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World Testosterone Replacement Therapy (TRT) Industry

  • January 2015
  • -
  • Global Industry Analysts
  • -
  • 166 pages

This report analyzes the worldwide markets for Testosterone Replacement Therapy (TRT) in US$ Million. The Global and the US markets are analyzed by the following Product Segments: Topicals, Patches, and Others. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, 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 35 companies including many key and niche players such as -

AbbVie, Inc.
Acrux Limited
Actavis, Inc.
Antares Pharma, Inc.
Auxilium Pharmaceuticals, Inc.

Table Of Contents

World Testosterone Replacement Therapy (TRT) Industry



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
Topicals I-4
Patches I-4
Others I-4


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
High Incidence of Testosterone Deficiency Offers Growth Potential II-1
Table 1: World Hypogonadism Prevalence by Age Group:
Percentage of the Disorder in 21-30, 31-40, 41-50, 51-60,
61-70, 71-80, and >80 Age Groups (includes corresponding
Graph/Chart) II-1
Recently Approved/ Pipeline Testosterone Replacement Therapy
Products II-2
US Dominates the Global TRT Market II-3
Markets, Other than the US, to Witness Tremendous Growth II-3
Topicals Dominate the US Market, Conventional Drugs Rule
Elsewhere II-4
Leading TRT Products Available in the Market II-5
Cardiovascular Risks Taint the TRT Market II-5

2. GROWTH DRIVERS AND MARKET TRENDS II-6
Aging Global Population Drives Adoption II-6
Table 2: Percentage of Total Population above 65 Years of Age
in Select Countries for 2000 and 2025(F) (includes
corresponding Graph/Chart) II-6

Table 3: Global Male Population Distribution (15-64 Yrs) by
Geographic Region/Country: 2010 (includes corresponding
Graph/Chart) II-6

Table 4: Global Male Population Distribution (65+Yrs) by
Geographic Region/Country: 2010 (includes corresponding
Graph/Chart) II-7

Table 5: Top 20 Countries with Male Population Aged 15 - 64:
2010 (in Millions) (includes corresponding Graph/Chart) II-7

Table 6: Top 20 Countries with Male Population Aged 65 and
Above: 2010 (in Millions) (includes corresponding
Graph/Chart) II-8
Undiagnosed Patients - A Strong Indicator of Growth Potential II-8
Rising Awareness - A Critical Factor for Growth II-9
Emerging Data on Positive Impact on Co-morbidities to Support
Growth II-9
Marketing Campaigns and Patient Referrals to Fuel Growth II-9
Easy-to-use Formulations - A Major Boost to TRT Market II-9
Untapped Developing Markets - The Future Growth Engine for TRT II-10
Testosterone as Treatment for Other Conditions - A Growing
Area of Focus II-10
FDA Rejects Citizen “Black Box” Petition II-10
Aggressive DTC Advertising Eases in 2014 II-11

3. COMPETITION II-12
TRT- A Highly Consolidated Market II-12
Table 7: World Testosterone Replacement Therapy Products
Market by Leading Player (2012 and 2013): Percentage Market
Share Breakdown of Value Sales for AndroGel, Testim,
Androderm, Axiron, Testopel, and Fortesta (includes
corresponding Graph/Chart) II-12
Entry of Large Multinational Players II-13
Generic Incursion - A Major Threat II-13
Expiration of Patents and Market Exclusivity of Leading TRT
Brands in the US II-13

4. AN OVERVIEW OF SELECT DRUGS ON THE MARKET II-14
AndroGel (AbbVie) II-14
Axiron (Eli Lilly) II-14
Axiron - A Comparison with Other Products II-14
Axiron's Patent Profile II-15
Testim (Auxilium) II-15
Table 8: Global Market of Testim by Geographic Region (2012 and
2013): Breakdown of Annual Value Sales Markets in US$ Million
for US and Rest of World (includes corresponding Graph/Chart) II-16
Testim Scores High on Efficacy over AndroGel II-16
Small Packaging Works for Testim II-16
Androderm (Actavis) II-16
Fortesta (Endo Pharmaceuticals) II-17
Tostran (Prostrakan Group) II-17
Threat from New Products II-17
Pipeline Analysis II-18
Oral Drugs Dominate Drug Development Pipeline II-18
An Overview of Select Drugs in Pipeline II-18
Natestoâ„¢ TRT - A Comparative Review II-18
VIBEX QS T - A New Hope to Injectables Users II-18
Androxal II-19
Rextoro (formerly CLR-610) II-19

5. 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 9: 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 10: 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-24
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

6. PRODUCT LAUNCHES/APPROVALS II-27
FDA Denies Rextoro Oral Testosterone by Clarus Therapeutics II-27
FDA Approves sNDA for STENDRA II-27
Endo International Launches Generic Version of its Fortesta II-27
MonoSol Rx Launches Clinical Trial of MSRX-110 II-27
Perrigo Receives AB Therapeutic Equivalent Rating from FDA for
Testosterone Gel II-27
FDA Confirms Endpoints for ZA-304 and ZA-305 Studies II-27
Auxilium and Prasco Launch Testim® Generic II-28
FDA Approves NDA for Vogelxo II-28
USFDA Approves Natesto Testosterone Nasal Gel II-28
BioThermo Labs Introduces T9 Testosterone Supplement II-28
iSatori Launches Fenu Test II-28
HRTI Obtains FDA Clearance for Commencing Testagen® TDS
Clinical Trials II-28
Eli Lily Launches Axiron® in Canada II-28
FDA Approves Generic Depo-Testosterone Injection of Sun
Pharmaceutical II-29
Perrigo Obtains FDA Approval for AndroGel® 1% II-29
TestoMeds Launches Androfeme, Andromforte and Profeme
Testosterone Replacement Creams II-29
BioSante's Bio-T-Gelâ„¢ Receives FDA Clearance II-29

7. RECENT INDUSTRY ACTIVITY II-30
TesoRx Awards Aspen Global with Select International License
of TSX-002 II-30
Viramal Acquires TestoCream License from Aptys II-30
Vivus Provides Auxilium North American Marketing Rights for
STENDRA II-30
CoreRx and TesoRx Pharma Form Production Joint Venture for
TSX-002 II-30
Eli Lilly Files Lawsuit against Perrigo for Infringing Axiron
Patents II-30
Perrigo Files for Generic Axiron Approval with FDA II-30
Auxilium Wins Patent Challenges for Testim II-31
Auxilium Pharmaceuticals Takes Over Actient Holdings II-31
Ferring Submits Patent Application for New Testosterone
Formulations in Australia II-31
Perrigo Submits ANDA for Testosterone 1.62% with the US FDA II-31
Watson Pharmaceuticals Rebrands to Actavis II-31
US FDA Accepts to Review Complete Response Submission for NDA
of Endo Pharmaceuticals' Aveed II-31
Lipocine Announces Positive Phase I Clinical Trial for LPCN
1111 Candidate II-31
Auxilium Pharmaceuticals and GlaxoSmithKline Enter into Co-
Promotion Deal for Testim Gel II-32
Lipocine Receives Approval for Phase III Study of LPCN 1021
from US FDA II-32
Clarus Therapeutics Announces Positive Phase III Clinical
Trial Data for CLR-610 Oral TRT II-32
Watson Laboratories Submits ANDA for Testosterone 1% Gel to US
FDA II-32

8. FOCUS ON SELECT PLAYERS II-33
AbbVie, Inc. (US) II-33
Acrux Limited (Australia) II-33
Actavis, Inc. (US) II-34
Antares Pharma, Inc. (US) II-34
Auxilium Pharmaceuticals, Inc. (US) II-35
Bayer HealthCare Pharmaceuticals (Germany) II-35
Columbia Laboratories, Inc. (US) II-36
Eli Lilly and Company (US) II-36
Endo Pharmaceuticals Inc. (US) II-37
ProStrakan Group PLC. (UK) II-37
Trimel Pharmaceutical Corporation (Canada) II-37

9. GLOBAL MARKET PERSPECTIVE II-39
Table 11: World Recent Past, Current and Future Analysis for
Testosterone Replacement Therapy (TRT) 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 2013 through 2020 (includes
corresponding Graph/Chart) II-39

Table 12: World Historic Review for Testosterone Replacement
Therapy (TRT) 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 2006 through 2012 (includes corresponding
Graph/Chart) II-40

Table 13: World 15-Year Perspective for Testosterone
Replacement Therapy (TRT) by Geographic Region - Percentage
Breakdown of Dollar Sales for US, Canada, Europe,
Asia-Pacific, Latin America, and Rest of World Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) II-41

Table 14: World Recent Past, Current and Future Analysis for
Testosterone Replacement Therapy (TRT) by Product Segment -
Topicals, Patches, and Other Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2013
through 2020 (includes corresponding Graph/Chart) II-42

Table 15: World Historic Review for Testosterone Replacement
Therapy (TRT) by Product Segment - Topicals, Patches, and
Other Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) II-43

Table 16: World 15-Year Perspective for Testosterone
Replacement Therapy (TRT) by Product Segment - Percentage
Breakdown of Dollar Sales for Topicals, Patches, and Other
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) II-44


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Hypogonadism - High Prevalence, Low Treatment, Offers
Increasing Potential III-1
Topical Gels - The Largest Selling Segment III-1
Table 17: The US TRT Market by Leading Brand (2012 and 2013):
Percentage Market Share Breakdown of Revenues for
Androderm, Androgel, Axiron, Fortesta, Injections, Testim,
and Others (includes corresponding Graph/Chart) III-2

Table 18: Total TRT Annual Transdermal Prescriptions in the
US: Number of Total Prescriptions (Nov 2012 - June 2014)
(includes corresponding Graph/Chart) III-2
A Comparison of Commonly Prescribed Topical TRT Products in
the US III-3
“Low T” Trend Litigations III-3
New Products Strive to Address Transference Issues III-3
High-Concentration Products Gain Market Share in the
Topicals Market III-4
Debate Continues Over the Need for TRT III-4
Big Pharma Spends Millions to Push TRT Sales III-5
Table 19: The US Ad Spending on Testosterone Products:
2010- 2014 (1st Half) (includes corresponding Graph/Chart) III-5
Increasing Ad Spending Draws Flak III-5
Product Landscape III-6
AndroGel Retains Leadership in Total Prescriptions III-6
Table 20: The US Testosterone Gel and Patch Market by
Leading Player (Mid 2013 and Mid 2014): Percentage Market
Share Breakdown of Total Prescriptions for AndroGel (1% and
1.62%), Androderm, Axiron, Fortesta, and Testim (includes
corresponding Graph/Chart) III-6
AbbVie Fights on for AndroGel's Market Sustenance III-7
Axiron Regains Growth Momentum III-7
Table 21: Axiron Quarterly Sales in the US: 2011 through
2014 (includes corresponding Graph/Chart) III-8
Co-Pay Scheme Helps Axiron Attract Users III-8
Testim Prescriptions Shoot up, Revenues Head South III-8
Impending Patent Expiries III-9
Patent Expiries of Leading TRT Brands in the US III-9
Generics in the Pipeline III-9
List of Testosterone Generics in the Pipeline for US Market III-10
Product Launches/Approvals III-10
Strategic Corporate Developments III-12
Key Players III-14
B.Market Analytics III-18
Table 22: The US Recent Past, Current and 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 2013
through 2020 (includes corresponding Graph/Chart) III-18

Table 23: The 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 2006 through 2012 (includes
corresponding Graph/Chart) III-19

Table 24: The US 15-Year Perspective for Testosterone
Replacement Therapy by Product Segment - Percentage
Breakdown of Dollar Sales for Topicals, Patches, and Other
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-20

2. CANADA III-21
A.Market Analysis III-21
Current and Future Analysis III-21
Available TRT Therapies in Canada III-21
Competitive Scenario III-21
Product Approval/Launch III-22
Trimel Pharmaceutical Corp. - A Key Canadian Player III-22
B.Market Analytics III-23
Table 25: Canadian Recent Past, Current and Future Analysis
for Testosterone Replacement Therapy Market Analyzed with
Annual Sales Figures in US$ Million for Years 2013 through
2020 (includes corresponding Graph/Chart) III-23

Table 26: Canadian Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-24

3. EUROPE III-25
A.Market Analysis III-25
Current and Future Analysis III-25
Gels to Drive European TRT Market III-25
Lower Normal Serum Testosterone Concentration in Select
European Nations III-25
B.Market Analytics III-26
Table 27: European Recent Past, Current and Future Analysis
for Testosterone Replacement Therapy 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-26

Table 28: European Historic Review for Testosterone
Replacement Therapy 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-27

Table 29: European 15-Year Perspective for Testosterone
Replacement Therapy 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-28

3a. FRANCE III-29
Market Analysis III-29
Table 30: French Recent Past, Current and Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-29

Table 31: French Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-30

3b. GERMANY III-31
A.Market Analysis III-31
Bayer Healthcare Pharmaceuticals - A Key Player III-31
B.Market Analytics III-32
Table 32: German Recent Past, Current and Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-32

Table 33: German Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-33

3c. ITALY III-34
Market Analysis III-34
Table 34: Italian Recent Past, Current and Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-34

Table 35: Italian Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-35

3d. THE UNITED KINGDOM III-36
A.Market Analysis III-36
Market Overview III-36
Table 36: The UK TRT Market by Product Type (2012):
Percentage Breakdown of Value Sales for Topical Gels,
Injectables, Patches, and Oral Products (includes
corresponding Graph/Chart) III-36
Product Launch/Approval III-36
Strategic Corporate Development III-37
Select Key Player III-37
B.Market Analytics III-38
Table 37: The UK Recent Past, Current and Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-38

Table 38: The UK Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-39

3e. SPAIN III-40
Market Analysis III-40
Table 39: Spanish Recent Past, Current and Future Analysis for
Testosterone Replacement Therapy Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-40

Table 40: Spanish Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-41

3f. REST OF EUROPE III-42
Market Analysis III-42
Table 41: Rest of European Recent Past, Current and Future
Analysis for Testosterone Replacement Therapy Market
Analyzed with Annual Sales Figures in US$ Million for Years
2013 through 2020 (includes corresponding Graph/Chart) III-42

Table 42: Rest of European Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-43

4. ASIA-PACIFIC III-44
A.Market Analysis III-44
Current and Future Analysis III-44
Increasing Use of Testosterone in Australia III-44
Strategic Corporate Development III-44
Select Key Player III-44
B.Market Analytics III-45
Table 43: Asia-Pacific Recent Past, Current and Future
Analysis for Testosterone Replacement Therapy Market
Analyzed with Annual Sales Figures in US$ Million for Years
2013 through 2020 (includes corresponding Graph/Chart) III-45

Table 44: Asia-Pacific Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-46

5. LATIN AMERICA III-47
Market Analysis III-47
Table 45: Latin American Recent Past, Current and Future
Analysis for Testosterone Replacement Therapy Market
Analyzed with Annual Sales Figures in US$ Million for Years
2013 through 2020 (includes corresponding Graph/Chart) III-47

Table 46: Latin American Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-48

6. REST OF WORLD III-49
A.Market Analysis III-49
Product Launch III-49
B.Market Analytics III-49
Table 47: Rest of World Recent Past, Current and Future
Analysis for Testosterone Replacement Therapy Market
Analyzed with Annual Sales Figures in US$ Million for Years
2013 through 2020 (includes corresponding Graph/Chart) III-49

Table 48: Rest of World Historic Review for Testosterone
Replacement Therapy Market Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-50


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 35 (including Divisions/Subsidiaries - 36)

The United States (21)
Canada (3)
Japan (1)
Europe (8)
- Germany (1)
- The United Kingdom (4)
- Rest of Europe (3)
Asia-Pacific (Excluding Japan) (3)

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