OpportunityAnalyzer: Acne Vulgaris – Opportunity Analysis and Forecasts to 2018

Published: June 2014
No. of Pages: 177
  

Despite its considerable patient population, the acne market has been overlooked and remained stagnant for the last decade. There has been a lack of research efforts due to the perception of a poor return on investment for topical treatments, the mainstay of acne therapy. There is an array of treatment options for acne, though with the exception of isotretinoin, most only provide symptomatic relief as opposed to a curative or disease-modifying solution. However, isotretinoin is unable to serve a significant proportion of the acne market owed to its teratogenic nature, making its prescription for women of child-bearing age problematic.

In the past decade, there has been a shift in the acne market, with greater appreciation of its patient pool and potential for a lucrative payoff. Furthermore, there has been greater stress put on the social and psychological implications of the disease, which impact patients' quality of life. As a result, R&D investments have been initiated by key pharmaceutical players.

Key strategies underway in the acne market include -

  • Drive for combination therapies, for example, Galderma's Epiduo (adapalene and benzoyl peroxide), which continues to experience rapid uptake.
  • Expansion of the market into the pediatric population and for late-onset acne in women.
  • A push towards disease-modifying therapies; for example, launch of AndroScience's ASC-J9 androgen receptor degradation enhancer is anticipated to be a game-changer and is expected to rival isotretinoin, the current market leader for severe acne.

Highlights

Key Questions Answered

  • How will the US and 5EU acne markets evolve over the forecast period from 2012 to 2018 in terms of sales and patient numbers?
  • How will the launch of late-stage pipeline therapies such as ASC-J9 and Visonac shape the future treatment landscape?
  • How do the clinical and commercial attributes of late-stage pipeline therapies compare to one another and against existing treatment options?
  • Why has there been a void of R&D interest from Big Pharma in this highly populated dermatology indication?
  • What are the remaining unmet needs and opportunities for drug developers within the acne space?

Key Findings

  • The main drivers of growth in the acne market during the 2012-2018 forecast period include the launch of AndroScience's ASC-J9, a therapeutic that is highly anticipated in the previously stagnant acne market and will make hormonal therapies available to males with acne, the continued success and uptake of Galderma's Epiduo, and the launch of Photocure's Visonac; potentially the first photodynamic therapy for use in acne.
  • The lack of dedicated R&D programs in acne has been attributed to pharmaceutical companies viewing topicals, the mainstay of acne therapy, as being inexpensive, with a poor return on investment. Instead, R&D strategies have centered on reformulations of existing products and/or fixed-dose combination therapies, acquisitions of key dermatology products by Big Pharma, and label expansions into the previously untapped pediatric market. Targeting the pediatric market is a strategy that GlobalData expects will be used by other dermatology companies during the coming decade.
  • A continued unmet need for acne is the need for new and innovative products to treat the underlying condition. Ideally, these products should be molecules that can specifically target critical pathways in the acne pathophysiology. Given the acne market's substantial patient pool (estimated to be 103.9 million patients in the US and 5EU) and increasing understanding of the disease's pathophysiology, GlobalData expects continued interest in the acne market from biotechs and pharmaceutical companies over the coming decade.

Scope

  • Overview of acne, including epidemiology, etiology, pathophysiology, symptoms, and current treatment options.
  • Annualized acne prescription therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 to 2018.
  • Key topics covered include strategic product assessment, market characterization, unmet needs, R&D strategies, clinical trial design, and benchmarking analysis for the acne prescription therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late stage pipeline drugs. Accompanied by an interactive clinical and commercial benchmarking analysis tool.
  • Analysis of the current and future market competition in the US and 5EU acne prescription therapeutics market. 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 early-stage pipeline products list.
  • Develop business strategies by understanding the trends shaping and driving the US and 5EU acne prescription therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the US and 5EU acne prescription 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 therapy sales in the US and 5EU acne prescription therapeutics markets from 2012-2018.
  • Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

OpportunityAnalyzer: Acne Vulgaris – Opportunity Analysis and Forecasts to 2018

Table of Contents

1 Table of Contents 9
1.1 List of Tables 13
1.2 List of Figures 15

2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 17

3 Disease Overview 18
3.1 Etiology and Pathophysiology 18
3.2 Prognosis 22
3.3 Quality of Life 22
3.4 Symptoms 23

4 Epidemiology 25
4.1 Risk Factors and Comorbidities 26
4.1.1 A family history of acne increases the risk of acne by four times 26
4.1.2 Diet is the most common aggravating factor of acne 27
4.1.3 The relationship between smoking and acne is unclear 28
4.1.4 Depression and anxiety are common comorbidities in acne patients 29
4.2 Global Trends 30
4.2.1 US 31
4.2.2 5EU 32
4.3 Forecast Methodology 34
4.3.1 Sources Used 35
4.3.2 Sources Not Used 37
4.4 Forecast Assumptions and Methods 38
4.4.1 US 38
4.4.2 France 39
4.4.3 Germany 39
4.4.4 Italy and Spain 40
4.4.5 UK 40
4.5 Epidemiology Forecast for Acne (2012-2022) 41
4.5.1 Total Prevalent Cases of Acne Vulgaris 41
4.5.2 Age-Specific Total Prevalent Cases of Acne Vulgaris 43
4.5.3 Sex-Specific Total Prevalent Cases of Acne Vulgaris 44
4.5.4 Age-Standardized Total Prevalence of Acne Vulgaris 46
4.5.5 Total Prevalent Cases of Acne Vulgaris by Severity 47
4.6 Discussion 49
4.6.1 Conclusions on Epidemiological Trends 49
4.6.2 Limitations of the Analysis 50
4.6.3 Strengths of the Analysis 51

5 Current Treatment Options 53
5.1 Overview 53
5.2 Product Profiles - Major Brands 56
5.2.1 Tretinoin (numerous brand and generic names) 56
5.2.2 Isotretinoin 60
5.2.3 Adapalene (numerous generic names) 63
5.2.4 Benzoyl Peroxide (numerous generic names) 66
5.2.5 Azelaic Acid (numerous generic names) 70
5.2.6 Hormonal Therapy (numerous brand and generic names) 73
5.2.7 Epiduo (adapalene and benzoyl peroxide) 76
5.2.8 Tretinoin and Clindamycin Phosphate (numerous brand names) 81
5.2.9 Benzoyl Peroxide and Clindamycin Phosphate (numerous brand and generic names) 84
5.2.10 Benzoyl Peroxide and Erythromycin (numerous brand and generic names) 87
5.2.11 Isotretinoin and Erythromycin (numerous brand and generic names) 90
5.2.12 Zineryt (erythromycin and zinc acetate) 93

6 Unmet Needs Assessment and Opportunity Analysis 96
6.1 Overview 96
6.2 Unmet Needs Analysis 97
6.2.1 Inadequate Investment in Innovative Drugs 97
6.2.2 Improved Compliance 98
6.2.3 Cost-Prohibitive Products 99
6.2.4 Increased Patient and Caregiver Awareness 100
6.2.5 Non-Teratogenic Treatment Options for Female Acne Patients of Childbearing Age 100
6.3 Opportunity Analysis 101
6.3.1 Investment in Novel Systemic Compounds 101
6.3.2 Affordable and Accessible Combination Treatment Options 101
6.3.3 Holistic Management of Acne Patients 101
6.3.4 Exploring Photodynamic Therapy as a Potential Treatment for Acne 103

7 R&D Strategies 105
7.1 Overview - Lifecycle Management Strategies 105
7.1.1 Reformulation Strategies 105
7.1.2 M&A in the Dermatology Market 107
7.1.3 Label Expansion into Pediatric Population 107
7.2 Clinical Trial Design 108
7.2.1 Current Clinical Trial Design 108
7.2.2 Limitations of Current Clinical Trial Design 109
7.2.3 Future Outlook in Acne Clinical Trial Design 110

8 Pipeline Assessment 113
8.1 Overview 113
8.2 Promising Drugs in Clinical Development 114
8.2.1 ASC-J9 114
8.2.2 Visonac (methyl aminolevulinate) 120
8.3 Innovative Early-Stage Approaches 127
8.3.1 Anti-Inflammatory Drugs 128
8.3.2 Vaccine Development 129
8.3.3 Neuropeptides 131
8.3.4 Phages 131

9 Pipeline Valuation Analysis 132
9.1 Clinical Benchmark of Key Pipeline Drugs 132
9.2 Commercial Benchmark of Key Pipeline Drugs 134
9.3 Competitive Assessment 136
9.4 Top-Line Five-Year Forecast 138
9.4.1 US 142
9.4.2 5EU 143

10 Appendix 145
10.1 Bibliography 145
10.2 Abbreviations 159
10.3 Methodology 162
10.4 Forecasting Methodology 162
10.4.1 Diagnosed Acne Vulgaris Patients 162
10.4.2 Percent Drug-Treated Patients 163
10.4.3 Drugs Included in Each Therapeutic Class 163
10.4.4 Launch and Patent Expiry Dates 164
10.4.5 General Pricing Assumptions 164
10.4.6 Individual Drug Assumptions 165
10.4.7 Pricing of Pipeline Agents 171
10.5 Physicians and Specialists Included in this Study 172
10.6 About the Authors 173
10.6.1 Author 173
10.6.2 Author/Reviewer 173
10.6.3 Reviewer 174
10.6.4 Epidemiologist 174
10.6.5 Global Head of Healthcare 175
10.7 About GlobalData 176
10.8 Disclaimer 176

List of Tables

Table 1: Risk Factors and Comorbidities for Acne 26
Table 2: Classification of Acne Severity 34
Table 3: 6MM, Sources of Acne Prevalence Data 34
Table 4: 6MM, Sources of Acne Severity Data 35
Table 5: 6MM, Total Prevalent Cases of Acne Vulgaris, Ages 10-44 Years, Both Sexes, N (Millions), 2012-2022 42
Table 6: 6MM, Total Prevalent Cases of Acne Vulgaris, by Age, Both Sexes, N (Millions), (Row %), 2012 43
Table 7: 6MM, Total Prevalent Cases of Acne Vulgaris, by Sex, Ages 10-44 Years, N (Row %), 2012 45
Table 8: 6MM, Total Prevalent Cases of Acne Vulgaris by Severity, Ages 10-44 Years, Both Sexes, N (Millions) (Row %), 2012 48
Table 9: Commonly Used Treatments for the Management of Acne 55
Table 10: Product Profile - Tretinoin 57
Table 11: Tretinoin SWOT Analysis, 2014 59
Table 12: Product Profile - Isotretinoin 61
Table 13: Isotretinoin SWOT Analysis, 2014 63
Table 14: Product Profile - Adapalene 64
Table 15: Adapalene SWOT Analysis, 2014 66
Table 16: Product Profile - Benzoyl Peroxide 68
Table 17: Benzoyl Peroxide SWOT Analysis, 2014 70
Table 18: Product Profile - Azelaic Acid 71
Table 19: Azelaic Acid SWOT Analysis, 2014 72
Table 20: Product Profile - Hormonal Therapy 74
Table 21: Hormonal Therapy SWOT Analysis, 2014 76
Table 22: Product Profile - Epiduo 78
Table 23: Epiduo SWOT Analysis, 2014 80
Table 24: Product Profile -Tretinoin and Clindamycin Phosphate 82
Table 25: Tretinoin and Clindamycin Phosphate SWOT Analysis, 2014 84
Table 26: Product Profile - Benzoyl Peroxide and Clindamycin Phosphate 85
Table 27: Benzoyl Peroxide and Clindamycin Phosphate SWOT Analysis, 2014 87
Table 28: Product Profile - Benzoyl Peroxide and Erythromycin 88
Table 29: Benzoyl Peroxide and Erythromycin SWOT Analysis, 2014 90
Table 30: Product Profile - Isotretinoin and Erythromycin 91
Table 31: Isotretinoin and Erythromycin SWOT Analysis, 2014 92
Table 32: Product Profile - Zineryt 93
Table 33: Zineryt SWOT Analysis, 2014 95
Table 34: Overall Unmet Needs in Acne - Current Level of Attainment 97
Table 35: Acne - Late-Stage Pipeline, 2014 114
Table 36: Product Profile - ASC-J9 117
Table 37: ASC-J9 SWOT Analysis, 2014 120
Table 38: Product Profile - Visonac (methyl aminolevulinate) 123
Table 39: Visonac SWOT Analysis, 2014 126
Table 40: Early-Stage Pipeline Products in Acne, April 2014 128
Table 41: Clinical Benchmark for Acne, 2014 133
Table 42: Commercial Benchmark for Acne, 2014 134
Table 43: Top-Line Sales Forecasts ($m) for Acne, 2012-2018 139
Table 44: Key Events Impacting Sales for Acne, 2012-2018 141
Table 45: Acne Market - Drivers and Barriers, 2012-2018 141
Table 46: Key Launch Dates 164

List of Figures

Figure 1: Pathophysiology of Acne 19
Figure 2: Acne Grades and Correlation with Scarring 21
Figure 3: Acne Symptoms 23
Figure 4: Classification of Acne Severity 24
Figure 5: 6MM, Total Prevalent Cases of Acne Vulgaris, Ages 10-44 Years, Both Sexes, N (Millions), 2012-2022 42
Figure 6: 6MM, Total Prevalent Cases of Acne Vulgaris, by Age, Both Sexes, N (Millions), 2012 44
Figure 7: 6MM, Total Prevalent Cases of Acne Vulgaris, by Sex, Ages 10-44 Years, N (Millions), 2012 46
Figure 8: 6MM, Age-Standardized Total Prevalence of Acne Vulgaris, Ages 10-44 Years, 2012 47
Figure 9: 6MM, Total Prevalent Cases of Acne Vulgaris by Severity, Ages 10-44 Years, Both Sexes, N (Millions), 2012 49
Figure 10: Acne Treatment Algorithm 54
Figure 11: Competitive Assessment of Acne Therapies and Late-Stage Pipeline Agents in Acne, 2012-2018 136
Figure 12: Global Sales for Acne by Region, 2012-2018 140

Published By: GlobalData
Product Code: GlobalData29900


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