Summary
The visual system, including the eye and its surrounding structures, can be affected by a number of pathological conditions. Ophthalmology encompasses a diverse range of indications affecting this system. Key diseases within this therapy area include glaucoma, age-related macular degeneration, diabetic macular edema, diabetic retinopathy and dry eye syndrome.
While treatments for dry eye syndrome are generally able to control its symptoms in the majority of patients, the other four diseases are progressive, chronic, incurable and can lead to visual impairment and even blindness if not adequately treated. Treatment is aimed at managing the disease, in order to reduce the severity of symptoms and to slow progression, rather than being curative.
Scientific advancements over recent decades have revealed a broad range of novel potential molecular targets, enabling progress in a previously stagnant field. This is reflected by the high number of products in development, with 782 pipeline products currently in the ophthalmology therapy area pipeline.
Moreover, there are a total of 158 first-in-class pipeline products in development for ophthalmology indications, representing 36% of the 438 pipeline products for which there is a disclosed molecular target. They appear generally promising in terms of safety and efficacy, and appear to have significant potential to strengthen the treatment landscape for key ophthalmological conditions - as well as representing promising commercial opportunities.
Many first-in-class products in the current ophthalmology pipeline have previously been involved in licensing and co-development deals. This indicates a strong degree of strategic consolidation uptake for first-in-class products in ophthalmology, and a willingness on the part of companies to invest in innovative products that show promise in both preclinical and clinical trials.
Scope
- Analysis of innovation in the ophthalmology markets in the context of the overall pipeline and current market landscape. Also includes analysis of the deals landscape surrounding first-in-class products in ophthalmology, and highlights opportunities for in-licensing. Key indications covered in detail include glaucoma, age-related macular degeneration, diabetic retinopathy and diabetic macular edema.
- A brief introduction to ophthalmology, including symptoms, pathophysiology, and an overview of pharmacotherapy for the key diseases.
- The changing molecular target landscape between the market and the pipeline, and particular focal points of innovation in the pipeline.
- Comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of stage of development, molecule type and molecular target.
- Identification and assessment of first-in-class molecular targets, with a particular focus on early-stage programs for which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets.
- Assessment of the licensing and co-development deal landscape for ophthalmology therapies, and benchmarking of deals involving first-in-class versus non-first-in-class-products.
Reasons to buy
- Understand the current clinical and commercial landscape, including a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options available at each stage of diagnosis.
- Visualize the composition of the ophthalmology market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of the gaps in the current market.
- Analyze the ophthalmology pipeline, stratified by indication, 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 early-stage targets have been further reviewed in greater detail.
- Identify commercial opportunities in the ophthalmology deals landscape by analyzing trends in licensing and co-development deals, and producing a list of ophthalmology therapies that are not yet involved in deals and may be potential investment opportunities.
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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
4 Clinical and Commercial Landscape 9
4.1 Therapy Area Overview 9
4.1.1 Glaucoma 9
4.1.2 Age-related Macular Degeneration 9
4.1.3 Diabetic Macular Edema 9
4.1.4 Diabetic Retinopathy 9
4.1.5 Dry Eye Syndrome 10
4.2 Disease Symptoms 10
4.3 Epidemiology and Etiology 12
4.3.1 Glaucoma 12
4.3.2 Age-related Macular Degeneration 12
4.3.3 Diabetic Retinopathy and Diabetic Macular Edema 12
4.3.4 Dry Eye Syndrome 12
4.4 Diagnosis 13
4.5 Pathophysiology 13
4.5.1 Healthy Eye Physiology 13
4.5.2 Glaucoma 14
4.5.3 Age-related Macular Edema 15
4.5.4 Diabetic Macular Edema and Diabetic Retinopathy 16
4.6 Treatment Options 17
4.7 Prognosis 19
4.7.1 Glaucoma 19
4.7.2 Age-Related Macular Degeneration 19
4.7.3 Diabetic Retinopathy and Diabetic Macular Edema 19
4.7.4 Dry Eye Syndrome 20
4.8 Overview of Marketed Products in Ophthalmology 20
4.8.1 Molecule Type and Target Analysis 20
5 Assessment of Pipeline Product Innovation 22
5.1 Ophthalmology Pipeline by Molecular Target 25
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 28
6 Signaling Network, Disease Causation and Innovation Alignment 35
6.1 Complexity of Signaling Networks in Ophthalmology 35
6.2 First-in-Class Matrix Assessment 35
7 First-in-Class Target Evaluation 39
7.1 Pipeline Programs Targeting RPE65 and RBP4 39
7.2 Pipeline Programs Targeting Eotaxin-1 and CCR3 41
7.3 Pipeline Programs Targeting LRP6 43
7.4 Pipeline Programs Targeting TGF-Beta 2 44
7.5 Pipeline Programs Targeting NGF, and LNGFR and TrkA Nerve Growth Factor Receptors 45
7.6 Pipeline Programs Targeting Serine Protease HtrA1 48
7.7 Conclusion 49
8 Deals and Strategic Consolidations 50
8.1 Industry-Wide First-in-Class Deals 50
8.2 Licensing Deals 51
8.2.1 Licensing Deals by Molecule Type 53
8.2.2 Licensing Deals by Molecular Target 53
8.2.3 Licensing Deals Valued Above $100m 55
8.3 Co-development Deals 56
8.3.1 Co-development Deals by Molecule Type 57
8.3.2 Co-development Deals by Molecular Target 57
8.3.3 Co-development Deals Valued Above $100m 59
8.4 First-in-Class Programs Not Involved in Licensing or Co-development Deals 60
9 Appendix 63
9.1 Abbreviations 63
9.2 References 63
9.3 Research Methodology 68
9.4 Secondary Research 69
9.4.1 Market Analysis 69
9.4.2 Pipeline Analysis 69
9.4.3 First-in-Class Matrix Assessment 69
9.4.4 First-in-Class Target Profiles 70
9.4.5 Licensing and Co-development Deals 70
9.5 Contact Us 70
9.6 Disclaimer 70
1.1 List of Tables
Table 1: Ophthalmology Therapeutics Market, Main Symptoms of Glaucoma, AMD, DR and DES, 2016 11
Table 2: Ophthalmology Therapeutics Market, Prevalence of Major Ophthalmologic Disorders, 2016 12
Table 3: Ophthalmology Therapeutics Market, Treatment options available for glaucoma, 2016 18
Table 4: Ophthalmology Therapeutics Market, Data for RPE65 as a Molecular Target, 2016 40
Table 5: Ophthalmology Therapeutics Market, Data for RBP4 as a Molecular Target, 2016 40
Table 6: Ophthalmology Therapeutics Market, Data for CCR 3 as a Molecular Target, 2016 42
Table 7: Ophthalmology Therapeutics Market, Data for Eotaxin-1 as a Molecular Target, 2016 42
Table 8: Ophthalmology Therapeutics Market, Data for LRP6 as a Molecular Target, 2016 44
Table 9: Ophthalmology Therapeutics Market, Data for TGF- Beta 2 as a Molecular Target, 2016 45
Table 10: Ophthalmology Therapeutics Market, Data for LNGFR as a Molecular Target, 2016 46
Table 11: Ophthalmology Therapeutics Market, Data for TrkA as a Molecular Target, 2016 47
Table 12: Ophthalmology Therapeutics Market, Data for NGF as a Molecular Target, 2016 47
Table 13: Ophthalmology Therapeutics Market, Data for Serine Protease HTRA1 as a Molecular Target, 2016 48
1.2 List of Figures
Figure 1: Ophthalmology Therapeutics Market, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987-2012 6
Figure 2: Ophthalmology Therapeutics Market, First-in-Class and Non-First-in-Class Products, Sales Performance After Marketing Approval ($m) 8
Figure 3: Ophthalmology Therapeutics Market, Overview of Marketed Products, 2016 21
Figure 4: Ophthalmology Therapeutics Market, Overview of Pipeline Products, 2016 22
Figure 5: Ophthalmology Therapeutics Market, Pipeline by Stage of Development and Molecule Type, 2016 23
Figure 6: Ophthalmology Therapeutics Market, Pipeline by Key Indications and Stage of Development, 2016 24
Figure 7: Ophthalmology Therapeutics Market, Pipeline by Key Indications and Molecular Type, 2016 25
Figure 8: Ophthalmology Therapeutics Market, Pipeline by Molecular Target, 2016 26
Figure 9: Ophthalmology Therapeutics Market, Pipeline by Molecular Target and Stage of Development, 2016 26
Figure 10: Ophthalmology Therapeutics Market, Pipeline by Key Indications and Molecular Target, 2016 27
Figure 11: Ophthalmology Therapeutics Market, Molecular Target Family Comparison, Pipeline and Marketed Products, 2016 28
Figure 12: Ophthalmology Therapeutics Market, Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets, 2016 29
Figure 13: Ophthalmology Therapeutics Market, Key Indications and Pipeline First-in-Class and Established Targets, 2016 30
Figure 14: Ophthalmology Therapeutics Market, Percentage of First-in-Class Products in Pipeline by Stage of Development (%), 2016 31
Figure 15: Ophthalmology Therapeutics Market, Percentage of First-in-Class Products in Pipeline by Molecular Target Family (%), 2016 31
Figure 16: Ophthalmology Therapeutics Market, First-in-Class Products in Pipeline (Part 1), 2016 32
Figure 17: Ophthalmology Therapeutics Market, First-in-Class Products in Pipeline (Part 2), 2016 33
Figure 18: Ophthalmology Therapeutics Market, First-in-Class Products in Pipeline (Part 3), 2016 34
Figure 19: Ophthalmology Therapeutics Market, Target Matrix Assessment (Part 1), 2016 37
Figure 20: Ophthalmology Therapeutics Market, Target Matrix Assessment (Part 2), 2016 38
Figure 21: Ophthalmology Therapeutics Market, Pipeline Programs Targeting RPE65, 2016 41
Figure 22: Ophthalmology Therapeutics Market, Pipeline Programs Targeting RBP4, 2016 41
Figure 23: Ophthalmology Therapeutics Market, Pipeline Programs Targeting CCR 3, 2016 43
Figure 24: Ophthalmology Therapeutics Market, Pipeline Programs Targeting Eotaxin-1, 2016 43
Figure 25: Ophthalmology Therapeutics Market, Pipeline Programs Targeting LRP 6, 2016 44
Figure 26: Ophthalmology Therapeutics Market, Pipeline Programs Targeting TGF-Beta 2, 2016 45
Figure 27: Ophthalmology Therapeutics Market, Pipeline Programs Targeting LNGFR, 2016 47
Figure 28: Ophthalmology Therapeutics Market, Pipeline Programs Targeting TrkA, 2016 47
Figure 29: Ophthalmology Therapeutics Market, Pipeline Programs Targeting NGF, 2016 47
Figure 30: Ophthalmology Therapeutics Market, Pipeline Programs Targeting Serine Protease HTRA1, 2016 49
Figure 31: Pharmaceutical Industry, Global, Deals by Stage of Development, 2006-2014 50
Figure 32: Pharmaceutical Industry, Global, Licensing Deal Values by Stage of Development ($m), 2006-2014 51
Figure 33: Ophthalmology Therapeutics Market, Licensing Deal Value, 2006-2016 52
Figure 34: Ophthalmology Therapeutics Market, Licensing Deals by Stage of Development, 2006-2016 53
Figure 35: Ophthalmology Therapeutics Market, Licensing Deals by Molecule Type, 2006-2016 53
Figure 36: Ophthalmology Therapeutics Market, Licensing Deals by Molecular Target, 2006-2016 54
Figure 37: Ophthalmology Therapeutics Market, Licensing Deals Valued Above $100m, 2006-2016 55
Figure 38: Ophthalmology Therapeutics Market, Co-Development Deal Value, 2006-2016 56
Figure 39: Ophthalmology Therapeutics Market, Co-Development Deals by Stage of Development, 2006-2016 57
Figure 40: Ophthalmology Therapeutics Market, Co-Development Deals by Molecule Type, 2006-2016 57
Figure 41: Ophthalmology Therapeutics Market, Co-Development Deals by Molecular Target, 2006-2016 58
Figure 42: Ophthalmology Therapeutics Market, Co-Development Deals Valued Above $100m, 2006-2016 59
Figure 43: Ophthalmology Therapeutics Market, First-in-Class Therapies Involved in Previous Deals, 2016 60
Figure 44: Ophthalmology Therapeutics Market, First-in-Class Therapies Not Involved in Previous Deals (Part 1), 2016 61
Figure 45: Ophthalmology Therapeutics Market, First-in-Class Therapies Not Involved in Previous Deals (Part 2), 2016 62
