医薬品ろ過の世界市場規模：製品別、用途別、技術別、地域別、範囲および予測

医薬品ろ過の市場規模と予測

医薬品ろ過の市場規模は、2024年に266億9,000万米ドルと評価され、2024年から2031年にかけて10.49%のCAGRで成長し、2031年には552億1,000万米ドルに達すると予測されています。医薬品ろ過は、医薬品製造の重要なステップです。液体や気体をフィルターに通して、望ましくない粒子や微生物、その他の汚染物質を除去します。コーヒーフィルターを使って、コーヒーカップにコーヒーのカスが入らないようにすることを考えてみてほしいです。この方法は、完成品が純粋で安全であり、患者にとって有益であることを保証します。これらの溶液は、ワクチンやモノクローナル抗体を含む生物製剤の製造に使用されます。これらの製品は頻繁に汚染されやすく、高い純度が要求されます。ろ過は、生物製剤の安全性と有効性を確保するために、ウイルスやその他の細菌を除去するのに役立ちます。ろ過はまた、医薬品合成に必要な成分である原料や中間体の調製にも使用されます。

将来の医療において重要な役割を果たす可能性が高いです。医薬品分野の拡大と革新に伴い、効果的なろ過方法はますます重要になってきています。ろ過は、患者の安全性と治療効果に不可欠な薬剤の純度を保証します。個々の患者に合わせた治療を行うオーダーメード医療が普及するにつれて、ろ過方法はより正確である必要があります。

医薬品ろ過の世界市場力学

世界の医薬品ろ過市場を形成している主な市場力学

主な市場促進要因

医薬品生産の増加

医薬品セクターは、世界の医薬品需要の高まりを受けて急速に拡大しています。人口の増加と高齢化に伴い、さまざまな健康問題で医薬品を必要とする人が増えています。このような医薬品生産の増加には、効果的で信頼性の高いろ過技術の使用が必要です。製薬企業は、製品の純度と安全性を維持するための新しいろ過技術への投資を含め、この需要を満たすために製造能力を増強しています。

厳しい規制要件：

医薬品は、米国のFDA（食品医薬品局）や欧州のEMA（欧州医薬品庁）などの機関が定めた厳しい規制基準を遵守しなければなりません。これらの法律は、医薬品の安全性、有効性、品質を保証するものです。ろ過は、医薬品製剤から細菌、ウイルス、粒子状物質、およびその他の汚染物質を除去するのに役立つため、これらの基準を満たすための重要な側面です。

ろ過技術の進歩

ろ過技術の向上により、医薬品ろ過の効率と効果は大幅に改善されました。最新のろ過システムは、より高い精度、拡張性、信頼性を提供します。膜ろ過、深層ろ過、ナノろ過はすべて、この分野に変革をもたらした技術革新の一例です。

主な課題

無菌性の確保：

フィルターが医薬品からすべてのバクテリア、ウイルス、その他の細菌を確実に除去することは重要な問題です。フィルターは非常に小さくなければならないが、小さな不純物も捕捉できる信頼性が必要です。細菌が残っていると、病気の原因になったり、薬の効き目が弱まったりする可能性があるため、これは極めて重要です。製造業者は、フィルターが正しく作動するよう定期的に監視とテストを行わなければならないが、これには時間とコストがかかります。

製品の完全性の維持：

フィルターは、薬そのものにダメージを与えることなく汚染物質を除去しなければならないです。フィルターによっては、医薬品と相互作用してその組成を変えたり、有効性を低下させたりするものもあります。例えば、ある種のケミカルフィルターは、薬剤中の活性成分を除去したり変化させたりする可能性があります。その結果、最終製品の安全性と有効性が損なわれる可能性があります。そのため、特定の医薬品に適合する適切なタイプのフィルターを選択することが重要だが、難しいです。

製造のスケールアップ：

ラボスケールからフルスケール製造への移行には、緻密な計画が必要です。均一性を維持するためには、ろ過装置を拡張可能にし、工程を標準化する必要があります。このため、品質を犠牲にすることなく、より多くの量を管理できるシステムを構築するために、エンジニアリングの専門家との協力がしばしば必要となります。本格的な生産に先立ち、潜在的な懸念事項を特定するためのパイロット試験が頻繁に行われます。

主要動向：

高度なろ過技術

製薬セクターが進化するにつれ、ろ過に利用される技術も進化しています。深層ろ過や膜ろ過のような伝統的な技術は、より近代的なアプローチによって補完され、場合によっては置き換えられています。例えば、シングルユースのフィルター装置が一般的になってきています。

規制遵守と品質保証：

医薬品は人の健康に直接影響を与えるため、FDA（食品医薬品局）やEMA（欧州医薬品庁）などの規制当局は、製品の安全性と有効性を保証するために厳しい基準を設けています。この動向は、ろ過プロセス全体を通じてこれらの要件に従う必要性を浮き彫りにしています。

持続可能性と環境への影響：

環境への関心が高まるにつれ、製薬業界は環境への影響を低減する必要に迫られています。この動向は、より持続可能なろ過方法の開発と実施を後押ししています。例えば、企業はリサイクル可能な素材や生分解性素材を採用することで、ろ過工程で発生するゴミを減らす方法を検討しています。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主な調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 医薬品ろ過市場：製品別

• メンブレンフィルター
• フィルターホルダー
• ろ過アクセサリー
• その他

第5章 医薬品ろ過市場：用途別

• 最終製品加工
• 原料ろ過
• 細胞分離
• 浄水
• 空気ろ過
• その他

第6章 医薬品ろ過市場：技術別

• 精密ろ過
• 限外ろ過
• ナノろ過
• 逆浸透
• その他

第7章 地域分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第8章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第9章 競合情勢

• 主要企業
• 市場シェア分析

第10章 企業プロファイル

• Merck KGaA（Germany）
• Danaher Corporation（US）
• Sartorius AG（Germany）
• Thermo Fisher Scientific Inc.（US）
• 3M Company（US）
• Eaton Corporation PLC（US）
• Parker Hannifin Corporation（US）
• Donaldson Company Inc.（US）
• Alfa Laval Corporate AB（Sweden）
• Repligen Corporation（US）
• Porvair PLC（UK）
• Corning Incorporated（US）
• Meissner Filtration Products Inc.（US）

第11章 市場の展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第12章 付録

• 略語リスト
• 出典と参考文献

Pharmaceutical Filtration Market Size And Forecast

Pharmaceutical Filtration Market size was valued at USD 26.69 Billion in 2024 and is projected to reach USD 55.21 Billion by 2031, growing at a CAGR of 10.49% from 2024 to 2031. Pharmaceutical filtration is an important step in the manufacture of pharmaceuticals. It entails passing liquid or gas through a filter to remove undesirable particles, microorganisms, and other contaminants. Consider using a coffee filter to keep coffee grounds out of your cup but on a much more intricate and exact level. This method assures that the finished product is pure, safe, and beneficial to patients. These solutions are used to manufacture biologics including vaccines and monoclonal antibodies. These items are frequently prone to contamination and require a high degree of purity. Filtration helps to remove viruses and other germs ensuring that biologics are safe and effective. Filtration is also used to prepare raw materials and intermediates both of which are necessary components in medication synthesis.

It is likely to play an important role in the future of medicine. As the pharmaceutical sector expands and innovates, effective filtration methods become increasingly crucial. Filtration ensures drug purity which is critical for patient safety and therapeutic efficacy. Filtration methods will need to be more accurate as customized medicine which tailors treatments to individual patients becomes more prevalent.

Global Pharmaceutical Filtration Market Dynamics

The key market dynamics that are shaping the global pharmaceutical filtration market include:

Key Market Drivers:

Increasing Drug Production

: The pharmaceutical sector is expanding fast in response to rising global demand for drugs. As populations increase and age, more people need drugs for a variety of health issues. This increase in medication production necessitates the use of effective and dependable filtration technologies. Pharmaceutical businesses are increasing their manufacturing capacity to satisfy this demand including investments in new filtration technologies to maintain product purity and safety.

Stringent Regulatory Requirements:

Pharmaceutical products must adhere to stringent regulatory criteria established by organizations such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe. These laws ensure that pharmaceuticals are safe, effective, and high-quality. Filtration is an important aspect of meeting these criteria since it helps eliminate germs, viruses, particulate matter, and other contaminants from medicine formulations.

Advancements in Filtration Technology:

Filtering technology improvements have considerably improved the efficiency and effectiveness of pharmaceutical filtering. Modern filtering systems provide greater precision, scalability, and reliability. Membrane filtration, depth filtration, and nanofiltration are all examples of innovations that have transformed the sector.

Key Challenges:

Ensuring Sterility:

Ensure that filters eliminate all bacteria, viruses, and other germs from pharmaceutical items is a significant problem. Filters must be extremely tiny but yet dependable to capture even the smallest impurities. This is crucial since any lingering bacteria can lead to illnesses or diminish the medication's effectiveness. Manufacturers must regularly monitor and test the filters to ensure their correct operation which can be time-consuming and costly.

Maintaining Product Integrity:

Filters must eliminate pollutants without damaging the drug itself. Some filters may interact with the medications altering their composition or decreasing their effectiveness. For example, certain chemical filters may remove or change active components in the drug. This may jeopardize the safety and efficacy of the final product. As a result, selecting the appropriate type of filter that is compatible with the specific medicinal substance is critical but difficult.

Scaling Up Manufacturing:

The transition from lab-scale to full-scale manufacturing requires precise planning. To maintain uniformity, filtration equipment must be scalable and processes standardized. This frequently necessitates collaboration with engineering professionals to create systems that can manage higher quantities without sacrificing quality. Before full-scale production, pilot studies are frequently done to identify potential concerns.

Key Trends:

Advanced Filtration Technology

: As the pharmaceutical sector evolves, so does the technology utilized for filtration. Traditional technologies such as depth filtration and membrane filtration are being supplemented and in some cases replaced by more modern approaches. For example, single-use filtering devices are becoming more common.

Regulatory Compliance and Quality Assurance:

Pharmaceutical products have a direct impact on human health, hence regulatory authorities such as the FDA (Food and Drug Administration) and the EMA (European Medicines Agency) enforce tight criteria to assure product safety and efficacy. This trend highlights the need to follow these requirements throughout the filtration process.

Sustainability and Environmental Impact:

As environmental concerns develop, the pharmaceutical business faces pressure to lessen its environmental footprint. This trend is driving the development and implementation of more sustainable filtering practices. For example, companies are looking into ways to reduce trash generated during the filtration process by employing recyclable or biodegradable materials.

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Global Pharmaceutical Filtration Market Regional Analysis

Here is a more detailed regional analysis of the global pharmaceutical filtration market:

North America:

The United States dominates the North American pharmaceutical filtration market, accounting for the majority of regional revenue and growth. Canada and Mexico also make substantial contributions to the market's growth. Several factors have contributed to the substantial expansion of North America's pharmaceutical filtering market. According to the United States Food and Medicine Administration (FDA), the number of new medicine approvals has gradually increased with 53 in 2020 and 50 in 2021. This trend suggests an increase in demand for pharmaceutical filtration goods and technology. According to the Centers for Disease Control and Prevention (CDC), chronic diseases cause seven out of ten fatalities in the United States each year necessitating the use of modern drugs.

The US Department of Health and Human Services invested more than $10 billion in Operation Warp Speed to facilitate speedy vaccine development and production. This endeavor enhanced the demand for filtering technologies in vaccine manufacturing processes. Furthermore, the National Institutes of Health (NIH) estimated a $41.7 billion budget for medical research in fiscal year 2020 with a substantial amount going toward drug discovery and development initiatives. The Canadian government recently pledged CAD 1 billion to the COVID-19 Response Fund which would help vaccine research and production efforts. These investments have strengthened the pharmaceutical filtration sector in North America.

Asia Pacific:

The Asia-Pacific region is predicted to be the fastest-growing pharmaceutical filtration market in the future years. This increase is primarily driven by the rapid expansion of the biopharmaceutical industry, rising healthcare spending, and rising demand for high-quality pharmaceutical products in countries such as China, India, and Japan.

The pharmaceutical sector in Asia Pacific has been rapidly expanding with a special emphasis on biopharmaceuticals. According to the International Trade Administration, China's pharmaceutical market was worth USD 134.4 Billion in 2018 and is expected to reach USD 161.8 Billion by 2023 expanding at a compound annual growth rate (CAGR) of 3.8%. Similarly, the Indian Brand Equity Foundation estimates that India's pharmaceutical business will be worth USD 100 Billion by 2025.

The pharmaceutical filtration industry is also growing as the region places a greater emphasis on quality control and regulatory compliance. According to the World Health Organization, countries in the Asia Pacific region are enacting stronger laws and quality standards for pharmaceutical manufacture. For example, China's National Medical Products Administration (NMPA) has been attempting to harmonize its regulatory system with international standards while India's Central Drugs Standard Control Organization (CDSCO) has increased control of pharmaceutical production processes.

Global Pharmaceutical Filtration Market: Segmentation Analysis

The Global Pharmaceutical Filtration Market is segmented based on Product, Application, Technology, and Geography.

Pharmaceutical Filtration Market, By Product

• Membrane Filters
• Filter Holders
• Filtration Accessories
• Others

Based on the Product, the Global Pharmaceutical Filtration Market is bifurcated into Membrane Filters, Filter Holders, Filtration Accessories, and Others. In the global pharmaceutical filtration market, membrane filters are the dominant product. Membrane filters are crucial for their high efficiency in removing contaminants such as bacteria, particulates, and unwanted proteins from pharmaceutical products. Their ability to provide sterile filtration is essential for ensuring the safety and efficacy of drugs. Additionally, membrane filters are versatile and used in various applications like sterilizing liquids and gases, and different stages of pharmaceutical production.

Pharmaceutical Filtration Market, By Application

• Final Product Processing
• Raw Material Filtration
• Cell Separation
• Water Purification
• Air Filtration
• Others

Based on Application, the Global Pharmaceutical Filtration Market is bifurcated into Final Product Processing, Raw Material Filtration, Cell Separation, Water Purification, Air Filtration, and Others. In the global pharmaceutical filtration market, final product processing stands out as dominant due to its critical role in ensuring the purity and safety of pharmaceutical products. Final product processing involves the filtration of finished medicines to remove contaminants and ensure compliance with regulatory standards. This stage is vital for maintaining product quality and efficacy directly impacting patient safety. Raw material filtration also holds significant importance ensuring that starting materials are free from impurities that could affect the final product. However, final product processing takes precedence due to its direct impact on the end-user and the stringent regulatory scrutiny applied to finished pharmaceuticals.

Pharmaceutical Filtration Market, By Technology

• Microfiltration
• Ultrafiltration
• Nanofiltration
• Reverse Osmosis
• Others

Based on the Technology, the Global Pharmaceutical Filtration Market is bifurcated into Microfiltration, Ultrafiltration, Nanofiltration, Reverse Osmosis, and Others. In the global pharmaceutical filtration market, microfiltration stands out as a dominant technology. Microfiltration is widely preferred due to its versatility in removing particulate matter, bacteria, and other contaminants while allowing the passage of desirable molecules like proteins and enzymes. This capability is crucial in pharmaceutical manufacturing to ensure product purity and safety. Ultrafiltration follows closely, particularly in biopharmaceutical applications for its ability to separate and concentrate proteins and other biomolecules based on size.

Pharmaceutical Filtration Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World

Based on Geography, the Global Pharmaceutical Filtration Market is classified into North America, Europe, Asia Pacific, and the Rest of the World. In the global pharmaceutical filtration market, North America is emerging as the dominant region. North America leads due to its advanced pharmaceutical manufacturing capabilities, stringent regulatory standards, and substantial investment in research and development. The region hosts several major pharmaceutical companies and has a robust infrastructure supporting innovative filtration technologies. In contrast, Asia Pacific and the Rest of the World regions show potential growth opportunities driven by increasing healthcare expenditure expanding pharmaceutical industries, and rising investments in infrastructure and technology. Overall, North America's dominance in the pharmaceutical filtration market is underpinned by its technological ability, regulatory adherence, and market maturity.

Key Players

• The "Global Pharmaceutical Filtration Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Merck KGaA, Danaher Corporation, Sartorius AG, Thermo Fisher Scientific, Inc., 3M Company, Eaton Corporation PLC, Parker Hannifin Corporation, Donaldson Company, Inc., Alfa Laval Corporate AB, Repligen Corporation, Porvair PLC, Corning Incorporated, Meissner Filtration Products, Inc.

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.

Global Pharmaceutical Filtration Market Key Developments

• In June 2024, Cytiva announced its Supor Prime sterilizing grade filters for high-concentration biologic pharmaceuticals to help medication producers increase yields, reduce blockages, and reduce costs.
• In April 2024, Asahi Kasei introduced a membrane system for creating WFI (water for injection), a type of sterile water used in injection preparation. The membrane system was designed and developed using MicrozaTM hollow-fiber membrane for liquid product filtering and water purification.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Pharmaceutical Filtration Market, By Product

• Membrane Filters
• Filter Holders
• Filtration Accessories
• Others

5. Pharmaceutical Filtration Market, By Application

• Final Product Processing
• Raw Material Filtration
• Cell Separation
• Water Purification
• Air Filtration
• Others

6. Pharmaceutical Filtration Market, By Technology

• Microfiltration
• Ultrafiltration
• Nanofiltration
• Reverse Osmosis
• Others

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Merck KGaA (Germany)
• Danaher Corporation (US)
• Sartorius AG (Germany)
• Thermo Fisher Scientific Inc. (US)
• 3M Company (US)
• Eaton Corporation PLC (US)
• Parker Hannifin Corporation (US)
• Donaldson Company Inc. (US)
• Alfa Laval Corporate AB (Sweden)
• Repligen Corporation (US)
• Porvair PLC (UK)
• Corning Incorporated (US)
• Meissner Filtration Products Inc. (US)

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References