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市场调查报告书
商品编码
1916358
病患来源异种移植模型市场分析及预测(至2035年):依类型、产品类型、小鼠模型、服务、应用、最终使用者及技术划分Patient-Derived Xenograft Model Market Analysis and Forecast to 2035: Type, Product, Mice Models, Services, Application, End User, Technology |
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预计到2035年,患者来源异种移植模型(PDX)市场规模将从2025年的3.637亿美元成长至11.219亿美元,复合年增长率约为12.1%。肿瘤研发需求的不断成长主要源自于製药和生技公司对预测性临床前模型的强劲需求。各公司正在寻求多样化的PDX模型(固态肿瘤、血液肿瘤和儿童肿瘤),以进行转化研究和治疗评估。例如,Charles River提供超过1700种PDX模型,涵盖45种以上的癌症适应症,以支持多种肿瘤类型的药物疗效测试。
特殊模型供应-PDX模型供应有限,尤其是低代次肿瘤、罕见癌症类型和人源化平台。供体组织来源和移植成功率的挑战限制了产能。例如,Crown Bioscience的HSC-PDX和Hera Biolabs的MiXeno™ PBMC人源化模型需求量大,但供应有限。
法规遵从性和数据可靠性-市场对能够维持高遗传和组织学保真度、提供可重复结果并符合监管标准的PDX模型有着强烈的需求。具备这些特性的模式是IND申报和转化研究的首选。例如,Oncodesign和Charles River提供特征明确的PDX模型,确保其临床相关性和法规遵循。
| 市场区隔 | |
|---|---|
| 类型 | 胃肠道肿瘤、妇科肿瘤、呼吸系统肿瘤、中枢神经系统肿瘤、骨髓恶性肿瘤、皮肤肿瘤和其他固态肿瘤 |
| 产品 | 小鼠模型、大鼠模型 |
| 服务 | 模型创建与扩展、模型表征、冷冻保存及其他服务 |
| 科技 | 异位(皮下)移植,原位移植 |
| 应用 | 临床前研究、生物标记分析、转化研究、生物银行 |
| 最终用户 | 製药和生物技术公司、合约研究组织 (CRO) 和合约开发生产组织 (CDMO)、学术和研究机构 |
| 小鼠模型 | 裸鼠(无胸腺小鼠)、NOD/SCID小鼠、NSG小鼠、人源化小鼠 |
技术进步和自动化——例如人工智慧、成像技术和基于类器官的体外检测方法的引入——正在提高PDX研究的预测准确性和效率。例如,查尔斯河实验室的人工智慧驱动的虚拟控制和3D类器官PDX平台可以加速临床前试验,并减少对动物模型的依赖。
细分市场概览
根据肿瘤类型,患者来源的异种移植(PDX)模型市场分为消化器官系统肿瘤、呼吸系统肿瘤、妇科肿瘤、骨髓恶性肿瘤、中枢神经系统肿瘤、皮肤肿瘤和其他固态肿瘤。
由于肺癌在全球造成的巨大负担,呼吸肿瘤学领域是成长最快的领域之一。预计到 2022 年,肺癌新增病例将达到约 248 万例,使其成为全球最常见的癌症,也是癌症死亡的主要原因。
这种高发病率推动了非小细胞肺癌 (NSCLC) 研究领域对 PDX 模型的强劲需求,以探索驱动突变和抗药性机制。例如,2024 年,伦敦大学学院 (UCL) 的研究人员透过 CancerTools.org 註册了 44 个 NSCLC TRACERx PDX 模型,从而能够研究肿瘤演变、异质性、免疫逃脱和抗药性,满足了肺癌转化研究领域对 PDX 模型日益增长的需求。
胃肠肿瘤学也是 PDX 应用的主要推动因素,2022 年结直肠癌在全球排名第三(约 193 万新病例),胰腺癌记录了约 510,992 例新病例,这两种疾病都存在显着的未满足临床需求,而 PDX 平台比传统模型更能保留肿瘤异质性,因此将使这两种疾病受益。
胃肠肿瘤领域的发展得益于临床相关PDX模型的日益普及,这些模型能够进行高保真度的临床前研究。其中的关键进展包括Champion Oncology的胃癌PDX模型(保留了患者肿瘤的生物学特性)以及Crown Bioscience的庞大胃肠道PDX模型库(涵盖结直肠癌和胃癌)。
此外,查尔斯河实验室在2019年新增了79种消化器官系统PDX模型,杰克逊实验室也拥有经临床检验的消化器官系统产品组合,这些都为药物筛检和生物标记研究提供了强大的平台。这些资源正在加速转化研究,支持精准肿瘤学研发管线,并推动该领域的强劲成长。
由于迫切需要能够重现人类白血病、淋巴瘤和多发性骨髓瘤生物学特征的模型,骨髓恶性肿瘤正在推动PDX市场的成长。诸如Crown Bioscience的急性骨髓性白血病(AML)模型库(2017年)以及华盛顿大学PDX开发与测试中心(2025年,Siteman癌症中心)庞大的血液学PDX模型库等PDX平台,能够支持临床前药物测试、抗药性机制研究和个人化治疗评估。
地理概览
由于癌症负担呈指数级增长,以及由此产生的对可预测的、与患者相关的临床前模型的需求,北美患者来源异种移植(PDX)模型市场正在扩张。预计到2024年,美国将报告约2,001,140例新增癌症病例和611,720例癌症死亡病例,反映出人口老化、诊断覆盖率提高和筛检率上升所导致的创纪录的高发病率。所有这些都推动了对更生物学精确性的癌症研究模型的需求。
美国在北美PDX模型市场占据最大份额,这得益于其庞大的生物製药研发生态系统、专业的受託研究机构(CRO)以及在肿瘤领域雄厚的研发投入。根据美国科学与工程统计中心(NCSES)的数据显示,美国企业在2023年将投入约7,220亿美元用于研发,其中430亿美元(6%)将用于基础研究,1,100亿美元(15%)将用于应用研究,显示美国持续重视研发投入,以支持对PDX模型等转换平台的需求。
预计亚太地区将在预测期内成为成长最快的地区。由于癌症负担沉重以及肿瘤学研究的不断深入,该地区的患者来源异种移植(PDX)模型市场正在快速成长。根据辉瑞公司统计,亚洲主要国家约有360万男性和400万女性罹患癌症,其中光是中国就有160万男性和150万女性。中国已建立了用于胃肠道癌、肺癌、肝癌和食道癌的大规模PDX模型库,能够精确地保留肿瘤组织学特征和药物反应性。
在日本,J-PDX图书馆、福岛医科大学和金泽大学等高校正在利用乳癌、白血病、胰臟癌和儿童急性淋巴性白血病(ALL)的PDX模型来支持个人化医疗和药物试验。印度正在崛起为PDX研究中心,其中ACTREC正在开发三阴性乳癌(TNBC)和荷尔蒙受体阳性乳癌的模型,TheraIndx提供PDX/CDX模型,而Altogen Labs计划于2024年8月检验10种肺癌异种移植模型。
在澳大利亚,儿童癌症研究所、MURAL、新南威尔斯大学雪梨分校、WEHI 和彼得·麦卡勒姆癌症中心正在使用前列腺癌、乳癌、大肠直肠癌和儿童癌症的PDX模型。在韩国,CHA盆唐医疗中心和延世大学Severance医院正在引入卵巢、胃癌和胆道癌的PDX模型。
在新加坡,国家癌症研究中心(NCCS)、新加坡科技研究局(A*STAR)分子与细胞生物学研究所(IMCB)以及新加坡国立大学(NUS)正在利用这些模型进行肝癌和胆道癌研究。印尼正在开发用于乳癌和其他固态肿瘤的PDX模型,以支持转化研究。在全部区域,这些努力反映了癌症发生率的上升以及与患者相关的临床前模型的应用,从而推动了对PDX模型的强劲需求。
主要趋势和驱动因素
“PDX模型外包给CRO的增加正在加速市场扩张”
将临床前肿瘤研究外包给受託研究机构(CRO) 的做法正在推动市场成长。随着製药和生技公司不断拓展其研发管线,它们本身的研发能力已接近极限,因此越来越倾向于寻求拥有专业PDX(患者来源异种移植)能力的合作伙伴。
透过外包给合约研究组织 (CRO),申办方可以获得许多内部实验室所缺乏的专业知识、基础设施和可扩展的动物饲养资源,同时降低成本并缩短转化研究週期。例如,InnoSer 的肿瘤 CRO 服务提供全面的 PDX 小鼠模型,用于评估治疗效果,使申办者能够在体内重现肿瘤异质性和治疗反应。
同样,LIDE Biotech 拥有全球最大的 PDX 生物库之一,拥有超过 1900 个模型,涵盖近 50 种癌症类型,为外部合作伙伴提供了一套多样化的、特征明确的异种移植模型,用于药物筛检和转化研究。
策略联盟也推动了这种外包趋势。例如,2025年10月,Xenostart和Minerva Imaging扩大了双方为期10年的合作,推出了一个完全整合的PDX放射性药物开发平台。该平台结合了Xenostart的临床註释PDX库和Minerva的分子影像和放射性核素治疗专业知识以及CDMO能力,从而简化了从药物发现到临床应用的整个流程。
随着复杂的临床前试验成为肿瘤赞助商的标准外包策略,专门从事 PDX 模型的 CRO 正在经历高于市场平均水平的增长,巩固了其在中国、新加坡和印度等地的区域领导地位,并推动了全球 PDX 模型市场需求的成长。
癌症负担日益加重和筛检的进步
推动全球患者来源异种移植(PDX)模型市场发展的关键趋势是全球癌症发病率的上升和早期检测技术的进步,这促使人们对具有生物学相关性的临床前模型的需求不断增长。根据世界卫生组织(WHO)预测,全球癌症病例数预计将从2022年的2,000万例增加到2050年的3,500万例,增幅达77%。
同样,印度的癌症病例自1990年以来翻了一番,预计2025年将新增157万例,2023年将有超过82万人死亡。这主要是由于吸烟、饮酒、肥胖、缺乏运动和环境污染等因素造成的。这些地区最常见的癌症包括乳癌、肺癌、大肠癌、口腔癌和肾臟癌。此外,据预测,美国2025年将新增2041910例癌症病例,并有618120人死亡(NIH,2025),凸显了对预测性临床前模型的持续需求。
随着癌症负担的加重,早期检测技术也取得了长足进步,包括用于肺癌的低剂量CT扫描、数位乳房断层合成(3D乳房X光摄影)以及分析循环肿瘤DNA(ctDNA)和微量残存疾病(MRD)的微创液态生物检体。这些技术使得在更早期、更多样化的阶段识别肿瘤成为可能,从而扩大了可用于转化研究的肿瘤范围。
在亚太地区和中东及非洲等地区,PDX平台的应用正在加速,以将临床前研究成果转化为精准癌症治疗方案。诸如ARPA-H斥资2500万美元开展的居家癌症筛检计画等公共倡议正在推动这一趋势,并刺激了对异质骨移植的需求,以评估亚型特异性治疗方法。随着癌症的可检测性增强、多样性增加以及临床复杂性提高,PDX模型作为现代精准癌症治疗研发的重要工具,其应用日益广泛。
Patient-Derived Xenograft Model Market is anticipated to expand from $363.7 million in 2025 to $1,121.9 million by 2035, growing at a CAGR of approximately 12.1%. Rising Oncology Research & Drug Development Needs - High demand from pharmaceutical and biotech companies for predictive preclinical models drives growth. Companies seek diverse PDX models (solid tumors, hematologic cancers, pediatric cancers) for translational studies and therapy evaluation. For instance, Charles River offers 1,700+ PDX models covering 45+ cancer indications, supporting drug efficacy testing across multiple tumor types.
Availability of Specialized Models - The supply of PDX models is limited, particularly for low-passage tumors, rare cancer types, and humanized platforms. Challenges in sourcing donor tissue and successful engraftment restrict production capacity. For example, Crown Bioscience's HSC-PDX and Hera BioLabs' MiXeno(TM) PBMC-humanized models represent high-demand specialized models with limited availability.
Regulatory Compliance and Data Reliability - There is strong demand for PDX models that maintain high genetic and histological fidelity, provide reproducible results, and meet regulatory standards. Models with these attributes are preferred for IND-enabling studies and translational research. For instance, Oncodesign and Charles River offer fully characterized PDX models that ensure clinical relevance and regulatory compliance.
| Market Segmentation | |
|---|---|
| Type | Gastro-Intestinal Tumors, Gynecological Tumors, Respiratory Tumors, Central Nervous System Tumors, Hematological Malignancies, Dermatological Tumors, Other Solid Tumors |
| Product | Mice Models, Rat Models |
| Services | Model Creation & Expansion, Model Characterization, Cryopreservation, Other Services |
| Technology | Heterotopic (Subcutaneous) Implantation, Orthotopic Implantation |
| Application | Preclinical Research, Biomarker Analysis, Translational Research, Biobanking |
| End User | Pharma & Biotechnology Companies, CROs & CDMOs, Academics & Research Institutes |
| Mice Models | Nude (Athymic), NOD/SCID, NSG, Humanized Mice |
Technological Advancements and Automation - Adoption of AI, imaging technologies, and organoid-based in vitro assays is enhancing the predictive power and efficiency of PDX studies. For example, Charles River's AI-enabled virtual control groups and 3D organoid PDX platforms accelerate preclinical testing and reduce reliance on animal models.
Segment Overview
Based on tumor type, the patient-derived xenograft (PDX) model market is divided into Gastro-Intestinal Tumors, Respiratory Tumors, Gynecological Tumors, Hematological Malignancies, Central Nervous System Tumors, Dermatological Tumors, and Other Solid Tumors.
The respiratory tumor segment is one of the fastest-growing due to lung cancer's high global burden lung cancer was the most frequently diagnosed cancer worldwide in 2022 with about 2.48 million new cases and also the leading cause of cancer death.
This high incidence drives strong demand for PDX models in NSCLC research to study driver mutations and resistance mechanisms. For example, in 2024, UCL researchers deposited 44 NSCLC TRACERx PDX models via CancerTools.org, enabling studies on tumor evolution, heterogeneity, immune escape, and drug resistance, supporting the rising demand for translational PDX models in lung cancer.
The gastro-intestinal tumor segment also strongly contributes to PDX adoption, as colorectal cancer ranked third globally with approximately 1.93 million new cases in 2022 and pancreatic cancer had around 510,992 new cases, both representing substantial unmet clinical needs that benefit from PDX platforms that better preserve tumor heterogeneity than traditional models.
The Gastro-Intestinal tumor segment is driven by the growing availability of clinically relevant PDX models that enable high-fidelity preclinical testing. Key developments include Champions Oncology's gastric cancer PDXs, which preserve patient tumor biology, and Crown Bioscience's extensive GI PDX library, covering colorectal and gastric cancers.
Additionally, Charles River Laboratories' 2019 expansion of 79 GI PDX models and The Jackson Laboratory's clinically validated GI portfolio provide robust platforms for drug screening and biomarker research. These resources accelerate translational research, support precision oncology pipelines, and reinforce strong segment growth.
The hematological malignancies segment is driving PDX market growth due to the critical need for models that replicate human leukemia, lymphoma, and multiple myeloma biology. PDX platforms, such as the AML panels by Crown Bioscience (2017) and the extensive hematologic PDX collection at the Washington University PDX Development and Trial Center (2025, Siteman Cancer Center), enable preclinical drug testing, mechanism-of-resistance studies, and personalized therapy evaluation.
Geographical Overview
The North American patient-derived xenograft (PDX) model market is expanding due to the rapidly rising cancer burden and the corresponding demand for predictive, patient-relevant preclinical models. In 2024, the United States is projected to report approximately 2,001,140 new cancer cases and 611,720 cancer deaths, reflecting a record-high incidence driven by population aging, improved diagnostic coverage, and increased screening uptake, all of which enhance the need for more biologically faithful oncology research models.
The United States accounts for the largest share of the North American PDX model market, supported by its extensive biopharmaceutical research ecosystem, specialized contract research organizations (CROs), and strong oncology-focused R&D investments. According to the National Center for Science and Engineering Statistics (NCSES), in 2023, U.S. companies invested approximately $722 billion in R&D, including $43 billion (6%) in basic research and $110 billion (15%) in applied research, underscoring the sustained funding priorities that reinforce demand for translational platforms such as PDX models.
Asia-Pacific is expected to be the fastest-growing region during the forecast period. The Asia-Pacific patient-derived xenograft (PDX) model market is rapidly growing due to the region's high cancer burden and expanding oncology research. According to Pfizer, there are about 3.6 million males and 4.0 million females living with cancer in major Asian countries, with China alone accounting for 1.6 million males and 1.5 million females. China has established large PDX libraries for gastrointestinal, lung, liver, and esophageal cancers, accurately preserving tumor histology and drug response.
Japan utilizes the J-PDX Library, Fukushima Medical University, and universities like Kanazawa for breast cancer, leukemia, pancreatic cancer, and pediatric ALL, supporting personalized medicine and drug testing. India is emerging as a hub for PDX studies, with ACTREC developing models for TNBC and hormone receptor-positive breast cancer, TheraIndx providing PDX/CDX models, and Altogen Labs validating 10 lung cancer xenograft models in August 2024.
Australia uses PDX models at Children's Cancer Institute, MURAL, UNSW Sydney, WEHI, and Peter MacCallum Cancer Centre for prostate, breast, colorectal, and pediatric cancers. South Korea employs PDX models at CHA Bundang Medical Center and Yonsei University Severance Hospital for ovarian, gastric, and biliary tract cancers.
Singapore leverages NCCS, A*STAR IMCB, and NUS for liver and biliary tract cancers. Indonesia is developing PDX models for breast and other solid tumors to support translational research. Across the region, these initiatives reflect rising cancer prevalence and adoption of patient-relevant preclinical models, driving strong PDX demand.
Key Trends and Drivers
"Rising Outsourcing of PDX Models to CROs Accelerates Market Expansion -
increasing outsourcing of oncology preclinical research to contract research organizations (CROs) drive the market growth. As pharma and biotech pipelines widening in-house capacities and shifting sponsors toward partners with specialized PDX capabilities.
Outsourcing to CROs allows sponsors to access expertise, infrastructure, and scalable vivarium resources that many internal labs lack, while reducing costs and accelerating translational timelines. For example, InnoSer's oncology CRO services offer comprehensive PDX mouse models for evaluating therapeutic efficacy, enabling sponsors to recapitulate tumor heterogeneity and treatment responses in vivo.
Similarly, LIDE Biotech maintains one of the world's largest PDX biobanks with over 1,900+ models covering nearly 50 cancer types, providing outsourced partners access to diverse, well-characterized xenografts for drug screening and translational studies.
Strategic collaborations further illustrate this outsourcing trend for instance, in October, 2025, XenoSTART and Minerva Imaging expanded their decade-long partnership to deliver a fully integrated PDX-radiopharmaceutical drug development platform, combining XenoSTART's clinically annotated PDX repository with Minerva's molecular imaging, radionuclide therapy expertise, and CDMO capabilities to streamline discovery through clinical translation.
As complex preclinical studies become the default outsourcing strategy for oncology sponsors, CROs specializing in PDX models are achieving above-market growth, reinforcing regional leadership in hubs such as China, Singapore, and India and driving incremental demand across the global PDX models market.
Increasing Cancer Burden and Advanced Screening -
A key trend driving the global patient-derived xenograft (PDX) models market is the rising global cancer incidence coupled with advances in early detection technologies, which is intensifying demand for biologically relevant preclinical models. According to the World Health Organization (WHO), global cancer cases are projected to reach 35 million by 2050, a 77% increase from 20 million cases in 2022.
Similarly, In India, cancer cases have doubled since 1990, with 1.57 million new cases projected in 2025 and over 820,000 deaths in 2023, driven by tobacco and alcohol use, obesity, sedentary lifestyles, and environmental pollution. The most common cancers in these regions include breast, lung, colorectal, oral, and kidney cancers. Additionally, in the United States, 2,041,910 new cancer cases and 618,120 deaths are projected in 2025 (NIH, 2025), underscoring the ongoing need for predictive preclinical models.
The growing cancer burden is matched by advancements in early detection, including low-dose CT scans for lung cancer, digital breast tomosynthesis (3D mammography), and minimally invasive liquid biopsies that analyze circulating tumor DNA (ctDNA) or minimal residual disease (MRD). These technologies allow identification of tumors at earlier, more biologically diverse stages, expanding the range of tumors available for translational research.
Regions such as Asia-Pacific, the Middle East, and Africa are increasingly adopting PDX platforms to translate preclinical findings into precision oncology solutions, supported by public initiatives like ARPA-H's USD 25 million at-home multi-cancer screening program, which drives demand for xenografts to evaluate subtype-specific therapies. As cancer becomes more detectable, diverse, and clinically complex, accelerating the adoption of PDX models as essential tools in modern precision oncology research and drug development.
Research Scope