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HUMAN GROWTH HORMONE DRUGS - A GLOBAL STRATEGIC BUSINESS REPORT   

Research Abstract

This report analyzes the worldwide markets for Human Growth Hormone Drugs in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2018. Also, a six-year historic analysis is provided for these markets. The report profiles 37 companies including many key and niche players such as Eli Lilly and Company, Ferring Pharmaceuticals A/S, Genentech, Inc., GeneScience Pharmaceuticals Co., Ltd., Merck Serono SA, Sandoz International GmbH, Novo Nordisk A/S, Pfizer, Inc., and Teva Pharmaceutical Industries Limited. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Code : MCP-7129
Price : $4200
Companies : 37
Pages : 278
Date : August 2012
Market Data Tables : 78

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 TABLE OF CONTENTS

  HUMAN GROWTH HORMONE DRUGS (Complete Report) Pages : 278   | $4200
 
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS    
   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
  
   Product Definitions and Scope of Study.....I-3  
II. EXECUTIVE SUMMARY39$2250
  1. INDUSTRY OVERVIEW.....II-13 $300  
   Market Primer.....II-1
Analysis by Geographic Region.....II-1
US - The Single Largest Market for HGH Drugs.....II-1
1$100
   Europe – High Potential Market for HGH Drugs.....II-2
Prescription Variants – Higher in Efficacy and Prices.....II-2
List of Select Approved Prescription hGH Products by Indication.....II-2
1$100
   Key Market Drivers.....II-3
Major Market Restraining Factors.....II-3
1$100
  2. TRENDS & ISSUES.....II-46 $600  
   Recombinant hGH Propels Regulatory Approvals.....II-4
Non-Growth Hormone Deficiency Uses – Well Explored.....II-4
Adult Growth Hormone Deficient Market – Largely Under Penetrated.....II-4
Limited Pharmacological Differences Exist Among Current Agents.....II-4
1$100
   Long-Acting hGHs – the Flavor of the Season.....II-5
Risk of Cancer Necessitates Judicious Use of hGH in Children.....II-5
Other Concerns for Growth Hormone Use.....II-5
1$100
   Biosimilars Create Little Impact, Further Validation to Expand Indications and
  Growth.....II-6
Biosimilar hGH First Product Launch in Select Countries Worldwide.....II-6
1$100
   Biobetters Restrict Biosimilars’ Presence in Prescription hGH Market.....II-7
Phase IV Studies Necessitated for First Biosimilars.....II-7
Novel Drug Delivery Methods Come to Originators’ Rescue.....II-7
Next Generation hGH Products Promise Superior Adoption.....II-7
1$100
   Dose Titration – A Key to Achieve Enhanced Tolerability.....II-8
Delivery Device Dynamics.....II-8
1$100
   Delivery Device Options for Marketed hGH Products.....II-91$100
  3. COMPETITION.....II-105 $500  
   Multiple Manufacturers of hGH – Intensify Market Competition.....II-10
Manufacturers Bet on Novel Drug Delivery Technologies.....II-10
1$100
   Review of Leading Human Growth Hormone Drugs.....II-11
Table 1: Leading Human Growth Hormone Drugs Worldwide (2010-2013E): Annual Revenue Figures in US$ Million for Norditropin, Genotropin, Humatrope, Nutropin and Saizen (includes corresponding Graph/Chart).....II-11
Norditropin.....II-11
1$350
   New Delivery Device Eases Administration.....II-12
Genotropin.....II-12
Saizen.....II-12
1$100
   Technological Advancements Continue.....II-13
Merck-Serono Continues Studying Saizen.....II-13
Humatrope.....II-13
1$100
   Omnitrope – the Somatropin Biosimilar.....II-14
Review of hGH Products in Pipeline.....II-14
Select hGH Products in Pipeline by Stage of Development.....II-14
Prolar’s hGH-CTP – A Potential Product in Pipeline.....II-14
1$100
  4. HUMAN GROWTH HORMONE: AN OVERVIEW.....II-1514 $1400  
   Human Growth Hormone: An Introduction.....II-15
History.....II-15
Key Factors Controlling Natural hGH Secretion.....II-15
1$100
   Structure of hGH.....II-16
Functions Performed by hGH in the Human Body.....II-16
1$100
   Benefits of Adequate hGH.....II-17
Effects of Human Growth Hormone Imbalances.....II-17
1$100
   Dangers of Excessive Intake of hGH.....II-18
Causes of Hypopituitarism.....II-18
Requirement of Synthetic Human Growth Hormone.....II-18
1$100
   Types.....II-19
Somatotropin/Cadaver-GH.....II-19
Somatrem/Inclusion Body Technology/Met-hGH.....II-19
Somatropin/Mouse-Cell Manufacturing and Protein Secretion Technology/rhGH.....II-19
Benefits of Synthetic hGH Replacement Therapy.....II-19
1$100
   Symptoms, Diagnosis and Treatment of hGH Deficiency in Children and Adults.....II-20
In Children.....II-20
Symptoms.....II-20
Diagnostic Procedures.....II-20
1$100
   Key Procedure for Pediatric hGH Deficiency Treatment.....II-211$100
   In Adults.....II-22
Symptoms.....II-22
Diagnostic Procedures.....II-22
1$100
   Treatment Options for AGHD.....II-23
HGH Therapy.....II-23
Types of hGH Therapy.....II-23
Human Growth Hormone Injection Therapy.....II-23
Human Growth Hormone Secretagogues Therapy.....II-23
1$100
   Human Growth Hormone Releaser Therapy.....II-24
Types of hGH Products.....II-24
Human Growth Hormone Injections.....II-24
Human Growth Hormone Homeopathic Formulas.....II-24
Human Growth Hormone Supplements (Pills/Capsules).....II-24
1$100
   Insulin-like Growth Factor-1.....II-25
Leading hGH Pills.....II-25
1$100
   hGH Releasers.....II-26
hGH Releaser Stimulators.....II-26
Effects of hGH Releasers.....II-26
1$100
   Safety and hGH Therapy.....II-27
In Children.....II-27
1$100
   In Adults.....II-281$100
  5. RECENT INDUSTRY ACTIVITY.....II-295 $500  
   hGHmeds.com Unveils Xerendip Human Growth Hormone.....II-29
PROLOR Biotech Commences Phase 2 Trials of hGH-CTP.....II-29
1$100
   Merck Serono Begins Clinical Study of Easypod Electronic Auto-Injector.....II-30
Sandoz Introduces Somatropin Growth Hormone in Japan.....II-30
Dainippon Sumitomo Pharma Inks Agreement with JCR Pharmaceuticals for Growth Hormone
  Business.....II-30
Pfizer Establishes Biotech Unit in Sweden.....II-30
1$100
   Modigene Commences Operations as PROLOR Biotech.....II-31
Sandoz’s Omnitrope® Obtains FDA Approval for New Indication.....II-31
Novo Nordisk’s Norditropin® FlexPro® Injection Pen Obtains US FDA Approval.....II-31
Prolor’s hGH-CTP Obtains Orphan Drug Status.....II-31
Ascendis Pharma Starts Phase 2 Clinical Trial of ACP-001.....II-31
1$100
   Teva and Antares Receive FDA Approval for hGH Needle-Free Injection.....II-321$100
   Eli Lilly Receives FDA Approval for Humatrope Injection.....II-33
Pharmacia and Upjohn Receive FDA Approval for Genotropin Injection.....II-33
Prolor Biotech Received Two US Patents for Longer-Acting EPO and Longer-Acting
  hGH.....II-33
Ranbaxy Laboratories to Develop Novel Growth Hormone.....II-33
1$100
  6. FOCUS ON SELECT GLOBAL PLAYERS.....II-344 $400  
   Eli Lilly and Company (US).....II-34
Ferring Pharmaceuticals A/S (Switzerland).....II-34
Genentech, Inc. (US).....II-34
1$100
   GeneScience Pharmaceuticals Co., Ltd. (China).....II-35
Merck Serono SA (Switzerland).....II-35
Sandoz International GmbH (Germany).....II-35
1$100
   Novo Nordisk A/S (Denmark).....II-36
Pfizer, Inc. (US).....II-36
1$100
   Teva Pharmaceutical Industries Limited (Israel).....II-371$100
  7. GLOBAL MARKET PERSPECTIVE.....II-38   
   Table 2: World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region – US, Japan, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....II-381$350
   Table 3: World 10-Year Perspective for Human Growth Hormone Drugs by Geographic Region – Percentage Breakdown of Dollar Sales for US, Japan, Europe, and Rest of World Markets for Years 2009, 2012, and 2018 (includes corresponding Graph/Chart).....II-391$350
III. MARKET20$1950
  1. THE UNITED STATES.....III-110 $750  
   A. Market Analysis.....III-1
Current & Future Analysis.....III-1
US hGH Market – A Peek into GHD Prevalence and Cost of Treatment.....III-1
FDA Approvals Clears Way for Treating More Children.....III-1
1$75
   Major hGH Products and FDA Approved Indications.....III-2 1$75
   Table 4: Leading hGH Products in the US by Annual Revenues in US$ Million: 2011 (includes corresponding Graph/Chart).....III-3

Table 5: Leading hGH Products in the US Analyzed by Percentage Breakdown of Total Prescriptions: 2009-2012 (includes corresponding Graph/Chart).....III-3
1$200
   FDA Approval of First Biosimilars.....III-4
OmnitropeVs. Genotropin – A US Perspective.....III-4
FDA Regulations Governing Human Growth Hormone Products in OTC Drugs Market.....III-4
1$75
   Strategic Corporate Developments.....III-53$225
   Select Key Players.....III-82$150
   B. Market Analytics.....III-10
Table 6: US Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-10
1$200
  2. JAPAN.....III-112 $150  
   A. Market Analysis.....III-11
Current & Future Analysis.....III-11
Sandoz’ Omnitrope – the First Biosimilar hGH Launched in Japan.....III-11
Regulatory Environment in Japan.....III-11
Strategic Corporate Developments.....III-11
1$75
   B. Market Analytics.....III-12
Table 7: Japanese Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-12
1$200
  3. EUROPE.....III-136 $450  
   A. Market Analysis.....III-13
Current & Future Analysis.....III-13
A Focus on Regulations Pertaining to Biosimilars in the EU.....III-13
Uneven Adoption of Biosimilar hGH across EU Members.....III-13
Table 8: Biosimilar hGH Share of Originator Drug Sales in the EU by Country: 2011 (includes corresponding Graph/Chart).....III-13
1$200
   New Indications to Drive Future Growth.....III-14
Strategic Corporate Developments.....III-14
1$75
   Select Key Players.....III-153$225
   B. Market Analytics.....III-18
Table 9: European Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-18
1$200
  4. REST OF WORLD.....III-192 $400  
   A. Market Analysis.....III-19
Current & Future Analysis.....III-19
Strategic Corporate Development.....III-19
GeneScience Pharmaceuticals Co., Ltd. – A Key Chinese Producer of hGH.....III-19
1$75
   B. Market Analytics.....III-20
Table 10: Rest of World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-20
1$200
IV. COMPETITIVE LANDSCAPE 207$995
  
Total Companies Profiled: 37(including Divisions/Subsidiaries - 41)

Region/Country                 Players

The United States                 14   
Canada                             1
Japan                              1
Europe                            11
     France                        1
     Germany                       2
     The United Kingdom            1
     Rest of Europe                7
Asia-Pacific (Excluding Japan)    10
Latin America                      1
Middle-East                        3
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