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 パイロジェン検査とは、医療機器や生物製剤、医薬品などの製品が体内に入った際に、発熱を引き起こす可能性のある物質、すなわちパイロジェンを検出するための検査です。パイロジェンは、主に細菌やその代謝産物（エンドトキシン）、またはウイルス由来の物質を指し、これらが体内に入ることで免疫系が反応し、発熱が引き起こされることがあります。発熱は体の防御反応の一部であり、重篤な合併症につながる可能性があるため、適切な検査が求められます。 パイロジェン検査には主に三種類の方法があります。最も一般的な方法は、ラビットを用いた生物学的試験です。この方法では、通常、ウサギに試料を注射し、その後の体温変化を測定します。発熱が確認された場合、その試料にはパイロジェンが含まれていると判断されます。 次に、リポポリサッカライド（LPS）を用いた方法があります。LPSは細菌の細胞壁に存在する成分で、強力なパイロジェンとして知られています。この方法では、特定の細胞を用いてLPSに対する反応を観察することにより、試料中のパイロジェンの有無を確認します。 最後に、最近広がりを見せているのが、エンドトキシン検査キットを用いた方法です。特に、ある種の蛍光特性を持つ試薬を使用することで、迅速かつ定量的にエンドトキシンを検出できる方法です。この技術は特に品質管理の現場で広まりつつあります。 パイロジェン検査の用途は多岐にわたります。医薬品の製造においては、注射薬や生物製剤に対する安全性を確保するために必須です。また、医療機器や人工臓器など、体内に取り込まれる可能性がある製品に対しても同様の検査が求められます。これらの検査により、患者が重大な副作用を受けるリスクを減少させることができます。 関連する技術としては、分子生物学や細胞生物学の分野での進展があります。特に、PCR（ポリメラーゼ連鎖反応）技術を用いた検査が有望視されています。この技術を利用することで、特定の病原体やその成分を迅速に特定し、パイロジェンの有無を確認することが可能です。 また、近年ではサンプルの前処理の技術も発展しています。高性能な抽出技術や分離技術により、試料中のパイロジェンを効率よく濃縮し、検出感度を向上させることが可能になっています。これにより、低濃度のパイロジェン試料でも高い感度で検出できるようになっています。 パイロジェン検査は、規制当局によって厳しく管理されており、各国において異なる基準が設けられています。例えば、アメリカ食品医薬品局（FDA）や欧州薬品庁（EMA）などが定めたガイドラインに従い、製品の品質管理を行うことが求められます。これらの機関は、パイロジェン検査の実施方法や結果の解釈に関する詳細な指針を提供しており、製品の安全性確保に大きく貢献しています。 このように、パイロジェン検査は医療分野において極めて重要な役割を果たしており、製品の安全性を確保するためには欠かせない検査手法です。今後も新たな技術の開発や改善が期待される分野であり、より高精度かつ迅速な検査方法の確立が求められています。これにより、さらなる患者の安全と健康を守ることに繋がるでしょう。 |
