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Hyperparathyroidism - Analysis and Market Forecasts to 2019
GlobalData, October 2012, Pages: 70
Hyperparathyroidism – Analysis and Market Forecasts to 2019
The global hyperparathyroidism therapeutics market is forecast to grow to reach $2.6 billion by 2019. This moderate growth is primarily attributed to the increase in the hyperparathyroidism patient population and the expected launches of two novel drugs: CTAP101 and KAI-4169 IV. The major barriers for the hyperparathyroidism therapeutics market during forecast period are the introduction of bundled dialysis payment system in the US and the expected patent expirations of all three leading branded drugs in the market: Sensipar/Mimpara, Zemplar and Hectorol. The hyperparathyroidism pipeline is weak, with only seven molecules in various stages of development, including four first-in-class molecules and three me-too products. Amgen and Abbott are the leading companies in the current competitive landscape. Amgen is likely to maintain its position during the forecast period due to its acquisition in July 2012 of KAI Pharmaceuticals and its promising pipeline molecule KAI-4169.
- Overview of hyperparathyroidism, including epidemiology, etiology, symptoms, diagnosis, pathophysiology, management and treatment guidelines.
- Annualized hyperparathyroidism therapeutics market revenue, annual cost of therapy and forecast for eight years to 2019.
- Pipeline analysis: Comprehensive data split across different phases, emerging trends and mechanisms of action under development, including calcium sensing receptor agonist, vitamin D pro-hormone, vitamin D receptor agonist and CYP24 enzyme inhibitor.
- Analysis of the current and future market competition in the global hyperparathyroidism 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 topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the hyperparathyroidism therapeutics market.
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 hyperparathyroidism therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global hyperparathyroidism therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 hyperparathyroidism therapeutics market from 2011–2019.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1.1 List of Tables
1.2 List of Figures
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.3 Risk Factors
3.2.2 Diagnosed Prevalence
3.4 Diagnosis and Referral
3.5 Treatment Guidelines
3.6 Disease Management
3.6.1 Primary Hyperparathyroidism
3.6.2 Secondary Hyperparathyroidism
3.6.3 Tertiary Hyperparathyroidism
4 Competitive Assessment
4.2 Strategic Competitor Assessment
4.3 Product Profile - Major Brands
4.3.1 Sensipar (cinacalcet)
4.3.2 Zemplar (paricalcitol)
4.3.3 Hectorol (doxercalciferol)
4.3.4 Oxarol (maxacalcitol)
5 Opportunity and Unmet Need
5.2 Lower Adverse Effect on Serum Calcium and Phosphorus Level
5.3 New Treatment Options for Primary Hyperparathyroidism
5.4 Disease Awareness and Screening Programs in Primary Hyperparathyroidism
5.5 Convenient Dosing Regimen
5.6 Guidelines for Tertiary Hyperparathyroidism Management
6 Pipeline Assessment
6.2 Strategic Pipeline Assessment
6.3 Pipeline by Phases of Development
6.3.1 Phase III Pipeline
6.3.2 Phase II Pipeline
6.3.3 Phase I Pipeline
6.3.4 Preclinical Pipeline
6.3.5 Discovery Pipeline
6.4 Pipeline by Mechanism of Action
6.5 Technology Trends Analytic Framework
6.6 Hyperparathyroidism - Promising Drugs in Clinical Development
6.6.2 KAI-4169 IV
7 Clinical Trials Mapping
7.1 Clinical Trials by Country
7.2 Clinical Trials by Phase
7.3 Clinical Trials by Trial Status
7.4 Prominent Sponsors
8 Current and Future Players
8.2 Trends in Corporate Strategy
8.3 Company Profiles
8.3.1 Amgen Inc.
8.3.2 Abbott Laboratories
8.3.3 Cytochroma Inc.
8.3.4 KAI Pharmaceuticals Inc.
8.3.5 Other Companies in the Hyperparathyroidism Therapeutics Market
9 Licensing and Partnership Deals
9.2 Key Deals and Alliances in the Past 12 Months
10 Market Outlook
10.1 Seven Major Markets Overview
10.2 Regional Analysis
10.3 Key Events
10.4 Drivers and Barriers
10.4.1 Drivers for the Hyperparathyroidism Market
10.4.2 Barriers for the Hyperparathyroidism Market
11.3.2 Secondary Research
11.3.3 Forecasting Methodology
11.3.4 Primary Research
11.3.5 Expert Panel Validation
11.4 Physicians and Specialists Included in this Study
11.5 About the Authors
11.5.2 Global Head of Healthcare Research and Consulting
11.6 About Us
11.7 Contact Us
1.1 List of Tables
Table 1: Types of Hyperparathyroidism
Table 2: Etiology of Primary Hyperparathyroidism
Table 3: Etiology of Secondary Hyperparathyroidism
Table 4: Risk Factors for Hyperparathyroidism
Table 5: Prevalence of Secondary Hyperparathyroidism in Chronic Kidney Disease
Table 6: Total Prevalence of Hyperparathyroidism in the Major Markets, 2011-2019
Table 7: Diagnosed Prevalence of Hyperparathyroidism in the Major Markets, 2011-2019
Table 8: Symptoms of Hyperparathyroidism
Table 9: Diagnosis of Hyperparathyroidism
Table 10: Adoption of Treatment Guidelines by Physicians
Table 11: Treatment Guidelines for Hyperparathyroidism
Table 12: Surgery Criterion in Primary Hyperparathyroidism
Table 13: Monitoring Primary Hyperparathyroidism in Nonsurgical Patients
Table 14: Leading Treatments for Hyperparathyroidism, 2012
Table 15: Product Profile - Sensipar
Table 16: Adverse Incidents - Sensipar
Table 17: Sensipar SWOT Analysis, 2012
Table 18: Product Profile - Zemplar
Table 19: Zemplar SWOT Analysis, 2012
Table 20: Product Profile - Hectorol
Table 21: Hectorol SWOT Analysis, 2012
Table 22: Product Profile - Oxarol
Table 23: Oxarol SWOT Analysis, 2012
Table 24: Overall Unmet Needs - Current Level of Attainment
Table 25: Hyperparathyroidism - Phase III Pipeline, 2012
Table 26: Hyperparathyroidism - Phase II Pipeline, 2012
Table 27: Hyperparathyroidism - Phase I Pipeline, 2012
Table 28: Hyperparathyroidism - Preclinical Pipeline, 2012
Table 29: Hyperparathyroidism - Discovery Pipeline, 2012
Table 30: Comparison of Mechanisms of Actions in Development for Hyperparathyroidism, 2012
Table 31: Hyperparathyroidism - Promising Drugs in Clinical Development
Table 32: Product Profile - CTAP101
Table 33: CTAP101 SWOT Analysis, 2012
Table 34: Product Profile - KAI-4169 IV
Table 35: KAI-4169 IV SWOT Analysis, 2012
Table 36: Hyperparathyroidism Therapeutics, Clinical Trials by Phase, 2012
Table 37: Hyperparathyroidism Therapeutics, Clinical Trials by Status, 2012
Table 38: Hyperparathyroidism - Overall Sponsor Mix, 2012
Table 39: Key Companies in the Hyperparathyroidism Market, 2012
Table 40: Amgen’s Hyperparathyroidism Therapy Portfolio Assessment, 2012
Table 41: Amgen’s Hyperparathyroidism Therapy Portfolio SWOT Analysis, 2012
Table 42: Abbott’s Hyperparathyroidism Therapy Portfolio Assessment, 2012
Table 43: Abbott’s Hyperparathyroidism Therapy Portfolio SWOT Analysis, 2012
Table 44: Cytochroma’s Hyperparathyroidism Therapy Portfolio Assessment, 2012
Table 45: Cytochroma’s Hyperparathyroidism Therapy Portfolio SWOT Analysis, 2012
Table 46: KAI Pharmaceutical’s Hyperparathyroidism Therapy Portfolio Assessment, 2012
Table 47: KAI Pharmaceutical’s Hyperparathyroidism Therapy Portfolio SWOT Analysis, 2012
Table 48: Portfolio Assessment - Other Leading Players in Hyperparathyroidism Market, 2012
Table 49: Strategic Deals and Alliances for Hyperparathyroidism, 2012
Table 50: Sales Forecasts for Hyperparathyroidism in the Seven Major Markets, 2011-2019
Table 51: Sales Forecasts for Hyperparathyroidism in the US, 2011-2019
Table 52: Sales Forecasts for Hyperparathyroidism in France, 2011-2019
Table 53: Sales Forecasts for Hyperparathyroidism in Germany, 2011-2019
Table 54: Sales Forecasts for Hyperparathyroidism in Italy, 2011-2019
Table 55: Sales Forecasts for Hyperparathyroidism in Spain, 2011-2019
Table 56: Sales Forecasts for Hyperparathyroidism in the UK, 2011-2019
Table 57: Sales Forecasts for Hyperparathyroidism in Japan, 2011-2019
Table 58: Key Events Impacting Sales for Hyperparathyroidism, 2012
Table 59: Hyperparathyroidism Market - Drivers and Barriers, 2012
Table 60: Key Launch Dates
Table 61: Key Patent Expiries
1.2 List of Figures
Figure 1: Parathyroid Glands
Figure 2: Pathophysiology of Secondary Hyperparathyroidism
Figure 3: Referral and Management of Secondary Hyperparathyroidism in CKD Patients
Figure 4: Strategic Competitor Assessment of Marketed Products in Hyperparathyroidism, 2012
Figure 5: Opportunity and Clinical Unmet Need in Hyperparathyroidism, 2012
Figure 6: Hyperparathyroidism Therapeutics Pipeline by Phase of Clinical Development, 2012
Figure 7: Hyperparathyroidism - Pipeline by Mechanism of Action, 2012
Figure 8: Technology Trends Analytic Framework for Hyperparathyroidism Pipeline, 2012
Figure 9: Technology Trends Analytic Framework - Unmet Need Gap Analysis, 2012
Figure 10: Hyperparathyroidism Therapeutics, Clinical Trials by Country, 2012
Figure 11: Hyperparathyroidism - Leading Companies Participating in Clinical Trials, 2012
Figure 12: Sales Forecasts for Hyperparathyroidism in the Seven Major Markets, 2011-2019
Figure 13: Seven Major Market Sales for Hyperparathyroidism by Region, 2011-2019
New Report Forecasts Hyperparathyroidism Therapeutics Market at $2.62 Billion by 2019
Hyperparathyroidism (HPT) patients can expect a slow but steady change in treatment options, as pharmaceutical companies work through stringent clinical trials, states a new report published by healthcare experts The authors.
The new report* looks at the drug pipeline and subsequent market forecasts for the endocrine disorder, which sees excessive amounts of the Parathyroid Hormone (PTH) produced from the parathyroid glands located in the lower neck.
Parathyroid glands respond to low calcium levels by increasing production of PTH, which controls calcium, phosphorus and vitamin D levels within the blood and bones. This reaction results in higher levels of calcium in the blood and urine, loss of calcium from bones and hypercalcemia.
According to the report, the hyperparathyroidism patient population is expected to increase over future years, primarily due to increasing Chronic Kidney Disease (CKD) prevalence and an increase in the elderly population.
Treatment options currently available for hyperparathyroidism can effectively control PTH levels, while offering moderate safety profiles, but a space still exists in the market for novel products with superior efficacy, lower adverse effects, improved patient compliance and increased affordability.
Significant opportunities still exist for novel molecules and novel formulations, and several new treatments are anticipated - including CTAP101 capsules, expected to be launched in the US in 2015, KAI-4169 IV in the US in 2016, and KAI-4169 IV in the EU5 (France, Germany, Italy, Spain, and the UK) in 2017.
Cytochroma’s CTAP101 is a First-in-Class (FIC), vitamin D pro-hormone, which is hoped will enable the effective control of elevated PTH levels and correction of underlying vitamin D insufficiency in CKD stage 3 and 4 patients. Currently, CTAP101 is the only molecule in Phase III clinical trials.
KAI Pharmaceuticals (an Amgen company) is developing KAI-4169 IV,an FIC, second-generation, optimized Calcium-Sensing Receptor (CaSR) agonist, which has shown improved efficacy, tolerability and patient compliance with low adverse effects in CKD stage 5 patients, in Phase II trial results. The company is also developing a transdermal form of the drug for both pre-dialysis and dialysis HPT patients; this delivery system is in the preclinical phase of development.
In addition to the launches of these novel drugs, patent expiries are anticipated during the forecast period for the current market leaders—Zemplar in 2012, Hectorol in 2014 and Sensipar/Mimpara in 2015—which will change the competitive landscape in the foreseeable future. Despite the promising profiles of CTAP101 and KAI-4169 IV, the hyperparathyroidism pipeline as a whole is weak, with only seven molecules, and only one molecule in Phase III trials. The years of study necessitated for most new molecules will restrict the market growth over the forecast period. Furthermore, in the US market, recent and upcoming changes to the bundled dialysis payment system will hinder growth, as capped reimbursement amounts for Medicare recipients result in lower overall sales of marketed drugs, and even deter companies from pursuing R&D in the HPT space.
The hyperparathyroidism therapeutics market is forecast to show moderate growth during the forecast period. The authors estimates the global hyperparathyroidism therapeutics market in 2011 at $2.01 billion, and expects it to grow at a Compound Annual Growth Rate (CAGR) of 3.3% to reach $2.62 billion by 2019.
KAI Pharmaceuticals Inc.