Frontier Pharma: Dermatology – Intracellular Signal Transducers and Cytokine Signaling Molecules Dominate Pipeline and First-in-Class Innovation

Dermatology is a highly diverse therapy area that deals with diseases of the skin, hair and nails. Over 3,000 distinct dermatological conditions are thought to exist, ranging from rare autoimmune disorders such as scleroderma, to very common conditions such as acne vulgaris and atopic dermatitis. For the past decade the majority of the therapeutic dermatology market has been saturated and highly genericized, and strongly dominated by small molecules. There is a significant unmet need for more efficacious and safer treatment options, as physicians often cite poor efficacy, low patient compliance and problematic safety profiles as issues with the long-term use of many available treatments.

Although the scope of dermatological disorders is diverse in terms of severity, clinical presentation, and key patient demographics, there is a degree of crossover between many indications in terms of their underlying pathophysiology. Increased inflammation and aberrant immune response resulting in skin barrier dysfunction are commonly shared causes. Infections and dysfunctions in wound healing are also common causes of dermatological diseases.

Scientific advancements over the course of recent decades have revealed a broad range of novel potential molecular targets, enabling the advancement of a previously stagnant field. This is reflected in the high number of products being developed, with 961 pipeline products currently in the dermatology therapy area pipeline.

Analysis indicates that the current pipeline is following a trend of focusing on innovative biologic therapies, following the clinical and commercial success of such therapies in the treatment of psoriasis. There are various biologics in the pipeline for major skin disorders – including atopic dermatitis, acne vulgaris and rosacea – for which there is a significant unmet need in patients with moderate-to-severe conditions.

Moreover, there is a considerable degree of innovation present in the therapy area, as there are a total of 197 first-in-class pipeline products in development for dermatological indications, representing 32% of the 617 pipeline products for which there is a disclosed molecular target. Many of these appear promising in terms of safety and efficacy, and carry a significant potential to strengthen the treatment landscape for various dermatological conditions.

Scope

– With 961 products in active development, the pipeline is considerably large. How will pipeline innovation affect the future dermatology market?

– There are 197 first-in-class products in the dermatology pipeline. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?

– The majority of first-in-class products are in development for indications involving inflammation. Which first-in-class targets are most promising, and how does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?

– A significant number of first-in-class products have been identified with no prior involvement in deals. How do deal frequency and value compare between target families and molecule types, and which first-in-class programs have not yet been involved in a licensing or co-development deal?

Reasons to buy

- Understand the current clinical and commercial landscape. The report includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.

- Visualize the composition of the dermatology 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 gaps in the market.

- Analyze the dermatology 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 dermatological diseases, including rare conditions.

- Assess the therapeutic potential of first-in-class targets. Using proprietary matrices, first-in-class products have been assessed and ranked according to clinical potential. The matrices have been split into three categories: inflammatory diseases, infectious diseases, and wounds/scars. Promising targets have been reviewed in greater detail.

- Identify commercial opportunities in the dermatology deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals.

Table of Contents

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 Large Therapy Area Characterized by a High Degree of Pathophysiological Crossover 5

2.2 Biologics and mAbs Growing in Prominence in Dermatology Therapy Area 5

2.3 Highly Diversified Range of Innovative Programs in Early Pipeline 5

2.4 Deals Landscape Offers Significant Investment Opportunities for First-in-Class Products Landscape 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 Development Remains Attractive 9

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9

3.5 Sustained Innovation 10

3.6 GBI Research Report Guidance 10

4 Clinical and Commercial Landscape 11

4.1 Therapy Area Introduction 11

4.2 Symptoms 11

4.3 Epidemiology and Etiology 12

4.3.1 Atopic Dermatitis 12

4.3.2 Acne Vulgaris 13

4.3.3 Psoriasis 13

4.4 Pathophysiology 14

4.4.1 Atopic Dermatitis 14

4.4.2 Acne Vulgaris 15

4.4.3 Psoriasis 15

4.5 Co-morbidities and Complications 16

4.6 Treatment 17

4.6.1 Topical Corticosteroids 17

4.6.2 Calcineurin Inhibitors 18

4.6.3 Retinoids 18

4.6.4 Systemic Immunosuppressive Agents 19

4.6.5 Biologics 19

4.6.6 Antihistamines 19

4.6.7 Hormonal Therapy 19

4.6.8 Moisturizers 20

4.7 Overview of Marketed Products in Dermatology 20

5 Assessment of Pipeline Product Innovation 22

5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target 22

5.2 First-in-Class Programs Targeting Novel Molecular Targets 25

6 Signaling Network, Disease Causation and Innovation Alignment 42

6.1 Complexity of Signaling Networks in Dermatology 42

6.2 Signaling Pathways and First-in-Class Molecular Target Integration 42

6.3 First-in-Class Matrix Assessment 42

7 First-in-Class Target and Pipeline Program Evaluation 48

7.1 Pipeline Programs Targeting Non-Receptor Tyrosine-Protein Kinase TYK2 48

7.2 Pipeline Programs Targeting Granzyme B 51

7.3 Pipeline Programs Targeting ORAI1 53

7.4 Pipeline Programs Targeting CC motif chemokine 11 55

7.5 Pipeline Programs Targeting Potassium Voltage-Gated Channel Subfamily A Member 3 57

7.6 Pipeline Programs Targeting Toll-like Receptor 8 59

7.7 Pipeline Programs Targeting CC Chemokine Receptor Type 6 61

7.8 Pipeline Programs Targeting Targeting Spleen Tyrosine Kinase 63

7.9 Pipeline Programs Targeting Galectin-3 65

7.10 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 6 67

7.11 Pipeline Programs Targeting Sphingosine 1-phosphate receptor 4 69

7.12 Pipeline Programs Targeting Protein-Lysine 6-Oxidase 70

7.13 Pipeline Programs Targeting Leucine-Rich Repeat-Containing G-Protein Coupled Receptor 6 72

7.14 Conclusion 73

8 Strategic Consolidations 74

8.1 Industry-Wide First-in-Class Deals 74

8.2 Licensing Deals 75

8.2.1 Deals by Region, Value and Year 75

8.2.2 Deals by Stage of Development and Value 77

8.2.3 Deals by Molecule Type, Molecular Target and Value 77

8.2.4 List of Deals with Disclosed Deal Values 79

8.3 Codevelopment Deals 81

8.3.1 Deals by Region, Value and Year 81

8.3.2 Deals by Stage of Development and Value 82

8.3.3 Deals by Molecule Type, Molecular Target and Value 82

8.3.4 List of Deals with Disclosed Deal Values 84

8.4 First-in-Class Programs with and without Prior Involvement in Licensing and Co-development Deals 85

9 Appendix 90

9.1 References 90

9.2 Abbreviations 96

9.3 Research Methodology 96

9.4 Secondary Research 97

9.4.1 Market Analysis 97

9.4.2 Pipeline Analysis 97

9.4.3 First-in-Class Matrix Assessment 98

9.4.4 First-in-Class Target Profiles 98

9.4.5 Licensing and Co-Development Deals 98

9.5 Contact Us 98

9.6 Disclaimer 98

List of Tables

1.1 List of Tables

Table 1: Dermatology Therapeutics Market, Main Symptoms of Atopic Dermatitis, Acne Vulgaris and Psoriasis, 2017 12

Table 2: Dermatology Therapeutics Market, Global, Epidemiology of Dermatological Disorders, 2017 12

Table 3: Dermatology Therapeutics Market, Global, Key Features and Pipeline Activity of Non-Receptor Tyrosine-Protein Kinase TYK2, 2017 49

Table 4: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Non-Receptor Tyrosine-Protein Kinase TYK2, 2017 50

Table 5: Dermatology Therapeutics Market, Global, Key Features of Granzyme B, 2017 52

Table 6: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Granzyme B, 2017 53

Table 7: Dermatology Therapeutics Market, Global, Key Features of ORAI1, 2017 54

Table 8: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting ORAI1, 2017 55

Table 9: Dermatology Therapeutics Market, Global, Key Features and Pipeline Activity of CCL11, 2017 56

Table 10: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting CCL11, 2017 56

Table 11: Dermatology Therapeutics Market, Global, Key Features and Pipeline Activity of Voltage-Gated Channel Subfamily A Member 3, 2017 58

Table 12: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Voltage-Gated Channel Subfamily A Member 3, 2017 58

Table 13: Dermatology Therapeutics Market, Global, Key Features of TLR8, 2017 60

Table 14: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting TLR8, 2017 61

Table 15: Dermatology Therapeutics Market, Global, Key Features of CC Chemokine Receptor Type 6, 2017 62

Table 16: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting CC Chemokine Receptor Type 6, 2017 62

Table 17: Dermatology Therapeutics Market, Global, Key Features of Spleen Tyrosine Kinase, 2017 64

Table 18: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Spleen Tyrosine Kinase, 2017 64

Table 19: Dermatology Therapeutics Market, Global, Key Features and Pipeline Activity of Galectin-3, 2017 66

Table 20: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Galectin-3, 2017 66

Table 21: Dermatology Therapeutics Market, Global, Key Features of Tumor Necrosis Factor Receptor Superfamily Member 6, 2017 68

Table 22: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 6, 2017 68

Table 23: Dermatology Therapeutics Market, Global, Key Features of Sphingosine 1-Phosphate Receptor 4, 2017 70

Table 24: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Sphingosine 1-Phosphate Receptor 4, 2017 70

Table 25: Dermatology Therapeutics Market, Global, Key Features of Protein Lysine 6 Oxidase, 2017 71

Table 26: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Protein Lysine 6 Oxidase, 2017 72

Table 27: Dermatology Therapeutics Market, Global, Key Features of Leucine-Rich Repeat-Containing G-Protein Coupled Receptor 6, 2017 73

Table 28: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Leucine-Rich Repeat-Containing G-Protein Coupled Receptor 6, 2017 73

List of Figures

1.1 List of Figures

Figure 1: Dermatology Therapeutics Market, US, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Product Approvals, 1987-2014 8

Figure 2: Dermatology Therapeutics Market, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval ($m), 2006-2013 9

Figure 3: Dermatology Therapeutics Market, Global, Marketed Products by Molecule Type, 2017 20

Figure 4: Dermatology Therapeutics Market, Global, Marketed Products by Molecular Target, 2017 21

Figure 5: Dermatology Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 22

Figure 6: Dermatology Therapeutics Market, Global, Pipeline by Stage of Development and Molecule Type, 2017 23

Figure 7: Dermatology Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2017 25

Figure 8: Dermatology Therapeutics Market, Global, Distribution of Pipeline First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target, 2017 26

Figure 9: Dermatology Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development (%), 2017 27

Figure 10: Dermatology Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Molecular Target (%), 2017 27

Figure 11: Dermatology Therapeutics Market, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development, 2017 27

Figure 12: Dermatology Therapeutics Market, Global, Ratio of First-in-Class Products to First-in-Class Targets by Molecular Target, 2017 28

Figure 13: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 1) 28

Figure 14: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 2) 29

Figure 15: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 3) 30

Figure 16: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 4) 31

Figure 17: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 5) 32

Figure 18: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 6) 33

Figure 19: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 7) 33

Figure 20: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 8) 34

Figure 21: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 9) 35

Figure 22: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 10) 36

Figure 23: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 11) 37

Figure 24: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 12) 38

Figure 25: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 13) 39

Figure 26: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 14) 40

Figure 27: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 15) 41

Figure 28: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 1) 43

Figure 29: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 2) 44

Figure 30: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 3) 44

Figure 31: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 4) 45

Figure 32: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 5) 45

Figure 33: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Infectious Diseases), 2017 46

Figure 34: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Wounds/Scars), 2017 47

Figure 35: Dermatology Therapeutics Market, Global, Industry-Wide Deals by Stage of Development and First-in-Class Status, 2006-2014 74

Figure 36: Dermatology Therapeutics Market, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status, 2006-2014 75

Figure 37: Dermatology Therapeutics Market, Global, Licensing Deals by Region, Value and Year, 2006-2017 76

Figure 38: Dermatology Therapeutics Market, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2017 77

Figure 39: Dermatology Therapeutics Market, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type, 2006-2017 77

Figure 40: Dermatology Therapeutics Market, Global, Number and Aggregate Deal Value of Licensing Deals by Molecular Target, 2006-2017 78

Figure 41: Dermatology Therapeutics, Global, Licensing Deals with Disclosed Deal Values, 2006-2017 (Part 1) 79

Figure 42: Dermatology Therapeutics, Global, Licensing Deals with Disclosed Deal Values, 2006-2017 (Part 2) 80

Figure 43: Dermatology Therapeutics Market, Global, Co-development Deals by Region, Value and Year, 2006-2017 81

Figure 44: Dermatology Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 82

Figure 45: Dermatology Therapeutics Market, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type, 2006-2017 82

Figure 46: Dermatology Therapeutics Market, Global, Number of Co-development Deals by Molecular Target, 2006-2017 83

Figure 47: Dermatology Therapeutics Market, Global, Co-development Deals with Disclosed Deal Values, 2006-2017 84

Figure 48: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with Prior Involvement in Licensing or Co-development Deals, 2017 85

Figure 49: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals (Part 1), 2017 86

Figure 50: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals (Part 2), 2017 87

Figure 51: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals (Part 3), 2017 88

Figure 52: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals (Part 4), 2017 89

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