Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4
2 Executive Summary 6
2.1 Expanding Pipeline Has Potential to Address Unmet Needs of Large Prevalence Population 6
2.2 First-in-Class Innovation Concentrated Across Endometriosis, Polycystic Ovarian Syndrome and Cervical Intraepithelial Neoplasia 6
2.3 Despite High Licensing Deal Activity, Most First-in-Class Products Have No Prior Deal Involvement 6
3 The Case for Innovation 7
3.1 Growing Opportunities for Biologic Products 8
3.2 Diversification of Molecular Targets 8
3.3 Innovative First-in-Class Product Developments Remain Attractive 8
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9
3.5 Sustained Innovation in Women’s Health 9
3.6 GBI Research Report Guidance 10
4 Clinical and Commercial Landscape 11
4.1 Therapy Area Overview 11
4.2 Disease Overview and Symptoms 11
4.2.1 Endometriosis 11
4.2.2 Polycystic Ovarian Syndrome 12
4.2.3 Cervical Intraepithelial Neoplasia 12
4.3 Diagnosis 13
4.3.1 Endometriosis 13
4.3.2 Polycystic Ovarian Syndrome 13
4.3.3 Cervical Intraepithelial Neoplasia 14
4.4 Epidemiology and Etiology 14
4.4.1 Endometriosis 14
4.4.2 Polycystic Ovarian Syndrome 15
4.4.3 Cervical Intraepithelial Neoplasia 16
4.5 Pathophysiology 16
4.5.1 Endometriosis 16
4.5.2 Polycystic Ovarian Syndrome 17
4.5.3 Cervical Intraepithelial Neoplasia 18
4.6 Co-morbidities and Complications 18
4.6.1 Endometriosis 18
4.6.2 Polycystic Ovarian Syndrome 19
4.6.3 Cervical Intraepithelial Neoplasia 19
4.7 Treatment 19
4.7.1 Treatment Options 19
4.7.2 Treatment Algorithms 23
4.8 Overview of Marketed Products within Women’s Health 24
5 Pipeline Assessment 26
5.1 Overview 26
5.2 Pipeline by Stage of Development and Molecule Type 26
5.3 Pipeline by Molecular Target 29
5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 32
5.5 First-in-Class Programs Targeting Novel Molecular Targets 33
5.6 Ratio of First-in-Class Products to First-in-Class Targets 35
5.7 List of All Pipeline Products 36
6 Signalling Network, Disease Causation and Innovation Alignment 46
6.1 Complexity of Signaling Networks 46
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 46
6.3 First-in-Class Matrix Assessments 46
7 First-in-Class Target Evaluation 50
7.1 First-in-Class Programs Targeting XXX 50
7.2 First-in-Class Programs Targeting XXX 51
7.3 First-in-Class Programs Targeting XXX 53
7.4 First-in-Class Programs Targeting XXX 54
7.5 First-in-Class Programs Targeting XXX 55
7.6 First-in-Class Programs Targeting XXX 57
7.7 First-in-Class Programs Targeting XXX 58
7.8 First-in-Class Programs Targeting XXX 59
7.9 First-in-Class Programs Targeting XXX 61
7.10 First-in-Class Programs Targeting XXX 62
8 Strategic Consolidations 65
8.1 First-in-Class Products with and without Prior Deal Involvement in Licensing and Co-development Deals 65
8.1.1 Industry-Wide First-in-Class Deals 65
8.2 Licensing Deals 67
8.2.1 Deals by Region, Value and Year 67
8.2.2 Deals by Stage of Development and Value 68
8.2.3 Deals by Molecule Type, Molecular Target and Value 68
8.2.4 List of Deals with Disclosed Deal Values 69
8.3 Co-Development Deals 71
8.3.1 Deals by Region, Value and Year 71
8.3.2 Deals by Stage of Development and Molecule Type 72
8.3.3 Deals by Molecule Type, Molecular Target and Aggregate Deal value 73
8.3.4 List of Deals with Disclosed Deal Values 74
8.4 First-in-Class Programs with and without Prior Deal Involvement 74
9 Appendix 77
9.1 References 77
9.2 Abbreviations 83
9.3 Pipeline Disease List 84
9.4 Research Methodology 84
9.4.1 Data integrity 84
9.4.2 Innovative and meaningful analytical techniques and frameworks 84
9.4.3 Evidence based analysis and insight 84
9.5 Secondary Research 85
9.5.1 Market Analysis 85
9.5.2 Pipeline Analysis 85
9.5.3 Licensing and Co-development Deals 86
9.6 Contact Us 86
9.7 Disclaimer 86