Global Human Growth Hormone Drugs - Pharmaceuticals

NEW YORK, Feb. 20, 2017 /PRNewswire/ -- 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.


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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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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1 Disclaimers.............. I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definitions and Scope of Study I-3

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW.............. II-1 Market Outlook.............. II-1 Evolution of Recombinant Human Growth Hormones (hGH) II-2 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 Strong Innovation Drive Takes Hold of the hGH Industry II-4 Sizing the Market.............. II-4 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 Major Growth Restraining Factors II-6 Complex Delivery System..............II-6 High Cost of hGH Treatment..............II-6 Difficulty in Securing Reimbursement II-6 Biosimilars Threaten Revenue Growth Erosion II-7 Limited Pharmacological Differences Exist Among Current Agents II-7

2. MARKET TRENDS & ISSUES..............II-8 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 Long-Acting hGH Drugs - a Potential Game Changer II-9 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 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-11 Manufacturers Bet on Novel Drug Delivery Technologies II-12 Phase IV Studies Necessitated for First Biosimilars II-13 Needle-less Drug Delivery Systems to Wipe Out of Syringes II-13 Drug Delivery Device Options for Marketed hGH Products II-15 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 Risk of Cancer Necessitates Judicious Use of hGH in Children II-17 Dose Titration - A Key to Achieve Enhanced Tolerability II-18 Growth Concerns about Prolonged Usage of Growth Hormones II-18

3. COMPETITIVE LANDSCAPE..............II-19 hGH - A Highly Consolidated Market II-19 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 Genotropin.............. II-21 Humatrope.............. II-21 Saizen.............. II-21 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 Somavaratan Advances Further in Clinical Trials II-23 Somapacitan Moves Ahead in Development; Nears Commercial Launch II-24 TransCon hGH - the Potential Blockbuster hGH Product in Waiting II-24 HanAll's Vitatropin..............II-25

4. HUMAN GROWTH HORMONE: AN OVERVIEW II-26 Key Factors Controlling Natural hGH Secretion II-26 Structure of hGH.............. II-27 Functions Performed by hGH in the Human Body II-27 Benefits of Adequate hGH..............II-28 Effects of Human Growth Hormone Imbalances II-28 Hypopituitarism.............. II-28 Evolution of Growth Hormone Replacement Therapy II-29 Indications for Exogenous hGH Administration II-30 Growth Hormone Deficiency (GHD) II-30 Symptoms of Adult Growth Hormone Deficiency II-30 Idiopathic Short Stature..............II-31 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 Short Bowel Syndrome..............II-33 Other Medical Conditions..............II-33 Off-label Applications..............II-33 Contraindications for Somatropin Therapy II-33 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 Risks Involved with Adult hGH Replacement Therapy II-35

5. RECENT INDUSTRY ACTIVITY..............II-36 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 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

6. FOCUS ON SELECT GLOBAL PLAYERS..............II-38 Eli Lilly and Company (US)..............II-38 Ferring Holding SA (Switzerland) II-38 Genentech, Inc. (US)..............II-39 GeneScience Pharmaceuticals Co., Ltd. (China) II-39 Merck KgaA (Germany)..............II-40 Novo Nordisk A/S (Denmark)..............II-40 Pfizer, Inc. (US).............. II-41 Sandoz International GmbH (Germany) II-41

7. GLOBAL MARKET PERSPECTIVE..............II-43 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-43

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-44

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-45

III. MARKET

1. THE UNITED STATES.............. III-1 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

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 Major hGH Drugs Available in the US, and FDA Approved Indications.............. III-3 US FDA Promotes rhGH Development through Orphan Drug Designation.............. III-3 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 FDA Regulations Governing hGH Products in the OTC Drugs Market III-5 Alarming Increase in Sales of hGH Drugs for Anti-Ageing Therapy III-6 Strategic Corporate Developments III-6 Select Key Players..............III-7 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

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-10

2. CANADA.............. III-11 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

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-12

3. JAPAN.............. III-13 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

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 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 Strategic Corporate Developments III-16 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

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-18

4. EUROPE.............. III-19 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 European hGH Market Focuses on Product Differentiation to Revitalize Sales.............. III-20 Regulations Pertaining to Biosimilars in the EU III-20 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 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

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-23

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-24

4a. FRANCE.............. III-25 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

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-26

4b. GERMANY.............. III-27 A.Market Analysis.............. III-27 Current & Future Analysis..............III-27 Strategic Corporate Development III-27 Key Players.............. III-27 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

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-30

4c. ITALY.............. III-31 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

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-32

4d. THE UNITED KINGDOM..............III-33 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

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-34

4e. SPAIN.............. III-35 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

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-36

4f. REST OF EUROPE.............. III-37 A.Market Analysis.............. III-37 Current & Future Analysis..............III-37 Strategic Corporate Development III-37 Select Key Players..............III-37 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

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-40

5. ASIA-PACIFIC.............. III-41 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 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

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-43

6. REST OF WORLD.............. III-44 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

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-45

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 28 (including Divisions/Subsidiaries - 33)

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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