Global Hormone Replacement Therapy (HRT) Industry

News provided by

Jun 18, 2014, 11:03 ET

LONDON, June 18, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report:

Global Hormone Replacement Therapy (HRT) Industry

http://www.reportbuyer.com/pharma_healthcare/therapeutic/hormone_replacement_therapy_hrt.html

This report analyzes the worldwide markets for Hormone Replacement Therapy (HRT) in US$ Million. 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 2012 through 2020. 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.
Actavis Plc
Bayer Pharma AG
Hisamitsu Pharmaceutical Co., Inc.
Noven Pharmaceuticals, Inc.

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
HRT - A Prelude II-1
The Regional Divide II-2
Current and Future Analysis II-3

2. INDUSTRY OVERVIEW II-4
An Introduction to Menopause and Hormone Replacement Therapy II-4
An Overview of Select Estrogen Therapy Approaches II-5
WHI Study- A Major Blow to the HRT Market II-5
The HRT Controversy Evolution in the New Millennium II-6
Reappraisal of Data from Previous Studies - A Hope for
Resurgence in HRT Demand II-6
IMS Consensus Guidelines Paving Way for More Clarity of HRT II-7
Menopause Statistics - An Opportunity Indicator II-8
Ethnic Differences Exist in Menopausal Symptoms II-8

3. MARKET TRENDS & ISSUES II-9
Market Size Restricted by Lesser Number of Women Opting for
Treatment II-9
Safety Issues: A Major Deterrent to the HRT Market II-9
Manufacturers Continue to Face Legal Challenges II-9
Topical Estrogens - More Safe and Effective II-10
Transdermal HRT Products Present Exciting Opportunities II-10
Phytoestrogens - The New Panacea for Menopausal Symptoms? II-11
Diet Link to Menopause Symptoms Raises Interest II-11
Impact of Soy and Other Phytoestrogens - A Reality Check II-12
The Growing Buzz around Bioidentical Drugs II-13
Bio-identical Hormones - A Natural and Safe Substitute to
Synthetic HRT? II-13
List of Bio-identical Products Used in Conventional HRT II-14
Direct-to-Consumer Advertising for HRT - A Mixed Bag II-14

4. COMPETITIVE LANDSCAPE II-16
Intense Competition Marks the Global HRT Market II-16
Table 1: Global Sales of Select HRT Products (In US$ Million)
(includes corresponding Graph/Chart) II-16
The Premarin Saga II-17
Health Risks Tarnish Premarin's Image II-17
Table 2: Annual Sales of Premarin Family: 2002-2013 (includes
corresponding Graph/Chart) II-18
Pfizer Seeks Refuge in Line Extensions II-18
Better Safety Profile for Duavee - A Shot in the Arm for Pfizer II-19
Estrace Cream Drives Revenue Gains in Warner Chilcott's HRT
Portfolio II-19
Table 3: Annual Sales of Estrace Cream: 2010-2013 (includes
corresponding Graph/Chart) II-20
Table 4: Annual Sales of Warner Chilcott's HRT Portfolio -
Estrace Cream, Estrace Tablets, femhrt and Femring - in US$
Million for Years 2010 & 2011 (includes corresponding
Graph/Chart) II-20
New Drug Buoys Novo Nordisk's HRT Portfolio II-21
Estriol: The Next Generation Estrogen Therapy? II-21
What Makes Estriol Work? II-21
Topical Estriol - More Promising in Safety II-22
Estriol - Used More Commonly Outside the US II-22
Entry of Generics Threatens Market Growth Prospects II-22
Select Hormone Therapies for Post Menopausal Women by Year of
Patent Expiry II-23
Generic Incursion in Hormone Replacement Therapy - List of
Drugs With and Without Approved Generic Versions II-24
Select Hormone Therapies for Treatment of Postmenopausal
Symptoms by Generic Manufacturers II-25
Are Non-Hormonal Therapies A Threat to HRT? II-25
Earlier Failures Induce Lethargy in Non-Hormonal Therapies II-26
Menerba: A Promising Non-Hormone Therapy for Menopausal Hot
Flashes II-27

5. THERAPY PROFILE - A REVIEW OF SELECT RECENT STUDIES CONDUCTED II-28
Researchers at Yale University Discover Discontinuation HRT
May Lead to Premature Deaths II-28
Bioidenticals versus Synthetic Hormone Replacement Therapy Agents II-28
Studies at University of Sydney Researchers Reveal the Safety
of Short-Term Unopposed Estrogens II-29
US Researchers Reveal HRT Risks May be Dependent on Weight and
Other Factors II-29
Studies Prove HRT to Lower Risk of Pancreatic Cancer II-30
University of Texas Reveal HRT Linked to Risks of Kidney Stones II-30
Researchers at the Sundsvall Hospital Demonstrate Increased
Incidence of Cataract Development in Women Undergoing HRT II-30
Researchers at University of Southern California Demonstrate
Estrogen Replacement Therapies Lower Stress Levels in Older
Women II-31
Studies at Uppsala University Hospital Demonstrate HRT is
Associated with Improved Muscle Functioning in Postmenopausal
women II-31
Finnish Study Reveals HRT Usage Assist in the Treatment of Hot
Flashes in Post Menopausal Women II-31
Researchers at Johns Hopkins University Demonstrate Women
Undergoing Hormone Therapy Less Prone to Alzheimer's Disease II-32
French Study Reveals Hormone Replacement Pills May Affect Gall
Bladder II-32
Danish Studies Proves HRT Lowers Risk of Heart Attack and
Heart Failure II-32

6. PRODUCT OVERVIEW II-33
What are Hormones? II-33
What is Menopause? II-33
Menopause Symptoms and Complaints II-33
Introduction to Hormone Replacement Therapy II-34
HRT Products II-35
Estrogen II-35
Progestins II-35
Types of HRT II-36
Why HRT? II-36
Milestones and Downfalls in the Hormone Replacement Therapy
(HRT) Market II-36
Contraindications of HRT II-37
Historical Progression II-37
Advantages and Disadvantages of Using HRT II-37
Benefits of Hormone Therapy II-37
Relief from Vasomotor Symptoms II-37
Vaginal Symptoms II-38
Improvement in Sexual Functioning II-38
Urinary Health II-38
Management of Variations in Body Weight/ Mass II-38
Ensuring Quality of Life II-38
Osteoporosis II-39
Diabetes Mellitus (DM) II-39
Impact on Overall Mortality II-39
Treatment of Premature Menopause II-39
Risks Involved in Hormone Therapy II-39
Hormone Therapies in HRT and their Effect II-40
Potential Benefits and Risks of HRT in Menopausal Symptoms II-41
Common and Less Common Side Effects of Using Estrogen-alone,
Progesterone-alone or Combination Therapies II-41
Potential Issues II-41
Cardiovascular Problems II-41
Coronary Heart Disease (CHD) II-41
Stroke II-42
Venous Thromboembolism (VTE) II-42
Endometrial Cancer II-42
Breast Cancer II-42
Estrogen-Progestogen Therapy II-42
Estrogen Therapy II-42
Lung Cancer II-42
Depression and Mood Swings II-43
Ovarian Cancer II-43
Routes of Administration II-43
Systemic Treatment II-43
Pills II-43
Advantages and Disadvantages of Oral HRT II-43
Vaginal Estrogen Ring II-44
Transdermal Estrogen Skin Patches II-44
Localized Treatment II-44
Vaginal Estrogen Tablets II-44
Estrogen Creams II-44
Intrauterine Progestin System (IUS) II-44
Lower Dose Vaginal Estrogen Ring II-44
Vaginal Progesterone Gel II-45
Implants II-45
Advantages and Disadvantages of HRT Implants II-45
Bioidentical Hormone Replacement Therapy (BHRT) II-45
Historical Background II-46
More Claims than Evidence II-46
Other Alternatives II-47
Prescription Medication II-47
Gabapentin II-47
Clonidine II-47
SNRIs and SSRIs II-47
Botanicals II-47
Black Cohosh II-48
Phytoestrogens (Isoflavones) II-48
Other Botanical Products II-48
Non-botanical Supplements II-48
Mind/Body therapies II-48
Exercise and Diet II-49

7. PRODUCT INTRODUCTIONS/APPROVALS II-50
Pfizer Receives FDA Approval for DUAVEE™ for Treatment of
Vasomotor Symptoms II-50
Noven Pharmaceuticals Launches Brisdelle™ Capsules II-50
Lawley Pharmaceuticals Launches Profeme progesterone
Bioidentical Hormone Replacement Cream II-50
Bayer Receives FDA Approval for Low-Dose ANGELIQ® Tablets II-51
Noven Pharmaceuticals Receives USFDA Approval for Minivelle™ II-51
Mylan Pharmaceuticals Introduces Letrozole Tablets II-51
Novo Nordisk Unveils Vagifem® 10µg II-51
Amgen Obtains FDA Approval for Prolia in Treating
Postmenopausal Women at Greater Risk of Osteoporosis II-52

8. RECENT INDUSTRY ACTIVITY II-53
Actavis Takes Over Warner Chilcott II-53
US FDA Rejects SEFELSA™ from Depomed for Treatment of
Menopause Symptoms II-53
US FDA Advisory Committee Rejects Noven Pharmaceuticals' LDMP,
a Low-Dose Mesylate Salt of Paroxetine II-53
Piramal to Expand its Hormone Product Capacity in the UK II-54
BioSante Pharmaceuticals Merges with ANI Pharmaceuticals II-54
Biovive Medicine Establishes New Site for BHRT Production in
Boulder II-54
TherapeuticsMD Commences Phase I Clinical Trial of Estradiol
Vagicap™ II-54
US FDA Accepts TherapeuticsMD's IND for TX12-004HR II-54
TherapeuticsMD Files Patent Application for Proprietary New
Formulation Technologies II-55
Noven Takes over Commercial Rights to Minivelle™ from Novogyne
Pharmaceuticals II-55
Pfizer Halts Development of PRISTIQ® for Treatment of
Vasomotor Symptoms II-55
Teva Completes Takeover of Théramex II-56
Pfizer Global Manufacturing to Reconfigure Global Plant Network II-56
Watson Enters into Agreement to Acquire US rights of CLI's
Bioadhesive Progesterone Gel II-56
Solvay Divests Pharmaceutical Business II-56

9. FOCUS ON SELECT GLOBAL PLAYERS II-57
Abbott Laboratories (US) II-57
AbbVie, Inc. (US) II-57
Actavis Plc (Ireland) II-57
Bayer Pharma AG (Germany) II-58
Bayer Pharma's Hormone Replacement Therapy Product Pipeline II-59
Hisamitsu Pharmaceutical Co., Inc. (Japan) II-59
Noven Pharmaceuticals, Inc. (US) II-60
Merck Sharp & Dohme Corp. (UK) II-60
Novartis AG (Switzerland) II-60
Novo Nordisk A/S (Denmark) II-61
Orion Corporation (Finland) II-61
Pfizer, Inc. (US) II-62
Rottapharm Madaus (Italy) II-62
Teva Pharmaceutical Industries Ltd. (Israel) II-63
TherapeuticsMD, Inc. (US) II-63
Upsher-Smith Laboratories, Inc. (US) II-64

10. GLOBAL MARKET PERSPECTIVE II-65
Table 5: 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$ Million for Years 2012 through 2020 (includes
corresponding Graph/Chart) II-65

Table 6: 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$ Million for Years 2006
through 2011 (includes corresponding Graph/Chart) II-66

Table 7: World 15-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 2006, 2014 & 2020
(includes corresponding Graph/Chart) II-67

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
List of FDA Approved Drugs for Treatment of Menopause
Symptoms by Year of Approval III-1
List of FDA-Approved Prescription Estrogen- Only Drugs for
Preventing Postmenopausal Osteoporosis III-2
List of FDA-Approved Prescription Estrogen- Progestin
Combination Drugs for Preventing Postmenopausal
Osteoporosis III-2
List of FDA-Approved Oral Estrogen Therapy Products for Use
in Postmenopausal Indications III-3
List of FDA-Approved Progestogens III-3
The Menopause Opportunity III-3
Table 8: US Female Population Percentage Distribution by
Age Group: 2013 (includes corresponding Graph/Chart) III-4
Impact of the WHI Study III-4
Increasing Preference for Topical Vaginal Products III-4
Rising Interest in Low-Dose Hormone Therapies to Lead Market
Growth III-4
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-5
List of FDA-Approved Bioidentical Hormones III-6
Bioidenticals Remains a Lethargic Market in the US III-7
Regulatory Scenario for BHRT in the US III-7
Issues with Approved Bioidenticals III-7
Product Launches/Approvals III-8
Strategic Corporate Developments III-10
Select Key Players III-14
B.Market Analytics III-17
Table 9: The US Recent Past, Current & Future Analysis for
Hormone Replacement Therapy (HRT) Market - Analyzed with
Annual Sales Figures in US$ Million for Years 2012 through
2020 (includes corresponding Graph/Chart) III-17

Table 10: The US Historic Review for Hormone Replacement
Therapy (HRT) Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2006 through 2011 (includes
corresponding Graph/Chart) III-17

2. CANADA III-18
A.Market Analysis III-18
Canada - The Birth Place of Estrogens III-18
Current Market Scenario III-18
The Fallout of the WHI Study III-18
Table 11: Canadian Female Population Estimates by Age
Group: 2013 (includes corresponding Graph/Chart) III-19
List of Approved Prescription Estrogen-Only Drugs for
Preventing Postmenopausal Osteoporosis in Canada III-19
List of Approved Prescription Estrogen- Progestin
Combination Drugs for Preventing Postmenopausal
Osteoporosis in Canada III-19
List of Approved Topical and Transdermal Estrogens Products
in Canada III-20
List of Approved Vaginal Estrogen Therapy Products in Canada III-20
List of Approved Oral Estrogen Therapy Products for Use in
Postmenopausal Indications in Canada III-20
B.Market Analytics III-21
Table 12: Canadian Recent Past, Current & Future Analysis
for Hormone Replacement Therapy (HRT) Market - Analyzed with
Annual Sales Figures in US$ Million for Years 2012 through
2020 (includes corresponding Graph/Chart) III-21

Table 13: Canadian Historic Review for Hormone Replacement
Therapy (HRT) Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2006 through 2011 (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 14: 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$
Million for Years 2012 through 2020 (includes corresponding
Graph/Chart) III-25

Table 15: 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$ Million for Years 2006
through 2011 (includes corresponding Graph/Chart) III-26

Table 16: European 15-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 2006, 2014 & 2020
(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 17: French Recent Past, Current & Future Analysis for
Hormone Replacement Therapy (HRT) Market - Analyzed with
Annual Sales Figures in US$ Million for Years 2012 through
2020 (includes corresponding Graph/Chart) III-29

Table 18: French Historic Review for Hormone Replacement
Therapy (HRT) Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2006 through 2011 (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
Bayer Pharma's Hormone Replacement Therapy Product Pipeline III-32
B.Market Analytics III-32
Table 19: German Recent Past, Current & Future Analysis for
Hormone Replacement Therapy (HRT) Market - Analyzed with
Annual Sales Figures in US$ Million for Years 2012 through
2020 (includes corresponding Graph/Chart) III-32

Table 20: German Historic Review for Hormone Replacement
Therapy (HRT) Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2006 through 2011 (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 21: Italian Recent Past, Current & Future Analysis for
Hormone Replacement Therapy (HRT) Market - Analyzed with
Annual Sales Figures in US$ Million for Years 2012 through
2020 (includes corresponding Graph/Chart) III-35

Table 22: Italian Historic Review for Hormone Replacement
Therapy (HRT) Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2006 through 2011 (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-39
Strategic Corporate Development III-40
Key Player III-40
B.Market Analytics III-41
Table 23: The UK Recent Past, Current & Future Analysis for
Hormone Replacement Therapy (HRT) Market - Analyzed with
Annual Sales Figures in US$ Million for Years 2012 through
2020 (includes corresponding Graph/Chart) III-41

Table 24: The UK Historic Review for Hormone Replacement
Therapy (HRT) Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2006 through 2011 (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 25: Spanish Recent Past, Current & Future Analysis for
Hormone Replacement Therapy (HRT) Market - Analyzed with
Annual Sales Figures in US$ Million for Years 2012 through
2020 (includes corresponding Graph/Chart) III-44

Table 26: Spanish Historic Review for Hormone Replacement
Therapy (HRT) Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2006 through 2011 (includes
corresponding Graph/Chart) III-45

3f. REST OF EUROPE III-46
A.Market Analysis III-46
Current & Future Analysis III-46
Strategic Corporate Developments III-46
Select Key Players III-47
B.Market Analytics III-49
Table 27: Rest of European Recent Past, Current & Future
Analysis for Hormone Replacement Therapy (HRT) Market -
Analyzed with Annual Sales Figures in US$ Million for Years
2012 through 2020 (includes corresponding Graph/Chart) III-49

Table 28: Rest of European Historic Review for Hormone
Replacement Therapy (HRT) Market - Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2011
(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
Hisamitsu Pharmaceutical Co., Inc. - A Major Japan-Based HRT
Manufacturer III-52
B.Market Analytics III-53
Table 29: Asia-Pacific Recent Past, Current & Future
Analysis for Hormone Replacement Therapy (HRT) Market -
Analyzed with Annual Sales Figures in US$ Million for Years
2012 through 2020 (includes corresponding Graph/Chart) III-53

Table 30: Asia-Pacific Historic Review for Hormone
Replacement Therapy (HRT) Market - Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2011
(includes corresponding Graph/Chart) III-54

5. LATIN AMERICA III-55
Market Analysis III-55
Table 31: Latin American Recent Past, Current & Future
Analysis for Hormone Replacement Therapy (HRT) Market -
Analyzed with Annual Sales Figures in US$ Million for Years
2012 through 2020 (includes corresponding Graph/Chart) III-55

Table 32: Latin American Historic Review for Hormone
Replacement Therapy (HRT) Market - Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2011
(includes corresponding Graph/Chart) III-56

6. REST OF WORLD III-57
A.Market Analysis III-57
Current & Future Analysis III-57
Strategic Corporate Development III-57
Key Player III-57
B.Market Analytics III-58
Table 33: Rest of World Recent Past, Current & Future
Analysis for Hormone Replacement Therapy (HRT) Market -
Analyzed with Annual Sales Figures in US$ Million for Years
2012 through 2020 (includes corresponding Graph/Chart) III-58

Table 34: Rest of World Historic Review for Hormone
Replacement Therapy (HRT) Market - Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2011
(includes corresponding Graph/Chart) III-59

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 40 (including Divisions/Subsidiaries - 54)

The United States (29)
Canada (2)
Japan (5)
Europe (14)
- France (1)
- Germany (2)
- The United Kingdom (4)
- Italy (1)
- Rest of Europe (6)
Asia-Pacific (Excluding Japan) (3)
Middle East (1)