Acne Vulgaris – Opportunity Analysis and Forecasts to 2026

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 $2.6 billion. With $220 in sales from the 5EU, Germany was the largest market, with an estimated $62M in sales in 2016.

By the end of the forecast period in 2026, acne sales are forecast to reach over $4.3 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 $1.2B in sales to the acne market in 2026.

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.

Companies mentioned

Allergan

Almirall

AndroScience

AOBiome

Astellas

Bayer

Botanix Pharmaceuticals

Braintree Laboratories

Cassiopea SpA

Celtaxys

Common Pharma

Cutanea Life Sciences

Dermira

Dow Pharma

Elorac Inc.

Foamix Pharmaceuticals

Galderma

GSK

Guiliani SpA

Guthy-Renker

Medicis Pharmaceutical

Melinta Therapeutics

Mimetica

Novan

Novartis

Paratek

Photocure

Roche

Sanofi

Signum Dermalogix

Stiefel Laboratories

Sun Pharmaceutical

Taro Pharmaceutical Industries

Valeant

Vyome Biosciences

XBiotech

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Acne Vulgaris: Executive Summary

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

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

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

2.4 Acne Market to Experience a Period of Investment in Research

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

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

4.3 Symptoms

4.4 Prognosis

4.5 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 US

5.3.2 5EU

5.3.3 Japan

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for Acne Vulgaris (2016–2026)

5.5.1 Total Prevalent Cases of Acne Vulgaris

5.5.2 Diagnosed Prevalent Cases of Acne Vulgaris

5.5.3 Age-Specific Diagnosed Prevalent Cases of Acne Vulgaris

5.5.4 Sex-Specific Diagnosed Prevalent Cases of Acne Vulgaris

5.5.5 Diagnosed Prevalent Cases of Acne Vulgaris by Severity

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

6.2 Treatment Guidelines and Leading Prescribed Drugs

6.3 Tretinoin (numerous)

6.3.1 Overview

6.3.2 Efficacy

6.3.3 Safety

6.3.4 SWOT Analysis

6.4 Isotretinoin (numerous)

6.4.1 Overview

6.4.2 icacy

6.4.3 Safety

6.4.4 SWOT Analysis

6.5 Adapalene (numerous)

6.5.1 Overview

6.5.2 Efficacy

6.5.3 Safety

6.5.4 SWOT Analysis

6.6 Benzoyl Peroxide (numerous)

6.6.1 Overview

6.6.2 Efficacy

6.6.3 Safety

6.6.4 SWOT Analysis

6.7 Azelaic Acid (numerous)

6.7.1 Overview

6.7.2 Efficacy

6.7.3 Safety

6.7.4 SWOT Analysis

6.8 Hormonal Therapy (numerous)

6.8.1 Overview

6.8.2 Efficacy

6.8.3 Safety

6.8.4 SWOT Analysis

6.9 Epiduo

6.9.1 Overview

6.9.2 Efficacy

6.9.3 Safety

6.9.4 SWOT Analysis

6.10 Tretinoin and Clindamycin Phosphate (numerous)

6.10.1 Overview

6.10.2 Efficacy

6.10.3 Safety

6.10.4 SWOT Analysis

6.11 Benzoyl Peroxide and Clindamycin (numerous)

6.11.1 Overview

6.11.2 Efficacy

6.11.3 Safety

6.11.4 SWOT Analysis

6.12 Benzoyl Peroxide and Erythromycin (numerous)

6.12.1 Overview

6.12.2 Efficacy

6.12.3 Safety

6.12.4 SWOT Analysis

6.13 Minor Treatment Options

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Improved Compliance

7.2.1 Unmet Need

7.2.2 Gap Analysis

7.2.3 Opportunity

7.3 Increased Patient and Caregiver Awareness

7.3.1 Unmet Need

7.3.2 Gap Analysis

7.3.3 Opportunity

7.4 Cost-Prohibitive Products

7.4.1 Unmet Need

7.4.2 Gap Analysis

7.4.3 Opportunity

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

7.5.1 Unmet Need

7.5.2 Gap Analysis

7.5.3 Opportunity

8 R&D Strategies

8.1 Overview

8.1.1 Reformulation Strategies

8.1.2 M&A in the Dermatology Market

8.1.3 New Mechanisms of Action

8.2 Clinical Trials Design

8.2.1 Current Clinical Trial Design

8.2.2 Limitations of Current Clinical Trial Design

8.2.3 Future Outlook in Acne Clinical Trial Design

9 Pipeline Assessment

9.1 Promising Drugs in Late-Stage Clinical Development

9.2 B244

9.2.1 Overview

9.2.2 Efficacy

9.2.3 Safety

9.2.4 SWOT Analysis

9.3 FMX-101

9.3.1 Overview

9.3.2 Efficacy

9.3.3 Safety

9.3.4 SWOT Analysis

9.4 Seysara (Sarecycline)

9.4.1 Overview

9.4.2 Efficacy

9.4.3 Safety

9.4.4 SWOT Analysis

9.5 SB204

9.5.1 Overview

9.5.2 Efficacy

9.5.3 Safety

9.5.4 SWOT Analysis

9.6 Winlevi

9.6.1 Overview

9.6.2 Efficacy

9.6.3 Safety

9.6.4 SWOT Analysis

9.7 Other Phase III Candidates

9.7.1 Olumacostat Glasaretil

9.8 Innovative Early-Stage Approaches

9.8.1 Overview

9.8.2 Biologics

9.8.3 Antibiotics

9.8.4 Small Molecules

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Associate Analyst

11.6.3 Therapy Area Director

11.6.4 Epidemiologist

11.6.5 Epidemiology Reviewers

11.6.6 Global Director of Therapy Analysis and Epidemiology

11.6.7 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

List of Tables

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

Table 2: Clinical Classification of Acne According to Severity

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

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

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

Table 6: Treatment Guidelines for Acne Vulgaris

Table 7: Commonly Used Treatments for the Management of Acne

Table 8: Product Profile – Tretinoin

Table 9: Tretinoin SWOT Analysis, 2018

Table 10: Product Profile – Isotretinoin

Table 11: Isotretinoin SWOT Analysis, 2018

Table 12: Product Profile – Adapalene

Table 13: Adapalene SWOT Analysis, 2018

Table 14: Product Profile – Benzoyl Peroxide

Table 15: Benzoyl Peroxide SWOT Analysis, 2018

Table 16: Product Profile – Azelaic Acid

Table 17: Azelaic Acid SWOT Analysis, 2018

Table 18: Product Profile – Hormonal Therapy

Table 19: Hormonal Therapy SWOT Analysis, 2018

Table 20: Product Profile – Epiduo

Table 21: Epiduo SWOT Analysis, 2018

Table 22: Product Profile – Tretinoin and Clindamycin Phosphate

Table 23: Tretinoin and Clindamycin Phosphate SWOT Analysis, 2018

Table 24: Product Profile – Benzoyl Peroxide and Clindamycin Phosphate

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

Table 26: Product Profile – Benzoyl Peroxide and Erythromycin

Table 27: Benzoyl Peroxide and Erythromycin SWOT Analysis, 2018

Table 28: Summary of Minor Therapeutic Classes, 2018

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

Table 30: Product Profile – B244

Table 31: B244 SWOT Analysis, 2018

Table 32: Product Profile – FMX-101

Table 33: FMX-101 SWOT Analysis, 2018

Table 36: Product Profile – Seysara

Table 37: Seysara SWOT Analysis, 2018

Table 38: Product Profile – SB204

Table 39: SB204 SWOT Analysis, 2018

Table 40: Product Profile – Winlevi

Table 41: Winlevi SWOT Analysis, 2018

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

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

Table 44: Clinical Benchmark of Key Pipeline Drugs – Androgen Suppressors

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

Table 46: Commercial Benchmark of Key Pipeline Drugs – Androgen Suppressors

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

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

Table 49: Key Projected Launch Dates for Acne Vulgaris

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

List of Figures

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

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

Figure 3: Pathogenesis Pathway of Acne

Figure 4: Major Drug Targets for Acne Treatment

Figure 5: Symptomatic Representations of Acne

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

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

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

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

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

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

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

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

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

Figure 15: Acne Treatment Algorithm

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

Figure 17: Overview of the Development Pipeline in Acne Vulgaris

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

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

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

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

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