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Acne Vulgaris: Opportunity Analysis and Forecasts to 2026 [Report Updated: 01-03-2018]

Published by Global Data: 01 Mar 2018 | 211225 | In Stock

Introduction

Acne Vulgaris: Opportunity Analysis and Forecasts to 2026

Summary

Acne vulgaris (acne) is currently one of the most common and well-established dermatology conditions, affecting around 90% of the world’s population at some point in their lifetime. The disease is a chronic, inflammatory dermatological condition of the pilosebaceous gland of the skin with a multifactorial pathogenesis. It is usually initiated during puberty by hormonal changes and further exacerbated by genetic factors.

Acne is a polygenic and multifactorial disease. According to current literature, the four major factors that interact with each other to produce acne lesions are -

- Elevated sebum secretion: Excess sebum, known colloquially as oil, is produced as a result of overactive sebaceous glands in the skin. Overactivation of these glands is correlated to increased hormone levels, particularly androgens.

- Abnormal keratinization: Hair follicles that would typically release oils become blocked.

- Bacterial colonization: Commensal bacteria Propionibacterium acnes (P. acnes) grow and thrive on accumulated oil within the hair follicles.

- Inflammation: A variety of cell types including those from both innate and acquired immunity are released into the skin.

In addition to these pathogenic causes, other risk factors that may contribute to acne include diet, genetics, stress and neuroendocrine dysregulation.

GlobalData projects the global acne vulgaris marketplace - which, for the purposes of this report, comprises seven major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, and Japan) - to experience modest growth during the forecast period. The US contributes 90% of the 2016 7MM total sales, generating an estimated .6 billion. With 0 in sales from the 5EU, Germany was the largest market, with an estimated M in sales in 2016.

By the end of the forecast period in 2026, acne sales are forecast to reach over .3 billion, growing at a compound annual growth rate (CAGR) of 4.1% over the 10-year forecast period. The majority of sales will come from the US, which will maintain its 2016 lead and command 93% of the market in 2026. A substantial amount of growth in that market is attributed to the rapid uptake of Galderma’s Epiduo (benzoyl peroxide and adapalene) for moderate patients and the continued success of isotretinoin. The anticipated launches of AOBiome’s B244, Dermira’s olumacostat glasaretil, and Novan’s SB204 will add new molecular entities to the acne market for the first time in approximately 30 years. Paratek’s and Allergan’s Seysara, Foamix Pharmaceuticals’ FMX-101, and Cassiopea’s Winlevi are also expected to launch during the forecast period. Together, these late-stage pipeline products are expected to add approximately .2B in sales to the acne market in 2026.

Highlights

Key Questions Answered

- For years, the acne vulgaris pharmaceutical market has remained relatively stagnant, as the only new therapeutics that have come to market were reformulations of already approved drugs. However, the current pipeline, both late-stage and early-stage, contain a wide variety of drugs with novel mechanisms of action. Will the late-stage drugs make a significant impact on the acne market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

- Key Opinion Leaders (KOLs) interviewed by GlobalData have indicated that there are considerably high unmet needs within the indication. What are the main unmet needs in this market? How can the pharmaceutical industry address these needs? Will the drugs under development fulfil the unmet needs of the acne market?

- How does the pediatric acne population differ from the adult acne population? Which population is less compliant to acne therapies?

Scope

- Overview of acne vulgaris, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

- Annualized acne therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.

- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the acne therapeutics market.

- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

- Analysis of the current and future market competition in the global acne 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

The report will enable you to -

- Develop and design your 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 acne therapeutics market.

- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global acne therapeutics market in future.

- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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 acne therapeutics market from 2016-2026.

- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents
for Acne Vulgaris: Opportunity Analysis and Forecasts to 2026 [Report Updated: 01-03-2018]

  • 1 Table of Contents

    1 Table of Contents 2

    1.1 List of Tables 8

    1.2 List of Figures 9

    2 Acne Vulgaris: Executive Summary 10

    2.1 The US Acne Pharmaceutical Market Expected to Drive Moderate Global Growth between 2016 and 2026 10

    2.2 Pharmaceutical Giants Revisiting the Acne Arena, Deploying Notable R&D Strategies to Attain Market Share 12

    2.3 Innovative Products in Acne Should Focus on Cost-Effectiveness, Potential to Improve Compliance 13

    2.4 Acne Market to Experience a Period of Investment in Research 14

    2.5 The Late-Stage Pipeline Renews Hope for New and Novel Therapies That Can Further Challenge the Established Acne Landscape 14

    2.6 What Do Physicians Think? 16

    3 Introduction 18

    3.1 Catalyst 18

    3.2 Related Reports 18

    3.3 Upcoming Related Reports 19

    4 Disease Overview 20

    4.1 Etiology and Pathophysiology 20

    4.1.1 Etiology 20

    4.1.2 Pathophysiology 20

    4.2 Classification or Staging Systems 23

    4.3 Symptoms 24

    4.4 Prognosis 25

    4.5 Quality of Life 25

    5 Epidemiology 27

    5.1 Disease Background 27

    5.2 Risk Factors and Comorbidities 27

    5.3 Global and Historical Trends 28

    5.3.1 US 30

    5.3.2 5EU 30

    5.3.3 Japan 31

    5.4 Forecast Methodology 32

    5.4.1 Sources 32

    5.4.2 Forecast Assumptions and Methods 35

    5.5 Epidemiological Forecast for Acne Vulgaris (2016-2026) 41

    5.5.1 Total Prevalent Cases of Acne Vulgaris 41

    5.5.2 Diagnosed Prevalent Cases of Acne Vulgaris 42

    5.5.3 Age-Specific Diagnosed Prevalent Cases of Acne Vulgaris 43

    5.5.4 Sex-Specific Diagnosed Prevalent Cases of Acne Vulgaris 44

    5.5.5 Diagnosed Prevalent Cases of Acne Vulgaris by Severity 45

    5.6 Discussion 47

    5.6.1 Epidemiological Forecast Insight 47

    5.6.2 Limitations of Analysis 47

    5.6.3 Strengths of Analysis 48

    6 Current Treatment Options 49

    6.1 Overview 49

    6.2 Treatment Guidelines and Leading Prescribed Drugs 51

    6.3 Tretinoin (numerous) 53

    6.3.1 Overview 53

    6.3.2 Efficacy 54

    6.3.3 Safety 55

    6.3.4 SWOT Analysis 56

    6.4 Isotretinoin (numerous) 56

    6.4.1 Overview 56

    6.4.2 icacy 58

    6.4.3 Safety 58

    6.4.4 SWOT Analysis 59

    6.5 Adapalene (numerous) 59

    6.5.1 Overview 59

    6.5.2 Efficacy 61

    6.5.3 Safety 61

    6.5.4 SWOT Analysis 62

    6.6 Benzoyl Peroxide (numerous) 62

    6.6.1 Overview 62

    6.6.2 Efficacy 64

    6.6.3 Safety 64

    6.6.4 SWOT Analysis 65

    6.7 Azelaic Acid (numerous) 65

    6.7.1 Overview 65

    6.7.2 Efficacy 66

    6.7.3 Safety 67

    6.7.4 SWOT Analysis 67

    6.8 Hormonal Therapy (numerous) 67

    6.8.1 Overview 67

    6.8.2 Efficacy 69

    6.8.3 Safety 69

    6.8.4 SWOT Analysis 70

    6.9 Epiduo 70

    6.9.1 Overview 70

    6.9.2 Efficacy 72

    6.9.3 Safety 72

    6.9.4 SWOT Analysis 74

    6.10 Tretinoin and Clindamycin Phosphate (numerous) 74

    6.10.1 Overview 74

    6.10.2 Efficacy 75

    6.10.3 Safety 76

    6.10.4 SWOT Analysis 77

    6.11 Benzoyl Peroxide and Clindamycin (numerous) 77

    6.11.1 Overview 77

    6.11.2 Efficacy 78

    6.11.3 Safety 79

    6.11.4 SWOT Analysis 80

    6.12 Benzoyl Peroxide and Erythromycin (numerous) 80

    6.12.1 Overview 80

    6.12.2 Efficacy 81

    6.12.3 Safety 82

    6.12.4 SWOT Analysis 82

    6.13 Minor Treatment Options 83

    7 Unmet Needs and Opportunity Assessment 84

    7.1 Overview 84

    7.2 Improved Compliance 85

    7.2.1 Unmet Need 85

    7.2.2 Gap Analysis 86

    7.2.3 Opportunity 87

    7.3 Increased Patient and Caregiver Awareness 88

    7.3.1 Unmet Need 88

    7.3.2 Gap Analysis 89

    7.3.3 Opportunity 89

    7.4 Cost-Prohibitive Products 89

    7.4.1 Unmet Need 89

    7.4.2 Gap Analysis 90

    7.4.3 Opportunity 91

    7.5 Non-teratogenic Treatment Options for Female Acne Patients of Childbearing Age 91

    7.5.1 Unmet Need 91

    7.5.2 Gap Analysis 91

    7.5.3 Opportunity 91

    8 R&D Strategies 93

    8.1 Overview 93

    8.1.1 Reformulation Strategies 93

    8.1.2 M&A in the Dermatology Market 94

    8.1.3 New Mechanisms of Action 95

    8.2 Clinical Trials Design 96

    8.2.1 Current Clinical Trial Design 96

    8.2.2 Limitations of Current Clinical Trial Design 97

    8.2.3 Future Outlook in Acne Clinical Trial Design 97

    9 Pipeline Assessment 100

    9.1 Promising Drugs in Late-Stage Clinical Development 101

    9.2 B244 103

    9.2.1 Overview 103

    9.2.2 Efficacy 104

    9.2.3 Safety 104

    9.2.4 SWOT Analysis 105

    9.3 FMX-101 105

    9.3.1 Overview 105

    9.3.2 Efficacy 107

    9.3.3 Safety 107

    9.3.4 SWOT Analysis 108

    9.4 Seysara (Sarecycline) 108

    9.4.1 Overview 108

    9.4.2 Efficacy 109

    9.4.3 Safety 110

    9.4.4 SWOT Analysis 110

    9.5 SB204 111

    9.5.1 Overview 111

    9.5.2 Efficacy 112

    9.5.3 Safety 113

    9.5.4 SWOT Analysis 113

    9.6 Winlevi 114

    9.6.1 Overview 114

    9.6.2 Efficacy 115

    9.6.3 Safety 115

    9.6.4 SWOT Analysis 116

    9.7 Other Phase III Candidates 116

    9.7.1 Olumacostat Glasaretil 116

    9.8 Innovative Early-Stage Approaches 117

    9.8.1 Overview 117

    9.8.2 Biologics 119

    9.8.3 Antibiotics 119

    9.8.4 Small Molecules 120

    10 Pipeline Valuation Analysis 121

    10.1 Clinical Benchmark of Key Pipeline Drugs 121

    10.2 Commercial Benchmark of Key Pipeline Drugs 123

    10.3 Competitive Assessment 125

    10.4 Top-Line 10-Year Forecast 126

    10.4.1 US 128

    10.4.2 5EU 129

    10.4.3 Japan 130

    11 Appendix 131

    11.1 Bibliography 131

    11.2 Abbreviations 142

    11.3 Methodology 143

    11.3.1 Forecasting Methodology 144

    11.3.2 Diagnosed Patients 144

    11.3.3 Percent Drug-Treated Patients 144

    11.3.4 Drugs Included in Each Therapeutic Class 144

    11.3.5 Launch Dates 145

    11.3.6 General Pricing Assumptions 145

    11.3.7 Individual Drug Assumptions 146

    11.3.8 Pricing of Pipeline Agents 149

    11.4 Primary Research - KOLs Interviewed for This Report 150

    11.5 Primary Research - Prescriber Survey 153

    11.6 About the Authors 153

    11.6.1 Analyst 153

    11.6.2 Associate Analyst 154

    11.6.3 Therapy Area Director 154

    11.6.4 Epidemiologist 154

    11.6.5 Epidemiology Reviewers 155

    11.6.6 Global Director of Therapy Analysis and Epidemiology 155

    11.6.7 Global Head and EVP of Healthcare Operations and Strategy 156

    11.7 About GlobalData 156

    11.8 Contact Us 157

    11.9 Disclaimer 157

List Of Tables
in Acne Vulgaris: Opportunity Analysis and Forecasts to 2026 [Report Updated: 01-03-2018]

1.1 List of Tables

Table 1: Acne Vulgaris: Key Metrics in the 7MM 10

Table 2: Clinical Classification of Acne According to Severity 24

Table 3: Risk Factors and Comorbidities for Diagnosed Prevalent Cases of Acne Vulgaris 28

Table 4: 7MM, Total Prevalent Cases of Acne Vulgaris, Ages 7-60 Years, Both Sexes, N, Select Years 2016-2026 42

Table 5: 7MM, Diagnosed Prevalent Cases of Acne Vulgaris, Ages 7-60 Years, Both Sexes, N, Select Years 2016-2026 43

Table 6: Treatment Guidelines for Acne Vulgaris 51

Table 7: Commonly Used Treatments for the Management of Acne 52

Table 8: Product Profile - Tretinoin 54

Table 9: Tretinoin SWOT Analysis, 2018 56

Table 10: Product Profile - Isotretinoin 58

Table 11: Isotretinoin SWOT Analysis, 2018 59

Table 12: Product Profile - Adapalene 60

Table 13: Adapalene SWOT Analysis, 2018 62

Table 14: Product Profile - Benzoyl Peroxide 63

Table 15: Benzoyl Peroxide SWOT Analysis, 2018 65

Table 16: Product Profile - Azelaic Acid 66

Table 17: Azelaic Acid SWOT Analysis, 2018 67

Table 18: Product Profile - Hormonal Therapy 68

Table 19: Hormonal Therapy SWOT Analysis, 2018 70

Table 20: Product Profile - Epiduo 71

Table 21: Epiduo SWOT Analysis, 2018 74

Table 22: Product Profile - Tretinoin and Clindamycin Phosphate 75

Table 23: Tretinoin and Clindamycin Phosphate SWOT Analysis, 2018 77

Table 24: Product Profile - Benzoyl Peroxide and Clindamycin Phosphate 78

Table 25: Benzoyl Peroxide and Clindamycin Phosphate SWOT Analysis, 2018 80

Table 26: Product Profile - Benzoyl Peroxide and Erythromycin 81

Table 27: Benzoyl Peroxide and Erythromycin SWOT Analysis, 2018 82

Table 28: Summary of Minor Therapeutic Classes, 2018 83

Table 29: Acne Vulgaris - Late-Stage Pipeline, 2017 102

Table 30: Product Profile - B244 104

Table 31: B244 SWOT Analysis, 2018 105

Table 32: Product Profile - FMX-101 107

Table 33: FMX-101 SWOT Analysis, 2018 108

Table 36: Product Profile - Seysara 109

Table 37: Seysara SWOT Analysis, 2018 110

Table 38: Product Profile - SB204 112

Table 39: SB204 SWOT Analysis, 2018 113

Table 40: Product Profile - Winlevi 115

Table 41: Winlevi SWOT Analysis, 2018 116

Table 42: Innovative Early-Stage Approaches for Acne Vulgaris, 2018 118

Table 43: Clinical Benchmark of Key Pipeline Drugs - Tetracycline-Derived Antibiotics 121

Table 44: Clinical Benchmark of Key Pipeline Drugs - Androgen Suppressors 122

Table 45: Commercial Benchmark of Key Pipeline Drugs - Tetracycline-Derived Antibiotics 123

Table 46: Commercial Benchmark of Key Pipeline Drugs - Androgen Suppressors 124

Table 47: Key Events Impacting Sales for Acne Vulgaris, 2016-2026 127

Table 48: Acne Vulgaris Market - Global Drivers and Barriers, 2016-2026 128

Table 49: Key Projected Launch Dates for Acne Vulgaris 145

Table 50: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 153

List Of Figures, Charts and Diagrams
in Acne Vulgaris: Opportunity Analysis and Forecasts to 2026 [Report Updated: 01-03-2018]

1.2 List of Figures

Figure 1: Global Sales Forecast by Country for Acne Vulgaris in 2016 and 2026 12

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), Acne Vulgaris 15

Figure 3: Pathogenesis Pathway of Acne 21

Figure 4: Major Drug Targets for Acne Treatment 23

Figure 5: Symptomatic Representations of Acne 25

Figure 6: Age-Standardized Total Prevalence of Acne Vulgaris, Ages 7-60 Years, 2016 29

Figure 7: Age-Standardized Diagnosed Prevalence of Acne Vulgaris, Ages 7-60 Years, 2016 30

Figure 8: Sources Used and Not Used to Forecast Total Prevalent Cases of Acne Vulgaris 33

Figure 9: Sources Used to Forecast Diagnosed Prevalent Cases of Acne Vulgaris 34

Figure 10: Sources Used and Not Used to Forecast Diagnosed Prevalent Cases of Acne Vulgaris by Severity 35

Figure 11: 7MM, Age-Specific Diagnosed Prevalent Cases of Acne Vulgaris, Both Sexes, 2016 44

Figure 12: 7MM, Sex-Specific Diagnosed Prevalent Cases of Acne Vulgaris, Ages 7-60 Years, 2016 45

Figure 13: 7MM, Diagnosed Prevalent Cases of Acne Vulgaris, Ages 7-17 Years, Both Sexes, N, 2016 46

Figure 14: 7MM, Diagnosed Prevalent Cases of Acne Vulgaris, Ages 18-60 Years, Both Sexes, 2016 46

Figure 15: Acne Treatment Algorithm 50

Figure 16: Unmet Need and Opportunity in Acne Vulgaris, 2018 85

Figure 17: Overview of the Development Pipeline in Acne Vulgaris 101

Figure 18: Key Phase IIb/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for Acne Vulgaris in the 7MM During the Forecast Period 102

Figure 19: Competitive Assessment of the Marketed and Pipeline Tetracycline-Derived Antibiotics 125

Figure 20: Competitive Assessment of the Marketed and Pipeline Androgen Suppressors 126

Figure 21: Global (7MM) Sales Forecast by Country for Acne Vulgaris in 2016 and 2026 127

Additional Details

Publisher

Global Data

Publisher Information

Reference

211225 | GDHC083POA

Number of Pages

159

Report Format

PDF

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