Interstitial Cystitis (IC) - Market Insights, Epidemiology and Market Forecast - 2030

This report delivers an in-depth understanding of the Interstitial Cystitis (IC), historical and forecasted epidemiology as well as the Interstitial Cystitis (IC) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Interstitial Cystitis (IC) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Interstitial Cystitis (IC) market size from 2017 to 2030. The report also covers current Interstitial Cystitis (IC) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geographies Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017-2030

Interstitial Cystitis (IC) Disease Understanding and Treatment Algorithm

Interstitial Cystitis (IC) Overview

Interstitial Cystitis (IC), also called as Painful Bladder Syndrome, is a chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain. The pain ranges from mild discomfort to severe levels. Bladder is a hollow, muscular organ that stores urine. The bladder expands until it is full and then gives signals to the brain that it is time to urinate, communicating through the pelvic nerves. This creates the urge to urinate for most people. With IC, these signals get mixed up and then patients feel the need to urinate more often and with smaller volumes of urine than most people. The IC disease most often affects women and can have a long-lasting impact on the quality of life. Although there is no cure, medications and other therapies may offer some relief.

There are two type of IC such as Non-Ulcerative, which is found in 90% of the population suffering from Interstitial Cystitis. It is characterized by pinpoint hemorrhages called as glomerulations. Another types is Ulcerative, which comprises of about 5-10% of the patient population. . It is mainly characterized by Hunner’s ulcers and the patches that bleed on bladder walls. Hunner’s ulcers, also called “Hunner’s lesions” or “Hunner’s patches,” are a subtype of Interstitial Cystitis (also called IC) and are not ulcers in the usual sense. They are distinctive areas of inflammation on the bladder wall that characterize the “classic” form of IC. Hunner’s ulcers are the one diagnostic feature that clinches the IC diagnosis, but this “classic” form of IC affects only about 5 to 10 percent of patients. Often, patients with this form of IC have more severe symptoms than patients with non-ulcerative IC.

The Interstitial Cystitis market report gives the thorough understanding of the IC by including details such as disease introduction, signs and symptoms, risk factors, causes, pathophysiology, biomarkers and diagnosis. It also provides treatment algorithms and treatment guidelines for AKI in the US, Europe, and Japan.

Interstitial Cystitis (IC) Diagnosis

A thorough general medical history is of paramount importance to identify typical diagnostic symptoms of IC/BPS and other potential mimicking causative conditions. Unfortunately, delay of diagnosis is common, with an average time of 3-7 years from the time of presentation to the general practitioner to diagnosis by a specialist.

Despite the absence of urinary infection (UTI) being a prerequisite at the time of diagnosis, up to 50% of patients will have a previous history of UTI. It is important to elicit a comprehensive medical history, including past pelvic surgery or radiation, medications that can cause cystitis (nonsteroidal anti-inflammatory drugs, cyclophosphamide, and ketamine), fibromyalgia, depression, sexual dysfunction, autoimmune diseases, allergies, and other gynecological conditions (vulvodynia, endometriosis, dyspareunia). Not only is the past medical history important for diagnosis, but also because many of these conditions may co-exist, further stressing the importance of multidisciplinary management.

The most commonly used methods to diagnose IC include physical examination, ultrasound/pelvic imaging, laboratory tests such as urinalysis, culture, cytology, potassium sensitivity test, etc.

Interstitial Cystitis (IC) Treatment

Since the etiology and pathogenesis of IC are not well understood and there is no curative treatment, the goal of management is to provide relief of symptoms to improve quality of life of the patients. However, still bladder pain syndrome can be treated using a step wise approach depending upon the identified risk of adverse effects and invasiveness of the treatment options. The therapeutic options used to treat IC include over the counter medicines (Aspirin, Acetaminophen, NSAIDs, etc.), non-narcotic pain medicines (Pyridium, Topical Medicines, Lidocaine Patch, etc.), narcotic pain medicines (Codeine, Oxycodone, Tapentadol, etc.).

Other interventions include use of physical therapy, antidepressants, selective serotonin reuptake inhibitors (SSRIS), serotonin and norepinephrine reuptake inhibitors (SNRIS), Bladder Instillations, Immunosuppressants, etc.

Till date there are only two approved therapies to treat IC such as oral Elmiron (Pentosan polysulfate sodium) and intravesical Dimethyl Sulfoxide (DMSO).

Interstitial Cystitis (IC) Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Prevalent Population of Interstitial Cystitis, Gender-specific Prevalent Population of Interstitial Cystitis, Total Diagnosed Prevalent Population of Interstitial Cystitis, Severity-based Diagnosed Prevalent Population of Interstitial Cystitis, Type-specific Diagnosed Prevalent Population of Interstitial Cystitis, Age-specific Diagnosed Prevalent Population of Interstitial Cystitis in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.

Key Findings

This section provides glimpse of the Interstitial Cystitis (IC) epidemiology in the 7MM.

• The total diagnosed prevalent population of Interstitial Cystitis in the 7 major markets was found to be 2,264,118 in 2017. In case of Interstitial Cystitis patients in the United States, the diagnosed prevalent cases was found to be 1,459,502 in 2017.
• The prevalent population of Interstitial Cystitis in the United States was found to be 5,838,009 in 2017, which is expected to increase by 2030.
• The publisher has analyzed severity-based data for Interstitial Cystitis. Interstitial Cystitis can be divided as three types based on this data, namely, mild, moderate and severe type. It was found that in the United States the number of cases of mild, moderate and severe were 525,421, 729,751 and 204,330 respectively in 2017.
• In Japan, the diagnosed prevalence of Interstitial Cystitis was found to be 151,513 in 2017, which will increase in the forecast period 2020-2030.

Country Wise- Interstitial Cystitis (IC) Epidemiology

The epidemiology segment also provides the Interstitial Cystitis (IC) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

Interstitial Cystitis (IC) Drug Chapters

The drug chapter segment of the Interstitial Cystitis (IC) report encloses the detailed analysis of Interstitial Cystitis (IC) marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Interstitial Cystitis (IC) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.

Interstitial Cystitis (IC) Marketed Drugs

Elmiron: Janssen Pharmaceutical

Elmiron (Pentose polysulfate sodium) is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects. It is formulated for oral use. Elmiron is indicated for the relief of bladder pain or discomfort associated with Interstitial Cystitis. It 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. Elmiron is supplied in white opaque hard gelatin capsules containing 100 mg pentosan polysulfate sodium, microcrystalline cellulose, and magnesium stearate.

Product detail in the report.

RIMSO-50: Mylan Pharmaceutical

Rimso-50 also known as Dimethyl Sulfoxide (DMSO) is first and only FDA approved bladder instillation that is specifically being developed for Interstitial Cystitis. RIMSO-50 is a 50% w/w aqueous solution for intravesical instillation. Dimethyl sulfoxide is a clear, colorless and essentially odorless liquid which is miscible with water and most organic solvents. RIMSO-50 acts as anti-inflammatory (it reduces bladder irritation and pain), antispasmodic (helps in relaxing bladder and pelvic muscles) and relives pain by depleting the level of P substance in bladder nerves. It increases bladder capacity by breaking the scar tissues and preventing the formation of collagen that creates scar tissue. Dimethyl Sulfoxide is clear and colorless.

However, there are several other intravesical instillations approved by the regulatory authorities that are used to provide relief to the patients with IC.

Product detail in the report.

Interstitial Cystitis (IC) Emerging Drugs

KRP-116D: Kyorin Pharmaceutical

KRP-116D is a 50% w/w DMSO solution, which is administered intravesically and allowed to remain in the bladder for 15 min. Kyorin Pharmaceutical has planned the development of 50% DMSO (KRP-116D) for the treatment of IC/BPS based on a request from the Committee on Unapproved Drugs and Drugs of Off-label Use urgently required for healthcare organized by the Ministry of Health, Labour and Welfare, Japan. Evidences suggest that the patient notes a garlic-like taste within a few minutes after intravesical instillation of 50% DMSO, which persists for several hours, and that an odor on the breath and skin may remain for 72 h; this suggests that DMSO is absorbed from the bladder into the body. The drug has already completed phase III clinical developmental trial in Japan for interstitial cystitis, and the company is preparing for application for the approval of the drug.

Product detail in the report.

Certolizumab pegol (Cimzia): UCB Pharma

Certolizumab pegol (Cimzia) is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). It has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Certolizumab pegol binds to human TNFα with a KD of 90 pM; TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. The drug selectively neutralizes TNFα (IC90 of 4 ng/mL for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralize lymphotoxin α (TNFβ). It is also shown to neutralize membrane-associated and soluble human TNFα in a dose-dependent manner. UCB Pharma has completed its investigation of Cimzia in phase III clinical developmental trial for the treatment of patients with IC in July 2017 itself. The complete results of this trial were published in 2018; however, the company has not published any recent updates since then. Additionally, the drug is also indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), plaque psoriasis, Crohn's disease (CD), adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS).

Product detail in the report.

LP-08: Lipella Pharmaceuticals

LP-08, investigated by Lipella Pharmaceuticals, is a novel intravesical treatment for IC, a poorly understood chronic disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that dramatically affects the quality of life. LP-08 is a patent-protected investigational drug for IC comprised of pure liposomes. The purified phospholipid component of LP-08 is known to be safe as a food source when eaten or delivered as a component of intravenous nutrition. There is no expectation that a novel route of bladder administration will present any safety issues. The company has completed its investigation of the safety and efficacy of LP-08 in phase II clinical developmental trial in June 2018 for IC.

Product detail in the report.

GRT6010: Grünenthal

Grünenthal is developing GRT6010 for the treatment of Interstitial Cystitis. It is a novel analgesic and nociceptin opioid receptor (NOP) agonist. The company has completed the phase II clinical trial for the treatment of IC in Germany, and the results were published in December 2018.

Product detail in the report.

ASP6294: Astellas Pharma

ASP6294, being developed by Astellas Pharma, is a Nerve Growth Factor (NGF) neutralization antibody. NGF is responsible for the growth and maintenance of sensory neurons and appears to play a role in neuroimmune interactions, in tissue inflammation, and neuroplasticity for neuronal events leading to OAB and bladder pain/interstitial cystitis. ASP6294 inhibits the NGF, thereby blocking its role in bladder pain. The product has completed phase II clinical trial for the treatment of BPS/IC. The drug has completed phase II trial in March 2019.

SI-722: Seikagaku Corporation

SI-722 is a novel chemical compound in which a steroid is conjugated with chondroitin sulfate using Seikagaku's proprietary glycosaminoglycan (GAG) modification technology and drug delivery systems (DDS). Intravesically instilled SI-722 provides sustained release of the steroid having anti-inflammatory activity resulting in a demonstration of long-lasting improvement in the conditions of frequent urination and bladder pain. The company follows a drug discovery approach of increasing the bioactivity of GAG, mainly through GAG modification and processing, and is currently applying GAG to DDS. It is designed for sustained release by bonding steroids to chondroitin sulfate; this leads to anti-inflammatory effects of steroids under sustained release, which should provide sustainable relief of frequent urination and bladder pain, thereby, improving patient’s quality of life. SI-722 has completed a phase I clinical study in the US. As per clinicaltrials.gov, the drug is in phase I/II developmental clinical trial for IC/BPS. This clinical study will evaluate the drug for safety, tolerability, and pharmacokinetics, and will conduct an exploratory evaluation of its effectiveness.

Interstitial Cystitis (IC) Market Outlook

According to the Interstitial Cystitis Association (ICA), interstitial cystitis or IC, is a bladder condition that usually consists of multiple symptoms. Most IC patients have recurring pelvic pain, pressure, or discomfort in the bladder and pelvic region, and urinary frequency and urgency (feeling a strong need to go). IC may also be referred to as painful bladder syndrome (PBS), bladder pain syndrome (BPS), and chronic pelvic pain. Approximately, 3-8 million women in the United States may have IC, which constitutes about 3-6% of all women in the US. On the other hand, 1-4 million men have IC as well. However, this number is likely lower than the actual rate because IC in men may often be mistaken for another disorder, such as chronic prostatitis/chronic pelvic pain syndrome.

Oral pentosan polysulfate sodium (PPS) and intravesical dimethyl sulfoxide (DMSO) are the only The US Food and Drug Administration (FDA) approved treatments for the relief of IC symptoms. Fortunately, a variety of other therapies are often used alone or in combination for the treatment of IC. Among these orally administered therapies, only Elmiron (Pentosan polysulfate sodium; Janssen Pharmaceuticals) is approved by the US Food and Drug Administration (FDA) for the treatment of IC. The US FDA approved it in September 1996. Pentosan Polysulfate is a semisynthetic heparin-like glycosaminoglycan. On the other hand, intravesical instillations with anesthetic solutions are used to control bladder pain, and heparin agents as they are thought to repair the damaged urothelium. The American Urological Association’s practice guideline for IC indicates bladder installations as a second-line treatment option when diet modification, stress management, and over-the-counter products are not enough. Bladder instillations or bladder cocktails are mixtures of medicines when introduced directly into the bladder. Types of instillations include Alkalinized Lidocaine and Heparin, DMSO, Sodium Hyaluronate, and BCG. Among these, Dimethyl sulfoxide (DMSO, brand name RIMSO-50, by Mylan Pharmaceutical), was the first and remains the only FDA-approved bladder instillation specifically for Interstitial Cystitis (IC). It was approved in 1978, and its exact mechanism of action is still not fully known, though it is believed to have several positive effects such as anti-inflammatory, antispasmodic, painkiller, and increasing bladder capacity by breaking down scar tissue by preventing the formation of collagen, a protein the body uses to create scar tissue.

The current treatment of IC also follows use of interventions as monotherapies or Combination Therapies. Monotherapy includes Oral Medications, Intravesical Instillations, and Other treatment options while combination therapy involves combination of one or more of these therapies.

Key Findings

This section includes a glimpse of the Interstitial Cystitis (IC) 7MM market.

• The United States accounts for the largest market size of Interstitial Cystitis (IC), in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
• The market size of Interstitial Cystitis in the seven major markets was found to be USD 1,599 Million in 2017, which will increase in the study period 2017-2030.
• Expected Launch of potential therapies may increase the market size in the coming years, assisted by an increase in diagnosed prevalent population of Interstitial Cystitis. Owing to the positive outcomes of the several products during the developmental stage by key players such as Kyorin Pharmaceutical, UCB Pharma, Lipella Pharmaceuticals, Grünenthal and Astellas Pharma, the market is expected to witness a significant positive shift in the Interstitial Cystitis Market Size.
• Among the EU5 countries, Germany was estimated to have the highest market size with USD 90 Million in 2017, while Spain was found to have the lowest market size of Interstitial Cystitis with USD 53 Million in 2017.
• In Japan, the market size was estimated to be USD 90 Million in 2017, which is anticipated to increase by 2030.

The United States Market Outlook

This section provides the total Interstitial Cystitis (IC) market size and market size by therapies in the United States.

EU-5 Market Outlook

The total aspregillosis market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Interstitial Cystitis (IC) market size and market size by therapies in Japan are provided.

Interstitial Cystitis (IC) Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Interstitial Cystitis (IC) market or expected to get launched in the market during the study period 2017-2030. The analysis covers Interstitial Cystitis (IC) market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Interstitial Cystitis (IC) Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Interstitial Cystitis (IC) emerging therapies.

Competitive Intelligence Analysis

The publisher performs competitive and market Intelligence analysis of the Interstitial Cystitis (IC) market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Interstitial Cystitis (IC), explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
• Comprehensive insight has been provided into the Interstitial Cystitis (IC) epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Interstitial Cystitis (IC) are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of Interstitial Cystitis (IC) market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Interstitial Cystitis (IC) market.

Report Highlights

• In the coming years, Interstitial Cystitis (IC) market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Interstitial Cystitis (IC) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• The report contains Gender-specific prevalence of IC in the 7MM, wherein females are found to suffer more as compared to male.
• Report also covers Severity-based Diagnosed Prevalent Population of Interstitial Cystitis, including several mild, moderate and severe IC.
• The publisher has also estimated Type-specific Diagnosed Prevalent Population of Interstitial Cystitis, comprising of Non-ulcerative and Ulcerative types. It was found that the Non-ulcerative is more prevalent across the 7MM.
• The report also encompasses another major segment, i.e., Age-specific Diagnosed Prevalent Population of Interstitial Cystitis, wherein various age groups have been considered, such as 18-35, 36-55, 56-74 and 75+. It has been found that IC majorly affects patients whose age is 40 years or above.
• The current US market of IC is mainly dominated by the use of monotherpies and combination therapies.
• The publisher estimates that there are several upcoming therapies targeting specific IC patient pool, such as Kyorin Pharmaceutical, UCB Pharma, Lipella Pharmaceuticals, Grünenthal and Astellas Pharma. Kyorin Pharmaceutical is developing KRP-116D, which has completed phase III trial and is expected to enter the market soon. It has shown improvements in IC/BPS symptoms, bladder pain and voiding parameters. On the other hand, Certolizumab pegol (Cimzia) by UCB Pharma has also completed phase III trial in the US and has demonstrated an acceptable safety profile for treating IC/BPS due to occurrence of microbiologically documented urinary infection in patients.

Interstitial Cystitis (IC) Report Insights

• Patient Population
• Therapeutic Approaches
• Interstitial Cystitis (IC) Pipeline Analysis
• Interstitial Cystitis (IC) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Interstitial Cystitis (IC) Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Interstitial Cystitis (IC) Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Interstitial Cystitis (IC) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions Answered

Market Insights:

• What was the Interstitial Cystitis (IC) market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the Interstitial Cystitis (IC) total market size as well as market size by therapies across the 7MM during the forecast period (2020-2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Interstitial Cystitis (IC) market size during the forecast period (2020-2030)?
• At what CAGR, the Interstitial Cystitis (IC) market is expected to grow at the 7MM level during the forecast period (2020-2030)?
• What would be the Interstitial Cystitis (IC) market outlook across the 7MM during the forecast period (2020-2030)?
• What would be the Interstitial Cystitis (IC) market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of Interstitial Cystitis (IC)?
• What is the historical Interstitial Cystitis (IC) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of Interstitial Cystitis (IC) at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Interstitial Cystitis (IC)?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Interstitial Cystitis (IC) during the forecast period (2020-2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020-2030)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of Interstitial Cystitis (IC) along with the approved therapy?
• What are the current treatment guidelines for the treatment of Interstitial Cystitis (IC) in the US and Europe?
• What are the Interstitial Cystitis (IC) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Interstitial Cystitis (IC)?
• How many therapies are developed by each company for the treatment of Interstitial Cystitis (IC)?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Interstitial Cystitis (IC)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Interstitial Cystitis (IC) therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Interstitial Cystitis (IC) and their status?
• What are the key designations that have been granted for the emerging therapies for Interstitial Cystitis (IC)?
• What are the 7MM historical and forecasted market of Interstitial Cystitis (IC)?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Interstitial Cystitis (IC).
• To understand the future market competition in the asprgillosis market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Interstitial Cystitis (IC) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Interstitial Cystitis (IC) market.
• To understand the future market competition in the Interstitial Cystitis (IC) market.