GMP 细胞治疗耗材市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPRE00029780
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 220
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GMP细胞治疗耗材市场预计将从2021年的110.3125亿美元增长到2028年的599.8589亿美元;预计 2022 年至 2028 年复合年增长率为 27.5%。

GMP 细胞治疗耗材市场根据产品、细胞治疗、工艺、最终用途和地区进行细分。该报告提供了对市场的见解和深入分析,强调了市场动态、趋势和机会等各种参数,以及各地区领先市场参与者的竞争格局分析。它还包括各地区 COVID-19 大流行的影响分析。

市场洞察

研究与应用的崛起开发和药物发现推动市场增长

药物发现是一个漫长的过程,包括早期发现、临床前阶段、临床阶段和监管审批等各个步骤。该过程极大地涉及使用细胞治疗耗材来达到预期的结果。根据世界卫生组织的数据,2020 年约有 1000 万人死于癌症,最常见的癌症是乳腺癌、肺癌、结肠癌、直肠癌和前列腺癌。各种研究表明,药物可以有效治疗癌症、神经系统疾病、自身免疫性疾病和其他慢性疾病,取得积极成果。因此,慢性疾病患病率的上升推动了对研发 (R&D) 活动的需求。

此外,市场上运营的众多生物技术公司正在相互合作,加速针对以下疾病的研发活动:全球水平。例如,2022 年 10 月,Century Therapeutics 和百时美施贵宝宣布达成研究合作和许可协议,开发和商业化多达四种诱导多能干细胞 (“iPSC”) 衍生的工程自然杀伤细胞 (“iNK”) 和/或用于血液恶性肿瘤和实体瘤的T细胞(“iT”)程序。此外,对个性化和再生医学的需求不断增长,进一步推动了细胞治疗耗材市场的增长。药物发现和研发的增加需要良好的生产规范,并且需要 GMP 消耗品才能从这些活动中获得所需的结果。因此,研究和应用的增加。开发活动以及药物发现的激增增加了 GMP 细胞治疗耗材的使用。

GMP 细胞治疗耗材市场 - 战略见解

基于产品的见解

根据产品,GMP细胞治疗耗材市场分为试剂盒、试剂/分子生物学试剂、生长因子/细胞因子和白细胞介素等。 2021年,套件细分市场占据最大的市场份额。然而,预计生长因子/细胞因子和白介素细分市场将在 2022 年至 2028 年实现最高的复合年增长率。专为细胞培养设计的试剂和补充剂允许多种细胞类型在受控条件下生长和繁殖。 TheraPEAK 产品包括一系列 GMP 缓冲液和试剂,专用于细胞和基因疗法的创建和开发。它们主要在 ISO: 13485 工厂生产,因此这些用于细胞和基因治疗的 GMP 解决方案被各种客户用于众多临床应用。有多种类型的分子生物学试剂本质上符合 GMP 标准,主要用于学术和临床环境。

GMP 细胞治疗耗材市场,按产品划分 - 2021-2028

基于细胞治疗的洞察

以细胞治疗为基础,GMP细胞治疗耗材市场细分为NK细胞治疗、干细胞治疗、T 细胞疗法等。 2021年,T细胞治疗领域占据最大的市场份额。然而,NK 细胞治疗领域的市场预计在预测期内将以最快的速度增长。嵌合抗原受体 (CAR) T 细胞疗法是一种免疫疗法,用于治疗某些类型的癌症,尤其是血癌或白血病。该疗法利用免疫系统的力量,通过消灭病毒和细菌等有害入侵者来预防感染和疾病。目前正在进行针对癌症治疗的 CAR T 细胞疗法的各种研究和临床试验。例如,2022 年 1 月,伦敦大学学院 (UCL) 研究人员开发了一种新的 CAR T 细胞疗法。该疗法在伦敦大学学院医院 (UCLH) 进行的 I 期临床试验得出的结论是,该疗法毒性作用较小且持久。 CAR T细胞治疗临床试验的不断增加,对GMP细胞治疗耗材的需求激增。

基于工艺的洞察

基于工艺,GMP细胞治疗耗材市场细分细胞收集和表征/分选和分离、细胞培养和扩增/制备、冷冻保存、细胞处理和配制、细胞分离和激活、细胞分配/处理、过程监测和控制/重新给药/质量保证等。 2021年,细胞收集和表征/分选和分离领域占据了最大的市场份额。然而,冷冻保存领域的 GMP 细胞治疗耗材市场预计在预测期内将以最快的速度增长。细胞表征对于理解细胞增殖、功能和整体过程中涉及的内在因素至关重要。根据这些特征对细胞进行分类和分离。公司正在构建符合 GMP 的细胞分选机,以避免过程中的污染。例如,Miltenyi Biotec 销售 MACSQuant Tyto 细胞分选仪,这是一种采用封闭盒系统的无菌且符合 GMP 的多参数细胞分选仪。该公司还提供分析证书 (CoA)、原产地证书 (CoO) 和产品信息文件 (PIF),用于细胞制造协议的监管批准。

基于最终用途的见解

根据最终用途,GMP 细胞治疗耗材市场分为临床、商业和研究。 2021年,临床细分市场占据最大市场份额。此外,同一领域的 GMP 细胞治疗耗材市场预计在预测期内将以最快的速度增长。在临床应用中,细胞疗法研究是在人体上进行的,以评估特定疗法的医学、外科或行为干预。由于慢性疾病患病率的上升、生物制剂的增加以及开展临床研究的合同研究组织数量的增加,临床试验正在扩大。预计各种细胞疗法将在未来几年获得市场授权。根据 Nature 的一篇文章,2021 年 4 月有 2,073 种活性细胞治疗药物正在研发中,比 2020 年更新增加了 572 种。

GMP 细胞治疗耗材市场参与者采用有机策略,例如产品推出和扩张,以扩大其在全球的足迹和产品组合,并满足不断增长的需求。市场上见证的无机增长战略是伙伴关系和合作。这些增长战略使市场参与者能够扩大业务并增强其地域影响力。此外,收购、合作伙伴关系和其他增长战略有助于增强公司的客户群并扩大其产品组合。

  • 2021 年 1 月,Sartorius 签署了一份与人类间充质干/基质细胞(hMSC)领先供应商RoosterBio Inc.进行战略合作。此次合作推动了再生医学 hMSC 生产规模的扩大。 RoosterBio 和 Sartorius 使用 RoosterBio 的 hMSC 和培养基系统以及 Sartorius 的一次性制造技术、过程控制软件和 hMSC 最终产品制造的细胞分析工具,创建了一套符合 GMP 兼容、以客户为中心的方案。
  • 2020 年 9 月,Bio-Techne Corporation 开设了约 61,000 平方英尺的最先进的良好生产规范 (GMP) 制造工厂。新工厂位于明尼苏达州圣保罗,致力于支持 GMP 级材料的大规模生产,这些材料是许多免疫肿瘤学和再生医学细胞和基因修饰治疗工作流程的重要组成部分。该设施帮助公司满足当前和未来对支持快速增长的细胞治疗市场所必需的 GMP 级试剂的需求。

GMP 细胞治疗耗材市场 - 公司简介

  • 赛多利斯股份公司                      
  • Thermo Fisher Scientific Inc         
  • Miltenyi Biotec BV &两合公司         
  • Bio-Techne Corp                      
  • 康宁公司                           
  • 富士胶片欧文科学公司    
  • 龙沙集团股份公司               ;      
  • BPS Bioscience Inc                 
  • 默克公司                          
  • 全球生命科学解决方案美国有限责任公司。
Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

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

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What are GMP cell therapy consumables?

Good Manufacturing Practices (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. Cell therapy manufacturing processes range in complexity. Cell therapy manufacturing processes require an underpinning pharmaceutical quality system and quality control (QC) laboratory, and all aspects of cell therapy manufacturing require trained personnel. As the process is complex there may be chances of contamination, therefore GMP in cell therapy is becoming mandatory. Also, the use of cell therapy for treatment of various diseases is increasing the demand for cell therapy consumables that are manufactured according to GMP regulations.

What are the driving factors for the global GMP cell therapy consumables worldwide?

The factors driving the growth of GMP cell therapy consumables are Increase in research & development and drug discovery, as well as increase in strategic collaborations.

What are the restraining factors for the global GMP cell therapy consumables worldwide?

Stringent regulatory policies are expected to restrict the GMP cell therapy consumables growth during the forecast period.

Who are the major players in GMP cell therapy consumables across the globe?

The GMP cell therapy consumables majorly consist of the players, such as Sartorius AG, Thermo Fisher Scientific Inc, Miltenyi Biotec BV & Co KG, Bio-Techne Corp, Corning Inc, FUJIFILM Irvine Scientific Inc, Lonza Group AG, BPS Bioscience Inc, Merck KGaA, and Global Life Sciences Solutions USA LLC among others.

Which segment is dominating the GMP cell therapy consumables market?

The global GMP cell therapy consumables based on the product are segmented into kits, reagents/molecular biology reagents, cell culture media and supplements, growth factors/cytokines and interleukins (including protein and nucleic acid purification buffers), and others. The kits segment held the largest market share in 2021. However, growth factors/cytokines and interleukins is anticipated to register the highest CAGR during the forecast period.

Which region is dominating the GMP cell therapy consumables market?

The global GMP cell therapy consumables based on regions is segmented into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. In 2021, the North American area held the largest market share. However, the Asia Pacific region is estimated to grow at the fastest CAGR of 29.6% during the forecast period

The List of Companies - GMP Cell Therapy Consumables Market

  1. Sartorius AG
  2. Thermo Fisher Scientific Inc
  3. Miltenyi Biotec BV & Co KG
  4. Bio-Techne Corp
  5. Corning Inc
  6. FUJIFILM Irvine Scientific Inc
  7. Lonza Group AG
  8. BPS Bioscience Inc
  9. Merck KGaA
  10. Global Life Sciences Solutions USA LLC

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

  1. Data Collection and Secondary Research:

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

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

  1. Primary Research:

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

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

A typical research interview fulfils the following functions:

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

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

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

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

Research Methodology

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

  1. Data Analysis:

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

  • Macro-Economic Factor Analysis:

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

  • Country Level Data:

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

  • Company Profile:

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

  • Developing Base Number:

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

  1. Data Triangulation and Final Review:

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

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

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

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