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市场调查报告书
商品编码
1859715
细胞和基因治疗製造市场预测至2032年:按治疗类型、规模、工作流程、模式、技术、最终用户和地区分類的全球分析Cell and Gene Therapy Manufacturing Market Forecasts to 2032 - Global Analysis By Therapy Type, Scale, Workflow, Mode, Technology, End User and By Geography |
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根据 Stratistics MRC 的数据,全球细胞和基因治疗製造市场预计到 2025 年将达到 60.4 亿美元,到 2032 年将达到 193.5 亿美元,预测期内复合年增长率为 18.2%。
细胞和基因治疗(CGT)生产是指对人体细胞和遗传物质进行改造和利用,以生产治疗疾病的治疗产品的复杂过程。它涉及生物原料的获取、细胞分离、基因改造、扩增、纯化、製剂配製和品管,以确保安全性、有效性和一致性。生产可以是自体(患者特异性)或异体(现成)的,通常需要专门的设施、先进的生物反应器和严格的监管合规性。 CGT生产整合了生物技术、分子生物学和工程学,旨在为癌症、罕见遗传疾病和退化性疾病等疾病开发创新治疗方法。
慢性病和罕见疾病的增加
治疗癌症、血友病和神经退化性疾病等疾病需要标靶性强且疗效持久的疗法,而传统药物无法满足这些需求。相关平台支援自体和异体细胞处理、病毒载体生产以及体外基因编辑等一系列治疗流程。与个人化医疗和孤儿药计画的整合能够增强临床相关性并符合监管要求。人口老化和疾病治疗不足的现状正在推动对治癒性和精准疗法的需求。这些趋势正在推动先进治疗药物製造生态系统的基础设施扩张和平台部署。
供应炼和物流问题
短低温运输需求、保质期限制以及针对特定患者的工作流程,都使运输和库存管理变得复杂。原材料采购、设备可用性以及技术纯熟劳工短缺会扰乱生产计划和品质保证。跨多个地点和跨境营运的监管合规性增加了复杂性和营运风险。企业在使生产与临床需求和报销週期相符方面面临挑战。这些限制阻碍了细胞和基因治疗计画的平台成熟度和全球可及性。
增加对生物製药研发的投资
政府创业投资和策略伙伴关係关係正在为该平台的规模化流程优化和监管参与提供资金支持。该平台支援封闭式系统自动化、数位化批次记录以及人工智慧主导的品管,涵盖上下游工作流程。肿瘤学、罕见疾病和再生医学领域对可扩展、符合GMP规范的生产需求日益增长。 CDMO与学术中心和医院网路的整合增强了灵活性和地理覆盖范围。这些趋势正在推动整个生产生态系统的发展,而技术创新和投资则为其提供了支持。
有限的製造基础设施
许多地区缺乏符合GMP标准的设施、训练有素的人员以及能够处理大量、高度复杂疗法的设备。自体製剂的工作流程需要分散式、病患特异性的设置,这对传统的生产模式提出了挑战。由于产能有限和需求旺盛,CDMO在载体生产细胞扩增和放行检测方面面临瓶颈。监管审批的延迟和技术转移方面的挑战进一步限制了扩充性和商业化。这些限制持续限制该平台在新兴市场和高成长治疗领域的部署。
疫情扰乱了细胞和基因治疗生产的临床试验和设施供应链。封锁和资源重新分配导致设备交付、病患招募和监管审批延迟。然而,疫情后的復苏凸显了医疗保健系统数位化以及先进疗法的加速发展。生物製药和合约研发生产机构(CDMO)网路在模组化无尘室远端监控和分散式生产方面的投资激增。消费者和临床领域对基因药物和个人化疗法的认知度也随之提升。这些变化强化了对细胞和基因治疗基础设施以及全球生产能力的长期投资。
预计在预测期内,病毒载体平台细分市场将成为最大的细分市场。
由于病毒载体平台在基因递送领域发挥着至关重要的作用,预计在预测期内,该领域将占据最大的市场份额。这些平台支援腺相关病毒(AAV)、慢病毒和逆转录病毒的生产,用于体内和体外基因治疗。与可扩展的上游製程、纯化和分析环节的整合,可提高产量、效力和安全性。肿瘤、眼科和罕见疾病领域的研发管线对高性能、符合监管标准的载体的需求日益增长。供应商提供模组化平台、封闭式系统和数位化品管工具,以支援GMP合规性和技术转移。这些优势巩固了该领域在整个基因治疗生产流程中的主导地位。
预计在预测期内,商业製造领域将实现最高的复合年增长率。
随着细胞和基因疗法从临床试验阶段迈向市场审批和全球分销,预计商业化生产领域在预测期内将呈现最高的成长率。相关平台支援已通过核准疗法和后期疗法的规模化批次放行和监管文件编制。 CDMO与医院网路和物流供应商的整合提高了产能和地理覆盖范围。 CAR-T基因编辑和再生医学计画正在推动对经济高效且合规的生产方式的需求。各公司正在调整商业性准备工作,以配合支付方的参与和上市后监测策略。
在预测期内,北美预计将占据最大的市场份额,这得益于其先进的生物製药生态系统、完善的监管体係以及成熟的细胞和基因治疗生产基础设施。企业和合约研发生产机构(CDMO)正在肿瘤罕见疾病和再生医学专案中部署整合分析和自动化技术的平台。对GMP设施人才培养和数位化製造的投资有助于扩充性和合规性。主要治疗药物开发商的学术中心和监管机构的存在推动了创新和标准化。企业正在根据FDA指南、NIH资金筹措和商业化蓝图调整其生产策略。
由于亚太地区各国经济在医疗现代化、生物技术投资和疾病负担方面的融合,预计该地区在预测期内将呈现最高的复合年增长率。中国、印度、日本和韩国等国家正在扩大用于公共卫生、学术研究和商业性治疗计画的生产平台。政府支持的倡议正在促进基础设施建设,并推动合约研发生产机构(CDMO)的扩张以及先进疗法领域的国际合作。本地企业正在提供符合法律规范和患者需求的、具有成本效益且本地化的解决方案。这些趋势正在推动细胞和基因治疗製造创新和应用在亚太地区的成长。
According to Stratistics MRC, the Global Cell and Gene Therapy Manufacturing Market is accounted for $6.004 billion in 2025 and is expected to reach $19.35 billion by 2032 growing at a CAGR of 18.2% during the forecast period. Cell and Gene Therapy (CGT) Manufacturing refers to the complex process of producing therapeutic products that involve modifying or using human cells or genetic material to treat diseases. It encompasses the sourcing of raw biological materials, cell isolation, genetic modification, expansion, purification, formulation, and quality control to ensure safety, efficacy, and consistency. Manufacturing can be autologous (patient-specific) or allogeneic (off-the-shelf) and often requires specialized facilities, advanced bioreactors, and strict regulatory compliance. CGT manufacturing integrates biotechnology, molecular biology, and engineering to create innovative therapies for conditions such as cancer, rare genetic disorders, and degenerative diseases.
Rising incidence of chronic and rare diseases
Conditions such as cancer hemophilia and neurodegenerative disorders require targeted and durable treatments that conventional drugs cannot address. Platforms support autologous and allogeneic cell processing viral vector production and ex vivo gene editing across therapeutic pipelines. Integration with personalized medicine and orphan drug programs enhances clinical relevance and regulatory alignment. Demand for curative and precision therapies is rising across aging populations and underserved disease areas. These dynamics are propelling infrastructure expansion and platform deployment across advanced therapy manufacturing ecosystems.
Supply chain and logistics issues
Cold chain requirements short shelf life and patient-specific workflows complicate transportation and inventory management. Raw material sourcing equipment availability and skilled labor shortages disrupt production timelines and quality assurance. Regulatory compliance across multi-site and cross-border operations adds to complexity and operational risk. Enterprises face challenges in aligning manufacturing with clinical demand and reimbursement cycles. These constraints continue to hinder platform maturity and global accessibility across cell and gene therapy programs.
Increased investment in biopharmaceutical R&D
Governments venture capital and strategic partnerships are funding platform scale-up process optimization and regulatory engagement. Platforms support closed-system automation digital batch records and AI-driven quality control across upstream and downstream workflows. Demand for scalable and GMP-compliant manufacturing is rising across oncology rare diseases and regenerative medicine. Integration with CDMOs academic centers and hospital networks enhances flexibility and geographic reach. These trends are fostering growth across innovation-driven and investment-backed manufacturing ecosystems.
Limited manufacturing infrastructure
Many regions lack GMP facilities trained personnel and validated equipment for high-volume and high-complexity therapies. Autologous workflows require decentralized and patient-specific setups that challenge traditional manufacturing models. CDMOs face bottlenecks in vector production cell expansion and release testing due to limited capacity and high demand. Regulatory delays and technology transfer issues further constrain scalability and commercialization. These limitations continue to restrict platform deployment across emerging markets and high-growth therapeutic areas.
The pandemic disrupted supply chains clinical trials and facility operations across cell and gene therapy manufacturing. Lockdowns and resource reallocation delayed equipment delivery patient recruitment and regulatory review. However post-pandemic recovery emphasized resilience digitization and advanced therapy acceleration across healthcare systems. Investment in modular cleanrooms remote monitoring and decentralized manufacturing surged across biopharma and CDMO networks. Public awareness of genetic medicine and personalized therapies increased across consumer and clinical segments. These shifts are reinforcing long-term investment in cell and gene therapy infrastructure and global manufacturing capacity.
The viral vector platforms segment is expected to be the largest during the forecast period
The viral vector platforms segment is expected to account for the largest market share during the forecast period due to their foundational role in gene delivery across therapeutic applications. Platforms support AAV Lentivirus and retrovirus production for in vivo and ex vivo gene therapies. Integration with scalable upstream processing purification and analytics enhances yield potency and safety. Demand for high-performance and regulatory-grade vectors is rising across oncology ophthalmology and rare disease pipelines. Vendors offer modular platforms closed systems and digital QC tools to support GMP compliance and tech transfer. These capabilities are boosting segment dominance across gene therapy manufacturing workflows.
The commercial manufacturing segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the commercial manufacturing segment is predicted to witness the highest growth rate as cell and gene therapies transition from clinical trials to market authorization and global distribution. Platforms support scale-up batch release and regulatory documentation across approved and late-stage therapies. Integration with CDMOs hospital networks and logistics providers enhances throughput and geographic coverage. Demand for cost-efficient and compliant manufacturing is rising across CAR-T gene editing and regenerative medicine programs. Enterprises are aligning commercial readiness with payer engagement and post-market surveillance strategies.
During the forecast period, the North America region is expected to hold the largest market share due to its advanced biopharma ecosystem regulatory engagement and infrastructure maturity across cell and gene therapy manufacturing. Enterprises and CDMOs deploy platforms across oncology rare disease and regenerative medicine programs with integrated analytics and automation. Investment in GMP facilities workforce development and digital manufacturing supports scalability and compliance. Presence of leading therapeutic developers academic centers and regulatory bodies drives innovation and standardization. Firms align manufacturing strategies with FDA guidance NIH funding and commercialization roadmaps.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR as healthcare modernization biotech investment and disease burden converge across regional economies. Countries like China India Japan and South Korea scale manufacturing platforms across public health academic research and commercial therapy programs. Government-backed initiatives support infrastructure development CDMO expansion and international collaboration across advanced therapies. Local firms offer cost-effective and regionally adapted solutions tailored to regulatory frameworks and patient needs. These trends are accelerating regional growth across cell and gene therapy manufacturing innovation and deployment.
Key players in the market
Some of the key players in Cell and Gene Therapy Manufacturing Market include Thermo Fisher Scientific Inc., Lonza Group AG, Catalent Inc., Fujifilm Diosynth Biotechnologies Inc., WuXi Advanced Therapies Inc., Samsung Biologics Co., Ltd., AGC Biologics Inc., Minaris Regenerative Medicine GmbH, Oxford Biomedica plc, Charles River Laboratories International Inc., Recipharm AB, Merck KGaA, Takara Bio Inc., Miltenyi Biotec B.V. & Co. KG and BioNTech SE.
In July 2025, Lonza confirmed that its $1.2 billion acquisition of Genentech's Vacaville facility (2024) drove CHF 3.1 billion in H1 2025 CDMO sales, with 23.1% growth at constant exchange rates. The 330,000-liter bioreactor site significantly boosted Lonza's biologics capacity and margin resilience, outperforming peers like WuXi and Samsung. This acquisition positioned Lonza as a global CDMO leader in large-scale cell and gene therapy manufacturing.
In April 2025, Thermo Fisher launched Gibco(TM) CTS Viral Vector Production System, a closed modular solution for AAV and lentiviral manufacturing. The system enabled scalable, GMP-compliant production for clinical and commercial gene therapies. It integrated with Thermo's bioprocessing and analytics platforms, supporting faster turnaround and reduced contamination risk in cell and gene therapy workflows.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.