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市場調査レポート

テストステロン補充療法 (TRT) の世界市場

Testosterone Replacement Therapy (TRT)

発行 Global Industry Analysts, Inc. 商品コード 236874
出版日 ページ情報 英文 203 Pages
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テストステロン補充療法 (TRT) の世界市場 Testosterone Replacement Therapy (TRT)
出版日: 2018年02月01日 ページ情報: 英文 203 Pages
概要

当レポートでは、世界のテストステロン補充療法市場について調査し、市場の概要と2022年までの予測、地域別動向、および市場に参入する主要企業のプロファイルなどをまとめています。

第1章 イントロダクション、調査方法、製品定義

第2章 エグゼクティブサマリー

  • 業界概要
    • テストステロン補充療法(TRT)市場概要
    • FDA認可リスト
    • 様々なタイプのテストステロン補充療法の上市スケジュール
    • 近年認可された/パイプラインのテストステロン補充療法製品
    • 米国が世界市場を独占
    • 米国以外の市場も大きく成長
    • 市場で入手可能な主力製品
    • 心血管リスクが市場成長を促進
  • 成長促進因子と市場動向
    • 世界的高齢化
    • 未診断患者
    • 認識の高まり
    • 未開拓の途上国市場
    • 併存疾患への影響に関する新興のデータが成長を支持
    • マーケティングキャンペーンと患者紹介が成長を加速
    • 使いやすい形態
    • 他の症状を治療するためのテストステロン
  • 競争
  • テストステロン欠乏症とTRT:概要
    • テストステロン:イントロダクション
    • テストステロン欠乏症
    • 性腺機能低下症
    • 症状
    • 併存疾患
    • 糖尿病と性腺機能低下症
    • テストステロン補充療法
    • TRTの主なメリット
    • TRTの主なリスク
    • 警告
    • 代替治療法
  • 製品上市/認可
  • 近年の業界活動
  • 主要企業
    • AbbVie, Inc.
    • Acerus Pharmaceuticals Corporation
    • Acrux Limited
    • Antares Pharma, Inc.
    • Bayer HealthCare Pharmaceuticals
    • Eli Lilly and Company (US)
    • Endo Pharmaceuticals Inc.
    • Kyowa Kirin
  • 世界市場見通し

第3章 市場

  • 米国
  • カナダ
  • 日本
  • 欧州
  • アジア太平洋地域
  • ラテンアメリカ
  • その他の諸国
目次
Product Code: MCP-6770

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

Table of 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(tm) 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(tm) in Canada
  • Endo Pharmaceuticals Launches Natesto(tm)
  • Perrigo Releases AB Therapeutics Equivalent of Testosterone Gel
  • Endo Introduces Authorized Generic FORTESTA(r) 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(r) 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(r) TDS Clinical Trials
  • Eli Lily Launches Axiron(r) in Canada
  • FDA Approves Generic Depo-Testosterone Injection of Sun Pharmaceutical
  • Perrigo Obtains FDA Approval for AndroGel(r) 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)
    • 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 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) TESTOSTERONE REPLACEMENT THERAPY (TRT) MCP-6770 CONTENTS
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