겨드랑이 다한증 시장 - 인사이트, 역학, 예측(2034년)

Key Highlights:

• Axillary hyperhidrosis is a form of primary focal hyperhidrosis characterized by excessive sweating of the underarms (armpits) not related to heat or exercise.
• It is the most prevalent subtype of primary focal hyperhidrosis, often serving as the initial and most disruptive presentation due to its visible impact on daily life, clothing, and social interactions.
• A wide range of nonsurgical (e.g., topical, systemic) treatments is available for patients with axillary hyperhidrosis.
• Treatment options include aluminum chloride, sofpironium, anticholinergics, microwave therapy, radiofrequency therapy, endoscopic thoracic sympathectomy, liposuction and excision, photodynamic therapy, lasers, and others.
• Drugs approved for the treatment of axillary hyperhidrosis include QBREXZA (Journey Medical Corporation), Brella sweat control patch (Candesant Biomedical), SOFDRA (Botanix Pharmaceuticals), and others.
• Since 2018, topical anticholinergics have become foundational for axillary disease, with SOFDRA's 2024 FDA approval adding a second U.S. option and regional alternatives in the EU and Japan.
• Despite the availability of several FDA-approved therapies for axillary hyperhidrosis, the emerging development pipeline remains limited.
• Dermatarx completed a proof-of-concept Phase I clinical trial using DMT410 in combination with Botox for the treatment of primary axillary hyperhidrosis. In this study, 80% of patients achieved a reduction in gravimetric sweat production greater than 50% four weeks after a single treatment.
• With almost 40% of the hyperhidrosis market currently being treated with intradermal injections of botulinum toxin, there could be a significant opportunity for DMT410 to break into this market and replace intradermal injections of botulinum toxin.

DelveInsight's "Axillary hyperhidrosis- Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of Axillary hyperhidrosis epidemiology, market, and clinical development in Axillary hyperhidrosis. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the Axillary hyperhidrosis cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain ), the United Kingdom, and Japan.

The Axillary hyperhidrosis market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Axillary hyperhidrosis market size from 2020 to 2034 in 7MM. The report also covers current Axillary hyperhidrosis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

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

Axillary Hyperhidrosis Understanding and Treatment Algorithm

Axillary Hyperhidrosis Overview and Diagnosis

Axillary hyperhidrosis is a chronic condition characterized by excessive, uncontrollable sweating of the underarms, beyond what is necessary for thermoregulation. It is the most common subtype of primary focal hyperhidrosis, often beginning in adolescence or early adulthood. The condition typically occurs symmetrically in both armpits and is not triggered by heat or exercise, but rather by emotional or unknown stimuli. It significantly impacts quality of life, leading to social embarrassment, occupational difficulties, and emotional distress.

Axillary hyperhidrosis is diagnosed clinically, based on persistent, excessive underarm sweating without an identifiable cause, typically present for over six months. Key features include bilateral, symmetrical sweating that impairs daily life, often beginning before age 25 and stopping during sleep. The Hyperhidrosis Disease Severity Scale (HDSS) helps assess symptom impact. In unclear cases, tests like the starch-iodine test or gravimetric measurement can confirm severity. Secondary causes-such as hyperthyroidism, diabetes, or neurological disorders-should be ruled out if sweating is generalized, asymmetric, or occurs during sleep or later in life.

Axillary hyperhidrosis Treatment

First-line treatment includes aluminum chloride hexahydrate (e.g., DRYSOL), applied nightly to block sweat glands. If ineffective, FDA-approved topical anticholinergics like QBREXZA (wipes) and SOFDRA (gel) are used. For more widespread cases, oral anticholinergics such as OXYBUTYNIN or GLYCOPYRROLATE may help but can cause side effects. BOTOX injections offer 4-14 months of relief by blocking nerve signals to sweat glands. Other options include MIRADRY (microwave therapy), BRELLA (a quick office patch), and laser treatments. In severe cases, endoscopic thoracic sympathectomy (ETS) may be considered, though it carries significant risks and is used as a last resort.

Axillary hyperhidrosis Epidemiology

The Axillary hyperhidrosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as Total diagnosed prevalent cases of axillary hyperhidrosis, type-specific cases of axillary hyperhidrosis, age-specific cases of axillary hyperhidrosis, gender-specific cases of axillary hyperhidrosis, and site-specific cases of axillary hyperhidrosis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• In the UK, hyperhidrosis is considered common by the NHS, with estimates suggesting it affects between 1% and 3% of the population.
• The prevalence of healthcare-seeking behavior for hyperhidrosis was higher among women (47.5%) compared to men (28.6%).
• Axillary hyperhidrosis affects 51% of patients, either as an isolated condition or in combination with sweating in other areas, with 9.5% experiencing axillary sweating alone. Palmar hyperhidrosis is seen in 25% of cases, also as isolated or combined involvement, but only 1% of patients have palmar hyperhidrosis as the sole affected area.
• Primary hyperhidrosis is not solely dictated by the season, with 65% of patients reporting that their sweating bothers them equally throughout the year.
• In Germany, axillary hyperhidrosis has a notably high prevalence, affecting approximately 16% of the population.

Axillary hyperhidrosis Drug Chapters

The drug chapter segment of the Pediatric Axillary hyperhidrosis report encloses a detailed analysis of Axillary hyperhidrosis marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into Axillary hyperhidrosis pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

SOFDRA: Botanix Pharmaceuticals

In June 2024, SOFDRA received approval from the FDA for the treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older. SOFDRA is a topical prescription gel that differs from traditional antiperspirants by working through a distinct mechanism and containing no aluminum. Its active ingredient, sofpironium (12.45%), is an anticholinergic agent that blocks nerve signals to the sweat glands, preventing their activation. Applied directly to the underarms, SOFDRA targets sweating at the source with limited systemic absorption. Its novel chemical structure distinguishes it from oral anticholinergics, which often cause side effects such as dry mouth, muscle cramps, or urinary retention. By acting locally, SOFDRA minimizes the risk of systemic side effects, though it must be used as directed and should not be combined with other anticholinergic products to avoid potential adverse effects.

QBREXZA: Journey Medical Corporation

QBREXZA (glycopyrronium tosylate) is a prescription topical anticholinergic approved for the treatment of primary axillary hyperhidrosis in patients aged 9 and older. It is applied once daily using a pre-moistened cloth to clean, dry underarms, where it works by blocking nerve signals that activate sweat glands. This targeted mechanism provides a localized, non-invasive alternative to traditional antiperspirants, offering significant relief for individuals whose underarm sweating interferes with daily functioning, social confidence, and emotional well-being. While generally well-tolerated, potential side effects include dry mouth, blurred vision, and skin irritation, and it should be avoided in individuals with conditions contraindicated for anticholinergic use.

Axillary Hyperhidrosis Market Outlook

Hyperhidrosis, affecting approximately 2.8% of the US population, remains an under-recognized condition with a significant impact on quality of life and limited treatment options. Despite its prevalence and burden, there are no FDA-approved disease-modifying therapies, highlighting a clear unmet medical need. Current treatments-ranging from topical agents and oral medications to procedures like botulinum toxin injections and microwave therapy-often offer only temporary relief and are limited by side effects or recurrence. With few companies actively developing targeted therapies, there is a substantial opportunity for innovation in this space. Advancing safe, effective, and durable treatments that address the underlying mechanisms of hyperhidrosis could significantly improve patient outcomes and fill a critical therapeutic gap.

Axillary hyperhidrosis drug uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Axillary hyperhidrosis Activities

The report provides insights into different therapeutic candidates in the Phase III and Phase II stages. 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 Axillary hyperhidrosis therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Professors, and Others.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as UT Health San Antonio, MD Anderson Cancer Center, Virginia Mason Medical Center, University of Bari, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Axillary hyperhidrosis market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

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.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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 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

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used 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, a descriptive overview of Axillary hyperhidrosis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Axillary hyperhidrosis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our 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 in shaping and driving the 7MM Axillary hyperhidrosis market.

Axillary hyperhidrosis Report Insights

• Patient Population
• Therapeutic Approaches
• Axillary Hyperhidrosis Pipeline Analysis
• Axillary Hyperhidrosis Market Size and Trends
• Existing and future Market Opportunity

Axillary hyperhidrosis Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Axillary hyperhidrosis Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Axillary Hyperhidrosis Report Assessment

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

FAQs:

• What is the historical and forecasted Axillary hyperhidrosis patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination of treatment approaches will have a significant impact on the Axillary hyperhidrosis drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of Axillary hyperhidrosis?
• How many companies are developing therapies for the treatment of Axillary hyperhidrosis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Axillary hyperhidrosis 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.
• Understand the existing market opportunities 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.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives 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.

Table of Contents

1. Key Insights

2. Report Introduction

3. Epidemiology and Market Forecast Methodology

4. Axillary hyperhidrosis: Market Overview at a Glance

• 4.1. Market Size (%) of Axillary Hyperhidrosis in 2020
• 4.2. Market Size (%) of Axillary Hyperhidrosis in 2034

5. Executive Summary

6. Key Events

7. Disease Background and Overview: Axillary Hyperhidrosis

• 7.1. Introduction
• 7.2. Causes
• 7.3. Pathophysiology
• 7.4. Symptoms
• 7.5. Risk Factor
• 7.6. Diagnosis

8. Treatment and Management

• 8.1. Treatment Guidelines

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Total Incident Population of Axillary Hyperhidrosis
• 9.4. United States
  • 9.4.1. Total Diagnosed Prevalent Cases of Axillary Hyperhidrosis in the United States
  • 9.4.2. Type-specific Cases of Axillary Hyperhidrosis in the United States
  • 9.4.3. Age-specific Cases of Axillary Hyperhidrosis in the United States
  • 9.4.4. Gender-specific Cases of Axillary Hyperhidrosis in the United States
  • 9.4.5. Site-specific Cases of Axillary Hyperhidrosis in the United States
• 9.5. EU4 and the UK
  • 9.5.1. Total Diagnosed Prevalent Cases of Axillary Hyperhidrosis in the EU4 and the UK
  • 9.5.2. Type-specific Cases of Axillary Hyperhidrosis in the EU4 and the UK
  • 9.5.3. Age-specific Cases of Axillary Hyperhidrosis in the EU4 and the UK
  • 9.5.4. Gender-specific Cases of Axillary Hyperhidrosis in the EU4 and the UK
  • 9.5.5. Site-specific Cases of Axillary Hyperhidrosis in the EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Diagnosed Prevalent Cases of Axillary Hyperhidrosis in Japan
  • 9.6.2. Type-specific Cases of Axillary Hyperhidrosis in Japan
  • 9.6.3. Age-specific Cases of Axillary Hyperhidrosis in Japan
  • 9.6.4. Gender-specific Cases of Axillary Hyperhidrosis in Japan
  • 9.6.5. Site-specific Cases of Axillary Hyperhidrosis in Japan

10. Patient Journey

11. Marketed Drugs

• 11.1. Key Cross Competition
• 11.2. SOFDRA: Botanix Pharmaceuticals
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Other Developmental Activities
  • 11.2.4. Clinical Developmental Activities
  • 11.2.5. Safety and Efficacy
• 11.3. QBREXZA: Journey Medical Corporation
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Developmental Activities
  • 11.3.4. Clinical Developmental Activities
  • 11.3.5. Safety and Efficacy

Continued in the report...

13. Axillary Hyperhidrosis: Market Size

• 13.1. Key Findings
• 13.2. Market Outlook
• 13.3. Conjoint Analysis
• 13.4. Key Market Forecast Assumptions
  • 13.4.1. Cost Assumptions and Rebates
  • 13.4.2. Pricing Trends
  • 13.4.3. Analogue Assessment
  • 13.4.4. Launch Year and Therapy Uptake
• 13.5. Total Axillary Hyperhidrosis Market Analysis: 7MM
• 13.6. United States
  • 13.6.1. Total Market Size of Axillary Hyperhidrosis in the United States
  • 13.6.2. Market Size of Axillary Hyperhidrosis by Therapies in the United States
• 13.7. EU4 and the UK
  • 13.7.1. Total Market Size of Axillary Hyperhidrosis in EU4 and the UK
  • 13.7.2. Market Size of Axillary Hyperhidrosis by Therapies in EU4 and the UK
• 13.8. Japan
  • 13.8.1. Total Market Size of Axillary Hyperhidrosis in Japan
  • 13.8.2. Market Size of Axillary Hyperhidrosis by Therapies in Japan

14. Unmet Needs

15. SWOT Analysis

16. KOL Views

17. Market Access and Reimbursement

• 17.1. United States
• 17.2. EU4 and the UK
• 17.3. Japan

18. Appendix

• 18.1. Bibliography
• 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight