인터류킨-2 - 시장 규모, 표적 집단, 경쟁 구도, 시장 예측(2034년)
Interleukin-2-Market Size, Target Population, Competitive Landscape & Market Forecast - 2034
상품코드 : 1809424
리서치사 : DelveInsight
발행일 : On Demand Report
페이지 정보 : 영문 200 Pages
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한글목차

주요 하이라이트

인터류킨-2 시장 전망

면역반응에 중요한 사이토카인인 IL-2는 면역요법, 특히 암에서 오랫동안 최전선에 있었습니다. 신체의 면역계를 자극함으로써 IL-2는 T세포와 자연살해세포의 활성을 높여 신체의 암에 대한 저항을 돕습니다. 지난 30년간 IL-2 기반 치료는 선구적인 치료에서 보다 광범위한 암과 면역 관련 질환을 대상으로 하는 혁신적인 면역요법으로 발전해 왔습니다. 연구가 진행됨에 따라 IL-2는 암뿐만 아니라 자가면역 질환 및 기타 치료 영역에서도 치료 영역을 확대될 전망입니다. IL-2를 기반으로 하는 새로운 치료법과 IL-2를 표적으로 하는 치료제의 승인과 개발 증가는 IL-2가 현대의 면역요법에 혁명을 가져올 가능성을 보여줍니다.

암 치료에서 IL-2의 이야기는 면역 콜로지가 크게 진보한 1990년대 초반에 시작되었습니다. IL-2의 면역계, 특히 T 세포와 NK 세포를 활성화시키는 능력은 혁신적인 면역요법 도구로 채택된 계기가 되었습니다. 최초로 승인된 IL-2 제제인 PROLEUKIN(유전자 재조합 인간 IL-2 또는 Aldesleukin)은 1992년 5월에 전이성 RCC의 치료제로서 미국 FDA의 승인을 취득했고, 이 진행성 암에 대한 새로운 치료법을 제공하는 최초의 면역요법이 되었습니다. PROLEUKIN은 종양 세포에 대한 신체의 면역 방어 기능을 활용한 암 치료에 새로운 작용기전을 제공하는 획기적인 약제로 주목받았습니다.

본 보고서에서는 인터류킨-2의 주요 7개 시장(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)에 대해 조사 분석하여 각 지역 시장 규모, 현재의 치료법, 암메트니즈, 신약 등의 정보를 제공합니다.

목차

제1장 중요한 지견

제2장 보고서 서론

제3장 주요 요약

제4장 주요 사건

제5장 역학과 시장 예측 조사 방법

제6장 주요 7시장의 IL-2시장 개요 : 적응증별

제7장 주요 7시장의 IL-2시장 개요 : 치료법별

제8장 질병의 배경과 개요

제9장 역학과 환자 인구

제10장 가미시 끝난 약품

제11장 신약

제12장 IL-2 : 주요 7개 시장 분석

제13장 미충족 수요(Unmet Needs)

제14장 SWOT 분석

제15장 KOL의 견해

제16장 시장 진입과 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 정보

KTH
영문 목차

영문목차

Key Highlights:

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:

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.

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).

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:

Interleukin-2 Report Insights

Interleukin-2 Report Insights

Interleukin-2 Report Key Strengths

Interleukin-2 Report Assessment

FAQs:

Reasons to buy:

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

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

13. Unmet Needs

14. SWOT Analysis

15. KOL Views

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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