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市場調查報告書

商品編碼

1624419

一次性生物反應器市場規模（按地區、範圍和預測）

Single-use Bioreactors Market Size By Product, By Cell, By Molecule, By End-User, By Geographic Scope And Forecast

出版日期: 2024年09月26日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

一次性生物反應器的市場規模及預測

2023 年一次性生物反應器市場規模價值為 43.7 億美元，預計到 2031 年將達到 179 億美元，2024 年至 2031 年的複合年增長率為 19.26%。一次性生物反應器市場是指生物加工產業的一個部分，專注於開發、製造和利用用於各種生物製藥和生物技術應用的一次性生物反應器系統。這些系統旨在為細胞生長、發酵和蛋白質表現等細胞培養過程提供高效、經濟的解決方案，同時最大限度地減少對傳統不銹鋼生物反應器的需求。

一次性生物反應器的全球市場動態

主要市場驅動因子

對生物製劑的需求不斷增加：

全球對治療和管理各種慢性疾病有效的生物製劑和生物相似藥的需求激增是一次性生物反應器市場的主要驅動力。這些反應器為生物製劑製造提供了一種經濟高效、多功能且更快捷的解決方案，以滿足日益增長的醫藥產品需求。

成本效益高，降低污染風險：

一次性生物反應器減少了對先進無菌技術的需求和交叉污染的風險，這對於製藥生產至關重要。它的一次性特性減少了清潔、維護和停機成本，使其成為組織經濟可行的選擇。

靈活性和可擴充性：

一次性生物反應器不需要大規模的資本投入，並且用途廣泛，可以適應從中試到商業生產的廣泛生產規模，這推動了它們的應用。這種適應性滿足了生物製藥研發的動態需求，實現了快速的營運擴展，並加速了產品上市。

技術進步與監管支援：

生物反應器設計、材料和感測器技術的不斷發展正在提高生物過程的效率和控制。監管機構批准一次性系統用於臨床和商業製造，確保符合行業標準，從而促進市場成長。

主要問題：

廢棄物管理與環境問題：

一次性生物反應器的處理會因產生塑膠廢棄物而造成嚴重的環境問題。這些廢棄物很難得到負責任的管理，並且會抑制市場需求，因為它與製藥和生物技術行業對環境永續性的日益關注相衝突。

規模限制：

一次性生物反應器在某些生產規模下具有靈活性和成本效益，但在大規模生物製造方面具有局限性。由於需要較大的容量，一次性系統變得不切實際，並限制其在大容量生物過程中的使用。

材料相容性與可萃取物：

一次性生物反應器中使用的材料必須與多種生物過程相容，並且不會與產品產生不利的相互作用。可能污染生物製劑的可浸出物和可萃取物對維持產品純度和安全性構成了重大障礙，限制了該行業的擴張。

主要趨勢：

擴展到細胞和基因治療：

隨著細胞和基因療法成為主流治療方法，一次性生物反應器在細胞和基因療法生產中的應用越來越多。它的高適應性和低污染風險使其成為這些藥物所需的精確和敏感的製造過程的理想選擇。

我們對永續發展的承諾：

出於對環境問題的考慮，創建更永續的一次性生物反應器系統的運動日益增多。這些努力包括回收舊材料、減少一次性物品的碳足跡、開發可生物降解或環保的替代品以減少對環境的影響。

客製化和可擴充性解決方案：

開發人員專注於提供客製化解決方案，以滿足您獨特的製造需求，從小規模研發到大規模商業生產。這種可自訂和可擴展的一次性生物反應器設定的趨勢滿足了生物製藥公司的不同需求並實現了廣泛的應用。

Single-use Bioreactors Market size was valued at USD 4.37 Billion in 2023 and is projected to reach USD 17.9 Billion by 2031, growing at a CAGR of 19.26% from 2024 to 2031. The Single-use Bioreactors Market refers to the segment within the bioprocessing industry that focuses on the development, manufacturing, and utilization of single-use bioreactor systems for various biopharmaceutical and biotechnology applications. These systems are designed to provide efficient and cost-effective solutions for cell culture processes, including cell growth, fermentation, and protein expression, while minimizing the need for traditional stainless steel bioreactors.

Global Single-Use Bioreactors Market Dynamics

The key market dynamics that are shaping the single-use bioreactors market include:

Key Market Drivers

Increasing Demand for Biologics:

The global spike in demand for biologics and biosimilars, which are effective in treating and managing a variety of chronic diseases, is a major driver of the single-use bioreactors market. These reactors provide a cost-effective, versatile, and speedier solution for biologics manufacturing, meeting the growing need for medicinal pharmaceuticals.

Cost Efficiency and Lower Contamination Risks:

Single-use bioreactors decrease the need for sophisticated sterilization techniques and the risk of cross-contamination, which is critical in pharmaceutical manufacturing. Their disposability results in cost savings on cleaning, maintenance, and downtime, making them an economically viable option for organizations.

Flexibility and Scalability:

The versatility of single-use bioreactors to various production sizes, from pilot to commercial, without requiring major capital investment, drives their application. This adaptability meets the dynamic needs of biopharmaceutical research and development, enabling quick scaling of operations and propelling market growth.

Technological Advancements and Regulatory Support:

Continuous developments in bioreactor design, materials, and sensor technology improve bioprocess efficiency and control. The approval of single-use systems for clinical and commercial manufacturing by regulatory organizations contributing to market growth by assuring compliance with industry standards.

Key Challenges:

Waste Management and Environmental Concerns:

The disposability of single-use bioreactors presents serious environmental problems due to the production of plastic trash. This waste is difficult to manage responsibly because it contradicts the pharmaceutical and biotech industries' growing emphasis on environmental sustainability, inhibiting the market demand.

Limitations in Scale:

While single-use bioreactors are flexible and cost-effective for particular scales of production, they have limitations when it comes to large-scale biomanufacturing. The requirement for bigger volumes makes single-use systems less practicable, potentially limiting their use in high-volume biologic processes.

Material Compatibility and Leachables:

The materials used in single-use bioreactors must be suitable with a wide range of bioprocesses and have no unfavorable interactions with the product. The concerning leachables and extractables that could contaminate biologic goods present significant hurdles to maintaining product purity and safety, limiting industry expansion.

Key Trends:

Expansion into Cell and Gene Therapies:

Single-use bioreactors are being used more and more in the manufacturing of cell and gene therapies as they become mainstream medical treatments. Their adaptability and low contamination risk make them perfect for the precise and sensitive manufacturing processes required by these medicines.

Sustainability Initiatives:

In response to environmental concerns, there is a rising movement to create more sustainable single-use bioreactor systems. This involves attempts to recycle used materials, minimize the carbon footprint of disposables, and develop biodegradable or eco-friendly alternatives that aim to lessen environmental effects.

Customization and Scalability Solutions:

Manufacturers are focusing on delivering customized solutions that meet unique manufacturing requirements, ranging from small-scale research and development to large-scale commercial production. This trend towards customizable and scalable single-use bioreactor setups meets the different needs of biopharmaceutical firms, enabling a wide range of applications.

Global Single-use Bioreactors Market Regional Analysis

Here is a more detailed regional analysis of the single-use bioreactors Market:

North America:

According to Verified Market Research, North America is estimated to dominate in single-use bioreactors market over the forecast period. North America, particularly the United States, has a thriving and advanced biopharmaceutical industry that leads in biologics and vaccine production. This industry's strength provides a sizable client base for single-use bioreactors, promoting their usage in flexible, cost-effective, and efficient biomanufacturing processes.

The region's strong investment in R&D, which is supported by both the commercial and public sectors, drives innovation in bioprocessing technology. This investment promotes the use of single-use bioreactors, which are essential for the development and production of next-generation biopharmaceuticals.

The strict regulatory framework in North America, which focuses on product safety and manufacturing efficiency, promotes the usage of single-use bioreactors. These systems provide advantages in terms of compliance, reduced contamination risk, and scalability, while also meeting regulatory agencies' quality assurance standards for pharmaceutical manufacturing.

Furthermore, North America has been at the forefront of introducing new technology into biomanufacturing, such as single-use bioreactors. The region's openness to embrace innovation promotes operational efficiencies, shorter production timelines, and cheaper prices, cementing its dominance in the global market for single-use bioreactors.

Asia Pacific:

The biopharmaceutical industry in the Asia Pacific is growing quickly, fueled by a rise in investments in biotech startups and the regional growth of multinational pharmaceutical corporations. This expansion increases demand for single-use bioreactors, which provide flexibility and efficiency in biologics production.

Many nations in the Asia Pacific are enacting supporting laws and providing funds to grow their biotech industry. Government attempts to improve healthcare infrastructure, promote R&D, and attract foreign investment all contribute to the growing need for single-use bioreactors.

Furthermore, the region's huge and ageing population, combined with expanding healthcare awareness and expenditure, is driving up demand for biopharmaceuticals. Single-use bioreactors, which are essential for the quick manufacture of vaccines and biologics, are increasingly being used to address these healthcare demands efficiently.

Europe:

Europe is experiencing tremendous investment in biopharmaceutical research and development from both the public and private sectors. This funding promotes innovation in bioprocessing technologies, such as single-use bioreactors, thereby facilitating their application in the development and manufacturing of improved medicinal solutions.

European regulatory organizations have backed innovative manufacturing technologies that promise to improve product quality and safety. This regulatory environment pushes pharmaceutical companies to deploy single-use bioreactor systems, which increase sterility and reduce contamination risk while adhering to regulatory requirements.

Furthermore, the increased emphasis on sustainability and decreasing environmental footprints in European manufacturing promotes the usage of single-use bioreactors. Despite waste concerns, the overall environmental impact is offset through lower energy and water consumption, which is consistent with the region's sustainability goals.

Global Single-Use Bioreactors Market Segmentation Analysis

The Single-use Bioreactors Market is segmented based on Product, Cell, Molecule, End-User, And Geography.

Single-use Bioreactors Market, By Product

Bioreactor Systems
Media Bags
Filtration Assemblies
Others

Based on Product, the market is segmented into Bioreactor Systems, Media Bags, Filtration Assemblies and Others. The bioreactor systems segment is estimated to dominate the single-use bioreactors market due to the critical role that these systems play in cell culture and biopharmaceutical synthesis. Single-use bioreactor systems provide substantial benefits, such as reduced contamination risk, lower initial investment, and shorter batch turnaround times, which are especially useful in the fast-paced pharmaceutical and biotech sectors. Their scalability and flexibility make them appropriate for a wide range of applications, from small-scale R&D to large-scale commercial manufacturing.

Single-use Bioreactors Market, By Cell

Mammalian Cell
Bacteria
Yeast
Others

Based on Cell, the market is segmented into Mammalian Cells, Bacteria, Yeast and Others. The mammalian cell segment is estimated to dominate the single-use bioreactors market due to the important role mammalian cells play in the synthesis of complex biologics such as monoclonal antibodies, vaccines, and recombinant proteins. These cells are critical for expressing proteins with appropriate folding, assembly, and post-translational modifications, which are required for therapeutic efficacy and safety.

Single-use Bioreactors Market, By Molecule

Vaccines
Monoclonal Antibodies
Stem Cells
Recombinant Proteins
Others

Based on Molecule, the market is segmented into Vaccines, Monoclonal Antibodies, Stem Cells, Recombinant Proteins and Others. The vaccines segment is estimated to dominate the single-use bioreactors market owing to the global emphasis on immunization programmes and the rapid development of vaccines, as evidenced by the urgent manufacture of the COVID-19 vaccine. Single-use bioreactors provide significant benefits for vaccine production, including increased flexibility in scaling operations, a lower risk of cross-contamination, and faster turnaround times for vaccine development and manufacturing.

Single-use Bioreactors Market, By End-User

Pharmaceutical & Biopharmaceutical Industries
Contract Research Organizations (CRO)
Others

Based on End-User, the market is divided into Pharmaceutical & Biopharmaceutical Industries, Contract Research Organizations (CROs) and Others. The pharmaceutical & biopharmaceutical industries segment is estimated to dominate the market over the forecast period. This dominance is due to the substantial role these industries play in biopharmaceutical research, development, and manufacture, which includes vaccines, monoclonal antibodies, and other biologics. The rising frequency of chronic diseases and the desire for personalized medicine have contributed to an increase in the use of single-use bioreactors.

Single-use Bioreactors Market, By Geography

North America
Europe
Asia Pacific
Rest of the world

Based on Geography, the single-use bioreactors market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America is expected to dominate the single-use bioreactors market during the forecast period. North America, particularly the United States, has a highly developed biopharmaceutical sector that is at the forefront of biologics and vaccine invention and production worldwide. This thriving industry generates enormous demand for single-use bioreactors, which are critical for the efficient and adaptable manufacturing procedures required by modern biopharmaceutical production.

Key Players

The "Single-use Bioreactors Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
Thermo Fisher Scientific, Merck KGaA, Danaher Corporation, Sartorius Stedim Biotech, GE Healthcare, Eppendorf AG, Inovenio, MilliporeSigma, XCell Biotek, PBS Biotech, HYCON Bruggemann GmbH, Dolomite Bio, Applikon Biotechnology, Boehringer Ingelheim, Lonza Group Ltd and Samsung Biologics.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Single-use Bioreactors Market Recent Developments
In November 2022, Sartorius AG, a major participant in the region from Germany, announced plans to broaden its operations. To better meet the needs of the biopharmaceutical industry, this expansion comprises the establishment of new R&D laboratories as well as the implementation of equipment automation and digitization.
In November 2022, Danaher Corporation's subsidiary Cytiva invested roughly USD 8 million to expand its Fast Trak centre in Shanghai, China. The expansion seeks to promote the adoption of single-use technologies (SUT) in the region and facilitate the industry's transition to single-use bioprocessing solutions.