市场调查报告书
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1466262
连续生物加工市场:按产品、製程、应用、业务规模、最终用户划分 - 2024-2030 年全球预测Continuous Bioprocessing Market by Product (Bioreactors, Cell Culture Media & Reagent, Centrifuges), Process (Downstream Bioprocess, Upstream Bioprocess), Application, Scale of Operation, End-User - Global Forecast 2024-2030 |
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预计2023年连续生物加工市场规模为2.3344亿美元,2024年将达2.8242亿美元,2030年将达9.0223亿美元,复合年增长率为21.30%。
连续生物加工代表了疫苗、单株抗体和治疗性蛋白质等生物製药生产的模式转移。连续生物加工允许材料和产品在整个生产週期中不间断地流动,从而提高效率、品管和可扩展性,这与传统的批量加工不同,传统的批量加工可以预期在单独的步骤中加工固定数量的产品。製药业正在不断发展,政府对该领域的支持是连续生物加工成长的关键驱动力。超批量加工和一次性技术的引入带来的好处不断增加,以及对生物製药生产的持续需求,正在刺激连续生物加工技术的采用。相较之下,高昂的设备成本、操作困难以及对製程变化的担忧对生物製程的持续采用提出了挑战。此外,必须考虑监管因素,因为连续生物过程可能需要新的验证策略才能符合卫生当局製定的严格标准。然而,一些市场供应商正在投资研发,以解决连续生物加工技术中的许多营运挑战,并为进一步的市场扩张做好准备。此外,灌注的采用与一次性设备相关,基质细胞製造的连续生物製程方法的市场开拓预计将在未来几年显着促进整体市场成长。
主要市场统计 | |
---|---|
基准年[2023] | 2.3344亿美元 |
预测年份 [2024] | 2.8242亿美元 |
预测年份 [2030] | 9.0223亿美元 |
复合年增长率(%) | 21.30% |
产物:在重组蛋白的大规模生产中越来越偏好反应器
反应器是发生生物反应的容器,特别适用于培养细菌、酵母菌和哺乳动物细胞等生物。这对于扩大生物製程规模至关重要。细胞培养基和试剂列出了生物过程中细胞生长和产物表现所需的必需营养素。离心机用于根据混合物的密度分离混合物的成分。在生物加工中,它对于细胞澄清和产品回收至关重要。层析法系统用于精製生物产品。连续层析法技术,包括模拟移动床 (SMB) 系统,可提供高生产率和层析法介质的高效使用,从而降低耗材成本。过滤系统对于製程流体的灭菌和澄清至关重要,确保去除杂质和污染物。培养箱和摇床对于优化细胞培养生长条件、控制温度、湿度和搅拌至关重要。混合系统确保反应器和储存罐内的均匀性,并影响细胞生长、营养分布和产物形成的一致性。相较之下,连续反应器可以不间断地运作,确保产品品质一致并可能降低製造成本,而连续离心机可以不间断地加工生物产品,提高效率和一致性。
流程:由于效率和产能的提高,上游工程的使用增加
上游工程构成生物生产的初始阶段,涉及适合微生物、植物和哺乳动物细胞生长和繁殖的环境的开发和维护。此步骤通常包括培养基製备、细胞培养、细胞储存和初次回收。在上游工程之后,下游生物过程精製并製备这些生物产品以供最终使用或进一步配製。由于生物製品固有的复杂性和多样性,下游加工通常需要复杂的分离和精製技术,例如离心、过滤和层析法。上游和下游生物过程对于最终产品的生产率和品质都很重要。然而,它们的主要目的、复杂性和挑战差异很大。上游着重于培养细胞培养和增殖的最佳环境,下游着重于所得产物的精製和精製。
应用:在疫苗产业广泛使用连续生物製程来改善公众健康
细胞和基因治疗中的连续生物加工利用尖端技术来产生个人化治疗。该领域的优势包括减少批次差异、提高可扩展性以及提高产品一致性。连续生产单株抗体的製程可减少劳动力和设施占地面积,并实现即时品质监控,提高生产率和成本效益。在疫苗行业,由于大流行期间需要快速开发和部署以及流感等季节性疫苗的生产,对连续生物加工的兴趣正在增加。连续生物加工可以显着缩短开发时间并提高对公共卫生需求的应对力。相较之下,连续加工提供了提高疫苗加工集约化、稳定性和产量的机会。
业务规模:扩大连续生物加工在临床业务的应用
临床业务对于连续生物加工至关重要,对开发的生技药品的功效和品质具有至关重要的影响。它涵盖广泛的活动,从早期临床试验到遵守药物安全性和有效性监管指南的程序。连续生物加工的商业运作围绕着大规模实施该工艺以实现商业化和销售的实用性。目标是扩大生产规模并确保一致的品质、成本效益和法规遵循。连续生物加工为简化生物製药生产提供了一种有前途的方法,但其实施在规模、临床和商业业务存在很大差异。
最终用户:连续生物加工在 CDMO 中的作用非常重要,它优先考虑弹性和增强向客户提供的服务。
学术和研究机构通常专注于连续生物加工的基础科学和概念验证研究。这些机构透过进行创新研究并经常与产业合作伙伴合作,在推动技术进步方面发挥着至关重要的作用。受託製造厂商描述了向製药和生物技术公司外包开发和製造服务。它们是药品供应链不可或缺的一部分,越来越多地采用连续生物加工来实现产品差异化并提高成本效率。製药和生物技术公司是推动连续生物製程商业性实施的主要最终用户。另一方面,学术和研究机构透过出版物、专利和熟练专业人员的培训为连续生物加工做出贡献。与研究机构不同,CDMO 投资于可扩展且适应性强的技术,可以支援多种产品和流程,从而为客户优化上市时间。与学术机构和 CDMO 不同,製药和生物技术公司既进行内部产品开发又进行商业生产。
区域洞察
在美洲地区,对生物製造创新的浓厚兴趣、对生物技术领域的大量投资以及鼓励先进製造技术的法规环境正在推动连续生物加工的采用。随着主要製药公司和生物风险公司寻求更高效、更具成本效益和可扩展的製造工艺,连续生物加工代表了一种竞争优势。此外,强大的技术基础设施和熟练劳动力的存在正在促进美洲从传统批量工艺向连续方法的转变。此外,在欧洲、中东和非洲,高昂的营运成本和严格的监管标准导致公司采用连续生物製程来降低成本并提高生技药品的品质。欧洲製药业以注重创新和永续性而闻名,这反映在快速成长的生物相似药市场。此外,中东和非洲也开始采用此类流程。由于对生物製药的需求不断增长以及药品生产能力本地化的努力,连续生物加工预计将在该地区增长。在亚太地区,由于生物製药行业的快速扩张和全球竞争的需要,连续生物加工的采用正在迅速增加。越来越多的患者需要高品质的生技药品,生物技术公司不断增加投资,并支持政府旨在提高生物製造能力的措施。一些国家对实施连续流程以加快药物开发和製造时间表、减少製造足迹并节省成本,同时遵守国际品质标准表现出了浓厚的兴趣。
FPNV定位矩阵
FPNV定位矩阵对于评估连续生物加工市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限。最前线 (F)、探路者 (P)、利基 (N) 和重要 (V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对连续生物加工市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该细分市场竞争特征的宝贵见解,包括在研究基准年观察到的累积、碎片化主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:包括新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:包括对未来技术、研发活动和突破性产品开发的见解。
1.连续生物加工市场的市场规模与预测是多少?
2. 在连续生物加工市场的预测期内,我们应该考虑投资哪些产品和应用?
3.连续生物加工市场的技术趋势和法规结构是什么?
4.连续生物加工市场主要供应商的市场占有率为何?
5. 进入连续生物加工市场的适当型态和策略手段是什么?
[189 Pages Report] The Continuous Bioprocessing Market size was estimated at USD 233.44 million in 2023 and expected to reach USD 282.42 million in 2024, at a CAGR 21.30% to reach USD 902.23 million by 2030.
Continuous bioprocessing represents a paradigm shift in the production of biopharmaceutical products, such as vaccines, monoclonal antibodies, or therapeutic proteins. Continuous bioprocessing allows for the uninterrupted flow of materials and products through the production cycle, offering potential improvements in efficiency, quality control, and scalability, unlike traditional batch processing, which processes a fixed volume of products in discrete steps. Pharmaceutical industries are advancing, and government support for the sector is the principal driver of growth for continuous bioprocessing. Increased benefits of over-batch processing & uptake of single-use technology and the continued demand for the production of biopharmaceutical products are spurring the adoption of continuous bioprocessing technologies. In contrast, high equipment costs, operational difficulties, and process change concerns pose a challenge to adopting a continuous bioprocess. In addition, regulatory considerations must be managed, as continuous bioprocessing may necessitate new validation strategies to comply with the stringent standards set by health authorities. However, several market vendors invest in research and development to address many operational challenges in the continuous bioprocessing technologies and further chart to expand the market. Moreover, the adoption of perfusion is associated with single-use equipment, and the development of a continuous bioprocessing approach to stromal cell manufacturing is expected to enhance overall market growth in the coming years significantly.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 233.44 million |
Estimated Year [2024] | USD 282.42 million |
Forecast Year [2030] | USD 902.23 million |
CAGR (%) | 21.30% |
Product: Growing preference for bioreactors in large-scale production of recombinant proteins
Bioreactors are vessels in which biological reactions are carried out, especially for culturing organisms such as bacteria, yeast, and mammalian cells. They are crucial for scaling up bioprocessing. Cell culture media and reagents provide the essential nutrients required for cell growth and product expression in bioprocessing. Centrifuges are utilized to separate components of a mixture based on their density. In bioprocessing, they are essential for cell clarification and product recovery. Chromatography systems are employed for the purification of biological products. Continuous chromatography technologies, including simulated moving bed (SMB) systems, offer higher productivity and better utilization of chromatography media, reducing the cost of consumables. Filtration systems are imperative for sterilizing and clarifying process fluids, warranting the removal of impurities and contaminants. Incubators and shakers are vital for optimizing growth conditions for cell cultures, providing control over temperature, humidity, and agitation. Mixing systems ensure homogeneity in bioreactors and holding tanks, influencing cell growth, nutrient distribution, and product formation consistency. In comparison, continuous bioreactors operate without interruption, ensuring consistent product quality and potentially lower manufacturing costs, and continuous centrifuges allow for the uninterrupted processing of bioproducts, enhancing efficiency and consistency.
Process: Rising usage of upstream processes owing to progress in terms of efficiency and capacity
Upstream processing, constituting the initial steps of bioproduction, involves developing and maintaining a suitable environment for the growth and multiplication of microbial cells, plant, or mammalian cells. This phase often includes media preparation, cell culture, cell preservation, and primary recovery. Downstream bioprocessing, which follows the upstream step, involves purifying these biological products, and preparing them for their final use or further formulation. Due to inherent complexity and diversity of biological products, downstream processes typically entail complex separation and purification techniques, including centrifugation, filtration, chromatography and more. Both upstream and downstream bioprocessing are critical for both productivity and quality of end products. However, they differ significantly in their chief objectives, complexities, and challenges. Upstream focuses on fostering an optimal environment for cell culture and propagation, while downstream is centered around the purification and refinement of the resultant product.
Application: Extensive utilization of continuous bioprocessing in the vaccine industry to improve public health
Continuous bioprocessing in cell and gene therapies involves using cutting-edge techniques to manufacture personalized treatments. This sector benefits from reduced batch-to-batch variability, enhanced scalability, and improved product consistency. Continuous processes for manufacturing monoclonal antibodies increase productivity and cost-effectiveness due to reduced labor and facility footprint and the potential for real-time quality monitoring. The vaccine industry is experiencing a growing interest in continuous bioprocessing, given the need for rapid development and deployment during pandemics and the production of seasonal vaccines, such as those for influenza. Continuous bioprocessing can substantially shorten development times and improve responsiveness to public health needs. In comparison, continuous processing offers opportunities for enhancing process intensification, stability, and throughput for vaccines.
Scale of Operation: Growing application of continuous bioprocessing in the clinical operations
Clinical operations are integral to continuous bioprocessing, pivotally influencing the efficacy and quality of the developed biologics. It encapsulates a broad range of activities, from early-stage clinical trials to procedures adhering to regulatory guidelines for the safety and efficacy of medicinal products. Commercial operations in continuous bioprocessing revolve around the practicality of implementing the processes on a large scale for commercialization and sale. It's about scaling up production and ensuring consistent quality, cost-effectiveness, and regulatory compliance. While continuous bioprocessing presents a promising approach to streamline biopharmaceutical production, its implementation differs widely across the scale, clinical, and commercial operations.
End-User: Significant role of continuous bioprocessing in CDMO as they prioritize flexibility and service offering enhancements for their clients
Academic and research institutes often focus on fundamental science and proof-of-concept studies in continuous bioprocessing. They are crucial in advancing technology by conducting innovative research, often collaborating with industry partners. Contract development & manufacturing organizations offer outsourced development and manufacturing services to pharmaceutical and biotech companies. They are an integral part of the pharmaceutical supply chain and increasingly incorporate continuous bioprocessing to differentiate their offerings and improve cost efficiencies. Pharmaceutical and biotechnology companies are the primary end-users driving the commercial implementation of continuous bioprocessing. In comparison, academic and research institutes contribute to the continuous bioprocessing through publications, patents, and training of skilled professionals. In contrast to research institutes, CDMOs invest in scalable and adaptable technologies that can cater to multiple products and processes, optimizing time-to-market for their clients. Pharmaceutical & biotechnology companies carry out both in-house product development and commercial production, unlike academic institutes or CDMOs.
Regional Insights
In the American region, the adoption of continuous bioprocessing is driven by a strong focus on innovation in biomanufacturing, significant investments in the biotech sector, and a regulatory environment encouraging advanced production techniques. With major pharmaceutical companies and biotech startups striving to achieve more efficient, cost-effective, and scalable manufacturing processes, continuous bioprocessing offers a competitive advantage. Additionally, the presence of a robust technological infrastructure and highly skilled workforce has facilitated the transition from traditional batch processes to continuous approaches in the Americas. Furthermore, in EMEA, high operational costs and stringent regulatory standards have pushed companies to adopt continuous bioprocessing to reduce costs and enhance the quality of biologics. The European pharmaceutical landscape is known for its strong emphasis on innovation and sustainability, which is further reflected in its rapidly growing biosimilar market, where continuous bioprocessing delivers substantial benefits in terms of production agility and speed to market. Additionally, adopting such processes is nascent in the Middle East and Africa. In this region, the continuous bioprocessing is expected to grow by the increasing need for biologics and efforts to localize pharmaceutical production capabilities. The APAC region has seen a surge in adopting continuous bioprocessing due to its rapidly expanding biopharmaceutical sector and the need to compete globally. A growing patient population needs high-quality biologics, increasing investments from players in biotechnology, and supportive government initiatives aiming to boost biomanufacturing capabilities. Several countries have demonstrated significant interest in incorporating continuous processes to accelerate drug development and production timelines, reduce manufacturing footprints, and enable cost savings, all while complying with international quality standards.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Continuous Bioprocessing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Continuous Bioprocessing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Continuous Bioprocessing Market, highlighting leading vendors and their innovative profiles. These include 3D Biotek LLC, 3M Company, Adolf Kuhner AG, bbi-biotech GmbH, Belach Bioteknik AB, Bio-Rad Laboratories, Inc., Bionet Servicios Tecnicos S.L., Colder Products Company, Danaher Corporation, Esco Aster Pte Ltd., Esco VacciXcell, FiberCell Systems Inc., Fujifilm Holdings Corporation, GE HealthCare Technologies Inc., GEA Group, Getinge AB, Infors AG, Merck KGaA, Repligen Corporation, Sartorius AG, simAbs NV, Suzhou Transcenta Therapeutics Co., Ltd., Thermo Fisher Scientific Inc., Watson-Marlow Fluid Technology Group, and WuXi Biologics Co., Ltd..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Continuous Bioprocessing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Continuous Bioprocessing Market?
3. What are the technology trends and regulatory frameworks in the Continuous Bioprocessing Market?
4. What is the market share of the leading vendors in the Continuous Bioprocessing Market?
5. Which modes and strategic moves are suitable for entering the Continuous Bioprocessing Market?