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Frontier Pharma: Ophthalmology Therapeutics - Gene Therapies and First-in-Class Targets Offer Novel Treatments for Substantial Unmet Needs in a Pipeline Dominated by Angiogenic and Immune Signaling Drugs

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Frontier Pharma: Ophthalmology Therapeutics - Gene Therapies and First-in-Class Targets Offer Novel Treatments for Substantial Unmet Needs in a Pipeline Dominated by Angiogenic and Immune Signaling Drugs
Published: October 1, 2017 Content info: 71 Pages
Description

Executive Summary

Ophthalmology is a therapy area that encompasses the diagnosis, treatment and prevention of diseases associated with the eyes and the visual system. The visual system, including the eye and its surrounding structures, can be affected by a number of pathological conditions. In 2015, it was estimated that over 3 million Americans suffer from visual impairment, defined as having 20/40 vision or worse after best possible correction. A person with 20/40 vision is able to read letters from 20 feet away that an individual with ''normal'' 20/20 vision could read from 40 feet, so a person that can still not perform this after best possible intervention with glasses or contact lenses is classed as being visually impaired.

Ophthalmology pipeline has a highly active deals landscape. There were 271 licensing deals and 152 co-development deals completed between 2006 and 2016 across the therapy area, of which 94 licensing deals and 33 co-development deals had a disclosed value. Many products in the ophthalmology pipeline have previously been involved in licensing and co-development deals. Most of these are in the Preclinical stage of development, although many deals also took place for products at Phase II.

The pipeline contains a diverse range of molecular targets, and no single target dominates by any clear margin. However, products acting on components of the immune system - largely cytokines and cytokine receptors - and its regulatory signaling pathways make up the largest segment, followed by angiogenesis inhibitors. Generally, the composition by molecular target across the pipeline suggests that product development is shifting away from the type of therapies that currently dominate the market, indicating that the available therapeutic options could diversify.

The report "Frontier Pharma: Ophthalmology Therapeutics - Gene Therapies and First-in-Class Targets Offer Novel Treatments for Substantial Unmet Needs in a Pipeline Dominated by Angiogenic and Immune Signaling Drugs" assesses first-in-class innovation in the ophthalmology pipeline, highlighting key trends in the distribution of these products. In-depth analysis reveals that the level of innovation within the therapy area pipeline is high, with strong potential for drugs to address unmet needs and be commercially lucrative.

Scope

  • The pipeline is large, with 865 products in active development. Does current pipeline innovation hold the potential to affect the future ophthalmology market?
  • There are 194 first-in-class products in the ophthalmologic disorder pipeline. Which of these possess the greatest potential to improve disease outcome and be commercially successful, based on their target?
  • Analysis of strategic consolidations and deals revealed a high level of activity in recent years for licensing agreements, but a low level of co-development. How do deal frequency and value compare between molecular targets and molecule types, and which first-in-class targets have not yet been involved in deals?

Reasons to buy

  • Understand the current clinical and commercial landscape. This includes a comprehensive study of disease pathogenesis, diagnosis and prognosis, and the treatment options available.
  • Visualize the composition of the ophthalmological disorders market in terms of dominant molecule types and targets, and understand the current unmet needs and how they can be addressed. This knowledge allows a competitive understanding of gaps in the market.
  • Analyze the ophthalmological disorders pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating ophthalmological disorders to overcome the overwhelming level of unmet need.
  • 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 early-stage targets have been reviewed in greater detail.
  • Identify commercial opportunities in the ophthalmological disorders deals landscape by analyzing trends in licensing and co-development deals, and a curated list of ophthalmological disorder therapies that have not yet been involved in deals, and may offer potential investment opportunities.
Table of Contents
Product Code: GBIHC457MR

1 Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 3
  • 1.2 List of Figures 3

2 Executive Summary 5

  • 2.1 Market Landscape Poised for Entry of Novel Products 5
  • 2.2 Moderately Sized but Strong First-in-Class Pipeline 5
  • 2.3 Strong Uptake of First-in-Class Products in Strategic Consolidations 5

3 The Case for Innovation 6

  • 3.1 Growing Opportunities for Biologic Products 7
  • 3.2 Diversification of Molecular Targets 7
  • 3.3 Innovative First-in-Class Product Development Remains Attractive 7
  • 3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
  • 3.5 Sustained Innovation 8
  • 3.6 GBI Research Report Guidance 9

4 Clinical and Commercial Landscape 10

  • 4.1 Therapy Area Overview 10
    • 4.1.1 Glaucoma 10
    • 4.1.2 Age-related Macular Degeneration 10
    • 4.1.3 Diabetic Macular Edema 10
    • 4.1.4 Diabetic Retinopathy 10
    • 4.1.5 Dry Eye Syndrome 11
    • 4.1.6 Inherited Genetic Disorders 11
  • 4.2 Disease Symptoms 11
  • 4.3 Epidemiology and Etiology 12
    • 4.3.1 Glaucoma 13
    • 4.3.2 Age-Related Macular Degeneration 13
    • 4.3.3 Diabetic Retinopathy and Diabetic Macular Edema 13
    • 4.3.4 Dry Eye Syndrome 13
  • 4.4 Diagnosis 13
  • 4.5 Pathophysiology 14
    • 4.5.1 Healthy Eye Physiology 14
    • 4.5.2 Glaucoma 15
    • 4.5.3 Age-Related Macular Degeneration 16
    • 4.5.4 Diabetic Macular Edema and Diabetic Retinopathy 17
    • 4.5.5 Dry Eye Syndrome 17
    • 4.5.6 Inherited Genetic Diseases 18
  • 4.6 Prognosis 18
    • 4.6.1 Glaucoma 18
    • 4.6.2 Age-Related Macular Degeneration 19
    • 4.6.3 Diabetic Retinopathy and Diabetic Macular Edema 19
    • 4.6.4 Dry Eye Syndrome 19
  • 4.7 Treatment Options 20
  • 4.8 Overview of Marketed Products in Ophthalmology 22
    • 4.8.1 Molecule Type and Target Analysis 22

5 Assessment of Pipeline Product Innovation 23

  • 5.1 Ophthalmology Pipeline by Molecular Target 26
  • 5.2 Comparative Distribution of Programs between the Ophthalmology Market and Pipeline by Therapeutic Target Family 28
  • 5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 29

6 Signaling Network, Disease Causation and Innovation Alignment 40

  • 6.1 Complexity of Signaling Networks in Ophthalmology 40
  • 6.2 Signaling Pathways and First-in-Class Molecular Target Integration 40
  • 6.3 First-in-Class Matrix Assessment 41

7 First-in-Class Target Evaluation 45

  • 7.1 Pipeline Programs Targeting MER 45
  • 7.2 Pipeline Programs Targeting Rhodopsin 46
  • 7.3 Pipeline Programs Targeting NLRP3 47
  • 7.4 Pipeline Programs Targeting ABCA4 48
  • 7.5 Pipeline Programs Targeting Complement Factor B 48
  • 7.6 Pipeline Programs Targeting RPE65 AND RBP4 50
  • 7.7 Conclusion 52

8 Deals and Strategic Consolidations 53

  • 8.1 Industry-Wide First-in-Class Deals 53
  • 8.2 Licensing Deals 55
    • 8.2.1 Deals by Region, Year and Value 55
    • 8.2.2 Deals by Stage of Development and Value 56
    • 8.2.3 Deals by Molecule Type, Mechanism of Action and Value 56
    • 8.2.4 Table for Licensing Deals Valued Above $100m 58
  • 8.3 Co-development Deals 58
    • 8.3.1 Deals by Region, Year and Value 58
    • 8.3.2 Deals by Stage of Development and Value 60
    • 8.3.3 Deals by Molecule Type, Mechanism of Action and Value 60
    • 8.3.4 Table for Co-development Deals Valued Above $100m 61
  • 8.4 First-in-Class Programs With and Without Prior Deal Involvement 61

9 Appendix 65

  • 9.1 Abbreviations 65
  • 9.2 References 65
  • 9.3 Research Methodology 69
  • 9.4 Primary Research 70
  • 9.5 Secondary Research 70
    • 9.5.1 Market Analysis 70
    • 9.5.2 Pipeline Analysis 70
    • 9.5.3 First-in-Class Matrix Assessment 71
    • 9.5.4 First-in-Class Target Profiles 71
    • 9.5.5 Licensing and Co-development Deals 71
  • 9.6 Contact Us 71
  • 9.7 Disclaimer 71

1.1 List of Tables

  • Table 1: Ophthalmology Therapeutics, Global, Main Symptoms of Glaucoma, AMD, DR and DES, 2017 12
  • Table 2: Ophthalmology Therapeutics, Global, Prevalence of Major Ophthalmologic Disorders, 2017 13
  • Table 3: Ophthalmology Therapeutics, Global, Treatment Options Available for Glaucoma, 2017 21
  • Table 4: Ophthalmology Therapeutics, Global, Data for MERTK as a Molecular Target, 2017 46
  • Table 5: Ophthalmology Therapeutics, Global, Data for RHO as a Molecular Target, 2017 47
  • Table 6: Ophthalmology Therapeutics, Global, Data for NLRP3 as a Molecular Target, 2017 47
  • Table 7: Ophthalmology Therapeutics, Global, Data for ABCA4 as a Molecular Target, 2017 48
  • Table 8: Ophthalmology Therapeutics, Global, Data for Cfb as a Molecular Target, 2017 50
  • Table 9: Ophthalmology Therapeutics, Global, Data for Serine Protease RPE65 as a Molecular Target, 2017 51
  • Table 10: Ophthalmology Therapeutics, Global, Data for Serine Protease RBP4 as a Molecular Target, 2017 52

1.2 List of Figures

  • Figure 1: Ophthalmology Therapeutics, Global, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987-2012 6
  • Figure 2: Ophthalmology Therapeutics, Global, First-in-Class and Non-First-in-Class Products, Sales Performance After Marketing Approval ($m) 8
  • Figure 3: Ophthalmology Therapeutics, Global, Overview of Marketed Products, 2017 22
  • Figure 4: Ophthalmology Therapeutics, Global, Overview of Pipeline Products, 2017 23
  • Figure 5: Ophthalmology Therapeutics, Global, Pipeline by Stage of Development and Molecule Type, 2017 24
  • Figure 6: Ophthalmology Therapeutics, Global, Pipeline by Key Indications and Stage of Development, 2017 25
  • Figure 7: Ophthalmology Therapeutics, Global, Pipeline by Key Indications and Molecule Type, 2017 26
  • Figure 8: Ophthalmology Therapeutics, Global, Pipeline by Molecular Target, 2017 27
  • Figure 9: Ophthalmology Therapeutics, Global, Pipeline by Key Indications and Molecular Target, 2017 28
  • Figure 10: Ophthalmology Therapeutics, Global, Molecular Target Family Comparison, Pipeline and Marketed Products, 2017 28
  • Figure 11: Ophthalmology Therapeutics, Global, Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets, 2017 29
  • Figure 12: Ophthalmology Therapeutics, Global, Percentage of First-in-Class Products in Pipeline by Stage of Development (%), 2017 30
  • Figure 13: Ophthalmology Therapeutics, Global, Percentage of First-in-Class Products in Pipeline by Molecular Target Family (%), 2017 30
  • Figure 14: Ophthalmology Therapeutics, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development, 2017 30
  • Figure 15: Ophthalmology Therapeutics, Global, Percentage of First-in-Class Products in Pipeline by Stage of Development (%), 2017 31
  • Figure 16: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 1), 2017 31
  • Figure 17: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 2), 2017 32
  • Figure 18: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 3), 2017 32
  • Figure 19: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 4), 2017 33
  • Figure 20: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 5), 2017 33
  • Figure 21: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 6), 2017 34
  • Figure 22: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 7), 2017 35
  • Figure 23: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 8), 2017 35
  • Figure 24: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 9), 2017 36
  • Figure 25: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 10), 2017 36
  • Figure 26: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 11), 2017 37
  • Figure 27: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 12), 2017 38
  • Figure 28: Ophthalmology Therapeutics, Global, First-in-Class Products in Pipeline (Part 13), 2017 39
  • Figure 29: Ophthalmology Therapeutics, Global, Target Matrix Assessment (Part 1), 2017 42
  • Figure 30: Ophthalmology Therapeutics, Global, Target Matrix Assessment (Part 2), 2017 43
  • Figure 31: Ophthalmology Therapeutics, Global, Target Matrix Assessment (Part 3), 2017 44
  • Figure 32: Ophthalmology Therapeutics, Global, Pipeline Programs Targeting MERTK, 2017 46
  • Figure 33: Ophthalmology Therapeutics, Global, Pipeline Programs Targeting RHO, 2017 47
  • Figure 34: Ophthalmology Therapeutics, Global, Pipeline Programs Targeting NLRP3, 2017 48
  • Figure 35: Ophthalmology Therapeutics, Global, Pipeline Programs Targeting ABCA4, 2017 48
  • Figure 36: Ophthalmology Therapeutics, Global, Pipeline Programs Targeting Cfb, 2017 50
  • Figure 37: Ophthalmology Therapeutics, Global, Pipeline Programs Targeting Serine Protease RPE65, 2017 52
  • Figure 38: Ophthalmology Therapeutics, Global, Pipeline Programs Targeting Serine Protease RBP4, 2017 52
  • Figure 39: Pharmaceutical Industry, Global, Licensing Deals by Stage of Development, 2006-2015 53
  • Figure 40: Pharmaceutical Industry, Global, Licensing Deal Values by Stage of Development ($m), 2006-2014 54
  • Figure 41: Ophthalmology Therapeutics, Global, Licensing Deals, 2006-2017 55
  • Figure 42: Ophthalmology Therapeutics, Global, Licensing Deals by Indication and Value, 2006-2017 56
  • Figure 43: Ophthalmology Therapeutics, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 56
  • Figure 44: Ophthalmology Therapeutics, Global, Licensing Deals by Molecule Type and Mechanism of Action, 2006-2017 57
  • Figure 45: Ophthalmology Therapeutics, Global, Licensing Deals Valued Above $100m 58
  • Figure 46: Ophthalmology Therapeutics, Global, Co-development Deals, 2006-2017 59
  • Figure 47: Ophthalmology Therapeutics, Global, Co-development Deals by Indication and Value, 2006-2017 59
  • Figure 48: Ophthalmology Therapeutics, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 60
  • Figure 49: Ophthalmology Therapeutics, Global, Co-development Deals by Molecule Type and Mechanism of Action, 2006-2017 61
  • Figure 50: Ophthalmology Therapeutics, Global, Licensing Deals Valued Above $100m 61
  • Figure 51: Ophthalmology Therapeutics, Global, First-in-Class Therapies Involved in Previous Deals, 2017 62
  • Figure 52: Ophthalmology Therapeutics, Global, First-in-Class Therapies Not Involved in Previous Deals (Part 1), 2017 63
  • Figure 53: Ophthalmology Therapeutics, Global, First-in-Class Therapies Not Involved in Previous Deals (Part 2), 2017 64
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