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

Testosterone Replacement Therapy (TRT) - Global Strategic Business Report

  • ID: 1824157
  • October 2013
  • Region: Global
  • 152 Pages
  • Global Industry Analysts, Inc

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.

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
- Others

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

Please note: Reports are sold as single-site single-user licenses. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks.

For information on site licence pricing please click on Enquire before buying.

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

II. EXECUTIVE SUMMARY

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

2. INDUSTRY OVERVIEW
High Incidence, Low Treatment
Aging Global Population Drives Adoption
Table 1: Percentage of Total Population Above 65 Years of Age in Select Countries for 2000 and 2025(F) (includes corresponding Graph/Chart)
Table 2: Global Male Population Distribution (15-64 Yrs) by Geographic Region/Country: 2010 (includes corresponding Graph/Chart)
Table 3: Global Male Population Distribution (65+Yrs) by Geographic Region/Country: 2010 (includes corresponding Graph/Chart)
Table 4: Top 20 Countries with Male Population Aged 15 - 64: 2010 (in Millions) (includes corresponding Graph/Chart)
Table 5: 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 to 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 Markets - The Future Prospects for TRT
Testosterone as a Treatment for Other Conditions - A Growing Area of Focus

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

4. TESTOSTERONE DEFICIENCY AND TRT - AN OVERVIEW
Testosterone - An Introduction
Testosterone Deficiency
Primary Hypogonadism
Secondary Hypogonadism
Symptoms
General Symptoms
Clinical Symptoms
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)
Causes
Co-Morbid Conditions
Table 9: 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

5. PRODUCT LAUNCHES/APPROVALS
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
Eli Lilly Launches Axiron Topical Solution in the US
US FDA Grants Approval Low-Dose Formulations of Watson’s Androderm®
Abbott Obtains FDA Clearance for AndroGel® 1.62%
Teva Pharmaceuticals Receives NDA Acceptance from FDA for Bio -T-Gel
Endo Pharmaceuticals’ Fortesta Gel Secures FDA Acceptance
Acrux Receives US FDA Approval for Axiron® Topical Solution

6. RECENT INDUSTRY ACTIVITY
CoreRx and TesoRx Pharma Form Production Joint Venture for TSX
Eli Lilly Files Lawsuit against Perrigo for Infringing Axiron Patents
Perrigo Files for Generic Axiron Approval with FDA
Auxilium Wins Patents 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
Trimel Pharmaceuticals Files NDA for CompleoTRT™ with US FDA (US)
Watson Pharmaceuticals Rebrands to Actavis
US FDA Accepts to Review Complete Response Submission for NDA of Endo Pharmaceuticals’s 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
Repros Therapeutics Receives IRB for Phase 2b Study of Androxal
Columbia Laboratories and Actient Pharmaceuticals Ink Asset
Purchase Agreement for STRIANT® in US
Kyowa Hakko Kirin Acquires ProStrakan Group
Trimel Pharmaceuticals Amalgamates Operations with Trimel BioPharma Holdings
Actient Pharmaceuticals Bags the US Rights to Columbia Laboratories’ Striant®
Abbott Takes Over Solvay Pharmaceuticals
Eli Lilly Signs Global License Agreement with Acrux
ProStrakan and Paladin Labs to Enter Strategic Partnership
Endo Pharmaceuticals Files Class 2 Resubmission for Fortesta
Acrux Announces Phase III Clinical Trial Results for Axiron
Repros Announces Phase 2b Proof-of-Concept Clinical Trial Results for Androxal
Boston Medical Group Expands Extensive ED Treatment by Adding Testopel® TRT
Cell Genesys Merges with BioSante Pharmaceuticals
Endo Purchases US Rights for Fortesta
Endo Pharmaceutical Acquires Indevus Pharmaceuticals
Solvay Pharmaceutical to Market Lipocine’s Oral Testosterone Pill
US FTC Files Lawsuit against Solvay, Watson and Par for 2006 Patent Settlement for Androgel
Endo Pharmaceuticals Receives Complete Response Letter from FDA for Aveed™
ProStrakan Submits Response to FDA’s Action Letter Regarding NDA for Fortigel™

7. 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)
Clarus Therapeutics (US)
Columbia Laboratories, Inc. (US)
Eli Lilly and Company (US)
Endo Health Solutions Inc. (US)
GlaxoSmithKline plc. (UK)
ProStrakan Group PLC. (UK)
Trimel Pharmaceutical Corporation (Canada)

8. GLOBAL MARKET PERSPECTIVE
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)
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)
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)
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)
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)
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)

III. MARKET

1. THE UNITED STATES
A.Market Analysis
Current & Future Analysis
Table 16: Total Prescriptions of Testosterone Products in the US for Years 2010-2012 (includes corresponding Graph/Chart)
Topical Gels - The Largest Selling Segment
A Comparison of Commonly Prescribed Topical TRT Products in the US
Hypogonadism - High on Prevalence, Low on Treatment
US Market Slows Down
Efforts to Increase Awareness to Fuel Growth
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 17: Ad Spending on Testosterone Products in the US for Years 2010-2012 (includes corresponding Graph/Chart)
Increasing Ad Spending Draws Flak
Product Landscape
Axiron and High-Concentration AndroGel - Major Gainers in New Prescriptions
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)
AndroGel Retains Leadership in Total Prescriptions
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)
AbbVie Fights on for AndroGel’s Market Sustenance
Axiron Regains Growth Momentum
Table 20: Quarterly Sales of Axiron in the US: 2011 through 2013 (includes corresponding Graph/Chart)
Co-Pay Scheme Helps Axiron Attract Users
Competition and Other Issues Dent Testim’s Prospects in the US
Testim’s Performance in Prescriptions Improves, Revenues Head South
Product Launches/ Approvals
Strategic Corporate Developments
Key Players
B.Market Analytics
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)
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)
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)

2. CANADA
A.Market Analysis
Current & Future Analysis
Market Overview
Available TRT Therapies in Canada
Competition in the Canadian TRT Market - An Overview
Table 24: Canadian Topical Testosterone Gel Market (2011): Breakdown of Annual Revenues for AndroGel and Testim in US$ Million (includes corresponding Graph/Chart)
Product Launch
Strategic Corporate Developments
Key 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 2010 through 2018 (includes corresponding Graph/Chart)
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)

3. EUROPE
A.Market Analysis
Current & Future Analysis
Market Overview
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, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
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)
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)
3a. FRANCE
A.Market Analysis
Current & Future Analysis
B.Market Analytics
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)
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)
3b. GERMANY
A.Market Analysis
Current & Future Analysis
Bayer HealthCare Pharmaceuticals - A Key Player in TRT Market
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 2010 through 2018 (includes corresponding Graph/Chart)
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)
3c. ITALY
A.Market Analysis
Current & Future Analysis
B.Market Analytics
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)
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)
3d. THE UNITED KINGDOM
A.Market Analysis
Current & Future Analysis
Market Overview
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)
Strategic Corporate Development
Key Players
B.Market Analytics
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)
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)
3e. REST OF EUROPE
A.Market Analysis
Current & Future Analysis
Strategic Corporate Development
B.Market Analytics
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)
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)

4. ASIA-PACIFIC
A.Market Analysis
Current & Future Analysis
Increasing Use of Testosterone in Australia
Strategic Corporate Development
Key Player
B.Market Analytics
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)
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)

5. LATIN AMERICA
A.Market Analysis
Current & Future Analysis
B.Market Analytics
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)
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)

6. REST OF WORLD
A.Market Analysis
Current & Future Analysis
Product Launch
B.Market Analytics
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)
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)

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)

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