Testosterone Replacement Therapy (TRT): Market Research Report

January 2018 | 203 pages | ID: T0CDDE8E146EN
Global Industry Analysts, Inc

Abstracts

This report analyzes the worldwide markets for Testosterone Replacement Therapy (TRT) in US$ Million. The Global and US markets are further analyzed by the following Product Segments: Topicals, 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 2015 through 2022.

Also, a six-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 29 companies including many key and niche players such as -

• AbbVie, Inc.
• Acerus Pharmaceuticals Corporation
• Acrux Limited
• Antares Pharma, Inc.
• Bayer HealthCare Pharmaceuticals

Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. 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)

III. 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)