IL-23 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Interleukins are a group of immunomodulatory proteins- cytokines that are secreted by the leukocytes and some other body cells. There are many types of interleukins in the body that perform diverse functions and are responsible for many physiological functions with a significant role in regulating the immune response in the body. IL-23 is a member of the IL-12 family of cytokines. It has a function in innate and adaptive immunity modulation. One primary function of IL-23 is the development and differentiation of effector Th17 cells. IL-23 is produced by the macrophages and dendritic cells and is activated when the body encounters any bacterial infection.  It then activates Th17 and other IL-17-producing cells, such as CD8+ T cells. It has been seen to have a relationship with many types of diseases like gastritis,  colitis, arthritis, and psoriasis. It binds with the IL-23 receptor to elicit its responses which are expressed mostly in T-cells, NK (Natural killer) cells, monocytes/macrophages, and others. IL-23 has a significant role to play in the pathogenesis of the above diseases and is, therefore, a target for medicines. IL-23 can help reduce the inflammatory symptoms associated with many diseases, such as Rheumatoid Arthritis (RA), by blocking the IL-23 receptor. Research is being conducted globally to discover new and novel molecules to be used as anti-IL-23 agents. The development and launch of new products will thus increase the revenue of the market in the forecasted years.

Several of these inhibitors are on the market, while many are in ongoing clinical trials. 35 companies have various products in their pipelines, with 24 products in various stages of clinical trials. 1 product in Phase 4, 10 products in Phase 3, 7 products in Phase 2, and 5 products in Phase 1 of the clinical trials.

Key Developments of IL-23 Inhibitors

  • In November 2022, Skyrizi (rizankizumab-rzaa) was approved by the European Commission (EU) for treating adults with moderate to severe Active Crohn’s disease.
  • In June 2022, Skyrizi (rizankizumab-rzaa) was approved by the FDA as the 1st and only for treating adults with moderate to severe Active Crohn’s disease.
  • In January 2022, Skyrizi (rizankizumab-rzaa) was approved by the FDA for the treatment of adults with Active Psoriatic Arthritis.
  • In July 2020, Tremfya (guselkumab) became the 1st IL-23 Inhibitor approved by the FDA for patients with active psoriatic arthritis.
  • In September 2018, Ilumya (tildrakizumab-asmn) was approved by the European Medical Agency (EMA) for the treatment of adults with moderate to severe plaque psoriasis.
  • In April 2018, Tremfya (guselkumab) was approved by the MHRA of Japan for treating psoriatic arthritis.
  • In September 2018, Ilumya (tildrakizumab-asmn) was approved by FDA for the treatment of adults with moderate to severe plaque psoriasis.

Approved molecules of IL-23 Inhibitors

  • Tremfya (guselkumab)
  • Ilumya (tildrakizumab-asmn)
  • Skyrizi (rizankizumab-rzaa)
  • Stelara (ustekinumab)

Drugs in the Pipeline of IL-23 Inhibitors

  • Ozespa (briakinumab)
  • brazikumab (AMG 139)
  • apilimod (STA-5326)
  • VB-201
  • golimumab/guselkumab (JNJ-4804)
  • apilimod dimesylate (AIT-101)
  • ebdarokimab (AK101)
  • VTX958
  • ABP 654 (ustekinumab biosimilar)
  • AVT04 (ustekinumab biosimilar)
  • BAT2206 (ustekinumab biosimilar)
  • CT-P43 (ustekinumab biosimilar)
  • SB17 (ustekinumab biosimilar)
  • AN2898
  • BFI-751 (ustekinumab biosimilar)
  • Bmab1200 (ustekinumab biosimilar)
  • DMB-3115 (ustekinumab biosimilar)
  • FYB202 (ustekinumab biosimilar)
  • LY2525623
  • NBL-012
  • NeuLara (ustekinumab biosimilar)
  • PF-07261271
  • RT-111 (ustekinumab biosimilar)

Clinical Activity and Developments of IL-23 Inhibitors

As of June 2023, 35 companies have approximately 24 IL-23 Inhibitors for 36 diseases. For these diseases, 67 trials are being conducted by the players globally. For instance,

  • In December 2022, Leo Pharma completed a Phase 4 clinical trial to study the efficacy and safety of Brodalumab compared to Guselkumab in the treatment of Plaque psoriasis after inadequate response to Ustekinumab.
  • In November 2022, AbbVie completed a Phase 3 clinical trial to study the safety and efficacy of Risankizumab in adult patients with Plaque Psoriasis who have had a suboptimal response to secuniumab or ixekizumab.
  • In July 2021, AbbVie completed a Phase 3 clinical trial to assess the efficacy of Rizanikumab compared to Secukinumab for the treatment of adult subjects with moderate to severe Plaque Psoriasis who are candidates for systemic therapy.       

Molecule name

Number of studies

Tremfya (guselkumab)

87

Ozespa (briakinumab)

11

brazikumab (AMG 139)

10

apilimod (STA-5326)

7

VB-201

6

Target Indication Analysis of IL-23 Inhibitors

Drugs like Tremfya (guselkumab), Skyrizi (rizankizumab-rzaa), and Ilumya (tildrakizumab-asmn) are approved IL-23 Inhibitors that inhibit inflammatory reactions and are, therefore, used for the treatment of many diseases. These are indicated for indications like Plaque psoriasis, Plaque Arthritis, Active Crohn’s disease, and others. These are in the clinical trials for the treatment of various other diseases like Papulosquamous skin disease, Blood coagulation disorders, Digestive system diseases, Rheumatoid Arthritis, Skin diseases, and others. These have shown promising results for the approved indications and have sought approval in many regions like the USA, Europe, Germany, Japan, and others.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario

Frequently Asked Questions

Tremfya (guselkumab), Ilumya (tildrakizumab-asmn), Skyrizi (rizankizumab-rzaa), and Stelara (ustekinumab) are approved by the FDA

These are used in various indications like Plaque psoriasis, Plaque Arthritis, and Active Crohn’s disease. These are in trials for various other indications.

J&J (USA), AbbVie (USA), AstraZeneca (USA), Madrigal Pharmaceutical (USA), and VBL Therapeutics (Israel) are some of the major market players for IL-23 Inhibitors.

Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market, and changing lifestyles leading to Rheumatoid Arthritis and Plaque psoriasis are the key opportunities for IL-23 Inhibitors in the market.

  • J&J (USA)
  • AbbVie (USA)
  • AstraZeneca (USA)
  • Madrigal Pharmaceutical (USA)
  • VBL Therapeutics (Israel)
  • AI Therapeutics (USA)
  • Akeso Biopharma Co., Ltd (China)
  • Ventyx Biosciences (USA)
  • Amgen Inc. (USA)
  • Alvotech AG (Switzerland)
  • Fuji Pharma Co., Ltd. (Japan)
  • Cipla Inc (India)
  • Teva Pharmaceutical Industries Ltd (Israel)
  • Bio-Thera Solutions, Ltd (China)
  • Pharmapark LLC (Russia)
  • Hikma Pharmaceuticals Plc (UK)
  • Biomm Sa (Brazil)
  • Celltrion Healthcare Co., Ltd (South Korea)
  • Samsung (South Korea)
  • Pfizer (USA)
  • BioFactura Inc (USA)
  • Biocon (India)
  • Yoshindo Inc (Japan)
  • Dong-A (Japan)
  • Intas Pharmaceuticals Ltd (India)
  • Meiji Seika Pharma (Japan)
  • Formycon AG (Germany)
  • Fresenius Kabi AG (Germany)
  • Eli Lilly (USA)
  • CSPC Pharma (China)
  • NeuClone (Australia)
  • Serum Institute of India (India)
  • Rani Therapeutics (USA)

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