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This BCC Research report covers the key diseases of women’s health market, key growth areas and quantitative market projections for services and devices. Forecast provided through 2020.

Use this report to:

Analyze the historical and current population under treatment for women’s health disordersby regional markets.
Identify and evaluate the impact of demographic, economic and other factors that will drive future demand for women’s health therapeutics market.
Identify promising new drugs and therapies in the development and testing stage and assess the probability of their success.
Identify more accurately leading drug manufacturers and analyze the structure of the women’s health therapeutics industry.

Highlights

The global market for women’s health therapeutics will grow from nearly $33.0 billion in 2015 to nearly $40.6 billion by 2020, with a compound annual growth rate (CAGR) of 4.2% for the period of 2015-2020.
The U.S. dominated the women’s health therapeutics market and will grow from nearly $19.5 billion in 2015 to $25.3 billion by 2020, rising at a CAGR of 5.4%.
The European market is expected to increase from nearly $11.4 billion in 2015 to $13.0 billion by 2020 with a CAGR of 2.7%.

INTRODUCTION

Women’s health disorders include health issues unique and specific to the female gender. Women’s health concerns have gained significant attention in recent times due to disease pattern (illness, symptoms and response) and treatment differences between men and women. Gynecological, cancer and musculoskeletal disorders are considered the key areas of focus within the women’s health disorder market.

Menopause, postmenopausal osteoporosis, endometriosis, breast cancer and polycystic ovary syndrome (PCOS) are the most common issues within women’s health.

Menopause is one of the most common stages of the natural or surgically induced cessation of estradiol and progesterone production by the ovaries. It is also a major risk factor for the development of osteoporosis. PCOS is also another common endocrine disorder in women of reproductive age.

Endometriosis is a chronic inflammatory disease observed in women of reproductive age. Women have a lifetime risk of one in three of developing cancer. Breast cancer is a growing concern due to the significant numbers of women involved.

Postmenopausal osteoporosis is another known women’s health disorder across the globe. It is also known as type I osteoporosis and affects women 45 to 50 years old and above who have gone through menopause. Attention to women’s health disorders has increased dramatically in the past few decades, expanding from a focus on reproductive care to a new, comprehensive life span approach.

STUDY BACKGROUND

Worldwide, an estimated 300 million females suffer from a women’s health disorder. However, only 25 million to 30 million female patients are actively receiving treatment (e.g., hormone therapy/drugs), primarily due to poor diagnosis of the diseases and lack of awareness. There are a few diseases, such as endometriosis, where the cause of the disease is unknown and thus its treatment remains an intensely debated subject among physicians and patients. There are several treatment options available to obtain relief from the symptoms of endometriosis but there is no cure.

Because of the large patient pool of women’s health disorders, there is a pressing need to develop an up-to-date base of market information to better understand the dynamics of the women’s health therapeutics, technologies and global markets.

This report is the second edition to cover the key diseases of women’s health market, key growth areas and quantitative market projections for services and devices.

Increasing prevalence and the rising concern of patients toward their health is boosting the women’s health market. This study attempts to provide the reader the information and analysis needed to deal with these challenges.

Table Of Contents

Therapeutics for Women%s Health: Technologies and Global Markets

CHAPTER 1 INTRODUCTION 2
STUDY BACKGROUND 2
STUDY GOALS AND OBJECTIVES 3
INTENDED AUDIENCE 4
SCOPE OF THE REPORT 4
METHODOLOGY AND INFORMATION SOURCES 4
ANALYST'S CREDENTIALS 5
RELATED BCC RESEARCH REPORTS 5
BCC RESEARCH WEBSITE 5
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
EXECUTIVE SUMMARY 7
SUMMARY TABLE GLOBAL MARKET FOR WOMEN'S HEALTH THERAPEUTICS,
THROUGH 2020 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL MARKET FOR WOMEN'S HEALTH THERAPEUTICS,
2014-2020 ($ MILLIONS) 7
CHAPTER 3 OVERVIEW OF WOMEN'S HEALTH DISORDERS 10
DISEASE OVERVIEW AND DEFINITIONS 10
TABLE 1 GLOBAL GENERAL FEMALE POPULATION VS POPULATION SUFFERING
FROM A WOMEN'S DISORDER, THROUGH 2020 (MILLIONS) 11
FIGURE 1 DISTRIBUTION OF GLOBAL POPULATION SUFFERING FROM A WOMEN'S
DISORDER BY TYPE, 2015 (% OF TOTAL GENERAL FEMALE POPULATION) 12
HISTORICAL BACKGROUND 12
AGING AND WOMEN'S HEALTH DISORDERS 14
FIGURE 2 FEMALE LIKELIHOOD OF BECOMING PREGNANT VERSUS INFERTILITY AS
AGE PROGRESSES, 2015 (%) 14
NEW USE FOR CONTRACEPTIVES 15
WOMEN AND SEXUAL HEALTH 17
FEMALE SEXUAL AROUSAL DISORDER 17
FEMALE ORGASMIC DISORDER 18
VAGINISMUS 19
INFERTILITY AND CANCER 19
CHAPTER 4 MENOPAUSE-RELATED SYMPTOMS AND DISEASES 21
OVERVIEW 21
ETIOLOGY 22
EPIDEMIOLOGY AND ECONOMIC BURDEN 22
TABLE 2 GLOBAL PREVALENCE OF MENOPAUSE-RELATED CONDITIONS BY REGION,
THROUGH 2020 (MILLIONS) 22
FIGURE 3 GLOBAL PREVALENCE OF MENOPAUSE-RELATED CONDITIONS BY REGION,
2014-2020 (MILLIONS) 22
FIGURE 4 GLOBAL POPULATION OF FEMALES SUFFERING FROM
MENOPAUSE-RELATED CONDITIONS VS THE GENERAL FEMALE POPULATION,
2014-2020 (MILLIONS)
23
FIGURE 5 GLOBAL DISTRIBUTION OF FEMALES SUFFERING FROM
MENOPAUSE-RELATED CONDITIONS BY REGION, 2015 (% OF GENERAL FEMALE
POPULATION)
24
SYMPTOMS OF MENOPAUSE 24
RISK FACTORS FOR EARLY ONSET MENOPAUSE 25
DIAGNOSIS AND TREATMENT 26
DIAGNOSIS OF MENOPAUSE 26
TREATMENT OPTIONS 27
TABLE 3 COMMONLY PRESCRIBED DRUGS USED TO TREAT THE SYMPTOMS OF
MENOPAUSE 27
Minivelle (Estradiol) 28
FemSeven (Estradiol) 29
Premarin (Conjugated Estrogens) 29
Prempro (Conjugated Estrogens/Medroxyprogesterone Acetate
Tablets) 30
Vagifem (Estradiol Vaginal Tablets) 30
Femring (Estradiol Acetate Vaginal Ring) 30
ISSUES ASSOCIATED WITH HORMONE THERAPY 31
REDUCING THE RISK OF EARLY MENOPAUSE 31
CHAPTER 5 POSTMENOPAUSAL OSTEOPOROSIS 34
DISEASE OVERVIEW 34
HUMAN BONE STRUCTURE 34
EPIDEMIOLOGY AND ECONOMIC BURDEN 35
TABLE 4 GLOBAL PREVALENCE OF POSTMENOPAUSAL OSTEOPOROSIS BY REGION,
THROUGH 2020 (MILLIONS) 35
FIGURE 6 GLOBAL PREVALENCE OF POSTMENOPAUSAL OSTEOPOROSIS BY REGION,
2014-2020 (MILLIONS) 36
FIGURE 7 GLOBAL POPULATION OF FEMALES WITH POSTMENOPAUSAL
OSTEOPOROSIS VS THE OVERALL FEMALE POPULATION, 2014-2020 (MILLIONS) 36
FIGURE 8 GLOBAL DISTRIBUTION OF FEMALES WITH POSTMENOPAUSAL
OSTEOPOROSIS BY GEOGRAPHIC REGION, 2015 (% OF FEMALE POPULATION) 37
DISEASE SYMPTOMS AND RISK FACTORS 38
DISEASE SYMPTOMS 38
Fractures 38
Spinal Deformities 39
Pain 39
RISK FACTORS 39
DIAGNOSIS AND TREATMENT 40
DIAGNOSIS OF POSTMENOPAUSAL OSTEOPOROSIS 40
TREATMENT OPTIONS FOR POSTMENOPAUSAL OSTEOPOROSIS 41
Bisphosphonates 41
Hormone Therapy 42
Selective Estrogen Receptor Modulators (SERMs) 43
Calcitonin 43
Parathyroid Hormone 44
TABLE 5 COMMONLY PRESCRIBED DRUGS USED TO TREAT POSTMENOPAUSAL
OSTEOPOROSIS 44
Caltrate (Calcium Carbonate) 45
Edirol (Eldecalcitol) 46
Pralia (Denosumab) 46
Protelos (Strontium Ranelate) 46
Miacalcin (Calcitonin Salmon) 46
Fosamax (Alendronate Sodium) 46
Actonel (Risedronate Sodium) 47
Evista (Raloxifene Hydrochloride) 48
Boniva (Ibandronate Sodium) 48
Forteo (Teriparatide (rDNA Origin)) Injection 49
Reclast (Zoledronate) 49
Calcitonin (Calcimar, Miacalcin) 50
Forteo (Teriparatide) 50
Aprela (Bazedoxifene/Conjugated Estrogen) 51
Viviant (Bazedoxifene) 51
REDUCING THE RISK OF OSTEOPOROSIS 51
CHAPTER 6 ENDOMETRIOSIS 54
DISEASE OVERVIEW 54
ETIOLOGY AND PATHOPHYSIOLOGY 55
DISEASE SYMPTOMS AND RISK FACTORS 56
PELVIC PAIN 56
DIFFICULTY BECOMING PREGNANT 56
ENDOMETRIOMAS 57
RISK FACTORS 57
Genetic Factors 57
Delayed Pregnancy 57
Age 57
Dietary Factors 58
STAGES OF ENDOMETRIOSIS 58
EPIDEMIOLOGY AND ECONOMIC BURDEN 59
TABLE 6 PREVALENCE OF ENDOMETRIOSIS BY REGION, THROUGH 2020 (MILLIONS) 59
FIGURE 9 PREVALENCE OF ENDOMETRIOSIS BY REGION, 2014-2020 (MILLIONS) 59
FIGURE 10 GLOBAL ENDOMETRIOSIS POPULATION VS OVERALL FEMALE
POPULATION, 2014-2020 (MILLIONS) 60
FIGURE 11 GLOBAL DISTRIBUTION OF ENDOMETRIOSIS POPULATION BY REGION,
2015 (% OF FEMALE POPULATION) 61
DIAGNOSIS AND TREATMENT 62
DIAGNOSIS OF ENDOMETRIOSIS 62
Pelvic Exam 62
Laparoscopy 62
Other Diagnostic Procedures 63
TREATMENT OPTIONS FOR ENDOMETRIOSIS 63
Pharmacological Treatment 64
NSAIDs 64
Hormonal Birth Control Treatments 64
Progestins 65
Gonadotropin Releasing Hormone Agonists 65
TABLE 7 DRUGS COMMONLY USED TO TREAT ENDOMETRIOSIS 66
Zoladex 66
Visanne (Dienogest) 67
Lupron Depot (Leuprolide Acetate) 67
Synarel (Nafarelin Acetate) 67
Danazol 67
Visanne 67
Surgery 68
LOWERING THE RISK OF ENDOMETRIOSIS 69
CHAPTER 7 POLYCYSTIC OVARY SYNDROME 71
DISEASE OVERVIEW 71
ETIOLOGY 71
EPIDEMIOLOGY AND ECONOMIC BURDEN 72
TABLE 8 PREVALENCE OF POLYCYSTIC OVARY SYNDROME BY REGION, THROUGH
2020 (MILLIONS) 72
FIGURE 12 PREVALENCE OF POLYCYSTIC OVARY SYNDROME BY REGION,
2014-2020 (MILLIONS) 73
FIGURE 13 GLOBAL POLYCYSTIC OVARY SYNDROME DISEASE POPULATION VS
FEMALE POPULATION, 2014-2020 (MILLIONS) 73
FIGURE 14 GLOBAL DISTRIBUTION OF POLYCYSTIC OVARY SYNDROME
POPULATION BY REGION, 2015 (% OF FEMALE POPULATION) 74
DISEASE SYMPTOMS AND RISK FACTORS 74
DIAGNOSIS AND TREATMENT 75
DIAGNOSIS OF POLYCYSTIC OVARY SYNDROME 75
Medical History and Physical Examination 75
Pelvic Examination 75
Laboratory Testing 75
Imaging Tests 76
TREATMENT OPTIONS FOR POLYCYSTIC OVARY SYNDROME 76
TABLE 9 COMMONLY PRESCRIBED GENERIC DRUGS FOR THE TREATMENT OF
POLYCYSTIC OVARY SYNDROME 77
Medications 79
Clomid (Clomiphene) 79
Vaniqa (Eflornithine) 79
Glucophage (Metformin) 79
Actos (Pioglitazone) and Avandia (Rosiglitazone) 79
Aldactone (Spironolactone) 79
Precose (Acarbose) 80
Apri (Desogestrel/Ethinyl Estradiol) 80
Propecia (Finasteride) 80
Eulexin (Flutamide) 80
Femara (Letrozole) 80
REDUCING THE RISK OF PCOS 80
CHAPTER 8 BREAST CANCER 83
DISEASE OVERVIEW 83
ETIOLOGY AND PATHOPHYSIOLOGY 83
DISEASE SYMPTOMS AND RISK FACTORS 84
SYMPTOMS 84
RISK FACTORS 84
TYPES AND STAGES OF BREAST CANCER 85
TABLE 10 TNM CLASSIFICATIONS OF BREAST CANCERS 86
TABLE 11 FIVE-YEAR SURVIVAL RATE BASED ON STAGE OF BREAST CANCER FOR
WOMEN IN THE U.S, 2015 (%) 87
EPIDEMIOLOGY AND ECONOMIC BURDEN 87
TABLE 12 PREVALENCE OF BREAST CANCER BY REGION, THROUGH 2020
(MILLIONS) 87
FIGURE 15 PREVALENCE OF BREAST CANCER BY REGION, 2014-2020 (MILLIONS) 88
FIGURE 16 GLOBAL BREAST CANCER POPULATION VS OVERALL FEMALE
POPULATION, 2014-2020 (MILLIONS) 88
FIGURE 17 GLOBAL DISTRIBUTION OF BREAST CANCER POPULATION BY REGION,
2015 (% OF FEMALE POPULATION) 89
DIAGNOSIS AND TREATMENT 90
DIAGNOSIS OF BREAST CANCER 90
TREATMENT OPTIONS FOR BREAST CANCER 92
TABLE 13 TYPES OF HORMONE THERAPY FOR BREAST CANCER 93
Cancer Treatment: Local or Systemic 93
TABLE 14 DRUGS COMMONLY USED TO TREAT BREAST CANCER 94
Medications 95
Alkeran (Melphalan) 95
Taxol (Paclitaxel) 96
Methotrexate Sodium 96
Herceptin (Trastuzumab) 96
Ellence (Epirubicin Hydrochloride) 96
Aromasin (Exemestane) 97
Adrucil (Fluorouracil) 97
Femara (Letrozole) 97
Velban (Vinblastine) 97
Gemzar 98
Abraxane (Paclitaxel [Albumin-bound]) 98
Arimidex (Anastrozole) 98
Faslodex (Fulvestrant) 98
Fareston 99
Xeloda (Capecitabine) 99
Zoladex (Goserelin Acetate) 99
Ixempra (Ixabepilone) 99
Tykerb (Lapatinib Ditosylate) 99
Abraxane (Paclitaxel [Albumin-bound]) 100
Perjeta (Pertuzumab) 100
Ibrance (Palbociclib) 100
Kadcyla (Ado-trastuzumab Emtansine) 100
Halaven (Eribulin Mesylate) 100
Afinitor (Everolimus) 100
Avastin (Bevacizumab) 101
Leuplin (Leuprolide Acetate) 101
Taxotere (Docetaxel) 101
Prognosis After Treatment 101
Breast Cancer Treatment Guidelines 102
Prevention 102
CHAPTER 9 WOMEN'S HEALTH DISORDER THERAPEUTICS MARKET ASSESSMENT 104
GLOBAL WOMEN'S HEALTH MARKET 104
FIGURE 18 GLOBAL WOMEN'S HEALTH THERAPEUTICS MARKET BY REGION,
2014-2020 ($ MILLIONS) 104
FIGURE 19 GLOBAL WOMEN'S HEALTH THERAPEUTICS MARKET BY DISORDER TYPE,
2014-2020 ($ MILLIONS) 105
FIGURE 20 GLOBAL MARKET SHARES OF WOMEN'S HEALTH THERAPEUTICS
MARKET BY DISORDER TYPE, 2015 (%) 106
FIGURE 21 AVERAGE ANNUAL COST OF THERAPY FOR WOMEN'S HEALTH
DISORDERS, 2014-2020 ($) 107
ENDOMETRIOSIS 108
FIGURE 22 GLOBAL ENDOMETRIOSIS THERAPEUTICS MARKET BY REGION,
2014-2020 ($ MILLIONS) 108
MENOPAUSE 109
FIGURE 23 GLOBAL MARKET FOR THERAPEUTICS TO TREAT MENOPAUSE-RELATED
CONDITIONS BY REGION, 2014-2020 ($ MILLIONS) 109
POSTMENOPAUSAL OSTEOPOROSIS 111
FIGURE 24 GLOBAL POSTMENOPAUSAL OSTEOPOROSIS THERAPEUTICS MARKET BY
REGION, 2014-2020 ($ MILLIONS) 111
POLYCYSTIC OVARY SYNDROME 112
FIGURE 25 GLOBAL MARKET FOR POLYCYSTIC OVARY SYNDROME THERAPEUTICS
BY REGION, 2014-2020 ($ MILLIONS) 112
BREAST CANCER 113
FIGURE 26 GLOBAL BREAST CANCER THERAPEUTICS MARKET BY REGION,
2014-2020 ($ MILLIONS) 114
ANNUAL COST OF THERAPY 114
FIGURE 27 GLOBAL AVERAGE ANNUAL COST OF THERAPY BY DISORDER,
2014-2020 ($) 115
GENERICS VERSUS BRANDED 116
FIGURE 28 GLOBAL SHARES OF WOMEN'S HEALTH THERAPEUTICS MARKET:
BRANDED VS. GENERIC, 2015 (%) 116
MARKET GROWTH DRIVERS AND RESTRAINTS 117
Growth Drivers for Menopause-Related Conditions 117
Aging Female Population 117
Growth Restraints for Menopause 117
Low Rate of Prescriptions for Hormone Therapy 117
Availability of Alternative Treatment Options 117
Lack of Safe and Efficacious Drug 118
Growth Drivers for Endometriosis 118
Increasing Awareness 118
Growth Restraints for Endometriosis 118
Poor Diagnosis 118
Absence of Non-hormonal Therapy 119
Growth Drivers for Postmenopausal Osteoporosis 119
Increasing Disease Population 119
Sedentary Lifestyle 120
Growth Restraints for Postmenopausal Osteoporosis 120
Poor Diagnosis 120
Growth Drivers for PCOS 120
Growing Treated Population 120
Growth Restraints for PCOS 120
Unavailability of Novel Drugs 120
Growth Drivers for Breast Cancer 121
Increasing Prevalence of Breast Cancer 121
Rising Government Involvement 121
Increasing Funding 121
Ethical Acceptance 121
DNA Vaccines 121
Growth Restraints for Breast Cancer 121
Lack of Awareness 121
High Cost 122
CHAPTER 10 COMPETITION AND MARKET SHARES 124
TABLE 15 LEADING COMPANIES IN THE GLOBAL MARKET FOR WOMEN'S HEALTH
THERAPEUTICS, 2015 ($ MILLIONS/%) 124
FIGURE 29 GLOBAL MARKET SHARES OF LEADING COMPANIES IN WOMEN'S
HEALTH THERAPEUTICS INDUSTRY, 2015 (%) 125
CHAPTER 11 MARKET STRATEGY 127
TABLE 16 KEY MERGERS/ACQUISITIONS WITHIN THE WOMEN'S HEALTH MARKET,
2009-JANUARY 2016 127
MERGERS AND ACQUISITIONS 129
TRILLIUM THERAPEUTICS' ACQUISITION OF FLUORINOV PHARMA 129
SHIRE'S ACQUISITION OF DYAX 129
ASTRAZENECA SELLS PCOS CANDIDATE RIGHTS TO MILLENDO
THERAPEUTICS 129
PFIZER'S ACQUISITION OF HOSPIRA 129
MEDIVATION'S ACQUISITION OF OF ALL WORLDWIDE RIGHTS TO
TALAZOPARIB (BMN 673), A POTENT PARP INHIBITOR, FROM BIOMARIN 130
SHIRE'S ACQUISITION OF NPS PHARMACEUTICALS 130
OPKO HEALTH'S ACQUISITION OF EIRGEN PHARMA 130
ABBVIE'S ACQUISITION OF PHARMACYCLICS 130
ACTAVIS' ACQUISITION OF ALLERGAN 130
NOVARTIS' ACQUISITION OF GSK'S ONCOLOGY DIVISION 130
ENDO INTERNATIONAL'S ACQUISITION OF PAR PHARMACEUTICAL 131
VALEANT'S ACQUISITION OF DENDREON 131
SUN PHARMACEUTICALS' ACQUISITION OF RANBAXY 131
ABBOTT'S ACQUISITION OF VEROPHARM 131
ROCHE'S ACQUISITION OF SERAGON PHARMACEUTICALS 131
BAYER'S ACQUISITION OF ALGETA 131
ENDO INTERNATIONAL'S ACQUISITION OF PALADIN LABS 132
PRESCIENT THERAPEUTICS' ACQUISITION OF AKTIVATE THERAPEUTICS
AND PATHWAY ONCOLOGY 132
ACTAVIS' ACQUISITION OF WARNER CHILCOTT 132
AMGEN'S ACQUISITION OF MUSTAFA NEVZAT (MN) PHARMACEUTICALS 132
VALEANT PHARMACEUTICALS' ACQUISITION OF INOVA 132
TAKEDA'S ACQUISITION OF NYCOMED 133
TEVA PHARMACEUTICAL'S ACQUISITION OF THERAMEX 133
THERAPEUTICSMD'S ACQUISITION OF VITAMEDMD 133
SANOFI-AVENTIS' ACQUISITION OF BMP SUNSTONE 133
ABBOTT'S ACQUISITION OF SOLVAY PHARMACEUTICALS 134
FERRING PHARMACEUTICALS' ACQUIRED GLOBAL RIGHTS TO LYSTEDA
FROM XANODYNE PHARMACEUTICALS 134
BIOSANTE ACQUIRED ELESTRIN ROYALTY FROM AZUR PHARMA 134
TEVA-KOWA PHARMA ACQUIRED MAJORITY STAKE IN TAISHO
PHARMACEUTICAL 135
SCIELE PHARMA'S ACQUISITION OF ADDRENEX PHARMACEUTICALS 135
WARNER CHILCOTT'S ACQUISITION OF PROCTER and GAMBLE'S
PRESCRIPTION DRUG BUSINESS 135
BIOSANTE PHARMACEUTICALS MERGES WITH CELL GENESYS 136
HISAMITSU PHARMACEUTICAL'S ACQUISITION OF NOVEN
PHARMACEUTICALS 136
PFIZER'S ACQUISITION OF WYETH 136
PAR PHARMACEUTICALS' ACQUISITION OF MDRNA'S CALCITONIN ASSETS
AND MANUFACTURING FACILITY 136
CHAPTER 12 DRUG PIPELINE ANALYSIS 139
TABLE 17 PIPELINE DRUGS IN WOMEN'S HEALTH 139
DRUGS UNDER DEVELOPMENT 144
PB272 (NERATINIB) 144
Description 144
Safety/Efficacy 145
Clinical Trials 145
ABP 215 (BEVACIZUMAB) 145
Description 145
Clinical Trials 146
AD-RTS-IL-12 146
Description 146
Clinical Trials 146
ABEMACICLIB (LY2835219) 146
Description 146
Clinical Trials 146
ATEZOLIZUMAB 147
Description 147
Clinical Trials 147
BUPARLISIB (BKM120) 147
Description 147
Clinical Trials 147
ALPELISIB (BYL719) 148
Description 148
Clinical Trials 148
CDX-011 (GLEMBATUMUMAB VEDOTIN) 148
Description 148
ENTINOSTAT 148
Description 148
Clinical Trials 149
LEE011 (RIBOCICLIB) 149
Description 149
Clinical Trials 149
LYNPARZA (OLAPARIB) 149
Description 149
Clinical Trials 149
TRASTUZUMAB 150
VELIPARIB (ABT-888) 150
Description 150
Clinical Trials 150
TASELISIB 150
TALAZOPARIB (BMN 673) 151
Description 151
Clinical Trials 151
NK105 (PACLITAXEL) 151
NIRAPARIB 151
Description 151
Clinical Trials 151
JDS-CR-004 (ORAL, PCOS) 152
Description 152
Clinical Trials 152
DIAMEL 152
Description 152
Clinical Trials 152
DLBS-3233; INLACIN 152
MLE4901 153
Description 153
Clinical Trials 153
BAYER- SPRM (BAY 1002670) VILAPRISAN 153
Description 153
Clinical Trials 153
INTRAVAGINAL RING (BAY 98-7196) 153
OBE2109 154
Description 154
Clinical Trials 154
ABALOPARATIDE-SC 154
Description 154
Clinical Trials 154
RAD1901 155
Description 155
Clinical Trials 155
BPS-804 155
Description 155
Clinical Trials 155
BA058/ITM-058 (ABALOPARATIDE) 155
CAPSITONIN (CALCITONIN SALMON) AND CAPTHYMONE (PARATHYROID
HORMONE) 156
FABLYN (LASOFOXIFENE) 156
PREOB (AUTOLOGOUS OSTEOBLAST) 156
Description 156
Clinical Trials 156
SALUBRIN HF 156
TBRIA (CALCITONIN-SALMON [RDNA ORIGIN]) 157
Description 157
Clinical Trials 157
TX 12-002-HR (PROGESTERONE) 157
Description 157
Clinical Trials 157
TAK-385 (RELUGOLIX) 157
Description 157
Safety/Efficacy 158
Clinical Trials 158
ELAGOLIX 158
Description 158
Safety/Efficacy 159
Clinical Trials 159
ASP1707 161
Description 161
Clinical Trials 161
PROELLEX (TELAPRISTONE ACETATE) (6 MG AND 12 MG, LOW DOSE ORAL) 161
Description 161
Safety/Efficacy 162
Low Dose Oral Study 162
Vaginal Administration 163
PGL2001 (PGL2) 163
Description 163
Safety/Efficacy 164
Clinical Trials 164
PGL5001 (PGL5) (BENTAMAPIMOD/PROOF OF CONCEPT) 164
Description 164
Clinical Trials 164
KLH-2109 165
Description 165
Clinical Trials 165
AUS-131 (S-EQUOL) 165
Description 165
Safety/Efficacy 165
Clinical Trials 165
MPI-676 AND MPI-674 (FEMATHINA) 166
Description 166
Clinical Trials 166
17HSD1 (17-BETA-HYDROXYSTEROID DEHYDROGENASE 1) 167
Description 167
Safety/Efficacy 167
Clinical Trials 168
FEMITRA (ACOLBIFENE + DHEA (ORAL) + GNRH AGONIST)
(SUBCUTANEOUS) 168
Description 168
BAY 1026153 168
Description 168
MK-0822 (ODANACATIB) 168
Description 168
Safety and Efficacy 169
Clinical Trials 169
MENERBA 170
Description 170
Safety/Efficacy 170
Clinical Trials 171
SEALA 172
Description 172
Clinical Trials 172
BA058-SC (ABALOPARATIDE) 172
Description 172
Safety/Efficacy 173
Clinical Trials 173
BA058-TD (TRANSDERMAL DELIVERY) 175
Description 175
Safety/Efficacy 175
Clinical Trials 175
RAD1901 176
Description 176
Safety/Efficacy 176
Clinical Trials 176
ZP-PTH (TERIPARATIDE) 177
Description 177
Safety/Efficacy 177
Clinical Trials 177
RECOMBINANT ORAL SALMON CALCITONIN 178
Description 178
Safety/Efficacy 178
Clinical Trials 179
ESN364 179
Description 179
Safety/Efficacy 179
Clinical Trials 179
VAGINORM 180
Description 180
Clinical Trials 180
AZD4901 180
Description 180
Clinical Trials 180
ESTRADIOL + TESTOSTERONE GEL 180
Description 180
AMG 785/CDP7851 (ROMOSOZUMAB) 181
Description 181
Safety/Efficacy 181
Clinical Trials 181
TX 12-001HR (17B ESTRADIOL + PROGESTERONE) 182
Description 182
Clinical Trials 182
CHAPTER 13 REGULATORY STRUCTURE 184
UNITED STATES 184
EUROPE 185
REGULATORY PROCEDURES 186
National Authorization Procedure 186
Centralized Procedure 186
Decentralized Procedure 186
Mutual Recognition Procedure 186
JAPAN 186
CHAPTER 14 PRICING AND REIMBURSEMENT 190
UNITED STATES 190
EUROPE 192
JAPAN 193
CHAPTER 15 CONCLUSIONS-OUTLOOK FOR WOMEN'S HEALTH THERAPEUTICS 195
MAJOR DEVELOPMENTS TO INFLUENCE MARKET 195
THERAPEUTIC DEVELOPMENTS 195
DEMOGRAPHIC AND ECONOMIC TRENDS 197
Increasing Aging Population 197
TABLE 18 ESTIMATES OF ANTICIPATED U.S. LIFE EXPECTANCY AT BIRTH AND
PROJECTIONS BY GENDER, 2005-2020 (YEARS) 197
FIGURE 30 ESTIMATES OF ANTICIPATED U.S. LIFE EXPECTANCY AT BIRTH AND
PROJECTIONS BY GENDER, 2005-2020 (YEARS) 197
TABLE 19 PROJECTED GLOBAL FEMALE POPULATION BY AGE, THROUGH 2030
(MILLIONS) 198
FIGURE 31 PROJECTED GLOBAL FEMALE POPULATION BY AGE, 2000-2030
(MILLIONS) 198
TABLE 20 PROJECTED U.S. FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 199
FIGURE 32 PROJECTED U.S. FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 199
TABLE 21 PROJECTED EUROPEAN FEMALE POPULATION BY AGE, 2000-2030
(MILLIONS) 200
FIGURE 33 PROJECTED EUROPEAN FEMALE POPULATION BY AGE, 2000-2030
(MILLIONS) 200
TABLE 22 PROJECTED JAPAN FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 201
FIGURE 34 PROJECTED JAPAN FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 201
Income Growth in Developing Markets 202
TABLE 23 PROJECTED TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION,
2015-2020 (ANNUAL AVERAGE PERCENTAGE CHANGE) 203
TRENDS IN REIMBURSEMENT 203
FUTURE OUTLOOK 204
CHAPTER 16 COMPANY PROFILES 206
ABBVIE 206
ALLERGAN 206
AMGEN 207
ASAHI KASAI 208
ASTELLAS PHARMA INC. 208
ASTRAZANECA 209
BAYER 210
BIONOVO 210
CELGENE 211
CHUGAI PHARMACEUTICALS 212
DEPOMED INC. 212
EISAI 213
ELI LILLY 213
ENDOCEUTICS 214
FORENDO PHARMA OY 215
GLAXOSMITHKLINE 215
IPSEN SA 216
LES LABORATORIES SERVIER SAS 217
MERCK 217
MOCHIDA PHARMA CO. LTD. 218
MEDITRINA PHARMACEUTICALS INC. 219
NEUROCRINE BIOSCIENCES INC. 219
NOVARTIS AG 220
NOVO NORDISK A/S 221
NOVOGYNE PHARMACEUTICALS 221
OASMIA PHARMACEUTICAL 222
ORION PHARMA LTD. 222
OTSUKA HOLDINGS 222
PALADIN LABS INC. 223
PFIZER INC. 224
PREGLEM SA 225
PUMA BIOTECHNOLOGY 225
ROCHE 226
RADIUS HEALTH INC. 227
REPROS THERAPEUTICS INC. 227
SANOFI 228
TAKEDA PHARMACEUTICAL 228
TARSA THERAPEUTICS INC. 229
TEVA PHARMACEUTICAL INDUSTRIES 229
THERAPEUTICSMD 230
TSUMURA and CO. 231
WARNER CHILCOTT CORP. (SUBSIDIARY OF ACTAVIS) 231
Copyright © BCC Research, Wellesley MA USA, Website: www.bccresearch.com
ZIOPHARM ONCOLOGY 232
ZOSANO PHARMA INC. 232
CHAPTER 17 INDUSTRY AND PROFESSIONAL ORGANIZATIONS 235
AMERICAN ASSOCIATION FOR CANCER RESEARCH (AACR) 235
AMERICAN CANCER SOCIETY 235
AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE (ASRM) 235
AMERICAN SOCIETY OF BREAST SURGEONS 235
AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) 235
ANDROGEN EXCESS AND PCOS SOCIETY 236
ASIA-PACIFIC MENOPAUSE FEDERATION 236
AVON BREAST CANCER CRUSADE 236
BREASTCANCER.ORG 236
ENDOMETRIOSIS ASSOCIATION 236
ENDOMETRIOSIS FOUNDATION OF AMERICA (EFA) 237
ENDOMETRIOSIS.ORG 237
ENDOMETRIOSIS RESEARCH CENTRE (ERC) 237
ENDOMETRIOSIS U.K. 237
EUROPEAN CANCER OBSERVATORY 238
EUROPEAN ENDOMETRIOSIS LEAGUE (EEL) 238
EUROPEAN MENOPAUSE AND ANDROPAUSE SOCIETY (EMAS) 238
EUROPEAN SOCIETY OF HUMAN REPRODUCTION AND EMBRYOLOGY (ESHRE) 239
FOOD AND DRUG ADMINISTRATION (FDA) 239
GLOBAL CANCER FOUNDATION 239
HORMONE FOUNDATION 239
INTERNATIONAL AGENCY FOR RESEARCH ON CANCER 240
INTERNATIONAL FEDERATION OF PHARMACEUTICAL MANUFACTURERS and
ASSOCIATIONS (IFPMA) 240
INTERNATIONAL MENOPAUSE SOCIETY (IMS) 240
INTERNATIONAL OSTEOPOROSIS FOUNDATION (IOF) 240
JAPAN ENDOMETRIOSIS ASSOCIATION (JEMA) 241
JAPAN SOCIETY FOR MENOPAUSE AND WOMEN'S HEALTH 241
JAPANESE BREAST CANCER SOCIETY 241
NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION (NCBI) 241
NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) 242
NATIONAL INSTITUTE ON AGING (NIA) 242
NORTH AMERICAN MENOPAUSE SOCIETY (NAMS) 242
NATIONAL OSTEOPOROSIS FOUNDATION (NOF) 243
NATIONAL WOMEN'S HEALTH INFORMATION CENTER (NWHIC) 243
PCOSUPPORT 243
WORLD CANCER RESEARCH FUND INTERNATIONAL 243
WORLD ENDOMETRIOSIS RESEARCH FOUNDATION (WERF) 244
WORLDWIDE CANCER RESEARCH 244
CHAPTER 18 ABBREVIATIONS 246

LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR WOMEN'S HEALTH THERAPEUTICS,
THROUGH 2020 ($ MILLIONS) 7
TABLE 1 GLOBAL GENERAL FEMALE POPULATION VS POPULATION SUFFERING FROM
A WOMEN'S DISORDER, THROUGH 2020 (MILLIONS) 11
TABLE 2 GLOBAL PREVALENCE OF MENOPAUSE-RELATED CONDITIONS BY REGION,
THROUGH 2020 (MILLIONS) 22
TABLE 3 COMMONLY PRESCRIBED DRUGS USED TO TREAT THE SYMPTOMS OF
MENOPAUSE 27
TABLE 4 GLOBAL PREVALENCE OF POSTMENOPAUSAL OSTEOPOROSIS BY REGION,
THROUGH 2020 (MILLIONS) 35
TABLE 5 COMMONLY PRESCRIBED DRUGS USED TO TREAT POSTMENOPAUSAL
OSTEOPOROSIS 44
TABLE 6 PREVALENCE OF ENDOMETRIOSIS BY REGION, THROUGH 2020 (MILLIONS) 59
TABLE 7 DRUGS COMMONLY USED TO TREAT ENDOMETRIOSIS 66
TABLE 8 PREVALENCE OF POLYCYSTIC OVARY SYNDROME BY REGION, THROUGH
2020 (MILLIONS) 72
TABLE 9 COMMONLY PRESCRIBED GENERIC DRUGS FOR THE TREATMENT OF
POLYCYSTIC OVARY SYNDROME 77
TABLE 10 TNM CLASSIFICATIONS OF BREAST CANCERS 86
TABLE 11 FIVE-YEAR SURVIVAL RATE BASED ON STAGE OF BREAST CANCER FOR
WOMEN IN THE U.S, 2015 (%) 87
TABLE 12 PREVALENCE OF BREAST CANCER BY REGION, THROUGH 2020 (MILLIONS) 87
TABLE 13 TYPES OF HORMONE THERAPY FOR BREAST CANCER 93
TABLE 14 DRUGS COMMONLY USED TO TREAT BREAST CANCER 94
TABLE 15 LEADING COMPANIES IN THE GLOBAL MARKET FOR WOMEN'S HEALTH
THERAPEUTICS, 2015 ($ MILLIONS/%) 124
TABLE 16 KEY MERGERS/ACQUISITIONS WITHIN THE WOMEN'S HEALTH MARKET,
2009-JANUARY 2016 127
TABLE 17 PIPELINE DRUGS IN WOMEN'S HEALTH 139
TABLE 18 ESTIMATES OF ANTICIPATED U.S. LIFE EXPECTANCY AT BIRTH AND
PROJECTIONS BY GENDER, 2005-2020 (YEARS) 197
TABLE 19 PROJECTED GLOBAL FEMALE POPULATION BY AGE, THROUGH 2030
(MILLIONS) 198
TABLE 20 PROJECTED U.S. FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 199
TABLE 21 PROJECTED EUROPEAN FEMALE POPULATION BY AGE, 2000-2030
(MILLIONS) 200
TABLE 22 PROJECTED JAPAN FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 201
TABLE 23 PROJECTED TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION,
2015-2020 (ANNUAL AVERAGE PERCENTAGE CHANGE) 203

LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR WOMEN'S HEALTH THERAPEUTICS,
2014-2020 ($ MILLIONS) 7
FIGURE 1 DISTRIBUTION OF GLOBAL POPULATION SUFFERING FROM A WOMEN'S
DISORDER BY TYPE, 2015 (% OF TOTAL GENERAL FEMALE POPULATION) 12
FIGURE 2 FEMALE LIKELIHOOD OF BECOMING PREGNANT VERSUS INFERTILITY AS
AGE PROGRESSES, 2015 (%) 14
FIGURE 3 GLOBAL PREVALENCE OF MENOPAUSE-RELATED CONDITIONS BY REGION,
2014-2020 (MILLIONS) 22
FIGURE 4 GLOBAL POPULATION OF FEMALES SUFFERING FROM
MENOPAUSE-RELATED CONDITIONS VS THE GENERAL FEMALE POPULATION,
2014-2020 (MILLIONS)
23
FIGURE 5 GLOBAL DISTRIBUTION OF FEMALES SUFFERING FROM
MENOPAUSE-RELATED CONDITIONS BY REGION, 2015 (% OF GENERAL FEMALE
POPULATION)
24
FIGURE 6 GLOBAL PREVALENCE OF POSTMENOPAUSAL OSTEOPOROSIS BY REGION,
2014-2020 (MILLIONS) 36
FIGURE 7 GLOBAL POPULATION OF FEMALES WITH POSTMENOPAUSAL
OSTEOPOROSIS VS THE OVERALL FEMALE POPULATION, 2014-2020 (MILLIONS) 36
FIGURE 8 GLOBAL DISTRIBUTION OF FEMALES WITH POSTMENOPAUSAL
OSTEOPOROSIS BY GEOGRAPHIC REGION, 2015 (% OF FEMALE POPULATION) 37
FIGURE 9 PREVALENCE OF ENDOMETRIOSIS BY REGION, 2014-2020 (MILLIONS) 59
FIGURE 10 GLOBAL ENDOMETRIOSIS POPULATION VS OVERALL FEMALE
POPULATION, 2014-2020 (MILLIONS) 60
FIGURE 11 GLOBAL DISTRIBUTION OF ENDOMETRIOSIS POPULATION BY REGION,
2015 (% OF FEMALE POPULATION) 61
FIGURE 12 PREVALENCE OF POLYCYSTIC OVARY SYNDROME BY REGION, 2014-2020
(MILLIONS) 73
FIGURE 13 GLOBAL POLYCYSTIC OVARY SYNDROME DISEASE POPULATION VS
FEMALE POPULATION, 2014-2020 (MILLIONS) 73
FIGURE 14 GLOBAL DISTRIBUTION OF POLYCYSTIC OVARY SYNDROME POPULATION
BY REGION, 2015 (% OF FEMALE POPULATION) 74
FIGURE 15 PREVALENCE OF BREAST CANCER BY REGION, 2014-2020 (MILLIONS) 88
FIGURE 16 GLOBAL BREAST CANCER POPULATION VS OVERALL FEMALE
POPULATION, 2014-2020 (MILLIONS) 88
FIGURE 17 GLOBAL DISTRIBUTION OF BREAST CANCER POPULATION BY REGION,
2015 (% OF FEMALE POPULATION) 89
FIGURE 18 GLOBAL WOMEN'S HEALTH THERAPEUTICS MARKET BY REGION,
2014-2020 ($ MILLIONS) 104
FIGURE 19 GLOBAL WOMEN'S HEALTH THERAPEUTICS MARKET BY DISORDER TYPE,
2014-2020 ($ MILLIONS) 105
FIGURE 20 GLOBAL MARKET SHARES OF WOMEN'S HEALTH THERAPEUTICS MARKET
BY DISORDER TYPE, 2015 (%) 106
FIGURE 21 AVERAGE ANNUAL COST OF THERAPY FOR WOMEN'S HEALTH
DISORDERS, 2014-2020 ($) 107
FIGURE 22 GLOBAL ENDOMETRIOSIS THERAPEUTICS MARKET BY REGION,
2014-2020 ($ MILLIONS) 108
FIGURE 23 GLOBAL MARKET FOR THERAPEUTICS TO TREAT MENOPAUSE-RELATED
CONDITIONS BY REGION, 2014-2020 ($ MILLIONS) 109
FIGURE 24 GLOBAL POSTMENOPAUSAL OSTEOPOROSIS THERAPEUTICS MARKET BY
REGION, 2014-2020 ($ MILLIONS) 111
FIGURE 25 GLOBAL MARKET FOR POLYCYSTIC OVARY SYNDROME THERAPEUTICS BY
REGION, 2014-2020 ($ MILLIONS) 112
FIGURE 26 GLOBAL BREAST CANCER THERAPEUTICS MARKET BY REGION,
2014-2020 ($ MILLIONS) 114
FIGURE 27 GLOBAL AVERAGE ANNUAL COST OF THERAPY BY DISORDER, 2014-2020
($) 115
FIGURE 28 GLOBAL SHARES OF WOMEN'S HEALTH THERAPEUTICS MARKET:
BRANDED VS. GENERIC, 2015 (%) 116
FIGURE 29 GLOBAL MARKET SHARES OF LEADING COMPANIES IN WOMEN'S HEALTH
THERAPEUTICS INDUSTRY, 2015 (%) 125
FIGURE 30 ESTIMATES OF ANTICIPATED U.S. LIFE EXPECTANCY AT BIRTH AND
PROJECTIONS BY GENDER, 2005-2020 (YEARS) 197
FIGURE 31 PROJECTED GLOBAL FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 198
FIGURE 32 PROJECTED U.S. FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 199
FIGURE 33 PROJECTED EUROPEAN FEMALE POPULATION BY AGE, 2000-2030
(MILLIONS) 200
FIGURE 34 PROJECTED JAPAN FEMALE POPULATION BY AGE, 2000-2030 (MILLIONS) 201

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