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.
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.
IL-2 also plays a critical role in the immune system's self-regulation by promoting the differentiation of regulatory T-cells (Tregs), which help prevent autoimmune reactions and maintain immune tolerance. Due to its immune-enhancing properties, IL-2 has been utilized therapeutically in immunotherapy, especially in the treatment of certain cancers like melanoma and renal cell carcinoma.
Despite these challenges, IL-2 remains a promising tool in cancer immunotherapy, and ongoing research aims to refine its applications by minimizing adverse effects and maximizing its therapeutic potential in cancer, autoimmune diseases, and transplant rejection.
Soquelitinib has also demonstrated the ability to prevent T-cell exhaustion, a significant limitation of current immunotherapies and CAR-T therapies. Additionally, Corvus Pharmaceuticals plans to initiate a Phase I clinical trial of soquelitinib in patients with solid tumors. In November 2024, Corvus Pharmaceuticals announced new preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis in Fra-2 transgenic mice, further supporting its promise as a therapeutic candidate for fibrotic diseases.
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 analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as Pharmaceutical Research and Manufacturers of America and other organizations. Their opinion helps understand and validate current and emerging therapies or market trends in Interleukin-2. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.
In efficacy, the trial’s primary and secondary outcome measures are evaluated.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
- 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 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.
Geography Covered
- The United States
- EU4 (Germany, France, Italy, and Spain) and the United Kingdom
- Japan
Study Period: 2020-2034
Interleukin-2 Understanding
Interleukin-2 Overview
Interleukin-2 (IL-2) is a cytokine, a small protein that plays a pivotal role in the immune system by regulating the growth, activation, and differentiation of T-cells. It is produced primarily by activated CD4+ T-helper cells, although it can also be secreted by CD8+ T-cells, natural killer (NK) cells, and other immune cells. IL-2 is essential for the expansion and survival of T-cells during immune responses, particularly in response to infections or the presence of tumors. It promotes the activation and proliferation of both helper T-cells (which assist other immune cells) and cytotoxic T-cells (which directly kill infected or cancerous cells).IL-2 also plays a critical role in the immune system's self-regulation by promoting the differentiation of regulatory T-cells (Tregs), which help prevent autoimmune reactions and maintain immune tolerance. Due to its immune-enhancing properties, IL-2 has been utilized therapeutically in immunotherapy, especially in the treatment of certain cancers like melanoma and renal cell carcinoma.
Despite these challenges, IL-2 remains a promising tool in cancer immunotherapy, and ongoing research aims to refine its applications by minimizing adverse effects and maximizing its therapeutic potential in cancer, autoimmune diseases, and transplant rejection.
Interleukin-2 Epidemiology
The epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Selected Indications for Interleukin-2 in the 7MM, Indication-wise Eligible Cases in the 7MM, and Indication-wise Treated Cases in the 7MM, covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.- Among all the prevalent cases of selected indications for Interleukin-2, the highest cases comprised Atopic Dermatitis, with approximately 38,412,058 cases in the 7MM in 2020.
- In the US, the highest number of prevalent cases comprised Atopic Dermatitis with approximately 16,014,815, while the lowest cases comprised of Aplastic Anemia 776 in 2020.
- In EU4 and the UK, Germany accounted for the highest number of Atopic Dermatitis treated cases with approximately 1,069,104 in 2020.
- In Japan, the total number of Amyotrophic Lateral Sclerosis (ALS) -eligible cases was approximately 11,150 in 2020.
Interleukin-2 Drug Chapters
The drug chapter segment of the Interleukin-2 report encloses a detailed analysis of Interleukin-2 emerging (Phase-III and Phase II and Phase I/II) pipeline drugs. It also helps to understand Interleukin-2 clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.Marketed Drugs
LYMPHIR/REMITORO (denileukin diftitox): Eisai and Citius Oncology
LYMPHIR is an immune therapy designed for relapsed or refractory CTCL, indicated for Stage I-III disease after at least one prior systemic treatment. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments. The therapy specifically targets IL-2 receptors on the cell surface, allowing diphtheria toxin fragments to enter the cell and inhibit protein synthesis. It was approved by the US FDA in August 2024; expected to launch in January 2025, and by MHLW in March 2021.Emerging Drugs
Soquelitinib (CPI-818): Corvus Pharmaceuticals
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (IL-2-inducible T-cell kinase) and enzyme that is expressed predominantly in T cells and plays a role in T-cell and natural killer cell immune function. Soquelitinib is currently being evaluated in a randomized, placebo-controlled Phase I clinical trial in patients with atopic dermatitis. Enrollment in the first cohort (100 mg, twice per day) has been completed, and the data review committee has met and found no safety signals. The endpoints include safety and improvement in the eczema area and severity index. The second cohort (200 mg, once daily) is now enrolling patients.Soquelitinib has also demonstrated the ability to prevent T-cell exhaustion, a significant limitation of current immunotherapies and CAR-T therapies. Additionally, Corvus Pharmaceuticals plans to initiate a Phase I clinical trial of soquelitinib in patients with solid tumors. In November 2024, Corvus Pharmaceuticals announced new preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis in Fra-2 transgenic mice, further supporting its promise as a therapeutic candidate for fibrotic diseases.
ILT-101: ILTOO Pharma
ILT-101 is a ready-to-use, injectable liquid formulation of low-dose IL-2, available in vials, and is specifically designed to meet patient needs. It has been developed for the treatment of a wide range of conditions, including autoimmune and inflammatory diseases, as well as certain central nervous system disorders. ILTOO Pharma is well-positioned to seek approval for the treatment and has made significant progress already. Future announcements will provide details of the company’s progress. For now, the company is focusing on providing the treatment on a compassionate basis for patients who participated in the trial.Note: Detailed therapy assessment will be provided in the final report.
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.
Interleukin-2 Drugs Uptake
This section focuses on the rate of uptake of the potential drugs expected to be launched in the market during the study period 2020-2034. The analysis covers Interleukin-2 market uptake by drugs; patient uptake by therapies; and sales of each drug.Interleukin-2 Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.Pipeline Development Activities
The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for Interleukin-2 emerging therapies.KOL- Views
To keep up with current market trends, we take KOLs and ’ SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on Interleukin-2's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as Pharmaceutical Research and Manufacturers of America and other organizations. Their opinion helps understand and validate current and emerging therapies or market trends in Interleukin-2. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.
In efficacy, the trial’s primary and secondary outcome measures are evaluated.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.
Market Access and Reimbursement
Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Note: Detailed assessment will be provided in the final report.
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)
FAQs
- What was the Interleukin-2 market share (%) distribution in 2020 and what it would look like in 2034?
- What would be the Interleukin-2 total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
- What are the key findings about the market across the 7MM and which country will have the largest Interleukin-2 market size during the study period (2020-2034)?
- At what CAGR, the Interleukin-2 market is expected to grow at the 7MM level during the study period (2020-2034)?
- What would be the IL-2 market outlook across the 7MM during the study period (2020-2034)?
- What would be the Interleukin-2 market growth till 2034 and what will be the resultant market size in the year 2034?
- What are the disease risks, burdens, and unmet needs of Interleukin-2?
- What is the historical Interleukin-2 patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
- What would be the forecasted patient pool of Interleukin-2 at the 7MM level?
- What will be the growth opportunities across the 7MM concerning the patient population about Interleukin-2?
- At what CAGR the population is expected to grow across the 7MM during the study period (2020-2034)?
- How many emerging therapies are in the mid-stage and late stage of development for Interleukin-2?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to Interleukin-2?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
- What are the key designations that have been granted for IL-2 based therapies?
- What are the 7MM historical and forecasted market of Interleukin-2?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving Interleukin-2.
- To understand the future market competition in the Interleukin-2 market and an Insightful review of the SWOT analysis of Interleukin-2.
- Organize sales and marketing efforts by identifying the best opportunities for Interleukin-2 in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for Interleukin-2 market.
- To understand the future market competition in Interleukin-2 market.
Table of Contents
1. Key Insights2. Report Introduction3. Executive Summary4. Key Events5. Epidemiology and Market Forecast Methodology13. Unmet Needs14. SWOT Analysis15. KOL Views18. Publisher Capabilities19. Disclaimer20. About the Publisher
6. IL-2 Market Overview at a Glance by Indication in the 7MM
7. IL-2 Market Overview at a Glance by Therapies in the 7MM
8. Disease Background and Overview
9. Epidemiology and Patient Population
10. Marketed Drug
11. Emerging Drugs
12. IL-2: 7MM analysis
16. Market Access and Reimbursement
17. Appendix
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 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
