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OpportunityAnalyzer: Hyperparathyroidism - Opportunity Analysis and Forecasts to 2025

OpportunityAnalyzer: Hyperparathyroidism - Opportunity Analysis and Forecasts to 2025

Summary

Hyperparathyroidism (HPT) is a common endocrinal disorder characterized 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.

Sales of hyperparathyroidism (HPT) therapeutics is estimated to be approximately $6.69B in 2015 across the seven major markets covered in this report (7MM): the US, the five major European markets (5EU: France, Germany, Italy, Spain, and UK), and Japan. In the 2015 base year, 92% of market share was attributed to secondary HPT (SHPT) therapy sales ($6.16B), whereas primary HPT (PHPT) and tertiary HPT (THPT) held just 4.5% ($307M) and 3.5% ($225M) of the market, respectively.

The most notable trend in corporate strategy in the hyperparathyroidism space was the attempt to develop drugs without the adverse effects seen with the available drug classes. This led to the introduction of cornerstone therapies: Sanofi/Genzyme’s first non-metal based phosphate binders, Renvela/Renagel (sevelamer hydrochloride/carbonate), and AbbVie’s first selective vitamin D receptor agonist (VDRA), Zemplar (paricalcitol), both of which did not cause the associated hypercalcemia seen with the previous standard of care (SOC). Corporate strategy at present follows a similar trend, being particularly gauged towards improving compliance with existing drug classes by enhancing their safety, tolerability, and/or efficacy profiles.

By 2025, it is expected that the HPT market will grow at a strong Compound Annual Growth Rate (CAGR) of 1.8%, reaching sales of $8.04B by the end of the forecast period. This is mainly attributed to growth in the SHPT space, which is forecast to reflect a CAGR of 2.2%, reaching $7.68B in sales by 2025 (96% of market share). In general, the US will contribute the most to the HPT market growth, as it is predicted to grow at a CAGR of 2.4%, from $3.97B in 2015 to $5.04B in 2025.

Major drivers of HPT market growth over the forecast period are the -

  • Launch of Amgen’s first intravenous (IV) calcimimetic, Parsabiv (etelcalcetide), in all 7MM throughout 2017
  • Increase in the global prevalence of HPT
  • Launch of Rayaldee (calcifediol ER) in the US in 2016
  • Increased use of new iron-based phosphate binders, Velphoro (sucroferric oxyhydroxide) and Auryxia (ferric citrate)
Companies mentioned in this report: Amgen, Shire, Shield Therapeutics, Keryx Biopharmaceuticals, Sanofi/Genzyme, Vifor Pharmaceuticals, OPKO Health, Inc., Deltanoid Pharmaceuticals, Ardelyx, Spectrum Pharmaceuticals.

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.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Symptoms
3.3 Prognosis
3.3.1 Primary Hyperparathyroidism
3.3.2 Secondary Hyperparathyroidism
3.3.3 Tertiary Hyperparathyroidism
3.4 Quality of Life
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.2.1 Global Trends
4.2.2 Forecast Methodology
4.2.3 Sources Not Used
4.3 Epidemiological Forecast of HPT (2015-2025)
4.3.1 Diagnosed Prevalent Cases
4.3.2 Total Prevalent Cases of SHPT
4.3.3 Diagnosed Prevalent Cases of THPT
4.4 Discussion
4.4.1 Epidemiological Forecast Insight
4.4.2 Limitations of the Analysis
4.4.3 Strengths of the Analysis
5 Current Treatment Options
5.1 Overview
5.1.1 Diagnosis and Monitoring
5.1.2 Treatment Guidelines and Leading Prescribed Drugs
5.2 Clinical Practice
5.2.1 Primary HPT
5.2.2 Secondary HPT
5.2.3 Tertiary HPT
5.3 Calcimimetics
5.3.1 Sensipar (cinacalcet hydrochloride)
5.4 Vitamin D Sterols
5.4.1 Nutritional/Native Vitamin D
5.4.2 Vitamin D Receptor Agonists (VDRA)
5.5 Phosphate Binding Therapies
5.5.1 Calcium-Based Phosphate Binders
5.5.2 Aluminum-Containing Phosphate Binders
5.5.3 Magnesium-Containing Phosphate Binders
5.5.4 Renvela/Renagel (sevelamer carbonate/hydrochloride)
5.5.5 Fosrenol (Lanthanum carbonate)
5.5.6 Velphoro (Sucroferric oxyhydroxide)
5.5.7 Auryxia (ferric citrate)
5.6 Bisphosphonates
5.6.1 Overview
5.6.2 Efficacy
5.6.3 Safety
5.6.4 SWOT analysis
5.7 Surgical Management
6 Unmet Needs Assessment and Opportunity Analysis
6.1 Overview
6.2 Optimal Management of Phosphate in SHPT
6.2.1 Unmet Need
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 Optimal Treatments for PHPT
6.3.1 Unmet Need
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 Cost of Drugs and Market Access
6.4.1 Unmet Need
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 Improved Compliance of HPT Therapies
6.5.1 Unmet Need
6.5.2 Gap Analysis
6.5.3 Opportunity
7 Research and Development Strategies
7.1 Overview
7.1.1 Licensing and Alliances
7.1.2 Optimizing Safety and Compliance
7.1.3 Iron-based Phosphate Binders
7.2 Clinical Trial Design
7.2.1 Hyperphosphatemia
7.2.2 Secondary Hyperparathyroidism
8 Pipeline Assessment
8.1 Overview
8.2 Promising Drugs in Clinical Development
8.2.1 Parsabiv (etelcalcetide hydrochloride)
8.2.2 DP-001
8.2.3 PT20
8.3 Innovative Early-Stage Approaches
8.3.1 CTAP-201
8.3.2 Lunacalcipol
8.3.3 Renazorb (SPI-014)
8.3.4 Tenapanor hydrochloride
8.3.5 Alpharen (fermagate)
9 Pipeline Valuation Analysis
9.1 Clinical Benchmark of Key Pipeline Drugs
9.2 Commercial Benchmark of Key Pipeline Drugs
9.3 Competitive Assessment
9.4 Top-Line 10-Year Forecast
9.4.1 US
9.4.2 5EU
9.4.3 Japan
10 Appendix
10.1 Bibliography
10.2 Abbreviations
10.3 Methodology
10.4 Forecasting Methodology
10.4.1 Diagnosed HPT Patients
10.4.2 Percent Drug-Treated Patients
10.4.3 Drugs Included in Each Therapeutic Class
10.4.4 Launch and Patent Expiration Dates
10.4.5 General Pricing Assumptions
10.4.6 Individual Drug Assumptions
10.4.7 Generic Erosion
10.4.8 Pricing of Pipeline Agents
10.5 Primary Research - KOLs Interviewed for this Report
10.6 Primary Research - Prescriber Survey
10.7 About the Authors
10.7.1 Analyst
10.7.2 Therapy Area Director
10.7.3 Epidemiologist
10.7.4 Managing Epidemiologist
10.7.5 Global Director of Therapy Analysis and Epidemiology
10.8 About GlobalData
10.9 Disclaimer
1.1 List of Tables
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
1.2 List of 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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