细胞和基因治疗制造服务市场基于(主要区域、市场参与者、规模和份额)- 预测至 2030 年

  • Report Code : TIPRE00024304
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 216
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Cell and Gene Therapy Manufacturing Services Market Report | 2022–2030

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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 2022-2030 年期间的复合年增长率为 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的细胞和基因技术生产治疗产品。这些服务通常涵盖从工艺开发到大规模生产的所有内容,确保安全有效地为各种医疗状况制定个性化治疗。提供这些服务的公司专注于保持严格的质量控制并遵守监管​​准则,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的增加、细胞和基因治疗的批准增加以及外包细胞和基因治疗制造的日益普及等因素。然而,细胞和基因治疗制造的高成本正在抑制市场的增长。

 

增长动力与挑战:

将自动化融入细胞和基因治疗制造将降低污染风险、提高一致性并降低生产成本。Lonza Cocoon 和Miltenyi的CliniMACS Prodigy 系统是市场上少数可实现自动化的设备。这些产品旨在在单个系统内自动执行 CAR-T 工艺中最连续的单元操作。对细胞和基因治疗的需求不断增长,已将全球细胞和基因治疗产品的生产从小批量工艺转变为大批量工艺。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发展到大规模生产和商业化,也推动了商业制造对自动化的需求。

2020 年 7 月,赛默飞世尔科技公司 ( Thermo Fisher Scientific Inc.) 和 Lyell Immunopharma合作开发和制造用于为癌症患者设计有效细胞疗法的工艺。在这种合作关系下,两家公司旨在提高 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、消耗品和仪器。此外,政府机构正在采用自动化技术制造细胞疗法,以提高该国的国内生产能力。截至 2023 年 3 月,英国药品和保健产品管理局 ( MHRA ) 的干细胞库测试了自动化机器人技术,用于开发用于制造基于干细胞的疗法的干细胞技术。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。

赛默飞世尔科技公司、默克公司、Charles River Laboratories International Inc.、龙沙集团、 明康德股份有限公司、康泰伦特公司、Takara Bio Inc.、尼康公司、富士胶片控股公司、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。

 

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细胞和基因治疗制造服务市场:

细胞和基因治疗制造服务市场

  • 复合年增长率(2022 - 2030 年)
    17.1%
  • 2022 年市场规模
    75.8 亿美元
  • 2030 年市场规模
    267.2 亿美元

市场动态

增长动力
  • 细胞和基因疗法获批数量增加
  • 外包细胞和基因治疗制造日益流行
未来的趋势
  • 细胞和基因治疗制造服务的自动化
机会
  • 企业的战略举措

关键人物;主力;重要一员

  •  
  • 赛默飞世尔科技公司
  • 默克公司
  • 查尔斯河实验室国际公司
  • 龙沙集团
  • 药明康德
  • 康泰伦特公司
  • 宝生物公司
  • 尼康公司
  • 富士胶片控股公司

区域概况

  • 北美
  • 欧洲
  • 亚太
  • 南美洲和中美洲
  • 中东和非洲

市场细分

类型
  • 细胞疗法
指征
  • 癌症
  • 骨科
  • 其他的
应用
  • 临床制造和商业制造
最终用户
  • 制药和生物技术公司以及合同研究组织
  • 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。

 

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。根据地理位置,细胞和基因治疗制造服务市场分为北美(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、阿联酋和中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷和南美洲和中美洲其他地区)。

 

节段分析:

市场根据类型、适应症、应用和最终用户进行细分。就类型而言,细胞和基因治疗制造服务市场细分为细胞治疗和基因治疗。细胞治疗部分进一步分为自体和同种异体。此外,基因治疗部分分为病毒载体和非病毒载体。细胞治疗部分在 2022 年占据了更大的市场份额。预计基因治疗部分在 2022-2030 年期间的复合年增长率更高。自体细胞治疗制造部分占据了更大的市场份额,而同种异体细胞治疗制造部分预计在 2022-2030 年期间的复合年增长率更高。同种异体治疗的优势包括细胞和组织的潜在可用性和多样性。

人们对同种异体细胞疗法的认识不断提高,用于新细胞系的资金激增,以及用于细胞分析的先进基因组学方法的发展,都使同种异体细胞和基因疗法领域受益。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的飞跃。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。

根据适应症,细胞和基因治疗制造服务市场分为癌症、骨科和其他。癌症领域在 2022 年占据了最大的市场份额,预计在 2022-2030 年期间将实现最高的复合年增长率。细胞和基因治疗的广阔领域有望带来许多可能预防癌症死亡的创新治疗方法。根据癌症基因治疗联盟 2022 年 4 月的通讯,美国食品药品监督管理局 (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 批准了一种非复制型腺病毒载体基因疗法 Adstiladrin,用于治疗患有高风险卡介苗 (BCG) 无反应的非肌层浸润性膀胱癌 (NMIBC) 的成人患者,无论是否伴有乳头状肿瘤,均应进行治疗。 2022 年,FDA 批准了 Kimmtrak,这是一种用于治疗眼部罕见黑色素瘤(葡萄膜黑色素瘤)的 T 细胞受体疗法。随着 FDA 批准的用于癌症治疗的细胞和基因疗法数量不断增加,这些疗法的生产在过去几年中也随之增加。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,细胞和基因治疗制造服务市场分为五个主要区域:北美、欧洲、亚太地区、南美和中美洲以及中东和非洲。北美细胞和基因治疗制造服务市场基于三个主要国家——美国、加拿大和墨西哥进行分析。预计美国细胞和基因治疗制造服务市场在预测期内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解决的患者。制造 CGT 是一个非常复杂的过程,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 制造过程包括通过“单采”提取自体细胞,将它们发送到专门的实验室,然后将它们送回诊所给患者使用,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,新产品的渠道达到约 1,200 种实验疗法。其中一半处于第 2 阶段临床试验阶段,根据《化学与工程新闻》2023 年报告估计,细胞疗法的年销售额增长率估计为 15%,基因疗法的年销售额增长率估计为 ~30%。

许多制造商与 Labcorp、Lonza 和 Catalent 等合同开发制造组织 (CDMO) 接洽,以克服生产和商业化其细胞和基因治疗产品所面临的障碍。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。

英国拥有全球最佳的先进疗法研究、开发、制造、临床应用和报销生态系统。目前,英国正在进行超过 85 项临床试验,有 70 家 CGT 公司正在开发潜在治愈疗法。

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五大公司之一。该公司正在开发更智能的自动化 CGT 制造工艺,可以自动适应不断变化的环境和工艺要求,只需最少的干预。因此,这些公司为提高生产力和降低最终成本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强势地位

 

机会:

以下列出了全球细胞和基因治疗制造服务市场的主要参与者采取的各种举措:

  • 2022 年 3 月,Oxford Biomedica plc 与 Homology Medicines Inc. 达成协议,成立 Oxford Biomedica Solutions LLC,这是一家新的美国全方位腺相关病毒 (AAV) 制造和创新企业。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)现已可供客户使用。
  • 2023 年 3 月,赛默飞世尔科技与 Arsenal Biosciences, Inc. (ArsenalBio) 达成战略合作,以开发新型癌症治疗的生产工艺。ArsenalBio 是一家临床阶段细胞治疗公司,专门为实体肿瘤设计先进的 CAR-T 细胞疗法。此次以研究和工艺开发为重点的合作使 ArsenalBio 能够开发出强大的生产工艺。
  • 2022 年 6 月,National Resilience, Inc. 与德克萨斯大学 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),旨在加速开发和制造针对癌症患者的创新细胞疗法。该合资企业在学术创新和工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。  

 

细胞和基因治疗制造服务市场报告范围

报告属性细节
2022 年市场规模75.8亿美元
2030 年的市场规模267.2亿美元
全球复合年增长率(2022 - 2030 年)17.1%
历史数据2020-2021
预测期2023-2030
涵盖的领域按类型
  • 细胞疗法
按适应症
  • 癌症
  • 骨科
  • 其他的
按应用
  • 临床制造和商业制造
按最终用户
  • 制药和生物技术公司以及合同研究组织
覆盖地区和国家北美
  • 我们
  • 加拿大
  • 墨西哥
欧洲
  • 英国
  • 德国
  • 法国
  • 俄罗斯
  • 意大利
  • 欧洲其他地区
亚太
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 亚太其他地区
南美洲和中美洲
  • 巴西
  • 阿根廷
  • 南美洲和中美洲其他地区
中东和非洲
  • 南非
  • 沙特阿拉伯
  • 阿联酋
  • 中东和非洲其他地区
市场领导者和主要公司简介
  •  
  • 赛默飞世尔科技公司
  • 默克公司
  • 查尔斯河实验室国际公司
  • 龙沙集团
  • 药明康德
  • 康泰伦特公司
  • 宝生物公司
  • 尼康公司
  • 富士胶片控股公司
  • 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。

 

竞争格局和重点公司:

市场上的一些细胞和基因治疗制造公司包括赛默飞世尔科技公司、默克集团、Charles River Laboratories International Inc.、龙沙集团、药明康德、Catalent Inc.、Takara Bio Inc、尼康公司、富士胶片控股公司、National Resilience Inc 和 Oxford BioMedica Plc。这些公司专注于各种增长战略,如合作、产品发布、业务扩展和协议,以保持其在全球市场的地位。他们广泛的全球影响力使他们能够为许多客户提供服务,从而增加了其细胞和基因治疗制造服务市场份额。

Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

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

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


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.

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 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 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.

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       

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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