GMP Cell Therapy Consumables Market Size & Growth | 2028
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年的复合年增长率为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深入分析和见解,强调了各种参数,例如市场动态、趋势和机会以及各地区主要市场参与者的竞争格局分析。它还包括 COVID-19 大流行对各地区的影响分析。
市场洞察
研发和药物发现的增加推动市场增长
药物研发是一个漫长的过程,包括早期研发、临床前阶段、临床阶段和监管部门批准等多个步骤。该过程大量涉及使用细胞治疗耗材来实现预期效果。根据世界卫生组织的数据,2020 年因癌症死亡的人数约为 1000 万人,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,能够有效治疗癌症、神经系统疾病、自身免疫性疾病和其他慢性疾病的药物具有积极效果。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,以在全球范围内加速研发活动。例如,2022 年 10 月,Century Therapeutics 和 Bristol Myers Squibb 宣布了研究合作和许可协议,以开发和商业化多达四个诱导多能干细胞(“iPSC”)衍生的工程自然杀伤细胞(“iNK”)和/或 T 细胞(“iT”)计划,用于治疗血液系统恶性肿瘤和实体瘤。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,而 GMP 耗材是获得这些活动预期结果所必需的。因此,研发活动的增加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 -
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GMP 细胞治疗耗材市场:
复合年增长率(2021 - 2028 年)27.5%- 2021 年市场规模
110.3 亿美元 - 2028 年市场规模
599.9 亿美元
市场动态
- 財政部
- 財政部
- 財政部
- 財政部
- 財政部
- 財政部
- 財政部
- 財政部
- 財政部
关键人物;主力;重要一员
- 赛多利斯公司
- 赛默飞世尔科技公司
- 美天旎生物技术有限公司
- 生物技术公司
- 康宁公司
- 富士胶片尔湾科学公司
- 龙沙集团
- BPS 生物科学公司
- 默克公司
区域概况
- 北美
- 欧洲
- 亚太
- 南美洲和中美洲
- 中东和非洲
市场细分
- 套件
- 试剂/分子生物学试剂
- 生长因子/细胞因子和白细胞介素
- 其他的
- NK 细胞疗法
- 干细胞治疗
- T 细胞疗法
- 其他的
- 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
- 细胞加工和配方
- 细胞分离和激活
- 细胞分布/处理
- 过程监控和控制/重新管理/质量保证
- 其他的
- 临床
- 商业的
- 与研究
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
基于产品的洞察
根据产品,GMP 细胞治疗耗材市场细分为试剂盒、试剂/分子生物学试剂、生长因子/细胞因子和白介素等。2021 年,试剂盒部分占据了最大的市场份额。然而,生长因子/细胞因子和白介素部分预计将在 2022-2028 年期间在市场上实现最高的复合年增长率。专门为细胞培养设计的试剂和补充剂允许在受控条件下生长和繁殖多种细胞类型。TheraPEAK 产品包括一系列专用于细胞和基因疗法的创建和开发的 GMP 缓冲液和试剂。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。有各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。
基于细胞治疗的见解
根据细胞疗法,GMP 细胞治疗耗材市场细分为 NK 细胞疗法、干细胞疗法、T 细胞疗法等。2021 年,T 细胞疗法领域占据了最大的市场份额。然而,预计 NK 细胞疗法领域的市场在预测期内将以最快的速度增长。嵌合抗原受体 (CAR) T 细胞疗法是一种用于治疗某些类型癌症(尤其是血癌或白血病)的免疫疗法。该疗法利用免疫系统的力量,通过摧毁病毒和细菌等有害入侵者来抵御感染和疾病。正在进行各种关于 CAR T 细胞疗法的研究和临床试验,以治疗癌症。例如,2022 年 1 月,伦敦大学学院 (UCL) 的研究人员开发了一种新的 CAR T 细胞疗法。在伦敦大学学院医院 (UCLH) 进行的该疗法的 I 期临床试验得出结论,该疗法毒性较小且持久。越来越多的 CAR-T 细胞疗法临床试验正在激增对 GMP 细胞疗法耗材的需求。
基于流程的洞察
根据工艺,GMP 细胞治疗耗材市场细分为细胞收集和表征/分选和分离、细胞培养和扩增/制备、低温保存、细胞加工和配制、细胞分离和激活、细胞分配/处理、过程监控和控制/重新管理/质量保证等。2021 年,细胞收集和表征/分选和分离部分占据了最大的市场份额。然而,低温保存部分的 GMP 细胞治疗耗材市场预计将在预测期内以最快的速度增长。细胞表征对于了解细胞增殖、功能和整体过程所涉及的内在因素至关重要。细胞根据这些特性进行分类和分离。公司正在构建符合 GMP 标准的细胞分选器,以避免过程中的污染。例如,Miltenyi Biotec 销售 MACSQuant Tyto 细胞分选器,这是一种在封闭盒式系统中进行无菌和符合 GMP 的多参数细胞分选。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),以供监管部门批准细胞制造协议。
基于最终用途的洞察
根据最终用途,GMP 细胞治疗耗材市场细分为临床、商业和研究。2021 年,临床领域占据了最大的市场份额。此外,同一细分市场的 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,细胞治疗研究是在人身上进行的,以评估特定疗法的医疗、外科或行为干预。由于慢性病患病率上升、生物制剂增加以及从事临床研究的合同研究组织数量增加,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《自然》杂志的一篇文章,2021 年 4 月有 2,073 种活性细胞治疗药物正在研发中,比 2020 年的更新数量多 572 种。
GMP 细胞治疗耗材市场参与者采用产品发布和扩展等有机策略,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合作伙伴关系和协作。这些增长战略使市场参与者能够扩大业务并增强其地理影响力。此外,收购、合作伙伴关系和其他增长战略有助于加强公司的客户群并增加其产品组合。
GMP 细胞治疗耗材市场报告范围
报告属性 | 细节 |
---|---|
2021 年市场规模 | 110.3亿美元 |
2028 年市场规模 | 599.9 亿美元 |
全球复合年增长率(2021 - 2028) | 27.5% |
历史数据 | 2019-2020 |
预测期 | 2022-2028 |
涵盖的领域 | 按产品
|
覆盖地区和国家 | 北美
|
市场领导者和主要公司简介 |
|
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
- 2021 年 1 月,Sartorius 与人类间充质干细胞/基质细胞 (hMSC) 的领先供应商 RoosterBio Inc. 签署了战略合作协议。此次合作推动了再生医学 hMSC 制造规模的扩大。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 要求、以客户为中心的协议。
- 2020 年 9 月,Bio-Techne Corporation 开设了一座约 61,000 平方英尺的先进良好生产规范 (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改造治疗工作流程的重要组成部分。该工厂帮助公司满足当前和未来对 GMP 级试剂的需求,这些试剂对于支持快速增长的细胞治疗市场必不可少。
GMP 细胞治疗耗材市场 - 公司简介
- 赛多利斯公司
- 赛默飞世尔科技公司
- 美天旎生物技术有限公司
- 生物技术公司
- 康宁公司
- 富士胶片尔湾科学公司
- 龙沙集团
- BPS 生物科学公司
- 默克公司
- 全球生命科学解决方案美国有限责任公司。
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
Frequently Asked Questions
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 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.
Stringent regulatory policies are expected to restrict the GMP cell therapy consumables growth during the forecast period.
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.
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.
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.
The List of Companies - GMP Cell Therapy Consumables Market
- 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
- 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.
- 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.
- 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:
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.
- 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.
- 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.