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细胞和基因治疗生物製造市场-全球和区域分析：按产品类型、应用、用途、最终用户和区域-分析和预测（2025-2035）
市场调查报告书
商品编码
1715253

细胞和基因治疗生物製造市场-全球和区域分析：按产品类型、应用、用途、最终用户和区域-分析和预测（2025-2035）

Cell and Gene Therapy Biomanufacturing Market - A Global and Regional Analysis: Focus on Product Type, Application, Usage, End User, and Region - Analysis and Forecast, 2025-2035
出版日期: | 出版商: BIS Research | 英文 140 Pages | 商品交期: 1-5个工作天内

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全球细胞和基因疗法生物製造市场规模正在快速增长，这得益于製造技术的进步、对创新治疗方法的需求不断增长以及对生物製药研究的大量投资。

关键驱动因素包括製造过程中自动化和人工智慧的整合、病毒载体技术的改进以及需要个人化治疗的慢性病的盛行率不断上升。人们对个人化医疗的日益关注，加上政府措施和创业投资的不断增加的支持，正在刺激市场进一步扩张。此外，虽然 FDA 和 EMA 等监管机构正在为基因疗法提供快速核准途径，但该行业正在努力克服高生产成本和扩充性挑战。

有几个关键因素推动细胞和基因治疗生物製造市场的成长。生物製造技术的不断进步，包括改进的细胞培养系统、病毒载体生产和 CRISPR 等基因编辑工具，正在推动对专业製造能力的需求。随着基因和细胞疗法变得越来越复杂和个人化，製造过程也需要更高的精度、专门的设备和个人化的方法来确保高品质的生产。此外，FDA 和 EMA 等监管机构对这些疗法的生产提出了严格的要求，需要采取强有力的品管(QC) 措施来满足安全性、有效性和合规性标准。个人化医疗的兴起，即根据个人基因图谱设计治疗方法，导致对更复杂的製造流程和更高的品质控制标准的需求增加。

儘管存在巨大的机会，细胞和基因治疗生物製造市场仍存在一些挑战。主要障碍之一是製造过程的复杂性，它比传统药物製造过程复杂得多。这种复杂性意味着更高的製造成本、更长的时间表以及更大的一致性和品质风险。此外，法规环境也在不断发展，特别是在个人化治疗方面，这对必须不断适应新指南并保持合规的製造商提出了挑战。此外，细胞和基因治疗製造成本高昂，需要先进的基础设施和熟练的人力，这进一步增加了扩充性。这些障碍可能会阻止小型生技公司和新兴製造商与更大的竞争对手竞争，并限制这些治疗方法的可及性和可负担性，特别是在早期市场。这些挑战也可能影响细胞和基因疗法的广泛应用。细胞和基因疗法成本过高，通常需要在专门的设备、培训和监管流程上进行大量投资。

全球细胞和基因治疗生物製造市场目前正处于快速发展阶段，其特征是显着的成长和发展。这种成长背后的主要因素是个人化医疗需求的增加、技术创新以及研发投入的增加。随着越来越多的基因疗法开发，人们的注意力转向先进的製造技术，例如改进的病毒载体生产、CRISPR 等基因编辑技术以及干细胞应用。此外，法规环境正在不断发展以支持这些治疗方法，FDA 和 EMA 等机构的更清晰的核准途径缩短了新治疗方法的上市时间。

这些治疗方法的复杂性加上对专门製造系统的需求，导致了品管（QC）服务、流程优化和製造扩充性的提高。市场上生物技术公司、製药公司和受託製造厂商(CMO) 之间的伙伴关係正在涌入，从而促进进一步的创新和製造能力的获取。

现阶段，市场正从早期开发转向扩张，商业化程度不断提高，并专注于扩大生产以满足全球市场需求。现阶段，产业领导者之间存在着明显的竞争，以建立更有效率、更具成本效益的生产系统，从而确保未来更广泛地使用这些治疗方法。

细胞和基因治疗生物製造市场透过为一系列遗传疾病、癌症和其他复杂疾病提供尖端治疗方法，处于医疗保健治疗革命的前沿。由于基因编辑、病毒载体生产和干细胞应用技术的进步，该行业正在蓬勃发展。随着这些治疗方法进入临床和商业阶段，生物製造过程的显着改进对于满足日益增长的需求至关重要。

该行业的关键技术进步包括：

  • CRISPR 和基因编辑：CRISPR 技术释放了精确、有针对性的基因修饰的潜力，从而能够开发高度个人化的遗传疾病治疗方法。这项技术可以实现更有效率的基因编辑，从而带来需要更少资源和时间的製造流程的创新。
  • 病毒载体生产：病毒载体，尤其是AAV（腺结合病毒）和慢病毒，在基因转移系统中扮演重要角色。病毒载体製造、精製和扩大规模技术的进步对于基因治疗的成功生产至关重要，尤其是在治疗方法变得更加个人化的情况下。
  • 干细胞技术：基于干细胞的治疗方法越来越多地与再生医学的基因疗法结合。干细胞製造过程的创新，包括细胞培养和分化技术，正在开闢新的治疗可能性，特别是在再生医学和免疫疗法领域。
  • 自动化和人工智慧：生物製造中自动化和人工智慧的融合正在提高效率、减少人为错误并提高生产一致性。人工智慧也被用于预测分析、简化品管和优化製造流程。
  • 模组化和一次性技术：使用模组化生物製造系统和一次性技术可以实现更灵活、更具成本效益和可扩展的生产。

技术进步对细胞和基因治疗生物製造市场的影响

提高製造效率：技术创新大大减少了生产时间、成本和资源消耗。自动化系统和模组化平台的采用正在提高製造的可扩展性和一致性，使公司能够更有效率、更大规模地生产基因疗法。

降低成本并提高可近性：细胞培养系统、病毒载体生产和自动化的进步有可能降低与基因治疗製造相关的高成本。随着生产成本的下降，更多患者，特别是在新兴市场，可以获得这些治疗方法。

提高产品品质：即时监控和人工智慧分析等先进品管(QC) 技术的集成，确保基因治疗产品符合安全性、有效性和一致性的最高标准。这些技术提高了个人化医疗所需的产品的可靠性。

更快的上市时间：更有效率的製造流程和监管途径的结合将使公司能够更快地将基因疗法推向市场。 FDA 和 EMA 等监管机构正在简化突破性治疗方法的核准流程，为更快的商业化创造机会。

个人化医疗：对个​​人化医疗的需求从未如此高涨。 CRISPR 等治疗开发技术和病毒载体製造的进步使得开发适合每个人基因特征的治疗方法成为可能，改善了治疗效果并为标靶治疗开闢了新兴市场。

细胞和基因治疗生物製造市场挑战和市场影响：

儘管取得了这些进展，细胞和基因疗法生物製造市场仍面临重大挑战：

可扩展性：扩大生产以满足全球对基因疗法的需求仍然是一项挑战。儘管技术进步正在提高效率，但在保持高品质的同时实现具有成本效益的大规模生产仍然是一个持续的挑战。

高成本：製造成本高仍然是一个主要障碍，特别是因为需要专门的设备、熟练的人力和先进的技术。这些成本可能会限制基因治疗的获取，特别是对于规模较小的生物技术和早期公司。

监管障碍：虽然监管机构正在简化核准流程，但要适应基因治疗（尤其是个人化治疗）复杂的法规环境，仍需要持续的适应和投资。这些不断变化的法规可能会减缓开发进程并增加成本。

根据产品，2024 年全球细胞和基因治疗生物製造市场以消耗品领域为主。该设备的使用寿命为5至7年，软体解决方案也需要一次性投资和每年的维护成本。然而，细胞和基因治疗生产需要更频繁、更大的消耗品数量。

根据应用，2024 年全球细胞和基因治疗生物製造市场以研究阶段製造领域为主。

根据最终用户，2024 年全球细胞和基因疗法生物製造市场将由生命科学公司主导。

全球细胞和基因疗法生物製造市场的最新趋势

  • 2023 年 1 月，Sartorius AG 与 Roosterbio Inc. 合作，推动外泌体开发的下游精製製程。
  • 2022 年 2 月，Sartorius AG 完成对 Novasep层析法部门的收购，以补充产品系列。
  • 2022年8月，默克公司推出了VirusExpress 293腺相关病毒（AAV）生产平台，以加速细胞和基因疗法的开发。
  • 2022 年 6 月，龙沙集团 (Lonza Group AG) 与 Adva Biotechnology Ltd. 签署了授权合约，允许 Adva Biotechnology 使用其核心智慧财产权，从而实现自动化生物反应器的全球扩张。
  • 2022年6月，碧迪公司推出了搭载CellView成像技术的FACSDiscover S8细胞分选仪。
  • 2023 年 1 月，Bio-Techne 公司推出了 RNAscope plus 检测，以推动基因疗法的发展。
  • 2023 年 4 月，丹纳赫 (Cytiva) 推出了 X-platform 生物反应器，旨在优化一次性上游生物加工作业。这些生物反应器在单株抗体、蛋白质药物、细胞和基因疗法药物以及病毒载体的生产方面具有灵活性和效率，以支持各种治疗产品的开发和製造。

推动细胞和基因治疗生物製造市场需求的因素：

  • 核准治疗方法的数量不断增加以及对基础设施增加的需求正在推动对细胞和基因疗法生物製造产品的需求激增。
  • 扩大细胞和基因治疗应用将创造大规模生物製造的需求
  • 细胞和基因治疗市场新参与企业推动生物製造设施和设备需求
  • 细胞和基因治疗投资和资金筹措了细胞和基因治疗生物製造的成长

限制细胞和基因治疗生物製造市场的因素：

  • 建立生物製造设施的成本高昂

细胞和基因治疗生物製造市场机会：

  • 根据个人基因图谱客製化治疗的需求日益增长，为专业化製造流程创造了机会。
  • 基因传递系统中对病毒载体的需求不断增加，为专门从事可扩展病毒载体生产的公司提供了机会，特别是在 AAV 和慢病毒载体的开发方面。

工作流程/创新策略：细胞和基因疗法生物製造市场（按产品类型）分为消耗品、设备和软体解决方案。此外，它还为读者提供了对细胞和基因治疗生物製造的原材料製备、上游工程、下​​游加工和包装中的各种应用的详细了解。

成长/行销策略：细胞和基因治疗生物製造用于原料製备、上游工程、下​​游加工和包装。各种公司提供有助于製造各种细胞和基因疗法的产品和服务，这也是市场参与者在当前细胞和基因疗法生物製造市场中获得优势的关键策略。

竞争策略：对全球细胞和基因治疗生物製造市场的主要企业进行了分析和描述，包括参与新产品发布、收购、扩张和策略联盟的製造商。此外，我们也对全球细胞和基因疗法生物製造市场中的参与者进行了详细的竞争基准化分析，以呈现清晰的市场格局，帮助读者了解参与者之间的竞争情况。此外，伙伴关係、协议和联盟等全面的竞争策略可帮助读者了解市场中尚未开发的收益来源。

本报告研究了全球细胞和基因治疗生物製造市场，并概述了市场以及产品类型、应用、用途、最终用户、地区和参与市场的公司概况的趋势。

目录

执行摘要

第一章 产业展望

  • 市场概况与生态系统
  • 主要趋势
  • 机会评估
  • 法律规范
  • 产品基准
  • 专利分析
  • 经营模式分析
  • 研发线产品
  • 技术采用
  • 市场动态

2. 全球细胞和基因疗法生物製造市场（按产品类型划分），百万美元，2023 年至 2035 年

  • 概述
  • 耗材
  • 装置
  • 软体解决方案

3. 全球细胞和基因治疗生物製造市场（按应用划分），百万美元，2023-2035 年

  • 概述
  • 上游处理
  • 收成
  • 下游加工

4. 全球细胞和基因治疗生物製造市场（按应用划分），百万美元，2023 年至 2035 年

  • 概述
  • 商业阶段製造
  • 研究阶段製造

5. 全球细胞和基因治疗生物製造市场（按最终用户划分），百万美元，2023 年至 2035 年

  • 概述
  • 生命科学公司
  • CRO
  • CMO
  • 细胞库

6. 全球细胞和基因治疗生物製造市场（按地区划分），百万美元，2023-2035 年

  • 概述
  • 北美洲
  • 欧洲
  • 亚太地区
  • 拉丁美洲
  • 中东和非洲

第七章 竞争格局及公司概况

  • 竞争格局
  • Becton, Dickinson and Company
  • Bio-Rad Laboratories, Inc.
  • Bio-Techne Corporation
  • Danaher Corporation
  • Endress+Hauser Group Services AG, (Analytik Jena GmbH)
  • General Electric Company (GE Healthcare)
  • Getinge AB
  • Infors AG
  • Lonza Group Ltd.
  • Merck KGaA
  • Miltenyi Biotech BV & Co. KG
  • Pierre Guerin
  • Sartorius AG (Sartorious Stedim Biotech SA)
  • Thermo Fisher Scientific Inc
  • WuXi App Tech

第八章调查方法

Product Code: BHL1358SB

Market Overview

The global cell and gene therapy biomanufacturing market is experiencing rapid growth, driven by advancements in manufacturing technologies, increased demand for innovative therapies, and substantial investments in biopharmaceutical research. Key drivers include the integration of automation and AI in manufacturing processes, improvements in viral vector technologies, and the rising prevalence of chronic diseases that demand personalized treatments. The growing focus on personalized medicine, along with increasing support from government initiatives and venture capital, is fueling further market expansion. Additionally, regulatory bodies such as the FDA and EMA are facilitating faster approval pathways for gene therapies, while the industry works to overcome challenges related to high production costs and scalability.

Several key factors are driving the growth of the cell and gene therapy biomanufacturing market. Ongoing advancements in biomanufacturing technologies, such as improvements in cell culture systems, viral vector production, and gene editing tools such as CRISPR, are creating an increased need for specialized manufacturing capabilities. As gene and cell therapies become more complex and personalized, the manufacturing processes also require greater precision, specialized equipment, and tailored approaches to ensure high-quality production. Moreover, regulatory bodies such as the FDA and EMA are enforcing stringent requirements for the production of these therapies, necessitating robust quality control (QC) measures to meet safety, efficacy, and compliance standards. The rise of personalized medicine, where therapies are designed based on an individual's genetic profile, is contributing to the growing demand for more sophisticated manufacturing processes and higher QC standards.

Despite the significant opportunities, several challenges persist in the cell and gene therapy biomanufacturing market. One of the major hurdles is the complexity of the manufacturing processes, which are significantly more intricate than those used for traditional pharmaceutical products. This complexity leads to higher production costs, longer timelines, and greater risk in terms of consistency and quality. Furthermore, the constantly evolving regulatory environment, particularly with regard to personalized therapies, presents a challenge for manufacturers who must continuously adapt to new guidelines and maintain compliance. Additionally, the high cost of cell and gene therapy manufacturing, paired with the need for advanced infrastructure and skilled personnel, further complicates scalability. These barriers may hinder the ability of smaller biotech companies and emerging manufacturers to compete on a larger scale, limiting the accessibility and affordability of these therapies, especially in early-stage markets. These challenges may also affect the broader adoption of cell and gene therapies, as they often require large investments in specialized equipment, training, and regulatory processes that can be prohibitively expensive.

Market Lifecycle Stage of Cell and Gene Therapy Biomanufacturing:

The global cell and gene therapy biomanufacturing market is currently in a phase of rapid advancement, characterized by significant growth and development. This growth is primarily driven by the increasing demand for personalized medicine, technological innovations, and heightened investment in research and development. As more gene therapies are developed, there is a greater focus on advanced manufacturing technologies such as improved viral vector production, gene editing techniques such as CRISPR, and stem cell applications. The regulatory environment has also evolved to support these therapies, with clearer approval pathways from organizations such as the FDA and EMA, facilitating faster time-to-market for new therapies.

The complexity of these therapies, coupled with the need for specialized manufacturing systems, has resulted in the expansion of quality control (QC) services, process optimization, and manufacturing scalability. The market is witnessing an influx of partnerships between biotech firms, pharmaceutical companies, and contract manufacturing organizations (CMOs), driving further innovation and access to production capabilities.

At this stage, the market is transitioning from early-stage development to expansion, with increasing commercialization and a growing focus on scaling production to meet the demands of global markets. This phase is marked by a competitive race among industry leaders to establish more efficient and cost-effective production systems, ensuring broad access to these therapies in the future.

Impact on Cell and Gene Therapy Biomanufacturing

The cell and gene therapy biomanufacturing market is at the forefront of revolutionizing medical treatments, offering cutting-edge therapies for a range of genetic disorders, cancers, and other complex diseases. The industry is growing rapidly due to technological advancements in gene editing, viral vector production, and stem cell applications. As these therapies move toward clinical and commercial stages, significant improvements in biomanufacturing processes are essential to meet rising demand.

Key technological advancements in the industry include:

  • CRISPR and Gene Editing: CRISPR technology has unlocked the potential for precise and targeted genetic modifications, enabling the development of highly personalized therapies for genetic diseases. This technology allows for more efficient gene editing, leading to innovations in manufacturing processes that require fewer resources and time.
  • Viral Vector Production: Viral vectors, especially AAV (Adeno-Associated Virus) and lentivirus, play a critical role in gene delivery systems. Advances in viral vector manufacturing, purification, and scale-up technologies are essential to the success of gene therapy production, particularly as therapies become more personalized.
  • Stem Cell Technologies: Stem cell-based therapies are increasingly integrated into gene therapies for regenerative medicine. Innovations in stem cell manufacturing processes, including cell culturing and differentiation techniques, are opening up new treatment possibilities, particularly in regenerative and immune therapies.
  • Automation and AI: The integration of automation and AI in biomanufacturing is enhancing efficiency, reducing human error, and improving the consistency of production. AI is also being used for predictive analytics, streamlining quality control, and optimizing manufacturing processes.
  • Modular and Single-Use Technologies: The use of modular biomanufacturing systems and single-use technologies allows for more flexible, cost-efficient, and scalable production, which is particularly crucial for meeting the needs of personalized medicine.

Impact of Technological Advancements on the Cell and Gene Therapy Biomanufacturing Market:

Improved Manufacturing Efficiency: Technological innovations are drastically reducing production time, costs, and resource consumption. The adoption of automated systems and modular platforms has improved manufacturing scalability and consistency, enabling companies to produce gene therapies more efficiently and at a larger scale.

Lower Costs and Increased Accessibility: Advances in cell culture systems, viral vector production, and automation have the potential to reduce the high costs associated with gene therapy manufacturing. As production costs decrease, these therapies could become more accessible to a broader patient population, especially in emerging markets.

Enhanced Product Quality: The integration of advanced quality control (QC) technologies, such as real-time monitoring and AI-driven analytics, ensures that gene therapies meet the highest standards for safety, efficacy, and consistency. These technologies improve the reliability of the products, which is essential in personalized medicine.

Faster Time-to-Market: The combination of more efficient manufacturing processes and regulatory pathways is enabling companies to bring gene therapies to market faster. Regulatory bodies such as the FDA and EMA have streamlined approval processes for breakthrough therapies, creating opportunities for quicker commercialization.

Personalization of Medicine: The demand for personalized medicine is at an all-time high. Technologies such as CRISPR and advances in viral vector production allow for the development of treatments tailored to individual genetic profiles, which enhances the effectiveness of therapies and opens new markets for targeted treatments.

Challenges and Market Impact on Cell and Gene Therapy Biomanufacturing Market:

Despite these advancements, there are significant challenges impacting the cell and gene therapy biomanufacturing market:

Scalability: Scaling production to meet the global demand for gene therapies remains a challenge. While technological advancements have improved efficiency, achieving large-scale, cost-effective production that maintains high quality is still an ongoing challenge.

High Costs: The high cost of manufacturing, particularly due to the specialized equipment, skilled personnel, and advanced technologies required, is still a major barrier. These costs can limit the accessibility of gene therapies, especially for smaller biotech firms and early-stage companies.

Regulatory Hurdles: While regulatory bodies have streamlined some approval processes, navigating the complex regulatory environment for gene therapies-especially personalized treatments-requires ongoing adaptation and investment. These evolving regulations can slow down the development process and increase costs.

Market Segmentation for Cell and Gene Therapy Biomanufacturing Market:

Segmentation 1: by Product Type

  • Consumables
  • Equipment
  • Software Solutions

Based on product, the consumables segment in the global cell and gene therapy biomanufacturing market dominated in 2024. The equipment has a shelf life of five to seven years and software solutions also require a one-time investment with yearly maintenance costs. However, consumables are required more frequently and in large quantities for the production of cell and gene therapies.

Segmentation 2: by Usage

  • Commercial Stage Manufacturing
  • Research Stage Manufacturing

Based on usage, the global cell and gene therapy biomanufacturing market was dominated by the research stage manufacturing segment in 2024.

Segmentation 3: by Application

  • Upstream Processing
  • Harvesting
  • Downstream Processing

Based on application, the downstream processing segment accounted for the largest share of the global cell and gene therapy biomanufacturing in 2024.

Segmentation 4: by End User

  • Life Science Companies
  • Contract Research Organizations (CROs)
  • Contract Manufacturing Organizations (CMOs)
  • Cell Banks

Based on end user, the global cell and gene therapy biomanufacturing market is dominated by the life sciences companies segment in 2024.

Segmentation 5: by Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

Recent Developments in the Global Cell and Gene Therapy Biomanufacturing Market

  • In January 2023, Sartorius AG collaborated with Roosterbio Inc. to advance its downstream purification processes for the development of exosomes.
  • In February 2022, Sartorius AG completed the acquisition of Novasep's chromatography division to complement its product portfolio.
  • In August 2022, Merck KGaA launched the VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform to speed up the development of cell and gene therapies.
  • In June 2022, Lonza Group AG and Adva Biotechnology Ltd. entered into a license agreement that provides the latter access to the former's core intellectual property enabling the expansion of automated bioreactors worldwide.
  • In June 2022, Becton, Dickinson and Company launched FACSDiscover S8 Cell Sorter featuring CellView Image Technology.
  • In January 2023, Bio-Techne Corporation launched RNAscope plus assay to advance its gene therapy development.
  • In April 2023, Danaher (Cytiva) introduced X-platform bioreactors, designed to optimize single-use upstream bioprocessing operations. These bioreactors offer flexibility and efficiency in the production of monoclonal antibodies, protein-based drugs, cell and gene therapies, and viral vectors, supporting the development and manufacturing of a broad range of therapeutic products.

Demand - Drivers and Limitations

Market Demand Drivers for Cell and Gene Therapy Biomanufacturing:

  • Increasing number of approved therapies and growing infrastructure requirements creating an upsurge in demand for cell and gene therapy biomanufacturing products
  • Expansion in target indications for cell and gene therapies creates a demand for large-scale biomanufacturing
  • Entry of new market participants in cell and gene therapies driving the demand for biomanufacturing facilities and equipment
  • Increasing investments and funding in cell and gene therapy fuelling the growth of cell and gene therapy biomanufacturing

Market Restraints for Cell and Gene Therapy Biomanufacturing:

  • High set-up cost of biomanufacturing facilities

Market Opportunities for Cell and Gene Therapy Biomanufacturing:

  • Increasing demand for tailored therapies based on individual genetic profiles creates opportunities for specialized manufacturing processes.
  • Increased demand for viral vectors in gene delivery systems offers opportunities for companies specializing in scalable viral vector production, especially in the development of AAV and lentivirus vectors.

How can cell and gene therapy biomanufacturing market reports add value to an organization?

Workflow/Innovation Strategy: The cell and gene therapy biomanufacturing market (by product type) has been segmented into consumables, equipment, and software solutions. Moreover, the study provides the reader with a detailed understanding of the different applications of cell and gene therapy biomanufacturing in raw material preparation, upstream processing, downstream processing, and packaging.

Growth/Marketing Strategy: Cell and gene therapy biomanufacturing is being used for raw material preparation, upstream processing, downstream processing, and packaging. Various companies are providing products and services to aid in the manufacturing of various cell and gene therapies, which is also the key strategy for market players to excel in the current cell and gene therapy biomanufacturing market.

Competitive Strategy: Key players in the global cell and gene therapy biomanufacturing market have been analyzed and profiled in the study, including manufacturers involved in new product launches, acquisitions, expansions, and strategic collaborations. Moreover, a detailed competitive benchmarking of the players operating in the global cell and gene therapy biomanufacturing market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

  • The base year considered for the calculation of the market size is 2024. The historical year analysis has been done from FY2021 to FY2023, and the market size has been estimated for FY2024 and projected for the period 2025-2035.
  • The regional distribution of the market revenue has been estimated to be the same as the company's net revenue distribution. All the numbers have been adjusted off to two digits after decimal for report presentation reasons. However, the real figures have been utilized for compound annual growth rate (CAGR) estimation. The CAGR has been calculated for the forecast period 2025-2035.
  • The market has been mapped based on different types of products available in the market for various applications. All key companies having a significant number of offerings for the global cell and gene therapy biomanufacturing market have been considered and profiled in the report.
  • The primary respondent's verification has been considered to finalize the estimated market for the global cell and gene therapy biomanufacturing market.
  • The latest annual reports of each market player have been taken into consideration for market revenue calculation.
  • Market strategies and developments of key players have been considered for the calculation of the sub-segment split.
  • The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations, considering the average conversion rate for that particular year. The currency conversion rate has been taken from the historical exchange rate of the Oanda website.

Primary Research

The key data points taken from the primary sources include:

  • Validation and triangulation of all the numbers and graphs
  • Validation of the report's segmentation and key qualitative findings
  • Understanding of the numbers of the various markets for market type
  • Percentage split of individual markets for regional analysis

Secondary Research

Open Sources

  • Alliance for Regenerative Medicine (ARM), American Society of Gene and Cell Therapy (ASGCT), Centre for Biologics Evaluation and Research (CBER), Centre for Drug Evaluation and Research (CDER), Central Drugs Standard Control Organization (CDSCO), Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS), European Medicines Agency (EMA), Institute for Health Metrics and Evaluation (IHME), Medicines and Healthcare Products Regulatory Agency (MHRA), National Organization for Rare Disorders (NORD), Pharmaceuticals and Medical Devices Agency (PMDA), World Health Organization (WHO), and World Intellectual Property Organization (WIPO)
  • Annual reports, SEC filings, and investor presentations of the leading market players
  • Company websites and detailed study of their portfolio
  • Gold standard magazines, journals, whitepapers, press releases, and news articles
  • Databases

The key data points taken from the secondary sources include:

  • Segmentations, split-ups, and percentage shares
  • Data for market value
  • Key industry trends of the top players in the market
  • Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
  • Quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis for Cell and Gene Therapy Biomanufacturing:

Cell and gene-based therapies, particularly chimeric antigen receptor T-cell (CAR-T) therapies and gene-editing technologies have garnered significant attention in the biomanufacturing market. Key players in the cell and gene therapy biomanufacturing market are leading the way in developing innovative therapies, manufacturing processes, and scaling production. These companies are heavily investing in advancing biomanufacturing technologies, forming strategic partnerships, and navigating regulatory hurdles to bring cutting-edge therapies to market.

Some of the prominent companies in the cell and gene therapy biomanufacturing market are:

  • Lonza.
  • Thermo Fisher Scientific, Inc.
  • Merck KGaA
  • Danaher (Cytiva)
  • WuXi AppTec
  • Becton, Dickinson, and Company
  • Bio-Rad Laboratories, Inc.
  • Bio-Techne Corporation
  • Endress+Hauser Group Services AG (Analytik Jena GmbH)
  • General Electric Company (GE Healthcare)
  • Getinge AB
  • Infors AG
  • Miltenyi Biotec B.V. & Co. KG
  • PIERRE GUERIN
  • Sartorius AG (Sartorius Stedim Biotech S.A.)

Companies that are not a part of the aforementioned pool have been well represented across different sections of the cell and gene therapy biomanufacturing market report (wherever applicable).

Table of Contents

Executive Summary

Scope and Definition

Market/Product Definition

Key Questions Answered

Analysis and Forecast Note

1. Industry Outlook

  • 1.1 Market Overview and Ecosystem
  • 1.2 Key Trends
  • 1.3 Opportunity Assessment
  • 1.4 Regulatory Framework
  • 1.5 Product Benchmarking
  • 1.6 Patent Analysis
    • 1.6.1 Patent Analysis (by Year)
    • 1.6.2 Patent Analysis (by Country)
    • 1.6.3 Awaited Technologies
  • 1.7 Business Model Analysis
  • 1.8 Pipeline Products
  • 1.9 Technology Adoption
    • 1.9.1 Funding Scenario
    • 1.9.2 Key Success Factors
  • 1.10 Market Dynamics
    • 1.10.1 Overview
    • 1.10.2 Market Opportunities
    • 1.10.3 Market Drivers
      • 1.10.3.1 Impact Analysis
    • 1.10.4 Market Restraints
      • 1.10.4.1 Impact Analysis

2. Global Cell and Gene Therapy Biomanufacturing Market (By Product Type), $Million, 2023-2035

  • 2.1 Overview
  • 2.2 Consumables
    • 2.2.1 Culture Supplements
    • 2.2.2 Single-Use Liquids
    • 2.2.3 Cell Culture Reagents
    • 2.2.4 Cell Quantification Kits
  • 2.3 Equipment
    • 2.3.1 Bioreactors/Fermenters
    • 2.3.2 Mixing System
    • 2.3.3 Cell Counters
    • 2.3.4 Cell Sorters
    • 2.3.5 Centrifuges
    • 2.3.6 Incubators
    • 2.3.7 Biosafety Cabinets
    • 2.3.8 Freezers
    • 2.3.9 PCR Systems
    • 2.3.10 Transfection Systems
    • 2.3.11 Storage Tanks
    • 2.3.12 Others
  • 2.4 Software Solutions

3. Global Cell and Gene Therapy Biomanufacturing Market (By Application), $Million, 2023-2035

  • 3.1 Overview
  • 3.2 Upstream Processing
    • 3.2.1 Formulation and Hydration
    • 3.2.2 Cell Culture Processing
  • 3.3 Harvesting
  • 3.4 Downstream Processing
    • 3.4.1 Separation and Filteration
    • 3.4.2 Fill and Finish Operations

4. Global Cell and Gene Therapy Biomanufacturing Market (By Usage), $Million, 2023-2035

  • 4.1 Overview
  • 4.2 Commercial Stage Manufacturing
  • 4.3 Research Stage Manufacturing

5. Global Cell and Gene Therapy Biomanufacturing Market (By End User), $Million, 2023-2035

  • 5.1 Overview
  • 5.2 Life Sciences Companies
    • 5.2.1 Equipment
    • 5.2.2 Consumables
    • 5.2.3 Software Solutions
  • 5.3 Contract Research Organizations (CROs)
    • 5.3.1 Equipment
    • 5.3.2 Consumables
    • 5.3.3 Software Solutions
  • 5.4 Contract Manufacturing Organizations (CMOs)
    • 5.4.1 Equipment
    • 5.4.2 Consumables
    • 5.4.3 Software Solutions
  • 5.5 Cell Banks
    • 5.5.1 Equipment
    • 5.5.2 Consumables
    • 5.5.3 Software Solutions

6. Global Cell and Gene Therapy Biomanufacturing Market, by Region, $Million, 2023-2035

  • 6.1 Overview
  • 6.2 North America
    • 6.2.1 Key Findings
    • 6.2.2 Market Dynamics
    • 6.2.3 Market Sizing and Forecast Analysis
      • 6.2.3.1 By Product Type
      • 6.2.3.2 By End User
      • 6.2.3.3 By Country
        • 6.2.3.3.1 U.S.
          • 6.2.3.3.1.1 By Product Type
          • 6.2.3.3.1.2 By End User
        • 6.2.3.3.2 Canada
          • 6.2.3.3.2.1 By Product Type
          • 6.2.3.3.2.2 By End User
  • 6.3 Europe
    • 6.3.1 Key Findings
    • 6.3.2 Market Dynamics
    • 6.3.3 Market Sizing and Forecast Analysis
      • 6.3.3.1 By Product Type
      • 6.3.3.2 By End User
      • 6.3.3.3 By Country
        • 6.3.3.3.1 Germany
          • 6.3.3.3.1.1 By Product Type
          • 6.3.3.3.1.2 By End User
        • 6.3.3.3.2 U.K.
          • 6.3.3.3.2.1 By Product Type
          • 6.3.3.3.2.2 By End User
        • 6.3.3.3.3 France
          • 6.3.3.3.3.1 By Product Type
          • 6.3.3.3.3.2 By End User
        • 6.3.3.3.4 Italy
          • 6.3.3.3.4.1 By Product Type
          • 6.3.3.3.4.2 By End User
        • 6.3.3.3.5 Spain
          • 6.3.3.3.5.1 By Product Type
          • 6.3.3.3.5.2 By End User
        • 6.3.3.3.6 Rest of Europe
          • 6.3.3.3.6.1 By Product Type
          • 6.3.3.3.6.2 By End User
  • 6.4 Asia-Pacific
    • 6.4.1 Key Findings
    • 6.4.2 Market Dynamics
    • 6.4.3 Market Sizing and Forecast Analysis
      • 6.4.3.1 By Product Type
      • 6.4.3.2 By End User
      • 6.4.3.3 By Country
        • 6.4.3.3.1 Japan
          • 6.4.3.3.1.1 By Product Type
          • 6.4.3.3.1.2 By End User
        • 6.4.3.3.2 China
          • 6.4.3.3.2.1 By Product Type
          • 6.4.3.3.2.2 By End User
        • 6.4.3.3.3 India
          • 6.4.3.3.3.1 By Product Type
          • 6.4.3.3.3.2 By End User
        • 6.4.3.3.4 South Korea
          • 6.4.3.3.4.1 By Product Type
          • 6.4.3.3.4.2 By End User
        • 6.4.3.3.5 Australia
          • 6.4.3.3.5.1 By Product Type
          • 6.4.3.3.5.2 By End User
        • 6.4.3.3.6 Rest-of-Asia-Pacific
          • 6.4.3.3.6.1 By Product Type
          • 6.4.3.3.6.2 By End User
  • 6.5 Latin America
    • 6.5.1 Key Findings
    • 6.5.2 Market Dynamics
    • 6.5.3 Market Sizing and Forecast Analysis
      • 6.5.3.1 By Product Type
      • 6.5.3.2 By End User
      • 6.5.3.3 By Country
        • 6.5.3.3.1 Argentina
          • 6.5.3.3.1.1 By Product Type
          • 6.5.3.3.1.2 By End User
        • 6.5.3.3.2 Brazil
          • 6.5.3.3.2.1 By Product Type
          • 6.5.3.3.2.2 By End User
        • 6.5.3.3.3 Mexico
          • 6.5.3.3.3.1 By Product Type
          • 6.5.3.3.3.2 By End User
        • 6.5.3.3.4 Rest-of-Latin-America
          • 6.5.3.3.4.1 By Product Type
          • 6.5.3.3.4.2 By End User
  • 6.6 Middle East and Africa
    • 6.6.1 Key Findings
    • 6.6.2 Market Dynamics
    • 6.6.3 Market Sizing and Forecast Analysis
      • 6.6.3.1 By Product Type
      • 6.6.3.2 By End User
      • 6.6.3.3 By Country
        • 6.6.3.3.1 K.S.A.
          • 6.6.3.3.1.1 By Product Type
          • 6.6.3.3.1.2 By End User
        • 6.6.3.3.2 U.A.E.
          • 6.6.3.3.2.1 By Product Type
          • 6.6.3.3.2.2 By End User
        • 6.6.3.3.3 Israel
          • 6.6.3.3.3.1 By Product Type
          • 6.6.3.3.3.2 By End User
        • 6.6.3.3.4 Rest-of-Middle East and Africa
          • 6.6.3.3.4.1 By Product Type
          • 6.6.3.3.4.2 By End User

7. Competitive Landscape and Company Profiles

  • 7.1 Competitive Landscape
    • 7.1.1 Overview
    • 7.1.2 Segmental Growth Matrix
      • 7.1.2.1 Growth Share Analysis (By Product Type)
      • 7.1.2.2 Growth Share Analysis (By Application)
    • 7.1.3 Key Strategies and Developments
      • 7.1.3.1 Regulatory and Legal Activities
      • 7.1.3.2 Funding Activities
      • 7.1.3.3 New Offerings
      • 7.1.3.4 Mergers and Acquisitions
      • 7.1.3.5 Partnership, Collaboration and Business Expansion
  • 7.2 Becton, Dickinson and Company
    • 7.2.1 Overview
    • 7.2.2 Product Portfolio
    • 7.2.3 Target Customers
    • 7.2.4 Key Professionals
    • 7.2.5 Analyst View
  • 7.3 Bio-Rad Laboratories, Inc.
    • 7.3.1 Overview
    • 7.3.2 Product Portfolio
    • 7.3.3 Target Customers
    • 7.3.4 Key Professionals
    • 7.3.5 Analyst View
  • 7.4 Bio-Techne Corporation
    • 7.4.1 Overview
    • 7.4.2 Product Portfolio
    • 7.4.3 Target Customers
    • 7.4.4 Key Professionals
    • 7.4.5 Analyst View
  • 7.5 Danaher Corporation
    • 7.5.1 Overview
    • 7.5.2 Product Portfolio
    • 7.5.3 Target Customers
    • 7.5.4 Key Professionals
    • 7.5.5 Analyst View
  • 7.6 Endress+Hauser Group Services AG, (Analytik Jena GmbH)
    • 7.6.1 Overview
    • 7.6.2 Product Portfolio
    • 7.6.3 Target Customers
    • 7.6.4 Key Professionals
    • 7.6.5 Analyst View
  • 7.7 General Electric Company (GE Healthcare)
    • 7.7.1 Overview
    • 7.7.2 Product Portfolio
    • 7.7.3 Target Customers
    • 7.7.4 Key Professionals
    • 7.7.5 Analyst View
  • 7.8 Getinge AB
    • 7.8.1 Overview
    • 7.8.2 Product Portfolio
    • 7.8.3 Target Customers
    • 7.8.4 Key Professionals
    • 7.8.5 Analyst View
  • 7.9 Infors AG
    • 7.9.1 Overview
    • 7.9.2 Product Portfolio
    • 7.9.3 Target Customers
    • 7.9.4 Key Professionals
    • 7.9.5 Analyst View
  • 7.10 Lonza Group Ltd.
    • 7.10.1 Overview
    • 7.10.2 Product Portfolio
    • 7.10.3 Target Customers
    • 7.10.4 Key Professionals
    • 7.10.5 Analyst View
  • 7.11 Merck KGaA
    • 7.11.1 Overview
    • 7.11.2 Product Portfolio
    • 7.11.3 Target Customers
    • 7.11.4 Key Professionals
    • 7.11.5 Analyst View
  • 7.12 Miltenyi Biotech B.V. & Co. KG
    • 7.12.1 Overview
    • 7.12.2 Product Portfolio
    • 7.12.3 Target Customers
    • 7.12.4 Key Professionals
    • 7.12.5 Analyst View
  • 7.13 Pierre Guerin
    • 7.13.1 Overview
    • 7.13.2 Product Portfolio
    • 7.13.3 Target Customers
    • 7.13.4 Key Professionals
    • 7.13.5 Analyst View
  • 7.14 Sartorius AG (Sartorious Stedim Biotech S.A.)
    • 7.14.1 Overview
    • 7.14.2 Product Portfolio
    • 7.14.3 Target Customers
    • 7.14.4 Key Professionals
    • 7.14.5 Analyst View
  • 7.15 Thermo Fisher Scientific Inc.
    • 7.15.1 Overview
    • 7.15.2 Product Portfolio
    • 7.15.3 Target Customers
    • 7.15.4 Key Professionals
    • 7.15.5 Analyst View
  • 7.16 WuXi App Tech
    • 7.16.1 Overview
    • 7.16.2 Product Portfolio
    • 7.16.3 Target Customers
    • 7.16.4 Key Professionals
    • 7.16.5 Analyst View

8. Research Methodology

List of Figures

  • Figure: Global Cell and Gene Therapy Biomanufacturing Market, Market Dynamics Impact Analysis
  • Figure: Global Cell and Gene Therapy Biomanufacturing Market Coverage
  • Figure: Global Cell and Gene Therapy Biomanufacturing Market Key Trends, Impact Analysis, 2023-2035
  • Figure: Global Cell and Gene Therapy Biomanufacturing Market, Patent Analysis, January 2022-March 2025
  • Figure: Global Cell and Gene Therapy Biomanufacturing Market, Competitive Landscape, January 2022-March 2025

List of Tables

  • Table: Global Cell and Gene Therapy Biomanufacturing Market, Comparative Analysis
  • Table: Global Cell and Gene Therapy Biomanufacturing Market, Regulatory Scenario
  • Table: Global Cell and Gene Therapy Biomanufacturing Market Dynamics, Impact Analysis
  • Table: Global Cell and Gene Therapy Biomanufacturing Market (by Product), $Million, 2023-2035
  • Table: Global Cell and Gene Therapy Biomanufacturing Market (by Application), $Million, 2023-2035
  • Table: Global Cell and Gene Therapy Biomanufacturing Market (by Usage), $Million, 2023-2035
  • Table: Global Cell and Gene Therapy Biomanufacturing Market (by End User), $Million, 2023-2035