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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, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-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 28 companies including many key and niche players such as -

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

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Code: MCP-7129
Price: $4950
Companies: 28
Pages: 158
Date: January 2017
Market Data Tables: 39
  Status: * New Report



TABLE OF CONTENTS


  HUMAN GROWTH HORMONE DRUGS (Complete Report) Pages : 158   | $4950

   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 Outlook.....II-11$100
   Evolution of Recombinant Human Growth Hormones (hGH).....II-21$100
   List of Select Approved Prescription Daily-dose hGH Products by Indication.....II-3
Patent Expiry Paves Way for the Emergence of Biosimilars; Impact Remains Small.....II-3
1$100
   Strong Innovation Drive Takes Hold of the hGH Industry.....II-4
Sizing the Market.....II-4
1$100
   Key Growth Drivers.....II-5
High Prevalence of Growth Hormone Deficiency Disorders.....II-5
Innovations Hold the Key to Market Growth.....II-5
New Indications for hGH Replacement Therapy.....II-5
1$100
   Major Growth Restraining Factors.....II-6
Complex Delivery System.....II-6
High Cost of hGH Treatment.....II-6
Difficulty in Securing Reimbursement.....II-6
1$100
   Biosimilars Threaten Revenue Growth Erosion.....II-7
Limited Pharmacological Differences Exist Among Current Agents.....II-7
1$100
   Pediatric GHD Rules, while Adult GHD Remains Underserved.....II-8
Table 1: Worldwide Recombinant Human Growth Hormone Market by Indication (2016E): Percentage Breakdown of Value Sales for Adult GHD, Turner Syndrome & Idiopathic Short Stature; Pediatric GHD; and Others (includes corresponding Graph/Chart).....II-8
1$350
   Long-Acting hGH Drugs – a Potential Game Changer.....II-91$100
   Select Long-Acting hGH Products in Pipeline by Development Stage.....II-10
Biosimilars Create Little Impact, Further Validation to Expand Indications and
  Growth.....II-10
1$100
   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-111$350
   Manufacturers Bet on Novel Drug Delivery Technologies.....II-121$100
   Phase IV Studies Necessitated for First Biosimilars.....II-13
Needle-less Drug Delivery Systems to Wipe Out of Syringes.....II-13
2$200
   Drug Delivery Device Options for Marketed hGH Products.....II-151$100
   Growing Non-Prescription/Off-Label Usage – A Potential Health Hazard.....II-16
Oral hGH Secretagogues – An Alternative to Controversial hGH Injections in
  Professional Sports.....II-16
1$100
   Risk of Cancer Necessitates Judicious Use of hGH in Children.....II-171$100
   Dose Titration – A Key to Achieve Enhanced Tolerability.....II-18
Growth Concerns about Prolonged Usage of Growth Hormones.....II-18
1$100
   hGH – A Highly Consolidated Market.....II-19 1$100
   Table 3: Leading Recombinant hGH Products in the Global Market (2015): Annual Sales in US$ Million for Genotropin, Humatrope, Norditropin, Nutropin and Saizen (includes corresponding Graph/Chart).....II-20
Overview of Select Leading Marketed hGH Products.....II-20
Norditropin.....II-20
1$350
   Genotropin.....II-21
Humatrope.....II-21
Saizen.....II-21
1$100
   Omnitrope – the Somatropin Biosimilar.....II-22
Somatropin Biopartners.....II-22
Review of Select hGH Products in Pipeline.....II-22
OPKO’s Lagova to be the Earliest of Long-Acting hGHs to Hit the Market.....II-22
1$100
   Somavaratan Advances Further in Clinical Trials.....II-231$100
   Somapacitan Moves Ahead in Development; Nears Commercial Launch.....II-24
TransCon hGH – the Potential Blockbuster hGH Product in Waiting.....II-24
1$100
   HanAll’s Vitatropin.....II-251$100
   Key Factors Controlling Natural hGH Secretion.....II-261$100
   Structure of hGH.....II-27
Functions Performed by hGH in the Human Body.....II-27
1$100
   Benefits of Adequate hGH.....II-28
Effects of Human Growth Hormone Imbalances.....II-28
Hypopituitarism.....II-28
1$100
   Evolution of Growth Hormone Replacement Therapy.....II-291$100
   Indications for Exogenous hGH Administration.....II-30
Growth Hormone Deficiency (GHD).....II-30
Symptoms of Adult Growth Hormone Deficiency.....II-30
1$100
   Idiopathic Short Stature.....II-311$100
   Noonan Syndrome.....II-32
Prader-Willi Syndrome.....II-32
Turner Syndrome.....II-32
Short Stature Homeobox Gene.....II-32
Small for Gestational Age.....II-32
Chronic Renal Insufficiency.....II-32
1$100
   Short Bowel Syndrome.....II-33
Other Medical Conditions.....II-33
Off-label Applications.....II-33
Contraindications for Somatropin Therapy.....II-33
1$100
   Safety Review of hGH Therapy.....II-34
Reported Adverse Effects of Inaccurate rhGH Dosages.....II-34
Risks Involved with Pediatric/Adolescent hGH Replacement Therapy.....II-34
1$100
   Risks Involved with Adult hGH Replacement Therapy.....II-351$100
   NHI Includes JCR Pharmaceuticals’s GROWJECT Liquid hGH Formulations in Reimbursement
  Listing.....II-36
Ascendis Pharma Commences Phase III Trial on TransCon hGH.....II-36
Teijin Inks License Deal with Versartis for Somavaratan.....II-36
JCR Pharmaceuticals Obtains Japanese MHLW Approval for Growject® Liquid
  Formulations.....II-36
Merck Dissolves Merck Serono and Merck Millipore Brands, Relaunches Merck
  Brand.....II-36
1$100
   EMD Serono and Aeterna Zentaris Finalize Promotional Services Deal for Saizen.....II-37
Versartis Commences Phase II/III Studies for VRS-317 in Japan.....II-37
Ferring Pharmaceuticals Obtains FDA Clearance for Name Change of Growth
  Hormone.....II-37
Hanmi Introduces Development-Stage Long Acting hGH.....II-37
Novo Nordisk Obtains FDA Approval for Norditropin® FlexPro® Prefilled Pen.....II-37
OPKO and Pfizer Ink Agreement for Development of OPKO's Long-acting hGH-CTP.....II-37
Pfizer Announces Positive Results from Phase 3B Study on Genotropin for SGA in
  Children.....II-37
1$100
   Eli Lilly and Company (US).....II-38
Ferring Holding SA (Switzerland).....II-38
1$100
   Genentech, Inc. (US).....II-39
GeneScience Pharmaceuticals Co., Ltd. (China).....II-39
1$100
   Merck KgaA (Germany).....II-40
Novo Nordisk A/S (Denmark).....II-40
1$100
   Pfizer, Inc. (US).....II-41
Sandoz International GmbH (Germany).....II-41
2$200
   Table 4: World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....II-431$350
   Table 5: World Historic Analysis for Human Growth Hormone Drugs by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....II-441$350
   Table 6: World 14-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 2009, 2016 & 2022 (includes corresponding Graph/Chart).....II-451$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
Table 7: US Patient Volumes Receiving Growth Hormone Therapy by Indication (2016E): Breakdown of Number of Patients in Thousands for Adult GHD, Pediatric GHD and Other Indications (includes corresponding Graph/Chart).....III-1
1$200
   Table 8: US hGH Market by Indication (2016E): Percentage Breakdown of Value Sales for Adult GHD, Idiopathic Short Stature, Pediatric GHD, Turner Syndrome and Others (includes corresponding Graph/Chart).....III-2
FDA Approvals Clear Way for Treating More Children.....III-2
1$200
   Major hGH Drugs Available in the US, and FDA Approved Indications.....III-3
US FDA Promotes rhGH Development through Orphan Drug Designation.....III-3
1$75
   FDA Approval of First Biosimilar.....III-4
Omnitrope Versus Genotropin – A US Perspective.....III-4
FDA Issues First Draft of Guidelines for Biosimilar and Interchangeable
  Biologicals.....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
1$75
   Select Key Players.....III-72$150
   B. Market Analytics.....III-9
Table 9: The US Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-9
1$200
   Table 10: The US Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-101$200
   Market Analysis.....III-11
Table 11: Canadian Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-11
1$200
   Table 12: Canadian Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-121$200
   A. Market Analysis.....III-13
Current & Future Analysis.....III-13
Market Overview.....III-13
Table 13: Japanese Patient Volumes Receiving Growth Hormone Therapy by Indication (2016E): Breakdown of Number of Patients in Thousands for Adult GHD, Pediatric GHD and Other Indications (includes corresponding Graph/Chart).....III-13
1$200
   Table 14: Japanese hGH Market by Indication (2016E): Percentage Breakdown of Value Sales for Pediatric GHD and Others (includes corresponding Graph/Chart).....III-14
Competition in the Japanese hGH Market.....III-14
Table 15: Key Players in the Japanese hGH Market (2012, 2014 & 2016): Percentage Breakdown of Value Sales for Eli Lilly, JCR, Novo Nordisk, Pfizer and Others (includes corresponding Graph/Chart).....III-14
1$200
   Timeline of Major Approvals for JCR Pharmaceutical’s hGH Product Growject.....III-15
Japanese Biosimilar Regulatory Guidelines.....III-15
Sandoz’ Omnitrope – the First Biosimilar hGH Launched in Japan.....III-15
1$75
   Strategic Corporate Developments.....III-161$75
   B. Market Analytics.....III-17
Table 16: Japanese Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-17
1$200
   Table 17: Japanese Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-181$200
   A. Market Analysis.....III-19
Current & Future Analysis.....III-19
Pediatric GHD – Leading Target Indication for hGH Products.....III-19
Table 18: European Patient Volumes Receiving Growth Hormone Therapy by Indication (2016E): Breakdown of Number of Patients in Thousands for Adult GHD, Pediatric GHD and Other Indications (includes corresponding Graph/Chart).....III-19

Table 19: European hGH Market by Indication (2016E): Percentage Breakdown of Value Sales for Adult GHD, Pediatric GHD and Others (includes corresponding Graph/Chart).....III-19
1$200
   European hGH Market Focuses on Product Differentiation to Revitalize Sales.....III-20
Regulations Pertaining to Biosimilars in the EU.....III-20
1$75
   Table 20: Adoption Rates for hGH Biosimilar in Major Western Europe Markets: 2016 (includes corresponding Graph/Chart).....III-21
New Indications Could Drive Growth.....III-21
1$200
   B. Market Analytics.....III-22
Table 21: European Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-22
1$200
   Table 22: European Historic Analysis for Human Growth Hormone Drugs by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-231$200
   Table 23: European 14-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 2009, 2016 & 2022 (includes corresponding Graph/Chart).....III-241$200
   Market Analysis.....III-25
Table 24: French Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-25
1$200
   Table 25: French Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-261$200
   A. Market Analysis.....III-27
Current & Future Analysis.....III-27
Strategic Corporate Development.....III-27
Key Players.....III-27
2$150
   B. Market Analytics.....III-29
Table 26: German Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-29
1$200
   Table 27: German Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-301$200
   Market Analysis.....III-31
Table 28: Italian Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-31
1$200
   Table 29: Italian Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-321$200
   Market Analysis.....III-33
Table 30: The UK Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-33
1$200
   Table 31: The UK Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-341$200
   Market Analysis.....III-35
Table 32: Spanish Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-35
1$200
   Table 33: Spanish Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-361$200
   A. Market Analysis.....III-37
Current & Future Analysis.....III-37
Strategic Corporate Development.....III-37
Select Key Players.....III-37
2$150
   B. Market Analytics.....III-39
Table 34: Rest of Europe Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-39
1$200
   Table 35: Rest of Europe Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-401$200
   A. Market Analysis.....III-41
Current & Future Analysis.....III-41
Biosimilar Regulations In Asian Countries.....III-41
South Korea.....III-41
China.....III-41
India.....III-41
Genescience Pharmaceuticals Co., Ltd. – A Leading Chinese Player.....III-41
1$75
   B. Market Analytics.....III-42
Table 36: Asia-Pacific Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-42
1$200
   Table 37: Asia-Pacific Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-431$200
   Market Analysis.....III-44
Table 38: Rest of World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-44
1$200
   Table 39: Rest of World Historic Analysis for Human Growth Hormone Drugs Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-451$200
  
Total Companies Profiled: 28 (including Divisions/Subsidiaries - 33)

Region/Country Players

The United States 10 Canada 1 Japan 2 Europe 10 Germany 4 The United Kingdom 2 Rest of Europe 4 Asia-Pacific (Excluding Japan) 9 Middle East 1
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