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市場調查報告書
商品編碼
1700181
2032 年皮癬菌病和灰指甲治療市場預測:按產品類型、給藥途徑、治療方法、配銷通路和地區進行的全球分析Dermatophytic Onychomycosis Treatment Market Forecasts to 2032 - Global Analysis By Product Type, Route of Administration, Treatment, Distribution Channel and By Geography |
根據 Stratistics MRC 的數據,全球皮灰指甲治療市場預計在 2025 年將達到 57 億美元,到 2032 年將達到 108 億美元,預測期內的複合年成長率為 9.5%。
皮癬菌灰指甲甲癬的治療主要涉及醫療程序以根除感染指甲的真菌感染。這種疾病由皮癬菌引起,會導致指甲變厚、變色、變弱並最終脫落。治療策略包括全身性抗真菌藥物,如Terbinafine或Itraconazole,有助於從內部消除真菌感染,以及外用溶液,如環吡酮,塗抹於表面。對於頑固的感染疾病,雷射療法或機械去爪等附加治療方法可能有效。
根據美國疾病管制與預防中心 2022 年的數據,灰指甲(又稱皮癬菌性灰指甲)每年在美國影響約 2,600 萬人。
真菌性甲癬的盛行率不斷上升
全球皮癬菌性灰指甲治療市場受到真菌性甲癬感染疾病發病率不斷上升的推動,尤其是在老齡化人口和免疫力缺乏的人群中。糖尿病和周邊血管疾病等治療會增加灰指甲的可能性,從而增加對有效治療的需求。透過診斷宣傳活動和遠端醫療平台提高人們的意識,提高了早期發現率。長期穿著封閉式鞋子和接觸公共空間等生活方式因素進一步加劇了感染的傳播。此外,老年人口的增加,導致指甲變厚、血流量減少,加速了市場的成長。
治療週期長,復發率高
治療時間通常延長至6至12個月,導致患者違規並放棄治療。局部治療不能很好地滲透到指甲中,也不能完全根除真菌。由於生物膜的形成和孢子的持續存在,高復發率(20-30%)降低了患者對現有治療方法的信心。長期治療方法的經濟負擔(包括頻繁就醫)會阻礙患者堅持治療。此外,非處方藥對嚴重病例的療效有限,也增加了患者的挫折感。
新型抗真菌療法的進展
基於奈米粒子的局部製劑等創新技術增強了藥物向指甲床的輸送,提高了療效並縮短了治療時間。福斯拉康唑等肝毒性副作用較少的口服抗真菌藥物的開發受到了患者的偏好。針對真菌細胞和生物膜的聯合治療有望降低復發率。製藥公司和生物技術新興企業之間的合作正在加速基因和雷射療法的研究和開發。角蛋白干擾物等新機制的監管核准將進一步擴大治療選擇。
抗藥性真菌的出現
過度使用Terbinafine等傳統抗真菌藥物導致皮癬菌產生抗藥性,使治療結果變得複雜。與抗生素研究相比,抗真菌藥物的研究管道有限,延誤了抗藥性感染疾病的解決方案。真菌交叉抗藥性機制正在降低新推出的治療方法的療效。識別抗藥性菌株的診斷挑戰阻礙了標靶治療策略。此外,核准下一代抗真菌藥物的監管障礙正在減緩市場對不斷演變的病原體的反應。
疫情擾亂了常規足病護理,延誤了灰指甲的診斷和治療。供應鏈中斷影響了外用和口服抗真菌藥物的供應,尤其是在新興市場。加強衛生措施暫時降低了感染率,但卻將醫療資源從較不緊急的情況中轉移出去。疫情過後,遠距皮膚科平台已成為遠端諮詢和配方更新的熱門選擇。復健工作優先考慮家庭療法的研發投資,以滿足患者對盡量減少就診次數的偏好。
預計軟膏和乳霜市場將在預測期內實現最大幅度成長
由於藥膏和乳霜作為一線治療藥物和方便的商店治療藥物而廣泛普及,預計在預測期內將佔據最大的市場佔有率。它的非侵入性使其對那些不願接受全身性治療和侵入性手術的患者俱有吸引力。滲透促進劑的創新,例如基於尿素的配方,可以提高對指甲的滲透性並提供更好的功效。與處方藥相比,它們的成本效益導致其在低收入地區的採用率不斷提高。然而,由於治療嚴重感染疾病的局限性,其用途僅限於治療輕度至中度病例。
預計在預測期內,製藥業將以最高的複合年成長率成長。
預計在預測期內,療程更短、治癒率更高的先進口服抗真菌藥物的採用將實現最高的成長率。 VT-1161(奧替康唑)等較新的藥物針對真菌特異酵素,從而最大限度地減少對人類細胞的毒性。對於難治性病例,全身性治療的偏好日益增加,支持了這一領域的成長。新興國家醫療支出的增加使得人們獲得處方藥的機會增加。此外,探索脈衝給藥方案的臨床試驗提高了患者的依從性和治療效果。
在預測期內,由於熱帶氣候和人口密度導致的真菌感染疾病高,預計亞太地區將佔據最大的市場佔有率。印度和中國等國家正在發展醫療基礎設施並提高診斷能力。可支配收入的增加使得人們能夠享受優質治療,包括雷射治療。政府為防治被忽視的熱帶疾病而做出的努力優先考慮抗真菌藥物的研究和開發。在公共區域赤腳的習慣等文化因素也導致了該地區的需求。
由於其先進的醫療保健系統和患者對治療方案的高度認知,預計北美將在預測期內見證最高的複合年成長率。各大製藥公司實力雄厚,新療法的推出正在加速。聯合抗真菌藥物的保險覆蓋提高了其可負擔性和普及性。糖尿病和肥胖症的發生率不斷上升,導致灰指甲的流行。對稀有真菌孤兒藥指定的監管激勵將進一步推動市場成長。
According to Stratistics MRC, the Global Dermatophytic Onychomycosis Treatment Market is accounted for $5.7 billion in 2025 and is expected to reach $10.8 billion by 2032 growing at a CAGR of 9.5% during the forecast period. The treatment of dermatophytic onychomycosis involves medical procedures designed to eradicate fungal infections that primarily affect the nails. This condition, caused by dermatophytes, results in nail thickening, discoloration, fragility, and in advanced cases, detachment. Management strategies include systemic antifungal medications like terbinafine and itraconazole, which help eliminate fungal infections internally, and topical solutions such as ciclopirox for surface application. For stubborn infections, additional therapies like laser treatment and mechanical nail removal may be used to enhance effectiveness.
According to the Centre for Disease Control and Prevention in 2022, nail fungus or dermatophytic onychomycosis affects around 26 million people in the U.S. each year.
Rising prevalence of fungal nail infections
The global dermatophytic onychomycosis treatment market is driven by the increasing incidence of fungal nail infections, particularly among aging populations and immunocompromised individuals. Conditions like diabetes and peripheral vascular disease heighten susceptibility to onychomycosis, fueling demand for effective treatments. Rising awareness through diagnostic campaigns and telehealth platforms has improved early detection rates. Lifestyle factors, such as prolonged use of occlusive footwear and exposure to communal spaces, further contribute to infection spread. Additionally, the growing geriatric demographic, prone to nail thickening and reduced blood flow, amplifies market growth.
Long treatment duration and high recurrence rates
Extended therapy periods, often spanning 6-12 months, lead to patient non-compliance and treatment abandonment. Topical solutions struggle with poor nail penetration, resulting in incomplete eradication of fungi. High recurrence rates (20-30%) due to biofilm formation and residual spores diminish patient confidence in existing therapies. The financial burden of prolonged treatment regimens, including frequent clinical visits, discourages adherence. Additionally, limited efficacy of over-the-counter products in severe cases exacerbates frustration among patients.
Advancements in novel antifungal therapies
Innovations like nanoparticle-based topical formulations enhance drug delivery to the nail bed, improving efficacy and reducing treatment timelines. Development of oral antifungals with fewer hepatotoxic side effects, such as fosravuconazole, attracts patient preference. Combination therapies targeting both fungal cells and biofilms show promise in lowering recurrence rates. Partnerships between pharmaceutical firms and biotech startups accelerate R&D in gene-based and laser therapies. Regulatory approvals for novel mechanisms, such as keratin disruptors, further expand therapeutic options.
Emergence of drug-resistant fungal strains
Overuse of conventional antifungals like terbinafine has led to resistant dermatophyte strains, complicating treatment outcomes. Limited antifungal drug pipelines compared to antibacterial research delay solutions for resistant infections. Cross-resistance mechanisms in fungi reduce the effectiveness of newly launched therapies. Diagnostic challenges in identifying resistant strains hinder targeted treatment strategies. Additionally, regulatory hurdles in approving next-generation antifungals slow market response to evolving pathogens.
The pandemic disrupted routine podiatric care, delaying diagnoses and treatments for onychomycosis. Supply chain interruptions affected the availability of topical and oral antifungals, particularly in emerging markets. Increased focus on hygiene practices temporarily reduced infection rates but diverted healthcare resources away from non-urgent conditions. Post-pandemic, tele-dermatology platforms gained traction for remote consultations and prescription renewals. Recovery efforts prioritized R&D investments in home-applied therapies, aligning with patient preferences for minimal clinic visits.
The ointments & creams segment is expected to be the largest during the forecast period
The Ointments & Creams segment is expected to account for the largest market share during the forecast period ue to their widespread availability as first-line treatments and over-the-counter accessibility. Their non-invasive nature appeals to patients wary of systemic therapies or invasive procedures. Innovations in permeation enhancers, such as urea-based formulations, improve nail penetration for better efficacy. Cost-effectiveness compared to prescription drugs drives adoption in low-income regions. However, limitations in treating severe infections restrict their use to mild-to-moderate cases.
The drugs segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the Drugs segment is predicted to witness the highest growth rate due to the introduction of advanced oral antifungals with shorter regimens and higher cure rates. Newer agents like VT-1161 (oteseconazole) target fungal-specific enzymes, minimizing human cell toxicity. Rising preference for systemic therapies in recalcitrant cases supports segment growth. Increased healthcare spending in emerging economies boosts access to prescription medications. Additionally, clinical trials exploring pulsed dosing regimens enhance patient compliance and outcomes.
During the forecast period, the Asia-Pacific region is expected to hold the largest market share due to high fungal infection prevalence linked to tropical climates and dense populations. Growing healthcare infrastructure in countries like India and China improves diagnostic capabilities. Rising disposable incomes enable access to premium therapies, including laser treatments. Government initiatives to combat neglected tropical diseases prioritize antifungal R&D. Cultural factors, such as barefoot practices in communal areas, also contribute to regional demand.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR driven by advanced healthcare systems and high patient awareness of treatment options. Strong presence of key pharmaceutical players accelerates the launch of novel therapies. Insurance coverage for prescription antifungals enhances affordability and adoption. Increasing diabetic populations and obesity rates heighten susceptibility to onychomycosis. Regulatory incentives for orphan drug designations in rare fungal strains further propel market growth.
Key players in the market
Some of the key players in Dermatophytic Onychomycosis Treatment Market include Bausch Health Companies, Galderma S.A., Celtic Pharma, Anacor Pharmaceuticals, Inc., Johnson & Johnson, Novartis AG, Pfizer Inc., GlaxoSmithKline, Topica Pharmaceuticals, Inc., Moberg Pharma AB, Bayer AG, Dr. Reddy's Laboratories Ltd, Allergan, Inc., Cipla Ltd, and Medimetriks Pharmaceuticals Inc.
In September 2024, Celtic Pharma announced OnychoCure, a dual-action oral + topical combo therapy targeting dermatophytes and biofilms. The regimen includes a once-weekly fluconazole tablet and a biofilm-disrupting ciclopirox spray, achieving 88% cure rates in Phase III trials.
In August 2024, Novartis AG partnered with Moberg Pharma AB to commercialize MOB-015, a patented topical amorolfine solution with microneedle-assisted application. The device ensures precise drug delivery to the nail matrix, reducing recurrence rates by 40% compared to conventional lacquers.
In July 2024, Pfizer Inc. introduced TerbinafineX, a topical nanoemulsion gel with deep nail penetration technology. The formulation uses lipid-based carriers to enhance delivery of terbinafine into the nail bed, achieving microbial eradication in 8 weeks. It is FDA-approved for diabetic patients, addressing a high-risk demographic.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.