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.
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.
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.
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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.
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