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1691634

自然殺手(NK)細胞療法的全球市場:臨床試驗,專利技術,共同研究,市場機會(2025年)

Global Natural Killer (NK) Cell Therapy Clinical Trials, Proprietary Technologies, Collaborations & Market Opportunity Insight 2025

出版日期: | 出版商: KuicK Research | 英文 320 Pages | 商品交期: 最快1-2個工作天內

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近年來,細胞療法取得了巨大進步,改變了多種疾病的治療方法。其中,NK(自然殺手)細胞療法因其潛力而引起了人們的極大興趣。最初,它主要用於癌症治療,但現在也應用於自體免疫疾病等其他疾病。 NK 細胞在免疫系統對抗腫瘤和感染中發揮關鍵作用,研究人員正在努力增強其瞄準和摧毀有害細胞的自然能力。儘管該領域仍在發展中,許多治療方法處於臨床試驗的早期階段,但在創新研發和不斷增加的研究資金的支持下,NK 細胞療法的迅速興起標誌著醫療保健領域的重大轉變。

NK 細胞療法最顯著的發展之一是人們對同種異體 NK 細胞的興趣日益濃厚。同種異體 NK 細胞可直接使用,源自於健康捐贈者,為大規模治療提供可擴展的解決方案。這些治療方法正在針對自體免疫疾病和癌症進行研究,反映出它們的應用範圍正在擴大。例如,Nkarta 等公司正在推進針對重症肌無力(一種慢性自體免疫疾病)等疾病的同種異體 NK 細胞療法,這表明 NK 細胞療法有可能重塑癌症和自體免疫疾病的免疫療法模式。同樣,SMT Bio 的 SMT-NK 正在膽道癌領域進行評估。該療法將帕博利珠單抗等免疫檢查點抑制劑與NK細胞結合,以提高療效,標誌著基於NK細胞的聯合療法取得了重要進展。

NK 細胞療法的快速發展得到了私人投資者和政府機構的大力資金支持。例如,2024年末,Indapta Therapeutics獲得2,250萬美元資金,用於支持用於治療癌症和自體免疫疾病的同種異體NK細胞療法IDP-023的臨床開發。這筆資金對於從正在進行的試驗中產生數據以及進一步探索 NK 細胞療法的潛力至關重要。同樣,香港城市大學也獲得了政府資助,用於開發CAR-NK細胞,以治療一種罕見的兒科疾病——自體免疫性青少年皮肌炎。這些資金凸顯了人們對 NK 細胞療法日益增長的興趣和投資,該療法不僅用於治療癌症,還用於治療一系列其他免疫介導疾病。

總之,NK 細胞治療市場即將迎來一段顯著增長期,大量投資和技術進步將推動其進步。對同種異體 NK 細胞及其治療癌症和自體免疫疾病的潛力的關注代表著免疫療法的一個有希望的轉變。策略合作、尖端技術和持續的資金流入可能會加速 NK 細胞療法的發展,這可能會改變各種疾病的治療模式。隨著臨床數據的出現,NK 細胞治療市場預計將在未來的精準醫療中發揮關鍵作用,為傳統療法難以治療的疾病提供新穎、直接的解決方案。

本報告提供全球自然殺手(NK)細胞療法市場相關調查,提供市場概要,以及藥物趨勢,臨床試驗趨勢,各地區趨勢,及加入此市場的主要企業競爭情形等資訊。

目錄

第1章 自然殺手(NK)細胞療法的簡介

第2章 NK細胞療法的作用機制

  • NK細胞的細胞傷害作用
  • NK細胞療法的工作
  • NK細胞療法的方法

第3章 NK細胞療法的治療策略

  • NK細胞療法單獨療法
  • 複式混合劑的NK細胞療法

第4章 自然殺手(NK)細胞療法的研究開發趨勢(各適應症)

  • 癌症
    • 血液癌症
    • 固體癌
  • 自體免疫疾病及發炎性疾病
  • 微生物感染疾病
  • 神經退化性疾病

第5章 NK細胞療法的特徵強化方法

  • 奈米技術的利用
  • CAR的改造
  • CRISPR/Cas9遺傳基因編輯的使用

第6章 世界自然殺手細胞療法臨床試驗概要

  • 各國
  • 各適應症
  • 患者各市場區隔
  • 各期
  • 優先級

第7章 企業,適應症,各期的世界自然殺手細胞療法臨床試驗

  • 研究
  • 前臨床
  • 第0相
  • 第一階段
  • 第一/二階段
  • 第二階段
  • 第二/三階段

第8章 NK細胞療法獨自的方法和技術的洞察

  • 概要
  • 企業獨自的技術

第9章 NK細胞療法的夥伴關係與資金籌措

  • 最近的夥伴關係,合作,授權契約
  • 各企業資金籌措交易

第10章 FDA 指定的研究性 NK 細胞療法

  • FDA簡審類
  • FDA罕見疾病用醫藥品指定
  • 再生醫療尖端醫療指定

第11章 NK細胞療法的市場趨勢和臨床試驗預測

  • 目前市場趨勢,開發,臨床試驗的評估
  • 未來的商業化的機會

第12章 競爭情形

  • Acepodia
  • Beijing JD Biotech
  • Cartherics
  • Catamaran Bio
  • Century Therapeutics
  • City of Hope National Medical Center
  • CRISPR Therapeutics
  • CytoImmune Therapeutics
  • Cytovia Therapeutics
  • Dragonfly Therapeutics
  • Editas Medicine
  • Fate Therapeutics
  • Gamida-Cell
  • GC Biopharma/GC Lab Cell
  • GICELL
  • Glycostem
  • HK inno.N
  • ImmunityBio
  • Karolinska Institute
  • Kiadis Pharma
  • Nkarta Therapeutics
  • NKGen Biotech
  • ONK Therapeutics
  • Sanofi
  • Senti Biosciences
  • Shoreline Biosciences
  • Sian Wuhan Medical Technology
  • Smart Immune
  • Sorrento Therapeutics
  • Therabest Korea
  • University of Texas M. D. Anderson Cancer Center
  • XNK Therapeutics
  • Zelluna Immunotherapy

Global Natural Killer (NK) Cell Therapy Clinical Trials, Proprietary Technologies, Collaborations & Market Opportunity Insight 2025 Report Highlights & Findings:

  • Global & Regional Market Trends By Indication
  • First NK Cell Therapy Approval Expected By 2028
  • Number Of NK Cell Therapies In Clinical Trials: >180 Therapies
  • Highest Phase For NK Cell Therapies Clinical Trials: Phase II/III
  • NK Cell Therapies Granted Fast Track & Orphan Status: > 5 Therapies
  • Global Natural Killer Cell Therapies Clinical Trials By Company

Indication & Phase

  • Insight On Recent Partnerships, Collaborations & Licensing Agreements
  • NK Cell Therapies Proprietary Technologies By Company
  • Monotherapy & Combinational Treatment Strategies

This Report Exclusively Examines Therapeutic Strategies That Employ Natural Killer (NK) Cells, Excluding Any Methods That Incorporate Antibody Engagers Intended To Bind To & Activate NK Cells.

Cell therapies have made significant progress in recent years, transforming treatment methods for a variety of diseases. Among these, NK (natural killer) cell therapies have gained considerable interest due to their potential. While they initially focused on cancer treatment, these therapies are now branching out to tackle non-cancerous conditions such as autoimmune diseases. NK cells play vital role in the immune system's fight against tumors and infections, and researchers are working to enhance their natural ability to target and destroy harmful cells. Although this field is still developing, with many therapies in early stages of clinical trials, the rapid enhancement of NK cell therapies, bolstered by innovative research and increasing funding, suggests a significant change in healthcare.

One of the most notable developments in NK cell therapies is the growing interest in allogeneic NK cells, which are derived from healthy donors and can be used off-the-shelf, offering a scalable solution for mass treatment. These therapies are being explored not only in cancer but also in autoimmune conditions, reflecting a broadening of their application. For example, companies like Nkarta are advancing allogeneic NK cell therapies for conditions such as myasthenia gravis, a chronic autoimmune disease, showing how NK cell therapy could potentially reshape the landscape of immunotherapy for both cancer and autoimmune disorders. Similarly, several companies are targeting specific cancers with engineered NK cells, such as SMT Bio's SMT-NK, which is being evaluated for biliary tract cancer. This therapy combines NK cells with immune checkpoint inhibitors like pembrolizumab to improve efficacy, marking a significant step forward in NK cell-based combination therapies.

The rapid advancement of NK cell therapies is being supported by robust funding from both private investors and government agencies. For instance, in late 2024, Indapta Therapeutics secured US$ 22.5 million in financing to support the clinical development of its allogeneic NK cell therapy, IDP-023, for cancer and autoimmune diseases. This influx of capital is crucial for generating data in ongoing trials, allowing for further exploration of NK cell therapy's potential. Similarly, the City University of Hong Kong received a government grant to develop CAR-NK cells for treating autoimmune juvenile dermatomyositis, a rare pediatric disease. This funding highlights the increasing interest and investment in NK cell therapies not just for cancer but also for a range of other immune-mediated conditions.

At the same time, collaborations between biotechnology firms and pharmaceutical giants are helping to drive clinical development. For example, Indapta Therapeutics partnered with Sanofi to explore the combination of IDP-023 with Sarclisa (isatuximab) for multiple myeloma. This collaboration underscores the importance of integrating NK cell therapies with other established treatments to enhance their effectiveness. By combining NK cells with existing monoclonal antibodies or chemotherapy regimens, these treatments could overcome some of the limitations seen with monotherapies. Additionally, innovative technologies such as nanomaterials and gene editing are being incorporated into NK cell therapy to enhance targeting precision and improve clinical outcomes. Nanoparticles are being used to stabilize NK cells and boost their ability to reach and eliminate tumor cells, offering an exciting new approach to improving the performance of these therapies.

To conclude, the NK cell therapy market is entering a period of significant growth, with substantial investments and technological advancements driving progress. The focus on allogeneic NK cells and their potential for treating both cancer and autoimmune diseases represents a promising shift in immunotherapy. Strategic collaborations, cutting-edge technologies, and the continued influx of funding will likely accelerate the development of NK cell therapies, transforming the treatment paradigm for a wide array of diseases. As clinical data continues to emerge, the NK cell therapy market is poised to play a pivotal role in the future of precision medicine, offering novel, off-the-shelf solutions for conditions that have historically been difficult to treat with conventional therapies.

Table of Contents

1. Introduction to Natural Killer (NK) Cell Therapy

2. Mechanism Of Action of NK Cell Therapy

  • 2.1 Cytotoxic Action Of NK Cells
  • 2.2 Working Of NK Cell Therapy
  • 2.3 NK Cell Therapies Approaches
    • 2.3.1 CAR NK Cell Therapies
    • 2.3.2 TCR NK Cell Therapies

3. Treatment Strategies For NK Cell Therapies

  • 3.1 NK Cell Therapy As Monotherapy
  • 3.2 NK Cell Therapy As Combinatorial Agent

4. Natural Killer (NK) Cell Therapy Research & Development Trends By Indication

  • 4.1 Cancer
    • 4.1.1 Hematological Cancers
    • 4.1.2 Solid Cancers
  • 4.2 Autoimmune & Inflammatory Disorders
  • 4.3 Microbial Infections
  • 4.4 Neurodegenerative Diseases

5. NK Cell Therapy Characteristics Enhancement Approaches

  • 5.1 Use Of Nanotechnology
  • 5.2 Modifications In CARs
  • 5.3 Use Of CRISPR/Cas9 Gene Editing

6. Global Natural Killer Cell Therapies Clinical Trials Overview

  • 6.1 By Country
  • 6.2 By Indication
  • 6.3 By Patient Segment
  • 6.4 By Phase
  • 6.5 By Priority Status

7. Global Natural Killer Cell Therapies Clinical Trials By Company, Indication & Phase

  • 7.1 Research
  • 7.2 Preclinical
  • 7.3 Phase-0
  • 7.4 Phase-I
  • 7.5 Phase-I/II
  • 7.6 Phase-II
  • 7.7 Phase-II/III

8. NK Cell Based Therapy Proprietary Approaches & Technologies Insight

  • 8.1 Overview
  • 8.2 Proprietary Technologies By Company

9. Partnerships & Funding for NK Cell Therapies

  • 9.1 Recent Partnerships, Collaborations & Licensing Agreements
  • 9.2 Funding Deals By Companies

10. Investigational NK Cell Therapies With FDA Designations

  • 10.1 FDA Fast Track Designation
  • 10.2 FDA Orphan Drug Designation
  • 10.3 Regenerative Medicine Advanced Therapy Designation

11. NK Cell Therapies Market Trends & Clinical Trials Outlook

  • 11.1 Current Market Trends, Developments & Clinical Trials Assessment
  • 11.2 Future Commercialization Opportunity

12. Competitive Landscape

  • 12.1 Acepodia
  • 12.2 Beijing JD Biotech
  • 12.3 Cartherics
  • 12.4 Catamaran Bio
  • 12.5 Century Therapeutics
  • 12.6 City of Hope National Medical Center
  • 12.7 CRISPR Therapeutics
  • 12.8 CytoImmune Therapeutics
  • 12.9 Cytovia Therapeutics
  • 12.10 Dragonfly Therapeutics
  • 12.11 Editas Medicine
  • 12.12 Fate Therapeutics
  • 12.13 Gamida-Cell
  • 12.14 GC Biopharma/GC Lab Cell
  • 12.15 GICELL
  • 12.16 Glycostem
  • 12.17 HK inno.N
  • 12.18 ImmunityBio
  • 12.19 Karolinska Institute
  • 12.20 Kiadis Pharma
  • 12.21 Nkarta Therapeutics
  • 12.22 NKGen Biotech
  • 12.23 ONK Therapeutics
  • 12.24 Sanofi
  • 12.25 Senti Biosciences
  • 12.26 Shoreline Biosciences
  • 12.27 Sian Wuhan Medical Technology
  • 12.28 Smart Immune
  • 12.29 Sorrento Therapeutics
  • 12.30 Therabest Korea
  • 12.31 University of Texas M. D. Anderson Cancer Center
  • 12.32 XNK Therapeutics
  • 12.33 Zelluna Immunotherapy

List of Figures

  • Figure 1-1: NK Cells - Identification & Discovery Timeline
  • Figure 1-2: NK Cell Subsets - CD56low/dim v/s CD56bright
  • Figure 2-1: Cytotoxic Action Of NK Cells
  • Figure 2-2: CAR-NK Cells Preparation
  • Figure 2-3: Delivery Of CAR Gene Into NK Cell
  • Figure 2-4: NK Cells Sources For Therapy
  • Figure 2-5: Structure Of CAR/TCR-NK Cell
  • Figure 4-1: PRAME-TCR-NK Cells Therapy Phase 1/2 (NCT06383572) Study - Initiation & Completion Year
  • Figure 4-2: GCC2005A-P101 Phase 1 (NCT06699771) Study - Initiation & Completion Year
  • Figure 4-3: QUILT-106 Phase 1 (NCT06334991) Study - Initiation & Completion Year
  • Figure 4-4: TAK-007-2001 Phase 2 (NCT05020015) Study - Initiation & Completion Year
  • Figure 4-5: Indapta-Trial-1 Phase 1/2 (NCT06119685) Study - Initiation & Completion Year
  • Figure 4-6: PRAMETIME-Mel Phase 1 (NCT06660420) Study - Initiation & Completion Year
  • Figure 4-7: Ntrust-1 Phase 1 (NCT06557265) Study - Initiation & Completion Year
  • Figure 4-8: Ntrust-2 Phase 1 (NCT06733935) Study - Initiation & Completion Year
  • Figure 4-9: IDP023-2-101 Phase 1 (NCT06677710) Study - Initiation & Completion Year
  • Figure 4-10: CALiPSO-1 Phase 1 (NCT06255028) Study - Initiation & Completion Year
  • Figure 5-1: Improvements In NK Cell Therapy Using Nanotechnology
  • Figure 5-2: Basic Structure Of CARs On NK Cell
  • Figure 5-3: Gene Editing Tools
  • Figure 6-1: Global - NK Cell Therapies Clinical Trials By Country, 2025
  • Figure 6-2: Global - NK Cell Therapies Clinical Trials By Indication, 2025
  • Figure 6-3: Global - NK Cell Therapies Clinical Trials By Patient Segment, 2025
  • Figure 6-4: Global - NK Cell Therapies Clinical Trials By Phase, 2025
  • Figure 6-5: Global - NK Cell Therapies Clinical Trials By Priority Status, 2025
  • Figure 8-1: Artiva Biotherapeutics - Proprietary CAR-NK Cell Platform
  • Figure 8-2: Artiva Biotherapeutics - Proprietary AlloNKTM NK Cell Therapy Scaling Platform
  • Figure 8-3: Catamaran Bio - Proprietary Tailwind(R) Platform
  • Figure 8-4: Cellularity - CYNK-CARs
  • Figure 8-5: GAIA BioMedicine - Proprietary NK Cell Therapy Working Mechanism
  • Figure 8-6: GAIA BioMedicine - Proprietary Technologies' Salient Features
  • Figure 8-7: Gamida Cell - NK Cell Therapy Manufacturing Process
  • Figure 8-8: HebeCell - Proprietary Scalable NK Cell Technology
  • Figure 8-9: ImmunityBio - Proprietary haNK(R) Cell Structure
  • Figure 8-10: Nkarta - Proprietary CAR-NK Cell Structure
  • Figure 8-11: Nkarta - Proprietary NK Cell Therapy Platform
  • Figure 8-12: Senti Biosciences - Gene Circuit Technology Platform
  • Figure 8-13: Senti Biosciences - Gene Circuit Technology Platform Applicability
  • Figure 8-14: Wugen - Proprietary Memory NK Cell Platform

List of Tables

  • Table 10-1: Investigational NK Cell Therapies With Fast Track Designation
  • Table 10-2: Investigational NK Cell Therapies With Orphan Drug Designation
  • Table 10-3: Investigational NK Cell Therapies With Regenerative Medicine Advanced Therapy Designation