バイオプロセス検証の世界市場予測（～2024年）...市場調査レポートについてご紹介

1 Introduction (Page No. – 19)
1.1 Objectives of the Study
1.2 Market Definition
1.3 Market Scope
1.3.1 Markets Covered
1.3.2 Years Considered for the Study
1.4 Currency
1.5 Limitations
1.6 Stakeholders
2 Research Methodology (Page No. – 23)
2.1 Research Data
2.1.1 Secondary Data
2.1.1.1 Key Data From Secondary Sources
2.1.2 Primary Data
2.1.2.1 Key Data From Primary Sources
2.1.2.2 Key Industry Insights
2.2 Market Size Estimation
2.3 Market Breakdown and Data Triangulation
2.4 Assumptions for the Study
3 Executive Summary (Page No. – 33)
4 Premium Insights (Page No. – 38)
4.1 Bioprocess Validation Services: Market Overview
4.2 Asia Pacific: Bioprocess Validation Services Market, By End User (2018)
4.3 Geographical Snapshot of the Market
4.4 Regional Mix: Market
4.5 Bioprocess Validation Market: Developing vs Developed Countries
5 Market Overview (Page No. – 42)
5.1 Introduction
5.2 Market Dynamics: Impact Analysis
5.2.1 Drivers
5.2.1.1 Stringent Safety and Quality Regulations
5.2.1.2 Increasing Demand for Biopharmaceuticals
5.2.1.3 Increasing Demand for Outsourcing Bioprocess Validation
5.2.1.4 Rising Life Science R&D Expenditure
5.2.2 Restraints
5.2.2.1 Issues Related to Extractables & Leachables
5.2.3 Opportunities
5.2.3.1 Growth Opportunities in Asia Pacific and Latin American Countries
5.2.3.2 Patent Expiry
5.2.4 Challenges
5.2.4.1 Waste Disposal
5.2.4.2 Development of New Validation Methods for Next Generation Bioproducts
6 Industry Insights (Page No. – 48)
6.1 Industry Trends
6.1.1 Automation in Bioprocess Validation Services
6.1.2 Geographic Expansions By Market Players
6.2 Regulatory Guidelines for Bioprocess Validation
7 Bioprocess Validation Market, By Test Type (Page No. – 51)
7.1 Introduction
7.2 Extractables/Leachables Testing Services
7.2.1 Specifications and Guidelines for Extractables/ Leachables Testing have Ensured the Continued Demand for These Services
7.3 Microbiological Testing Services
7.3.1 Large-Scale Eukaryotic Cell Culture Testing Services
7.3.1.1 North America Shows the Highest Demand for Large-Scale Eukaryotic Cell Culture Testing Services
7.3.2 Virus Production & Purification Testing Services
7.3.2.1 Increased Concerns of Viral Contaminant Presence in Raw Materials are Driving the Adoption of Testing Services
7.3.3 Electron Microscopy Testing Services
7.3.3.1 Electron Microscopy Provides High-Resolution Images of Specimens Present in Bioprocesses
7.4 Physiochemical Testing Services
7.4.1 Need for Detection and Characterization of Impurities in the Final Product is Driving Market Growth
7.5 Integrity Testing Services
7.5.1 Integrity Testing is Vital to Detect Wear and Tear and Pressure-Caused Damage
7.6 Compatibility Testing Services
7.6.1 Demand for Evaluating Process Component-Formulation Interaction has Necessitated Compatibility Testing
7.7 Other Testing Services
8 Bioprocess Validation Market, By Process Component (Page No. – 66)
8.1 Introduction
8.2 Filter Elements
8.2.1 Stringent Regulations for Biopharmaceutical Products are Driving the Growth of This Segment
8.3 Media Containers and Bags
8.3.1 Validation and Qualification of Media Containers and Bags is Necessary to Maintain the Safety of the Final Biopharmaceutical Product
8.4 Freezing and Thawing Process Bags
8.4.1 The High Risk of Seal Leaks in the Pre-Freezing and Thawing Stage is Driving Market Growth
8.5 Mixing Systems
8.5.1 Growing Need to Meet FDA and Other Regulatory Guidelines During the Mixing of Ingredients to Maintain Product Quality is A Key Driver
8.6 Bioreactors
8.6.1 Biopharmaceutical Companies are Increasingly Adopting Bioprocess Validation Services for Bioreactors to Lower the Risk of Cross-Contamination
8.7 Transfer Systems
8.7.1 The Necessity to Maintain Sterile Conditions During Transfer is Driving the Market
8.8 Other Process Component
9 Bioprocess Validation Market, By End User (Page No. – 77)
9.1 Introduction
9.2 Pharmaceutical Companies
9.2.1 Increasing Production Volume has Enabled Pharma Companies to Dominate the End-User Market
9.3 Contract Development & Manufacturing Organizations
9.3.1 Emerging Countries have Become Key Hubs for the Outsourcing of Production and Validation Processes
9.4 Biotechnology Companies
9.4.1 Need for Regulatory Compliance has Driven the Demand for Bioprocess Validation in Biotech Companies
9.5 Other End Users
10 Bioprocess Validation Market, By Region (Page No. – 85)
10.1 Introduction
10.2 North America
10.2.1 US
10.2.1.1 US Dominated the North American Bioprocess Validation Market in 2018
10.2.2 Canada
10.2.2.1 Growing Investments in the Canadian Biopharmaceuticals Sector to Support Market Growth During the Forecast Period
10.3 Europe
10.3.1 Germany
10.3.1.1 Germany Accounted for the Largest Share of the European Bioprocess Validation Market in 2018
10.3.2 France
10.3.2.1 High Demand for Biologics and Implementation of Favorable Government Initiatives to Drive the Demand for Bioprocess Validation Services in France
10.3.3 UK
10.3.3.1 Growing Demand for Outsourcing Compliance-Related Testing Services in Biopharmaceutical Production to Support Market Growth in the UK
10.3.4 Italy
10.3.4.1 Growing Biopharmaceutical Manufacturing to Drive the Adoption of Bioprocess Validation Services in Italy
10.3.5 Spain
10.3.5.1 High Consumption of Biologics to Support the Growth of The Bioprocess Validation Market in Spain
10.3.6 Rest of Europe
10.4 Asia Pacific
10.4.1 China
10.4.1.1 China is One of the Most-Preferred Destinations for Leading Biopharmaceutical Companies for Biologics Production
10.4.2 Japan
10.4.2.1 Japan is One of the Largest and Most Established Markets for Pharmaceutical Products in the Asia Pacific
10.4.3 India
10.4.3.1 Rising Volume of Biopharmaceutical Production to Drive Market Growth in India
10.4.4 Rest of Asia Pacific
10.5 Latin America
10.5.1 Brazil
10.5.1.1 Growing Investments in Biopharmaceutical Research to Drive Market Growth in Brazil
10.5.2 Mexico
10.5.2.1 Strong Presence of Global Pharmaceutical Companies in the Country to Support Market Growth
10.5.3 Rest of Latin America
10.6 Middle East & Africa
11 Competitive Landscape (Page No. – 149)
11.1 Overview
11.2 Market Share Analysis
11.3 Competitive Leadership Mapping, 2018
11.4 Vendor Inclusion Criteria
11.5 Vendor Dive
11.5.1 Visionary Leaders
11.5.2 Innovators
11.5.3 Emerging Companies
11.5.4 Dynamic Differentiators
11.6 Competitive Situations and Trends
11.6.1 Acquisitions
11.6.2 Collaborations, Partnerships, and Agreements
11.6.3 Service Launches
11.7 Service Portfolio Analysis
11.7.1 Service Portfolio Analysis
12 Company Profiles (Page No. – 162)
(Business Overview, Services Offered, Recent Developments, MnM View, SWOT Analysis)*
12.1 Merck KGaA
12.2 Pall Corporation (A Part of Danaher Corporation)
12.3 Sartorius Stedim Biotech S.A.
12.4 SGS S.A.
12.5 Eurofins Scientific
12.6 Cobetter Filtration Equipment Co., Ltd.
12.7 Toxikon Corporation
12.8 Doc S.R.L.
12.9 Meissner Filtration Products, Inc.
12.10 Thermo Fisher Scientific, Inc.
12.11 Additional Company Profiles
12.11.1 Porvair PLC
12.11.2 Biozeen
12.11.3 Tianshan (Ts Filter) Precision Filter Material Co., Ltd.
12.11.4 Hangzhou Anow Microfiltration Co., Ltd.
12.11.5 Almac Group
*Business Overview, Services Offered, Recent Developments, MnM View, SWOT Analysis Might Not Be Captured in Case of Unlisted Companies.
13 Appendix (Page No. – 186)
13.1 Insights of Industry Experts
13.2 Discussion Guide
13.3 Knowledge Store: Marketsandmarkets’ Subscription Portal
13.4 Available Customizations
13.5 Related Reports
13.6 Author Details