市場調査レポート

世界のヒト成長ホルモン剤市場

Human Growth Hormone Drugs

発行 Global Industry Analysts, Inc. 商品コード 252329
出版日 ページ情報 英文 127 Pages
納期: 即日から翌営業日
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世界のヒト成長ホルモン剤市場 Human Growth Hormone Drugs
出版日: 2014年06月01日 ページ情報: 英文 127 Pages
概要

当レポートでは、世界のヒト成長ホルモン剤市場について分析し、米国、カナダ、日本、欧州、アジア太平洋地域などの地域別の動向、今後の市場予測、および市場に参入する企業のプロファイルなどをまとめています。

第1章 イントロダクション、調査方法、製品定義

第2章 エグゼクティブサマリー

  • 業界概要
    • 市場概要
    • 組換えヒト成長ホルモンの発展
    • ヒト成長ホルモン置換療法の急速な導入
    • 特許失効がバイオシミラーの登場に道を開く
    • ヒト成長ホルモン業界における技術革新
    • 今後の見通し
    • 米国:最大市場
    • アジア太平洋地域:高い成長可能性
    • 成長促進因子
    • 成長ホルモン欠損症の高い罹患率
    • 市場成長のカギを握る技術革新
    • ヒト成長ホルモン置換療法の新たな適応
    • 主な成長阻害因子
    • 複雑なデリバリーシステム
    • 治療コストの高さ
    • 償還確保のむずかしさ
    • バイオシミラーの導入が収益拡大を阻害
    • 薬理学的差異が現在の薬剤に存在する
  • 市場動向と課題
    • 成人成長ホルモン欠損市場はまだ浸透していない
    • 長期作用型薬剤
    • 開発段階別パイプラインにある製品
    • バイオシミラーの影響は少なく、適応拡大のために更なるバリデーションが必要
    • バイオベターが処方市場におけるバイオシミラーの存在を制限
    • 初のバイオシミラーに必要な第4相治験
    • 容量漸増法
    • ニードルレスドラッグデリバリーシステム
    • 上市済み製品のためのドラッグデリバリー装置 他
  • 競合
  • ヒト成長ホルモン:概要
  • 近年の業界活動
  • 主要参入企業
    • 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
  • 世界市場見通し

第3章 市場

  • 米国
  • カナダ
  • 日本
  • 欧州
  • アジア太平洋地域
  • その他の諸国

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目次
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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