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Testosterone Replacement Therapy (TRT) - Global Strategic Business Report Product Image

Testosterone Replacement Therapy (TRT) - Global Strategic Business Report

  • ID: 1824157
  • January 2015
  • Region: Global
  • 166 Pages
  • Global Industry Analysts, Inc

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.

Note: Product cover images may vary from those shown

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
Topicals
Patches
Others

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW
High Incidence of Testosterone Deficiency Offers Growth Potential
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)
Recently Approved/ Pipeline Testosterone Replacement Therapy Products
US Dominates the Global TRT Market
Markets, Other than the US, to Witness Tremendous Growth
Topicals Dominate the US Market, Conventional Drugs Rule Elsewhere
Leading TRT Products Available in the Market
Cardiovascular Risks Taint the TRT Market

2. GROWTH DRIVERS AND MARKET TRENDS
Aging Global Population Drives Adoption
Table 2: Percentage of Total Population above 65 Years of Age in Select Countries for 2000 and 2025(F) (includes corresponding Graph/Chart)
Table 3: Global Male Population Distribution (15-64 Yrs) by Geographic Region/Country: 2010 (includes corresponding Graph/Chart)
Table 4: Global Male Population Distribution (65+Yrs) by Geographic Region/Country: 2010 (includes corresponding Graph/Chart)
Table 5: Top 20 Countries with Male Population Aged 15 - 64: 2010 (in Millions) (includes corresponding Graph/Chart)
Table 6: Top 20 Countries with Male Population Aged 65 & Above: 2010 (in Millions) (includes corresponding Graph/Chart)
Undiagnosed Patients - A Strong Indicator of Growth Potential
Rising Awareness - A Critical Factor for Growth
Emerging Data on Positive Impact on Co-morbidities to Support Growth
Marketing Campaigns and Patient Referrals to Fuel Growth
Easy-to-use Formulations - A Major Boost to TRT Market
Untapped Developing Markets - The Future Growth Engine for TRT
Testosterone as Treatment for Other Conditions - A Growing Area of Focus
FDA Rejects Citizen “Black Box” Petition
Aggressive DTC Advertising Eases in 2014

3. COMPETITION
TRT- A Highly Consolidated Market
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)
Entry of Large Multinational Players
Generic Incursion - A Major Threat
Expiration of Patents and Market Exclusivity of Leading TRT Brands in the US

4. AN OVERVIEW OF SELECT DRUGS ON THE MARKET
AndroGel (AbbVie)
Axiron (Eli Lilly)
Axiron - A Comparison with Other Products
Axiron’s Patent Profile
Testim (Auxilium)
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)
Testim Scores High on Efficacy over AndroGel
Small Packaging Works for Testim
Androderm (Actavis)
Fortesta (Endo Pharmaceuticals)
Tostran (Prostrakan Group)
Threat from New Products
Pipeline Analysis
Oral Drugs Dominate Drug Development Pipeline
An Overview of Select Drugs in Pipeline
Natesto™ TRT - A Comparative Review
VIBEX QS T - A New Hope to Injectables Users
Androxal
Rextoro (formerly CLR-610)

5. TESTOSTERONE DEFICIENCY AND TRT - AN OVERVIEW
Testosterone - An Introduction
Testosterone Deficiency
Primary Hypogonadism
Secondary Hypogonadism
Symptoms
General Symptoms
Clinical Symptoms
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)
Causes
Co-Morbid Conditions
Table 10: Hypogonadism Prevalence in Some Common Medical Conditions (includes corresponding Graph/Chart)
Diabetes and Hypogonadism
Diagnosis
Testosterone Replacement
Testosterone Replacement Therapy - Evolution
Topicals
Patches
Others
Injections
Orals
Pellets
A Comparison of Key Benefits and Drawbacks of Existing Testosterone Preparations
Major Potential Benefits of TRT
Major Potential Risks of TRT
Precautions
Treatment Alternatives

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

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

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

9. GLOBAL MARKET PERSPECTIVE
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)
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)
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)
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)
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)
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)

III. MARKET

1. THE UNITED STATES
A.Market Analysis
Hypogonadism - High Prevalence, Low Treatment, Offers Increasing Potential
Topical Gels - The Largest Selling Segment
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)
Table 18: Total TRT Annual Transdermal Prescriptions in the US: Number of Total Prescriptions (Nov 2012 - June 2014) (includes corresponding Graph/Chart)
A Comparison of Commonly Prescribed Topical TRT Products in the US
“Low T” Trend Litigations
New Products Strive to Address Transference Issues
High-Concentration Products Gain Market Share in the Topicals Market
Debate Continues Over the Need for TRT
Big Pharma Spends Millions to Push TRT Sales
Table 19: The US Ad Spending on Testosterone Products: 2010- 2014 (1st Half) (includes corresponding Graph/Chart)
Increasing Ad Spending Draws Flak
Product Landscape
AndroGel Retains Leadership in Total Prescriptions
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)
AbbVie Fights on for AndroGel’s Market Sustenance
Axiron Regains Growth Momentum
Table 21: Axiron Quarterly Sales in the US: 2011 through 2014 (includes corresponding Graph/Chart)
Co-Pay Scheme Helps Axiron Attract Users
Testim Prescriptions Shoot up, Revenues Head South
Impending Patent Expiries
Patent Expiries of Leading TRT Brands in the US
Generics in the Pipeline
List of Testosterone Generics in the Pipeline for US Market
Product Launches/Approvals
Strategic Corporate Developments
Key Players
B.Market Analytics
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)
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)
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)

2. CANADA
A.Market Analysis
Current & Future Analysis
Available TRT Therapies in Canada
Competitive Scenario
Product Approval/Launch
Trimel Pharmaceutical Corp. - A Key Canadian Player
B.Market Analytics
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)
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)

3. EUROPE
A.Market Analysis
Current & Future Analysis
Gels to Drive European TRT Market
Lower Normal Serum Testosterone Concentration in Select European Nations
B.Market Analytics
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)
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)
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 & 2020 (includes corresponding Graph/Chart)
3a. FRANCE
Market Analysis
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)
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)
3b. GERMANY
A.Market Analysis
Bayer Healthcare Pharmaceuticals - A Key Player
B.Market Analytics
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)
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)
3c. ITALY
Market Analysis
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)
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)
3d. THE UNITED KINGDOM
A.Market Analysis
Market Overview
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)
Product Launch/Approval
Strategic Corporate Development
Select Key Player
B.Market Analytics
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)
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)
3e. SPAIN
Market Analysis
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)
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)
3f. REST OF EUROPE
Market Analysis
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)
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)
4. ASIA-PACIFIC
A.Market Analysis
Current & Future Analysis
Increasing Use of Testosterone in Australia
Strategic Corporate Development
Select Key Player
B.Market Analytics
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)
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)
5. LATIN AMERICA
Market Analysis
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)
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)
6. REST OF WORLD
A.Market Analysis
Product Launch
B.Market Analytics
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)
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)

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)

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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