Dublin, March 20, 2025 (GLOBE NEWSWIRE) -- The "Interleukin-2 - Market Size, Target Population, Competitive Landscape & Market Forecast - 2034" report has been added to ResearchAndMarkets.com's offering.
The report delivers an in-depth understanding of the Interleukin-2, historical and forecasted epidemiology as well as the Interleukin-2 market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
The Interleukin-2 market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Interleukin-2 market size from 2020 to 2034. The report also covers current Interleukin-2 treatment practices/algorithms, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Key Market Insights
- Currently, there is only two Interleukin-2 approved drugs that is LYMPHIR, which was approved by the US FDA in August 2024, and PROLEUKIN by the US FDA in 1992.
- In 2023, the market size of Interleukin-2 was highest in the US among the 7MM, accounting for approximately USD 6 million, which is further expected to increase by 2034.
- Among the total prevalent cases of selected indications across the 7MM, the highest number of cases comprised Atopic Dermatitis, followed by Non-Segmental Vitiligo (NSV), and the lowest number of cases comprised Aplastic Anemia in 2020.
- Among the indication-wise treated cases across the 7MM, the lowest number of cases comprised of Aplastic Anemia in 2020.
- In September 2024, SYNCAR-001 + STK-009 received Fast Track Designation (FTD) from the US FDA for patients with severe, refractory systemic lupus erythematosus (SLE), without the use of lymphodepletion.
- In April 2024, Asher Biotherapeutics announced the publication of two manuscripts in Cancer Discovery, a journal of the American Association for Cancer Research, detailing the design of AB248 and reviewing preclinical data supporting its development as a potentially best-in-class Interleukin-2 therapy.
- In July 2023, the FDA granted FTD to intratumoral KB707 for the treatment of anti-programmed cell death protein-1 ('PD-1') r/r locally advanced or metastatic melanoma.
- In January 2023, Alkermes announced that nemvaleukin had been granted an Innovation Passport for the treatment of mucosal melanoma under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare Products Regulatory Agency (MHRA), the regulatory body of the UK.
- In September 2024, LYMPHIR has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). LYMPHIR was added based on an NCCN Category 2A recommendation, indicating a unanimous NCCN consensus that the drug is an appropriate option for patients with CTCL.
- Medicenna Therapeutics, in December 2024, announced that the company anticipates starting the expanded combination dosing study of MDNA11 in the first half of 2025.
- Looking ahead, Interleukin-2 therapies are poised for significant growth, driven by a robust pipeline, precision medicine advancements, and rising cancer, autoimmune and inflammatory disease prevalence.
Interleukin-2 Market Outlook
IL-2, a critical cytokine in the immune response, has long been at the forefront of immunotherapy, particularly in oncology. By stimulating the body's immune system, IL-2 enhances the activity of T cells and natural killer cells, helping the body fight cancer. Over the past three decades, IL-2-based therapies have evolved from pioneering treatments to innovative immunotherapies targeting a broader range of cancers and immune-related conditions. As research advances, IL-2 is poised to expand its therapeutic footprint, not only in oncology but in autoimmune diseases and other therapeutic areas. The increasing approval and development of new IL-2-based and IL-2-targeting therapies demonstrate its potential to revolutionize modern immunotherapy.
The story of IL-2 in cancer treatment began in the early 1990s, a period of significant advancement in immuno-oncology. IL-2's ability to activate the immune system, particularly T cells and NK cells, led to its adoption as an innovative immunotherapeutic tool. The first approved IL-2 product, PROLEUKIN (recombinant human IL-2 or Aldesleukin), gained US FDA approval in May 1992 for the treatment of metastatic RCC, making it the first immunotherapy to offer a new avenue of treatment for this aggressive cancer. PROLEUKIN was heralded as a breakthrough, offering a novel mechanism of action for cancer treatment that leveraged the body's immune defenses against tumor cells.
In subsequent years, PROLEUKIN's clinical use expanded, with approval in 1998 for metastatic melanoma, another difficult-to-treat malignancy. However, despite its groundbreaking nature, the use of high-dose IL-2 was hampered by significant challenges, including severe toxicity, systemic inflammatory reactions, and a short half-life. These limitations, though substantial, led to a series of innovative improvements and led to the exploration of combination therapies designed to enhance the effectiveness of IL-2 while minimizing its adverse effects.
The clinical adoption of IL-2 was further complicated by the advent of immune checkpoint inhibitors in the 2010s, which introduced new, highly effective treatment options. Despite these challenges, IL-2 remained a key player in immunotherapy, often in combination with other drugs, due to its complementary mechanism of action with checkpoint inhibitors. The success of combinations targeting both the PD-1/PD-L1 axis and IL-2-based therapies rejuvenated interest in the cytokine, offering a renewed sense of hope for patients with cancers that were previously deemed untreatable
Nevertheless, PROLEUKIN's journey did not end with its approval. Over the years, PROLEUKIN underwent continuous clinical scrutiny and improvement. It became evident that the therapeutic efficacy of IL-2 could be optimized by modifying delivery methods, developing combination therapies, and enhancing patient selection strategies. The promising potential of PROLEUKIN has led to significant collaborations and continued innovation.
Overall, Interleukin-2 market is further expected to increase in the forecast period (2024-2034).
- The total market size of Interleukin-2 in the 7MM was nearly USD 6 million in 2023 and is projected to grow during the forecast period (2024-2034).
- According to the estimates, the highest market size of Interleukin-2 is from Japan is around USD 5.8 million, in 2023 and is anticipated to grow significantly by 2034.
- Apart from Atopic Dermatitis, Non-small cell lung cancer (NSCLC) may offer the most commercial potential for IL-2 based therapy because millions of people suffer with lung cancer and other types.
- Of the target indications, Atopic Dermatitis and Non-small cell lung cancer (NSCLC) are anticipated to generate the most revenue by 2034 due to the highest level of clinical development and authorization of IL-2 therapies.
Scope of the Report
- The report covers a descriptive overview of Interleukin-2, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
- Comprehensive insight has been provided into Interleukin-2 epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for Interleukin-2 is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the Interleukin-2 market; historical and forecasted is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Interleukin-2 market.
Interleukin-2 Report Insights
- Patient Population
- Therapeutic Approaches
- Interleukin-2 Pipeline Analysis
- Interleukin-2 Market Size and Trends
- Market Opportunities
- Impact of Upcoming Therapies
Interleukin-2 Report Key Strengths
- Eleven Years Forecast
- 7MM Coverage
- Interleukin-2 Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Interleukin-2 Report Assessment
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Qualitative Analysis (SWOT and Conjoint Analysis)
Company Coverage:
- Mural Oncology
- Corvus Pharmaceuticals
- Philogen
- Merck
- Nektar
- Cue Biopharma
- Krystal Biotech
- ILTOO Pharma
- Innovent
- Regeneron Pharmaceuticals
- R2T Biopharma (XEME Biopharma)
- GI Innovation, AstraZeneca and Merck (MSD)
- GI Innovation and Merck
- R2T Biopharma (XEME Biopharma)
- Sanofi
- Synthekine
- BioNTech
- Medicenna Therapeutics
- Ascendis Pharma
- Sanofi/Synthorx
- Cugene/AbbVie
- Deka Biosciences
- Dragonfly Therapeutics
- Werewolf Therapeutics
- Xilio Therapeutics
- Bioniz Therapeutics/Equillium
- Asher Bio
- Synthekine
- Anaveon
- Aulos Bioscience
- Selecxine/ProBio
- Hoffmann-La Roche
- TILT Biotherapeutics
For more information about this report visit https://www.researchandmarkets.com/r/cni43o
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
