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(Medical-NewsWire.com, October 29, 2019 )
Market Overview
• Vocal fold augmentation refers to procedures that are carried out to augment the vocal folds to improve its function. For the treatment of a single process, only one vocal fold is enlarged, while for the treatment of bilateral system both vocal folds are augmented.
• Augmentation of the vocal folds is used to treat glottic insufficiency. Glottic insufficiency can be defined as the vocal folds that do not close fully or do not close firmly. Symptoms of glottic insufficiency include; weak or quiet voice, a breathy voice, or vocal fatigue.
Market Dynamics
• The increasing cases of voice problem are one of the factors fueling the global vocal fold augmentation market.
• According to NIDCD (National Institute on Deafness and Other Communication Disorders), 7.5 million or more people in the U.S are suffering from voice problem in 2016
• According to the National Cancer Institute, there are about 13,150 new estimated new cases of Laryngeal Cancer and 3,710 number of expected deaths globally
• The number of new cases of laryngeal cancer was 3.0 per 100,000 men and women per year. The number of deaths was 1.0 per 100,000 men and women per year.
• These rates are age-adjusted and based on 2011-2015 cases and deaths.
• According to The American Cancer Society, 2017, around 13,150 new cases are added to the existing laryngeal cancer patients. With the rising cases of human papillomavirus (HPV) infection and the high consumption of tobacco and alcohol, the risk of laryngeal cancer is increasing which would further drive the demand for global vocal fold augmentation market.
• The short duration for some temporary vocal fold augmentation is the primary restraint to the market, as it may be a considerable cost for continues procedures for vocal fold augmentation.
• The autologous collagen act for a short span duration, expensive, and high time consuming that is three months from harvest to injection.
• Fat injection consumes more time to harvest. Furthermore, the unpredictability of fat survival causes variability in the outcomes of fat injections, and the patient needs to undergo general anesthesia before the procedure. Also, patients tend to suffer a prolonged postoperative dysphonia for up to a few weeks.
Market Segmentation
• Based on the product the global market for Vocal fold augmentation is broadly segmented as by material type as carboxymethyl cellulose, calcium hydroxylapatite, hyaluronic acid, collagen-derived products, gel foam, Teflon, and fats.
• Currently, calcium hydroxylapatite is the dominant segment, and it accounts for approximately XX% of the market, due to the distribution agreement between companies for products with calcium hydroxylapatite material.
• For instance, In June 2018, InHealth Technologies have the exclusive right to distribute RENÚ Voice and RENÚ Gel in the United States. RENÚ Voice is for long-term augmentation.
• It is a buffered hydrogel of synthetic, proven-biocompatible calcium hydroxylapatite (CaHA) particles 25 to 45 microns in size for consistent and easy injection.
• Calcium hydroxylapatite (CaHA), known by the trade name Radiesse Voice, which is currently FDA approved substance for potentially long term vocal fold injection.
• Also, Synthetic calcium hydroxylapatite was approved for vocal fold augmentation by the United States Food and Drug Administration, Center for Devices and Radiological Health in January 2002. CaHA have been developed and have been shown to be a safe and effective long-term option
• Calcium hydroxylapatite (CaHA) is the primary mineral constituent of bone and teeth. It is highly biocompatible that is well accepted for implantation by the body and has the potential to perform for long-term and even permanent vocal fold augmentation. Injection augmentation of the vocal folds with CaHA is best reserved for small and medium-sized space between the vocal folds.
• The amount of CaHA to inject depends on the degree of vocal fold mobility, need for a bilateral injection, the degree of atrophy, and the position of the vocal fold if immobile. Calcium hydroxyapatite effect typically lasts 1 to 2 years, with an average of 18 months.
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Geographical Analysis
• The global Vocal fold augmentation market is segmented into North America, Europe, Asia Pacific, South America, and ROW.
• North America is dominating the global Vocal fold augmentation market, due to the increase in the high prevalence of laryngeal cancer and voice problem.
• For instance, The American Cancer Society estimates that 13,430 new cases of laryngeal cancer are expected to be diagnosed in the US in 2016, or 0.79% of all new cancers diagnosed (excluding basal cell and squamous cell skin cancer and in situ carcinoma except urinary bladder).
• Laryngeal cancers account for about one-quarter of all head and neck cancers, most of which affect the right vocal folds (vocal cords). Black men are affected more commonly than white men. The male to female incidence ratio is about 4:1.
• According to the American Cancer Society’s estimates for laryngeal cancer in the United States for 2018 are about 13,150 new cases of laryngeal cancer (10,490 in men and 2,660 in women), and approximately 3,710 people (2,970 men and 740 women) die from laryngeal cancer.
• About 60% of laryngeal cancers start in the glottis (the area containing the vocal cords themselves), while about 35% develop in the supraglottic area (above the vocal cords). The rest develop in either the subglottis (below the vocal cords) or overlap more than one area so that it is hard to tell where they started.
Competitive Analysis
• The regulatory approval for Vocal fold augmentation is one of the critical factor driving the global Vocal fold augmentation market.
• For instance, In January 2016, REGENSCIENTIFIC has received the CE-mark (CE 630688) for the Renu Soft Tissue (Volumizing) Implant for Lipoatrophy, Vocal Fold Insufficiency, and Soft Tissue Augmentation. The CE-mark allows REGENSCIENTIFIC to sell the Renu product for these indications in the 32 states of the European Union as well as in seven cooperating countries of the European Economic Area, and in other countries that recognize or require the CE-mark.
• In June 2016, Merz Pharma had received CE mark for its dermal filler Radiesse Lidocaine, with integral 0.3% Lidocaine, and will available to physicians in Europe. Radiesse Lidocaine provides an immediate lifting effect and stimulates the natural production of collagen, as well as a significant reduction in pain due to the addition of lidocaine within each syringe.
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