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市場調查報告書

OpportunityAnalyzer:庫欣氏症候群 - 機會分析與2018年為止的預測

OpportunityAnalyzer: Cushing's Syndrome - Opportunity Analysis and Forecasts to 2018

出版商 GlobalData 商品編碼 328674
出版日期 內容資訊 英文 194 Pages
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OpportunityAnalyzer:庫欣氏症候群 - 機會分析與2018年為止的預測 OpportunityAnalyzer: Cushing's Syndrome - Opportunity Analysis and Forecasts to 2018
出版日期: 2015年01月09日 內容資訊: 英文 194 Pages
簡介

庫欣氏症候群的治療藥市場,主要6個國家在2013年的銷售額,達到約1億7,900萬美元。製藥、生物科技企業,持續投資這個領域,採用無數的研究、開發策略。

本報告提供庫欣氏症候群的治療藥市場相關調查分析、疾病概要、流行病學、目前治療選項、未滿足需求和機會、研究、開發策略、開發平台評估等相關的系統性資訊。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因、病理生理學
  • 預後
  • 生活品質
  • 症狀
  • 診斷

第4章 流行病學

  • 疾病的背景
  • 危險因素和共生病症
  • 全球趨勢
    • 美國
    • EU5個國家
  • 預測手法
  • 庫欣氏症候群的流行病學預測
  • 議論

第5章 目前治療選項

  • 概要
  • 治療方法
  • 產品簡介:領導品牌

第6章 未滿足需求評估與機會分析

  • 概要
  • 未滿足需求分析
  • 機會分析

第7章 研究、開發策略

  • 概要
  • 臨床試驗設計

第8章 開發平台評估

  • 概要
  • 臨床開發中的有前途藥物
  • 創新的初期階段的方法

第9章 開發平台評估分析

  • 主要開發平台藥物臨床基準
  • 主要開發平台藥物的商業基準
  • 競爭評估
  • 銷售額的5年預測
    • 美國
    • EU5個國家

第10章 附錄

圖表

目錄
Product Code: GDHC026POA

GlobalData estimates that the 2013 sales for the Cushing's syndrome (CS) therapeutic market was approximately $179m across the 6MM covered in this report. Pharmaceutical and biotechnology companies that are investing their attention, time, and financial resources in the CS field, have adopted a myriad of research and development (R&D) strategies. One notable example is the fact that drug developers are focused on developing superior, next-generation inhibitors of cortisol synthesis in the adrenal glands. Steroidogenesis inhibitors were responsible for approximately 28% of total drug sales in the 6MM in 2013, equating to around $50m. As a consequence of this trend, GlobalData expects overall revenues generated by this drug class to increase by approximately 390% to reach around $247m, encompassing 49% of total drug sales in the 6MM in 2018. The expansion in this segment of the CS market is fuelled by the introduction of premium-priced pharmacological agents such as Novartis' LCI699 and Cortendo AB's NormoCort (COR-003) in the US, as well as the arrival of HRA Pharma's Ketoconazole HRA (ketoconazole) to the European CS stage. One of the greatest unmet needs in this indication is a lack of effective drugs directed against the underlying cause of Cushing's disease (the pituitary tumor). Despite this demand, pharmaceutical companies are continuing to adopt a strategy that simply targets the adrenal glands. As a result, there is a vast amount of room for new or existing players to penetrate the market and capture considerable patient share.

Highlights

Key Questions Answered

  • Although the current standard of care (ketoconazole) is cheap and reasonably effective in most CS patients, it possesses worrying safety profiles, inconvenient dosing schedules, is difficult to obtain and can display waning efficacy over time. Newer medical treatments, for example, Novartis' Signifor (pasireotide) and Corcept Therapeutics' Korlym (mifepristone) address only some of these issues; yet, present their own limitations. The CS market is still marked by the existence of a multitude of unmet needs. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the CS market?
  • The late-stage CS pipeline is sparsely populated; however, those drugs in development will be a strong driver of CS market growth. Which of these drugs will attain high sales revenues during 2013-2018? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

Key Findings

  • One of the main drivers influencing growth in the Cushing's syndrome market will be the introduction of second-generation steroidogenesis inhibitors, LCI699 and NormoCort (COR-003), in the US, which will rival existing standard of care medical treatments.
  • Another strong driver will be the arrival of Corcept Therapeutics' Korlym (mifepristone) and HRA Pharma's Ketoconazole HRA (ketoconazole) to the European CS market. Both drugs will stimulate significant growth here.
  • The launch of Novartis' Signifor LAR (pasireotide) in the 6MM will equip physicians with a less frequently administered formulation of Signifor.
  • Reasons for inadequate CS treatment include poor physician awareness of the condition, delayed diagnosis, a lack of efficacious drugs for individuals suffering from severe hypersecretion, and a shortage of effective medicines targeting the source of Cushing's disease.

Scope

  • Overview of Cushing's syndrome, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized Cushing's syndrome therapeutics market revenues, annual cost of therapies and treatment usage pattern data from 2013 and forecast for five years to 2018.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Cushing's syndrome 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 Cushing's syndrome 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. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the Cushing's syndrome therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the Cushing's syndrome 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.
  • Track drug sales in the 6MM Cushing's syndrome therapeutics market from 2013-2018.
  • 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

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
  • 3.2. Prognosis
  • 3.3. Quality of Life
  • 3.4. Symptoms
  • 3.5. Diagnosis

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. US
    • 4.3.2. 5EU
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods - Prevalent Cases
    • 4.4.4. Forecast Assumptions and Methods - Immediate TSS Outcomes
  • 4.5. Epidemiological Forecast for Cushing's Syndrome (2013-2023)
    • 4.5.1. Cushing's Syndrome
    • 4.5.2. Cushing's Disease
    • 4.5.3. Ectopic Adrenocorticotropic Hormone Cushing's Syndrome
    • 4.5.4. Adrenal Adenoma Cushing's Syndrome
    • 4.5.5. Adrenal Carcinoma Cushing's Syndrome
    • 4.5.6. Age-Standardized Diagnosed Prevalence Rates
    • 4.5.7. Immediate Transsphenoidal Adenomectomy Surgery Outcomes
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Treatment Options

  • 5.1. Overview
  • 5.2. Treatment Approach
  • 5.3. Product Profiles - Major Brands
    • 5.3.1. Signifor (pasireotide) and Signifor LAR (pasireotide)
    • 5.3.2. Korlym (mifepristone)
    • 5.3.3. Ketoconazole and Ketoconazole HRA (ketoconazole)
    • 5.3.4. Metopirone (metyrapone)
    • 5.3.5. Lysodren (mitotane)

6. Unmet Needs Assessment and Oppportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Unmet Need: Effective Drugs Directed against the Underlying Cause of Cushing's Disease
    • 6.2.2. Unmet Need: Few Drugs - Especially Those for Severe Cushing's Syndrome - Possess Favorable Safety and Efficacy
    • 6.2.3. Unmet Need: Physician Awareness of Cushing's Syndrome Symptomatology
    • 6.2.4. Unmet Need: Accelerated Referral Systems to Specialists in Secondary and Tertiary Care Settings
    • 6.2.5. Unmet Need: Uniform Guidelines Unambiguously Defining Treatment and Remission
  • 6.3. Opportunity Analysis
    • 6.3.1. Opportunity: Development of Improved Adrenocorticotropic Hormone Modulator Drugs
    • 6.3.2. Opportunity: Reformulation of the Steroidogenic Inhibitors into Longer-Acting Release Treatments
    • 6.3.3. Opportunity: Development of Universally Accepted Tests and Measures for Better Diagnosis and Monitoring of Cushing's Syndrome Activity and Treatment Response
    • 6.3.4. Opportunity: Prospective, Randomized Trials for Off-Label Cushing's Syndrome Agents
    • 6.3.5. Opportunity: Gaining Understanding of the Pathophysiology of Cushing's Syndrome

7. Research and Development Strategies

  • 7.1. Overview
    • 7.1.1. Inhibitors of Cortisol Synthesis in the Adrenal Glands
    • 7.1.2. Licensing Agreements, Partnerships, and Alliances
    • 7.1.3. Secondary Indications
  • 7.2. Clinical Trial Design
    • 7.2.1. Selecting Suitable Comparator Arms
    • 7.2.2. Evaluating and Determining Appropriate Clinical Trial Endpoints
    • 7.2.3. Accurately Representing the Patient Population in Clinical Trials

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. NormoCort (COR-003)
    • 8.2.2. LCI699
  • 8.3. Innovative Early-Stage Approaches
    • 8.3.1. Somatoprim (DG3173)
    • 8.3.2. Anti-Sense Technology and RNA Interference
    • 8.3.3. Retinoic Acid
    • 8.3.4. Other Early-Stage Approaches and Non-Pharmacotherapies

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 Five-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Diagnosed Cushing's Syndrome Patients
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. Launch and Patent Expiry Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Individual Drug Assumptions
    • 10.4.7. Pricing of Pipeline agents
  • 10.5. Physicians and Specialists Included in This Study
  • 10.6. About the Authors
    • 10.6.1. Analyst
    • 10.6.2. Therapy Director
    • 10.6.3. Epidemiologist
    • 10.6.4. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Various Subtypes of Endogenous Cushing's Syndrome
  • Table 2: Symptoms of Cushing's Syndrome
  • Table 3: Risk Factors for Cushing's Syndrome
  • Table 4: 6MM, Sources of CS Prevalence Data
  • Table 5: 6MM, Diagnosed Prevalent Cases of CS, Ages ≥18 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 6: 6MM, Age-Specific Diagnosed Prevalent Cases of CS, Both Sexes, N (Row %), 2013
  • Table 7: 6MM, Sex-Specific Diagnosed Prevalent Cases of CS, Ages ≥18 Years, N (Row %), 2013
  • Table 8: 6MM, Diagnosed Prevalent Cases of Cushing's Disease, Ages ≥18 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 9: 6MM, Age-Specific Diagnosed Prevalent Cases of Cushing's Disease, Both Sexes, N (Row %), 2013
  • Table 10: 6MM, Sex-Specific Diagnosed Prevalent Cases of Cushing's Disease, Ages ≥18 Years, N (Row %), 2013
  • Table 11: 6MM, Diagnosed Prevalent Cases of Ectopic ACTH CS, Ages ≥18 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 12: 6MM, Age-Specific Diagnosed Prevalent Cases of Ectopic ACTH CS, Both Sexes, N (Row %), 2013
  • Table 13: 6MM, Sex-Specific Diagnosed Prevalent Cases of Ectopic ACTH CS, Ages ≥18 Years, N (Row %), 2013
  • Table 14: 6MM, Diagnosed Prevalent Cases of Adrenal Adenoma CS, Ages ≥18 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 15: 6MM, Age-Specific Diagnosed Prevalent Cases of Adrenal Adenoma CS, Both Sexes, N (Row %), 2013
  • Table 16: 6MM, Sex-Specific Diagnosed Prevalent Cases of Adrenal Adenoma CS, Ages ≥18 Years, N (Row %), 2013
  • Table 17: 6MM, Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Ages ≥18 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 18: 6MM, Age-Specific Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Both Sexes, N (Row %), 2013
  • Table 19: 6MM, Sex-Specific Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Ages ≥18 Years, N (Row %), 2013
  • Table 20: 6MM, Immediate TSS Outcomes, Both Sexes, N, 2013
  • Table 21: Leading Pharmacological Treatments for Cushing's Syndrome
  • Table 22: Product Profile - Signifor
  • Table 23: Signifor SWOT Analysis
  • Table 24: Product Profile - Korlym
  • Table 25: Korlym SWOT Analysis
  • Table 26: Product Profile - Nizoral
  • Table 27: Ketoconazole SWOT Analysis
  • Table 28: Product Profile - Metopirone
  • Table 29: Metopirone SWOT Analysis
  • Table 30: Product Profile - Lysodren
  • Table 31: Lysodren SWOT Analysis
  • Table 32: Overall Unmet Needs - Current Level of Attainment
  • Table 33: Clinical Trial Design of Key Marketed and Pipeline Drugs for Cushing's Syndrome, August 2014
  • Table 34: Cushing's Syndrome - Late Stage Pipeline, 2014
  • Table 35: Product Profile - NormoCort (COR-003)
  • Table 36: NormoCort (COR-003) SWOT Analysis
  • Table 37: Product Profile - LCI699
  • Table 38: LCI699 SWOT Analysis
  • Table 39: Early-Stage Pipeline Products in Cushing's Syndrome
  • Table 40: Clinical Benchmark of Key Pipeline Drugs
  • Table 41: Commercial Benchmark of Key Pipeline Drugs
  • Table 42: Top-Line Sales Forecasts ($) for Cushing's Syndrome, 2013-2018
  • Table 43: Key Events Impacting Sales for Cushing's Syndrome, 2013-2018
  • Table 44: Cushing's Syndrome - Drivers and Barriers, 2013-2018
  • Table 45: Abbreviations
  • Table 46: Key Launch Dates
  • Table 47: Key Patent Expiries

List of Figures

  • Figure 1: Pathophysiology of Cushing's Syndrome
  • Figure 2: The Diagnosis Algorithm for Cushing's Syndrome
  • Figure 3: The Diagnosis Algorithm for ACTH-Dependent Cushing's Syndrome
  • Figure 4: 6MM, Diagnosed Prevalent Cases of CS, Ages ≥18 Years, Both Sexes, N, 2013-2023
  • Figure 5: 6MM, Age-Specific Diagnosed Prevalent Cases of CS, Both Sexes, N, 2013
  • Figure 6: 6MM, Sex-Specific Diagnosed Prevalent Cases of CS, Ages ≥18 Years, N, 2013
  • Figure 7: 6MM, Diagnosed Prevalent Cases of Cushing's Disease, Ages ≥18 Years, Both Sexes, N, 2013-2023
  • Figure 8: 6MM, Age-Specific Diagnosed Prevalent Cases of Cushing's Disease, Both Sexes, N, 2013
  • Figure 9: 6MM, Sex-Specific Diagnosed Prevalent Cases of Cushing's Disease, Ages ≥18 Years, N, 2013
  • Figure 10: 6MM, Diagnosed Prevalent Cases of Ectopic ACTH CS, Ages ≥18 Years, Both Sexes, N, 2013-2023
  • Figure 11: 6MM, Age-Specific Diagnosed Prevalent Cases of Ectopic ACTH CS, Both Sexes, N, 2013
  • Figure 12: 6MM, Sex-Specific Diagnosed Prevalent Cases of Ectopic ACTH CS, Ages ≥18 Years, N, 2013
  • Figure 13: 6MM, Diagnosed Prevalent Cases of Adrenal Adenoma CS, Ages ≥18 Years, Both Sexes, N, 2013-2023
  • Figure 14: 6MM, Age-Specific Diagnosed Prevalent Cases of Adrenal Adenoma CS, Both Sexes, N, 2013
  • Figure 15: 6MM, Sex-Specific Diagnosed Prevalent Cases of Adrenal Adenoma CS, Ages ≥18 Years, N, 2013
  • Figure 16: 6MM, Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Ages ≥18 Years, Both Sexes, N, 2013-2023
  • Figure 17: 6MM, Age-Specific Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Both Sexes, N, 2013
  • Figure 18: 6MM, Sex-Specific Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Ages ≥18 Years, N, 2013
  • Figure 19: 6MM, Age-Standardized Diagnosed Prevalence of CS (%), Ages ≥18 Years, 2013
  • Figure 20: 6MM, Age-Standardized Diagnosed Prevalence of Cushing's Disease (%), Ages ≥18 Years, 2013
  • Figure 21: Treatment Paradigm for Cushing's Syndrome
  • Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in Cushing's Syndrome, 2013-2018
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