TESTOSTERONE REPLACEMENT THERAPY (TRT) - A GLOBAL STRATEGIC BUSINESS REPORT   

Research Abstract

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


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Code : MCP-6770
Price : $4950
Companies : 30
Pages : 152
Date : October 2013
Market Data Tables : 46

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 TABLE OF CONTENTS


 
   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
  
   Product Definitions and Scope of Study.....I-3  
   TRT Market – A Primer.....II-11$100
   Current & Future Analysis.....II-2
US Dominates the Global TRT Market.....II-2
Outside US Markets to Witness Tremendous Growth.....II-2
1$100
   Topicals Dominate US Market; Conventional Drugs Rule Elsewhere.....II-3
Growth Rate Dips in the Global TRT Market.....II-3
1$100
   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
1$350
   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
1$350
   Table 4: Top 20 Countries with Male Population Aged 15 - 64: 2010 (in Millions) (includes corresponding Graph/Chart).....II-61$350
   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
1$350
   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
1$100
   Untapped Markets - The Future Prospects for TRT.....II-9
Testosterone as a Treatment for Other Conditions – A Growing Area of Focus.....II-9
1$100
   A Consolidated Market.....II-10
Table 6: Global Sales of Leading Testosterone Replacement Therapy Products: 2011 & 2012 (includes corresponding Graph/Chart).....II-10
1$350
   Entry of Large Multinational Players.....II-11
Leading Brands and Companies.....II-11
Generic Incursion – A Major Threat.....II-11
1$100
   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
1$100
   Eli Lilly to Turn Axiron into a Global TRT Brand.....II-131$100
   Axiron’s Patent Profile.....II-14
Testim (Auxilium).....II-14
Table 7: Global Market of Testim by Geographic Region (2011 & 2012): Breakdown of Annual Value Sales in US$ Million for US and Rest of World Markets (includes corresponding Graph/Chart).....II-14
1$350
   Testim Scores High on Efficacy over AndroGel.....II-15
Small Packaging Works for Testim.....II-15
Androderm (Actavis).....II-15
1$100
   Fortesta (Endo Health Solutions).....II-16
Tostran (Prostrakan Group).....II-16
Testopel (Auxilium).....II-16
Restandol (Organon).....II-16
1$100
   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
1$100
   Major Testosterone Replacement Therapy Products in Pipeline.....II-18
An Overview of Select Drugs in Pipeline.....II-18
CompleoTRT – A Comparative Review.....II-18
1$100
   VIBEX QS T – A New Hope to Injectables Users.....II-19
Androxal.....II-19
CLR-610.....II-19
1$100
   Testosterone – An Introduction.....II-20
Testosterone Deficiency.....II-20
Primary Hypogonadism.....II-20
Secondary Hypogonadism.....II-20
Symptoms.....II-20
General Symptoms.....II-20
1$100
   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
1$350
   Causes.....II-22
Co-Morbid Conditions.....II-22
Table 9: Hypogonadism Prevalence in Some Common Medical Conditions (includes corresponding Graph/Chart).....II-22
1$350
   Diabetes and Hypogonadism.....II-23
Diagnosis.....II-23
Testosterone Replacement.....II-23
Testosterone Replacement Therapy – Evolution.....II-23
Topicals.....II-23
1$100
   Patches.....II-24
Others.....II-24
Injections.....II-24
Orals.....II-24
1$100
   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
1$100
   Precautions.....II-26
Treatment Alternatives.....II-26
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   Cell Genesys Merges with BioSante Pharmaceuticals.....II-37
Endo Purchases US Rights for Fortesta.....II-37
Endo Pharmaceutical Acquires Indevus Pharmaceuticals.....II-37
1$100
   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
1$100
   AbbVie Inc. (US).....II-39
Acrux Limited (Australia).....II-39
1$100
   Actavis, Inc. (US).....II-40
Antares Pharma, Inc. (US).....II-40
1$100
   Auxilium Pharmaceuticals, Inc. (US).....II-41
Bayer HealthCare Pharmaceuticals (Germany).....II-41
1$100
   Clarus Therapeutics (US).....II-42
Columbia Laboratories, Inc. (US).....II-42
1$100
   Eli Lilly and Company (US).....II-43
Endo Health Solutions Inc. (US).....II-43
1$100
   GlaxoSmithKline plc. (UK).....II-44
ProStrakan Group PLC. (UK).....II-44
1$100
   Trimel Pharmaceutical Corporation (Canada).....II-451$100
   Table 10: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....II-461$350
   Table 11: World Historic Review for Testosterone Replacement Therapy by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....II-471$350
   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-481$350
   Table 13: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Product Segment - Topicals, Patches, and Other Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....II-491$350
   Table 14: World Historic Review for Testosterone Replacement Therapy by Product Segment - Topicals, Patches, and Other Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....II-501$350
   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-511$350
   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
1$200
   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
1$75
   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
1$75
   Debate Continues Over the Need for TRT.....III-4
Big Pharma Spends Millions to Push TRT Sales.....III-4
1$75
   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
1$200
   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
1$200
   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
1$200
   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
1$75
   Product Launches/ Approvals.....III-93$150
   Strategic Corporate Developments.....III-127$275
   Key Players.....III-195$225
   B. Market Analytics.....III-24
Table 21: US Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Product Segment - Topicals, Patches and Other Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-24
1$200
   Table 22: US Historic Review for Testosterone Replacement Therapy by Product Segment - Topicals, Patches and Other Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-251$200
   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-261$200
   A. Market Analysis.....III-27
Current & Future Analysis.....III-27
Market Overview.....III-27
Available TRT Therapies in Canada.....III-27
1$75
   Competition in the Canadian TRT Market – An Overview.....III-28
Table 24: Canadian Topical Testosterone Gel Market (2011): Breakdown of Annual Revenues for AndroGel and Testim in US$ Million (includes corresponding Graph/Chart).....III-28
1$200
   Product Launch.....III-29
Strategic Corporate Developments.....III-29
Key Player.....III-29
1$75
   B. Market Analytics.....III-30
Table 25: Canadian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-30
1$200
   Table 26: Canadian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-311$200
   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
1$75
   B. Market Analytics.....III-33
Table 27: European Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Geographic Region - France, Germany, Italy, UK, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-33
1$200
   Table 28: European Historic Review for Testosterone Replacement Therapy by Geographic Region - France, Germany, Italy, UK, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-341$200
   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-351$200
   A. Market Analysis.....III-36
Current & Future Analysis.....III-36
B. Market Analytics.....III-36
Table 30: French Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-36
1$200
   Table 31: French Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-371$200
   A. Market Analysis.....III-38
Current & Future Analysis.....III-38
Bayer HealthCare Pharmaceuticals – A Key Player in TRT Market.....III-38
1$75
   B. Market Analytics.....III-39
Table 32: German Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-39
1$200
   Table 33: German Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-401$200
   A. Market Analysis.....III-41
Current & Future Analysis.....III-41
B. Market Analytics.....III-41
Table 34: Italian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-41
1$200
   Table 35: Italian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-421$200
   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
1$200
   Strategic Corporate Development.....III-44
Key Players.....III-44
1$75
   B. Market Analytics.....III-45
Table 37: UK Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-45
1$200
   Table 38: UK Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-461$200
   A. Market Analysis.....III-47
Current & Future Analysis.....III-47
Strategic Corporate Development.....III-47
1$75
   B. Market Analytics.....III-48
Table 39: Rest of Europe Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-48
1$200
   Table 40: Rest of Europe Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-491$200
   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
1$75
   B. Market Analytics.....III-51
Table 41: Asia-Pacific Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-51
1$200
   Table 42: Asia-Pacific Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-521$200
   A. Market Analysis.....III-53
Current & Future Analysis.....III-53
B. Market Analytics.....III-53
Table 43: Latin American Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-53
1$200
   Table 44: Latin American Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-541$200
   A. Market Analysis.....III-55
Current & Future Analysis.....III-55
Product Launch.....III-55
1$75
   B. Market Analytics.....III-56
Table 45: Rest of World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-56
1$200
   Table 46: Rest of World Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-571$200
  
Total Companies Profiled: 30 (including Divisions/Subsidiaries - 36)

Region/Country Players

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
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