Atopic Dermatitis - Japan Drug Forecast and Market Analysis to 2024

Introduction

Atopic Dermatitis - Japan Drug Forecast and Market Analysis to 2024

Summary

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 2014 to 2024 forecast, Sanofi/Regeneron’s dupilumab is expected to reshape the adult moderate and severe treatment landscape and to slowly enter the market for younger patients with milder forms of the disease.

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.

GlobalData values the atopic dermatitis market in Japan at 7.0m in 2014. Growth within that market will stem from the positive uptake of systemic agents and the pipeline therapy dupilumab. In terms of branded products, Protopic dominates the topical calcineurin inhibitor class in Japan with estimated sales of .5m in 2014. Since its key competitor Elidel is not available in Japan, Protopic’s strong stance in that market remains relatively unchallenged throughout the 10-year forecast.

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 Atopic Dermatitiscription, safety and efficacy profiles as well as a SWOT analysis.

- Sales forecast for the top drugs in Japan from 2014-2024.

- 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 2014-2024 in Japan.

Table of Contents
for Atopic Dermatitis - Japan Drug Forecast and Market Analysis to 2024

• 1 Table of Contents

  1 Table of Contents 2

  1.1 List of Tables 5

  1.2 List of Figures 7

  2 Introduction 8

  2.1 Catalyst 8

  2.2 Related Reports 8

  2.3 Upcoming Related Reports 9

  3 Disease Overview 10

  3.1 Etiology and Pathophysiology 10

  3.1.1 Etiology 10

  3.1.2 Pathophysiology 11

  3.2 Symptoms 15

  4 Disease Management 17

  4.1 Diagnosis and Treatment Overview 17

  4.1.1 Diagnosis 17

  4.1.2 Treatment Guidelines 19

  4.1.3 Leading Prescribed Drugs for the Treatment of Atopic Dermatitis 21

  4.1.4 Clinical Practice 23

  4.2 Japan 24

  5 Competitive Assessment 27

  5.1 Overview 27

  5.2 Strategic Competitor Assessment 28

  5.3 Product Profiles - Major Brands 29

  5.3.1 Protopic (tacrolimus) 29

  5.3.2 Elidel 37

  5.3.3 Cyclosporine (numerous generic names) 42

  5.3.4 Other Therapeutic Drug Classes Used in Atopic Dermatitis 47

  5.4 Product Profiles - Off-Label Therapies 49

  5.4.1 Xolair (omalizumab) 49

  5.4.2 Actimmune (interferon gamma-1b) 54

  6 Opportunity and Unmet Need 59

  6.1 Overview 59

  6.1.1 A Systemic Drug for Severe Recalcitrant Patients 60

  6.1.2 Tests that Stratify Patients and Allow for a Tailored Treatment Approach 63

  6.1.3 A Drug that Effectively Controls Patients’ Pruritus 67

  6.1.4 Further Research into the Pathophysiology of Atopic Dermatitis 69

  6.1.5 A Drug that Induces Disease Remission 72

  6.1.6 Improved Quality of Life for Both Patients and their Carers 73

  7 Pipeline Assessment 76

  7.1 Overview 76

  7.2 Clinical Trial Mapping 77

  7.2.1 Clinical Trials by Therapy Type 77

  7.3 Promising Drugs in Clinical Development 78

  7.3.1 Dupilumab (SAR231893/ REGN668) 81

  7.3.2 AN2728 95

  7.3.3 Other Drugs in Development 107

  8 Market Outlook 109

  8.1 Japan 109

  8.1.1 Forecast 109

  8.1.2 Key Events 112

  8.1.3 Drivers and Barriers 112

  9 Appendix 115

  9.1 Bibliography 115

  9.2 Abbreviations 128

  9.3 Methodology 130

  9.4 Forecasting Methodology 130

  9.4.1 Diagnosed Atopic Dermatitis Patients 130

  9.4.2 Percent Drug-treated Patients 131

  9.4.3 Drugs Included in Each Therapeutic Class 131

  9.4.4 Launch and Patent Expiry Dates 131

  9.4.5 General Pricing Assumptions 132

  9.4.6 Individual Drug Assumptions 133

  9.4.7 Generic Erosion 135

  9.4.8 Pricing of Pipeline Agents 135

  9.5 Physicians and Specialists Included in this Study 136

  9.6 Primary Research - Prescriber Survey 138

  9.7 About the Authors 139

  9.7.1 Author 139

  9.7.2 Reviewer 139

  9.7.3 Epidemiologist 140

  9.7.4 Global Director of Therapy Analysis and Epidemiology 140

  9.7.5 Global Head of Healthcare 141

  9.8 About GlobalData 142

  9.9 Disclaimer 142

List Of Tables
in Atopic Dermatitis - Japan Drug Forecast and Market Analysis to 2024

1.1 List of Tables

Table 1: Symptoms of Atopic Dermatitis 16

Table 2: Treatment Guidelines for Atopic Dermatitis 21

Table 3: Most Prescribed Drugs for Atopic Dermatitis by Severity in the Global Markets, 2014 23

Table 4: Country Profile - Japan 26

Table 5: Leading Treatments for Atopic Dermatitis, 2014 29

Table 6: Product Profile - Protopic 31

Table 7: 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 32

Table 8: Protopic SWOT Analysis, 2015 35

Table 9: Global Sales Forecasts ($m) for Protopic, 2014-2024 37

Table 10: Product Profile - Elidel 38

Table 11: Combined Clinical Efficacy Results of Elidel versus Vehicle Cream at Week 6 from Two Phase III Studies 39

Table 12: Elidel SWOT Analysis, 2015 41

Table 13: Global Sales Forecasts ($m) for Elidel, 2014-2024 42

Table 14: Product Profile - Cyclosporine 44

Table 15: Cyclosporine SWOT Analysis, 2015 46

Table 16: Global Sales Forecasts ($m) for Cyclosporine, 2014-2024 47

Table 17: Summary of Other Therapeutic Classes for Atopic Dermatitis, 2015 48

Table 18: Product Profile - Xolair 50

Table 19: Xolair SWOT Analysis, 2015 52

Table 20: Global Sales Forecasts ($m) Xolair, 2014-2024 53

Table 21: Product Profile - Actimmune 55

Table 22: Actimmune SWOT Analysis, 2015 57

Table 23: Global Sales Forecasts ($m) Actimmune, 2014-2024 58

Table 24: Overall Unmet Needs in Atopic Dermatitis - Current Level of Attainment 60

Table 25: Clinical Unmet Needs in Atopic Dermatitis - Gap Analysis, 2015 63

Table 26: Late-Stage Atopic Dermatitis Pipeline, 2015 80

Table 27: Product Profile - Dupilumab 83

Table 28: Ongoing Clinical Trials of Dupilumab in Atopic Dermatitis Patients, as of December 2014 87

Table 29: Dupilumab SWOT Analysis, 2015 93

Table 30: Global Sales Forecasts ($m) for Dupilumab, 2014-2024 94

Table 31: Product Profile - AN2728 97

Table 32: Efficacy Results for AN2728 in Mild to Moderate Adolescent Atopic Dermatitis Patients (Day 29) 98

Table 33: AN2728 SWOT Analysis, 2015 104

Table 34: Global Sales Forecasts ($m) for AN2728, 2014-2024 106

Table 35: Drugs in Early-stage Clinical Development for Atopic Dermatitis, 2015 107

Table 36: Sales Forecasts ($m) for Atopic Dermatitis in Japan, 2012-2022 110

Table 37: Key Event Impacting Sales for Atopic Dermatitis in Japan, 2014-2024 112

Table 38: Atopic Dermatitis Market in Japan - Drivers and Barriers, 2014-2024 112

Table 39: Key Launch Dates 131

Table 40: Key Patent Expiries 131

Table 41: Physicians Surveyed, By Country 138

List Of Figures, Charts and Diagrams
in Atopic Dermatitis - Japan Drug Forecast and Market Analysis to 2024

1.2 List of Figures

Figure 1: Immunologic Pathway Involved in Healthy, Acute Atopic Dermatitis, and Chronic Atopic Dermatitis Skin 13

Figure 2: Flow Chart of the Diagnosis and Management of Atopic Dermatitis 20

Figure 3: Atopic Dermatitis Therapeutics - Clinical Trials by Therapy Type and Development Stage, October 2015 78

Figure 4: Atopic Dermatitis - Phase III Pipeline, December 2014 79

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Atopic Dermatitis, 2014-2024 80

Figure 6: Sales for Atopic Dermatitis in Japan by Drug Class, 2014-2024 111

Additional Details

Publisher

Global Data

Publisher Information

Reference

27213 | GDHC302CFR

Number of Pages

143

Report Format

PDF

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