过去十年，CAR-T疗法在血液系统恶性肿瘤中取得突破，验证了工程化免疫细胞治疗的巨大潜力。但传统 ex vivo CAR-T仍依赖个体化制备，流程涵盖细胞采集、体外改造、扩增、质控、运输和回输等多个环节，导致治疗周期较长、制造成本和供应链复杂度较高。
in vivo CAR-T 的出现，为传统 CAR-T 的行业瓶颈提供了新的解题思路。作为细胞治疗、RNA 药物、递送技术和基因工程交汇下的重要创新方向，其通过病毒载体或脂质纳米颗粒等递送系统，在体内诱导免疫细胞表达 CAR，实现“体内工程化”细胞治疗，有望推动 CAR-T 从个体化定制走向更标准化的平台化模式。
在此背景下，弗若斯特沙利文联合 Cytiva 共同撰写并正式发布《In vivo CAR-T行业蓝皮书》（以下简称“《蓝皮书》”）。《蓝皮书》系统梳理了 in vivo CAR-T 行业的发展背景、技术路径、临床转化、产业化挑战及未来趋势，旨在为产业界、学术界、投资机构及临床领域提供更加系统的行业观察与研究参考。
Over the past decade, CAR-T therapy has achieved remarkable breakthroughs in hematological malignancies, validating the transformative potential of engineered immune cell therapies. However, conventional ex vivo CAR-T therapies still rely on individualized manufacturing processes, which involve multiple steps including cell collection, ex vivo genetic modification, cell expansion, quality control, transportation, and reinfusion. This complex workflow results in prolonged treatment timelines, high manufacturing costs, and significant supply chain challenges.
The emergence of in vivo CAR-T has introduced a promising new approach to addressing the limitations of conventional CAR-T therapies. As an important innovation at the intersection of cell therapy, RNA therapeutics, delivery technologies, and genetic engineering, in vivo CAR-T utilizes delivery systems such as viral vectors and lipid nanoparticles (LNPs) to induce immune cells to express chimeric antigen receptors (CARs) directly within the body, enabling “in vivo engineering” of therapeutic cells. This approach has the potential to transform CAR-T therapy from a highly individualized treatment paradigm into a more standardized and scalable platform-based model.
Against this backdrop, Frost & Sullivan (hereinafter referred to as “F&S”), in collaboration with Cytiva, has jointly prepared and officially released the In Vivo CAR-T Industry Blue Book (hereinafter referred to as the “Blue Book”). The Blue Book provides a comprehensive review of the industry's development background, technological approaches, clinical translation progress, industrialization challenges, and future trends. It aims to offer industry participants, academic researchers, investors, and clinical professionals a systematic perspective and reference.
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沙利文 毛先生
E-mail: fred.mao@frostchina.com
