细胞和基因治疗制造服务市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPRE00024304
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 216
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【研究报告】细胞和基因治疗制造服务市场规模预计将从2022年的75.8197亿美元增长到2030年的267.249亿美元;预计 2022 年至 2030 年复合年增长率为 17.1%。

市场洞察和分析师观点:

细胞和基因治疗制造服务涉及使用先进技术生产治疗产品细胞和遗传技术。这些服务通常涵盖从工艺开发到大规模生产的各个方面,确保针对各种医疗状况安全有效地创建个性化治疗。提供这些服务的公司注重保持严格的质量控制并遵守监管指南,以确保最高的安全性和有效性标准。全球细胞和基因治疗制造服务市场的增长归因于制药和生物制药公司研发支出增加、细胞和基因疗法批准增加以及外包细胞和基因治疗制造日益普及等因素。然而,细胞和基因疗法制造的高成本限制了市场增长。

增长动力和挑战:

在细胞和基因疗法制造中融入自动化将导致降低污染风险、提高一致性并降低生产成本。 Lonza Cocoon 和 Miltenyi 的 CliniMACS Prodigy 系统是市场上可实现自动化的几种设备。这些产品旨在自动化单个系统内 CAR-T 流程的最连续的单元操作。对细胞和基因治疗的需求不断增长,使得全球范围内细胞和基因治疗产品的生产从小批量生产转向大批量生产。除了不断增加的研究活动外,细胞和基因治疗从学术和临床环境到大规模生产和商业化的演变也推动了商业制造对自动化的需求。

2020 年 7 月,Thermo Fisher Scientific Inc. 和 Lyell Nutrition 合作开发和制造工艺,为癌症患者设计有效的细胞疗法。根据这一合作伙伴关系,两家公司的目标是提高 T 细胞的能力,并支持开发符合现行良好生产规范 (cGMP) 的综合平台(系统和软件)以及试剂、耗材和仪器。此外,政府机构正在细胞疗法的生产中采用自动化,以提高该国的国家生产能力。截至 2023 年 3 月,英国药品和保健品监管机构 (MHRA) 干细胞银行测试了自动化机器人技术,用于开发用于制造干细胞疗法的干细胞技术。因此,自动化正在成为细胞和基因治疗制造服务市场的新趋势。

Thermo Fisher Scientific Inc.、Merck KGaA、Charles River Laboratories International Inc.、Lonza Group AG、药明康德股份有限公司Ltd、Catalent Inc、Takara Bio Inc.、尼康公司、FUJIFILM Holdings Corp、National Resilience Inc 和 Oxford BioMedica Plc。是细胞和基因治疗制造服务市场的主要参与者之一。

战略见解

报告细分和范围:

“全球细胞和基因治疗制造服务市场”根据类型、适应症、应用、最终用户和地理位置进行细分。细胞和基因治疗制造服务市场根据地理位置分为北美(美国、加拿大和墨西哥)、欧洲(德国、法国、意大利、英国、俄罗斯和欧洲其他地区)、亚太地区(澳大利亚、中国、日本、印度、韩国和亚太其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋以及中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。

细分分析:

市场根据类型、适应症、应用和最终用户进行细分。从类型来看,细胞和基因治疗制造服务市场分为细胞治疗和基因治疗。细胞治疗部分进一步分为自体细胞治疗和同种异体细胞治疗。此外,基因治疗部分分为病毒载体和非病毒载体。细胞治疗领域在 2022 年占据了更大的市场份额。基因治疗领域预计在 2022 年至 2030 年期间将实现更高的复合年增长率。自体细胞疗法制造领域占据了更大的市场份额,异体细胞疗法制造领域预计在2022-2030年期间将实现更高的复合年增长率。同种异体治疗的优点包括细胞和组织的潜在更广泛的可用性和多样性。

人们对同种异体细胞疗法的认识不断增强,新细胞系的资金激增,以及先进基因组学方法的开发细胞分析有利于同种异体细胞和基因治疗领域。医生倾向于使用同种异体疗法进行治疗,因为这些细胞疗法在治疗各种癌症类型(白血病或淋巴瘤)和其他疾病方面取得了巨大飞跃。因此,这些因素是细胞和基因治疗制造服务市场增长的原因。

内窥镜手术市场,按产品类型 - 2022 年和 2030 年

根据指示,细胞基因治疗制造服务市场分为癌症、骨科等。 2022 年,癌症细分市场占据最大市场份额,预计 2022 年至 2030 年复合年增长率最高。细胞和基因疗法的广阔领域有望带来许多可以预防癌症死亡的创新疗法。据癌症基因治疗联盟 2022 年 4 月通讯报道,美国食品和药物管理局 (FDA) 已批准 6 种 CAR T 细胞疗法用于治疗骨髓瘤、白血病和淋巴瘤。 2022年12月,FDA批准Adstiladrin,一种基于非复制腺病毒载体的基因疗法,用于治疗患有高危卡介苗(BCG)无反应的非肌层浸润性膀胱癌(NMIBC)的成人患者伴或不伴乳头状肿瘤的原位癌(CIS)。 2022 年,FDA 批准了 Kimmtrak,一种 T 细胞受体疗法,用于治疗一种罕见的眼部黑色素瘤——葡萄膜黑色素瘤。随着 FDA 批准用于癌症治疗的细胞和基因疗法数量的增加,这些疗法的产量在过去几年中也有所增加。因此,许多CDMO都专注于癌细胞和基因疗法的制造服务。

区域分析:

根据地理位置,细胞和基因疗法制造服务市场分为五个重点地区:北美、欧洲、亚太地区、南美洲和中美洲、中东和非洲。我们根据美国、加拿大和墨西哥这三个主要国家对北美细胞和基因治疗制造服务市场进行了分析。据估计,在预测期内,美国细胞和基因治疗制造服务市场将占据最大的细胞和基因治疗制造服务市场份额。细胞和基因疗法 (CGT) 治疗患有严重和罕见疾病且治疗需求未得到满足的患者。制造 CGT 是一个高度复杂的过程,基础设施和专业知识不足是主要限制因素。与中间体和最终产品相关的物流挑战也限制了公司的 CGT 制造能力。 CGT的制造过程包括通过“单采术”提取自体细胞,将其送往专门实验室,然后送回诊所给患者注射,所有这些都必须在严格的质量控制下进行。美国食品和药物管理局 (USFDA) 仅批准了 7 种 CGT 药物,新产品管线达到约 1,200 种实验疗法。其中一半处于 2 期临床试验中,根据《化学与工程新闻》2023 年报告的估计,细胞疗法的年销售额增长预计为 15%,基因疗法的年销售额增长约为 30%。

许多制造商与 Labcorp、Lonza 和 Catalent 等合同开发制造组织 (CDMO) 接洽,以克服与生产和商业化其细胞和基因治疗产品相关的障碍。 Lonza 已投资约 920 万美元来加强其细胞和基因治疗制造能力和支持。 CDMO 的此类举措正在促进美国细胞和基因治疗市场的增长。

英国是世界上先进疗法的研究、开发、制造、临床采用和报销的最佳生态系统之一。目前,英国正在进行超过 85 项临床试验,70 家 CGT 公司正在运营以开发潜在的治疗疗法。

Catapult 是另一家为英国 CGT 生态系统做出重大贡献的顶级公司;它是该国开发制造工艺的前五名公司之一。该公司正在开发更智能的自动化 CGT 制造流程,能够以最少的干预自动适应不断变化的环境和流程要求。因此,这些公司在提高生产力和降低最终成本方面所做的努力是推动英国细胞和基因治疗市场增长的主要因素。此外,由于对研究的持续和有针对性的投资,英国在欧洲细胞和基因治疗市场中占据了强势地位

机遇:

欧洲主要参与者采取的各种举措全球细胞和基因治疗制造服务市场如下:

2022 年 3 月,Oxford Biomedica plc 完成与 Homology Medicines Inc. 的交易,成立 Oxford Biomedica Solutions LLC,这是一家新的美国全范围制药公司、腺相关病毒(AAV)制造和创新业务。新业务已全面投入运营,并提供专有的“即插即用”平台。独特的平台和完全集成的端到端功能,包括载体设计和工艺开发直至临床试验,现已向客户开放。2023 年 3 月,Thermo Fisher Scientific 与 Arsenal Biosciences, Inc. (ArsenalBio) 合作,后者是一家临床研究公司。阶段细胞治疗公司为实体瘤设计先进的 CAR-T 细胞疗法,双方达成战略合作,开发新癌症治疗的制造工艺。以研究和工艺开发为重点的合作使 ArsenalBio 能够开发出强大的制造工艺。2022 年 6 月,National Resilience, Inc. 和德克萨斯大学 MD 安德森癌症中心成立了一家合资企业,即细胞疗法制造中心 (CTMC),以加速癌症患者创新细胞疗法的开发和制造。该合资企业在学术创新和行业专业知识文化中推进其工作。该合资企业与 MD 安德森研究人员和外部行业合作者合作,通过临床前和临床开发推进新疗法。竞争格局和主要公司:

市场上运营的一些细胞和基因治疗制造公司包括 Thermo Fisher Scientific Inc.、Merck KGaA、Charles River Laboratories International Inc.、Lonza Group AG、WuXi AppTec Co Ltd、Catalent Inc.、Takara Bio Inc、尼康公司、FUJIFILM Holdings Corp、National Resilience Inc 和 Oxford BioMedica Plc。这些公司专注于各种增长战略,例如合作、产品发布、业务扩张和协议,以保持其在全球市场的地位。他们广泛的全球业务使他们能够为许多客户提供服务,增加他们的细胞和基因治疗制造服务市场份额。
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Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
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Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

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Frequently Asked Questions


Which indication segment held the largest revenue (US$ Mn) in the Cell and Gene Therapy Manufacturing Services market?

Based on indication, the cell and gene therapy manufacturing services market is divided into cancer, orthopedics, and others. The cancer segment held the largest share of the market in 2022 and same segment is expected to grow at the highest CAGR during the forecast period.

Who are the key players in the Cell and Gene Therapy Manufacturing Services market?

Companies operating in the market are Thermo Fisher Scientific Inc, Merck KGaA, Charles River Laboratories International Inc, Lonza Group AG, WuXi AppTec Co Ltd, Catalent Inc, Takara Bio Inc, Nikon Corp, FUJIFILM Holdings Corp, National Resilience Inc, and Oxford BioMedica Plc.

What is the regional market scenario of the Cell and Gene Therapy Manufacturing Services market?

Cell and Gene Therapy Manufacturing Services market is segmented by region into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America is likely to continue its dominance the cell and gene therapy manufacturing services market during 2022–2030.

What is meant by the cell and gene therapy manufacturing services?

Cell & gene therapy (CGT) programs are rapidly advancing from research & development to clinical trials and commercial approval. Establishing a robust, repeatable, and sustainable process help accelerate development, avoiding manufacturing transfer-related delays. Additionally, cell and gene therapy comprises the next generation of life-enhancing and curative therapies. With therapies experiencing new approvals, the demand for skilled professionals in cell and gene therapy manufacturing services will rise.

Which segment led the cell and gene therapy manufacturing services market?

Cell and Gene Therapy Manufacturing Services market, based on type, is segmented into cell therapy and gene therapy. Cell therapy is segmented as autologous and allogenic. Further, gene therapy is bifurcated into viral vector and non-viral vector. The cell therapy segment held a larger market share in 2022. However, gene therapy segment is anticipated to register the highest CAGR during the forecast period (2020-2030).

What are the driving factors for the cell and gene therapy manufacturing services market across the globe?

Major factors driving the market growth includes increase in number of approvals of cell and gene therapies and increasing popularity of outsourcing cell and gene therapy manufacturing. Additionally, automation of cell and gene therapy manufacturing services are likely to emerge as significant future trends in the market during the forecast period.

The List of Companies - Cell and Gene Therapy Manufacturing Services Market

  1. Thermo Fisher Scientific Inc
  2. Merck KGaA
  3. Charles River Laboratories International Inc
  4. Lonza Group AG
  5. WuXi AppTec Co Ltd
  6. Catalent Inc
  7. Takara Bio Inc
  8. Nikon Corp
  9. FUJIFILM Holdings Corp
  10. National Resilience Inc,
  11. Oxford BioMedica Plc       

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