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市场调查报告书

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1140701

全球一次性生物加工市场-2022-2029

Global Single-Use Bioprocessing Market - 2022-2029

出版日期: 2022年10月20日 | 出版商:

DataM Intelligence | 英文 180 Pages | 商品交期: 约2个工作天内

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简介目录

市场概况

一次性生物加工市场规模预计将在 2021 年达到 76.2 亿美元，在 2029 年达到 254 亿美元，在预测期间（2022-2029 年）以 18.93% 的复合年增长率增长。

一次性生物处理系统是使用一次然后丢弃的生物处理设备。一次性生物处理系统由塑料部件组成，可以使用伽马射线进行灭菌和密封。一次性生物处理系统用于生物药物的混合、过滤、纯化、上游表达、储存和分离。该市场主要由多种一次性生物处理系统的可用性主导，例如生物反应器和发酵罐、混合器、袋子、生物处理容器和过滤。

市场动态

由于生物製药的日益普及，市场对一次性生物处理系统的需求不断增长。一次性生物处理系统具有高能效、低用水量、占地面积要求以及产品交叉污染风险极低或无风险等优点。一次性生物处理系统可以快速部署。

对生物製药的不断增长的需求推动了一次性生物加工市场的增长

根据联合国人口老龄化要闻，预计到 2020 年，世界人口中将有 7.27 亿人年龄在 65 岁以上，到 2050 年这一数字有望翻一番，达到 15 亿。随着老年人口在主要市场的增长，对生物製药的需求预计将增加，因为老年人更容易患慢性病和疾病。为了满足对生物製药日益增长的需求，越来越多的公司正在采用一次性生物工艺系统。这是为了提高工艺效率并降低与钢基生物反应器系统的清洁、灭菌和维护等复杂步骤相关的成本。过滤、混合、纯化、上游表达、储存和分离都是使用一次性生物处理技术的生物製药应用。

2019 年 1 月，Sartorius Stedim Biotech 推出了“Biostat RM TX with Flexsafe RM TX”，用于生产质量稳定的细胞产品。Biostat RM TX 是一种一次性生物反应器，是一种新的波浪混合系统，专门为封闭式、自动扩展质量一致的细胞产品（如离体细胞免疫疗法）而开发。它将一次性 flexsafe 袋技术与我们在生物製药自动化方面的专业知识相结合。Biostat RM TX 专为细胞（包括患者特异性 T 细胞）的横向扩展而设计，是一个封闭系统，由一个自动控制单元和最多两个摇摆平台组成，可轻轻搅动一次性 Flexsafe RM TX 袋。 .

与废物处理相关的问题可能会阻碍一次性生物加工市场的增长

由于与一次性生物加工产品相关的众多好处，例如降低成本、加快工艺开发时间和降低资本支出，生物製药公司越来越多地采用一次性生物加工产品。然而，对于这种替代技术产生的固体废物的处理，仍然存在严重的担忧。回收被排除在此类产品的一种选择之外，因为将成分分离成同质部分需要付出很多努力。因此，大多数一次性系统及其组件不适合回收利用。这些因素阻碍了预测期内的市场增长。

行业分析

全球一次性生物加工市场基于波特五力、监管分析、供应链分析和定价分析等各种行业因素对市场进行了深入分析。

细分分析

一次性/一次性生物反应器部分预计将占全球一次性生物加工市场的最大市场份额

一次性生物加工市场根据产品细分为培养基袋和容器、过滤组件、一次性/一次性生物反应器、一次性混合器等。一次性/一次性生物反应器细分市场在 2019 年占有相当大的市场份额。一次性/一次性生物反应器由一次性袋子而不是培养容器组成。用于哺乳动物细胞培养的最佳一次性/一次性生物反应器依赖于高细胞密度或基于微载体的工艺。一次性生物反应器减少了清洁和灭菌的需要。这些生物反应器可有效提高生物安全性和工艺安全性。这个市场主要由几个一次性/一次性生物反应器的可用性主导。例如，Sartorius 一次性生物反应器（Ambr15 至 BiostatSTR 2,000 L）的开发是为了便于放大和缩小。即使在大规模放大时，它也具有前所未有的高性能。这些生物反应器非常适合从工艺开发到商业生产的所有当前和未来需求。几家公司正在通过一次性/一次性生物反应器扩大其製造设施。例如，Millipore Sigma 扩大了其一次性 cGMP 设施，增加了 Mobius 2,000 L 一次性生物反应器，并通过其提供的 Provantage 端到端服务，上游开发，我们现在能够提供製造服务。

此外，一次性生物加工市场按最终用户细分为生物製药製造商、生命科学研发公司、学术研究机构、研究机构/製造商等。合同研究机构和製造商部门占据了最高的市场份额。合同研究实验室和製造商专注于在其製造设施中安装一次性生物加工产品。合同研究实验室和製造商正在部署一次性生物处理设备，包括生物反应器，用于大规模的内部生物製造。合同研究实验室和製造商使用一次性血袋、转移套件、T 型烧瓶和移液器进行基于细胞疗法的临床研究。

区域分析

北美占全球一次性生物加工市场的最大市场份额。

按地区划分，一次性生物加工市场分为北美、南美、欧洲、亚太地区、中东和非洲。在所有地区中，由于在疫苗、单克隆抗生素、细胞疗法和其他疗法的生产中大量采用一次性生物加工系统，北美在一次性生物加工市场中占据主导地位。一次性生物处理系统使用高级聚合物材料和具有整体强度增强的塑料复合材料製造。一些製造商使用一次性生物处理系统，因为它们可以降低总体运营成本并提供生物製造的连续性。还有大型生物製药生产设施。市场正在见证技术进步，例如生物过程中的自动化、大数据和机器学习 (ML) 解决方案。这些技术进步对于在医疗程序中预测错误和提高准确性很有用。

欧洲一次性生物加工市场在全球市场中占据仅次于北美的第二位，市场份额突出。由于研发计划的增加和巨大的生产能力，欧洲的一次性生物加工市场是潜在市场增长的关键因素。在欧洲，英国主导市场，预计在预测期内将稳步增长。预计德国和法国将在预测期内见证一次性生物加工市场的显着增长。

预计亚太地区在预测期内将表现出积极的市场增长。一次性生物处理系统使药物製造过程更快、更简单、更便宜，并且一次性生物处理系统的使用正在增长。一次性生物处理系统的使用提高了产品的生产效率。有几家公司正在开发一次性生物加工系统。一些公共和私营公司正在增加对开发一次性生物处理系统的投资。

竞争格局

一次性生物加工市场与众多国际和国内参与者竞争激烈。产品多样化、技术进步、收入获取和机会正在使市场更具竞争力。3M 公司、Applikon Biotechnology、Cesco Bioengineering Co.、Danaher Corporation、General Electric Company、Merck KGaA、PBS Biotech Inc. 和 Thermo Fisher Scientific Inc. 是拥有重要市场份额的主要参与者。

公司利用新产品发布、产能利用、技术进步、新产品开发和市场扩张战略来维持其市场地位。例如，2021 年 7 月，Sartorius收购了德国公司 Xell，并将其纳入赛多利斯 Stedim Biotech 子集团。这将扩大细胞培养基和饲料补充剂的业务。Xell 还将扩展其 Sartorius 分析产品和服务，用于介质及其组件的表征和量化，以及介质成分的优化。

2019年1月，Boehringer-Ingelheim扩大了其在中国的商业生物製剂生产基地。此次扩建是为了整合一个具有所有必要基础设施和公用设施的生物反应器，以支持 2x 2.000 L 一次性生物反应器生产线的 GMP 操作。

例如，2019 年 3 月，生物製药行业的领先供应商 Sartorius Stedim Biotech (SSB) 与 Novasep 在色谱和一次性生物加工领域展开合作。Novasep基于生命科学行业的专业技术提供各种产品和服务。Novasep 已建立的 BioSC 平台和 SSB 的一次性技术将成为开发创新色谱系统的基础。

2019 年 2 月，Pall Biotech与一次性组件和流体管理技术专家 Artesyn Biosolutions 建立了合作伙伴关係。该协议包括一个联合开发合作伙伴关係，为一次性自动化生物处理系统提供完整的临床到商业规模的解决方案。这些系统可以通过用于生物技术和生物产品的 cGMP 製造的完全工业化标准平台加快产品开发和上市时间。此次合作将 Pall Biotech 的 Allegro 一次性解决方案从上游延伸到下游，再到最终灌装。该合作伙伴关係将提供具有强大流体管理功能的工业和模块化一次性生物工艺解决方案。

值得关注的重点公司

Thermo Fisher Scientific Inc

概述 Thermo Fisher 是一家美国公司，提供范围广泛的科学分析仪器、实验室试剂和耗材以及科学软件服务。成立于 1956 年，总部位于美国马萨诸塞州沃尔瑟姆。

产品介绍

Thermo Scientific HyPerforma DynaDrive 一次性生物反应器。一次性使用的生物反应器，具有出色的性能和大容量的可扩展性。适用于灌注和分批补料工艺。

重大发展。2021 年 10 月，Thermo Fisher Scientific宣布将承担其位于瑞士 Lengnau 的最先进生物製剂製造工厂的运营责任。它将拥有高度灵活的生物製造技术，例如一次性生物反应器和不銹钢生物反应器。

这份研究报告提供了对全球一次性生物加工市场大约 45 多个市场数据表、40 多个数字和 180 页的访问权限。

Market Overview

Single-use Bioprocessing Market size was valued US$ 7.62 billion in 2021 and is estimated to reach US$ 25.40 billion by 2029, growing at a CAGR of 18.93% during the forecast period (2022-2029).

Single-use bioprocessing systems are bioprocessing equipment that is used once and disposed of. Single-use bioprocessing systems are made up of plastic components that can be sterilized and sealed by using gamma irradiation. Single-use bioprocessing systems are used for mixing, filtration, purification, upstream expression, storage, and separation of biopharmaceutical products. The market is dominated by the availability of several single-use bioprocessing systems such as bioreactors & fermenters, mixers, bags, bioprocess containers, and filtration.

Market Dynamics

The market is driven by the increasing demand for single-use bioprocessing systems with the growing penetration of biopharmaceuticals. Single-use bioprocessing systems have several advantages, such as high energy efficiency, low water usage, less floor space requirement, and very low or no risk of product cross-contamination. Single-use bioprocessing systems are faster to implement.

Growing demand for biopharmaceuticals drives the growth of single-use bioprocessing market

According to the UN Ageing Population Highlights, an estimated 727 million people in the global population will be 65 and older in 2020, by 2050, this figure is expected to double to 1.5 billion. The elderly population is more prone to chronic conditions and diseases, so demand for biopharmaceuticals is expected to rise as the senior population grows in major markets. Companies increasingly prefer single-use bioprocessing systems to meet the growing demand for biopharmaceuticals because they increase process efficiency and reduce costs associated with complicated steps such as cleaning, sterilization, and maintenance of steel-based bioreactor systems. Filtration, mixing, purification, upstream expression, storage, and separation are all biopharmaceutical applications that use single-use bioprocessing technology.

In January 2019, Sartorius Stedim Biotech launched the Biostat RM TX with Flexsafe RM TX for producing consistent quality cellular products. Biostat RM TX is a single-use bioreactor, a new wave hybrid system developed specifically for closed, automated expansion of consistent quality cell products such as ex vivo cellular immunotherapies. It combines single-use Flexsafe bag technology with the company's expertise in biopharmaceutical automation. Biostat RM TX is designed for scale-out expansion of cells, including patient-specific T cells, and is a closed system comprising an automated control unit and up to two rocking platforms to gently agitate single-use Flexsafe RM TX bags.

The problem associated with waste disposal is likely to hamper the growth of the single-use bioprocessing market

Biopharmaceutical firms are increasingly adopting single-use bioprocessing Products due to the numerous benefits associated with them, including cost savings, faster process development time, and lower capital investments. However, there are still serious concerns about the disposal of solid waste materials generated by this alternative technology. Recycling is not an option for such products because separating the components into homogeneous parts requires significant effort. As a result, most single-use systems and their parts are unsuitable for recycling. These factors are hampering the growth of the market in the forecast period.

Industry Analysis

The global single-use bioprocessing market provides in-depth analysis of the market based on various industry factors such as porter's five forces, regulatory analysis, supply chain analysis and pricing analysis.

Segment Analysis

Disposable/ single-use bioreactor segment is expected to hold the largest market share in global single-use bioprocessing market

The single-use bioprocessing market is segmented based on product as media bags and containers, filtration assemblies, disposable/single-use bioreactors, disposable mixers, and others. The disposable/single-use bioreactors segment accounts for a significant market share in 2019. The disposable/single-use bioreactors comprised of the disposable bag instead of a culture vessel. Disposable/single-use bioreactors that are ideal for mammalian cell culture depend on high cell density or microcarrier-based processes. Single-use bioreactors reduce the cleaning and sterilization demands. These bioreactors are effective for enhancing biological and process safety. The market is dominated by the availability of several disposable/single-use bioreactors. For instance, Sartorius's single-use bioreactors i.e., Ambr15 to BiostatSTR 2,000 L have been developed to ensure easy scale-up and scale-down. It is combined with unprecedented high performance even at a large scale. These bioreactors make the products perfectly suitable to serve all the current and future needs from process development to commercial production phases. Several companies are expanding their manufacturing facilities with the use of disposable/single-use bioreactors. For instance, MilliporeSigma had expanded its single-use cGMP facility with the addition of the Mobius 2,000 L single-use bioreactor, enabling the company to provide upstream development and manufacturing services using its equipment through its Provantage End-to-End Services offering

Further, the single-use bioprocessing market is also classified based on the end-users as biopharmaceutical manufacturers, life science R&D companies, academic research institutes, contract research organizations & manufacturers, and others. The contract research organizations & manufacturers segment accounts for the highest market share. Contract research organizations & manufacturers are focusing on installing single-use bioprocessing products at their manufacturing facilities. Contract research organizations & manufacturers are installing single-use bioprocessing equipment including bioreactors at a large scale for in-house biomanufacturing. Contract research organizations & manufacturers are using single-use blood bags, transfer sets, T-flasks, and pipettes for cell therapy-based clinical research.

Geographical Analysis

North America region holds the largest market share in the global single-use bioprocessing market

By region, the single-use bioprocessing market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the single-use bioprocessing market due to the higher adoption of single-use bioprocessing systems for the production of vaccines, monoclonal antibiotics, cell therapies, and other therapies. The single-use bioprocessing systems are manufactured by using high-grade polymer materials and plastic composites that provide enhanced integral strength. Several manufacturers are using single-use bioprocessing systems as the use of these systems reduced the overall operational costs and provides continuity in biomanufacturing. There is a presence of large-scale biopharmaceutical manufacturing facilities. The market is witnessing technological advancement including automation, big data, and machine learning (ML) solutions in bioprocessing. These technological advancements are useful for predicting errors and improving accuracy during medical procedures.

Europe single-use bioprocessing market acquired the second position followed by North America in the global market with a prominent share of the market. Significant factors are probable the growth of the market owing to rising R&D initiatives, and huge production capabilities. In the Europe region, the United Kingdom is majorly controlling the market and estimated constant growth over the forecast period. Germany and France are projected to develop prominent growth in the Single-use Bioprocessing Market over the forecast period.

The Asia-Pacific is expected to witness positive market growth over the forecasted period. There is growing usage of single-use bioprocessing systems as these bioprocessing systems have made the drug manufacturing process faster, simpler, and cheaper. The use of single-use bioprocessing systems increases the productivity of the manufacturing of the products. There is a presence of several companies developing single-use bioprocessing systems. Several public and private players are raising their investment in the development of single-use bioprocessing systems.

Competitive Landscape

The single-use bioprocessing market is highly competitive with the presence of several international and local market players. Product diversification, technological advancement, revenue generation, and opportunities intensify the market competition. 3M Company, Applikon Biotechnology, Cesco Bioengineering Co., Danaher Corporation, General Electric Company, Merck KGaA, PBS Biotech Inc., and Thermo Fisher Scientific Inc. are the leading Market players with significant market share.

Companies are using novel product launches, capacity utilization, technology advancement, new product development, and market expansion strategies for holding their position in the market. For instance, in Jul 2021, Sartorius acquired German firm Xell, including it to subgroup Sartorius Stedim Biotech. This will lead to expanding its business of media and feed supplement for cell cultures. Xell also extends Sartorius analytical products and services for characterizing and quantifying media and its components and for optimizing the composition of media.

In Jan 2019, Boehringer Ingelheim expanded its commercial biologics manufacturing site in China. The expansion covered the incorporation of a bioreactor with all required infrastructure and utility to support the GMP operations of 2x 2.000 L single-use bioreactor manufacturing lines.

For instance, in Mar 2019, Sartorius Stedim Biotech (SSB), a leading supplier in the biopharmaceutical industry entered into a collaboration with Novasep in the area of chromatography and single-use bioprocessing. Novasep provides various products and services to the life science industry, based on specialized technologies. Novasep's established BioSC platform and SSB's single-use technology would form the basis for the development of innovative chromatography systems.

In Feb 2019, Pall Biotech entered into a collaboration with Artesyn Biosolutions, a company specializing in single-use components and fluid management technologies. The agreement would encompass a co-development partnership, delivering complete solutions from clinical to commercial-scale for single-use automated bioprocessing systems. These systems would accelerate product development and time to market through a fully industrialized and standard platform for cGMP manufacturing of biotech and biological products. This collaboration expands Pall Biotech's Allegro single-use solution portfolio from upstream through downstream, and to final filling. This collaboration would provide industrial and modular single-use bioprocess solutions, resulting in robust fluid management.

Key Companies to Watch

Thermo Fisher Scientific Inc.:

Overview: Thermo Fisher is an American company that supplies variety of scientific or analytical instruments, lab reagents & consumables, and some scientific software services. It was founded in 1956 and headquartered in Waltham, Massachusetts, U.S.

Product Portfolio:

Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactor: It is a single-use bioreactor that is better in performance and scalability for larger volumes. It is suitable for perfusion and fed batch processes.

Key Developments: In Oct 2021, Thermo Fisher Scientific announced about assuming operational responsibility for Lengnau, Switzerland their latest site for biologics manufacturing. It will have a flexible bioproduction technology including single use bioreactor and stainless steel bioreactors.

The global single-use bioprocessing market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Market Definition and Overview

3. Executive Summary

4. Market Dynamics

4.1. Market Impacting Factors
- 4.1.1. Drivers:
  - 4.1.1.1. Growing demand for biopharmaceuticals
  - 4.1.1.2. Growing technological advancements
- 4.1.2. Restraints:
  - 4.1.2.1. Problem associated with waste disposal
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1 Porter's Five Forces Analysis
5.2 Regulatory Analysis
5.3 Supply Chain Analysis
5.4 Pricing Analysis

6. By Product

6.1. Introduction
- 6.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Segment
- 6.1.2. Market Attractiveness Index, By Product Segment
6.2. Media Bags and Containers
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
6.3. Filtration Assemblies
6.4. Disposable/Single-Use Bioreactors
6.5. Disposable Mixers
6.6. Other

7. By Application

7.1. Introduction
- 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 7.1.2. Market Attractiveness Index, By Application
7.2. Filtration
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis, US$ Mn, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
- 7.2.3. Storage
- 7.2.4. Cell Culture
- 7.2.5. Mixing
- 7.2.6. Purification

8. By End User

8.1. Introduction
- 8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End User Segment
- 8.1.2. Market Attractiveness Index, By End User Segment
8.2. Biopharmaceutical Manufacturers
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
8.3. Life Science R&D Companies
8.4. Academic Research Institutes
8.5. Contract Research Organizations & Manufacturers
8.6. Others

9. By Region

9.1. Introduction
- 9.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Region
- 9.1.2. Market Attractiveness Index, By Region
9.2. North America
- 9.2.1. Introduction
- 9.2.2. Key Region-Specific Dynamics
- 9.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
- 9.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 9.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
- 9.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 9.2.6.1. The U.S.
  - 9.2.6.2. Canada
  - 9.2.6.3. Mexico
9.3. Europe
- 9.3.1. Introduction
- 9.3.2. Key Region-Specific Dynamics
- 9.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
- 9.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 9.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
- 9.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 9.3.6.1. Germany
  - 9.3.6.2. The U.K.
  - 9.3.6.3. France
  - 9.3.6.4. Rest of Europe
9.4. South America
- 9.4.1. Introduction
- 9.4.2. Key Region-Specific Dynamics
- 9.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
- 9.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 9.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
- 9.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 9.4.6.1. Brazil
  - 9.4.6.2. Argentina
  - 9.4.6.3. Rest of South America
9.5. Asia Pacific
- 9.5.1. Introduction
- 9.5.2. Key Region-Specific Dynamics
- 9.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
- 9.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 9.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
- 9.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 9.5.6.1. China
  - 9.5.6.2. India
  - 9.5.6.3. Japan
  - 9.5.6.4. Australia
  - 9.5.6.5. Rest of Asia Pacific
9.6. The Middle East and Africa
- 9.6.1. Introduction
- 9.6.2. Key Region-Specific Dynamics
- 9.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
- 9.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 9.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

10.1. Competitive Scenario
10.2. Market Positioning/Share Analysis
10.3. Mergers and Acquisitions Analysis

11. Company Profiles

11.1. Thermo Fisher Scientific Inc.
- 11.1.1. Company Overview
- 11.1.2. Product Portfolio and Description
- 11.1.3. Key Developments
- 11.1.4. Financial Overview
11.2. 3M Company
11.3. Applikon Biotechnology
11.4. Danaher Corporation
11.5. Merck KGaA
11.6. General Electric Company
11.7. PBS Biotech Inc.
11.8. Sartorius
11.9. Boehringer Ingelheim
11.10. NovoSep

LIST NOT EXHAUSTIVE