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.

Strong uptake of branded and generic topical calcineurin inhibitors as well as systemic vitamin derivatives will be the key growth drivers, while prescribing behavior of Indian dermatologists from GlobalData’s July 2013 survey suggests a highly crowded, genericized market.

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

Table of Contents

1 Table of Contents 6

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 India 28

4.3.1 Diagnosis 28

4.3.2 Clinical Practice 30

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 64

7.2.1 Phase II Pipeline Products 66

8 Market Outlook 67

8.1 Global Drivers and Barriers 67

8.1.1 Driver: Anticipated launch of the first biologic for the treatment of moderate to severe disease 67

8.1.2 Driver: The underserved severe refractory patient segment presents an untapped market opportunity 68

8.1.3 Driver: A drug that is able to target two or more atopic diseases would gain a foothold in these markets 68

8.1.4 Driver: Atopic dermatitis presents an attractive patient population for drug developers 68

8.1.5 Driver: Restoring skin barrier function remains a key goal of disease management, meaning a continued need for moisturizers and topical agents 69

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 70

8.1.7 Barrier: The largest atopic dermatitis patient segment - mild disease - can be well-controlled on most forms of topical therapy 70

8.1.8 Barrier: Pediatric sufferers are the largest patient group and pose a high bar in terms of safety for new products 70

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 71

8.1.10 Barrier: A significant proportion of patients experience disease remission in their early adolescent years and this may occur without drug therapy 72

8.2 India 73

8.2.1 Forecast 73

8.2.2 Key Events 75

8.2.3 Drivers and Barriers 76

9 Appendix 78

9.1 Bibliography 78

9.2 Abbreviations 83

9.3 Methodology 85

9.4 Forecasting Methodology 85

9.4.1 Diagnosed Atopic Dermatitis Patients 86

9.4.2 Percent Drug-treated Patients 86

9.4.3 Drugs Included in Each Therapeutic Class 87

9.4.4 General Pricing Assumptions 87

9.4.5 Individual Drug Assumptions 88

9.4.6 Generic Erosion 89

9.5 Physicians and Specialists Included in this Study 90

9.6 Primary Research - Prescriber Survey 91

9.7 About the Authors 92

9.7.1 Author 92

9.7.2 Global Head of Healthcare 93

9.8 About GlobalData 94

9.9 Disclaimer 94

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 Indian 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 India 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 64

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

Table 20: Phase II and Phase I Atopic Dermatitis Pipeline, 2013 66

Table 21: Global Atopic Dermatitis Market - Drivers and Barriers, 2012-2022 67

Table 22: Sales Forecasts ($m) for Atopic Dermatitis in India, 2012-2022 74

Table 23: Key Event Impacting Sales for Atopic Dermatitis in India, 2012-2022 75

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

Table 25: Physicians Surveyed, By Country 91

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 India by Drug Class, 2012-2022 75