Interstitial cystitis, or bladder pain syndrome, is a chronic inflammatory non-infectious disease. It is characterized by pain in the pelvic area, frequent daytime and nighttime urination. The causes of interstitial cystitis are not fully studied. The disease probably begins due to a decrease in the protective properties of the bladder mucous membrane (1). This caused the metabolites excreted in the urine to painfully penetrate the bladder wall, damaging, inter alia, the microvascular network, nerve terminals and unstriated muscles.
Risk factors
Since the causes of interstitial cystitis have not been reliably described, we can only talk about the factors that provoke the onset of the disease or relapses.
What is the main problem of the disease
Interstitial cystitis is a chronic disease that is prone to gradual progression and, unfortunately, has not yet been sufficiently studied, and therefore effective treatment has not yet been developed. Existing methods of drug therapy are symptomatic. At the same time, serious complications develop due to the use of certain drugs. For example, long-term use of corticosteroids increases blood pressure, blood sugar levels, osteoporosis, and edema. However, the side effects of corticosteroids are well described in the literature.
The botox injection into the bladder wall was occasionally used to treat this disease. However, such therapy could cause atony, which led, inter alia, to urinary retention and other problems.
The disease is poorly managed. As a result, the quality of life becomes poor, work capacity drops to zero level, and the risk of suicide is high (especially after amputation of the bladder and installation of a urinal in women of working age). In neglected cases, the urologist has no choice but to amputate the bladder, since the progressive decrease in its volume leaves the attending physician no other choice.
Treatment methods
Therapy is divided into drug and surgical. To relieve symptoms, non-steroidal anti-inflammatory drugs, antidepressants, medications injected into the bladder (hyaluronic acid, chondroitin sulfate, botulinum toxin type A, etc.) are used. With the help of surgical treatment, they try to increase the capacity of the bladder, optimize the outflow of urine, and treat ulcerative lesions of the mucous membrane, if any.
Global market
Until the late 1980s and early 1990s, interstitial cystitis used to be considered a rare disease(1). Urologists attributed it to a complication of postmenopause, and they believed that the disease was of a psychosomatic nature. An educational campaign for patients and doctors in the United States drew public attention to this problem. It turned out that interstitial cystitis affects not only older women, but also women and men of working age. There are not enough studies on the prevalence of interstitial cystitis to talk about the exact number of patients suffering from this disease. Estimates* suggest that there are approximately 9.5 million sick people in the world, and about 840 thousand people become newly ill each year. Due to new diagnostic methods, we can expect an increase in the prevalence of the disease by 10-30%.
The global interstitial cystitis market was worth USD 1.2 bln in 2022(2), of which USD 234.9 mln is accounted for by drugs. The market’s average annual increase is estimated at approximately 10.5%. By 2030, the volume is expected to grow to two billion dollars. According to other estimates, the market for interstitial cystitis in the seven largest countries — the United States, five European countries and Japan — amounted to USD 1.9 bln in 2023, and by 2034, with an average annual growth of 5.07%, it will reach USD 3.3 bln (3).
US market
Epidemiological studies in the USA have shown that interstitial cystitis occurs in 197 women per 100 thousand women and 41 men per 100 thousand men in the country. The annual increase in cases is 70 women per 100 thousand women and four men per 100 thousand men(4). The total number of sick people is about 400 thousand people.
According to a study(5), patients with this disease are twice as likely to visit a doctor compared to ordinary people; medical expenses per patient are 3-4 thousand US dollars more. Direct and indirect economic damage from interstitial cystitis is estimated at USD 20-40 bln. Patients lose 2.2 mln work hours per year.
In 2022, the interstitial cystitis treatment market in the US is valued at approximately 0.58 bln and is projected to reach 0.7 bln by 2030.
Russian market
There have been no epidemiological studies of interstitial cystitis in Russia. Estimates show that about 180 thousand people may suffer from the disease in our country, the annual increase in patients is 20 thousand people (7). The estimated cost of treating one patient with medications ranges from RUB 21.5 to 50 thousand per year. Surgical treatment costs RUB 100-300 thousand per year, while the number of such interventions during the year can reach four surgeries(8).
The assessment of direct and indirect damage to the economy is estimated at RUB 0.5-3 bln a year*.
In Russia, nonsteroidal anti-inflammatory drugs, antihistamines, corticosteroids, botox, analgesics, and antidepressants are used to treat interstitial cystitis. There is only one drug that is indicated for the treatment of pain in IC — pentosan sodium polysulfate. In 2022, the market for these drugs amounted to 4.8 mln packages worth RUB 886.8 mln. In 2023, the market volume decreased to 3.9 mln packages by RUB 760.5 mln, which is most likely due to inventory shortage.
In January 2024, the Ministry of Health issued permission for clinical trials of Neovasculgen for the treatment of interstitial cystitis. Now the drug has already been approved for patients with ischemia of the lower extremities, that is, with impaired blood circulation in the legs. Neovasculgen is a drug that promotes neoangiogenesis, and therefore is used for ischemia of the lower extremities. Since the drug stimulates therapeutic angiogenesis (vascular growth) and targets tissue ischemia, it has the potential to treat other diseases that need to increase vascular density – particularly interstitial cystitis.
Of all patients with IC in 2023, 11% were treated, i.e., about 20 thousand patients received therapy for this disease. According to the base scenario, the number of patients being treated will increase to 22 thousand people in ten years. Of these, 25%, that is, 5.5 thousand, will use Nevasculgen. Sales of the drug will amount to RUB 858 mln (11 thousand packages).
The optimistic scenario assumes that the number of patients treated will be 33 thousand, and 9.9 thousand of which will use Neovasculgen. Then sales will reach RUB 1.5 bln (19.8 thousand packages.)
*Calculations by Artgen Biotech