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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Xerostomia is a condition of dry mouth associated with salivary gland hypo-function, wherein the salivary gland fails to produce enough saliva to carry out normal bodily functions. Xerostomia is not diagnosed as a disease but as a side effect of several other procedures such as radiation therapy and chemotherapy. It is more common in elderly people but is not limited to any particular age group. Saliva in mouth serves a variety of functions such as protection of oral tissues, maintenance of neutral pH balance, cleansing of the oral cavity, and enabling swallowing and speech. A reduction in the salivary flow gives rise to various problems such as difficulty in eating, swallowing, speaking and also lead to the risk of developing dental problems such as tooth in-sensitivity, demineralization of tooth, and dental caries due to decrease in pH.

The major causes of xerostomia include anticholinergic drug use, head and neck radiotherapy, chemotherapy, HIV infection, autoimmune disease such as Sjögren disease, comorbidities such as Alzheimer’s disease, uncontrolled hypertension or diabetes, and hormonal changes. Xerostomia can be treated by practicing general oral hygiene, stopping the use of causative drug, administering cholinergic drugs, and using saliva substitute. Saliva substitutes such as Carboxymethyl or mucopolysaccharides solutions and saliva stimulants such as cevimeline can be used for relief from xerostomia.

Global Xerostomia Therapeutics Market: Dynamics

The major drivers of xerostomia therapeutics market include rising geriatric population and increasing incidence of medical conditions such as Sjögren disease, hypertension, Parkinson’s disease, cancer, HIV, diabetes, and others. For instance, the American College of Rheumatology reported that around 3.1 million people suffered from Sjogren's disorder in the U.S. in 2019. Moreover, the use of treatments such as chemotherapy and radiography for head or neck cancer treatment is expected to drive growth of xerostomia therapeutic market over the forecast period. Chemotherapy leads to damage of salivary gland cells and makes saliva thicker. However, this is a temporary side effect, which lasts for two-eight weeks post therapy. Radiotherapy related xerostomia lasts up to atleast six months post therapy. For instance, internal radiotherapy, external radiotherapy and systemic radiotherapy are widely used treatment methods for head and neck cancer.

Medicinal products such as toothpaste, mouthwash, lozenges, saliva substitute gels, and sugar-free chewing gums are easily available and inexpensive, hence driving the growth of the market. Furthermore, some expensive drugs such as Salagen, which are used as salivary stimulants for xerostomia treatment have favorable reimbursement policies. For instance, Ontario Ministry of Health and Long-Term Care provides funds to patients with radiation-induced xerostomia undergoing treatment with drug, Salagen, under the Exceptional Access Program (EAP). Furthermore, prescribed medicines such as antiparkinsonian, sedatives, antidepressants, and others cause xerostomia and its increasing usage is expected to drive the market growth. For instance, the National Institute of Dental and Craniofacial Research states that over 400 medications may cause xerostomia.

Global Xerostomia Therapeutics Market: Restraints

High cost, ineffectiveness and side effects of some available treatments for xerostomia are the major factors that are expected to restraint the xerostomia therapeutics market growth. Moreover, stringent U.S. Food and Drug Administration (FDA) regulations for drug approval can hamper the market growth. For instance, Amifostine-sold under the trade name Ethyol is the only drug available in the market that has been approved by the U.S FDA for providing protection from radiation-induced xerostomia. Radiation leads to generation of certain oxygen derived free radicals which damage the cells of the salivary gland and cause xerostomia. Ethyol acts as a scavenger of these oxygen derived free radicals to protect the salivary gland cells and prevent xerostomia. However, Ethyol is costly and reduces the tumor control activity of the radiation therapy.

Pilocarpine (Salagen) and cevimeline hydrochloride (Evoxac capsules) have been approved by U.S FDA to be used as salivary stimulants for the treatment of xerostomia. Several adverse side effects associated with these drugs include diarrhea, vision problems, sweating, nausea, vomiting, cutaneous vasodilation, bradycardia, and hypotension. Also, products like artificial saliva spray or gels have to be applied frequently to give relief from xerostomia, which significantly hampers a good night's sleep and daily activities. 

Global Xerostomia Therapeutics Market: Product Insights

Artificial saliva products are helpful in offering relief from pain or discomfort caused by xerostomia. These products are available in a liquid or aerosol form. Moreover, dentifrices segment of the xerostomia market is expected to account for major market share over the forecast period, owing to its effectiveness, availability, affordability, and higher adoption among end users. For instance, dentifrices such as toothpaste and mouthwash constitute daily needs of a consumer, irrespective of the geographical region and can be chosen from a wide range of brands selling the same product at a reasonable cost.

Global Xerostomia Therapeutics Market: Regional Insights

North America is expected to dominate the global xerostomia therapeutics market, followed by Europe during the forecast period. This is attributed to increase in awareness initiatives and increasing prevalence of xerostomia, and other dry mouth associated diseases such as Parkinson’s disease, diabetes, Sjogren’s syndrome, and HIV. For instance, Sjogren Syndrome Foundation in the U.S. was set up in 1985 with an objective of raising awareness and helping patients to manage xerostomia symptoms. Moreover, improved medical and healthcare infrastructure along with easily accessible health benefit compensation policies helped North American region to dominate over xerostomia therapeutics market of other geographical regions such as Asia-Pacific, Europe, etc.

In 2018, Prisyna, the oral care division of Synedgen, Inc., received the U.S. FDA approval for marketing Moisyn products that can manage the symptoms of xerostomia and also improves oral health of patients suffering from xerostomia. According to Prisyna, the clinical study results show that patients using Moisyn products experienced less pain while eating, less dryness while speaking, improved sleep, and an increase in the mouth sensation for better sense of taste. Moreover, in 2020, the University of Wisconsin Carbone Cancer Center received the IND (Investigational New Drug) license issued by U.S FDA to begin clinical trials on the first personalized immune activated cell therapy to treat radiotherapy related xerostomia. This cell therapy involves the patient’s own interferon-gamma activated marrow stromal cells.

Asia Pacific region is expected to witness an exponential growth owing to factors such as growing investments in healthcare, an increase in initiatives for xerostomia awareness, and rising prevalence of diseases, such as Alzheimer’s disease, hypertension, diabetes, HIV, cancer, and Parkinson’s disease that cause xerostomia. For instance, in 2020 World Health Organization estimated that dementia affected over 23 million people in Asia Pacific region and at this rate the numbers would triple in next 30 years. Asia Pacific is witnessing a significant increase in the prevalence of cancer due to an increase in the life expectancy in the region, which increases the chance of acquiring lifestyle related diseases such as cancer. For instance, in 2020 the WHO reported around 20 million prevalent cancer cases over a period of five years in the Asia Pacific region. Many countries such as China, India, etc. have managed to reduce the cost of chemotherapy and radiotherapy by encouraging local industries to manufacture cancer drugs. Reduced therapy costs, as well as a rise in the number of initiatives for creating awareness regarding xerostomia, lead to an increase in the adoption of chemotherapy and radiation therapy for cancer treatment.

Global Xerostomia Therapeutics Market: Competitive landscape

The major players operating in the xerostomia therapeutics market include Eisai Inc., Hikma Pharmaceuticals, Synedgen, 3M, Lupin Pharmaceuticals, Inc., Apotex Inc., Church & Dwight Co. Inc., Parnell Pharmaceuticals, Colgate-Palmolive Co., EUSA Pharma, Cumberland Pharmaceuticals Inc., OraHealth Inc., Daiichi Sankyo Co. Ltd., Forward Science, Eisai Co. Ltd., GlaxoSmithKline Plc, Pharmascience Inc., Mission Pharmacal Company, Quest Products Inc., Saliwell Ltd., Sun Pharmaceutical Industries Ltd., and Dentaid.

Market players are focused on adoption of inorganic growth strategies such as acquisitions and collaborations, in order to enhance their product portfolio in the potential market. For instance, in July 2015, Hikma Pharmaceuticals acquired Roxane Laboratories, which is a part of West-Ward Pharmaceuticals Corp, for product profile enhancement in oral care segment. Moreover, in May 2018, Moisyn products developed by the oral care division of Synedgen have been approved for marketing by the U.S. Food and Drug Administration (FDA) to treat xerostomia.

Global Xerostomia Therapeutics Market: Taxonomy

By Product Type

  • Salivary Stimulants
  • Salivary Substitutes
  • Salivary Pen
  • Dentifrices
  • Others

By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

By Region

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa
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