人类细胞治疗材料市场－全球产业规模、份额、趋势、机会及预测（依产品、最终用户、地区及竞争格局划分，2021-2031年）

全球人类细胞治疗材料市场预计将从 2025 年的 30.1 亿美元成长到 2031 年的 60.8 亿美元，复合年增长率为 12.43%。

这些原料包括源自人类捐赠者的生物物质，例如白血球浓缩物和血清白蛋白，它们是治疗产品生产所必需的。推动市场成长的关键因素是全球肿瘤疾病发生率的上升（这些疾病需要个人化治疗），以及对再生医学研究投入的资金不断增加。这些不断变化的临床环境正在推动对高品质生物原料的需求，而这些原材料对于开发新型免疫疗法至关重要。

然而，由于获取供体来源的材料需要严格的监管合规，市场面临巨大的挑战，这往往导致复杂的供应链。製造商必须遵守各种国际标准，包括捐赠者合格和材料安全标准，这可能会阻碍快速扩大生产规模。根据国际细胞与基因治疗学会（ISCT）的数据，到2024年，全球在开发平臺治疗方法达到3,063种，比上半年成长7.5%。如此庞大的规模将为现有的供应链带来巨大的压力。

市场驱动因素

细胞疗法临床试验和研发投资的激增正成为原料市场的重要催化剂，也使得建构可扩展的供应链变得更加迫切。随着生物製药公司和研究机构加速推进研发项目，对高品质生物原料（例如人类血清和白血球製剂）的需求也随之飙升。大量资金的涌入使得研发人员能够推进候选药物完成成本高昂的后期临床试验，从而增加了製程开发和生产所需的原料数量。根据再生医学联盟预测，截至2024年10月，该领域预计将在2024年上半年吸引109亿美元的投资，为这些资源密集阶段提供必要的流动性。

同时，合约研发生产机构（CDMO）和生物製药公司扩大生产能力，直接缓解了原料供应瓶颈。为了缓解供不应求并确保符合良好生产规范（GMP），主要企业正在大力投资基础设施，以支援辅助材料的生产。这种对内部和外部能力的策略性扩张，确保了供应链能够承受商业规模生产的压力。例如，BioIVT于2024年8月在维吉尼亚温彻斯特开设了一家新的无尘室生产设施，旨在扩大符合GMP标准的辅助材料的生产。这些发展对于支持快速成长的生态系统至关重要。根据美国基因与细胞治疗学会统计，截至2024年4月，全球在开发平臺基因、细胞及RNA治疗方法超过4000种。

市场挑战

严格的监管要求是取得供体来源材料的重要限制阻碍因素。由于这些材料生物来源，因此必须遵守严格的供体合格安全通讯协定。然而，全球缺乏统一标准导致了市场环境的碎片化，在一个地区检验的材料可能不符合其他地区的标准。这种不一致迫使製造商建立独立的供应链并进行重复测试，这直接影响了营运效率，并延缓了治疗方法的商业化。

在产业活动活性化、资源流动亟需保障的当下，这些监管障碍尤其具有破坏性。原材料跨境运输的不便限制了满足全球临床试验需求所需的柔软性。再生医学联盟报告称，到2025年，全球研发公司数量将成长6%。对有限的匹配供体材料的竞争日益激烈，加剧了供不应求，并最终阻碍了整体市场的成长潜力。

市场趋势

在同种异体移植疗法中，经鑑定的白血球製剂的日益普及正在从根本上改变原材料格局，使可扩展的供体来源材料取代患者特异性来源材料成为首要考虑因素。随着研发人员转向使用现成疗法以降低生产成本，符合GMP标准且针对特定HLA类型进行全面鑑定的白血球製剂对于确保大批量生产的一致性至关重要。这项转变需要强大的供体网络和高通量处理能力来维持高品质细胞材料的稳定供应。根据BioLife Solutions于2024年11月发布的“2024财年第三季财报”，该公司细胞处理平台营收年增43%，凸显了业界对检验的生物储存和原料解决方案日益增长的需求。

人类血小板裂解物 (HPL) 作为一种无异种成分添加剂，其应用正在加速普及。这主要是由于製造商希望消除与牛等动物性成分相关的安全风险。推动这一趋势的因素之一是市场对化学成分明确、病原体减少的培养基的需求，这种培养基能够支持间质干细胞和 T 细胞的临床级扩增，同时又不影响表型稳定性。因此，供应商正在扩展其生产基础设施，以提供符合严格国际品质标准的标准化、病毒灭活的 HPL 配方。根据 PL BioScience 公司 2024 年 8 月发布的新闻稿“PL BioScience 完成 A 轮资金筹措”，该公司已资金筹措780 万欧元用于扩大产能，这反映了该行业正迅速向永续的、无动物成分的培养系统转型。

目录

第一章概述

第二章调查方法

第三章执行摘要

第四章：客户评价

第五章 人类细胞治疗材料的全球市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 副产物（细胞培养基、细胞培养血清、细胞培养添加剂、试剂及缓衝溶液、其他）
  • 依最终用户（生物製药/製药公司、CRO/CMO、学术/研究机构）划分
  • 按地区
  • 按公司（2025 年）
• 市场地图

第六章：北美人类细胞治疗材料市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国家分析
  • 我们
  • 加拿大
  • 墨西哥

7. 欧洲人类细胞治疗材料市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国家分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

8. 亚太地区人类细胞治疗材料市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

9. 中东和非洲人类细胞治疗材料市场展望

• 市场规模及预测
• 市占率及预测
• 中东和非洲：国家分析
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 南非

第十章：南美洲人类细胞治疗材料市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国家分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章 市场动态

• 司机
• 任务

第十二章 市场趋势与发展

• 併购
• 产品发布
• 最新进展

第十三章 全球细胞治疗人体材料市场：SWOT分析

第十四章 波特五力分析

• 产业竞争
• 新进入者的可能性
• 供应商电力
• 顾客权力
• 替代品的威胁

第十五章 竞争格局

• Thermo Fisher Scientific, Inc.
• Merck KgaA
• Danaher Corporation
• Sartorius AG
• Aceto Holding GmbH
• Acrobiosystems Inc.
• Grifols, SA
• Charles River Laboratories International, Inc.
• RoosterBio, Inc

第十六章 策略建议

第十七章：关于研究公司及免责声明

The Global Cell Therapy Human Raw Materials Market is projected to expand from USD 3.01 Billion in 2025 to USD 6.08 Billion by 2031, registering a CAGR of 12.43%. These raw materials encompass biological substances sourced from human donors, including leukopaks and serum albumin, which are indispensable for manufacturing therapeutic products. Key drivers propelling market growth include the increasing global incidence of oncological diseases requiring personalized interventions and heightened capital allocation for regenerative medicine research. This dynamic clinical environment fuels the demand for high-quality biological inputs essential for the development of new immunotherapies.

However, the market encounters significant challenges regarding the strict regulatory compliance needed for sourcing donor-derived materials, often resulting in supply chain complexities. Manufacturers must navigate diverse international standards for donor eligibility and material safety, which can hinder rapid scalability. According to the International Society for Cell & Gene Therapy, the global pipeline included 3,063 therapies in 2024, marking a 7.5% increase from the first half of the year; this volume imposes immense pressure on existing supply networks.

Market Driver

The surge in cell therapy clinical trials and R&D investment serves as a primary catalyst for the raw materials market, creating an urgent need for scalable supply chains. As biopharmaceutical companies and research institutions accelerate their development programs, the demand for high-grade biological inputs like human serum and leukopaks has intensified. This influx of capital allows developers to advance candidates through costly late-stage trials, thereby increasing the volume of raw materials required for process development and manufacturing. According to the Alliance for Regenerative Medicine, the sector attracted $10.9 billion in investment during the first half of the year as of October 2024, providing the necessary liquidity to sustain these resource-intensive phases.

Simultaneously, the expansion of manufacturing capabilities by CDMOs and biopharma companies is directly addressing bottlenecks in raw material availability. To mitigate supply shortages and ensure compliance with Good Manufacturing Practice (GMP) standards, key industry players are investing heavily in infrastructure that supports the production of ancillary materials. This strategic broadening of internal and external capacity ensures that the supply chain can withstand the pressures of commercial-scale production. For instance, BioIVT opened a new cleanroom manufacturing facility in Winchester, Virginia, in August 2024, specifically designed to enhance the output of GMP-compliant ancillary materials. These advancements are critical to supporting the rapidly growing ecosystem; according to the American Society of Gene & Cell Therapy, the global development pipeline comprised over 4,000 gene, cell, and RNA therapies in April 2024.

Market Challenge

The stringent regulatory compliance required for sourcing donor-derived materials acts as a significant restraint on the Global Cell Therapy Human Raw Materials Market. Since these inputs are biological, they are subject to rigorous safety protocols regarding donor eligibility. However, the lack of global harmonization creates a fragmented landscape where material validated for one region may not meet the criteria of another. This discrepancy compels manufacturers to establish segregated supply chains and conduct redundant testing, which directly impedes operational efficiency and slows the commercialization of therapies.

These regulatory hurdles are particularly damaging given the intensification of industry activity, which demands a seamless flow of resources. The inability to easily transfer raw materials across borders restricts the flexibility needed to meet global clinical trial demands. According to the Alliance for Regenerative Medicine, the sector reported a 6% increase in the number of developers globally in 2025. This expansion in companies vying for limited, compliant donor material exacerbates supply shortages, ultimately hampering the overall growth potential of the market.

Market Trends

The increased utilization of characterized leukopaks for allogeneic therapies is fundamentally reshaping the raw materials landscape by prioritizing scalable, donor-derived starting materials over patient-specific sources. As developers shift toward off-the-shelf modalities to reduce manufacturing costs, there is a critical requirement for leukopaks that are GMP-compliant and extensively characterized for specific HLA types to ensure consistency across large batches. This transition necessitates robust donor networks and high-throughput processing capabilities to maintain a steady supply of high-quality cellular starting material. According to BioLife Solutions, in their 'Third Quarter 2024 Financial Results' released in November 2024, the company reported a 43% increase in cell processing platform revenue compared to the prior year, highlighting the surging industrial demand for validated biopreservation and starting material solutions.

The widespread adoption of Human Platelet Lysate (HPL) as a xeno-free supplement is accelerating as manufacturers seek to eliminate the safety risks associated with animal-derived components like Fetal Bovine Serum. This trend is driven by the need for chemically defined, pathogen-reduced media that supports the clinical-grade expansion of Mesenchymal Stem Cells and T-cells without compromising phenotypic stability. Consequently, suppliers are expanding their manufacturing infrastructure to provide standardized, viral-inactivated HPL formulations that meet stringent international quality standards. According to PL BioScience, in the August 2024 press release 'PL BioScience closes Series A Financing', the company secured €7.8 million specifically to scale up its production capacities, reflecting the sector's urgent move toward sustainable, non-animal derived culture systems.

Key Market Players

• Thermo Fisher Scientific, Inc.
• Merck KgaA
• Danaher Corporation
• Sartorius AG
• Aceto Holding GmbH
• Acrobiosystems Inc.
• Grifols, S.A
• Charles River Laboratories International, Inc.
• RoosterBio, Inc

Report Scope

In this report, the Global Cell Therapy Human Raw Materials Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Cell Therapy Human Raw Materials Market, By Product

• Cell Culture Media
• Cell Culture Sera
• Cell Culture Supplements
• Reagents & Buffers
• Other

Cell Therapy Human Raw Materials Market, By End User

• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs
• Academic & Research Institutions

Cell Therapy Human Raw Materials Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cell Therapy Human Raw Materials Market.

Available Customizations:

Global Cell Therapy Human Raw Materials Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Cell Therapy Human Raw Materials Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Cell Culture Media, Cell Culture Sera, Cell Culture Supplements, Reagents & Buffers, Other)
  • 5.2.2. By End User (Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs, Academic & Research Institutions)
  • 5.2.3. By Region
  • 5.2.4. By Company (2025)
• 5.3. Market Map

6. North America Cell Therapy Human Raw Materials Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By End User
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Cell Therapy Human Raw Materials Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Product
      • 6.3.1.2.2. By End User
  • 6.3.2. Canada Cell Therapy Human Raw Materials Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Product
      • 6.3.2.2.2. By End User
  • 6.3.3. Mexico Cell Therapy Human Raw Materials Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Product
      • 6.3.3.2.2. By End User

7. Europe Cell Therapy Human Raw Materials Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By End User
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Cell Therapy Human Raw Materials Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Product
      • 7.3.1.2.2. By End User
  • 7.3.2. France Cell Therapy Human Raw Materials Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Product
      • 7.3.2.2.2. By End User
  • 7.3.3. United Kingdom Cell Therapy Human Raw Materials Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Product
      • 7.3.3.2.2. By End User
  • 7.3.4. Italy Cell Therapy Human Raw Materials Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Product
      • 7.3.4.2.2. By End User
  • 7.3.5. Spain Cell Therapy Human Raw Materials Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Product
      • 7.3.5.2.2. By End User

8. Asia Pacific Cell Therapy Human Raw Materials Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By End User
  • 8.2.3. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Cell Therapy Human Raw Materials Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Product
      • 8.3.1.2.2. By End User
  • 8.3.2. India Cell Therapy Human Raw Materials Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Product
      • 8.3.2.2.2. By End User
  • 8.3.3. Japan Cell Therapy Human Raw Materials Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Product
      • 8.3.3.2.2. By End User
  • 8.3.4. South Korea Cell Therapy Human Raw Materials Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Product
      • 8.3.4.2.2. By End User
  • 8.3.5. Australia Cell Therapy Human Raw Materials Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Product
      • 8.3.5.2.2. By End User

9. Middle East & Africa Cell Therapy Human Raw Materials Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By End User
  • 9.2.3. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Cell Therapy Human Raw Materials Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Product
      • 9.3.1.2.2. By End User
  • 9.3.2. UAE Cell Therapy Human Raw Materials Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Product
      • 9.3.2.2.2. By End User
  • 9.3.3. South Africa Cell Therapy Human Raw Materials Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Product
      • 9.3.3.2.2. By End User

10. South America Cell Therapy Human Raw Materials Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By End User
  • 10.2.3. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Cell Therapy Human Raw Materials Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Product
      • 10.3.1.2.2. By End User
  • 10.3.2. Colombia Cell Therapy Human Raw Materials Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Product
      • 10.3.2.2.2. By End User
  • 10.3.3. Argentina Cell Therapy Human Raw Materials Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Product
      • 10.3.3.2.2. By End User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Cell Therapy Human Raw Materials Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Thermo Fisher Scientific, Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Merck KgaA
• 15.3. Danaher Corporation
• 15.4. Sartorius AG
• 15.5. Aceto Holding GmbH
• 15.6. Acrobiosystems Inc.
• 15.7. Grifols, S.A
• 15.8. Charles River Laboratories International, Inc.
• 15.9. RoosterBio, Inc

16. Strategic Recommendations

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