市場調查報告書
商品編碼
1466262
連續生物加工市場:按產品、製程、應用、業務規模、最終用戶分類 - 2024-2030 年全球預測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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預計2023年連續生物加工市場規模為2.3344億美元,2024年將達2.8242億美元,2030年將達9.0223億美元,複合年成長率為21.30%。
連續生物加工代表了疫苗、單株抗體和治療性蛋白質等生物製藥生產的模式轉移。連續生物加工允許材料和產品在整個生產週期中不間斷地流動,從而提高效率、品管和可擴展性,這與傳統的批量加工不同,傳統的批量加工可以預期在單獨的步驟中加工固定數量的產品。製藥業正在不斷發展,政府對該領域的支持是連續生物加工成長的關鍵驅動力。超批量加工和一次性技術的引入帶來的好處不斷增加,以及對生物製藥生產的持續需求,正在刺激連續生物加工技術的採用。相較之下,高昂的設備成本、操作困難以及對製程變化的擔憂對生物製程的持續採用提出了挑戰。此外,必須考慮監管因素,因為連續生物過程可能需要新的驗證策略才能符合衛生當局製定的嚴格標準。然而,一些市場供應商正在投資研發,以解決連續生物加工技術中的許多營運挑戰,並為進一步的市場擴張做好準備。此外,灌注的採用與一次性設備相關,基質細胞製造的連續生物製程方法的市場開拓預計將在未來幾年顯著促進整體市場成長。
主要市場統計 | |
---|---|
基準年[2023] | 2.3344億美元 |
預測年份 [2024] | 2.8242億美元 |
預測年份 [2030] | 9.0223億美元 |
複合年成長率(%) | 21.30% |
產物:在重組蛋白的大規模生產中越來越偏好反應器
反應器是發生生物反應的容器,特別適用於培養細菌、酵母菌和哺乳動物細胞等生物。這對於擴大生物製程規模至關重要。細胞培養基和試劑列出了生物過程中細胞生長和產物表現所需的必需營養素。離心機用於根據混合物的密度分離混合物的成分。在生物加工中,它對於細胞澄清和產品回收至關重要。層析法系統用於精製生物產品。連續層析法技術,包括模擬移動床 (SMB) 系統,可提供高生產率和層析法介質的高效使用,從而降低耗材成本。過濾系統對於製程流體的滅菌和澄清至關重要,確保去除雜質和污染物。培養箱和搖床對於最佳化細胞培養生長條件、控制溫度、濕度和攪拌至關重要。混合系統確保反應器和儲存罐內的均勻性,並影響細胞生長、營養分佈和產物形成的一致性。相較之下,連續反應器可以不間斷地運作,確保產品品質一致並可能降低製造成本,而連續離心機可以不間斷地加工生物產品,提高效率和一致性。
流程:由於效率和產能的提高,上游工程的使用增加
上游工程構成生物生產的初始階段,涉及適合微生物、植物和哺乳動物細胞生長和繁殖的環境的開發和維護。此步驟通常包括培養基製備、細胞培養、細胞儲存和初次回收。在上游工程之後,下游生物過程精製並製備這些生物產品以供最終使用或進一步配製。由於生物製品固有的複雜性和多樣性,下游加工通常需要複雜的分離和精製技術,例如離心、過濾和層析法。上游和下游生物過程對於最終產品的生產率和品質都很重要。然而,它們的主要目的、複雜性和挑戰差異很大。上游著重於培養細胞培養和增殖的最佳環境,下游著重於所得產物的精製和精製。
應用:在疫苗產業廣泛使用連續生物製程來改善公眾健康
細胞和基因治療中的連續生物加工利用尖端技術來產生個人化治療。該領域的優勢包括減少批次差異、提高可擴展性以及提高產品一致性。連續生產單株抗體的製程可減少勞動力和設施佔地面積,並實現即時品質監控,提高生產率和成本效益。在疫苗行業,由於大流行期間需要快速開發和部署以及流感等季節性疫苗的生產,對連續生物加工的興趣正在增加。連續生物加工可以顯著縮短開發時間並提高對公共衛生需求的應對力。相較之下,連續加工提供了提高疫苗加工集約化、穩定性和產量的機會。
業務規模:擴大連續生物加工在臨床業務的應用
臨床業務對於連續生物加工至關重要,對開發的生技藥品的功效和品質具有至關重要的影響。它涵蓋廣泛的活動,從早期臨床試驗到遵守藥物安全性和有效性監管指南的程序。連續生物加工的商業運作圍繞著大規模實施該工藝以實現商業化和銷售的實用性。目標是擴大生產規模並確保一致的品質、成本效益和法規遵循。連續生物加工為簡化生物製藥生產提供了一種有前途的方法,但其實施在規模、臨床和商業業務存在很大差異。
最終用戶:連續生物加工在 CDMO 中的作用非常重要,它優先考慮彈性和增強向客戶提供的服務。
學術和研究機構通常專注於連續生物加工的基礎科學和概念驗證研究。這些機構透過進行創新研究並經常與產業合作夥伴合作,在推動技術進步方面發揮著至關重要的作用。受託製造廠商描述了向製藥和生物技術公司外包開發和製造服務。它們是藥品供應鏈不可或缺的一部分,擴大採用連續生物加工來實現產品差異化並提高成本效率。製藥和生物技術公司是推動連續生物製程商業性實施的主要最終用戶。另一方面,學術和研究機構透過出版物、專利和熟練專業人員的培訓為連續生物加工做出貢獻。與研究機構不同,CDMO 投資於可擴展且適應性強的技術,可以支援多種產品和流程,從而為客戶最佳化上市時間。與學術機構和 CDMO 不同,製藥和生物技術公司既進行內部產品開發又進行商業生產。
區域洞察
在美洲地區,對生物製造創新的濃厚興趣、對生物技術領域的大量投資以及鼓勵先進製造技術的法規環境正在推動連續生物加工的採用。隨著主要製藥公司和生物風險公司尋求更高效、更具成本效益和可擴展的製造程序,連續生物加工代表了一種競爭優勢。此外,強大的技術基礎設施和熟練勞動力的存在正在促進美洲從傳統批量工藝向連續方法的轉變。此外,在歐洲、中東和非洲,高昂的營運成本和嚴格的監管標準導致公司採用連續生物製程來降低成本並提高生技藥品的品質。歐洲製藥業以注重創新和永續性而聞名,這反映在快速成長的生物相似藥市場。此外,中東和非洲也開始採用此類流程。由於對生物製藥的需求不斷成長以及藥品生產能力本地化的努力,連續生物加工預計將在該地區成長。在亞太地區,由於生物製藥行業的快速擴張和全球競爭的需要,連續生物加工的採用正在迅速增加。越來越多的患者需要高品質的生技藥品,生物技術公司不斷增加投資,並支持政府旨在提高生物製造能力的措施。一些國家對實施連續流程以加快藥物開發和製造時間表、減少製造足跡並節省成本,同時遵守國際品質標準表現出了濃厚的興趣。
FPNV定位矩陣
FPNV定位矩陣對於評估連續生物加工市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限。最前線 (F)、探路者 (P)、利基 (N) 和重要 (V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對連續生物加工市場中供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該細分市場競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、碎片化主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:包括新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:包括對未來技術、研發活動和突破性產品開發的見解。
1.連續生物加工市場的市場規模與預測是多少?
2. 在連續生物加工市場的預測期內,我們應該考慮投資哪些產品和應用?
3.連續生物加工市場的技術趨勢和法規結構是什麼?
4.連續生物加工市場主要供應商的市場佔有率為何?
5. 進入連續生物加工市場的適當型態和策略手段是什麼?
[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?