Axillary Hyperhidrosis - Market Insight, Epidemiology and Market Forecast - 2030
|出版商||DelveInsight Business Research LLP||商品編碼||966663|
|出版日期||按訂單生產||內容資訊||英文 94 Pages
|腋下多汗症市場:洞察，流行病學及2030年前的預測 Axillary Hyperhidrosis - Market Insight, Epidemiology and Market Forecast - 2030|
|出版日期: 按訂單生產||內容資訊: 英文 94 Pages||
DelveInsight's 'Axillary Hyperhidrosis (AH) -Market Insights, Epidemiology, and Market Forecast-2030' report delivers an in-depth understanding of the Axillary Hyperhidrosis (AH), historical and forecasted epidemiology as well as the Axillary Hyperhidrosis (AH) market trends in the United States.
The Axillary Hyperhidrosis (AH) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted US Axillary Hyperhidrosis (AH) market size from 2017 to 2030. The Report also covers current Axillary Hyperhidrosis (AH) treatment practice/algorithm, market drivers, market barriers, unmet medical needs, SWOT analysis to curate the best of the opportunities, and assesses the underlying potential of the market.
Study Period: 2017-2030
Axillary Hyperhidrosis (AH) Overview
Axillary hyperhidrosis, a form of excessive sweating from armpits, is a disease that affects the social and occupational lives of many people on all continents. Axillary hyperhidrosis begins during the teenage years and equally affects men and women. Hyperhidrosis initially begins from the hands and feet during early childhood, whereas axillary hyperhidrosis often starts in adolescence. When associated with axillary malodor, it is known as bromhidrosis. The sweat glands-small tubular structures in the skin-secrete sweat onto the skin via a duct. Eccrine sweat glands are distributed throughout the body, and they secrete sweat directly onto the surface of the skin. Apocrine sweat glands are 10 times larger than eccrine sweat glands. They are localized in the axilla (underarms) and perianal areas.
The various causes of hyperhidrosis can be compounded by anxiety and stress. They can range from moderate moisture to severe dripping, which can, in turn, exacerbate the associated anxiety and stress. Excessive armpit sweating may be caused by genetic predisposition, medications, neurologic/metabolic, or other systemic diseases, hormonal changes such as menopause, social anxiety, stress, nervousness, or unknown factors.
Axillary Hyperhidrosis (AH) Diagnosis
There are no controlled studies on the sensitivity and specificity of the history, physical examination, or testing to diagnose primary hyperhidrosis accurately or quantify its severity. Criteria for diagnosis of primary hyperhidrosis include focal, visible, and excessive sweating for longer than 6 months without apparent cause, and at least two of the following: bilateral and symmetric sweating, impairment of daily activities, an occurrence at least once per week, age of onset younger than 25 years, no occurrence during sleep, and positive family history.
Continued in the report…..
Axillary Hyperhidrosis (AH) Treatment
The choice of treatment will depend on how severe the sweating is, the affordability of treatment, and whether a permanent solution is desired. The International Hyperhidrosis Society (IHHS) recommends a step-therapy approach in which patients would use conservative therapies first and step up to more invasive treatments depending on their responses.
First-line treatment: Topical antiperspirants and Qbrexza are considered as first-line treatment of primary axillary hyperhidrosis. Patients with primary axillary hyperhidrosis often use nonprescription products such as zirconium salts. Patients with severe disease may opt for botulin toxin injections.
Second-line treatment: Botox treatment is considered a second-line treatment in patients who do not respond to topical medications. Further, oral pharmacological agents such as anticholinergics, beta-blockers, and benzodiazepines are also considered. Anticholinergics work quickly, with most individuals seeing some improvement within a week of starting. Limitations of their use include large dose adjustments and subsequent adverse effects (AEs), such as xerostomia, blurred vision, sedation, and urinary retention.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Axillary Hyperhidrosis, Diagnosed Prevalence of Axillary Hyperhidrosis, Age-specific Diagnosed Prevalent Cases of Axillary Hyperhidrosis, Type-specific Diagnosed Prevalent Cases of Axillary Hyperhidrosis, and Severity-specific Diagnosed Prevalent Cases of Axillary Hyperhidrosis in the United States from 2017 to 2030.
The epidemiology segment also provides the Axillary Hyperhidrosis (AH) epidemiology data and findings across the United States.
The drug chapter segment of the Axillary Hyperhidrosis (AH) report encloses the detailed analysis of Axillary Hyperhidrosis (AH) current therapies, mid-phase, and late-stage pipeline drugs. It also helps to understand the Axillary Hyperhidrosis (AH) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug, and the latest news and press releases.
Axillary Hyperhidrosis (AH) Marketed Drugs
Botox (OnabotulinumtoxinA): Allergan
Botox (onabotulinumtoxinA) is an injectable, purified protein, acetylcholine release inhibitor, and a neuromuscular blocking agent. Botulinum toxin A is one of the highly effective neurotoxins produced by the bacterium Clostridium botulinum. It is administered intradermally and is approved by the US FDA for the treatment of PAH in patients unable to obtain relief using topical agents. It is also approved for various other conditions such as blepharospasm, strabismus, cervical dystonia, upper limb spasticity, chronic migraines, urinary incontinence in people with neurologic conditions, overactive bladder, lower limb spasticity, etc.
Products detail in the report…
Qbrexza (Glycopyrronium tosylate): Dermira
Qbrexza is a topical, once-daily anticholinergic cloth approved by the US FDA for the treatment of PAH in adult and pediatric patients 9 years of age and older. Each pouch of Qbrexza contains 105 mg glycopyrronium tosylate, equivalent to 66 mg of glycopyrronium.
The International Hyperhidrosis Society algorithm for the treatment of PAH included Qbrexza as the first-line treatment along with topical antiperspirants. Qbrexza was shown in clinical trials to improve sweating symptoms as soon as 1 week after starting the regimen. Studies also found that patients using Qbrexza wipes once daily for 4 weeks improved their "sweating severity" by nearly 25-30% (compared with 4-5% with placebo) and that measured sweat volume was reduced by 50% or more (in most patients.) The wipes were well-tolerated, and any reported side effects were primarily mild to moderate.
Products detail in the report…
Axillary Hyperhidrosis (AH) Emerging Drugs
WO3970 (1% Glycopyrronium Bromide): Dr. August Wolff GmbH & Co. KG Arzneimittel
WO3970 is a topical cream containing 1% glycopyrronium bromide. Glycopyrronium bromide is a small molecule, quaternary ammonium salt, muscarinic anticholinergic agent. It inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands (e.g., sweat glands), and to a limited degree, in the autonomic ganglia.
Glycopyrronium is also approved as the medicated cloth for the treatment of primary axillary hyperhidrosis (PAH). Dr. August Wolff GmbH is currently evaluating WO3970 in phase III and phase II trials to treat PAH. The first part of an international clinical multicenter study (phase IIIa) was successfully completed in 2019. The active ingredient-containing cream is currently being tested in a second part to obtain further information on application safety. The submission of documents for approval as a medicinal product in EU countries is planned for the end of 2020. The phase I results shows that it is effective in reducing sweat.
Products detail in the report…
Sofpironium Bromide (BBI-4000): Brickell Biotech/Kaken Pharmaceutical
Sofpironium bromide is a small molecule, topical anticholinergic product candidate. It is developed to be delivered as a gel formulation in a metered-dose pump with an applicator that allows patients to avoid unwanted direct contact to the hands or other non-axillary body parts. Brickell Biotech intends to develop it for once-daily treatment of PAH in adult and pediatric patients 9 years of age and older. It acts by binding to the M3 acetylcholine receptor and potentially inhibiting the production of sweat.
The company planned to evaluate sofpironium bromide gel in phase III clinical trials. The planned program will be comprised of two pivotal phase III trials to evaluate approximately 350 subjects per trial with primary axillary hyperhidrosis in the US. The first phase III study is expected to begin in the fourth quarter of 2020. Brickell Biotech and its development partner in Asia, Kaken Pharmaceutical, conducted 19 clinical trials of sofpironium bromide gel that encompass over 1,300 subjects in the United States and Japan. In January 2020, Kaken submitted a new drug application (NDA) for approval in Japan of sofpironium bromide for PAH. The company recently published the results of a phase IIb trial showing a significant reduction in hyperhidrosis severity and an acceptable safety profile. The company also evaluated sofpironium bromide in palmar hyperhidrosis in the phase II clinical trial.
Products detail in the report…
DMVT-504 (THVD-102, Oxybutynin/pilocarpine): Dermavant Sciences/TheraVida
DMVT-504 (THVD-102, RVT-504) is a combination of oxybutynin with a muscarinic agonist (pilocarpine) in a twice-daily oral formulation. Studies of the muscarinic antagonist, oxybutynin, have shown efficacy in hyperhidrosis, but it is seldom used due to poor patient tolerance, most commonly dry mouth. In THVD-102, TheraVida used proprietary technology that controls the release and dosing of the muscarinic agonist (pilocarpine) to reduce the frequency and severity of dry mouth possibly, other side effects. This is expected to improve patient compliance and clinical outcomes. DMVT-504 (THVD-102) evaluated in phase II clinical trial, and the results show that it effectively reduces primary focal hyperhidrosis, including axillary and palmar sweating.
Products detail in the report…
The treatment of axillary hyperhidrosis involves antiperspirants Qbrexza, Botox, miraDry, oral medications, surgery, and other procedures.
The first line-of-defense against excessive underarm sweating are antiperspirants. Antiperspirants are non-invasive, topical, and are available in several different strengths, including "regular" over-the-counter products, "clinical strength" over-the-counter products, and perhaps even prescription antiperspirants. The recent advent of clinical strength antiperspirants have shown the same level of sweat management as prescription products, but with much less irritation. Drysol (aluminum chloride [hexahydrate] 20% topical solution) is approved by the US FDA as an astringent to be used to aid in the management of axillary hyperhidrosis.
In 2018, the US FDA approved Qbrexza (glycopyrronium tosylate), an anticholinergic, for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. It is a once-daily anticholinergic cloth containing 105 mg glycopyrronium tosylate, equivalent to 66 mg of glycopyrronium. The International Hyperhidrosis Society recommends Qbrexza and topical antiperspirants as the first-line treatment for PAH.
Botox (onabotulinumtoxinA) is an injectable, purified protein, acetylcholine release inhibitor, and a neuromuscular blocking agent. It is administered intradermally and approved by the US FDA for the treatment of PAH in patients, who were unable to obtain relief using topical agents. Several other versions of botox such as Myobloc, Dysport, Xeomin, etc. are available in the US. However, they are not approved for the treatment of axillary hyperhidrosis. It is usually preferred for patients failed to topical therapies or have severe disease. In January 2011, the miraDry system was cleared by the FDA through the 510(k) process for treating PAH. This is a microwave device designed to heat tissue at the dermal-hypodermal interface, the location of the sweat glands. Treatment consists of two sessions of approximately 1 h in duration.
Oral medications such as anticholinergics, beta-blockers, and benzodiazepines work systemically to reduce sweating. They are usually referred to patients who do not benefit from other therapies like clinical strength antiperspirants, iontophoresis, Botox, or a customized combination of these. Anticholingergics include glycopyrrolate, oxybutynin, benztropine, propantheline, etc. Long-term use of anticholinergics is found to have a potential link between the developments of dementia and/or brain atrophy.
Most of the patients get benefited from antiperspirants, Botox injections, miraDry, or a combination of these hyperhidrosis treatments (or these treatments combined with an oral medication). In most severe cases, patients may seek a surgical approach to treat their axillary hyperhidrosis, such as excision, curettage, liposuction, and laser. Combinations of curettage and central excision, or of curettage and liposuction may be used, as well as combinations of liposuction and laser treatments. Dermatologists often have good results with these techniques. There are few approved therapies and procedures by the US FDA for this indication such as Drysol, botulinum toxin (Botox), miraDry, and Qbrexza. According to DelveInsight, ICCA US is expected to change in the study period 2017-2030.
This section provides the total Axillary Hyperhidrosis (AH) market size and; market size by therapies in the United States.
This section focuses on the rate of uptake of the drugs expected to get launched in the market during the study period 2017-2030. The analysis covers Axillary Hyperhidrosis (AH) market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Axillary Hyperhidrosis (AH) Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Axillary Hyperhidrosis (AH) emerging therapies.
Reimbursement Scenario in Axillary Hyperhidrosis (AH)
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Axillary Hyperhidrosis (AH) market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies: