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生長激素缺乏症 - 機會分析及至2024年的預測

OpportunityAnalyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecast to 2024

出版商 GlobalData 商品編碼 344233
出版日期 內容資訊 英文 147 Pages
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生長激素缺乏症 - 機會分析及至2024年的預測 OpportunityAnalyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecast to 2024
出版日期: 2015年08月01日 內容資訊: 英文 147 Pages
簡介

全球生長激素缺乏症市場2014年的銷售額在7大市場中成為12億6,000萬美元。預計該市場今後10年,以年複合成長率4.08%緩慢成長,2024年終達18億8,000萬美元。預計美國最快成長,預計2024年佔據全球銷售額的59%。

本報告提供生長激素缺乏症的流行病學、病因、症狀、診斷、治療指南等概要,以及治療藥市場收益、至2024年的10年預測、市場上未滿足需求、開發平台趨勢等彙整資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因與病理學
  • 症狀
  • 診斷
  • 預後
  • 生活品質

第4章 流行病學

  • 背景
  • 風險因素和共生病症
  • 全球的趨勢
  • 預測方法
  • 流行病學的預測
  • 考察

第5章 競爭評估

  • 概要
  • 治療流程
  • 市場進入、償付、臨床
  • 產品簡介
    • 概要
    • 功效
    • 安全性
    • SWOT分析

第6章 未滿足需求的評估與機會分析

  • 概要
  • 改善的遵守性和適合性
  • 早期診斷
  • 日本的疾病的認識和法律規章政策
  • 帶給患者獲取影響的保險政策
  • 癌症生存者的更安全治療方法

第7章 研究開發策略

  • 概要
  • 臨床實驗設計

第8章 開發平台評估

  • 概要
  • 臨床開發的潛力藥物
  • 創新的早期方法

第9章 開發平台評估分析

  • 開發平台藥物臨床基準
  • 開發平台藥物的商業性基準
  • 競爭評估
  • 10年預測
    • 美國
    • 歐洲5國
    • 日本

第10章 附錄

圖表

目錄
Product Code: GDHC029POA

GlobalData estimates the 2014 sales for growth hormone deficiency (GHD) at approximately $1.26 billion across the 7MM covered in this report. The market will grow moderately at a CAGR of 4.08% during the 10-year forecast period, generating sales of approximately $1.88 billion at the end of 2024. The US market is expected to grow the fastest of the three regions, recording a CAGR of 4.88% and generating around 59% of global sales in 2024. The major driver for this growth across the 7MM will be the launch of long-acting biobetter growth hormones (GH), which will rapidly take away shares from the currently marketed daily injectable growth hormones.

Highlights

Key Questions Answered

  • Overall, the greatest unmet need in the GHD space is the issue with treatment adherence and compliance. There are other prominent unmet needs highlighted by the Key Opinion Leaders (KOLs). What are these? Will the pipeline drugs fulfil these unmet needs of the market?
  • The 10-year forecast period will mark the launch of six pipeline long-acting GH drugs. How will the sales of the existing drugs be impacted? Which of the pipeline drugs will have the highest peak sales at the highest CAGR, and why?
  • What are the roles of payers in this highly competitive disease space? How does this affect market shares of the GH brands, especially in the US? What are the chances of reimbursement for the long-acting GH drugs in pipeline?

Key Findings

  • The major driver for growth in the GHD market during the forecast period will be the launch of six long-acting GH biobetters with less frequent dosing regimens. These will not only boost the use of GH, but will in addition increase adherence and compliance in patients.
  • KOLs interviewed by GlobalData opined that these long-acting biobetters will eventually replace most of the patient shares of currently marketed GH drugs during the forecast period.
  • In other interviews, US payers revealed to GlobalData the current trend of GH manufacturers negotiating with insurance companies as a means of gaining market access for their particular brand.
  • Low disease awareness and stringent regulatory policies lead to sub-optimal dosing and treatment outcomes in the Japanese market.
  • Companies in the early-stage GHD space demonstrate two major trends - development of long-acting GH formulations and innovation in GH delivery strategies.

Scope

  • Overview of GHD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized GHD therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the GHD 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 GHD 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 GHD therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the GHD 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 7MM GHD therapeutics market from 2014-2024.
  • 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

3. Disease Overview

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

4. Epidemiology

  • 4.1. Disease Background
    • 4.1.1. GHD in Children
    • 4.1.2. GHD in Adults
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. GHD in Children
    • 4.3.2. GHD in Adults
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
      • 4.4.1.1. 7MM
        • 4.4.1.2. Diagnosed Cases of GHD in Children
        • 4.4.1.3. Diagnosed Cases of GHD in Adults
        • 4.4.1.4. GHD Etiological Classification in Children
        • 4.4.1.5. GHD Etiological Classification in Adults
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods
      • 4.4.3.1. Temporal Trends
      • 4.4.3.2. Sex-Specific Trends
      • 4.4.3.3. Diagnosed Prevalent Cases of GHD in Children
      • 4.4.3.4. Diagnosed Prevalent Cases of GHD in Adults
      • 4.4.3.5. GHD Etiological Classification in Children
      • 4.4.3.6. GHD Etiological Classification in Adults
  • 4.5. Epidemiological Forecast of GHD (2014-2024)
    • 4.5.1. Diagnosed Prevalent Cases of GHD
    • 4.5.2. Diagnosed Prevalent Cases of GHD by Sex
    • 4.5.3. Diagnosed Prevalent Cases of GHD by Age
      • 4.5.3.1. Diagnosed Prevalent Cases of GHD in Children
      • 4.5.3.2. Diagnosed Prevalent Cases of GHD in Adults
    • 4.5.4. Age-Adjusted Diagnosed Prevalence of GHD
    • 4.5.5. Diagnosed Prevalent Cases of GHD in Children by Etiological Classification
    • 4.5.6. Diagnosed Prevalent Cases of GHD in Adults by Etiological Classification
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Treatment Algorithm
  • 5.3. Market Access, Reimbursement, and Clinical Practice
  • 5.4. Product Profiles - Recombinant Human Growth Hormones
    • 5.4.1. Overview
      • 5.4.1.1. Genotropin
      • 5.4.1.2. Humatrope
      • 5.4.1.3. Norditropin
      • 5.4.1.4. Nutropin AQ
      • 5.4.1.5. Saizen
      • 5.4.1.6. Tev-Tropin/Zomacton/Growject
      • 5.4.1.7. Omnitrope Biosimilar
    • 5.4.2. Efficacy
      • 5.4.2.1. Pediatric GHD
      • 5.4.2.2. Adult GHD
    • 5.4.3. Safety
      • 5.4.3.1. Pediatric GHD
      • 5.4.3.2. Adult GHD
    • 5.4.4. SWOT Analysis

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Improved Adherence and Compliance
    • 6.2.1. Unmet Needs
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Early Diagnosis
    • 6.3.1. Unmet Needs
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Disease Awareness and Regulatory Policy in Japan
    • 6.4.1. Unmet Needs
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Insurance Policies that Impact Patient Access
    • 6.5.1. Unmet Needs
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity Analysis
  • 6.6. Safer Treatments for Cancer Survivors
    • 6.6.1. Unmet needs
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity Analysis

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Development of Long-Acting Biobetter Growth Hormones
    • 7.1.2. Novel Drug Delivery Strategies
    • 7.1.3. Targeting the Growth Hormone Releasing Hormone
    • 7.1.4. Licensing and Acquisitions
  • 7.2. Clinical Trial Design
    • 7.2.1. Current Clinical Trial Design
    • 7.2.2. Future Clinical Trial Design

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. Somatropin Biopartners
      • 8.2.1.1. Overview
      • 8.2.1.2. Efficacy
      • 8.2.1.3. Safety
      • 8.2.1.4. SWOT Analysis
    • 8.2.2. NNC0195-0
      • 8.2.2.1. Overview
      • 8.2.2.2. Efficacy
      • 8.2.2.3. Safety
      • 8.2.2.4. SWOT Analysis
    • 8.2.3. MOD-4
      • 8.2.3.1. Overview
      • 8.2.3.2. Efficacy
      • 8.2.3.3. Safety
      • 8.2.3.4. SWOT Analysis
    • 8.2.4. VRS-
      • 8.2.4.1. Overview
      • 8.2.4.2. Efficacy
      • 8.2.4.3. Safety
      • 8.2.4.4. SWOT Analysis
    • 8.2.5. ACP-
      • 8.2.5.1. Overview
      • 8.2.5.2. Efficacy
      • 8.2.5.3. Safety
      • 8.2.5.4. SWOT Analysis
    • 8.2.6. TV-1
      • 8.2.6.1. Overview
      • 8.2.6.2. Efficacy
      • 8.2.6.3. Safety 103
      • 8.2.6.4. SWOT Analysis
  • 8.3. Innovative Early-Stage Approaches

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 Ten 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 GHD 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 Included in This Study
  • 10.6. Payers Included in This Study
  • 10.7. Primary Research - Prescriber Survey
  • 10.8. About the Authors
    • 10.8.1. Analyst
    • 10.8.2. Epidemiologist
    • 10.8.3. Therapy Director - CVMD
    • 10.8.4. Global Head of Healthcare
  • 10.9. About GlobalData
  • 10.10. Disclaimer

List of Tables

  • Table 1: Risk Factors for GHD
  • Table 2: 7MM, Sources for the Diagnosed Cases of GHD in Children
  • Table 3: 7MM, Sources for the Prevalent Cases of GHD Diagnosed in Adults
  • Table 4: 7MM, Sources for the Etiological Classifications of Diagnosed Prevalent Cases of GHD in Children
  • Table 5: 7MM, Sources for the Etiological Classifications of Diagnosed Prevalent Cases of GHD in Adults
  • Table 6: 7MM, Diagnosed Prevalent Cases of GHD, All Ages, Both Sexes, N, Selected Years 2014-2024
  • Table 7: 7MM, Diagnosed Prevalent Cases of GHD by Sex, Children and Adults, N (Row %), 2014
  • Table 8: 7MM, Diagnosed Prevalent Cases of GHD in Children, Both Sexes, Ages ≤18 Years, N,Selected Years 2014-2024
  • Table 9: 7MM, Diagnosed Prevalent Cases of GHD in Adults, Both Sexes, Ages >18 Years, N, Selected Years 2014-2024
  • Table 10: 7MM, Diagnosed Prevalent Cases of GHD by Etiological Classification, N (Col %), Both Sexes, Ages ≤18, 2014
  • Table 11: 7MM, Diagnosed Prevalent Cases of GHD in Adults by Etiological Classification, N (Row %), Both Sexes, Ages >18, 2014
  • Table 12: GHD Treatment Guidelines Available
  • Table 13: Leading Treatments for GHD
  • Table 14: Product Profiles of Marketed Recombinant Growth Hormones for GHD Treatment
  • Table 15: SWOT Analysis of Marketed Recombinant Human Growth Hormones, 2014
  • Table 16: Unmet Needs in GHD
  • Table 17: Examples of Pivotal Trials for Approved Treatments for Growth Hormone Deficiency
  • Table 18: Growth Hormone Deficiency - Late Stage Pipeline, 2014
  • Table 19: Product Profile - Somatropin Biopartners
  • Table 20: Somatropin Biopartners SWOT Analysis, 2015
  • Table 21: Product Profile - NNC0195-0092
  • Table 22: NNC0195-0092 SWOT Analysis, 2015
  • Table 23: Product Profile - MOD-4023
  • Table 24: MOD-4023 SWOT Analysis, 2015
  • Table 25: Product Profile - VRS-317
  • Table 26: VRS-317 SWOT Analysis, 2015
  • Table 27: Product Profile - ACP-001
  • Table 28: ACP-001 SWOT Analysis, 2015
  • Table 29: Product Profile - TV-1106
  • Table 30: TV-1106 SWOT Analysis, 2015
  • Table 31: Early-Stage Pipeline Products in GHD
  • Table 32: Clinical Benchmark of Key Pipeline Drugs for GHD
  • Table 33: Clinical Benchmark of Key Pipeline Drugs for GHD (Cont.)
  • Table 34: Commercial Benchmark of Key Pipeline Drugs for GHD
  • Table 35: Commercial Benchmark of Key Pipeline Drugs for GHD (Cont.)
  • Table 36: Top Line Sales Forecasts ($m) for GHD, 2014-2024
  • Table 37: Key Events Impacting Sales for GHD, 2014-2024
  • Table 38: Growth Hormone Deficiency Market - Drivers and Barriers, 2014-2024
  • Table 39: Key Launch Dates
  • Table 40: Key Patent Expiration Dates
  • Table 41: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Overview of the GH/IGF-1 Pathway and Physiological Regulation of GH Secretion
  • Figure 2: 7MM, Diagnosed Prevalence of GHD in Children, Both Sexes, Ages ≤18 Years
  • Figure 3: 7MM, Diagnosed Prevalence of GHD in Adults, Both Sexes, Ages >18 Years
  • Figure 4: Case-Flow for GHD Epidemiological Forecast
  • Figure 5: 7MM, Diagnosed Prevalent Cases of GHD, Both Sexes, All Ages, N, 2014-2024
  • Figure 6: 7MM, Age-Specific Diagnosed Prevalent Cases of GHD, Both Sexes, Ages ≤18 Years, 2014
  • Figure 7: 7MM, Age-Specific Diagnosed Prevalent Cases of GHD, Both Sexes, Ages >18 Years, 2014
  • Figure 8: 7MM, Age-Standardized Diagnosed Prevalence of GHD, All Ages, by Sex, 2014
  • Figure 9: GHD Treatment Algorithm
  • Figure 10: Competitive Assessment of Key Pipeline Drugs for GHD, 2014-2024
  • Figure 11: Sales for GHD in the US, 5EU, and Japan, 2014-2024
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