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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 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.

Click here to request a full list of companies covered in the report...

Code: MCP-6770
Price: $4950
Companies: 35
Pages: 166
Date: January 2015
Market Data Tables: 48
 



TABLE OF CONTENTS


  TESTOSTERONE REPLACEMENT THERAPY (TRT) (Complete Report) Pages : 166   | $4950

   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
  
   Product Definitions and Scope of Study.....I-3  
   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
1$350
   Recently Approved/ Pipeline Testosterone Replacement Therapy Products.....II-21$100
   US Dominates the Global TRT Market.....II-3
Markets, Other than the US, to Witness Tremendous Growth.....II-3
1$100
   Topicals Dominate the US Market, Conventional Drugs Rule Elsewhere.....II-41$100
   Leading TRT Products Available in the Market.....II-5
Cardiovascular Risks Taint the TRT Market.....II-5
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   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
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   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
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   Table 6: Top 20 Countries with Male Population Aged 65 & Above: 2010 (in Millions) (includes corresponding Graph/Chart).....II-8
Undiagnosed Patients – A Strong Indicator of Growth Potential.....II-8
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   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
1$100
   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
1$100
   Aggressive DTC Advertising Eases in 2014.....II-111$100
   TRT- A Highly Consolidated Market.....II-12
Table 7: World Testosterone Replacement Therapy Products Market by Leading Player (2012 & 2013): Percentage Market Share Breakdown of Value Sales for AndroGel, Testim, Androderm, Axiron, Testopel, and Fortesta (includes corresponding Graph/Chart).....II-12
1$350
   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
1$100
   AndroGel (AbbVie).....II-14
Axiron (Eli Lilly).....II-14
Axiron – A Comparison with Other Products.....II-14
1$100
   Axiron’s Patent Profile.....II-15
Testim (Auxilium).....II-15
1$100
   Table 8: Global Market of Testim by Geographic Region (2012 & 2013): Breakdown of Annual Value Sales Markets in US$ 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
1$350
   Fortesta (Endo Pharmaceuticals).....II-17
Tostran (Prostrakan Group).....II-17
Threat from New Products.....II-17
1$100
   Pipeline Analysis.....II-18
Oral Drugs Dominate Drug Development Pipeline.....II-18
An Overview of Select Drugs in Pipeline.....II-18
Natesto™ TRT – A Comparative Review.....II-18
VIBEX QS T – A New Hope to Injectables Users.....II-18
1$100
   Androxal.....II-19
Rextoro (formerly 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 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
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   Causes.....II-22
Co-Morbid Conditions.....II-22
Table 10: Hypogonadism Prevalence in Some Common Medical Conditions (includes corresponding Graph/Chart).....II-22
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   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
Pellets.....II-24
1$100
   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
   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
1$100
   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
1$100
   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-Gel™ Receives FDA Clearance.....II-29
1$100
   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
1$100
   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
1$100
   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
1$100
   AbbVie, Inc. (US).....II-33
Acrux Limited (Australia).....II-33
1$100
   Actavis, Inc. (US).....II-34
Antares Pharma, Inc. (US).....II-34
1$100
   Auxilium Pharmaceuticals, Inc. (US).....II-35
Bayer HealthCare Pharmaceuticals (Germany).....II-35
1$100
   Columbia Laboratories, Inc. (US).....II-36
Eli Lilly and Company (US).....II-36
1$100
   Endo Pharmaceuticals Inc. (US).....II-37
ProStrakan Group PLC. (UK).....II-37
Trimel Pharmaceutical Corporation (Canada).....II-37
2$200
   Table 11: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy (TRT) by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....II-391$350
   Table 12: World Historic Review for Testosterone Replacement Therapy (TRT) by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....II-401$350
   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 & 2020 (includes corresponding Graph/Chart).....II-411$350
   Table 14: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy (TRT) by Product Segment - Topicals, Patches, and Other Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....II-421$350
   Table 15: World Historic Review for Testosterone Replacement Therapy (TRT) by Product Segment - Topicals, Patches, and Other Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....II-431$350
   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 & 2020 (includes corresponding Graph/Chart).....II-441$350
   A. Market Analysis.....III-1
Hypogonadism – High Prevalence, Low Treatment, Offers Increasing Potential.....III-1
Topical Gels – The Largest Selling Segment.....III-1
1$75
   Table 17: The US TRT Market by Leading Brand (2012 & 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
1$200
   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
1$75
   High-Concentration Products Gain Market Share in the Topicals Market.....III-4
Debate Continues Over the Need for TRT.....III-4
1$75
   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
1$200
   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 & Mid 2014): Percentage Market Share Breakdown of Total Prescriptions for AndroGel (1% & 1.62%), Androderm, Axiron, Fortesta, and Testim (includes corresponding Graph/Chart).....III-6
1$200
   AbbVie Fights on for AndroGel’s Market Sustenance.....III-7
Axiron Regains Growth Momentum.....III-7
1$75
   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
1$200
   Impending Patent Expiries.....III-9
Patent Expiries of Leading TRT Brands in the US.....III-9
Generics in the Pipeline.....III-9
1$75
   List of Testosterone Generics in the Pipeline for US Market.....III-10
Product Launches/Approvals.....III-10
2$150
   Strategic Corporate Developments.....III-122$150
   Key Players.....III-144$300
   B. Market Analytics.....III-18
Table 22: The US Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Product Segment - Topicals, Patches, and Other Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-18
1$200
   Table 23: The US Historic Review for Testosterone Replacement Therapy by Product Segment - Topicals, Patches, and Other Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-191$200
   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 & 2020 (includes corresponding Graph/Chart).....III-201$200
   A. Market Analysis.....III-21
Current & Future Analysis.....III-21
Available TRT Therapies in Canada.....III-21
Competitive Scenario.....III-21
1$75
   Product Approval/Launch.....III-22
Trimel Pharmaceutical Corp. – A Key Canadian Player.....III-22
1$75
   B. Market Analytics.....III-23
Table 25: Canadian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-23
1$200
   Table 26: Canadian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-241$200
   A. Market Analysis.....III-25
Current & Future Analysis.....III-25
Gels to Drive European TRT Market.....III-25
Lower Normal Serum Testosterone Concentration in Select European Nations.....III-25
1$75
   B. Market Analytics.....III-26
Table 27: European Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-26
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 2006 through 2012 (includes corresponding Graph/Chart).....III-271$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 2006, 2014 & 2020 (includes corresponding Graph/Chart).....III-281$200
   Market Analysis.....III-29
Table 30: French Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-29
1$200
   Table 31: French Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-301$200
   A. Market Analysis.....III-31
Bayer Healthcare Pharmaceuticals – A Key Player.....III-31
1$75
   B. Market Analytics.....III-32
Table 32: German Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-32
1$200
   Table 33: German Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-331$200
   Market Analysis.....III-34
Table 34: Italian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-34
1$200
   Table 35: Italian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-351$200
   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
1$200
   Strategic Corporate Development.....III-37
Select Key Player.....III-37
1$75
   B. Market Analytics.....III-38
Table 37: The UK Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-38
1$200
   Table 38: The UK Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-391$200
   Market Analysis.....III-40
Table 39: Spanish Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-40
1$200
   Table 40: Spanish Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-411$200
   Market Analysis.....III-42
Table 41: Rest of European Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-42
1$200
   Table 42: Rest of European Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-431$200
   A. Market Analysis.....III-44
Current & Future Analysis.....III-44
Increasing Use of Testosterone in Australia.....III-44
Strategic Corporate Development.....III-44
Select Key Player.....III-44
1$75
   B. Market Analytics.....III-45
Table 43: Asia-Pacific Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-45
1$200
   Table 44: Asia-Pacific Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-461$200
   Market Analysis.....III-47
Table 45: Latin American Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-47
1$200
   Table 46: Latin American Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-481$200
   A. Market Analysis.....III-49
Product Launch.....III-49
B. Market Analytics.....III-49
Table 47: Rest of World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-49
1$200
   Table 48: Rest of World Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-501$200
  
Total Companies Profiled: 35 (including Divisions/Subsidiaries - 36)

Region/Country Players

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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