT Therapies

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

7Research and Development Strategies

7.1Overview

7.1.1Licensing and Alliances

7.1.2Optimizing Safety and Compliance

7.1.3Iron-based Phosphate Binders

7.2Clinical Trial Design

7.2.1Hyperphosphatemia

7.2.2Secondary Hyperparathyroidism

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1Parsabiv (etelcalcetide hydrochloride)

8.2.2DP-001

8.2.3PT20

8.3Innovative Early-Stage Approaches

8.3.1CTAP-201

8.3.2Lunacalcipol

8.3.3Renazorb (SPI-014)

8.3.4Tenapanor hydrochloride

8.3.5Alpharen (fermagate)

9Pipeline Valuation Analysis

9.1Clinical Benchmark of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top-Line 10-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1Diagnosed HPT Patients

10.4.2Percent Drug-Treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4Launch and Patent Expiration Dates

10.4.5General Pricing Assumptions

10.4.6Individual Drug Assumptions

10.4.7Generic Erosion

10.4.8Pricing of Pipeline Agents

10.5Primary Research – KOLs Interviewed for this Report

10.6Primary Research – Prescriber Survey

10.7About the Authors

10.7.1Analyst

10.7.2Therapy Area Director

10.7.3Epidemiologist

10.7.4Managing Epidemiologist

10.7.5Global Director of Therapy Analysis and Epidemiology

10.8About GlobalData

10.9Disclaimer

Table

Table 1: Genetic Abnormalities Associated with Hereditary PHPT

Table 2: Main Conditions Associated with HPT

Table 3: Risk Factors and Comorbidities of HPT

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Table 20: Treatment Guidelines for HPT

Table 21: Leading Treatments for HPT, 2015

Table 22: Product Profile – Sensipar/Mimpara

Table 23: Sensipar SWOT Analysis 2015

Table 24: Nutritional Vitamin D Sterols

Table 25: Product Profile – Rayaldee

Table 26: Rayaldee SWOT Analysis

Table 27: Common Vitamin D Receptor Agonists

Table 28: Product Profile – VDRAs

Table 29: Paricalcitol SWOT Analysis

Table 30: Product Profile – Sevelamer

Table 31: Sevelamer SWOT Analysis

Table 32: Product Profile – Fosrenol

Table 33: Fosrenol SWOT Analysis

Table 34: Product Profile – Velphoro

Table 35: Velphoro SWOT Analysis

Table 36: Product Profile – Auryxia

Table 37: Auryxia SWOT Analysis

Table 38: Product Profile – Bisphosphonates

Table 39: Bisphosphonate SWOT Analysis

Table 40: Guidelines for surgery in asymptomatic PHPT

Table 41: Unmet Need and Opportunity in HPT, 2015

Table 42: Key Late-Stage Pipeline Agents for HPT

Table 43: Product Profile – Etelcalcetide

Table 44: Etelcalcetide SWOT Analysis

Table 45: Product Profile – DP-001

Table 46: DP-001 SWOT Analysis

Table 47: Product Profile – PT20

Table 48: PT20 SWOT Analysis

Table 49: Early-Stage Pipeline Products for HPT

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

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

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

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

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

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

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

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

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

Table 59: Key Launch Dates for HPT

Table 60: Key Patent Expirations for HPT

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

Figures

Figure 1: Key Pathways Controlling PTH Secretion

Figure 2: The Pathogenesis of SHPT.

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

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

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

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

Figure 7: 7MM, Total Prevalent Cases of SHPT, Ages =20 Years, Both Sexes, N, Selected Years 2015–2025

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

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

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

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

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

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

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

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

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

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

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

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

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