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PharmaPoint: Atopic Dermatitis - Global 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.

Exciting times lay ahead for the atopic dermatitis marketplace, as the above events are due to occur against the backdrop of increasing research into the multiple etiologies that give rise to the disease. With existing unmet need for a better treatment armamentarium for severe, recalcitrant patients and an estimated drug-treated population that hovers around the 110 million mark over the next decade, atopic dermatitis represents an attractive dermatology sector for drug developers, and this should fuel commercial interest into this marketplace.

Highlights

Key Questions Answered

- How will the atopic dermatitis market (sales and patient numbers) evolve over the 10-year forecast period from 2014 to 2024?
- Which brands and specific drug classes did physicians select for their atopic dermatitis patients in 2014 and how do they foresee their prescribing behavior evolving over the next five years?
- How will the launch of late-stage pipeline therapies such as dupilumab and AN2728 shape the future treatment landscape?
- What are the remaining unmet needs and opportunities for drug developers within the atopic dermatitis market?

Key Benefits

- The main drivers of growth in the atopic dermatitis over the 2014-2024 forecast period include the launch of the first biologic; Sanofi/Regeneron’s dupilumab, and continued uptake of calcineurin inhibitors of systemic therapies.
- Owing to high genericization, no distinct trends in corporate strategy exist within the atopic dermatitis market. However, over the coming decade, the introduction of biologics, in particular interleukin (IL) inhibitors, will emerge as a key future strategy for this marketplace.
- High unmet need exists for a better treatment armamentarium for severe, recalcitrant patients. This patient segment remains underserved as physicians have few to no pharmacological options following treatment failure with or intolerability to cyclosporine, and as a result physicians often resort to prescribing off-label therapies.
- Although dupilumab is forecast to gain a foothold in the severe population by late-forecast, it will not completely eradicate the high unmet need within the refractory group in the severe patient segment. There will still be a gap for other novel systemics, as dermatologists stress a desire for more than one treatment option to be added to their armamentarium.

Scope

- Overview of atopic dermatitis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Annualized atopic dermatitis therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 to 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the atopic dermatitis therapeutics markets.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-to-late stage pipeline drugs.
- Analysis of the current and future market competition in the global atopic dermatitis therapeutics markets. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global atopic dermatitis therapeutics markets.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global atopic dermatitis therapeutics markets in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global atopic dermatitis therapeutics markets from 2014-2024.
- Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

PharmaPoint: Atopic Dermatitis - Global Drug Forecast and Market Analysis to 2024
1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 14
1.2 List of Figures 18
2 Introduction 19
2.1 Catalyst 19
2.2 Related Reports 19
2.3 Upcoming Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 22
3.2 Symptoms 26
4 Epidemiology 28
4.1 Disease Background 28
4.2 Risk Factors and Comorbidities 28
4.3 Global Trends 29
4.3.1 US 30
4.3.2 France 30
4.3.3 Germany 31
4.3.4 Italy 31
4.3.5 Spain 31
4.3.6 UK 32
4.3.7 Japan 32
4.3.8 China 32
4.3.9 India 33
4.4 Forecast Methodology 33
4.4.1 Sources Used 36
4.4.2 Sources Not Used 41
4.4.3 Forecast Assumptions and Methods 41
4.5 Epidemiological Forecast for Atopic Dermatitis (2014-2024) 42
4.5.1 One-Year Total Prevalent Cases of Atopic Dermatitis 42
4.5.2 Age-Specific One-Year Total Prevalent Cases of Atopic Dermatitis 44
4.5.3 Sex-Specific One-Year Total Prevalent Cases of Atopic Dermatitis 45
4.5.4 Age-Standardized One-Year Total Prevalence of Atopic Dermatitis 47
4.5.5 One-Year Total Prevalent Cases of Atopic Dermatitis by Severity 48
4.6 Discussion 50
4.6.1 Epidemiological Forecast Insight 50
4.6.2 Limitations of the Analysis 50
4.6.3 Strengths of the Analysis 51
5 Disease Management 52
5.1 Diagnosis and Treatment Overview 52
5.1.1 Diagnosis 52
5.1.2 Treatment Guidelines 54
5.1.3 Leading Prescribed Drugs for the Treatment of RA 56
5.1.4 Clinical Practice 58
5.2 US 59
5.3 5EU 64
5.4 Japan 71
6 Competitive Assessment 74
6.1 Overview 74
6.2 Strategic Competitor Assessment 75
6.3 Product Profiles - Major Brands 76
6.3.1 Protopic (tacrolimus) 76
6.3.2 Elidel 84
6.3.3 Cyclosporine (numerous generic names) 89
6.3.4 Other Therapeutic Drug Classes Used in Atopic Dermatitis 94
6.4 Product Profiles - Off-Label Therapies 96
6.4.1 Xolair (omalizumab) 96
6.4.2 Actimmune (interferon gamma-1b) 101
7 Opportunity and Unmet Need 106
7.1 Overview 106
7.1.1 A Systemic Drug for Severe Recalcitrant Patients 107
7.1.2 Tests that Stratify Patients and Allow for a Tailored Treatment Approach 110
7.1.3 A Drug that Effectively Controls Patients' Pruritus 114
7.1.4 Further Research into the Pathophysiology of Atopic Dermatitis 116
7.1.5 A Drug that Induces Disease Remission 119
7.1.6 Improved Quality of Life for Both Patients and their Carers 120
8 Pipeline Assessment 123
8.1 Overview 123
8.2 Clinical Trial Mapping 124
8.2.1 Clinical Trials by Therapy Type 124
8.3 Promising Drugs in Clinical Development 125
8.3.1 Dupilumab (SAR231893/ REGN668) 128
8.3.2 AN2728 142
8.3.3 Other Drugs in Development 154
9 Current and Future Players 156
9.1 Overview 156
9.2 Trends in Corporate Strategy 158
9.3 Company Profiles 159
9.3.1 Astellas 159
9.3.2 Meda 162
9.3.3 Sanofi/Regeneron/Boehringer Ingelheim 164
9.3.4 Anacor 166
10 Market Outlook 169
10.1 Global Markets 169
10.1.1 Forecast 169
10.1.2 Global Drivers and Barriers 173
10.2 US 178
10.2.1 Forecast 178
10.2.2 Key Events 182
10.2.3 Drivers and Barriers 182
10.3 5EU 184
10.3.1 Forecast 184
10.3.2 Key Events 189
10.3.3 Drivers and Barriers 189
10.4 Japan 194
10.4.1 Forecast 194
10.4.2 Key Events 197
10.4.3 Drivers and Barriers 197
11 Appendix 200
11.1 Bibliography 200
11.2 Abbreviations 213
11.3 Methodology 215
11.4 Forecasting Methodology 215
11.4.1 Diagnosed Atopic Dermatitis Patients 215
11.4.2 Percent Drug-treated Patients 216
11.4.3 Drugs Included in Each Therapeutic Class 216
11.4.4 Launch and Patent Expiry Dates 216
11.4.5 General Pricing Assumptions 217
11.4.6 Individual Drug Assumptions 218
11.4.7 Generic Erosion 220
11.4.8 Pricing of Pipeline Agents 220
11.5 Physicians and Specialists Included in this Study 221
11.6 Primary Research - Prescriber Survey 223
11.7 About the Authors 224
11.7.1 Author 224
11.7.2 Reviewer 224
11.7.3 Epidemiologist 225
11.7.4 Global Director of Therapy Analysis and Epidemiology 225
11.7.5 Global Head of Healthcare 226
11.8 About GlobalData 227
11.9 Disclaimer 227

1.1 List of Tables
Table 1: Symptoms of Atopic Dermatitis 27
Table 2: Risk Factors and Comorbidities of Atopic Dermatitis 29
Table 3: Diagnostic Criteria for Atopic Dermatitis 34
Table 4: The Hanifin and Rajka Diagnostic Criteria for Atopic Dermatitis 34
Table 5: 9MM, Sources of Epidemiological Data used for the Forecast for the One-Year Total Prevalent Cases of Atopic Dermatitis 35
Table 6: 9MM, Sources of Epidemiological Data Used for the Segmentation of One-Year Total Prevalent Cases of Atopic Dermatitis by Severity 36
Table 7: 9MM, One-Year Total Prevalent Cases of Atopic Dermatitis, All Ages, Both Sexes, N, 2014-2024 43
Table 8: 9MM, One-Year Total Prevalent Cases of Atopic Dermatitis, by Age Group, Both Sexes, N, (Row %), 2014 44
Table 9: 9MM, One-Year Total Prevalent Cases of Atopic Dermatitis, by Sex, All Ages, N (Row %), 2014 46
Table 10: 9MM, One-Year Total Prevalent Cases of Atopic Dermatitis by Severity, All Ages, Both Sexes, N (Row %), 2014 49
Table 11: Treatment Guidelines for Atopic Dermatitis 56
Table 12: Most Prescribed Drugs for Atopic Dermatitis by Severity in the Global Markets, 2014 58
Table 13: Country Profile - US 63
Table 14: Country Profile - 5EU 70
Table 15: Country Profile - Japan 73
Table 16: Leading Treatments for Atopic Dermatitis, 2014 76
Table 17: Product Profile - Protopic 78
Table 18: 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 79
Table 19: Protopic SWOT Analysis, 2015 82
Table 20: Global Sales Forecasts ($m) for Protopic, 2014-2024 84
Table 21: Product Profile - Elidel 85
Table 22: Combined Clinical Efficacy Results of Elidel versus Vehicle Cream at Week 6 from Two Phase III Studies 86
Table 23: Elidel SWOT Analysis, 2015 88
Table 24: Global Sales Forecasts ($m) for Elidel, 2014-2024 89
Table 25: Product Profile - Cyclosporine 91
Table 26: Cyclosporine SWOT Analysis, 2015 93
Table 27: Global Sales Forecasts ($m) for Cyclosporine, 2014-2024 94
Table 28: Summary of Other Therapeutic Classes for Atopic Dermatitis, 2015 95
Table 29: Product Profile - Xolair 97
Table 30: Xolair SWOT Analysis, 2015 99
Table 31: Global Sales Forecasts ($m) Xolair, 2014-2024 100
Table 32: Product Profile - Actimmune 102
Table 33: Actimmune SWOT Analysis, 2015 104
Table 34: Global Sales Forecasts ($m) Actimmune, 2014-2024 105
Table 35: Overall Unmet Needs in Atopic Dermatitis - Current Level of Attainment 107
Table 36: Clinical Unmet Needs in Atopic Dermatitis - Gap Analysis, 2015 110
Table 37: Late-Stage Atopic Dermatitis Pipeline, 2015 127
Table 38: Product Profile - Dupilumab 131
Table 39: Ongoing Clinical Trials of Dupilumab in Atopic Dermatitis Patients, as of December 2014 134
Table 40: Dupilumab SWOT Analysis, 2015 140
Table 41: Global Sales Forecasts ($m) for Dupilumab, 2014-2024 141
Table 42: Product Profile - AN2728 144
Table 43: Efficacy Results for AN2728 in Mild to Moderate Adolescent Atopic Dermatitis Patients (Day 29) 145
Table 44: AN2728 SWOT Analysis, 2015 151
Table 45: Global Sales Forecasts ($m) for AN2728, 2014-2024 153
Table 46: Drugs in Early-stage Clinical Development for Atopic Dermatitis, 2015 154
Table 47: Key Companies in the Atopic Dermatitis Market, 2015 157
Table 48: Astellas Pharma's Atopic Dermatitis Portfolio Assessment, 2015 161
Table 49: Astellas Pharma SWOT Analysis, 2015 162
Table 50: Meda's Atopic Dermatitis Portfolio Assessment, 2015 163
Table 51: Meda SWOT Analysis, 2015 164
Table 52: Regeneron's Atopic Dermatitis Portfolio Assessment, 2015 166
Table 53: Regeneron SWOT Analysis, 2015 166
Table 54: Anacor's Atopic Dermatitis Portfolio Assessment, 2015 168
Table 55: Anacor's SWOT Analysis, 2015 168
Table 56: Global Sales Forecasts ($m) for Atopic Dermatitis, 2014-2024 171
Table 57: Global Atopic Dermatitis Market - Drivers and Barriers, 2014-2024 173
Table 58: Sales Forecasts ($m) for Atopic Dermatitis in the US, 2014-2024 180
Table 59: Key Events Impacting Sales for Atopic Dermatitis in the US, 2014-2024 182
Table 60: Drivers and barriers of the atopic dermatitis market in the US during the forecast period. 182
Table 61: Sales Forecasts ($m) for Atopic Dermatitis in the 5EU, 2014-2024 187
Table 62: Key Event Impacting Sales for Atopic Dermatitis in 5EU, 2014-2024 189
Table 63: Atopic Dermatitis Market in 5EU - Drivers and Barriers, 2014-2024 189
Table 64: Sales Forecasts ($m) for Atopic Dermatitis in Japan, 2012-2022 195
Table 65: Key Event Impacting Sales for Atopic Dermatitis in Japan, 2014-2024 197
Table 66: Atopic Dermatitis Market in Japan - Drivers and Barriers, 2014-2024 197
Table 67: Key Launch Dates 216
Table 68: Key Patent Expiries 216
Table 69: Physicians Surveyed, By Country 223

1.2 List of Figures
Figure 1: Immunologic Pathway Involved in Healthy, Acute Atopic Dermatitis, and Chronic Atopic Dermatitis Skin 24
Figure 2: 9MM, One-Year Total Prevalent Cases of Atopic Dermatitis, All Ages, Both Sexes, N, 2014-2024 43
Figure 3: 9MM, One-Year Total Prevalent Cases of Atopic Dermatitis, by Age Group, Both Sexes, N, 2014 45
Figure 4: 9MM, One-Year Total Prevalent Cases of Atopic Dermatitis, by Sex, All Ages, N, 2014 47
Figure 5: 9MM, Age-Standardized One-Year Total Prevalence (%) of Atopic Dermatitis, All Ages, Both Sexes, 2014 48
Figure 6: 9MM, One-Year Total Prevalent Cases of Atopic Dermatitis by Severity, All Ages, Both Sexes, N, 2014 49
Figure 7: Flow Chart of the Diagnosis and Management of Atopic Dermatitis 55
Figure 8: Atopic Dermatitis Therapeutics - Clinical Trials by Therapy Type and Development Stage, October 2015 125
Figure 9: Atopic Dermatitis - Phase III Pipeline, December 2014 126
Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in Atopic Dermatitis, 2014-2024 127
Figure 11: Company Portfolio Gap Analysis in Atopic Dermatitis, 2014-2024 158
Figure 12: Global Sales for Atopic Dermatitis by Region, 2012-2022 172
Figure 13: Sales for Atopic Dermatitis in the US by Drug Class, 2014-2024 181
Figure 14: Sales for Atopic Dermatitis in 5EU by Drug Class, 2014-2024 188
Figure 15: Sales for Atopic Dermatitis in Japan by Drug Class, 2014-2024 196

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