Global Women’s Health Drugs Market to 2024 – Influx of New Products Including Orilissa, Relugolix and Bremelanotide to Diversify Landscape and Drive Growth

The women’s health therapy area covers medical disorders that affect females only, primarily disorders of the female reproductive system, including those associated with menstruation, conception, pregnancy, childbirth and menopause. Many of these disorders are highly prevalent among the female population.

The women’s health market is relatively small considering the high prevalence of many women’s health indications. However, robust growth is projected over the forecast period due to the influx of a number of new products.

This report covers all indications within women’s health with a particular focus on five key indications: endometriosis, polycystic ovarian syndrome (PCOS), cervical intraepithelial neoplasia (CIN), menopausal disorders and infertility.

Scope

– There are 277 pipeline products in active development for women’s health disorders. Which molecule types and molecular targets are most prominent within the pipeline?

– Merck&Co and Bayer currently represent leading companies within women’s health. Will they maintain this dominance over the forecast period?

– Gardasil, Mirena and Nuvaring and are among the most lucrative drugs within the women’s health market. Which of these will experience a considerable decline in revenue over the forecast period following loss of patent protection?

– The influx of a number of recent market entrants and late-stage pipeline products will have a considerable impact on the women’s health market over the forecast period. Which of these drugs are projected to achieve blockbuster status by 2024?

– In total, 246 licensing deals relating to women’s health products have been completed since 2006. Which types of assets attracted the largest deal values?

Reasons to buy

- Understand the current treatment landscape, with portfolios of key marketed products and a focus on historical and forecast sales patterns, and an overview of each drug’s mechanism of action.

- Analyze the women’s health pipeline through a comprehensive review of the pipeline segmented by stage of development, molecule type and molecular target.

- Consider market opportunities and potential risks by examining trends in clinical trial duration and size, as well as clinical trial failure rates.

- Predict growth in market size by examining multi-scenario forecasting trends from 2017 to 2024 and determine the contributions that different products and companies will make to this growth.

- Identify commercial opportunities in the women’s health deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 11

2.1 Therapy Area Overview 11

2.1.1 Endometriosis 12

2.1.2 Polycystic Ovarin Syndrome 12

2.1.3 Cervical Intraepithelial Neoplasia 12

2.1.4 Menopausal Disorders 12

2.1.5 Infertility 13

2.2 Symptoms 13

2.2.1 Endometriosis 13

2.2.2 Polycystic Ovarian Syndrome 13

2.2.3 Cervical Intraepithelial Neoplasia 14

2.2.4 Menopausal Disorders 14

2.2.5 Infertility 14

2.3 Diagnosis 14

2.3.1 Endometriosis 14

2.3.2 Polycystic Ovarian Syndrome 15

2.3.3 Cervical Intraepithelial Neoplasia 16

2.3.4 Menopausal Disorders 17

2.3.5 Infertility 17

2.4 Etiology and Epidemiology 17

2.4.1 Endometriosis 18

2.4.2 Polycystic Ovarian Syndrome 19

2.4.3 Cervical Intraepithelial Neoplasia 20

2.4.4 Menopause 21

2.4.5 Infertility 21

2.5 Pathophysiology 22

2.5.1 Endometriosis 22

2.5.2 Polycystic Ovarian Syndrome 23

2.5.3 Cervical Intraepithelial Neoplasia 24

2.6 Co-morbidities and Complications 24

2.6.1 Endometriosis 24

2.6.2 Polycystic Ovarian Syndrome 25

2.6.3 Cervical Intraepithelial Neoplasia 26

2.6.4 Menopause and Menopausal Disorders 26

2.6.5 Infertility 27

2.7 Treatment 27

2.7.1 Treatment Options 27

3 Key Marketed Products 33

3.1 Overview 33

3.2 Premarin family (conjugated estrogens) - Pfizer 33

3.3 Lupron/Lupron Depot (leuprolide acetate SR) - AbbVie 35

3.4 Gonal-F (follitropin alfa) - Merck KGaA 36

3.5 Mirena (levonorgestrel) - Bayer 38

3.6 Celebrex (celecoxib) - Pfizer 39

3.7 Implanon/Nexplanon (etonogestrel) - Merck & Co. 40

3.8 Yasmin/Yaz (drospirenone and ethinylestradiol) - Bayer 42

3.9 Nuvaring (ethinylestradiol and etonogestrel) - Merck & Co 43

3.10 Gardasil - Merck and Co 44

3.11 Esmya (ulipristal acetate) - Gedoen Richter/Allergan 46

3.12 Orilissa (elagolix sodium) - AbbVie 48

4 Pipeline Landscape Assessment 50

4.1 Overview 50

4.2 Pipeline Development Landscape 51

4.3 Molecular Targets in the Pipeline 54

4.4 Clinical Trials Landscape 56

4.4.1 Clinical Trial Failure Rates 57

4.4.2 Clinical Trial Duration 61

4.4.3 Clinical Trial Size 65

4.4.4 Cumulative Clinical Trial Size 69

4.5 Assessment of Key Pipeline Products 72

4.5.1 Relugolix - Takeda Pharmaceutical Co. Ltd 72

4.5.2 Bremelanotide - AMAG Pharmaceuticals Inc 74

4.5.3 SAGE-217 - Sage Therapeutics Inc. 75

4.5.4 Fezolinetant - Ogeda SA 76

4.5.5 Zulresso - Sage Therapeutics 77

4.5.6 Bizalimogene Ralaplasmid + Mavilimogene Ralaplasmid - Inovio Pharmaceuticals Inc 78

4.5.7 Retosiban - GlaxoSmithKline 79

5 Multi-scenario Market Forecast to 2024 81

5.1 Overall Market Size 81

5.2 Generic Penetration 85

5.3 Revenue Forecast by Molecular Target Class 85

5.3.1 G Protein-Coupled Receptor 85

5.3.2 Nuclear Receptor 87

5.3.3 Pathogen 88

5.3.4 Ion Channels/Transporter 89

6 Company Analysis and Positioning 90

6.1 Revenue and Market Share Analysis by Company 92

6.1.1 Bayer AG - Company to Remain a Market Leader within Women’s Health 97

6.1.2 AbbVie Inc - Orilissa to Reach Blockbuster Status, Boosting Company’s Market Share 98

6.1.3 Allergan - Revenue Gains From Fibristal, Lo Loestrin Fe and Liletta to Offset Losses from Minastrin 24 Fe and Estrace 99

6.1.4 Merck & Co. - Company to Remain a Key Player Due to Growth of Gardasil/Gardasil 9 100

6.1.5 GlaxoSmithKline - Cervarix and Retosiban to Drive Strong Growth 102

6.1.6 Pfizer - How will patent expiration affect revenues for women’s health market? 103

6.1.7 TherapeuticsMD - Women’s Health Specialist to Gain Considerable Market Share by 2024 104

6.2 Company Landscape 105

6.3 Marketed and Pipeline Portfolio Analysis 105

7 Strategic Consolidations 108

7.1 Licensing Deals 108

7.1.1 Deals by Region, Value and Year 108

7.1.2 Deals by Key Indication 110

7.1.3 Deals by Stage of Development and Value 111

7.1.4 Deals by Molecule Type, Molecular Target and Value 112

7.1.5 Licensing Deals with Disclosed Values 113

7.2 Co-development Deals 115

7.2.1 Deals by Region, Value and Year 115

7.2.2 Deals by Key Indication 116

7.2.3 Deals by Stage of Development and Value 117

7.2.4 Deals by Molecule Type, Molecular Target and Value 118

7.2.5 Co-development Deals with Disclosed Values 119

8 Appendix 120

8.1 References 120

8.2 Abbreivations 127

8.3 List of All Pipeline Products 128

8.4 Disease List 138

8.5 Methodology 138

8.5.1 Coverage 138

8.5.2 Secondary Research 139

8.5.3 Market Size and Revenue Forecasts 139

8.5.4 Pipeline Analysis 139

8.5.5 Competitive Landscape 140

8.6 Contact Us 140

8.7 Disclaimer 140

List of Tables

1.1 List of Tables

Table 1: Women’s Health Drugs Market, Global, Classification of Cervical Intraepithelial Neoplasia, 2018 12

Table 2: Women’s Health Drugs Market, Common Symptoms of the Perimenopause and Menopause, 2018 14

Table 3: Women’s Health Drugs Market, Global, Comparison of PCOS Diagnostic Criteria Classification Systems, 2018 16

Table 4: Women’s Health Drugs Market, 7MM, Prevalence of Endometriosis, Polycystic Ovarian Syndrome, and Women’s Infertility, 2017 18

Table 5: Women’s Health Drugs Market, Global, Types of Female Contraceptives, 2018 28

Table 6: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Premarin, 2018 34

Table 7: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Lupron/Lupron Depot, 2018 35

Table 8: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Gonal-F, 2018 37

Table 9: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Mirena, 2018 38

Table 10: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Celebrex, 2018 39

Table 11: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Implanon ,2018 41

Table 12: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Yasmin/Yaz, 2018 42

Table 13: Women’s Health Drugs Market, Global, Approved Health Indications for Nuvaring, 2018 43

Table 14: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Gardasil, 2018 45

Table 15: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Esmya, 2018 46

Table 16: Women’s Health Drugs Market, Global, Approved Women’s Health Indications for Orilissa, 2018 48

Table 17: Women’s Health Drugs Market, Global, Annual Revenue Forecast for Key Products ($m), 2017-2024 (part 1) 82

Table 18: Women’s Health Drugs Market, Global, Annual Revenue Forecast for Key Products ($m), 2017-2024 (part 2) 83

Table 19: Women’s Health Drugs Market, Global, Forecast Revenue by Company, 2017-2024 92

List of Figures

1.2 List of Figures

Figure 1: Women’s Health Drugs Market, 7MM, Epidemiology Patterns for Endometriosis, 2017-2024 19

Figure 2: Women’s Health Drugs Market, 7MM, Epidemiology Patterns for Polycystic Ovarian Syndrome, 2017-2024 20

Figure 3: Women’s Health Drugs Market, 7MM, Epidemiology Patterns for Infertility, 2017-2024 22

Figure 4: Women’s Health Drugs Market, Global, Key Marketed Products and Approved Indications, 2018 33

Figure 5: Women’s Health Drugs Market, Global, Annual Revenue for Premarin ($bn), 2006-2024 35

Figure 6: Women’s Health Drugs Market, Global, Annual Revenue for Lupron ($bn), 2006-2024 36

Figure 7: Women’s Health Drugs Market, Global, Annual Revenue for Gonal-F ($m), 2017-2024 38

Figure 8: Women’s Health Market, Global, Annual Revenue for Mirena ($bn), 2006-2024 39

Figure 9: Women’s Health Drugs Market, Global, Annual Revenue for Celebrex ($bn), 2006-2024 40

Figure 10: Women’s Health Drugs Market, Global, Annual Revenue for Implanon/Nexplanon ($m), 2007-2024 41

Figure 11: Women’s Health Drugs Market, Global, Annual Revenue for Yasmin/Yaz ($bn), 2006-2024 43

Figure 12: Women’s Health Drugs Market, Global, Annual Revenue for Nuvaring ($m), 2006-2024 44

Figure 13: Women’s Health Drugs Market, Global, Annual Revenue for Gardasil ($bn), 2017-2023 46

Figure 14: Women’s Health Drugs Market, Global, Annual Revenue for Esmya ($bn), 2013-2024 47

Figure 15: Women’s Health Drugs Market, Global, Annual Revenue for Orilissa ($bn), 2018-2024 49

Figure 16: Women’s Health Drugs Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2018 50

Figure 17: Women’s Health Drugs Market, Global, Pipeline by Stage of Development, Molecule Type and Program Type, 2018 51

Figure 18: Women’s Health Drugs Market, Global, Pipeline for Key Indications by Stage of Development, 2018 52

Figure 19: Women’s Health Market, Global, Pipeline for Key Indications by Molecule Type, 2018 53

Figure 20: Women’s Health Drugs Market, Global, Pipeline by Molecular Target, 2018 55

Figure 21: Women’s Health Drugs Market, Global, Pipeline for Key Indications by Molecular Target Class, 2018 56

Figure 22: Women’s Health Drugs Market, Global, Clinical Trial Failure Rates by Stage of Development (%), 2006-2018 57

Figure 23: Women’s Health Drugs Market, Global, Clinical Trial Failure Rates by Stage of Development and Indication (%), 2006-2018 58

Figure 24: Women’s Health Drugs Market, Global, Clinical Trial Failure Rates by Stage of Development and Molecule Type (%), 2006-2018 59

Figure 25: Women’s Health Drugs Market, Global, Clinical Trial Failure Rates by Stage of Development and Molecular Target Class (%), 2006-2018 60

Figure 26: Women’s Health Drugs Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2018 61

Figure 27: Women’s Health Drugs Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2018 62

Figure 28: Women’s Health Drugs Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2018 63

Figure 29: Women’s Health Drugs Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target Class (months), 2006-2018 64

Figure 30: Women’s Health Drugs Market, Global, Clinical Trial Size by Stage of Development (participants), 2006-2018 65

Figure 31: Women’s Health Drugs Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2018 66

Figure 32: Women’s Health Drugs Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2018 67

Figure 33: Women’s Health Drugs Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2018 68

Figure 34: Women’s Health Drugs Market, Global, Clinical Program Size by Stage of Development (participants), 2006-2018 69

Figure 35: Women’s Health Drugs Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006-2018 70

Figure 36: Women’s Health Drugs Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2018 71

Figure 37: Women’s Health Drugs Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2018 72

Figure 38: Women’s Health Drugs Market, Global, Revenue Forecast for Relugolix ($m), 2021-2024 73

Figure 39: Women’s Health Drugs Market, Global, Annual Revenue Forecast for Bremelanotide ($m), 2019-2024 74

Figure 40: Women’s Health Drugs Market, Global, Revenue Forecast for SAGE-217 ($m), 2019-2024 75

Figure 41: Women’s Health Drugs Market, Global, Annual Revenue Forecast for Fezolinetant ($m), 2021-2024 76

Figure 42: Women’s Health Drugs Market, Global, Revenue Forecast for Zulresso ($m), 2019-2024 77

Figure 43: Women’s Health Drugs Market, Global, Revenue Forecast for Bizalimogene Ralaplasmid and Mavilimogene Ralaplasmid ($m), 2021-2024 78

Figure 44: Women’s Health Drugs Market, Global, Revenue Forecast for Retosiban ($m), 2019-2024 80

Figure 45: Women’s Health Drugs Market, Global, Market Size ($bn), 2017-2024 81

Figure 46: Women’s Health Drugs Market, Global, Annual Revenue Forecast for Premium and Generic Products ($bn), 2017-2024 85

Figure 47: Women’s Health Market, Global, Annual Revenue Forecast for G Protein-Coupled Receptor Target Class ($bn), 2017-2024 86

Figure 48: Women’s Health Drugs Market, Global, Annual Revenue Forecast for Nuclear Receptor Target Class ($bn), 2017-2024 87

Figure 49: Women’s Health Drugs Market, Global, Annual Revenue Forecast for Pathogen Target Class ($bn), 2017-2024 88

Figure 50: Women’s Health Drugs Market, Global, Annual Revenue Forecast for Ion Channels/Transporters ($bn), 2017-2024 89

Figure 51: Women’s Health Drugs Market, Global, Company Analysis Matrix, 2017-2024 90

Figure 52: Women’s Health Market, Global, Companies by CAGR and Market Share, 2017-2024 91

Figure 53: Women’s Health Drugs Market, Global, Market Share by Company (%), 2017-2024 94

Figure 54: Women’s Health Market, Global, Companies by Compound Annual Growth Rate (%), 2017-2024 95

Figure 55: Women’s Health Market, Global, Revenues by Route of Acquisition, 2017-2024 96

Figure 56: Women’s Health Drugs Market, Global, Bayer AG Annual Revenue Forecast ($bn), 2017-2024 97

Figure 57: Women’s Health Market, Global, AbbVie Inc Annual Revenue Forecast ($bn), 2017-2024 98

Figure 58: Women’s Health Market, Global, Allergan Plc Annual Revenue Forecast ($bn), 2017-2024 99

Figure 59: Women’s Health Market, Global, Merck& Co. Annual Revenue Forecast ($bn), 2017-2024 101

Figure 60: Women’s Health Market, Global, GlaxoSmithKline Annual Revenue Forecast ($m), 2016-2023 102

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