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Global Testosterone Replacement Therapy (TRT) - Pharmaceuticals

Monday, May 29, 2017 Drug News
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NEW YORK, May 29, 2017 /PRNewswire/ -- 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: 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. Read the full report: http://www.reportlinker.com/p04910451/Global-Testosterone-Replacement-Therapy-TRT-Pharmaceuticals.htmlMarket 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. Read the full report: http://www.reportlinker.com/p04910451/Global-Testosterone-Replacement-Therapy-TRT-Pharmaceuticals.htmlI. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONSStudy Reliability and Reporting LimitationsDisclaimersData Interpretation & Reporting LevelQuantitative Techniques & AnalyticsProduct Definitions and Scope of StudyTopicalsPatchesOthersII. EXECUTIVE SUMMARY1. INDUSTRY OVERVIEWTRT Market in a State of FluxList of FDA Approved TRTs by Formulation and Year of ApprovalTimeline for Launch of Various Types of Testosterone Replacement TherapiesTable 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 ProductsUS Dominates the Global TRT MarketMarkets, Other than the US, to Witness Tremendous GrowthTopicals Dominate the US Market, Conventional Drugs Rule ElsewhereLeading TRT Products Available in the MarketCardiovascular Risks Taint the TRT Market2. GROWTH DRIVERS AND MARKET TRENDSAging Global Population Drives AdoptionTable 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 PotentialRising Awareness - A Critical Factor for GrowthUntapped Developing Markets - The Future Growth Engine for TRTEmerging Data on Positive Impact on Co-morbidities to Support GrowthDebunking Conventional Wisdom, New Studies Dissociate Prostate Cancer Risk with TRTMarketing Campaigns and Patient Referrals to Fuel GrowthEasy-to-use Formulations - A Major Boost to TRT MarketTestosterone as Treatment for Other Conditions - A Growing Area of Focus3. COMPETITIONTRT- A Highly Consolidated MarketTable 5: Sales of Select testosterone Replacement Therapies: 2015 & 2016 (in US$ Million) (includes corresponding Graph/Chart)Entry of Large Multinational PlayersGeneric Incursion - A Major ThreatExpiration of Patents and Market Exclusivity of Leading TRT Brands in the USAn Overview of Select Drugs on The MarketAndroGel (AbbVie)AndroGel's Market Performance Raises Concerns for AbbVieAxiron (Eli Lilly)Axiron - A Comparison with Other ProductsAxiron's Patent ProfileTestim (Endo/Auxilium)Testim Scores High on Efficacy over AndroGelSmall Packaging Works for TestimTestim' Sales Continue to PlungeAndroderm (Actavis)Fortesta (Endo Pharmaceuticals)Tostran (Kyowa Kirin)Natesto™ TRT - A Comparative ReviewInherent Attributes to Help Natesto Scale Sizable GrowthThreat from New ProductsPipeline AnalysisOral Drugs Dominate Drug Development PipelineLipocine's Tlando Hits Regulatory BumpUncertainly Looms Large Over Enclomiphene's Pending ApprovalClarus Persists with its Oral TRTVIBEX QS T - A New Hope to Injectables UsersRextoro (formerly CLR-610)New Drug in Development Promises Availability of Native Oral TestosteroneSpray-on Testosterone - A New Chapter in Topical Testosterone Therapies4. TESTOSTERONE DEFICIENCY AND TRT - AN OVERVIEWTestosterone - An IntroductionTestosterone DeficiencyPrimary HypogonadismSecondary HypogonadismSymptomsGeneral SymptomsClinical SymptomsTable 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)CausesCo-Morbid ConditionsTable 7: Hypogonadism Prevalence in Some Common Medical Conditions (includes corresponding Graph/Chart)Diabetes and HypogonadismDiagnosisTestosterone ReplacementTestosterone Replacement Therapy - EvolutionTopicalsPatchesOthersInjectionsOralsPelletsA Comparison of Key Benefits and Drawbacks of Existing Testosterone PreparationsMajor Potential Benefits of TRTMajor Potential Risks of TRTPrecautionsTreatment Alternatives5. PRODUCT LAUNCHES/APPROVALSPerrigo Obtains FDA Clearance of ANDA for Generic AxironAcerus Launches Natesto™ in CanadaEndo Pharmaceuticals Launches Natesto™Perrigo Releases AB Therapeutics Equivalent of Testosterone GelEndo Introduces Authorized Generic FORTESTA® GelAuxilium Rolls Out Authorized Generic Version of TestimEndo Gets FDA Nod for AveedFDA Denies Rextoro Oral Testosterone by Clarus TherapeuticsFDA Approves sNDA for STENDRAEndo International Launches Generic Version of its FortestaMonoSol Rx Launches Clinical Trial of MSRX-110Perrigo Receives AB Therapeutic Equivalent Rating from FDA for Testosterone GelFDA Confirms Endpoints for ZA-304 and ZA-305 StudiesAuxilium and Prasco Launch Testim® GenericFDA Approves NDA for VogelxoUSFDA Approves Natesto Testosterone Nasal GelBioThermo Labs Introduces T9 Testosterone SupplementiSatori Launches Fenu TestHRTI Obtains FDA Clearance for Commencing Testagen® TDS Clinical TrialsEli Lily Launches Axiron® in CanadaFDA Approves Generic Depo-Testosterone Injection of Sun PharmaceuticalPerrigo Obtains FDA Approval for AndroGel® 1%TestoMeds Launches Androfeme, Andromforte and Profeme Testosterone Replacement Creams6. RECENT INDUSTRY ACTIVITYLipocine Finishes Enrollment for New Dosage Studies on LPCN 1021FDA Accepts NDA for Antares Pharma's QSTTeva Sells Actavis' Operations in UK and Ireland to AccordTesoRx and ASKA Team Up to Commercializes Oral TRT in JapanAcerus Grants Korean Commercialization License for NATESTO to Hyundai PharmRepros Files for European Approval of EnclomipheneTeva Acquires Actavis GenericsAcerus Consummates Transition of NATESTO from Endo to AytuFDA Rejects NDA for Lipocine's Oral Testosterone ProductProStrakan Changes Name to Kyowa KirinApricus Biosciences Shelves Fispemifene Developmental TrialsAcerus Cancels Commercialization Deal for NATESTO with Endo VenturesNovartis and Phase 4 Partners form Mereo BioPharma GroupRepros Gets Complete Response Letter of NDA Rejecting Approval for EnclomipheneANI Acquires Approved NDA for Teva's Testosterone Gel 1%Endo Takes Over Auxilium PharmaceuticalsTrimel Files for Approval for Natesto with Health CanadaTrimel Confers Endo with Natesto Marketing RightsTesoRx Awards Aspen Global with Select International License of TSX-002Viramal Acquires TestoCream License from AptysVivus Provides Auxilium North American Marketing Rights for STENDRACoreRx and TesoRx Pharma Form Production Joint Venture for TSX-002Eli Lilly Files Lawsuit against Perrigo for Infringing Axiron PatentsPerrigo Files for Generic Axiron Approval with FDAAuxilium Wins Patent Challenges for TestimAuxilium Pharmaceuticals Takes Over Actient HoldingsFerring Submits Patent Application for New Testosterone Formulations in AustraliaPerrigo Submits ANDA for Testosterone 1.62% with the US FDAWatson Pharmaceuticals Rebrands to ActavisUS FDA Accepts to Review Complete Response Submission for NDA of Endo Pharmaceuticals's AveedLipocine Announces Positive Phase I Clinical Trial for LPCN 1111 Candidate7. FOCUS ON SELECT PLAYERSAbbVie, Inc. (US)Acerus Pharmaceuticals Corporation (Canada)Acrux Limited (Australia)Antares Pharma, Inc. (US)Bayer HealthCare Pharmaceuticals (Germany)Eli Lilly and Company (US)Endo Pharmaceuticals Inc. (US)Kyowa Kirin (UK)8. GLOBAL MARKET PERSPECTIVETable 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. MARKET1. THE UNITED STATESA.Market AnalysisHypogonadism - High Prevalence, Low Treatment, Offers Increasing PotentialTopical Gels - The Largest Selling SegmentTable 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 LitigationsNew Products Strive to Address Transference IssuesHigh-Concentration Products Gain Market Share in the Topicals MarketDebate Continues Over the Need for TRTBig Pharma Spends Millions to Push TRT SalesIncreasing Ad Spending Draws FlakProduct LandscapeAndroGel Retains Leadership in Total PrescriptionsTable 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 SustenanceAxiron Faces Tough Market ConditionsTable 17: Axiron Quarterly Sales Worldwide: FY2012 through FY2016 (includes corresponding Graph/Chart)Co-Pay Scheme Helps Axiron Attract UsersTestim Revenues Head SouthImpending Patent ExpiriesPatent Expiries of Leading TRT Brands in the USGenerics Hurt Sales of Branded DrugsFDA Mandates Labeling Changes despite Lack of Consensus Related to Cardiac Events after TRTProduct Launches/ApprovalsStrategic Corporate DevelopmentsKey PlayersB.Market AnalyticsTable 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. CANADAA.Market AnalysisCurrent & Future AnalysisAvailable TRT Therapies in CanadaProduct Approvals/LaunchesStrategic Corporate DevelopmentsAcerus Pharmaceuticals Corporation - A Major Canada-based TRT PlayerB.Market AnalyticsTable 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. EUROPEA.Market AnalysisCurrent & Future AnalysisGels to Drive European TRT MarketLower Normal Serum Testosterone Concentration in Select European NationsStrategic Corporate DevelopmentsB.Market AnalyticsTable 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. FRANCEMarket AnalysisTable 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. GERMANYA.Market AnalysisCurrent & Future AnalysisStrategic Corporate DevelopmentBayer Healthcare Pharmaceuticals - A Key Player in the TRT MarketB.Market AnalyticsTable 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. ITALYMarket AnalysisTable 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 KINGDOMA.Market AnalysisMarket OverviewProduct Launch/ApprovalStrategic Corporate DevelopmentSelect Key PlayerB.Market AnalyticsTable 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. SPAINMarket AnalysisTable 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 EUROPEA.Market AnalysisCurrent & Future AnalysisProduct LaunchB.Market AnalyticsTable 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-PACIFICA.Market AnalysisCurrent & Future AnalysisIncreasing Use of Testosterone in AustraliaStrategic Corporate DevelopmentsSelect Key PlayerB.Market AnalyticsTable 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 AMERICAMarket AnalysisTable 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 WORLDA.Market AnalysisCurrent & Future AnalysisProduct LaunchB.Market AnalyticsTable 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)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)IV. COMPETITIVE LANDSCAPETotal 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)Read the full report: http://www.reportlinker.com/p04910451/Global-Testosterone-Replacement-Therapy-TRT-Pharmaceuticals.htmlAbout Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.http://www.reportlinker.com__________________________Contact Clare: [email protected]US: (339)-368-6001Intl: +1 339-368-6001

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