上游生物加工市场战略、顶尖企业、增长机会、2030 年分析及预测

  • Report Code : TIPRE00006819
  • Category : Life Sciences
  • Status : Published
  • No. of Pages : 210
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[研究报告] 上游生物加工市场价值预计将从 2022 年的 91.7409 亿美元增长到 2030 年的 250.4669 亿美元。 预计上游生物加工市场在 2022 年至 2030 年期间的复合年增长率将达到13.4%。

 

市场洞察和分析师观点:

上游生物加工是生物加工的第一阶段,包括细胞系开发、培养基开发和培养。推动上游生物加工市场增长的关键因素包括一次性生物反应器的商业化使用、生物制药制造外包以及制药和生物技术行业的快速增长。然而,严格的监管框架阻碍了上游生物加工市场的增长。  

 

增长动力和限制因素:

由于一次性生物反应器 ( SUB ) 结构坚固、性能卓越,是生物制药商业化生产所必需的,因此各制造商都在开发此类反应器。通过结合与生物膜形成、搅拌机制、生物反应器设计和传感器系统等相关的技术,一次性反应器在实验室和生产规模中的应用日益增多。一次性生物反应器用于制造下一代细胞和基因疗法,适用于连续生物处理。细胞培养工艺的进步现在能够实现更高的滴度和细胞密度,这表明SUB的应用前景广阔。一次性生物反应器的污染风险低、生产周转时间更短、验证时间更短。在过去几年中,由于一次性生物反应器具有独特的能力,能够提高灵活性、减少投资并限制运营成本,因此在现代生物制药工艺中的应用日益增多。此外,许多公司还开发了一次性生物反应器,用于生产多种治疗药物。 20213 月,赛默飞世尔科技推出了容量为 3,000 L 和 5,000 L 的HyPerforma DynaDrive一次性生物反应器。Sartorius AG 提供各种一次性生物反应器。该公司提供用于 10–15 mL微型生物反应器规模的ambr 15 和用于 50–2,000L 的Biostat STR 。因此,一次性生物反应器在上游生物加工中的使用正在增加。因此,一次性生物反应器在治疗剂生产中的接受度越来越高,推动了上游生物加工市场的发展。

美国食品药品管理局(FDA)和欧洲药品管理局(EMA)等监管机构对制药商的运营进行一贯严格的监控。因此,这些企业必须遵守最新法规,以促进现行良好生产规范(cGMP)和良好实验室规范(GLP),确保对制造流程和设施的控制和监控。目前,FDA 的 CBER法规未提及一次性生物反应器。任何偏离本指南的注册协议、需求和要求的行为都可能导致制造商或外包组织安排的临床试验终止。尽管与生物技术行业相关的严格法规刺激了对生物反应器的需求,但中国、印度和巴西等发展中国家缺乏明确的监管框架,阻碍了上游生物加工市场的整体增长。

通过生物加工获得的分子在临床试验中产生的结果可能与在实验室环境中产生的结果不同,这是使用SUB的另一个重大问题。SUB 的混合机制也可能导致难以遵守规定,从而限制了其使用。例如,在波型SUB中,混合原理仅限于摇摆运动,导致混合不均匀并引起错误。因此,生物制剂的安全性和有效性可能会在SUB的应用中引起重大担忧

 

趋势:

未来几年,生物制药行业对研发 (R&D) 的投入不断增加,可能会为上游生物加工市场带来新的趋势。2020 年 3 月,Culture Biosciences宣布在 A 轮投资中获得 1500 万美元(1340 万欧元)的资金,并得到了新老风险投资支持者的支持。据 Culture Biosciences介绍,这笔资金已用于将生物反应器的容量提高三倍,以及为生物制造研发开发更多基于云的软件监控和开发工具。该公司表示,这项投资将帮助科学家通过软件应用程序管理整个研发工作流程,从而支持生物制造研发的数字化

随着研发投入持续激增,特别是在新型生物制剂、先进疗法和个性化医疗方面,人们也开始重视优化上游生物加工技术和方法。这一趋势推动了创新生物反应器系统、细胞培养基配方和过程自动化解决方案的开发,以提高生物制药生产运营的效率、可扩展性和生产力。此外,对研发投资的关注有利于开发迎合不断发展的生物制药格局的尖端生物加工平台,包括下一代治疗方式和生物仿制药。此外,为生物加工趋势(如连续生物加工和用于过程监控的高级分析)投入研发资金预计将重塑上游生物加工的未来,推动最先进技术的采用,并为工艺性能、质量和法规遵从性建立新的基准。

 

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上游生物加工市场:

Upstream Bioprocessing Market
  • 获取此报告的关键市场趋势。
    这个免费样品将包括数据分析,从市场趋势到估计和预测。

 

报告细分和范围:

上游生物加工市场根据产品类型、工作流程、使用类型和模式进行细分。根据产品类型,市场细分为生物反应器/发酵罐、细胞培养、过滤器、袋子和容器等。在工作流程方面,市场分为培养基制备、细胞培养和细胞分离。上游生物加工市场按用途分为一次性和多次使用。根据模式,上游生物加工市场分为内部和外包。在地理方面,上游生物加工市场细分为北美(美国、加拿大和墨西哥)、欧洲(德国、法国、意大利、英国、俄罗斯和欧洲其他地区)、亚太地区(澳大利亚、中国、日本、印度、韩国和亚太其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋和中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷和南美洲和中美洲其他地区)。

 

节段分析:

2022 年,按产品类型划分,生物反应器/发酵罐部分占据上游生物加工市场的最大份额。预计细胞培养部分将在 2022-2030 年期间在市场上实现显著的复合年增长率。生物反应器发酵罐是细胞和微生物生长的核心容器,可用于各种治疗和生物加工应用,包括生物衍生化合物的表达和生产。这些系统经过精心设计,可为细胞生长提供最佳环境,包括对温度、pH、溶解氧和搅拌等参数的精确控制。这些参数对于在大规模生物加工操作中培养细胞和微生物至关重要。

根据工作流程,上游生物加工市场分为培养基制备、细胞培养和细胞分离。2022 年,细胞分离部分占据上游生物加工市场的最大份额。预计同一部分将在 2022 年至 2030 年期间在市场上实现显著的复合年增长率。细胞分离是从培养物中分离蛋白质产品(细胞)的初始阶段。生物反应器中收集的产品的数量和质量在决定是否停止细胞培养方面起着关键作用。

根据使用类型,全球上游生物加工市场分为一次性和多用途。一次性部分在 2022 年占据了更大的市场份额。预计该细分市场的市场将在 2022-2030 年期间以显着的复合年增长率增长。随着一次性技术的广泛采用,上游生物加工市场经历了变革性转变。一次性系统(包括生物反应器、袋子和连接器)因其灵活性、成本效益和降低交叉污染风险而备受瞩目。这些一次性组件取代了传统的不锈钢设备,为生物生产提供了更灵活和可扩展的方法。一次性趋势加速了工艺开发,最大限度地减少了清洁和验证工作,并促进了生产运行之间的快速切换。

上游生物加工市场根据模式分为内部和外包。2022 年,内部部分占据了更大的市场份额。预计外包部分在 2022-2030 年期间的复合年增长率将更高。随着生物制药公司寻求对其生产流程的更大控制,内部制造在上游生物加工市场中越来越受欢迎。建立内部上游生物加工设施使公司能够根据自己的需求定制流程,从而确保采用更加定制化和高效的方法。该策略通常涉及对最先进的生物反应器、细胞培养系统和相关技术的投资。

 

区域分析:

根据地区,上游生物加工市场分为北美、欧洲、亚太、南美和中美以及中东和非洲。2022 年,北美占据全球上游生物加工市场的最大份额。预计亚太地区在 2022-2030 年期间的复合年增长率最高。

美国是生物反应器的最大市场——美国有多家市场参与者为制药和生物技术公司制造生物反应器。新生物反应器的推出、地域扩张战略以及市场参与者之间的合作推动了美国上游生物加工市场的增长。2023 年 4 月,BioMADE 宣布了 5 个新项目,重点是解决美国生物工业制造中生物反应器的研究空白和采用。承诺提供 1050 万美元的资金,这些项目将涵盖工程、硬件开发和可扩展性,以解决与规模经济相关的困难。这些项目将专注于创新,以引入由 Schmidt Futures 支持的先进生物反应器设计。2023 年 4 月,Cytiva 推出了 X-Platform 生物反应器,以使用一次性产品简化上游生物加工操作。最初,生物反应器有 50 L 和 200 L 两种尺寸。X-Platform 生物反应器配备了 Figurate 自动化解决方案软件,它们可以通过人体工程学改进、生产能力和简化的供应链运营来提高流程效率。

生物制药行业的增长主要得益于技术进步、灵活性提高和运营成本降低,这也使美国上游生物加工市场受益。根据国际贸易管理局 (ITA) 的数据,美国是生物制药的最大市场,也是全球生物制药研发的领导者。根据美国制药研究与制造商协会 (PhRMA) 的数据,美国公司占全球制药研发工作的近 50%,他们成功开发了许多拥有知识产权的新型药物。新生物制剂的开发不断增加,导致监管机构批准了更多新分子实体 (NME),为美国上游生物加工市场的增长创造了机会。根据《化学与工程新闻》报道,美国食品药品管理局 (FDA) 分别在 2022 年、2021 年和 2020 年批准了约 37、50 和 53 个新 NME。此外,美国制药和生物技术公司增加研发投资以改善临床试验结果并确保患者安全,这也有助于美国上游生物加工市场的增长。随着美国政府加大投资,精准医疗的吸引力也随之增加,这可能会在未来几年促进市场增长。

 

 

上游生物加工市场区域洞察

Insight Partners 的分析师已详细解释了预测期内影响上游生物加工市场的区域趋势和因素。本节还讨论了北美、欧洲、亚太地区、中东和非洲以及南美和中美洲的上游生物加工市场细分和地理位置。

Upstream Bioprocessing Market
  • 获取上游生物加工市场的区域特定数据

上游生物加工市场报告范围

报告属性细节
2022 年市场规模91.7亿美元
2030 年市场规模250.5亿美元
全球复合年增长率(2022 - 2030 年)13.4%
史料2020-2021
预测期2023-2030
涵盖的领域按产品类型
  • 生物反应器/发酵罐
  • 细胞培养
  • 筛选器
  • 袋子和容器
按工作流程
  • 媒体准备
  • 细胞培养
  • 细胞分离
按使用类型
  • 单次使用和多次使用
按模式
  • 内部和外包
覆盖地区和国家北美
  • 我们
  • 加拿大
  • 墨西哥
欧洲
  • 英国
  • 德国
  • 法国
  • 俄罗斯
  • 意大利
  • 欧洲其他地区
亚太
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 亚太其他地区
南美洲和中美洲
  • 巴西
  • 阿根廷
  • 南美洲和中美洲其他地区
中东和非洲
  • 南非
  • 沙特阿拉伯
  • 阿联酋
  • 中东和非洲其他地区
市场领导者和主要公司简介
  •  
  • 赛默飞世尔科技公司
  • Esco Micro 私人有限公司
  • 赛莱克斯国际有限公司
  • 赛多利斯公司
  • 丹纳赫公司
  • 洁定公司
  • 默克公司
  • 康宁公司
  • 恩特格里斯公司

市场参与者密度:了解其对商业动态的影响

上游生物加工市场正在快速增长,这得益于终端用户需求的不断增长,而这些需求又源于消费者偏好的不断变化、技术进步以及对产品优势的认识不断提高等因素。随着需求的增加,企业正在扩大其产品范围,进行创新以满足消费者的需求,并利用新兴趋势,从而进一步推动市场增长。

市场参与者密度是指在特定市场或行业内运营的企业或公司的分布情况。它表明在给定市场空间中,相对于其规模或总市场价值,有多少竞争对手(市场参与者)存在。

在上游生物加工市场运营的主要公司有:

  1. 赛默飞世尔科技公司
  2. Esco Micro 私人有限公司
  3. 赛莱克斯国际有限公司
  4. 赛多利斯公司
  5. 丹纳赫公司

免责声明上面列出的公司没有按照任何特定顺序排列。


Upstream Bioprocessing Market

 

  • 获取上游生物加工市场顶级关键参与者的概述

 

行业发展和未来机遇: 

以下列出了全球上游生物加工市场知名参与者的不同举措:

  1. 2023 年 12 月,默克收购了总部位于马萨诸塞州的 Erbi Biosystems 公司,该公司开发了“Breez”2 毫升微型生物反应器平台技术。此次收购增强了默克的上游治疗性蛋白质产品组合,使其能够迅速开发实验室规模的可扩展细胞灌注生物反应器工艺方案,容量从 2 毫升到 2000 升不等。此外,它还为进一步研究和推进细胞疗法等尖端模式应用提供了机会。
  2. 2023 年 10 月,Getinge AB 以 1.2 亿美元收购了 High Purity New England, Inc.。到 2024 年底,该公司将全面整合 High Purity New England, Inc. 此次收购帮助 Getinge AB 获得了从药物发现、上游和下游加工到灌装和成品的一系列专有和分销产品。
  3. 2023 年 1 月,Sartorius 与 RoosterBio Inc. 合作,解决纯化难题,并建立可扩展的外泌体疗法下游制造工艺。通过此次合作,Sartorius 和 RoosterBio 将为基于人类间充质干细胞/基质细胞 (hMSC) 的外泌体生产平台提供一流的解决方案和专业知识,该平台可提供行业领先的产量、纯度和效力。
  4. 2022 年 2 月,赛默飞世尔科技宣布扩大其生物加工业务。该公司已投资 4000 万美元在宾夕法尼亚州米勒斯堡建造和维护一次性技术制造工厂。此次扩建是多年期 6.5 亿美元投资的一部分,旨在提高公司以灵活、可扩展和可靠的方式生产生物加工产品的能力。
  5. 2021 年 3 月,赛默飞世尔科技公司推出了不同容量的 HyPerforma DynaDrive SUB,分别为 3,000 升和 5,000 升。赛默飞世尔科技最大的商用 SUB,也是同类产品中首款 5,000 升 SUB,它使生物制药企业能够将一次性技术融入大规模生物工艺中,例如在极高细胞密度下进行 cGMP 制造和灌注细胞培养。

 

竞争格局和重点公司:

Thermo Fisher Scientific Inc、Esco Micro Pte Ltd、Cellexus International Ltd、Sartorius AG、Danaher Corp、Getinge AB、Merck KGaA、Corning Inc、Entegris Inc 和 PBS Biotech Inc 是上游生物加工市场的知名企业。这些公司专注于开发和采用新技术、改进现有产品以及扩大其地理覆盖范围,以满足全球日益增长的消费者需求。  

  • Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
  • PEST and SWOT Analysis
  • Market Size Value / Volume - Global, Regional, Country
  • Industry and Competitive Landscape
  • Excel Dataset
Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

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Regional Scope
Regional Scope

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

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to country scope.

Frequently Asked Questions


What is upstream bioprocessing?

Upstream bioprocessing is the first stage of the bioprocess. Upstream phase includes processes such as cell line development, media development and cultivation.

What factors drive the upstream bioprocessing market?

Factors such as the commercial use of single-use bioreactors, outsourcing of biopharmaceutical manufacturing, and rapid growth of pharmaceutical and biotechnology industries propel market growth.

Who are the major players in the upstream bioprocessing market?

The upstream bioprocessing market majorly consists of the players, including Thermo Fisher Scientific Inc, Esco Micro Pte Ltd, Cellexus International Ltd, Sartorius AG, Danaher Corp, Getinge AB, Merck KGaA, Corning Inc, Entegris Inc, and PBS Biotech Inc.

What are the growth estimates for the upstream bioprocessing market till 2030?

The upstream bioprocessing market is expected to be valued at US$ 25,046.69 million in 2030.

Which product type segment dominates the upstream bioprocessing market?

The upstream bioprocessing market, based on product type, is segmented into bioreactors and fermenters, cell culture media, filters, bags and containers, and others. The bioreactors/fermenters segment held the largest share of the upstream bioprocessing market in 2022. Moreover, the cell culture segment is anticipated to register a significant CAGR during 2022–2030.

What was the estimated upstream bioprocessing market size in 2022?

The upstream bioprocessing market was valued at US$ 9,174.09 million in 2022.

Which workflow segment dominates the upstream bioprocessing market?

Based on workflow, the upstream bioprocessing market is classified into media preparation, cell culture, and cell separation. The cell separation segment held the largest share of the upstream bioprocessing market in 2022. It is further anticipated to register a significant CAGR from 2022 to 2030.

Which mode segment dominates the upstream bioprocessing market?

Based on mode, the upstream bioprocessing market is segmented into in-house and outsourced. In 2022, the in-house segment held a larger market share. The outsourced segment is expected to record a higher CAGR during 2022–2030.

Which usage type segment dominates the upstream bioprocessing market?

The global upstream bioprocessing market, based on usage type, is classified into single use and multiuse. The single use segment held a larger share of the market in 2022. The same segment is anticipated to record a significant CAGR in the upstream bioprocessing market during 2022–2030.

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The List of Companies - Upstream Bioprocessing Market 

  1. Thermo Fisher Scientific Inc         
  2. Esco Micro Pte Ltd          
  3. Cellexus International Ltd            
  4. Sartorius AG       
  5. Danaher Corp     
  6. Getinge AB         
  7. Merck KGaA       
  8. Corning Inc         
  9. Entegris Inc         
  10. PBS Biotech Inc

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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.