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市場調査レポート
商品コード
1541120
ウイルスろ過市場レポート:製品、用途、最終用途、地域別、2024年~2032年Virus Filtration Market Report by Product, Application, End Use, and Region 2024-2032 |
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カスタマイズ可能
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ウイルスろ過市場レポート:製品、用途、最終用途、地域別、2024年~2032年 |
出版日: 2024年08月10日
発行: IMARC
ページ情報: 英文 146 Pages
納期: 2~3営業日
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世界のウイルスろ過市場規模は2023年に43億米ドルに達しました。今後、IMARC Groupは、2024年から2032年にかけての成長率(CAGR)は8.5%を示し、2032年には92億米ドルに達すると予測しています。世界の健康危機の勃発、タイトなスケジュールでのバイオ医薬品大量生産の必要性の高まり、新薬・治療薬・ワクチン開発への投資の拡大などが、市場成長を促進する主な要因となっています。
ウイルスろ過は、ワクチン、抗体、生物製剤などの医薬品の安全性と純度を確保することを目的としたバイオ医薬品製造プロセスにおける重要なステップです。この方法は、人体に有害な可能性のあるウイルス汚染物質を除去するために採用されます。特に、体内に直接導入されるため高い純度基準が要求される非経口薬の製造には不可欠です。通常、ウイルスを捕捉・除去するためには、孔径が規定された特殊なメンブレンフィルターが使用されます。これらのフィルターは、ウイルス粒子を効果的に捕捉しながら、目的の製品の通過を可能にするように設計されています。このプロセスは、実施前に厳密に検証され、その有効性を確認するために定期的なテストが実施されます。さらに、医薬品製造における強固なセーフガードとして機能し、製品の安全性と規制要件への準拠を強化します。
世界市場は、パンデミックや広範なウイルスの発生など、世界の健康危機の発生がエスカレートしていることが主な要因となっています。このことは、医療用品や医薬品の安全性を確保するためのろ過技術の重要性を浮き彫りにしています。このような時期には、ワクチンやその他の治療薬の需要が急激に増加します。この需要により、安全性を損なうことなく、タイトなスケジュールでバイオ医薬品を大量生産する必要があります。そのため、これは市場にプラスの影響を与えています。これとともに、バイオ医薬品業界における製造受託機関(CMO)の台頭も、市場の成長に大きく寄与しています。さらに、新薬、治療薬、ワクチンの開発への投資が急増しており、安全性とコンプライアンスのためにこれらのプロセスが本質的に必要とされていることも、市場を大きく支えています。
バイオ医薬品需要の増加
ウイルスろ過業界にとって重要な市場促進要因の1つは、モノクローナル抗体、組み換えタンパク質、ワクチンなどのバイオ医薬品に対する需要の高まりです。これらの複雑な分子はしばしば生きた細胞に由来するため、ウイルス汚染の影響を受けやすいです。これとともに、がん、糖尿病、自己免疫疾患などの慢性疾患の有病率の上昇が市場に影響を与えています。このような需要の増加は、厳しい安全性と品質基準を満たすバイオ医薬品を製造するメーカーに負担を強いています。ウイルスろ過は、こうした製品の純度と安全性を確保するために極めて重要であるため、このシナリオでは不可欠なステップとなります。規制機関はウイルスクリアランスに厳格なガイドラインを課しており、こうした技術の重要性をさらに強調しています。より多くのバイオ医薬品が市場に参入したり、臨床試験を受けたりするにつれて、ウイルスろ過サービスのニーズはそれに応じて加速しており、それによって業界が前進しています。
技術と研究の絶え間ない進歩
ろ過膜やろ過方法の分野における技術の進歩は、ウイルスろ過業界の成長に大きな影響を与えています。これに伴い、より効率的でスケーラブルかつ費用対効果の高いろ過システムの開発により、製薬会社はこれらのソリューションを既存の生産ラインに組み込むことが容易になっています。ナノテクノロジーと材料科学の革新は、より高い有効性と優れた処理能力を持つフィルターにつながり、その結果、より迅速で信頼性の高いウイルス除去を可能にしています。ろ過技術の研究開発が進むにつれ、この分野で事業を展開する企業は技術の採用を増やしています。この技術進歩は医薬品製造の水準を高め、世界市場の強力な市場促進要因となっています。
規制遵守と品質保証への重点化
規制基準の遵守は、ウイルス濾過業界の要件であり市場促進要因です。当局は生物学的製剤のウイルス安全性に関する特定のガイドラインを定めています。これらのガイドラインは、ウイルスろ過を含むウイルスクリアランスのための複数のステップを必要とすることが多いです。製薬企業が製品承認を取得し、市場の信頼性を維持するためには、これらの規制上の期待に応えることが最も重要です。製品上市の遅れから法的責任に至るまで、ウイルス汚染による悲惨な結果を考えると、規制遵守の重視は、ウイルスろ過技術の採用に対する説得力として作用します。さらに、このように品質保証が重視されることで、業界は利益を得ており、バイオ医薬品製造のバリューチェーンにおいて不可欠な要素となっています。
The global virus filtration market size reached US$ 4.3 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 9.2 Billion by 2032, exhibiting a growth rate (CAGR) of 8.5% during 2024-2032. 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 2024-2032. 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.