Testosterone Replacement Therapy (TRT) (MCP-6770) - Global Industry Analysts, Inc.

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: Gels, 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 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 20 companies including many key and niche players such as Abbott Laboratories, Acrux Ltd., Auxilium Pharmaceuticals, Inc., Bayer Schering Pharma AG, BioSante Pharmaceuticals, Inc., Clarus Therapeutics, Inc., Columbia Laboratories, Inc., Eli Lilly and Company, Endo Pharmaceuticals Holding, Inc., Ferring Pharmaceuticals, GlaxoSmithKline PLC, Ipsen, Kyowa Hakko Kirin Co., Ltd., ProStrakan Group Plc, Lipocine, Inc., Paladin Labs, Inc., Procter & Gamble Pharmaceuticals, Inc., Repros Therapeutics, Inc., Slate Pharmaceuticals, Inc., Trimel Biopharma Srl, and Watson Pharmaceuticals, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Code :	MCP-6770
Price :	$4600
Companies :	20

Pages :	201
Date :	March 2012
Market Data Tables :	31

Complimentary Market Brief:

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TESTOSTERONE REPLACEMENT THERAPY (TRT) (Complete Report)

Pages : 201

$4600

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations.....I-1

Disclaimers.....I-2

Data Interpretation & Reporting Level.....I-2

Quantitative Techniques & Analytics.....I-3

Product Definitions and Scope of Study.....I-3

Testosterone Replacement Therapy (TRT).....I-3

Gels.....I-3

Patches.....I-4

Others.....I-4

II. EXECUTIVE SUMMARY

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1. OUTLOOK.....II-1

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Outlook.....II-1

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2. INDUSTRY OVERVIEW.....II-2

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High Incidence, Low Treatment.....II-2

Gels Displacing Alternative Therapies.....II-2

Testosterone Treatment in Females: An Unmet Clinical Need.....II-2

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Growth Drivers.....II-3

Favorable Demographics.....II-3

Table 1: Percentage of Total Population Above 65 Years of Age in Select Countries for 2000 and 2025(F) (includes corresponding Graph/Chart).....II-3

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Table 2: Global Male Population Distribution (15-64 Yrs) by Geographic Region/Country: 2010 (includes corresponding Graph/Chart).....II-4

Table 3: Global Male Population Distribution (65+Yrs) by Geographic Region/Country: 2010 (includes corresponding Graph/Chart).....II-4

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Table 4: Top 20 Countries with Male Population Aged 15 - 64: 2010 (in millions) (includes corresponding Graph/Chart).....II-5

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Table 5: Top 20 Countries with Male Population Aged 65 & Above: 2010 (in millions) (includes corresponding Graph/Chart).....II-6

Rising Awareness.....II-6

Innovation and Improvement: Keys to Success.....II-6

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Untapped Markets.....II-7

Undiagnosed Patients.....II-7

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3. PRODUCT OVERVIEW.....II-8

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Testosterone � An Introduction.....II-8

Testosterone Deficiency.....II-8

Primary Hypogonadism.....II-8

Secondary Hypogonadism.....II-8

Symptoms.....II-8

General Symptoms.....II-8

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Clinical Symptoms.....II-9

Table 6: 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-9

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Causes.....II-10

Co-Morbid Conditions.....II-10

Table 7: Hypogonadism Prevalence in Some Common Medical Conditions (includes corresponding Graph/Chart).....II-10

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Diabetes and Hypogonadism.....II-11

Diagnosis.....II-11

Testosterone Replacement.....II-11

Testosterone Replacement Therapy � Evolution.....II-11

Treatment Alternatives.....II-11

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Gels.....II-12

Patches.....II-12

Others.....II-12

Injections.....II-12

Orals.....II-12

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Pellets.....II-13

Guidelines for Treatment of Hypogonadism.....II-13

Side Effects of TRT.....II-13

Precautions.....II-13

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4. COMPETITIVE ANALYSIS.....II-14

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Table 8: Global TRT Market (2010): Percentage Breakdown of Value Revenue for Androgel, Testim, Androderm and Others (includes corresponding Graph/Chart).....II-14

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Entry of Large Multinational Players.....II-15

Companies and Leading Brands.....II-15

Review of Select Brands.....II-15

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The Generic Incursion.....II-16

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Patent Expiration of Leading TRT Brands.....II-17

Threat from New Products.....II-17

Testosterone Therapies in Pipeline.....II-17

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New Delivery Methods.....II-18

Androxal.....II-18

CLR-610.....II-18

CompleoTRT.....II-18

SARMs.....II-18

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5. CLINICAL STUDIES/TRIALS.....II-19

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Repros Therapeutics receives IRB for Phase 2b study of Androxal.....II-19

Acrux Announces Phase III Clinical Trial Results for Axiron.....II-19

Repros Announces Phase 2b Proof-of-Concept Clinical Trial Results for Androxal.....II-19

ProStrakan Announces Positive Results from Study on Testosterone Replacement in

Diabetic Males.....II-19

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ProStrakan Announces Positive Results from US Clinical Study on Fortigel�.....II-20

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6. PRODUCT LAUNCHES/INNOVATIONS/ REGULATORY APPROVALS.....II-21

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BioSante�s Bio-T-Gel� Receives FDA Clearance.....II-21

Abbott Obtains FDA Clearance for AndroGel� 1.62%.....II-21

Teva Pharmaceuticals Receives NDA Acceptance from FDA for Bio-T-Gel.....II-21

Endo Pharmaceuticals� Fortesta Gel Secures FDA Acceptance.....II-21

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Acrux Receives US FDA Approval for Axiron� Topical Solution.....II-22

Acrux Applies to FDA for NDA for AXIRON�.....II-22

Endo Pharmaceuticals Files Class 2 Resubmission for Fortesta.....II-22

Endo Pharmaceuticals Receives Complete Response Letter from FDA for Aveed�.....II-22

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ProStrakan Submits Response to FDA�s Action Letter Regarding NDA for Fortigel�.....II-23

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7. RECENT INDUSTRY ACTIVITY.....II-24

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Kyowa Hakko Kirin Acquires ProStrakan Group.....II-24

Trimel Pharmaceuticals Amalgamates Operations with Trimel BioPharma Holdings.....II-24

Actient Pharmaceuticals Bags the US Rights to Columbia Laboratories� Striant�.....II-24

Abbott Takes Over Solvay Pharmaceuticals.....II-24

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Eli Lilly Signs Global License Agreement with Acrux.....II-25

ProStrakan and Paladin Labs to Enter Strategic Partnership.....II-25

Boston Medical Group Expands Extensive ED Treatment by Adding Testopel� TRT.....II-25

Cell Genesys Merges with BioSante Pharmaceuticals.....II-25

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Endo Purchases US Rights for Fortesta.....II-26

Endo Pharmaceutical Inks Merger Agreement with Indevus Pharmaceuticals.....II-26

Solvay Pharmaceutical to Market Lipocine�s Oral Testosterone Pill.....II-26

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US FTC Files Lawsuit Against Solvay, Watson and Par for 2006 Patent Settlement for

Androgel.....II-27

Auxilium and Ferring Ink Licensing Deal for Testim�.....II-27

Noven Inks Supply and License Pact with P&GP for Testosterone Patches to Treat HSDD in

Women.....II-27

Auxilium Terminates Distribution Deal for Testim with Ipsen.....II-27

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ProStrakan Grants Exclusive License to Bayer Schering Pharma for the Development of

Tostran� in 65 Countries.....II-28

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8. FOCUS ON SELECT GLOBAL PLAYERS.....II-29

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Abbott Laboratories (US).....II-29

Acrux Limited (Australia).....II-29

Auxilium Pharmaceuticals, Inc. (US).....II-29

Bayer Schering Pharma AG (Germany).....II-29

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Columbia Laboratories, Inc. (US).....II-30

Eli Lilly and Company (US).....II-30

Endo Pharmaceuticals, Inc. (US).....II-30

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GlaxoSmithKline plc. (UK).....II-31

Kyowa Hakko Kirin Co., Ltd. (Japan).....II-31

ProStrakan Group PLC. (UK).....II-31

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Slate Pharmaceuticals, Inc. (US).....II-32

Trimel BioPharma SRL (Canada).....II-32

Watson Pharmaceuticals, Inc. (US).....II-32

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9. GLOBAL MARKET PERSPECTIVE.....II-33

Table 9: 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 Revenue Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....II-33

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Table 10: 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 2003 through 2008 (includes corresponding Graph/Chart).....II-34

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Table 11: World 15-Year Perspective for Testosterone Replacement Therapy by Geographic Region � Percentage Breakdown of Dollar Revenues for US, Canada, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2003, 2010 & 2017 (includes corresponding Graph/Chart).....II-35

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Table 12: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Product Segments � Gels, Patches, and Others Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....II-36

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Table 13: World Historic Review for Testosterone Replacement Therapy by Product Segments � Gels, Patches, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart).....II-37

$350

Table 14: World 15-Year Perspective for Testosterone Replacement Therapy by Product Segments � Percentage Breakdown of Dollar Revenues for Gels, Patches, and Others Markets for Years 2003, 2011& 2017 (includes corresponding Graph/Chart).....II-38

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III. MARKET

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1. THE UNITED STATES.....III-1

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A. Market Analysis.....III-1

Hypogonadism Prevalence.....III-1

Table 15: Low Testosterone Prevalence in US Men Above 45 Years of Age (2010): Percentage of Men Population Suffering from Low Testosterone for Different Age Groups (includes corresponding Graph/Chart).....III-1

Competitive Scenario.....III-1

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Table 16: US Gel TRT Market (2009): Percentage Breakdown of Prescriptions for Androgel and Testim (includes corresponding Graph/Chart).....III-2

Table 17: US Gel TRT Market (2009): Percentage Breakdown of Value Revenue for Androgel and Testim (includes corresponding Graph/Chart).....III-2

Generic Threat to Gel Brands.....III-2

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Secondary Exposure.....III-3

$75

B. Market Analytics.....III-4

Table 18: US Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Product Segment � Gels, Patches and Others Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....III-4

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Table 19: US Historic Review for Testosterone Replacement Therapy by Product Segment � Gels, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 Through 2008 (includes corresponding Graph/Chart).....III-5

$200

Table 20: US 15-Year Perspective for Testosterone Replacement Therapy by Product Segment � Percentage Breakdown of Dollar Revenue for Gels, Patches and Others Markets for Years 2003, 2011& 2017 (includes corresponding Graph/Chart).....III-6

$200

2. CANADA.....III-7

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Market Analytics.....III-7

Table 21: Canadian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Markets Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....III-7

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Table 22: Canadian Historic Review for Testosterone Replacement Therapy Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart).....III-8

$200

3. EUROPE.....III-9

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A. Market Analysis.....III-9

Lower Normal Serum Testosterone Concentration in Select European Nations.....III-9

$75

B. Market Analytics.....III-10

Table 23: 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 2009 Through 2017 (includes corresponding Graph/Chart).....III-10

$200

Table 24: 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 2003 through 2008 (includes corresponding Graph/Chart).....III-11

$200

Table 25: 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 2003, 2011 & 2017(includes corresponding Graph/Chart).....III-12

$200

4. ASIA-PACIFIC.....III-13

$395

Market Analytics.....III-13

Table 26: Asia-Pacific Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Markets Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....III-13

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Table 27: Asia-Pacific Historic Review for Testosterone Replacement Therapy Markets Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart).....III-14

$200

5. LATIN AMERICA.....III-15

$395

Market Analytics.....III-15

Table 28: Latin American Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Markets Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....III-15

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Table 29: Latin American Historic Review for Testosterone Replacement Therapy Markets Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart).....III-16

$200

6. REST OF WORLD.....III-17

$395

Market Analytics.....III-17

Table 30: Rest of World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Markets Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....III-17

$200

Table 31: Rest of World Historic Review for Testosterone Replacement Therapy Markets Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart).....III-18

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IV. COMPETITIVE LANDSCAPE

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Total Companies Profiled: 19 
Region/Country                 Players

The United States                 12   
Canada                             1
Europe                             5
     France                        1
     Germany                       1
     The United Kingdom            2
     Rest of Europe                1
Asia-Pacific (Excluding Japan)     1

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

Research Abstract

Complimentary Market Brief:

TABLE OF CONTENTS