Ulcerative Colitis (UC) - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights

• Ulcerative Colitis is an idiopathic inflammatory bowel condition. It affects the colonic mucosa and is characterized clinically by diarrhea, stomach discomfort, pain, and hematochezia.
• Approximately 40% and 60% of patients present with mild and moderate to severe at initial diagnosis, and ~15% of mild patients may eventually progress to the moderate to severe patient group.
• Treatment for ulcerative colitis is complex and comprises the use of medication, alterations in diet and nutrition, and at times surgical procedures to repair or remove affected portions of the patient's gastrointestinal tract.
• Currently, several types of medications are used for treatments, namely aminosalicylates, corticosteroids, immunomodulators, biologic therapies, S1P modulators, Janus kinase inhibitors, and others. However, the ulcerative colitis treatment landscape is evolving with many emerging therapies.
• However, due to unfavorable clinical characteristics and the limited efficacy of existing therapies, many patients stop responding and thus require new therapeutic management options.
• In the United States, anti-TNFaagents (adalimumab, infliximab, golimumab), interleukin antagonists (ustekinumab, mirikizumab), anti-integrin agents (vedolizumab), S1P receptor modulator (ozanimod), and JAK inhibitors (tofacitinib, upadacitinib), are approved for the treatment of moderate to severe ulcerative colitis patients.
• In 2022, the market size of ulcerative colitis was the highest in the US among the 7MM, accounting for approximately USD 5,700 million, which is expected to increase by 2032.
• Among emerging therapies, etrasimod (Arena /Pfizer), obefazimod (Abivax), cobitolimod (InDex), risankizumab (AbbVie/Boehringer Ingelheim), guselkumab (Janssen), and others will be expanding the treatment landscape of ulcerative colitis.

This “Ulcerative Colitis - Market Insights, Epidemiology and Market Forecast - 2032” report delivers an in-depth understanding of the Ulcerative Colitis, historical and forecasted epidemiology as well as the Ulcerative Colitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Ulcerative Colitis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Ulcerative Colitis market size from 2019 to 2032. The report also covers current Ulcerative Colitis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Ulcerative Colitis Disease Understanding and Treatment Algorithm

Ulcerative Colitis Overview

Ulcerative colitis is one of the two main forms of chronic inflammatory disease of the gastrointestinal tract, called inflammatory bowel disease, the other being Crohn's disease. Ulcerative colitis is an idiopathic, chronic inflammatory disorder of the colonic mucosa and is clinically characterized by diarrhea, abdominal pain, and hematochezia. The extent of the disease is variable and may include either the rectum (ulcerative proctitis), the splenic flexure of the left side of the colon, or the whole of the rectum and bowel. Histologically, the severity of the disorder can also be very complex, varying from minimal to florid ulceration and dysplasia.

There are different types of ulcerative colitis: ulcerative proctitis, proctosigmoiditis, left-sided colitis (also limited or distal colitis), and pancolitis. Environmental factors, microbiome and abnormal immune reactions, and several variables, such as diet, lifestyle, age, and genetics, can increase the risk of ulcerative colitis.
The symptoms of ulcerative colitis can range from mild to extremely severe. Some commonly observed symptoms are bloody diarrhea, cramping in the abdomen, tiredness and weakness, feeling unwell generally, loss of appetite and weight, and anemia. Individuals with ulcerative colitis can experience disorders that affect other parts of their body, such as the joints, eyes, or skin.

Ulcerative Colitis Diagnosis

Ulcerative Colitis diagnosis is based on medical history, clinical judgment, serological observations, and findings. Ulcerative Colitis patients may be identified by the degree of disease, severity of disease, age of onset, extraintestinal symptoms, and genetic markers. Classification of disease severity is based on the number of daily stools and systemic signs of inflammation (or absence). Infectious (e.g., bacterial, parasitic, viral, and fungal) and non-infectious (e.g., microscopic colitis, malabsorption of bile acid, bacterial overgrowth, drug-induced) causes of diarrhea should be ruled out before a diagnosis.

There is no one test to diagnose ulcerative colitis; instead, the symptoms of inflammatory bowel diseases are considered together with the results of endoscopies, biopsies, stool tests, x-rays, and imaging procedures (plain radiograph, fluoroscopy, CT, and MRI). Other than this, laboratory tests like full blood count, inflammatory marker tests, liver function tests, urea, electrolytes, etc., are also performed.

Flexible sigmoidoscopy and colonoscopy are the most accurate methods for diagnosing Ulcerative Colitis and ruling out other possible conditions, such as Crohn's disease, diverticular disease, or cancer. More sophisticated blood tests are now being used to help distinguish between Crohn's disease and Ulcerative Colitis based on antibody identification. Many patients with Ulcerative Colitis have Perinuclear anti-neutrophil antibodies in their blood, while patients with Crohn's disease are more likely to have Anti-Saccharomyces Cerevisiae antibodies.

Ulcerative Colitis Treatment

Treatment goals in Ulcerative Colitis have evolved from treating symptoms and induction of clinical remission to more stringent outcomes, including maintenance of steroid-free remission, prevention of hospital admission and surgery, mucosal healing, improved quality of life, and avoidance of disability. Treatment in Ulcerative Colitis is individualized to the specific needs of the patient, depending on the severity of the disease and its symptoms.

Treatment for Ulcerative Colitis is complex and comprises the use of medication, alterations in diet and nutrition, and at times surgical procedures to repair or remove affected portions of the patient's gastrointestinal tract. Surgery for Ulcerative Colitis is indicated for those patients who are unresponsive to medical therapy and have a severely compromised quality of life. Current surgical alternatives include total proctocolectomy, restorative proctocolectomy, and elective colorectal cancer surgery.

Several types of medications are used for treatment, including aminosalicylates that reduce inflammation in the lining of the intestine. These corticosteroids block substances that trigger allergic and inflammatory responses, immunosuppressants, Janus kinase inhibitors, and others. REMICADE, STELARA, XELJANZ, and RINVOQ are some of the approved therapies for treating moderate-to-severe ulcerative colitis.

However, over the next few years, the Ulcerative Colitis market is expected to experience growth as its treatment landscape is evolving with many new entries.

Ulcerative Colitis Cancer Epidemiology

The prevalence of Ulcerative Colitis has been rising, and factoring costs related to Ulcerative colitis health care and societal costs are substantial. In developed countries, including the United States, Ulcerative Colitis affects roughly 300 people per 100,000 population. Unlike most autoimmune diseases, Ulcerative Colitis does not seem to discriminate by sex, as it can be seen nearly the same in men and women. The most common age for Ulcerative Colitis to appear is early adulthood. The inflammatory nature of Ulcerative Colitis, left inadequately treated, can result in continuous bowel damage with increased risks of hospitalizations, surgeries, and colorectal cancer.

As the market is derived using the patient-based model, the Ulcerative Colitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Ulcerative Colitis, Age-specific Cases of Ulcerative Colitis, Severity-specific Cases of Ulcerative Colitis, and Total Treated Patients of Ulcerative Colitis, in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2019 to 2032. The total diagnosed prevalent cases of Ulcerative Colitis in the 7MM comprised approximately 3,012,700 in 2022 and are projected to increase during the forecasted period.

• In the United States, the total number of diagnosed prevalent cases of ulcerative colitis was 1,437,600 in 2022.
• The United States contributed to the largest diagnosed prevalent ulcerative colitis population, acquiring ~47% of the 7MM in 2022. Whereas Germany and Japan accounted for around 10% each of the total 7MM population share in 2022.
• Among EU4 countries and the UK, Germany accounted for the largest number of diagnosed prevalent Ulcerative colitis cases, followed by the United Kingdom, whereas Italy accounted for the lowest number of cases in 2022.
• According to the publisher's estimates, the severity-specific diagnosed prevalent cases of Ulcerative colitis were approximately 575,050 mild and 948,835 total moderate to severe cases in 2022 in the US. These cases are projected to increase during the forecasted period.
• In the 7MM, approximately 86% of the patient share is attributed to the 18-64 age group.
• The diagnosis and treatment rate of Ulcerative colitis is expected to increase in the coming years due to the increase in expected approvals of several pipeline-targeted therapies for the treatment of Ulcerative colitis, thus leading to the increase in awareness among patients and clinicians for disease symptoms and their management.

Ulcerative Colitis Drug Chapters

The drug chapter segment of the Ulcerative Colitis report encloses a detailed analysis of Ulcerative Colitis marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand Ulcerative Colitis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

SIMPONI (golimumab): Janssen Pharmaceuticals

SIMPONI is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to the bones, cartilage, and tissue. SIMPONI is the first subcutaneous anti-tumor necrosis factor (TNF)-alpha treatment administered as an every 4-week maintenance therapy for ulcerative colitis.

It is approved to treat moderately to severely active ulcerative colitis in adults. However, it is also being evaluated in pediatric patients with moderately to severely active ulcerative colitis in currently ongoing trials.

ENTYVIO (vedolizumab): Takeda Pharmaceuticals

It is a humanized monoclonal antibody designed to antagonize the alpha 4 beta 7 integrin specifically, inhibiting the binding of alpha 4 beta 7 integrins to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1). The alpha 4 beta 7 integrin is expressed on a subset of circulating white blood cells, and these cells have been shown to mediate the inflammatory process in ulcerative colitis and Crohn's disease. By inhibiting alpha 4 beta 7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.

Currently, it is approved to treat moderately to severely active ulcerative colitis in adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFa)-antagonist.

Note: Detailed current therapies assessment will be provided in the full ulcerative colitis report.

Emerging Drugs

Etrasimod (APD334): Arena Pharmaceuticals/Pfizer

Etrasimod (APD334) is a next-generation, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator designed to optimize pharmacology and engage S1P receptors 1, 4, and 5. Etrasimod provides systemic and local effects on specific immune cell types and can potentially treat multiple immune-mediated inflammatory diseases, including Crohn's disease and ulcerative colitis.

Currently, etrasimod is being investigated in Phase III (NCT03950232) and a few Phase II trials for treating moderately to severely active ulcerative colitis. It is expected to be launched by 2023 in the US and will get approximately 4% of the peak share in the Ulcerative colitis market.

ABX464 (obefazimod): Abivax

ABX464 is an oral, first-in-class, small molecule that selectively upregulates miR-124 in immune cells. Because of its ability to greatly upregulate the production of a unique RNA splicing product and anti-inflammatory agent, miR-124, ABX464's mechanism of action is unique. It has shown promise in clinical trials in bringing patients into remission and healing inflammatory lesions in ulcerative colitis.

Currently, obefazimod is being evaluated in various Phase III trials to treat moderately to severely active ulcerative colitis. Expected to be in the US market by 2026 with slow-medium uptake.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

A diverse class of treatment agents re now been prescribed for Ulcerative Colitis treatment, like anti-TNFa, anti-leukotriene antagonists, anti-integrins, S1P receptor modulators, and JAK inhibitors. Among all classes, anti-TNF alfa is recommended in first-line treatment.

Drugs that block both JAK and tyrosine kinase may also be effective in stopping or slowing the growth of Ulcerative Colitis. Ritlecitinibis, developed by arena pharmaceuticals/Pfizer, could be an efficacious treatment in the Ulcerative Colitis market.

Remestemcel-L is a product candidate of Mesoblast, which consists of 100 million mesenchymal stem cells (MSCs). Remestemcel-L has demonstrated immunomodulatory properties in preclinical studies to regulate T-cell mediated inflammatory responses by inhibiting T-cell proliferation and down-regulating the production of the pro-inflammatory cytokines, including tumor necrosis factor-alpha, or TNF-alpha, and interferon-gamma. More critically, MLCs can effectively down-regulation of Th17 cells, reduce IL-17 levels, and induce FOXP3 regulatory T cells. These inflammatory pathways are considered central to inflammatory conditions' pathogenesis.

Moreover, the upcoming treatment landscape is poised to expand further after new classes emerge, such as toll-like receptor 9 activators, miR-124 enhancers, T-cell therapy, etc.

Ulcerative Colitis Market Outlook

Treatment for Ulcerative Colitis is complex and comprises the use of medication, alterations in diet and nutrition, and at times surgical procedures to repair or remove affected portions of the patient's gastrointestinal tract. The current treatment landscape of Ulcerative Colitis consists of conventional choices such as aminosalicylates, corticosteroids, thiopurines, calcineurin inhibitors, anti-TNF agents (HUMIRA [adalimumab], REMICADE [infliximab], and SIMPONI [golimumab]), antiadhesion molecules (ENTYVIO [vedolizumab]), and, more recently, small molecule directed against the JAK pathways (XELJANZ [tofacitinib]), anti-IL12/23 (STELARA [ustekinumab]), and S1P receptor modulator (ZEPOSIA [ozanimod]).

Current US guidelines recommend first-line treatment with aminosalicylate or sequential induction with corticosteroids followed by aminosalicylate maintenance therapy in patients with mild-to-moderate Ulcerative Colitis. In patients with moderate-to-severe Ulcerative Colitis, an immunosuppressant such as azathioprine or 6-mercaptopurine may be prescribed as maintenance therapy following corticosteroid induction. Alternatively, a biologic, typically an anti-tumor necrosis factors antibody such as infliximab or adalimumab, can be prescribed with or without a concurrent immunosuppressant to promote and maintain mucosal healing and clinical remission.

The current market has been segmented into different commonly used drugs based on the prevailing treatment pattern across the 7MM, presenting minor variations in the overall prescription pattern. Conventional therapies, anti-TNF agents, anti-adhesion molecules, JAK pathways, and others are the major drug classes covered in the forecast model.

The expected launch of upcoming therapies and greater integration of early patient screening, medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. However, the higher cost of new therapies and the higher cost burden of associated complications on patients may hinder the adoption of newer therapies.

Key players such as etrasimod (Arena /Pfizer), obefazimod (Abivax), cobitolimod (InDex), risankizumab (AbbVie/Boehringer Ingelheim), guselkumab (Janssen), and several others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Ulcerative Colitis.

• The total market size of Ulcerative Colitis in the 7MM was approximately USD 8090 million in 2022 and is projected to increase during the forecast period (2023-2032).
• The market size in the 7MM will increase due to increased awareness regarding Ulcerative Colitis, and the corresponding rise in product launches, with various awareness campaigns, is expected to increase early diagnosis and treatment of Ulcerative Colitis.
• Among EU4 countries, Germany accounted for the maximum market size in 2022.
• By 2032, among all the emerging therapies, the highest revenue will be generated by vedolizumab, followed by adalimumab in the 7MM.

Ulcerative Colitis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in 2019-2032. For example, for etrasimod, being developed by Arena Pharmaceuticals/Pfizer, we expect the drug uptake to be medium-fast with a probability-adjusted peak share of approximately 4%, and years to the peak is expected to be 6 years from the year of launch.

Ulcerative Colitis Pipeline Development Activities

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

Pipeline development activities

The report covers information on collaborations, acquisition and merger, licensing, and patent details for Ulcerative Colitis emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on Ulcerative Colitis evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, drug uptake along with challenges related to accessibility, including Medical/scientific writers, Division of Gastroenterology and Hepatology, State Key Laboratory for Oncogenes and Related Genes, Duke Cancer Institute at Duke University School, and others.

This analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Ulcerative Colitis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs qualitative and market intelligence analysis using various approaches, such as SWOT and Conjoint 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.

Conjoint analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, treatment duration and frequency of administration, route of administration, patient segment, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in Ulcerative Colitis trials, the most important primary outcome measures are overall survival, progression-free survival, and objective response rate.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement is a crucial factor affecting the drug's market access. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. Drugs approved for Ulcerative Colitis in the United States include SIMPONI (golimumab), ENTYVIO (vedolizumab), XELJANZ (tofacitinib), STELARA (ustekinumab), RINVOQ (upadacitinib), ZEPOSIA (ozanimod), REMICADE (infliximab), and HUMIRA (adalimumab). Market access and reimbursement options can differ depending on regulatory status, the size of the target population, the setting of care, unmet needs, the magnitude of incremental benefit claims, and costs.

Besides the patient assistance programs provided by the companies for their respective drugs, certain organizations also provide reimbursement assistance to Ulcerative Colitis patients. For instance, Medicare reimburses biologics in a clinical setting when used following FDA-approved labeling. Under §1861(b) of the statute of Medicare, anti-integrins, such as vedolizumab, are covered.

Additionally, the Health Well Foundation, an independent non-profit, provides a financial lifeline for inadequately insured Americans. The Crohn's & Colitis Foundation provides copayment and premium assistance to eligible Medicare patients. Health Well provides up to USD 10,000 in copayment or premium assistance to individuals with annual household incomes up to 400% of the federal poverty level through the fund.

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.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Ulcerative Colitis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Ulcerative Colitis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Ulcerative Colitis market.

Ulcerative Colitis Report Insights

• Patient population
• Therapeutic approaches
• Ulcerative Colitis pipeline analysis
• Ulcerative Colitis market size and trends
• Existing and future market opportunities

Ulcerative Colitis Report Key Strengths

• 10 years forecast
• 7MM coverage
• Ulcerative Colitis epidemiology segmentation
• Key cross competition
• Conjoint analysis
• Drugs Uptake and key market forecast assumptions

Ulcerative Colitis Report Assessment

• Current treatment practices
• Unmet needs
• Pipeline product profiles
• Market attractiveness
• Qualitative analysis (SWOT and Conjoint Analysis)

Key Questions Answered

Market Insights

• What was Ulcerative Colitis's total market size, the market size by therapies, market share (%) distribution in 2019, and how would it look in 2032? What are the contributing factors for this growth?
• What kind of uptake will approved therapies witness in Ulcerative Colitis patients in the coming 10 years?
• How will emerging drugs compete with recently approved therapy in the market?
• Which class is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risk, burdens, and unmet needs of Ulcerative Colitis? What will be the growth opportunities across the 7MM concerning the patient population of Ulcerative Colitis?
• What is the historical and forecasted Ulcerative Colitis patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Even with a large patient pool, why the Ulcerative Colitis receive rare disease benefits?
• What factors are affecting the increase in the diagnosis of symptomatic cases?

Current treatment scenario marketed drugs and emerging therapies

• What are the current options for the treatment of Ulcerative Colitis? What are the current guidelines for treating Ulcerative Colitis in the US, Europe, and Japan?
• How many companies are developing therapies for the treatment of Ulcerative Colitis?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Ulcerative Colitis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Ulcerative Colitis?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapy?
• What is the 7MM historical and forecasted market of Ulcerative Colitis?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Ulcerative Colitis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy