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 key growth drivers in Italy will be systemic products, in particular cyclosporine and those within the corticosteroids class. The increasing uptake of these market drivers will be most notable in the moderate and severe patient segments. In addition, Italian dermatologists surveyed by GlobalData in July 2013 anticipate growing uptake of off-label biologic Xolair within their severe population.

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

Table of Contents

1 Table of Contents 5

1.1 List of Tables 9

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 Italy 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) 45

5.3.4 Other Therapeutic Drug Classes Used in Atopic Dermatitis 48

5.4 Product Profiles - Off-Label Therapies 50

5.4.1 Xolair (omalizumab) 50

6 Opportunity and Unmet Need 54

6.1 Overview 54

6.2 Unmet Needs 55

6.2.1 A Systemic Drug for Severe Recalcitrant Patients 55

6.2.2 Tests that Stratify Patients and Allow for a Tailored Treatment Approach 57

6.2.3 A Drug that Effectively Controls Patients' Pruritus 58

6.2.4 Further Research into the Pathophysiology of Atopic Dermatitis 59

6.2.5 A Drug that Induces Disease Remission 60

6.2.6 Improved Quality of Life for Both Patients and their Carers 61

6.3 Unmet Needs Gap Analysis 61

6.4 Opportunities 63

6.4.1 Increase Treatment Armamentarium for Severe Recalcitrant Patients 63

6.4.2 Predictive Tests for Patient Stratification 63

6.4.3 More Therapeutic Options that Address Patients' Pruritus 64

7 Pipeline Assessment 65

7.1 Overview 65

7.2 Promising Drugs in Clinical Development 67

7.2.1 Dupilumab (SAR231893/ REGN668) 68

7.2.2 Phase II Pipeline Products 78

8 Market Outlook 79

8.1 Global Drivers and Barriers 79

8.1.1 Driver: Anticipated launch of the first biologic for the treatment of moderate to severe disease 79

8.1.2 Driver: The underserved severe refractory patient segment presents an untapped market opportunity 80

8.1.3 Driver: A drug that is able to target two or more atopic diseases would gain a foothold in these markets 80

8.1.4 Driver: Atopic dermatitis presents an attractive patient population for drug developers 80

8.1.5 Driver: Restoring skin barrier function remains a key goal of disease management, meaning a continued need for moisturizers and topical agents 81

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 82

8.1.7 Barrier: The largest atopic dermatitis patient segment - mild disease - can be well-controlled on most forms of topical therapy 82

8.1.8 Barrier: Pediatric sufferers are the largest patient group and pose a high bar in terms of safety for new products 82

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 83

8.1.10 Barrier: A significant proportion of patients experience disease remission in their early adolescent years and this may occur without drug therapy 84

8.2 Italy 84

8.2.1 Forecast 84

8.2.2 Key Events 87

8.2.3 Drivers and Barriers 88

9 Appendix 90

9.1 Bibliography 90

9.2 Abbreviations 96

9.3 Methodology 98

9.4 Forecasting Methodology 98

9.4.1 Diagnosed Atopic Dermatitis Patients 99

9.4.2 Percent Drug-treated Patients 99

9.4.3 Drugs Included in Each Therapeutic Class 99

9.4.4 Launch and Patent Expiry Dates 100

9.4.5 General Pricing Assumptions 100

9.4.6 Individual Drug Assumptions 101

9.4.7 Generic Erosion 102

9.4.8 Pricing of Pipeline Agents 103

9.5 Physicians and Specialists Included in this Study 103

9.6 Primary Research - Prescriber Survey 104

9.7 About the Authors 105

9.7.1 Author 105

9.7.2 Global Head of Healthcare 106

9.8 About GlobalData 107

9.9 Disclaimer 107

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 an Italian 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 Italy 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 44

Table 13: Product Profile - Cyclosporine 46

Table 14: Cyclosporine SWOT Analysis, 2013 48

Table 15: Summary of Other Therapeutic Classes for Atopic Dermatitis, 2013 49

Table 16: Product Profile - Xolair 51

Table 17: Xolair SWOT Analysis, 2013 53

Table 18: Overall Unmet Needs in Atopic Dermatitis - Current Level of Attainment 55

Table 19: Clinical Unmet Needs in Atopic Dermatitis - Gap Analysis, 2013 62

Table 20: Late-Stage Atopic Dermatitis Pipeline, 2013 67

Table 21: Comparison of Therapeutic Classes in Development for Atopic Dermatitis, 2013 68

Table 22: Product Profile - Dupilumab 70

Table 23: Ongoing Clinical Trials of Dupilumab in Atopic Dermatitis Patients, as of September 2013 72

Table 24: Dupilumab SWOT Analysis, 2013 77

Table 25: Phase II and Phase I Atopic Dermatitis Pipeline, 2013 78

Table 26: Global Atopic Dermatitis Market - Drivers and Barriers, 2012-2022 79

Table 27: Sales Forecasts ($m) for Atopic Dermatitis in Italy, 2012-2022 86

Table 28: Key Event Impacting Sales for Atopic Dermatitis in Italy, 2012-2022 87

Table 29: Atopic Dermatitis Market in Italy - Drivers and Barriers, 2012-2022 88

Table 30: Key Launch Dates 100

Table 31: Key Patent Expiries 100

Table 32: Physicians Surveyed, By Country 104

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 67

Figure 4: Sales for Atopic Dermatitis in Italy by Drug Class, 2012-2022 87