Idiopathic Inflammatory Myositis - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights

• In 2023, there were approximately 29.43 million diagnosed prevalent cases of acne vulgaris in the 7MM, these cases are further expected to increase during the forecast period (2024-2034). Factors contributing to the rise of diagnosed prevalent cases of acne vulgaris include hormonal changes, dietary influences, genetic predisposition, and environmental factors such as pollution.
• In 2023, the market size of Acne Vulgaris was highest in the US among the 7MM, accounting for approximately USD 2.94 billion which is further expected to increase by 2034.
• The Age-specific prevalent cases of acne vulgaris are divided into the following groups: 15-19 years, 20-29 years, 30-39 years, 40-49 years, and 50 years and older. In the United States, a higher number of cases were observed in the age group 15-19 years compared to others, comprising around 5.85 million cases in 2023.
• The emerging drug SB204 is expected to launch in the US market by 2027, the drug has the potential to reduce the disease burden of acne vulgaris in the forecasted years.

This report delivers an in-depth understanding of the Acne Vulgaris, historical and forecasted epidemiology as well as the Acne Vulgaris market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Acne Vulgaris market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Acne Vulgaris market size from 2020 to 2034. The report also covers current Acne Vulgaris treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Acne Vulgaris Overview

Acne vulgaris is a chronic inflammatory dermatological condition characterized by pimples, blackheads, and whiteheads on the skin, primarily affecting pilosebaceous units across various age groups, with adolescents being the most commonly affected demographic. The severity of acne can be classified into mild, moderate, and severe based on the presence of non-inflammatory and inflammatory lesions, erythema, and scarring. The pathogenesis involves a multifactorial interplay of hormonal influences, sebum production, follicular hyperkeratinization, bacterial proliferation, and inflammation, exacerbated by genetic predisposition, medications, and environmental factors. Key symptoms include comedones, inflammatory lesions, and scarring. The management of acne is challenging due to various risk factors, emphasizing the need for comprehensive understanding and targeted interventions.

Acne Vulgaris Diagnosis

Diagnosis of acne vulgaris typically involves a thorough clinical examination of the skin to assess the type, severity, and distribution of lesions. In some instances, additional diagnostic procedures are employed to rule out other skin conditions or determine bacterial involvement. These procedures include skin biopsies and microbial cultures. Furthermore, additional tests such as microbial testing, hormonal evaluations, and liver function tests may be conducted in specific cases to provide a comprehensive understanding of the condition.

Acne Vulgaris Treatment

Current acne treatments face significant limitations, including side effects and the need for long-term use. Retinoids, for example, can cause skin irritation, dryness, and photosensitivity, while antibiotics may lead to resistance, and hormonal therapies are not suitable for all patients. Chemical peels, laser treatments, and isotretinoin, while effective, can be harsh on the skin and require careful monitoring. There is a critical need for innovative treatments that are both effective and safe for prolonged use, with minimal adverse effects.

Non-invasive treatments with minimal side effects, such as light-based therapies or topical probiotics, are needed to provide safer alternatives that can be used by a broader population without the risk of severe adverse effects.

Furthermore, acne vulgaris varies significantly among individuals in terms of severity, skin type, and underlying causes, making a one-size-fits-all approach inadequate. Personalized medicine, which tailors treatment based on genetic, environmental, and lifestyle factors, can significantly improve outcomes. Advances in genomics and artificial intelligence hold the potential to revolutionize acne management by developing customized treatment plans that optimize efficacy and minimize side effects. Addressing these unmet needs is essential for enhancing the standard of care and achieving sustainable, long-term management of acne.

Acne Vulgaris Epidemiology

As the market is derived using a patient-based model, the Acne Vulgaris epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Prevalent Cases of Acne Vulgaris, Diagnosed Prevalent Cases of Acne Vulgaris, Severity-specific Diagnosed Prevalent Cases of Acne Vulgaris, Gender-specific Diagnosed Prevalent Cases of Acne Vulgaris, and Age-specific Diagnosed Prevalent Cases of Acne Vulgaris in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• In 2023, an estimated ~140,217 thousand prevalent cases of Acne Vulgaris occurred across the 7MM, with approximately 69.50 million cases attributed to the US alone. These numbers are expected to increase steadily throughout the forecast period.
• The categorization based on gender, showed that diagnosed prevalent cases in females were higher than in males in the 7MM. The female-diagnosed prevalent cases accounted for 63% of the total cases in the 7MM.
• The prevalent cases of acne vulgaris were sub-segmented further based on the severity of the acne as mild, moderate, and severe. In 2023, the highest diagnosed prevalent cases of acne vulgaris were reported as moderate (45%), whereas there were least cases in the severe (10%) segment in the 7MM.

Acne Vulgaris Drug Chapters

The drug chapter segment of the Acne Vulgaris report encloses a detailed analysis of Acne Vulgaris off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Acne Vulgaris clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

AKLIEF (Trifarotene)/ CD-5789: Galderma S.A.

Trifarotene, a first-in-class fourth-generation topical retinoid, has been approved by the FDA for the treatment of acne vulgaris in patients aged 9 years and older. This novel retinoid selectively targets retinoic acid receptor gamma (RAR?), the most common RAR found in the skin, making it a more targeted and skin-specific treatment compared to earlier-generation retinoids. Trifarotene is effective in reducing inflammatory lesions on the face and trunk, with significant improvements observed as early as 2 weeks on the face and 4 weeks on the back, shoulders, and chest. The cream is well tolerated, with common adverse reactions including application-site irritation, pruritus, and sunburn. In June 2017, Mayne Pharma and Galderma entered a global licensing agreement for trifarotene, with Galderma retaining rights to develop and commercialize the drug for common dermatological indications like acne vulgaris while Mayne Pharma obtained rights for rare skin disease treatments. In October 2019, the US FDA approved AKLIEF (trifarotene) Cream, 0.005%, for the new retinoid molecule for the treatment of acne.

AMZEEQ (minocycline): Journey Medical Corporation/Vyne Therapeutics Inc.

In 2019, the FDA approved AMZEEQ, a foam formulation of the tetracycline antibiotic minocycline, for treating severe acne in adults and children aged 9 years and older. AMZEEQ is specifically indicated for treating pimples and red bumps (non-nodular inflammatory lesions) linked to moderate to severe acne. This new formulation utilizes Foamix's proprietary Molecule Stabilizing Technology (MST) platform to deliver minocycline in a foam form, offering a more targeted and effective treatment option. Furthermore, minocycline is also approved by the FDA for treating rosacea in adult patients, expanding its therapeutic applications in dermatology. In January 2021, VYNE Therapeutics signed a contract with a major PBM to provide coverage for its topical minocycline products AMZEEQ and ZILXI, with the aim of expanding access for millions of patients with acne and rosacea.

ARAZLO (tazarotene): Bausch Health Companies Inc. / Ortho Dermatologics

ARAZLO, a topical cream containing tazarotene as the active ingredient, is a treatment option for acne vulgaris in patients aged 9 years and older. The cream combines tazarotene with three moisturizers: sebacic acid, light mineral oil, and sorbitol, allowing it to be highly effective against acne while minimizing skin irritation. Additionally, ARAZLO lotion employs patented polymeric emulsion technology, which enhances skin absorption and reduces irritation, making it a comprehensive treatment option for acne patients.

Emerging Drugs

SB204: Pelthos Therapeutics

SB204, an investigational topical nitric oxide-releasing drug developed by Pelthos Therapeutics, has shown promising efficacy in treating acne vulgaris. This topical monotherapy is designed to address the multi-factorial nature of acne, which involves four key pathophysiological factors: inflammation, bacterial colonization, and other factors. SB204 utilizes the same active pharmaceutical ingredient as berdazimer gel 10.3% and is formulated to provide anti-inflammatory and anti-bacterial activity, making it a potential treatment option for acne patients.

B244: AOBiome LLC

B244 is a proprietary topical formulation that incorporates a single strain of beneficial AOB, Nitrosomonas eutropha, developed by AOBiome. This patented formulation is designed to restore the skin microbiome by repopulating it with AOBs that are naturally present in the body but often stripped away by most soaps. Once applied to the skin, B244 converts ammonia into nitrite, which exhibits antibacterial properties, and nitric oxide, a signaling molecule that regulates inflammation and vasodilation. Furthermore, this strain of AOB has been shown to reduce inflammatory and pruritic cytokines, such as IL-4, IL-5, IL-13, and IL-31, which are characteristic of atopic responses, thereby providing a comprehensive treatment option for skin conditions.

DMT310: Dermata Therapeutics

DMT310, developed by Dermata Therapeutics from Spongilla platform technology, is under clinical investigation for the treatment of acne vulagris. The novel product candidate comes from a naturally occurring source of Spongilla lacustris, which has several active ingredients that act by targeting interleukin 17A and 17F. In November 2023, Dermata Therapeutics received an FDA response to its DMT310 Phase II study concentrating on the treatment of medical and cosmetic skin conditions. Currently the drug is being evaluated in Phase III of clinical development for the treatment of acne vulgaris.

Acne Vulgaris Market Outlook

Effective management of acne requires a comprehensive approach that addresses the underlying factors and incorporates lifestyle modifications, topical treatments, and systemic therapies as needed. The current treatment market for acne vulgaris is driven by the increasing prevalence of acne, rising awareness of skincare, and the need for alternative treatment options.

Key developments include a diverse array of topical and systemic therapies, each targeting specific aspects of the complex pathogenesis of this common skin disorder. Topical treatments such as salicylic acid and azelaic acid are used to improve skin moisture, reduce inflammation, and eliminate comedones. Systemic therapies, including oral antibiotics like tetracycline and doxycycline, oral retinoids like isotretinoin, and hormonal agents like spironolactone, are utilized for severe cases.

Keeping in mind, that the current strategies are insufficient to manage the disease burden there is an urgent need for the development of novel therapy. The market awaits the launch of the potential entities SB204 (Pelthos Therapeutics), DMT310 (Dermata Therapeutics), B244 (AOBiome LLC.), BPX-01 (Timber Pharmaceuticals), BTX-1503 (Botanix Pharmaceuticals), and others that would be helpful in the reduction of affected population accomplishing a critical global public health need, if proved to be efficacious.

• The total market size of Acne Vulgaris in the 7MM was approximately USD 4.25 billion in 2023 and is projected to increase during the forecast period (2024-2034).
• Among European countries, Germany accounted for the maximum market size of USD 311 million in 2023 while the UK occupied the bottom of the ladder in the same year with USD 121 million.
• The market size of Acne Vulgaris in Japan was nearly USD 316 million in 2023, which is further expected to increase by 2034.

Acne Vulgaris Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, DMT310 in the US is expected to be launched by 2026 with a peak share of 2%. DMT310 is anticipated to take 7 years to peak with medium-fast uptake.

Acne Vulgaris Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Acne Vulgaris emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Acne Vulgaris evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from the Department of Dermatology, Emory University School of Medicine, Atlanta, Georgia; Wake Forest University School of Medicine, North Carolina; Department of Dermatology and Venereology, University Clinic Hamburg-Eppendorf, Hamburg, Germany; La Roche-Posay Pharmaceutical Laboratory, France, and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Acne Vulgaris market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Acne Vulgaris, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Acne Vulgaris market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Acne Vulgaris market.

Acne Vulgaris Report Insights

• Patient Population
• Therapeutic Approaches
• Acne Vulgaris Pipeline Analysis
• Acne Vulgaris Market Size and Trends
• Existing and Future Market Opportunity

Acne Vulgaris Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Acne Vulgaris Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Acne Vulgaris Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the Acne Vulgaris total market size, the market size by therapies, and market share (%) distribution in 2020, and how it would all look in 2034? What are the contributing factors for this growth?
• Will the coverage of drugs depend on their efficacy in Acne Vulgaris?
• What will be the impact on the market with the launch of emerging drugs?
• Which is going to be the largest contributor to the market in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Acne Vulgaris? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Acne Vulgaris?
• What is the historical and forecasted Acne Vulgaris patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• Why do patients develop persistent Acne Vulgaris symptoms? Why is the current year diagnosis rate not high?
• Which type of severity is the largest contributor in patients affected with Acne Vulgaris?
• What factors are affecting the increase in the diagnosis of Acne Vulgaris?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Acne Vulgaris? What are the current treatment guidelines for the treatment of Acne Vulgaris in the US and Europe?
• How many companies are developing therapies for the treatment of Acne Vulgaris?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Acne Vulgaris?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Acne Vulgaris?
• What will be the impact on the market after the expected patent expiry of the emerging drug?
• What is the cost burden of off-label therapies on patients?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of recommended therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted market of Acne Vulgaris?

Reasons to Buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Acne Vulgaris Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Acne Vulgaris Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Acne Vulgaris market?

The Acne Vulgaris market is quite robust. The major layers are AOBiome LLC, Botanix Pharmaceuticals, Dermata Therapeutics, and others which are currently developing drugs for the treatment of Acne Vulgaris.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Acne Vulgaris market?

The increase in diagnosed prevalent cases of Acne Vulgaris and the launch of emerging therapies are attributed to be the key drivers for increasing the Acne Vulgaris market.

5. What is the expected impact of emerging therapies or advancements in Acne Vulgaris treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Acne Vulgaris treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Acne Vulgaris market.