NEW YORK, Sept. 22, 2016 /PRNewswire/ -- This report analyzes the worldwide markets for Hormone Replacement Therapy (HRT) in US$ Thousand. 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 40 companies including many key and niche players such as -
Abbott Laboratories
AbbVie, Inc.
Allergan plc
Bayer Pharma AG
Hisamitsu Pharmaceutical Co., Inc.
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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1 Disclaimers.............. I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definition and Scope of Study I-3
II. EXECUTIVE SUMMARY
1. OUTLOOK.............. II-1 Amid Controversies, Confusion and Competition, Demand for HRT Continues to Rise..............II-1 The HRT Controversy - An Insight II-2 Current and Future Analysis..............II-3 The Regional Divide.............. II-3 Increasing Number of Women in Menopause - A Major Market Driver II-4 Dearth in Safe Drugs is Hurting the Market, and Women II-4
2. INDUSTRY OVERVIEW.............. II-5 An Introduction to Menopause and Hormone Replacement Therapy II-5 An Overview of Select Estrogen Therapy Approaches II-6 WHI Study- A Major Blow to the HRT Market II-6 The HRT Controversy Evolution in the New Millennium II-7 Reappraisal of Data from Previous Studies - A Hope for Resurgence in HRT Demand..............II-7 IMS Consensus Guidelines Paving Way for More Clarity of HRT II-8 Menopause Statistics - An Opportunity Indicator II-9 Ethnic Differences Exist in Menopausal Symptoms II-9
3. MARKET TRENDS & ISSUES..............II-10 Market Size Restricted by Lesser Number of Women Opting for Treatment.............. II-10 Safety Issues: A Major Deterrent to the HRT Market II-10 Manufacturers to Face Legal Challenges II-10 Unmet Needs in the Combination Therapies for HRT drive Research for New Medicines..............II-11 Topical Estrogens - More Safe and Effective II-11 Transdermal HRT Products Present Exciting Opportunities II-12 Phytoestrogens - The New Panacea for Menopausal Symptoms? II-12 Diet Link to Menopause Symptoms Raises Interest II-13 Impact of Soy and Other Phytoestrogens - A Reality Check II-13 Select Botanical Treatments Studied for Menopause Symptoms Treatment and Identified Risks and Limitations II-14 EstroG - A Successful Herbal Health Supplement in Alleviating Menopausal Symptoms..............II-15 The Growing Buzz around Bioidentical Drugs II-15 Bio-identical Hormones - A Natural and Safe Substitute to Synthetic HRT?.............. II-15 List of Bio-identical Products Used in Conventional HRT II-16 Pellet Therapy - A New Innovation Downsizes Conventional Issues with Bioidentical HRT..............II-17 Direct-to-Consumer Advertising for HRT - A Mixed Bag II-17
4. COMPETITIVE LANDSCAPE..............II-19 Intense Competition Marks the Global HRT Market II-19 Table 1: Global Sales of Select HRT Products (in US$ Million): 2014 & 2015 (includes corresponding Graph/Chart) II-19 The Premarin Saga.............. II-20 Health Risks Tarnish Premarin's Image II-20 Table 2: Annual Sales of Premarin Family: 2002-2015 (includes corresponding Graph/Chart)..............II-21 Pfizer Seeks Refuge in Line Extensions II-21 Better Safety Profile for Duavee - A Shot in the Arm for Pfizer II-22 Estrace Cream Drives Revenue Gains in Allergan's HRT Portfolio II-22 Table 3: Annual Sales of Estrace Cream: 2010-2015 (includes corresponding Graph/Chart)..............II-22 New Drug Buoys Novo Nordisk's HRT Portfolio II-23 Estriol: The Next Generation Estrogen Therapy? II-23 What Makes Estriol Work?..............II-23 Topical Estriol - More Promising in Safety II-23 Estriol - Used More Commonly Outside the US II-24 Entry of Generics Threatens Market Growth Prospects II-24 Select Hormone Therapies for Post-Menopausal Women by Year of Patent Expiry: 2015 to 2022..............II-25 Generic Incursion in Hormone Replacement Therapy - List of Drugs With and Without Approved Generic Versions II-26 Select Hormone Therapies for Treatment of Postmenopausal Symptoms by Generic Manufacturers II-27 Are Non-Hormonal Therapies A Threat to HRT? II-27 Earlier Failures Induce Lethargy in Non-Hormonal Therapies II-28 Menerba: A Promising Non-Hormone Therapy for Menopausal Hot Flashes.............. II-29
5. THERAPY PROFILE - A REVIEW OF SELECT RECENT STUDIES CONDUCTED II-30 New Meta-Analysis Positively Links Ovarian Cancer to Use of HRT, Albeit Modest.............. II-30 Nanotechnology for HRT - New Drug under Development Eyes Better Absorption and Safety..............II-30 Researchers at Yale University Discover Discontinuation HRT May Lead to Premature Deaths..............II-31 Bioidenticals versus Synthetic Hormone Replacement Therapy Agents II-31 Studies at University of Sydney Researchers Reveal the Safety of Short-Term Unopposed Estrogens II-32 US Researchers Reveal HRT Risks May be Dependent on Weight and Other Factors.............. II-32 Studies Prove HRT to Lower Risk of Pancreatic Cancer II-33 University of Texas Reveal HRT Linked to Risks of Kidney Stones II-33 Researchers at the Sundsvall Hospital Demonstrate Increased Incidence of Cataract Development in Women Undergoing HRT II-33 Researchers at University of Southern California Demonstrate Estrogen Replacement Therapies Lower Stress Levels in Older Women.............. II-34 Studies at Uppsala University Hospital Demonstrate HRT is Associated with Improved Muscle Functioning in Postmenopausal women.............. II-34 Finnish Study Reveals HRT Usage Assist in the Treatment of Hot Flashes in Post-Menopausal Women II-34 Researchers at Johns Hopkins University Demonstrate Women Undergoing Hormone Therapy Less Prone to Alzheimer's Disease II-35 French Study Reveals Hormone Replacement Pills May Affect Gall Bladder.............. II-35 Danish Studies Proves HRT Lowers Risk of Heart Attack and Heart Failure.............. II-35
6. PRODUCT OVERVIEW.............. II-36 What are Hormones?..............II-36 What is Menopause?..............II-36 Menopause Symptoms and Complaints II-36 Introduction to Hormone Replacement Therapy II-37 HRT Products.............. II-38 Estrogen.............. II-38 Progestins.............. II-38 Types of HRT.............. II-39 Why HRT?.............. II-39 Milestones and Downfalls in the Hormone Replacement Therapy (HRT) Market.............. II-39 Contraindications of HRT..............II-40 Historical Progression..............II-40 Advantages and Disadvantages of Using HRT II-40 Benefits of Hormone Therapy..............II-40 Relief from Vasomotor Symptoms II-40 Vaginal Symptoms..............II-41 Improvement in Sexual Functioning II-41 Urinary Health.............. II-41 Management of Variations in Body Weight/ Mass II-41 Ensuring Quality of Life..............II-41 Osteoporosis.............. II-42 Diabetes Mellitus (DM)..............II-42 Impact on Overall Mortality..............II-42 Treatment of Premature Menopause II-42 Risks Involved in Hormone Therapy II-42 Hormone Therapies in HRT and their Effect II-43 Potential Benefits and Risks of HRT in Menopausal Symptoms II-44 Common and Less Common Side Effects of Using Estrogen-alone, Progesterone-alone or Combination Therapies II-44 Potential Issues.............. II-44 Cardiovascular Problems..............II-44 Coronary Heart Disease (CHD) II-44 Stroke.............. II-45 Venous Thromboembolism (VTE) II-45 Endometrial Cancer.............. II-45 Breast Cancer.............. II-45 Estrogen-Progestogen Therapy II-45 Estrogen Therapy..............II-45 Lung Cancer.............. II-45 Depression and Mood Swings..............II-46 Ovarian Cancer.............. II-46 Routes of Administration..............II-46 Systemic Treatment.............. II-46 Pills.............. II-46 Advantages and Disadvantages of Oral HRT II-46 Vaginal Estrogen Ring..............II-47 Transdermal Estrogen Skin Patches II-47 Localized Treatment..............II-47 Vaginal Estrogen Tablets..............II-47 Estrogen Creams..............II-47 Intrauterine Progestin System (IUS) II-47 Lower Dose Vaginal Estrogen Ring II-48 Vaginal Progesterone Gel..............II-48 Implants.............. II-48 Advantages and Disadvantages of HRT Implants II-48 Bioidentical Hormone Replacement Therapy (BHRT) II-48 Historical Background..............II-49 More Claims than Evidence..............II-50 Other Alternatives..............II-50 Prescription Medication..............II-50 Gabapentin.............. II-50 Clonidine.............. II-50 SNRIs and SSRIs.............. II-50 Botanicals.............. II-51 Black Cohosh.............. II-51 Phytoestrogens (Isoflavones) II-51 Other Botanical Products..............II-51 Non-botanical Supplements..............II-52 Mind/Body therapies..............II-52 Exercise and Diet.............. II-52
7. PRODUCT INTRODUCTIONS/APPROVALS II-53 Acrux and Gedeon Richter Announce European Approval for Lenzetto II-53 Noven Launches New Lose Dose-Strength Minivelle® for Treating Postmenopausal Osteoporosis..............II-53 Mylan Launches Generic Vivelle-DOT® II-53 Sandoz Rolls Out Authorized Generic for Vivelle-Dot® in the US II-53 Amneal Launches Lopreeza™ - Authorized Generic Form of Activella® II-53 Hisamitsu Secures Extended Dosage and Indication for Estrana® Tape Estradiol Transdermal Patch II-53
8. RECENT INDUSTRY ACTIVITY..............II-54 TherapeuticsMD Completes Patient Enrolment for Replenish Trial for TX-001HR.............. II-54 Actavis Changes Name to Allergan II-54 Actavis Takes Over Allergan..............II-54 Perrigo to Acquire Evamist from Lumara Health II-54 Trimel Acquires Canadian Rights to Estrace from Shire II-54 Upsher-Smith Inks Deal to Sell Divigel to Vertical Pharmaceuticals.............. II-54 Meda Inks Promotion Agreement with Mission Pharmacal for Elestrin II-55 IDT Australia Inks Agreement with Perrigo to Acquire Conjugated Estrogens ANDA Filing II-55
9. FOCUS ON SELECT GLOBAL PLAYERS..............II-56 Abbott Laboratories (US)..............II-56 AbbVie, Inc. (US).............. II-56 Allergan plc (Ireland)..............II-56 Bayer Pharma AG (Germany)..............II-57 Hisamitsu Pharmaceutical Co., Inc. (Japan) II-57 Noven Pharmaceuticals, Inc. (US) II-58 Novartis AG (Switzerland)..............II-58 Novo Nordisk A/S (Denmark)..............II-59 Orion Pharma AB (Finland)..............II-59 Pfizer, Inc. (US).............. II-60 Rottapharm Madaus (Italy)..............II-60 Teva Pharmaceutical Industries Ltd. (Israel) II-61 TherapeuticsMD, Inc. (US)..............II-61
10. GLOBAL MARKET PERSPECTIVE..............II-62 Table 4: World Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............II-62
Table 5: World Historic Review for Hormone Replacement Therapy (HRT) by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) II-63
Table 6: World 14-Year Perspective for Hormone Replacement Therapy (HRT) by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Europe, Asia-Pacific, Latin America and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) II-64
III. MARKET
1. THE UNITED STATES.............. III-1 A.Market Analysis.............. III-1 Current & Future Analysis..............III-1 HRT Market in the US - An Overview III-1 Select FDA Drug Approvals for Treatment of Menopause Symptoms by Year of Approval III-1 List of Approved Oral Estrogen Therapy Products III-2 List of Approved Transdermal Estrogen Therapy Products III-2 List of Approved Vaginal Estrogen Therapy Products III-3 List of Approved Combination Estrogen Products III-3 The Menopause Opportunity..............III-4 Table 7: US Female Population Percentage Distribution by Age Group: 2015 (includes corresponding Graph/Chart) III-4 Impact of the WHI Study..............III-4 Increasing Preference for Topical Vaginal Products III-5 Rising Interest in Low-Dose Hormone Therapies to Lead Market Growth.............. III-5 Low-Dose Hormone Replacement Therapy Formulations of Estrogens and Estrogen- Progestin Combinations Available in the United States..............III-5 Are Custom Compounded Bioidenticals Products Better? III-6 List of FDA-Approved Bioidentical Hormones III-7 Bioidenticals Remains a Lethargic Market in the US III-7 Regulatory Scenario for BHRT in the US III-8 Issues with Approved Bioidenticals III-8 VVA Market Remains Underpenetrated III-8 FDA Appealed to Make Changes to Boxed Warnings on Low-Dose Vaginal Estrogen to Drive Adoption III-9 Growing Pharmacy Compounding of HRT Raises Concerns; Proposed Bill to Put Shackles III-9 Product Approvals/Launches..............III-10 Strategic Corporate Developments III-11 Select Key Players..............III-12 B.Market Analytics..............III-15 Table 8: The US Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-15
Table 9: The US Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)..............III-16
2. CANADA.............. III-17 A.Market Analysis.............. III-17 Canada - The Birth Place of Estrogens III-17 Current Market Scenario..............III-17 The Fallout of the WHI Study III-17 Table 10: Canadian Female Population Estimates by Age Group: 2015 (includes corresponding Graph/Chart) III-18 List of Approved Oral Estrogen Therapy Products III-18 List of Approved Transdermal Estrogen Therapy Products III-19 List of Approved Vaginal Estrogen Therapy Products III-19 List of Approved Combination Estrogen Products III-20 Strategic Corporate Development III-20 B.Market Analytics..............III-21 Table 11: Canadian Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-21
Table 12: Canadian Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)..............III-22
3. EUROPE.............. III-23 A.Market Analysis.............. III-23 Current & Future Analysis..............III-23 Growing Demand for Topical and Transdermal HRT III-23 European Medicines Agency Imposes New Restrictions on Linoladiol HN and Linoladiol N Estradiol Creams III-23 B.Market Analytics..............III-25 Table 13: European Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart).............. III-25
Table 14: European Historic Review for Hormone Replacement Therapy (HRT) by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-26
Table 15: European 14-Year Perspective for Hormone Replacement Therapy (HRT) by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-27
3a. FRANCE.............. III-28 A.Market Analysis.............. III-28 Current & Future Analysis..............III-28 A Peek into the HRT Prescription Practices in France III-28 B.Market Analytics..............III-29 Table 16: French Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-29
Table 17: French Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)..............III-30
3b. GERMANY.............. III-31 A.Market Analysis.............. III-31 Current & Future Analysis..............III-31 Bayer Pharma AG - A Major Germany-Based Player III-31 B.Market Analytics..............III-32 Table 18: German Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-32
Table 19: German Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)..............III-33
3c. ITALY.............. III-34 A.Market Analysis.............. III-34 Current & Future Analysis..............III-34 Rottapharm Madaus - A Major Italy-Based Regional Player III-34 B.Market Analytics..............III-35 Table 20: Italian Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-35
Table 21: Italian Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)..............III-36
3d. THE UNITED KINGDOM..............III-37 A.Market Analysis.............. III-37 Current & Future Analysis..............III-37 Post-Menopausal Symptoms in British Women III-37 British Menopause Society and Women's Health Concern Revises Recommendations on HRT..............III-37 List of the Hormone Replacement Therapy Products Available in the UK.............. III-38 List of HRT Products Available in the UK by Format III-40 New Guidelines from NHS May Improve Uptake of HRT III-40 B.Market Analytics..............III-41 Table 22: The UK Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-41
Table 23: The UK Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)..............III-42
3e. SPAIN.............. III-43 A.Market Analysis.............. III-43 Current & Future Analysis..............III-43 HRT Prescription Status in Spain III-43 B.Market Analytics..............III-44 Table 24: Spanish Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-44
Table 25: Spanish Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)..............III-45
3f. REST OF EUROPE.............. III-46 A.Market Analysis.............. III-46 Current & Future Analysis..............III-46 Product Approval..............III-46 Strategic Corporate Development III-46 Select Key Players..............III-46 B.Market Analytics..............III-49 Table 26: Rest of Europe Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-49
Table 27: Rest of Europe Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-50
4. ASIA-PACIFIC.............. III-51 A.Market Analysis.............. III-51 Current and Future Analysis..............III-51 Focus on Select Regional Markets III-51 Australia.............. III-51 Dwindling Options for Estrogen Patients - A Growing Concern III-51 Japan.............. III-52 Japan - A Small yet Growing Market for HRT III-52 Menopausal Characteristics and Impact of Diet III-52 Product Approval..............III-52 Hisamitsu Pharmaceutical Co., Inc. - A Major Japan-Based HRT Manufacturer.............. III-53 B.Market Analytics..............III-54 Table 28: Asia-Pacific Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-54
Table 29: Asia-Pacific Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-55
5. LATIN AMERICA.............. III-56 Market Analysis.............. III-56 Table 30: Latin American Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-56
Table 31: Latin American Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-57
6. REST OF WORLD.............. III-58 A.Market Analysis.............. III-58 Current & Future Analysis..............III-58 Teva Pharmaceutical Industries Ltd. - A Key Player Israel- based Player.............. III-58 B.Market Analytics..............III-59 Table 32: Rest of World Recent Past, Current & Future Analysis for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-59
Table 33: Rest of World Historic Review for Hormone Replacement Therapy (HRT) Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-60
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 40 (including Divisions/Subsidiaries - 47)
The United States (22) Canada (3) Japan (3) Europe (12) - Germany (1) - The United Kingdom (5) - Rest of Europe (6) Asia-Pacific (Excluding Japan) (6) Middle East (1)
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