Global Testosterone Replacement Therapy (TRT) Industry

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Dec 09, 2013, 08:02 ET

NEW YORK, Dec. 9, 2013 /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=Drug_and_Medication

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: Topicals, 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 2010 through 2018. 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 30 companies including many key and niche players such as -

AbbVie Inc.
Acrux Ltd.
Actavis, Inc.
Antares Pharma, Inc.
Auxilium Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals
Clarus Therapeutics

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
Testosterone Replacement Therapy (TRT) I-3
Topicals I-3
Patches I-4
Others I-4

II. EXECUTIVE SUMMARY

1. OUTLOOK II-1
TRT Market - A Primer II-1
Current & Future Analysis II-2
US Dominates the Global TRT Market II-2
Outside US Markets to Witness Tremendous Growth II-2
Topicals Dominate US Market; Conventional Drugs Rule Elsewhere II-3
Growth Rate Dips in the Global TRT Market II-3

2. INDUSTRY OVERVIEW II-4
High Incidence, Low Treatment II-4
Aging Global Population Drives Adoption II-4
Table 1: Percentage of Total Population Above 65 Years of Age
in Select Countries for 2000 and 2025(F) (includes
corresponding Graph/Chart) II-4

Table 2: Global Male Population Distribution (15-64 Yrs) by
Geographic Region/Country: 2010 (includes corresponding
Graph/Chart) II-5

Table 3: Global Male Population Distribution (65+Yrs) by
Geographic Region/Country: 2010 (includes corresponding
Graph/Chart) II-5

Table 4: Top 20 Countries with Male Population Aged 15 - 64:
2010 (in Millions) (includes corresponding Graph/Chart) II-6

Table 5: Top 20 Countries with Male Population Aged 65 &
Above: 2010 (in Millions) (includes corresponding
Graph/Chart) II-7
Undiagnosed Patients - a Strong Indicator of Growth Potential II-7
Rising Awareness - A Critical Factor to Growth II-8
Emerging Data on Positive Impact on Co-morbidities to Support
Growth II-8
Marketing Campaigns and Patient Referrals to Fuel Growth II-8
Easy-to-use Formulations - A Major Boost to TRT Market II-8
Untapped Markets - The Future Prospects for TRT II-9
Testosterone as a Treatment for Other Conditions - A Growing
Area of Focus II-9

3. PRODUCT LANDSCAPE II-10
A Consolidated Market II-10
Table 6: Global Sales of Leading Testosterone Replacement
Therapy Products: 2011 & 2012 (includes corresponding
Graph/Chart) II-10
Entry of Large Multinational Players II-11
Leading Brands and Companies II-11
Generic Incursion - A Major Threat II-11
Expiration of Patents and Market Exclusivity of Leading TRT
Brands in the US II-12
An Overview of Select Drugs on the Market II-12
AndroGel (AbbVie) II-12
Axiron (Acrux and Eli Lilly) II-12
Axiron - A Comparison with Other Products II-12
Eli Lilly to Turn Axiron into a Global TRT Brand II-13
Axiron's Patent Profile II-14
Testim (Auxilium) II-14
Table 7: Global Market of Testim by Geographic Region (2011 &
2012): Breakdown of Annual Value Sales in US$ Million for
US and Rest of World Markets (includes corresponding
Graph/Chart) II-14
Testim Scores High on Efficacy over AndroGel II-15
Small Packaging Works for Testim II-15
Androderm (Actavis) II-15
Fortesta (Endo Health Solutions) II-16
Tostran (Prostrakan Group) II-16
Testopel (Auxilium) II-16
Restandol (Organon) II-16
Striant® (Auxilium) II-17
Testopel® (Auxilium) II-17
Nebido (Bayer HealthCare Pharmaceuticals) II-17
Threat from New Products II-17
Pipeline Analysis II-17
Oral Drugs Dominate Drug Development Pipeline II-17
Major Testosterone Replacement Therapy Products in Pipeline II-18
An Overview of Select Drugs in Pipeline II-18
CompleoTRT - A Comparative Review II-18
VIBEX QS T - A New Hope to Injectables Users II-19
Androxal II-19
CLR-610 II-19

4. TESTOSTERONE DEFICIENCY AND TRT - AN OVERVIEW II-20
Testosterone - An Introduction II-20
Testosterone Deficiency II-20
Primary Hypogonadism II-20
Secondary Hypogonadism II-20
Symptoms II-20
General Symptoms II-20
Clinical Symptoms II-21
Table 8: 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-21
Causes II-22
Co-Morbid Conditions II-22
Table 9: Hypogonadism Prevalence in Some Common Medical
Conditions (includes corresponding Graph/Chart) II-22
Diabetes and Hypogonadism II-23
Diagnosis II-23
Testosterone Replacement II-23
Testosterone Replacement Therapy - Evolution II-23
Topicals II-23
Patches II-24
Others II-24
Injections II-24
Orals II-24
Pellets II-25
A Comparison of Key Benefits and Drawbacks of Existing
Testosterone Preparations II-25
Major Potential Benefits of TRT II-25
Major Potential Risks of TRT II-25
Precautions II-26
Treatment Alternatives II-26

5. PRODUCT LAUNCHES/APPROVALS II-27
HRTI Obtains FDA Clearance for Commencing Testagen® TDS
Clinical Trials II-27
Eli Lily Launches Axiron® in Canada II-27
FDA Approves Generic Depo-Testosterone Injection of Sun
Pharmaceutical II-27
Perrigo Obtains FDA Approval for AndroGel® 1% II-28
TestoMeds Launches Androfeme, Andromforte and Profeme
Testosterone Replacement Creams II-28
BioSante's Bio-T-Gel™ Receives FDA Clearance II-28
Eli Lilly Launches Axiron Topical Solution in the US II-29
US FDA Grants Approval Low-Dose Formulations of Watson's
Androderm® II-29
Abbott Obtains FDA Clearance for AndroGel® 1.62% II-29
Teva Pharmaceuticals Receives NDA Acceptance from FDA for Bio
-T-Gel II-30
Endo Pharmaceuticals' Fortesta Gel Secures FDA Acceptance II-30
Acrux Receives US FDA Approval for Axiron® Topical Solution II-30

6. RECENT INDUSTRY ACTIVITY II-31
CoreRx and TesoRx Pharma Form Production Joint Venture for
TSX-002 II-31
Eli Lilly Files Lawsuit against Perrigo for Infringing Axiron
Patents II-31
Perrigo Files for Generic Axiron Approval with FDA II-31
Auxilium Wins Patents Challenges for Testim II-31
Auxilium Pharmaceuticals Takes Over Actient Holdings II-32
Ferring Submits Patent Application for New Testosterone
Formulations in Australia II-32
Perrigo Submits ANDA for Testosterone 1.62% with the US FDA II-32
Trimel Pharmaceuticals Files NDA for CompleoTRT™ with US FDA (US) II-32
Watson Pharmaceuticals Rebrands to Actavis II-33
US FDA Accepts to Review Complete Response Submission for NDA
of Endo Pharmaceuticals's Aveed II-33
Lipocine Announces Positive Phase I Clinical Trial for LPCN
1111 Candidate II-33
Auxilium Pharmaceuticals and GlaxoSmithKline Enter into Co-
Promotion Deal for Testim Gel II-33
Lipocine Receives Approval for Phase III Study of LPCN 1021
from US FDA II-33
Clarus Therapeutics Announces Positive Phase III Clinical
Trial Data for CLR-610 Oral TRT II-34
Watson Laboratories Submits ANDA for Testosterone 1% Gel to US
FDA II-34
Repros Therapeutics Receives IRB for Phase 2b Study of Androxal II-34
Columbia Laboratories and Actient Pharmaceuticals Ink Asset-
Purchase Agreement for STRIANT® in US II-34
Kyowa Hakko Kirin Acquires ProStrakan Group II-34
Trimel Pharmaceuticals Amalgamates Operations with Trimel
BioPharma Holdings II-35
Actient Pharmaceuticals Bags the US Rights to Columbia
Laboratories' Striant® II-35
Abbott Takes Over Solvay Pharmaceuticals II-35
Eli Lilly Signs Global License Agreement with Acrux II-35
ProStrakan and Paladin Labs to Enter Strategic Partnership II-36
Endo Pharmaceuticals Files Class 2 Resubmission for Fortesta II-36
Acrux Announces Phase III Clinical Trial Results for Axiron II-36
Repros Announces Phase 2b Proof-of-Concept Clinical Trial
Results for Androxal II-36
Boston Medical Group Expands Extensive ED Treatment by Adding
Testopel® TRT II-36
Cell Genesys Merges with BioSante Pharmaceuticals II-37
Endo Purchases US Rights for Fortesta II-37
Endo Pharmaceutical Acquires Indevus Pharmaceuticals II-37
Solvay Pharmaceutical to Market Lipocine's Oral Testosterone Pill II-38
US FTC Files Lawsuit against Solvay, Watson and Par for 2006
Patent Settlement for Androgel II-38
Endo Pharmaceuticals Receives Complete Response Letter from
FDA for Aveed™ II-38
ProStrakan Submits Response to FDA's Action Letter Regarding
NDA for Fortigel™ II-38

7. FOCUS ON SELECT PLAYERS II-39
AbbVie Inc. (US) II-39
Acrux Limited (Australia) II-39
Actavis, Inc. (US) II-40
Antares Pharma, Inc. (US) II-40
Auxilium Pharmaceuticals, Inc. (US) II-41
Bayer HealthCare Pharmaceuticals (Germany) II-41
Clarus Therapeutics (US) II-42
Columbia Laboratories, Inc. (US) II-42
Eli Lilly and Company (US) II-43
Endo Health Solutions Inc. (US) II-43
GlaxoSmithKline plc. (UK) II-44
ProStrakan Group PLC. (UK) II-44
Trimel Pharmaceutical Corporation (Canada) II-45

8. GLOBAL MARKET PERSPECTIVE II-46
Table 10: 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 Sales Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-46

Table 11: 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 2004 through 2009 (includes corresponding
Graph/Chart) II-47

Table 12: World 15-Year Perspective for Testosterone
Replacement Therapy by Geographic Region - Percentage
Breakdown of Dollar Sales for US, Canada, Europe,
Asia-Pacific, Latin America, and Rest of World Markets for
Years 2004, 2013 & 2018 (includes corresponding Graph/Chart) II-48

Table 13: World Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy by Product Segment -
Topicals, Patches, and Other Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2010
through 2018 (includes corresponding Graph/Chart) II-49

Table 14: World Historic Review for Testosterone Replacement
Therapy by Product Segment - Topicals, Patches, and Other
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) II-50

Table 15: World 15-Year Perspective for Testosterone
Replacement Therapy by Product Segment - Percentage Breakdown
of Dollar Sales for Topicals, Patches, and Other Markets for
Years 2004, 2013 & 2018 (includes corresponding Graph/Chart) II-51

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current & Future Analysis III-1
Table 16: Total Prescriptions of Testosterone Products in
the US for Years 2010-2012 (includes corresponding
Graph/Chart) III-1
Topical Gels - The Largest Selling Segment III-1
A Comparison of Commonly Prescribed Topical TRT Products in
the US III-2
Hypogonadism - High on Prevalence, Low on Treatment III-2
US Market Slows Down III-2
Efforts to Increase Awareness to Fuel Growth III-3
New Products Strive to Address Transference Issues III-3
High-Concentration Products Gain Market Share in the
Topicals Market III-3
Debate Continues Over the Need for TRT III-4
Big Pharma Spends Millions to Push TRT Sales III-4
Table 17: Ad Spending on Testosterone Products in the US
for Years 2010-2012 (includes corresponding Graph/Chart) III-5
Increasing Ad Spending Draws Flak III-5
Product Landscape III-5
Axiron and High-Concentration AndroGel - Major Gainers in
New Prescriptions III-5
Table 18: US Testosterone Gel and Patch Market (2013 E):
Percentage Breakdown of New Weekly Prescriptions for
AndroGel, Axiron, Testim, Fortesta and Androderm (includes
corresponding Graph/Chart) III-6
AndroGel Retains Leadership in Total Prescriptions III-6
Table 19: US Testosterone Gel and Patch Market (2013 E):
Percentage Breakdown of Total Weekly Prescriptions for
AndroGel, Axiron, Testim, Fortesta and Androderm (includes
corresponding Graph/Chart) III-6
AbbVie Fights on for AndroGel's Market Sustenance III-7
Axiron Regains Growth Momentum III-7
Table 20: Quarterly Sales of Axiron in the US: 2011
through 2013 (includes corresponding Graph/Chart) III-7
Co-Pay Scheme Helps Axiron Attract Users III-8
Competition and Other Issues Dent Testim's Prospects in the US III-8
Testim's Performance in Prescriptions Improves, Revenues
Head South III-8
Product Launches/ Approvals III-9
Strategic Corporate Developments III-12
Key Players III-19
B.Market Analytics III-24
Table 21: US Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy by Product Segment -
Topicals, Patches and Other Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2010
through 2018 (includes corresponding Graph/Chart) III-24

Table 22: US Historic Review for Testosterone Replacement
Therapy by Product Segment - Topicals, Patches and Other
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-25

Table 23: US 15-Year Perspective for Testosterone
Replacement Therapy by Product Segment - Percentage
Breakdown of Dollar Sales for Topicals, Patches and Other
Markets for Years 2004, 2013 & 2018 (includes corresponding
Graph/Chart) III-26

2. CANADA III-27
A.Market Analysis III-27
Current & Future Analysis III-27
Market Overview III-27
Available TRT Therapies in Canada III-27
Competition in the Canadian TRT Market - An Overview III-28
Table 24: Canadian Topical Testosterone Gel Market (2011):
Breakdown of Annual Revenues for AndroGel and Testim in US$
Million (includes corresponding Graph/Chart) III-28
Product Launch III-29
Strategic Corporate Developments III-29
Key Player III-29
B.Market Analytics III-30
Table 25: Canadian Recent Past, Current & Future Analysis
for Testosterone Replacement Therapy Market Analyzed with
Annual Sales Figures in US$ Million for Years 2010 through
2018 (includes corresponding Graph/Chart) III-30

Table 26: Canadian Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-31

3. EUROPE III-32
A.Market Analysis III-32
Current & Future Analysis III-32
Market Overview III-32
Gels to Drive European TRT Market III-32
Lower Normal Serum Testosterone Concentration in Select
European Nations III-32
B.Market Analytics III-33
Table 27: 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 2010 through 2018 (includes corresponding
Graph/Chart) III-33

Table 28: 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 2004
through 2009 (includes corresponding Graph/Chart) III-34

Table 29: 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 2004, 2013 & 2018
(includes corresponding Graph/Chart) III-35

3a. FRANCE III-36
A.Market Analysis III-36
Current & Future Analysis III-36
B.Market Analytics III-36
Table 30: French Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2010 through 2018
(includes corresponding Graph/Chart) III-36

Table 31: French Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-37

3b. GERMANY III-38
A.Market Analysis III-38
Current & Future Analysis III-38
Bayer HealthCare Pharmaceuticals - A Key Player in TRT Market III-38
B.Market Analytics III-39
Table 32: German Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2010 through 2018
(includes corresponding Graph/Chart) III-39

Table 33: German Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-40

3c. ITALY III-41
A.Market Analysis III-41
Current & Future Analysis III-41
B.Market Analytics III-41
Table 34: Italian Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2010 through 2018
(includes corresponding Graph/Chart) III-41

Table 35: Italian Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-42

3d. THE UNITED KINGDOM III-43
A.Market Analysis III-43
Current & Future Analysis III-43
Market Overview III-43
Table 36: TRT Market in the UK by Product Type (2012):
Percentage Breakdown of Value Sales for Topical Gels,
Injectables, Patches and Oral Products (includes
corresponding Graph/Chart) III-43
Strategic Corporate Development III-44
Key Players III-44
B.Market Analytics III-45
Table 37: UK Recent Past, Current & Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2010 through 2018
(includes corresponding Graph/Chart) III-45

Table 38: UK Historic Review for Testosterone Replacement
Therapy Market Analyzed with Annual Sales Figures in US$
Million for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-46

3e. REST OF EUROPE III-47
A.Market Analysis III-47
Current & Future Analysis III-47
Strategic Corporate Development III-47
B.Market Analytics III-48
Table 39: Rest of Europe Recent Past, Current & Future
Analysis for Testosterone Replacement Therapy Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-48

Table 40: Rest of Europe Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-49

4. ASIA-PACIFIC III-50
A.Market Analysis III-50
Current & Future Analysis III-50
Increasing Use of Testosterone in Australia III-50
Strategic Corporate Development III-50
Key Player III-50
B.Market Analytics III-51
Table 41: Asia-Pacific Recent Past, Current & Future
Analysis for Testosterone Replacement Therapy Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-51

Table 42: Asia-Pacific Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-52

5. LATIN AMERICA III-53
A.Market Analysis III-53
Current & Future Analysis III-53
B.Market Analytics III-53
Table 43: Latin American Recent Past, Current & Future
Analysis for Testosterone Replacement Therapy Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-53

Table 44: Latin American Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-54

6. REST OF WORLD III-55
A.Market Analysis III-55
Current & Future Analysis III-55
Product Launch III-55
B.Market Analytics III-56
Table 45: Rest of World Recent Past, Current & Future
Analysis for Testosterone Replacement Therapy Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-56

Table 46: Rest of World Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-57

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 30 (including Divisions/Subsidiaries - 36)

The United States (20)
Canada (4)
Japan (1)
Europe (7)
- France (1)
- Germany (1)
- The United Kingdom (2)
- Italy (1)
- Rest of Europe (2)
Asia-Pacific (Excluding Japan) (4)