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市場調查報告書

全球人體生長荷爾蒙劑市場

Human Growth Hormone Drugs

出版商 Global Industry Analysts, Inc. 商品編碼 252329
出版日期 內容資訊 英文 127 Pages
商品交期: 最快1-2個工作天內
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全球人體生長荷爾蒙劑市場 Human Growth Hormone Drugs
出版日期: 2014年06月01日 內容資訊: 英文 127 Pages
簡介

本報告提供全球人體生長荷爾蒙劑市場相關分析,彙整美國,加拿大,日本,歐洲,亞太地區等各地區的趨勢,今後的市場預測,及加入此市場的主要企業簡介等資料。

第1章 簡介,調查方法,產品定義

第2章 摘要整理

  • 產業概要
    • 市場概要
    • 人類重組生長激素的發展
    • 人體生長荷爾蒙置換療法的迅速引進
    • 專利失效打開了生技仿製藥的登場之道
    • 人體生長荷爾蒙產業的技術創新
    • 今後預測
    • 美國:最大市場
    • 亞太地區:高成長可能性
    • 促進成長要素
    • 生長激素缺乏症的高罹患率
    • 掌握市場成長關鍵的技術創新
    • 人體生長荷爾蒙重組療法的新適應
    • 主要的阻礙成長要素
    • 複雜的遞送系統
    • 治療成本高
    • 給付確保難
    • 生技仿製藥的引進阻礙收益擴大
    • 藥理學性差異存在於目前藥物中
  • 市場趨勢與課題
    • 成人生長激素缺損市場還未普及
    • 長效型藥物
    • 各開發階段開發平台的產品
    • 生技仿製藥的影響不大,為了擴大適應需要更進一步驗證
    • 生技改良藥限制處方市場上生技仿製藥的存在
    • 需要第一個生技仿製藥的第四階段臨床實驗
    • 容量遞增法
    • 無針藥物遞輸系統
    • 已上市產品的藥物遞輸設備 其他
  • 競爭
  • 人體生長荷爾蒙:概要
  • 近幾年的產業活動
  • 主要加入企業
    • Eli Lilly and Company
    • Ferring Holding SA
    • Genentech, Inc.
    • GeneScience Pharmaceuticals Co., Ltd.
    • Merck Serono SA
    • Novo Nordisk A/S
    • Pfizer, Inc.
    • Sandoz International GmbH
    • Teva Pharmaceutical Industries Limited
  • 全球市場預測

第3章 市場

  • 美國
  • 加拿大
  • 日本
  • 歐洲
  • 亞太地區
  • 其他各國

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目錄
Product Code: MCP-7129

This report analyzes the worldwide markets for Human Growth Hormone Drugs in US$ Million by the following Brands: Humatrope, Norditropin, Genotropin, Nutropin, Saizen, and Others. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 30 companies including many key and niche players such as -

Eli Lilly and Company
Ferring Holding SA
Genentech, Inc.
GeneScience Pharmaceuticals Co., Ltd.
Merck Serono SA

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

  • Study Reliability and Reporting Limitations
  • Disclaimers
  • Data Interpretation & Reporting Level
    • Quantitative Techniques & Analytics
  • Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW

  • Market Primer
  • Evolution of Recombinant Human Growth Hormones (hGH)
  • Rapid Adoption of hGH Replacement Therapy
  • Patent Expiry Paves Way for the Emergence of Biosimilar
    • List of Select Approved Prescription Daily-dose hGH Products by Indication
  • Strong Innovation Drive in hGH Industry
  • Outlook
  • US - The Single-Largest Market for HGH Drugs
  • Asia-Pacific - High Potential Market for hGH Drugs
  • Key Growth Drivers
  • High Prevalence of Growth Hormone Deficiency Disorders
  • Innovations Hold the Key to Market Growth
    • Manufacturers Bet on Novel Drug Delivery Technologies
  • New Indications for hGH Replacement Therapy
  • Major Growth Restraining Factors
  • Complex Delivery System
  • High Cost of hGH Treatment
  • Difficulty in Securing Reimbursement
  • Introduction of Biosimilars Erodes Revenue Growth
  • Limited Pharmacological Differences Exist Among Current Agents

2. MARKET TRENDS & ISSUES

  • Adult Growth Hormone Deficient Market Remains Underpenetrated
    • Table 1: Worldwide Recombinant Human Growth Hormone Market by End-use Indication (2013): Percentage Breakdown of Sales Revenues for Adult GHD, Turner Syndrome & Idiopathic Short Stature; Pediatric GHD; and Other Rare Conditions (includes corresponding Graph/Chart)
  • Long-Acting hGH Drugs - a Potential Game Changer
  • Select Long-Acting hGH Products in Pipeline by Development Stage
  • Biosimilars Create Little Impact, Further Validation to Expand Indications and Growth
    • Table 2: Worldwide Biosimilar Demand by Product Category (2013): Percentage Breakdown of Value Sales for Epoetina, Granulocyte Colony-Stimulating Factors (G-CSFs), Interferons, Insulins, Low Molecular Weight Heparins (LMWH), Recombinant Human Growth Hormones (rhGHs), and Others (includes corresponding Graph/Chart)
  • Biobetters Restrict Biosimilar Presence in Prescription hGH Market
  • Phase IV Studies Necessitated for First Biosimilars
  • Dose Titration - A Key to Achieve Enhanced Tolerability
  • Needle-less Drug Delivery Systems to Wipe Out of Syringes
    • Table 3: Worldwide Pediatric rhGH Market by Geographic Region (2013): Percentage Breakdown of Sales Revenues for Europe, Japan, The United States, and Rest of World (includes corresponding Graph/Chart)
  • Drug Delivery Device Options for Marketed hGH Products
  • Risk of Cancer Necessitates Judicious Use of hGH in Children
  • Growth Concerns about Prolonged Usage of Growth Hormones
  • Growing Non-Prescription/Off-Label Usage - A Potential Health Hazard
  • Oral hGH Secretagogues - An Alternative to Controversial hGH Injections in Professional Sports

3. COMPETITION

  • MNC Manufacturers Dominate hGH Market, New Entrants to Intensify Competition
    • Table 4: Worldwide Human Growth Hormone Drugs Market by Leading Players (2014): Percentage Market Share Breakdown of Sales Revenues for Eli Lilly, Novo Nordisk, Merck Serono, Pfizer, Roche/Genentech, and Others (includes corresponding Graph/Chart)
  • Norditropin
  • Genotropin
  • Humatrope
  • Saizen
  • Omnitrope - the Somatropin Biosimilar
  • Somatropin Biopartners
  • Review of Select hGH Products in Pipeline
  • OPKO Biologics/ Prolor Biotech's hGH-CTP
  • Versartis VRS-317
  • Ambrx ARX201
  • HanAll's Vitatropin

4. HUMAN GROWTH HORMONE: AN OVERVIEW

  • Key Factors Controlling Natural hGH Secretion
  • Structure of hGH
  • Functions Performed by hGH in the Human Body
  • Benefits of Adequate hGH
  • Effects of Human Growth Hormone Imbalances
  • Hypopituitarism
  • Evolution of Growth Hormone Replacement Therapy
  • Indications for Exogenous hGH Administration
  • Growth Hormone Deficiency (GHD)
    • Symptoms of Adult Growth Hormone Deficiency
  • Idiopathic Short Stature
  • Noonan Syndrome
  • Prader-Willi Syndrome
  • Turner Syndrome
  • Short Stature Homeobox Gene
  • Small for Gestational Age
  • Chronic Renal Insufficiency
  • Short Bowel Syndrome
  • Other Medical Conditions
  • Off-label Applications
  • Contraindications for Somatropin Therapy
  • Safety Review of hGH Therapy
  • Reported Adverse Effects of Inaccurate rhGH Dosages
  • Risks Involved with Pediatric/Adolescent hGH Replacement Therapy
  • Risks Involved with Adult hGH Replacement Therapy

5. RECENT INDUSTRY ACTIVITY

  • Pfizer Announces Positive Outcome in Phase 3B for Genotropin for SGA in Infants
  • Hanmi Science Applies for Taiwan Patent for Liquid Long-Acting hGH Conjugate
  • OPKO Health Acquires PROLOR Biotech, Renames as OPKO Biologics
  • Somatropin Biopartners Awarded Approval by EMA
  • Sandoz Unveils SurePal Injection Pen for Administering Omnitrope hGH
  • Versartis Secures USFDA Orphan Drug Designation for VRS-317 hGH
  • Ascendis Pharma Applies for Israel Patent for hGH Prodrug Conjugates
  • Anke Biotech Files Application for New Indications of pegylation rhGH with China FDA
  • Serono Lab Receives Cyprus Patent for Use of hGH for Mobilizing Pluripotent Hematopoietic Cells
  • Generium Aozt Awarded Russian Patent for Commercial Production Process of hGH
  • Novo Nordisk Reports Phase I Clinical Trial Data for NN 8640 rhGH
  • Genentech's Canadian and European Patents for Aqueous hGH Formulation Expire
  • Hanmi Commences Phase II of Clinical Trials for LAPS-hGH in Romania
  • PROLOR Initiates Phase III of Clinical Trials for hGH-CTP in US, Europe, Israel

6. FOCUS ON SELECT GLOBAL PLAYERS

  • Eli Lilly and Company (US)
  • Ferring Holding SA (Switzerland)
  • Genentech, Inc. (US)
  • GeneScience Pharmaceuticals Co., Ltd. (China)
  • Merck Serono SA (Switzerland)
  • Novo Nordisk A/S (Denmark)
  • Pfizer, Inc. (US)
  • Sandoz International GmbH (Germany)
  • Teva Pharmaceutical Industries Limited (Israel)

7. GLOBAL MARKET PERSPECTIVE

    • Table 5: World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 6: World Historic Analysis for Human Growth Hormone Drugs by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)
    • Table 7: World 15-Year Perspective for Human Growth Hormone Drugs by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets for Years 2006, 2014, and 2020 (includes corresponding Graph/Chart)
    • Table 8: World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Brands - Norditropin, Genotropin, Humatrope, Nutropin, Saizen, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 9: World Historic Analysis for Human Growth Hormone Drugs by Brands - Norditropin, Genotropin, Humatrope, Nutropin, Saizen, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)
    • Table 10: World 15-Year Perspective for Human Growth Hormone Drugs by Brands - Percentage Breakdown of Dollar Sales for Norditropin, Genotropin, Humatrope, Nutropin, Saizen, and Others Markets for Years 2006, 2014, and 2020 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

  • A. Market Analysis
    • Current & Future Analysis
    • US hGH Market - A Peek into GHD Prevalence and Cost of Treatment
    • FDA Approvals Clear Way for Treating More Children
      • Major hGH Drugs Available in the US, and FDA Approved Indications
    • Table 11: The US Human Growth Hormone Drugs Market by Leading Players (2013): Percentage Market Share Breakdown of Sales Revenues for Eli Lilly, Merck Serono, Novo Nordisk, Pfizer, Roche/Genentech, Sandoz, Teva Pharmaceutical (includes corresponding Graph/Chart)
    • FDA Approval of First Biosimilars
      • Omnitrope Versus Genotropin - A US Perspective
      • FDA Issues First Draft of Guidelines for Biosimilar and Interchangeable Biologicals
    • US FDA Promotes rhGH Development through Orphan Drug Designation
    • FDA Regulations Governing hGH Products in the OTC Drugs Market
      • Alarming Increase in Sales of hGH Drugs for Anti-Ageing Therapy
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 12: The US Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 13: The US Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

2. CANADA

  • Market Analysis
    • Table 14: Canadian Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 15: Canadian Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

3. JAPAN

  • A. Market Analysis
    • Current & Future Analysis
      • Japanese Biosimilar Regulatory Guidelines
    • Sandoz' Omnitrope - the First Biosimilar hGH Launched in Japan
  • B. Market Analytics
    • Table 16: Japanese Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 17: Japanese Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

4. EUROPE

  • A. Market Analysis
    • Current & Future Analysis
    • European hGH Market Focuses on Product Differentiation to Revitalize Sales
    • Regulations Pertaining to Biosimilars in the EU
    • Table 18: Adoption Rates for hGH Biosimilar in Major Western Europe Markets: 2013 (includes corresponding Graph/Chart)
    • Uneven Adoption of Biosimilar hGH across EU Members
    • Table 19: Biosimilar hGH Share of Originator Drug Sales in the EU by Country: 2011 (includes corresponding Graph/Chart)
    • New Indications to Drive Future Growth
  • B. Market Analytics
    • Table 20: European Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 21: European Historic Analysis for Human Growth Hormone Drugs by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)
    • Table 22: European 15-Year Perspective for Human Growth Hormone Drugs by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain, and Rest of Europe Markets for Years 2006, 2014, and 2020 (includes corresponding Graph/Chart)

4a. FRANCE

  • Market Analysis
    • Table 23: French Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 24: French Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

4b. GERMANY

  • A. Market Analysis
    • Current & Future Analysis
    • Sandoz International GmbH - A Leading German Player
  • B. Market Analytics
    • Table 25: German Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 26: German Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

4c. ITALY

  • Market Analysis
    • Table 27: Italian Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 28: Italian Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

4d. THE UNITED KINGDOM

  • Market Analysis
    • Table 29: The UK Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 30: The UK Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

4e. SPAIN

  • Market Analysis
    • Table 31: Spanish Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 32: Spanish Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

4f. REST OF EUROPE

  • A. Market Analysis
    • Current & Future Analysis
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 33: Rest of Europe Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 34: Rest of Europe Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

5. ASIA-PACIFIC

  • A. Market Analysis
    • Current & Future Analysis
    • Biosimilar Regulations in Asian Countries
      • South Korea
      • China
      • India
    • Strategic Corporate Developments
    • Genescience Pharmaceuticals Co., Ltd. - A Leading Chinese Player
  • B. Market Analytics
    • Table 35: Asia-Pacific Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 36: Asia-Pacific Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)

6. REST OF WORLD

  • A. Market Analysis
    • Current & Future Analysis
    • Strategic Corporate Development
    • Teva Pharmaceutical Industries Limited - A Key Player
  • B. Market Analytics
    • Table 37: Rest of World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart)
    • Table 38: Rest of World Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart)
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