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.

GlobalData attributes this to the low drug treatment rates in that market, which lower the aforementioned patient pool to 3.3 million, and also because that market is saturated with generic topical therapies. Nonetheless, similar market dynamics to that of the 7MM are at play in the Chinese market, in that topical corticosteroids and moisturizers/emollients dominate the treatment landscape, with 60%-90% of patients across all severities receiving these therapies.

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

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 China 28

4.3.1 Diagnosis 28

4.3.2 Clinical Practice 29

5 Competitive Assessment 30

5.1 Overview 30

5.2 Strategic Competitor Assessment 31

5.3 Product Profiles - Major Brands 32

5.3.1 Protopic (tacrolimus) 32

5.3.2 Elidel 39

5.3.3 Other Therapeutic Drug Classes Used in Atopic Dermatitis 44

6 Opportunity and Unmet Need 46

6.1 Overview 46

6.2 Unmet Needs 47

6.2.1 A Systemic Drug for Severe Recalcitrant Patients 47

6.2.2 Tests that Stratify Patients and Allow for a Tailored Treatment Approach 48

6.2.3 A Drug that Effectively Controls Patients' Pruritus 49

6.2.4 Further Research into the Pathophysiology of Atopic Dermatitis 51

6.2.5 A Drug that Induces Disease Remission 52

6.2.6 Improved Quality of Life for Both Patients and their Carers 52

6.3 Unmet Needs Gap Analysis 53

6.4 Opportunities 54

6.4.1 Increase Treatment Armamentarium for Severe Recalcitrant Patients 54

6.4.2 Predictive Tests for Patient Stratification 54

6.4.3 More Therapeutic Options that Address Patients' Pruritus 55

7 Pipeline Assessment 56

7.1 Overview 56

7.2 Promising Drugs in Clinical Development 57

7.2.1 Phase II Pipeline Products 59

8 Market Outlook 61

8.1 Global Drivers and Barriers 61

8.1.1 Driver: Anticipated launch of the first biologic for the treatment of moderate to severe disease 61

8.1.2 Driver: The underserved severe refractory patient segment presents an untapped market opportunity 62

8.1.3 Driver: A drug that is able to target two or more atopic diseases would gain a foothold in these markets 62

8.1.4 Driver: Atopic dermatitis presents an attractive patient population for drug developers 62

8.1.5 Driver: Restoring skin barrier function remains a key goal of disease management, meaning a continued need for moisturizers and topical agents 63

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 63

8.1.7 Barrier: The largest atopic dermatitis patient segment - mild disease - can be well-controlled on most forms of topical therapy 64

8.1.8 Barrier: Pediatric sufferers are the largest patient group and pose a high bar in terms of safety for new products 64

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 65

8.1.10 Barrier: A significant proportion of patients experience disease remission in their early adolescent years and this may occur without drug therapy 66

8.2 China 66

8.2.1 Forecast 66

8.2.2 Key Events 68

8.2.3 Drivers and Barriers 69

9 Appendix 71

9.1 Bibliography 71

9.2 Abbreviations 76

9.3 Methodology 78

9.4 Forecasting Methodology 78

9.4.1 Diagnosed Atopic Dermatitis Patients 78

9.4.2 Percent Drug-treated Patients 79

9.4.3 Drugs Included in Each Therapeutic Class 79

9.4.4 Individual Drug Assumptions 80

9.4.5 Generic Erosion 81

9.4.6 Physicians and Specialists Included in this Study 82

9.5 Primary Research - Prescriber Survey 83

9.6 About the Authors 84

9.6.1 Author 84

9.6.2 Global Head of Healthcare 85

9.7 About GlobalData 86

9.8 Disclaimer 86

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 Chinese 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 China in 2012 29

Table 6: Leading Treatments for Atopic Dermatitis, 2013 32

Table 7: Product Profile - Protopic 34

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 35

Table 9: Protopic SWOT Analysis, 2013 38

Table 10: Product Profile - Elidel 40

Table 11: Combined Clinical Efficacy Results of Elidel versus Vehicle Cream at Week 6 from Two Phase III Studies 41

Table 12: Elidel SWOT Analysis, 2013 43

Table 13: Summary of Other Therapeutic Classes for Atopic Dermatitis, 2013 45

Table 14: Overall Unmet Needs in Atopic Dermatitis - Current Level of Attainment 47

Table 15: Clinical Unmet Needs in Atopic Dermatitis - Gap Analysis, 2013 54

Table 16: Late-Stage Atopic Dermatitis Pipeline, 2013 57

Table 17: Comparison of Therapeutic Classes in Development for Atopic Dermatitis, 2013 59

Table 18: Phase II and Phase I Atopic Dermatitis Pipeline, 2013 59

Table 19: Global Atopic Dermatitis Market - Drivers and Barriers, 2012-2022 61

Table 20: Sales Forecasts ($m) for Atopic Dermatitis in China, 2012-2022 67

Table 21: Key Event Impacting Sales for Atopic Dermatitis in China, 2012-2022 68

Table 22: Atopic Dermatitis Market in China - Drivers and Barriers, 2012-2022 69

Table 23: Physicians Surveyed, By Country 83

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 58

Figure 4: Sales for Atopic Dermatitis in China by Drug Class, 2012-2022 68