Interstitial cystitis (IC), also known as painful bladder syndrome, is a chronic bladder issue often associated with bladder pressure and pain, with occasional pain in either the lower abdomen, pelvic, or lower back. The patient could experience pain raging from mild to severe. The pelvic nerve signal to the brain gets mixed up in an individual suffering from interstitial cystitis. Consequently, an urgency to urinate, often in a small volume, is observed. On an average, a person urinates seven times a day; however, in severe cases of IC, urination may occur around 40-60 times a day. IC is not an infection, but is often mistaken to be a bladder infection. Factors contributing to interstitial cystitis are: a defect of the epithelium layer of the bladder, leaking epithelium allows toxic agents in urine to irritate the bladder wall. Other anticipated, but not clear, contributing factors include heredity, an autoimmune reaction, infection or allergy. Various therapies and medication may provide relief from the symptoms for IC; however, there is still no cure for this disease.
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Studies conducted on interstitial cystitis and associated data have shown that it is thrice more prevalent in women than in men, and the risk increases with age. The female-to-male ratio is estimated to be 10:1. It is estimated that around 1 to4 million men and 3 to8 million women suffer from IC. Rise in prevalence of IC stimulates the research and development on the drug, as it is likely to provide an appropriate environment for newer products to be profitable. The prevalence of IC is estimated to be between 2.7% to 6.53% among older women in the United States. Patients suffering from other conditions such as fibromyalgia, irritable bowel syndrome, or allergies often experience IC. According to a publication by National Institutes of Health (NIH), in 2012, the annual expenditure for medication for the geriatric population aged ≥65 years who are Medicare beneficiaries was US$ 249,160,233 (nonspecific and specific IC combined).
IC is mainly diagnosed by urine analysis, bladder ultrasound, cystoscopy, biopsy of bladder and urethra, bladder stretching, and prostrate fluid culture. The main goal is to relieve the symptoms of IC, and thus treatment is segmented into five phases: First phase by Physical therapy, second phase treatment by oral medication such as Amitriptyline – to regulate the bladder spasms, Pentosan (Elmiron) – helps rebuild the tissue lining the bladder, hydroxyzine, use of steroids, and dimethyl sulfoxide to treat severe IC conditions by blocking the pain and reducing the inflammation is also recommended.
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The third phase is neurostimulation - transcutaneous electrical nerve stimulation or sacral nerve stimulation. The fourth phase includes administering cyclosporine to alter the immune response on the bladder, and the fifth phase involves bladder detention or surgery. The market currently has only two approved treatment options for IC: Elmiron (pentosan polysulfate sodium) and Rimso-50 (dimethyl sulfoxide). Elmiron was approved on September 26, 1996, and its patent expired on January 19, 2010. Similarly, Rimso-50 was approved prior to January 1, 1982, and its patent expired before 2002. The current line of treatment is dominated by off-label drug options such as antidepressants (amitriptyline), antihistamines (hydroxyzine), and analgesics (opioid and non-steroidal) due to the limited availability of approved therapies.
The IC therapeutics market is currently weak due to limitations regarding the efficacy and compliance of available products. Other factors contributing to the significant unmet needs include limited approved treatment options, lack of awareness, and need for disease modifying therapies. Current pipeline for the IC therapeutics market is very weak with a majority of the molecules in the early stage of development. These significant unmet needs and weak pipeline with a majority of the molecules in early stage pose new opportunities for new entrants.
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In terms of geography, the interstitial cystitis market can be segmented into North America, Europe, Asia Pacific, and Rest of the World (RoW). The interstitial cystitis market is estimated to expand at a sluggish rate primarily due to the limited availability of approved products, low diagnosis rate, and lack of new product approvals.
Key players operating in the interstitial cystitis market are Aquinox Pharmaceuticals Inc., Astellas Pharma Inc, Merck & Co Inc, Allergan Plc., Kytogenics Pharmaceuticals Inc., BELLUS Health Inc, UCB SA, Lipella Pharmaceuticals Inc, Urigen Pharmaceuticals Inc, and Xigen SA.