Frontier Pharma: Womens Health - An Expanding Therapy Area, with Endometriosis Therapies Prominent among the First-in-Class Pipeline

Frontier Pharma: Womens Health - An Expanding Therapy Area, with Endometriosis Therapies Prominent among the First-in-Class Pipeline

  • GBI Research
  • February 2018
  • Pharmaceutical
  • 86 pages

Report Description

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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.

Despite this, the women’s health market is relatively small. This reflects diagnostic barriers and high levels of non-treatment for women’s health disorders, as well as high levels of genericization and relatively limited innovation within recent decades.

Consequently, there is strong rationale for continued R&D investment in women’s health therapeutics due to high levels of unmet need across many indications.

This report assesses first-in-class innovation across the women’s health therapy area, with a particular focus on three key indications: endometriosis, polycystic ovarian syndrome (PCOS) and cervical intraepithelial neoplasia (CIN).

Scope

  • Many women’s health disorders are highly prevalent. How do epidemiology trends vary for endometriosis, PCOS and CIN?
  • Innovation within women’s health has been relatively limited over recent decades. What are the most prominent unmet needs across this therapy area?
  • There are 261 pipeline programs in active development for women’s health. What proportion of these products are first-in-class? How does first-in-class innovation vary by indication, development stage and molecular target class?
  • Although the first-in-class pipeline is relatively modest in size it is considerably diverse with eight distinct molecular target classes represented. Which first-in-class targets have been identified as most promising for women’s health conditions?
  • Over 200 licensing deals relating to women’s health have been completed since 2006. Do women’s health products typically attract high deal values? Which first-in-class products have prior deal involvement?

Reasons to buy

  • Understand the current clinical and commercial landscape. This includes a comprehensive study of symptoms, epidemiology, etiology, pathophysiology, co-morbidities and complications, diagnosis and treatment options.
  • Visualize the composition of the women’s health market in terms of dominant molecule types and molecular targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.
  • Analyze the women’s health pipeline and stratify by stage of development, molecule type and molecular target.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising first-in-class targets have been reviewed in greater detail.
  • Recognize commercial opportunities in the women’s health deals landscape by analyzing trends in licensing and co-development deals, and identifying women’s health therapies that have not yet been involved in deals and may offer potential investment opportunities.

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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

Table 1: Women’s Health, Global, Classification of CIN, 2018 12
Table 2: Women’s Health, Global, PCOS Diagnostic Criteria for NIH, Rotterdam and AE-PCOS Classification Systems, 2018 14
Table 3: Women’s Health, Global, Types of Female Contraceptives, 2018 20
Table 4: Women’s Health, Global, Key Details of Prostaglandin E2 Receptor EP4 Subtype (PTGER4), 2018 51
Table 5: Women’s Health, Global, Pipeline Programs Targeting Prostaglandin E2 Receptor EP4 Subtype (PTGER4), 2018 51
Table 6: Women’s Health, Global, Key Details of Patatin-Like Phospholipase Domain Containing Protein 2 (PNPLA2), 2018 52
Table 7: Women’s Health, Global, Women’s Health, Global, Pipeline Programs Patatin-like Phospholipase Domain Containing Protein 2 (PNPLA2), 2018 52
Table 8: Women’s Health, Global, Key Details of Glutamyl Aminopeptidase (ENPEP), 2018 53
Table 9: Women’s Health, Global, Pipeline Programs Targeting Glutamyl Aminopeptidase (ENPEP), 2018 53
Table 10: Women’s Health, Global, Key Details of Prostaglandin E synthase (PTGES), 2018 55
Table 11: Women’s Health, Global, Pipeline Programs Targeting Prostaglandin E synthase (PTGES), 2018 55

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