Interleukin-12 & 23 (IL-12/IL-23) Inhibitors Market Size, Clinical Trials, Product Pipelines and Investment Trends, till 2032

Interleukin-12 & 23 (IL-12/IL-23) Inhibitors Market Size is estimated to be $6520 million in 2024 and is expected to grow at an average yearly rate of around 11% during the timeframe (2025-2032).

What is Interleukin-12 & 23 (IL-12/IL-23) Inhibitors and what are the growth drivers of Interleukin-12 & 23 (IL-12/IL-23) Inhibitors Market?

Interleukin-12 and Interleukin-23 (IL-12/IL-23) inhibitors are a class of biologic drugs designed to target and block the activity of interleukins IL-12 and IL-23. These cytokines play a critical role in the inflammatory pathways that are involved in autoimmune and inflammatory diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. By inhibiting these interleukins, these drugs help reduce inflammation and prevent disease progression. The most commonly used IL-12/IL-23 inhibitors include monoclonal antibodies that bind to the p40 subunit shared by both interleukins. This targeted mechanism of action allows for a highly specific immune modulation with fewer systemic side effects compared to traditional immunosuppressants.

Rising Prevalence of Autoimmune Diseases

One of the primary drivers of the IL-12/IL-23 inhibitors market is the increasing global prevalence of autoimmune and chronic inflammatory conditions. Diseases like psoriasis and inflammatory bowel diseases are becoming more common due to genetic predispositions, environmental factors, and changes in lifestyle. As the number of patients affected by these conditions continues to grow, the demand for effective and targeted treatments like IL-12/IL-23 inhibitors is also rising. These inhibitors offer a superior therapeutic alternative for patients who are unresponsive to conventional therapies.

Advancements in Biologic Drug Development

Technological advancements in biotechnology and immunology have significantly influenced the growth of the IL-12/IL-23 inhibitors market. Continuous research and development efforts have led to the creation of more effective and safer biologics. The development of humanized monoclonal antibodies and improved drug delivery systems has enhanced treatment outcomes and patient adherence. As biologics become more refined and tailored, they are expected to dominate the treatment landscape for immune-mediated diseases, contributing to market expansion.

Favorable Regulatory Environment

Regulatory agencies across the globe have been supportive in accelerating the approval of biologic therapies that show significant clinical benefit in treating autoimmune diseases. Expedited approval pathways and increasing designations for orphan drugs or breakthrough therapies help bring IL-12/IL-23 inhibitors to market faster. This regulatory support reduces time-to-market and encourages pharmaceutical companies to invest in research and commercial development, thus fostering market growth.

Increasing Patient Awareness and Access to Healthcare

Improved access to healthcare services, particularly in emerging economies, is contributing to the growth of the IL-12/IL-23 inhibitors market. In addition, rising awareness about autoimmune conditions and available biologic treatment options is leading more patients to seek advanced therapies. Patient advocacy groups, digital health campaigns, and educational initiatives by healthcare providers are all playing a role in promoting the benefits of IL-12/IL-23 inhibitors.

Strategic Collaborations and Market Expansion

Pharmaceutical companies are engaging in strategic collaborations, mergers, and licensing agreements to enhance their product pipelines and expand global reach. These partnerships facilitate knowledge sharing, joint research, and improved distribution channels. As more companies enter the market and competition increases, innovation is expected to accelerate, further driving the market forward.



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Clinical Trials in Interleukin-12 & 23 (IL-12/IL-23) Inhibitors Market and New Product Pipelines

The landscape of clinical trials for IL-12/IL-23 inhibitors has significantly evolved, targeting multiple immune-mediated indications. These trials range from mid-stage to late-stage (Phase II and Phase III) and explore efficacy, safety, dosing regimens, and expanded indications. One focus is on chronic plaque psoriasis, where newer molecules are being compared head-to-head with existing standards of care to establish superiority or non-inferiority. Other trials address psoriatic arthritis, Crohn's disease, ulcerative colitis, and even off-label areas such as hidradenitis suppurativa and uveitis. Many studies are randomized, double-blinded, and multicentric, providing robust data to inform clinical practice.

Key clinical studies involve exploring optimized dosing intervals, such as every 12 weeks versus every 8 weeks, aiming to balance convenience with continuous disease control. Comparative trials also examine real-world effectiveness against TNF inhibitors and IL-17 antagonists. Additionally, combination trials assess the safety and incremental benefit of IL‐12/23 inhibitors with topical agents or small molecules such as JAK inhibitors. Safety endpoints in these trials examine serious infections, malignancy signals, and long-term immunogenicity, ensuring comprehensive evaluation of risk-benefit profiles over extended periods.

New Product Pipelines in IL-12/IL-23 Inhibition

The pipeline for IL-12/IL-23 inhibitors is dynamic, featuring next-generation antibodies and innovative biologics. Unlike first-generation blockers that target the shared p40 subunit, newer agents focus on the p19 subunit specific to IL-23 or dual-pathway inhibitors. These show potential for improved safety and enhanced efficacy by selectively modulating immune pathways. Clinical development of oral small-molecule inhibitors that disrupt signaling cascades downstream of IL-12/23 is also underway, offering alternatives to parenteral biologics.

Notably, several experimental molecules are advancing through Phase II and III trials across indications: narrow-spectrum, p19-specific antibodies for Crohn's disease and ulcerative colitis seek to minimize unwanted immune interference; engineered fusion proteins combine IL-12/23 blockade with novel half-life extension strategies for less frequent dosing; and investigational bispecific antibodies aim to simultaneously inhibit IL-23 and another inflammatory cytokine such as IL-17 or TNF. These multifunctional biologics target broader disease control in conditions with complex pathophysiology.

Pediatric and Special Population Development

Development programs have expanded into pediatric populations, responding to unmet needs in juvenile psoriasis and inflammatory bowel disease. Age-specific dosing and safety profiles are being evaluated, alongside investigations into use during pregnancy and breastfeeding. Trials also include elderly populations and those with multiple comorbidities, ensuring the new therapies align with the needs of diverse patient demographics.

Biomarker-Guided Approaches

A growing trend in trial design is incorporation of biomarkers and personalized medicine. Genetic markers, serum cytokine levels, and gut microbiome signatures are being used to stratify patients most likely to respond to IL-12/23 inhibition. Adaptive trial designs tailor the dosing or therapy based on interim biomarker assessments, which can accelerate development and reduce unnecessary exposure for non-responders.

Regulatory Strategy and Market Readiness

Several new candidates are on track for regulatory submissions, supported by robust Phase III trial results showing rapid onset of action, durable remission rates, and favorable safety outcomes. Post-marketing commitments include long-term observational studies and registries. Enhanced label claims, such as improved joint outcomes or mucosal healing in IBD, are targeted to differentiate these products in crowded markets. Preparedness initiatives include establishing manufacturing capacity for global distribution and engaging medical education networks ahead of launch.

Future Direction and Outlook

The clinical trials and pipelines for IL‐12/23 inhibitors reflect a vibrant and mature therapeutic arena. Next-gen p19-specific inhibitors, multispecific antibodies, and oral alternatives are poised to expand treatment choices. Evolving trial designs focus on personalization, convenience, and broader patient populations. Overall, the future promises refined therapies with enhanced efficacy, safety, and accessibility for patients with complex immune-mediated diseases.


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Important target segments driving the demand for Interleukin-12 & 23 (IL-12/IL-23) Inhibitors Market

One of the most significant target segments driving demand for IL-12/IL-23 inhibitors is patients suffering from chronic plaque psoriasis. This autoimmune skin condition affects millions globally and is characterized by red, scaly patches that can severely impact quality of life. Traditional treatments such as topical therapies or systemic agents often provide limited relief or cause adverse effects. IL-12/IL-23 inhibitors offer a highly effective alternative with long-lasting skin clearance and improved patient satisfaction. As awareness of biologic therapies increases and healthcare providers become more comfortable prescribing them, the demand among psoriasis patients continues to rise.

Individuals with Psoriatic Arthritis

Psoriatic arthritis is another important segment where IL-12/IL-23 inhibitors play a key role. This inflammatory arthritis affects a significant proportion of psoriasis patients, leading to joint pain, swelling, and long-term joint damage. IL-12/IL-23 inhibitors have been proven to reduce both skin symptoms and joint inflammation, offering a dual benefit. The ability of these biologics to slow disease progression and improve physical function positions them as a preferred option among rheumatologists and patients seeking comprehensive disease management.

Patients with Inflammatory Bowel Diseases

Patients diagnosed with inflammatory bowel diseases such as Crohn's disease and ulcerative colitis also represent a growing segment contributing to the market. These chronic gastrointestinal disorders are often difficult to manage, with many patients developing resistance to conventional therapies. IL-12/IL-23 inhibitors offer a targeted mechanism that helps reduce gut inflammation, induce remission, and maintain long-term disease control. As clinical trial data supports their efficacy and safety in IBD, the use of these inhibitors in gastroenterology is expected to expand, boosting demand further.

Pediatric and Adolescent Populations

Although autoimmune conditions are more common in adults, the pediatric and adolescent population is increasingly becoming a focus for IL-12/IL-23 inhibitor therapies. Children with severe forms of psoriasis or IBD who fail to respond to first-line treatments often require advanced biologic options. The development of age-appropriate formulations, safety data, and regulatory approvals in younger age groups are making these treatments more accessible, representing a critical segment for future market growth.

Patients with Moderate-to-Severe Disease

Another vital target group includes individuals with moderate-to-severe autoimmune conditions who are unresponsive to traditional treatments. These patients typically experience more frequent disease flares and lower quality of life. IL-12/IL-23 inhibitors provide a high level of efficacy with manageable safety profiles, making them an attractive option for those needing aggressive disease control. The chronic nature of these diseases ensures long-term treatment, contributing to sustained market demand.

Health-Conscious and Informed Patients

The rise of health-conscious, digitally informed patients is also influencing market dynamics. This segment actively seeks out the latest therapies, including biologics, and is more likely to request advanced treatment options from their healthcare providers. Online resources, social media, and patient advocacy groups are playing a pivotal role in educating patients about the benefits of IL-12/IL-23 inhibitors, leading to increased adoption and market penetration.


Key Players in Interleukin-12 & 23 (IL-12/IL-23) Inhibitors, Market Share

The Interleukin-12 and Interleukin-23 (IL-12/IL-23) inhibitors market is highly competitive and is primarily led by major pharmaceutical companies specializing in biologic therapies for autoimmune and inflammatory conditions. These companies have established strong product portfolios, robust research pipelines, and widespread global reach. Their dominance is largely based on the clinical efficacy, safety, and brand strength of their flagship drugs. A few leading biologics in this market have set the benchmark for treatment standards, helping key players capture a significant share of the overall market.

AbbVie Inc.

AbbVie is one of the most prominent players in the IL-12/IL-23 inhibitors space, largely due to the success of its blockbuster drug. The company's strategic positioning in the immunology market, supported by an extensive global distribution network and strong R&D capabilities, enables it to maintain a large market share. With its proven product in treating plaque psoriasis, psoriatic arthritis, and Crohn's disease, AbbVie has established a loyal prescriber and patient base. The company continues to invest in expanding indications and developing next-generation therapies.

Johnson & Johnson (Janssen Pharmaceuticals)

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, holds a significant portion of the IL-12/IL-23 inhibitors market. Its leading biologic agent was one of the first to gain approval for multiple autoimmune conditions, giving the company a competitive edge. The broad label coverage, durable efficacy, and established safety profile of the product make it a preferred choice among dermatologists and gastroenterologists. Janssen's continued focus on expanding access through affordability programs and global marketing strategies strengthens its market position.

Novartis AG

Novartis is another major contributor to the IL-12/IL-23 inhibitors market, with a focus on differentiated biologics targeting the IL-23 pathway specifically. Though its product is more IL-23 selective, its overlap with this market segment places the company among the key competitors. Novartis benefits from a strong pipeline and innovation-driven approach that targets unmet needs in psoriasis and inflammatory bowel diseases. Its global research facilities and collaborations support continued growth and market penetration.

Eli Lilly and Company

Eli Lilly has emerged as a strong player in the IL-23-focused segment of the market, with therapies that offer high skin clearance rates and long dosing intervals. Though its portfolio targets IL-23 rather than both IL-12 and IL-23, the therapeutic overlap with this market has allowed the company to secure substantial market share. The company's marketing efforts, payer engagement strategies, and focus on physician education have been critical in accelerating adoption.

Other Emerging Players

Several emerging biopharmaceutical companies are entering the IL-12/IL-23 space, aiming to capture niche segments through biosimilars, novel biologics, or oral alternatives. These players often focus on cost-effective therapies, regional markets, or combination treatments to differentiate themselves. As patents expire and biosimilar pathways open, competition is expected to intensify, creating opportunities for new entrants.


Key Questions Answered in the Interleukin-12 & 23 (IL-12/IL-23) Inhibitors market report:

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

What is Interleukin-12 & 23 (IL-12/IL-23) Inhibitors investment trend?

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

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

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

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

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

How do government policies, environmental regulations, and trade restrictions affect Interleukin-12 & 23 (IL-12/IL-23) Inhibitors and market dynamics?

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