Oral Mucositis
An Analysis of Drugs in Development, Market Opportunity, unmet need, Disease prevalence and occurrence in oral mucositis in Various Geographies

Oral Mucositis (OM) is a complication of aggressive chemotherapy and radiotherapy treatments in Head and neck cancer, Hematopoietic stem cell transplantation (HSCT) and multiple chemotherapies. Severe form of OM causes odynophagia and/or dysphagia leading to difficulty in eating/swallowing and can increase the cost of total cancer therapy. While the mechanism of OM is well established, there are very few targeted drugs or therapeutic options available to the patient. Untreated it can be life threatening (sepsis) and Palliative care offer temporary relief. Novel therapies could lead to a cut in this major cost burden along with improving the quality of life. There is a grave need for systematic management of oral mucositis triggered by anti-neoplastic protocols. Several products are marketed as palliative care for management of the OM that include anti-oxidant, anti-inflammatory agents, cryotherapy, oral rinse and ointments. However, there is high unmet medical need for systemic interventions.

Currently, ~800,000 worldwide patients per year suffer from mucositis during cancer therapy and the incidence is increasing. ~80-100% of Head and Neck cancer patients develop Ulcerative OM. The incidence of oral cancer in Asia, especially in India and China, is very high due to the lifestyle and tobacco consumption. Only drug Amgen/SOBI’s Kepivance (palifermin) is approved for oral mucositis in transplantation; but is contra-indicated for solid tumor patients. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. Considering all these factors we expect the market to grow manifold from the existing ~$200mln (palliative and mouth wash) to $5,000mln in the next ~ten years. Mid-size and small companies are targeting this opportunity through in-house pipeline offers a good opportunity for In-licensing or M&A.

In the report, we have highlighted novel mechanism / targets which have obtained Fast Track designation from FDA and have advanced in the clinical trials. The report also indicates Drivers of M&A/Licensing Deals and Key Markets' potential.

Research Methodology

Research methodology is based on in-depth research and market study, scientific journals or technical literature, industry publications, company reports and published information, and statistical data from government agencies and other therapy foundation or associations.  Forecasts and projections of market size and future market activity are derived using standard modelling and statistical techniques.

Author Bio

Sanjeev Mishra

ProGrow Pharma (PGP) Partners caters the full spectrum of services to Pharma companies (Pharma/ Biotech, Generic, CRAMS, CROs, Start-ups) and its Investors (Private Equity, Fund Managers, HNI).  With decades of experience in strategic advisory, regulatory aspects, technical publications, understanding complex drugs, identifying market potential and all related services, the team is widely approached by pharmaceutical companies and experts.  Our team can support you from defining strategic programmes to providing expert guidance for tactical operations to transform your operational or market based challenges into growth aligned opportunities.

  1. Executive Summary
    • Unmet Need
    • Market Opportunity in Various Geographies
    • Limited Treatment Alternatives and Drugs in the Pipeline
    • Drivers of M&A/Licensing Deals
  2. Disease Overview
    • Management of Oral Mucositis Falls into Two Main Categories
    • Market Potential
    • Key Growth Drivers
    • Current Market & Unmet Medical Need
    • Challenges in Developing Drugs for Oral Mucositis
    • Etiology, Pathogenesis, Diagnosis, Prevention and Current
  3. Companies Developing Novel Drugs For Oral Mucositis
    • SGX942 (Soligenix)
    • GC4419 (Galera therapeutics)
    • Brilacidin (Innovation Pharmaceuticals)
    • SP13004 (Spherium Biomed)
    • Validive (Onxeo)
    • AG103 (Oragenics/Intrexon)
    • Easyef (Daewoong pharmaceuticals)
    • 0.25% EISO mouth rinse (Santalis pharmaceuticals)
    • IZN-6N4 (Izun pharma corp)
    • Dentoxol (Ingalfarma SpA)
  4. Market Model – US
  5. Market Model – EU (Top 5 Countries)
  6. Market Model – INDIA
  7. Key Markets’ Potential (US + EU - Top 5 Countries + INDIA + ROW)
  • Soligenix
  • Galera therapeutics
  • Innovation Pharmaceuticals
  • Spherium Biomed
  • Onxeo
  • Oragenics
  • Intrexon
  • Daewoong pharmaceuticals
  • Santalis pharmaceuticals
  • Izun pharma corp
  • Ingalfarma SpA
  • Amgen
  • SOBI Biopharma
  • Daewoong Pharma
  • Otsuka pharma
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