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1938910

人類細胞治療材料市場－全球產業規模、佔有率、趨勢、機會及預測（依產品、最終用戶、地區及競爭格局分類，2021-2031年）

Cell Therapy Human Raw Materials Market- Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product, By End User, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 180 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球人類細胞治療材料市場預計將從 2025 年的 30.1 億美元成長到 2031 年的 60.8 億美元，複合年成長率為 12.43%。

這些原料包括源自人類捐贈者的生物物質，例如白血球濃縮物和血清白蛋白，它們是治療產品生產所必需的。推動市場成長的關鍵因素是全球腫瘤疾病發生率的上升（這些疾病需要個人化治療），以及對再生醫學研究投入的資金不斷增加。這些不斷變化的臨床環境正在推動對高品質生物原料的需求，而這些原料對於開發新型免疫療法至關重要。

市場概覽
預測期 2027-2031
市場規模：2025年 30.1億美元
市場規模：2031年 60.8億美元
複合年成長率：2026-2031年 12.43%
成長最快的細分市場 生物製藥和製藥公司
最大的市場 北美洲

然而，由於獲取供體來源的材料需要嚴格的監管合規，市場面臨巨大的挑戰，這往往導致複雜的供應鏈。製造商必須遵守各種國際標準，包括捐贈者合格和材料安全標準，這可能會阻礙快速擴大生產規模。根據國際細胞與基因治療學會（ISCT）的數據，到2024年，全球在開發平臺治療方法達到3,063種，比上半年成長7.5%。如此龐大的規模將為現有的供應鏈帶來巨大的壓力。

市場促進因素

細胞療法臨床試驗和研發投資的激增正成為原料市場的重要催化劑，也使得建構可擴展的供應鏈變得更加迫切。隨著生物製藥公司和研究機構加速推進研發項目，對高品質生物原料（例如人類血清和白血球製劑）的需求也隨之飆升。大量資金的湧入使得研發人員能夠推進候選藥物完成成本高昂的後期臨床試驗，從而增加了製程開發和生產所需的原料數量。根據再生醫學聯盟預測，截至2024年10月，該領域預計將在2024年上半年吸引109億美元的投資，為這些資源密集階段提供必要的流動性。

同時，合約研發生產機構（CDMO）和生物製藥公司擴大生產能力，直接緩解了原料供應瓶頸。為了緩解供不應求並確保符合良好生產規範（GMP），主要企業正在大力投資基礎設施，以支援輔助材料的生產。這種對內部和外部能力的策略性擴張，確保了供應鏈能夠承受商業規模生產的壓力。例如，BioIVT於2024年8月在維吉尼亞溫徹斯特開設了一家新的無塵室生產設施，旨在擴大符合GMP標準的輔助材料的生產。這些發展對於支持快速成長的生態系統至關重要。根據美國基因與細胞治療學會統計，截至2024年4月，全球在開發平臺基因、細胞及RNA治療方法超過4000種。

市場挑戰

嚴格的監管要求是取得供體來源材料的重要限制阻礙因素。由於這些材料生物來源，因此必須遵守嚴格的供體合格安全通訊協定。然而，全球缺乏統一標準導致了市場環境的碎片化，在一個地區檢驗的材料可能不符合其他地區的標準。這種不一致迫使製造商建立獨立的供應鏈並進行重複測試，這直接影響了營運效率，並延緩了治療方法的商業化。

在產業活動活性化、資源流動亟需保障的當下，這些監管障礙尤其具有破壞性。原料跨境運輸的不便限制了滿足全球臨床試驗需求所需的柔軟性。再生醫學聯盟報告稱，到2025年，全球研發公司數量將成長6%。對有限的匹配供體材料的競爭日益激烈，加劇了供不應求，並最終阻礙了整體市場的成長潛力。

市場趨勢

在同種異體移植療法中，經鑑定的白血球製劑的日益普及正在從根本上改變原料格局，使可擴展的供體來源材料取代患者特異性來源材料成為首要考慮因素。隨著研發人員轉向使用現成療法以降低生產成本，符合GMP標準且針對特定HLA類型進行全面鑑定的白血球製劑對於確保大批量生產的一致性至關重要。這項轉變需要強大的供體網路和高通量處理能力來維持高品質細胞材料的穩定供應。根據BioLife Solutions於2024年11月發布的“2024會計年度第三季財報”，該公司細胞處理平台營收年增43%，凸顯了業界對檢驗的生物儲存和原料解決方案日益成長的需求。

人類血小板裂解物 (HPL) 作為一種無異種成分添加劑，其應用正在加速普及。這主要是由於製造商希望消除與牛等動物性成分相關的安全風險。推動這一趨勢的因素之一是市場對化學成分明確、病原體減少的培養基的需求，這種培養基能夠支持間質幹細胞和 T 細胞的臨床級擴增，同時又不影響表現型穩定性。因此，供應商正在擴展其生產基礎設施，以提供符合嚴格國際品質標準的標準化、病毒去活化的 HPL 配方。根據 PL BioScience 公司 2024 年 8 月發布的新聞稿“PL BioScience 完成 A 輪資金籌措”，該公司已資金籌措780 萬歐元用於擴大產能，這反映了該行業正迅速向永續的、無動物成分的培養系統轉型。

目錄

第1章概述

第2章調查方法

第3章執行摘要

第4章：客戶評價

第5章 人類細胞治療材料的全球市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 副產物（細胞培養基、細胞培養血清、細胞培養添加劑、試劑及緩衝溶液、其他）
    • 依最終用戶（生物製藥/製藥公司、CRO/CMO、學術/研究機構）分類
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美人類細胞治療材料市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國家分析
    • 美國
    • 加拿大
    • 墨西哥

7. 歐洲人類細胞治療材料市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國家分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

8. 亞太地區人類細胞治療材料市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國家分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

9. 中東和非洲人類細胞治療材料市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東和非洲：國家分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲人類細胞治療材料市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國家分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進要素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 最新進展

第13章 全球細胞治療人體材料市場：SWOT分析

第14章 波特五力分析

  • 產業競爭
  • 新進入者的可能性
  • 供應商電力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • 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16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 23922

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.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 3.01 Billion
Market Size 2031USD 6.08 Billion
CAGR 2026-203112.43%
Fastest Growing SegmentBiopharmaceutical & Pharmaceutical Companies
Largest MarketNorth America

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

17. About Us & Disclaimer