PharmaPoint: Atopic Dermatitis – Japan Drug Forecast and Market Analysis to 2022

99 pages report Published in
Pharmaceuticals
Publisher: GlobalData

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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.

Growth within that market will stem from the positive uptake of three therapies: cyclosporine, systemic antihistamines and the Japanese-manufactured topical calcineurin inhibitor, Astellas/Maruho’s Protopic. Collectively, these three therapies will contribute $361.9m sales to the 2022.

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

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 Japan 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 Cyclosporine (numerous generic names) 40

5.3.3 Other Therapeutic Drug Classes Used in Atopic Dermatitis 43


6 Opportunity and Unmet Need 45

6.1 Overview 45

6.2 Unmet Needs 46

6.2.1 A Systemic Drug for Severe Recalcitrant Patients 46

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 50

6.2.5 A Drug that Induces Disease Remission 51

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

6.3 Unmet Needs Gap Analysis 52

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 58

7.2.1 Dupilumab (SAR231893/ REGN668) 59

7.2.2 Phase II Pipeline Products 69


8 Market Outlook 70

8.1 Global Drivers and Barriers 70

8.1.1 Driver: Anticipated launch of the first biologic for the treatment of moderate to severe disease 70

8.1.2 Driver: The underserved severe refractory patient segment presents an untapped market opportunity 71

8.1.3 Driver: A drug that is able to target two or more atopic diseases would gain a foothold in these markets 71

8.1.4 Driver: Atopic dermatitis presents an attractive patient population for drug developers 71

8.1.5 Driver: Restoring skin barrier function remains a key goal of disease management, meaning a continued need for moisturizers and topical agents 72

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 73

8.1.7 Barrier: The largest atopic dermatitis patient segment - mild disease - can be well-controlled on most forms of topical therapy 73

8.1.8 Barrier: Pediatric sufferers are the largest patient group and pose a high bar in terms of safety for new products 73

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 74

8.1.10 Barrier: A significant proportion of patients experience disease remission in their early adolescent years and this may occur without drug therapy 75

8.2 Japan 75

8.2.1 Forecast 75

8.2.2 Key Events 78

8.2.3 Drivers and Barriers 79


9 Appendix 82

9.1 Bibliography 82

9.2 Abbreviations 87

9.3 Methodology 89

9.4 Forecasting Methodology 89

9.4.1 Diagnosed Atopic Dermatitis Patients 90

9.4.2 Percent Drug-treated Patients 90

9.4.3 Drugs Included in Each Therapeutic Class 90

9.4.4 Launch and Patent Expiry Dates 91

9.4.5 General Pricing Assumptions 91

9.4.6 Individual Drug Assumptions 92

9.4.7 Generic Erosion 93

9.4.8 Pricing of Pipeline Agents 93

9.5 Physicians and Specialists Included in this Study 94

9.6 Primary Research - Prescriber Survey 95

9.7 About the Authors 96

9.7.1 Author 96

9.7.2 Global Head of Healthcare 97

9.8 About GlobalData 98

9.9 Disclaimer 98


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 Japanese Dermatologist, Split by Severity and Specialist Type, 2013 29

Table 5: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in Japan 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 - Cyclosporine 41

Table 11: Cyclosporine SWOT Analysis, 2013 43

Table 12: Summary of Other Therapeutic Classes for Atopic Dermatitis, 2013 44

Table 13: Overall Unmet Needs in Atopic Dermatitis - Current Level of Attainment 46

Table 14: Clinical Unmet Needs in Atopic Dermatitis - Gap Analysis, 2013 53

Table 15: Late-Stage Atopic Dermatitis Pipeline, 2013 58

Table 16: Comparison of Therapeutic Classes in Development for Atopic Dermatitis, 2013 59

Table 17: Product Profile - Dupilumab 61

Table 18: Ongoing Clinical Trials of Dupilumab in Atopic Dermatitis Patients, as of September 2013 63

Table 19: Dupilumab SWOT Analysis, 2013 68

Table 20: Phase II and Phase I Atopic Dermatitis Pipeline, 2013 69

Table 21: Global Atopic Dermatitis Market - Drivers and Barriers, 2012-2022 70

Table 22: Sales Forecasts ($m) for Atopic Dermatitis in Japan, 2012-2022 77

Table 23: Key Event Impacting Sales for Atopic Dermatitis in Japan, 2012-2022 78

Table 24: Atopic Dermatitis Market in Japan - Drivers and Barriers, 2012-2022 79

Table 25: Key Launch Dates 91

Table 26: Key Patent Expiries 91

Table 27: Physicians Surveyed, By Country 95


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 Japan by Drug Class, 2012-2022 78


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