Global Testosterone Replacement Therapy (TRT) Industry
NEW YORK, May 21, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Global Testosterone Replacement Therapy (TRT) Industry
http://www.reportlinker.com/p0552808/Global-Testosterone-Replacement-Therapy-TRT-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Therapy
This report analyzes the worldwide markets for Testosterone Replacement Therapy (TRT) in US$ Million. The global and the US markets are further analyzed by the following Product Segments: Gels, Patches, and Others. The report provides separate comprehensive analytics for the US, Canada, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 19 companies including many key and niche players such as Abbott Laboratories, Acrux Limited, Auxilium Pharmaceuticals, Inc., Bayer Schering Pharma AG, Columbia Laboratories, Inc., Eli Lilly and Company, Endo Pharmaceuticals, Inc., GlaxoSmithKline plc, Kyowa Hakko Kirin Co., Ltd., ProStrakan Group PLC, Slate Pharmaceuticals, Inc., Trimel BioPharma SRL, and Watson Pharmaceuticals, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Testosterone Replacement Therapy (TRT) I-3
Gels I-4
Patches I-4
Others I-4
II. EXECUTIVE SUMMARY
1. OUTLOOK II-1
2. INDUSTRY OVERVIEW II-2
High Incidence, Low Treatment II-2
Gels Displacing Alternative Therapies II-2
Testosterone Treatment in Females: An Unmet Clinical Need II-2
Growth Drivers II-3
Favorable Demographics II-3
Table 1: Percentage of Total Population Above 65 Years of
Age in Select Countries for 2000 and 2025(F) (includes
corresponding Graph/Chart) II-3
Table 2: Global Male Population Distribution (15-64 Yrs) by
Geographic Region/Country: 2010 (includes corresponding
Graph/Chart) II-4
Table 3: Global Male Population Distribution (65+Yrs) by
Geographic Region/Country: 2010 (includes corresponding
Graph/Chart) II-4
Table 4: Top 20 Countries with Male Population Aged 15 - 64:
2010 (in millions) (includes corresponding Graph/Chart) II-5
Table 5: Top 20 Countries with Male Population Aged 65 &
Above: 2010 (in millions) (includes corresponding
Graph/Chart) II-6
Rising Awareness II-6
Innovation and Improvement: Keys to Success II-6
Untapped Markets II-7
Undiagnosed Patients II-7
3. PRODUCT OVERVIEW II-8
Testosterone - An Introduction II-8
Testosterone Deficiency II-8
Primary Hypogonadism II-8
Secondary Hypogonadism II-8
Symptoms II-8
General Symptoms II-8
Clinical Symptoms II-9
Table 6: Major Symptoms in Hypogonadal Patients: Percentage
of Hypogonadal Patients Affected with Moderate to Severe
Symptoms of Low Energy Levels, Irritability, Sparse Beard,
Diminished Libido, and Sleepiness After Lunch (includes
corresponding Graph/Chart) II-9
Causes II-10
Co-Morbid Conditions II-10
Table 7: Hypogonadism Prevalence in Some Common Medical
Conditions (includes corresponding Graph/Chart) II-10
Diabetes and Hypogonadism II-11
Diagnosis II-11
Testosterone Replacement II-11
Testosterone Replacement Therapy - Evolution II-11
Treatment Alternatives II-11
Gels II-12
Patches II-12
Others II-12
Injections II-12
Orals II-12
Pellets II-13
Guidelines for Treatment of Hypogonadism II-13
Side Effects of TRT II-13
Precautions II-13
4. COMPETITIVE ANALYSIS II-14
Table 8: Global TRT Market (2010): Percentage Breakdown of
Value Revenue for Androgel, Testim, Androderm and Others
(includes corresponding Graph/Chart) II-14
Entry of Large Multinational Players II-15
Companies and Leading Brands II-15
Review of Select Brands II-15
The Generic Incursion II-17
Patent Expiration of Leading TRT Brands II-17
Threat from New Products II-17
Testosterone Therapies in Pipeline II-18
New Delivery Methods II-18
Androxal II-18
SARMs II-18
5. CLINICAL STUDIES/TRIALS II-19
Repros Therapeutics receives IRB for Phase 2b study of Androxal II-19
Acrux Announces Phase III Clinical Trial Results for Axiron II-19
Repros Announces Phase 2b Proof-of-Concept Clinical Trial
Results for Androxal II-19
ProStrakan Announces Positive Results from Study on
Testosterone Replacement in Diabetic Males II-19
ProStrakan Announces Positive Results from US Clinical Study
on Fortigel™ II-20
6. PRODUCT LAUNCHES/INNOVATIONS/ REGULATORY APPROVALS II-21
BioSante's Bio-T-Gel™ Receives FDA Clearance II-21
Abbott Obtains FDA Clearance for AndroGel® 1.62% II-21
Teva Pharmaceuticals Receives NDA Acceptance from FDA for Bio
-T-Gel II-21
Endo Pharmaceuticals' Fortesta Gel Secures FDA Acceptance II-21
Acrux Receives US FDA Approval for Axiron® Topical Solution II-22
Acrux Applies to FDA for NDA for AXIRON™ II-22
Endo Pharmaceuticals Files Class 2 Resubmission for Fortesta II-22
Endo Pharmaceuticals Receives Complete Response Letter from
FDA for Aveed™ II-22
ProStrakan Submits Response to FDA's Action Letter Regarding
NDA for Fortigel™ II-23
7. RECENT INDUSTRY ACTIVITY II-24
Kyowa Hakko Kirin Acquires ProStrakan Group II-24
Trimel Pharmaceuticals Amalgamates Operations with Trimel
BioPharma Holdings II-24
Actient Pharmaceuticals Bags the US Rights to Columbia
Laboratories' Striant® II-24
Abbott Takes Over Solvay Pharmaceuticals II-24
Eli Lilly Signs Global License Agreement with Acrux II-25
ProStrakan and Paladin Labs to Enter Strategic Partnership II-25
Boston Medical Group Expands Extensive ED Treatment by Adding
Testopel® TRT II-25
Cell Genesys Merges with BioSante Pharmaceuticals II-26
Endo Purchases US Rights for Fortesta II-26
Endo Pharmaceutical Inks Merger Agreement with Indevus
Pharmaceuticals II-26
Solvay Pharmaceutical to Market Lipocine's Oral Testosterone Pill II-27
US FTC Files Lawsuit Against Solvay, Watson and Par for 2006
Patent Settlement for Androgel II-27
Auxilium and Ferring Ink Licensing Deal for Testim® II-27
Noven Inks Supply and License Pact with P&GP for Testosterone
Patches to Treat HSDD in Women II-27
Auxilium Terminates Distribution Deal for Testim with Ipsen II-28
ProStrakan Grants Exclusive License to Bayer Schering Pharma
for the Development of Tostran® in 65 Countries II-28
8. FOCUS ON SELECT GLOBAL PLAYERS II-29
Abbott Laboratories (US) II-29
Acrux Limited (Australia) II-29
Auxilium Pharmaceuticals, Inc. (US) II-29
Bayer Schering Pharma AG (Germany) II-30
Columbia Laboratories, Inc. (US) II-30
Eli Lilly and Company (US) II-30
Endo Pharmaceuticals, Inc. (US) II-31
GlaxoSmithKline plc. (UK) II-31
Kyowa Hakko Kirin Co., Ltd. (Japan) II-31
ProStrakan Group PLC. (UK) II-32
Slate Pharmaceuticals, Inc. (US) II-32
Trimel BioPharma SRL (Canada) II-32
Watson Pharmaceuticals, Inc. (US) II-32
9. GLOBAL MARKET PERSPECTIVE II-33
Table 9: World Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy by Geographic Region - US,
Canada, Europe, Asia-Pacific, Latin America and Rest of World
Markets Independently Analyzed with Annual Revenue Figures in
US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) II-33
Table 10: World Historic Review for Testosterone Replacement
Therapy by Geographic Region - US, Canada, Europe,
Asia-Pacific, Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-34
Table 11: World 15-Year Perspective for Testosterone
Replacement Therapy by Geographic Region - Percentage
Breakdown of Dollar Revenues for US, Canada, Europe,
Asia-Pacific, Latin America, and Rest of World Markets for
Years 2003, 2010 & 2017 (includes corresponding Graph/Chart) II-35
Table 12: World Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy by Product Segments - Gels,
Patches, and Others Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) II-36
Table 13: World Historic Review for Testosterone Replacement
Therapy by Product Segments - Gels, Patches, and Others
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) II-37
Table 14: World 15-Year Perspective for Testosterone
Replacement Therapy by Product Segments - Percentage Breakdown
of Dollar Revenues for Gels, Patches, and Others Markets for
Years 2003, 2011& 2017 (includes corresponding Graph/Chart) II-38
III. MARKET
1. THE UNITED STATES III-1
A.Market Analysis III-1
Hypogonadism Prevalence III-1
Table 15: Low Testosterone Prevalence in US Men Above 45
Years of Age (2010): Percentage of Men Population Suffering
from Low Testosterone for Different Age Groups (includes
corresponding Graph/Chart) III-1
Competitive Scenario III-1
Table 16: US Gel TRT Market (2009): Percentage Breakdown of
Prescriptions for Androgel and Testim (includes
corresponding Graph/Chart) III-2
Table 17: US Gel TRT Market (2009): Percentage Breakdown of
Value Revenue for Androgel and Testim (includes
corresponding Graph/Chart) III-2
Generic Threat to Gel Brands III-2
Secondary Exposure III-3
B.Market Analytics III-4
Table 18: US Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy by Product Segment - Gels,
Patches and Others Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2009 through
2017 (includes corresponding Graph/Chart) III-4
Table 19: US Historic Review for Testosterone Replacement
Therapy by Product Segment - Gels, Patches and Others
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2003 Through 2008 (includes
corresponding Graph/Chart) III-5
Table 20: US 15-Year Perspective for Testosterone
Replacement Therapy by Product Segment - Percentage
Breakdown of Dollar Revenue for Gels, Patches and Others
Markets for Years 2003, 2011& 2017 (includes corresponding
Graph/Chart) III-6
2. CANADA III-7
Market Analytics III-7
Table 21: Canadian Recent Past, Current & Future Analysis
for Testosterone Replacement Therapy Markets Analyzed with
Annual Revenue Figures in US$ Million for Years 2009 through
2017 (includes corresponding Graph/Chart) III-7
Table 22: Canadian Historic Review for Testosterone
Replacement Therapy Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2003 through
2008 (includes corresponding Graph/Chart) III-8
3. EUROPE III-9
A.Market Analysis III-9
Lower Normal Serum Testosterone Concentration in Select
European Nations III-9
B.Market Analytics III-10
Table 23: European Recent Past, Current & Future Analysis
for Testosterone Replacement Therapy by Geographic Region -
France, Germany, Italy, UK, and Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 Through 2017 (includes corresponding
Graph/Chart) III-10
Table 24: European Historic Review for Testosterone
Replacement Therapy by Geographic Region - France, Germany,
Italy, UK, and Rest of Europe Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2003
through 2008 (includes corresponding Graph/Chart) III-11
Table 25: European 15-Year Perspective for Testosterone
Replacement Therapy by Geographic Region - Percentage
Breakdown of Dollar Sales for France, Germany, Italy, UK,
and Rest of Europe Markets for Years 2003, 2011 &
2017(includes corresponding Graph/Chart) III-12
4. ASIA-PACIFIC III-13
Market Analytics III-13
Table 26: Asia-Pacific Recent Past, Current & Future
Analysis for Testosterone Replacement Therapy Markets
Analyzed with Annual Revenue Figures in US$ Million for
Years 2009 through 2017 (includes corresponding Graph/Chart) III-13
Table 27: Asia-Pacific Historic Review for Testosterone
Replacement Therapy Markets Analyzed with Annual Sales
Figures in US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-14
5. LATIN AMERICA III-15
Market Analytics III-15
Table 28: Latin American Recent Past, Current & Future
Analysis for Testosterone Replacement Therapy Markets
Analyzed with Annual Revenue Figures in US$ Million for
Years 2009 through 2017 (includes corresponding Graph/Chart) III-15
Table 29: Latin American Historic Review for Testosterone
Replacement Therapy Markets Analyzed with Annual Sales
Figures in US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-16
6. REST OF WORLD III-17
Market Analytics III-17
Table 30: Rest of World Recent Past, Current & Future
Analysis for Testosterone Replacement Therapy Markets
Analyzed with Annual Revenue Figures in US$ Million for
Years 2009 through 2017 (includes corresponding Graph/Chart) III-17
Table 31: Rest of World Historic Review for Testosterone
Replacement Therapy Markets Analyzed with Annual Sales
Figures in US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-18
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 19
------------------------------------------
Region/Country Players
------------------------------------------
The United States 12
Canada 1
Europe 5
France 1
Germany 1
The United Kingdom 2
Rest of Europe 1
Asia-Pacific (Excluding Japan) 1
------------------------------------------
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