Although the past decade has seen the atopic dermatitis market remain relatively unchanged and a saturated, highly genericized arena, the coming decade could see the launch of the first biologic, which will set a precedent and pave the way for others to follow suit.

By the mid-to-late term of GlobalData’s 2012 to 2022 forecast, Sanofi/Regeneron’s dupilumab is expected to reshape the moderate and severe treatment landscape.

Other events that are expected to invoke change to the previously stagnant atopic dermatitis market include the launch of a non-steroidal topical from Anacor, AN2728, generic erosion of branded topicals Protopic and Elidel in the US, and the increasing use of pharmacological treatments in the growing markets of India and China.

The UK atopic dermatitis market is estimated to have reached $163.0m in 2012 and contributes approximately 13.1% of the total 5EU atopic dermatitis market value. This will primarily be due to strong uptake of systemic vitamin derivatives, but also the increasing uptake of systemic agents, namely methotrexate, antibiotics and corticosteroids.

Scope

• Overview of Atopic Dermatitis including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
• Detailed information on the key drugs in the UK including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for the top drugs in the UK from 2012-2022.
• Analysis of the impact of key events as well the drivers and restraints affecting the UK Atopic Dermatitis market.

Reasons to buy

• Understand and capitalize by identifying products that are most likely to ensure a robust return
• Stay ahead of the competition by understanding the changing competitive landscape for Atopic Dermatitis
• Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
• Make more informed business decisions from insightful and in-depth analysis of drug performance
• Obtain sales forecast for drugs from 2012-2022 in the UK

Table of Contents

1 Table of Contents 6

1.1 List of Tables 9

1.2 List of Figures 11

2 Introduction 12

2.1 Catalyst 12

2.2 Related Reports 12

2.3 Upcoming Related Reports 13

3 Disease Overview 14

3.1 Etiology and Pathophysiology 14

3.1.1 Etiology 14

3.1.2 Pathophysiology 15

3.2 Symptoms 19

4 Disease Management 21

4.1 Diagnosis 21

4.2 Treatment Overview 23

4.3 UK 29

4.3.1 Diagnosis 29

4.3.2 Clinical Practice 31

5 Competitive Assessment 34

5.1 Overview 34

5.2 Strategic Competitor Assessment 35

5.3 Product Profiles - Major Brands 36

5.3.1 Protopic (tacrolimus) 36

5.3.2 Elidel 43

5.3.3 Cyclosporine (numerous generic names) 48

5.3.4 Other Therapeutic Drug Classes Used in Atopic Dermatitis 51

6 Opportunity and Unmet Need 53

6.1 Overview 53

6.2 Unmet Needs 54

6.2.1 A Systemic Drug for Severe Recalcitrant Patients 54

6.2.2 Tests that Stratify Patients and Allow for a Tailored Treatment Approach 56

6.2.3 A Drug that Effectively Controls Patients' Pruritus 57

6.2.4 Further Research into the Pathophysiology of Atopic Dermatitis 58

6.2.5 A Drug that Induces Disease Remission 59

6.2.6 Improved Quality of Life for Both Patients and their Carers 60

6.3 Unmet Needs Gap Analysis 60

6.4 Opportunities 62

6.4.1 Increase Treatment Armamentarium for Severe Recalcitrant Patients 62

6.4.2 Predictive Tests for Patient Stratification 62

6.4.3 More Therapeutic Options that Address Patients' Pruritus 63

7 Pipeline Assessment 64

7.1 Overview 64

7.2 Promising Drugs in Clinical Development 66

7.2.1 Dupilumab (SAR231893/ REGN668) 67

7.2.2 Phase II Pipeline Products 77

8 Market Outlook 78

8.1 Global Drivers and Barriers 78

8.1.1 Driver: Anticipated launch of the first biologic for the treatment of moderate to severe disease 78

8.1.2 Driver: The underserved severe refractory patient segment presents an untapped market opportunity 79

8.1.3 Driver: A drug that is able to target two or more atopic diseases would gain a foothold in these markets 79

8.1.4 Driver: Atopic dermatitis presents an attractive patient population for drug developers 79

8.1.5 Driver: Restoring skin barrier function remains a key goal of disease management, meaning a continued need for moisturizers and topical agents 80

8.1.6 Barrier: First to second line of therapy is dominated by cheap, genericized topical drugs which create significant obstacles for novel drugs hoping to penetrate the market 81

8.1.7 Barrier: The largest atopic dermatitis patient segment - mild disease - can be well-controlled on most forms of topical therapy 81

8.1.8 Barrier: Pediatric sufferers are the largest patient group and pose a high bar in terms of safety for new products 81

8.1.9 Barrier: The complexity of the multiple etiologies that lead to atopic dermatitis means that treatment outcomes with existing drugs are not universal across all patient groups 82

8.1.10 Barrier: A significant proportion of patients experience disease remission in their early adolescent years and this may occur without drug therapy 83

8.2 UK 83

8.2.1 Forecast 83

8.2.2 Key Events 86

8.2.3 Drivers and Barriers 87

9 Appendix 90

9.1 Bibliography 90

9.2 Abbreviations 95

9.3 Methodology 97

9.4 Forecasting Methodology 97

9.4.1 Diagnosed Atopic Dermatitis Patients 97

9.4.2 Percent Drug-treated Patients 98

9.4.3 Drugs Included in Each Therapeutic Class 98

9.4.4 Launch and Patent Expiry Dates 98

9.4.5 General Pricing Assumptions 99

9.4.6 Individual Drug Assumptions 100

9.4.7 Generic Erosion 101

9.4.8 Pricing of Pipeline Agents 101

9.5 Physicians and Specialists Included in this Study 102

9.6 Primary Research - Prescriber Survey 103

9.7 About the Authors 104

9.7.1 Author 104

9.7.2 Global Head of Healthcare 105

9.8 About GlobalData 106

9.9 Disclaimer 106

List of Tables

Table 1: Symptoms of Atopic Dermatitis 20

Table 2: Treatment Guidelines for Atopic Dermatitis 26

Table 3: Most Prescribed Drugs for Atopic Dermatitis by Severity in the Global Markets, 2013 28

Table 4: Referral Rates to a UK Dermatologist, Split by Severity and Specialist Type, 2013 30

Table 5: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in the UK in 2012 31

Table 6: Stepped Treatment Approach Used by UK Dermatologists in the Management of Atopic Dermatitis 32

Table 7: Leading Treatments for Atopic Dermatitis, 2013 36

Table 8: Product Profile - Protopic 38

Table 9: Clinical Response Data of Protopic (0.03% and 0.1%) versus Vehicle Ointment at Week 12 from One Study in Pediatric Patients and Two Combined Studies in Adult Patients 39

Table 10: Protopic SWOT Analysis, 2013 42

Table 11: Product Profile - Elidel 44

Table 12: Combined Clinical Efficacy Results of Elidel versus Vehicle Cream at Week 6 from Two Phase III Studies 45

Table 13: Elidel SWOT Analysis, 2013 47

Table 14: Product Profile - Cyclosporine 49

Table 15: Cyclosporine SWOT Analysis, 2013 51

Table 16: Summary of Other Therapeutic Classes for Atopic Dermatitis, 2013 52

Table 17: Overall Unmet Needs in Atopic Dermatitis - Current Level of Attainment 54

Table 18: Clinical Unmet Needs in Atopic Dermatitis - Gap Analysis, 2013 61

Table 19: Late-Stage Atopic Dermatitis Pipeline, 2013 66

Table 20: Comparison of Therapeutic Classes in Development for Atopic Dermatitis, 2013 67

Table 21: Product Profile - Dupilumab 69

Table 22: Ongoing Clinical Trials of Dupilumab in Atopic Dermatitis Patients, as of September 2013 71

Table 23: Dupilumab SWOT Analysis, 2013 76

Table 24: Phase II and Phase I Atopic Dermatitis Pipeline, 2013 77

Table 25: Global Atopic Dermatitis Market - Drivers and Barriers, 2012-2022 78

Table 26: Sales Forecasts ($m) for Atopic Dermatitis in the UK, 2012-2022 85

Table 27: Key Event Impacting Sales for Atopic Dermatitis in the UK, 2012-2022 86

Table 28: Atopic Dermatitis Market in the UK - Drivers and Barriers, 2012-2022 87

Table 29: Key Launch Dates 98

Table 30: Key Patent Expiries 98

Table 31: Physicians Surveyed, By Country 103

List of Figures

Figure 1: Immunologic Pathway Involved in Healthy, Acute Atopic Dermatitis, and Chronic Atopic Dermatitis Skin 17

Figure 2: Flow Chart of the Diagnosis and Management of Atopic Dermatitis 24

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in Atopic Dermatitis, 2012-2022 66

Figure 4: Sales for Atopic Dermatitis in the UK by Drug Class, 2012-2022 86