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  • Published On : Jul 2021
  • Code : CMI4548
  • Industry : Pharmaceutical
  • Pages : 166
  • Formats :

Fungal otitis externa is a condition that causes inflammation (redness and swelling) of the external ear canal. Fungal otitis externa is often referred to as swimmer's ear, as repeated exposure to water can make the ear canal more vulnerable to inflammation. The most common pathogen is Aspergillus (80 to 90% of cases), followed by Candida. Fungal infection is the result of prolonged treatment of bacterial otitis externa that alters the flora of the ear canal.

The global fungal otitis externa market is estimated to be valued at US$ 169.40 million in 2021 and is expected to exhibit a CAGR of 2.9% over the forecast period (2021-2028).

Figure 1. Global Fungal Otitis Externa Market Share (%) in Terms of Value, By Drug Type, 2021

Fungal Otitis Externa  | Coherent Market Insights

Increasing incidence and prevalence of fungal otitis externa are expected to drive the market growth over the forecast period. 

Increasing incidence of fungal otitis externa is expected to drive the growth of global fungal otitis externa market over the forecast period. For instance, according to the article published in the National Center for Biotechnology Information, in March 2019, fungal otitis externa is common all over the world, with a higher incidence in tropical than in temperate zones owing to higher temperature and humidity. Its lifetime prevalence is estimated at 10%. It affects adults commonly, and children very rarely generally in the age range between seven to 12 years. Similarly, according to the same studies from the Netherlands and the U.K. have shown an annual incidence of 1%.

Figure 2. Global Fungal Otitis Externa Market Share (%), Fungus Type, 2021

Fungal Otitis Externa  | Coherent Market Insights

Robust product pipeline expected to offer the market growth opportunities over the forecast period.

Robust product pipeline for the treatment of fungal otitis externa which are expected to launch during the forecast period is anticipated to drive the growth of the global fungal otitis externa market. For instance, in February 27, 2020, Salvat Laboratories, a Spain-based pharmaceutical company, initiated a phase III, multicenter, randomized, doubleblind clinical trial to assess the efficacy and safety of SVT-15652 Otic Solution compared to placebo for the treatment of fungal otitis externa (otomycosis).

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Fungal Otitis Externa Market Report Coverage

Report Coverage Details
Base Year: 2020 Market Size in 2021: US$ 169.40 Mn
Historical Data for: 2017 to 2019 Forecast Period: 2021 to 2028
Forecast Period 2021 to 2028 CAGR: 2.9% 2028 Value Projection: US$ 206.94 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Drug Type: Ear Drops (Clotrimazole, Fluconazole, Acetic Acid (2%)), Oral Medications (Itraconazole, NSAIDS), Topical Medications, Late Stage Pipeline Drugs
  • By Fungus Type: Aspergillus, Candida
  • By Route of Administration: Otic, Oral, Topical
  • By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
Companies covered:

Novartis,  Bayer AG,  Sanofi,  GlaxoSmithKline plc.,  AbbVie,  Par Pharmaceutical, Inc.,  Hi-Tech Pharma,  Actavis Mid-Atlantic,  Hill Dermaceuticals Inc,  NuLife Pharmaceuticals,  Glenmark Pharmaceuticals Limited,  Pfizer Inc.,   Janssen Pharmaceutical,  McNeil Consumer Healthcare,  Mylan N.V.,  Salvat Laboratories

Growth Drivers:
  • Increasing incidence and prevalence of fungal otitis externa 
  • Robust product pipelines
Restraints & Challenges:
  • Increasing generic competition
  • Complications associated with drugs used in the treatment of fungal otitis externa

Global Fungal Otitis Externa Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread over 100 countries across the globe and the World Health Organization has declared it a public health emergency. According to the World Health Organization’s report, the manifestation of Coronavirus disease (COVID-19) has resulted in more than 189 million infected individuals worldwide as of July 19, 2021.

COVID-19 can affect the economy in three main ways; by directly affecting production and demand, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, UAE, Egypt, and others are facing problems with regards to transportation of drugs from one place to another.

Furthermore, players operating in the global fungal otitis externa market are facing major challenges on various fronts due to the COVID- 19 pandemic. The major challenges include supply of raw materials required for manufacturing drug formulations due to irregularities in transportation facility. Moreover, distributors of products are experiencing irregular demand for products from the retailers due to increasing number of patients suffering from COVID-19 and other life threatening disorders.

Moreover, according to the article published in the National Center for Biotechnology Information in August 2020, the incidence of otitis externa increased in the patients suffering from COVID-19. According to the study results, increased incidence of otitis externa in COVID- 19 patients that is 18% of study group out of 257 cases were infected with COVID-19 and the symptoms were observed mainly between the fifth to eighth day of COVID-19 infection.

Global Fungal Otitis Externa Market- Restraint

Complications associated with drugs used in the treatment of fungal otitis externa and increasing generic competition is expected to hinder growth of the global fungal otitis externa market. Presence of generic drugs, at much lower price compared to branded drugs, in the market for the treatment of fungal otitis externa is a major factor, which is expected to hamper the market growth in the near future For instance, on July 2012, Mylan Inc., its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole Capsules, 100 mg. This product is the generic version of Janssen Pharmaceutical Inc.'s Sporanox and is indicated for the treatment of fungal infections.

Key Players

Major players operating in the global fungal otitis externa market include Novartis,  Bayer AG,  Sanofi,  GlaxoSmithKline plc.,  AbbVie,  Par Pharmaceutical, Inc.,  Hi-Tech Pharma,  Actavis Mid-Atlantic,  Hill Dermaceuticals Inc,  NuLife Pharmaceuticals,  Glenmark Pharmaceuticals Limited,  Pfizer Inc.,   Janssen Pharmaceutical,  McNeil Consumer Healthcare,  Mylan N.V., and Salvat Laboratories, among others

Fungal otitis externa is an infection of the outer ear canal. Fungal otitis externa mostly affects people who live in warm or tropical areas. It also often affects people who swim frequently, live with diabetes, or have other chronic medical and skin conditions. The Symptoms of otitis externa include ear pain, itchiness in the ear canal, a discharge of liquid or pus from the ear and some degree of temporary hearing loss. Otitis externa is relatively common. It's estimated that around 1 in 10 people will be affected by it at some point in their lives.

Market Dynamics

Robust product pipeline for the treatment of fungal otitis externa which are expected to launch during the forecast period is anticipated to drive the growth of the global fungal otitis externa market. For instance, on July 8, 2020, Hill Dermaceuticals, Inc., a U.S.-based pharmaceutical company, initiated a phase II/III Study of the efficacy and safety of miconazole oil versus vehicle oil in the treatment of otomycosis, followed by an open-label safety evaluation. The study is estimated to be completed by December 2021. Furthermore, increasing prevalence of fungal otitis externa is expected to lead to high demand for various treatment therapy. For instance, according to the Sandoz, a subsidiary of Novartis AG, over 80% of the U.S. children experience at least one ear infection by their third birthday. Moreover, according to the American Academy of Family Physicians, the Fungi are identified in about 10% of cases of otitis externa. The most common pathogen is Aspergillus (80 to 90% of cases), followed by Candida.

Key features of the study:

  • This report provides in-depth analysis of the global fungal otitis externa market, and provides market size (US$ Mn) and compound annual growth rate (CAGR%) for the forecast period (2021–2028), considering 2020 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global fungal otitis externa market based on the following parameters – Company Highlights, Product Portfolio, Key Highlights, Financial Performance, Market Strategies
  • Key companies covered as a part of this study include Novartis,  Bayer AG,  Sanofi,  GlaxoSmithKline plc.,  AbbVie,  Par Pharmaceutical, Inc.,  Hi-Tech Pharma,  Actavis Mid-Atlantic,  Hill Dermaceuticals Inc,  NuLife Pharmaceuticals,  Glenmark Pharmaceuticals Limited,  Pfizer Inc.,   Janssen Pharmaceutical,  McNeil Consumer Healthcare,  Mylan N.V.,  and Salvat Laboratories
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global fungal otitis externa market  report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global fungal otitis externa market

Detailed Segmentation:

  • Global Fungal Otitis Externa Market, By Drug Type:
    • Ear Drops
      • Clotrimazole
      • Fluconazole
      • Acetic Acid (2%)
    • Oral Medications
      • Itraconazole
      • NSAIDS
    • Topical Medications
    • Late Stage Pipeline Drugs
  • Global Fungal Otitis Externa Market, By Fungus Type:
    • Aspergillus
    • Candida
  • Global Fungal Otitis Externa Market, By Route of Administration:
    • Otic
    • Oral
    • Topical
  • Global Fungal Otitis Externa Market, By Distribution Channel:
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
  • Global Fungal Otitis Externa Market, By Region:
    • North America
      • By Drug Type:
        • Ear Drops
          • Clotrimazole
          • Fluconazole
          • Acetic Acid (2%)
        • Oral Medications
          • Itraconazole
          • NSAIDS
        • Topical Medications
        • Late Stage Pipeline Drugs
      • By Fungus Type:
        • Aspergillus
        • Candida
      • By Route of Administration:
        • Otic
        • Oral
        • Topical
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Drug Type:
        • Ear Drops
          • Clotrimazole
          • Fluconazole
          • Acetic Acid (2%)
        • Oral Medications
          • Itraconazole
          • NSAIDS
        • Topical Medications
        • Late Stage Pipeline Drugs
      • By Fungus Type:
        • Aspergillus
        • Candida
      • By Route of Administration:
        • Otic
        • Oral
        • Topical
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Drug Type:
        • Ear Drops
          • Clotrimazole
          • Fluconazole
          • Acetic Acid (2%)
        • Oral Medications
          • Itraconazole
          • NSAIDS
        • Topical Medications
        • Late Stage Pipeline Drugs
      • By Fungus Type:
        • Aspergillus
        • Candida
      • By Route of Administration:
        • Otic
        • Oral
        • Topical
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Drug Type:
        • Ear Drops
          • Clotrimazole
          • Fluconazole
          • Acetic Acid (2%)
        • Oral Medications
          • Itraconazole
          • NSAIDS
        • Topical Medications
        • Late Stage Pipeline Drugs
      • By Fungus Type:
        • Aspergillus
        • Candida
      • By Route of Administration:
        • Otic
        • Oral
        • Topical
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Drug Type:
        • Ear Drops
          • Clotrimazole
          • Fluconazole
          • Acetic Acid (2%)
        • Oral Medications
          • Itraconazole
          • NSAIDS
        • Topical Medications
        • Late Stage Pipeline Drugs
      • By Fungus Type:
        • Aspergillus
        • Candida
      • By Route of Administration:
        • Otic
        • Oral
        • Topical
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Drug Type:
        • Ear Drops
          • Clotrimazole
          • Fluconazole
          • Acetic Acid (2%)
        • Oral Medications
          • Itraconazole
          • NSAIDS
        • Topical Medications
        • Late Stage Pipeline Drugs
      • By Fungus Type:
        • Aspergillus
        • Candida
      • By Route of Administration:
        • Otic
        • Oral
        • Topical
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
      • Novartis
        • Company Highlights
        • Product Portfolio
        • Key Highlights
        • Financial Performance
        • Market Strategies
      • Bayer AG
      • Sanofi
      • GlaxoSmithKline plc
      • AbbVie
      • Par Pharmaceutical, Inc
      • Hi-Tech Pharma
      • Actavis Mid-Atlantic
      • Hill Dermaceuticals Inc
      • NuLife Pharmaceuticals
      • Glenmark Pharmaceuticals Limited
      • Pfizer Inc
      • Janssen Pharmaceutical
      • McNeil Consumer Healthcare
      • Mylan N.V.
      • Salvat Laboratories

 “*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

The global fungal otitis externa market size is estimated to be valued at US$ 169.40 Mn in 2021 and is expected to exhibit a CAGR of 2.9 % between 2021 and 2028.
Increasing incidence and prevalence of fungal otitis externa and robust product pipeline are expected to drive the market growth over the forecast period.
Ear drops is the leading drug type segment in market.
North America region is expected to hold the largest market share in the market.
Increasing generic competition and complications associated with drugs used in the treatment of fungal otitis externa are the major factors restraining growth of the market.
Major players operating in the market include Novartis, Bayer AG, Sanofi, GlaxoSmithKline plc., AbbVie, Par Pharmaceutical, Inc., Hi-Tech Pharma, Actavis Mid-Atlantic, Hill Dermaceuticals Inc, NuLife Pharmaceuticals, Glenmark Pharmaceuticals Limited, Pfizer Inc., Janssen Pharmaceutical, McNeil Consumer Healthcare, Mylan N.V., and Salvat Laboratories, among others

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