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市場調查報告書
商品編碼
1859715
細胞和基因治療製造市場預測至2032年:按治療類型、規模、工作流程、模式、技術、最終用戶和地區分類的全球分析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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根據 Stratistics MRC 的數據,全球細胞和基因治療製造市場預計到 2025 年將達到 60.4 億美元,到 2032 年將達到 193.5 億美元,預測期內複合年成長率為 18.2%。
細胞和基因治療(CGT)生產是指對人體細胞和遺傳物質進行改造和利用,以生產治療疾病的治療產品的複雜過程。它涉及生物原料的獲取、細胞分離、基因改造、擴增、純化、製劑配製和品管,以確保安全性、有效性和一致性。生產可以是自體(患者特異性)或異體(現成)的,通常需要專門的設施、先進的生物反應器和嚴格的監管合規性。 CGT生產整合了生物技術、分子生物學和工程學,旨在為癌症、罕見遺傳疾病和退化性疾病等疾病開發創新治療方法。
慢性病和罕見疾病的增加
治療癌症、血友病和神經退化性疾病等疾病需要標靶性強且療效持久的療法,而傳統藥物無法滿足這些需求。相關平台支援自體和異體細胞處理、病毒載體生產以及體外基因編輯等一系列治療流程。與個人化醫療和孤兒藥計畫的整合能夠增強臨床相關性並符合監管要求。人口老化和疾病治療不足的現狀正在推動對治癒性和精準療法的需求。這些趨勢正在推動先進治療藥物製造生態系統的基礎設施擴張和平台部署。
供應鍊和物流問題
短低溫運輸需求、保存期限限制以及針對特定患者的工作流程,都使運輸和庫存管理變得複雜。原料採購、設備可用性以及技術純熟勞工短缺會擾亂生產計劃和品質保證。跨多個地點和跨境營運的監管合規性增加了複雜性和營運風險。企業在使生產與臨床需求和報銷週期相符方面面臨挑戰。這些限制阻礙了細胞和基因治療計畫的平台成熟度和全球可及性。
增加對生物製藥研發的投資
政府創業投資和策略夥伴關係關係正在為該平台的規模化流程最佳化和監管參與提供資金支持。該平台支援封閉式系統自動化、數位化批次記錄以及人工智慧主導的品管,涵蓋上下游工作流程。腫瘤學、罕見疾病和再生醫學領域對可擴展、符合GMP規範的生產需求日益成長。 CDMO與學術中心和醫院網路的整合增強了靈活性和地理覆蓋範圍。這些趨勢正在推動整個生產生態系統的發展,而技術創新和投資則為其提供了支持。
有限的製造基礎設施
許多地區缺乏符合GMP標準的設施、訓練有素的人員以及能夠處理大量、高度複雜療法的設備。自體製劑的工作流程需要分散式、病患特異性的設置,這對傳統的生產模式提出了挑戰。由於產能有限和需求旺盛,CDMO在載體生產細胞擴增和放行檢測方面面臨瓶頸。法規核准的延遲和技術轉移方面的挑戰進一步限制了擴充性和商業化。這些限制持續限制該平台在新興市場和高成長治療領域的部署。
疫情擾亂了細胞和基因治療生產的臨床試驗和設施供應鏈。封鎖和資源重新分配導致設備交付、病患招募和法規核准延遲。然而,疫情後的復甦凸顯了醫療保健系統數位化以及先進療法的加速發展。生物製藥和合約研發生產機構(CDMO)網路在模組化無塵室遠端監控和分散式生產方面的投資激增。消費者和臨床領域對基因藥物和個人化療法的認知度也隨之提升。這些變化強化了對細胞和基因治療基礎設施以及全球生產能力的長期投資。
預計在預測期內,病毒載體平台細分市場將成為最大的細分市場。
由於病毒載體平台在基因遞送領域發揮著至關重要的作用,預計在預測期內,該領域將佔據最大的市場佔有率。這些平台支援腺相關病毒(AAV)、慢病毒和逆轉錄病毒的生產,用於體內和體外基因治療。與可擴展的上游製程、純化和分析環節的整合,可提高產量、效力和安全性。腫瘤、眼科和罕見疾病領域的研發管線對高性能、符合監管標準的載體的需求日益成長。供應商提供模組化平台、封閉式系統和數位化品管工具,以支援GMP合規性和技術轉移。這些優勢鞏固了該領域在整個基因治療生產流程中的主導地位。
預計在預測期內,商業製造領域將實現最高的複合年成長率。
隨著細胞和基因療法從臨床試驗階段邁向市場核准和全球分銷,預計商業化生產領域在預測期內將呈現最高的成長率。相關平台支援已通過核准療法和後期療法的規模化批次放行和監管文件編制。 CDMO與醫院網路和物流供應商的整合提高了產能和地理覆蓋範圍。 CAR-T基因編輯和再生醫學計畫正在推動對經濟高效且合規的生產方式的需求。各公司正在調整商業性準備工作,以配合支付方的參與和上市後監測策略。
在預測期內,北美預計將佔據最大的市場佔有率,這得益於其先進的生物製藥生態系統、完善的監管體係以及成熟的細胞和基因治療生產基礎設施。企業和合約研發生產機構(CDMO)正在腫瘤罕見疾病和再生醫學專案中部署整合分析和自動化技術的平台。對GMP設施人才培養和數位化製造的投資有助於擴充性和合規性。主要治療藥物開發商的學術中心和監管機構的存在推動了創新和標準化。企業正在根據FDA指南、NIH資金籌措和商業化藍圖調整其生產策略。
由於亞太地區各國經濟在醫療現代化、生物技術投資和疾病負擔方面的融合,預計該地區在預測期內將呈現最高的複合年成長率。中國、印度、日本和韓國等國家正在擴大用於公共衛生、學術研究和商業性治療計畫的生產平台。政府支持的舉措正在促進基礎設施建設,並推動合約研發生產機構(CDMO)的擴張以及先進療法領域的國際合作。本地企業正在提供符合法律規範和患者需求的、具有成本效益且本地化的解決方案。這些趨勢正在推動細胞和基因治療製造創新和應用在亞太地區的成長。
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.