IL-23 Inhibitors - Target Population, Competitive Landscape, and Market Forecast -2034

Key Highlights:

• IL-23 inhibitors block the p19 subunit of interleukin-23, preventing its interaction with the IL-23 receptor. This halts the activation and survival of Th17 cells, reducing the production of pro-inflammatory cytokines like IL-17 and IL-22. The result is targeted immune modulation with reduced systemic immunosuppression.
• IL-23 inhibitors are primarily used in the treatment of immune-mediated inflammatory disorders, particularly ulcerative colitis, Crohn's disease and psoriasis, where they help reduce inflammation by selectively targeting the IL-23 cytokine pathway.
• Currently, there are several IL-23 inhibitors available in the market, recent additions include OMVOH (mirikizumab-mrkz), SKYRIZI (risankizumab-rzaa), ILUMYA/ILUMETRI (tildrakizumab-asmn), TREMFYA (guselkumab), and others.
• IL-23 inhibitors has a pipeline consisting of products such as icotrokinra (JNJ-77242113), SFA-002, bezisterim (NE3107), and others which are in late Phases (III and II).
• Johnson & Johnson/Protagonist Therapeutics, SFA Therapeutics, BioVie and several other companies are currently engaged in the development and production of IL-23 inhibitors, which have the potential to significantly impact and enhance the IL-23 inhibitors market.
• In March 2025, Sun Pharmaceuticals announced presentation of a Phase IIIb, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of ILUMYA for the treatment of moderate-to-severe psoriasis affecting the nails, results, at the 2025 American Academy of Dermatology (AAD) conference.
• In February 2025, Johnson & Johnson announced the submission of TREMFYA for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis to the European Medicines Agency (EMA).

DelveInsight's "IL-23 Inhibitors - Target Population, Competitive Landscape, and Market Forecast-2034" report delivers an in-depth understanding of the IL-23, historical and Competitive Landscape as well as the IL-23 inhibitor market trends in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The IL-23 inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM IL-23 inhibitors market size from 2020 to 2034. The report also covers current IL-23 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: 2020-2034

IL-23 Inhibitor Understanding

IL-23 Inhibitor Overview

Interleukin-23 (IL-23) inhibitors are a class of monoclonal antibodies that selectively target the p19 subunit of IL-23, a cytokine involved in the activation and maintenance of Th17 cells. By inhibiting IL-23 signaling, these therapies reduce the production of downstream pro-inflammatory cytokines such as IL-17A, IL-17F, and IL-22, thereby suppressing inflammation and halting the progression of immune-mediated diseases.

IL-23 inhibitors are indicated for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, especially in patients who have shown inadequate response or intolerance to conventional systemic treatments or TNF-a inhibitors.

The mechanism centers on disrupting the IL-23/Th17 axis, which is central to the chronic inflammatory response seen in these conditions. By blocking IL-23, these agents decrease Th17 cell proliferation and cytokine production, leading to significant clinical improvement. Currently approved IL-23 inhibitors include TREMFYA, SKYRIZI, ILUMYA, and OMVOH.

IL-23 Inhibitor Epidemiology

The IL-23 inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indications for IL-23 inhibitor, total eligible patient pool of selected indications for IL-23 inhibitor, and total treated cases of selected indications for IL-23 inhibitor in the 7MM covering the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the location-specific contributions, scalp psoriasis had the highest occurrence of cases from 4,811,200 in 2024 in the US.
• Psoriasis is predominantly observed in adults, accounting for approximately 97% of all cases in the 7MM in 2024, also among the type-specific cases of psoriasis, erythrodermic psoriasis accounted for the least number of cases in the 7MM.
• Among the EU4 countries, Germany accounted for the largest number of diagnosed prevalent Crohn's disease cases followed by the UK, whereas Spain accounted for the lowest number of cases in 2024.
• It has been observed that the highest number of ulcerative colitis affected people was found in 18-44 years of age group.
• Assessments show that based on the severity, ulcerative colitis is classified into two categories i.e. mild and moderate-to-severe. Approximately ~60% of cases of ulcerative colitis belong to the moderate-to-severe category, whereas ~40% of cases are mild.
• In EU4 and the UK, Germany accounted for the highest number of Parkinson's disease treated cases with approximately 501,500 in 2024.

IL-23 Drug Chapters

The drug chapter segment of the IL-23 inhibitor reports encloses a detailed analysis of late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the IL-23 inhibitor's 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 IL-23 Inhibitor

SKYRIZI (risankizumab-rzaa): AbbVie/Boehringer Ingelheim

SKYRIZI is an IL-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. It is a biologic therapy approved to treat the diseases in North America, the European Union, and Japan. In psoriatic disease (psoriasis or psoriatic arthritis), SKYRIZI is administered as a quarterly Subcutaneous (SC) injection following two induction doses.

SKYRIZI is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. SKYRIZI inhibits the release of proinflammatory cytokines and chemokines.

• In April 2019, the US FDA approved SKYRIZI for the treatment of moderate-to-severe plaque psoriasis and also the European Commission approved SKYRIZI for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy
• In March 2019, AbbVie announced that the Japanese Ministry of Health, Labour, and Welfare (MHLW) approved SKYRIZI, an IL-23 inhibitor, for the treatment of plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis in adult patients who have an inadequate response to conventional therapies.

ILUMYA/ILUMETRI (tildrakizumab-asmn): Sun Pharma

ILUMYA is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of IL23 and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of proinflammatory cytokines and chemokines. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.

• In May 2018, Sun Pharmaceuticals announced that the US FDA has approved ILUMYA for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
• In September 2018, Sun Pharmaceuticals announced Almirall has received European Commission approval for ILUMETRI for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy.
• In September 2020, Sun Pharmaceuticals announced the launch of ILUMYA in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies.

Emerging IL-23 Inhibitors

Icotrokinra (JNJ-77242113): Johnson & Johnson Innovative Medicine/Protagonist Therapeutics

Icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque psoriasis and offers potential in other IL-23-mediated diseases. Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrates potent, selective inhibition of IL-23 signaling in human T cells. The license and collaboration agreement established between Protagonist Therapeutics and Johnson & Johnson company in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.

• In May 2024, Johnson & Johnson announced new data from the Phase III ICONIC-TOTALa study investigating icotrokinra for treatment of adults and adolescents 12 years of age and older with body surface area as low as 1% and at least moderate plaque psoriasis affecting high-impact skin sites.
• As per Johnson & Johnson's earning presentation for the first quarter of 2025, the company anticipates potential clinical data of Phase III ICONIC-LEAD, ICONIC-Advance 1/2, and ICONIC-TOTAL trials in 2025.

SFA-002: SFA Therapeutics

SFA-002 is a first-in-class oral immunomodulator that operates through multiple cellular pathways to treat autoimmune conditions, with an initial focus on mild-to-moderate chronic plaque psoriasis. Unlike current therapies that target single pathways through immunosuppression, SFA-002 works by simultaneously down-regulating multiple proinflammatory cytokines, including TNF-a, IL-23, IL-10, IL-12, IL-17, and INF-?, while modulating autoimmune responses. This oral compound has demonstrated promising efficacy in clinical trials, with an excellent safety profile and no observed adverse events.

Currently, in Phase Ib clinical development, SFA-002 represents a potential paradigm shift in autoimmune disease treatment, offering a multi-targeted approach that could provide patients with a safer, more accessible alternative to current injectable immunosuppressive therapies.

IL-23 Inhibitor Market Outlook

The IL-23 inhibitor class has become a cornerstone in the treatment of chronic immune-mediated inflammatory diseases, particularly plaque psoriasis, Crohn's disease, and ulcerative colitis, due to its targeted mechanism and favorable long-term safety profile. IL-23, a pro-inflammatory cytokine, plays a central role in the differentiation and maintenance of Th17 cells, which are key drivers of inflammation in several autoimmune disorders. Since the approval of the first IL-23 inhibitor in 2017, the market has grown steadily, driven by increasing biologic adoption, improved disease control, and the development of novel delivery platforms.

Currently, the IL-23 inhibitor market is led by TREMFYA from Janssen Biotech, the agent approved in 2017 for psoriasis, followed by ILUMYA from Sun Pharma/Almirall in 2018, SKYRIZI from AbbVie and Boehringer Ingelheim in 2019, and most recently OMVOH from Eli Lilly, which gained FDA approval in 2023 for ulcerative colitis. These agents, administered via subcutaneous or intravenous injection, have demonstrated durable efficacy, minimal immunosuppression, and convenient dosing schedules, making them preferred options in both dermatology and gastroenterology.

While the current market is dominated by injectable biologics, innovation is now focused on oral IL-23 inhibitors aimed at improving patient convenience and adherence. Icotrokinra (JNJ-77242113), an oral IL-23 inhibitor developed by Johnson & Johnson and Protagonist Therapeutics, is the most advanced candidate, in Phase III trials for psoriasis and Phase II for ulcerative colitis. If successful, icotrokinra could become the first oral IL-23 inhibitor, offering a compelling alternative to injectable biologics. Another oral agent, SFA-002 from SFA Therapeutics, is in Phase II/III trials for psoriasis, and represents an emerging class of orally administered cytokine inhibitors with the potential to expand access and improve quality of life for patients.

The IL-23 inhibitor class faces intensifying competition from other biologics and small molecules targeting overlapping pathways, such as IL-17, TNF-a, and JAK inhibitors, especially in ulcerative colitis and inflammatory bowel disease. However, IL-23 inhibitors continue to differentiate themselves through lower infection risk, sustained clinical remission, and a favorable safety profile, making them an attractive long-term option for chronic disease management.

Looking ahead, biologic IL-23 inhibitors are expected to retain their stronghold in the psoriasis market due to their proven efficacy and established prescriber confidence. However, the emergence of oral agents like icotrokinra could disrupt the current market dynamics, particularly among patients and physicians prioritizing convenience and non-injectable formulations. If approved, these oral options could expand the overall IL-23 market size by reaching previously untreated or biologic-averse populations.

IL-23 Drugs Uptake

This section focuses on the uptake rate of potential emerging IL-23 expected to be launched in the market during 2025-2034.

IL-23 Pipeline Development Activities

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

The presence of numerous drugs under different stages is expected to generate immense opportunity for IL-23 inhibitor market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for IL-23 inhibitor therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on IL-23 Inhibitor's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Yale University/Central Connecticut Dermatology, Kyoto University, University of Manchester/Salford Royal NHS Trust, CHU de Nantes, University of Lubeck, University of Verona, Hospital de la Santa Creu i Sant Pau, Barcelona, and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or IL-23 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

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, 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 event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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 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 may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services and educational programs to aid patients are also present.

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.

Key Updates on IL-23 Inhibitors

• In March 2025, Johnson & Johnson announced new Icotrokinra data from its comprehensive Phase III clinical program and the start of the first-ever head-to-head study in plaque psoriasis seeking to demonstrate the superiority of an oral pill, Icotrokinra, compared to an injectable biologic, ustekinumab.
• In April 2025, Johnson & Johnson released new Icotrokinra data from a subgroup analysis of ICONIC-LEAD in moderate-to-severe plaque psoriasis to assess the efficacy and safety of systemic therapy in adolescents and adults simultaneously. These data were presented at the 2025 WCPD annual meeting.
• In March 2025, SFA Therapeutics announced the presentation of two head-to-head preclinical studies of its oral psoriasis treatment candidate, SFA-002, at the American Academy of Dermatology Annual Meeting in Orlando, Florida.
• In March 2025, SFA Therapeutics announced positive data from its Phase Ib clinical trial of SFA-002, an oral treatment for mild-to-moderate chronic plaque psoriasis. The study met its primary endpoint of safety, with no TRAEs or toxicities observed during the treatment period, and no rebound effects were noted.
• In September 2024, Sun Pharmaceuticals announced presentation of ILUMYA results for psoriasis at the 2024 European Academy of Dermatology and Venereology (EADV) Congress.
• In December 2024, Johnson & Johnson announced the submission of a sBLA to the US FDA seeking approval of TREMFYA for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis.

The abstract list is not exhaustive, will be provided in the final report

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the IL-23, explaining its mechanism, and therapies (emerging).
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the IL-23 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, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM IL-23 market.

IL-23 Inhibitor Report Insights

• IL-23 Targeted Patient Pool
• Therapeutic Approaches
• IL-23 Pipeline Analysis
• IL-23 Market Size and Trends
• Existing and Future Market Opportunity

IL-23 Inhibitor Report Key Strengths

• Ten years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

IL-23 Inhibitor Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint)

Key Questions:

• What was the IL-23 inhibitor total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for IL-23 Inhibitor?
• What are the risks, burdens, and unmet needs of treatment with IL-23 -based/targeting therapies? What will be the growth opportunities across the 7MM for the patient population of IL-23 -based/targeting therapies?
• What are the key factors hampering the growth of the IL-23 Inhibitor market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for IL-23 inhibitors?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the IL-23 Inhibitor market.
• Understand the existing market opportunities 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), 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 indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of market Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.