市場調査レポート
商品コード
1625356

インターロイキン2(IL-2)- 市場規模、標的集団、競合情勢、市場予測(2034年)

Interleukin-2 - Market Size, Target Population, Competitive Landscape, and Market Forecast - 2034


出版日
発行
DelveInsight
ページ情報
英文 308 Pages
納期
2~10営業日
カスタマイズ可能
適宜更新あり
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価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.99円
インターロイキン2(IL-2)- 市場規模、標的集団、競合情勢、市場予測(2034年)
出版日: 2025年01月01日
発行: DelveInsight
ページ情報: 英文 308 Pages
納期: 2~10営業日
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  • 概要
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概要

主なハイライト

  • 現在、承認されているインターロイキン2の医薬品は、2024年8月に米国FDAから承認されたLYMPHIRと、1992年に米国FDAから承認されたPROLEUKINの2種類のみです。
  • 2023年、インターロイキン2の市場規模は主要7市場中で米国がもっとも大きく、約600万米ドルを占め、2034年までにさらに拡大すると予測されています。
  • 2020年、主要7市場全体の適応症別の患者数のうち、アトピー性皮膚炎がもっとも多く、非分節性白斑(NSV)がそれに続き、再生不良性貧血はもっとも少数でした。
  • 2024年9月、SYNCAR-001 + STK-009は、米国FDAより、リンパ節除去療法を用いない重症難治性全身性エリテマトーデス(SLE)患者を対象としたFast Track Designation(FTD)を取得しました。
  • 2024年4月、Asher Biotherapeuticsは、AB248の設計を詳述し、クラス最高のインターロイキン2治療薬としての開発を裏付ける前臨床データをレビューした2本の原稿をAmerican Association for Cancer Researchの学会誌、Cancer Discoveryで発表しました。
  • 2023年7月、FDAは、抗プログラム細胞死タンパク質1(PD-1)r/rの局所進行性または転移性メラノーマの治療を適応とする腫瘍内KB707のFTDを承認しました。
  • 2023年1月、Alkermesは、nemvaleukinが英国の規制機関であるHealthcare Products Regulatory Agency(MHRA)からInnovative Licensing and Access Pathway(ILAP)の下、粘膜部黒色腫の治療薬としてInnovation Passportを取得したと発表しました。
  • 2024年9月、LYMPHIRはNCCN Clinical Practice Guidelines in Oncology(NCCN Guidelines)に収載されました。LYMPHIRは、NCCN Category 2Aの推奨に基づき追加され、本薬がCTCL患者にとって適切な選択肢であるというNCCNの全員一致のコンセンサスを示しています。
  • Medicenna Therapeuticsは2024年12月、MDNA11の拡大併用投与試験を2025年前半に開始する予定であると発表しました。
  • 今後、インターロイキン2治療法は強力なパイプライン、精密医療の進歩、がん、自己免疫疾患、炎症性疾患の有病率の増加により大きな成長が見込まれます。

インターロイキン2市場の見通し

免疫反応において重要なサイトカインであるIL-2は、免疫療法、特に腫瘍において、長きにわたり最前線にありました。身体の免疫系を刺激することにより、IL-2はT細胞とナチュラルキラー細胞の活性を高め、身体ががんと闘うのを助けます。過去30年間で、IL-2に基づく治療は、先駆的な治療から、より広範ながんや免疫関連疾患を対象とする革新的な免疫療法へと発展してきました。研究の進歩に伴い、IL-2は、腫瘍のみならず、自己免疫疾患やその他の治療領域においても、その治療領域を拡大する見込みです。IL-2をベースとした新治療法やIL-2を標的とした治療薬の承認と開発の増加は、IL-2が現代の免疫療法に革命をもたらす可能性を示しています。

  • 主要7市場のインターロイキン2の総市場規模は、2023年に600万米ドル近くであり、予測期間(2024年~2034年)に成長する見込みです。
  • 推計によると、インターロイキン2の市場規模がもっとも大きいのは日本で、2023年に約580万米ドルであり、2034年までに大きく成長すると予測されています。
  • アトピー性皮膚炎を除けば、非小細胞肺がん(NSCLC)がIL-2ベースの治療でもっとも商業的な可能性があると見られます。
  • 標的適応症のうち、アトピー性皮膚炎と非小細胞肺がん(NSCLC)は、IL-2療法の臨床開発と認可のレベルがもっとも高いため、2034年までにもっとも多くの収益を生み出すと予測されます。

当レポートでは、インターロイキン2(IL-2)の主要7市場(米国、ドイツ、スペイン、イタリア、フランス、英国、日本)について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 エグゼクティブサマリー

第4章 重要な出来事

第5章 疫学と市場予測の調査手法

第6章 主要7市場のIL-2市場の概要:適応症別

  • IL-2の市場シェアの分布:適応症別(2025年)
  • IL-2の市場シェアの分布:適応症別(2034年)

第7章 主要7市場のIL-2市場の概要:治療法別

  • IL-2の市場シェアの分布:治療法別(2025年)
  • IL-2の市場シェアの分布:治療法別(2034年)

第8章 疾患の背景と概要

  • イントロダクション
  • IL-2受容体のクラス
  • IL-2の生物学
    • TCRシグナル伝達とIL-2産生
    • IL-2Rシグナル伝達
    • IL-2の多面的作用
  • 治療法としてのIL-2
    • 治療法としてのIL-2シグナル伝達の阻害
  • さまざまな適応症の治療におけるIL-2の可能性
  • 課題
  • ガイドライン

第9章 疫学と患者人口

  • 主な調査結果
  • 前提条件と根拠:主要7市場
  • 主要7市場の疫学シナリオ

第10章 上市済み薬品

  • 主な競合
  • LYMPHIR/REMITORO/E7777/ONTAK(denileukin diftitox):Citius Oncology、Eisai
  • PROLEUKIN(aldesleukin):Iovance Biotherapeutics/Clinigen/Novartis

第11章 新薬

  • 主な競合相手
  • Nemvaleukin Alfa(ALKS 4230):Mural Oncology
  • Soquelitinib(CPI-818):Corvus Pharmaceuticals
  • Darleukin(L19IL2):Philogen
  • MK-6194:Merck
  • Rezpegaldesleukin(REZPEG、NKTR-358、LY3471851):Nektar
  • CUE-101:Cue Biopharma
  • KB707:Krystal Biotech
  • ILT-101:ILTOO Pharma
  • IBI363:Innovent
  • REGN7257:Regeneron Pharmaceuticals
  • Oncoquest-L Vaccine:R2T Biopharma(XEME Biopharma)
  • GI-101/GI-101A:GI Innovation、AstraZeneca、Merck(MSD)
  • GI-102:GI Innovation、Merck
  • Oncoquest-CLL Vaccine:R2T Biopharma(XEME Biopharma)
  • SAR444336(THOR-809):Sanofi
  • STK-012:Synthekine
  • BNT152+ BNT153:BioNTech
  • MDNA11:Medicenna Therapeutics
  • TransCon IL-2 β/γ:Ascendis Pharma
  • Pegenzileukin/THOR-707(SAR444245):Sanofi/Synthorx
  • CUG252:Cugene/AbbVie
  • DK210(EGFR):Deka Biosciences
  • DF6215:Dragonfly Therapeutics
  • WTX-124:Werewolf Therapeutics
  • XTX202:Xilio Therapeutics
  • BNZ132-1-40/EQ 101:Bioniz Therapeutics/Equillium
  • AB248:Asher Bio
  • SYNCAR-001 + STK-009:Synthekine
  • ANV419:Anaveon
  • AU-007:Aulos Bioscience
  • SLC-3010:Selecxine/ProBio
  • Eciskafusp alfa(PD1-IL-2v、RG6279):Hoffmann-La Roche
  • TILT-123:TILT Biotherapeutics

第12章 IL-2:主要7市場の分析

  • 主な調査結果
  • 市場見通し
  • コンジョイント分析
  • 主な市場予測の前提条件
  • 主要7市場のIL-2の市場規模
  • 米国の市場規模
    • 米国のIL-2の市場規模:適応症別
    • 米国の市場規模:治療法別
  • 欧州4ヶ国・英国の市場規模
    • 欧州4ヶ国・英国のIL-2の市場規模:適応症別
    • 欧州4ヶ国・英国の市場規模:治療法別
  • 日本の市場規模
    • 日本のIL-2の市場規模:適応症別
    • 日本の市場規模:治療法別

第13章 アンメットニーズ

第14章 SWOT分析

第15章 KOLの見解

第16章 市場参入と償還

  • 米国
  • 欧州4ヶ国・英国
    • ドイツ
    • フランス
    • イタリア
    • スペイン
    • 英国
  • 日本
  • IL-2の市場参入と償還

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

図表

List of Tables

  • Table 1: Summary of IL-2 Market and Epidemiology (2020-2034)
  • Table 2: List of Sources Used for Epidemiology Evaluation for Shortlisted Indication
  • Table 3: Total Cases of Selected Indications in the 7MM in thousand (2020-2034)
  • Table 4: Indication-wise Eligible Cases in the 7MM in thousand (2020-2034)
  • Table 5: Indication-wise Treated Cases in the 7MM in thousand (2020-2034)
  • Table 6: Key Cross of Marketed Drug
  • Table 7: LYMPHIR/E777/ONTAK (denileukin diftitox), Clinical Trial Description, 2024
  • Table 8: PROLEUKIN (aldesleukin), Clinical Trial Description, 2024
  • Table 9: Comparison of Emerging Drugs Under Development
  • Table 10: Nemvaleukin Alfa (ALKS 4230), Clinical Trial Description, 2024
  • Table 11: Soquelitinib (CPI-818), Clinical Trial Description, 2024
  • Table 12: Darleukin (L19IL2), Clinical Trial Description, 2024
  • Table 13: MK-6194, Clinical Trial Description, 2024
  • Table 14: Rezpegaldesleukin (REZPEG, NKTR-358, LY3471851), Clinical Trial Description, 2024
  • Table 15: CUE-101, Clinical Trial Description, 2024
  • Table 16: KB707, Clinical Trial Description, 2024
  • Table 17: ILT-101, Clinical Trial Description, 2024
  • Table 18: IBI363, Clinical Trial Description, 2024
  • Table 19: REGN7257, Clinical Trial Description, 2024
  • Table 20: Oncoquest-L Vaccine, Clinical Trial Description, 2024
  • Table 21: GI-101/GI-101A, Clinical Trial Description, 2024
  • Table 22: GI-102, Clinical Trial Description, 2024
  • Table 23: Oncoquest-CLL Vaccine, Clinical Trial Description, 2024
  • Table 24: SAR444336 (THOR-809), Clinical Trial Description, 2024
  • Table 25: STK-012, Clinical Trial Description, 2024
  • Table 26: BNT152 + BNT153, Clinical Trial Description, 2024
  • Table 27: MDNA11, Clinical Trial Description, 2024
  • Table 28: TransCon IL-2 B/?, Clinical Trial Description, 2024
  • Table 29: Pegenzileukin/THOR-707 (SAR444245), Clinical Trial Description, 2024
  • Table 30: CUG252, Clinical Trial Description, 2024
  • Table 31: DK210 (EGFR) Clinical Trial Description, 2024
  • Table 32: DF6215, Clinical Trial Description, 2024
  • Table 33: WTX-124, Clinical Trial Description, 2024
  • Table 34: XTX202, Clinical Trial Description, 2024
  • Table 35: BNZ132-1-40/EQ 101, Clinical Trial Description, 2024
  • Table 36: AB248, Clinical Trial Description, 2024
  • Table 37: SYNCAR-001 + STK-009, Clinical Trial Description, 2024
  • Table 38: ANV419, Clinical Trial Description, 2024
  • Table 39: AU-007, Clinical Trial Description, 2024
  • Table 40: SLC-3010, Clinical Trial Description, 2024
  • Table 41: Eciskafusp alfa (PD1-IL-2v, RG6279), Clinical Trial Description, 2024
  • Table 42: TILT-123, Clinical Trial Description, 2024
  • Table 43: Key Market Forecast Assumption of IL-2 in the United States
  • Table 44: Key Market Forecast Assumption of IL-2 in EU4 and the UK
  • Table 45: Key Market Forecast Assumption of IL-2 in Japan
  • Table 46: Market size of IL-2 by Country in the 7MM, USD million (2020-2034)
  • Table 47: Market size of IL-2 by Indications in the US, USD million (2020-2034)
  • Table 48: Market Size by Therapies in the US, USD million (2020-2034)
  • Table 49: Market size of IL-2 by Indications in EU4 and the UK, USD million (2020-2034)
  • Table 50: Market Size by Therapies in EU4 and the UK, USD million (2020-2034)
  • Table 51: Market size of IL-2 by Indications in Japan, USD million (2020-2034)
  • Table 52: Market Size by Therapies in Japan, USD million (2020-2034)
  • Table 53: HAS Opinions for PROLEUKIN
  • Table 54: AIFA Assessment for PROLEUKIN

List of Figures

  • Figure 1: Classes of IL-2 receptors
  • Figure 2: Interactions among CD4+ T Cells, Treg Cells, TFH Cells, and TFR Cells Within the Germinal Center
  • Figure 3: Total Cases of Selected Indications in the 7MM (2020-2034)
  • Figure 4: Indication-wise Eligible Cases in the 7MM (2020-2034)
  • Figure 5: Indication-wise Treated Cases in the 7MM (2020-2034)
  • Figure 6: Market size of IL-2 in the 7MM, USD million (2020-2034)
  • Figure 7: Market size of IL-2 by Indications in the US, USD million (2020-2034)
  • Figure 8: Market Size by Therapies in the US, USD million (2020-2034)
  • Figure 9: Market size of IL-2 by Indications in EU4 and the UK, USD million (2020-2034)
  • Figure 10: Market Size by Therapies in EU4 and the UK, USD million (2020-2034)
  • Figure 11: Market size of IL-2 by Indications in Japan, USD million (2020-2034)
  • Figure 12: Market Size by Therapies in Japan, USD million (2020-2034)
  • Figure 13: Health Technology Assessment
  • Figure 14: Reimbursement Process in Germany
  • Figure 15: Reimbursement Process in France
  • Figure 16: Reimbursement Process in Italy
  • Figure 17: Reimbursement Process in Spain
  • Figure 18: Reimbursement Process in the United Kingdom
  • Figure 19: Reimbursement Process in Japan
目次
Product Code: DIIM0116

Key Highlights:

  • 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.

DelveInsight's ""Interleukin-2-Market Size, Target Population, Competitive Landscape & Market Forecast - 2034" 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.

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.

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.

DelveInsight's 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.

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

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 Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. IL-2 Market Overview at a Glance by Indication in the 7MM

  • 6.1. Market Share (%) Distribution of IL-2 by Indication in 2025
  • 6.2. Market Share (%) Distribution of IL-2 by Indication in 2034

7. IL-2 Market Overview at a Glance by Therapies in the 7MM

  • 7.1. Market Share (%) Distribution of IL-2 by Therapies in 2025
  • 7.2. Market Share (%) Distribution of IL-2 by Therapies in 2034

8. Disease Background and Overview

  • 8.1. Introduction
  • 8.2. Classes of IL-2 receptors
  • 8.3. Biology of IL-2
    • 8.3.1. TCR Signaling and IL-2 Production
    • 8.3.2. IL-2R Signaling
    • 8.3.3. Pleiotropic Action of IL-2
  • 8.4. IL-2 as a Therapeutic Modality
    • 8.4.1. Inhibition of IL-2 Signaling as a Therapeutic Modality
  • 8.5. Potential of IL-2 in the Treatment of Different Indications
  • 8.6. Challenges
  • 8.7. Guidelines

9. Epidemiology and Patient Population

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale: 7MM
  • 9.3. Epidemiology Scenario in the 7MM
    • 9.3.1. Total Cases of Selected Indications in the 7MM
    • 9.3.2. Indication-wise Eligible Cases in the 7MM
    • 9.3.3. Indication-wise Treated Cases in the 7MM

10. Marketed Drug

  • 10.1. Key Cross Competition
  • 10.2. LYMPHIR/REMITORO/E7777/ONTAK (denileukin diftitox): Citius Oncology and Eisai
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Development Activities
    • 10.2.4. Clinical Development
      • 10.2.4.1. Clinical Trial Information
    • 10.2.5. Safety and Efficacy
  • 10.3. PROLEUKIN (aldesleukin): Iovance Biotherapeutics /Clinigen/Novartis
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Other Development Activities
    • 10.3.4. Clinical Development
      • 10.3.4.1. Clinical Trial Information
    • 10.3.5. Safety and Efficacy

11. Emerging Drugs

  • 11.1. Key Competitors
  • 11.2. Nemvaleukin Alfa (ALKS 4230): Mural Oncology
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trial Information
    • 11.2.4. Safety and Efficacy
  • 11.3. Soquelitinib (CPI-818): Corvus Pharmaceuticals
    • 11.3.1. Product Description
    • 11.3.2. Other Developmental Activities
    • 11.3.3. Clinical Development
      • 11.3.3.1. Clinical Trial Information
    • 11.3.4. Safety and Efficacy
  • 11.4. Darleukin (L19IL2): Philogen
    • 11.4.1. Product Description
    • 11.4.2. Clinical Development
      • 11.4.2.1. Clinical Trial Information
    • 11.4.3. Safety and Efficacy
  • 11.5. MK-6194: Merck
    • 11.5.1. Product Description
    • 11.5.2. Other Developmental Activities
    • 11.5.3. Clinical Development
      • 11.5.3.1. Clinical Trial Information
  • 11.6. Rezpegaldesleukin (REZPEG, NKTR-358, LY3471851): Nektar
    • 11.6.1. Product Description
    • 11.6.2. Other Development Activities
    • 11.6.3. Clinical Development
      • 11.6.3.1. Clinical Trial Information
    • 11.6.4. Safety and Efficacy
  • 11.7. CUE-101: Cue Biopharma
    • 11.7.1. Product Description
    • 11.7.2. Other Developmental Activities
    • 11.7.3. Clinical Development
      • 11.7.3.1. Clinical Trial Information
    • 11.7.4. Safety and Efficacy
  • 11.8. KB707: Krystal Biotech
    • 11.8.1. Product Description
    • 11.8.2. Other Developmental Activities
    • 11.8.3. Clinical Development
      • 11.8.3.1. Clinical Trial Information
    • 11.8.4. Safety and Efficacy
  • 11.9. ILT-101: ILTOO Pharma
    • 11.9.1. Product Description
    • 11.9.2. Other Developmental Activities
    • 11.9.3. Clinical Development
      • 11.9.3.1. Clinical Trial Information
    • 11.9.4. Safety and Efficacy
  • 11.1. IBI363: Innovent
    • 11.10.1. Product Description
    • 11.10.2. Other Developmental Activities
    • 11.10.3. Clinical Development
      • 11.10.3.1. Clinical Trial Information
    • 11.10.4. Safety and Efficacy
  • 11.11. REGN7257: Regeneron Pharmaceuticals
    • 11.11.1. Product Description
    • 11.11.2. Clinical Development
      • 11.11.2.1. Clinical Trial Information
    • 11.11.3. Safety and Efficacy
  • 11.12. Oncoquest-L Vaccine: R2T Biopharma (XEME Biopharma)
    • 11.12.1. Product Description
    • 11.12.2. Other Developmental Activities
    • 11.12.3. Clinical Development
      • 11.12.3.1. Clinical Trial Information
  • 11.13. GI-101/GI-101A: GI Innovation, AstraZeneca and Merck (MSD)
    • 11.13.1. Product Description
    • 11.13.2. Other Developmental Activities
    • 11.13.3. Clinical Development
      • 11.13.3.1. Clinical Trial Information
    • 11.13.4. Safety and Efficacy
  • 11.14. GI-102: GI Innovation and Merck
    • 11.14.1. Product Description
    • 11.14.2. Other Developmental Activities
    • 11.14.3. Clinical Development
      • 11.14.3.1. Clinical Trial Information
    • 11.14.4. Safety and Efficacy
  • 11.15. Oncoquest-CLL Vaccine: R2T Biopharma (XEME Biopharma)
    • 11.15.1. Product Description
    • 11.15.2. Clinical Development
      • 11.15.2.1. Clinical Trial Information
  • 11.16. SAR444336 (THOR-809): Sanofi
    • 11.16.1. Product Description
    • 11.16.2. Clinical Development
      • 11.16.2.1. Clinical Trial Information
  • 11.17. STK-012: Synthekine
    • 11.17.1. Product Description
    • 11.17.2. Clinical Development
      • 11.17.2.1. Clinical Trial Information
    • 11.17.3. Safety and Efficacy
  • 11.18. BNT152+ BNT153: BioNTech
    • 11.18.1. Product Description
    • 11.18.2. Clinical Development
      • 11.18.2.1. Clinical Trial Information
  • 11.19. MDNA11: Medicenna Therapeutics
    • 11.19.1. Product Description
    • 11.19.2. Other Developmental Activities
    • 11.19.3. Clinical Development
      • 11.19.3.1. Clinical Trial Information
    • 11.19.4. Safety and Efficacy
  • 11.2. TransCon IL-2 B/?: Ascendis Pharma
    • 11.20.1. Product Description
    • 11.20.2. Other Developmental Activities
    • 11.20.3. Clinical Development
      • 11.20.3.1. Clinical Trial Information
    • 11.20.4. Safety and Efficacy
  • 11.21. Pegenzileukin/THOR-707 (SAR444245): Sanofi/Synthorx
    • 11.21.1. Product Description
    • 11.21.2. Other Developmental Activities
    • 11.21.3. Clinical Development
      • 11.21.3.1. Clinical Trial Information
    • 11.21.4. Safety and Efficacy
  • 11.22. CUG252: Cugene/AbbVie
    • 11.22.1. Product Description
    • 11.22.2. Other Development Activities
    • 11.22.3. Clinical Development
      • 11.22.3.1. Clinical Trial Information
  • 11.23. DK210 (EGFR): Deka Biosciences
    • 11.23.1. Product Description
    • 11.23.2. Other Development Activities
    • 11.23.3. Clinical Development
      • 11.23.3.1. Clinical Trial Information
    • 11.23.4. Safety and Efficacy
  • 11.24. DF6215: Dragonfly Therapeutics
    • 11.24.1. Product Description
    • 11.24.2. Other Development Activities
    • 11.24.3. Clinical Development
      • 1.1.1.1. Clinical Trial Information
    • 11.24.4. Safety and Efficacy
  • 11.25. WTX-124: Werewolf Therapeutics
    • 11.25.1. Product Description
    • 11.25.2. Other Development Activities
    • 11.25.3. Clinical Development
      • 11.25.3.1. Clinical Trial Information
    • 11.25.4. Safety and Efficacy
  • 11.26. XTX202: Xilio Therapeutics
    • 11.26.1. Product Description
    • 11.26.2. Other Development Activities
    • 11.26.3. Clinical Development
      • 11.26.3.1. Clinical Trial Information
    • 11.26.4. Safety and Efficacy
  • 11.27. BNZ132-1-40/EQ 101: Bioniz Therapeutics/Equillium
    • 11.27.1. Product Description
    • 11.27.2. Other Development Activities
    • 11.27.3. Clinical Development
      • 11.27.3.1. Clinical Trial Information
    • 11.27.4. Safety and Efficacy
  • 11.28. AB248: Asher Bio
    • 11.28.1. Product Description
    • 11.28.2. Other Development Activities
    • 11.28.3. Clinical Development
      • 11.28.3.1. Clinical Trial Information
    • 11.28.4. Safety and Efficacy
  • 11.29. SYNCAR-001 + STK-009: Synthekine
    • 11.29.1. Product Description
    • 11.29.2. Other Developmental Activities
    • 11.29.3. Clinical Development
      • 11.29.3.1. Clinical Trial Information
    • 11.29.4. Safety and Efficacy
  • 11.3. ANV419: Anaveon
    • 11.30.1. Product Description
    • 11.30.2. Other Developmental Activities
    • 11.30.3. Clinical Development
      • 11.30.3.1. Clinical Trial Information
    • 11.30.4. Safety and Efficacy
  • 11.31. AU-007: Aulos Bioscience
    • 11.31.1. Product Description
    • 11.31.2. Other Developmental Activities
    • 11.31.3. Clinical Development
      • 11.31.3.1. Clinical Trial Information
    • 11.31.4. Safety and Efficacy
  • 11.32. SLC-3010: Selecxine/ProBio
    • 11.32.1. Product Description
    • 11.32.2. Other Developmental Activities
    • 11.32.3. Clinical Development
      • 11.32.3.1. Clinical Trial Information
    • 11.32.4. Safety and Efficacy
  • 11.33. Eciskafusp alfa (PD1-IL-2v, RG6279): Hoffmann-La Roche
    • 11.33.1. Product Description
    • 11.33.2. Other Developmental Activities
    • 11.33.3. Clinical Development
      • 11.33.3.1. Clinical Trial Information
  • 11.34. TILT-123: TILT Biotherapeutics
    • 11.34.1. Product Description
    • 11.34.2. Other Developmental Activities
    • 11.34.3. Clinical Development
      • 11.34.3.1. Clinical Trial Information
    • 11.34.4. Safety and Efficacy

12. IL-2: 7MM analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook
  • 12.3. Conjoint Analysis
  • 12.4. Key Market Forecast Assumptions
  • 12.5. Market Size of IL-2 in the 7MM
  • 12.6. United States Market Size
    • 12.6.1. Market size of IL-2 by Indications in the United States
    • 12.6.2. Market Size by Therapies in the United States
  • 12.7. EU4 and the UK Market Size
    • 12.7.1. Market size of IL-2 by Indications in EU4 and the UK
    • 12.7.2. Market Size by Therapies in EU4 and the UK
  • 12.8. Japan Market Size
    • 12.8.1. Market size of IL-2 by Indications in Japan
    • 12.8.2. Market Size by Therapies in Japan

13. Unmet Needs

14. SWOT Analysis

15. KOL Views

16. Market Access and Reimbursement

  • 16.1. United States
    • 16.1.1. Centre for Medicare and Medicaid Services (CMS)
  • 16.2. EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
    • 16.3.1. MHLW
  • 16.4. Market Access and Reimbursement of IL-2

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight