The Global "Oral Mucositis Market" is expected to grow at a high CAGR during the forecasting period (2022-2029).
Oral Mucositis (OM) is ulceration and inflammation of the mucosal membranes in the mouth and throat. It is a common side effect and serious complication for patients receiving radiation and chemotherapy with head and neck cancer treatments. About 40% of chemotherapy and all radiation patients develop oral mucositis. Serious OM complications include intolerable pain and inflammation, increased risk of infections, malnutrition, dehydration, difficulty speaking, and increased use of narcotics. If left untreated, these sores can lead to life-threatening infections. Oral mucositis is diagnosed through various tests, including biopsy and fungal testing. Antiseptic mouth rinses, pain killer medicines, water-soluble lubricating agents, bland rinses, and mucosal coating agents are some of the products used to treat OM.
The global oral mucositis market growth is majorly driven by the rising incidences of head and neck cancer. The annual incidence of HNC in the U.S. and Europe is approximately 150,000 and 750,000 cases globally. Approximately 60 to 70% of these patients will develop Severe Oral Mucositis (SOM). The side-effects of radiation effects and cytotoxic chemotherapy agents on oral mucosa lead to oral mucositis. As per the National Institutes of Health estimates, over 400,000 patients are diagnosed with oral mucositis annually in the United States. With the increasing prevalence of cancer patients globally, the market for oral mucositis therapeutics is also growing. Hence, the demand for oral mucositis treatment is rapidly growing, which is expected to drive market growth over the forecast period.
Besides, increasing clinical trials and the adoption of collaboration strategies are enhancing the oral mucositis therapeutics pipeline. As of March 2019, the oral mucositis therapeutics pipeline comprised more than twenty drugs (in addition to nine marketed drugs) in different development stages. In June 2020, Soligenix, Inc., a biopharmaceutical company developing and commercializing products to treat rare diseases, has completed patient enrollment in its Phase 3 DOM-INNATE study for SGX942 (dusquetide) for the treatment of oral mucositis (OM) in head and neck cancer (HNC) patients. With the enrollment completed, top-line results are expected in the fourth quarter of 2020.
Growing research to develop new drugs for oral mucositis is also expected to boost market growth during the forecast period. For instance, in May 2020, researchers at the University of Arizona College of Pharmacy have reformulated Suramin, a 100-year old drug previously used to treat African sleeping sickness, to fight oral mucositis and diabetic foot ulcers. This breakthrough development can benefit thousands of patients whose current healing options are either partially effective or painful and invasive.
In July 2020, Innovation Pharmaceuticals, a clinical-stage biopharmaceutical company, reported research into Brilacidin as a potential treatment for COVID-19. Brilacidin is being evaluated at a U.S. Regional Biocontainment Laboratory (RBL) and has consistently demonstrated robust in vitro antiviral properties against SARS-CoV-2, the novel coronavirus responsible for COVID-19.
However, the issuance of patents and long stringent approvals for products in the form of grants and designations from regulatory bodies, including the U.S. Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the National Institutes of Health (NIH), among others is a slowing down the market growth.
Its cause segments the global oral mucositis market into chemotherapy, radiotherapy, and hematopoietic stem cell transplantation. Among these, the oral mucositis caused by the chemotherapy segment is expected to hold a major share in the market as chemotherapy is widely used as a treatment method for cancer. For instance, as per the U.S. Department of Health & Human Services, every year, more than 650,000 cancer patients receive chemotherapy in an outpatient oncology clinic in the U.S.
The oral mucositis therapeutics market includes several kinds of drug formulations and treatments such as cryotherapy, growth factors, antioxidants, anti-inflammatory agents, low-level laser therapy (LLLT), mouthwashes, barriers, and coating agents. Some of the approved drugs for oral mucositis treatment include Kepivance, GelX, NeutraSal, Easy, and Caphosol. On May 4th, 2020, the U.S. WorldMeds, launched GELX ORAL GEL, a Zinc-Taurine bioactive barrier therapy for relief from oral pain associated with oral mucositis. GELX ORAL GEL is a bioactive therapy that can build an effective barrier against oral mucositis's pain and inflammation. It biomechanically protects against intraoral pain, coating exposed nerve endings and open sores. Through a polyvinylpyrrolidone delivery system, which can improve the release rate and solubility of drugs, GELX supplies the mucosal environment with a bioactive Zinc-Taurine Complex known to hinder and delay the inflammatory cycle of oral mucositis.
SGX942 (Soligenix, Inc.), MuGard (Daewoong Pharmaceutical Co.), CVXL-0095, Nu-3, Brilacidin, among others, are in the pipeline, which is expected to further drive the oral mucositis therapeutics market over the forecast period. Also, A phase 2 trial of Brilacidin, as an oral rinse for preventing Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer (HNC), met its primary and secondary endpoints, including reducing the incidence of SOM. The price for Brilacidin is anticipated at $5,000 to $10,000 per full course of treatment based on the large unmet need as well based on initial pricing for the only other O.M. drug ever approved (Palifermin, hematopoietic stem cell transplantation, HSCT). Based on the company’s estimates, the total Brilacidin oral rinse market opportunity annually in the U.S. and Europe would be approximately $600 million to $1.2 billion.
Based on end-user, the market is segmented into hospitals, oncology centers, dental clinics, and research institutes. The hospital segment is expected to hold a major share in the market due to its close association with cancer availability of all possible treatment options.
North American region is dominating the global oral mucositis market, accounting for the largest market share in 2019, owing to huge funding and investments for the development of new products to treat the condition. For instance, according to the American Society of Clinical Oncology (ASCO), head and neck cancer account for about 4% of all cancers in the US. In 2019, an estimated 65,410 people will develop head and neck cancer. High cases of cancer in the US and Canada are expected to drive market growth. Besides, rising expenses in research & development by healthcare bodies to improve oral mucositis treatment are expected to fuel the market's growth in this region.
Europe is estimated to hold the second-largest market share in the global oral mucositis market due to the availability of an advanced healthcare system, rise in cancer cases, and the expansion of major companies in this region. For instance, in April 2016, EUSA Pharma has acquired the global rights to next-generation oncology supportive care product Arcoral Tab from Arcoral Pharma.
The Asia-Pacific oral mucositis market is projected to grow at the fastest CAGR due to the rising prevalence of cancer and progressing government initiatives for healthcare reforms. The market in the Middle East & Africa is projected to account for the global market's least share due to low per capita disposable income in the region.
The oral mucositis market is highly competitive and consists of several major players and new players in the market. Some of the key players which are contributing to the growth of the market are EUSA Pharma Inc., Daewoong Pharmaceutical Co., Soligenix, Inc., Sunstar Suisse SA, Swedish Orphan Biovitrum Ltd., Amgen Inc., Bausch Health, EKR Therapeutics, Inc., Access Pharmaceuticals, Inc., Eisai Inc., Innovation Pharmaceuticals, Moberg Pharma AB, among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, contributing to the growth of the oral mucositis market globally. For instance,
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