Interstitial Cystitis Market Summary

• Interstitial cystitis is a chronic pelvic condition characterized by pain, pressure, or discomfort linked to the bladder. It involves persistent inflammation and lower urinary tract symptoms, such as urgency and frequency, without any identifiable infection or clear underlying cause.
• Interstitial cystitis is classified into ulcerative and nonulcerative types. The ulcerative form is defined by the presence of Hunner lesions, reddish erosions with surrounding scarring, while the non-ulcerative type lacks Hunner lesions and typically involves similar symptoms with less inflammation.
• Diagnosis is primarily based on clinical symptoms such as persistent pelvic pain, urinary urgency, and frequency in the absence of infection.
• In 2024, the total diagnosed prevalent cases of interstitial cystitis were approximately 3.5 million in the 7MM, reflecting a significant clinical burden.
• As per DelveInsight analysis, the US showed the highest number of prevalent cases of interstitial cystitis, accounting for approximately 60% of the of total prevalent cases of interstitial cystitis in the 7MM in 2024.
• Treatment typically begins with lifestyle and dietary modifications, pelvic floor physical therapy, and bladder retraining to reduce symptom burden and avoid known triggers.
• When conservative measures are ineffective, treatment may involve pharmacologic options like amitriptyline, cyclosporine A, or intravesical agents such as DMSO, heparin, or lidocaine, tailored to symptom severity and the presence of Hunner lesions. For refractory cases, advanced therapies including botulinum toxin A, sacral neuromodulation, or surgery may be considered.
• In 2024, the US dominated the interstitial cystitis market among the 7MM, capturing approximately 75% of the total 7MM market share.
• In 2024, the total market size for interstitial cystitis in EU4 and the UK was approximately USD 700 million, accounting for almost 25% of market in 7MM.
• In March 2025, Hyloris announced a positive interim review outcome for the ALENURA clinical trial, with the IDMC recommending its continuation. Patient enrollment is expected to be completed by the end of 2025. ALENURA is being developed as a potential first-line treatment for Interstitial Cystitis.
• There are currently only two approved treatments for interstitial cystitis: ELMIRON by Johnson & Johnson, and ZYMSO by Kyorin Pharmaceuticals, an intravesical therapy approved in Japan. This limited availability highlights the urgent need for more effective and broadly accessible treatment options.
• The interstitial cystitis pipeline shows promising advancement with diverse therapies under development, including Vaneltix Pharma’s ALENURA, Ono Pharmaceutical’s ONO-1110, Seikagaku Corporation’s SI-722, Imbrium Therapeutics Sunobinop, and Aska Pharmaceutical’s AKP-021. These candidates aim to improve symptom control through novel mechanisms, reflecting growing efforts to address the condition’s significant unmet need.

Factors Impacting the Interstitial Cystitis Market Growth

Increasing Interstitial Cystitis Prevalence and Awareness

The rising prevalence of interstitial cystitis, particularly among women, is a primary driver for the interstitial cystitis market growth. In 2024, females represented approximately 60% of interstitial cystitis cases in the US, while males accounted for 40% cases. This gender disparity reflects a significantly higher disease burden among women, emphasizing the need for tailored research and treatment strategies. Enhanced awareness among healthcare providers and patients is leading to better diagnosis and treatment, thereby expanding the patient base and market demand.

Advancements in Diagnostic Techniques

Improvements in diagnostic methods are facilitating earlier and more accurate detection of interstitial cystitis, which is crucial for effective treatment and management.

Emerging Therapies for Interstitial Cystitis

Emerging interstitial cystitis therapies in clinical trials include Ono Pharmaceutical’s ONO-1110, Vaneltix Pharma’s Alenura, Imbrium Therapeutics’ Sunobinop, and others.

Interstitial Cystitis Market Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the interstitial cystitis market, providing an in-depth examination of its historical and projected market size (2020–2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM interstitial cystitis market.

The table given below further depicts the key segments provided in the report:

Interstitial Cystitis Drug Analysis

The section dedicated to drugs in the interstitial cystitis report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to interstitial cystitis. The drug chapters section provides valuable information on various aspects related to clinical trials of interstitial cystitis, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting interstitial cystitis.

Interstitial Cystitis Marketed Therapies

ELMIRON (pentosan polysulfate sodium): Johnson & Johnson

ELMIRON is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water to 50% at pH 6. ELMIRON is supplied in white opaque hard gelatin capsules containing 100 mg pentosane polysulfate sodium, microcrystalline cellulose, and magnesium stearate. It is formulated for oral use.

In June 2017, ELMIRON received marketing authorisation from the European Commission, granting approval across the entire European Union for the treatment of interstitial cystitis.

ZYMSO (Dimethyl Sulfoxide): KYORIN Pharmaceuticals

ZYMSO is an intravesical solution containing 50% dimethyl sulfoxide (DMSO). ZYMSO offers a targeted, non-systemic option for patients with refractory Hunner-type interstitial cystitis. By administering high-concentration DMSO directly into the bladder, it delivers potent local anti-inflammatory and analgesic effects with a known safety profile.

In January 2021, Kyorin Pharmaceutical obtained marketing authorization from the Ministry of Health, Labour and Welfare (MHLW) for ZYMSO Intravesical Solution 50%, a treatment developed for interstitial cystitis.

Interstitial Cystitis Emerging Therapies

ALENURA (Lidocaine + Heparin): Vaneltix Pharma/Hyloris Pharma

ALENURA is a combination product of the glycosaminoglycan heparin and alkalinized lidocaine, which provides immediate pain relief to patients experiencing acute painful episodes of interstitial cystitis. ALENURA is supplied as a prefilled syringe for intravesicular installation into the bladder for on-demand relief of acute pain episodes.

As of 2025, a second Phase II clinical trial of ALENURA is underway—a 2-week, open-label study evaluating the safety and efficacy of multiple doses in patients experiencing episodes of acute bladder pain. The trial is currently in the recruiting phase.

In March 2025, Hyloris announced a positive interim review outcome for the ALENURA clinical trial, with the Independent Data Monitoring Committee (IDMC) recommending its continuation. Patient enrollment is expected to be completed by the end of 2025. ALENURA is being developed as a potential first-line treatment for Interstitial Cystitis.

Interstitial Cystitis Market Outlook

During the forecast period (2025–2034), pipeline candidates such as Vaneltix Pharma’s ALENURA, Ono Pharmaceutical’s ONO-1110, Seikagaku Corporation’s SI-722, Imbrium Therapeutics Sunobinop, and Aska Pharmaceutical’s AKP-021, and others are expected to drive the rise in interstitial cystitis market size

• In 2024, the total market size of interstitial cystitis in 7MM was approximately USD 3 billion, highlighting a high economic burden and significant unmet therapeutic need.
• In 2024, in the EU4 and the UK, Germany has the highest market size for interstitial cystitis at approximately USD 300 million, followed by UK with approximately USD 200 million.
• In 2024, the total market size for interstitial cystitis in Japan was approximately 60 USD million.
• The interstitial cystitis market is limited by few approved treatments and high unmet need. However, pipeline innovation and rising awareness are expected to drive modest growth and improve future therapeutic options. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2024–2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of interstitial cystitis in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.

Further details are provided in the report…

Interstitial Cystitis Disease Understanding

Interstitial Cystitis Overview

Interstitial cystitis, is a chronic pelvic condition lasting over six weeks, characterized by bladder-related pain, pressure, or discomfort. It involves ongoing inflammation and urinary symptoms like urgency and frequency, without evidence of infection or another identifiable cause.

Patients often experience bladder or suprapubic pain with an urgent need to urinate, which worsens as the bladder fills and eases temporarily after voiding—leading to frequent day and night urination. Additional symptoms may include burning during urination and sexual discomfort, significantly impacting emotional, psychological, and social well-being.

The pathophysiology of interstitial cystitis is not fully understood, but it involves chronic inflammation, nerve hypersensitivity, mast cell activation, urothelial damage, and GAG layer dysfunction. Inflammatory markers like CRP, TNF-a, and NGF support inflammation as a central mechanism. The condition may manifest with or without visible inflammation, is often linked to autoimmune disorders, and is exacerbated by chronic stress and central sensitization.

Further details are provided in the report…

Interstitial Cystitis Diagnosis

Interstitial cystitis is primarily diagnosed based on clinical symptoms and by ruling out other urological, gynecological, or infectious conditions. According to AUA guidelines, cystoscopy and urodynamic studies are not mandatory but may be useful in unclear or severe cases. Laboratory tests such as CBC, CMP, urinalysis, and STI screening are typically performed. Hunner ulcers, when present, are considered diagnostic and may warrant targeted treatments like fulguration or steroid injections.

Biomarkers like TNF-a and IL-6 may be elevated, though their diagnostic role is still under review. Cystoscopy with hydrodistension and bladder biopsy can help exclude malignancy, especially in older patients. Glomerulations are nonspecific and not diagnostic on their own. Ultimately, diagnosis is based on persistent symptoms lasting over six weeks, exclusion of other causes, and, when applicable, supportive cystoscopic findings.

Further details related to country-based variations are provided in the report…

Interstitial Cystitis Treatment

Interstitial cystitis management primarily aims at symptom relief through a trial-and-error approach, as no single therapy proves universally effective. Initial treatment focuses on conservative measures, including dietary modifications, bladder training, stress management, and pelvic floor relaxation. Standard pelvic exercises like Kegels are discouraged as they may worsen symptoms.

Pharmacological options include oral agents such as amitriptyline, cyclosporine A, hydroxyzine, gabapentin, and pentosan polysulfate, although their efficacy and tolerability vary. Intravesical therapies like DMSO, heparin, lidocaine, and triamcinolone are often used in combination. Botulinum toxin A is reserved for refractory cases and requires patients to be capable of self-catheterization. Advanced options include sacral or tibial neuromodulation, cystoscopy-guided fulguration of Hunner lesions, and, in severe cases, surgical interventions like bladder augmentation or urinary diversion.

Investigational therapies under study include monoclonal antibodies, stem cells, PRP, liposomes, and antiviral agents such as valacyclovir. These approaches reflect an evolving treatment landscape targeting the diverse and often unclear pathophysiology of interstitial cystitis.

Further details related to treatment and management are provided in the report…

Interstitial Cystitis Epidemiology

The interstitial cystitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by prevalent cases, total diagnosed prevalent cases, age-specific cases of interstitial cystitis, gender-specific cases, severity-specific cases, type-specific cases, total treated cases of interstitial cystitis in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 2024, the prevalent cases of interstitial cystitis were approximately 11 million across the 7MM, reflecting its significant disease burden and the pressing need for improved diagnostic tools and more effective treatments.
• In 2024, interstitial cystitis cases in the EU4 and the UK were distributed as approximately 50% moderate, 35% mild, and 15% severe, indicating that moderate cases represent the largest share of the clinical burden.
• In 2024, the highest burden of interstitial cystitis in the US was seen in the 56–74 age group with approximately 900 thousand cases, followed by ~700 thousand cases in those aged 36–55, highlighting the growing impact among middle-aged and older adults.
• In 2024, females represented approximately 60% of interstitial cystitis cases in the US while males accounted for 40% cases. This gender disparity reflects a significantly higher disease burden among women, emphasizing the need for tailored research and treatment strategies.

Latest KOL Views on Interstitial Cystitis

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of interstitial cystitis, including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at Delveinsight connected with more than 10 KOLs across the 7MM. We contacted institutions such as the University of Munich, the University of Tokyo, Brady Urological Institute, and University of Minnesota, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the interstitial cystitis market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Interstitial Cystitis Report Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Interstitial Cystitis Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

Johnson and Johnson offers the ELMIRON Savings Program to reduce prescription costs for eligible patients. Those with commercial or private insurance may pay as little as USD 25 for a 30-day supply, with a monthly benefit cap of USD 300 and an annual maximum of USD 3,600. The program is not available to patients enrolled in Medicare, Medicaid, or other government-funded insurance plans. Eligibility requirements apply, and the offer is subject to change or discontinuation at any time. Cost assistance is provided directly to patients and is not intended for insurers or their affiliates.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Interstitial Cystitis Report Insights

• Patient Population
• Therapeutic Approaches
• Interstitial Cystitis Market Size and Trends
• Existing Market Opportunity

Interstitial Cystitis Report Key Strengths

• Ten-year Forecast
• The 7MM Coverage
• Interstitial Cystitis Epidemiology Segmentation
• Key Cross Competition

Interstitial Cystitis Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Unmet needs)

Key Questions Answered in the Interstitial Cystitis Report

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in interstitial cystitis management recommendations?
• Would research and development advances pave the way for future tests and therapies for interstitial cystitis?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of interstitial cystitis?
• What kind of uptake will the new therapies witness in the coming years in interstitial cystitis patients?