Global Human Growth Hormone Drugs Industry

  • August 2012
  • -
  • Global Industry Analysts
  • -
  • 274 pages

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.

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
Analytics in the report refer to sales of prescription
therapeutic growth hormone drugs I-3


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Market Primer II-1
Analysis by Geographic Region II-1
US - The Single Largest Market for HGH Drugs II-1
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
Key Market Drivers II-3
Major Market Restraining Factors II-3

2. TRENDS and ISSUES II-4
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
Long-Acting hGHs - the Flavor of the Season II-5
Sustained-Release hGH Products in Pipeline II-5
Risk of Cancer Necessitates Judicious Use of hGH in Children II-5
Other Concerns for Growth Hormone Use II-6
Biosimilars Create Little Impact, Further Validation to Expand
Indications and Growth II-6
Biosimilar hGH First Product Launch in Select Countries
Worldwide II-6
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
Dose Titration - A Key to Achieve Enhanced Tolerability II-8
Delivery Device Dynamics II-8
Delivery Device Options for Marketed hGH Products II-9

3. COMPETITION II-10
Multiple Manufacturers of hGH - Intensify Market Competition II-10
Table 1: Leading Companies in the Global Human Growth Hormone
Drugs Market (2011): Percentage Breakdown of Dollar Sales for
Novo Nordisk, Pfizer, Roche, Eli Lilly and Company and Others
(includes corresponding Graph/Chart) II-10
Manufacturers Bet on Novel Drug Delivery Technologies II-10
Saizen’s Patronage Grows, Revenues Sulk II-11
Technological Advancements Continue II-11
Merck-Serono Continues Studying Saizen II-11
Norditropin’ Sales Continues to Flourish II-11
New Delivery Device Eases Administration II-11
Genotropin’s Sales Stagnate II-12
Omnitrope - the Somatropin Biosimilar II-12

4. HUMAN GROWTH HORMONE: AN OVERVIEW II-13
Human Growth Hormone: An Introduction II-13
History II-13
Key Factors Controlling Natural hGH Secretion II-13
Structure of hGH II-14
Functions Performed by hGH in the Human Body II-14
Benefits of Adequate hGH II-15
Effects of Human Growth Hormone Imbalances II-15
Dangers of Excessive Intake of hGH II-16
Causes of Hypopituitarism II-16
Requirement of Synthetic Human Growth Hormone II-16
Types II-17
Somatotropin/Cadaver-GH II-17
Somatrem/Inclusion Body Technology/Met-hGH II-17
Somatropin/Mouse-Cell Manufacturing and Protein Secretion
Technology/rhGH II-17
Benefits of Synthetic hGH Replacement Therapy II-17
Symptoms, Diagnosis and Treatment of hGH Deficiency in
Children and Adults II-18
In Children II-18
Symptoms II-18
Diagnostic Procedures II-18
Key Procedure for Pediatric hGH Deficiency Treatment II-19
In Adults II-20
Symptoms II-20
Diagnostic Procedures II-20
Treatment Options for AGHD II-21
HGH Therapy II-21
Types of hGH Therapy II-21
Human Growth Hormone Injection Therapy II-21
Human Growth Hormone Secretagogues Therapy II-21
Human Growth Hormone Releaser Therapy II-22
Types of hGH Products II-22
Human Growth Hormone Injections II-22
Human Growth Hormone Homeopathic Formulas II-22
Human Growth Hormone Supplements (Pills/Capsules) II-22
Insulin-like Growth Factor-1 II-23
Leading hGH Pills II-23
hGH Releasers II-24
hGH Releaser Stimulators II-24
Effects of hGH Releasers II-24
Safety and hGH Therapy II-25
In Children II-25
In Adults II-26

5. RECENT INDUSTRY ACTIVITY II-27
hGHmeds.com Unveils Xerendip Human Growth Hormone II-27
PROLOR Biotech Commences Phase 2 Trials of hGH-CTP II-27
Merck Serono Begins Clinical Study of Easypod Electronic Auto -
Injector II-28
Sandoz Introduces Somatropin Growth Hormone in Japan II-28
Dainippon Sumitomo Pharma Inks Agreement with JCR
Pharmaceuticals for Growth Hormone Business II-28
Pfizer Establishes Biotech Unit in Sweden II-28
Modigene Commences Operations as PROLOR Biotech II-29
Sandoz’s Omnitrope® Obtains FDA Approval for New Indication II-29
Novo Nordisk’s Norditropin® FlexPro® Injection Pen Obtains US
FDA Approval II-29
Prolor’s hGH-CTP Obtains Orphan Drug Status II-29
Ascendis Pharma Starts Phase 2 Clinical Trial of ACP-001 II-29
Teva and Antares Receive FDA Approval for hGH Needle-Free
Injection II-30
Eli Lilly Receives FDA Approval for Humatrope Injection II-31
Pharmacia and Upjohn Receive FDA Approval for Genotropin
Injection II-31
Prolor Biotech Received Two US Patents for Longer-Acting EPO
and Longer-Acting hGH II-31
Ranbaxy Laboratories to Develop Novel Growth Hormone II-31

6. FOCUS ON SELECT GLOBAL PLAYERS II-32
Eli Lilly and Company (US) II-32
Ferring Pharmaceuticals A/S (Switzerland) II-32
Genentech, Inc. (US) II-32
GeneScience Pharmaceuticals Co., Ltd. (China) II-33
Merck Serono SA (Switzerland) II-33
Sandoz International GmbH (Germany) II-33
Novo Nordisk A/S (Denmark) II-34
Pfizer, Inc. (US) II-34
Teva Pharmaceutical Industries Limited (Israel) II-35

7. GLOBAL MARKET PERSPECTIVE II-36
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-36

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-37


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and Future Analysis III-1
FDA Approvals Clears Way for Treating More Children III-1
Major hGH Products and FDA Approved Indications III-1
FDA Approval of First Biosimilars III-2
FDA Regulations Governing Human Growth Hormone Products in
OTC Drugs Market III-2
Strategic Corporate Developments III-3
Select Key Players III-6
B.Market Analytics III-8
Table 4: 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-8

2. JAPAN III-9
A.Market Analysis III-9
Current and Future Analysis III-9
Sandoz’ Omnitrope - the First Biosimilar hGH Launched in Japan III-9
Regulatory Environment in Japan III-9
Strategic Corporate Developments III-9
B.Market Analytics III-10
Table 5: 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-10

3. EUROPE III-11
A.Market Analysis III-11
Current and Future Analysis III-11
A Focus on Regulations Pertaining to Biosimilars in the EU III-11
Uneven Adoption of Biosimilar hGH across EU Members III-11
Table 6: Biosimilar hGH Share of Originator Drug Sales in
the EU by Country: 2011 (includes corresponding
Graph/Chart) III-11
New Indications to Drive Future Growth III-12
Strategic Corporate Developments III-12
Select Key Players III-13
B.Market Analytics III-16
Table 7: 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-16

4. REST OF WORLD III-17
A.Market Analysis III-17
Current and Future Analysis III-17
Strategic Corporate Development III-17
GeneScience Pharmaceuticals Co., Ltd. - A Key Chinese
Producer of hGH III-17
B.Market Analytics III-18
Table 8: 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-18


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 37 (including Divisions/Subsidiaries - 41)

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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