Interleukin-12 (IL-12) Analogues Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Interleukin-12 (IL-12) is a heterodimeric cytokine with broad immunomodulatory properties that belongs to a larger family of proteins called IL-12-related cytokines. IL-12-related cytokines are produced by five independently regulated genes that homodimerize and heterodimerize to form seven secretory family members. These proteins have overlapping and distinct biological properties and are produced primarily by dendritic cells, monocytes, macrophages, and to a lesser extent, by B cells. It has been identified as an immune cell stimulant that promotes T cell differentiation and proliferation and increases interferon-gamma production. Therefore, they have been implicated in CD4 and CD8 T cell differentiation, host defense, autoimmunity, immune recognition of tumor cells, alloimmunization, and regulation of the host response to vaccination. Therefore, IL-12 functions as a potent regulator of immunity. IL-12 stimulates natural killer (NK) cells and T lymphocytes, promoting their proliferation and secretion of interferon-gamma, which enhances the cytotoxic response against pathogens and malignant cells. The nature of the adaptive immune response is regulated by the innate response to infection and influenced by IL-12 expression at that time. This powerful cytokine has therapeutic applications in various diseases, including certain cancers, chronic viral infections, and autoimmune disorders. In cancer immunotherapy, IL-12 has been utilized to bolster anti-tumor immunity by activating immune cells to target and destroy cancerous cells. However, due to its potent nature, precise dosing and targeted delivery are crucial to minimize potential adverse effects. Harnessing the therapeutic potential of IL-12 continues to hold great promise for advancing immunotherapies and improving patient outcomes in numerous debilitating conditions. Extensive research is being conducted globally to discover new and novel molecules, like ustekizumab, which treats many infections like Mycobacterium infections. The development and launch of new products will thus increase the market's revenue in the forecasted years.

Several of these inhibitors are on the market, while many are in ongoing clinical trials. Various companies have various products in their pipelines, with 140 products in multiple stages of clinical trials – 1 in Phase 4, 11 in Phase 3, 3 in Phase 2, and 4 in Phase 1 of the clinical trials.

Approved Interleukin-12 (IL-12) Analogues

Stelara (ustekinumab)

Drugs in the Pipeline of Interleukin-12 (IL-12) Analogues

Rocakinogene Sifuplasmid (INO-9012)
PDS0301
Ozespa (Briakinumab)
Tavo (Tavokinogene Telsaplasmid)
Ad-RTS-Hil-12
IMNN-001
Apilimod (STA-5326)
MEDI0457
VB-201
Hemamax (Rhuil-12)
T3011
VG161
Trivax (AV0113)
Apilimod Dimesylate (AIT-101)
Ebdarokimab (AK101)
SON-1010
Urocidin (Mycobacterium Cell Wall-DNA Complex)
VTX958
ABP 654 (Ustekinumab Biosimilar)
AVT04 (Ustekinumab Biosimilar)
Ad-TD-Nsil12
BAT2206 (Ustekinumab Biosimilar)
Corvax12
CT-P43 (Ustekinumab Biosimilar)
Expressgraft (Anti-Tumor IL-12)
INO-9112
JCXH-211
M032
SB17 (Ustekinumab Biosimilar)
VG201
ABOD2011
ADV/IL-12 Gene Therapy
AGX-148
AN2898
AS1409
ASP9801
BFI-751 (Ustekinumab Biosimilar)
Bmab1200 (Ustekinumab Biosimilar)
CAR-T Targeting Nectin4/FAP
DF6002
DMB-3115 (Ustekinumab Biosimilar)
Descartes-25
EGFR IL12 CART Cells
FYB202 (Ustekinumab Biosimilar)
GX-051
INO-5151
INXN-3001
JCAR020
MEDI1191
MEDI9253
MVR-C5252
Neulara (Ustekinumab Biosimilar)
ONCR-177
PF-07261271
RPTR-168
RT-111 (Ustekinumab Biosimilar)
RTX-224
RTX-321
SAR441000
Tbio-6517
TG6050
WTX-330
XTX301
Bactrl-IL-12
Detalimogene Voraplasmid (EG-70)
Dodekin (F8-IL12)

Clinical Activity and Developments of Interleukin-12 (IL-12) Analogues

As of July 2023, various companies have approximately 126 products for 232 diseases. For these diseases, many trials are being conducted by players globally. For instance,

D. Anderson Cancer Center is conducting a Phase 2 clinical trial to evaluate the efficacy of combination treatment with MEDI0457 (iINO-3112) and durvalumab (MEDI4736) in patients with Recurrent/Metastatic Human Papilloma Virus associated cancers that were expected to complete by December 2022.
The University of Alabama is conducting a Phase 1/2 clinical trial to study Pembrolizumab and M032 (NSC 733972), a genetically engineered HSV-1 expressing IL-12, in patients with Recurrent/Progressive and newly diagnosed Glioblastoma Multiforme, Anaplastic Astrocytoma, or Gliosarcoma that is expected to complete by March 2025.
Sonnet BioTherapeutics is conducting a Phase1/2 clinical trial to assess the combination of SON-1010 (IL12-FHAB) and Atezolizumab in patients with Platinum-resistant Ovarian Cancer that is expected to complete by May 2025.

Molecule name	Number of studies
Stelara (ustekinumab)	192
rocakinogene sifuplasmid (INO-9012)	14
PDS0301	12
Ozespa (briakinumab)	11
Tavo (tavokinogene telsaplasmid)	11

Target Indication Analysis of Interleukin-12 (IL-12) Analogues

IL-12 is used in various indications due to its potent immunomodulatory properties. One of the primary areas of use is in cancer immunotherapy, where IL-12 is employed to bolster the body's immune response against tumors. It activates natural killer (NK) cells and T lymphocytes, enhancing their cytotoxic activity against cancer cells. Additionally, IL-12 finds application in managing chronic viral infections, such as hepatitis B and C, by promoting antiviral responses. Furthermore, IL-12's ability to regulate the immune system makes it a potential treatment for autoimmune disorders like multiple sclerosis, where it can help modulate the aberrant immune response. However, precise dosing and targeted delivery are critical to avoid potential adverse effects, as IL-12's potency can lead to immune-related toxicities. Despite these challenges, harnessing the therapeutic potential of IL-12 continues to hold promise for advancing immunotherapies and improving outcomes in various debilitating conditions.

Interleukin-12 (IL-12) Analogues Regional Analysis

Interleukin-12 Analogues Market

J&J’s Stelara (ustekinumab) had global net sales of around $9.7 billion in the financial year 2022. The net sales were of $9.1 billion in the financial year 2021 and it has seen an upward trend every year since 2014. According to the Asthma and Allergy Foundation of America (AAFA), approximately 26 million individuals in the United States will have asthma in 2022, with 21 million being adults over the age of 18 and 4.8 million being children under the age of 18. Also, the prevalence of Alzheimer's disease in the United States in 2019 was 7.3%. According to the American Lung Association report, about 1.8 billion global population are infected with Tuberculosis while 10 million people have active Tuberculosis globally. According to the National Brain Tumor Society 2023 report, Glioblastoma accounts for more than 50% of primary malignant brain tumor with more than 14,490 people expected to be diagnosed with Glioblastoma in the USA in 2023.

Latin America

Europe

Asia Pacific

Middle East

North America

Frequently Asked Questions

Stelara (ustekinumab) is the only FDA approved IL-12 Analogue drug.

These find use in the treatment in cancer immunotherapy like Cutaneous T-cell Lymphoma, Non-Hodgkin’s Lymphoma, Glioblastoma, Hepatitis B and C and many more

AbbVie, AstraZeneca, Takeda Pharmaceuticals, Pfizer and Mezzion Pharma are some of the major market players for IL-12 Analogues.

Rising incidence of diseases improvement in technologies, development of new treatment lines in the market and rising incidence of various types of diseases like Cutaneous T-cell Lymphoma, Glioblastoma, Asthma, Mycobacterium infections and others are the key opportunities for IL-12 Analogues in the market.

Key Features of the Report

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