PharmaPoint: Atopic Dermatitis - Global Drug Forecast and Market Analysis to 2022

PharmaPoint: Atopic Dermatitis - Global Drug Forecast and Market Analysis to 2022

PharmaPoint: Atopic Dermatitis - Global Drug Forecast and Market Analysis to 2022

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 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.

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 54 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 2012 to 2022?
- Which brands and specific drug classes did physicians select for their atopic dermatitis patients in 2012 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 Findings

- The main drivers of growth in the atopic dermatitis over the 2012–2022 forecast period include the launch of the first biologic; Sanofi/Regeneron’s dupilumab, strong uptake of topical calcineurin inhibitors, particularly within India and China, and continued uptake 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 2012 to 2022.
- 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

- 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 2012-2022.
- Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 10


2 Introduction 23
2.1 Catalyst 23
2.2 Related Reports 23
2.3 Upcoming Related Reports 23
3 Disease Overview 24
3.1 Etiology and Pathophysiology 24
3.1.1 Etiology 24
3.1.2 Pathophysiology 25
3.2 Symptoms 29
4 Epidemiology 31
4.1 Disease Background 31
4.2 Risk Factors and Comorbidities 31
4.2.1 Children ages ?10 years are three times more likely to develop atopic dermatitis 32
4.2.2 Family history of atopic disease increases the risk of atopic dermatitis six-fold 33
4.2.3 Allergens are associated with a six-fold risk of atopic dermatitis 34
4.2.4 Breastfeeding for more than four months protects children from atopic dermatitis 35
4.2.5 Asthma, allergic rhinitis and allergic conjunctivitis commonly occur with atopic dermatitis 36
4.2.6 Atopic dermatitis patients are up to three times more likely to have psychiatric disorders 37
4.3 Global Trends 38
4.3.1 US 39
4.3.2 5EU 39
4.3.3 Japan 43
4.3.4 China 43
4.3.5 India 44
4.4 Forecast Methodology 45
4.4.1 Sources Used 48
4.4.2 Sources Not Used 55
4.5 Forecast Assumptions and Methods 56
4.5.1 US 56
4.5.2 France 57
4.5.3 Germany 57
4.5.4 Italy 58
4.5.5 Spain 59
4.5.6 UK 59
4.5.7 Japan 60
4.5.8 China 61
4.5.9 India 61
4.6 Epidemiology Forecast of Atopic Dermatitis (2012-2022) 62
4.6.1 Lifetime Prevalent Cases of Atopic Dermatitis 62
4.6.2 Age-Specific Prevalent Cases of Lifetime Atopic Dermatitis 64
4.6.3 Sex-Specific Prevalent Cases of Lifetime Atopic Dermatitis 67
4.6.4 Age-Standardized Lifetime Prevalence of Atopic Dermatitis 68
4.6.5 Prevalent Cases of Atopic Dermatitis by Severity 69
4.7 Discussion 71
4.7.1 Conclusions on Epidemiological Trends 71
4.7.2 Limitations of the Analysis 73
4.7.3 Strengths of the Analysis 74
5 Disease Management 75
5.1 Diagnosis 75
5.2 Treatment Overview 77
5.3 US 82
5.3.1 Diagnosis 82
5.3.2 Clinical Practice 85
5.4 France 87
5.4.1 Diagnosis 87
5.4.2 Clinical Practice 89
5.5 Germany 91
5.5.1 Diagnosis 91
5.5.2 Clinical Practice 93
5.6 Italy 95
5.6.1 Diagnosis 95
5.6.2 Clinical Practice 96
5.7 Spain 97
5.7.1 Diagnosis 97
5.7.2 Clinical Practice 99
5.8 UK 100
5.8.1 Diagnosis 100
5.8.2 Clinical Practice 102
5.9 Japan 104
5.9.1 Diagnosis 104
5.9.2 Clinical Practice 106
5.10 China 107
5.10.1 Diagnosis 107
5.10.2 Clinical Practice 108
5.11 India 109
5.11.1 Diagnosis 109
5.11.2 Clinical Practice 110
6 Competitive Assessment 112
6.1 Overview 112
6.2 Strategic Competitor Assessment 113
6.3 Product Profiles - Major Brands 114
6.3.1 Protopic (tacrolimus) 114
6.3.2 Elidel 122
6.3.3 Cyclosporine (numerous generic names) 129
6.3.4 Other Therapeutic Drug Classes Used in Atopic Dermatitis 133
6.4 Product Profiles - Off-Label Therapies 135
6.4.1 Xolair (omalizumab) 135
6.4.2 Actimmune (interferon gamma-1b) 140
7 Opportunity and Unmet Need 146
7.1 Overview 146
7.2 Unmet Needs 147
7.2.1 A Systemic Drug for Severe Recalcitrant Patients 147
7.2.2 Tests that Stratify Patients and Allow for a Tailored Treatment Approach 148
7.2.3 A Drug that Effectively Controls Patients' Pruritus 149
7.2.4 Further Research into the Pathophysiology of Atopic Dermatitis 151
7.2.5 A Drug that Induces Disease Remission 152
7.2.6 Improved Quality of Life for Both Patients and their Carers 152
7.3 Unmet Needs Gap Analysis 153
7.4 Opportunities 154
7.4.1 Increase Treatment Armamentarium for Severe Recalcitrant Patients 154
7.4.2 Predictive Tests for Patient Stratification 154
7.4.3 More Therapeutic Options that Address Patients' Pruritus 155
8 Pipeline Assessment 156
8.1 Overview 156
8.2 Clinical Trial Mapping 157
8.2.1 Clinical Trials by Country 157
8.3 Clinical Trials by Phase and Trial Status 158
8.4 Promising Drugs in Clinical Development 159
8.4.1 Dupilumab (SAR231893/ REGN668) 161
8.4.2 AN2728 172
8.4.3 Phase II Pipeline Products 182
9 Current and Future Players 184
9.1 Overview 184
9.2 Trends in Corporate Strategy 186
9.3 Company Profiles 188
9.3.1 Astellas 188
9.3.2 Meda 191
9.3.3 Regeneron 193
9.3.4 Anacor 195
10 Market Outlook 198
10.1 Global Markets 198
10.1.1 Forecast 198
10.1.2 Global Drivers and Barriers 202
10.2 US 207
10.2.1 Forecast 207
10.2.2 Key Events 210
10.2.3 Drivers and Barriers 211
10.3 France 213
10.3.1 Forecast 213
10.3.2 Key Events 216
10.3.3 Drivers and Barriers 217
10.4 Germany 219
10.4.1 Forecast 219
10.4.2 Key Events 222
10.4.3 Drivers and Barriers 223
10.5 Italy 225
10.5.1 Forecast 225
10.5.2 Key Events 228
10.5.3 Drivers and Barriers 229
10.6 Spain 231
10.6.1 Forecast 231
10.6.2 Key Events 233
10.6.3 Drivers and Barriers 234
10.7 UK 235
10.7.1 Forecast 235
10.7.2 Key Events 238
10.7.3 Drivers and Barriers 239
10.8 Japan 242
10.8.1 Forecast 242
10.8.2 Key Events 244
10.8.3 Drivers and Barriers 245
10.9 China 248
10.9.1 Forecast 248
10.9.2 Key Events 250
10.9.3 Drivers and Barriers 251
10.10 India 252
10.10.1 Forecast 252
10.10.2 Key Events 254
10.10.3 Drivers and Barriers 255
11 Appendix 257
11.1 Bibliography 257
11.2 Abbreviations 273
11.3 Methodology 275
11.4 Forecasting Methodology 275
11.4.1 Diagnosed Atopic Dermatitis Patients 275
11.4.2 Percent Drug-treated Patients 276
11.4.3 Drugs Included in Each Therapeutic Class 276
11.4.4 Launch and Patent Expiry Dates 276
11.4.5 General Pricing Assumptions 277
11.4.6 Individual Drug Assumptions 278
11.4.7 Generic Erosion 280
11.4.8 Pricing of Pipeline Agents 281
11.5 Physicians and Specialists Included in this Study 282
11.6 Primary Research - Prescriber Survey 283
11.7 About the Authors 284
11.7.1 Author 284
11.7.2 Epidemiologist 285
11.7.3 Global Head of Healthcare 285
11.8 About GlobalData 286
11.9 Disclaimer 286

1.1 List of Tables
Table 1: Symptoms of Atopic Dermatitis 30
Table 2: Atopic Dermatitis, Risk Factors and Comorbidities 32
Table 3: Diagnostic Criteria for Atopic Dermatitis 45
Table 4: The Hanifin and Rajka Diagnostic Criteria for Atopic Dermatitis 46
Table 5: All Markets, Epidemiological Sources for Lifetime Atopic Dermatitis Prevalence 47
Table 6: All Markets, Epidemiological Sources of Atopic Dermatitis Severity Data 48
Table 7: All Markets, Prevalent Cases of Lifetime Atopic Dermatitis, All Ages, Both Sexes, N (Millions), 2012-2022 63
Table 8: All Markets, Prevalent Cases of Lifetime Atopic Dermatitis, by Age, N (Millions), (Row %), 2012 65
Table 9: All Markets, Prevalent Cases of Lifetime Atopic Dermatitis, by Sex, All Ages, N (Row %), 2012 67
Table 10: All Markets, Prevalent Cases of Lifetime Atopic Dermatitis by Severity, All Ages, Both Sexes, N (Millions) (Row %), 2012 70
Table 11: Treatment Guidelines for Atopic Dermatitis 80
Table 12: Most Prescribed Drugs for Atopic Dermatitis by Severity in the Global Markets, 2013 82
Table 13: Referral Rates to a US Dermatologist, Split by Severity and Specialist Type, 2013 84
Table 14: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in the US, 2013 85
Table 15: Referral Rates to a French Dermatologist, Split by Severity and Specialist Type, 2013 88
Table 16: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in France in 2012 88
Table 17: Referral Rates to a German Dermatologist, Split by Severity and Specialist Type, 2013 92
Table 18: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in Germany in 2012 92
Table 19: Referral Rates to an Italian Dermatologist, Split by Severity and Specialist Type, 2013 95
Table 20: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in Italy in 2012 96
Table 21: Referral Rates to a Spanish Dermatologist, Split by Severity and Specialist Type, 2013 98
Table 22: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in Spain in 2012 98
Table 23: Referral Rates to a UK Dermatologist, Split by Severity and Specialist Type, 2013 101
Table 24: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in the UK in 2012 102
Table 25: Stepped Treatment Approach Used by UK Dermatologists in the Management of Atopic Dermatitis 103
Table 26: Referral Rates to a Japanese Dermatologist, Split by Severity and Specialist Type, 2013 105
Table 27: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in Japan in 2012 106
Table 28: Referral Rates to a Chinese Dermatologist, Split by Severity and Specialist Type, 2013 107
Table 29: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in China in 2012 108
Table 30: Referral Rates to an Indian Dermatologist, Split by Severity and Specialist Type, 2013 109
Table 31: Key Metrics Relating to the Diagnosis, Relapse and Remission Rates of Atopic Dermatitis in India in 2012 110
Table 32: Leading Treatments for Atopic Dermatitis, 2013 114
Table 33: Product Profile - Protopic 116
Table 34: 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 117
Table 35: Protopic SWOT Analysis, 2013 120
Table 36: Global Sales Forecasts ($m) for Protopic, 2012-2022 122
Table 37: Product Profile - Elidel 124
Table 38: Combined Clinical Efficacy Results of Elidel versus Vehicle Cream at Week 6 from Two Phase III Studies 125
Table 39: Elidel SWOT Analysis, 2013 127
Table 40: Global Sales Forecasts ($m) for Elidel, 2012-2022 128
Table 41: Product Profile - Cyclosporine 130
Table 42: Cyclosporine SWOT Analysis, 2013 132
Table 43: Global Sales Forecasts ($m) for Cyclosporine, 2012-2022 133
Table 44: Summary of Other Therapeutic Classes for Atopic Dermatitis, 2013 134
Table 45: Product Profile - Xolair 136
Table 46: Xolair SWOT Analysis, 2013 138
Table 47: Global Sales Forecasts ($m) Xolair, 2012-2022 140
Table 48: Product Profile - Actimmune 142
Table 49: Actimmune SWOT Analysis, 2013 144
Table 50: Global Sales Forecasts ($m) Actimmune, 2012-2022 145
Table 51: Overall Unmet Needs in Atopic Dermatitis - Current Level of Attainment 147
Table 52: Clinical Unmet Needs in Atopic Dermatitis - Gap Analysis, 2013 154
Table 53: Atopic Dermatitis - Clinical Trials by Phase and Status, 2013 159
Table 54: Late-Stage Atopic Dermatitis Pipeline, 2013 159
Table 55: Comparison of Therapeutic Classes in Development for Atopic Dermatitis, 2013 161
Table 56: Product Profile - Dupilumab 163
Table 57: Ongoing Clinical Trials of Dupilumab in Atopic Dermatitis Patients, as of September 2013 165
Table 58: Dupilumab SWOT Analysis, 2013 170
Table 59: Global Sales Forecasts ($m) for Dupilumab, 2012-2022 171
Table 60: Product Profile - AN2728 173
Table 61: Efficacy Results for AN2728 in Mild to Moderate Adolescent Atopic Dermatitis Patients (Day 29) 174
Table 62: AN2728 SWOT Analysis, 2013 179
Table 63: Global Sales Forecasts ($m) for AN2728, 2012-2022 182
Table 64: Phase II and Phase I Atopic Dermatitis Pipeline, 2013 182
Table 65: Key Companies in the Atopic Dermatitis Market, 2013 185
Table 66: Astellas Pharma's Atopic Dermatitis Portfolio Assessment, 2013 190
Table 67: Astellas Pharma SWOT Analysis, 2013 190
Table 68: Meda's Atopic Dermatitis Portfolio Assessment, 2013 192
Table 69: Meda SWOT Analysis, 2013 192
Table 70: Regeneron's Atopic Dermatitis Portfolio Assessment, 2013 194
Table 71: Regeneron SWOT Analysis, 2013 194
Table 72: Anacor's Atopic Dermatitis Portfolio Assessment, 2013 196
Table 73: Anacor's SWOT Analysis, 2013 197
Table 74: Global Sales Forecasts ($m) for Atopic Dermatitis, 2012-2022 200
Table 75: Global Atopic Dermatitis Market - Drivers and Barriers, 2012-2022 202
Table 76: Sales Forecasts ($m) for Atopic Dermatitis in the US, 2012-2022 209
Table 77: Key Events Impacting Sales for Atopic Dermatitis in the US, 2012-2022 210
Table 78: Atopic Dermatitis Market in the US - Drivers and Barriers, 2012-2022 211
Table 79: Sales Forecasts ($m) for Atopic Dermatitis in France, 2012-2022 215
Table 80: Key Event Impacting Sales for Atopic Dermatitis in France, 2012-2022 216
Table 81: Atopic Dermatitis Market in France - Drivers and Barriers, 2012-2022 217
Table 82: Sales Forecasts ($m) for Atopic Dermatitis in Germany, 2012-2022 221
Table 83: Key Event Impacting Sales for Atopic Dermatitis in Germany, 2012-2022 222
Table 84: Atopic Dermatitis Market in Germany - Drivers and Barriers, 2012-2022 223
Table 85: Sales Forecasts ($m) for Atopic Dermatitis in Italy, 2012-2022 227
Table 86: Key Event Impacting Sales for Atopic Dermatitis in Italy, 2012-2022 228
Table 87: Atopic Dermatitis Market in Italy - Drivers and Barriers, 2012-2022 229
Table 88: Sales Forecasts ($m) for Atopic Dermatitis in Spain, 2012-2022 232
Table 89: Key Event Impacting Sales for Atopic Dermatitis in Spain, 2012-2022 233
Table 90: Atopic Dermatitis Market in Spain - Drivers and Barriers, 2012-2022 234
Table 91: Sales Forecasts ($m) for Atopic Dermatitis in the UK, 2012-2022 237
Table 92: Key Event Impacting Sales for Atopic Dermatitis in the UK, 2012-2022 238
Table 93: Atopic Dermatitis Market in the UK - Drivers and Barriers, 2012-2022 239
Table 94: Sales Forecasts ($m) for Atopic Dermatitis in Japan, 2012-2022 243
Table 95: Key Event Impacting Sales for Atopic Dermatitis in Japan, 2012-2022 244
Table 96: Atopic Dermatitis Market in Japan - Drivers and Barriers, 2012-2022 245
Table 97: Sales Forecasts ($m) for Atopic Dermatitis in China, 2012-2022 249
Table 98: Key Event Impacting Sales for Atopic Dermatitis in China, 2012-2022 250
Table 99: Atopic Dermatitis Market in China - Drivers and Barriers, 2012-2022 251
Table 100: Sales Forecasts ($m) for Atopic Dermatitis in India, 2012-2022 253
Table 101: Key Event Impacting Sales for Atopic Dermatitis in India, 2012-2022 254
Table 102: Atopic Dermatitis Market in India - Drivers and Barriers, 2012-2022 255
Table 103: Key Launch Dates 276
Table 104: Key Patent Expiries 277
Table 105: Physicians Surveyed, By Country 283

1.2 List of Figures
Figure 1: Immunologic Pathway Involved in Healthy, Acute Atopic Dermatitis, and Chronic Atopic Dermatitis Skin 27
Figure 2: All Markets, Prevalent Cases of Lifetime Atopic Dermatitis, All Ages, Both Sexes, N (Millions), 2012-2022 63
Figure 3: All Markets, Prevalent Cases of Lifetime Atopic Dermatitis, by Age, N (Millions), 2012 66
Figure 4: All Markets, Prevalent Cases of Lifetime Atopic Dermatitis, by Sex, N (Millions), 2012 68
Figure 5: All Markets, Age-Standardized Prevalence of Lifetime Atopic Dermatitis, All Ages, Both Sexes, %, 2012 69
Figure 6: All Markets, Prevalent Cases of Lifetime Atopic Dermatitis by Severity, All Ages, Both Sexes, N (Millions), 2012 71
Figure 7: Flow Chart of the Diagnosis and Management of Atopic Dermatitis 78
Figure 8: Atopic Dermatitis Therapeutics - Clinical Trials by Country, 2013 158
Figure 9: Competitive Assessment of Late-Stage Pipeline Agents in Atopic Dermatitis, 2012-2022 160
Figure 10: Company Portfolio Gap Analysis in Atopic Dermatitis, 2012-2022 185
Figure 11: Global Sales for Atopic Dermatitis by Region, 2012-2022 201
Figure 12: Sales for Atopic Dermatitis in the US by Drug Class, 2012-2022 210
Figure 13: Sales for Atopic Dermatitis in France by Drug Class, 2012-2022 216
Figure 14: Sales for Atopic Dermatitis in Germany by Drug Class, 2012-2022 222
Figure 15: Sales for Atopic Dermatitis in Italy by Drug Class, 2012-2022 228
Figure 16: Sales for Atopic Dermatitis in Spain by Drug Class, 2012-2022 233
Figure 17: Sales for Atopic Dermatitis in the UK by Drug Class, 2012-2022 238
Figure 18: Sales for Atopic Dermatitis in Japan by Drug Class, 2012-2022 244
Figure 19: Sales for Atopic Dermatitis in China by Drug Class, 2012-2022 250
Figure 20: Sales for Atopic Dermatitis in India by Drug Class, 2012-2022 254