Axillary Hyperhidrosis (AHH) - Market Insights, Epidemiology and Market Forecast - 2032

Key Highlights:

• Axillary hyperhidrosis (AHH), characterized by excessive underarm sweating, is an uncontrollable, annoying, embarrassing, and isolating problem. It significantly affects one's psychological and physical health and occupational life. From the discomfort of sweat running down one's sides to the embarrassment of obvious sweat stains to the fear of being “discovered,” uncontrollable underarm sweating can often feel like ruining one's life.
• In 2022, the market size of AHH was highest in the US, accounting for approximately USD 500 million, which is further expected to increase by 2032.
• The main genes linked to hyperhidrosis are butyrylcholinesterase (BCHe) and Cholinergic Receptor Nicotinic Alpha-7 subunit (CHRNA7). Both genes influence the activity and production of acetylcholine, and mutations of these genes can lead to abnormal neurotransmitter production
• Currently, there is no cure for Axillary Hyperhidrosis (AH); many products, medications, and home remedies exist to help minimize underarm sweat. Topical antiperspirant treatments are the recommended first-line treatment being the least expensive. However, they are not as effective as the other treatments in the long term and cause skin irritations. Botulinum toxin A injections are the recommended second-line treatment for patients who fail topical treatments.
• As per the International Hyperhidrosis Society Clinical Guidelines for the Treatment of Primary Focal Axillary Hyperhidrosis, the general recommendation is to try more conservative therapy before resorting to invasive treatment. For many patients, treatment will begin with topical antiperspirants starting with over-the-counter “clinical strength” products (active ingredient often zirconium salts) and then prescription products.
• Oral systemic medications, including anticholinergics (glycopyrrolate, oxybutynin, and propantheline), propranolol, clonidine, and diltiazem may be used to treat primary axillary hyperhidrosis but require patient education regarding potential side effects (such as dry mouth, blurred vision, urinary retention, tachycardia, and constipation).
• QBREXZA (glycopyrronium) was approved by the US FDA in 2018. Recently in 2022, Journey Medical Corporation received notice from its exclusive licensing partner in Japan, Maruho Co., Ltd. (“Maruho”), that Japan's Ministry of Health, Labor and Welfare (“MHLW”) approved RAPIFORT Wipes 2.5% (glycopyrronium tosylate hydrate) to treat primary axillary hyperhidrosis.
• Research on AHH still has a lot of opportunity for improvement as it is often underdiagnosed and understudied as a disease. QBREXZA (glycopyrronium) is US FDA approved, but its safety in children below 9 years of age is unknown. Moreover, it has various side effects, including blurred vision and dehydration.
• The emerging therapies in the market for AHH include ECCLOCK (Botanix Pharmaceuticals) and others that might create a significant positive shift in the AHH market size.

This “Axillary hyperhidrosis (AHH) - Market Insights, Epidemiology and Market Forecast - 2032” report delivers an in-depth understanding of historical and forecasted epidemiology as well as market trends of AHH in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

Axillary hyperhidrosis (AHH) market report provides current treatment practices, emerging drugs, market share of individual therapies, current and forecasted 7MM AHH market size from 2019 to 2032. The report also covers current AHH treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered

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

Study Period: 2019-2032

Axillary hyperhidrosis (AHH) Disease Understanding and Treatment

Axillary hyperhidrosis (AHH) Overview

As per International Hyperhidrosis Society, axillary hyperhidrosis is defined by excessive underarm sweating. It is an uncontrollable, annoying, embarrassing, and isolating problem. Hyperhidrosis is categorized as either primary or secondary hyperhidrosis. Primary hyperhidrosis is idiopathic and is localized in a bilateral and symmetrical pattern affecting the axilla, palms, soles, and face. Secondary hyperhidrosis is usually focal or generalized due to underlying medical conditions.

In the US population, axillary hyperhidrosis (AHH) affects about 3.12%, of whom about 52% found sweating to interfere with daily activities and is barely tolerable (Sammons & Khachemoune, 2017).

Axillary hyperhidrosis (AHH) diagnosis

The diagnosis of Axillary hyperhidrosis (AHH) is based on Gravimetric testing (literally weighing the moisture on a filter paper, which is tedious and impractical in the clinical setting), Minor-starch-iodine test, which consists of placing starch and iodine on the area, and Ninhydrin test, which is based on the principle that ninhydrin reacts with amino acids in sweat.

Axillary hyperhidrosis (AHH) treatment

For the management and treatment of axillary hyperhidrosis, the goal is to reduce sweat production and sweat glands and ultimately to ameliorate symptoms and improve quality of life. A wide range of nonsurgical (e.g., topical, systemic) and surgical treatments are available for patients with focal hyperhidrosis.

Topical antiperspirant treatments are the recommended first-line treatment being the least expensive. However, they are not as effective as the other treatments in the long term and cause skin irritations. Botulinum toxin A injections are the recommended second-line treatment for patients who fail topical treatment.

Topical cryotherapy using a surface nitrous oxide cryoprobe applicator has also been tried with the rationale of freeze-damaging the sweat glands.

Microwave thermolysis is being used to treat hyperhidrosis. MiraDry is a US FDA-approved device that provides long-term efficacy with minimal transient side effects of local inflammation.

Surgery is advised when other conventional therapies fail. Local surgical approaches include excision, curettage, liposuction, and/or a combination. Conservative excision, called “Shelly procedure,” scores over radical excision, which may lead to scarring and restricted arm movement.

The treatment landscape of AHH is expected to change substantially and experience growth. The upcoming launch of innovative therapies such as ECCLOCK (Botanix Pharmaceuticals) and others are expected to drive the market further.

Axillary Hyperhidrosis (AHH) Epidemiology

As the market is derived using a patient-based model, the Axillary hyperhidrosis (AHH) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Hyperhidrosis (HH), Total Diagnosed Prevalent Cases of Axillary Hyperhidrosis (AHH), Type-specific Cases of Axillary Hyperhidrosis (AHH), Age-specific Cases of Axillary Hyperhidrosis (AHH), and Severity-specific Cases of Axillary Hyperhidrosis (AHH) in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

• In 2022, the total diagnosed prevalent cases of hyperhidrosis were 18,000,000 cases in the 7MM.
• Among EU4 and the UK, Germany had the highest diagnosed prevalent cases of Axillary Hyperhidrosis (AHH) cases, with 2,000,000 cases in 2022.
• Among the 7MM, Spain accounted for the least number of total diagnosed prevalent cases of axillary hyperhidrosis (AHH), i.e., 200,000 cases, in 2022.
• In 2022, the total diagnosed prevalent cases of AHH were 2,000,000 cases in Japan.

Axillary Hyperhidrosis (AHH) Drug Chapters

The drug chapter segment of the axillary hyperhidrosis (AHH) report encloses a detailed analysis of AHH-marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the AHH 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

QBREXZA (glycopyrronium): Journey Medical Corporation

QBREXZA (glycopyrronium) is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 and older. It is applied directly to the skin and blocks sweat production by inhibiting sweat gland activation.

The safety of QBREXA in children below 9 years of age is unknown. Moreover, the most common serious adverse effect of using QBREXA wipes are blurred vision and dehydration. Co-administration of QBREXZA with other anticholinergic wipes should also be avoided. It is also not recommended for people with kidney, prostate, or bladder problems, especially if they have trouble passing urine. Thus, there is a need for better anticholinergic treatment options for axillary hyperhidrosis.

AXHIDROX (glycopyrronium bromide): Dr. Wolff Group

AXHIDROX contains the active glycopyrronium and belongs to a group of sweat-reducing medicines called antihidrotics. Axhidrox is used for topical treatment of severe primary axillary hyperhidrosis in adults. In June 2022, Dr. Wolff Group recently announced that its topical cream AXHIDROX, containing 1% glycopyrronium bromide, was granted marketing authorization in Germany to treat severe primary axillary hyperhidrosis in adults.

The administration of AXHIDROX is associated with blurred vision, drowsiness, tiredness, and dizziness. Blurred vision, in particular, may occur if AXHIDROX gets into the eyes.

Note: Detailed current therapies assessment will be provided in the full report of AHH…

Emerging Drugs

ECCLOCK (sofpironium bromide): Botanix Pharmaceuticals

Sofpironium Bromide is an anticholinergic/antimuscarinic drug that blocks sweating at the gland by binding to the receptor, thereby blocking the sweat signal. It is formulated as a gel for topical application. Ecclock is indicated to treat primary axillary hyperhidrosis.

A patented applicator delivers it to the underarms as a gel formulation that allows the patient to avoid direct contact with the drug on their hands. The drug blocks sweating at the gland by binding to the receptor, thereby blocking the sweat signal.

As per this analysis, ECCLOCK (sofpironium bromide) is expected to generate approximately USD 300 million in the 7MM by 2032.

Note: Detailed emerging therapies assessment will be provided in the final report…

Drug Class Insights

A wide range of nonsurgical (e.g., topical, systemic) and surgical treatments are available for patients with focal hyperhidrosis. These treatment modalities vary in their therapeutic efficacy, duration of effect, side effects, cost, and scientific evidence of their efficacy.

Topical antiperspirant treatments are the recommended first-line treatment being the least expensive. However, they are not as effective as the other treatments in the long term and cause skin irritations. Botulinum toxin A injections are the recommended second-line treatment for patients who fail topical treatments. Results last average, between 4 and 9 months, but are painful and costly.

Axillary Hyperhidrosis (AHH) Market Outlook

First-line treatment recommendations for primary focal axillary hyperhidrosis include a topical antiperspirant that may be either a clinical-strength formulation available over the counter or a prescription-strength formulation containing aluminum and zirconium salts, or glycopyrronium cloth, which was approved in June 2018 and made commercially available in October 2018 for treatment of primary axillary hyperhidrosis in the US.

Second-line therapies include focal injections of botulinum toxin A or microwave thermolysis, although botulinum toxin A may be used as a first-line therapy in severe cases. Other options for persistent symptoms of hyperhidrosis include oral systemic therapies, such as glycopyrrolate or oxybutynin, removal of sweat glands (suction curettage), and endoscopic thoracic sympathectomy surgery.

QBREXZA (glycopyrronium) was approved in 2018 by the US FDA for the topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years and older. However, this drug also has various side effects and is not recommended for people with kidney, prostate, or bladder problems, especially if they have trouble passing urine. Thus, there is a need for better anticholinergic treatment options for axillary hyperhidrosis.

As few potential therapies are being investigated to manage axillary hyperhidrosis, predicting that the treatment space will experience significant reconstitution during 2023-2032 is safe. However, the challenges of the rigid and burdensome structure of regulatory authorities will decide the fate of all these pipeline therapies and their impact on overall revenue generation.

Key players such as ECCLOCK (Botanix Pharmaceuticals) and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of AHH.

• In 2022, the US captured the largest market share (57%) of all the 7MM countries.
• In EU4 and the UK, Germany captured the largest market share (16%) in 2022.
• The AHH market size in Japan is expected to increase at a CAGR of 2.8% during the forecast period (2023-2032).

Axillary Hyperhidrosis (AHH) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, for ECCLOCK, which is expected to be launched in the US by 2024, the drug uptake is expected to be slow-medium, with a probability-adjusted peak patient share of ~2% in the US, expected to peak at 8 years from the year of launch.

Axillary Hyperhidrosis (AHH) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. 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 (AHH) emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and 'SME's opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on AHH evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake, along with challenges related to accessibility, include Medical/scientific writers and Professors from renowned universities in the US, Europe, the UK, and Japan.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. New York University School of Medicine, East Virginia Medical School, King's College London, etc., were contacted. Their opinion helped understand and validate current and emerging therapy treatment patterns of AHH 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

The publisher performs Qualitative and Market Intelligence analysis using SWOT 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.

There has been an increase in the prevalence due to the introduction of newer tools such as Axillary Sweating Daily Diary (ASDD) for proper clinical evaluation of patient-reported outcome (PRO) measures to assess the severity of axillary hyperhidrosis in clinical trials. This has reduced underreporting of physicians, contributing to the strengths of the AHH market.

The market of AHH presents wide opportunities as, apart from QBREXZA, there are no better therapies for the anticholinergic class of drugs due to its adverse effects. Pharmaceutical companies have a huge opportunity due to the dearth of approved treatment options in the anticholinergic class of drugs in axillary hyperhidrosis.

Market Access and Reimbursement

The cost of newly approved medications is usually high, so patients escape from proper treatment or opt for off-label and cheap medications. It affects market access to newly launched medications, and reimbursement is crucial. The decision to reimburse often comes down to the 'drug's price relative to the benefit it produces in treated patients. Market access and reimbursement options can differ depending on regulatory status, target population size, the setting of care, unmet needs, the magnitude of incremental benefit claims, and costs.

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, and a descriptive overview of AHH, explaining the definition of AHH, types and risk factors involved in AHH, pathophysiology, and the treatment of AHH.
• Comprehensive insights into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• 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 AHH 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 shape and drive the 7MM AHH market.

Axillary hyperhidrosis (AHH) Report Insights

• Patient Population
• Therapeutic Approaches
• Axillary hyperhidrosis (AHH) Pipeline Analysis
• Axillary hyperhidrosis (AHH) Market Size and Trends
• Existing and future Market Opportunity

Axillary hyperhidrosis (AHH) Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Axillary hyperhidrosis (AHH) Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Axillary hyperhidrosis (AHH) Report Assessment

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

Key Questions Answered

Market Insights

• What was the AHH total market size, the market size by therapies, market share (%) distribution in 2019, and what would it look like by 2032? What are the contributing factors for this growth?
• What kind of uptake the new therapies approved will witness in AHH patients in the coming years?
• Which therapy is going to be the largest contributor by 2032?
• What are the pricing variations among different geographies for approved 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 risk, burdens, and unmet needs of AHH? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to AHH?
• What is the historical and forecasted AHH patient pool in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What is the diagnostic pattern of AHH?
• Which clinical factors will affect AHH?
• Which factors will affect the increase in the diagnosis of AHH?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of AHH? What are the current guidelines for treating AHH in the US, Europe, the UK, and Japan?
• How many companies are developing therapies for the treatment of AHH?
• How many emerging therapies are in the mid-stage and late stage of development for treating AHH?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What key designations have been granted for the emerging therapies for AHH?
• What is the cost burden of approved therapies on the patient?
• 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?
• What are the 7MM historical and forecasted market of AHH?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the AHH 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 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, Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis of emerging therapies to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.