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

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

Summary


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.


  • Executive Summary
    • Expanding Pipeline Has Potential to Address Unmet Needs of Large Prevalence Population
    • First-in-Class Innovation Concentrated Across Endometriosis, Polycystic Ovarian Syndrome and Cervical Intraepithelial Neoplasia
    • Despite High Licensing Deal Activity, Most Firstin- Class Products Have No Prior Deal Involvement
  • The Case for Innovation
    • Table Figure 1: Women’s Health, US, Innovation Trends in Product Approvals, 1987–2014
    • Growing Opportunities for Biologic Products
    • Diversification of Molecular Targets
    • Innovative First-in-Class Product Developments Remain Attractive
      • Table Figure 2: Women’s Health, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006–2013
    • Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
    • Sustained Innovation in Women’s Health
    • GBI Research Report Guidance
  • Clinical and Commercial Landscape
    • Therapy Area Overview
    • Disease Overview and Symptoms
      • Endometriosis
      • Polycystic Ovarian Syndrome
      • Cervical Intraepithelial Neoplasia
        • Table Women’s Health, Global, Classification of CIN, 2018
    • Diagnosis
      • Endometriosis
      • Polycystic Ovarian Syndrome
        • Table Women’s Health, Global, PCOS Diagnostic Criteria for NIH, Rotterdam and AE-PCOS Classification Systems, 2018
      • Cervical Intraepithelial Neoplasia
    • Epidemiology and Etiology
      • Endometriosis
      • Polycystic Ovarian Syndrome
      • Cervical Intraepithelial Neoplasia
    • Pathophysiology
      • Endometriosis
      • Polycystic Ovarian Syndrome
      • Cervical Intraepithelial Neoplasia
    • Co-morbidities and Complications
      • Endometriosis
      • Polycystic Ovarian Syndrome
      • Cervical Intraepithelial Neoplasia
    • Treatment
      • Treatment Options
        • Table Women’s Health, Global, Types of Female Contraceptives, 2018
      • Treatment Algorithms
    • Overview of Marketed Products within Women’s Health
      • Table Figure 3: Women’s Health, Global, Market by Molecule Type, 2018
      • Table Figure 4: Women’s Health, Global, Market by Molecular Target, 2018
  • Pipeline Assessment
    • Overview
      • Table Figure 5: Women’s Health, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2018
    • Pipeline by Stage of Development and Molecule Type
      • Table Figure 6: Women’s Health, Global, Pipeline by Stage of Development and Molecule Type, 2018
      • Table Figure 7: Women’s Health, Global, Key Indications by Stage of Development, 2018
      • Table Figure 8: Women’s Health, Global, Key Indications by Molecule Type, 2018
    • Pipeline by Molecular Target
      • Table Figure 9: Women’s Health, Global, Pipeline by Molecular Target, 2018
      • Table Figure 10: Women’s Health, Global, Breakdown of Key Molecular Target Classes, 2018
      • Table Figure 11: Women’s Health, Global, Key Indications by Molecular Target Class, 2018
    • Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class
      • Table Figure 12: Women’s Health, Global, Pipeline and Marketed Products by Molecular Target Class, 2018
    • First-in-Class Programs Targeting Novel Molecular Targets
      • Table Figure 13: Women’s Health, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2018
      • Table Figure 14: Women’s Health, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target Class, 2018
    • Ratio of First-in-Class Products to First-in-Class Targets
      • Table Figure 15: Women’s Health, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2018
    • List of All Pipeline Products
      • Table Figure 16: Women’s Health, Global, List of All Pipeline Products, 2018
  • Signalling Network, Disease Causation and Innovation Alignment
    • Complexity of Signaling Networks
    • Signaling Pathways and First-in-Class Molecular Target Integration
    • First-in-Class Matrix Assessments
      • Table Figure 26: Women’s Health, Global, First-in-Class Matrix Assessment for Endometriosis, 2018
      • Table Figure 27: Women’s Health, Global, First-in-Class Matrix Assessment for PCOS, 2018
      • Table Figure 28: Women’s Health, Global, First-in-Class Matrix Assessment for CIN (Human Proteins), 2018
      • Table Figure 29: Women’s Health, Global, First-in-Class Matrix Assessment for CIN (Viral Proteins), 2018
      • Table Figure 30: Women’s Health, Global, All First-in-Class Molecular Targets Across the Women’s Health Pipeline, 2018
  • First-in-Class Target Evaluation
    • First-in-Class Programs Targeting Prostaglandin E2 Receptor EP4 Subtype (PTGER4) for Endometriosis
      • Table Women’s Health, Global, Key Details of Prostaglandin E2 Receptor EP4 Subtype (PTGER4), 2018
      • Table Women’s Health, Global, Pipeline Programs Targeting Prostaglandin E2 Receptor EP4 Subtype (PTGER4), 2018
    • First-in-Class Programs Targeting Patatin-Like Phospholipase Domain Containing Protein 2 (PNPLA2) for Endometriosis, PCOS and Ovarian Hyperstimulation Syndrome
      • Table Women’s Health, Global, Key Details of Patatin-Like Phospholipase Domain Containing Protein 2 (PNPLA2), 2018
      • Table Women’s Health, Global, Women’s Health, Global, Pipeline Programs Patatin-like Phospholipase Domain Containing Protein 2 (PNPLA2), 2018
    • First-in-Class Programs Targeting Glutamyl Aminopeptidase (ENPEP) for Endometriosis
      • Table Women’s Health, Global, Key Details of Glutamyl
      • Table Women’s Health, Global, Pipeline Programs Targeting Glutamyl Aminopeptidase (ENPEP), 2018
    • First-in-Class Programs Targeting Prostaglandin E Synthase (PTGES) for Endometriosis
      • Table Women’s Health, Global, Key Details of Prostaglandin E synthase (PTGES), 2018
      • Table Women’s Health, Global, Pipeline Programs Targeting Prostaglandin E synthase (PTGES), 2018
    • First-in-Class Programs Targeting Kiss 1 Receptor (KISS1R) for Endometriosis, PCOS and Infertility
      • Table Women’s Health, Global, Key Details of Kiss 1 Receptor (KISS1R), 2018
      • Table Women’s Health, Global, Women’s Health, Global, Pipeline Programs Targeting Kiss 1 Receptor (KISS1R), 2018
    • First-in-Class Programs Targeting Interleukin-1 Receptor Associated Kinase 4 (IRAK4) for Endometriosis
      • Table Women’s Health, Global, Key Details of Interleukin-1 Receptor Associated Kinase 4 (IRAK4), 2018
      • Table Women’s Health, Global, Pipeline Programs Targeting Interleukin-1 Receptor Associated Kinase 4 (IRAK4), 2018
    • First-in-Class Programs Targeting Type 2 Angiotensin II Receptor (AGTR2) for PCOS
      • Table Women’s Health, Global, Key Details of Type 2 angiotensin II receptor (AGTR2), 2018
      • Table Women’s Health, Global, Pipeline Programs Targeting Type 2 angiotensin II receptor (AGTR2), 2018
    • First-in-Class Programs Targeting Neuromedin K Receptor (TACR3) for PCOS, Endometriosis, Uterine Fibroids and Vasomotor Symptoms of Menopause
      • Table Women’s Health, Global, Key Details of Neuromedin K Receptor (TACR3), 2018
      • Table Women’s Health, Global, Women’s Health, Global, Pipeline Programs Targeting Neuromedin K Receptor (TACR3), 2018
    • First-in-Class Programs Targeting Eukaryotic Translation Initiation Factor 2 Alpha Kinase 3 (EIF2AK3) for CIN
      • Table Women’s Health, Global, Key Details of Eukaryotic Translation Initiation Factor 2 Alphas Kinase 3 (EIF2AK3), 2018
      • Table Women’s Health, Global, Women’s Health, Global, Pipeline Programs Targeting Eukaryotic Translation Initiation Factor 2 Alphas Kinase 3 (EIF2AK3), 2018
    • First-in-Class Programs Targeting Human Papillomavirus Protein E6 (E6) and Human Papillomavirus Protein E7 for CIN
      • Table Women’s Health, Global, Key Details of Human Papillomavirus Protein E6 (E6), 2018
      • Table Women’s Health, Global, Key Details of Human Papillomavirus Protein E7 (E7), 2018
      • Table Women’s Health, Global, Women’s Health, Global, Pipeline Programs Targeting Human Papillomavirus Protein E6 (E6)
      • Table Women’s Health, Global, Women’s Health, Global, Pipeline Programs Targeting Human Papillomavirus Protein E7 (E7), 2018
  • Strategic Consolidations
    • First-in-Class Products with and without Prior Deal Involvement in Licensing and Codevelopment Deals
      • Industry-Wide First-in-Class Deals
        • Table Figure 31: Women’s Health, Global, Industry-Wide Licensing Deals by Stage of Development and First-in-Class Product Status, 2006–2015
        • Table Figure 32: Women’s Health, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in- Class Product Status ($m), 2006–2015
    • Licensing Deals
      • Deals by Region, Value and Year
        • Table Figure 33: Women’s Health, Global, Licensing Deals by Region, Value and Year, 2018
      • Deals by Stage of Development and Value
        • Table Figure 34: Women’s Health, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2018
      • Deals by Molecule Type, Molecular Target and Value
        • Table Figure 35: Women’s Health, Global, Licensing Deals by Molecule Type, Molecular Target and Aggregate Deal Value, 2018
      • List of Deals with Disclosed Deal Values
        • Table Figure 36: Women’s Health, Global, Licensing Deals with Disclosed Deal Values, 2018
    • Co-Development Deals
      • Deals by Region, Value and Year
        • Table Figure 38: Women’s Health, Global, Co-development Deals by Region, Value and Year, 2018
      • Deals by Stage of Development and Molecule Type
        • Table Figure 39: Women’s Health, Global, Co-Development Deals by Stage of Development and Molecule Type
      • Deals by Molecule Type, Molecular Target and Aggregate Deal value
        • Table Figure 40: Women’s Health, Global, Co-Development Deals by Molecule Type, Molecular Target and Aggregate Deal value
      • List of Co-Development Deals with Disclosed Deal Values
        • Table Figure 41: Women’s Health, Global, Co-development with Disclosed Deal Values, 2018
    • First-in-Class Programs with and without Prior Deal Involvement
      • Table Figure 42: Women’s Health, Global, First-in-Class Products with and without Prior Involvement in Licensing and Co-development Deals, 2018
  • Appendix
    • References
    • Abbreviations
    • Pipeline Disease List
    • Research Methodology
      • Data integrity
      • Innovative and meaningful analytical techniques and frameworks
      • Evidence based analysis and insight
    • Secondary Research
      • Market Analysis
      • Pipeline Analysis
      • Licensing and Co-development Deals
    • Contact Us
    • Disclaimer

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