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細胞和基因治療生物製造市場-全球和區域分析：按產品類型、應用、用途、最終用戶和區域-分析和預測（2025-2035）
市場調查報告書
商品編碼
1715253

細胞和基因治療生物製造市場-全球和區域分析：按產品類型、應用、用途、最終用戶和區域-分析和預測（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個工作天內

價格

全球細胞和基因療法生物製造市場規模正在快速成長，這得益於製造技術的進步、對創新治療方法的需求不斷成長以及對生物製藥研究的大量投資。

關鍵促進因素包括製造過程中自動化和人工智慧的整合、病毒載體技術的改進以及需要個人化治療的慢性病的盛行率不斷上升。人們對個人化醫療的日益關注，加上政府措施和創業投資的不斷增加的支持，正在刺激市場進一步擴張。此外，雖然 FDA 和 EMA 等監管機構正在為基因療法提供快速核准途徑，但該行業正在努力克服高生產成本和擴充性挑戰。

有幾個關鍵因素推動細胞和基因治療生物製造市場的成長。生物製造技術的不斷進步，包括改進的細胞培養系統、病毒載體生產和 CRISPR 等基因編輯工具，正在推動對專業製造能力的需求。隨著基因和細胞療法變得越來越複雜和個人化，製造過程也需要更高的精度、專門的設備和個人化的方法來確保高品質的生產。此外，FDA 和 EMA 等監管機構對這些療法的生產提出了嚴格的要求，需要採取強力的品管(QC) 措施來滿足安全性、有效性和合規性標準。個人化醫療的興起，即根據個人基因圖譜設計治療方法，導致對更複雜的製造流程和更高的品質控制標準的需求增加。

儘管存在巨大的機會，細胞和基因治療生物製造市場仍存在一些挑戰。主要障礙之一是製造過程的複雜性，它比傳統藥物製造過程複雜得多。這種複雜性意味著更高的製造成本、更長的時間表以及更大的一致性和品質風險。此外，法規環境也在不斷發展，特別是在個人化治療方面，這對必須不斷適應新指南並保持合規的製造商提出了挑戰。此外，細胞和基因治療製造成本高昂，需要先進的基礎設施和熟練的人力，這進一步增加了擴充性。這些障礙可能會阻止小型生技公司和新興製造商與更大的競爭對手競爭，並限制這些治療方法的可及性和可負擔性，特別是在早期市場。這些挑戰也可能影響細胞和基因療法的廣泛應用。細胞和基因療法成本過高，通常需要在專門的設備、培訓和監管流程上進行大量投資。

全球細胞和基因治療生物製造市場目前正處於快速發展階段，其特徵是顯著的成長和發展。這種成長背後的主要因素是個人化醫療需求的增加、技術創新以及研發投入的增加。隨著越來越多的基因療法開發，人們的注意力轉向先進的製造技術，例如改進的病毒載體生產、CRISPR 等基因編輯技術以及幹細胞應用。此外，法規環境正在不斷發展以支持這些治療方法，FDA 和 EMA 等機構的更清晰的核准途徑縮短了新治療方法的上市時間。

這些治療方法的複雜性加上對專門製造系統的需求，導致了品管（QC）服務、流程最佳化和製造擴充性的提高。市場上生物技術公司、製藥公司和受託製造廠商(CMO) 之間的夥伴關係正在湧入，從而促進進一步的創新和製造能力的獲取。

現階段，市場正從早期開發轉向擴張，商業化程度不斷提高，並專注於擴大生產以滿足全球市場需求。現階段，產業領導者之間存在著明顯的競爭，以建立更有效率、更具成本效益的生產系統，從而確保未來更廣泛地使用這些治療方法。

細胞和基因治療生物製造市場透過為一系列遺傳疾病、癌症和其他複雜疾病提供尖端治療方法，處於醫療保健治療革命的前沿。由於基因編輯、病毒載體生產和幹細胞應用技術的進步，該行業正在蓬勃發展。隨著這些治療方法進入臨床和商業階段，生物製造過程的顯著改進對於滿足日益成長的需求至關重要。

該行業的關鍵技術進步包括：

  • CRISPR 和基因編輯：CRISPR 技術釋放了精確、有針對性的基因修飾的潛力，從而能夠開發高度個人化的遺傳疾病治療方法。這項技術可以實現更有效率的基因編輯，從而帶來需要更少資源和時間的製造流程的創新。
  • 病毒載體生產：病毒載體，尤其是AAV（腺結合病毒）和慢病毒，在基因轉移系統中扮演重要角色。病毒載體製造、精製和擴大規模技術的進步對於基因治療的成功生產至關重要，尤其是在治療方法變得更加個人化的情況下。
  • 幹細胞技術：基於幹細胞的治療方法擴大與再生醫學的基因療法結合。幹細胞製造過程的創新，包括細胞培養和分化技術，正在開闢新的治療可能性，特別是在再生醫學和免疫療法領域。
  • 自動化和人工智慧：生物製造中自動化和人工智慧的融合正在提高效率、減少人為錯誤並提高生產一致性。人工智慧也被用於預測分析、簡化品管和最佳化製造流程。
  • 模組化和一次性技術：使用模組化生物製造系統和一次性技術可以實現更靈活、更具成本效益和可擴展的生產。

技術進步對細胞和基因治療生物製造市場的影響

提高製造效率：技術創新大大減少了生產時間、成本和資源消耗。自動化系統和模組化平台的採用正在提高製造的可擴展性和一致性，使公司能夠更有效率、更大規模地生產基因療法。

降低成本並提高可近性：細胞培養系統、病毒載體生產和自動化的進步有可能降低與基因治療製造相關的高成本。隨著生產成本的下降，更多患者，特別是在新興市場，可以獲得這些治療方法。

提高產品品質：即時監控和人工智慧分析等先進品管(QC) 技術的整合，確保基因治療產品符合安全性、有效性和一致性的最高標準。這些技術提高了個人化醫療所需的產品的可靠性。

更快的上市時間：更有效率的製造流程和監管途徑的結合將使公司能夠更快地將基因療法推向市場。 FDA 和 EMA 等監管機構正在簡化突破性治療方法的核准流程，為更快的商業化創造機會。

個人化醫療：對個​​人化醫療的需求從未如此高漲。 CRISPR 等治療開發技術和病毒載體製造的進步使得開發適合每個人基因特徵的治療方法成為可能，改善了治療效果並為標靶治療開闢了新興市場。

細胞和基因治療生物製造市場挑戰和市場影響：

儘管取得了這些進展，細胞和基因療法生物製造市場仍面臨重大挑戰：

可擴展性：擴大生產以滿足全球對基因療法的需求仍然是一項挑戰。儘管技術進步正在提高效率，但在保持高品質的同時實現具有成本效益的大規模生產仍然是一個持續的挑戰。

高成本：製造成本高仍然是一個主要障礙，特別是因為需要專門的設備、熟練的人力和先進的技術。這些成本可能會限制基因治療的獲取，特別是對於規模較小的生物技術和早期公司。

監管障礙：雖然監管機構正在簡化核准流程，但要適應基因治療（尤其是個人化治療）複雜的法規環境，仍需要持續的適應和投資。這些不斷變化的法規可能會減緩開發進程並增加成本。

根據產品，2024 年全球細胞和基因治療生物製造市場以消耗品領域為主。該設備的使用壽命為5至7年，軟體解決方案也需要一次性投資和每年的維護成本。然而，細胞和基因治療生產需要更頻繁、更大的消耗品數量。

根據應用，2024 年全球細胞和基因治療生物製造市場以研究階段製造領域為主。

根據最終用戶，2024 年全球細胞和基因療法生物製造市場將由生命科學公司主導。

全球細胞和基因療法生物製造市場的最新趨勢

  • 2023 年 1 月，Sartorius AG 與 Roosterbio Inc. 合作，推動外泌體開發的下游精製製程。
  • 2022 年 2 月，Sartorius AG 完成對 Novasep層析法部門的收購，以補充產品系列。
  • 2022年8月，默克公司推出了VirusExpress 293腺相關病毒（AAV）生產平台，以加速細胞和基因療法的開發。
  • 2022 年 6 月，龍沙集團 (Lonza Group AG) 與 Adva Biotechnology Ltd. 簽署了授權合約，允許 Adva Biotechnology 使用其核心智慧財產權，從而實現自動化生物反應器的全球擴張。
  • 2022年6月，碧迪公司推出了搭載CellView成像技術的FACSDiscover S8細胞分選儀。
  • 2023 年 1 月，Bio-Techne 公司推出了 RNAscope plus 檢測，以推動基因療法的發展。
  • 2023 年 4 月，丹納赫 (Cytiva) 推出了 X-platform 生物反應器，旨在最佳化一次性上游生物加工作業。這些生物反應器在單株抗體、蛋白質藥物、細胞和基因療法藥物以及病毒載體的生產方面具有靈活性和效率，以支持各種治療產品的開發和製造。

推動細胞和基因治療生物製造市場需求的因素：

  • 核准治療方法的數量不斷增加以及對基礎設施增加的需求正在推動對細胞和基因療法生物製造產品的需求激增。
  • 擴大細胞和基因治療應用將創造大規模生物製造的需求
  • 細胞和基因治療市場新參與企業推動生物製造設施和設備需求
  • 細胞和基因治療投資和資金籌措了細胞和基因治療生物製造的成長

限制細胞和基因治療生物製造市場的因素：

  • 建立生物製造設施的成本高昂

細胞和基因治療生物製造市場機會：

  • 根據個人基因圖譜客製化治療的需求日益成長，為專業化製造流程創造了機會。
  • 基因傳遞系統中對病毒載體的需求不斷增加，為專門從事可擴展病毒載體生產的公司提供了機會，特別是在 AAV 和慢病毒載體的開發方面。

工作流程/創新策略：細胞和基因療法生物製造市場（按產品類型）分為消耗品、設備和軟體解決方案。此外，它還為讀者提供了對細胞和基因治療生物製造的原料製備、上游工程、下​​游加工和包裝中的各種應用的詳細了解。

成長/行銷策略：細胞和基因治療生物製造用於原料製備、上游工程、下​​游加工和包裝。各種公司提供有助於製造各種細胞和基因療法的產品和服務，這也是市場參與者在當前細胞和基因療法生物製造市場中獲得優勢的關鍵策略。

競爭策略：對全球細胞和基因治療生物製造市場的主要企業進行了分析和描述，包括參與新產品發布、收購、擴張和策略聯盟的製造商。此外，我們也對全球細胞和基因療法生物製造市場中的參與者進行了詳細的競爭基準化分析，以呈現清晰的市場格局，幫助讀者了解參與者之間的競爭情況。此外，夥伴關係、協議和聯盟等全面的競爭策略可幫助讀者了解市場中尚未開發的收益來源。

本報告研究了全球細胞和基因治療生物製造市場，並概述了市場以及產品類型、應用、用途、最終用戶、地區和參與市場的公司概況的趨勢。

目錄

執行摘要

第1章 產業展望

  • 市場概況與生態系統
  • 主要趨勢
  • 機會評估
  • 法律規範
  • 產品基準
  • 專利分析
  • 經營模式分析
  • 研發線產品
  • 技術採用
  • 市場動態

2. 全球細胞和基因療法生物製造市場（按產品類型分類），百萬美元，2023 年至 2035 年

  • 概述
  • 耗材
  • 裝置
  • 軟體解決方案

3. 全球細胞和基因治療生物製造市場（按應用分類），百萬美元，2023-2035 年

  • 概述
  • 上游處理
  • 收成
  • 下游加工

4. 全球細胞和基因治療生物製造市場（按應用分類），百萬美元，2023 年至 2035 年

  • 概述
  • 商業階段製造
  • 研究階段製造

5. 全球細胞和基因治療生物製造市場（按最終用戶分類），百萬美元，2023 年至 2035 年

  • 概述
  • 生命科學公司
  • CRO
  • CMO
  • 細胞庫

6. 全球細胞和基因治療生物製造市場（按地區分類），百萬美元，2023-2035 年

  • 概述
  • 北美洲
  • 歐洲
  • 亞太地區
  • 拉丁美洲
  • 中東和非洲

第7章 競爭格局及公司概況

  • 競爭格局
  • 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8章調查方法

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