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.

Based on GlobalData’s July 2013 survey data, the key growth drivers in Spain in the near term will be systemic products, particularly those within the antibiotics class, and off-label therapies Xolair and Actimmune. The anticipated uptake of these off-label therapies will be most prominent in patients with severe disease. Another important growth driver will be increasing uptake of the topical calcineurin inhibitor brand Elidel.

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 Spain including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for the top drugs in Spain from 2012-2022.
• Analysis of the impact of key events as well the drivers and restraints affecting Spain 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 Spain

Table of Contents

1 Table of Contents 5

1.1 List of Tables 8

1.2 List of Figures 10

2 Introduction 11

2.1 Catalyst 11

2.2 Related Reports 11

2.3 Upcoming Related Reports 12

3 Disease Overview 13

3.1 Etiology and Pathophysiology 13

3.1.1 Etiology 13

3.1.2 Pathophysiology 14

3.2 Symptoms 18

4 Disease Management 20

4.1 Diagnosis 20

4.2 Treatment Overview 22

4.3 Spain 28

4.3.1 Diagnosis 28

4.3.2 Clinical Practice 29

5 Competitive Assessment 31

5.1 Overview 31

5.2 Strategic Competitor Assessment 32

5.3 Product Profiles - Major Brands 33

5.3.1 Protopic (tacrolimus) 33

5.3.2 Elidel 40

5.3.3 Cyclosporine (numerous generic names) 46

5.3.4 Other Therapeutic Drug Classes Used in Atopic Dermatitis 49

6 Opportunity and Unmet Need 51

6.1 Overview 51

6.2 Unmet Needs 52

6.2.1 A Systemic Drug for Severe Recalcitrant Patients 52

6.2.2 Tests that Stratify Patients and Allow for a Tailored Treatment Approach 54

6.2.3 A Drug that Effectively Controls Patients' Pruritus 55

6.2.4 Further Research into the Pathophysiology of Atopic Dermatitis 56

6.2.5 A Drug that Induces Disease Remission 57

6.2.6 Improved Quality of Life for Both Patients and their Carers 58

6.3 Unmet Needs Gap Analysis 58

6.4 Opportunities 60

6.4.1 Increase Treatment Armamentarium for Severe Recalcitrant Patients 60

6.4.2 Predictive Tests for Patient Stratification 60

6.4.3 More Therapeutic Options that Address Patients' Pruritus 61

7 Pipeline Assessment 62

7.1 Overview 62

7.2 Promising Drugs in Clinical Development 63

7.2.1 Dupilumab (SAR231893/ REGN668) 65

7.2.2 Phase II Pipeline Products 74

8 Market Outlook 76

8.1 Global Drivers and Barriers 76

8.1.1 Driver: Anticipated launch of the first biologic for the treatment of moderate to severe disease 76

8.1.2 Driver: The underserved severe refractory patient segment presents an untapped market opportunity 77

8.1.3 Driver: A drug that is able to target two or more atopic diseases would gain a foothold in these markets 77

8.1.4 Driver: Atopic dermatitis presents an attractive patient population for drug developers 77

8.1.5 Driver: Restoring skin barrier function remains a key goal of disease management, meaning a continued need for moisturizers and topical agents 78

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 79

8.1.7 Barrier: The largest atopic dermatitis patient segment - mild disease - can be well-controlled on most forms of topical therapy 79

8.1.8 Barrier: Pediatric sufferers are the largest patient group and pose a high bar in terms of safety for new products 79

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 80

8.1.10 Barrier: A significant proportion of patients experience disease remission in their early adolescent years and this may occur without drug therapy 81

8.2 Spain 81

8.2.1 Forecast 81

8.2.2 Key Events 84

8.2.3 Drivers and Barriers 85

9 Appendix 87

9.1 Bibliography 87

9.2 Abbreviations 92

9.3 Methodology 93

9.4 Forecasting Methodology 94

9.4.1 Diagnosed Atopic Dermatitis Patients 94

9.4.2 Percent Drug-treated Patients 94

9.4.3 Drugs Included in Each Therapeutic Class 95

9.4.4 Launch and Patent Expiry Dates 95

9.4.5 General Pricing Assumptions 95

9.4.6 Individual Drug Assumptions 97

9.4.7 Generic Erosion 99

9.4.8 Pricing of Pipeline Agents 99

9.5 Physicians and Specialists Included in this Study 99

9.6 Primary Research - Prescriber Survey 100

9.7 About the Authors 101

9.7.1 Author 101

9.7.2 Global Head of Healthcare 102

9.8 About GlobalData 103

9.9 Disclaimer 103

List of Tables

Table 1: Symptoms of Atopic Dermatitis 19

Table 2: Treatment Guidelines for Atopic Dermatitis 25

Table 3: Most Prescribed Drugs for Atopic Dermatitis by Severity in the Global Markets, 2013 27

Table 4: Referral Rates to a Spanish Dermatologist, Split by Severity and Specialist Type, 2013 28

Table 5: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in Spain in 2012 29

Table 6: Leading Treatments for Atopic Dermatitis, 2013 33

Table 7: Product Profile - Protopic 35

Table 8: 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 36

Table 9: Protopic SWOT Analysis, 2013 39

Table 10: Product Profile - Elidel 41

Table 11: Combined Clinical Efficacy Results of Elidel versus Vehicle Cream at Week 6 from Two Phase III Studies 42

Table 12: Elidel SWOT Analysis, 2013 45

Table 13: Product Profile - Cyclosporine 47

Table 14: Cyclosporine SWOT Analysis, 2013 49

Table 15: Summary of Other Therapeutic Classes for Atopic Dermatitis, 2013 50

Table 16: Overall Unmet Needs in Atopic Dermatitis - Current Level of Attainment 52

Table 17: Clinical Unmet Needs in Atopic Dermatitis - Gap Analysis, 2013 59

Table 18: Late-Stage Atopic Dermatitis Pipeline, 2013 63

Table 19: Comparison of Therapeutic Classes in Development for Atopic Dermatitis, 2013 65

Table 20: Product Profile - Dupilumab 67

Table 21: Ongoing Clinical Trials of Dupilumab in Atopic Dermatitis Patients, as of September 2013 69

Table 22: Dupilumab SWOT Analysis, 2013 74

Table 23: Phase II and Phase I Atopic Dermatitis Pipeline, 2013 74

Table 24: Global Atopic Dermatitis Market - Drivers and Barriers, 2012-2022 76

Table 25: Sales Forecasts ($m) for Atopic Dermatitis in Spain, 2012-2022 83

Table 26: Key Event Impacting Sales for Atopic Dermatitis in Spain, 2012-2022 84

Table 27: Atopic Dermatitis Market in Spain - Drivers and Barriers, 2012-2022 85

Table 28: Key Launch Dates 95

Table 29: Key Patent Expiries 95

Table 30: Physicians Surveyed, By Country 100

List of Figures

Figure 1: Immunologic Pathway Involved in Healthy, Acute Atopic Dermatitis, and Chronic Atopic Dermatitis Skin 16

Figure 2: Flow Chart of the Diagnosis and Management of Atopic Dermatitis 23

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in Atopic Dermatitis, 2012-2022 64

Figure 4: Sales for Atopic Dermatitis in Spain by Drug Class, 2012-2022 84