Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Market Size, Clinical Trials, Product Pipelines and Investment Trends, till 2032

Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Market Size is estimated to be $4150 million in 2024 and is expected to grow at an average yearly rate of around 10.8% during the timeframe (2025-2032).

What is Interleukin (IL)-12/23 Inhibitors for Crohn's Disease and what are the growth drivers of Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Market?

Interleukin (IL)-12/23 inhibitors are a class of biologic therapies used to manage Crohn's disease, a chronic inflammatory bowel disease characterized by relapsing inflammation of the gastrointestinal tract. These inhibitors target specific cytokines - IL-12 and IL-23 - that play a critical role in regulating immune responses driving the inflammation seen in Crohn's disease. By blocking these cytokines, IL-12/23 inhibitors help to reduce inflammation, promote healing of the intestinal lining, and maintain remission in patients who may not respond adequately to conventional therapies. Ustekinumab is one of the most well-known IL-12/23 inhibitors approved for treating moderate-to-severe Crohn's disease and has demonstrated significant benefits in reducing disease activity and improving quality of life for patients.

Mechanism of Action and Benefits

IL-12/23 inhibitors work by targeting the shared p40 subunit of the interleukin-12 and interleukin-23 cytokines. By binding to this subunit, these agents prevent the activation of T-cells involved in the inflammatory pathways that sustain Crohn's disease. This precise targeting leads to a more controlled immune response compared to broader immunosuppressants, reducing the risk of widespread immune suppression and associated infections. Clinical trials have shown that IL-12/23 inhibitors can induce and maintain remission, improve endoscopic healing, and decrease reliance on corticosteroids, which are often associated with significant side effects.

Growth Drivers of the IL-12/23 Inhibitors Market for Crohn's Disease

The market for IL-12/23 inhibitors in Crohn's disease is experiencing robust growth due to several key drivers. First, there is a rising prevalence of Crohn's disease globally, with increasing awareness and diagnosis rates supporting higher demand for advanced treatment options. Second, the limitations of conventional therapies, including immunosuppressants and steroids, have created a strong need for safer, more effective alternatives, encouraging physicians to adopt biologic therapies like IL-12/23 inhibitors.

Another important growth driver is the expanding body of clinical evidence supporting the efficacy and safety of these inhibitors. Patients who have not responded to anti-TNF agents often benefit from switching to IL-12/23 inhibitors, broadening their use across different treatment lines. Additionally, continued innovation in biologics and the development of subcutaneous administration options have enhanced convenience and adherence for patients, further propelling market growth.

Favorable reimbursement policies and increasing healthcare spending in developed and emerging economies also support the adoption of IL-12/23 inhibitors. Pharmaceutical companies are investing significantly in research and development to expand indications, improve formulations, and reduce manufacturing costs, which will drive wider accessibility in the coming years.



The research and analytics firm Datavagyanik released the updated version of its report on "Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Market - Detailed Analysis, Business Opportunities and Forecasts".

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Clinical Trials in Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Market and New Product Pipelines

Clinical trials have been fundamental in establishing the safety and efficacy of IL-12/23 inhibitors for Crohn's disease. Ustekinumab was the first IL-12/23 inhibitor approved for moderate-to-severe Crohn's disease after demonstrating significant clinical remission rates in large-scale Phase III trials. These studies confirmed its effectiveness in patients who had previously failed conventional or anti-TNF therapies. Long-term extension studies are ongoing to evaluate sustained response, durability of remission, and long-term safety, providing valuable data for optimizing treatment strategies and personalizing patient care.

Selective IL-23 inhibitors, which target the p19 subunit while sparing IL-12 pathways, have also progressed through advanced clinical trials. Risankizumab has shown promising results in multiple Phase III trials, achieving both induction and maintenance of remission with favorable safety outcomes. Similarly, guselkumab has moved from encouraging Phase II results into Phase III studies, focusing on its role in patients with inadequate response to standard therapies. These trials are critical because they not only confirm the benefits of selective cytokine inhibition but also help define treatment sequences in a complex disease like Crohn's.

Mirikizumab is another selective IL-23 inhibitor that has completed pivotal Phase III trials with strong evidence of endoscopic healing and clinical remission in Crohn's patients. These trials are expanding treatment options, particularly for patients with refractory disease. In addition, ongoing observational studies and registries are following patients in real-world settings to assess safety profiles outside of controlled environments, supporting confidence in their long-term use. Overall, the robust clinical trial activity around IL-12/23 and IL-23 inhibitors is shaping the current and future treatment landscape for Crohn's disease.

New Product Pipelines in IL-12/23 Inhibitors for Crohn's Disease

The development pipeline for IL-12/23 and selective IL-23 inhibitors continues to grow as pharmaceutical companies aim to address unmet needs in Crohn's disease management. Several new agents are in mid-to-late stage development with the potential to offer more targeted approaches, improved administration methods, and enhanced safety profiles. Emerging candidates include next-generation selective IL-23 inhibitors being designed with greater receptor specificity, which could translate to higher efficacy and reduced immunogenicity.

Other investigational products are exploring alternative formulations, such as subcutaneous or oral delivery systems, to improve patient convenience and adherence. Biopharmaceutical developers are also studying biomarkers and companion diagnostics to identify patients most likely to benefit from these therapies, supporting a move toward personalized medicine in Crohn's disease.

Beyond monoclonal antibodies, innovative therapeutic platforms such as bispecific antibodies targeting multiple cytokines, as well as novel small-molecule inhibitors affecting downstream signaling pathways, are entering early clinical development. These approaches reflect the industry's drive to address disease complexity and overcome primary or secondary treatment failures observed with current biologics.



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Important target segments driving the demand for Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Market

Interleukin (IL)-12/23 inhibitors have transformed the therapeutic landscape for Crohn's disease by offering targeted immune modulation with a favorable safety profile. As their acceptance grows, it is essential to understand the key patient segments driving their demand. These segments represent populations where conventional therapies have fallen short, or where treatment goals have evolved toward more sustained remission and improved quality of life.

Patients with Moderate-to-Severe Crohn's Disease

The most significant demand for IL-12/23 inhibitors comes from patients suffering from moderate-to-severe Crohn's disease. These patients often experience persistent inflammation, severe symptoms, and complications such as strictures and fistulas that significantly impact their daily functioning. Conventional therapies, including corticosteroids and immunosuppressants, may fail to induce or maintain remission, leaving these patients in need of alternatives. IL-12/23 inhibitors, by specifically blocking key cytokines in the inflammatory pathway, have proven highly effective in controlling disease activity and inducing long-term remission in this population.

Patients with Anti-TNF Failure or Intolerance

Another crucial target segment includes patients who have either lost response to anti-TNF therapies or cannot tolerate their side effects. Anti-TNF agents have been frontline biologics for Crohn's disease for years, but a considerable proportion of patients develop primary non-response or secondary loss of response over time. IL-12/23 inhibitors offer an alternative mechanism of action, making them highly relevant for these patients. Switching to an IL-12/23 inhibitor has been shown to help recapture disease control and reduce the risk of surgery or further complications.

Patients Seeking Steroid-Sparing Treatment

Corticosteroids are often used to manage disease flares, but their long-term use is associated with significant side effects, including osteoporosis, diabetes, and infections. There is a growing demand among patients and clinicians for therapies that reduce or eliminate the need for steroids. IL-12/23 inhibitors provide an effective steroid-sparing option by maintaining remission without ongoing corticosteroid dependence. This trend supports growing uptake of these inhibitors among patients who prioritize minimizing systemic steroid exposure for long-term safety.

Younger and Newly Diagnosed Patients

Younger patients, including adolescents and young adults, represent another important target group. These patients often have a longer disease course ahead of them and are motivated to achieve deep remission early to prevent complications and maintain their quality of life. IL-12/23 inhibitors, with their high rates of endoscopic healing and sustained remission, are increasingly being considered earlier in treatment algorithms for this group, reflecting a shift toward proactive and aggressive disease management.

Patients Prioritizing Quality of Life and Convenience

Lastly, patients who value convenience and lifestyle considerations also drive demand. Subcutaneous formulations of IL-12/23 inhibitors, which allow self-administration at home, have improved adherence and reduced the burden of frequent clinic visits. Patients who work or travel frequently are particularly drawn to these options.



Key Players in Interleukin (IL)-12/23 Inhibitors for Crohn's Disease, Market Share

The market for Interleukin (IL)-12/23 inhibitors in Crohn's disease is dominated by a few key players with strong portfolios, robust research pipelines, and established commercial presence. These companies have played a crucial role in bringing targeted biologics to patients suffering from moderate-to-severe Crohn's disease, expanding the treatment options beyond traditional immunosuppressants and anti-TNF agents. The focus on innovation, market expansion, and strategic collaborations has allowed these players to strengthen their market share and maintain a competitive advantage.

Johnson & Johnson

Johnson & Johnson, through its Janssen division, is a major player in this market with ustekinumab. Ustekinumab was the first IL-12/23 inhibitor approved for Crohn's disease and has maintained a significant market share due to its proven safety and efficacy in clinical practice. The company's extensive marketing reach, physician education programs, and continued investment in real-world studies have reinforced ustekinumab's leadership position. In addition, the drug's indication for other immune-mediated diseases supports its brand recognition and overall growth.

AbbVie

AbbVie has emerged as a significant competitor with risankizumab, a selective IL-23 inhibitor targeting the p19 subunit. Although risankizumab was initially developed for psoriasis, its success in Crohn's disease trials has enabled AbbVie to expand its presence in the inflammatory bowel disease market. AbbVie has leveraged its experience in biologics and strong commercial network to secure a growing market share for risankizumab, which is now widely used as an option for patients who have failed or are intolerant to anti-TNF therapies.

Eli Lilly

Eli Lilly is establishing itself in this space with mirikizumab, another selective IL-23 inhibitor with demonstrated benefits in Crohn's disease patients. With positive Phase III data supporting its effectiveness in inducing and maintaining remission, mirikizumab has gained regulatory approvals and is entering competitive positioning. Eli Lilly's commercial capabilities and its focus on expanding into gastrointestinal indications will likely strengthen its share in the coming years.

Merck & Co.

Merck has also invested in the IL-12/23 inhibitor space through its acquisition strategies and pipeline development. While Merck does not yet have an approved product for Crohn's disease in this category, its research collaborations and interest in novel biologics signal potential future competition. Merck's track record in immunology suggests that it may become a more prominent player if it succeeds in advancing IL-23 inhibitors through later-stage trials.



Key Questions Answered in the Interleukin (IL)-12/23 Inhibitors for Crohn's Disease market report:

What is the total global Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Sales, and how has it changed over the past five years?

What is Interleukin (IL)-12/23 Inhibitors for Crohn's Disease investment trend?

Which countries have the highest Interleukin (IL)-12/23 Inhibitors for Crohn's Disease, and what factors contribute to their dominance in the market?

How does Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Sales vary across key manufacturers, and what expansions have been observed recently?

What is the current global revenue generated from Interleukin (IL)-12/23 Inhibitors for Crohn's Disease Sales, and how does it compare to previous years?

Which industries drive the highest demand for Interleukin (IL)-12/23 Inhibitors for Crohn's Disease, and how is this demand expected to evolve in the next five years?

What are the major challenges impacting Interleukin (IL)-12/23 Inhibitors for Crohn's Disease industry and supply chain operations across key markets?

How do government policies, environmental regulations, and trade restrictions affect Interleukin (IL)-12/23 Inhibitors for Crohn's Disease and market dynamics?

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