The Interleukin-2 Market is Set to Reach USD 4 Billion by 2034, Driven by IL-2 Targeting Fusion Proteins, Monoclonal antibodies, and Gene Therapies Across Immunology, Dermatology, Neurodegenerative Disorders, and Oncology | DelveInsight

With the emergence of novel therapies and expanded indications, the United States IL-2 market is projected to reach USD 4 billion by 2034. Key players driving this expansion include Iovance Biotherapeutics, Eisai, Citius Pharmaceuticals, Nektar Therapeutics, Mural Oncology, Corvus Pharmaceuticals, and Krystal Biotech, among others.

LAS VEGAS, March 27, 2025 /PRNewswire/ —

Key Highlights

• The total treatment-eligible cases for IL-2 therapies are approximately 13.6 million in the 7MM in 2024. This patient segment comprises an eligible population from 13 leading indications where either IL-2 therapy has been approved or is in clinical trials. The list of indications includes Peripheral T-cell lymphoma (PTCL), Cutaneous T-cell lymphoma (CTCL)Non-segmental Vitiligo (NSV), Aplastic Anemia, Amyotrophic Lateral Sclerosis (ALS), Ovarian cancer, Head and neck squamous cell carcinoma (HNSCC), Melanoma, Atopic Dermatitis, Alopecia Areata, Non-small cell lung cancer (NSCLC), and Mucosal Melanoma.
• In terms of large patient size and volume, leading treatable populations for IL-2 development are NSV, Atopic Dermatitis, Alopecia Areata, NSCLC, and ALS.
• The journey of IL-2 in cancer treatment began in the early 1990s, a time of major advancements in immuno-oncology. Its capacity to stimulate the immune system, particularly T cells and NK cells, positioned IL-2 as a pioneering immunotherapy. The first IL-2-based treatment, PROLEUKIN (recombinant human IL-2 or Aldesleukin), received US FDA approval in May 1992 for metastatic renal cell carcinoma (RCC), marking it as the first immunotherapy to provide a novel treatment approach for this aggressive cancer. PROLEUKIN was regarded as a groundbreaking innovation, utilizing the body’s immune defenses to combat tumors.  
• Beyond cancer treatment, IL-2 holds promise for autoimmune diseases, inflammatory disorders, and other conditions. 
• The FDA’s approval of LYMPHIR (denileukin diftitox-cxdl) in the US in August 2024 for the treatment of adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy was a landmark event in this field.
• Prominent players in this space include Mural Oncology (ALKS 4230 – Nemvaleukin Alfa), Nektar Therapeutics (Rezpegaldesleukin – NKTR-358), Cue Biopharma (CUE-101), Anaveon (ANV419), Krystal Biotech (KB707), Merck Sharp & Dohme (MK-6194), Philogen (Darleukin), Synthekine (STK 012), Assistance Publique Hopitaux de Paris/ILTOO Pharma (ILT-101), Innovent Biologics (IBI-363), and Werewolf Therapeutics (WTX-124). These companies are developing a range of IL-2 therapies to treat various cancers and autoimmune conditions, showcasing the potential of IL-2-based treatments to address a broad spectrum of unmet medical needs.
• In terms of revenue estimates, Moderate to severe Atopic dermatitis is the leading indication for IL-2 in the 7MM with total cases of nearly 39 million in 2024, which is expected to increase by 2034 in the 7MM. 
• The eligible cases of NSV in the US comprised nearly 1.7 million in 2024.

Learn more about the IL-2 treatment landscape @ Interleukin-2 Therapeutic Landscape

In the years that followed, PROLEUKIN’s approval extended to metastatic melanoma in 1998, another challenging cancer to treat. However, despite its revolutionary impact, high-dose IL-2 therapy posed significant obstacles, including severe toxicity, systemic inflammatory responses, and a short half-life. These drawbacks spurred efforts to refine its clinical use, leading to advancements in combination therapies aimed at enhancing IL-2’s effectiveness while mitigating its side effects.  

The emergence of immune checkpoint inhibitors in the 2010s further complicated IL-2’s clinical role, as these novel therapies provided highly effective treatment alternatives. Nonetheless, IL-2 remained a crucial component of immunotherapy, particularly in combination with checkpoint inhibitors, due to their complementary mechanisms of action. The successful integration of IL-2-based therapies with PD-1/PD-L1 inhibitors revitalized interest in IL-2, offering renewed hope for patients with previously untreatable cancers.  

PROLEUKIN’s evolution did not stop with its initial approvals. Continuous research and clinical refinements demonstrated that its therapeutic potential could be maximized through improved delivery methods, combination strategies, and more precise patient selection. These ongoing developments, alongside strategic collaborations, have sustained innovation in IL-2-based therapies, reinforcing their relevance in the evolving landscape of cancer treatment.

Additionally, in an unexpected turn, LYMPHIR (denileukin diftitox-cxdl) has emerged as the next generation of IL‑2 therapy. The FDA’s approval of LYMPHIR in the US in August 2024 for adults with relapsed or refractory Stage I-III CTCL, following at least one prior systemic treatment, was a major milestone in the field. While not a dedicated Treg therapy, LYMPHIR has shown the ability to reduce immunosuppressive Tregs and exert antitumor effects by directly targeting IL-2R-expressing tumors.  

Recently, LYMPHIR was added to the NCCN Clinical Practice Guidelines in Oncology with a Category 2A recommendation, highlighting strong, consistent support from the NCCN as a viable treatment option for CTCL patients.

To know more about FDA-approved IL-2 inhibitors, visit @ Approved Interleukin-2 Drugs

The IL-2 therapy pipeline remains strong, featuring a diverse array of clinical-stage candidates. Beyond cancer treatments, several therapies for autoimmune diseases are also under investigation. Advancements in technology are shaping the IL-2 therapy landscape, with efforts focused on reducing toxicity, enhancing receptor specificity, and integrating with other immunotherapies such as checkpoint inhibitors. As the pipeline matures, IL-2-based therapies are poised to revolutionize the treatment of cancer, autoimmune conditions, and inflammatory disorders.  

The emerging IL-2-targeted drug pipeline includes a range of promising candidates, such as Nemvaleukin Alfa (Mural Oncology), Soquelitinib (Corvus Pharmaceuticals), Darleukin (Philogen), ILT-101 (ILTOO Pharma), Rezpegaldesleukin (Nektar Therapeutics), MK-6194 (Merck Sharp & Dohme LLC), CUE-101 (Cue Biopharma), KB707 (Krystal Biotech), IBI-363 (Innovent Biologics), and others.

Discover which therapies are expected to grab major IL-2 market share @ Interleukin-2 Market Report

Nemvaleukin alfa, developed by Mural Oncology, is an emerging therapy with significant potential. This recombinant fusion protein functions as an IL-2 receptor agonist, selectively stimulating immune cells within the tumor microenvironment while limiting systemic activation. By doing so, ALKS 4230 seeks to enhance anti-tumor immunity while mitigating the toxicity commonly associated with high-dose IL-2. This targeted approach has demonstrated promise in multiple cancers, including melanoma, mucosal melanoma, and platinum-resistant ovarian cancer (PROC).

The ability to direct immune activation specifically to the tumor site marks a major advancement in IL-2-based therapies, making them more precise and effective. As per Mural Oncology’s latest presentation in November 2024, interim overall survival data for the PROC cohort (ARTISTRY-7) is expected by late Q1 or early Q2 2025, while top-line results for mucosal melanoma (ARTISTRY-6, Cohort 2) are anticipated in Q2 2025. These upcoming data readouts could provide critical insights that may reshape the treatment landscape. ALKS 4230 has also garnered key regulatory designations that underscore its potential to expedite its path toward commercialization and reach a market of nearly USD 140 million by 2034.

Soquelitinib is an experimental oral small-molecule drug designed to selectively inhibit IL-2-inducible T-cell kinase (ITK), an enzyme primarily found in T cells that contributes to T-cell and natural killer cell immune function. This novel therapy is being evaluated for moderate-to-severe atopic dermatitis (Phase I) and relapsed/refractory peripheral T-cell lymphoma (PTCL) (Phase III).  

In August 2024, the U.S. FDA granted Fast Track Designation (FTD) for relapsed/refractory PTCL after at least two prior systemic treatments, while in February 2024, it received Orphan Drug Designation (ODD) for T-cell lymphoma. Early-stage data from December 2024 for atopic dermatitis showed promising results, with final outcomes anticipated in the first half of 2025, whereas its first launch is expected in PTCL by 2027 in the US. Combining both PTCL and atopic dermatitis, it is expected to reach a market of approximately USD 360 million by 2034.

Rezpegaldesleukin (NKTR-358), a recombinant protein developed by Nektar Therapeutics, represents a significant advancement in treating autoimmune diseases. This innovative therapy targets T-regulatory cells (Tregs) through the IL-2 pathway and is being studied in Phase II trials for moderate-to-severe atopic dermatitis and severe alopecia areata. Nektar anticipates topline results in the first and second halves of 2025 for these indications. Offering a more targeted and less toxic method for managing inflammation, Rezpegaldesleukin’s self-administered subcutaneous injection further adds to its appeal, with projections for a market size of approximately USD 930 million by 2034.

ILT-101 is a pre-prepared injectable liquid formulation of low-dose IL-2, supplied in vials and tailored to meet patient needs. It has been developed to treat various conditions, including autoimmune and inflammatory diseases, as well as specific central nervous system disorders. ILTOO Pharma is in a strong position to pursue regulatory approval and has already made notable advancements. Future updates will share details on the company’s progress. At present, the company is prioritizing compassionate use access for patients who were part of the clinical trial.

Krystal Biotech’s KB707 is a groundbreaking gene therapy designed to deliver IL-2 and IL-12 directly to tumors. The company, known for developing VYJUVEK—the first approved topical gene therapy for dystrophic epidermolysis bullosa in May 2023—is now exploring two administration methods for KB707: intratumoral injection for metastatic melanoma and inhalation for advanced NSCLC. The therapy has received Fast Track Designation (FTD) for both indications. Early clinical trials have shown promising outcomes, particularly in NSCLC, where post-anti-PD-1 patients demonstrated a 27% overall response rate (ORR) and 73% disease control rate (DCR) in monotherapy trials. KB707 highlights the potential of targeted gene therapies to revolutionize cancer treatment by providing localized, potent immune responses with reduced side effects.

Similarly, Cue Biopharma’s CUE-101 represents a significant innovation in IL-2-based therapies, specifically targeting the HPV16 antigen in head and neck squamous cell carcinoma (HNSCC). In October 2022, the FDA granted Fast Track Designation to CUE-101 for treating HPV16+ refractory/metastatic HNSCC, both as a monotherapy and in combination with KEYTRUDA. By combining IL-2 replacement with precise antigen presentation, CUE-101 enhances tumor targeting and strengthens the anti-cancer immune response. Currently, in clinical trials, the therapy has shown promising results, especially when paired with immune checkpoint inhibitors like KEYTRUDA, and is projected to reach a market value of approximately USD 370 million by 2034.

Discover more about IL-2 drugs in development @ Interleukin-2 Based Therapies Clinical Trials

Many companies are working on the development of IL-2-based or IL-2-targeting therapies, currently in the early preclinical stage. These include Medicenna Therapeutics (MDNA223, MDNA209, MDNA113), a collaboration between Medicenna Therapeutics and Merck (MDNA223), Xilio Therapeutics (XTX501), Shanghai Junshi Biosciences (JS206), Egle Therapeutics (EGL001, EGL002, EGL003), Cue Biopharma (CUE-401), Iovance Biotherapeutics (IOV3001), and others.

With the growth of the IL-2-based therapy pipeline, the future looks very promising. The next-generation therapies aim to not only improve survival rates in cancer patients but also address the unmet needs of those with autoimmune diseases. The key feature of these therapies is the ability to precisely modulate the immune system, enhancing its ability to combat disease while minimizing harm.

The anticipated launch of these emerging therapies are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the IL-2-based therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

As a result, the IL-2 market is set for swift transformation in the near future. Existing therapies such as PROLEUKIN and LYMPHIR are already making notable strides in oncology, while emerging treatments like ALKS 4230, Rezpegaldesleukin, and Soquelitinib are expanding the possibilities for autoimmune diseases and immuno-oncology.

DelveInsight estimates that the market size for IL-2-based/targeting therapies in the 7MM is expected to reach an estimated USD 4 billion by 2034, reflecting the expanding role of IL-2 in treating both cancer and autoimmune diseases.

DelveInsight’s latest published market report titled as Interleukin-2 Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the IL-2 country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market’s underlying potential. The IL-2 market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Cases of Selected Indications
• Indication-wise Eligible Cases
• Indication-wise Treated Cases 

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM IL-2-based therapies market. Highlights include:

• 10-year Forecast
• 7MM Analysis
• Epidemiology-based Market Forecasting
• Historical and Forecasted Market Analysis upto 2034
• Emerging Drug Market Uptake
• Launch Timelines and Peak Sales Analysis
• Key Cross Competition Analysis 
• Industry Expert’s Opinion
• Access and Reimbursement

Download this IL-2 market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs’ opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the IL-2 market. Also, stay abreast of the mitigating factors to improve your market position in the IL-2 therapeutic space.

Table of Contents

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