Global Human Growth Hormone Drugs Industry

  • June 2014
  • -
  • Global Industry Analysts
  • -
  • 127 pages

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 and PRODUCT DEFINITIONS

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


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
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
List of Select Approved Prescription Daily-dose hGH Products
by Indication II-2
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
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
Major Growth Restraining Factors II-5
Complex Delivery System II-5
High Cost of hGH Treatment II-5
Difficulty in Securing Reimbursement II-5
Introduction of Biosimilars Erodes Revenue Growth II-6
Limited Pharmacological Differences Exist Among Current Agents II-6

2. MARKET TRENDS and ISSUES II-7
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 and 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
Select Long-Acting hGH Products in Pipeline by Development Stage II-8
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
Biobetters Restrict Biosimilar Presence in Prescription hGH
Market II-10
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
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-12
Drug Delivery Device Options for Marketed hGH Products II-14
Risk of Cancer Necessitates Judicious Use of hGH in Children II-14
Growth Concerns about Prolonged Usage of Growth Hormones II-15
Growing Non-Prescription/Off-Label Usage - A Potential Health
Hazard II-15
Oral hGH Secretagogues - An Alternative to Controversial hGH
Injections in Professional Sports II-16

3. COMPETITION II-18
MNC Manufacturers Dominate hGH Market, New Entrants to
Intensify Competition II-18
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
Humatrope II-20
Saizen II-20
Omnitrope - the Somatropin Biosimilar II-20
Somatropin Biopartners II-21
Review of Select hGH Products in Pipeline II-21
OPKO Biologics/ Prolor Biotech’s hGH-CTP II-21
Versartis VRS-317 II-22
Ambrx ARX201 II-22
HanAll’s Vitatropin II-22

4. HUMAN GROWTH HORMONE: AN OVERVIEW II-23
Key Factors Controlling Natural hGH Secretion II-23
Structure of hGH II-24
Functions Performed by hGH in the Human Body II-24
Benefits of Adequate hGH II-25
Effects of Human Growth Hormone Imbalances II-25
Hypopituitarism II-25
Evolution of Growth Hormone Replacement Therapy II-26
Indications for Exogenous hGH Administration II-27
Growth Hormone Deficiency (GHD) II-27
Symptoms of Adult Growth Hormone Deficiency II-27
Idiopathic Short Stature II-28
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
Short Bowel Syndrome II-30
Other Medical Conditions II-30
Off-label Applications II-30
Contraindications for Somatropin Therapy II-30
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
Risks Involved with Adult hGH Replacement Therapy II-32

5. RECENT INDUSTRY ACTIVITY II-33
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
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
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
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

6. FOCUS ON SELECT GLOBAL PLAYERS II-37
Eli Lilly and Company (US) II-37
Ferring Holding SA (Switzerland) II-37
Genentech, Inc. (US) II-38
GeneScience Pharmaceuticals Co., Ltd. (China) II-38
Merck Serono SA (Switzerland) II-38
Novo Nordisk A/S (Denmark) II-39
Pfizer, Inc. (US) II-39
Sandoz International GmbH (Germany) II-40
Teva Pharmaceutical Industries Limited (Israel) II-41

7. GLOBAL MARKET PERSPECTIVE II-42
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-42

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-43

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-44

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-45

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-46

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-47


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and 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
Major hGH Drugs Available in the US, and FDA Approved
Indications III-2
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
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
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-8
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

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-11

2. CANADA III-12
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

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-13

3. JAPAN III-14
A.Market Analysis III-14
Current and Future Analysis III-14
Japanese Biosimilar Regulatory Guidelines III-14
Sandoz’ Omnitrope - the First Biosimilar hGH Launched in Japan III-14
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

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-16

4. EUROPE III-17
A.Market Analysis III-17
Current and 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
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
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

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-20

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-21

4a. FRANCE III-22
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

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-23

4b. GERMANY III-24
A.Market Analysis III-24
Current and Future Analysis III-24
Sandoz International GmbH - A Leading German Player III-24
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

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-26

4c. ITALY III-27
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

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-28

4d. THE UNITED KINGDOM III-29
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

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-30

4e. SPAIN III-31
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

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-32

4f. REST OF EUROPE III-33
A.Market Analysis III-33
Current and Future Analysis III-33
Strategic Corporate Developments III-33
Select Key Players III-34
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

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-37

5. ASIA-PACIFIC III-38
A.Market Analysis III-38
Current and Future Analysis III-38
Biosimilar Regulations in Asian Countries III-38
South Korea III-38
China III-38
India III-38
Strategic Corporate Developments III-39
Genescience Pharmaceuticals Co., Ltd. - A Leading Chinese
Player III-39
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

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-41

6. REST OF WORLD III-42
A.Market Analysis III-42
Current and Future Analysis III-42
Strategic Corporate Development III-42
Teva Pharmaceutical Industries Limited - A Key Player III-42
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

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-44


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 30 (including Divisions/Subsidiaries - 33)

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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