Atopic Dermatitis - Unmet needs and market opportunities
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- About the Immune Disorders and Inflammation (IDI) pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the report - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the atopic dermatitis market - page 4
- CHAPTER 2 INTRODUCTION AND EPIDEMIOLOGY - page 12
- Classification of atopic dermatitis - page 12
- Atopic dermatitis is a chronic, relapsing skin disease and has many clinical features - page 12
- Atopic dermatitis occurs in three distinct clinical phases: infantile, childhood and adult - page 14
- Segmenting the AD population - page 15
- Assessing disease severity in AD can be problematic - page 15
- Patients are segmentated according to mild, moderate and severe atopic dermatitis - page 15
- There is no single way of assessing disease severity - page 16
- Will there ever be a single standardized index to assess disease severity? - page 17
- Atopic dermatitis significantly affects quality of life - page 18
- Assessing disease severity in AD can be problematic - page 15
- Pathophysiology of atopic dermatitis - page 19
- There is an acute and chronic phase involved in the pathogenesis of atopic dermatitis - page 19
- Atopic dermatitis is driven by T cells and specific cytokines - page 20
- Phosphodiesterase IV hyperactivity is thought to be a feature of atopic dermatitis - page 20
- Epidemiology of atopic dermatitis - page 21
- Atopic dermatitis has both genetic and environmental risk factors - page 21
- Family history remains the strongest predictor for the development of atopic dermatitis - page 21
- Environmental factors play a major role in atopic dermatitis - page 21
- Atopic dermatitis affects females slightly more than males - page 22
- The prevalence of atopic dermatitis has risen in the past three decades - page 22
- Comparing epidemiological studies is a challenge - page 22
- There are around 40 million patients with atopic dermatitis in the seven major markets - page 26
- US - page 27
- Japan - page 29
- Europe - page 30
- Atopic dermatitis has both genetic and environmental risk factors - page 21
- Classification of atopic dermatitis - page 12
- CHAPTER 3 UNMET NEEDS - page 34
- Introduction - page 34
- Unmet medical needs in atopic dermatitis - page 34
- Patient education is seen as critical by opinion leaders - page 34
- Standardized treatment regimens and patient education will help improve compliance - page 36
- How can pharmaceutical companies help with patient education? - page 37
- Tackling the itch: more drugs are needed to specifically target pruritus - page 40
- Lack of treatment options for severe atopic dermatitis - page 43
- Preventative strategies will become increasingly important - page 44
- There is another unmet need for less expensive therapies - page 46
- Providing therapies for the infant population - page 47
- Identifying the processes involved in lichenification - page 49
- Patient education is seen as critical by opinion leaders - page 34
- Summary of unmet needs - page 51
- CHAPTER 4 CURRENT TREATMENTS FOR ATOPIC DERMATITIS - page 52
- Treatment overview - page 52
- Datamonitor's definition of atopic dermatitis - page 54
- Size of the atopic dermatitis market - page 54
- Non-pharmacological therapy - page 56
- Combination of behavioral modification techniques with topical therapies reduces scratching associated with atopic dermatitis - page 56
- UV phototherapy can be an effective treatment option but is limited to adult sufferers or severe cases of atopic dermatitis - page 56
- Emollients reduce the symptoms of dry skin and can reduce the need for topical corticosteroid treatment - page 57
- Pharmacological therapy - page 57
- Topical corticosteroids remain the cornerstone of treatment for atopic dermatitis - page 57
- The arrival of topical calcineurin inhibitors represented a significant advance in the treatment options for atopic dermatitis - page 59
- Combination of topical therapies can accelerate remission of atopic dermatitis and helps to lessen the risk of side effects - page 61
- Antihistamines are used to treat pruritus but their efficacy remains questionable - page 62
- Tricyclic antidepressants, such as doxepin hydrochloride, can be prescribed to promote restful sleep and tackle pruritus - page 63
- Systemic and topical antibiotics are prescribed in order to counteract secondary bacterial infections associated with atopic dermatitis - page 64
- Systemic corticosteroids should be avoided unless they are required for acute flare-ups in severe atopic dermatitis - page 65
- A number of immunosuppresive drugs, including cyclosporin A and mycophenolate mofetil, are used off-label to treat atopic dermatitis - page 65
- Treatment overview - page 52
- CHAPTER 5 TREATMENT CONTROVERSIES - page 69
- Patient's phobia of corticostoids can lead to non-compliance and ultimately to treatment failure - page 69
- The long-term safety of topical calcineurin inhibitors has been questioned - page 70
- The FDA imposed a black box warning for Protopic and Elidel - page 70
- The black box warning was based on theoretical risk and not on clinical evidence - page 70
- The FDA's decision limits the availability of TCIs and pushes patients back on to topical corticosteroids or on to more harmful systemic drugs - page 72
- Safety concerns and black box warning have impacted on the sales of Elidel and Protopic in the US, 5EU and Japan - page 73
- In Europe, the EMEA reviewed the safety data of Protopic and Elidel and concluded the benefits outweigh the risks - page 76
- Most clinical trials to date suggest a favorable safety profile for topical calcineurin inhibitors - page 77
- An oral formulation of pimecrolimus has been discontinued by Novartis - page 80
- The FDA imposed a black box warning for Protopic and Elidel - page 70
- Cost of topical calcineurin inhibitors is high - page 81
- In general TCIs are 20 times more expensive than corticosteroids - page 81
- Topical calcineurin inhibitors cost nearly twice as much in the US than in the UK - page 82
- Cream versus ointment: what type of topical formulation is most appropriate for atopic dermatitis? - page 84
- In the US and 5EU, creams are the most popular formulation of topcial corticosteroid, however, ointments are more popular in Japan - page 84
- Ointments are more effective than creams, but creams are preferred for cosmetic reasons - page 86
- Pressure foam preparations are becoming more popular for dermatoses - page 87
- Novartis was looking to expand the Elidel product range with an ointment formulation - page 90
- Protopic cream is in late-stage clinical development - page 91
- Marketing strategies for topical calcineurin inhibitors - page 91
- Fujisawa and GSK joined forces to co-promote Protopic in the US in light of increased competition from Novartis' Elidel - page 91
- Protopic and the Eczema Beast - page 94
- Despite being the second topical calcineurin inhibitor to market, sales of Elidel were double those of Protopic within two years after launch - page 95
- Novartis signed co-marketing agreements with Esteve in Spain and 3M in Germany for pimecrolimus - page 98
- Protopic and Elidel are prescribed off-label in a number of dermatological diseases - page 98
- Around 40% of Elidel and Protopic sales are for off-label indications - page 98
- The psoriasis market is an attractive prospect but current safety fears may limit potential - page 100
- CHAPTER 6 PIPELINE DRUGS - page 102
- The atopic dermatitis pipeline lacks innovative drugs in Phase III - page 102
- There are only two drugs in Phase III development for atopic dermatitis - page 102
- The majority of drugs in development for atopic dermatitis are topically administered - page 108
- Biologics used in psoriasis are undergoing clinical trials for atopic dermatitis - page 109
- Raptiva (efalizumab) is being evaluated as an alternative to systemic immunosuppressive agents in severe atopic dermatitis - page 109
- The immunopharmacological effects of Rituxan/MabThera (rituximab) in atopic dermatitis are being investigated in a Phase I study - page 112
- Amevive (alefacept), the first biologic developed for psoriasis, is in Phase II for atopic dermatitis - page 113
- Is there potential for other psoriasis therapies to expand into the atopic dermatitis indication? - page 113
- High cost of biologicals may be an issue with in atopic dermatitis as it is in psoriasis - page 114
- Histamine may not be a justifiable target for pharmacological intervention - page 115
- Topical patch will be interesting for localized disease but not for widely affected areas - page 116
- Protease inhibitors will have a place in the treatment of atopic dermatitis but remain in Phase II development - page 116
- With a promising portfolio, which includes Sabarep for atopic dermatitis, York Pharma aims to be a force in the field of dermatology - page 117
- Arriva's and ProMetic's topical rAAT gel may require reformulation for atopic dermatitis - page 118
- Cytos Biotechnology are aiming to provide a more effective immunotherapy than those that are currently available - page 119
- Early-stage treatments for atopic dermatitis are directed against a variety of targets - page 120
- Cytokines and NF-KappaB modulators - page 121
- Topical PDE IV inhibitors - page 122
- The atopic dermatitis pipeline lacks innovative drugs in Phase III - page 102
- CHAPTER 7 APPENDIX - page 124
- Contributing experts - page 124
- Market Profile: Protopic (tacrolimus) and Elidel (pimecrolimus) - page 125
- Methodology - page 126
- Calculation of 2006 sales figures - page 126
- Datamonitor's definition of vitiligo, psoriasis, seborrheic dermatitis and contact dermatitis - page 126
- Bibliography - page 128
- Journal articles - page 128
- Websites - page 134
- Datamonitor reports - page 137
- About Datamonitor - page 138
- About Datamonitor Healthcare - page 138
- Datamonitor Healthcare's research and analysis methodologies - page 139
- Datamonitor Healthcare's therapy area capabilities - page 139
- Disclaimer - page 141
- List of Tables
- Table 1: Clinical features of atopic dermatitis - page 13
- Table 2: Criteria for the diagnosis of atopic dermatitis - page 14
- Table 3: Prevalence studies for atopic dermatitis in the seven major markets, 1994-2004 - page 24
- Table 4: Datamonitor's estimation of the atopic dermatitis population (000s) in the seven major markets, 2007 - page 26
- Table 5: Estimated AD population in the US, 2007 - page 29
- Table 6: Estimated AD population in Japan, 2007 - page 30
- Table 7: Estimated AD population in France, 2007 - page 31
- Table 8: Estimated AD population in Germany, 2007 - page 32
- Table 9: Estimated AD population in the UK, 2007 - page 32
- Table 10: Estimated AD population in Spain, 2007 - page 33
- Table 11: Estimated AD population in Italy, 2007 - page 33
- Table 12: Examples of available therapies for atopic dermatitis, 2007 - page 53
- Table 13: Datamonitor's definition of atopic dermatitis according to ICD10 code - page 54
- Table 14: Key facts: topical calcineurin inhibitors for atopic dermatitis, 2007 - page 60
- Table 15: Antihistamines used in the management of atopic dermatitis - page 63
- Table 16: Cost of Protopic (tacrolimus) and Elidel (pimecrolimus) in the UK, 2007 - page 81
- Table 17: Cost of Protopic (tacrolimus) and Elidel (pimecrolimus) in the US - page 82
- Table 18: Pipeline products in all stages of development for atopic dermatitis, 2007 - page 103
- Table 19: Market profile: Protopic (tacrolimus) and Elidel (pimecrolimus), 2007 - page 125
- Table 20: Datamonitor's definition of vitiligo, psoriasis, seborrheic dermatitis and contact dermatitis according to ICD10 codes - page 127
- List of Figures
- Figure 1: Pathogenesis of atopic dermatitis - page 19
- Figure 2: Datamonitor's estimation of the atopic dermatitis population (000s) in the seven major markets, 2007 - page 27
- Figure 3: Rationale behind the development of antipruritic drugs for AD - page 42
- Figure 4: Summary of unmet medical needs in the atopic dermatitis market, 2007 - page 51
- Figure 5: The atopic dermatitis market, 2005 - page 55
- Figure 6: Common topical corticosteroids used to treat atopic dermatitis grouped by strength - page 59
- Figure 7: The mechanism of action of topical calcineurin inhibitors - page 60
- Figure 8: Topical treatment paradigm for atopic dermatitis - page 61
- Figure 9: The FDA black box warning that appears as part of the label change for Protopic and Elidel, January 2006 - page 71
- Figure 10: AD-specific sales of Protopic (tacrolimus) in the US, 5EU and Japan ($m), 2005-06 - page 73
- Figure 11: AD-specific sales of Elidel (pimecrolimus) in the US and 4EU ($m), 2005-06 - page 75
- Figure 12: Year-on-year sales growth of Protopic and Elidel in the seven major markets (%), 2003-06 - page 76
- Figure 13: Sales of topical corticosteroids for all therapeutic indications categorized by formulation ($m), 2005 - page 85
- Figure 14: Sales of pressure foam corticosteroids in the US and 5EU by brand for all therapeutic indications ($m), 2005-06 - page 88
- Figure 15: Total promotional spend for Elidel and Protopic in the US only ($m), 2003 - page 93
- Figure 16: Astellas' DTC campaign for Protopic featured the Eczema Beast - page 94
- Figure 17: Example of DTC advertising for Novartis' Elidel - page 97
- Figure 18: Elidel and Protopic sales in the seven major markets for atopic dermatitis and off-label indications ($m), 2005 - page 99
- Figure 19: Pipeline drugs for atopic dermatitis categorized by phase of development, 2007 - page 102
- Figure 20: Pipeline drugs for atopic dermatitis categorized by method of administration, 2007 - page 109
- Figure 21: Molecular targets for therapies in Phase I and preclinical development for atopic dermatitis, 2007 - page 120
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