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TESTOSTERONE REPLACEMENT THERAPY INDUSTRY REPORT

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TRT Global Trends and Report - Testosterone Therapy

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I. TRT REPORT 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
Topicals I-4
Patches I-4
Others I-4

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II. TRT REPORT EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1 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 Recently Approved Pipeline Testosterone Replacement Therapy Products II-2 US Dominates the Global TRT Market II-3 Markets, Other than the US, to Witness Tremendous Growth II-3 Topicals Dominate the US Market, Conventional Drugs Rule Elsewhere II-4 Leading TRT Products Available in the Market II-5 Cardiovascular Risks Taint the TRT Market II-5

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2. TESTOSTERONE PRODUCT GROWTH DRIVERS AND MARKET TRENDS II-6 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

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

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 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 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 Aggressive DTC Advertising Eases in 2014 II-11

Learn about Testosterone Replacement for Men - Diagnosing Testosterone Deficiency

3. TRT GLOBAL COMPETITION II-12 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 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 Pfizer, Watson, Paddock, Sandoz, Endo Pharma

4. AN OVERVIEW OF SELECT DRUGS ON THE MARKET II-14 AndroGel (AbbVie) II-14 Axiron (Eli Lilly) II-14 Axiron - A Comparison with Other Products II-14 Axiron’s Patent Profile II-15 Testim (Auxilium) II-15 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 Fortesta (Endo Pharmaceuticals) II-17 Tostran (Prostrakan Group) II-17 Threat from New Products II-17 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 Androxal II-19 Rextoro (formerly CLR-610) II-19 Depo-Testosterone Delatestryl Sustanon Omnadren Cypiponate Enanthate Propionate

Learn about Testosterone Drug Medications - Testosterone Drugs Review

5. TESTOSTERONE DEFICIENCY AND TRT - AN OVERVIEW II-20 Testosterone - An Introduction II-20 Testosterone Deficiency II-20 Primary Hypogonadism II-20 Secondary Hypogonadism II-20 Symptoms II-20 General Symptoms II-20 Clinical Symptoms II-21

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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 Causes II-22 Co-Morbid Conditions II-22 Table 10: Hypogonadism Prevalence in Some Common Medical Conditions (includes corresponding Graph/Chart) II-22 Diabetes and Hypogonadism II-23 Diagnosis II-23 Testosterone Replacement II-23 Testosterone Replacement Therapy - Evolution II-23 Topicals II-23 Patches II-24 Others II-24 Injections II-24 Orals II-24 Pellets II-24

Learn about Hypogonadism and Testosterone - Testosterone to Treat Hypogonadism

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 Precautions II-26 Treatment Alternatives II-26

Results of Testosterone Therapy - Testosterone Treatment Results

6. PRODUCT LAUNCHES/APPROVALS II-27 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 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 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 Aveed® from Endo Pharmaceuticals Receives FDA Clearance Vogelxo® Upsher-Smith T Gel Receives FDA Clearance Testosterone Injections

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7. RECENT INDUSTRY ACTIVITY II-30 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 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 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

* Eli Lilly & Co. sued generic-drug maker Perrigo Co. and its subsidiary on Friday in Indiana federal court over its alleged infringement of patents on Eli Lilly’s testosterone drug Axiron, a topical treatment used by adult males with low or no testosterone.

8. FOCUS ON SELECT PLAYERS II-33 AbbVie, Inc. (US) II-33 Acrux Limited (Australia) II-33 Actavis, Inc. (US) II-34 Antares Pharma, Inc. (US) II-34 Auxilium Pharmaceuticals, Inc. (US) II-35 Bayer HealthCare Pharmaceuticals (Germany) II-35 Columbia Laboratories, Inc. (US) II-36 Eli Lilly and Company (US) II-36 Endo Pharmaceuticals Inc. (US) II-37 ProStrakan Group PLC. (UK) II-37 Trimel Pharmaceutical Corporation (Canada) II-37 Pfizer and Depo-Testosterone - Depo-Testosterone Injections

9. GLOBAL MARKET PERSPECTIVE II-39 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-39

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-40

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-41

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-42

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-43

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-44 Learn more about Testosterone Prescriptions - Testosterone Prescriptions

III. TRT MARKET

1. THE UNITED STATES III-1 A.Market Analysis III-1 Hypogonadism - High Prevalence, Low Treatment, Offers Increasing Potential III-1 Topical Gels - The Largest Selling Segment III-1 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 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 High-Concentration Products Gain Market Share in the Topicals Market III-4 Debate Continues Over the Need for TRT III-4 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 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 AbbVie Fights on for AndroGel’s Market Sustenance III-7 Axiron Regains Growth Momentum III-7

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 Impending Patent Expiries III-9 Patent Expiries of Leading TRT Brands in the US III-9 Generics in the Pipeline III-9 List of Testosterone Generics in the Pipeline for US Market III-10 Product Launches/Approvals III-10 Strategic Corporate Developments III-12 Key Players III-14 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 Online Sales of Testosterone Injections

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-19

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-20

2. TT+RT in CANADA III-21

A.Market Analysis III-21 Current & Future Analysis III-21 Available TRT Therapies in Canada III-21 Competitive Scenario III-21 Product Approval/Launch III-22 Trimel Pharmaceutical Corp. - A Key Canadian Player III-22

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

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-24

3. TRT in EUROPE III-25

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

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

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) III-27

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) III-28

3a. TRT in FRANCE III-29 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 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-30

3b. TRT in GERMANY III-31 A.Market Analysis III-31 Bayer Healthcare Pharmaceuticals - A Key Player III-31 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 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-33

3c. TRT in ITALY III-34 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 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-35

3d. TRT in THE UNITED KINGDOM III-36 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 Strategic Corporate Development III-37 Select Key Player III-37 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 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-39

3e. TRT in SPAIN III-40 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 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-41

3f. REST OF EUROPE III-42 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 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-43

4. TRT in ASIA-PACIFIC III-44 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 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

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-46

5. TRT in LATIN AMERICA III-47

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

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-48

6. REST OF WORLD III-49 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

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-50

IV. TRT MEDICAL INDUSTRY 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)


IMPORTANT: NO PRESCRIPTION FOR TESTOSTERONE WILL BE PROVIDED UNLESS A CLINICAL NEED EXISTS BASED ON REQUIRED LAB WORK, PHYSICIAN CONSULTATION, PHYSICAL EXAMINATION AND CURRENT MEDICAL HISTORY. PLEASE NOTE, AGREEING TO LAB WORK AND PHYSICAL EXAM DOES NOT GUARANTEE A FINDING OF CLINICAL NECESSITY AND A PRESCRIPTION FOR HORMONE THERAPY, HORMONE REPLACEMENT TREATMENT OR PRESCRIPTION HORMONE MEDICATIONS INCLUDING TESTOSTERONE, HCG AND HUMAN GROWTH HORMONE (HGH INJECTIONS). These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. No claim or opinion on the TestosteroneTherapy.org website is intended to be nor should it be construed to be medical advice or hormone diagnosis. Please consult with a healthcare professional before starting any therapeutic program including HRT - Hormone Replacement Therapy.

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