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

Research Abstract

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

Click here to request a full list of companies covered in the report...

Code: MCP-6770
Price: $4950
Companies: 29
Pages: 203
Date: April 2017
Market Data Tables: 43
  Status: * New Report



TABLE OF CONTENTS


  TESTOSTERONE REPLACEMENT THERAPY (TRT) (Complete Report) Pages : 203   | $4950

   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
  
   Product Definitions and Scope of Study.....I-3  
   TRT Market in a State of Flux.....II-11$100
   List of FDA Approved TRTs by Formulation and Year of Approval.....II-2
Timeline for Launch of Various Types of Testosterone Replacement Therapies.....II-2
1$100
   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-31$350
   Recently Approved/ Pipeline Testosterone Replacement Therapy Products.....II-4
US Dominates the Global TRT Market.....II-4
1$100
   Markets, Other than the US, to Witness Tremendous Growth.....II-5
Topicals Dominate the US Market, Conventional Drugs Rule Elsewhere.....II-5
1$100
   Leading TRT Products Available in the Market.....II-61$100
   Cardiovascular Risks Taint the TRT Market.....II-71$100
   Aging Global Population Drives Adoption.....II-8
Table 2: Percentage of Total Population above 65 Years of Age in Select Countries for 2000 and 2025 (F) (includes corresponding Graph/Chart).....II-8

Table 3: Global Male Population Distribution (15-64 Yrs) by Geographic Region: 2015 (includes corresponding Graph/Chart).....II-8
1$350
   Table 4: Global Male Population Distribution (65+Yrs) by Geographic Region: 2015 (includes corresponding Graph/Chart).....II-9
Undiagnosed Patients – A Strong Indicator of Growth Potential.....II-9
Rising Awareness – A Critical Factor for Growth.....II-9
Untapped Developing Markets - The Future Growth Engine for TRT.....II-9
1$350
   Emerging Data on Positive Impact on Co-morbidities to Support Growth.....II-10
Debunking Conventional Wisdom, New Studies Dissociate Prostate Cancer Risk with
  TRT.....II-10
1$100
   Marketing Campaigns and Patient Referrals to Fuel Growth.....II-11
Easy-to-use Formulations – A Major Boost to TRT Market.....II-11
1$100
   Testosterone as Treatment for Other Conditions – A Growing Area of Focus.....II-121$100
   TRT- A Highly Consolidated Market.....II-13
Table 5: Sales of Select testosterone Replacement Therapies: 2015 & 2016 (in US$ Million) (includes corresponding Graph/Chart).....II-13
1$350
   Entry of Large Multinational Players.....II-14
Generic Incursion – A Major Threat.....II-14
Expiration of Patents and Market Exclusivity of Leading TRT Brands in the US.....II-14
An Overview of Select Drugs on The Market.....II-14
AndroGel (AbbVie).....II-14
1$100
   AndroGel’s Market Performance Raises Concerns for AbbVie.....II-15
Axiron (Eli Lilly).....II-15
Axiron – A Comparison with Other Products.....II-15
1$100
   Axiron’s Patent Profile.....II-16
Testim (Endo/Auxilium).....II-16
1$100
   Testim Scores High on Efficacy over AndroGel.....II-17
Small Packaging Works for Testim.....II-17
Testim’ Sales Continue to Plunge.....II-17
1$100
   Androderm (Actavis).....II-18
Fortesta (Endo Pharmaceuticals).....II-18
Tostran (Kyowa Kirin).....II-18
Natesto™ TRT – A Comparative Review.....II-18
1$100
   Inherent Attributes to Help Natesto Scale Sizable Growth.....II-19
Threat from New Products.....II-19
1$100
   Pipeline Analysis.....II-20
Oral Drugs Dominate Drug Development Pipeline.....II-20
Lipocine’s Tlando Hits Regulatory Bump.....II-20
1$100
   Uncertainly Looms Large Over Enclomiphene’s Pending Approval.....II-211$100
   Clarus Persists with its Oral TRT.....II-22
VIBEX QS T – A New Hope to Injectables Users.....II-22
1$100
   Rextoro (formerly CLR-610).....II-23
New Drug in Development Promises Availability of Native Oral Testosterone.....II-23
1$100
   Spray-on Testosterone – A New Chapter in Topical Testosterone Therapies.....II-241$100
   Testosterone – An Introduction.....II-25
Testosterone Deficiency.....II-25
Primary Hypogonadism.....II-25
Secondary Hypogonadism.....II-25
Symptoms.....II-25
General Symptoms.....II-25
1$100
   Clinical Symptoms.....II-26
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-26
1$350
   Causes.....II-27
Co-Morbid Conditions.....II-27
Table 7: Hypogonadism Prevalence in Some Common Medical Conditions (includes corresponding Graph/Chart).....II-27
1$350
   Diabetes and Hypogonadism.....II-28
Diagnosis.....II-28
Testosterone Replacement.....II-28
Testosterone Replacement Therapy – Evolution.....II-28
Topicals.....II-28
1$100
   Patches.....II-29
Others.....II-29
Injections.....II-29
Orals.....II-29
Pellets.....II-29
1$100
   A Comparison of Key Benefits and Drawbacks of Existing Testosterone
  Preparations.....II-30
Major Potential Benefits of TRT.....II-30
Major Potential Risks of TRT.....II-30
1$100
   Precautions.....II-31
Treatment Alternatives.....II-31
1$100
   Perrigo Obtains FDA Clearance of ANDA for Generic Axiron.....II-32
Acerus Launches Natesto™ in Canada.....II-32
Endo Pharmaceuticals Launches Natesto™.....II-32
Perrigo Releases AB Therapeutics Equivalent of Testosterone Gel.....II-32
Endo Introduces Authorized Generic FORTESTA® Gel.....II-32
1$100
   Auxilium Rolls Out Authorized Generic Version of Testim.....II-33
Endo Gets FDA Nod for Aveed.....II-33
FDA Denies Rextoro Oral Testosterone by Clarus Therapeutics.....II-33
FDA Approves sNDA for STENDRA.....II-33
Endo International Launches Generic Version of its Fortesta.....II-33
MonoSol Rx Launches Clinical Trial of MSRX-110.....II-33
Perrigo Receives AB Therapeutic Equivalent Rating from FDA for Testosterone
  Gel.....II-33
1$100
   FDA Confirms Endpoints for ZA-304 and ZA-305 Studies.....II-34
Auxilium and Prasco Launch Testim® Generic.....II-34
FDA Approves NDA for Vogelxo.....II-34
USFDA Approves Natesto Testosterone Nasal Gel.....II-34
BioThermo Labs Introduces T9 Testosterone Supplement.....II-34
iSatori Launches Fenu Test.....II-34
HRTI Obtains FDA Clearance for Commencing Testagen® TDS Clinical Trials.....II-34
1$100
   Eli Lily Launches Axiron® in Canada.....II-35
FDA Approves Generic Depo-Testosterone Injection of Sun Pharmaceutical.....II-35
Perrigo Obtains FDA Approval for AndroGel® 1%.....II-35
TestoMeds Launches Androfeme, Andromforte and Profeme Testosterone Replacement
  Creams.....II-35
1$100
   Lipocine Finishes Enrollment for New Dosage Studies on LPCN 1021.....II-36
FDA Accepts NDA for Antares Pharma’s QST.....II-36
Teva Sells Actavis’ Operations in UK and Ireland to Accord.....II-36
TesoRx and ASKA Team Up to Commercializes Oral TRT in Japan.....II-36
Acerus Grants Korean Commercialization License for NATESTO to Hyundai Pharm.....II-36
Repros Files for European Approval of Enclomiphene.....II-36
1$100
   Teva Acquires Actavis Generics.....II-37
Acerus Consummates Transition of NATESTO from Endo to Aytu.....II-37
FDA Rejects NDA for Lipocine’s Oral Testosterone Product.....II-37
ProStrakan Changes Name to Kyowa Kirin.....II-37
Apricus Biosciences Shelves Fispemifene Developmental Trials.....II-37
Acerus Cancels Commercialization Deal for NATESTO with Endo Ventures.....II-37
Novartis and Phase 4 Partners form Mereo BioPharma Group.....II-37
1$100
   Repros Gets Complete Response Letter of NDA Rejecting Approval for
  Enclomiphene.....II-38
ANI Acquires Approved NDA for Teva’s Testosterone Gel 1%.....II-38
Endo Takes Over Auxilium Pharmaceuticals.....II-38
Trimel Files for Approval for Natesto with Health Canada.....II-38
Trimel Confers Endo with Natesto Marketing Rights.....II-38
TesoRx Awards Aspen Global with Select International License of TSX-002.....II-38
Viramal Acquires TestoCream License from Aptys.....II-38
1$100
   Vivus Provides Auxilium North American Marketing Rights for STENDRA.....II-39
CoreRx and TesoRx Pharma Form Production Joint Venture for TSX-002.....II-39
Eli Lilly Files Lawsuit against Perrigo for Infringing Axiron Patents.....II-39
Perrigo Files for Generic Axiron Approval with FDA.....II-39
Auxilium Wins Patent Challenges for Testim.....II-39
Auxilium Pharmaceuticals Takes Over Actient Holdings.....II-39
Ferring Submits Patent Application for New Testosterone Formulations in
  Australia.....II-39
1$100
   Perrigo Submits ANDA for Testosterone 1.62% with the US FDA.....II-40
Watson Pharmaceuticals Rebrands to Actavis.....II-40
US FDA Accepts to Review Complete Response Submission for NDA of Endo Pharmaceuticals’s
  Aveed.....II-40
Lipocine Announces Positive Phase I Clinical Trial for LPCN 1111 Candidate.....II-40
1$100
   AbbVie, Inc. (US).....II-41
Acerus Pharmaceuticals Corporation (Canada).....II-41
1$100
   Acrux Limited (Australia).....II-42
Antares Pharma, Inc. (US).....II-42
Bayer HealthCare Pharmaceuticals (Germany).....II-42
1$100
   Eli Lilly and Company (US).....II-43
Endo Pharmaceuticals Inc. (US).....II-43
1$100
   Kyowa Kirin (UK).....II-441$100
   Table 8: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy (TRT) by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....II-451$350
   Table 9: World Historic Review for Testosterone Replacement Therapy (TRT) by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....II-461$350
   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).....II-471$350
   Table 11: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy (TRT) by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....II-481$350
   Table 12: World Historic Review for Testosterone Replacement Therapy (TRT) by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....II-491$350
   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-501$350
   A. Market Analysis.....III-1
Hypogonadism – High Prevalence, Low Treatment, Offers Increasing Potential.....III-1
Topical Gels – The Largest Selling Segment.....III-1
1$75
   Table 14: Total TRT Prescriptions Trends in the US: Number of Total Prescriptions (March 2015 - December 2016) (includes corresponding Graph/Chart).....III-2
A Comparison of Commonly Prescribed Topical TRT Products in the US.....III-2
“Low T” Trend Litigations.....III-2
1$200
   New Products Strive to Address Transference Issues.....III-3
High-Concentration Products Gain Market Share in the Topicals Market.....III-3
Debate Continues Over the Need for TRT.....III-3
1$75
   Big Pharma Spends Millions to Push TRT Sales.....III-4
Increasing Ad Spending Draws Flak.....III-4
1$75
   Product Landscape.....III-5
AndroGel Retains Leadership in Total Prescriptions.....III-5
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).....III-5
1$200
   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).....III-6
AbbVie Fights on for AndroGel’s Market Sustenance.....III-6
Axiron Faces Tough Market Conditions.....III-6
1$200
   Table 17: Axiron Quarterly Sales Worldwide: FY2012 through FY2016 (includes corresponding Graph/Chart).....III-71$200
   Co-Pay Scheme Helps Axiron Attract Users.....III-8
Testim Revenues Head South.....III-8
Impending Patent Expiries.....III-8
Patent Expiries of Leading TRT Brands in the US.....III-8
1$75
   Generics Hurt Sales of Branded Drugs.....III-9
FDA Mandates Labeling Changes despite Lack of Consensus Related to Cardiac Events
  after TRT.....III-9
Product Launches/Approvals.....III-9
3$225
   Strategic Corporate Developments.....III-123$225
   Key Players.....III-152$150
   B. Market Analytics.....III-17
Table 18: US Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-17
1$200
   Table 19: US Historic Review for Testosterone Replacement Therapy by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-181$200
   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).....III-191$200
   A. Market Analysis.....III-20
Current & Future Analysis.....III-20
Available TRT Therapies in Canada.....III-20
Product Approvals/Launches.....III-20
1$75
   Strategic Corporate Developments.....III-21
Acerus Pharmaceuticals Corporation – A Major Canada-based TRT Player.....III-21
1$75
   B. Market Analytics.....III-22
Table 21: Canadian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-22
1$200
   Table 22: Canadian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-231$200
   A. Market Analysis.....III-24
Current & Future Analysis.....III-24
Gels to Drive European TRT Market.....III-24
Lower Normal Serum Testosterone Concentration in Select European Nations.....III-24
1$75
   Strategic Corporate Developments.....III-251$75
   B. Market Analytics.....III-26
Table 23: European Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-26
1$200
   Table 24: European Historic Review for Testosterone Replacement Therapy by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-271$200
   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).....III-281$200
   Market Analysis.....III-29
Table 26: French Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-29
1$200
   Table 27: French Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-301$200
   A. Market Analysis.....III-31
Current & Future Analysis.....III-31
Strategic Corporate Development.....III-31
Bayer Healthcare Pharmaceuticals – A Key Player in the TRT Market.....III-31
1$75
   B. Market Analytics.....III-32
Table 28: German Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-32
1$200
   Table 29: German Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-331$200
   Market Analysis.....III-34
Table 30: Italian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-34
1$200
   Table 31: Italian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-351$200
   A. Market Analysis.....III-36
Market Overview.....III-36
Product Launch/Approval.....III-36
Strategic Corporate Development.....III-36
Select Key Player.....III-36
1$75
   B. Market Analytics.....III-37
Table 32: UK Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-37
1$200
   Table 33: UK Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-381$200
   Market Analysis.....III-39
Table 34: Spanish Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-39
1$200
   Table 35: Spanish Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-401$200
   A. Market Analysis.....III-41
Current & Future Analysis.....III-41
Product Launch.....III-41
B. Market Analytics.....III-41
Table 36: Rest of Europe Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-41
1$200
   Table 37: Rest of Europe Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-421$200
   A. Market Analysis.....III-43
Current & Future Analysis.....III-43
Increasing Use of Testosterone in Australia.....III-43
Strategic Corporate Developments.....III-43
1$75
   Select Key Player.....III-441$75
   B. Market Analytics.....III-45
Table 38: Asia-Pacific Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-45
1$200
   Table 39: Asia-Pacific Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-461$200
   Market Analysis.....III-47
Table 40: Latin American Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-47
1$200
   Table 41: Latin American Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-481$200
   A. Market Analysis.....III-49
Current & Future Analysis.....III-49
Product Launch.....III-49
B. Market Analytics.....III-49
Table 42: Rest of World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).....III-49
1$200
   Table 43: Rest of World Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).....III-501$200
  
Total Companies Profiled: 29 (including Divisions/Subsidiaries - 31)

Region/Country Players

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
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