Global Oral Mucositis Market - 2022-2029

Market Overview

The Oral Mucositis Market size was valued at US$ 1,337.30 million in 2021 and is estimated to reach US$ XX billion by 2029, growing at a CAGR of 5.6% during the forecast 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.

Market Dynamics

Increase in hematological disorders and technological advancements are the major factors driving the global Oral Mucositis market.

Rising incidences of head and neck cancer are expected to drive market growth.

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-yearold 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.

Stringent approvals associated with oral mucositis products is expected to hamper the market growth.

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.

Industry Analysis

The global oral mucositis market provides in-depth analysis of the market based on various industry factors such as porter's five forces, regulatory & reimbursement analysis, value chain analysis, pricing analysis, supply chain analysis, unmet needs, epidemiology etc.

Segment Analysis

Cause segment is expected to hold the largest market share in global oral mucositis market

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.

Geographical Analysis

North America region holds the largest market share in the global oral mucositis market

North America is dominating the market due to increased prevalence of chronic lifestyle related diseases in the region. It accounts for the largest market share and is mainly attributed to the increasing prevalence of head and neck cancer in the country. 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.

According to the American Society of Clinical Oncology (ASCO)'s 2021 report, approximately 4% of individuals suffered from head and neck cancer in the U.S. and an estimate of 66,630 people were expected to develop head and neck cancer. High cases of cancer in the US is expected to drive market growth.

Oral mucositis affects over half a million people in the United States each year, and it provides a new market in which unmet health care needs are primarily intrinsically a long-standing problem. According to the Centers for Disease Control and Prevention, around 650,000 cancer patients get chemotherapy in an outpatient environment in the United States each year, and approximately 500,000 cases of oral mucositis occur in the United States each year, according to a consensus.

Moreover, huge funding and investments for the development of new products to treat the condition is expected to drive the market growth in the United States. Soligenix, Inc., for instance, announced in June 2020 that patient enrollment in its Phase 3 DOM-INNATE study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in patients with head and neck cancer (HNC) had been completed.

Galera Therapeutics, Inc. disclosed full tumour outcomes of patients with head and neck cancer treated with avasopasem manganese (GC4419), which is Galera's primary product candidate for severe oral mucositis (SOM) that was in a Phase 2b clinical trial, in February 2020.

Competitive Landscape

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.

Key Companies to Watch

EUSA Pharma Inc:

Overview: EUSA Pharma Inc is a global speciality pharmaceutical company. The company creates, manufactures, and sells specialised pharmaceutical products. The company provides oncology drugs, oncology support, and critical care. EUSA Pharma sells its products all over the world. EUSA Pharma Clinical Research and Development is involved in improving the use of its products to maximize the clinical benefit for patients who have cancer or rare diseases. The company is a subsidiary of Jazz Pharmaceuticals.

Product Portfolio: Caphosol: It is approved for the treatment and prevention of oral mucositis, a side effect of cancer treatment (including radiation and chemotherapy). It contains a high concentration of phosphate and calcium ions, which lubricate the mucosa of the mouth, tongue, and oropharynx and aid in the preservation of the oral cavity's integrity. Caphosol is available in ampules or as a dispersible solution.

MyLab™9V

The global oral mucositis market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.