I.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

I. EXECUTIVE SUMMARY

1.INDUSTRY OVERVIEW

TRT Market in a State of Flux

List of FDA Approved TRTs by Formulation and Year of Approval

Timeline for Launch of Various Types of Testosterone Replacement Therapies

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: 2015 (includes corresponding Graph/Chart)

Table 4: Global Male Population Distribution (65+Yrs) by Geographic Region: 2015 (includes corresponding Graph/Chart)

Undiagnosed Patients – A Strong Indicator of Growth Potential

Rising Awareness – A Critical Factor for Growth

Untapped Developing Markets - The Future Growth Engine for TRT

Emerging Data on Positive Impact on Co-morbidities to Support Growth

Debunking Conventional Wisdom, New Studies Dissociate Prostate Cancer Risk with TRT

Marketing Campaigns and Patient Referrals to Fuel Growth

Easy-to-use Formulations – A Major Boost to TRT Market

Testosterone as Treatment for Other Conditions – A Growing Area of Focus

3.COMPETITION

TRT- A Highly Consolidated Market

Table 5: Sales of Select testosterone Replacement Therapies: 2015 & 2016 (in US$ Million) (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

An Overview of Select Drugs on The Market

AndroGel (AbbVie)

Axiron (Eli Lilly)

Testim (Endo/Auxilium)

Androderm (Actavis)

Fortesta (Endo Pharmaceuticals)

Tostran (Kyowa Kirin)

Natesto? TRT – A Comparative Review

Threat from New Products

Pipeline Analysis

Oral Drugs Dominate Drug Development Pipeline

Lipocine’s Tlando Hits Regulatory Bump

Uncertainly Looms Large Over Enclomiphene’s Pending Approval

Clarus Persists with its Oral TRT

VIBEX QS T – A New Hope to Injectables Users

Rextoro (formerly CLR-610)

New Drug in Development Promises Availability of Native Oral Testosterone

Spray-on Testosterone – A New Chapter in Topical Testosterone Therapies

4.TESTOSTERONE DEFICIENCY AND TRT - AN OVERVIEW

5.PRODUCT LAUNCHES/APPROVALS

Perrigo Obtains FDA Clearance of ANDA for Generic Axiron

Acerus Launches Natesto? in Canada

Endo Pharmaceuticals Launches Natesto?

Perrigo Releases AB Therapeutics Equivalent of Testosterone Gel

Endo Introduces Authorized Generic FORTESTA? Gel

Auxilium Rolls Out Authorized Generic Version of Testim

Endo Gets FDA Nod for Aveed

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

6.RECENT INDUSTRY ACTIVITY

Lipocine Finishes Enrollment for New Dosage Studies on LPCN 1021

FDA Accepts NDA for Antares Pharma’s QST

Teva Sells Actavis’ Operations in UK and Ireland to Accord

TesoRx and ASKA Team Up to Commercializes Oral TRT in Japan

Acerus Grants Korean Commercialization License for NATESTO to Hyundai Pharm

Repros Files for European Approval of Enclomiphene

Teva Acquires Actavis Generics

Acerus Consummates Transition of NATESTO from Endo to Aytu

FDA Rejects NDA for Lipocine’s Oral Testosterone Product

ProStrakan Changes Name to Kyowa Kirin

Apricus Biosciences Shelves Fispemifene Developmental Trials

Acerus Cancels Commercialization Deal for NATESTO with Endo Ventures

Novartis and Phase 4 Partners form Mereo BioPharma Group

Repros Gets Complete Response Letter of NDA Rejecting Approval for Enclomiphene

ANI Acquires Approved NDA for Teva’s Testosterone Gel 1%

Endo Takes Over Auxilium Pharmaceuticals

Trimel Files for Approval for Natesto with Health Canada

Trimel Confers Endo with Natesto Marketing Rights

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’s Aveed

Lipocine Announces Positive Phase I Clinical Trial for LPCN 1111 Candidate

7.FOCUS ON SELECT PLAYERS

AbbVie, Inc. (USA)

Acerus Pharmaceuticals Corporation (Canada)

Acrux Limited (Australia)

Antares Pharma, Inc. (USA)

Bayer HealthCare Pharmaceuticals (Germany)

Eli Lilly and Company (USA)

Endo Pharmaceuticals Inc. (USA)

Kyowa Kirin (UK)

8.GLOBAL MARKET PERSPECTIVE

Table 8: 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 2015 through 2022 (includes corresponding Graph/Chart)

Table 9: 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 2009 through 2014 (includes corresponding Graph/Chart)

Table 10: World 14-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 2009, 2017 & 2022 (includes corresponding Graph/Chart)

Table 11: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy (TRT) by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 12: World Historic Review for Testosterone Replacement Therapy (TRT) by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

Table 13: World 14-Year Perspective for Testosterone Replacement Therapy (TRT) by Product Segment - Percentage Breakdown of Dollar Sales for Topicals, Patches and Others Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart)

II. MARKET

1.THE UNITED STATES

A. Market Analysis

Hypogonadism – High Prevalence, Low Treatment, Offers Increasing Potential

Topical Gels – The Largest Selling Segment

Table 14: Total TRT Prescriptions Trends in the US: Number of Total Prescriptions (March 2015 - December 2016) (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

Increasing Ad Spending Draws Flak

Product Landscape

AndroGel Retains Leadership in Total Prescriptions

Table 15: Leading Drugs in the US TRT Market (2015): Percentage Breakdown of Value Sales for Androderm, Androgel, Axiron, Fortesta, Testim, Transdermal Testosterone and Others (includes corresponding Graph/Chart)

Table 16: TRT Prescriptions in the US (2015): Percentage Breakdown of Total Prescriptions for Androgel, Axiron, Fortesta, Transdermal Testosterone and Injectables (includes corresponding Graph/Chart)

AbbVie Fights on for AndroGel’s Market Sustenance

Axiron Faces Tough Market Conditions

Table 17: Axiron Quarterly Sales Worldwide: FY2012 through FY2016 (includes corresponding Graph/Chart)

Co-Pay Scheme Helps Axiron Attract Users

Testim Revenues Head South

Impending Patent Expiries

Generics Hurt Sales of Branded Drugs

FDA Mandates Labeling Changes despite Lack of Consensus Related to Cardiac Events after TRT

Product Launches/Approvals

Strategic Corporate Developments

Key Players

B. Market Analytics

Table 18: US Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 19: US Historic Review for Testosterone Replacement Therapy by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

Table 20: US 14-Year Perspective for Testosterone Replacement Therapy by Product Segment - Percentage Breakdown of Dollar Sales for Topicals, Patches and Others Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart)

2.CANADA

A. Market Analysis

Current & Future Analysis

Available TRT Therapies in Canada

Product Approvals/Launches

Strategic Corporate Developments

Acerus Pharmaceuticals Corporation – A Major Canada-based TRT Player

B. Market Analytics

Table 21: Canadian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 22: Canadian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (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

Strategic Corporate Developments

B. Market Analytics

Table 23: 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 2015 through 2022 (includes corresponding Graph/Chart)

Table 24: 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 2009 through 2014 (includes corresponding Graph/Chart)

Table 25: European 14-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 2009, 2017 & 2022 (includes corresponding Graph/Chart)

3a.FRANCE

Market Analysis

Table 26: French Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 27: French Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

3b.GERMANY

A. Market Analysis

Current & Future Analysis

Strategic Corporate Development

Bayer Healthcare Pharmaceuticals – A Key Player in the TRT Market

B. Market Analytics

Table 28: German Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 29: German Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

3c.ITALY

Market Analysis

Table 30: Italian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 31: Italian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

3d.THE UNITED KINGDOM

A. Market Analysis

Market Overview

Product Launch/Approval

Strategic Corporate Development

Select Key Player

B. Market Analytics

Table 32: UK Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 33: UK Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

3e.SPAIN

Market Analysis

Table 34: Spanish Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 35: Spanish Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

3f.REST OF EUROPE

A. Market Analysis

Current & Future Analysis

Product Launch

B. Market Analytics

Table 36: Rest of Europe Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 37: Rest of Europe Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4.ASIA-PACIFIC

A. Market Analysis

Current & Future Analysis

Increasing Use of Testosterone in Australia

Strategic Corporate Developments

Select Key Player

B. Market Analytics

Table 38: Asia-Pacific Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 39: Asia-Pacific Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

5.LATIN AMERICA

Market Analysis

Table 40: Latin American Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 41: Latin American Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

6.REST OF WORLD

A. Market Analysis

Current & Future Analysis

Product Launch

B. Market Analytics

Table 42: Rest of World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)III-49

Table 43: Rest of World Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)III-50IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 29 (including Divisions/Subsidiaries - 31)

The United States (17)

Canada (2)

Japan (2)

Europe (7)

- Germany (1)

- The United Kingdom (4)

- Rest of Europe (2)

Asia-Pacific (Excluding Japan) (3)