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 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


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Code: MCP-7129
Price: $4950
Companies: 30
Pages: 127
Date: June 2014
Market Data Tables: 38
Status: * New Report

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 TABLE OF CONTENTS


 
   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
  
   Product Definitions and Scope of Study.....I-3  
   Market Primer.....II-1
Evolution of Recombinant Human Growth Hormones (hGH).....II-1
Rapid Adoption of hGH Replacement Therapy.....II-1
Patent Expiry Paves Way for the Emergence of Biosimilar.....II-1
1$100
   List of Select Approved Prescription Daily-dose hGH Products by Indication.....II-21$100
   Strong Innovation Drive in hGH Industry.....II-3
Outlook .....II-3
US - The Single-Largest Market for HGH Drugs.....II-3
Asia-Pacific – High Potential Market for hGH Drugs.....II-3
Key Growth Drivers.....II-3
High Prevalence of Growth Hormone Deficiency Disorders.....II-3
1$100
   Innovations Hold the Key to Market Growth.....II-4
Manufacturers Bet on Novel Drug Delivery Technologies.....II-4
New Indications for hGH Replacement Therapy.....II-4
1$100
   Major Growth Restraining Factors.....II-5
Complex Delivery System.....II-5
High Cost of hGH Treatment.....II-5
Difficulty in Securing Reimbursement.....II-5
1$100
   Introduction of Biosimilars Erodes Revenue Growth.....II-6
Limited Pharmacological Differences Exist Among Current Agents.....II-6
1$100
   Adult Growth Hormone Deficient Market Remains Underpenetrated.....II-7
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).....II-7
Long-Acting hGH Drugs – a Potential Game Changer.....II-7
1$350
   Select Long-Acting hGH Products in Pipeline by Development Stage.....II-81$100
   Biosimilars Create Little Impact, Further Validation to Expand Indications and
  Growth.....II-9
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).....II-9
1$350
   Biobetters Restrict Biosimilar Presence in Prescription hGH Market.....II-101$100
   Phase IV Studies Necessitated for First Biosimilars.....II-11
Dose Titration – A Key to Achieve Enhanced Tolerability.....II-11
Needle-less Drug Delivery Systems to Wipe Out of Syringes.....II-11
1$100
   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).....II-122$350
   Drug Delivery Device Options for Marketed hGH Products.....II-14
Risk of Cancer Necessitates Judicious Use of hGH in Children.....II-14
1$100
   Growth Concerns about Prolonged Usage of Growth Hormones.....II-15
Growing Non-Prescription/Off-Label Usage – A Potential Health Hazard.....II-15
1$100
   Oral hGH Secretagogues - An Alternative to Controversial hGH Injections in
  Professional Sports.....II-16
2$200
   MNC Manufacturers Dominate hGH Market, New Entrants to Intensify Competition.....II-18 1$100
   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).....II-19
Norditropin.....II-19
Genotropin.....II-19
1$350
   Humatrope.....II-20
Saizen.....II-20
Omnitrope – the Somatropin Biosimilar.....II-20
1$100
   Somatropin Biopartners.....II-21
Review of Select hGH Products in Pipeline.....II-21
OPKO Biologics/ Prolor Biotech’s hGH-CTP.....II-21
1$100
   Versartis VRS-317.....II-22
Ambrx ARX201.....II-22
HanAll’s Vitatropin.....II-22
1$100
   Key Factors Controlling Natural hGH Secretion.....II-231$100
   Structure of hGH.....II-24
Functions Performed by hGH in the Human Body.....II-24
1$100
   Benefits of Adequate hGH.....II-25
Effects of Human Growth Hormone Imbalances.....II-25
Hypopituitarism.....II-25
1$100
   Evolution of Growth Hormone Replacement Therapy.....II-261$100
   Indications for Exogenous hGH Administration.....II-27
Growth Hormone Deficiency (GHD).....II-27
Symptoms of Adult Growth Hormone Deficiency.....II-27
1$100
   Idiopathic Short Stature.....II-281$100
   Noonan Syndrome.....II-29
Prader-Willi Syndrome.....II-29
Turner Syndrome.....II-29
Short Stature Homeobox Gene.....II-29
Small for Gestational Age.....II-29
Chronic Renal Insufficiency.....II-29
1$100
   Short Bowel Syndrome.....II-30
Other Medical Conditions.....II-30
Off-label Applications.....II-30
Contraindications for Somatropin Therapy.....II-30
1$100
   Safety Review of hGH Therapy.....II-31
Reported Adverse Effects of Inaccurate rhGH Dosages.....II-31
Risks Involved with Pediatric/Adolescent hGH Replacement Therapy.....II-31
1$100
   Risks Involved with Adult hGH Replacement Therapy.....II-321$100
   Pfizer Announces Positive Outcome in Phase 3B for Genotropin for SGA in
  Infants.....II-33
Hanmi Science Applies for Taiwan Patent for Liquid Long-Acting hGH Conjugate.....II-33
OPKO Health Acquires PROLOR Biotech, Renames as OPKO Biologics.....II-33
1$100
   Somatropin Biopartners Awarded Approval by EMA.....II-34
Sandoz Unveils SurePal Injection Pen for Administering Omnitrope hGH.....II-34
Versartis Secures USFDA Orphan Drug Designation for VRS-317 hGH.....II-34
1$100
   Ascendis Pharma Applies for Israel Patent for hGH Prodrug Conjugates.....II-35
Anke Biotech Files Application for New Indications of pegylation rhGH with China
  FDA.....II-35
Serono Lab Receives Cyprus Patent for Use of hGH for Mobilizing Pluripotent
  Hematopoietic Cells.....II-35
Generium Aozt Awarded Russian Patent for Commercial Production Process of hGH.....II-35
Novo Nordisk Reports Phase I Clinical Trial Data for NN 8640 rhGH.....II-35
1$100
   Genentech’s Canadian and European Patents for Aqueous hGH Formulation Expire.....II-36
Hanmi Commences Phase II of Clinical Trials for LAPS-hGH in Romania.....II-36
PROLOR Initiates Phase III of Clinical Trials for hGH-CTP in US, Europe,
  Israel.....II-36
1$100
   Eli Lilly and Company (US).....II-37
Ferring Holding SA (Switzerland).....II-37
1$100
   Genentech, Inc. (US).....II-38
GeneScience Pharmaceuticals Co., Ltd. (China).....II-38
Merck Serono SA (Switzerland).....II-38
1$100
   Novo Nordisk A/S (Denmark).....II-39
Pfizer, Inc. (US).....II-39
1$100
   Sandoz International GmbH (Germany).....II-401$100
   Teva Pharmaceutical Industries Limited (Israel).....II-411$100
   Table 5: World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....II-421$350
   Table 6: World Historic Analysis for Human Growth Hormone Drugs by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....II-431$350
   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).....II-441$350
   Table 8: World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Brands - Norditropin, Genotropin, Humatrope, Nutropin, Saizen, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....II-451$350
   Table 9: World Historic Analysis for Human Growth Hormone Drugs by Brands - Norditropin, Genotropin, Humatrope, Nutropin, Saizen, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....II-461$350
   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).....II-471$350
   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 Clear Way for Treating More Children.....III-1
1$75
   Major hGH Drugs Available in the US, and FDA Approved Indications.....III-2 1$75
   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).....III-3
FDA Approval of First Biosimilars.....III-3
1$200
   Omnitrope Versus Genotropin – A US Perspective.....III-4
FDA Issues First Draft of Guidelines for Biosimilar and Interchangeable
  Biologicals.....III-4
US FDA Promotes rhGH Development through Orphan Drug Designation.....III-4
1$75
   FDA Regulations Governing hGH Products in the OTC Drugs Market.....III-51$75
   Alarming Increase in Sales of hGH Drugs for Anti-Ageing Therapy.....III-6
Strategic Corporate Developments.....III-6
2$150
   Select Key Players.....III-82$150
   B. Market Analytics.....III-10
Table 12: The US Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-10
1$200
   Table 13: The US Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-111$200
   Market Analysis.....III-12
Table 14: Canadian Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-12
1$200
   Table 15: Canadian Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-131$200
   A. Market Analysis.....III-14
Current & Future Analysis.....III-14
Japanese Biosimilar Regulatory Guidelines.....III-14
Sandoz’ Omnitrope – the First Biosimilar hGH Launched in Japan.....III-14
1$75
   B. Market Analytics.....III-15
Table 16: Japanese Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-15
1$200
   Table 17: Japanese Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-161$200
   A. Market Analysis.....III-17
Current & Future Analysis.....III-17
European hGH Market Focuses on Product Differentiation to Revitalize Sales.....III-17
Regulations Pertaining to Biosimilars in the EU.....III-17
1$75
   Table 18: Adoption Rates for hGH Biosimilar in Major Western Europe Markets: 2013 (includes corresponding Graph/Chart).....III-18
Uneven Adoption of Biosimilar hGH across EU Members.....III-18
Table 19: Biosimilar hGH Share of Originator Drug Sales in the EU by Country: 2011 (includes corresponding Graph/Chart).....III-18
1$200
   New Indications to Drive Future Growth.....III-19
B. Market Analytics.....III-19
Table 20: European Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-19
1$200
   Table 21: European Historic Analysis for Human Growth Hormone Drugs by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-201$200
   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).....III-211$200
   Market Analysis.....III-22
Table 23: French Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-22
1$200
   Table 24: French Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-231$200
   A. Market Analysis.....III-24
Current & Future Analysis.....III-24
Sandoz International GmbH – A Leading German Player.....III-24
1$75
   B. Market Analytics.....III-25
Table 25: German Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-25
1$200
   Table 26: German Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-261$200
   Market Analysis.....III-27
Table 27: Italian Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-27
1$200
   Table 28: Italian Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-281$200
   Market Analysis.....III-29
Table 29: The UK Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-29
1$200
   Table 30: The UK Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-301$200
   Market Analysis.....III-31
Table 31: Spanish Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-31
1$200
   Table 32: Spanish Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-321$200
   A. Market Analysis.....III-33
Current & Future Analysis.....III-33
Strategic Corporate Developments.....III-33
1$75
   Select Key Players.....III-342$150
   B. Market Analytics.....III-36
Table 33: Rest of Europe Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-36
1$200
   Table 34: Rest of Europe Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-371$200
   A. Market Analysis.....III-38
Current & Future Analysis.....III-38
Biosimilar Regulations in Asian Countries.....III-38
South Korea.....III-38
China.....III-38
India.....III-38
1$75
   Strategic Corporate Developments.....III-39
Genescience Pharmaceuticals Co., Ltd. – A Leading Chinese Player.....III-39
1$75
   B. Market Analytics.....III-40
Table 35: Asia-Pacific Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-40
1$200
   Table 36: Asia-Pacific Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-411$200
   A. Market Analysis.....III-42
Current & Future Analysis.....III-42
Strategic Corporate Development.....III-42
Teva Pharmaceutical Industries Limited - A Key Player.....III-42
1$75
   B. Market Analytics.....III-43
Table 37: Rest of World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-43
1$200
   Table 38: Rest of World Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-441$200
  
Total Companies Profiled: 30 (including Divisions/Subsidiaries - 33)

Region/Country Players

The United States 12 Japan 1 Europe 10 Germany 3 The United Kingdom 2 Rest of Europe 5 Asia-Pacific (Excluding Japan) 8 Middle East 2
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