市場調查報告書
商品編碼
1378937
2023-2028 年按產品、應用、最終用途和地區分類的病毒過濾市場報告Virus Filtration Market Report by Product, Application, End Use, and Region 2023-2028 |
2022年全球病毒過濾市場規模達39億美元。展望未來, IMARC Group預計到2028年市場規模將達到69億美元,2022-2028年複合年成長率(CAGR)為10.0%。全球健康危機的發生率不斷上升,在緊張的工期內大規模生產生物製藥的需求不斷成長,以及對新藥、療法和疫苗開發的投資不斷增加,是推動市場成長的關鍵因素。
病毒過濾是生物製藥生產過程中的關鍵步驟,旨在確保疫苗、抗體和生物製劑等醫藥產品的安全性和純度。此方法用於去除可能對人類健康有害的病毒污染物。它對於直接進入體內的腸外藥物的生產尤其重要,因此需要高純度標準。通常,使用具有特定孔徑的專用薄膜過濾器來捕獲和去除病毒。這些過濾器旨在允許所需產品通過,同時有效捕捉病毒顆粒。該流程在實施前經過嚴格驗證,並定期進行測試以確認其有效性。此外,它還可以作為藥品生產的強大保障,提高產品安全性和符合法規要求。
全球市場主要受到流行病和廣泛病毒爆發等全球健康危機不斷升級的推動。這凸顯了這種過濾技術對於確保醫療用品和藥品安全的重要性。在此期間,對疫苗和其他治療劑的需求呈指數級成長。這項需求使得生物製藥必須在緊迫的時間內進行大規模生產,同時又不影響安全性。因此,這對市場有正面影響。除此之外,生物製藥產業合約製造組織(CMO)的興起是促進市場成長的另一個重要因素。此外,對新藥物、療法和疫苗開發的投資不斷增加,這些投資本質上需要這些流程來確保安全性和合規性,這也極大地支持了市場。
對生物製藥的需求不斷增加
病毒過濾產業的重要市場驅動力之一是對單株抗體、重組蛋白和疫苗等生物製藥的需求不斷成長。這些複雜的分子通常源自活細胞,使它們容易受到病毒污染。同時,癌症、糖尿病和自體免疫疾病等慢性疾病盛行率的上升正在影響市場。需求的成長給製造商帶來了生產符合嚴格安全和品質標準的生物製藥的負擔。在這種情況下,病毒過濾成為不可或缺的步驟,因為它對於確保這些產品的純度和安全性至關重要。監管機構正在製定嚴格的病毒清除指南,進一步強調了這些技術的重要性。隨著越來越多的生物製藥進入市場或進行臨床試驗,對病毒過濾服務的需求也隨之加速,從而推動產業向前發展。
技術和研究的不斷進步
過濾膜和方法領域的技術進步正在顯著影響病毒過濾產業的成長。同時,更有效率、可擴展且更具成本效益的過濾系統的開發使製藥公司更容易將這些解決方案整合到其現有的生產線中。奈米技術和材料科學的創新使過濾器具有更高的效率和更好的吞吐能力,從而能夠更快速、更可靠地去除病毒。隨著過濾技術的研究和開發工作不斷進行,該領域的公司正在增加該技術的採用。這項技術進步提高了藥品製造的水平,並為全球市場提供了強大的市場驅動力。
更加重視法規遵從性和品質保證
遵守監管標準是病毒過濾產業的要求和市場驅動力。各機構對生物源醫藥產品的病毒安全性有具體的指導方針。這些指南通常需要採取多個步驟來清除病毒,包括病毒過濾。滿足這些監管期望對於製藥公司獲得產品批准和維持市場信譽至關重要。考慮到病毒污染帶來的可怕後果,從產品上市延遲到法律責任,對監管合規性的重視成為採用病毒過濾技術的強制力量。此外,該行業受益於對品質保證的高度關注,使其成為生物製藥製造價值鏈的重要組成部分。
IMARC Group提供了全球病毒過濾市場報告各細分市場主要趨勢的分析,以及 2023-2028 年全球、區域和國家層面的預測。我們的報告根據產品、應用和最終用途對市場進行了分類。
耗材
試劑盒和試劑
其他
儀器
過濾系統
色譜系統
服務
耗材佔據最大市場佔有率
該報告根據產品提供了詳細的市場細分和分析。這包括消耗品(試劑盒和試劑等)、儀器(過濾系統、色譜系統)和服務。報告顯示,消耗品佔據了最大的市場佔有率。
由於製藥過程中對過濾耗材(例如膜、濾芯和盒)的反覆需求,病毒過濾行業的耗材市場正在經歷大幅成長。與生命週期長的資本設備不同,消耗品在單一製造週期中使用,需要頻繁更換,以確保需求的一致性。此外,擴大採用一次性技術,特別是在生物加工領域,增加了對一次性過濾耗材的需求,這些耗材被認為更方便且不易發生交叉污染。此外,監管機構不斷收緊生物製藥產品病毒安全指南,這反過來又需要使用符合這些嚴格標準的高品質消耗品。此外,疫苗和療法的不斷開發和製造,特別是在包括流行病在內的全球健康危機期間,大大增加了這些一次性產品的消費。
生物製品
疫苗和治療方法
血液和血液製品
細胞和基因療法產品
其他
醫療設備
淨水
空氣淨化
其他
生物製品佔據大部分市場佔有率
報告還提供了基於應用程式的詳細市場細分和分析。這包括生物製品(疫苗和治療藥物、血液和血液製品、細胞和基因治療產品等)、醫療器材、水淨化、空氣淨化等。報告稱,生物製品佔據最大的市場佔有率。
生物製品領域是推動市場的關鍵應用領域,這主要是由於對單株抗體、疫苗和基因療法等生物療法產品的需求不斷成長。這些複雜的分子是在活細胞中產生的,使它們容易受到病毒污染,因此需要強大的過濾過程。同時,對生物製品安全性的監管審查也在加強,各機構要求採取嚴格的病毒清除措施。這些監管要求強制執行嚴格的品質控制,推動先進的病毒過濾技術在生物領域的採用。此外,癌症、糖尿病和自體免疫疾病等慢性疾病的盛行率不斷上升,也增加了對生物治療的需求。此外,製藥公司正在提高生產能力並實施最先進的過濾方法,以滿足消費者需求和監管要求。
生物製藥和生物技術公司
合約研究組織
學術機構與研究實驗室
其他
生物製藥和生物技術公司佔據最大的市場佔有率
該報告根據最終用途提供了詳細的市場細分和分析。這包括生物製藥和生物技術公司、合約研究組織、學術機構和研究實驗室等。報告顯示,生物製藥和生技公司佔據了最大的市場。
對生物製藥的需求不斷成長和生物技術公司的快速成長是病毒過濾行業的關鍵市場驅動力。這些實體處於開發複雜生物產品(如單株抗體、疫苗和重組蛋白)的最前沿,這些產品本質上容易受到病毒污染。此外,確保產品安全性和有效性的必要條件是科學必要性和監管要求。同時,組織正在製定嚴格的指導方針,要求應用強大的病毒過濾流程來確保品質。隨著生物製藥在治療從慢性病到疫情相關疾病等一系列疾病中變得越來越重要,對有效病毒過濾的需求也隨之成長。此外,CRISPR和基因療法等生物技術的進步進一步擴大了生物產品的範圍和複雜性,從而增強了對先進病毒過濾解決方案的必要性。
北美洲
美國
加拿大
亞太
中國
日本
印度
韓國
澳洲
印尼
其他
歐洲
德國
法國
英國
義大利
西班牙
俄羅斯
其他
拉丁美洲
巴西
墨西哥
其他
中東和非洲
北美表現出明顯的主導地位,佔據最大的病毒過濾市場佔有率
市場研究報告還對所有主要區域市場進行了全面分析,其中包括北美(美國和加拿大);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);歐洲(德國、法國、英國、義大利、西班牙、俄羅斯等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。報告稱,北美地區佔最大佔有率。
在有利的產業擴張環境的推動下,北美市場正在經歷顯著成長。主要促進因素之一是全球生物製藥公司和先進研究機構在該地區的強勁存在,這需要高品質的病毒過濾解決方案來確保產品安全。同時,各機構制定的監管框架正在執行嚴格的病毒清除指南,從而提高了對高效過濾技術的需求。此外,北美一直是生物技術進步的先驅,為新療法、疫苗和其他需要病毒過濾的生物產品的開發做出了貢獻。
除此之外,該地區醫療保健研發投資的大幅成長,進一步推動了市場的成長。全球健康危機(例如流行病)的發生通常會導致疫苗和治療藥物生產迅速擴大,從而大大增加對可靠病毒過濾系統的需求。所有這些因素匯聚在一起,使北美成為病毒過濾技術的強大市場,推動了該行業的創新和採用。
主要參與者不斷致力於開發更有效率、更可靠的過濾技術。這包括過濾膜、過濾系統和一次性技術的創新,以便為客戶提供更好的解決方案。除此之外,各大公司都提供滿足或超過這些法規的產品和服務,通常為其客戶提供強大的驗證支援。此外,公司正在建立策略合作夥伴關係或收購,以擴大其地理範圍和產品組合。除此之外,有些品牌在其產品的同時也提供諮詢服務,以幫助客戶最佳化其過濾流程,這是另一個促進成長的因素。隨著人們對環境責任的日益關注,一些公司正在探索和開發更永續的過濾技術,例如可重複使用或可回收的過濾組件。
旭化成醫療株式會社
查爾斯河實驗室公司
清潔細胞
丹納赫公司
默克公司
賽多利斯公司
賽默飛世爾科技公司
2023 年 3 月,Charles River Laboratories Inc. 宣布發布其現成的 pHelper 解決方案,該解決方案旨在加快並確保基於 AAV 的基因治療項目從研究早期階段到商業生產的供應。
2022年2月,旭化成醫療株式會社宣佈在日本宮崎延岡市新建組裝工廠,以提高PlanovaTM過濾器的產能。
2021 年 9 月,Clean Cells 宣布投資 1,300 萬歐元(1,530 萬美元)投資新建 Montaigu-Vendee 製造廠。該組織由醫療保健投資公司 ArchiMed 支持,希望透過將生物製藥的分析和生產能力提高四倍,在加快 COVID-19 創新藥物和疫苗的開發和上市時間方面發揮重要作用。
The global virus filtration market size reached US$ 3.9 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 6.9 Billion by 2028, exhibiting a growth rate (CAGR) of 10.0% during 2022-2028. The rising occurrences of global health crises, the growing need for mass production of biopharmaceuticals under tight schedules, and the growing investments in the development of new medicines, therapies, and vaccines are among the key factors driving the market growth.
Virus filtration is a critical step in the biopharmaceutical manufacturing process aimed at ensuring the safety and purity of medicinal products, including vaccines, antibodies, and biologics. This method is employed to remove viral contaminants that could be harmful to human health. It is especially essential in the production of parenteral medications, which are introduced directly into the body and thus require high purity standards. Typically, specialized membrane filters with defined pore sizes are used to capture and remove viruses. These filters are designed to allow the passage of the desired product while effectively trapping viral particles. The process is rigorously validated before implementation, and periodic testing is performed to confirm its effectiveness. Furthermore, it serves as a robust safeguard in pharmaceutical manufacturing, enhancing product safety and compliance with regulatory requirements.
The global market is majorly driven by the escalating occurrence of global health crises such as pandemics and widespread viral outbreaks. This highlights the importance of this filtration technique to ensure the safety of medical supplies and pharmaceuticals. During such times, there is an exponential increase in the demand for vaccines and other therapeutic agents. This demand necessitates the mass production of biopharmaceuticals under tight schedules, without compromising on safety. Therefore, this is positively influencing the market. Along with this, the rise of contract manufacturing organizations (CMOs) in the biopharmaceutical industry is another significant factor contributing to the growth of the market. In addition, the escalating investments in the development of new medicines, therapies, and vaccines, which inherently require these processes for safety and compliance are also significantly supporting the market.
Increasing demand for biopharmaceuticals
One of the significant market drivers for the virus filtration industry is the growing demand for biopharmaceuticals such as monoclonal antibodies, recombinant proteins, and vaccines. These complex molecules are often derived from living cells, making them susceptible to viral contamination. Along with this, the rising prevalence of chronic diseases, including cancer, diabetes, and autoimmune disorders is impacting the market. This increase in demand places a burden on manufacturers to produce biopharmaceuticals that meet stringent safety and quality criteria. Virus filtration becomes an indispensable step in this scenario, as it is crucial for ensuring the purity and safety of these products. Regulatory bodies are imposing strict guidelines for viral clearance, further emphasizing the importance of these technologies. As more biopharmaceuticals enter the market or undergo clinical trials, the need for virus filtration services is accelerating correspondingly, thereby driving the industry forward.
Continual advancements in technology and research
Technological advancements in the field of filtration membranes and methods are significantly impacting the growth of the virus filtration industry. Along with this, the development of more efficient, scalable, and cost-effective filtration systems is making it easier for pharmaceutical companies to integrate these solutions into their existing production lines. Innovations in nanotechnology and material science are leading to filters with higher efficacy and better throughput capabilities, thus enabling more rapid and reliable virus removal. As research and development efforts continue in filtration technology, companies operating in this domain are increasing the adoption of the technology. This technological progress elevates the standard of pharmaceutical manufacturing and serves as a strong market driver for the global market.
An enhanced focus on regulatory compliance and quality assurance
Compliance with regulatory standards is a requirement and a market driver for the virus filtration industry. Agencies have specific guidelines about the viral safety of biologically-derived medicinal products. These guidelines often necessitate multiple steps for viral clearance, including virus filtration. Meeting these regulatory expectations is paramount for pharmaceutical companies to obtain product approvals and maintain market credibility. Given the dire consequences of viral contamination, ranging from delayed product launches to legal liabilities, the emphasis on regulatory compliance acts as a compelling force for the adoption of virus filtration technologies. Moreover, the industry benefits from this heightened focus on quality assurance, making it an essential component in the biopharmaceutical manufacturing value chain.
IMARC Group provides an analysis of the key trends in each segment of the global virus filtration market report, along with forecasts at the global, regional, and country levels from 2023-2028. Our report has categorized the market based on product, application, and end use.
Consumables
Kits and Reagents
Others
Instruments
Filtration Systems
Chromatography Systems
Services
Consumables hold the largest market share
The report has provided a detailed breakup and analysis of the market based on the product. This includes consumables (kits and reagents, and others), instruments (filtration systems, chromatography systems), and services. According to the report, consumables accounted for the largest market share.
The market for consumables in the virus filtration industry is experiencing substantial growth, driven by the recurring need for filtration consumables, such as membranes, cartridges, and cassettes in the pharmaceutical manufacturing process. Unlike capital equipment that has a long lifecycle, consumables are used in a single manufacturing cycle and need frequent replacement, ensuring a consistent demand. Furthermore, the increasing adoption of single-use technologies, particularly in bioprocessing, amplifies the need for disposable filtration consumables, which are viewed as more convenient and less prone to cross-contamination. In addition, regulatory bodies are continually tightening the guidelines for viral safety in biopharmaceutical products, which, in turn, necessitates the use of high-quality consumables that meet these stringent standards. Moreover, the growing development and manufacturing of vaccines and therapies, especially during global health crises, including pandemics, drastically increase the consumption of these disposable products.
Biologicals
Vaccines and Therapeutics
Blood and Blood Products
Cellular and Gene Therapy Products
Others
Medical Devices
Water Purification
Air Purification
Others
Biologicals account for the majority of the market share
A detailed breakup and analysis of the market based on the application has also been provided in the report. This includes biologicals (vaccines and therapeutics, blood and blood products, cellular and gene therapy products, and others), medical devices, water purification, air purification, and others. According to the report, biologicals accounted for the largest market share.
The biologicals segment is a key application area driving the market, primarily due to the rising demand for biotherapeutic products, such as monoclonal antibodies, vaccines, and gene therapies. These complex molecules are produced in living cells, making them vulnerable to viral contamination, thereby necessitating robust filtration processes. Along with this, regulatory scrutiny over the safety of biological products is intensifying, with agencies mandating rigorous viral clearance steps. These regulatory imperatives enforce stringent quality controls, propelling the adoption of advanced virus filtration technologies in the biologicals domain. In addition, the increasing prevalence of chronic diseases such as cancer, diabetes, and autoimmune conditions has also amplified the need for biotherapeutic treatments. Moreover, pharmaceutical companies are ramping up their production capacities and implementing state-of-the-art filtration methods to meet both consumer demand and regulatory requirements.
Biopharmaceuticals and Biotechnology Companies
Contract Research Organizations
Academic Institutes and Research Laboratories
Others
Biopharmaceuticals and biotechnology companies hold the largest market share
The report has provided a detailed breakup and analysis of the market based on the end use. This includes biopharmaceuticals and biotechnology companies, contract research organizations, academic institutes and research laboratories, and others. According to the report, biopharmaceuticals and biotechnology companies accounted for the largest market share.
The escalating demand for biopharmaceuticals and the rapid growth of biotechnology companies serve as pivotal market drivers in the virus filtration industry. These entities are at the forefront of developing complex biological products such as monoclonal antibodies, vaccines, and recombinant proteins, which are inherently susceptible to viral contamination. Additionally, the imperative for ensuring product safety and efficacy is a scientific necessity and a regulatory mandate. In confluence with this, organizations are setting stringent guidelines that require the application of robust virus filtration processes for quality assurance. As biopharmaceuticals become increasingly central in treating a range of diseases, from chronic conditions to pandemic-related illnesses, the need for effective virus filtration grows proportionally. Furthermore, advancements in biotechnology, such as CRISPR and gene therapy, have further extended the scope and complexity of bioproducts, subsequently amplifying the necessity for advanced virus filtration solutions.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance, accounting for the largest virus filtration market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest segment.
The market in North America is experiencing significant growth, propelled by a favorable environment for industry expansion. One of the leading drivers is the robust presence of global biopharmaceutical companies and advanced research institutions in the region, which necessitates high-quality virus filtration solutions for product safety. Along with this, regulatory frameworks set by agencies are enforcing stringent guidelines on viral clearance, thereby elevating the demand for efficient filtration technologies. In addition, North America has been a pioneer in biotechnological advancements, contributing to the development of new therapies, vaccines, and other bioproducts that require virus filtration.
Besides this, considerable growth in the investment in healthcare research and development is substantial in this region, further fueling the growth of the market. The occurrence of global health crises, such as pandemics, often leads to a rapid scale-up in vaccine and therapeutic production, dramatically increasing the need for reliable virus filtration systems. All these elements converge to make North America a strong market for virus filtration technologies, driving both innovation and adoption in the industry.
The key players are continually working on developing more efficient and reliable filtration technologies. This includes innovations in filter membranes, filtration systems, and single-use technologies to provide better solutions to clients. Along with this, the major companies are offering products and services that meet or exceed these regulations, often providing robust validation support for their customers. In addition, companies are entering into strategic partnerships or acquisitions to expand their geographical reach and product portfolio. Apart from this, several brands are offering consultancy services alongside their products to help customers optimize their filtration processes, which is acting as another growth-inducing factor. With an increasing focus on environmental responsibility, some companies are exploring and developing more sustainable filtration technologies, such as reusable or recyclable filter components.
Asahi Kasei Medical Co. Ltd.
Charles River Laboratories Inc.
Clean Cells
Danaher Corporation
Merck KGaA
Sartorius AG
Thermo Fisher Scientific Inc.
In March 2023, Charles River Laboratories Inc. announced the release of its off-the-shelf pHelper solution, which is intended to expedite and assure supplies for AAV-based gene therapy programs from the early stages of research to commercial manufacture.
In February 2022, Asahi Kasei Medical Co. Ltd. announced to build of a new assembly factory in Nobeoka, Miyazaki, Japan in order to increase the production capacity of PlanovaTM filters.
In September 2021, Clean Cells announced a €13 million ($15.3 million) investment in a new Montaigu-Vendee manufacturing facility. The organization supported by healthcare investment firm ArchiMed wants to play a significant part in accelerating the development and time-to-market of innovative medicines and vaccines for COVID-19 by quadrupling its analytical and production capacity for biopharmaceuticals.