CHAPTER 1: INTRODUCTION
1.1. Report description
1.2. Key market segments
1.3. Key benefits to the stakeholders
1.4. Research methodology
1.4.1. Primary research
1.4.2. Secondary research
1.4.3. Analyst tools and models
CHAPTER 2: EXECUTIVE SUMMARY
2.1. CXO Perspective
CHAPTER 3: MARKET OVERVIEW
3.1. Market definition and scope
3.2. Key findings
3.2.1. Top impacting factors
3.2.2. Top investment pockets
3.3. Porter’s five forces analysis
3.3.1. Low bargaining power of suppliers
3.3.2. Low threat of new entrants
3.3.3. Low threat of substitutes
3.3.4. Low intensity of rivalry
3.3.5. Low bargaining power of buyers
3.4. Market dynamics
3.4.1. Drivers
3.4.2. Restraints
3.4.3. Opportunities
CHAPTER 4: PYROGEN TESTING MARKET, BY PRODUCT AND SERVICE
4.1. Overview
4.1.1. Market size and forecast
4.2. Reagents and Kits
4.2.1. Key market trends, growth factors and opportunities
4.2.2. Market size and forecast, by region
4.2.3. Market share analysis by country
4.3. Instruments
4.3.1. Key market trends, growth factors and opportunities
4.3.2. Market size and forecast, by region
4.3.3. Market share analysis by country
4.4. Services
4.4.1. Key market trends, growth factors and opportunities
4.4.2. Market size and forecast, by region
4.4.3. Market share analysis by country
CHAPTER 5: PYROGEN TESTING MARKET, BY TEST TYPE
5.1. Overview
5.1.1. Market size and forecast
5.2. LAL Test
5.2.1. Key market trends, growth factors and opportunities
5.2.2. Market size and forecast, by region
5.2.3. Market share analysis by country
5.3. Rabbit Pyrogen Test
5.3.1. Key market trends, growth factors and opportunities
5.3.2. Market size and forecast, by region
5.3.3. Market share analysis by country
5.4. Others
5.4.1. Key market trends, growth factors and opportunities
5.4.2. Market size and forecast, by region
5.4.3. Market share analysis by country
CHAPTER 6: PYROGEN TESTING MARKET, BY END USER
6.1. Overview
6.1.1. Market size and forecast
6.2. Pharmaceutical and Biotechnology Companies
6.2.1. Key market trends, growth factors and opportunities
6.2.2. Market size and forecast, by region
6.2.3. Market share analysis by country
6.3. Medical Device Companies
6.3.1. Key market trends, growth factors and opportunities
6.3.2. Market size and forecast, by region
6.3.3. Market share analysis by country
6.4. Others
6.4.1. Key market trends, growth factors and opportunities
6.4.2. Market size and forecast, by region
6.4.3. Market share analysis by country
CHAPTER 7: PYROGEN TESTING MARKET, BY REGION
7.1. Overview
7.1.1. Market size and forecast By Region
7.2. North America
7.2.1. Key market trends, growth factors and opportunities
7.2.2. Market size and forecast, by Product and Service
7.2.3. Market size and forecast, by Test Type
7.2.4. Market size and forecast, by End User
7.2.5. Market size and forecast, by country
7.2.5.1. U.S.
7.2.5.1.1. Market size and forecast, by Product and Service
7.2.5.1.2. Market size and forecast, by Test Type
7.2.5.1.3. Market size and forecast, by End User
7.2.5.2. Canada
7.2.5.2.1. Market size and forecast, by Product and Service
7.2.5.2.2. Market size and forecast, by Test Type
7.2.5.2.3. Market size and forecast, by End User
7.2.5.3. Mexico
7.2.5.3.1. Market size and forecast, by Product and Service
7.2.5.3.2. Market size and forecast, by Test Type
7.2.5.3.3. Market size and forecast, by End User
7.3. Europe
7.3.1. Key market trends, growth factors and opportunities
7.3.2. Market size and forecast, by Product and Service
7.3.3. Market size and forecast, by Test Type
7.3.4. Market size and forecast, by End User
7.3.5. Market size and forecast, by country
7.3.5.1. Germany
7.3.5.1.1. Market size and forecast, by Product and Service
7.3.5.1.2. Market size and forecast, by Test Type
7.3.5.1.3. Market size and forecast, by End User
7.3.5.2. France
7.3.5.2.1. Market size and forecast, by Product and Service
7.3.5.2.2. Market size and forecast, by Test Type
7.3.5.2.3. Market size and forecast, by End User
7.3.5.3. UK
7.3.5.3.1. Market size and forecast, by Product and Service
7.3.5.3.2. Market size and forecast, by Test Type
7.3.5.3.3. Market size and forecast, by End User
7.3.5.4. Italy
7.3.5.4.1. Market size and forecast, by Product and Service
7.3.5.4.2. Market size and forecast, by Test Type
7.3.5.4.3. Market size and forecast, by End User
7.3.5.5. Spain
7.3.5.5.1. Market size and forecast, by Product and Service
7.3.5.5.2. Market size and forecast, by Test Type
7.3.5.5.3. Market size and forecast, by End User
7.3.5.6. Rest of Europe
7.3.5.6.1. Market size and forecast, by Product and Service
7.3.5.6.2. Market size and forecast, by Test Type
7.3.5.6.3. Market size and forecast, by End User
7.4. Asia-Pacific
7.4.1. Key market trends, growth factors and opportunities
7.4.2. Market size and forecast, by Product and Service
7.4.3. Market size and forecast, by Test Type
7.4.4. Market size and forecast, by End User
7.4.5. Market size and forecast, by country
7.4.5.1. Japan
7.4.5.1.1. Market size and forecast, by Product and Service
7.4.5.1.2. Market size and forecast, by Test Type
7.4.5.1.3. Market size and forecast, by End User
7.4.5.2. China
7.4.5.2.1. Market size and forecast, by Product and Service
7.4.5.2.2. Market size and forecast, by Test Type
7.4.5.2.3. Market size and forecast, by End User
7.4.5.3. India
7.4.5.3.1. Market size and forecast, by Product and Service
7.4.5.3.2. Market size and forecast, by Test Type
7.4.5.3.3. Market size and forecast, by End User
7.4.5.4. Australia
7.4.5.4.1. Market size and forecast, by Product and Service
7.4.5.4.2. Market size and forecast, by Test Type
7.4.5.4.3. Market size and forecast, by End User
7.4.5.5. South Korea
7.4.5.5.1. Market size and forecast, by Product and Service
7.4.5.5.2. Market size and forecast, by Test Type
7.4.5.5.3. Market size and forecast, by End User
7.4.5.6. Rest of Asia-Pacific
7.4.5.6.1. Market size and forecast, by Product and Service
7.4.5.6.2. Market size and forecast, by Test Type
7.4.5.6.3. Market size and forecast, by End User
7.5. Latin America
7.5.1. Key market trends, growth factors and opportunities
7.5.2. Market size and forecast, by Product and Service
7.5.3. Market size and forecast, by Test Type
7.5.4. Market size and forecast, by End User
7.5.5. Market size and forecast, by country
7.5.5.1. Brazil
7.5.5.1.1. Market size and forecast, by Product and Service
7.5.5.1.2. Market size and forecast, by Test Type
7.5.5.1.3. Market size and forecast, by End User
7.5.5.2. Colombia
7.5.5.2.1. Market size and forecast, by Product and Service
7.5.5.2.2. Market size and forecast, by Test Type
7.5.5.2.3. Market size and forecast, by End User
7.5.5.3. Argentina
7.5.5.3.1. Market size and forecast, by Product and Service
7.5.5.3.2. Market size and forecast, by Test Type
7.5.5.3.3. Market size and forecast, by End User
7.5.5.4. Rest Of La
7.5.5.4.1. Market size and forecast, by Product and Service
7.5.5.4.2. Market size and forecast, by Test Type
7.5.5.4.3. Market size and forecast, by End User
7.6. Middle East and Africa
7.6.1. Key market trends, growth factors and opportunities
7.6.2. Market size and forecast, by Product and Service
7.6.3. Market size and forecast, by Test Type
7.6.4. Market size and forecast, by End User
7.6.5. Market size and forecast, by country
7.6.5.1. Gcc
7.6.5.1.1. Market size and forecast, by Product and Service
7.6.5.1.2. Market size and forecast, by Test Type
7.6.5.1.3. Market size and forecast, by End User
7.6.5.2. South Africa
7.6.5.2.1. Market size and forecast, by Product and Service
7.6.5.2.2. Market size and forecast, by Test Type
7.6.5.2.3. Market size and forecast, by End User
7.6.5.3. North Africa
7.6.5.3.1. Market size and forecast, by Product and Service
7.6.5.3.2. Market size and forecast, by Test Type
7.6.5.3.3. Market size and forecast, by End User
7.6.5.4. Rest Of Mea
7.6.5.4.1. Market size and forecast, by Product and Service
7.6.5.4.2. Market size and forecast, by Test Type
7.6.5.4.3. Market size and forecast, by End User
CHAPTER 8: COMPETITIVE LANDSCAPE
8.1. Introduction
8.2. Top winning strategies
8.3. Product mapping of top 10 player
8.4. Competitive dashboard
8.5. Competitive heatmap
8.6. Top player positioning, 2022
CHAPTER 9: COMPANY PROFILES
9.1. Lonza Group AG
9.1.1. Company overview
9.1.2. Key executives
9.1.3. Company snapshot
9.1.4. Operating business segments
9.1.5. Product portfolio
9.1.6. Business performance
9.1.7. Key strategic moves and developments
9.2. Thermo Fisher Scientific Inc.
9.2.1. Company overview
9.2.2. Key executives
9.2.3. Company snapshot
9.2.4. Operating business segments
9.2.5. Product portfolio
9.2.6. Business performance
9.2.7. Key strategic moves and developments
9.3. Fujifilm Holdings Corporation
9.3.1. Company overview
9.3.2. Key executives
9.3.3. Company snapshot
9.3.4. Operating business segments
9.3.5. Product portfolio
9.3.6. Business performance
9.3.7. Key strategic moves and developments
9.4. GenScript
9.4.1. Company overview
9.4.2. Key executives
9.4.3. Company snapshot
9.4.4. Operating business segments
9.4.5. Product portfolio
9.4.6. Business performance
9.4.7. Key strategic moves and developments
9.5. SEIKAGAKU CORPORATION
9.5.1. Company overview
9.5.2. Key executives
9.5.3. Company snapshot
9.5.4. Operating business segments
9.5.5. Product portfolio
9.5.6. Business performance
9.5.7. Key strategic moves and developments
9.6. Charles River Laboratories
9.6.1. Company overview
9.6.2. Key executives
9.6.3. Company snapshot
9.6.4. Operating business segments
9.6.5. Product portfolio
9.6.6. Business performance
9.6.7. Key strategic moves and developments
9.7. STERIS plc
9.7.1. Company overview
9.7.2. Key executives
9.7.3. Company snapshot
9.7.4. Operating business segments
9.7.5. Product portfolio
9.7.6. Business performance
9.7.7. Key strategic moves and developments
9.8. Wuxi AppTec
9.8.1. Company overview
9.8.2. Key executives
9.8.3. Company snapshot
9.8.4. Operating business segments
9.8.5. Product portfolio
9.8.6. Business performance
9.8.7. Key strategic moves and developments
9.9. Eurofins Scientific SE
9.9.1. Company overview
9.9.2. Key executives
9.9.3. Company snapshot
9.9.4. Operating business segments
9.9.5. Product portfolio
9.9.6. Business performance
9.9.7. Key strategic moves and developments
9.10. Merck KGaA
9.10.1. Company overview
9.10.2. Key executives
9.10.3. Company snapshot
9.10.4. Operating business segments
9.10.5. Product portfolio
9.10.6. Business performance
9.10.7. Key strategic moves and developments
| ※参考情報 パイロジェン検査は、医療製品や生物製剤において重要な品質管理の一環として実施される検査です。パイロジェンとは、体内に注入されると発熱を引き起こす物質であり、主に細菌やその代謝産物であるエンドトキシンが含まれます。パイロジェン検査は、これらの有害な物質の存在を確認することで、患者への安全性を確保するために行われます。 パイロジェン検査には主に二つの種類があります。一つ目は、ウサギを用いた生物学的検査である「ウサギ発熱試験（Rabbits Pyrogen Test）」です。この検査では、ウサギに検査対象物質を注入し、その後の体温変化を観察します。体温が特定の基準値を超えると、その物質にはパイロジェンが含まれているとみなされます。この方法は、長い歴史を持ち、特に新薬やワクチンなどの開発・製造過程で広く用いられています。 二つ目は、細菌内毒素を特異的に検出する「リムルス試薬によるエンドトキシン試験（LAL試験）」です。リムルス試薬は、バイオルミネセンスを利用した検査方法で、細菌内毒素が存在する場合に特定の反応を示します。LAL試験は、ウサギを使用しないため、動物福祉の観点からも注目されています。また、検査の迅速性や高感度も特徴で、近年ではこの方法が広く採用されています。 これらのパイロジェン検査は、医療分野だけではなく、製薬業界や医療機器メーカーなどにおいても重要な役割を果たしています。特に、注射剤や輸血用製剤、ワクチン、インプラント材料などは、パイロジェンによるリスクが高いため、厳格な検査が求められます。これにより、医療製品の品質を保証し、患者の安全を守ることができます。 関連技術としては、分子生物学的手法や高度な分析機器の導入が進んでいます。PCR（ポリメラーゼ連鎖反応）やマススペクトロメトリー（質量分析法）などの技術が、パイロジェンの検出感度や特異性を向上させるために利用されています。また、これらの技術は、より迅速かつ効率的な検査を可能にし、製品の市場投入時期を短縮することにも寄与しています。 さらに、パイロジェン検査の国際基準も整備されています。国際的なガイドラインや規制に従った検査を実施することで、製品の国際競争力を高めることができます。特に、FDA（米国食品医薬品局）やEMA（欧州医薬品庁）の規制を遵守することは、製薬企業にとって重要な課題となっています。 今後、パイロジェン検査に関する研究はさらに進むことが期待されます。新しい検査方法の開発や、既存の方法の改善により、より高い精度と信頼性を持つパイロジェン検査が実現するでしょう。このような進展は、医療安全の向上や医療製品の品質向上に寄与し、多くの患者にとってメリットとなると考えられます。 総じて、パイロジェン検査は医療製品や生物製剤の安全性を確保するために極めて重要なプロセスであり、その技術や基準の進化は、今後の医療現場においてますます重要性を増していくでしょう。 |
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